Regulations (Preambles to Final Rules) - Table of Contents|
| Record Type:||Occupational Exposure to Bloodborne Pathogens|
| Title:||Section 9 - IX. Summary and Explanation of the Standard|
IX. Summary and Explanation of the Standard
OSHA believes that the requirements set forth in this final standard are those, based on currently available data in the record, which are necessary and appropriate to provide adequate protection to employees exposed to blood and other potentially infectious materials. In the development of this final standard, OSHA has carefully considered the comments and testimony from interested parties given in response to the Proposed Standard and the Advance Notice of Proposed Rulemaking. In addition, numerous reference works, journal articles, and other data, collected by OSHA and others since the initiation of this proceeding have been taken into consideration in the development of this final standard. All of this information is in the rulemaking record.
Paragraph (a) Scope and Application
The standard applies to all occupational exposure to blood and other potentially infectious material as defined in paragraph (b) of this standard. The risk of infection with bloodborne pathogens is dependent on the likelihood of exposure to blood and other potentially infectious materials wherever that exposure occurs. A single exposure incident may result in infection and subsequent illness and in some cases, death. The hazard affects employees in many types of employment and is not restricted to the healthcare industry. By relating coverage to occupational exposure, OSHA hopes to protect all employees at risk regardless of their job title or place of employment.
Blood has long been recognized as a potential source of pathogenic microorganisms that may present a risk to individuals who are exposed during the performance of their duties. In 1983, the CDC published guidelines for controlling infections in hospitals (Ex 6-74). One section, entitled "Blood and Body Fluid Precautions," recommended that certain precautions be taken in handling the blood and body fluids of patients who were known or were suspected of being infected with bloodborne pathogens. Special precautions were recommended to be followed with these patients. The patients were identified using special placards, and their blood specimens were labeled in order to alert employees who had contact with the specimens. Specimens of blood from other patients whose infection status was unknown were collected and analyzed using no special precautions to protect the employee.
Although some patients could be identified as infected with HIV or HBV, allowing employees to be alerted to the increased risks present, it soon became apparent that many individuals infected with these viruses were either undiagnosed or their infection status was not known to the healthcare employee. Patients being treated for unrelated injuries or illnesses, dental patients, trauma victims, and blood donors are all examples of individuals whose infection status may not be known and whose blood may present a risk to the employees who come in contact with it. The possibility of undiagnosed infection combined with the increasing prevalence of HIV and HBV led CDC to recommend that blood and certain other body fluids from all patients be considered potentially infectious and that rigorous infection control precautions be taken to minimize the risk of exposure. This approach is called "Universal Precautions," and the CDC published this recommendation in its August 1987 guidelines (Ex. 6-153). This is the approach taken by OSHA in the final standard.
CDC/NIOSH supported this approach to the scope of the standard when they stated that "protection of workers against reasonably anticipated exposure to blood and other potentially infectious materials is the only practical approach" (CDC/NIOSH, Ex. 20-634). They explained their basis for this support in their comment on the proposed standard.
The scope of the regulation should not be based on employment in one or a few specified industries. OSHA is correct in defining the scope in terms of reasonably anticipated occupational exposure to blood or other potentially infectious material. These exposures occur predominantly but not exclusively in the healthcare industry. Healthcare workers may therefore be most commonly at risk, but it is their blood exposure, not the industry in which they are exposed, that places them at risk. Regardless of the industry in which they may be exposed, all workers with reasonably anticipated occupational exposure to blood or other potentially infectious materials should be included in the scope of this rule. (CDC/NIOSH, Ex. 20-634, p.3)
The recommendations of the Immunization Practices Advisory Committee (ACIP), Protection Against Viral Hepatitis, published by the U.S. Public Health Service in 1990 also support the idea that employees who have blood exposure are at risk and should be protected. Recommendations for those at occupational risk were included as two of the 13 groups recommended for preexposure hepatitis B vaccination. The recommendations state:
Persons at substantial risk of HBV who are demonstrated or judged likely to be susceptible should be vaccinated. They include the following:
1. Persons with occupational risk. HBV is a major infectious occupational hazard for health care and public safety workers. The risk of acquiring HBV infection from occupational exposures is dependent on the frequency of percutaneous and permucosal exposure to blood or blood products. Any health-care or public-safety worker may be at risk for HBV exposure depending on the tasks that he or she performs. If those tasks involve contact with blood or blood-contaminated body fluids, such workers should be vaccinated. Vaccination should be considered for other workers depending on the nature of the task.
Risks among health-care professionals vary during the training and working career of each individual but are often highest during the professional training period. For this reason, when possible, vaccination should be completed during training in schools of medicine, dentistry , nursing, laboratory technology, and other allied health professions before workers have their first contact with blood.
2. Clients and staff of institutions for the developmentally disabled ... Staff who work closely with clients should also be vaccinated. This risk in institutional environments is associated not only with blood exposure but may be consequent to bites and contact with skin lesions and other infective secretions...Susceptible clients and staff who live or work in smaller (group) residential setting with known HBV carriers should also receive hepatitis B vaccine....Staff of nonresidential day-care programs (e.g., schools, sheltered workshops for the developmentally disabled) attended by known HBV carriers have a risk of HBV infection comparable to that among health-care workers and therefore should be vaccinated. (Ex. 286G)
Many of the issues raised by commenters who disagreed with the Agency's approach to the "Scope of the Standard" related to coverage of workplaces where employees provide service to individuals who are not members of groups known to be at increased risk for HIV or HBV infection. OSHA recognizes that certain populations have more members who are infected with HIV or HBV than other populations. A hospital ward dedicated to the care of AIDS patients, for example, would be expected to contain a population that is 100% HIV positive. A group of young male trauma victims entering the emergency room of an urban hospital might reasonably be expected to have a higher percentage of HIV positive individuals than the population as a whole. Conversely, a group of repeat blood or plasma donors would be expected to have a relatively low number of individuals who are HIV positive. However, even populations of volunteer blood donors are not free of infected individuals and considerable efforts are expended to identify and discard units donated by those individuals.
A similar assessment can be made of the risk for HBV. For example, immigrant and refugee populations from areas of high HBV endemicity have a high percentage of members who are hepatitis B surface antigen positive. In other words, they are carriers of the hepatitis B virus. Users of illicit parenteral drugs and household contacts of HBV carriers also have a substantially increased risk of being HBV carriers. Elderly nursing home residents would be expected to have fewer infected individuals, but it is clear that even an elderly population has individuals who are hepatitis B carriers often as the result of infections that occurred earlier in life.
Unlike AIDS, a substantial number of cases of hepatitis B infection have not been associated with a known risk factor. In CDC's Sentinel County Study, the percentage of cases where no known risk factor could be identified averaged 36% for the years 1982 to 1987. The risk factors remained unidentified, despite a thorough effort to pinpoint the source, as described below:
Each patient with viral hepatitis is extensively interviewed for risk factors associated with acquiring the disease. In addition, to determine the actual source of infection for HB patients who have no identifiable source, attempts are made to obtain serum from household and sexual contacts of these patients. (Ex 6-245)
Some commenters contended that blood or other potentially infectious materials present a negligible risk after a few hours. The record contradicts this and contains evidence that the hepatitis B virus can survive for at least one week dried at room temperatures on environmental surfaces (Exs. 6-422; 6-458). Transmission of HBV infection as the result of exposure to contaminated environmental surfaces has been documented to be a major mode of HBV spread in certain settings, particularly hemodialysis units (Exs. 6-56; 6-446; 6-461; 6-480). Likewise, the death of the source individual does not result in the instantaneous inactivation of HIV or HBV that may be present in the individual's blood and body fluids. For example, HIV was recovered at autopsy from a person with AIDS who had died 18 hours earlier (Ex. 286M).
An LPN from rural Pennsylvania addressed another mistaken notion, the belief that people who are infected with HIV are only found in urban areas when she said:
Don't be fooled by the statistics of our rural areas. AIDS patients are counted where they are diagnosed, not where they die. I've had patients from California, New York and Florida come home to die. It is vital that we treat every patient as if he or she has an infectious disease and then take the appropriate precautions. (Ms. Alice Donovan, Ex. 36)
Section 6(b)(5) of the OSH Act instructs the Secretary to promulgate a standard that protects an employee "even if such employee has regular exposure to the hazard dealt with by such standard for the period of his working life." An employee may have occupational exposure to blood or other potentially infectious materials from a large number of source individuals in a working lifetime. For example, the record contains several estimates of the number of hemoglobin determinations and phlebotomies that are performed per hour (for example, Dr. Tom Carson, ARC, Ex. 20-215; DuPage Hospital, Ex. 20-347). The estimates range from 8 to 24 per hour. If we use the lower end of the range with 10 patients per hour, the employee would have occupational exposure to the blood of 17,500 different source individuals per year and 87,500 different source individuals after 5 years [10 per hour X 7 hours X 5 days X 50 weeks X number of years]. The number of occupational exposures over a working lifetime of 45 years would be 787,500 source individuals. A single needlestick contaminated with blood containing HIV gives a risk of infection of 3 to 4 per 1,000. A single needlestick contaminated with blood containing HBV gives a risk of infection of 60 to 300 per 1,000. It is important to note, however, that an employee can become infected as the result of a single exposure incident. Infection does not require multiple exposures.
Both HIV and HBV infections have been reported in rural as well as urban populations and in every state and territory. The fact that the viruses are transmitted sexually and through the sharing of needles by I.V. drug users points to the fact that the viruses may be present in any group. Furthermore, the likelihood that infected individuals will become carriers means that individuals may continue to pose a threat of infection years after the initial infection takes place. In summary, the Agency knows of no population that is free of these infections.
Although OSHA does not intend to present an exhaustive list of job classifications that may be associated with tasks that have occupational exposure to blood and other potentially infectious materials. A brief discussion of some of the environments where occupational exposure may occur follows.
The 1985 CDC guideline recommending HBV vaccination for personnel at risk included these examples of occupational groups having frequent exposure to blood: medical technologists; operating room staff; phlebotomists and intravenous therapy nurses; surgeons and pathologists; oncology and dialysis unit staff; emergency room staff; nursing personnel; and staff physicians. CDC also cites the need for vaccination of students in schools of medicine, dentistry, nursing, laboratory technology and other allied health professions. This set of recommendations also included healthcare workers based outside hospitals such as dental professionals, laboratory and blood bank technicians, dialysis center staff, emergency medical technicians, and morticians (Ex. 4-9).
Hospitals: There is almost universal agreement that healthcare workers, such as nurses and physicians, who are employed in hospitals, provide patient care, and have occupational exposure are at risk for infection by bloodborne pathogens. Since their risks are so extensively documented (See Section IV: Health Effects), no additional discussion is provided here. The occupational exposure encountered by other hospital employees is discussed below under Laundry, Housekeeping, and Clinical/Diagnostic Laboratories.
Clinical/Diagnostic Laboratories: These include but are not limited to hospital labs, free-standing clinical or diagnostic labs, labs in dentists' or physicians' offices, blood and plasma center labs, dental labs, and laboratories preparing reagents from human blood or blood components. Laboratories that conduct research using blood or blood components but do not produce or use concentrated amounts of HIV or HBV also fall into this category. Employees who work in clinical or diagnostic laboratories that perform a variety of tests to aid in the diagnosis of disease and the management of treatment are also at risk if they have occupational exposure. In the United States, millions of blood specimens are collected and analyzed in these laboratories each year. One commenter referenced a report that 898 million blood collection tubes were sold in 1986 (3M, Ex. 233). Although not all laboratory tasks involve blood or other potentially infectious materials, a relatively high potential for exposure exists for employees who analyze and process these fluids and tissues. In addition, environmental surfaces and equipment in clinical laboratory areas have been shown to be contaminated with HB surface antigen and present a potential risk for the laboratorian (Ex. 6-56). Several organizations and groups have devised procedures for reducing risks in the laboratory and these procedures are part of our record (for example, Exs. 6-153; 6-312; 11-71; 11-159; 11-280).
One expert witness described his experience in auditing laboratories over the preceding 14 years.
Since 1976, I have conducted many dozens of site visits to clinical and research laboratories to perform biosafety audits. These audits have included blood laboratories... For years it has been accepted that 15 - 30% of blood lab and hospital workers will contract hepatitis B over their lifetime as a result of exposure on the job. The attitude is that this risk goes with the territory. A few years ago only a modest number of blood samples per year were positive for HBV and/or HIV in a clinical laboratory. Today, based on my experience it is not uncommon to find one in fifty to one in every 100 clinical samples in a 24 hour run of thousands of samples in a metropolitan blood laboratory to be positive for HBV and/or HIV. As the pool of positive samples is growing rapidly, so also is the danger to those who must handle the blood specimens. (Dr.Joseph Coggin, Ex. 26)
Dr. Coggin's observation is supported by the study of Handsfield and colleagues. In 1987, they reported that a large number of serum and plasma specimens submitted for analysis to the clinical chemistry lab of an urban teaching hospital were positive for HIV or HBV. Specifically 6.3% were hepatitis B surface antigen positive and 3.0% were HIV antibody positive. Taking into account that some samples had both viruses, 8.7% of the samples contained at least one of these viruses (Ex. 6-351).
Although laboratorians may not have direct patient contact, most of those employed in clinical or diagnostic labs do have exposure to the blood and other potentially infectious materials of patients. An examination of the tasks performed by clinical laboratorians as they analyze human blood and other human body fluids as part of the diagnosis and treatment of disease makes it clear that these individuals have occupational exposure and, therefore, are at risk.
Housekeeping: The housekeeping workers in healthcare facilities may also be at risk of exposure to bloodborne pathogens. Individuals who perform housekeeping duties particularly in patient care and laboratory areas may be at increased risk for exposure when they perform tasks such as cleaning blood spills and handling infectious wastes. They often encounter carelessly discarded contaminated sharps. One witness testified:
Our members who work in the housekeeping departments often pick up waste baskets and bags which often contain needles. They continually face the possibility of needles which have been improperly discarded... For instance, one of our members, who is now retired, was cleaning a room when she picked up some trash on a window sill and was stuck by a contaminated needle from an AIDS patient. The needle was lying in an alcohol pad. (Mr. Robert Moore, Ex. 36)
Laundry: Laundry workers may also be at risk of exposure to bloodborne pathogens. These individuals may be employed in either hospital laundries or in commercial laundries that service healthcare, public safety and other institutions where occupational exposure to blood or other potentially infectious material occurs. Laundry workers may be exposed to laundry contaminated with blood or to contaminated sharps inadvertently left in the laundry.
Laundry employees who testified at the public hearings gave examples of occupational exposure. For example, an employee of a hospital laundry told of the types of exposure that are found in these laundries.
I think the sorters who have to sort out the dirty linen, they are always finding needles, syringes, scalpels and other sharps in the dirty line. Most of these instruments are bloody. Employees have been stuck because they don't always see the things until they've been stuck. Another thing, if sharps get by the sorters and find their way into the wash deck, this puts the washers who load and unload the machine at risk....Like some of the surgery we get a lot of congealed blood. We get a lot of different parts of the body....You also get some from labor and delivery. You get different congealed blood in sheets and in blankets....They have to handle all of this. (Ms. Georgia Davenport, Tr. 1/16/90, pp.779-780)
One witness told of receiving needle sticks from needles in the laundry. He said:
In my work as a sorter, I have been stuck twice by a needle, as recently as two years ago -- once by picking up a plastic bag full of bloody surgery towels .... Myself and other employee in the laundry still encounter needles in the linen, mostly coming from surgery. The number has decreased in the last four years but there shouldn't be any at all. (Mr. Raymond Montez, Tr. 1/16/90,pp 768-769)
Most recommendations for minimizing or eliminating these hazards focus on limiting the risk by minimizing handling of soiled laundry. This practice not only reduces the likelihood of skin contact with blood contaminated laundry but also reduces the likelihood of a puncture wound from a needle or other sharp object. The risk of handling this laundry is present whether the servicing laundry is within the institution or at another site.
Personnel Services: These agencies provide nurses and other healthcare professionals to hospital and other healthcare facilities that require their services. The occupational exposure experienced by these employees would be expected to occur in hospitals, physician's offices, and other healthcare facilities, rather than in the facility of the Personnel Service. These employees' occupational exposure would be similar to other employees performing the same tasks and procedures in the healthcare facility that has contracted for their services.
Tissue Banks: Another potential source of bloodborne pathogens is human tissue that is removed for transplantation. The American Association of Tissue Banks, representing 700 individual and institutional members, supported the implementation of a standard and recommended including the category "tissue bank personnel" in the coverage (Exs. 11-50; 20-720). Examples of tasks and procedures that may result in occupational exposure in tissue banks were described by Dr. John Kateley, president of the American Association of Tissue Banks (AATB).
Tissue banking professionals are at risk for infection in a manner similar to laboratory technologists, phlebotomists, surgeons and other healthcare professionals dealing in patient care. Tissue banks are responsible for the removal, preparation and storage of bone, skin, ligaments, tendons, corneas, heart valves, and saphenous veins for transplantation. These tissues are surgically removed and then further processed in a tissue bank laboratory for storage and future transplantation. (Dr. John Kateley, AATB, Ex. 20-720)
The evidence in the record shows that tissue bank employees have exposures similar to those seen in hospital and medical laboratory personnel.
Drug Treatment Facilities: These facilities include hospitals, residential treatment programs, and outpatient treatment facilities. The types of occupational exposures that occur would range from those described above for hospitals to those associated with rendering first aid and performing phlebotomy in an outpatient clinic or residential setting.
Physicians' Offices: The physician's office is often the scene of blood collection, treatment of wounds, minor surgery, and other invasive procedures. Physicians, nurses, nurse practitioners, physicians' assistants and other healthcare employees may be exposed in this setting. The office may also contain a laboratory where additional exposure may occur when blood and other potentially infectious materials are analyzed. Employees who perform these tasks have the same risk as their hospital-based colleagues.
Freestanding Clinics: A number of healthcare employees work in freestanding clinics that operate outside the hospital. For example, employees of hemodialysis clinics, urgent care clinics, health maintenance organization (HMO) clinics, and family planning clinics perform many of the same tasks that have traditionally taken place in either the hospital or the physician's office. Examples of these tasks include performing hemodialysis, phlebotomy, surgery, wound care and dressing changes. These tasks clearly carry the same risk whether they are conducted in a hospital or a free-standing clinic.
Clinics in Industrial, Educational, and Correctional Facilities: Many commenters made the point that healthcare is also being provided as a service to a larger facility, such as in industrial, in educational, and in correctional settings. These facilities often provide services such as emergency first aid, collection of blood, and cleaning and dressing of wounds, activities that may place the healthcare provider at risk for exposure to blood and other potentially infectious materials. (Exs. 11-111; 11-86; 11-216).
Dental Facilities: Dentists, dental hygienists, dental assistants and dental laboratory technicians are continually exposed to blood and bloody saliva during almost all dental procedures. Because saliva in dental procedures is so likely to contain blood, the CDC recommends personal protective equipment to practitioners for all dental procedures (Ex. 6-316). The record contains many references to occupational hepatitis B infections in dental health professionals.(Exs. 6-68; 6-441) Ms. Karen Boulton, a dental hygienist who testified at the public hearings, gave examples of preventive dental hygiene services, including scaling and polishing of the teeth, periodontal root planing and subgingival curettage. She estimated that "almost 100 percent of [her] patients in private practice exhibit some extent of bleeding during routine treatment." (Tr. 1/16/90, pp. 563-565) A number of commenters who considered this issue agreed that these dental employees are at risk and supported a standard for dental operations (Exs. 11-162; 11-177; 11-327). The position of the American Dental Association (ADA) regarding the scope of the standard and the major provisions was given by Dr. Enid Neidle in her testimony at the public hearing on the proposed rule. She stated, in part:
The purpose of OSHA in protecting, through this proposed rule, the health care worker is clear, unequivocal, and laudable. The American Dental Association shares that purpose. Over the past 15 years, the Association has invested substantial resources in the development of educational materials to prevent the transmission of infection in the dental office. (Dr. Enid Neidle, ADA, Ex. 58)
However, the ADA stated its belief that OSHA overstated the risks to dental healthcare workers in the preamble to the proposed standard. In their posthearing comments (Ex. 282), they stated:
Over the past several years, data have been amassed that suggest that the dental profession is at very low risk of contracting infectious bloodborne diseases. The following documented facts support this position:
* Over the past five years, the American Dental Association Health Screening Program and other testing programs have done a total of 4,973 tests on dentists for antibodies to HIV. In 1988, Klein et al. reported that one dentist in their sample of 1,132 dentists...was seropositive; this case was subsequently adjudged by the Centers for Disease Control to meet the criteria for an occupational transmission. As shown in Table 1, of the total sample of 4,973 tests between 1985 and 1989, only two have been positive. Table 2 shows that the prevalence of HIV infection among dentists is low compared to the general population. Inasmuch as dentists have been treating HIV-infected patients for at least 15 years (and did not wear personal protective equipment for at least the first ten years), the occupational risk to dentists is extremely low.
* In response to an inquiry from the Association, the Centers for Disease Control has stated that no dental staff members (hygienist, assistant, dental laboratory technician) have been reported to have been infected with HIV as a result of occupational exposure.
* As of 1989, 71% of U.S. dentists had been vaccinated against HBV; this percentage has increased steadily since the vaccine first became available in 1982. (ADA, Ex.282)
One of the difficulties in relating this information to the final standard is that it focuses almost entirely on dentists, who are more likely to be employers and not covered by the standard. It does not adequately address the status of dental hygienists, dental assistants, and dental laboratory technicians who make up 75% of dental healthcare workers who are employees and are therefore covered by this standard.
In any case, we will address the points made by the ADA to support their contention that OSHA has overestimated the occupational risk faced by dentists. First, it would be more complete to say that the Klein study, cited above in the quote from the ADA, found five (5) HIV infected dentists, not one (Ex.6-366). Four of these individuals were found to have other risk factors leaving one occupational HIV infection in a group of 1,132 dentists. A finding of 1 occupational HIV infections in a group of 1,132 dentists, or 2 occupational HIV infections in a group of 4,973 for that matter, is not "extremely low" or "minimal" or "insignificant" as the ADA has argued. On the contrary, this finding is compatible with a finding of a 1 in 1,000 risk of a fatal illness as the result of an occupational exposure. In the "Benzene Decision," the Supreme Court clearly defined this as a significant risk. (See Section VI: Significance of Risk) This does not take into consideration the additional occupational risk caused by HBV. The ADA's contention that the HIV risk in dentists is lower than that of the general population is confusing and is not supported by the data the ADA cited in their posthearing comments. They use the figure "2 HIV infected dentists per 4,973" and as we have noted above, the Klein study alone found 5 HIV infected dentists (5 per 1,132). There is no information in the record to indicate how many other HIV positive dentists with other risk factors were found in the other groups that make up the total 4,973 tested individuals. Second, in the past it has been relatively uncommon for dental hygienists, dental assistants and dental laboratory technicians to be tested for HIV following occupational exposure. Since an HIV infection may be silent for many years before AIDS develops, it is highly unlikely that untested individuals would know whether or not they were infected with HIV. Third, OSHA agrees that the HB vaccine is a central component of any effort to control hepatitis B, and it is important to note that a relatively high percentage (71%) of dentists are vaccinated. However, the remaining 29% who have not been vaccinated continue to be at increased risk. An article from the Journal of the American Dental Association begins, "In the late 1970s, it became clear that dentists are at a risk three times greater than that of the general population for hepatitis B (ADA, Ex. 282-2b)] In addition, as the ADA acknowledged in their posthearing brief, other dental healthcare workers are considerably less likely to have been vaccinated (ADA, Ex. 295). For example, in 1989 only 15% of dental laboratory technicians had been vaccinated.
Clearly, dental health professionals perform tasks that place them at risk for infection due to their occupational exposure.
Institutions for the Developmentally Disabled: Although the overwhelming majority of cases of HBV and HIV infections occur in adults, one group of children have a high risk for hepatitis B infection. This group consists of developmentally disabled children who are or have been institutionalized. Surveys conducted in large state institutions indicate that the risk of a child contracting hepatitis B in one of these institutions ranges from 50% to 90% with 5% to 20% of those infected becoming hepatitis B carriers (Ex. 11-165, p. 4). The behavior of these children, including scratching, biting, and self-mutilation, may present a risk to those who teach or otherwise care for them. Developmentally disabled adults who are or have been institutionalized also have an increased risk for being infected with HBV. In 1990, the CDC recommended the hepatitis B vaccine for both the clients and the staff of institutions for the developmentally disabled (Ex. 286G).
Hospice: A hospice is one of several alternative health care programs open to the terminally ill, including terminally ill AIDS patients. Employees provide healthcare services to these patients which place the employee at risk for occupational exposure. The Hospice Association of America provided examples of the types of employees (and volunteers) who provide hospice care and some of the types of care rendered by these individuals that place them at risk.
Hospice employees engaged in direct patient care include, but are not limited to, registered nurses, homemaker/home health aides, physicians, licensed practical nurses and various therapists....Hospice services provided in the home include...dressing change, intravenous drug administration, blood specimen collection, intramuscular and subcutaneous injections, management of intrathecal, epidural, venous and arterial shunts and catheters and suctioning of tracheal and upper respiratory secretions. In other words, much of the direct patient care provided in the hospital is also provided in the home by hospice employees and volunteers. (Hospice Association of America, Ex. 11-202)
Hospice employees who perform the services outlined above as well as other duties that result in occupational exposure are at risk of infection by bloodborne pathogens.
Home Health Care: Another alternative to hospital care is home healthcare. There was recognition among the commenters that some employees who provide home health care have occupational exposure and are at risk of HIV and HBV infection. Tasks that home healthcare providers may be expected to perform include collecting a blood specimen, cleaning and dressing wounds, and managing intrathecal, epidural, venous and arterial shunts and catheters (National Association for Home Care, Ex. 11-203).
A common theme among the commenters concerned with home health care is the environment in which the care must be rendered. For example, one group stated:
... Unlike other types of providers, home health agencies (HHAs) do not control the worksite. The worksite is the patient's home; the nurse, home health aide, or therapist is only a visitor. Attempts to apply universal precautions, decontaminate the worksite, and otherwise control the risk of infection by bloodborne pathogens must take this into account.
A home nurse, for example, cannot control the level of general sanitation or cleanliness in the home. Some homes do not have amenities such as running water. Home health employees cannot ensure that patients and their non-professional caregivers will take precautions that they may find objectionable or bothersome. Many beneficiaries and their caregivers are quite elderly and confused, and would have great difficulty in following through on decontamination instructions (Amer. Fed. of Home Health Agencies, Inc., Ex. 20-544).
OSHA is aware that in most instances home healthcare must be provided in an environment and at a location that is not under the control of the employer. In addition to home healthcare employees, emergency medical service providers are another group who provide healthcare services in a variety of locations outside the employer's facility. However, it is clear that both types of employees have occupational exposure; are at risk for HIV and HBV infection; and must be provided the protection afforded by the provisions of the standard. OSHA has modified several provisions of the proposed standard to take into account the circumstances described above. For example, paragraph (d)(2)(iv) of the standard allows the use of antiseptic hand cleansers when handwashing facilities are not available.
Blood Banks/Plasma Centers: In blood banks and plasma centers, the potential for occupational exposure begins with the initial finger stick of the donor and continues until contaminated units are identified and destroyed. The blood and blood products in these facilities are regulated by the Food and Drug Administration (FDA), and all plasma and blood collection facilities have extensive written procedures for donor requirements, donor room procedures, and laboratory testing of the blood with blood components (ABRA, Ex. 11-71). However, the FDA does not set standards for the health and safety of the employees.
One witness, a nurse employed by the American Red Cross, testified concerning the likelihood of contact with blood.
To the uninitiated, phlebotomy appears to be a clean operation. After all, we aren't performing surgery, emergency service, or even patient care. Instead, we're dealing with individuals who don't appear to be sick.
.. It may come as a surprise to some people, then, that mobile collection staff may come in contact with large amounts of blood on the job. I'm not just talking about needle sticks. Since we handle large amounts of blood all day long, the potential for contact is always present. (Pam Talbot, RN, Tr. 9/15, p. 157)
Dr. Robert G. Chapman, President of the Council of Community Blood Centers, agreed that occupationally exposed blood bank personnel should be offered the hepatitis B vaccine and other protection. He felt, however, that there should be a two tiered approach to protective clothing with less stringent requirements for, for example, phlebotomists drawing homologous donors in nonhospital blood banks. (Tr. 10/20/89. p. 731) Dr. Paul V. Holland, representing the American Association of Blood Banks, argued that the risk from voluntary blood donors is very low, that wearing gloves often presents a problem to the phlebotomist (applying labels, for example). He further stated that they require gloves for autologous patients and hepatitis B vaccination for employees in their laboratories (Tr. 10/20/89, pp. 764-765). The American Blood Resources Association (ABRA) has argued that workers in a plasma center are at a reduced risk of exposure to bloodborne pathogens because many plasma donors donate frequently, as often twice a week, and therefore their antibody status is known (Ex. 11-71). Similarly, the American Red Cross stated that "its healthy blood donor population does not present any increased health risks to its employees and volunteers" (ARC, Ex. 11-280). However, despite prescreening, both blood banks and plasma centers have donors who are infected with HIV, HBV, and other bloodborne pathogens including non-A non-B hepatitis.
A 1990 study of intravenous drug users published in the Journal of the American Medical Association showed that 27% of a cohort of 2921 intravenous drug users had donated blood or plasma. Of this group 82.2% had donated after they had started using drugs and most donated at commercial plasma centers. (Ex.299, attachment) In a study published in the New England Journal of Medicine in 1989, Leitman and her colleagues conducted an in depth analysis of a group of volunteer blood donors who were found to be infected with HIV. One of the issues studied was the donors' estimation of whether or not they were at risk for HIV.
The results of our study suggest that current measures for donor education and screening are not uniformly effective in eliminating people at high risk from the donor pool. The majority of our HIV-infected donors understood the definition of high-risk behavior but did not view themselves as having engaged in such behavior. Even more disturbing, a large proportion donated specifically in order to discover the results of HIV testing. Furthermore, less than 5 percent understood the purpose of the post-donation confidential unit-exclusion system and would have designated their units as solely for research. Clearly, both donor-education policies and interview strategies need to be strengthened. (Ex. 281-3)
Twenty six percent of the subjects of this study did not believe their earlier behavior placed them at risk, because they had changed their lifestyles and they remained in good health. A similar percentage attempted to donate blood in order to undergo HIV-antibody testing because they viewed the donor center as more pleasant, more accessible, and not associated with any stigma. Fifteen percent of the donors felt pressured to donate despite a history of high-risk behavior. Only 6 percent did not read or understand the informational material provided by the blood center that presumably would have led them to disqualify themselves. The authors concluded that a small number of persons with HIV infection continue to donate blood despite attempts to exclude them.
In any discussion of the risk to employees in the blood and plasma centers it is important to note that these facilities dedicate a substantial amount of their resources to identifying these contaminated units and ensuring that they are not released for transfusion or for other use. Units of blood from donors who test positive are discarded and do not present a risk to recipients of transfusions. However, employees engaged in the collecting, processing, and testing of these units are at risk for exposure.
Nursing Homes/Longterm Care: Nursing homes or other long term care facilities were cited by commenters as places of employment where employees are at risk for blood and body fluid exposure (ANA, Ex. 11-86; Exs. 11-74; 11-172). For example, employees provide care for decubitus ulcers and skin tears. Employees give insulin injections and perform finger sticks which present the added risk of handling contaminated sharps.
Information from the National Health and Nutrition Examination Survey II gave us the most recent in depth look at the prevalence of hepatitis B markers in people from age 6 months to 74 years and from different racial groups (Exs. 20-834, 6-340). In other words, it provided information that would tell what percentage of people in each age group have been infected with hepatitis B at some time in their lives. In the age group 65 to 74, 6.4 out of 100 white females had serological evidence of past hepatitis B infection, 7.5 out of 100 white males, 39.5 out of 100 black females, and 39.7 out of 100 black males. This indicates that many individuals who are of an age group that would be either residents of nursing homes or candidates for nursing homes have at some time in their lives had a hepatitis B infection. Most of these individuals would no longer be infected but a percentage of these individuals would be expected to have developed hepatitis B carrier status and would still be infected with the virus years after the initial infection. Further data from this same study indicates that in persons aged 45-74 years, approximately 3 out of 1,000 whites and 8 out of 1,000 blacks were carriers of hepatitis B surface antigen, and thus presented a risk to those who came in contact with their blood. This can be compared to hospital patients where one would expect approximately 10 out of 1,000 patients (1%) to be infected with hepatitis B (Ex. 6-427).
The Service Employees International Union urged OSHA not to exclude nursing homes from the standard. They stated:
An exclusion of nursing homes based on their current low AIDS population is inappropriate. Nursing home workers are as likely as other health care workers to be exposed to HBV. They also face other infectious diseases such as TB. Moreover, such a policy would be dangerously short sighted. CDC estimates that more than 1.5 million individuals are today infected with the HIV virus. The growing numbers of AIDS patients together with soaring hospital-based health costs will spur treatment in alternative healthcare settings like nursing homes and respite homes. (SEIU, Ex. 11-61)
The American Health Care Association, which represents more than 10,000 long term care facilities and allied health care providers, stated:
[L]ong term health care facilities should be included, [in the standard] but we believe that recognition should be given to the differences in both type of care and population served in long term care facilities as opposed to acute care facilities. (AHCA, Ex. 11-27)
In its posthearing comment, the American Health Care Association gave a number of reasons why they feel that the nursing home industry should not be subjected to the "wholesale application of the OSHA standard." Some of these are listed below:
(AHCA, Ex. 278)
[W]e believe that nursing homes comprise a discreet segment of the health care industry where, due to the nature of the resident population and the types of care provided, there is no reasonable expectation of employee exposure to blood or other potentially infectious body fluids in the performance of normal job tasks. The proposed standard utterly ignores the fact that the average patient in a nursing home is an 84-year old woman who will be given care in a stable setting for over a year.... Furthermore, nursing homes do not encounter their residents under the transient acute episodic and emergency circumstances which characterize all [emphasis in the original] of the other high risk health care categories.... Nursing homes are unique among health care providers because continuous regulatory oversight, survey, and compliance actions are built into the federal certification process for participation in the Medicare and Medicaid programs (AHCA, Ex. 278).
OSHA does not agree that employees of nursing homes have no reasonable expectation of occupational exposure. First, based on evidence in the record, it appears that some employees in nursing homes and some other long term care facilities do have occupational exposure despite the AHCA statement to the contrary. However, it is reasonable to expect that some nursing home employees, for example those employed in the dietary department, may not have occupational exposure and would not be covered by the standard. Second, as discussed above, elderly individuals may be carriers of bloodborne pathogens, particularly HBV, as the result of an earlier infection. In addition, although the average patient may be an elderly woman, the population is not made up exclusively of elderly women, but includes men as well. In fact, the population may contain adults of all ages whose personal circumstances require more care than they are able to provide for themselves. For example, a nurse's assistant testified:
While it may be true many nursing homes fit [a] typical resident profile. In every home I've worked in, I've taken care of male as well as female patients, young as well as old patients and short-term stays as well as long-term care of patients. There is a wide variety of patients in nursing homes, some of whom have history of behavior which would put them at high risk for HBV and AIDS... as well as people who have had blood transfusion in the past 10 to 15 years. (Ms. Kathy Lucas, Tr. 1/16/90, p.751)
Third, the nursing home industry is not unique among the covered industries in that long term care, as opposed to acute, episodic care, is provided. The staff of institutions for the developmentally disabled also provide long term care, and these individuals are also at risk when they have occupational exposure as discussed above.
Fourth, the fact that nursing homes are subject to infection control requirements imposed by the Health Care Financing Administration (HCFA) of the U.S. Department of Health and Human Services under the Medicare and Medicaid programs and to infection control requirements of states does not obviate the need to cover the employees of these facilities under this standard. These infection control requirements are primarily to protect the patients (residents).
The preamble to 42 CFR 438.65, which requires nursing homes to have infection control programs, states, "... [T]he emphasis we wanted to place was on the actual performance of a facility in providing care..." (emphasis added) 54 FR 5345 (February 2, 1989). The interpretative guidelines for this regulation suggest that HCFA surveyors ask whether the HIV/HBV infection control policies agree with OSHA requirements for protecting employees and current accepted standards of practice recommended by CDC. It does not appear that HCFA mandates compliance with OSHA requirements and CDC occupational health guidelines as a matter of its own regulations. To the contrary, HCFA in effect notes that nursing homes must comply with OSHA requirements. Thus, there is no conflict with HCFA or duplication of effort. Similarly, since States implement the same infection control requirements under 42 U.S.C. 139 6r (h), the same arguments apply to state regulations. State licensing agencies may possibly have different, additional occupational health requirements. See 42 U.S.C. 139 6r (h)(8). However, the purpose of the OSH Act is to provide uniform protection. Usery v. Lacy, 628 F. 2d 1226 (9th Cir. 1980). States which desire to address issues covered by OSHA standards must adopt a plan approved by Federal OSHA. 29 U.S.C. 667 (b). Finally, the Congress has expressly indicated that OSHA is to protect healthcare and public safety workers from HIV and HBV. The Congress mandated CDC to develop guidelines for protecting healthcare and public safety workers from HIV and HBV and to submit the guidelines to OSHA for its use in the development of this standard. 42 U.S.C. 300ee-2 (a)(1)(2) and (b).
Funeral Homes and Mortuaries: The CDC considers morticians to be healthcare workers who should observe precautions because of their exposure to blood (Ex. 4-9). From the beginning of the rulemaking, there was a consensus among the commenters that employees of mortuaries have been at occupational risk because they are exposed to blood and certain body fluids and should be covered by the standard (Exs. 11-161; 11-111; 11-293; 11-282; 11-240; 11-181; 11-169; 11-157; 11-165).
- For example:
It is generally agreed upon within the funeral service profession that risk of occupational exposure to bloodborne pathogens exists to varying degrees during the handling of human remains prior to embalming and during the embalming process (National Funeral Directors Association, Ex. 311).
Mortuary workers are potentially exposed to large quantities of blood during the preparation of cadavers; there is also potential for certain abrasions (SEIU, Ex. 11-161).
Embalmers constitute a group of long ignored non-hospital based health care workers. During the embalming procedure they often come into contact with large amounts of uncontainerized blood as the vascular system is drained. Depending on the cause of death and whether an autopsy has been performed, they may be required to handle various body parts and tissues, as well as to make numerous incisions and subsequently suture the incised tissue. These procedures put them at risk of exposure. (AAOHN, Ex. 11-111)
Exposure in funeral homes during embalming and other procedures described above may result in exposures similar to those encountered in surgery and autopsy.
Research Labs and Production Facilities: Research and production facilities that produce or manipulate concentrated virus are also included within the scope of this standard. There are many researchers in academia, government and industry who are studying HIV and HBV. These individuals may be at even greater risk than healthcare providers because the concentration of virus is often greater than that found in blood or other body fluids. The record contains evidence that two individuals who worked with concentrated HIV in a production facility became infected as the result of occupational exposure (Exs. 6-187; 6-312; 6-368). The circumstances surrounding these infections were the subject of a thorough review by a committee of experts appointed by the Director of the National Institutes of Health.
Expert witness Jolanda Janczewski, formerly Biological Safety Officer for the AIDS Research Program at the National Cancer Institute, Frederick Cancer Research Facility (NCI-FCRF), described the events in her testimony at OSHA's public hearings on the proposed standard.
In 1984, the NCI-FCRF began to produce the large amounts of HIV-1 that were needed for assays to test the nation's blood supply. Subsequently, and to date, the NCI-FCRF production laboratory was employed to prepare large quantities of HIV-1 as an agent for structural, immunological, and biochemical studies. Other commercial laboratories took over the process of producing the concentrated virus needed for the FDA-approved blood testing kits. By 1987, and to date [9/12/89], seven laboratories within the United States were involved in large scale HIV-1 production and employ an estimated 150 workers.
In September 1987, the first occupationally-acquired HIV-1 infection of a worker in a large scale HIV-1 production facility was confirmed. A second worker was reported to be infected in October, of the same year... Dr. James Wyngaarden, Director, National Institutes of Health convened a Review Group to investigate the reported HIV-1 infection[s].... The Review Group... concluded with recommendations for worker training, enforcement of safety practices, medical surveillance, and evaluation of processes and equipment. (Ex. 25)
The reporting of two infections as the result of occupational exposure in a group of employees that number less than 200 documents the potential for viral infection whenever employees concentrate or otherwise manipulate highly concentrated virus. The final standard incorporates many of the recommendations of the Review Committee described above and the provisions specific for these facilities are found in paragraph (e) and paragraph (g)(2)(ix).
Although at present, HBV cannot be grown in tissue or organ culture, this may be possible in the future. Any concentrated HBV prepared from human or animal blood or body fluids would also present a risk to the laboratorian or other researcher who had occupational exposure in the laboratory or production facility.
Medical/Infectious/Regulated Waste Operations: Although OSHA is not aware of any documented cases of HBV or HIV infection associated with the collection, transportation, and final disposal of "regulated" waste, the potential for such an infection prior to final disposal of the waste is clear. The situation facing employees who handle "regulated" waste within healthcare and other facilities was described by Judith Gordon, testifying as an expert witness for OSHA. She stated:
At many worksites, concern for employee safety and health is directed primarily toward the professional and skilled workers, and the impact of work practices on the safety and health of the maintenance and janitorial staff is often overlooked. Yet, if the exposure to bloodborne pathogens that are present on blood-contaminated items constitutes an occupational hazard to, for example, the healthcare worker, it poses the same risk for the person who must handle the same blood-contaminated items when they are waste.
Scientifically and logically, handlers of infectious waste are also at risk of occupational exposure to bloodborne pathogens.
Infectious waste management has many aspects including discard of the infectious waste, its collection and storage, and treatment of the waste before disposal. Each of these activities has an inherent risk of occupational exposure to bloodborne pathogens. The work practices of those who initially discard infectious waste have a direct effect on the potential for exposure and the risks faced by those employees downstream who handle the infectious waste. (Ex. 30)
Browning-Ferris Industries (BFI) described the types of occupational exposure that may occur after the employee of the medical waste company has picked up the medical ("regulated") waste.
BFI's medical waste employees perform a variety of tasks associated with transporting and disposing of medical waste. Unlike healthcare and medical laboratory workers who may be exposed to bloodborne pathogens through direct and indirect patient contact, specimen collection and processing, or handling dressing, linens, waste and medical equipment, BFI medical waste employees handle waste only after it has been packaged and/or placed in a plastic container (tub) for transport and disposal. Medical waste workers load packages for transport, off load packages and tubs at transfer stations and destination facilities, prepare packages and tubs for treatment or destruction, and operate equipment which moves waste into and through treatment or destruction processes.
BFI's assessment is that the greatest potential occupational exposure of our employees to bloodborne pathogens is through needle sticks from sharps not properly packaged by generators in rigid containers, or from sharps containers not properly sealed. Medical waste workers are also exposed through improperly packaged fluids, and through spill response activities. BFI's own packaging and handling practices, including reliance on mechanical waste handling, as well as state and federal packaging requirements, substantially reduce these exposure routes. (BFI, Ex.20-138)
These comments clearly indicate the nature of the occupational exposure of employees who have contact with regulated waste from its generation to its ultimate disposal.
Equipment Service and Repair: Several commenters pointed out the potential risk to employees who service or repair medical instruments or other types of equipment contaminated with blood or body fluids such as dialysis pumps, pacemakers, liquid chromatographs, and centrifuges (Millipore Corp., Ex. 11-3; American Dental Association, Ex. 11-43; IBT, Ex. 11-97; 11-282; HIMA, Ex.66; Ex. 85). These devices are often contaminated both externally and internally (ADA, 11-43; YSI, 11-7). This hazard may be encountered when the equipment is serviced on site (Ex. 11-282) or at the factory or service center prior to decontamination (Ex. 11-7).
Dr. Amiram Daniel, testifying on behalf of the Health Industry Manufacturers Association, described how employees who sell and service medical equipment may be exposed. He stated:
In our industry we employee about 200,000 workers. About 10% of these workers are engaged in labor which may put them in contact with potentially infectious material...Our field force, composed of sales, service and repair, quality assurance and teaching personnel, must come in contact with the patient in the hospital, clinic or home environment, or with contaminated devices. Some of our used products are returned to the manufacturer for a variety of reasons -- replacements and failure investigation to mention but two. The manufacturing personnel handling these shipments do not always know the status of the devices, who used them and how, whether they were disinfected prior to shipping, etc. (Dr. Amiram Daniel, HIMA, Ex. 66)
One group opposed coverage of these employees. Mr. Timothy Fise, representing the American Dental Trade Association (ADTA), testified that it was the opinion of the ADTA that medical and dental companies that engage in equipment repair should be excluded from the standard because they contend that the risk of infection is remote. Mr. Fise stated:
Companies do these repairs either: (1) outside of the medical/dental facility, or (2) at a time substantially after the equipment was in use with exposure to any patient. With the likelihood that equipment is incapacitated for at least several hours (if done on-site) and more likely several days before repair (if the equipment is shipped to the medical/dental facility for repair) any HBV which may have been present on the equipment will long since have died, and the exposure/risk eliminated.
As noted above, any risk was remote at worst (Mr. Timothy Fise, ADTA, Ex. 65).
This argument, that blood contaminated equipment does not present a hazard was addressed in the opening paragraphs of this section. It is well documented that HBV can remain viable on environmental surfaces for at least a week, and transmission of HBV infection from exposure to contaminated environmental surfaces has been documented to be a major mode of spread in certain settings, particularly hemodialysis units (Exs. 6-56; 6-440; 6-461; 6-480).
Public Safety and Emergency Medical Services: Other employees who may be exposed to blood and other potentially infectious materials include emergency medical service providers, firefighters, law enforcement personnel and correctional officers. These employees would be covered under the final standard if they have actual or potential occupational exposure to blood or other body fluids and if they are employed by the private sector, the federal government, or a state or local government in a state that has an OSHA-approved state plan. Employees of state and local governments, including those employed in public hospitals and health clinics, in states without state occupational safety and health plans are not covered by OSHA regulations. (For more information on states and territories with OSHA state plans, see Section II: Legal Authority) Finally, the Congress has expressly indicated that OSHA is to protect healthcare and public safety workers from HIV and HBV. The Congress mandated CDC to develop guidelines for protecting healthcare and public safety workers from HIV and HBV and to submit the guidelines to OSHA for its use in the development of this standard. 42 U.S.C. 300ee-2 (a)(1)(2) and (b) (Ex. 15).
The following descriptions outline the occupational exposures that are common to Public Safety Officers and Emergency Medical Services personnel.
Emergency Medical Services: Individuals who render emergency medical services are clearly at risk for blood exposure incidents. Prehospital care is often rendered in a hostile or uncontrolled environment. Conditions beyond the control of the employee, broken glass and sharp metal at an accident scene, weapons at the scene of a violent crime, and inclement weather, may complicate the tasks and make them more hazardous. Many of the commenters considered the risk to these providers of emergency medical service to be substantial (ANA, Ex. 11-86; AAOHN, Ex. 11-111; International Association of Firefighters, Ex. 11-125; Merck, Ex.11-165). Moreover, recent CDC guidelines clearly apply to personnel rendering emergency medical service (Exs. 6-153; 6-199). A description of the hazards that may be faced by emergency medical responders was provided by Chief Ricky Davidson, Chairman of the Emergency Medical Services Committee for the International Association of Fire Chiefs.
The pre-hospital emergency care providers, unlike their counterparts in hospitals and other medical facilities, do not have the luxury of controlled clinical environments. As has already been stated, field delivery of medical care often involves the challenges of adverse operating conditions, limited equipment and resources, and limited time. The emergency medical providers must often contend with very hazardous situations, violent and uncooperative patients and hostile bystanders. The house call, once a regular part of a physician's practice, is now almost exclusively the duty of the emergency responder.
There is no such thing as a sterile work environment for emergency medical responders. Theirs is often one of untenable work conditions, whether attempting to safely deliver a baby on the floor of an abandoned tenement, strewn with human waste and drug paraphernalia, or crawling through the shattered window of a motor vehicle to treat an accident victim, contending with broken glass, jagged metal and leaking fuel. The explosive growth in drug use all over the United States now places the emergency rescuer directly on the battleground, often having to deal with the aftermath of a drug deal gone bad. The rescuer can do little to change the dynamics of the situation. This is the world in which we must operate. (Tr. 9/14/89, p.114-115)
Mr. Paul Maniscalco, Vice President of the National Association of Emergency Medical Technicians, said:
The EMS provider is called upon to render lifesaving techniques in what can be described as, at best, less than ideal situation. Some of these scenarios include, but are not limited to, hazardous materials incidents, overturned autos, inner-city tenements, or in rural areas many miles from any health care facility. These varying environments provide for problems that ate each highly unique, and nothing like the static environment that is offered by working in a fixed medical facility. For example, the potential for a needlestick to occur is greatly increased when an EMT is required, due to patient condition, to start an IV in a moving ambulance. (9/14/89 Tr. 121)
Fire Fighting and Law Enforcement: Many commenters urged OSHA to include fire fighters and law enforcement personnel within the scope of the standard (Mr. Richard Duffy, IAFF Tr. 9/14/89 p. 150; Mr. Clyde Bragdon 9/14/91 Tr 105; IBPO Ex. 20-1251; 11-86 ANA; 11-15 AFSCME; 11-74 NY State Dept of Health; 11-111 AAOHN; 11-165 Merck; 34 Int'l. Ass'n. of Fire fighters). When these individuals act as emergency first responders their risk is similar to that discussed earlier for emergency medical services. In addition, the potential for a hostile or uncontrolled environment at a fire or crime scene mandates special procedures in devising an adequate program of protection. The combination of broken glass, jagged metal and blood may present a hazard to the fire fighter who is attempting to extricate the victim of a motor vehicle accident. Even after the victim has been removed from the scene, the employee may have to remain in a blood contaminated environment while the investigation and cleanup continues. For law enforcement officers, weapons (including knives, ice picks and razor blades) and drug paraphernalia (including needles and syringes) encountered on a search may have to be collected as evidence. Also, facilities for personal cleanup can be inadequate or lacking altogether. In addition, the employee may have to work under time constraints when there is the threat of an explosion, the likelihood of a building collapse, or a hostage situation.
Mr. Clyde A. Bragdon, Jr., formerly Fire Chief of Los Angeles County and currently the Administrator of the United States Fire Academy, testified as to the duties of fire fighters that place them at risk. He stated:
Today's fire fighter is not just a fire fighter. He is also an emergency healthcare worker, often the first to arrive at the scene of an accident. In fact, 80 per cent of all field emergency medical care is provided by the fire service. The occupational exposures inherent to their jobs necessitates that the Rule cover all fire fighters, emergency medical technicians, and paramedics. (Tr. 9/14/89, 105)
Mr. Eric Lamar, a Fairfax County (Va.) fire fighter and emergency medical technician with more than 14 years service, described the changing role of the fire fighter.
I think that there may be, at least at some levels, some confusion about the applicability of the standard for fire fighters, and I think it's extremely important to re-emphasize again that, certainly in the time that I've been in the fire department, the nature of the job has changed dramatically in many ways, but the way it's changed the most is that we are now expected to be performing much more emergency medical service than we were before, and there's an incredibly high degree of integration that's occurring not only in urban areas but also in suburban areas, too.
I can also tell you that on a daily basis, some of us would be chagrined to admit to you that even though we consider ourselves to be fire fighters, that most of our calls are emergency medical calls. That's because in many municipalities we have tiered response where if an ambulance isn't available, the fire equipment is sent first since we are trained as emergency medical technicians. (Tr. 9/14/89, pp. 165-166)
Law enforcement officers and correctional officers may face a number of situations where there is occupational exposure to blood and other potentially infectious materials. In its publication "Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public Safety Workers" (Ex. 15), the CDC described some of these situations as follows:
Law enforcement and correctional facility officers may face the risk of exposure to blood during the conduct of their duties. For example, at the crime scene or during processing of suspects, law-enforcement officers may encounter blood-contaminated hypodermic needles or weapons, or be called upon to assist with body removal. Correctional officers may similarly be required to search prisoners or their cells for hypodermic needles or weapons, or subdue violent and combative inmates.
Law enforcement and correctional facility officers are exposed to a range of assaultive and disruptive behavior... Behaviors of particular concern are biting, attacks resulting in blood exposure, and attacks with sharp objects. Such behaviors may occur in a range of law-enforcement situations including arrests, routine interrogations, domestic disputes, and lockup operations...Hand-to-hand combat may result in bleeding and may thus incur a greater chance for blood-to-blood exposure...Criminal justice personnel have potential risk of acquiring HBV or HIV infection through exposures which occur during searches and evidence handling. Penetrating injuries are known to occur, and puncture wounds or needlesticks in particular pose a hazard during searches of persons, vehicles or cells and during evidence handling. (Ex.15 p.15-16)
The comment by the International Brotherhood of Police Officers listed a number of ways that occupational exposure may occur to law enforcement officers.
There are a variety of ways in which police potentially come in contact with blood-borne disease, the most dramatic of which is assaults by criminals wielding weapons. Frequently these criminals are drug users who are in one of the fastest growing populations of individuals infected by the AIDS and Hepatitis B virus. It is not uncommon for police officers to sustain cuts and abrasions in the course of these struggles and to come in contact with the criminal's blood and bodily products. Police are also at risk from needle sticks, while handling evidence samples and accident victims. (Ex. 20-1251)
Correctional Institutions: Many of the situations that place correctional officers at risk happen as the result of the violent behavior of the inmates, a group with a high prevalence of infection because of past and present high risk behavior. Studies of four prison populations in the U.S. revealed that approximately half of the prisoners had serological evidence of previous hepatitis B infection with 1.3% to 8.0% of the study population who were carriers (Ex. 6-132).
Mr. Jim Knapp, a correctional officer, testified to weapons made from silverware, razor blades, sharpened pencils, and pieces of steel and the inmates' use of needles and razors to tatoo other inmates. He and his coworkers have also found needles in searches for contraband, and they are often required to break up fights and then clean up the blood in the area (10/17/89 Tr. 71, 92). One witness, addressing himself to those who might be skeptical about whether correctional officers are exposed to blood, described the following incident that occurred two days earlier:
People look at a correctional officer and say, "Well, you're not like a nurse. You're not like a health service [worker] or whatever. You don't have that much contact." Well, just to emphasize my point, Sunday morning I was working in my unit. We had a code call in the unit next door to us. I ran over. Here were two guys fighting over the phone. As I ran up to break them up, one of the guys threw a punch into the other guy's face and I had red splattered all over my eyeglasses. This was just Sunday. Luckily, I was wearing eyeglasses. (Mr. Glenn Rude 10/17/89 Tr. 81).
Not everyone agreed that public safety officers should be covered by the standard. Dr. Richard Vogt, testifying on behalf of the Council of State and Territorial Epidemiologists (CSTE), stated:
[T]he initial rules should be confined to health care facilities, specifically health care providers... includ[ing] emergency medical technicians...[T]he risks of occupationally-related transmission of HIV and HBV to policemen, firemen and correctional facility personnel (also known as personal service workers) has never been demonstrated.(Ex. 132, p.3)
During questioning by the panel, Dr. Vogt disagreed with basing the scope of the standard on blood exposure but insisted that "actual data" be used.
OSHA must make the decision on whether or not to include employees on the basis of the best available evidence. These data, presented in both Section IV Health Effects and Section V: Quantitative Risk Assessment, demonstrate convincingly that it is blood exposure that is most closely correlated with risk of HBV. Furthermore, the likelihood of percutaneous exposure or exposure to mucous membranes further increases the risk. Clearly, these public safety officers not only have exposure to blood, but also have a risk for percutaneous exposures as described above. Therefore, the Agency concludes that they are at risk as the result of occupational exposure.
Ocean Lifeguards: Another group of employees, ocean lifeguards, were not included in the discussion of scope in the proposed standard and are added to this discussion of employees who have occupational exposure. OSHA was first made aware of the risks faced by ocean lifeguards in testimony by Mr. Ken Gunther representing a number of life saving associations and the Health Risk Duty Imperative of Ocean Lifeguards (HRDIOL) project. His testimony, first delivered at the Washington, D.C. hearings pointed to the occupational exposure to blood and other potentially infectious materials encountered by these employees (9/27/89 Tr. 300-313).
When OSHA held hearings in Miami, Florida on December 20, 1989, Mr. Gunther and 29 other lifeguards testified in detail as to the duties that place lifeguards at risk for blood exposure. Dr. Jim Dobbins, an epidemiologist, and a member of the Gulf Coast Region of the United States Life Saving Association, described the most common risk situations:
In general, lifeguards are exposed in the course of their duties to blood and bloodborne pathogens in two ways. Contact exposure when both the victim and the lifeguard are cut in the process of a rescue near rocks and pilings in the water, and after the rescue during attempted resuscitation and stabilization of the victim. (12/20/89 Tr. 1211)These routine exposures are separate from the sort of incidents ... that involve blood exposure through trauma and boating accidents, automobile crashes in the water or unusual injuries on the beach, or ... plane crashes. (12/20/89 Tr. 1216)
Testimony from other lifeguards pointed out other conditions that injure swimmers or other beach patrons and require the assistance of the lifeguard, thereby resulting in occupational exposure to the lifeguard. Patrons suffer lacerations from rocks, shells, broken glass, fish hooks, or reefs (12/20/89 Tr.1296, Tr.1287, Tr.1234, Tr.1235, Tr.1284, Tr.1235, Tr.1305). Swimmers may be injured when the surf propels them into jetties, rock groins, piers, pilings covered with barnacles, or underwater rebars from demolished piers (12/20/89 Tr.1305, Tr. 1186, Tr.1192, Tr.1332, Tr.1357). Swimmers may be stung by a man-of-war or attacked by sharks, barracudas, blue fish or moray eels (12/20/89 Tr.1233, Tr. 1240, Tr. 1186, Tr. 1235, Tr.1236). Surfers may suffer head or body trauma or skeg cuts from surfboards (12/20/89 Tr.1229, Tr.1236, Tr. 1286). Fist fights and bottle fights are not uncommon (12/20/89 Tr. 1228, Tr.1236-1238), and motor vehicle accidents are a problem on beaches where vehicles are allowed (12/20/89 Tr.1185, Tr. 1295). Boating accidents are a common occurrence, and witnesses described several incidents that required the rescue of persons who had been run over by a boat with an outboard motor (12/20/89 Tr. 1251, Tr. 1307, Tr. 1340, Tr. 1285).
Other witnesses testified to rendering emergency medical assistance to swimmers who had been struck by lightning or shot with spear guns (12/20/89 Tr. 1245, Tr. 1295). One witness assisted in the care of an individual who had fallen to the beach from a hotel balcony (12/20/89 Tr.1187). Another witness described his attempt to rescue a terminally ill, despondent man who was attempting to commit suicide by drowning (12/20/89 Tr.1194). Several witnesses described their attempts to rescue pilots of planes that crashed just off shore (12/20/89 Tr. 1193, Tr. 1216-7, Tr.1246, 1295, 1336).
Some of the duties performed by these ocean lifeguards are similar to those performed by emergency medical technicians (EMTs) who are members of EMS, fire departments or rescue squads, and, indeed, many ocean lifeguards are EMTs and some are paramedics (12/20/89 Tr.1226,1233,1236,1290,1298). Unfortunately, these duties must be performed under hazardous or hostile conditions, in the water or in a boat and while wearing only a bathing suit. Despite the obstacles presented by a hostile environment and the difficulties associated with the use of protective clothing and equipment, OSHA believes that training, the hepatitis B vaccine, postexposure follow-up, and other provisions of the standard will reduce the likelihood of infection caused by occupational exposure to bloodborne pathogens.
OSHA has not attempted to list all of the operations/worksites and name all job classifications where occupational exposure may occur. The Agency anticipates that when the employer prepares the exposure determination required by paragraph (c) of the standard, the employer is likely to identify job classifications with occupational exposure in addition to those described above. Worksites in addition to those named above may also require that individuals employed there perform duties that result in occupational exposure.
OSHA's conclusion is that employees who have reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of the employee's duties ("occupational exposure") are at risk of infection by bloodborne pathogens. This risk has been most thoroughly documented in healthcare workers employed in healthcare facilities such as hospitals; however, the risk is not confined to hospitals but is present whenever blood or other potentially infectious materials are present. Exposures do occur in worksites in addition to healthcare facilities and to employees who are not necessarily engaged in the direct delivery of healthcare (e.g. medical equipment repair). Therefore, the scope of the standard includes occupational activities that occur both in healthcare and non-healthcare facilities and in permanent and temporary work sites.
- Examples of health care facilities include, but are not limited to:
hospitals, clinics, dentists' and physicians' offices, blood banks and plasma centers, occupational health clinics, nursing (long term care) homes, hospices, urgent care centers, clinical laboratories, mortuaries and funeral homes, and institutions for the developmentally disabled. Examples of non-healthcare operations include, but are not limited to the service and repair of equipment, infectious waste disposal, virus research laboratories and production facilities, law enforcement and correctional institutions. In addition, examples of mobile (temporary) operations where there may be occupational exposure to blood and other potentially infectious materials includes mobile blood banks, crime scenes, and scenes of accidents or other trauma.
OSHA believes that under the scope of this standard each employee who has occupational exposure to blood or other potentially infectious material will be provided the necessary protection afforded by the proposed standard.
Paragraog (b) Definitions
"Assistant Secretary" means the Assistant Secretary of Labor for Occupational Safety and Health, or designated representative.
"Blood" is defined in this standard as human whole blood; human blood components such as plasma or platelets; and human blood products such as clotting factors.
At least two commenters stated that some human blood products such as sterile human albumin or blood products manufactured using recombinant DNA technology do not present a risk and suggested the definition be amended. Both commenters offered alternative definitions for "blood." For example:
"Blood" means human blood, human blood components and products made from human blood. Exempt from this definition are those blood components and/or products that are sterile, approved by the FDA, or produced using recombinant DNA technology where the genetic construct meets the following criteria: a) the host organism is not regulated as a human pathogen under the U.S. Public Health Service [42 CFR Part 72] and b) the recombinant DNA does not code for a bloodborne pathogen or toxin therefrom (Mr. Richard D. Godown, Industrial Biotechnology Association, Ex. 20-269).
Blood means human blood, human blood components and products made from human blood that have not been treated to render bloodborne pathogens noninfectious. (Dr. Joseph Van Houten, Schering Laboratories, Ex. 20-543)
On the matter of the products of recombinant DNA technology, it is not the intention of the Agency to regulate under this standard the products of recombinant DNA technology absent blood or other potentially infectious materials. The only exception would be the use of the hepatitis B vaccine, a product of recombinant DNA technology.
OSHA is concerned that the words "treated to render bloodborne pathogens noninfectious" may present a problem because there is little or no information in the record that deals with such treatment. The standard does recognize that some blood and blood components and blood products present little or no occupational risk and an exception to the labeling requirement was made for these products. The exemption is found in paragraph (g)(1)(i)(F) which states:
Containers of blood or blood components that are labeled as to their contents and have been released for transfusion or other clinical use are exempted from the labeling requirements of paragraph (g).
"Bloodborne Pathogens" means pathogenic microorganisms that are present in human blood and that can infect and cause disease in persons who are exposed to blood containing these pathogens. The definition lists hepatitis B virus (HBV) and human immunodeficiency virus (HIV) as examples of such microorganisms.
Dr. Jeffery Squires and Mr. Andrew Montano requested that OSHA provide a specific list of bloodborne pathogens as part of the definition (Ex. 20-749; 20-1028). Section IV Health Effects includes a discussion of other diseases caused by bloodborne pathogens including hepatitis C, malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeld-Jakob Disease, Human T-lymphotrophic virus Type I, and Viral Hemorrhagic Fever.
HBV and HIV are given as examples because they are the viruses of greatest interest and present the greatest risk. Adding additional examples to the definition would not improve the definition.
Another commenter suggested that the definition be modified to read "...microorganism and viruses..." because viruses are "not living creatures and the definition should include them." (Alpha Environmental Management, Ex. 20-115). It is true that viruses are not living cells. As a minimum, they are composed of nucleic acid protected by a protein or lipoprotein coat. As physical agents separated from a living host cell, they are incapable of reproducing or carrying on many of the functions that can be performed by bacteria and fungi. However, once they enter the cell they are capable of taking over the cellular machinery and reproducing themselves. The term "microorganism" is well understood to refer to viruses as well as bacteria and fungi (Ex. 6-74, p.7). In addition, the examples of HIV and HBV make the intention of the definition absolutely clear.
"Clinical Laboratory" is defined as a workplace where diagnostic procedures or other screening procedures are performed on blood or other potentially infectious materials.
"Contaminated/Decontaminated" In the proposal, OSHA requested public comment on whether the terms "contaminated" and "decontaminated" needed to be defined. Of the who commented on this issue, a large number supported defining these terms, and several proposed definitions (CDC/NIOSH, Ex. 20-634; AHA, Ex. 20-353; Society of Hospital Epidemiologists, Ex. 20-1002; American Biological Safety Association, Ex. 241; Abbott Laboratories, Ex. 20-1227; American Society of Clinical Pathologists, Ex. 20-351; American Association of Blood Banks, Ex. 20-1059; American Association of Critical-Care Nurses, Ex. 20-1162; Baystate Medical Center, Ex. 20-22; Boone Hospital Center, Ex. 20-556; Connecticut Dept. of Labor, Ex. 20-157; Office of the Assistant Secretary for Defense, Ex. 20-847; Pharmaceutical Manufacturers, Ex. 20-729; South Carolina Dept. of Health and Environmental Control, Ex. 20-1160; State of Utah Dept. of Health, Ex. 20-605; Service Master Company, Ex. 20-21; Visiting Nurse Corporation, Ex. 20-1268). The problem anticipated by the Agency was delineated clearly in the comment submitted by the Service Master Corporation which stated:
The terms "contaminated" and "decontaminated" should be defined. While their definitions are understood by many healthcare personnel, there is still some misunderstanding. Even journal articles by healthcare professionals, e.g. physicians, have used the term "infected" for inanimate surfaces and water, where "contaminated" was the proper term to use. Likewise, the term "contaminated" has been used where "colonized" was the appropriate term. Such misunderstanding can be even more widespread outside the healthcare community. (Ex. 20-21)
The Agency carefully reviewed the definitions offered by the commenters. While no single criterion existed, many commenters urged OSHA to include some form of the concept of an infectious agent capable of causing disease. Several commenters recommended that contamination be defined on the basis of "visibility" of the contaminant (Abbott Laboratories, Ex. 20-1227; South Carolina Dept. of Health and Environmental Control, Ex. 20-1160; Visiting Nurse Corporation, Ex. 20-1268). While this approach would certainly cover some instances in which contamination was present, OSHA does not believe that being able to observe a contaminant on a surface is an adequate criteria for determining "contamination." Surfaces or items can be heavily contaminated by a substance (e.g., serum, plasma), yet show no readily observable signs of such contamination. Other suggested definitions of contamination employed criteria such as contact or exposure to blood or other potentially infectious materials (Connecticut Dept. of Labor, Ex. 20-157; American Society of Clinical Pathologists, Ex. 20-351); the ability of a material to produce or transmit an infectious disease in humans (Pharmaceutical Manufacturers Association, Ex. 20-729); the presence of microorganisms capable of producing disease in humans (Service Master Company, Ex. 20-21); the presence of a bloodborne pathogens of sufficient hazard and concentration on an item or surface to cause disease in persons exposed to the surface or item (American Biological Safety Association, Ex. 241); and the soiling with blood or other potentially infectious material (CDC/NIOSH, Ex. 20-634). All of these suggestions point to the concept that "contamination" should encompass the known or suspected presence of an infectious agent on a surface or item. OSHA agrees and therefore, the term "contamination" has been defined as the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface.
Since contamination is determined by the presence or reasonably anticipated presence of blood and other potentially infectious materials presumed to contain bloodborne pathogens, then it is reasonable to assume that "decontamination" represent the process of removing or inactivating these pathogens. (CDC/NIOSH, Ex. 20-634; American Biological Safety Association, Ex. 241; Service Master Company, Ex. 20-21). Therefore, OSHA is defining "decontamination," for the purposes of this standard, as the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is considered safe for handling, use, or disposal.
The term "contaminated laundry" was used in the proposed standard in the description of paragraph (d)(4)(iv) housekeeping, but no definition was provided for the term. The final standard contains a definition "contaminated laundry". This term is used to identify laundry which has been soiled with blood or other potentially infectious materials or may contain blood or other potentially infectious materials or may contain contaminated sharps.
Several commenters suggested the use of the word "soiled" to describe laundry which required special handling (Exs. 20-37; 20-108; 20-41,p.1; 20-1001). However, although "soiled" laundry would certainly include laundry that may contain blood or other potentially infectious materials or contaminated sharps, the term also describes items that are merely used or contain substances other than bloodborne pathogens, such as urine or feces. This standard applies only to bloodborne pathogens so in the absence of visible blood, this standard does not apply to urine and feces. Therefore, OSHA has concluded that "soiled laundry" is not specific enough for the purpose of the standard. The term "contaminated laundry" has been chosen to clarify OSHA's intent to differentiate linens which require special handling. Since "contaminated" has been defined to mean the presence or reasonably anticipated presence of blood or other potentially infectious material on an item or surface, nearly all laundry used in patient care can be considered contaminated. The potential presence of contaminated sharps in used laundry creates a unique hazard which emphasizes the need to handle certain laundry as contaminated.
"Contaminated Sharps" are defined in this standard as any object, contaminated with blood or other potentially infectious material, that is capable of penetrating the skin. The proposed standard defined "sharps", using examples of needles, scalpels and broken capillary tubes.
The Environmental Protection Agency (EPA), in its Standards for the Tracking and Management of Medical Waste; Interim Final Rule and Request for Comments defines sharps as follows:
Sharps that have been used in animal or human patient care or treatment or in medical, research, or industrial laboratories, including hypodermic needles, syringes (with or without the attached needle), pasteur pipettes, scalpel blades, blood vials, test tubes, needles with attached tubing, and culture dishes (regardless of presence of infectious agents). (Ex. 6-497)
Because EPA's definition would encompass a wider variety of sharps than OSHA intended to regulate with this standard, OSHA chose not to use EPA's definition. OSHA's goal, which is the reduction or elimination of occupational bloodborne infections, is different than that of the EPA, which is the regulation of medical waste, including unused medical waste. However, the need for additional explanation was recognized and OSHA's definition was amended in two ways.
First, the word "contaminated" has been added to the description of sharps to clarify that OSHA is concerned in this standard with the handling and discarding of only those sharps which have the presence or the reasonably anticipated presence of blood or other potentially infectious materials on them.
Second, examples of sharps are expanded to include not only needles and scalpels, but also broken glass and the exposed ends of dental wires.
There are a number of "sharps" that could cause injury to workers. Broken pieces of glass, particularly broken specimen tubes, such as capillary tubes, are hazardous. In dental settings, a unique hazard is the potential for injury from exposed ends of dental wires. When these sharps are contaminated, they can be the source of a parenteral exposure to blood and are, therefore, included as examples of "contaminated sharps" in the definition.
"Decontamination" is discussed above under "Contaminated/Decontaminated."
"Director" means the Director of the National Institute for Occupational Safety and Health, U.S. Department of Health and Human Services, or designated representative.
"Engineering Controls" is defined as controls that isolate or remove a hazard from a workplace. Biosafety cabinets are examples of engineering controls since they not only remove contaminants through a local exhaust system but provide the added protection of confining the contaminant within an enclosed cabinet thereby isolating it from the worker. Other examples of engineering controls are sharps disposal containers which isolate contaminated needles or other sharps from employees.
- Mr. Stanley Dub suggested that the definition of "Engineering Controls"
should be changed to include controls "which substantially reduce the presence of the hazard in the workplace." (Ex. 20-516). He erroneously inferred that OSHA insists on "controls which completely isolate or remove the hazards." It is generally understood by the occupational health professionals, that engineering controls, such as local exhaust ventilation, remove air contaminants such as formaldehyde or ethylene oxide from occupational environment and thus reduce their concentrations in the workplace. This definition conveys the same principle. Therefore, the definition of "engineering controls" remains virtually unchanged for the purpose of this standard. The only modification is the addition of a few examples.
"Exposure Incident" means a specific exposure to the eye, mouth, other mucous membrane, non-intact skin, or parenteral exposure to blood or other potentially infectious materials that results from the performance of an employee's duties. Examples of an exposure incident include blood spattering into the eyes, splashing into the mouth or a puncture by a blood-contaminated needle.
- As was pointed out by one commenter, the term "occupational exposure"
has been used by others to describe the conditions that OSHA has labelled as an "exposure incident" (Klaman and Rao, Shadyside Hospital, Ex. 20-546). For the purpose of the standard, it is necessary to use one term, "occupational exposure," for reasonably anticipated exposure (which requires the implementation of protective measures) and another term, "exposure incident," for a discrete exposure event (which requires medical follow-up).
Although a small amount of blood on intact skin would not be considered an exposure incident under this definition, such an event should be a matter of concern to the employer. It may be an indication of inadequate personal protective clothing and equipment and the circumstances surrounding such events should be investigated to determine whether they can be prevented in the future.
"Handwashing Facilities" means a facility providing an adequate supply of running potable water, soap and single used towels. The Agency anticipates that most employees will have access to a sink that can be used for handwashing. Clean paper towels, clean roller towels, or a hot air hand dryer may be used. In cases where the above described requirements are not feasible alternative methods are permitted. See discussion of paragraph (d)(2)(iv)below.
- "HBV" means hepatitis B virus. "HIV" means human immunodeficiency
virus. "Licensed Healthcare Professional" means a person whose legally
permitted scope of practice allows him or her to independently perform the
activities required by paragraph (f) Hepatitis B Vaccination and
Post-exposure Follow-up. Paragraph (f)(1)(ii)(C) requires that medical
evaluations and procedures including the hepatitis B vaccine and
post-exposure prophylaxis and follow-up are performed by or under the
supervision of an appropriately trained and licensed healthcare professional.
A definition for licensed healthcare professional has been added to the final
standard because this term was not used in the proposed standard. The
definition reads "a person whose legally permitted scope of practice allows
him or her to independently perform the activities required by paragraph (f)
Hepatitis B Vaccination and Post-exposure Evaluation and
Several commenters noted that a variety of healthcare professionals are capable of and, in fact, currently are administering the hepatitis B vaccine and post-exposure evaluation and follow-up to employees as required in the standard (e.g., Tr. 9/20/89, pp. 29,31; Ex. 20-1222; Ex. 20-141). The final standard requires that the persons delivering care to employees are appropriately trained and licensed to carry out the activities required by section (f) of the standard. These services include activities such as providing Hepatitis B vaccine, ordering appropriate laboratory tests, determining contraindications to vaccination, providing post-exposure prophylaxis and counseling. The legal scope of practice for this professional must allow the independent performance of all the procedures described in paragraph (f) hepatitis B vaccination and post-exposure evaluation and follow-up.
A variety of healthcare professionals may perform these functions. For example, in addition to licensed physicians, the majority of states have laws that enable advanced practitioners in nursing to provide medical services independently. Nurse Practitioners and clinical nurse specialists are registered nurses prepared through a formal, organized education program and certified for an advanced practice role. This group of registered nurses provides primary healthcare that includes traditional medical services as well as nursing care.
A more complete discussion of this portion of the standard can be found in the Summary and Explanation of paragraph (f)(1)(ii)(C).
"Occupational Exposure" is one of the key terms upon which the standard rests. It contains the criteria which trigger application of the final standard.
- The definition reads:
Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.
Actual contact would be expected during an autopsy or surgery. In these cases, blood or other potentially infectious materials come in direct contact with the employee's gloves or other protective clothing. In other cases, contact may not occur each time the task or procedure is performed, but when blood or other potentially infectious materials are an integral part of the activity, it is reasonable to anticipate that contact may result. Examples of such tasks are phlebotomy and changing a surgical dressing.
The occupational exposure must be reasonably anticipated. For example, the employer would reasonably anticipate that contact with blood or other potentially infectious materials would occur when an employee is performing certain surgical, medical, dental, or laboratory procedures. On the other hand, the employer would not reasonably anticipate that contact with blood and other potentially infectious materials would occur when an employee is driving a bus down the highway or is processing insurance claims in an office setting.
In addition to being reasonably anticipated, the contact must result from the performance of an employee's duties. An example of a contact with blood and other potentially infectious materials that would not be considered to be an "occupational exposure" would be a "Good Samaritan" act. For example, one employee may assist another employee who has a nosebleed or who is bleeding as the result of a fall. This would not be considered an occupational exposure unless the employee who provides assistance is a member of a first aid team or is otherwise expected to render medical assistance as one of his or her duties.
One commenter questioned whether "Good Samaritan" acts should be excluded from the standard and listed a number of reasons why one worker might come to the aid of another even though it was not part of their duty to do so (Ms. Ruth Christos, S. C. Dept. of Health and Environmental Control, Ex. 20-1160). Since accidents and unexpected illness can occur in any workplace, exposure to blood is a theoretical possibility in all working environments. Many worksites have employees whose duty is to provide first aid or medical assistance, and employers must provide them with the protection of the standard. However, OSHA has concluded that it would be needlessly burdensome to require that all employers, including those where none of the employees have duties that can reasonably be expected to result in contact with blood and other potentially infectious materials, implement the provisions of the standard based on the chance that an employee will have contact with blood and other potentially infectious materials while performing a task that he or she is not required to do.
The definition of "occupational exposure" that appeared in the proposed standard included a second sentence:
The definition excludes incidental exposures that may take place on the job and that are neither reasonably nor routinely expected and that the worker is not required to incur in the normal course of employment (54 FR 23134).
A number of commenters found this second sentence confusing, contradictory or redundant. (Mr. V.J. Vincent, Boeing Support Services, Ex. 20-1150; Grady Memorial Hospital (Ohio), Ex. 20-834; Mrs. Ann Marie Witherow, Clearfield Hospital, Ex. 20-960; Dr. Carol Rice, MidWest Consortium for Hazardous Waste Worker Training, Ex. 20-892; AFSCME, Ex. 297). The terms "incidental exposure", "reasonably [expected]" and "routinely expected" were not defined. For instance, it was not clear whether the Agency intended to cover exposures that were not routine in nature. In addition, there was no guidance as to what constituted an incidental exposure or as to who would determine when one had occurred. "Incidental" can mean likely to happen or incurred casually in addition to the normal amount. For example, the State of Maryland Division of Labor and Industry submitted information indicating that certain funeral home operators among other employers believed that their exposures were incidental and therefore would not be covered by the standard (Ex. 20-1362). As discussed in "Scope," some funeral home employees can be expected to have occupational exposure.
Moreover, it was not clear whether "reasonably anticipated" from the first sentence meant the same as "reasonably expected" in the second sentence. Some commenters found the language contradictory in that there might be situations where the exposures are incidental or infrequent yet reasonably anticipated due to the nature of the employee's duties and thus, not excluded from coverage. Finally, some commenters pointed out that the language used in the second sentence was redundant in that the first sentence already defined occupational exposure as exposures to blood or other potentially infectious materials that may result from the performance of an employee's duties. Because the term "employee's duties" implies the performance of duties that are part of the employee's job description, the second sentence adds nothing by stating that exposure incidents not incurred by a worker in the normal course of his or her employment are not considered occupational.
In attempting to convey the idea that exposures, such as the "Good Samaritan" act described above, are not considered "occupational exposures" for the purposes of this standard, the wording of the definition in the proposal was confusing. Therefore, the Agency has concluded that the second sentence should be deleted.
The purpose of this standard is to prevent bloodborne infections by eliminating or reducing occupational exposure. In order to achieve this goal, it is necessary to know where and how such exposure can occur and who will be performing those tasks and procedures. In an ideal situation, no employee would ever have skin, eye, mucous membrane, or parenteral contact with blood and other potentially infectious materials. A definition of occupational exposure that was limited to events in which not only an exposure incident occurs but also occurs each time the task is performed, would not achieve the goal of the standard.
Despite the explanation in the proposal, some commenters interpreted the words "reasonably anticipated" to mean that contact with blood or other potentially infectious materials would have to occur each time the task was performed in order to be considered occupational exposure. For example:
Furthermore, the AABB maintains that, in the performance of a phlebotomist's duties in bleeding a normal blood donor, it is not reasonably anticipated that the phlebotomist will have skin or other contact with blood. It is the exception, not the rule, that the phlebotomist will have skin or other contact with blood. (AABB, Ex. 20-1059)
In order for employees to be protected from actual exposures, protective measures must be instituted before the blood or other potentially infectious materials come in contact with the person. OSHA has concluded that the words "reasonably anticipated" give the employer clear guidance in determining which of his or her employees are covered under the standard. It is necessary for the employer to know who is potentially exposed so that the employer can assure that proper training, engineering and work practice controls, personal protective equipment and the other provisions of the standard are implemented. This requires that the employer examine the tasks and procedures and determine if it can be reasonably anticipated that exposure may occur. For example, it is reasonable to anticipate that when a needle is inserted into a vein for the purpose of withdrawing blood that some of the blood may contact the gloved or ungloved fingers of the phlebotomist. Such contact would not necessarily be expected to occur with each phlebotomy.
"Other Potentially Infectious Materials" consists of three primary categories of material which have the potential to transmit bloodborne pathogens. OSHA has used the term "potentially" to acknowledge that body fluids and tissues may or may not contain bloodborne pathogens. However, the provisions of the standard must be followed in any case. Under this definition, OSHA has included the body fluids specified by the CDC in their June 1988 update of guidelines for healthcare workers (Ex. 6-316). The fluids covered by this definition are: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, amniotic fluid, saliva in dental procedures, and any other body fluid that is visibly contaminated with blood. In support of utilizing universal precautions when contacting these body fluids, CDC stated:
- Universal precautions also apply to tissues and to the following fluids:
cerebrospinal fluid (CSF), synovial fluid, pleural fluid, peritoneal fluid, pericardial fluid, and amniotic fluid. The risk of transmission of HIV and HBV from these fluids is unknown; epidemiologic studies in the health-care and community setting are currently inadequate to assess the potential risk to health-care workers from occupational exposures to them. However, HIV has been isolated from CSF, synovial, and amniotic fluid , and HbsAg has been detected in synovial fluid, amniotic fluid and peritoneal fluid. One case of HIV transmission was reported after a percutaneous exposure to bloody pleural fluid obtained by needle aspiration. Whereas aseptic procedures used to obtain these fluids for diagnostic or therapeutic purposes protect health-care workers from skin exposures, they cannot prevent penetrating injuries due to contaminated needles or other sharp instruments. (Ex. 6-316)
Commenters generally agreed with using the CDC list. However, a number expressed the opinion that the focus should be on blood rather than other body fluids. Some representatives of the dental profession wondered why OSHA singled out saliva in dental procedures. For example:
[W]hy is saliva singled out in "dental procedures"? If saliva is to be considered a potentially infectious material only in dental procedures, then the diversity of dental procedures must be addressed. The paragraph could be changed to read: "saliva visibly contaminated with blood" and thereby eliminate an apparent inconsistency with the public view regarding the infectiousness of saliva. (Federation of Prosthodontic Organizations, Ex. 20-232).
While universal precautions do not generally apply to saliva, exception is made in the case of saliva in dentistry. Addressing this situation, the CDC states:
Special precautions, however, are recommended for dentistry . Occupationally acquired infection with HBV in dental workers has been documented , and two possible cases of occupationally acquired HIV infection involving dentists have been reported. During dental procedures, contamination of saliva with blood is predictable, trauma to health-care workers' hands is common, and blood spattering may occur. Infection control precautions for dentistry minimize the potential for nonintact skin and mucous membrane contact of dental health-care workers to blood-contaminated saliva of patients.(Ex. 6-316)
OSHA has concluded that the CDC guidelines of June 1988 provide the best guidance for determining which body fluids are included in the definition for other potentially infectious materials, and we have adopted that list.
The Agency requested comments as to whether other body fluids should be added to the list of other potentially infectious materials. With the exception of those commenters who encouraged OSHA to expand the standard beyond bloodborne pathogens, most commenters agreed that body fluids such as urine and feces should not be added to the list unless they were visibly contaminated with blood (For example, Hospital Assn. of N.Y., Ex. 20-381; Ms. Mary Wilson, Central Florida APIC, Ex. 20-57; South Seminole Community Hospital, Ex. 20-251).
Hoffman-LaRoche requested a clarification as to whether materials which have been obtained from donors that have undergone a prescreening process would qualify as "other potentially infectious materials" (Ex. 20-291). None of the body fluids listed would be exempted because the donor has been prescreened. However, after the blood has been tested and is available for transfusion or other clinical use, then it is exempted from the labelling requirements in paragraph (g).
CDC's guidelines for public safety officers state that when it is difficult or impossible to differentiate between body fluids all body fluids should be treated as if they are potentially hazardous (Ex. 15).
The unpredictable and emergent nature of exposures encountered by emergency and public-safety workers may make differentiation between hazardous body fluids and those which are not hazardous very difficult and often impossible. For example, poor lighting may limit the worker's ability to detect visible blood in vomitus or feces. Therefore, when emergency medical and public-safety workers encounter body fluids under uncontrolled, emergency circumstances in which differentiation between fluid types is difficult, if not impossible, they should treat all body fluids as potentially hazardous. (Emphasis in the original) (Ex.15)
After reviewing the comments in the record on this issue, the Agency concluded that such a provision is needed in the standard. The definition of other potentially infectious materials has, therefore, been modified. The Agency also addresses this situation in Methods of Compliance, paragraph (d)(1).
The second category of other potentially infectious materials is "any unfixed tissue or organs (other than intact skin) from a human (living or dead)." These pose a risk because they may be contaminated with bloodborne pathogens. One example of a tissue is human bone which has transmitted HIV infection as the result of transplantation (Ex 6-357). In the same document, CDC also notes reported transmission of HIV through "transplantation of kidney, liver, heart, pancreas, possibly by skin, and by artificial insemination ... ".
Although tissues and organs may contain blood and body fluids, which may be the reason for the transmission hazard, they are not in reality "fluids". Therefore, to avoid confusion OSHA has listed them as a separate category. Since casual contact, including touching, does not pose a risk of transmission, intact skin is not considered to be "other potentially infectious materials."
- CDC/NIOSH stated that the parenthetical words "other than intact skin"
and "living or dead" should be deleted because they are superfluous (CDC/NIOSH, Ex. 20-634). OSHA agrees that, normally, one would want a simple definition without parenthetical elements. However, to avoid misinterpretation, the Agency has chosen to retain the parenthetical elements so that the meaning is clear.
The third group under "other potentially infectious materials" relates to the culture and propagation of HIV and HBV in laboratory cultures and experimental animals. This group contains HIV-containing cell or tissue cultures, organ cultures, and HIV- or HBV- containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals infected with HIV or HBV. This definition applies particularly to research activities and to production activities where concentrations of virus can be expected to exceed the concentration found in blood. Section IV - Health Effects discusses in detail the infection of two workers that resulted from occupational exposure to high concentrations of HIV virus in a production facility.
AFSCME, District Council 37 suggested that animal blood be included (Ex. 20-985). The current definition includes the blood of animals experimentally infected with HIV or HBV. It would not normally include the blood from companion animals (pets), other domestic animals, animals in zoos or research animals not infected with HIV or HBV. The record does not contain the information necessary to determine whether animal blood in these circumstances presents a significant occupational risk.
"Parenteral" refers to piercing the skin barrier (including mucous membranes), and the definition in the final standard is basically unchanged from the proposal; that is, parenteral refers to piercing the skin barrier. This route of transmission presents the greatest hazard to the employee (Ex. 6-430; 6-449). There was little comment on this definition during the comment period.
In the proposed rule, the definition of parenteral included examples of routes of parenteral exposure (e.g. subcutaneous, intramuscular, intravenous). In the final standard, examples of parenteral exposure are described again, but events rather than routes are used as examples. Needlesticks are an easily identified example of an event in which "parenteral" exposure may occur.
Human bites are another example of a parenteral exposure event. There is evidence in the record that individuals have been infected with HBV as the result of a human bite, and it is reasonable to expect that some workers will be bitten (Ex. 6-316). For example, law enforcement and correctional officers may be subject to human bites during interaction with violent suspects or prisoners. Human bites also occur in the emergency room or psychiatric setting with patients who are violent or psychotic. In these instances, due to the violent nature of the occurrences, bleeding from the mouth (gums, teeth or soft tissue) of the source individual can be anticipated, exposing the worker to blood from the source individual. For these reasons, human bites have been included as examples of parenteral exposures. However, not all bites that occur in a workplace would be considered occupational exposure. For example, if two coworkers fight in the workplace, and one bites the other, this is not occupational exposure for either of these workers since neither is expected to incur bites as part of his or her job. Moreover, elementary and high school teachers, particularly those whose students do not include the developmentally disabled or mentally ill, would not reasonably anticipate being bitten as part of the performance of their duties.
Cuts and abrasions also represent examples of interruption in the skin barrier and another route of entry for bloodborne pathogens. Since exposure to non-intact skin is included as an "exposure incident", cuts and abrasions are listed here as examples of a "parenteral" route.
"Personal Protective Equipment" is specialized clothing or equipment worn by an individual to protect him or her from a hazard. For the purposes of this standard, this term includes, but is not limited to, clothing and equipment such as a) gloves; b) gowns, aprons, laboratory coats; c) faceshields, protective eyewear and masks; and d) mouthpieces, resuscitation bags, or other ventilation devices. General work clothes (e.g., uniforms, pants, shirts and blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment. A more detailed discussion concerning general work clothes and personal protective equipment can be found under the discussion of paragraph (d)(3)(i).
OSHA received one comment which suggested that the definition of the personal protective equipment should include clothing "placed on the patients" (Mr. Stanley Dub, Ex. 20-516). The example used by the commenter was a dental dam which is an example of an engineering control rather than personal protective equipment and would be covered under that definition.
"Production Facility" is defined as a facility engaged in industrial-scale, large-volume or high concentration production of HIV or HBV. The 1988 Agent Summary Statement for Human Immunodeficiency Virus was the source for this term (Ex. 6-312).
"Regulated Waste" was called "Infectious Waste" in the proposal. "Infectious Waste" was defined as blood and blood products, contaminated sharps, pathological wastes, and microbiological wastes. In this final standard, the analogous term "regulated waste" has been defined as: 1) liquid or semi-liquid blood or other potentially infectious materials; 2) contaminated items that would release with blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; 3) items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; 4) contaminated sharps; and 5) pathological and microbiological wastes containing blood or other potentially infectious materials. Based upon the collected information, OSHA has concluded that these items are generally recognized as presenting a hazard of disease transmission and as such, warrant special handling.
- During the hearings, CDC/NIOSH testified:
The categories of items that we consider as potentially infectious and that should be handled in a special manner include microbiological waste, bulk blood or body fluid, contaminated blood, sharps or pathological waste, materials that contain those particular items would be defined by the CDC as infectious waste. (Ms. Polder - CDC/NIOSH, Tr. 9/14/89, p.54)
CDC explains their position further in their written comment, stating:
... As a related point of information, CDC considers it important to use the CDC definition of infectious waste, which has been adopted by OSHA in this proposed rule, in preference to the definition of medical waste adopted by EPA and used in the Medical Waste Tracking Act. The CDC definition is based on the epidemiology of disease transmission, whereas other definitions are much broader and include articles that should not require special handling. (CDC/NIOSH, Ex. 20-634)
With regard to EPA and their definition of wastes requiring special handling, some commenters expressed opinions similar to CDC and discouraged adoption of EPA's Medical Waste Tracking Act (MWTA) definition (e.g., APIC - Indiana, Ex. 20-139; McLeod Regional Medical Center, Ex. 20-527; Meadville Medical Center Ex. 20-624). However, other participants recommended that the MWTA definition be incorporated into the final standard (e.g. ADA, Ex. 20-665; Support Systems International, Ex. 20-1149). On a more general level, comments were also received which simply encouraged OSHA to assure that the final regulation's definition of "infectious waste" does not conflict with EPA's definition (e.g., AHA, Ex. 20-352; Tucson Medical Center, Ex. 20-141; Hospital of St. Raphael, Ex. 20-289).
- In their comment on the proposal, EPA states:
The proposed OSHA definition appears to be fairly consistent with the wastestreams EPA regulates in 40 CFR Part 259, if the term "microbiological wastes" corresponds to Class 1 wastes in 40 CFR 259.30(a)(1) ("Cultures and stocks of infectious agents...."). EPA's rules also may cover a broader range of wastes, but generally do not refer to them as "infectious wastes" due to the wastes' widely varying infective capability. (EPA, Ex. 20-991)
Reviewing 40 CFR Part 259 reveals that microbiological wastes, as OSHA has defined them in this final regulation, would fall under Class 1 since the presence of blood or other potentially infectious materials is, under universal precautions, assumed to indicate the presence of a disease-causing bloodborne pathogen. EPA goes on to remark that their rules may cover a broader range of wastes. OSHA does not feel that this presents a conflict of definitions since the wastes regulated under this rule are a subset of those regulated by EPA. The Agency has concluded that the wastes covered under this standard warrant special handling and are in accordance with both CDC and EPA definitions. Therefore, these categories of waste have been retained in this regulation with modifications adopted in response to public comment.
Several participants commented on the ability of medical waste to transmit disease (e.g., Good Samaritan Hospital, Ex. 20-1230; Anaheim Medical Center, Ex. 20-45; Lewis-Gale Hospital, Ex. 20-871). In conjunction with this, a number of commenters raised the issue of the necessity of regulating the handling of certain components of the medical wastestream such as blood-stained bandages which could fall under the proposed definition but which they felt posed no threat of disease transmission (e.g., Palomar Pomerado Hospital, Ex. 20-1260; Rowan Memorial Hospital, Ex. 20-629; Community Hospital of Chula Vista, Ex. 20-761). Reviewing the record, it was noted that very little information is available on the potential for contracting disease as a result of contacting medical waste. The primary basis for comments that medical waste is no more infectious than household waste seems to be several German studies conducted in the early to mid-1980's comparing bacterial load of hospital wastes which are usually collected daily with that of household waste that was up to 7-days old (Exs. 286C; 286T; 286W). The Agency does not intend to debate the merits of these studies and has not conducted original research in this area. Hence, OSHA cannot offer a more definitive determination of the "infectiousness" of these materials. To eliminate the implication that OSHA has determined the "infectiousness" of certain medical wastes, the aforementioned waste categories have been grouped under the term "Regulated Waste" rather than "Infectious Waste."
Non-sharp waste, such as bandages, can be contaminated with widely varying amounts of blood or other potentially infectious materials, ranging from a single drop to complete saturation. The proposal contained no specific reference to how blood-contaminated non-sharp waste was to be differentiated and handled but simply stated that blood and blood products were to be treated as infectious waste. During the informal public hearings, the Agency solicited information from participants regarding what criteria were currently being utilized to determine which of these types of wastes were treated as "infectious" and which wastes were placed into the general waste stream. Responses to this inquiry were widely divergent, ranging from considering only blood-saturated items as infectious waste (Nassau-Suffolk Hospital Council, Inc., Tr. 11/14/89, pp.466-467) to "red-bagging" all items contaminated with blood or body fluids (Baptist Medical Center Montclair, Tr. 9/19/89, p.98; Laura Williams - SEIU, Tr. 10/17/89, pp.66-67). In addition, several interested parties requested that OSHA clarify what wastes were encompassed by the phrase "blood and blood products" (e.g., Greater New York Hospital Association, Tr. 11/14/89, p.316; APIC -Greater Los Angeles, Ex. 20-213). It became obvious to the Agency that no generally-accepted criteria was being applied by those involved to classify which blood-contaminated non-sharp waste required special handling. Therefore, an easy-to-use, acceptable minimal benchmark would have to be developed to assure consistent compliance and enforcement in this area. A number of commenters offered suggestions as to what this benchmark should be. The majority of commenters who considered this issue suggested that only bulk blood be considered infectious waste (e.g., AHA, Ex. 20-352; Middle Tennessee Medical Center Inc., Ex. 20-105; Arizona Hospital Association, Ex. 20-69). The difficulty with this approach is that there is little agreement on how much blood constitutes "bulk blood." Some commenters recommended actual volume amounts of blood ranging from greater than 10 ml to more than 100 ml of blood (e.g., Kalispell Regional Hospital, Ex. 20-1212; Virginia Mason Hospital, Ex. 20-569; Providence Memorial Hospital, Ex. 20-744). The Agency has concluded that such a determination would be difficult to judge since the visual characteristics of a specific quantity of blood would vary based on the type and size of substrate on which it appeared. For example, 10 ml of blood on a bed sheet would appear as a spot while the same amount on a cotton ball would likely cause saturation and dripping. Suggestions offered by other participants included bulk blood and items heavily saturated with blood or which drip and splash (e.g., Redlands Community Hospital, Ex. 20-692; Mills-Peninsula Hospitals, Ex. 20-701; St. Anthony Hospital Systems, Ex. 20-221); waste heavily contaminated with blood (Cleveland Clinic Foundation, Ex. 20-563); blood soaked items - not blood stained items (e.g., Nassau-Suffolk Hospital Council, Inc, Tr. 11/14/89, p. 46); only bulk amounts of liquid or semi-liquid blood (i.e. pourable or ability to flow), excluding dried blood (e.g., APIC - Indiana, Ex. 20-139; APIC - Greater Omaha, Ex.20-943); and blood that readily separates from the solid portion of waste under ambient temperature and pressure (Paradise Valley Hospital, Ex. 20-217). The record indicates that a large number of commenters feel that bulk blood should be classified as infectious waste. Moreover, "bulk" blood seems to be generally associated with the ability to pour or flow. During the hearings, Ms. Polder of the CDC stated:
. . . [I]n terms of blood, we really feel that the only type of blood that you need to be concerned about, in terms of transmission of disease, is bulk blood, or bulk fluids that may contain blood which means essentially liquids. . . . In terms of items that are contaminated with blood that may be dry or may be wet, but are contained in a material such as gauze or a bandage, the risk of transmission of a pathogen to a susceptible host is extremely unlikely, and therefore, that type of waste can be handled like any other waste that is collected in the community, that may be contaminated in the same fashion. (Tr. 9/14/89, p.92)
Consequently, this physical characteristic (i.e., the ability to pour, flow, drip, etc.) has been adopted as one of the attributes of waste being regulated under this standard.
Comments such as those submitted by APIC - Greater Omaha Area and Paradise Valley Hospital make it apparent that in some circumstances solid waste is capable of generating bulk (i.e. liquid or semi-liquid) blood (Exs. 20-943; 20-217). While an item which is freely dripping blood or other potentially infectious materials obviously falls into this category, some items may adequately contain these materials when in a static state yet liberate them when compressed. During accumulation of waste in a container, the weight of items toward the top of the container naturally compress those items beneath. Wastes may also be purposefully compacted in order to increase the amount of waste which can be placed into a single container. This compression could generate potentially infectious liquids which would then accumulate at the bottom of the container. If the container's barrier capability is compromised, these materials would be released, presenting an exposure and/or contamination hazard. An EPA guidance document addressing EPA's Medical Waste Tracking Act states:
. . . Only those fibrous items that are completely saturated with blood (or would drip with blood if squeezed), or non-fibrous items that have enough blood present that they are dripping, are regulated medical waste. . . . (Ex.224, Attachment A)
Both the EPA document and the statement by Ms. Polder of the CDC indicate that blood or other potentially infectious materials which are contained in non-sharp contaminated waste, such as bandages, do not become a concern until these liquids are liberated from the substrate. The ability of the substrate to contain these substances is the deciding factor as to their proper handling and disposal. OSHA has therefore concluded that items contaminated with blood or other potentially infectious materials which would release these substances in a liquid or semi-liquid state if compressed should be considered regulated waste.
Dried blood or other potentially infectious materials could also pose a problem if these dried materials are released from a contaminated item during handling. A study by Bond et. al. (Ex. 20-634) showed hepatitis B virus could remain viable in dried material for up to seven days. Furthermore, CDC recognizes the potential for disease transmission by dried blood. In their 1989 document, Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public-Safety Workers, CDC recommends to law enforcement personnel:
Airborne particles of dried blood may be generated when a stain is scraped. It is recommended that protective masks and eyewear or face shields be worn by laboratory or evidence technicians when removing blood stain for laboratory analysis. (Ex. 15)
Based on this prolonged viability and potential for infection, items that are heavily contaminated or "caked" with dried blood or other potentially infectious materials have been included in those situations where such dried materials could flake or fall off of the item during handling.
In summary, the category "blood and blood products" contained in the proposal has been more specifically delineated in the final standard to read: 1) liquid or semi-liquid blood or other potentially infectious materials; 2) items contaminated with blood or other potentially infectious materials which would release these substances in a liquid or semi-liquid state if compressed; and 3) items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling. This expansion and clarification provides easily-recognized criteria for determining OSHA's intent as to those wastes it considers, at a minimum, to require special handling.
Very little comment was received about the remaining three categories of (infectious) regulated waste. Marion Memorial Hospital appeared to be referring to sharps that have not been contaminated by bloodborne pathogens when they stated that many sharps are utilized in hospitals that are never exposed to a patient (Ex. 20-1269). In consideration of those circumstances in which contamination of a sharp by bloodborne pathogens is known not to exist, the term "sharps" has been revised to "contaminated sharps" in the final standard to clarify that, for the purposes of this standard, sharps which are contaminated with blood or other potentially infectious materials are the items with which OSHA is concerned. However, it should be noted that other local, State, and Federal agencies (e.g., EPA) may have more expansive regulations regarding sharps and their disposal based upon factors such as transmission of diseases other than bloodborne diseases, aesthetic concerns, or the physical puncture hazard of sharps in general.
- As to the categories "pathological waste" and microbiological waste,"
Boone Hospital Center requested a clarification on which pathological wastes are considered infectious while the State of Connecticut, Office of Policy and Management, commented that some microbiological wastes will not present a hazard to humans (Exs. 20-556; 20-796). These issues have been addressed by adding that it is those pathological and microbiological wastes "containing blood or other potentially infectious materials" which are regulated by this standard. Again, one should be aware that other agencies may have more stringent and inclusive regulations concerning these wastes.
"Research Laboratory" is defined as a facility engaged in activities such as producing or using research-laboratory-scale amounts of HIV or HBV. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in production facilities.
While Abbott Laboratories found the requirements for research and production facilities appropriate, they raised a question about the definition of "research laboratory." Specifically they said:
We do find the use of the term "research laboratory" confusing since there are research laboratories where only clinical specimens are handled, and clinical or diagnostic laboratories where virus propagation for the purpose of diagnosis takes place (Abbott, Ex. 20-127).
Because the standard must address a number of different workplaces and activities, it has been necessary to define certain umbrella terms, such as "source individual" (see discussion below), "production facility" and "research facility". A "research facility is a facility that produces or uses concentrated virus, that is, virus in higher concentrations than would be found in human blood and body fluids. OSHA's intention in this matter is to parallel the intent of CDC/NIH quoted above.
On the second issue raised by Abbott, OSHA recognizes that there are laboratories that conduct research on blood and other body fluids and this research is unrelated to research on HIV or HBV. These laboratories are not considered research laboratories for the purpose of this standard. They would not be required to comply with paragraph (e), but would have to comply with all of the other provisions of the standard which are applicable.
"Source Individual" means any individual, living or dead, whose blood or other potentially infectious materials may be a source of occupational exposure to the employee. This term includes a wide spectrum of people when one considers both the need for universal precautions and the multitude of healthcare and nonhealthcare settings in which occupational exposure may occur. Examples of such individuals include, but are not limited to, hospital and clinic patients; clients in institutions for the developmentally disabled; trauma victims; clients of drug and alcohol treatment facilities; residents of nursing homes or hospices; human remains; individuals who donate or sell blood or blood components.
In the proposed standard, human remains prior to embalming was one example of a source individual or patient. In the final standard, the words "prior to embalming" were deleted because there is no evidence in the record that demonstrates when or if embalming inactivates HIV or HBV.
Individuals who donate or sell blood or blood components includes individuals who donate or sell plasma, a blood component.
The Agency was sharply criticized for defining blood donors as "patients" in the proposal (Ms. Joan Elise Dubinsky, ARC, Ex. 20-784; Dr. Laurence A. Sherman, AABB, Ex. 20-1059; Mr. James P. Reilly, ABRA, Ex. 20-1090). However, none of the representatives of these groups was able to suggest an alternate term. As it became clear, the objections of many of the representatives of blood and plasma banks industry go beyond the use of the term, "patient." They want blood and plasma donors to be removed from the list entirely (Dr. Paul Holland, AABB, Tr. 10/220/89 pp. 768- 775). As we discussed in "Scope," the Agency does not plan to exclude certain sectors, such as blood banks and nursing homes, because they provide services for individuals who are not at high risk for HIV and HBV infection. We do, however, agree that a more descriptive term than "patient" should be used. Therefore, we looked to the CDC for a more appropriate term.
In their recommendations, CDC has used several terms to refer to the individual whose blood or body fluids are a source of occupational exposure to the employee. In their August 1987 guidelines, they used the word "patient" (Ex. 6-153). In the more recent documents, they have used the terms "source individual" (Ex. 286 J) and "source of exposure" (Ex.286G).
OSHA has chosen to use the term "source individual" because it provides the best description without the limiting qualities inherent in the word "patient." It is clear that any human can be a "source individual."
"Sterilize" means the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores.
"Universal Precautions" is a method of infection control in which all human blood and certain human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.
In their 1987 document, "Recommendations for the Prevention of HIV Transmission in Health-Care Settings," CDC states:
Since medical history and examination cannot reliably identify all patients infected with HIV or other blood-borne pathogens, blood and body-fluid precautions should be consistently used for all patients. This approach, previously recommended by CDC and referred to as "universal blood and body-fluid precautions" or "universal precautions" should be used in the care of all patients, especially including those in emergency- care settings in which the risk of blood exposure is increased and the infection status of the patient is usually unknown (Ex. 6-153).
In their 1988 "Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings," CDC reiterates this concept in the statement:
Under universal precautions, blood and certain body fluids of all patients are considered potentially infectious for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and other bloodborne pathogens (Ex. 6-316).
The public safety worker guidelines issued by the Centers for Disease Control in 1989 extend the use of universal precautions to all body fluids in certain situations. These guidelines state:
[W]hen emergency medical and public-safety workers encounter body fluids under uncontrolled, emergency circumstances in which differentiation between fluid types is difficult, if not impossible, they should treat all body fluids as potentially hazardous (Ex. 15).
While the final standard's definition of universal precautions does not include this extension, it has been incorporated and discussed in the definition of "other potentially infectious materials" and in paragraph (d)(1) of the Methods of Compliance section of this document.
OSHA's definition of universal precautions in the proposed standard is perfectly consistent with the CDC's statements. A number of the comments relating to the proposal's definition of universal precautions appear to relate not to the definition per se but are directed to the Agency's proposed methods of implementing this infection control concept contained in paragraph (d) of the proposal. Based upon a careful review of the aforementioned CDC documents, OSHA has concluded that the proposed definition of "Universal Precautions" is correct and should be retained without modification. Therefore, the final regulation defines "Universal Precautions" as a method of infection control in which all human blood and certain body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens.
"Work Practice Controls" are controls that reduce the likelihood of exposure by altering the manner in which a task is performed. As they relate to this standard, examples of some work practice controls include 1) adherence to the practice of universal precautions in all situations of occupational exposure; 2) prohibiting the recapping of needles or other sharps by a two-handed technique; and 3) prohibition of pipetting or suctioning by mouth. To give an example of a workplace control, the words "e.g. prohibiting recapping of needles by hand" was incorporated in the definition. In each of these examples of work practice controls, the possibility for exposure to blood, or other potentially infectious materials has been eliminated or minimized simply by alteration of the way in which the employee performs the task.
Paragraph (c) Exposure Control
Employees incur risk each time they are exposed to bloodborne pathogens. Any exposure incident may result in infection and subsequent illness. Since it is possible to become infected from a single exposure incident, exposure incidents must be prevented whenever possible. It is the goal of this standard to reduce a significant risk of infection by minimizing or eliminating occupational exposure to blood and other potentially infectious materials, providing the hepatitis B vaccine, and post exposure medical follow-up. The purpose of paragraph (c), Exposure Control, is to identify those tasks and procedures where occupational exposure may occur and to identify the positions whose duties include those tasks and procedures identified with occupational exposure.
In the proposed standard, paragraph (c) was entitled "Infection Control." However, the Agency has been reminded that the term "infection control" is typically used in healthcare to mean control of nosocomial infections, the aim of which is to prevent the transmission of pathogens to the client/patient by the employee (from cross-contamination).
Throughout the standard the term infection control is used. Although this is accurate to a point, it implies that the plan implementation is under the aegis of the Infection Control Department. However, infection control personnel traditionally are concerned with patient care. Their teaching with employees is done with the emphasis on providing safe patient care; that is, protecting the patient, not the health care worker, from the potential hazards of medical care. (American Association of Occupational Health Nurses, 9/20/89, TR, pg. 7-37 and 7-38).
In addition, comments in the record regarding usage of the terms "infection control plan" and "infection control" indicated that these terms do not translate easily to settings other than hospitals (Abbott Laboratories, Ex. 20-1227; Health Industry Manufacturers Association (HIMA), Ex. 20-795), and may not be understood by workers in occupations outside of the health care industry (Pharmaceutical Manufacturers Association, Ex. 20-729).
Though the principles of controlling infection may be similar to those involved with controlling employee exposure, the focus of this standard is on protecting the employee from occupational exposure to bloodborne pathogens. Therefore, in order to most effectively express the intent of this standard, the Agency believes that a clarification of these terms is necessary. Since it is OSHA's intent to control or minimize occupational exposure, the title of Paragraph (c) of the final standard is "Exposure Control", and paragraph (c)(1) is titled "Exposure Control Plan".
The Exposure Control Plan required by paragraph (c)(1) is a key provision of the standard because it requires the employer to identify the individuals who will receive the training, protective equipment, vaccination, and other provisions of this standard.
The American Association of Dental Schools (AADS) supported the proposed requirement that employers establish a Plan (Ex. 20-876). In addition, the Austin Area Infection Control Council supported the preparation and use of a Plan as a means of documenting current standards and operating procedures (Ex. 20-982). Some commenters suggested that employees should be encouraged to be involved with developing Plan policies (American Dental Hygienists Association, Ex. 20-256). However, this is not a requirement in the final standard.
Paragraph (c)(1)(i) of the final standard requires that the exposure control plan be written. The need for a written plan was supported by testimony at the public hearings.
It is only reasonable that the efforts to identify the population at-risk and the methods to reduce that risk be published within the facility so that employees will know what provisions are in place at their work establishments. A written, periodically reviewed, infection control plan is key to the proposed standard. (Elise Yiasemides, 9/13/89, TR, pg. II-42).
The reasons for having a written Plan are threefold. First, because exposure control must be practiced by everyone--employee and employer--it is imperative that employees be able to find out what provisions are in place in his or her workplace. According to testimony from NIOSH, having the Plan in writing,
...would serve as an on-site adjunct to the overall infection control plan, would reinforce educational programs, and should be used in mandated training programs. (NIOSH, 9/14/89, TR, III-27 & 28).
Secondly, that the Plan be in writing is also important for enforcement. By reviewing the Plan, the OSHA Compliance Officer will be able to become familiar with the employer's determination of tasks and procedures with occupational exposure, the job classifications whose duties include those identified tasks, and the implementation and revisions to the Exposure Control Plan. In addition, Paragraph (g)(2)(vii)(D) requires that the Exposure Control Plan be explained as part of the employee training program.
According to the record, many commenters were not opposed to the idea of having a written Plan, but rather, they objected to writing a whole new Plan, especially when similar plans already exist. Many commenters suggested incorporating the Exposure Control Plan into existing infection control plans currently in place (Frankfort Hospital, Ex. 20-211; Casa Colina Hospital for Rehabilitative Medicine, Ex. 20-284).
- The Society of Hospital Epidemiologist of America commented that,
The requirement to establish "a written infection control plan" seems to imply that all applicable policies must be incorporated into a new, separate document. However, hospitals already have comprehensive Infection Control manuals which typically include many or all of the provisions required by OSHA (Ex. 20-1002).
The Veterans Administration requested that OSHA allow employers to integrate the intent of this standard into existing documents. Examples of existing documents that could be used are job descriptions, performance criteria, procedure manuals, and departmental guidelines in infection control manuals (Ex. 20-43).
The Wisconsin Association of Nursing Homes objected to the "intrusion upon systems that have already proven effective" and suggested that OSHA have some mechanism whereby existing plans could be evaluated for their effectiveness. Otherwise, they contend OSHA is essentially requiring that facilities go to the expense of reformulating infection control plans solely for the purpose of complying with a rule and not for the purpose of prevention of disease transmission (Wisconsin Association of Nursing Homes, Ex. 20-255).
The Pharmaceutical Manufacturers Association commented that OSHA should specifically allow the Plan required by the standard to be a component of a larger, overall plan. They said that establishing a separate plan would be burdensome and potentially confusing to personnel (Ex. 20-729).
It is not OSHA's intent for employers to duplicate current policies, however, if the Exposure Control Plan is incorporated into existing manuals, all requirements of the regulation must be followed. Dr. Hardin of NIOSH stated in his testimony that,
... compliance with this rule should be approached as a part of the larger program to control all health and safety hazards in health care and public-safety workplaces. When such plans exist, it would be an unnecessary and wasteful use of resources to develop independent plans, policies and procedures solely to administer the requirements of this rule. When they already exist, infection control plans, health and safety programs, training programs, and the like should be reviewed and modified as necessary to ensure that all of the requirements of this rule are addressed as an integral part of those more comprehensive plans. (NIOSH, 9/14/89, TR, pg. III-28 and 29, Ex. 13).
Therefore, the final standard requires a written Exposure Control Plan, but does not prohibit the plan from being part of a larger document. Paragraph (c)(1)(i) reads: "Each employer having an employee(s) with occupational exposure shall establish a written Exposure Control Plan designed to eliminate or minimize employee exposure."
The content of the Exposure Control Plan is stated in paragraph (c)(1)(ii) of the final standard which reads: "The Exposure Control Plan shall contain at least the following elements:
- (A) The exposure determination required by paragraph (c)(2), (B) The
schedule and method of implementation for paragraphs (d) Methods of
Compliance, (e) HIV and HBV Research Laboratories and production Facilities,
(f) Hepatitis B Vaccination and Post Exposure Followup, (g) Communication of
Hazards to Employees, and (h) Recordkeeping, of this standard, and (C) The
procedure for the evaluation of circumstances surrounding exposure
In the Final Rule, as in the proposal, the Plan must contain the exposure determination as described in paragraph (c)(2) of this standard. Exposure determination is a key element of the Plan. The rationale and support for the exposure determination is discussed under paragraph (c)(2).
In addition to the exposure determination, the Plan must include an explanation of when and how the employer will implement the other provisions of the standard in a manner appropriate to the circumstances in the employer's workplace. In the proposed standard, OSHA stated that an annotated copy of the final standard would be sufficient to meet the requirement for the Exposure Control Plan to state when and how the employer will implement the provisions of the standard. The requirement is in performance language, so that each employer can structure the plan to cover the circumstances in the employer's workplace.
Comment from the College of American Pathologists supported that "an annotated copy of the final standard would be sufficient to meet the requirements" for paragraph (c)(1)(ii)(B) (College of American Pathologists, Ex. L20-1688A).
Testimony from OSHA expert witness Elise Yiasemides indicated that an annotated copy of the final standard would be adequate for most small facilities. Larger facilities could develop a broad facility-wide program incorporating provisions from the OSHA standard that apply to their establishments (9/13/89, TR, pg II-41, Ex. 28).
In the final standard, the Exposure Control Plan also requires the employer to state the procedure for evaluation of exposure incidents. This requirement was not included in the proposed rule. According to testimony by NIOSH:
The Infection Control Plan needs to be expanded to include requirements for...evaluation of the circumstances of exposure incidents and significant failures of control procedures to determine whether changes in policies or practices are needed to prevent recurrences of similar incidents ...Formal, systematic protocols should be established to evaluate all exposure incidents and other failures of controls so that any contributory deficiencies in institutional policies and procedures can be identified and corrected (NIOSH, 9/14/89, TR, III-27 and III-28).
The need for a procedure to evaluate exposure incidents was also supported by AFSCME (Ex. 297) and SEIU (Ex. 299).
The procedure for evaluating the circumstances surrounding exposure incidents required by paragraph (c)(1)(ii)(C), could include the following elements: an evaluation of the policies and "failures of control" at the time of the exposure incident; the engineering controls in place at the time of the exposure incident; and, the work practices and protective equipment or clothing used at the time of the exposure incident. The goal of this evaluation is to identify and correct problems in order to prevent recurrence of similar incidents.
Other additional elements were suggested by commenters to be included in the plan. The University of Cincinnati Medical Center suggested that the Plan include a critique of emergency situations and follow-up, in addition to including initial and annual training, and Plan revision (Ex. 20-648). The Retail, Wholesale & Department Store Union contributed that the Plan must be a written site-and-task specific document and must include: the name of the designated employee, types of engineering controls in place, the personal protective equipment necessary for each task, and the standard operating procedures for that department and task (Retail, Wholesale & Department Store Union, AFL-CIO, Ex. L20-1505). In addition, the American Federation of State, County & Municipal Employees, AFL-CIO, commented that employers should designate someone to be responsible for carrying out the Plan during all working hours, and that there should be some minimal qualifications for the person or persons so designated (Ex. 20-985). Although not included in the final rule as elements of the Exposure Control Plan, many of these considerations are included elsewhere in the overall requirements of the rule (i.e. requirements for training, PPE, and maintenance of controls).
In addition to having a written Plan, paragraph (c)(1)(iii) requires that the Exposure Control Plan be accessible to the employee. The reason for this requirement is to assure that the employee can access and consult the Plan at any time. Testimony from the American Federation of State, County and Municipal Employees (AFSCME) suggested that all employees should have access to the Plan and that a single person responsible for the Plan should be designated within each facility (AFSCME, 9/15/89, TR, pg. 4-80.) The Service Employees International Union AFL-CIO commented that access to the Plan encourages workers to develop a complete understanding of the Plan and its application, assuring that the program is carried out by everyone--both employer and employee (Ex. 20-979). The Retail, Wholesale and Department Store Union commented that a copy of the Plan must be available in a central location on each floor of each facility covered by this standard so that employees may have access to the protocols when necessary (Ex. L20-1505). According to testimony offered by NIOSH, having the Plan available serves as an on-site adjunct to the overall infection control program and may reinforce educational and training programs (NIOSH, 9/14/89, TR, pg. III-27 and III-28).
OSHA agrees with the value of access that the commenters have stated, however, it does not wish take away from the flexibility or performance approach to compliance. As several commenters have suggested, and as discussed above, depending on the size and organization of a particular facility, elements of the Plan may be incorporated into existing overall infection control policies currently in place or the Plan may become a completely new and separate document. It is, however, OSHA's intention that while not dictating the specific form of the documentation comprising the Plan that it be in some manner a cohesive entity by itself or that a guiding document exist that states the overall policy goals and references elements of existing separate policies that comprise the plan. The "location" of the plan may also be adapted to the circumstances of a each particular workplace provided that the employee can access a copy of the plan at the workplace, during the workshift. For example, if the plan is maintained on a computer, access to the computer or hardcopy must be available to the employee. Likewise, if the Plan is comprised of several separate policy documents, copies of all documents must be accessible in addition to any general policy statement or guiding document that may exist.
Therefore, a new paragraph has been added to the final standard to assure employees that a written Exposure Control Plan, or a copy of the Plan, is accessible for employee use. Paragraph (c)(1)(iii) of the final standard reads: "Each employer shall assure that a copy of the Plan is accessible to employees."
Paragraph (c)(1)(iv) requires that the Plan be reviewed and updated periodically to reflect significant modifications in tasks or procedures. The purpose of this requirement is to assure that all new tasks and procedures are evaluated in order to determine whether they will result in occupational exposure. Testimony from NIOSH stated that the,
... Plan needs to be expanded to include requirements for periodic review...to ensure that it remains current with the latest workplace practices and scientific knowledge pertaining to the bloodborne pathogens (NIOSH, 9/14/89, TR, III-27 and III-28).
It is also important that new and revised job classifications be included in this review and are added to the lists of job classifications and tasks and procedures identified in (c)(2)(i) of this standard.
Several comments in the record suggested that a specific period of time for such review and update be identified.
Plans must be reevaluated, rewritten and updated at least every six months to reflect the current status of the program and any changes in the methods of compliance. The Plan must be flexible and reflect new information as it becomes available (Retail, Wholesale and Department Store Union AFL-CIO, Ex. L20-1505).
Some commenters suggested that the Exposure Control Plan should be reviewed at least annually, and updated as necessary (Tennessee Health Care Association, Ex. L20-1205; University of Cincinnati Medical Center, Ex. 20-648).
The American Hospital Association recommended that the Plan be reviewed biennially in light of new prevailing standards of infection control, and revised where significant changes in infection control procedures have been identified as effective (AHA, Ex. 20-352). The American Federation of Teachers (AFT) suggested that the Plan, its review and revisions be developed with a bargaining agent or designated representative of employees having occupational exposure. In addition, the AFT stated that OSHA should require that the review and updating process take place at least annually, or as needed (Ex. 20-257).
Because of the rapidly developing information and technology related to the prevention of occupational illness due to bloodborne pathogens, OSHA believes that it is reasonable to require that the Plan be updated and reviewed at least annually. However, if there is a significant change, for example, if a medical center plans to open an HIV research laboratory where none existed before, then the Exposure Control Plan would need to be amended so that employees in those Job Classifications performing those tasks and procedures with occupational exposure are included in the Plan. Therefore, paragraph (c)(1)(iv) in the final standard reads:
The Exposure Control Plan shall be reviewed and updated at least annually and whenever necessary to reflect new or modified tasks and procedures which affect occupational exposure and to reflect new or revised employee job classifications with occupational exposure.
OSHA proposed that the Plan be made available to the Assistant Secretary and Director for examination and copying. The justification for this requirement is to allow the OSHA representative to review an employer's Plan and become familiar with the exposure determination that places employees at risk for occupational exposure. It was suggested by some commenters that this requirement be deleted because documents are already inspected regularly by JCAHO, AHA, and other regulatory organizations with greater medical experience than OSHA (Good Samaritan Hospital, Ex. 20-373). However, in this requirement, it is OSHA's intention that an authorized OSHA Representative may request to examine or to have a copy of an employer's Exposure Control Plan. For example, a Compliance Safety and Health Officer may request to see an employer's Plan, or to have a copy of the Plan, during the course of a workplace inspection. By examining the Plan, the Compliance Officer can conduct an inspection with the employer's procedures and program planning for the control of occupational exposures in mind. In such a situation, the employer must make the Plan available to the OSHA Representative upon his/her request.
To clarify this section of the proposal, the final standard incorporates this intent. Paragraph (c)(1)(v) in the final standard reads: "The Exposure Control Plan shall be made available to the Assistant Secretary and the Director upon request for examination and copying."
Paragraph (c)(2) of the standard requires the employer to perform an exposure determination. As stated in the proposal, the employer most know which tasks or procedures involve occupational exposure in order to determine what measures can be taken to eliminate or minimize exposure incidents. The Agency proposed that the standard require each employer having employees with occupational exposure to perform an exposure determination to identify and document the tasks and procedures where occupational exposure occurs, and to identify and document the job classifications whose duties include performing those tasks and procedures. This is necessary in order to assure that the employees who hold these job classifications are included in the training programs, are provided with personal protective equipment, are provided with post-exposure follow-up where appropriate, are included in the HBV vaccination program, and receive all other protection afforded by this standard.
Considerable comment was received regarding the requirements of listing all tasks and procedures, and OSHA has concluded that a more flexible approach to exposure determination and documentation can be allowed in the final standard. Comments generally indicated objection to listing individual tasks and procedures and suggested that broader categories of tasks and procedures or job classifications be used to identify employees at risk. OSHA has incorporated both of these recommendations in the final rule.
The American Hospital Association (AHA) indicated that developing this plan may be a monumental administrative burden if a detailed listing of all tasks is required for each job.
... as a basis for the plan, employers should be permitted to use either broad categories of tasks or positions to determine which employees are at risk of exposure. This will permit the employer to identify who needs personal protective equipment and training to reduce risk. Most importantly, it will eliminate the administrative burden of documenting thousands of tasks and procedures, and constantly updating the list (AHA, Ex. 20-352).
Other commenters concurred with the AHA position that categories of responsibilities would be less of an administrative burden and at the same time provide adequate safety awareness (Montana Deaconess Medical Center, Ex. 20-380).
The Association for Practitioners in Infection Control (APIC) stated that the creation and maintenance of lists will not prevent injuries, needlesticks, or body fluid exposures, but will create paperwork (APIC, Ex. 20-55). Other commenters stated that identifying every task and procedure with occupational exposure would be an unreasonable burden (Tri-County Area Hospital District, Ex. 20-63; Augusta Hospital Corporation, Ex. 20-66; Leesburg Regional Medical Center, Ex. 20-67; Memorial Medical Center, Ex. 20-1111; Jefferson Park Hospital, Ex. 20-111A). The American Nurses' Association (ANA) recommended that OSHA clarify the extent to which tasks and procedures should be identified and documented (ANA, Ex. 20-953).
A number of other commenters also suggested that employers be allowed to group tasks into "broad categories" or "classify responsibilities". For example, the American Association of Blood Banks (AABB) stated that,
The Association recognizes that employers need to assess which positions, tasks, and procedures involve occupational exposure so that the affected employees can be provided with the appropriate training, protective equipment and HBV vaccinations. However, the Association is concerned that the exposure determination and infection control plan as proposed simply places a massive administrative burden and additional unnecessary paperwork on its member blood banks.
To identify and document for each position every task and procedure "where occupational exposures may take place" is a monumental undertaking. The Association recommends that OSHA allow for grouping or classifying responsibilities when conducting the exposure determination (AABB, Ex. 20-1059).
In addition, it was suggested by some commenters that if the purpose is to identify all employees who may have occupational exposure, that purpose can be accomplished without listing every task and procedure for every position (HIMA, Ex. 20-795; Abbott Laboratories, Ex. 20-1227). Another commenter stated that since precautions will be similar, many of the tasks could be categorized rather than listed separately (McGehee-Desha County Hospital, Ex. 20-58).
The Communications Workers of America, AFL-CIO, however, commented that although some employers have cited undue administrative burden as the reason for their opposition, this is not a compelling argument since employer personnel offices usually have written job classifications which include descriptions of employee duties which would aid employers in this process (Communications Workers of America, AFL-CIO, Ex. 20-273). In addition, some health care facilities commented that they have existing documents and manuals which already identify tasks and procedures with occupational exposure. (Norwood Hospital Ex 20-273; APIC TR 10-18; Mariana Memorial Hospital 20-1269; Frick Community Health Care 20-292) Many commenters suggested that job positions would be preferable to identify personnel at risk, and thereby eliminate the need for task identification (Veterans Administration, Ex. 20-635; Frankfort Hospital, Ex. 20-211; Pharmaceutical Manufacturers Association, Ex. 20-729).
Health care worker exposure determinations more readily lend themselves to categorization by duty title or job function. These categories already exist in healthcare. Utilizing an existing determination scheme will expedite the implementation of the standard. (APIC, Ex. 20-1118).
Some comments suggested that the exposure determination should be based on location; that is, employees working in "places where patients obtain care" (University of California, San Diego Medical Center, Ex. 20-156). However, another commenter disagreed with basing the plan on categories such as the "Emergency Room", because exposure is related to responsibility, not location. (Montana Deaconess Medical Center, Ex. 20-380).
Other comments regarding identification of job classifications with occupational exposure indicated similar concerns to those comments regarding task identification; that it would be an administrative burden (APIC, Middle Tennessee Chapter, Ex. 20-55; Casa Colina Hospital for Rehabilitative Medicine, Ex. 20-284).
Another approach suggested by NIOSH was that the exposure determination identify and document individual employees with occupational exposure (rather than using job titles).
It is not enough to simply identify those "positions" in which occupational exposures occur. It is essential to identify each individual who performs duties in which exposure to blood or other potentially infectious material can be reasonably anticipated. (NIOSH, Ex. 20-634).
OSHA has considered these suggestions and believes that grouping job classification according to location would not be sufficient to meet the requirement for task identification or for position identification with occupational exposure. For example, determining exposure by assignment to the "Emergency Department" does not identify the employee positions or the tasks that have occupational exposure. In addition, assignment to a "Patient Care Area" does not identify those tasks, procedures, or positions with occupational exposure. Also, this type of categorization excludes employees who may have occupational exposure, but hold a position outside of the patient care area, such as a laboratory technician or laundry worker.
On the other hand, OSHA believes that the listing of every employee's name would be burdensome for many employers. In addition, maintaining such a list of names would be time consuming for facilities with large number of employees and for those facilities where staff turnover is high. Furthermore, the identification of each employee's name would not sufficiently identify the job classifications whose duties include occupational exposure.
The Agency believes that the evidence supports allowing employers to identify and document those job classifications where employees have occupational exposure as basis of the required exposure determination. The employer, therefore, is not required by the final standard to list all tasks and procedures as originally proposed. OSHA does however, intend for employers to consider the duties, tasks, and procedures of all employees in each job classification, in each work area, in making the exposure determination. All personnel who hold positions determined to have occupational exposure are entitled to the protection of this standard.
Existing job titles and job descriptions could be used to identify the job classifications in which occupational exposure may occur. By identifying those job classifications with occupational exposure, the employer can then identify those employees who are entitled to the provisions of this standard.
It should be noted that in the proposed rule, OSHA used the term "position(s)" with reference to identification and documentation of employees at risk in the exposure determination. Other terms such as "Job Category", "Job Responsibility", "Job Function", "Job Title", "Job Description", "Position Description", and others, have also been used by commenters with reference to this identification. In the Final Standard, OSHA has chosen to use the term "Job Classification" because it has the broadest application to facilities both large and small and with both formal and nonformal designations of employment. Use of the term "Job Classification(s)" is not intended to alter the meaning, intent, or implications of previous comments or context of discussion by OSHA in terms of "Position(s)" or other similar terms.
The primary component of the exposure determination in the final rule is stated in paragraph (c)(2)(i)(A) which requires "A list of any job classifications in which all employees in those job classifications have occupational exposure;". For example, if a hospital determines that all employees within the job classification of "Nurse" have duties or responsibilities to perform tasks and procedures where occupational exposure occurs, the job classification of "Nurse" shall be listed in the exposure determination in accordance with paragraph (c)(i)(A) and subsequent listing of those tasks and procedures is not required with respect to exposure of "Nurse[s]".
Similarly in a small dental office, it is likely that the job classifications of "Dentist", "Dental Hygienist", and "Clinical Dental Assistant" would be identified in accordance with paragraph (c)(2)(i)(A) as job classifications in which all employees so designated have occupational exposure. It may be further determined that employees in other job classifications have duties that may occasionally require them to perform some tasks and procedures where occupational exposure occurs. If other employees, such as those classified as receptionist, bookkeepers, or office managers, for instance, assist at times in operative dental procedures, handle potentially contaminated impressions in the laboratories, or assist in cleaning the operatories or disposal of regulated waste, then those job classifications would be listed along with "Dentist", "Dental Hygienist", and "Dental Assistant" in accordance with paragraph (c)(2)(i)(A). If however, the employer determines that all employees in any job classifications clearly have no occupational exposure, then those job classifications need not be listed. For example, if the receptionist, the bookkeeper or the office manager do not have occupational exposure then the job classifications would not have to be listed.
If the employer determines that listing a particular job classification is not sufficiently specific to identify exposed employees, the employer may also, or instead, list the job classifications in which any (some, but not all) employees in those job classifications have occupational exposure and then clarify the exposures within those job classifications by listing the tasks and procedures or groups of closely related tasks and procedures associated with exposure for those job classifications.
This requirement is stated in paragraphs (2)(c)(i)(B) and (C) which state that the exposure determination shall also include:
(B) A list of all job classifications in which some employees have occupational exposure, and (C) A list of all tasks and procedures or groups of closely related tasks and procedures in which occupational exposure occurs and that are performed by employees in job classifications listed in accordance with the provisions of paragraph (c)(2)(i)(B) of this standard.
For example, within a funeral home there are typically several, employees classified as "Funeral Director[s]". Same, but not all, employees classified as funeral director may perform embalming, removals, or other tasks and procedures where occupational exposure occurs, whereas, other employees classified as "Funeral Directors" may have specific duties limited to making funeral arrangements or conducting services where occupational exposure does not occur. In this case, the job classification "Funeral Director" would be listed in accordance with paragraph (c)(2)(i)(B) and the tasks and procedures which place some, but all, "Funeral Directors" at risk would be listed in accordance with paragraph (c)(2)(i)(C).
Similarly, within a hospital Central Services and Supply Unit all Central Services Technicians may not have contact with potentially contaminated materials. For example some Central Services Technicians may have specific limited duties handling and distributing items after they are processed and sterilized and some Central Services Technicians may have specific duties where occupational exposure occurs such as decontaminating reusable instruments prior to sterilization. In this example, Central Services Technicians would be listed in the exposure determination in accordance with paragraph (c) (2)(i)(B) and those tasks and procedures which place some Central Services Technicians at risk for occupational exposure would be listed in accordance with paragraph (c)(2)(1)(c).
The final standard allows the exposure determination to be based primarily on list of job classifications. OSHA expects that some employers may, however, choose to list all tasks and procedures for all job classification identified. The employer will however, only be required to list tasks and procedures or groups of closely related tasks and procedures where necessary to identify certain employees within a job classification where some but not all, employees have occupational exposure.
In these cases where it is necessary to list certain tasks and procedures to identify exposed employees within a particular job classification, OSHA believes grouping of closely related tasks and procedures to be an effective and feasible method as suggested by several commenters (AHA 20-353; Bayshore Medical Center, 20-160; Hospital Employee Health, 20-627; Kaiser Permanente, 20-559). It is essential, however, that the tasks and procedures that are grouped must be related; that is, they must share a common activity. For example, tasks such as starting or discontinuing IV's, performing phlebotomy, accessing arteries, inserting central lines, could be grouped into the broad category of "vascular access procedures". Other examples might include tasks such as washing, cleaning, removing, disassembling, decontaminating, and disposing of contaminated, used needles, wires, knives, scalpels, blades, and razors which could be grouped into the broad task of "handling of contaminated sharps". Tasks such as post mortem removal or disposal of tubes, Ivs, and contaminated dressings; removal or disposal of contaminated clothing; collection of contaminated evidence; removing, lifting, transporting (carrying) and assisting with bleeding (bloody) post mortem bodies could be grouped into the broad task of "handling of deceased persons and their belongings".
In October 1987, the Departments of Labor and Health and Human Services issued a Joint Advisory Notice (52 FR 41818). One purpose of this document was to provide some additional guidance to employers to assist them in identifying employees at risk for occupational exposure. It suggested three categories of tasks that employees may perform. One of the difficulties with this approach has been the tendency to confuse the categorization of tasks with the categorization of employees or job classification. This sometimes results in ranking exposed employees with the result that some individuals are classified as being at greater risk than others. The purpose of paragraph (c) is not to determine whether one individual is at greater or lesser risk, but it is to identify all those employees who have occupational exposure and who are covered by the standard.
OSHA proposed that the standard require the exposure determination be made without taking into consideration the use of personal protective clothing or equipment. The reason for this is that several conditions must be met for personal protective equipment to effectively lessen exposures. First, the employee must be trained to use the equipment properly. Second, the personal protective equipment must be used each time the task is performed. Third, the equipment must fit properly and be appropriate for the task. Fourth, it must be free of physical flaws that could compromise safety. If even one of these conditions is not fully met, protection cannot be assured. For example, if blood covered gloves are not removed correctly, the hands may become contaminated. If utility gloves are torn or cracked, they will not provide protection. Therefore, all tasks that entail occupational exposure need to be included in the exposure determination, regardless of the personal protective equipment used, so that the workers who perform such tasks will receive training, HBV vaccination, and other provisions of this standard that will enhance their safety. Therefore, paragraph (c)(2)(ii) in the final standard reflects this and reads, "This exposure determination shall be made without regard to the use of personal protective equipment."
Paragraph (d) Methods of Compliance
Paragraph (d)(1) of the final standard states that universal precautions shall be observed to prevent contact with blood and/or other potentially infectious materials. It further requires that under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials.
Several significant changes have been made in this provision in response to additional information submitted to the record. First, the exemption to the use of universal precautions has been moved to paragraph (d)(3)(ii), Personal Protective Equipment - Use. As stated in the proposal's Summary and Explanation, pages 23114-23116, it was the Agency's intent that this exemption apply only to the use of personal protective equipment and was not intended to provide an excuse for non-adherence to the overall concept of universal precautions. Universal precautions, as noted above in the definition, is a method of preventing disease by preventing transfer of blood and certain body fluids. Universal precautions' underlying concept is that all blood and certain other body fluids are considered to be infectious for bloodborne pathogens. In most situations, an employee will treat all blood and certain body fluids as though they contained bloodborne pathogens and would accomplish this through a variety of measures. In rare instances, such as unexpected medical emergencies, employees may not be able to put on gloves, don a gown, or tie a face mask immediately. In those situations where some leeway must be accorded the provider of healthcare or safety services, the employees must not ignore the underlying concept of universal precautions (i.e., all blood and certain body fluids are to be considered to be infectious) nor should he or she decline to use any personal protective equipment simply because it is not practicable to use all the equipment appropriate to the task. To exempt an employee from universal precautions would subject the employee to needless risks in that some of the personal protective equipment can be donned.
OSHA requested comment on whether it was more appropriate to include this exemption under the section dealing with personal protective equipment in order to make the limitations of the exemption more clear. Numerous commenters raised concerns that, as written, the proposed exemption was too broad due to the use of vague terms such as "interfere with" and "proper delivery". More importantly, NIOSH/CDC pointed out that OSHA should state clearly that the exemption only covers the use of "personal protective equipment" (PPE) (Tr. 9/14/89, p. 31-2). NIOSH/CDC reiterated this concept in its post-hearing comment:
The exception provided in this proposal applies not to the general concept of univeral precautions, but to the use of personal protective equipment under rare and relatively limited circumstances. These circumstances and the exception to mandatory use or protective devices would be better addressed, in paragraph (d)(3) under a new subparagraph (ii) dealing specifically with the use of personal protective equipment. (Ex. 20-634).
Many other commenters supported this change. Service Employee International stated:
SEIU recognizes that there are extraordinary circumstances where workers can't use protective equipment. However, the proposed standard would define those situations broadly as those that would interfere with the proper delivery of services, opening up a large loophole.
SEIU recommends limiting the exemption to personal protective equipment and only if the worker determines that these precautions would prevent the proper delivery of health care or public safety services in extraordinary situations. Enforcing universal precautions and ensuring the availability of personal protective equipment must be the employer's responsibility. (Tr. 9/15/90, p.7).
OSHA's expert witness, Jolanda Janczewski, commented:
Under paragraph (d) (1), OSHA proposes what appears to be an exemption to the use of universal precautions. However, in the summary and explanation section on page 32115, OSHA clearly states that the exemption refers to the use of personal protective equipment and not to the actual concept of universal precautions. In no way do I believe that OSHA should intend for the proposed regulation to provide an excuse for complete non-adherence to this very important principle of infection control.
Only under extraordinary circumstances that are unexpected should employees have the option of deciding not to use personal protective equipment if they feel that such equipment will prevent the proper delivery of healthcare or public safety services or will create a greater hazard to their personal safety if they did not use such equipment. I agree with OSHA's statement in the preamble that the decision not to use personal protective equipment is to be made by the employee on a case-by-case basis and must be prompted by truly extenuating circumstances.
The exemption should be rewritten to apply only to the use of personal protective equipment. The provision also should be narrowly constructed and be placed under section (d)(3) which deals with personal protective equipment so that there will be no confusion over when it is to be used. (Tr. 9/12/89, p.46-7).
The American Federation of State, County and Municipal Employees also opposed the idea of having an exemption to universal precautions and supported the idea of moving the exemption to the personal protective equipment section. It specifically stated:
Public safety workers, such as fire fighters, emergency medical techs, are always present in emergency situations. By writing a specific exemption into the standard, OSHA is in essence inviting employers and employees to find and use extenuating circumstances as a justification for not following universal precautions.
In the event that OSHA decides that an explicit exemption is nevertheless necessary, AFSCME suggests that it be moved to the section under personal protective equipment, and I quote "The employer shall assure that the employee uses appropriate PPE unless doing so in a specific unexpected instance would in the professional judgment of the employee threaten the life or safety of the patient or worker or prevent the proper delivery of public safety services. Such exemptions shall be limited in extent and time, and shall not limit the employer's responsibility to comply with all other paragraphs of the section, nor should allow the employer under any circumstances to discourage employees from adhering to universal precautions." (Tr. 9/15/90, p.83).
In addition, AFSCME stated:
A final note on the subject of universal health care or public safety services in a particular circumstance.
As defined by the Centers for Disease Control, universal precautions is an approach by which blood and body fluids from all patients are treated as if they are potentially infectious for blood-borne pathogens.
Even if there is an extreme situation where it is totally impossible to use a particular preventive measure, the overall approach of using universal precautions and using those precautions that can be implemented should never be suspended. The language of the exemption as presently stated could be interpreted in a number of way that are not in accordance with OSHA's intent for this section, as explained in the preamble which states that the exemption will serve as an exemption for the use of personal protective equipment in appropriate cases and is not intended to provide an excuse for complete non-adherence to the overall concept of universal precautions. (Tr. 11/14/89, p.453).
OSHA agrees with NIOSH/CDC and the commenters who suggested that the exemption should only cover the use of personal protective equipment. Accordingly, the Agency has moved the exemption to paragraph (d)(3)(ii) which addresses the use of personal protective equipment.
The second modification of this provision is the addition of the requirement that all body fluids be considered potentially infectious materials in those circumstances where body fluid types are difficult or impossible to differentiate. In their June 23, 1989, document, "Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public Safety Workers," the Centers for Disease Control state:
The unpredictable and emergent nature of exposures encountered by emergency and public-safety workers may make differentiation between hazardous body fluids and those which are not hazardous very difficult and often impossible. For example, poor lighting may limit the worker's ability to detect visible blood in vomitus or feces. Therefore, when emergency medical and public-safety workers encounter body fluids under uncontrolled, emergency circumstances in which differentiation between fluid types is difficult, if not impossible, they should treat all body fluids as potentially hazardous. (Ex. 15)
This exposure control approach was supported by the American Federation of State, County, and Municipal Employees (Tr. 11/14/89, pp.455-456). Situations arise in which treating all body fluids as potentially infectious is the most prudent means of protecting employees against exposure because it may not be possible to differentiate between body fluids. For example, EMTs rendering aid to a car accident victim on a dark, rain-soaked roadway would find it extremely difficult to distinguish whether the victim's trousers are wet with blood, urine, or rain water. Consequently, the best method of assuring proper protection under these circumstances is to treat all fluids as potentially infectious. Recognizing this, OSHA has concluded that adding this provision to paragraph (d)(1) is appropriate and necessary to assure employee protection against occupational exposure to bloodborne pathogens.
One of the most important methods of compliance is the implementation of "Universal Precautions" as recommended by CDC. "Universal Precautions" requires the employer and employee to assume that all blood, and other potentially infectious materials are, indeed, infectious and must be handled accordingly. This infection control concept and suggested methods of implementation were discussed in detail in CDC's August 21, 1987, MMWR supplement "Recommendations for Prevention of HIV Transmission in Health-Care Settings" (Ex. 6-153). The Centers for Disease Control bases the rationale of universal precautions on the following:
Since medical history and examination cannot reliably identify all patients with HIV or other blood-borne pathogens, blood and body fluid precautions should be consistently used for all patients. This approach, previously recommended by CDC, and referred to as "universal blood and body fluid precautions" or "universal precautions" should be used in the care of all patients, especially including those in emergency-care settings in which the risk of blood exposure is increased and the infection status of the patient is usually unknown. (Ex. 6-153)
Use of universal precautions and protecting against exposure to blood and other potentially infectious materials as a means of eliminating or minimizing occupational transmission of bloodborne diseases was given specific support by a number of commenters who addressed this issue (e.g., AHA, Ex. 20-352; SEIU, Ex. 299; National Funeral Directors Association, Ex. 311; AARC, Ex. 20-107; AFSCME, Ex. 297; ANA, Tr. 9/20/89, p.122; APIC - Indiana, Ex. 20-139; Council of State and Territorial Epidemiologists, Tr. 11/14/89, p.216; Local 1199 Drug, Hospital and Health Care Employees Union, Tr. 11/14/89, p.372; New York Committee for Occupational Safety and Health, Tr. 11/13/89, p.15; George Washington University Hospital, Ex. 20-1203; Society of Hospital Epidemiologists of America, Ex. 20-1002). Only a few commenters voiced opposition to the use of universal precautions (American Association of Forensic Dentists, Ex. 20-109; Community Blood Center, Inc., Ex. 20-325; University of Washington, Department of Laboratory Medicine, Ex. 20-378; University of Medicine and Dentistry of New Jersey, New Jersey Dental School, Ex. 20-647). For example, the University of Washington comment stated that one of the reasons they opposed implementation of universal precautions was that too much reliance was placed on barrier precautions, primarily gloves. They stated:
. . . health care workers, including physicians, are increasingly seen wearing gloves when they are clearly not needed, eg., when punching computer buttons, handling telephones and doorknobs. Environmental contamination will increase throughout hospitals, laboratories and other public facilities. (Ex. 20-378)
This type of situation is addressed by other provisions of the standard (e.g., removal of personal protective equipment upon leaving the work area, decontamination of environmemtal surfaces) and the Agency does not feel that the arguments put forth are sufficiently compelling to delete the requirement for utilization of universal precautions.
OSHA agrees with CDC and the commenters who supported universal precautions, especially with those who had sucessfully implemented universal precautions in their workplaces. The Agency has, therefore, retained the general requirement for use of universal precautions in occupational exposure situations.
Body Substance Isolation (BSI) is a method of infection control in which all body fluids and substances are considered to be infectious. A number of respondents supported utilization of BSI rather than universal precautions for preventing employee exposure (Exs. 20-105; 20-1325; 20-136; 20-46; 20-886; 20-591; 20-316; 20-527; 20-609; 20-1304). The fluids and materials listed in the definitions of "Blood" and "Other Potentially Infectious Materials" in paragraph (b) of this standard are derived from those substances which CDC recommends handling with universal precautions (Ex. 6-153) and which OSHA believes present the potential for occupational transmission of bloodborne diseases. Since BSI incorporates not only the fluids and materials covered by this standard but expands coverage to include all body fluids and substances, BSI is an acceptable alternative to universal precautions provided facilities utilizing BSI adhere to all other provisions of this standard.
Throughout the comments, OSHA was urged to define Universal Precautions in accordance with CDC or to simply reference CDC's definition of this term (e.g., Society of Hospital Epidemiologists of America, Ex. 20-1002; AHA, Tr. 9/19/89, p.129; Cedars-Sinai Hospital, Tr. 12/21/89, p.1467; Good Samaritan Hospital, Tr. 12/21/89, p.1431; Nassau-Suffolk Hospital, Tr. 11/14/89, p.464; Exs. 20-148; 20-292; 20-557; 20-587; 20-692; 20-694; 20-701; 20-709; 20-716; 20-730; 20-744; 20-371; 20-932; 20-911; 20-967; 20-972; 20-978; 20-984; 20-992; 20-999; 20-514). Since the proposal's definition was taken directly from CDC's guidelines (Ex. 6-153), OSHA has concluded that commenters were not referring to an incorrect definition of the term on the Agency's part, but were referring instead to the means of implementing universal precautions. This conclusion is supported by several participants who specifically noted this view in their recommendations (Exs. 20-182; 20-556; 20-1247; 20-122; 20-220; 20-131; 20-582; 20-186; 20-1262; 20-158; 20-1223; 20-633; 20-1325; 20-343; 20-134; 20-546; 20-94; 20-184). Therefore, the controversy of conflicting OSHA requirements and CDC guidelines does not appear to focus on the concept of universal precautions but rather on methods for implementing the concept. For example, they may have disagreed with proposed requirements for the use of gloves for phlebotomists. As a result, OSHA sees no reason to modify its definition of universal precautions or rescind the requirement for general use of universal precautions in occupational exposure circumstances.
Engineering controls serve to reduce employee exposure in the workplace by either removing the hazard or isolating the worker from exposure. These controls encompass process or equipment redesign (e.g., self-sheathing needles), process or equipment enclosure (e.g., biosafety cabinets), and employee isolation. In general, engineering controls act on the source of the hazard and eliminate or reduce employee exposure without reliance on the employee to take self-protective action. Once implemented, engineering controls protect the employee permanently, subject only, in some cases, to periodic replacement or preventative maintenance. By comparison, work practice controls reduce the likelihood of exposure through alteration of the manner in which a task is performed. While work practice controls also act on the source of the hazard, the protection they provide is based upon the behavior of the employer and employee behavior rather than installation of a physical device such as a protective shield.
These two control methodologies frequently work in tandem because it is often necessary to employ work practice controls to assure effective operation of engineering controls. For example, a sharps disposal container provides no protection if an employee persists in recapping needles by hand and disposing of them in the wastebasket. Proper work practices and engineering controls must both be utilized to ensure safe, acceptable sharps disposal.
In addition, to engineering controls and work practices, administrative controls can be used to minimize employee exposure. Examples of administrative controls include methods such as scheduling of tasks to reduce exposure.
Paragraph (d)(2)(i) of the final standard requires the employer to institute engineering and work practice controls as the primary means of eliminating or minimizing employee exposure. Moreover, where occupational exposure remains after institution of these controls, employers must provide and assure employees use personal protective equipment as supplemental protection. Primary reliance on engineering controls and work practices for controlling exposure is consistent with good industrial hygiene practice and with the Agency's traditional adherence to a hierarchy of controls. This hierarchy specifies that engineering controls and work practices are to be used in preference to personal protective equipment.
The proposed standard did not specifically state that a preferential reliance on engineering controls and work practices over the use of personal protective equipment was required although it was not the Agency's intent to abandon its longstanding policy of hierarchy of controls in the control of exposure to bloodborne pathogens. During their testimony in Washington, D.C., the American Federation of State, County, and Municipal Employees (AFSCME) expressed concern over the apparent neglect to require adherence to the control hierarchy. They stated:
For reasons that are unknown to us, OSHA has seemingly abandoned its long-standing preference for engineering and work practice controls. OSHA tries to single out this standard as different, noting that in some circumstances engineering controls are not feasible. However, the hierarchy of controls clearly allows for a combination of controls to be used when engineering controls and work practices alone are not sufficient or feasible.
In fact, engineering controls are explicitly preferred in other OSHA standards, even where a combination of controls is needed in most situations. Therefore, there is no breach of the traditional hierarchy or of traditional OSHA practice in allowing the use of protective equipment to supplement employee protection.
There are several reasons why engineering controls must be a principal focus of this rulemaking:
First, work practices and personal protective equipment will not adequately reduce injuries from needles and other sharp objects. OSHA admits that as many as 60 percent of needle stick injuries will be unaffected by improved work practice procedures.
Secondly, a single exposure incident can lead to illness and death. Therefore, OSHA must require every feasible measure to reduce the incidence of accidental needlesticks and other sharp object injuries.
And third, the lifetime risk of occupational HIV transmission is not well-characterized. Therefore, it is likely that current risk estimates underestimate actual risks over a working lifetime. (Tr. 9/15/89, pp.95-97)
In their post-hearing comment, AFSCME again urged OSHA to insert the requirement that employers must adhere to the hierarchy, stating:
That engineering controls are the best method to protect employees is an important, longstanding, tested principle of industrial hygiene. Although OSHA attempts to single out this standard by claiming that engineering controls would rarely be the only control method used, the fact is that a combination of engineering controls, work practices, and personal protective equipment are needed to control almost any chemical as well. .. [T]his position should be clearly stated in the body of the standard so that there is no possibility of misinterpretation by employers. (Ex 297)
Strong support for the hierarchy of controls and/or development of safer equipment was also registered by a number of other sectors, including government agencies (NIOSH, Ex. 298; State of Michigan Advisory Committee on Occupational Exposure to Bloodborne Pathogens, Tr. 10/17/89, p.20), labor unions (Local 1199 - Drug, Hospital and Health Care Employees Union, Tr. 11/14/89, p.376; Retail, Wholesale, and Department Store Union, Tr. 11/14/89, p.428; SEIU, Tr. 1/16/90, p.692; UAW, Tr. 11/13/89, p.34; USWA, Tr. 11/13/89, p.99; CWA, Ex. 20-273; FAST, Ex. 261), professional organizations (AORN, Tr. 9/20/89, p.88; AAOHN, Tr. 9/20/89, p.38-39; College of American Pathologists, Tr. 11/13/89, p.191; American Association of Critical-Care Nurses, Tr. 12/19/89, p.956; APHA, Ex. 20-1361; American Society for Microbiology, Ex. 20-1188), manufacturers (Habley Medical Technology, Tr. 1/16/90 p.641; Labco, Tr. 9/22/89 p.90; On-Gard, Tr. 9/26/89 p.38; Health Industry Manufacturers Association, Tr. 10/17/89, p.128; Hoffman-LaRoche, Ex. 20-291), and other commenters (NY Committee for Occupational Safety and Health, Tr. 11/13/89, p.23; Northwest Center for Occupational Health and Safety, Ex. 20-526; MidWest Consortium for Hazardous Waste Worker Training, Ex. 20-892; Medical Arts Laboratory, Ex. 20-638). As stated in the proposal, OSHA recognizes that in many instances a combination of control methodologies (i.e. engineering controls, work practices, personal protective equipment) may be required to adequately protect employees against exposure. However, it is the Agency's intent, in paragraph (d)(2)(i), to clarify that primary reliance shall be placed upon engineering controls and work practices to eliminate or minimize employee exposure. In those circumstances where occupational exposure remains after institution of these controls, personal protective equipment is to be used.
Relative to the use of engineering controls to protect employees against occupational exposure, paragraph (d)(2)(ii) requires that engineering controls be examined and maintained or replaced on a regular schedule to ensure their effectiveness. This provision remains unchanged from that put forth in the proposal under paragraph (d)(2)(i). Regularly scheduled inspections are required to confirm that engineering controls such as protective shields have not been removed or broken; that ventilation systems are operating properly; that filters, sharps disposal containers, and so forth are being replaced on a sufficiently frequent interval; and that other physical, mechanical, or replacement-dependent controls are functioning as intended.
- The American Hospital Association (AHA) stated in their comments:
The provision requiring regular examinations of engineering controls in this section leaves too much discretion to OSHA inspectors, who are not usually qualified to make determinations about how health care should be delivered. Without a limit on the frequency of examination, the rule may permit unreasonable numbers of reviews of engineering controls by compliance officers.
Recommendation: Alter Sec. 1910.1030 (d)(2)(i) to require engineering controls to be examined on an annual basis, and changed where a reasonable alternative can be identified which can be expected to limit worker exposure, while not interfering with the delivery of medical care. (Ex.20-352)
It should be noted that responsibility for the regular examination and maintenance of engineering controls falls upon the employer, not an OSHA compliance officer, since the employer is required to assure proper protection of his or her employees. Therefore, an OSHA compliance officer (CSHO) would not be making regularly-scheduled inspections of a facility to examine engineering controls. However, a CSHO could be expected to ascertain the effectiveness and proper functioning of engineering controls during a normal inspection of a facility. While the AHA questions the qualifications of a CSHO to perform such inspections, the Agency does not believe that any specialized medical expertise is required to determine if, for example, the ventilation system of a biosafety cabinet is functioning properly, if the splash shield covering the segmenting unit of a hematron is broken or missing, if sharps disposal containers are overfilled, and if similar controls are functioning effectively.
Limiting examination of controls to a frequency of once per year is also inappropriate. Because not all controls are the same, differing frequencies of examination are required to assure proper functioning. For example, it would probably not be necessary to check the ventilation performance of a biosafety cabinet on a daily basis, while sharps disposal containers in some high use areas may need to be checked and replaced several times per day. Therefore, it is left to the employer to determine what frequency of examination is necessary for each control to assure that the protection it is intended to provide is maintained. In addition, the phrase "replaced on a regular schedule" is not meant to imply that an engineering control is to be regularly replaced by some alternative control method. It means, instead, that any portion of the control necessary for proper functioning of the control is to be replaced on whatever regularly-scheduled frequency is required to maintain the control's effectiveness.
OSHA has long recognized handwashing as a major precept of infection control. This viewpoint was amply supported by ANPR respondents such as the CDC (Ex. 6-153), the American Hospital Association (Ex. 11-233d), the American Blood Resources Association (Ex. 11-71) and the American Association of Occupational Health Nurses (Ex. 11-111). Therefore, paragraph (d)(2)(ii) of the proposal stated that employees must wash their hands immediately or as soon as possible after removal of gloves or other personal protective equipment and after hand contact with blood or other potentially infectious materials. This provision has been expanded in the final standard and renumbered as paragraphs (d)(2)(iii), (d)(2)(iv), (d)(2)(v), and (d)(2)(vi) to address several issues which arose in the course of public comment.
While the proposal required handwashing, the Agency overlooked requiring that a means of handwashing be provided to employees. This oversight was brought to OSHA's attention by several commenters (CDC/NIOSH, Ex. 20-634; American Biological Safety Association, Tr. 9/21/89, p.100; Food and Allied Service Trades, Ex. 20-888; Retail Wholesale, and Department Store Union, Ex. 20-1505). OSHA's expert witness in infection control, Ms. Elise Yiasemedes, stated in her testimony:
Because gloves may not provide complete protection, basic handwashing remains a fundamental element of infection control practices. Facilities for proper handwashing need to be readily available in all areas where occupational exposure to bloodborne pathogens is anticipated. (Tr. 9/13/89, p.49)
As with any provision which requires the use of ancillary equipment, OSHA also believes that such equipment should be located where employees have easy access to it, thereby, increasing the likelihood of use, minimizing the amount of time that contamination must remain in contact with the skin, reducing contaminant migration resulting from employees traveling to remote locations in order to wash hands, and fostering an attitude of compliance due to accessibility of proper facilities. Therefore, paragraph (d)(2)(iii) has been added requiring employers to provide handwashing facilities which are readily accessible to employees.
However, exposures can occur in a number of environments in which sinks and running water are not available for handwashing. In their written testimony, the American Ambulance Association stated:
We support the requirement to wash hands immediately after handling a patient. However, ambulances are not outfitted with sinks, and in many instances paramedics and EMTs must immediately return to service following delivery of a patient. We urge OSHA to consider the allowance of alternative methods in this and other instances where ambulance design and work practice make compliance with the regulation impractical. We suggest that substitute hand cleaning supplies which are not dependent on water for use. (Ex. 263)
In addition to ambulance-based paramedics and EMTs, other employees, such as firefighters, police, and mobile blood collection personnel, may find themselves exposed to blood or other potentially infectious materials with no means of washing up. In the proposal, OSHA requested information on whether an acceptable substitute for handwashing existed which could be used in these situations and, if so, did it provide protection that is equivalent to handwashing. The Association for Practitioners in Infection Control (APIC) - National responded:
There are effective substitutes for handwashing when sinks and running water are not available. These products include alcohol-based rinses, foams, and impregnated paper wipes. Data on these products support their efficacy when handwashing facilities are not available. (Ex. 20-1118)
Commenters supporting the existence of adequate substitutes included the American Red Cross - National Headquarters (Ex. 20-784), the American Society for Microbiology (Ex. 20-1188), the Johns Hopkins University (Ex. 20-17), and the University of California, San Diego (UCSD) Medical Center (Ex. 20-156). A number of other participants supported allowing handwashing substitutes although they added the caveat that regular soap and water handwashing must be performed as soon as possible after use of such alternative methods (CDC/NIOSH, Ex. 20-634; International Association of Firefighters, Tr. 9/14/89, p.154; American Association of Critical-Care Nurses, Ex. 20-1162; The Service Master Company, Ex. 20-21; Veterans Administration - Prescott, AZ, Ex. 20-31) For example, Mr. Richard Duffy of the International Association of Fire Fighters testified:
We believe that handwashing must be stringently enforced. Hands and other exposed surfaces must be washed, obviously, with a non-abrasive soap and running water after any direct patient contact and as soon as patient care allows.
We also believe that because running water and non-abrasive soap is not always available in the emergency setting, that other types of immediate disinfection be available, such as alcohol wipes or other disinfectant wipes, on the emergency vehicle, so that they can be utilized until such other handwashing, such as water and so forth, are available. (Tr. 9/14/89, pp.154-155)
This sentiment is echoed by the comment of CDC/NIOSH:
Handwashing with soap and water, alone or in combination with application of decontaminants, is preferred. When normal handwashing facilities (a sink with running water and soap) cannot be made available, the employer should be required to provide for handwashing using an antiseptic hand cleaner that does not require the use of water, or disposable disinfectant towelettes. A variety of products is available, but handwashing with soap and water should follow as soon as possible. Towels, either paper or cloth, should be provided in all cases. (Ex. 20-634)
While handwashing substitutes are available, their efficacy may be compromised in proportion to the amount of contamination present (Calgon-Vestal Laboratories, Ex. 20-49). The Service Master Company stated:
Proper handwashing is the most important means for preventing cross-infection and must not be overlooked or neglected even when handwashing facilities are not available. There are substitutes for handwashing facilities that have a water supply, such as the use of alcohol foams or gels that require no water. These can be substituted for soap and water "handwashing", but there should not be a substitute for handwashing itself, even when gloves are worn. Emergency vehicles, mobile blood collection vehicles, etc., can be supplied with a "waterless" handwashing product and paper toweling, as well as a glove supply, just as they are supplied with a first aid kit.
The waterless handwashing products provide good antiseptic activity, at least equivalent to handwashing products that require the use of water. However, the flushing/rinsing away of gross amounts of blood or other materials that is provided by a running water supply is not possible with the waterless products. Nevertheless, in the absence of water, handwashing with the waterless products provides adequate protection, especially if gloves are worn in the presence of gross amounts of blood or body fluids. (Ex. 20-21) (Emphasis in the original)
In view of the information received, the Agency accepts the use of alternative handwashing methods as an interim measure when soap and water are not a feasible means of handwashing. OSHA has concluded, however, that handwashing with soap and running water must still be performed as soon as possible, particularly in cases of gross contamination, to adequately flush contamination from the skin. Therefore, paragraph (d)(2)(iv) has been added to the final standard. This provision states that when handwashing facilities are not feasible, the employer must provide either an appropriate antiseptic hand cleaner in conjunction with clean cloth/paper towels or antiseptic towelettes. When antiseptic hand cleansers or towelettes are used, hands shall be washed with soap and running water as soon as feasible.
Paragraph (d)(2)(ii) of the proposal would have required employees to wash their hands immediately or as soon as possible after removal of gloves or other personal protective equipment and after hand contact with blood of other potentially infectious materials. The final standard has split this proposed requirement into two provisions, paragraphs (d)(2)(iv) and (d)(2)(v).
While the proposal only required that hands be washed after contact with blood or other potentially infectious materials, this provision has been expanded in paragraph (d)(2)(iv) of the final to state that employers shall ensure that employees wash hands and any other skin with soap and water, or flush mucous membranes with water, immediately or as soon as feasible following contact of such body areas with blood or other potentially infectious materials. In addition, this provision has been expanded to clarify that hands are not the only body area that needs to be washed upon contamination but also any other skin or mucous membrane which has had contact with blood or other potentially infectious materials. This will minimize the amount of time blood is in contact with potential routes of exposure such as mucous membranes or breaks in the skin.
Paragraph (d)(2)(v) requires that employers shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment. This portion of the proposed requirement remains essentially unchanged. The addition of the words "the employer shall ensure" merely make explicit what was implicit in the proposal, which is that the employer is responsible for making sure employees wash their hands as required.
CDC's "Guidelines for Handwashing and Hospital Environmental Control, 1985" states:
Moreover, handwashing is indicated, even when gloves are used, after situations during which microbial contamination of the hands is likely to occur, especially those involving contact with mucous membranes, blood and body fluids, and secretions or excretions, and after touching inanimate sources that are likely to be contaminated, such as urine-measuring devices. (Ex. 6-35)(Italics in original)
At the San Francisco hearings, Dow Chemical Company testified that they perform approximately 80 fingerpricks in a day every week or two as part of their monitoring program for cholinesterase inhibition (Tr. 1/11/90, p.356). While they change gloves between each individual, Dow feels that requiring handwashing along with each change of gloves would sharply increase the amount of time required for testing and would be burdensome. While OSHA recognizes that handwashing between glove changes would, naturally, take more time than a simple glove change, the Agency concluded that this is not a compelling argument to disregard handwashing after removal of gloves. OSHA believes that handwashing after removal of gloves or other personal protective equipment is consistent with CDC's handwashing guidelines and is an appropriate frequency for preventing occupational exposure.
OSHA requested comment in the proposal as to whether handwashing should be required upon leaving the work area. Several commenters supported this handwashing practice (American Biological Safety Association, Tr. 9/21/89, p.100; Association of Operating Room Nurses, Ex. 20-882; Ortho Diagnostic Systems, Ex. 20-969). The ServiceMaster Company, commented:
There may be many occasions when an employee will enter a work area where there is a potential for hand contamination, but with no intention of touching materials, surfaces, or persons that are contaminated. For example, there is no reason to require gloving when reading a medical chart, checking supply levels in a patient room, dispensing certain medications, etc. However, while in the work area, the employee may have to make unplanned hand contact during an emergency or a request for assistance. There should be a requirement that employees wash their hands upon leaving the work area if they have touched any items that may be contaminated or have touched any patients. (Ex. 20-21) (Emphasis in original)
The initial situations described in ServiceMaster's comment would not require handwashing since no occupational exposure occurred. The second scenario, which involves unplanned hand contact during emergency assistance would necessitate handwashing; however, this type of circumstance is already covered under paragraph (d)(2)(iv) of the final standard. It is not the Agency's intent to mandate unnecessary washing of hands that have not been potentially contaminated. Therefore, the standard does not to require handwashing upon leaving the work area unless, prior to leaving the work area, contact with blood or other potentially infectious materials has occurred or gloves or other personal protective equipment have been removed.
Needlesticks are a very efficient means of transmitting bloodborne diseases. As stated in the Health Effects section, the chance of becoming infected after a single needlestick from a hepatitis B source individual ranges from 7% to 30%. With regard to this hazard, CDC's Recommendations for Prevention of HIV Transmission in Health-Care Settings states:
. . . To prevent needlestick injuries, needles should not be recapped, purposely bent or broken by hand, removed from disposable syringes, or otherwise manipulated by hand. (Ex. 6-153)
In developing the proposed standard, OSHA adopted this philosophy and required that used needles and other sharps shall not be sheared, bent, broken, recapped, or resheathed by hand. In addition, used needles were not to be removed from disposable syringes. While the basic reasoning has been retained, the final provision has been revised to clarify intent and address the comments of interested parties.
Paragraph (d)(2)(vii) requires that contaminated needles and other contaminated sharps shall not be bent, recapped, or resheathed except as noted in paragraph (d)(2)(vii)(A) and (d)(2)(vii)(B) below. Shearing or breaking of contaminated needles is prohibited. This provision does not totally prohibit recapping or removal as the proposed standard was mistakenly interpreted to require by a number of respondents (e.g., AHA, Ex. 20-352; SEIU, Ex. 299; McLeod Regional Medical Center, Ex. 20-527; Guthrie Clinic, Inc., Ex. 20-1222; The Medical Center, Ex. 20-125). The phrase "by hand" is intended to mean "two-handed" or "hand-toward-hand" actions and is not intended to imply that "one-handed" techniques or use of special devices/mechanical means to accomplish recapping or removal are prohibited. A large number of commenters supported prohibition of "by hand", "manual", or "two-handed" recapping or removal and/or urged that alternative methods (i.e., one-handed techniques and use of devices/mechanical means) be permitted (e.g., ADA, Ex. 20-665, Tr. 9/21/89, p.164; Society of Hospital Epidemiologists of America, Ex. 20-1002; SEIU, Ex. 299; CDC/NIOSH, Ex. 20-634; Greater Houston Hospital Council, Ex. 20-1252; APIC - Greater Detroit, Ex. 20-662; Frick Community Health Center, Ex. 20-292; Texas Health Care Association, Ex. 20-636).
Many comments were received which stated that certain medical procedures or practices necessitated recapping or removal of contaminated needles (e.g., AHA, Ex. 20-352; CDC/NIOSH, Ex. 20-634; SEIU, Ex. 299; Society of Hospital Epidemiologists of America, Ex. 20-1002; ADA, Ex. 20-665; APIC, Tr. 10/18/89, pp.198-200; Hahnemann University Hospital, Ex. 20-356). Examples given included blood gas analysis, inoculation of a blood culture bottle, and administration of incremental doses of a medication (e.g., an anesthetic) to the same patient. OSHA recognizes that certain procedures or circumstances may require recapping and removal; however, it should not be construed that these two actions are acceptable as a general practice. The Agency believes that use and immediate discard into a readily accessible sharps container is the safest practice to minimize employee exposure. This belief is supported by the fact that some of the commenters urging allowance to use one-handed or mechanical means of recapping or removal qualified their recommendation by phrases such as "in certain circumstances," "limited use," or "in some instances" (e.g., Judith G. Novak, CEO, HCA, Ex. 20-1191; Tucson Medical Center, Ex. 20-141; Camden Clark Hospital, Ex. 20-200; East Alabama Medical Center, Ex. 20-89; Eliza Coffee Memorial Hospital, Ex. 20-220). CDC/NIOSH was more specific in that they recommended that OSHA should:
. . . permit use of devices for the mechanical removal and disposal of needles, permit the resheathing of needles for medical practices for which there are no alternatives (e.g., blood gas syringes, blood cultures), and permit removal of resheathed needles during those procedures that require it (Ex. 20-634)
In their post-hearing comment SEIU supported the approach of CDC/NIOSH. They stated:
SEIU recognizes that certain procedures require re-capping (e.g., blood gas analysis). We support the position of NIOSH that re-capping should be permitted in those instances where there is no alternative and re-capping is required by a specific medical procedure. In those cases, mechanical devices should be used to assist in re-capping and to reduce the likelihood of needlestick injuries. (Ex. 299)
After considering these comments, the Agency concluded that it is correct in the belief that recapping or removal should not be acceptable as a general practice, however, certain situations exist where these actions are necessary. Therefore, paragraph (d)(2)(vii)(A) of the final standard requires that contaminated needles and other contaminated sharps shall not be removed or recapped unless the employer can demonstrate that no alternative is feasible or that such action is required by a specific medical procedure. In addition, paragraph (d)(2)(vii)(B) stipulates that such recapping or needle removal must be accomplished through the use of a mechanical device or one-handed technique.
Some sharps are not disposable and are intended to be reprocessed and reused, for example, some large bore needles, scalpels, and saws (Norwood Hospital, Ex. 20-967; UCSD Medical Center, Ex. 20-156). Even though these items are reusable, they pose the same percutaneous exposure hazard as disposable sharps and must be contained in a manner that eliminates or minimizes this hazard until they are reprocessed. Since contaminated sharps, whether reusable or disposable, present the identical hazard, the containers into which they are placed need to possess the same characteristics. Therefore, paragraph (d)(2)(viii) requires that immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers must be: (A) puncture-resistant; (B) labeled or color-coded in accordance with this standard; (C) leakproof on the sides and bottom; and (D) in accordance with the requirements set forth in paragraph (d)(4)(ii)(E).
Puncture-resistance prevents the sharps from penetrating the container and protruding from the sides while labeling or color-coding warns employees of the containers' hazardous contents. Requiring the containers to be leakproof on the sides and bottom prevents any residual liquids from penetrating to the exterior where it would present the possibility of employee exposure and environmental contamination. These three characteristics are also required of containers used for the discarding of contaminated sharps and a more detailed discussion of the rationale behind these requirements can be found under paragraph (d)(4)(iii)(A)(1). The fourth required characteristic stipulates that the containers must be in accordance with the provisions of paragraph (d)(4)(ii)(E) of this standard. This paragraph states that reusable sharps, that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed. By eliminating the need for employees to reach into containers holding contaminated sharps, the chance of percutaneous injury and its associated risk of disease transmission is reduced.
Containers for reusable sharps have not been required to be closable as is required for containers for disposable sharps. It is anticipated that the containers used for collecting and holding reusable sharps will, themselves, be reusable. As such, paragraph (d)(4)(iii)(A)(4) under "Contaminated Sharps Discarding and Containment" stipulates that reusable containers (containing contaminated sharps) shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.
While there is no documented evidence showing transmission of HIV by environmental surfaces, there is evidence that surface contamination is a mode of HBV transmission. As stated in Laboratory Safety: Principles and Practices:
Hepatitis transmission, especially type B hepatitis, can occur by indirect means via common environmental surfaces in a laboratory, such as test tubes, laboratory benches, laboratory accessories, and other surfaces contaminated with infectious blood, serum, secretions, or excretions which can be transferred to the skin or mucous membranes. The probability of disease transmission with a single exposure of this type may be remote, but the frequency of such exposures makes this mechanism of transmission potentially an efficient one over a long period of time. Activities in laboratories such as nail biting, smoking, eating, and a variety of hand-to-nose, -mouth, and -eye actions contribute to indirect transmission.(Ex. 6-344)
The Agency believes that this type of exposure exists in any environment containing contaminated surfaces and is not confined to only laboratories. Therefore, paragraphs (d)(2)(ix) and (d)(2)(x) of the final have been retained essentially unchanged from the proposal in order to eliminate or minimize such indirect transmission.
Paragraph (d)(2)(ix) states that eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood for occupational exposure. This prohibition is supported by several sources (CDC/NIH, Ex. 6-338; AHA, Ex. 6-75; National Committee for Clinical Laboratory Standards, 11-159; American Red Cross, Ex. 11-280). The only change in this provision as opposed to that originally contained in the proposal is that the phrase "potential for occupational exposure" has been changed to "reasonable likelihood for occupational exposure." As discussed previously, this substitution for the word "potential" is consistent throughout this document and has been implemented for the purpose of clarification.
St. Vincent Hospital and Medical Center inquired whether the prohibition on application of cosmetics extended to applying hand cream in these areas, particularly when considering that frequent handwashing and/or glove usage may lead to chapped, irritated hands in some individuals (Ex. 20-524). Hand cream application is permitted provided hands are thoroughly washed immediately prior to application. It should be noted, however, that a workshop report submitted by the Northwest Center for Occupational Health and Safety contained a statement of direct concern relative to use of hand creams and gloves. It stated:
Information presented by Dr. T. Lowe of the Food and Drug Administration (FDA) at the Fourth Conference on Occupational Hazards to Health Care Workers (University of Washington, May 1989) addressed not only the FDA's current efforts to establish efficacy criteria for latex surgical and examination gloves, but also noted the significant deterioration of such gloves when exposed to petroleum-based lubricants. This was new information to most participants at the Conference and illustrates an added dimension of barrier protection, the degradation of performance which may be caused by contact with other materials, such as disinfectants, cleaning materials and lubricants. (Ex. 20-526)
Therefore, when hand creams are utilized, particular attention should be directed to the cream's formulation and the effect it has on barrier properties of the gloves.
Several participants associated with ambulance services commented that the prohibition on eating and drinking in the work area could present a problem if "work area" is interpreted to include the cab of an ambulance (Mercy Ambulance, Tr. 10/20/89, p.832; American Ambulance Association, Tr. 1/17/90, p.884-885; Professional Ambulance Inc., Ex. 20-2758; Campbell-Superior Ambulance Service, Ex. 20-2647A). Ms. Jeanne Herson of the American Ambulance Association testified:
. . . In active system status management plans, which is now currently used in many cities, ambulances are not based in stations but are constantly roving in areas which statistically have the highest incidence of calls. This system allows for quicker response times than otherwise would be achieved. In these circumstances ambulance workers, paramedics, and EMTs are often confined for long periods of time in the cab of the ambulance. In times of heavy call volume the worker may not have a chance to take a break for food. A clear definition that the cab is exempt is needed. (Tr. 1/17/90, pp.884-885)
In his testimony, Scott Bradley of Mercy Ambulance supported the comment that employees of ambulance services may, as a result of a high volume of calls, be too busy to suspend service in order to eat or drink (Tr. 10/20/89, p.832). However, both hearing participants also stated that the potential exists for contamination of the cab area if an employee entered the cab while wearing contaminated clothing. Ms. Herson testified:
I think that if they had blood on their clothing and did not change it and went back into the cab the potential exists. I think that that could be removed by writing policies, procedures and standard operating procedures that that did not happen, that they were to change their clothing if they were exposed. We want them to change their clothing if they've got blood on their clothing. That could be written in. The potential there exists. (Tr. 1/17/90, pp.903-904)
Addressing the same issue, Mr. Brady stated:
When -- our company policy is that when an employee is exposed and the blood -- and the universal precautions do not protect the employee, the employee is released from duty or given time to clean up and change uniform. (Tr. 10/20/89, p.842)
The Agency interprets this testimony as demonstrating that ambulance services find it feasible and, in fact, support an employee's changing contaminated clothing prior to entering the cab and resuming duties.
With regard to delineating what constitutes the "work area" of an ambulance, the Agency asked Mr. Brady if the cab is generally separate from the area where the patient would be transported. In response, Mr. Brady stated:
Yes, it is. Currently, there are three types of vehicles used in our industry. Type 1, Type 2 and Type 3.
Type 1 being a pick-up type cab with a box in the back. Type 2 being a normal van chassis, you would have like a conversion van, and Type 3 is a cab, van-type cab on the front with a box on the back. All of them, to my knowledge, right now are under federal KKK-1822(b) requirements, require that the cab and the patient area have some method of closing the --- separating those two areas. So, there is a door, usually an opening or something, and a door that can be closed to separate the two areas. (Tr. 10/20/89, p.841)
Ms. Herson also testified that the cab and patient area are separated, permitting limited patient contact and then only with difficulty (Tr. 1/17/90, p.904).
Reviewing the testimony, the Agency recognizes that circumstances could arise which would require employees to remain in ambulances for extended periods of time. It is not the Agency's intent to prohibit these employees from eating or drinking during such extended periods. Therefore, eating and drinking in ambulance cabs is permitted under the final standard provided the employer has implemented procedures to permit employees to wash up and change contaminated clothing prior to entering the cab. In addition, employers must prohibit the consumption, handling, storage, and transport of food and drink in the rear of the vehicle. Such procedures ensure that patients and contaminated material remain in the rear area of the vehicle (behind the separating partition).
Consistent with the above provision, OSHA has required, in paragraph (d)(2)(x), that food and drink shall not be kept in refrigerators, freezers, shelves, or cabinets, or on countertops or benchtops where blood or other potentially infectious materials are present. In addition to contamination of the mucous membranes of the mouth, one must consider that food and beverage containers may also become contaminated, resulting in unsuspected contamination of the hands.
In the proposal, food and drink were also not permitted to be stored in "other areas of possible contamination." Verdugo Hills Hospital (Ex. 20-573) felt that this phrase was so broad that it was, in reality, meaningless. Although it is not OSHA's intent to prohibit employees from keeping their lunch in or on their desk or other such areas, this phrase could be misinterpreted and thereby severely restrict where consumables may be kept. However, the Agency does not want food and drink to be kept in areas where it or its packaging may be contaminated through processes such as leakage/spilling of specimen containers, contact with contaminated items, or performance of activities (e.g., lab analysis) that could generate splashes, sprays, or droplets of blood or other potentially infectious materials. Therefore, for the purpose of clarification, the phrase "other areas of possible contamination" has been eliminated in favor of the more specific statement "on countertops or benchtops."
Paragraph (d)(2)(xi) requires that all procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances. This requirement will not only decrease the chances of direct employee exposure through means such as spraying into the eyes of splashing onto the face or arms, but will also reduce contamination of surfaces (e.g., benchtops, instruments) in the general work area.
The term "aerosolization," which was contained in this provision in the proposal, has been replaced with "generation of droplets." Aerosols are solid or liquid particles, ranging in size from submicrometer to multi-micrometer, which are suspended in a gas. This suspension can last from a few seconds to a day or more. In their testimony and written submissions, Dr. Don Jewett and Ms. Patricia Heinsohn of the University of California at San Francisco, presented the results of preliminary research that they have been conducting regarding the generation of blood- containing aerosols during orthopaedic surgery. Their studies indicate that inspirable aerosols containing hemoglobin (the marker used to determine the presence of blood) are produced by power tools used during surgical procedures. Dr. Jewett and Ms. Heinsohn go on to discuss their recovery of blood-containing aerosols in personal breathing zone samples collected during actual hip replacement operations; the results of other researchers which indicate recovery of viable HIV from known HIV-positive blood/tissue in some, but not all, aerosols generated by surgical power tools, lasers, and electrocautery devices; the ability of a number of other viruses to be transmitted by aerosols; the possibility of infection through alveolar deposition of blood-containing aerosols; and quantification of risk of infection by calculating the number of Tissue Culture Infective Doses (TCID) contained in their air samples. Utilizing this information, they conclude that a potential respiratory hazard exists with the inhalation of blood-containing aerosols and that inhalation exposure must be controlled. A few other commenters supported this viewpoint (AFSCME, Ex. 297; Dr. Gerald Johnson, Tr. 1/12/90, pp.508-509).
However, a number of other participants commented that respiratory protection against aerosols did not appear to be warranted (CDC - Dr. Steven Hadler, Tr. 9/14/89, p.21 & p.80; CDC/NIOSH, Ex. 20-634; AHA, Ex. 20-352; AORN, Ex. 20-882; Medical Arts Laboratory, Ex. 20-638; Abington Memorial Hospital, Ex. 20-943; Association for Practitioners in Infection Control - National, Ex. 20-1118; The Cleveland Clinic Foundation, Ex. 20- 563; Society of Hospital Epidemiologists of America, Ex. 20-1002; VA - Hines, Illinois, Ex. 20-961). During his testimony, Dr. Stephen Hadler of the Centers for Infectious Diseases at CDC stated:
... Although there has been concern about potential infectivity of aerosols generated by dental, medical, and laboratory equipment, HBV has not been detected in such aerosols, and risk is posed primarily by large particles of "spatter" that travel only short distances. (Tr. 9/14/89, p.21)
Later, in response to questioning, Dr. Edward Baker of NIOSH stated:
... There have been no documented cases in the literature, to the best of our knowledge, of HIV transmission via aerosols. Furthermore, there have been studies designed to culture aerosols and these viruses, both HIV and HBV have not been isolated.
To the best of our knowledge, . . . there have been no cases, either of transmission or of clear evidence of exposure. (Tr. 9/14/89, p.80)
CDC/NIOSH expands on this stance in their written comment which goes on to say: (Ex. 20-634)
Aerosols are not known to present a risk of transmission of bloodborne pathogens in the healthcare environment. There are no known instances in which bloodborne pathogens have been transmitted to workers by way of respirable particles generated during medical procedures, nor are other instances known in which airborne particulates containing bloodborne pathogens have presented a risk to healthcare workers. Therefore, use of respirators for protection against bloodborne pathogens is not recommended.
The possibility that healthcare workers might be infected via inhalation of aerosolized bloodborne pathogens has been investigated, focusing on hepatitis B. Almeida et. al.  reported possible airborne spread of hepatitis B in a dialysis unit following a spill of HBsAG-positive blood. However, experimental studies [MRC 1975] using tracer organisms (Bacillus Globigii spores and T3 phage) in a simulated dialysis unit suggested that aerosolization was not a probable route of transmission. Neither blood nor HBsAG could be detected in air samples collected in dialysis units [Peterson et. al. 1976] or during dental procedures [Peterson et. al. 1979]. The Immunization Practices Advisory Committee [ACIP 1985] did not mention inhalation of aerosols in their discussion of the modes of transmission of HBV in healthcare settings. The current opinion of experts is that, while aerosol transmission is a theoretical possibility, it does not contribute measurably to occupational transmission of HBV, which is attributed to direct blood exposure or contamination of environmental surfaces [Peterson 1980; Favero 1987, 1989].
Splattering of blood onto skin or mucous membranes is a recognized mode of transmission of hepatitis B.
Protection of the mucous membranes of the face and upper respiratory tract against large droplet spattering is needed. As required by OSHA in this draft rule, glasses, goggles, face shields, and surgical masks, alone or in combination as appropriate to the task being performed, can provide that protection.
Some workers have requested and some employers have attempted to provide respiratory protection against possible inhalation exposure to bloodborne pathogens in healthcare workplaces. Some manufacturers and suppliers of surgical masks have responded to these potential markets with sales programs implying that surgical masks offer respiratory protection. Reported filtering efficiencies of the mask material are sometimes offered as evidence that a product offers respiratory protection.
Surgical masks, designed and approved for use in the healthcare industry, including use in sterile environments, were not designed or approved as respiratory protective devices. The minimal testing specifications for surgical masks do not appear to measure filter efficiency accurately, precisely, or reproducibly, and do not require face fit testing. Whatever the filtering efficiencies of the mask material, most surgical masks do not form an occlusive seal to the face and therefore are not expected to be efficient respiratory protective devices. However, as previously stated, respirators are not recommended for protection against bloodborne disease because there is no evidence that bloodborne pathogens can be or have been transmitted in the healthcare workplace by the respiratory route.
In addition to comments recommending control of aerosol exposure and those that stated aerosols do not present a hazard, others expressed concern over aerosols and some of them suggested that more research would have to be performed to accurately assess the risk (Northwest Center for Occupational Health and Safety, Ex. 20-526; Hoffmann-LaRoche Inc., Ex. 20-291; Roche Biomedical Laboratories, Ex. 20-1157; American Biological Safety Association, Ex. 241; Lutheran General Hospitals, Park Ridge and Chicago, Ex. 20-655). More specifically, the American Biological Safety Association stated:
In most situations, aerosols do not appear to present a risk of transmission of bloodborne diseases, however, there are some high energy devices which may produce respirable aerosols. Although evidence is inconclusive, preliminary results from researchers at the University of California San Francisco suggest the possibility that cell-free human immunodeficiency virus (HIV) may be present in blood-containing aerosols generated during some surgical procedures. Examples of such devices include the use of bone saw and a laser. Additional studies are needed to assess the risk to employees in such areas, and to recommend appropriate respiratory protection. (Ex. 241)
With reference to the clinical laboratory setting, Roche Biomedical Laboratories commented:
. . . It is acknowledged that little research has been done regarding aerosol production from routine clinical laboratory procedures. These procedures as a whole should pose little potential. However, the ones that do have the greatest potential which are commonly performed throughout the clinical laboratory industry should be identified and evaluated by NIOSH. Until such time, "aerosol" should not be used in the same context as splatters and splashes. (Ex. 20-1157)
The topic of "aerosols" has undergone careful review by the Agency. The information provided by Dr. Jewett and Ms. Heinsohn is disquieting to OSHA, however, the Agency lacks sufficient information in some important areas which it feels must be obtained before it can require employers to control exposures to aerosols. For example, it may be inappropriate to assume that transmission of HIV and HBV may be analogous to other viruses transmitted by the airborne route. While Dr. Jewett and Ms. Heinsohn cite evidence of HIV viability in aerosols, CDC and NIOSH stated that they are unaware of research indicating viability of these viruses in aerosols. Also, the proportional relationship between TCID and the dose necessary to result in human infection through inhalation is not known. In a written supplementary statement to his testimony, Dr. Jewett stated:
It should be noted that it is not known how many TCID are necessary to infect a human by any route, including recognized routes of transmission. With respect to SIV (Simian Immunodeficiency Virus) a dose less than one TCID (less than that which will infect a tissue culture) can infect a macaque monkey. The minimal infectious dose of HIV in humans is not known, but is likely to be very small. Some think that only a single HIV can be infective . (Ex. 269)
Aerosols of blood can be generated by a number of processes in the healthcare setting. In addition to the use of surgical power tools, aerosols can result from activities such as removal of the rubber tops from evacuated blood collection tubes, blood spills, and automatic pipetting instruments. Assuming a "worst case" of single virion infectivity and knowing the capability of minute aerosols to remain suspended in air and therefore spread widely throughout a facility, respiratory protection would be necessary for essentially every person within the facility. However, if such a situation were true, the Agency would expect seroconversion rates to be drastically increased among those exposed; but this does not appear to be the case. However, even if the controversy over respiratory protection for aerosols were settled, questions would remain regarding what concentration of blood-containing aerosol should trigger its use and what monitoring should be done to ensure exposures do not exceed this level.
The hierarchy of controls provision, paragraph (d)(2)(i), of this standard requires employers to implement engineering controls and work practices prior to relying on personal protective equipment for protecting employees against exposure. In their post-hearing comment, Dr. Jewett and Ms. Heinsohn state that they know of no effective engineering controls to address aerosol exposure. Specifically, Ms. Heinsohn commented:
We know of no engineering controls and physical containment devices which can effectively prevent breathing zone contamination in the operating room which can allow surgeons and others the close patient contact required. The suction tube held at the operative site throughout each operation was clearly ineffective in capturing the aerosols generated. Administrative controls are not feasible; the surgeons, first assistants, and other personnel finish the procedures they start. Respiratory protection remains as the most viable control measure. (Ex. 269)
At the San Francisco hearings, however, Dr. Gerald Johnson presented an electrosurgical pencil equipped with a sheath surrounding the tip whereby the smoke generated during the use of the pencil was evacuated through the sheath's suction ports. While the device Dr. Johnson presented was his personal property, he had sold the design to a manufacturer who was, at the time of the hearings, in the pre-development phase of manufacture. Dr. Johnson also testified that he had read that similar integral evacuators for surgical lasers were planned or were in the planning stages but he did not know of any that were commercially available at that time (Tr. 1/12/90, p.521). In response to a question from the OSHA panel, Dr. Jewett stated:
...I fully expect that there will be studies in which the power tools themselves would be changed to possibly reduce the amount of aerosol generated. That methods of trapping the aerosol near the source can also be devised and so my comment [that surgical power tool users should be wearing respirators] applies only to the present situation in which we are using the power tools that we have tested and the data that we have. . .. (Tr.1/9/10, p.102) *[Bracketed information added by OSHA]
OSHA is not aware of specific engineering controls and work practices that are currently available to address control of aerosols. If such controls are available, the question remains as to what airborne concentration of blood-containing aerosol they should be designed to achieve.
With regard to the respiratory protective devices themselves, the Northwest Center for Occupational Health and Safety discusses several areas that need further investigation. They state:
High priority should be given to research to characterize the respirable and non-respirable airborne particles that are generated during various medical procedures and to determine whether these particles present a risk of infection. Research is also needed to determine the permeability and penetration of body fluids or resuspension of body fluids through surgical masks. Current performance standards for industrial respirators should be evaluated for appropriateness of application to surgical masks. Minimal performance criteria should be established for surgical masks, with particular emphasis on face seal leakage criteria. (Ex. 20-526)
In addition to the concerns about surgical masks registered in the above statement, OSHA also lacks information on the appropriateness of face mask respirators in the healthcare setting (e.g., their impact on the vision of the surgeon and/or speech communication between operating staff, ability of particular respirators and/or filter cartridges to provide proper protection, etc.).
As stated previously, the information presented by Dr. Jewett and Ms. Heinsohn suggests the potential for airborne transmission may exist. Conversely, CDC and NIOSH, both recognized experts in their respective fields, have stated that there are no cases traceable to airborne transmission. These conflicting opinions, coupled with the aforementioned lack of information, prevent OSHA from formulating a firm scientific opinion on this matter. Consequently, the Agency does not believe it is justified in pursuing regulation of aerosols at the current time. However, OSHA does believe that airborne transmission of these viruses through blood-containing aerosols needs to be thoroughly investigated with particular consideration being given to independent research currently being conducted. Therefore, the Agency will refer these matters to NIOSH for further study. If their findings indicate that respiratory protection against aerosol exposure is warranted, the final standard can be amended after appropriate rulemaking on the issues discussed above.
Paragraph (d)(2)(viii) of the proposal stated that mouth pipetting/suctioning would be prohibited. This provision remains unchanged in paragraph (d)(2)(xii) of the final regulation. The use of cotton plugs or other barriers does little to reduce the hazards of mouth pipetting. Even a technician who is skilled in mouth pipetting may inadvertently suck blood or other potentially infectious materials into the mouth which could result in bloodborne pathogens coming into contact with the mucous membranes of the mouth as well as any blisters, cuts, abrasions,or other lesions in the mouth or on the lips.
Paragraph (d)(2)(xiii) addresses the employer's obligations when specimens are placed in containers. A similar provision was put forth in the proposed standard under the housekeeping provisions. Upon review, however, the Agency feels that it is more appropriate to include this type of requirement under "Engineering and Work Practice Controls" because it is a work practice rather than a housekeeping concern. The original provision of the proposal also contained several requirements within one paragraph. For clarification, these requirements have been separated into individual paragraphs in this final standard.
Paragraph (d)(2)(xiii) of the final standard requires that specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, and shipping. The proposed standard required that specimens be placed in "leakproof" containers prior to being stored or transported. The American Hospital Association commented:
- ... [T]he rules distinction between "leakproof" and "puncture resistant"
is blurred. The performance-based standard of "leak resistant" is a far more realistic and appropriate standard for the health care setting. . .. (Ex. 20-352)(Emphasis in original)
This sentiment was reiterated by Dr. M. Scott Stirton, a Seatle pathologist, who stated:
. . . The use of "leakproof" containers for all specimens is again, very costly and needless. Only specimens not in a closed container or those in a closed container with contamination on the outside need to be placed in a leakproof container. Throughout the document, "leakproof" should be changed to "leak resistant" since there are no "leakproof" containers, gowns, etc. (Ex. 20-565)
For the final standard, the term "leakproof" has been changed to "prevents leakage during collection, handling, processing, storage, transport, and shipping." The intent of this requirement is to eliminate or minimize the possibility of inadvertent employee contact with blood or other potentially infectious materials which have leaked out of the container, contaminating the container's exterior surface and/or surrounding surfaces. The Agency believes that this modification increases the performance orientation of the provision by permitting more latitude in the selection of containers based upon the type of specimen and the handling it would be anticipated to undergo. For example, a screw top container, maintained in an upright position, would most likely prevent leakage during collection and processing. However, a screw top container placed on its side in a bin or envelope for shipping to an outside lab may not be able to prevent leakage of its contents.
In addition to preventing leakage of blood and other potentially infectious materials from containers, employees must be warned that these substances are present so that proper handling precautions can be taken. Therefore, paragraph (d)(2)(xiii)(A) stipulates that the container for storage, transport, and shipping shall be labeled or color-coded according to paragraph (g)(1)(ii) of this standard and closed prior to being stored, transported, or shipped. The label or color-coding serves to alert those coming into contact with the container that the specimen contains blood or other potentially infectious materials. Requiring that the container be closed prior to being stored, transported, or shipped assures not only that the specimen will remain in the container if it is tipped over or jostled but also prevents other objects (e.g. charts, clothing) from contacting the specimen and becoming contaminated.
OSHA believes it is vitally important to the safety of workers for them to know they may be handling bloodborne pathogens. For many facilities, the only practical way to accomplish this is to label the specimen containers. NIOSH supports OSHA's proposal to require labeling to alert workers ". . . when handling materials or containers of materials that require observation of universal, or barrier precautions." (Dr. Bryan Harden, NIOSH, Tr. 9/14/89, p. 29).
In general, the commenters who considered labeling raised three major concerns: (1) that the labeling of specimens HBV or HIV positive would encourage employees to take precautions only when handling those specimens known to be infectious; (2) that the use of the biohazard label on all containers would make it such a familiar symbol as to negate its effectiveness; and (3) that the labeling requirement is unnecessary and, some noted, inconsistent with universal precautions.
With regard to the first concern, the American Federation of State, County, and Municipal Employees (AFSCME) stated in their post-hearing brief:
Some commentors have recommended that a special Biohazard symbol be used on samples that contain known bloodborne pathogens. This additional labeling, so the argument goes, will provide workers with greater incentives to take protective measures above and beyond those associated with universal precautions.
However, we are concerned that differential labeling will encourage employees to become lax with samples that are not explicitly marked but may also be infectious (Ex. 297).
The University of Connecticut wrote in their comment:
. . . Universal precautions require that human blood and body fluids always be handled using barrier protection. Tentative Guidelines of the National Committee for Laboratory Clinical Standards on Protection of Laboratory Workers from Infectious Disease Transmitted by Blood, Body Fluids, and Tissue (M29-T, Vol. 9 No. 1, Jan. 1989) states, "[i]mplementing universal precautions also eliminates the need for using specific warning labels on specimens obtained from patients infected with HBV or HIV. . . .. The use of special labels may create a false sense of security that nonlableled blood is not infectious. . .. "(Ex. 20-191)
OSHA agrees with AFSCME, the University of Connecticut and other commenters who were concerned that in such a tiered system of specimen handling, employees who fail to take precautions with specimens of unknown seropositivity status will be at increased risk from those unidentified HIV and HBV positive specimens. The purpose of the label is only to indicate the presence of blood or other potentially infectious materials in the specimen. OSHA is not requiring the seropositivity of a particular specimen be on its label.
Similar concerns were raised by other commenters who argued that labeling specimens which contain blood or other potentially infectious materials would create a false sense of security and/or result in a deterioration in handling of unlabeled specimens. (e.g., Montana Deaconess Medical Center, Ex. 20-380; University of Connecticut Health Center, Ex. 20-191; Michigan Advisiory Committee on Occupational Exposure, Tr. 10/17/89, p.25).
Several commenters suggested the labeling requirements would lead to too many labels in the workplace. Specifically, the Society of Hospital Epidemiologists and The George Washington University Medical Center believe that the proposed rule would result in overlabeling which would erode the meaningfulness of the biohazard symbol. (Tr. 10/18/89, p.354; Ex. 20-1203). Ms. Patricia Lynch, a representative for the American Hospitial Association and Infection Control Coordinator for Harborview Medical Center testified that:
We found in our implementation that there was a marked difference in the behavior of the laboratory personnel when they received things that had coded labels of some sort on them, that they started doing additional stuff, and they stopped doing the precautions that we wanted them to use with everything. So, over a period of a year, or so, we withdrew our entire labeling system after a brief flirtation with labeling everything, which proved to be very burdensome. (Tr. 9/19/89, pp.163-164).
OSHA has considered this view but has decided that the chance that overlabeling could occur in a particular workplace is far outweighed by the need for employees to be readily informed about the potential hazards posed by bloodborne pathogens in specimens.
Many commenters stated that the proposed specimen labeling requirements were inconsistent with universal precautions and/or all specimens should be handled as if they were infectious (APIC - National, Ex. 20-1118; APIC - Dade County, Ex. 20-371; Baptist Medical Center, Ex. 20-146; Christine Bellefontaine, RN, BSN, Daniel Freeman Marina Hospital, Ex. 20-987; Independence Regional Health Center, Ex. 20-230; Shadyside Hospital, Ex. 20-546; VA - Kansas City, Ex. 20-187; Kaiser Permanente - Panorama City, Ex. 20-60; LASSA NW Ex. 20-680; Meadville Medical Center, Ex. 20-624; Memorial Hospital of Dodge County, Ex. 713; New England Medical Center Hospitals, Ex. 20-511; Norwood Hospital, Ex. 20-967; Saline Community Hospital, Ex. 20-869; Sequoia Hospital, Ex. 20-538; Stanford University, Ex. 20-984; University of Michigan, Ex. 20-1306; St. Luke's Hospital, Ex. 20-114). Many of these facilities expressed concern about being required to differentially label specimens containing blood or other potentially infectious materials when universal precautions were being followed in the handling of all specimens.
OSHA has considered these comments and believes they have merit. Handling all specimens with universal precautions is essentially the infection control method known as Body Substance Isolation which can provide more protection to employees and, in some facilities, be simpler to implement. Accordingly, in this final standard, OSHA is allowing workplaces where all specimens are handled with universal precautions to not label. However, since the hazards are great to employees who do not know they are handling bloodborne pathogens, OSHA has drawn this exception to the general labeling requirements narrowly. Specifically, employers may avoid labeling only if all employees who may have contact with specimen containers are able to recognize them as containing specimens requiring the use of universal precautions and all of these employees have been trained to follow universal precautions in handling these specimens. Moreover, OSHA believes that it is not sufficient to simply utilize universal precautions in the handling of all blood specimens in order to be exempt from labeling/color-coding. Other materials, some of which have no resemblance to blood or in which blood may not be readily observed, may also be potentially infectious (e.g., plasma, amniotic fluid). Therefore, the standard requires that the concept of universal precautions be applied to all specimens in order for the labeling/color-coding exemption to be permitted. This exemption only applies while such specimens/containers remain within the facility. Labeling or color-coding in accordance with paragraph (g)(1)(i) is required when such specimens/containers leave the facility. Labeling or color-coding the specimen container when it leaves the facility assures that employees outside the facility who may have contact with the specimen/container will be warned of its contents so that proper precautions can be taken.
Paragraph (d)(2)(xii)(B) states that if outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage during handling, processing, storage, transport, or shipping and that it is labeled according to the requirements. The requirement for a secondary container received several comments, all of which appear to interpret the provision as mandating double containers on all specimens (American Association for Clinical Chemistry, Ex. 20-368; AHA, Ex. 20-352; Christine Bellefontaine, RN, BSN, Daniel Freeman Marina Hospital, Ex. 20-987; Laboratory of Pathology, Ex. 20-716). Secondary containers are required only on those specimens in which the primary container is likely to be contaminated on its outside surface, as may occur by handling the container while wearing bloody gloves, or when it is reasonably anticipated that the primary container may not be able to prevent leakage. For example, a tissue specimen which is so large that it will not permit closure of the available primary container to the point of preventing leakage would necessitate a secondary container. OSHA believes, therefore, that secondary containers are necessary in situations such as those discussed above to prevent contaminant migration and inadvertent employee exposure.
If the specimen could puncture the primary container, paragraph (d)(2)(xii)(C) requires that the primary container be placed within a secondary container which is puncture-resistant in addition to the above characteristics (i.e., prevents leakage during handling, processing, storage, transport, or shipping and which is labeled or color-coded), again, to prevent inadvertent contaminant migration and employee exposure. The American Hospital Association recommended that this requirement be limited to only those circumstances when sharps are present in the specimen (Ex. 20-352). The term "sharps" encompasses a distinct set of items for the purposes of this standard and the Agency believes that items not contained within the definition of "sharps" could puncture a primary container. For example, a specimen containing a pointed bone sliver could puncture a plastic bag type container yet the bone would not be considered a "sharp" per se. Therefore, while it is not OSHA's intent to have all specimens placed in puncture-resistant containers, the Agency is not limiting implementation of this provision to only those situations where sharps are present. This course of action has been chosen in order to assure that other items which could cause puncture, such as a bone sliver, will trigger the use of a puncture-resistant container.
Equipment used for diagnosis, treatment, research and other applications may become contaminated with blood or other potentially infectious materials. Examples of such equipment include blood gas analyzers, mechanical pipetters, suctioning devices, centrifuges, and liquid chromatographs. During the development of the proposed standard, several sources recommended instruments and equipment be decontaminated prior to repair in the laboratory or shipment to the manufacturer for servicing (CDC, Ex. 6-153; ABRA, Ex. 11-71; NCCLS, Ex. 11-159A). In addition, Waters Chromatography Division of Millipore Corporation (Ex. 11-3) and YSI Incorporated (Ex. 11-7), both of whom are involved with instrument servicing, addressed the potential for exposure of repair personnel.
OSHA responded to these comments by proposing that such equipment be checked and decontaminated as necessary and prior to servicing or shipping. The intent behind this proposed requirement was to minimize the possibility of employees and servicing and shipping personnel becoming exposed due to leakage of potentially infectious materials from the equipment or through contact with interior/exterior contamination. The Agency believes that this requirement and the underlying reasoning remain valid and has retained the provision on the final standard. Therefore, paragraph (d)(2)(xiv) states that equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary unless the employer can demonstrate that decontamination of such equipment or portions of such equipment is not feasible. This provision was supported by the Health Industry Manufacturers Association (HIMA) (Exs. 85).
Several commenters, while not disagreeing with the proposed provision, stated that it may not always be possible to decontaminate equipment prior to servicing or shipping (William W. Backus Hospital, Ex. 20-911; Norwood Hospital, Ex. 20-967; American Red Cross Blood Services - Appalachian Region, Ex. 20-215; APIC - National, Ex. 20-1118; Medical Arts Laboratory, Ex. 20-638). The American Red Cross Blood Services commented:
In some instances this may not be feasible. Blood Center personnel operate technologically advanced equipment. They may not have the necessary training and experience to take apart technologically advanced equipment. (Ex. 20-215)
The Association for Practitioners in Infection Control (APIC) also voiced the concern that equipment design may prevent its effective cleaning in their statement:
The requirement to decontaminate equipment prior to servicing or shipping is stated "as necessary". Realistically, this should say "as possible". It is not always possible to effectively clean equipment prior to servicing because of equipment design. Therefore biomedical equipment engineers are taught to practice precautions until the equipment can be disassembled and cleaned. Computer keyboards in the clinical laboratory are an example of equipment that cannot be effectively cleaned by the user. (Ex. 20-1118)
Although the Maryland Safety and Health program felt that contaminated equipment should be automatically disinfected before servicing and recommended eliminating the phrase "as necessary", OSHA agrees that complete decontamination may not always be possible, particularly when equipment is highly technical, very sensitive, and/or presents limited access to contaminated parts (Ex. 20-1362). However, the Agency believes that there are few, if any, circumstances in which at least partial decontamination (e.g., flushing lines, wiping the exterior) cannot be accomplished. Therefore, an exemption to decontamination is not warranted. OSHA has concluded that the requirement to decontaminate equipment prior to servicing or shipping is appropriate and should only be limited by feasibility.
When decontamination of equipment or parts of equipment cannot be performed, it is necessary to warn those who may come in contact with the equipment of the hazard so that appropriate precautions can be taken. Consequently, paragraph (d)(2)(xiv)(A) mandates that whenever decontamination of such equipment or portions of such equipment is not feasible, a readily observable label in accordance with the requirements of paragraph (g)(1)(i)(H) shall be attached to the equipment. It should be noted that in addition to the other requirements of paragraph (g), the label is to state which portions of the equipment remain contaminated. This will assist individuals who may contact the equipment in determining what precautions need to be taken and when they should be implemented.
Consistent with the other hazard communication provisions of this standard, responsibility for transmitting this warning falls upon the employer. Paragraph (d)(2)(xiv)(B), therefore, requires the employer to assure that this information is conveyed to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping so that appropriate precautions will be taken. This provision is particularly important when equipment is being shipped or transported to an off-site servicing/repair facility to assure that downstream individuals are forewarned of the hazard.
Personal Protective Equipment
OSHA's requirements for personal protective equipment contained in paragraph (d)(3), have been set to assure adequate protection during task performance. In their response to the ANPR, the National Institute for Occupational Safety and Health (NIOSH) stated:
The purpose of personal protective clothing and equipment is to prevent or minimize the entry of materials into the worker's body. This includes entry via apparent or inapparent skin lesions or entry through the membranes of the eye, nose, or mouth. . . . Appropriate protective clothing and equipment should . . . be selected based on the specific work and exposure conditions that will be encountered and the anticipated level of risk. (CDC/NIOSH, Ex. 11-187)
This approach to the selection of protective barriers is echoed by CDC in their June 1988 guidelines:
. . . The type of protective barrier(s) should be appropriate for the procedure being performed and the type of exposure anticipated. (Ex. 6-316)
Personal protective equipment plays an important role in this standard. As discussed previously, when engineering controls and work practices are insufficient to eliminate exposure then personal protective equipment must be utilized to address the remaining exposure potential. Hence, paragraph (d)(3)(i) states that when there is occupational exposure, the employer shall provide, at no cost to the employee, appropriate personal protective equipment such as, but not limited to, gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. This provision also states that personal protective equipment will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used.
The proposed standard required employers to provide personal protective equipment when employees had the "potential for" occupational exposure. Again, a number of commenters questioned the interpretation of the word "potential" and/or recommended that it be replaced or deleted (Shriner's Hospital for Crippled Children, Ex. 20-254; St. Francis Regional Medical Hospital, Ex. 20-366; Mayo Clinic, Ex. 20-376; San Antonio Community Hospital, Ex. 20-530; Lutheran General Hospitals, Park Ridge and Chicago, Ex. 20-655; Iowa Lutheran Hospital, Ex. 20-885; Osteopathic Medical Center of Philadelphia, Ex. 20-1342). For clarification, the term "potential" has been deleted from the provision as has been done in other portions of the standard. Provision of personal protective equipment is based, therefore, upon the existence of occupational exposure which, by definition, is "reasonably anticipated" skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee's duties.
It has been the Agency's longstanding policy to hold the employer responsible for controlling exposure to hazards in his or her workplace and to fulfill this responsibility at no cost to the employee. Therefore, the financial burden for purchasing and providing personal protective equipment rests upon the employer just as it does for all other control measures (e.g., engineering controls). Support for this provision was registered by a number of commenters (SEIU, Ex. 299; RWDSU, Tr. 11/14/89, pp.432-433; Communication Workers of America, Ex. 20-787; American Association of Critical-Care Nurses, Ex. 20-1162; ADHA, Tr. 1/16/90, p.570; Douglas Kline, MCM, CIC, Ex. 20-87; Lee Hospital, Ex. 20-103; Abington Memorial Hospital, Ex. 20-557; Lutheran General Hospitals, Park Ridge and Chicago, Ex. 20-655). Some participants apparently interpreted the proposed regulations on provision of personal protective equipment to mean that all work clothing was to be provided by the employer (Tennessee Christian Medical Center, Ex. 20-54; Lutheran General Hospitals, Park Ridge and Chicago, Ex. 20-655). Specifically, Dr. Murray D. Batt, Chairman, Infection Control Committees, of Lutheran General Hospitals commented:
In the area of infection control it is clear that the hospital has responsibility to provide gloves, goggles where appropriate, masks where appropriate, waterproof aprons, protective gowns, etc. It is by no means clear that the employer should also make available clothing for its employees and I wonder why this is included in the rule making. (Ex. 20-655)
In discussing this provision, the Society of Hospital Epidemiologists of America suggested:
Simple cloth garb such as lab coats or scrub suits are commonly used for convenience, appearance, and to prevent routine soiling of street clothes, rather than for personal protection from the risk of bloodborne infection. It should be made clear that use in this manner (rather than to comply with the provisions of this standard) is not required, and if permitted by the employer, does not impose a duty on the employer to supply or clean the garments. (Ex. 20-1002)
The Agency is aware that some employees purchase their own uniforms and/or lab coats for use as general work clothes. It is not the intent of this provision to obligate employers to provide general work clothes to employees, however, the employer is responsible for providing personal protective equipment. If an item of clothing is intended to protect the employee's person or work clothes or street clothes against contact with blood or other potentially infectious materials then it would be considered as personal protective equipment and must be provided by the employer. With particular regard to lab coats (or gowns) and uniforms, if a lab coat is used to prevent an employee's uniform from becoming contaminated with blood or other potentially infectious materials then the lab coat is personal protective equipment and must be provided by the employer. If an employee's uniform is intended to protect the employee's body against contamination, then the uniform is personal protective equipment and is to be provided by the employer. Whether or not an item of clothing is considered personal protective equipment supplied by the employer, depends on its use. For example, a uniform is personal protective equipment if its purpose is to protect the employee from occupational exposure. If, on the other hand, a lab coat or protective gown is donned over the uniform, then the uniform is not protective clothing. Therefore, the employer's obligation to provide a particular item is based upon whether or not an item is to function as protection against contamination with blood or other potentially infectious materials.
A number of commenters expressed concern that strict interpretation of this requirement would require employers to provide all employees with all of the personal protective equipment mentioned in the standard and/or require them to use it, regardless of the task being performed, or employees would inappropriately utilize such equipment, resulting in unnecessary overuse of personal protective equipment (AHA, Ex. 20-352; ADA, Ex. 20-665; American Association for Respiratory Care, Exs. 20-107; Blood Systems Inc., Ex. 20-341; Southgate Medical Laboratory Systems, Ex. 20-577; Episcopal Hospital, Ex. 20-886; APIC - Greater Omaha, Ex. 20-943; AHCA, Tr. 9/21/89, p.61-62; American Association of Orthodontists, Tr. 11/14/89, pp.496-497; American Board of Orthodontists, Tr. 11/14/89, pp.501-502). For example, the American Association for Respiratory Care stated:
. . . We strongly urge OSHA to remain flexible in requiring the extensive use of protective equipment. By the very nature of the profession, the respiratory care practitioner, following strict OSHA standards would need to be gloved, gowned, goggled, and masked throughout the entire work shift. This is clearly over-prescriptive.
We support OSHA's requirement for employee education, for mandatory infection control plans, for the requirement that the employer must provide easy access to a variety of protective equipment and clothing, but we believe that, guided by Universal Precautions, the individual should decide the extent of the protective items needed, based on the procedure and type of exposure anticipated. (Ex. 20-107)
The American Hospital Association, in addressing this issue, commented:
. . . [B]y enumerating requirements to wear other protective equipment like masks, face shields, goggles, and aprons, but not limiting application to situations when exposure can reasonably be anticipated, the rule is vague enough to be construed to require such equipment for all patient encounters, regardless of the potential for exposure. . . . (Ex. 20-352)
It is not the Agency's intent that employees be outfitted in all possible personal protective equipment or a "moon suit" for all tasks or procedures that they perform. The protective equipment utilized is simply to be chosen to protect against contact with blood or other potentially infectious materials based upon the type of exposure and quantity of these substances which can be reasonably anticipated to be encountered during performance of a task or procedure. This approach to selection of the type of personal protective equipment to be utilized in a particular instance is supported by several commenters in addition to the recommendations of NIOSH and CDC cited at the beginning of this discussion (AHA, Ex.20-352; Hospital Laundry Services, Exs. 20-1225; APIC - Pittsburgh, Tr. 9/27/89, p.265; Elise Yiasemides, Tr. 9/13/89, p.63).
In the proposal, under paragraph (d)(3)(vii), "Gowns, Aprons, and Other Protective Body Clothing", OSHA stated:
Appropriate protective clothing shall be worn when the employee has a potential for occupational exposure. The type and characteristics will depend upon the task and degree of exposure anticipated; however, the clothing selected shall form an effective barrier.
The Agency then proposed, in three subsequent provisions, to delineate minimal characteristics of such protective body clothing based upon types of exposure. That is, gowns, lab coats, aprons or similar clothing were to be worn if the potential for soiling of clothes with blood or other potentially infectious materials existed; fluid-resistant clothing was to be worn if there was a potential for splashing or spraying; and fluid-proof clothing was to be utilized if there was a potential for clothing to become soaked with the substances of concern. In response, a large number of commenters requested that OSHA clarify or define the terms "fluid-resistant" and "fluid-proof" (Association of Operating Room Nurses, Inc., Ex. 20-882; AFSCME - New York, Ex. 20-985; American Association of Critical-Care Nurses, Ex. 20-1162; American Society for Microbiology, Ex. 20-1188; South Carolina Department of Health and Environmental Control, Ex. 20-1160; The Hospital Association of Pennsylvania, Ex. 20-874; The ServiceMaster Company, Ex. 20-21; Abington Memorial Hospital, Ex. 20-557; Mayo Clinic, Ex. 20-376). Other commenters, however, informed the Agency that there was no industry-accepted definition for these terms and, in fact, no generally recognized, standardized test methodology was employed to determine fluid-resistance (AHA, Ex. 20-352; Superior Surgical Manufacturing Co., Ex. 20-41; Abbott Laboratories, Ex. 20-1227; Surgikos, Ex. 20-252; APIC, Tr. 10/18/89, p.189; Joint Committee on Health Care Laundry Guidelines, Tr. 10/20/89, p.801; W.L. Gore and Associates, Inc., Tr. 9/25/89, p.180). Surgikos commented:
In the quest for standards on liquid repellency, the manufacturers of protective clothing vary greatly as to methodology for determining levels of liquid repellency. In the marketplace today, several fabrics exist that exhibit a threshold (market proven) level of liquid repellency. Design enhancements, such as sleeve and chest reinforcements exist, providing additional levels of liquid repellency. These design enhancements can render the fabric impervious (plastic reinforced). Additionally, liquid challenges to protective clothing vary greatly according to the procedure being performed. In the past, committees made up of surgeons and nurses, but primarily of manufacturers, have assembled with the goal of establishing liquid repellency standards. To date, no standards are available. . . . (Ex. 20-252)
The American Hospital Association also addressed this issue in their statement:
OSHA's attempt to differentiate between splashing, spraying, and soaking is specious, and will only burden workers and the health care facility, who must attempt to use this basis to determine when to use "fluid proof" or "fluid resistant" protective clothing. Because there is no method to assess the ability of a material to resist penetration of fluids and thus no scientific measures of barrier effectiveness against bloodborne pathogens, nothing can be gained by attempting to differentiate between fluid proof and fluid resistant garb. . . . (Ex. 20-352)
Conversely, the National Office of the Association for Practitioners in Infection Control felt that the distinction between fluid-resistant and fluid-proof was clear and the selection of such barrier properties based upon exposure (e.g. splashing, soaking) was appropriate (Ex. 20-1118). The Society of Hospital Epidemiologists of America also supported use of fluid-resistant and fluid-proof garb, but urged OSHA not to set stringent definitions for these terms. They commented:
The distinction between fluid-resistant and fluid-proof is reasonable. Currently available gowns represent different degrees of protection along this spectrum, and some institutions make several types available in accord with anticipated exposure. However, as noted, gowns are not either "fluid-resistant" or "fluid-proof"; the spectrum is continuous, and the degree of protection varies even within the garment (back vs chest vs elbows, etc). Recommendation: require that provided gowns offer a degree of fluid protection appropriate to the anticipated exposures, such that strike-through is unlikely. Do not establish standards for "fluid-resistant" and "fluid-proof". (Ex. 20-1002) (Emphasis in original)
A similar approach was recommended by The Service Master Company in their comment:
Characteristics of personal protective equipment should be performance oriented. The specification of characteristics of construction or fabric for personal protective equipment for each particular task would be monumental if it was to be all-inclusive. Furthermore, such specifications would be more limiting both in selection of current items available and acceptance of new items or materials as they are developed and became available. Performance-oriented characteristics provides for greater latitude and flexibility while still providing the desired employee protection. (Ex. 20-21) (Emphasis in original)
It appears from the comments that affected parties generally recognize that differing exposures (i.e., type of exposure and quantity of fluid) demand different levels of protective capability in a garment. While it was OSHA's intent in the proposal to assure that adequate protection was afforded employees by requiring the use of fluid-resistant and fluid-proof clothing based on exposure circumstance, the absence of a recognized industry standard for these characteristics has created confusion among both manufacturers and users of such garments. OSHA was informed that the American Society for Testing and Materials (ASTM) is working toward standardized methods of testing, terminology, classification, and performance specifications for resistance of clothing to biological hazards (ASTM, Ex. 20-51; American Reusable Textile Association, Ex. 20- 1272). This work, however, is still under development and was not accepted and available for OSHA to refer to during development of this standard. Therefore, the Agency has decided to be more performance-oriented in the standard and the terms "fluid-resistant" and "fluid-proof" have been eliminated from the final regulation.
Relative to this performance-oriented approach, the State of Maryland Occupational Safety and Health program (Ex. 20-1362) recommended that protective equipment should form an effective barrier under anticipated conditions of exposure. The Agency does not believe that the phrase "effective barrier" provides adequate instruction to those covered by the standard since this term was used in the proposal and a large number of commenters asked for it to be clarified or defined (APIC - National, Ex. 20-1118; Northwest Center for Occupational Health and Safety, Ex. 20-526; Clayton General Hospital, Ex. 20-661; Abington Memorial Hospital, Ex. 20-557; Anaheim Memorial Hospital, Ex. 20-523; Children's Hospital of Orange County, Ex. 20-568; Children's Hospital of San Francisco, Ex. 20-545; Hoag Memorial Hospital, Ex. 20-673; Pacific Hospital of Long Beach, Ex. 20-633; Healthcare Medical Center, Ex. 20-618). After reviewing several of the comments, OSHA believes that the endpoint to be achieved is for the chosen personal protective equipment to adequately protect the employee's skin, clothing and mucous membranes against contact with blood or other potentially infectious materials (Society of Hospital Epidemiologists of America, Ex. 20-1002; APIC - Indiana, Ex. 20-139; Parkview Memorial Hospital, Ex. 20-136; VA - Edward J. Hines Jr. Hospital, 20-961). Therefore, performance criteria have been added to paragraph (d)(3)(i) delineating the characteristics of "appropriate" personal protective equipment. This provision states that personal protective will be considered "appropriate" only if it does not permit blood or other potentially infectious materials to pass through to or otherwise reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use and for the duration of time which the protective equipment will be used. OSHA has concluded that this provision increases the performance-orientation of the regulation, supplies the criteria necessary for proper selection of equipment, and increases flexibility in attaining compliance. Since this endpoint is the purpose of any personal protective equipment, it should be noted that the provision refers to all personal protective equipment rather than a particular item (e.g., gowns, masks, aprons, etc.).
Two other issues were raised during the public comment period relative to provision of personal protective equipment. The first is directly related to the concept of "appropriate" in choosing personal protective equipment. Several commenters urged OSHA to insert a requirement concerning "quality" of equipment provided to employees (AFSCME, Tr. 9/15/89, p.100, Ex. 297; Repack Surgical Enterprises, Tr. 10/20/89, p.886; SEIU, Ex. 299; Frick Community Health Center, Ex. 20-292; John L. McClellan Memorial Veteran's Hospital, Ex. 20-548; VA - Southwestern Region, Ex. 20-549). A review of the record did not reveal quality specifications for specific items of personal protective equipment but, in any case, the Agency concludes that the final regulation adequately addresses this issue by requiring that protective equipment maintain its protective characteristics "under normal conditions of use and for the duration of time which the protective equipment will be used". Under this performance-oriented standard, a paper gown which ripped or fell apart under normal use would not be considered to be "appropriate."
The second query involved provision of protective equipment (particularly gowns, aprons, and other body clothing) in general. A number of commenters asserted that transmission of bloodborne diseases has not been shown to occur through intact skin and some argued that the effectiveness of such equipment to prevent transmission has not been demonstrated (APIC - Central Ohio, Ex. 20-1158; G.S. Naylor, M.D., & K.A. Yates, R.N., Ex. 20-255; UCSD Medical Center, Ex. 20-156; Dakota Hospital, Ex. 20-632; LASSA N.W., Ex. 20-680; Mission Bay Hospital, Ex. 20-666; Scripps Memorial Hospital, Ex. 20-522; The United Hospital, Ex. 20-682; Tucson Medical Center, Ex. 20-141). However, the CDC's "Recommendations for Prevention of HIV Transmission in Health-Care Settings" states:
1. All health-care workers should routinely use appropriate barrier precautions to prevent skin and mucous-membrane exposure when contact with blood or other body fluids of any patient is anticipated. . . .
2. Hands and other skin surfaces should be washed immediately and thoroughly if contaminated with blood or other body fluids. . . . (Ex. 6-153)
In their follow-up document, "Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings," the CDC continues to recommend preventing skin exposure and utilization of personal protective equipment.
Protective barriers reduce the risk of exposure of the health-care worker's skin and mucous membranes to potentially infective materials. For universal precautions, protective barriers reduce the risk of exposure to blood, body fluids containing visible blood, and other fluids to which universal precautions apply. Examples of protective barriers include gloves, gowns, masks, and protective eyewear. . . .
2. Use protective barriers to prevent exposure to blood, body fluids containing visible blood, and other fluids to which universal precautions apply.
3. Immediately and thoroughly wash hands and other skin surfaces that are contaminated with blood, body fluids containing visible blood, or other body fluids to which universal precautions apply. (Ex. 6-426)
With regard to preventing not only skin and mucous membrane contact but also contamination of work clothes or street clothes with blood or other potentially infectious materials, the CDC's document "Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public-Safety Workers" recommends to fire and emergency medical services:
. . . Gowns or aprons should be worn to protect clothing from splashes with blood. If large splashes or quantities of blood are present or anticipated, impervious gowns or aprons should be worn. An extra change of work clothing should be available at all times. (Ex. 15)
This same document, under Law-enforcement and Correctional Facilities, states:
. . . In case of blood contamination of clothing, an extra change of clothing should be available at all times. (Ex. 15)
The CDC recommends, therefore, that personal protective equipment should be used to protect not only skin and mucous membranes against contact with blood and other potentially infectious materials but should also be utilized to prevent contamination of clothing. Considering these recommendations, the Agency has concluded that requiring provision of personal protective equipment to prevent work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes from contact with blood or other potentially infectious materials is justified and appropriate.
With respect to preventing mucous membrane contact, the proposed standard required that emergency ventilation devices also fall under the scope of personal protective equipment and hence be provided by the employer for use in resuscitation. OSHA based this requirement on the possibility of employee exposure to blood or other potentially infectious materials in the mouth or in fluids that may be expelled by the patient during resuscitation. As little as one cubic centimeter (cc) of HBsAg positive blood can contain one hundred million infectious doses of Hepatitis B virus. As far as HIV is concerned, in their August 1987 guidelines, the CDC states:
4. Although saliva has not been implicated in HIV transmission, to minimize the need for emergency mouth-to-mouth resuscitation, mouthpieces, resuscitation bags, or other ventilation devices should be available for use in areas in which the need for resuscitation is predictable. (Ex. 6-153)
Provision of these devices was also supported by the American Federation of State, County, and Municipal Employees (AFSCME). (Ex. 11-157) The International Association of Fire Fighters (IAFF), during its public hearing testimony, commented that provision of resuscitation devices was a necessity. Mr. Richard Duffy, Director of Occupational Health and Safety for the IAFF, stated:
We have given the use of respiratory assistance equipment considerable thought. We certainly believe that unprotected mouth-to-mouth resuscitation should not be used by any emergency response personnel. To this end, we believe that mechanical respiratory devices, such as a bag-valve masks or an oxygen demand valve resuscitator, be available on all fire department emergency vehicles that respond or potentially respond to medical emergencies or victim rescues. -- hence, almost every vehicle in a fire department.
Additionally, pocket masks designed to isolate emergency response personnel from contact with victim saliva, respiratory secretions, vomitus, blood or body fluids must be provided to all personnel who provide or potentially provide emergency treatment. (Tr. 9/14/89, p.155)
In further support, Dr. Thomas Robins, Chair of the State of Michigan Advisory Committee on Occupational Exposure to Bloodborne Pathogens, testified that Michigan's draft regulation on occupational exposure to bloodborne pathogens would require provision of emergency ventilation devices (Tr. 10/17/89, p.22). The Centers for Disease Control retained their recommendation for use of these devices in their June 1989 document "Guidelines for Prevention of Transmission of Human Immunodeficiency Virus and Hepatitis B Virus to Health-Care and Public-Safety Workers" which states:
Mechanical respiratory assist devices (e.g., bag-valve masks, oxygen demand valve resuscitators) should be available on all emergency vehicles and to all emergency response personnel that respond or potentially respond to medical emergencies or victim rescues.
Pocket mouth-to-mouth resuscitation masks designed to isolate emergency response personnel (i.e., double lumen systems) form contact with the victim's blood and blood-contaminated saliva, respiratory secretions, and vomitus should be provided to all personnel who provide or potentially provide emergency treatment. (Ex. 15)
Rondex Products Inc. (Ex. 20-47) commented that some of the devices falling under the nomenclature of "masks", "mouthpieces", "resuscitation bags", and "shields/overlay barriers" may not be protective or could be improperly used by non-medical personnel. OSHA is reluctant , however, to prohibit use of specific types of resuscitation devices simply because some may not be protective under certain circumstances. There are many different personal protective equipment designs currently being marketed or being developed. OSHA believes that by choosing to apply a blanket prohibition to certain device types, the standard could become technology-limiting and it is not the Agency's intent to discourage development of safer and more protective devices. Moreover, it should be remembered that the same test of "appropriate" applies to emergency resuscitation devices as it does to other personal protective equipment. OSHA also believes that the issue of improper use of these devices has been addressed by paragraph (g)(2)(vii)(G) of this standard which requires that employees be trained in the types, proper use, location, removal, handling, decontamination, and disposal of personal protective equipment.
Based upon the information provided in the comments, OSHA has concluded that minimization of mouth-to-mouth resuscitation is prudent practice and that the most effective means to do so is to require ventilation devices be provided for resuscitation. Consequently, these devices have been retained under the requirements for provision of personal protective equipment. In addition, as required by paragraph (d)(3)(iii) of this standard, these devices are to be readily accessible to employees who can reasonably be expected to resuscitate a patient.
Paragraph (d)(3)(ii) of the standard requires the employer to ensure that the employee uses appropriate personal protective equipment. Furthermore, this provision states that the employee may temporarily and briefly decline to use personal protective equipment if, under rare and extraordinary circumstances, it is the employee's professional judgement that in the specific instance its use would prevent the delivery of health care or public services or would pose an increased hazard to the safety of the worker or co-worker. This exception to the use of personal protective equipment under certain circumstances was supported by a number of commenters (e.g., CDC/NIOSH, Ex. 20-634, Tr. 9/14/89, pp.31-32; ANA, Tr. 9/20/89, p.79; American Public Health Association, Ex. 20-1361; SEIU, Tr. 9/15/89, p.7). OSHA believes that in order to insure that employees are adequately protected, the employer has the responsibility to not only provide personal protective equipment but also to ensure that it is utilized when necessary. The word "ensure" is used in this final standard in view of this responsibility because it holds the employer to a higher and more consistent level of performance.
OSHA believes that the personal protective equipment required by this standard is the minimum equipment dictated by the exposure circumstances requiring its use. By permitting employees to judge, individually, what protective equipment they will utilize could result in such a wide variance of equipment used for the same task (e.g. from no equipment to a "moon suit" approach) that those minimum standards of protection may not be met. Also, The Agency does not believe that the employee should be entirely responsible for his or her personal safety. Section 5(a)(1) of the OSHAct stipulates that the employer is responsible for furnishing "employment and a place of employment which are free from recognized hazards that are likely to cause death or serious physical harm to his employees." Therefore, the OSHAct places the onus of protecting employees upon the employer since the hazard(s) are present in the workplace under his or her control. The Agency interprets this to mean not only that the employer provide training, personal protective equipment, engineering controls, and so forth, but also that the employer has the responsibility to take necessary measures to insure that employees adhere to safety and health procedures.
A large number of commenters expressed concern that the employer would be held responsible to "assure" that employees use appropriate personal protective equipment. Of these, some thought that employees should be permitted to judge for themselves what protective equipment should be worn for each procedure, based in whole or in part, upon their training, experience, skill, knowledge, procedure, and anticipated exposure (e.g., American Society for Medical Technology, Ex. 20-990; American Association for Respiratory Care, Ex. 20-107; APIC - Greater Omaha Area, Ex. 20-943; Lee Hospital, Ex. 20-103; United Steelworkers of America, Tr. 11/13/89, pp.104-105). Other participants felt that the employer should not be required to assure use of personal protective equipment and that this responsibility for self-protection should be shouldered by the individual employee (e.g., APIC - Virginia, Ex. 20-750; American Society for Microbiology, Ex. 20-1188; The State Medical Society of Wisconsin,Ex. 20-276). Furthermore, still other commenters stated that requiring the employer to "assure" use of personal protective equipment was a requirement that the employer would find difficult if not impossible to fulfill since there was no way to monitor all employees to assure total compliance all of the time (e.g., Kaiser Permanente - Panorama City, Ex. 20-60; Medical Arts Laboratory, Ex. 20-638; Stanford University Hospital, Ex. 20-984; California APIC Coordinating Council, Tr. 1/10/90, p.187). The University of Cleveland Hospitals questioned the methods required of employers to assure use of personal protective equipment. They inquired if a nurse, who had been properly educated and understood the risks yet still disregarded the rules, should be fired and they questioned what other option was available to assure use of proper personal protective equipment (Ex. 20-663). The Guthrie Clinic Ltd. expressed similar thoughts and urged OSHA to modify this provision to require that employers "endeavor to assure" use of personal protective equipment (Ex. 20-1222). The AHA supported this "endeavor to assure" approach in their statement:
...[R]equire only that the employer take "reasonable efforts" to direct employees to use personal protective equipment, and to provide the training necessary for them to use it. (Ex. 20-352)
It is not OSHA's intent that each employee be constantly monitored for compliance, however, the Agency does not believe that the employer is powerless to have employees follow specific rules. Most certainly, employers have other policies such as reporting to work on time, working a particular minimum number of hours a day, notifying the employer when the individual is unable to report to work, taking certain precautions to prevent nosocomial infections, and so forth that they require employees to follow . These basic procedures are assuredly not left to the employee's discretion as to whether or not they are followed and the employer must have some process to reinforce their adherence. While such a process may be a multi-stage disciplinary process, this is not necessarily the only alternative. Methodist Hospital of Southern California, for example, suggested that an employee's compliance rate be tied-in with the individual's performance evaluation (Ex. 20-246). More simply, increased compliance may possibly only require additional education efforts or a positive reinforcement approach. The Agency does not find the arguments to rescind this provision to be compelling and, therefore, has retained the requirement that employers ensure that the employee uses appropriate personal protective equipment. This requirement is also consistent with other recent OSHA standards such as Coke Oven Emissions, 29 CFR 1910.1029; 1,2-dibromo-3-chloropropane (DBCP), 29 CFR 1910.1044; Ethylene Oxide, 29 CFR 1910.1047; and Formaldehyde, 29 CFR 1910.1048.
During the public comment process, several dental organizations raised the issue of exempting dentists from use of personal protective equipment, in whole or in part, while treating young children in order to prevent scaring the child (ADA, Ex. 20-665; American Association of Orthodontists, Tr. 11/14/89, pp.496-497; American Association of Orthodontists, Tr. 9/22/89, p.57; American Academy of Pediatric Dentistry, Tr. 10/19/89, p.467; Florida Academy of Pediatric Dentistry, Tr. 12/19/89, pp. 1075-1076; SEIU, Dr. Norma Solarz, Tr. 1/16/90, pp.663-664). Testimony presented by Dr. Thomas Floyd on behalf of the Florida Academy of Pediatric Dentistry urged OSHA to afford the dentist flexibility in deciding if a child will be overly frightened by use of a mask and goggles (Tr. 12/19/89, pp.1075-1076). In response to OSHA's question about his normal protective equipment, however, Dr. Floyd responded:
Routinely, all examinations and all treatment are with gloves. We utilize the rubber dam routinely, and when we are using a rotary instrument and have the possibility of an aerosol, we will use a mask and a shield with protective eye covering. I wear glasses anyway for close up work.... (Tr. 12/19/89, p.1089)
When asked if he felt that this garb was appropriate for pediatric dentistry, Dr. Floyd stated:
If it has been explained properly and is accepted by the child, yes. There are certain situations where it could become threatening and then the practitioner has to utilize his judgement. We never relinquish the gloves. We never relinquish the glasses. We never relinquish the clinic jacket. Sometimes the faceshield, but we will wear the mask, and I do not think that we have frightened anyone to the point of running out of the office at this point. (Tr. 12/19/89, p.1089)
Ms. Karen Boulton of the American Dental Hygienists Association stated that she normally wore a 3/4-length sleeve lab coat, gloves, mask, and prescriptive eyewear. When asked if she found this equipment scared children under her care, she responded:
...I personally don't find it to be a problem. I think its all in the education process to the child and you know certainly you can speak with the parent before the child comes in for actual treatment, but I have not found that to be a problem at all. In fact you can kind of make it a fun game with the child when you put your mask on, you can even draw a smile on the mask. I haven't found that to be a problem. (Tr. 1/16/90, pp.580-581)
In addition, Ms. Mary Kelly, a dental hygienist appearing at the Chicago hearings, testified that she had cleaned the teeth of children down to two and a half years of age and that they did not mind her use of protective equipment (Tr. 10/19/89, p.718). This testimony, gathered from practitioners who treat or have treated children while utilizing protective equipment, demonstrates to the Agency that use of personal protective equipment during dental care of children can be accomplished without frightening the patient. Also, children, like adults, can be infected with HBV and HIV without manifesting external signs and, therefore, should be treated with universal precautions. Consequently, the Agency has concluded that exemption or deviation from required personal protective equipment during dental treatment of children is not warranted.
Paragraph (d)(3)(ii) of the standard, however, does contain a limited exemption to the use of personal protective equipment. It requires that the employer shall ensure that the employee uses appropriate personal protective equipment unless the employer shows that the employee temporarily and briefly declined to use personal protective equipment when, under rare and extraordinary circumstances, it was the employee's professional judgement that in the specific instance its use would have prevented the delivery of health care or public safety services or would have posed an increased hazard to the safety of the worker or co-worker. In addition, when the employee makes this judgement, the circumstances must be investigated and documented in order to determine whether changes can be instituted to prevent such occurrences in the future.
OSHA stated in the proposed standard that it recognized that on occasion particular circumstances arise in which the use of personal protective equipment may interfere with the proper delivery of health care or public safety services or create a significant risk to the personal safety of the worker. The following scenarios represent examples of when such a situation could occur:
1. A sudden change in patient status such as when an apparently stable patient unexpectedly begins to hemorrhage profusely, putting the patient's life in immediate jeopardy;
2. A firefighter rescues an individual who is not breathing from a burning building and discovers that his/her resuscitation equipment is lost/damaged and he/she must administer CPR;
3. A bleeding suspect unexpectedly attacks a police officer with a knife, threatening the safety of the officer and/or co-workers.
The first two scenarios are examples of situations which may be immediately life-threatening to the patient while the third illustrates circumstances in which the personal safety of the worker or co-workers could be compromised. In evaluating each of the above situations, it may be judged that the time required to don personal protective equipment is critical to the patient's life or preventing a threat to the worker's personal safety. In such circumstances, holding the employer responsible for ensuring that the employee utilizes personal protective equipment, regardless of the consequences, does not appear justified. Therefore, the Agency has retained a limited exemption in the belief that the flexibility it affords is appropriate.
While a large number of participants supported the overall concept of such an exemption, some questioned who should make the decision regarding such equipment. Many agreed with OSHA that the decision should rest with the employee (CDC/ NIOSH, Ex. 20-634; SEIU, Tr.11/13/89, p.131; American Nurses Association, Tr. 9/20/89, p.79; State of Maryland, Division of Labor and Industry, Ex. 20-1362; Tucson Medical Center, Ex. 20-141; Frick Community Health Center, Ex. 20-292; ServiceMaster Company, Ex. 20-21; American Public Health Association, Ex. 20-1361; Communication Workers of America, Ex. 20-273; ). Some felt that the decision should rest either completely or partially with the employer (Nassau-Suffolk Hospital Council, Inc., Tr. 11/14/89, pp.479-480; American Ambulance Association, Tr. 1/17/90, pp.883-884; California Association of Health Facilities, Tr. 1/17/90, pp.929-930; Exs. 20-109, American Association of Forensic Dentists, Ex. 20-109; 20-354, Hospital Council of Western Pennsylvania, Ex. 20-354; National Association of Children's Hospitals and Related Institutions Inc., Ex. 20-1003; Allegheny Valley Hospital, Ex. 20-966).
It is the intent of the Agency that the decision not to use personal protective equipment in the aforementioned types of situations rests with the employee, not the employer. The types of circumstances which OSHA envisions may necessitate invocation of the exemption are those which require an immediate on-the-spot decision and would not be conducive to awaiting approval or disapproval of the employer. If there were time to consult about the decision, there would be time to don the personal protective equipment. In any case, OSHA does not intend to compel an employee to bypass the use of appropriate personal protective equipment against the employee's will. In some situations, in fact, the "employer" may not be readily accessible such as would probably be found in the firefighter and police scenarios mentioned above. United University Professions (Ex. 20-26) felt that permitting an exemption invited abuse by the employer. However, since the employer has no input into the decision, OSHA believes such abuse is prevented. The California Association of Health Facilities and Beverly Enterprises Inc. stated that healthcare workers should not be placed in the dilemma of having to make such a decision (Tr. 1/17/90, pp.929-930; Ex. 20-1356) . If an employee has received proper, sufficient training, the decision whether or not to use protective equipment in a situation should not present a dilemma.
To prevent abuse of this exemption by the employee, the Agency has set some specific criteria for use in evaluating a course of action. In the proposal, OSHA queried whether the alternate wording "prevent" in place of "interfere with" and "greater hazard" rather than "significant risk" would be more appropriate. The ServiceMaster Company responded that the alternate wording represented stronger terms and should be adopted (Ex. 20-21). CDC/NIOSH also supported this phraseology by incorporating it into their recommended wording for this provision (Ex. 20-634). OSHA believes that "prevent" and "increased hazard" convey the Agency's intent much more clearly and provide the employee with a much more defined basis for evaluation. Therefore, these terms have been incorporated into the final standard. Consequently, the exemption applies to defined, limited, essentially life-threatening circumstances and, as such, discourages excessive use by employees.
Utilization of the exemption is to occur, as stated in the standard, only in rare and extraordinary circumstances which are unexpected and threaten the life or safety of the patient, worker, or co-worker. The exemption is to be limited in extent and time. The employee who takes advantage of this exemption in a particular circumstance must continue to take steps to reduce his or her risk. Those practices associated with universal precautions which can be used are to be implemented whenever possible. Moreover, as soon as the situation changes as, for example, when a properly-protected co-worker is available to relieve the employee, the criticality of the patient's condition decreases, or the violent patient/prisoner is subdued, the employee is expected to implement use of full precautions.
It should also be understood that the decision not to use personal protective equipment is to be made on a case-by-case basis and in no way is to be generally applied to a particular work area or recurring task. Employees must exercise their professional judgement in making such a decision and should be aware that they may be asked to explain the reasons for their course of action. For example, OSHA believes that disregarding the use of personal protective equipment because there is concern that the appropriate personal protective equipment may be alarming to the patient or because the patient population is perceived to be "low risk" are not legitimate reasons. Also, a concern that a job may not be properly performed because, for instance, gloves dull an employee's tactile sense or goggles become fogged is not considered a legitimate reason to use this exemption for routine procedures. Some employees may express the concern that gloves, because they don't fit properly, increase their risk of injury. Since the standard requires that personal protective equipment be provided in "appropriate sizes," the employer would be obligated, under paragraph (d)(3)(iii), to provide gloves and other equipment that fit. Therefore, a general concern that the use of gloves, for instance, increases risk to the personal safety of the worker cannot be a basis for an exemption. Similarly, OSHA anticipates that this exemption would be invoked only under unusual circumstances in an emergency room. It is reasonable to assume that critically ill patients would be routinely arriving at a hospital emergency room and that adequate planning would assure that very few occasions would arise when an employee would be forced to make such a decision.
In summary, employees may on rare occasion find themselves in extraordinary circumstances in which, based upon their professional judgement, they feel that utilizing personal protective equipment would prevent proper delivery of healthcare or safety services or would pose a increased hazard to the safety of the worker or co-worker. The decision not to use personal protective equipment is to be made on a case-by-case basis and must be prompted by legitimate and truly extenuating circumstances. In such cases, the employee may temporarily and briefly abandon use of personal protective equipment. However, this does not mean that the circumstances surrounding such a decision should not be scrutinized. It may be that the employee's decision was based upon a situation which could be corrected. For example, in the scenario given above in which the firefighter discovers that his/her resuscitation equipment has been lost or damaged, a possible solution to prevent this occurrence in the future could be placing the resuscitation equipment in a more durable protective case or affixing the equipment more securely to the firefighter's clothing. Therefore, the employer is required to investigate and document the circumstances surrounding those instances when an employee invokes the exemption to the use of personal protective equipment in order to determine if changes can be instituted that would prevent a reoccurrence of such a situation in the future. In addition, the employer is not relieved of the responsibility to assure that personal protective equipment is readily accessible at all times and shall not discourage adherence to universal precautions or the appropriate use of personal protective equipment.
Paragraph (d)(3)(iii) of the final standard requires the employer to ensure that appropriate personal protective equipment in the appropriate sizes is readily accessible at the worksite or is issued to employees. In addition, hypoallergenic gloves, glove liners, powderless gloves, or other similar alternatives are required to be readily accessible to those employees who are allergic to the gloves normally provided.
It is of great importance that personal protective equipment is easily accessible and of proper size. The consistent use of such items hinges, in part, upon the employee's motivation and acceptance. However, if access of the equipment is difficult, its use may be perceived as too time consuming and burdensome. Proper fit of personal protective equipment also plays a major role in its utilization by employees. If it is too large or too small it may be uncomfortable or could interfere with proper task performance, resulting in frustration and non-use. Ms. Delores Pfohl of the Communication Workers of America testified:
. . . We've had problems getting people to wear gloves while they change a dressing or make a bed because they say that the gloves don't always fit well. They're awkward to use. . . . (Tr. 11/14/89, p.250)
Proper employee protection rests upon utilization of this equipment, therefore, provision of proper sizes and accessibility must be maintained to ensure and promote its use. Several commenters supported this provision (SEIU, Tr. 11/13/89, p.131; American Association of Critical-Care Nurses, Tr. 12/19/89, pp.952,959; AFSCME, Tr. 1/16/90, p.604; Drug, Hospital, and Health Care Employees Union - Local 1199, Tr. 11/14/89, pp.396-397; RWDSU, Tr. 11/14/89, pp.432-433; Surgikos, Ex.20-252). In addition, some participants in the hearing provided examples of how accessibility of personal protective equipment is currently being achieved in their workplace (AFSCME, Tr. 10/17/89, p.83; AFSCME, Tr. 1/16/90, p.600; Presbyterian Hospital of Dallas and Presbyterian Healthcare System, Tr. 9/27/89, p.177; St. Paul Medical Center, Tr. 9/27/89, p.209). Roxborough Memorial Hospital and the Tennessee Health Care Association asked that accessibility be clarified (Exs. 20-920; 20-1205). Based on the evidence in the record, the Agency has concluded that appropriate protective equipment must be located so that acquiring it does not hinder performance of the task or be inconvenient to the point of discouraging use. For example, Mr. Martin Rosen, a paramedic and representative of SEIU, testified that blood-soaked clothing cannot always be changed before proceeding to the next emergency call. He stated that the company encouraged employees to keep a second change of clothing in their car at the ambulance's home base but that the ambulance may not return to base for prolonged periods, possibly the entire shift (Tr. 1/16/90, pp.778-779). The Agency would not consider this to be ready accessibility of personal protective equipment. OSHA agrees with Mr. Paul Maniscalco of the National Association of Emergency Medical Technicians who testified that he felt "accessible" would be on-scene, either on an individual's person or on the vehicle, depending upon the nature of the equipment (Tr. 9/14/89, pp.133-134). In the case related by Mr. Rosen, the second set of clothing could be kept on the ambulance or employees could be provided with several sets of replaceable coveralls to be kept on the vehicle. The employer's responsibility to ensure accessible personal protective equipment for employees at non-fixed worksites cannot be overemphasized. Adequate planning and reinventory should ensure that the necessary equipment is present on the response vehicle or on the employee's person. Based upon the evidence submitted, it is OSHA's opinion that maintenance of ready accessibility in both fixed and non-fixed worksites is feasible.
The Society of Hospital Epidemiologists of America urged OSHA to clarify that barrier precautions which would not be expected to be needed in a particular area would not, consequently, be required to be readily accessible in that area (Tr. 10/18/89, p.357; Ex. 20-1002). It is not OSHA's intent that the entire array of personal protective equipment be readily accessible to all work areas; only that equipment which can be reasonably anticipated to be needed based upon the types of occupational exposure expected in a work area must be provided. For example, head and shoe covers would not be expected to be readily accessible in an area where gross contamination of the head or shoes would not be reasonably anticipated.
The Agency is aware that use of gloves as a protective barrier is a major part of this standard's methods of preventing occupational exposure. In addition, it is known that some employees may exhibit an allergic dermal reaction to the gloves normally provided to workers or the powder that the gloves contain. To prevent exacerbation of such allergic dermatitis and thereby permit these individuals to continue working, the proposal required employers to make hypoallergenic gloves readily accessible to those employees who exhibited allergic reactions to the gloves normally provided. A number of commenters acknowledged that some type of concession should be made for employees who manifest allergic reactions to gloves (APIC - San Francisco Bay Area, Tr. 1/10/90, pp.168-169; AAOHN, Ex. 20-882; Infection Control Coordinators Conference - Connecticut Hospitals Association, Ex. 20-275; Kaiser Permanente - Fontana, CA, Ex. 20-551; St. Vincent Hospital, Ex. 20-524; William W. Backus Hospital, Ex. 20-911; MD Anderson Cancer Center - University of Texas, Ex. 20-390; Verdugo Hills Hospital, Ex. 20-573; El Camino Hospital, Ex. 20-879; Surgikos, Ex. 20-252). However, information was provided that hypoallergenic gloves may not be the proper solution or, at least, the only solution available to address such reactions and several alternatives were given including powderless gloves, glove liners, and simply changing to another brand of glove (Tr. 1/10/90, p.169; Exs. 20-524; 20-249; 20-390; 20-879; 20-109). The final standard, therefore, expands this provision to afford employers with the flexibility to provide their employees with hypoallergenic gloves, glove liners, powderless gloves, or similar alternatives to deal with allergic reactions rather than restrict them to the single recourse of hypoallergenic gloves.
Paragraph (d)(3)(iv) of the standard requires that the employer clean, launder, and dispose of personal protective equipment required by paragraph (d), Methods of Compliance, and paragraph (e), HIV and HBV Research Laboratories and Production Facilities, of this standard, at no cost to the employee. In addition, paragraph (d)(3)(v) stipulates that the employer must repair or replace personal protective equipment as needed to maintain its effectiveness, at no cost to the employee. These requirements remain basically unchanged from those contained in the proposal except for the addition of "at no cost to the employee." This addendum has been included to clarify that the employer's responsibility does not end with provision of personal protective equipment but is an ongoing responsibility to clean, maintain, and dispose of such equipment.
The first provision ensures that these items remain within the control of the employer and, therefore, will be properly disposed of, cleaned, or laundered consistent with that employer's control program. This will prevent contamination outside of the work area (e.g., non-work areas such as the employee's home). The requirement to repair or replace the protective equipment is needed to ensure proper functioning of these items and, thereby, proper employee protection. Moreover, requiring that the employer be responsible for this activity provides further insurance that the items will remain under the control of the employer who will make this a part of his or her overall program to control occupational exposure. Support for these specific provisions was received from several commenters (Minnesota Nurses Association, Ex. 20-995; Society of Hospital Epidemiologists of America, Ex. 20-1002; Rose Marie Unrein, Ex. 20-140; Fairfax County Fire Department, Tr. 9/14/89, p.179; RWDSU, Ex. 20-1505; Kathy Lampe, Ex. 20-1; State of Maryland, Division of Labor and Industry, Ex. 20-1362; ServiceMaster Company, Ex. 20-21).
Some confusion appears to exist as to the employer's responsibility (e.g., cleaning, repair, replacement) for employee-procured uniforms, lab coats and other items of clothing as evidenced by the number of participants requesting clarification of or stating opposition to this issue (APIC, Ex. 20-1118; American Association of Critical-Care Nurses, Ex. 20-1162; Exs. 20-523; 20-532; 20-1332; 20-568; 20-545; 20-661; 20-908; 20-105; 20-633; 20-320; 20-390; 20-548; 20-618; 20-967; 20-529; 20-1194; 20-43; 20-557; 20-886; 20-673; 20-11; 20-538; 20-527; California APIC Coordinating Council, Tr. 1/10/90, pp. 187-188). As stated previously in the discussion of "provision" of personal protective equipment, the employer's responsibility is based upon the intended function of an item. If an item is to function as personal protective equipment, then it is the employer's responsibility to provide that item, clean it, repair it, replace it, and dispose of it. These requirements imposed on the employer as part of his or her ongoing responsibility for employee personal protective equipment are consistent with other recent OSHA standards (Formaldehyde, 29 CFR 1910.1048; Asbestos, 29 CFR 1910.1001).
The record clearly indicates that some employees are currently laundering contaminated personal protective equipment at home (Frankford Hospital, Ex. 20-211; Hahnemann University Hospital, Ex. 20-356; ADA, Ex. 20-665; Oregon Dental Association, Ex. 20-1320; Kathy Lampe, Ex. 20-1; SEIU, Tr. 1/16/90, p.795; Dr. Frederick Preis, Tr. 9/25/89, p.12; Dr. Henry Finger, Tr. 9/22/89, p.39). In addition, some participants felt that contaminated clothing could be safely washed at home and that there was no evidence of disease transmission to support requiring that employers clean contaminated personal protective equipment (MetroHealth Medical Center, Ex. 20-190; Albert Einstein Medical Center, Ex. 20-945; Eisenhower Memorial Hospital, Ex. 20-1217; Laboratory of Pathology, Ex. 20-565; Lassa NW, Ex. 20-680; Osteopathic Medical Center, Ex. 20-1342).
The Agency does not believe that washing contaminated personal protective equipment at home is acceptable. Insurance of proper laundering procedures is one of the major reasons why the Agency believes that contaminated personal protective equipment must remain under the control of the employer. By permitting home laundering, the employer, obviously, cannot assure himself or herself that proper handling or laundering procedures are being followed. Moreover, as stated previously, home laundering could lead to migration of contaminants to non-work environments. Relative to the lack of evidence of disease transmission from washing contaminated equipment at home, reference to the "Laundry" section of this document will show that a large number of commenters believe that all contaminated laundry should be considered to be infectious and should be handled with universal precautions. This position is supported by ServiceMaster which listed the shortcomings of home laundering and recommended against allowing such practices (Ex. 20-21).
The Agency recognizes no distinction between dealing with contaminated institutional linen (e.g., bedsheets, surgical drapes) and the procedures for cleaning, laundering, and disposal of contaminated personal protective equipment. Therefore, OSHA concludes that while there are no specific studies linking disease transmission to home laundering, careful handling and cleaning of contaminated items is adequately supported to justify these provisions.
Paragraph (d)(3)(vi) stipulates that if a garment(s) is penetrated by blood or other potentially infectious materials, the garment(s) shall be removed immediately or as soon as feasible. This provision has been added to the final standard in response to a comment from CDC/NIOSH recommending insertion of a subparagraph stating:
Employees shall immediately wash hands and any other skin or mucous membrane that becomes contaminated with blood or other potentially infectious material. In the event that outer garments are penetrated by blood or other potentially infectious material, the contaminated clothing shall be removed and the skin washed immediately or as quickly as practicable. (Ex. 20-634)
The logic behind adoption of this provision is to 1) minimize further penetration of blood or other potentially infectious materials onto underlying garments and/or skin or mucous membranes and 2) minimize the amount of time these materials remain in contact with skin or mucous membranes if these materials have penetrated to the point of contacting the individual's skin or mucous membranes. It should be noted that if the latter case occurs (i.e., contact with skin or mucous membranes), the affected body areas are to be washed or flushed as required by paragraph (d)(2)(vi) of this standard.
The final standard, in paragraph (d)(3)(vii), requires that all personal protective equipment be removed prior to leaving the work area. This provision will minimize migration of contamination beyond the work area to such places as lunchrooms and offices. Several commenters and other documents in the record provided support for this provision (NIH, Ex. 6-338; NCCLS, Ex. 11-159A; Rose Marie Unrein, Ex. 20-140; American Society for Microbiology, Ex. 20-1188; Laurence R. Foster, Oregon State Epidemiologist, Ex. 20-932; St. Vincent Hospital, Ex. 20-524; State of Maryland, Division of Labor and Industry, Ex. 20-1362; American Red Cross, Ex. 11-280).
Upon removal of personal protective equipment, paragraph (d)(3)(viii) requires it to be placed in an appropriately designated area or container for storage, washing, decontamination or disposal. This ensures that the personal protective equipment will remain in a recognized area(s) and helps ensure that it will be dealt with by employees who have been trained in the proper handling of these items.
Performance of the majority of tasks that could result in occupational exposure usually requires some type of manual manipulation. Consequently, it is the individual's hands which have the highest probability for coming in contact with blood or other potentially infectious materials. Utilization of gloves has become the most widely used barrier precaution against transmission of infection, not only from employee-to-patient but also from patient-to-employee. Therefore, paragraph (d)(3)(ix) requires that gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, and non-intact skin; when performing vascular access procedures [except as specified in paragraph (d)(3)(ix)(D)]; and when handling or touching contaminated items or surfaces. Examples of tasks which require the use of gloves include dentistry, surgery, phlebotomy [except as specified in paragraph (d)(3)(ix)(D), starting IVs, laboratory analysis of blood or other potentially infectious materials, clean-up of blood spills, and rendering emergency medical assistance to individuals with traumatic injury. OSHA concludes that use of gloves is a basic precept of prevention of occupational transmission of bloodborne pathogens. Gloves act as the primary barrier between an employee's hands (and any attendant skin lesions or breaks) and contact with blood and other potentially infectious materials, thereby minimizing exposure to these substances. Overall, use of gloves as a barrier precaution is advocated by a number of recognized sources and interested parties (e.g., CDC, Exs. 6-153, 6-316, 15, Tr. 9/14/89, p.20; AHA, Tr. 9/19/89, p.120, Ex. 20-352; ADA, Tr. 10/19/89, p.443, Ex. 20-665A; Academy of General Dentistry, Tr. 9/22/89, p.17; NCCLS, Ex. 11-159A; CDC/NIOSH, Ex. 20-634; AFSCME, Ex. 297; SEIU, Ex. 299; International Association of Fire Fighters, Tr. 9/14/89, p.153).
Further support for the feasibility of glove usage can be found in the compliance statistics and recommendations provided as part of the information provided by several participants. For example, the American Association of Orthodontists support the use of gloves (Ex. 20-355, Dr. David McKenna, Tr. 11/14/89, p.497). The Academy of General Dentistry's 1987 survey showed that 75% of its members glove for all patients (Tr. 9/22/89, p.14). The American Board of Pediatric Dentistry found glove compliance in pediatric dentistry to be approximately 90% (Tr. 10/19/89, p.476). Ms. Pat Lynch, infection control coordinator at Harbor View Medical Center and an American Hospital Association representative, stated that a study conducted at Harbor View showed compliance with glove usage to be greater than 80% (Tr. 9/19/89, p.120). Moreover, a 1988 survey conducted by the American Dental Association and summarized in their post-hearing brief reported the following usage rates: Dentists - 76%, Hygienists - 97%, and Assistants - 78% (Ex. 282). Compliance rates from OSHA's survey can be found in the Regulatory Analysis section of this document.
While gloves are a generally-accepted method of protecting against exposure, a number of commenters took issue with requiring the use of gloves when performing phlebotomy and forwarded a number of arguments in support of their opinion. With specific regard to drawing blood, participants commented that inclusion of this task conflicted with the recommendations of CDC and urged the Agency to adopt the language of the CDC guidelines (e.g., AHA, Ex. 302; CDC/NIOSH, Ex. 20-634; Norwood Hospital, Ex. 20-967). Some also stated that employees, particularly skilled phlebotomists, should be allowed to decide for themselves whether or not gloves should be used (e.g., Iowa Lutheran Hospital, Ex. 20-885; Flint Osteopathic Hospital, Ex. 20-1154; Hurley Medical Center, Ex. 20-762).
In their 1988 document, Update: Universal Precautions for Prevention of Transmission of Human Immunodeficiency Virus, Hepatitis B Virus, and Other Bloodborne Pathogens in Health-Care Settings, CDC wrote:
...In universal precautions, all [Emphasis in the original] blood is assumed to be potentially infective for bloodborne pathogens, but in certain settings (e.g., volunteer blood-donation centers) the prevalence of infection with some bloodborne pathogens (e.g., HIV, HBV) is known to be very low. Some institutions have relaxed recommendations for using gloves for phlebotomy procedures by skilled phlebotomists in settings where the prevalence of bloodborne pathogens is known to be very low.
Institutions that judge that routine gloving for all [Emphasis in the original] phlebotomies is not necessary should periodically reevaluate their policy. Gloves should always be available to health-care workers who wish to use them for phlebotomy. In addition, the following general guidelines apply:
1. Use gloves for performing phlebotomy when the health-care worker has cuts, scratches, or other breaks in his/her skin.
2. Use gloves in situations where the health-care worker judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative patient.
3. Use gloves for performing finger and/or heel sticks on infants and children.
4. Use gloves when persons are receiving training in phlebotomy. (Ex. 6-316)
The above statement does not say that gloves are unnecessary for phlebotomy, simply that some institutions have chosen not to follow CDC's 1987 guidelines (requiring gloves for all phlebotomies) and have relaxed recommendations for the use of gloves by skilled phlebotomists. It is not a blanket statement about all settings (e.g., hospitals, clinics) where phlebotomies are performed nor does it refer to all vascular access procedures, only phlebotomy and, in particular, phlebotomy in volunteer blood donation centers. This specific setting is addressed in paragraph (d)(3)(ix)(D) below.
With regard to permitting skilled phlebotomists, in general, to decide when to use gloves, it is not the Agency's policy to base compliance with a regulation upon an employee's perception of his or her skill or experience at avoiding a hazard. Such an action would be analogous to permitting employees to enter a toxic atmosphere without respiratory protection based upon their belief that they could hold their breath long enough to accomplish the task at hand. The CDC recommends that gloves be used in situations where the healthcare worker judges that hand contamination with blood may occur. Evidence in the record indicates that a judgement of this sort would be simply an arbitrary selection on the part of the worker. For example, Ms. Carol Rogers, a physician's assistant and representative of AFSCME, who testified that she performed "a lot" of phlebotomies, stated:
. . . Sometimes when there's a tourniquet, the vein is under so much pressure that when you put the needle in, the blood spurts out. It's -- I mean, that's a good stick, too. It just happens. (Tr. 9/15/89, p.183)
In addition, Ms. Pam Talbot, a staff nurse for the American Red Cross who has twelve years experience drawing blood (and who feels herself to be a skilled phlebotomist) testified that she got blood on her hands when changing from test tube to test tube:
. . . Sometimes three or four days it won't [happen] and sometimes one day it'll happen every time. (Tr. 9/15/89, p.175)
Dr. Joseph H. Coggin, one of OSHA's expert witnesses stated:
In a clinical setting, I witnessed a phlebotomist drawing blood in the emergency room from a gentleman with chest pains. Several ounces of blood were released onto the emergency room table while changing tubes on the needle set. . . . (Tr. 9/12/89, p.52)
These statements demonstrate that during blood drawing, even by an experienced phlebotomist, predicting when an occupational exposure could occur would be extremely difficult if not impossible.
Many participants criticized the proposal's requirement for gloves during phlebotomy on the grounds that gloves did not prevent needlesticks (e.g., American Society for Clinical Pathologists, Ex. 20-351; American Blood Resources Association, Ex. 20-1090; Glendale Memorial Hospital, Ex. 20-9; St. Joseph Hospital, Ex. 20-913; St. Vincent Medical Center, Ex. 20-529). OSHA recognizes that gloves will not protect against needlestick and proposed this requirement to prevent contamination of the hands with blood. This was the intent of CDC's original recommendation (as stated in Ex. 6-316, CDC's Update: document) and is also recognized by the American Hospital Association. When asked by OSHA's Dr. Susan Harwood if the AHA understood that it was not CDC's intent for gloves to protect against needlesticks but, instead, to prevent hand contamination, AHA's representatives Mr. Dennis Brimhall and Ms. Margaret Hardy responded that this was their understanding. Dr. Harwood then asked if a skilled phlebotomist with a cooperative adult patient should base utilization of gloves on whether or not the patient was known to be infected with HIV or HBV. Mr. Brimhall responded:
Well, according to the spirit of universal precautions, the answer to that would have to be no. The precautions ought to be taken regardless of the knowledge of the status of the patient. You have to assume that you don't know the status, you have to assume that you [are] providing protection against unknown status. (Tr. 9/19/89 p.161-162)
Ms. Hardy and Mr. Brimhall continued that if this course of action was not adhered to then one was not truly protecting the worker and it was not, in actuality, universal precautions. St. Vincent Medical Center also felt that requiring gloves for phlebotomy would not increase worker safety since they felt needlesticks were the major hazard (Ex. 20-529). In general, most people have breaks in the hand's skin barrier (e.g., damaged cuticles, scrapes, microcuts, dermatitis) as a matter of course and the Agency does not believe phlebotomists to be any different in this respect. OSHA has concluded, therefore, that gloves increase worker protection by minimizing contact of blood or other potentially infectious materials with such breaks in the skin.
One of the major concerns voiced by interested parties regarding mandated glove usage was that gloves decrease tactile sensation, decreasing dexterity and possibly resulting in an increased hazard for failed task performance or needlestick (e.g., Department of Defense, Armed Forces Blood Program Office, Ex. 20-161; American Association of Blood Banks, Ex. 20-1059; Dr. Stutt, American Association of Orthodontists, Tr. 9/22/89, pp.65-66; Dr. Stephen D. Carter, DDS, Ex. 20-277). Information submitted does not support this opinion, however. Ms. Ellen Redick of the American Association of Critical-Care Nurses testified:
...[W]henever you change your practice, there is that learning curve and that at first you may have a little bit of fumbleitis, but because you know that you are using something new, you have got a pair of gloves that are too big or what ever the problem is, you are going to be more careful. I personally have never had an experience or heard of an experience where someone has caused themselves and or the patient harm because they were using protective equipment. . . . (Tr. 12/19/89, pp.958-959)
Three employees whose responsibilities include phlebotomy also commented on this issue. Ms. Pam Talbot stated:
...[I]f they fit properly...the gloves don't present any hinderance in drawing blood, as far as I'm concerned. I have no problems with them if they fit properly. (Tr. 9/15/89, p.163)
In a later discussion with the OSHA panel, as to why phlebotomists do not want to wear gloves or are not currently wearing them, Ms. Talbot responded:
The only thing that I can see is sometimes they don't fit properly. If they don't fit properly, if there's none in your size, then it's impossible to do a needlestick with gloves that are too big that are falling off your hands. (Tr. 9/15/89, p.184)
Similar sentiment was expressed by Ms. Carol Rogers when asked about the difficulty of changing from ungloved to gloved phlebotomy:
...[I]t was more psychological difficulty than -- it was just really more thinking of using the gloves when you were performing phlebotomy....I don't think its harder with gloves that fit than without them. (Tr. 9/15/89, p.179)
Ms. Nan Kaeser, an Assistant Head Nurse for the American Red Cross, Greater Hartford Chapter, with approximately thirty years phlebotomy experience commented:
I can't overemphasize how important fit is. The other day I went into someone else's unit to help out with a phlebotomy, and I used one of their gloves. The glove was huge -- you could have played baseball with it. I couldn't feel anything and had to put on a different pair before I could begin.
Our glove policy hasn't caused any major problems at our center, and now its like second nature. I wouldn't think of touching anyone without them. (Ex. 130)
Phlebotomy is not the only venous access procedure performed by workers. In this regard, Dr. Arnold Berry, Associate Professor of Anesthesiology at Emory University School of Medicine, stated:
. . . In my experience, anesthesia personnel have been slow to adopt the use of gloves because of a perception that they will interfere with their ability to perform these procedures where tactile perception is necessary. In my practice, I have learned to perform these tasks while wearing gloves, although I was not trained in these techniques during my residency. (Ex. 230)
It should be noted that all of the above individuals have switched from ungloved to gloved performance of their duties, demonstrating that use of gloves is feasible and can be successfully accomplished. In addition, proper fit of gloves obviously plays a central role in achieving proper task performance and acceptance of glove usage among employees. This factor has been addressed previously in paragraph (d)(3)(iii) which requires that employees be provided with personal protective equipment in appropriate sizes.
The American Red Cross submitted data that related to the number of unsuccessful collections (UN) that resulted when phlebotomists were required to wear gloves (American Red Cross, Ex. 238). Unfortunately, they did not give actual numbers for UN but rather gave percentages. It is unclear whether a UN rate that rose 100% represented 1 UN without gloves and 2 UN with gloves or 40 UN without gloves and 80 UN with gloves or some other number. In any case, the rate of unsuccessful collections dropped essentially to zero (0.2%) after four months. This supports the idea that it is a matter of learning a skill and not an intrinsic problem with the use of the gloves. Since the standard requires the use of gloves for all vascular access procedures, we conclude that phlebotomists will soon learn to perform phlebotomy using gloves with the same skill they previously showed using a bare handed technique.
In further reference to tactile sensation, the American Dental Hygienists Association (ADHA) submitted a study entitled: Gloved Versus Ungloved Dental Hygiene Clinicians: A Comparison of Tactile Discrimination (Ex. 275). In the study, subjects were to differentiate between grits of sandpaper using dental explorers while gloved and ungloved. Visual and auditory clues were blocked by a blindfold and stereo headphones. The following excerpts illustrate the conclusions of the study:
A decrease in tactile sensitivity is the primary reason dental practitioners prefer not to wear gloves. However, gynecologists, ophthalmologists, neurosurgeons and other medical personnel who require a high degree of tactile sensitivity wear gloves when performing examinations as well as in surgical procedures. A survey conducted by Solovan et. al. to determine operator effectiveness in performing scaling procedures while wearing gloves revealed that scaling efficiency was not affected. This finding supports King's study which indicated that wearing gloves did not impair the clinician's ability to achieve an accurate clinical diagnosis while using a vitalometer...
The results of this study suggest that there is no statistically significant difference between the gloved and ungloved operator in detecting surface roughness when using either the #17 of CH-3 explorer. Although the majority of the subjects (62.5%) responded that gloves affected their ability to accurately discriminate, the results of the gloved and ungloved test scores did not confirm this. These findings support the studies of Solovan and King which indicated that gloves did not impair operator effectiveness when performing clinical skills...
...The reluctance to wear gloves may be based more on habit than on actual loss of tactile sensitivity. (Ex. 275)
The American Association of Forensic Dentists (AAFD) on the other hand, submitted a study by Dr. E.J. Neiberger, DDS, entitled: Manual Dexterity and Associated Problems of 50 Practicing Dentists Using Latex Gloves (Ex. 20-109, C2). One of the aspects investigated in the study was the effect of latex gloves on light touch perception. This test was conducted by measuring the amount of force required for the test subject to first detect contact of the stylus of a dynamometer with his or her index finger. Tests were performed with the individual both wearing and not wearing gloves. Comparison of the force required to elicit response of the subject while wearing gloves with that required in the ungloved subject indicated a decrease in light touch perception. In addition, the AAFD study compared the average time required by the sample cohort to complete two assigned tasks while gloved and ungloved. While the average ungloved times were slightly faster (tenths to hundredths of a second) than the average gloved times, some individual subjects measured faster with gloves. None of the subjects failed in performing the assigned tasks.
The Agency is less concerned with definitive measurements of touch perception or maximum speed, than with actual ability to perform tasks while wearing gloves. The study submitted by the ADHA more accurately measures this parameter. Also, the testimony of witnesses supports the conclusion that employees can properly perform required tasks while utilizing gloves.
Reviewing the record, it is evident that employees who have not previously utilized gloves can successfully adapt to their use and that tasks can be properly performed while wearing gloves. It appears, in fact, that glove usage is already a widely-accepted practice among healthcare workers. OSHA has concluded, therefore, that the standard's required use of gloves is feasible and justified.
The proposal did not specify that a particular type of glove be utilized. Most of the gloves in use today are either latex or vinyl. However, representatives of SEIU testified in the hearings that they had been given plastic film food handling gloves ("baggie" gloves) to use in conducting exposure-related tasks (Tr. 1/16/90, pp.751-752). Such gloves are not strong enough to provide protection to the hands nor would they fit the employee as required by paragraph (3)(d)(iii). Therefore, such gloves would not be considered to be appropriate.
The American Association of Operating Room Nurses submitted an article, Integrity of Vinyl and Latex Procedure Gloves, which compared the barrier qualities of latex and vinyl (Ex. 20-882A). CDC/NIOSH specifically addressed the issue of vinyl versus latex in their post-hearing brief as follows:
A number of questions or comments were directed toward the degree of protection offered by gloves. Data are not sufficient to clearly distinguish benefits among various glove materials available (vinyl, latex, etc.). The collective experience in health-care settings during the last several decades indicates that gloves guard against transmission of infection. However, there are no documented differences related to type of material. (Ex.298)
Because data in the record is inconclusive as to whether vinyl or latex gloves provide better protection, the final standard does not specify use of a particular material. The Agency concludes that both vinyl and latex are appropriate materials for glove use. However, one should realize that no barrier is 100% effective, therefore, handwashing after glove removal [as required by paragraph (d)(2)(v)] is very important.
Gloves may have to be replaced in order to ensure adequate protection for the employee and limit contamination. Paragraph (d)(3)(ix)(A) requires that disposable (single use) gloves such as surgical or examination gloves, shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised. Replacement of disposable gloves when contaminated will reduce inadvertent contamination of items throughout the work area such as door knobs, telephones, computer keyboards, and so forth (Ex. 6-344). Since the glove acts as the primary physical barrier between blood and other potentially infectious materials and the employee's skin, any tear, puncture, or similar defect compromises the integrity of this barrier, dictating replacement to ensure maintenance of protection (CDC, Ex. 6-153; American Association of Critical-Care Nurses, Ex. 20-1162; ADA, Ex. 20-665A; American Red Cross, Ex. 11-280).
Interested parties did not appear to disagree with this provision and it remains basically unchanged from the proposed requirement. Several commenters did point out possible interpretation problems with the proposed provision and the Agency has reworded the requirement to address these comments and clarify its intent. Replacement of gloves when visibly contaminated may not be workable in procedures where continuous blood contact is anticipated, as for example, in surgery (APIC - Northwestern Wisconsin, Ex. 20-108; American Association of Critical-Care Nurses, Ex. 20-1162; VA - Department of Medicine and Surgery, Ex. 20-95). Moreover, requiring that gloves be changed "as soon as possible" when visibly contaminated does not allow for procedures (e.g., surgery, deliveries) where it may be "possible" to change gloves but it may not be practical to interrupt the procedure to do so (Dr. Jared Schwartz, Presbyterian Hospital - Charlotte, NC, Ex. 20-912; Office of the Assistant Secretary of Defense, Ex. 20-847). OSHA recognizes that some critical procedures cannot be interrupted to change gloves as soon as visibly contaminated. In addition, all contamination may not be visible (e.g., blood plasma). Some materials on gloves may not be contamination as defined by this standard, but may be other materials such as iodine stains. The provision has, consequently, been revised to clarify the Agency's intent. Disposable gloves are to be replaced as soon as practical when contaminated and as soon as feasible when their barrier properties are compromised.
Several participants urged OSHA to require gloves be changed between patient contacts (e.g., VA - Alexandria, LA, Ex. 20-39; Mercy Hospital of Johnstown, Ex. 20-628; District of Columbia Hospital Association, Ex. 20-342). While this is good infection control practice, the transmission being addressed is patient-to-patient and not patient-to-employee. Therefore, addition of such a provision to this document is beyond the scope of the OSH Act.
Paragraph (d)(3)(ix)(B) stipulates that disposable (single use) gloves shall not be washed or decontaminated for re-use (CDC, Ex. 6-316; ADA, Ex. 20-665A; Surgikos, Ex. 20-252). The CDC in its June 1988 Guidelines states that disinfecting agents may cause deterioration of the glove material while washing with surfactants could result in "wicking" or enhanced penetration of liquids into the glove via undetected holes, thereby transporting potentially infectious materials into contact with the hand (Ex. 6-316).
Utility gloves, often called "rubber" gloves, such as those which may be used for housekeeping chores, are of more substantial construction than surgical or examination gloves. The proposed standard, in agreement with CDC's recommendations, permitted disinfection and re-use of utility gloves provided they exhibit no signs of deterioration or their ability to function as a barrier was not compromised. The majority of commenters supported the use of utility gloves for housekeeping and laundry personnel and agreed with permitting their decontamination and re-use provided the gloves' integrity was maintained (e.g., AFSCME - NY, Ex. 20-985; CDC/NIOSH, Ex.20-634; American Society for Microbiology, Ex. 20-1188; ServiceMaster Company, Ex. 20-21; Society of Hospital Epidemiologists of America, Ex. 20-1002; American Biological Safety Association, Ex. 241). OSHA has concluded, therefore, that the proposed regulation was appropriate and, in paragraph (d)(3)(ix)(C), has stated that utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised, however, the gloves must be discarded if they are cracked, peeling, torn, punctured, or exhibit other signs of deterioration or when their ability to function as a barrier is compromised.
A few participants expressed reservations about decontamination of utility gloves (Tillotson Rubber Company, Ex. 20-1294; Calgon Vestal Laboratories, Ex. 20-49; Northwest Center for Occupational Safety and Health, Ex. 20-526). Tillotson commented that utility gloves should not be disinfected unless the method used can be validated to assure that the gloves are safe to use (i.e., could not contaminate co-workers or the environment with extended use). Similarly, Calgon Vestal Laboratories felt that it is the responsibility of glove manufacturers to supply users with appropriate decontamination procedures that do not compromise the integrity of the gloves. Calgon also felt that, in some cases, bloodborne pathogens may still reside on the glove's outer surface and, therefore, employees should be trained about accidental transmission. The Northwest Center for Occupational Safety and Health recommended that guidelines be set for how long utility gloves can be used, what types of utility gloves can be cleaned and re-used, and under what circumstances re-use is permitted.
OSHA believes "Decontamination", by definition, stipulates that the item must be safe for handling, use, or disposal. If the decontamination process compromises the gloves' integrity, they are to be discarded. Other provisions provide additional safeguards. Contamination migration is minimized since the standard requires that gloves are to be removed upon leaving the work area [paragraph (d)(3)(vii)] and that employees must wash their hands after glove removal [paragraph (d)(2)(v)]. With regard to setting guidelines for length of use time, the variability between gloves, tasks, and decontamination procedures would significantly affect how long gloves would be able to be used. Hence, a uniform time limitation would be extremely difficult to determine. However, appropriateness of re-use has been delineated by stipulating that gloves be discarded upon signs of deterioration or loss of barrier properties. Therefore, other provisions in this standard address the preceding concerns and ensure adequate protection of employees.
OSHA also sought comment on whether utility gloves should be required to be puncture-resistant. Several commenters supported this additional requirement (Society of Hospital Epidemiologists of America, Ex. 20-1002; Support Systems International, Ex. 20-1149; Visiting Nurse Corporation, Ex. 20-1268; AFSCME, Tr. 9/15/89, p.140; State of Michigan Advisory Committee on Occupational Exposure to Bloodborne Pathogens, Tr. 10/17/89, p.22). However, a large number of participants felt, for various reasons, that inclusion of such a requirement would be problematic. Some stated that puncture-resistant gloves would decrease dexterity to the point of impairing an employee's ability to function (Hospital Laundry Service, Ex. 20-1225; Lakeland Regional Hospital, Ex. 20-37; Superior Surgical Manufacturing Company, Ex. 20-41; ServiceMaster Company, Ex. 20-21; Angelica Corporation, Tr. 1/12/90, pp.531-532). Other parties stated that such gloves were unnecessary if proper sharps disposal practices were followed (Lutheran General Hospitals, Park Ridge and Chicago, Ex. 20-655; National HealthCorp, Ex. 20-856; ServiceMaster Company, Ex.20-21). Still other commenters stated that puncture-resistant gloves which would prevent a needle's penetration were either unknown to them or were not feasible (Carmen C. Birk, Ex. 20-106; Iowa Lutheran Hospital, Ex. 20-885; Superior Surgical Manufacturing Company, Ex. 20-41; Angelica Corporation, Tr. 1/12/90, pp.531-532). In her testimony, Ms. Jill Witter of the Angelica Corporation stated:
I have with me several types of gloves which we have experimented with in our laundries, and as you can see, they range from a disposable to a reusable glove. This glove is the closest that you can just about come to on a puncture-proof glove and yet, a needle at the right angle will still go through this glove. This glove is not acceptable and does not work because we can't figure out how to disinfect the glove. So, it's certainly not a disposable glove and its far too expensive to treat it as such. It also has virtually no dexterity to it. That means that if the employee were to find on the soil sort line a needle or a sharp instrument, he could not pick it up and properly dispose of it without first taking off the glove....None of these, as you can see, would be impervious to a needle going through them and we have not been able to find a glove that is puncture-resistant. (Tr. 1/12/90, pp.531-532)
With regard to puncture-resistant gloves, CDC/NIOSH commented:
No gloves are puncture-proof, and none are tested or certified for puncture-resistance. . . . (Ex. 20-634)
The record contains no definitive evidence that puncture-resistant gloves (i.e., capable of substantially resisting penetration by a needle) are currently available or that standards for puncture resistance exist. In view of this, the Final Standard does not address the use of puncture-resistent utility gloves.
Responding to the proposed standard, CDC/NIOSH urged OSHA to permit latitude in glove use for phlebotomy (Ex. 20-634). In consideration of this comment and to increase consistency with CDC guidelines, a new provision has been added in the final standard which permits a limited exception to the use of gloves for phlebotomy when this activity is performed in volunteer blood donation centers. Paragraph (d)(3)(ix)(D) states that if an employer in a volunteer blood donation center judges that routine gloving for all phlebotomies is not necessary, then the employer must: 1) periodically reevaluate this policy; 2) make gloves available to all employees who wish to use them for phlebotomy; 3) not discourage the use of gloves for phlebotomy; and 4) require that gloves be used for phlebotomy in the following circumstances: (i) when the employee has cuts, scratches, or other breaks in his or her skin; (ii) when the employee judges that hand contamination with blood may occur, for example, when performing phlebotomy on an uncooperative source individual; and (iii) when the employee is receiving training in phlebotomy. It is important to note that this exception has been strictly limited to phlebotomy performed in volunteer blood donation centers and does not apply to phlebotomy conducted in other settings such as plasmapheresis centers or hospitals. As has been extensively discussed above under general glove usage, the Agency has concluded that glove usage for venous access procedures (including phlebotomy in all settings except volunteer blood donation centers) is feasible and justified.
Exposure of mucous membranes to blood or other potentially infectious materials is a recognized route of transmission of bloodborne diseases. In his testimony, Dr. David Bell of the Centers for Disease Control stated:
. . . available data indicate that. . . transmission of HIV infection to healthcare workers has followed occupational exposure to HIV-infected blood via percutaneous inoculation or via contact with mucous membranes or non-intact skin . . . (Tr. 9/14/89, p.15)
Also, Dr. Stephen Hadler of CDC's Hepatitis Branch testified:
HBV infection is spread by several modes: parenteral, by direct inoculation through the skin; mucous membranes, blood contamination of the eye or mouth; sexual contact and perinatally, from infected mother to infant. . . . One cubic centimeter of blood may contain 100 million infectious doses of HBV; thus, extremely small inocula may transmit infection. . . . (Tr. 9/14/89, pp.19-20)
The final standard, therefore, retains the proposed provision requiring, in paragraph (d)(3)(x), that masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated and eye, nose, or mouth contamination can be reasonably anticipated. This overall requirement is supported by CDC/NIOSH who commented:
Splattering of blood onto skin or mucous membranes is a recognized mode of transmission of hepatitis B. Protection of mucous membranes of the face and upper respiratory tract against large droplet spattering is needed. As required by OSHA in this draft rule, glasses, goggles, face shields, and surgical masks, alone or in combination as appropriate to the task being performed, can provide that protection. (Ex. 20-634)
Additional support for the provision was provided by sources such as the Centers for Disease Control (Exs. 6-153; 15); American Association of Dental Schools (Ex. 20-876); ADA (Ex. 20-665A); AHA (Ex. 6-75); Minnesota Nurses Association (Ex. 20-995); Association of Operating Room Nurses (Ex. 20-882); and the South Carolina Department of Health and Environmental Control (Ex. 20-1160).
By way of clarification, the final standard specifically states that if glasses are the chosen method of eye protection, they are to be equipped with solid side shields. "Solid" should not be interpreted to mean opaque but has been stipulated simply to preclude the use of mesh or perforated side shields (Association of Operating Room Nurses, Ex. 20-882; New England Medical Center, Ex. 20-511). In addition, if protective eyewear is chosen over use of a face shield, the eyewear must be worn in conjunction with a face mask since the aim of this requirement is to provide protection for the eyes, nose, and mouth.
Many of the comments on this provision were proffered by dentists, dental hygienists, and their professional associates. Therefore, OSHA's response uses the dental operatory to illustrate what is required and why. However, the regulation covers all situations where eyes, nose or mouth contamination can be reasonably anticipated. With specific reference to eyewear, The American Board of Pediatric Dentistry felt that clear side shields would impede peripheral vision (Tr. 10/19/89, p.471). Also, the ADA commented that it was rare to have blood or saliva spray into the dental health care worker's eyes during routine procedures; that protective eyewear did not fit over some prescription glasses and could interfere with the use of magnifier loops; and that available side shields would not fit on thin-framed glasses (Tr. 9/21/89, p.158; Ex. 20-665).
Relative to the absence of spatter, Ms. Karen Boulton, representative for the American Dental Hygienists Association, responded to OSHA's inquiry during the hearings:
. . . it is definitely an education to take off this face shield when I wasn't wearing it and see the amount of splatter that does occur during treatment. Anything that you've got can be splattered, is physically splattered. (Tr. 1/16/90, p.580)
Ms. Boulton also stated that it was her personal feeling that protective eyewear should be mandated and that since exposure could occur through the sides of glasses, side shields were probably a good precautionary measure (Tr. 1/16/90, p.570, 584). Dr. Mary Quinn, a clinician and dental infection control consultant, also stated during the hearings that she had gotten pieces of amalgam behind her glasses and felt that some type of side shield was necessary (Tr. 10/19/89, p.601). Dr. Sheldon Wallack, President of the Illinois Society of Oral and Maxillofacial Surgeons, testified that while some products did distort vision, he was aware of a type side shield glasses used by surgical assistants which provided lateral protection and good vision (Tr. 10/19/89, p.566). Full face shields were advocated by Dr. Derrick Hars who commented that they did not distort vision if the shield's curvature was large enough (Tr. 10/19/89, pp.722-723). Moreover, Ms. Mary Kelly, a dental hygienist and dental office practice consultant, stated that she felt side shields were necessary, that she used them and that they did not impede her vision (Tr. 10/19/89, p.711, 718). The Agency has concluded from this testimony that facial exposure, from directly in front and from the side, does occur in the dental setting and that protective eyewear that provides side protection (e.g., side shields, curved face shields) are warranted. In addition, evidence indicates that there are products available which provide such protection without impeding vision.
From the statements in the ADA's comment, it appears that the association interpreted the proposed regulation to require protective eyewear to be worn over prescription glasses; presumably, because the Agency normally refers to protective eyewear in the context of meeting certain impact-resistance requirements in addition to preventing liquids and/or particles from entering the eye. However, the primary purpose of protective eyewear in this standard is to prevent blood or other potentially infectious materials from entering the eye through splashing, splattering, spraying, and so forth. Impact resistance would only become an Agency concern in those situations where projectiles (e.g., bone fragments) may be generated. Therefore, OSHA envisions that in most routine dental procedures prescription eyewear with side shields (either permanently affixed or of the "add-on" type) would be adequate protection. Also, the Association has stated that 66% of dentists currently wear prescription glasses (Ex. 20-665). Consequently, OSHA has concluded that prescription glasses with side shields will not interfere with the use of magnifying loops since this problem evidently does not exist with "unshielded" prescription glasses.
The Agency has determined that mucous membrane (i.e., eyes, nose, mouth) exposures occur in the occupational environment and must be prevented. The regulation provides employers with flexibility in choosing the types of protective measures to address the hazard and acceptable products which provide adequate protection with out impairing task performance are currently available. OSHA has concluded, therefore, that this provision is appropriate, feasible, and justified.
Gowns, aprons, and other protective body clothing minimize contaminant migration away from the work area and assist in eliminating skin exposure. Hence, paragraph (d)(3)(xi) requires that appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations (i.e., when contact with blood or other potentially infectious materials is reasonably anticipated). As with all personal protective equipment, the type of clothing (e.g., lab coat, gown) and its characteristics (i.e., protective capabilities) will depend upon the task being performed and the degree of exposure anticipated (i.e., quantity of blood or other potentially infectious materials). Utilization of protective body clothing is advocated or is currently being used by many of the participants in the rulemaking (e.g., CDC, Exs. 6-153, 15; CDC/NIOSH, Ex. 20-634; American Biological Safety Association, Ex. 241, ADA, Ex. 20-665; Society of Hospital Epidemiologists of America, Ex. 20-1002; Angelica Corporation, Tr. 9/18/89, p.178; American Dental Hygienists Association, Tr. 1/16/90, p.571).
The proposal contained three provisions relative to protective body clothing which would have required specified barrier characteristics, such as "fluid-resistant" and "fluid-proof", based upon the amount of blood or other potentially infectious materials anticipated to be encountered (e.g., soiling, splashing/spraying, soaking). As discussed previously under "Provision" of this section, the terms "fluid-resistant" and "fluid-proof" generated confusion among interested parties. The Agency has decided not to use the terms "fluid-resistant" and "fluid-proof" in the Final Standard. This assures that the employee will be protected and gives the employer flexibility in complying. The employer must evaluate the task and the type of exposure expected and based upon this determination, select appropriate personal protective clothing. "Appropriate" protective clothing must prevent contamination of an employee's skin or clothing by blood or other potentially infectious materials (See discussion under "Provision" paragraph of this section).
Paragraph (d)(3)(xii) requires that surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated. Circumstances where the use of such equipment may be necessary would include autopsies and orthopedic surgery. Wearing head and/or shoe covers in these situations is required to minimize contamination migration and the possibility of transmission through either direct routes (e.g., through non-intact skin resulting from dermatitis of the head or foot) or indirect routes (e.g., an individual's hand contacts blood in their hair and subsequently is put near their eyes or mouth). Use of these coverings for particular procedures is supported by several commenters (AHA, Tr. 9/19/89, pp.157-158, Ex. 6-75; CDC, Ex. 15; National Committee for Clinical Laboratory Standards, Ex. 11-159A; Dr. Donald Jewett, Tr. 1/9/90, p.106; APIC, Tr. 10/18/89, pp.188-189; Rocky Mountain Infection Control Association, Ex. 20-192).
According to the record, head coverings and shoe coverings have traditionally been utilized to protect the patient against infection from the caregiver's loose hair and to eliminate static electricity, respectively (e.g., Albert Einstein Medical Center, Ex, 20-945; The United Hospital, Ex. 20-550). However, information gathered in response to the proposal indicates that there are some situations where it is appropriate to protect the head and feet/shoes against contamination by blood and other potentially infectious materials. Dr. Donald Jewett, an orthopedic surgeon with the University of California - San Francisco, testified that he supported the use of waterproof shoes in orthopedic surgery (Tr. 1/9/90, p.106). Moreover, a study of contamination of surgeons and other surgical personnel during 102 separate operative procedures, conducted by Dr. Edward Quebbeman, Associate Professor of Surgery at the Medical College of Wisconsin, showed 16 instances of contamination of the foot area and 14 instances of head area contamination (Tr. 1/17/90, pp.866, 875-876). During discussions with the OSHA panel, representatives of the American Hospital Association stated that heavy shoe covers were worn in the operating room, trauma surgery, and urology where there often is a considerable amount of blood and, in addition, boots were worn in autopsy. The representatives agreed that there were occasions when such protective equipment was appropriate (Tr. 9/19/89, pp.157-158). Lauer and colleagues in their study entitled: Transmission of Hepatitis B Virus in Clinical Laboratory Areas, stated:
. . . Contamination of the head region of a person could lead to direct inoculation or, more likely, to indirect inoculation when he grooms his hair or touches his face during breaks or lunch periods. . . . (Ex. 6-56)
A large number of participants commented that the use of head covers and shoe covers as personal protective equipment was unnecessary (e.g., APIC - Palmetto, Ex. 20-581; Bowman Gray School of Medicine, Ex. 20-941; Baptist Medical Center, Ex. 20-146). Other commenters stated that use of these items was unnecessary outside of limited clinical settings such as the operating room, the morgue, or trauma care (e.g., Georgetown University Hospital, Ex. 20-833; Children's Hospital of Orange County, Ex. 20-568; APIC - Greater Omaha, Ex. 20-943; Abington Memorial Hospital, Ex. 20-557).
From the comments received, the proposed requirement for head covers and shoe covers was apparently misinterpreted as requiring their use in general clinical settings. However, the Agency's intent is to utilize these items only in circumstances where large quantities of blood or other potentially infectious materials are anticipated to be encountered. The Agency has revised this provision in the final to clarify its intent by requiring that such coverings are to be utilized in "instances when gross contamination can reasonably be anticipated."
A few interested parties commented on the permeability of shoe covers and it was suggested that fluid-resistant covers should be permitted (Lisa D'Amico, APIC - Pittsburgh, Tr. 9/27/89, p.283; Baxter Health Care Corporation, Tr. 10/20/89, p.870; Association of the Nonwoven Fabric Industry, Tr. 12/22/89, p.1651). The Association of Operating Room Nurses commented that shoe covers will not keep an individual's socks and feet dry in the presence of a large quantity of blood as would be encountered in urological, vascular, or trauma procedures and that contaminated shoes could be cleaned with a disinfectant (Ex. 20-882).
Selection of personal protective equipment is performance-oriented. Consequently, fluid-resistant equipment would be acceptable provided it meets the criteria of "appropriate" discussed above. Only that equipment necessary to protect against reasonably anticipated exposure associated with a specific task is required to be provided for performance of that task. Selection of the type and characteristics of necessary personal protective equipment is based upon the exposure anticipated to be associated with the task. In those instances where such equipment was incapable of halting penetration of blood or other potentially infectious materials normally encountered during a procedure, then a more resistant barrier (e.g., rubber boots) would be required. Decontamination of shoes in the situation described by the AORN (i.e., soaking of the sock and/or foot) would be inappropriate. While decontamination of the outside of the shoe may be possible, proper decontamination of the shoes' interior would be extremely difficult. In addition, the primary intent of this provision would not have been achieved, that is, prevention of foot exposure.
The Agency has concluded that circumstances exist in which gross contamination of the head or feet or both occur. Therefore, the use of head covers and/or shoe covers in such instances is required to prevent contaminant migration and the possibility of direct and indirect disease transmission.
Paragraph (d)(4)(i) requires employers to ensure that the worksite is maintained in a clean and sanitary condition. The employer must determine and implement an appropriate written schedule for cleaning and a method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks and procedures being performed. The term "worksite" refers not only to permanent fixed facilities such as hospitals, dental/medical offices, clinics, and so forth but also covers temporary non-fixed workplaces. Examples of such facilities include, but are not limited to, ambulances, bloodmobiles, temporary blood collection centers, and any other non-fixed worksites which have a reasonable possibility of becoming contaminated with blood or other potentially infectious materials.
This requirement has been adopted from CDC's Guideline for Handwashing and Hospital Environmental Control, 1985 and Recommendations for Prevention of HIV Transmission in Health-Care Settings where it is reiterated (Exs. 6-188; 6-153). Specifically, CDC states that while extraordinary attempts to disinfect or sterilize environmental surfaces such as walls and floors are rarely indicated, routine cleaning and removal of soil are recommended. In addition, it is stated that cleaning schedules and methods will vary according to the factors outlined in the provision. OSHA recognizes that different types of surfaces and soiling exist throughout a facility and that the employer is in the best position to evaluate the condition of his or her facility. Therefore, the employer must determine and implement the appropriate written schedule of cleaning and decontamination based upon the location within the facility (e.g., surgical operatory versus patient room), type of surface to be cleaned (e.g., hard-surfaced flooring versus carpeting), type of soil present (e.g., gross contamination versus minor spattering), and tasks and procedures being performed in the area (e.g., laboratory analyses versus normal patient care). The requirement for a written schedule of cleaning and method of decontamination is twofold: 1) the schedule will assist in ensuring that routine cleaning, as recommended by CDC, is performed and that the method of decontamination deemed appropriate by the employer is followed; and 2) the employees can utilize the schedule to determine when such cleaning should be done and what method they should use to properly accomplish the task.
Several comments were received urging OSHA to specify what disinfectants/procedures are effective or which questioned the need for using a "tuberculocidal" disinfectant (e.g., Abington Memorial Hospital, Ex. 20-557; Huntington Laboratories, Inc., Ex. 20-1328; S.C. Johnson & Sons, Inc., Ex. 20-639; AFSCME, Tr. 9/15/89, p.103; Elise Yiasimedes, Tr. 9/13/89, p.48). The Agency has not specified particular disinfectants or procedures due to the wide variance of circumstances in which housekeeping tasks occur. For example, routine cleaning of the floor in a clinical laboratory may only require a "low-level" germicide to achieve decontamination while a more powerful germicide may be required in the operatory due to, for instance, the increased amount of blood contamination. Specifying particular disinfectants and procedures in the final may have the effect of limiting the use of new products and of discouraging the development of new information relative to adequate decontamination. Hence, this provision states that the schedule for cleaning and method of decontamination are to be "appropriate." OSHA has concluded that the level of cleaning required under this performance-oriented provision will adequately ensure that risk of employee exposure is minimized.
Contamination of items and surfaces was investigated in the study Transmission of Hepatitis B Virus in Clinical Laboratory Areas (Ex. 6-56). The conclusion of the investigators was that "transmission of HBV in the clinical laboratory is subtle and mainly via hand contact with contaminated items . . . . " In addition to individual items such as marking devices and pipetting aids, contamination was found on analytical instruments and surfaces around instruments. Dr. Steven Hadler of CDC's Hepatitis Branch addressed and acknowledged hepatitis B transmission via contaminated surfaces in his testimony:
Spread of HBV in the workplace may occur in ways that are less apparent than direct inoculation of infectious blood by needlesticks or puncture wounds. Preexisting lesions on hands from injuries or from dermatitis may provide a route of entry for the virus. Although gloving will not stop direct puncture injuries, it can prevent the virus from contacting existing lesions. Transmission of HBV from contaminated environmental surfaces have been shown to be a major mode of HBV spread in certain areas such as hemodialysis units. The HBV can survive for at least one week in dried blood on environmental surfaces or contaminated needles and instruments. (Tr. 9/14/89, pp.20-21)
As discussed previously under paragraph (d)(2)(ix), Favero, Peterson, and Bond also state that environmental contamination is an effective method of disease transmission (Ex. 6-344). Therefore, paragraph (d)(4)(ii) requires that all equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials. This will minimize inadvertent employee exposure and contaminant migration resulting from contaminated items and surfaces.
Though there exists a broad range of work environments and circumstances where a work surface may become contaminated, OSHA has concluded that there are certain circumstances where decontamination procedures must be implemented to maintain cleanliness and minimize employee exposure and contaminant migration. Hence, paragraph (d)(4)(ii)(A) requires that contaminated work surfaces shall be decontaminated with an appropriate disinfectant 1) after completion of procedures; 2) immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and 3) at the end of the work shift if the surface may have become contaminated since the last cleaning.
Cleaning contaminated work surfaces after completion of procedures has been required to ensure that employees are not unwittingly exposed to blood or other potentially infectious materials remaining on a surface from previous procedures (CDC, Ex. 6-153). Some commenters stated that this requirement could be unduly burdensome on facilities such as laboratories which may perform a large number of procedures in a single shift or day (MetroHealth Medical Center, Ex. 20-190; Grady Memorial Hospital, Ex. 20-84). Where procedures are performed on an essentially continual basis throughout a shift or day, as may be the case of a clinical lab technician performing blood analyses, it is not the Agency's intent for the work surface to be decontaminated before the technician can proceed to the next analysis. This provision is intended to ensure that after procedures are completed, which in the above example would include a set of analyses, contaminated work surfaces are decontaminated. The completion of procedures might also occur when the employee is going to leave the work area for a period of time. In this instance, the work surface will not present a source of contamination to the employee upon his or her return, to employees who may enter the area, or to items which may be placed upon the surface. It should be noted that decontamination is not required after each patient care procedure as some parties have interpreted, but simply after procedures resulting in surface contamination (AHA, Ex. 20-352; Grady Memorial Hospital, Ex. 20-84).
Work surfaces must also be decontaminated immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials. Little comment was received relative to this provision but information and the few comments in the record which addressed this requirement indicate that it is generally recognized that decontamination is appropriate in circumstances of obvious overt contamination and spills (e.g., CDC Exs. 6-153, 15; Providence-St. Margaret Health Center, Ex. 20-46; Research Medical Center, Ex. 20-74; APIC - Kansas City, Ex. 20-689). The proposal required that work surfaces be decontaminated immediately in these circumstances. However, OSHA recognizes that there may be some instances where "immediate" decontamination may not be practical as in, for example, an operating table during surgery. Therefore, the final requirement has been modified to state "immediately or as soon as feasible" to address these situations and avoid holding employers to a sometimes unachievable standard.
In the third instance of mandated work surface decontamination, the proposal required that this be performed at the end of the work shift. A large number of commenters objected to this provision as redundant, citing that decontamination was already required to be done after completion of procedures and following overt contamination or spills (e.g., APIC - Greater Kansas, Ex. 20-294; Society of Hospital Epidemiologists of America, Ex. 20-1002, Tr. 10/18/89, pp.357-358; Baptist Medical Center, Ex. 20-146). OSHA has determined that these comments have merit and has revised the provision to require that decontamination is to be performed at the end of the work shift if the work surface may have become contaminated since the last cleaning. For example, if contaminated instruments or specimens had been set down on the surface since the last cleaning, the surface would need to be decontaminated.
Several other general issues were raised relative to the decontamination of work surfaces. First, some participants erroneously believed that all surfaces were being required to be decontaminated (Society of Hospital Epidemiologists of America, Ex. 20-1002; Children's Hospital - Richmond, VA, Ex. 20-587; Stanley M. Dub, Ex. 20-516; Wisconsin Association of Nursing Homes, Inc., Ex. 20-255). However, the requirement applies only to contaminated work surfaces and therefore would not encompass desks, countertops, and so forth in the area, provided they remained uncontaminated. Second, several commenters inquired whether this provision applied only to labs or stated that this requirement was inappropriate for patient-care areas (APIC - National, Ex. 20-1118; APIC - Kentuckiana, Ex. 20-948; Casa Colina Hospital, Ex. 20-284; McLeod Regional Medical Center, Ex. 20-527). In response to these comments, OSHA has determined that contaminated work surfaces present the same hazard regardless of where they are located in a facility. Hence, this provision is based upon the existence of a contaminated work surface rather than a particular worksite location. It should be noted that the above are minimum requirements and additional decontamination may be performed any time that it is deemed necessary.
Paragraph (d)(4)(ii)(B) of the final allows equipment and environmental surfaces to be covered with protective coverings such as plastic wrap, aluminum foil, or imperviously-backed absorbent paper. When utilized, such coverings must be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the work shift if they may have become contaminated during the shift. Use of protective coverings was initially adopted from the dentistry precautions portion of CDC's Recommendations for Prevention of HIV Transmission in Health-Care Settings (Ex. 6-153). However, protective coverings may also be used in other settings such as on laboratory benchtops. This approach to protecting an item or surface against contamination could prove particularly useful in a situation where a piece of equipment would be very difficult to decontaminate yet could be protected by a cover. As with decontamination of work surfaces above, comments were focused primarily on the necessity of changing coverings at the end of the shift (AHA., Ex. 20-352; Society of Hospital Epidemiologists of America, Ex. 20-1002, Tr. 10/18/89, pp. 357-358; University of Connecticut Health Center, Ex. 20-191). Consequently, the provision has been modified to require that protective coverings be removed and replaced at the end of the work shift if they may have become contaminated during the shift. Interested parties also stated that to prevent cross-contamination coverings should be changed between patients or recommended that equipment should be wiped with an appropriate disinfectant between patients rather than being covered (Office Sterilization and Asepsis Procedures Research Foundation, Ex. 20-797; VA - Salt Lake City, UT, Ex. 20-635; Rocky Mountain Infection Control Association, Ex. 20-192). Use of protective coverings is not required by the standard but is merely being permitted as an acceptable method of protecting items and surfaces against contamination. If this option is chosen, however, the final does require that they be removed and replaced at the stated minimum intervals. Relative to changing such coverings between patients, it should be remembered that, while this is prudent infection control practice which the Agency supports, OSHA's mandate is to protect employee health. Therefore, changing between patients has not been required as it falls into the realm of patient protection. These provisions represent housekeeping requirements directed toward ensuring that employee exposure to bloodborne pathogens is minimized; additional, more stringent decontamination rules that may be imposed to further infection control are not preempted.
In some cases, bins, pails, cans, and so forth, which are intended for re-use may be utilized in a manner which presents the potential for their becoming contaminated with blood or other potentially infectious materials. For example, a reusable metal trash can may be lined with a disposable plastic regulated waste bag. By virtue of a plastic bag's construction, the possibility for leakage is inherent and the can could become contaminated. If the can is not decontaminated, the contamination may be spread by leakage or spillage from the can or by fouling the outside of succeeding bags. Mr. Donald Gibbons, currently of United Linen Management and a former owner/operator of a laundry for institutional linen, also spoke of large plastic carts used to collect and transport soiled and cleaned linens. He stated that these transports, although contaminated with blood or other potentially infectious materials, were rarely cleaned (Tr. 9/25/89, pp.71-72). Paragraph (d)(4)(ii)(C) addresses this situation by requiring that all bins, pails, cans, and similar receptacles intended for re-use which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible upon visible contamination. This provision is consistent with OSHA's existing standard regarding maintenance of waste disposal containers, 29 CFR 1910.141 (a)(4)(i).
This requirement generated conflicting comments from interested parties. Some felt that the provision should be deleted as there has been no implication of these containers in disease transmission (UCSD Medical Center, Ex. 20-156; Good Samaritan Hospital, Ex. 20-373; Norwood Hospital, Ex. 20-967). Others commented that reusable bins, pails, cans, and so forth should be decontaminated only upon visible contamination (AHA, Ex. 20-352; William W. Backus Hospital, Ex. 20-911; VA - Edward Hines Jr. Hospital, Ex. 20-961). Still others asserted that decontamination should be performed on a regular schedule rather that upon visible contamination (CDC/ NIOSH, Ex. 20-634; Grady Memorial Hospital, Ex. 20-84). Finally, the proposed provision was supported, in essence, by other participants (DCI Laboratory, Ex. 20-664; San Antonio Community Hospital, Ex. 20-530).
Of those supporting the provision, DCI Laboratory commented that every time biohazard bags are removed from receptacles, the receptacles are inspected for leakage and so forth and contamination is cleaned and disinfected immediately. They felt that semi-annual or annual cleaning, in addition to this routine inspection and cleaning, appeared to be adequate (Ex. 20-664). San Antonio Community Hospital stated that requiring receptacles to be inspected and cleaned regularly and upon visible contamination was reasonable while regularly-scheduled disinfection was unreasonable. They felt that disinfection of these containers was unnecessary and that soap and water wash was adequate with the ultimate goal to be achieved being that all receptacles be sufficiently cleaned and processed to make them safe for their intended use (Ex. 20-530). This is the intent of the Agency and has been clarified by rewording the provision to state "decontamination" rather than "disinfection" of these containers.
In response to the other commenters, deletion of the provision is not appropriate since contamination presents the same hazard whether it exists on a work surface, on the exterior of a waste bag, or on the inside of a reusable container. Deletion of this provision falsely implies that contamination on bag exteriors or inside reusable containers should not be of concern to employees who must handle these items. Limiting the requirement to only visible contamination disregards the evidence that imperceptible quantities of blood or other potentially infectious materials may still harbor large quantities of HBV. On the other hand, adhering to only regularly-scheduled cleaning while ignoring visible contamination is in conflict with recommendations for decontamination of other surfaces and the principle that viral content increases with increasing quantity of blood. Hence, the Agency has concluded that both regularly-scheduled inspection and decontamination in addition to decontamination upon visible contamination are warranted to protect workers.
Paragraph (d)(4)(ii)(D) stipulates that broken glassware which may be contaminated shall not be picked up directly with the hands. It shall be cleaned up using mechanical means, such as brush and dust pan, tongs, or forceps. Contaminated broken glass is capable of inflicting percutaneous injury and direct inoculation of bloodborne pathogens into the bloodstream. Prohibiting picking up this glass directly with the hands eliminates or minimizes risk of such an injury and thereby the possibility of occupational transmission of bloodborne disease. This provision has been retained from the proposed standard with the exception of utilizing a vacuum cleaner or cotton swabs as an acceptable method of pick-up. Cotton swabs have been deleted to avoid confusion between swabs attached to a stick and a cotton ball-type "swab." Using a cotton ball-type swab is inappropriate as this type of swab can be penetrated by broken glass. Since an individual would normally hold such a "swab" directly with the fingers, injury or exposure could result. The American Society for Microbiology and Verdugo Hills Hospital commented that vacuum cleaners should not be used for clean-up as they could spread contaminant through their exhaust stream (Exs. 20-1188; 20-573). The Agency has concluded that vacuum cleaners and cotton swabs may not be appropriate for clean-up of contaminated broken glass and has deleted them from the examples of possible pick-up methods. It should also be remembered that tools used in clean-up must be properly decontaminated or discarded after use and the broken glass placed in a proper sharps container as required by other provisions of this standard.
The proposal required that reusable equipment, such as glassware or hand instruments, was to be decontaminated prior to washing and/or reprocessing. The rationale behind this proposed requirement was to rid such items of contamination before they entered the overall cycle of washing and reprocessing, thereby limiting the number of employees who must handle these contaminated items to only those performing the decontamination procedures. The great majority of comments received objected to this provision (e.g., AHA, Ex. 20-352; Society of Hospital Epidemiologists of America, Ex. 20-1002; APIC - New England, Ex. 20-216; Humana Hospital - Orange Park, Ex. 20-367; Ft Sander Regional Medical Center, Ex. 20-1214; Parkview Memorial Hospital, Ex. 20-136). The most frequently stated reason for objection was that proper decontamination cannot be achieved in the presence of organic debris (e.g., blood) as it interferes with the efficacy of the disinfecting/sterilizing process (e.g., Thomas Jefferson University Hospital, Ex. 20-363; Douglas E. Kline, MCM, CIC, Ex. 20-87; Anaheim Memorial Hospital, Ex. 20-523). Reviewing CDC's guidelines, it is noted that cleaning of reusable items prior to disinfection/sterilization is the recommended sequence of reprocessing. Specifically, these guidelines state:
Items must be thoroughly cleaned before processing, because organic material (e.g., blood and proteins) may contain such high concentrations of microorganisms. Also, such organic material may inactivate chemical germicides and protect microorganisms from the disinfection or sterilization process. (Ex. 6-188)
In addition, several commenters pointed out that the proposed requirement would, in actuality, result in more employees handling contaminated items (due to required cleaning prior to being sent for reprocessing) and that these employees would not be as well-trained and proficient in the decontamination process as reprocessing technicians (e.g., APIC - Middle Tennessee, Ex. 20-55; Eileen Upton, RN, ICP, Ex. 20-630; Presbyterian Hospital - Charolette, NC, Ex. 20-912; VA - Salisbury, NC, Ex. 20-1317).
A few participants supported disinfecting prior to cleaning (e.g., Caltech Industries, Ex. 20-12; Clinical Research Associates, Ex. 20-910; Sterling Drug Company, Ex. 20-40). However, the number of products which can successfully penetrate a heavy bioburden appears to be very limited - Clinical Research Associates cites only two of all products tested (Ex. 20-910).
Considering this information, the Agency has concluded that requiring reusable items to be decontaminated prior to washing/reprocessing may not accomplish the proposed intent (and, indeed, may have the opposite effect); is contrary to recognized, recommended procedures; and may be of limited feasibility. Therefore, this requirement has been dropped from the final standard.
With respect to decontamination of reusable items, however, a hazardous situation was related during the public hearings. Mr. Ivan Ruez, an employee in the central supply department of a metropolitan hospital, spoke of the process used in his facility to gather contaminated reusable items for reprocessing. Mr. Ruez testified:
Everybody coming into Central Supply you understand has to go through the process of orientation. In the process of orientation one of the first jobs that we do is decontamination. This is a process by which all the soiled used items retrieved from the floors must be sorted. Among those items, I'll give examples, are used trays, spinal needles, dirty commodes, suction machines, air mattresses, syringes, and any such items used by patients that can be recycled. . . .
All soiled items are dumped into central locations on the floors which are called soil utility rooms. Now a person going up to the floor to do the decontamination, what's called DC for short, has to actually physically reach into these bins. They're putting themselves at extreme risk when they do this, . . .
Now when they extract this equipment, a lot of the times the stuff is covered by wrapping paper which is what we use for wrapping the tray, reprocessing. There's no way that you know what is underneath that paper, just like on the floors. You go to pick up a sheet, there will be a needle, you're stuck. The same thing with the paper, you go to reach in as most people would do because you have to actually stretch it to get into the bin. Right there you're setting yourself up for contamination, for a puncture and this has happened in my department quite a few times, just within the year and a half because like I said before I was in nursing. Just a year and a half I've been in this department. This has happened over and over and over. (Tr. 11/14/89, pp.390-392)
Percutaneous injury by a contaminated item is the most efficient occupational method of contracting bloodborne diseases; therefore, at no time should an employee have to place his or her hand into a container which could contain items capable of causing injury (e.g., sharps). With regard to this hazard, paragraph (d)(4)(ii)(E) has been added to the final standard. It states that reusable sharps that are contaminated with blood or other potentially infectious materials, shall not be stored or processed in a manner that requires employees to reach by hand into the containers where these sharps have been placed. This provision will eliminate or minimize the risk of percutaneous injury resulting from reaching into containers of contaminated sharps.
Contaminated Sharps Discarding and Containment
Needles and sharps have been documented as prime mechanical agents of employee inoculation with both HIV and HBV. Therefore, their handling and discarding warrant special attention. Needles and sharps are capable of transferring infectious bloodborne pathogens directly into the bloodstream through accidental injuries such as needlesticks or scratches. The AHA states in their recommendations Management of HTLV-III/LAV Infection in the Hospital:
As with other bloodborne diseases, the potential for transmission is greatest when needles and other sharp instruments are used in patient care. Therefore, needles and syringes should be disposed of in rigid, puncture-resistant containers. (Ex. 6-75)
This position is maintained in the AHA's comment to the proposed standard (Ex. 20-352).
Several CDC documents address disposal of sharps and needles (Exs. 6-27; 6-153; 6-312). In addition, recommendation (4)(b) of CDC's publication The Center for Disease Control's Recommendations on Infectious Waste states:
Disposable syringes with needles, scalpel blades, and other sharp items capable of causing injury should be placed intact into puncture-resistant containers located as close as is practical to the area in which they were used. . . . (Ex. 6-395)
CDC/NIOSH also retains their stance on proper disposal of contaminated sharps as evidenced by their written comment and their 1989 guidelines for public safety workers (Exs. 20-634; 15).
In the final standard, paragraphs (d)(4)(iii)(A)(1) through (d)(4)(iii)(A)(4) deal specifically with management of disposable contaminated sharps. The proposal contained provisions addressing disposal container characteristics, accessibility, and maintenance. While the final also contains provisions relative to these aspects of sharps management, this section has been expanded and separated to clarify the Agency's intent and to address public comment. In addition, OSHA has decided to use the term "discarding" instead of "disposal" in order to more clearly show that what OSHA is addressing is the placement of the sharp before final disposal. This is consistent with EPA.
Paragraph (d)(4)(iii)(A)(1) puts forth the requirements for actual discarding of sharps and the physical characteristics of the container. It states that contaminated sharps shall be discarded immediately or as soon as feasible in containers that are: a) closable; b) puncture-resistant; c) leakproof on the sides and bottom; and d) labeled or color-coded in accordance with this standard. Containers must be closable in order to ensure that contaminated sharps remain inside the disposal unit while it is being transported and handled prior to terminal disposal (e.g. SHEA, Ex. 20-1002; CDC/NIOSH, Ex. 20-634; SEIU, Ex. 299; EPA, Ex. 6-497). The Association for Practitioners in Infection Control commented that by requiring containers be closable, the Agency failed to recognize the risk to the healthcare worker posed by the closure devices of some of the containers (Ex. 20-1118). However, OSHA believes workers receiving needlesticks as the result of a container's closure is most likely due to either overfilling of containers or poor container design. Both of these problems can be addressed. More frequent container replacement, as required by paragraph (d)(4)(iii)(2)(c), will eliminate needlesticks resulting from overfilling. If design of a container is leading to needlesticks from problems such as excessive manipulation of the sharps or container closure during discarding of the sharps or sharps becoming stuck in the container's opening upon discard, the employer should investigate and change to a different container design. Various designs are currently available.
Puncture-resistance is necessary to prevent the points of needles or other sharps from puncturing the container and protruding through the side of the container where they can present a hazard to unsuspecting staff (e.g., nurses, technicians, housekeepers). Ms. Judith Gordon, OSHA's expert witness on waste disposal, testified that puncture-resistance is the most important requirement for sharps containers (Tr. 9/13/89, pp.97-98). This requirement was also supported by several other sources (CDC/NIOSH, Ex. 20-634; AHA, Ex. 6-75; CDC, Ex. 6-153, 6-395; SEIU, Ex. 299, Toni Camasura, Tr. 1/16/90, p.731; IAFF, Tr. 9/14/89, p.152; EPA, Ex. 6-497). During the hearings, Dr. Diane Fleming of the American Biological Safety Association stated that she currently chairs an ASTM committee which is developing a standard for puncture-resistance of sharps disposal containers and urged OSHA to identify specifications for these containers (Tr. 9/21/89, p.97). During development of the Medical Waste Tracking Act, EPA was also requested to delineate specific performance standards for containers. EPA decided that such action was inappropriate for the following reason:
. . . [T]he Agency believes that it is inappropriate to specify specific performance standards for such containers, since packaging materials vary extensively in their physical and mechanical properties. For instance, it is quite possible that a 1-mil-thick film of one polymer material will be more puncture, impact, and abrasion resistant that a 2-mil-thick film of a different polymeric material. The physical properties can be affected further by the manufacturing process, such as extrusion and injection molding. The most appropriate manner of determining the suitability of a particular container with respect to its ability to resist puncture, leakage, and/or breaking under individual usage conditions is to subject the container to those conditions. (Ex. 6-497)
OSHA believes that the work of ASTM is valuable, and when completed, will provide users with specific criteria related to the puncture-resistance of containers. However, the Agency agrees with EPA and views the requirement of puncture-resistance to be one of performance-orientation. Thus, OSHA has concluded that requiring the container to be "puncture resistent" adequately informs the employer that the material and construction of the container must prevent sharps from protruding through the container.
Containers must be leakproof on the sides and bottom to prevent residual liquids which drain from syringes and pool in the container from leaking out onto countertops, floors, cart tops, and so forth, thereby spreading contamination. This requirement also prevents employee hand contact with liquids which could otherwise leak through and contaminate the outside of the container. Dr. Eric Steiner of On-Gard Systems Incorporated stated that it was his experience that it was commonplace to find residual liquids in the bottom of sharps containers (Tr. 9/26/89, p.61). EPA's MWTA also recognizes that residual liquids may collect in sharps containers and requires that all sharps be placed in leak-resistant containers (Ex. 6-497). The Agency has concluded that residual liquids can collect in sharps containers and that requiring containers to be leakproof on the sides and bottom is both justified and feasible.
Sharps containers must be labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard. This requirement serves essentially two purposes: 1) It allows the containers to be easily identified by employees having contaminated sharps to discard by clearly distinguishing the containers from others in the area; and 2) It gains the attention of other staff, such as housekeepers, by virtue of the readily recognizable label or color, thereby warning them of the potential hazard and signaling that special handling precautions are necessary. Labeling or color-coding of sharps containers was supported either specifically or in general in the recommendations of several participants (CDC/NIOSH, Ex. 20-634; SEIU, Ex. 299; EPA, Ex. 6-497; Judith Gordon, Tr. 9/13/89, p.98). In view of the particular hazard presented by contaminated sharps, OSHA has concluded that labeling or color-coding of containers is an appropriate requirement which is necessary to attract an employee's attention and warn him or her of the potential hazard.
Paragraphs (d)(4)(iii)(2) and (d)(4)(iii)(3) contain provisions relative to sharps containers during use and when moving them from the area of use as would occur when filled containers are being replaced. During use, sharps containers must be: (a) easily accessible to personnel and located as close as feasible to the area where sharps are used or can be reasonably anticipated to be found (e.g., laundries); (b) maintained in an upright position throughout use; and (c) replaced routinely and not allowed to overfill. When sharps discarding is perceived as inconvenient, chances are increased that needles and sharps will be left in bed linens, on night stands, or thrown into waste baskets, making them potential hazards for other staff such as laundry workers and housekeepers. In addition, the possibility of an accidental needlestick is greater if an employee must carry an uncapped needle or sharp to a remote location in order to discard it.
The proposed standard required that sharps containers be located in "the immediate area of use." A significant number of participants commented that it may be unwise or impossible to place sharps containers in certain areas, such as pediatric units, psychiatric units, areas where patients are confused or mentally impaired, or correctional facilities (e.g., AHA, Ex. 20-352; Donna Richardson, ANA, Tr. 9/20/89, p.80, 81; Toni Camasura, SEIU, Tr. 1/16/90, p.731). OSHA recognizes that there may be circumstances, such as in a correctional facility, which may not permit a sharps container to be located in the immediate area of use. However, Baylor University Medical Center stated that they have not found problems with having sharps containers in pediatric and psychiatric wards (Tr. 9/27/89, p.83). In order to provide the proper flexibility to address these situations, this provision has been modified to state that containers for contaminated sharps shall be located "as close as feasible to the immediate area where sharps are used . . . ." It should be realized that this revision is not intended to permit sharps containers to merely be located in the general area. For example, SEIU presented videotaped testimony of "Jane Doe," a nurse who HIV seroconverted after receiving a needlestick. The needlestick occurred when "Jane" attempted to insert the needle of a used IV set-up into the set-up's rubber port to protect it while she moved the set-up across the room and into the bathroom where the sharps container was located.
In terms of the actual incident that occurred, two things would have made a very significant difference, if not have prevented the thing entirely. The first is that the sharps containers, which are placed in the bathrooms, could be placed at the bedside, in which case I standing there with a contaminated needle would have been able to turn several inches and place the needle directly into the sharps container. I would not have had to entertain the possibility of walking through what I felt was an obstacle course, possibly tripping and impaling myself to get the bathroom. (Tr. 1/16/90, p.697)
According to testimony, sharps containers are uniformly located in the bathrooms throughout the basic medical and surgical floors of the facility (Jean Smith, SEIU, Tr. 1/16/90, p.702). This tragic incident supports OSHA's contention that when discarding of contaminated sharps is perceived to be, or in actuality is, inconvenient, the chance of improper sharps handling and the potential for needlestick is increased.
There are alternatives to locating a standard sharps container at the bedside of patients in the above situations. Containers can be used which are lockable or are designed to prevent removal of syringes while still maintaining easy accessibility for discarding. Several participants in the rulemaking, including a mental health facility, commented that another alternative was to have the healthcare worker bring a sharps container to the site, perform the procedure, and then remove the container upon leaving (APIC - National, Ex. 20-1118; Society of Hospital Epidemiologists of America, Ex. 20-1002; CDC, Ex. 15, Mendota Mental Health Institute, Ex. 20-794; Judith Gordon, Tr. 9/13/89, p.123; Norwood Hospital, Ex. 20-967).
This provision was also revised to require that sharps containers be located not only where sharps are used but also in areas where it can be reasonably anticipated that contaminated sharps could be found. Several participants involved with laundering of linens stated that contaminated sharps are found among these items (Angelica Corporation, Tr. 9/18/89, p.160; Georgia Davenport, SEIU, Tr. 1/16/90, p.766; Raymond Montez, SEIU, Tr. 1/16/90, pp.770, 782). Specifically, Mr. Montez, a laundry worker stated:
Myself and other employees in the laundry still encounter needles in the linen, mostly coming from surgery. The number has decreased in the last four years but there shouldn't be any at all. There are no containers in the sorting room to put needles in. I have been told by my supervisor to give them to him but many times he is not there and I don't know if he follows up and complains to the proper department about it.
I recently gave him one of these needles and he said he would take care of it and he left it on the ironing machine. The next day I picked it up. (Tr. 1/16/90, p.770)
This testimony helps illustrate why the Agency concluded that it was necessary to require sharps containers in areas where sharps are not normally used but may be found in order to provide affected employees with an appropriate method of discarding of these sharps. The design of the tops of a number of sharps containers will permit leakage if the container is tipped on its side or turned upside down, a fact substantiated by several parties (Judith Gordon, Tr. 9/13/89, p.99; American Biological Safety Association, Tr. 9/21/89, p.103; Winfield Corporation, Tr. 1/17/90, pp.913-914; On-Gard Systems, Ex. 20-645, Tr. 9/26/89, p.42; APIC - Northwestern Wisconsin, Ex. 20-108). The Agency has concluded, therefore, that the additional provision in paragraph (d)(4)(iii)(2)(b), which requires that sharps containers be maintained in an upright position throughout use, is necessary to prevent contaminant migration and inadvertent employee exposure through leakage from tipped containers.
A major concern when utilizing sharps containers is that they be replaced routinely and not allowed to overfill. The reason for this is twofold. First, a full container necessitates discarding of the sharp in some manner other than in the proper container, again leading to sharps being placed on night stands, thrown into waste baskets, and so forth. Mr. Carson Limbrick, a licensed practical nurse and representative of AFSCME stated:
As it stands now, we have one box and that's in the immunization room. What all the nurses do or the nurses that give immunizations they basically collect the needles in their rooms or offices where they give the shots. And whenever they find time to dispose of them they just take them to the immunization room and put them in the box that's there. If that box is full, then we find other areas to dispose of them. We find these little baggies and put them in the trash can, we put them in the trash can baggies. We have to find someplace to secret them away. We have kids who run through the clinic and whatnot so that's always a problem. . . . (Tr. 10/17/89, p.88)
This statement illustrates how overfilled containers directly contribute to improper discarding of contaminated sharps. It also demonstrates the improper actions necessitated when sharps containers are not easily accessible to the area of sharps usage.
Second, the employee may be tempted to get "just one more" sharp into the container by forcing it in by hand. In doing so, the possibility for an accidental needlestick increases, particularly if some of the discarded sharps are pointed toward the opening of the container. Several participants cited problems with overfilling and supported the requirement for routine replacement and prevention of overfilling (Diane Moats, Communication Workers of America, Tr. 11/14/89, p.292; Ruth Jeffries, AFSCME, Tr. 1/16/90, p.592; Joan Emslie, SEIU, Tr. 1/16/90, p.681; Toni Camasura, SEIU, Tr. 1/16/90, p.731; CDC/NIOSH, Ex. 20-634; SEIU, Ex. 299; AFSCME, Ex. 297). OSHA has concluded that replacement of containers before overfilling occurs is an appropriate requirement and reduces the chance of accidental needlestick by promoting proper handling and discarding of sharps.
When sharps containers are to be moved from the area of use, paragraph (d)(4)(iii)(3) requires that they be closed. A proper closing will ensure that if the container should become tipped or overturned, employees will not be exposed to contaminated sharps which may otherwise spill out. In addition, sharps containers must be placed in a secondary container if leakage is possible. This secondary container must be: (i) closable; (ii) constructed to contain all contents and prevent leakage during handling, storage, transport, and shipping; and (iii) labeled or color-coded according to paragraph (g)(1)(i) of this standard. From comments discussed above, it can be expected that at least some sharps containers will contain residual liquids and, based upon the particular container's design, may leak when tipped or overturned. These leaked fluids then present a contamination and exposure hazard which must be prevented. Judith Gordon urged addition of a provision specifying that measures must be taken to prevent exposures to spills and leaks from sharps containers during collection and transport (Tr. 9/13/89, p.99). In addition, Curtis Leland of Winfield Corporation stated the practice that most states recognize is that of immediately red-bagging filled sharps containers to prevent any residual liquids from spilling (Tr. 1/17/90, p.914). EPA also recognizes the potential for leakage from sharps containers in their Medical Waste Tracking Act and addresses this hazard as follows:
. . . If the container(s) cannot be sealed to prevent leakage, it must be placed in a plastic bag or other leak-resistant container that can be sealed to prevent leakage. The intent is to ensure that sharps and associated residual fluids (often blood) are securely contained and the integrity of the packaging is maintained from the time the waste leaves the generator's site until the time the waste is disposed of or is treated and destroyed. (Ex. 6-497)
This information leads the Agency to conclude that all of the above requirements are appropriate, justified, and feasible.
While the proposal specifically required disposable sharps containers, the final standard permits utilization of reusable containers for discarding of contaminated sharps. However, the final standard places restrictions on the processing of these containers to ensure that employees who handle them are not exposed to the risk of percutaneous exposure. As such, paragraph (d)(4)(iii)(4) requires that reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.
A number of participants urged OSHA to consider permitting use of reusable containers (e.g., CDC/NIOSH, Ex. 20-634; APIC - National, Ex. 20-1118; EPA, Ex. 20-991; Judith Gordon, Tr. 9/13/89, p.98; Florida Hospital Association, Tr. 12/19/89, pp.908-910; MedX Inc., Ex. 255, Tr. 12/21/89, pp.1587-1591; Biosystems Partners, Ex. 20-2887). CDC/NIOSH commented:
Paragraphs (d)(4)(iii)(B) and (d)(4)(iii)(B)(2) should be revised so they do not preclude the possibility of employing reusable containers if procedures are devised that do not increase the risk of puncture wounds. (Ex. 20-634)
Also, Judith Gordon echoed the above in her written comments, stating:
In my opinion, OSHA should look at other available systems. It may be appropriate to allow the use of sharps containers that are not disposable if their handling does not pose a risk of occupational exposure to the waste handlers. (Ex. 30)
In their comments to the proposal, EPA simply stated that while OSHA had stipulated disposable containers, EPA was allowing reusable rigid containers that had been decontaminated (Ex. 20-991). Obviously, even among some of those urging OSHA to consider reusable sharps containers, the potential for employee exposure is a concern. OSHA shares these concerns and this was a major point during consideration of this issue. Other participants provided information and comment which substantiated the Agency's concern.
Dr. Michael Decker, representing the Society of Hospital Epidemiologists of America, testified that the Society disagreed with permitting the use of reusable sharps containers. He stated:
We view the greatest hazard as being sharps and the area where the most rigorous rule making is appropriate is sharps. And we would not encourage anyone to handle any sharp after use. If it's reusable, by definition somebody had to clean it out. Nobody should have to do that. We think sharps should go into impervious, relatively crush-proof . . . containers that are never thereafter reopened by anyone until they're terminally destroyed. (Tr. 10/18/89, p.352)
The Society reiterated this stance in their written comment by stating that permitting reusable containers implied that some worker would empty the containers - an activity whose risk far outweighed the trivial economic benefit (Ex. 20-1002).
Also during the hearings, Joan Emslie, a SEIU union representative, described a reusable container system that had been in use at local hospital facility. Essentially, the system consisted of locked, yellow, hard plastic boxes, lined with plastic bags, into which sharps were discarded. When full, a central supply technician removed the box, took it to central supply, unlocked it, and emptied it into a larger red box by up-ending the yellow box and allowing the plastic liner and contents to fall out. Full red boxes were then removed by an independent hazardous waste company (Tr. 1/16/90, pp.665-666). When asked to detail some of the problems with this system, Ms. Emslie responded:
. . . once they open the lid like this they then grasp it by the sides, the lid comes all the way off and they grab it this way and dump it totally upside down. Now because of the size of the needles or the way they throw the needles in there, it actually goes through this plastic liner, the first few in, and it sticks into the bottom. So the needle is actually stuck into the plastic. So when they turn it upside down it does not always fall out. So then they would have to then set it back on the counter, lift the paper which is against the rules, but pull on the paper to get it out. In doing that if the needle comes loose quickly it could fly out at them. Also, if the needle that's disposed of in here has tape on it, it sticks to the side, you can't see that when you look inside. So when you turn it upside down some of the needles fall out and if the plastic doesn't fall out that needle then is swinging freely. Even if you had the glove on, which only goes to your wrist, the needle could swing out and hit you in the forearm, which it has done and at this particular arbitration we had testimony from an employee who was stuck just that way. Also, with the hole in the top the way it is, it is possible that when they go to remove the top if it's too full or a very large syringe is in here and in unlocking this and then unclamping it here it is possible to get stuck through the top. We also had testimony from a central supply worker who did get stuck that way as well. (Tr. 1/16/90, pp.680-681)
Moreover, Dr. Steiner of On-Gard Systems stated that he felt that a system requiring emptying of sharps containers was a totally ill-advised practice while the American Association of Critical-Care Nurses commented that disposable containers were safer since they reduced the number of people having to deal with the container (Tr. 9/26/89, p.73; Tr. 12/19/89, p.960).
MedX, Incorporated and Biosystems Partners, two companies supplying reusable sharps container services to facilities, presented an opposing viewpoint. Some of the advantages of reusable containers cited by these commenters included: higher quality container construction resulting in increased puncture-resistance; cheaper disposal costs for client facilities; reduced needlestick incidence within client facilities due to increased container replacement rate, minimizing overfilling; and a reduction in solid waste going to landfills or incinerators (Exs. 255, 20-2887). While these are certainly important benefits, OSHA shares the concern voiced by some of the previously-cited commenters relative to the risk of injury incurred by employees who open, empty, and/or clean the containers. Even though the occurrence of sharps injury may decrease in client facilities, the Agency cannot advocate transference of this risk to employees of the servicing company. This concern does not necessarily mean that utilization of reusable containers must be prohibited, however, and it is not the Agency's intent to eliminate a potentially viable alternative to disposable sharps containers, provided servicing employees are not placed at increased risk. In response to questions about viability of reusable container systems, Dr. Decker of the Society of Hospital Epidemiologists of America stated that he did not support individuals opening sharps containers; however, he continued by commenting:
If there were containers that were designed to be hauled off and in some automated way emptied, cleaned, and sent back, I don't see anything wrong with that. Certainly its doable. . . . (Tr. 10/18/89, p.369)
Ms. Barbara Russell of Baptist Hospital (a MedX client), who had visited the MedX plant and observed their procedures, stated that the actual emptying of containers was done by machine (Tr. 12/21/89, p.1594). MedX stated in their post-hearing comment that a fully-automated container cleaning system that eliminates employee sharps exposure was expected to be put into service by January 1991. MedX concludes their comment by stating:
It would create an undue hardship on companies such as MedX, who have devised reusable sharps container services, for OSHA to completely eliminate the service without first conducting a fair investigation. If the findings of an investigation demonstrate that some facet of the system presents an unreasonable risk, OSHA should demand that the industry modify the system appropriately. (Ex. 255)
After much deliberation, OSHA has concluded that reusable sharps container systems can be a viable alternative to disposable containers if the risk to servicing employees is eliminated. Based on the information presented, it is also the Agency's conclusion that it is currently feasible to alter the cleaning process to eliminate this risk. Therefore, reusable containers are permitted provided they are not opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of percutaneous injury.
Regulated Waste Containers
Paragraph (d)(4)(iii)(B) of the final standard puts forth the requirements for containing regulated wastes other than contaminated sharps, such as blood-saturated dressings. This waste must be placed in containers which are: (a) closable; (b) constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, and shipping; (c) labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard; and (d) closed prior to removal to prevent spillage or protrusion of contents during handling, storage, transport, or shipping.
Requiring the container to be closable is necessary to ensure that the waste is not spilled in the event of the container becoming tipped or upended (VA - Salt Lake City, Ex. 20-635; EPA, Ex. 6-497; CDC, Ex. 6-395). Simply being closed, however, is not enough to ensure that wastes are contained. For example, plastic bags containing waste may be torn due to rough handling, compaction, or punctures caused by pointed or sharp objects being placed into them. When the physical barrier surrounding the waste is compromised, the chance of employee exposure and work area contamination is increased. Mr. David Ares, a health and safety delegate for SEIU, stated that it was fairly common at the facility where he worked for waste-containing redbags to break and spill their contents (including liquid blood) into the work area and onto employees while being loaded into the incinerator hopper (Tr. 11/13/89, pp.176-177). Moreover, Ms. Lawrel Mueller, a certified nurse's assistant, described what resulted at her facility when plastic waste bags broke during handling. She stated:
. . . [A]t one time the porter would pick up from the floors. He would go around to all of the floors and he would take it out to the dock. This would be in plastic bags. Sometimes the bags would break and the blood would go all over him. That happened a number of times. They would throw it down the chute, blood products, I don't know how that happened but it did and one time I went down there, he called me and he was full of blood and the whole area where it had fallen into this huge cart, it was all over, the walls, the ceiling, everywhere, and all over the worker. (Tr. 1/16/90, p.783)
In some circumstances, duration of time that wastes remain in the container may also play a role in a container's ability to contain waste. Mr. Steve Whitney of Whitney Products testified that small-volume generators (e.g., doctors offices, clinics, or dentists offices), by virtue of the small amount of waste generated per day, may place waste into large holding boxes over the course of a number of consecutive days. These boxes may sit for weeks or months before they are picked up by specialized waste services (Tr. 10/20/89, p.927). Obviously, consideration would have to be given to the design of the container to ensure that it would be able to retain all wastes, including any liquids, for the period of time between pick-ups.
Other sources also indicated that some type of provision was needed to ensure proper waste containment. The comments of Ms. Bonnie Shacknies and APIC - Greater LA recommended that this provision state that containers or bags are to be of sufficient strength to prevent leakage and tearing in transport (Exs. 20-525; 20-213). Furthermore, EPA's Medical Waste Tracking Act requires that waste bags be of sufficient strength to prevent tearing and breaking and must be sealed securely to prevent leakage (Ex. 6-497). OSHA has reviewed the above information and agrees that a minimum performance requirement is necessary. Consequently, OSHA has stipulated in the final regulation that whatever containers are chosen for waste containment (e.g., boxes, plastic bags), they must be able to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping.
The proposed standard stated that waste containers had to be "leakproof." CDC documents also discuss "leakproof" and "impervious" containers (Exs. 15; 6-395). Several commenters, however, questioned the achievability of "leakproof" containers. The American Hospital Association wrote that no container was truly "leakproof" and that "leak-resistant" is a sufficient standard which permits enough flexibility for a facility to use heavier packaging when necessary (Ex. 20-352). The Cleveland Clinic recommended that "leakproof" be conditioned to apply to normal handling situations (Ex. 20-563). Moreover, the EPA commented that "leakproof" may be unattainable without further definition of the term (Ex. 20-991). Reviewing the Medical Waste Tracking Act, it was noted that EPA requires "leak-resistant" containers (Ex. 6-497). To reduce confusion and avoid requiring a possibly unachievable standard, the Agency has revised this provision to be more performance-oriented. The final standard requires that containers prevent leakage during handling, storage, transport, or shipping.
Regulated waste containers must also be labeled or color-coded in accordance with paragraph (g)(1)(i) of the standard in order to warn employees who may have contact with the containers of the potential hazard posed by their contents. Use of warning labels or color-coding was supported by several interested parties (EPA, Ex. 6-497; ADA, Ex. 20-665; AFSCME, Ex. 297; CDC/NIOSH, Ex. 20-634; APIC - Indiana, Ex. 20-139; Mohawk Valley Psychiatric Center, Ex. 20-950; American Biological Safety Association, Tr. 9/21/89, p.101; Baxter Health Care Corporation, Tr. 10/20/89, p.872). However, one commenter, Mercy Regional Medical Center, suggested that not all infectious waste would be required to be marked as such if it is handled on-site and the facility's policy is for all waste to be treated as infectious waste (Ex. 20-186). While OSHA believes that treating all waste as regulated waste is consistent with safe handling practices, elimination of all warnings on waste containers is not justified. Warning by label or color coding is still necessary for to alert employees who may not be aware of the facility's waste policy (e.g., new employees, employees who would not normally come in contact with wastes, employees from outside the facility). Facilities like Mercy can place all of their waste in labeled or color-coded containers. OSHA has concluded that such a policy does not warrant an exception to labeling or color-coding, particularly when considering the general recognition by commenters of the potential hazards posed by regulated waste.
OSHA proposed that if infectious waste was labelled rather than color-coded, the label include the biological hazard symbol. EPA supports the use of the biohazard symbol as evidenced by the fact that it is one of the three choices given to generators for designating regulated waste (Ex. 6-497). Dr. Michael Decker of the Society of Hospital Epidemiologists of America testified:
Speaking of labels, generally, we support to biohazard label and if there is to be a label, that would I think be the preferred label. Why have conflicting labels? Others are going to require us to biohazard label a lot of the same things you're going to require. The last thing we want is two different labels, one for each agency on it. . . . (Tr. 10/18/89, pp.353-354)
Both CDC/NIOSH and the American Biological Safety Association support labeling/color-coding, but they stated that the biohazard symbol should be reserved to designate known sources of etiologic agents and should not be used on regulated waste containers (Ex. 20-634; Tr. 9/21/89, p.101). However, under universal precautions, it is assumed that bloodborne pathogens are present in all blood and other potentially infectious materials. In fact, CDC adopted this stance in its recent notice of proposed rulemaking for interstate shipment of etiologic agents. Specifically, the CDC proposal states:
. . . Because all health care workers are encouraged to handle all patient's clinical specimens as though they are infectious, the proposed regulations are intended to apply to all clinical specimens. . . . The new label for clinical specimens and biological products has the same biohazard symbol as does the label for etiologic agents. However, instead of white and red, this label will be fluorescent orange and black, as recommended by the Occupational Safety and Health Administration requirements for labeling biological hazards. (Federal Register, Vol. 55, No. 42, pp. 7678-7682, Ex. 286K citing 29 CFR 1910.145)
The Agency agrees with the Society of Hospital Epidemiologists of America in that requiring use of a new symbol could prove confusing and burdensome. Keeping with the intent of universal precautions and considering the above information, the Agency has concluded that use of the biohazard symbol is appropriate in the labeling of regulated waste.
Some situations could result in the outside of a regulated waste container becoming contaminated with blood or other potentially infectious materials as would occur if potentially infectious materials were spilled on the exterior of the container while it was being filled. To address such situations, the proposal required that if outside contamination of the container or bag was likely to occur, the container was to be placed in a second container which was closable, color-coded or labeled, and closed to prevent leakage. The final standard retains this basic requirement, with minor revisions, to prevent an employee's handling of the contaminated exterior and to limit spread of contamination throughout the work area. More specifically, paragraph (d)(4)(iii)(B)(2) states that if outside contamination of the regulated waste container occurs, it shall be placed in a second container. The second container must be: (a) closable; (b) constructed to contain all contents and prevent leakage of fluids during handling, storage, transport, or shipping; (c) labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard; and (d) closed prior to removal to prevent spillage or protrusion of contents during handling storage, transport, or shipping. The second container must fulfill the same requirements as the contaminated primary container (closable, proper construction, labeled/color-coded, closed) for the same reasons discussed above relative to regulated waste containers.
Several commenters agreed that there were situations in which outside contamination of a primary container occurred and placing it in a second container was appropriate (East Jefferson General Hospital, Ex. 20-599; Elizabeth M. Rettig, RN, Ex. 20-588; Susan J. Williams, RN, CIC, St. Joseph Hospital, Ex. 20-148). However, a number of participants misinterpreted the proposed provision believing it to require "double-bagging" of all regulated waste or stated that the phrase "if outside contamination of the container or bag is likely to occur" was too vague to give proper guidance to employers about when a second bag would be required (e.g., American Association of Blood Banks, Ex. 20-1059; St. Alexis Hospital, Ex. 20-958; St. Luke's Hospital, Ex. 20-1236; Boone Hospital Center, Ex. 20-556). It was not the Agency's intent to imply that all regulated waste was to be "double-bagged" or to propose a provision that, due to its vagueness, would necessitate such a practice. Therefore, the provision has been revised to clarify that a second container would be required when outside contamination of the first occurs. Examples of when double bagging would be required include: a waste container that has been splashed with blood during surgery or autopsy, a container that has been handled by an employee wearing blood-contaminated gloves, or a waste bag that is leaking blood or other potentially infectious materials onto an adjacent bag(s). It should be noted that the Agency's reasoning for requiring secondary containers is not as a general infection control measure or to ensure containment of a particularly heavy load of waste. They are being required to address employee exposure and work area contamination in those instances where outside contamination of the primary container has occurred. In such circumstances, the Agency has concluded that this requirement is justified and appropriate.
As stated in the proposal, it is not OSHA's intent to set rigid regulations regarding regulated waste handling and disposal, but simply to put forth minimum requirements for containing waste which the Agency has determined warrants special handling in order to protect employees against exposure to bloodborne pathogens. The Agency maintains this intent and recognizes that additional requirements may apply to this waste under the jurisdiction of other governing bodies. Similar to the proposal, therefore, paragraph (d)(4)(iii)(C) requires that disposal of all regulated waste shall be in accordance with applicable regulations of the United States, States and Territories, and political subdivisions of States and Territories. Relative to this, some commenters stated that OSHA's proposed packaging regulations for waste were inconsistent with those of EPA (Connecticut Hospital Association, Ex. 20-275; William W. Backus Hospital, Ex. 20-911). EPA's comment contained the following statement on this issue:
EPA's regulations are more stringent than the proposed OSHA requirement for packaging; EPA requires medical waste packaging to meet a set of performance-based standards. One of the EPA performance standards requires packaging to be rigid; EPA believes that single- or double-bagging wastes is insufficient to protect medical waste handlers when wastes are transported off-site. . . . (Ex. 20-991)
In addition, EPA commented that they require the words "Medical Waste," "Infectious Waste," or the universal biohazard symbol on the outside of packaging of untreated medical waste (Ex. 20-991). Upon reviewing this information, OSHA sees no unresolvable conflict. No particular requirement is stipulated in this standard for rigid or non-rigid containers for shipping wastes off-site. Therefore, a facility may initially collect waste in rigid containers or place waste contained in plastic bags into rigid containers for off-site shipping. Either method appears to satisfy both OSHA and EPA regulations relative to rigidity of containers. With respect to labeling, OSHA's required label contains the universal biohazard symbol, one of the three labeling choices offered by EPA's regulations. Hence, the Agency concludes that the label required by this standard would satisfy EPA's regulations also.
The final standard, in paragraph (d)(4)(iv)(A), requires that contaminated laundry shall be handled as little as possible with a minimum of agitation. In addition, contaminated laundry is to be: 1) bagged or containerized at the location where it was used and shall not be sorted or rinsed in the location of use; 2) placed and transported in bags or containers that are labeled or color-coded in accordance with paragraph (g)(1)(i) of this standard (When a facility utilizes universal precautions in the handling of all laundry and all employees are trained to follow universal precautions with laundry until it has been laundered, alternative labeling or color-coding is sufficient if it permits all employees to recognize the containers as requiring compliance with universal precautions); and 3) placed and transported in bags or containers which prevent soak-through and/or leakage of fluids to the exterior if the laundry is wet and presents a reasonable likelihood of soak-through or leakage from the bag or container.
By requiring bagging or containerization of contaminated laundry at the location of use and prohibiting sorting or rinsing in these areas, the amount of manual handling of the laundry by staff, other than laundry personnel, is limited to that which is necessary for removal and bagging or containerization. Contamination of additional surfaces such as sinks and floors is also reduced from that which may occur if sorting and rinsing were permitted in areas other than the laundry. This provision was adopted directly from CDC's recommendation for routine handling of soiled linen contained in their Guideline for Handwashing and Hospital Environmental Control, 1985 and later reiterated in Recommendations for Prevention of HIV Transmission in Health-Care Settings (Exs. 6-188; 6-153). In addition, the 1988 Guidelines for Healthcare Linen Service by the Joint Committee in Healthcare Laundry Guidelines support handling soiled linen as little as possible and with a minimum of agitation (Ex. 113a). This provision was also specifically supported, in whole or in part, by several commenters (e.g., AFSCME, Ex. 297; Glendale Memorial Hospital, Ex. 20-169; RWDSU, Ex. 20-1505; G.S. Naylor, M.D. and K.A. Yates, R.N., Ex. 20-555).
Placing and transporting contaminated laundry in bags or containers that are color-coded or labeled in accordance with paragraph (g)(1)(i) is required to inform employees who may handle the bags or containers of their contaminated contents and that special handling procedures are in order. Labeling or color-coding of contaminated laundry was supported by several commenters, such as the Service Employees International Union, the American Federation of State, County, and Municipal Employees, the Food and Allied Service Trades, and the American Association of Critical-Care Nurses (Exs. 299; 297; 20-888; 20-1162). However, SEIU went on to say:
. . . SEIU recognizes that OSHA may want to reconsider its red-bagging and labelling requirements if all laundry is to be treated as potentially infectious. Additionally, if all laundry is considered potentially infectious, labelling and bagging of laundry that is handled by outside contractors may need separate consideration. (Emphasis in original)(Ex. 299)
A large number of commenters felt that labeling or color-coding laundry bags was unnecessary. However, this statement was generally qualified with the comment that use of consistent handling or Universal Precautions in the handling of all laundry obviates the use of labels or color-coding (e.g., SHEA, Tr. 10/18/89, p.356, 377; Casa Colina Hospital, Ex. 20-284; Dakota Hospital, Ex. 20-632; Frick Community Health Center, Ex. 20-292; Lakeland Regional Medical Center, Ex. 20-37). Harrisburg Medical Center discussed use of alternative labeling or color-coding (Ex. 20-738). Reviewing the record, it appears that a number of associations and facilities support and/or have adopted the policy of using universal precautions in the handling of all soiled laundry (e.g., Joint Committee on Healthcare Laundry Guidelines, Tr. 10/20/89, pp.794,803; Textile Rental Services Association of America, Ex. 20-383; AAOHN, Ex. 20-357; APIC - Kansas City, Ex. 20-689; AFSCME, Ex. 297; SEIU, Ex. 299; Standard Textile Company, Tr. 9/26/89, p.27; Society of Hospital Epidemiologists of America, Tr. 10/18/89, pp.356,377; Kaiser Permanente - Panorama City, Ex. 20-60; Greater Houston Hospital Council, Ex. 20-1252). Just as with the views expressed regarding specimen labeling, commenters following this policy felt that labeling/color-coding was unnecessary. The Agency has considered these comments and has reached a conclusion similar to that reached with specimen labeling. That is, when a facility utilizes universal precautions in the handling of all laundry and all employees are trained to follow universal precautions with laundry until it has been laundered, alternative labeling or color-coding is sufficient provided all employees who may come into contact with these bags or containers are able to recognize them as requiring compliance with universal precautions and the bags or containers remain within the facility. Labeling or color-coding of contaminated laundry shipped off-site is discussed below under paragraph (d)(4)(iv)(C). This addition to the provision increases the flexibility afforded to employers in the handling of contaminated laundry. They may either: 1) separate contaminated laundry from other soiled laundry and place it into bags or containers labeled or color-coded in accordance with paragraph (g)(1)(i); or 2) they may utilize universal precautions and alternatively labeled or color-coded bags or containers in the handling of all soiled laundry, eliminating segregation of contaminated laundry and the need for two different types of bags or containers (i.e., contaminated versus non-contaminated) to contain soiled laundry.
In some circumstances, laundry may contain enough blood or other potentially infectious materials that soak-through and/or leakage from the bag or container could occur. Therefore, paragraph (d)(4)(iv)(A)(3) states that whenever contaminated laundry is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through and/or leakage of fluids to the exterior. This will not only minimize environmental migration of contaminants but will also reduce employee exposure which would occur during handling of wet or leaking bags or containers. Again, this provision has essentially been adopted from CDC's 1985 hospital environmental control document and their Recommendations for Prevention of HIV Transmission in Health-Care Settings (Exs. 6-188; 6-153).
The American Hospital Association urged that the proposed requirement for "leakproof" bags be changed to "leak-resistant" (Ex. 20-352). The comment of CDC/NIOSH stated that rather than "leakproof," bags or containers should prevent leakage and be of sufficient quality to contain wet laundry without outside contamination (Ex. 20-634). The 1988 Guidelines for Healthcare Linen Service specify:
The collection bags or containers should be of sufficient quality to functionally contain wet/soiled linen to prevent contamination of the environment during collection, transportation, and storage prior to processing. (Ex. 113a)
The Agency has modified the provision to make it more performance-oriented and thereby permit more flexibility by eliminating the term "leakproof" and simply requiring that the container chosen must prevent soak-through and/or leakage of fluids to the exterior. The bag or container is not required to be made of any particular material (e.g., plastic versus cloth), merely that it satisfies the above performance criteria. It should also be noted that all contaminated laundry is not required to be placed in such bags or containers, only wet contaminated linen which presents a reasonable likelihood of soak-through and/or leakage to the exterior. The use of bags or containers which prevent soak-through and/or leakage of fluids contained in wet contaminated laundry was supported by a number of other commenters (e.g., American Biological Safety Association, Ex. 241; Textile Rental Services Association of America, Ex. 20-383; SEIU, Exs. 20-979, 299; AFSCME, Ex. 297; California APIC Coordinating Council, Tr. 1/10/90, p.191).
Paragraph (d)(4)(iv)(B) requires that the employer shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment. Gloves will reduce contact exposure to blood or other potentially infectious materials that are found in contaminated laundry. In addition, other appropriate personal protective equipment such as gowns, aprons, and possibly eyewear, may be necessary to prevent employee exposure. Use of gloves and other appropriate personal protective equipment during contact with contaminated laundry is supported by a number of participants in the rulemaking (e.g., CDC/NIOSH, Ex. 20-634; AHA, Ex. 20-352; Society of Hospital Epidemiologists of America, Tr. 10/18/89, p.377; Joint Committee on Healthcare Laundry Guidelines, Ex. 113a, Tr. 10/20/89, pp.800-801; Textile Rental Services Association of America, Ex. 20-383, Tr. 9/25/89, p.79; Angelica Corporation, Tr. 1/12/90, pp.526-527; SEIU, Exs. 20-979, 299).
Not all soiled laundry is processed on-site. Consequently, bags or containers of soiled laundry from a facility which utilizes universal precautions in the handling of all laundry and which have been labeled or color-coded using an alternative method recognized by all affected employees of the generating facility, may not be recognized as containing contaminated laundry by the employees of the off-site laundering facility. This problem is compounded in a laundry processing linen for a number of facilities, all of which may be utilizing different marking systems for their laundry containers. Employees of laundries which utilize universal precautions in handling all soiled laundry would not be affected by the differing markings since they would be uniformly treating all soiled laundry as potentially infectious regardless of its container markings. However, employees of laundries which did not adhere to universal precautions with all soiled laundry need to be informed as to which bags or containers hold contaminated laundry so that proper precautions can be taken. The situation of off-site laundering was brought up not only by SEIU as discussed in the labeling section above, but also was addressed by the RWDSU who commented that when institutions contract with a commercial laundry service to process soiled linens, it is necessary to inform the service's employees of the potential for infection from soiled linens (Exs. 299; 20-1505). Therefore, paragraph (d)(4)(iv)(C) has been added to the final standard to address this circumstance. This provision states that when a facility ships contaminated laundry off-site to a second facility which does not utilize universal precautions in the handling of all laundry, the facility generating the contaminated laundry must place such laundry in bags or containers which are labeled or color-coded in accordance with paragraph (g)(1)(i). In order to be effective and minimize confusion among employees, the hazard warning used should be one that is standardized and universally recognized. Since the biohazard symbol and the color red are generally recognized as warning of potentially infectious material, OSHA concludes that this label or color-coding system is the most appropriate to employ to warn off-site employees of the hazard of contaminated laundry.
An additional issue was raised relative to labeling or color-coding. The proposal required that bags of contaminated laundry be labeled with the biohazard label or colored red. Jill Witter of Angelica Corporation testified that linen shortages in many of Angelica's client hospitals were found to be the result of red-bagged soiled linen being mistaken for bagged infectious wastes and consequently incinerated (Tr. 1/12/90, pp.533-534). Ms. Witter also stated that using red plastic bags for packaging soiled linen was causing a problem in that since they cannot be washed they must be disposed of and landfills were either refusing red and yellow bags or were charging increased prices for their disposal (presumably since they are associated with containment of infectious waste) (Tr. 10/20/89, p.812). A similar comment was made by Carmen C. Birk, a registered nurse and infection control practitioner (Ex. 20-106). Since alternative labeling or color-coding in facilities which utilize universal precautions in the handling of all soiled laundry is permitted by the final standard, this problem can be eliminated if both the generating facility and the off-site laundering facility utilize universal precautions. Comment was received by a number of participants expressing that it was unnecessary for OSHA to regulate handling of laundry (e.g., Abington Memorial Hospital, Ex. 20-557; American Association of Blood Banks, Ex. 20-1059; Tri-County Area Hospital District, Ex. 20-63; Bingham Memorial Hospitals, Ex. 20-143). The most often cited rationale for this view was that laundry has not been implicated in the transmission of HBV or HIV; therefore, no special handling practices were indicated. During the hearings, Keith Mestrich, Director of Health and Safety for the Food and Allied Services Trades Union, questioned Dr. Stephen Hadler of CDC about the possibility of hepatitis B contraction among laundry workers, particularly in view of the virus's ability to survive even in a dried state (Tr. 9/14/89, p.73). Dr. Hadler responded:
I can comment that data shows the virus can survive a week, if it were to be -- if parenteral exposure were to occur, then it could cause infection . . . [O]ne would say if laundry is visibly blood-contaminated, then it is something that should be of concern. (Tr. 9/14/89, p.74)
Dr. Hadler testified further that it was theoretically possible for exposure to occur through contact of dried blood with non-intact skin (Tr. 9/14/89, p.74).
Information provided by laundry workers demonstrates that exposure to blood and other potentially infectious materials does occur during processing of contaminated laundry. Ms. Georgia Davenport, when asked if laundry workers in the facility where she worked handled blood-soaked laundry that was still wet, stated:
Yes they do. Like some of the surgery we get a lot of congealed blood, we get a lot of different parts of the body comes out. You also get some like from labor and delivery you get different congealed blood come down in sheets and in blankets and different things. They have to handle all of this. . . .
You have to sort the linen. You put bath blankets in one place and you put sheets in another, you put towels in another. You sort it. That means you have to handle it. . . . (Tr. 1/16/90, pp.780-781)
Other participants also presented testimony regarding exposure including splashes to face, hands, arms or body and contact with wet blood and other potentially infectious materials such as body parts and human placentas in soiled laundry (Tr. 10/18/89, p.167; Tr. 11/14/89, pp.444-445; Tr. 1/16/90, pp.781-782; Tr. 10/17/89, pp.46-47). In addition, contaminated sharps are also generally recognized to be a potential hazard contained in soiled laundry.
In view of this information, along with the recommendations for specific laundry handling practices put forth by organizations such as CDC, the Joint Committee for Healthcare Laundry Guidelines, and the Textile Rental Services Association of America, the Agency has concluded that the likelihood of exposure does exist in the handling of contaminated laundry and that the regulations contained in this final standard are warranted and justified.
Paragraph (e) HIV and HBV Research Laboratories and Production Facilities
This paragraph addresses additional requirements that must be met by research laboratories and production facilities engaged in the culture, production, concentration, and manipulation of HIV and HBV. The risks associated with direct and routine work with pathogens have long been recognized:
Microbiology laboratories are special, often unique, work environments that may pose special infectious disease risks to persons in or near them. Personnel have contracted infections in the laboratory throughout the history of microbiology (Ex. 6-338).
HIV and HBV research laboratories and production facilities are no exception, and the risks associated with work in such facilities warrant additional protective measures.
Prior to 1984, no single code of practice, standards, guidelines or other publication providing detailed descriptions of techniques or equipment for laboratory activities involving pathogens was available. In that year, the Centers for Disease Control (CDC) and the National Institutes of Health (NIH) published guidelines entitled "Biosafety in Microbiological and Biomedical Laboratories" (Ex. 6-338). These biosafety guidelines were based on combinations of standard and special practices, equipment, and facilities recommended for use when working with various infectious agents in laboratory settings. These guidelines were revised in 1988.
These biosafety guidelines are not limited the bloodborne pathogens which are the subject of this standard. They are applicable to work with any infectious agent. The basic format for the biosafety guidelines categorizes infectious agents and laboratory activities into four classes or levels denoted as biosafety levels 1 through 4. These biosafety levels (BSL) are comprised of combinations of laboratory practices and techniques, safety equipment, and laboratory facilities appropriate for the operations performed and the hazard posed. The Guidelines indicate the BSL to be used when working with various infectious agents and infected animals. Recommended BSL for working with HIV were not included in the original biosafety guidelines.
In 1988, CDC issued an "Agent Summary Statement for Human Immunodeficiency Virus" (Ex. 6-312) which outlined biosafety levels for various activities involving HIV. Activities performed in clinical laboratories were categorized at BSL 2 which covers standards and practices for handling all clinical specimens. For HIV research laboratories and production facilities, the Agent Summary states:
Activities such as producing research-laboratory-scale amounts of HIV, manipulating concentrated virus preparations, and conducting procedures that may produce aerosols or droplets should be performed in a BSL 2 facility with the additional practices and containment equipment recommended for BSL 3.
Activities involving industrial-scale, large-volume production or high concentration and manipulation of concentrated HIV should be conducted in a BSL 3 facility using BSL 3 practices and equipment (Ex. 6-312).
These recommendations with some modifications were adopted by OSHA to cover HIV/HBV research laboratories and production facilities. Accordingly, the Guideline's BSL 3 text for standard microbiological practices, special practices, and containment equipment was converted to regulatory language and comprises paragraph (e)(2) of the standard. Requirements for the facilities for research laboratories [paragraph (e)(3)] were derived from the text for BSL 2, while those for production facilities [paragraph (e)(4)] were derived from the text for BSL 3.
While general training requirements for employees working with pathogens are given in paragraph (g), OSHA feels that additional specialized training should be provided for employees of the research laboratories and production facilities covered by paragraph (e). HIV infection of a worker in an HIV production facility as a result of "undetected skin contact with virus culture supernatant" was attributed to inexperience coupled with "on-the-job training in a setting in which episodes of contamination may have occurred frequently" (Ex. 6-312). Therefore, the training recommendations of the NIH committee convened to investigate the incident were incorporated into paragraph (g)(2)(vii) of this standard as special training requirements.
OSHA recognizes the valuable contribution that is being made by research laboratories that are studying the human immuno-deficiency virus and the hepatitis B virus. The Agency also understands the need to produce extremely high concentrations of these viruses to prepare reagents and other products needed for research, diagnosis and, if an HIV vaccine is developed, prevention. The Agency has no desire to impede these efforts. However, there is clearly documented risk to individuals working with blood and other potentially infectious materials containing HIV and HBV. When the concentration of these viruses is increased as the result of growing virus in cell culture or artificial concentration, then the risk to employees increases. The two cases of HIV infection that occurred in HIV production facilities are discussed in the Health Effects section of this preamble.
The final standard for occupational exposure to bloodborne pathogens requires the employer to implement a number of provisions that are identical to those found in the Guidelines. The provisions in paragraph (e) are a minimal program, and OSHA anticipates that these employers will continue to follow the appropriate portions of the guideline in addition to those in the final standard.
The requirements in paragraph (e) are derived primarily from the CDC/NIH recommendations found in "Biosafety in Microbiological and Biomedical Laboratories" (Ex. 6-338). Only those provisions that relate to the health and safety of the employee are required by the standard. Since the employer is responsible for following the entire standard, requirements stated elsewhere in the standard (e.g. the prohibition of mouth pipetting) are not repeated. The special training requirements in paragraph (g)(2)(vii) are based on the conclusions and recommendations of an expert team convened by the Director of the National Institutes of Health.
This section applies to two types of facilities that we have designated "research laboratories" and "production facilities." For the purpose of this standard, "research laboratories" means a laboratory producing or using research-laboratory scale amounts. Research laboratories may produce high concentrations of HIV or HBV but not in the volume found in the production facilities. Although attempts to grow HBV in this manner have not been successful in the past, researchers are attempting to culture HBV and the in vitro culture of HBV may soon be possible. This standard does not require research laboratories such as laboratories using unconcentrated blood or blood components as the source of HIV or HBV to follow the requirements in paragraph (e) if this is the only source of virus used in the laboratory. However, they must follow the other provisions of the standard and avoid the production of aerosols.
David Silberman, the Manager for Safety and Health Programs for the Stanford University School of Medicine, in his testimony raised some concerns about applying the OSHA standard to academic research facilities (Tr. 1/10/90, pp. 212-235). Rather than following the requirements of the paragraph (e) he urged that the academic community collaborate on safety issues in research laboratories with NIH and CDC. While such collaboration has undoubtedly resulted in hazard identification and communication among research laboratories, even the guidelines developed by NIH and CDC do not always result in successful communication of hazards. Mr. Silberman testified he was not familiar with the "1988 Agent Summary Statement for Human Immunodeficiency Virus...", recommendations issued by CDC for handling HIV. To avoid gaps in crucial information, OSHA has concluded academic research laboratories must be covered by this standard.
For purposes of the standard, facilities that are engaged in industrial-scale, large volume or high concentration production of HBV or HIV are called "production facilities." These facilities reduce many liters of plasma or culture fluid into a concentrate of a few milliliters. These concentrated preparations are used for a number of purposes including use as testing reagents and, in the past for HBV and perhaps in the future for HIV, for vaccines. In many cases, the production of concentrated virus is a byproduct of the process and not the goal, for example, in the production of HBsAg.
The provisions in paragraph (e) remain essentially unchanged as initially proposed. OSHA's expert witnesses, (Tr. 9/12/89, p.35; Tr. 9/13/89, pp. 100-101) and NIOSH (Tr. 9/14/89, p.34) strongly supported the provisions. Ms. J. Janczewski, the President of Consolidated Safety Service, Inc., who had already an opportunity to implement similar provisions in a production facility, testified that OSHA proposed standard "...is feasible, reasonable, cost-effective, and more importantly, provides these employees with a workplace free from recognized hazards" (Tr. 9/12/89 p.35). Ms. J.G. Gordon, President of Gordon Resources Consultants, Inc., testified that OSHA requirements for HIV and HBV research laboratories and production facilities "...correspond to the CDC recommendation..." (Tr. 9/13/89, pp.100-101). And Dr. B. Hardin of NIOSH testified that "OSHA is correct to require a combination of engineering and work practice control, along with personal protective equipment, to manage the risks of occupational exposure to bloodborne pathogens." (Tr. 9/14/89, p. 26). In response to a few comments received in the record, several minor changes were made in the final standard. These changes only clarify or augment the requirements in this paragraph, and do not detract from the initial intent of the proposed provisions.
Paragraph (e)(2)(i) describes the requirement for the decontamination of regulated waste. The purpose is to prevent the accidental exposure of other employees to the concentrated virus. In the final standard the methods for decontamination of regulated waste were expanded to give specific examples including incineration and autoclaving. This change and reflects comments from CDC/NIOSH's (Ex. 20-634) and the State of Connecticut (Ex. 20-796).
Paragraph (e)(2)(ii) describes special practices to be followed and paragraph (e)(2)(ii)(A) (C) and (D) serve to further limit access to the laboratory and would warn of the hazards associated with bloodborne pathogens. These paragraphs ensure that unauthorized individuals are not placed at risk, and that they do not distract or otherwise interfere with the activity of the authorized employees. This works in concert with the requirement for signs in paragraph (g)(1)(ii). This ensures that only those individuals who meet special requirements, such as training, personal protective equipment and immunization, would enter the area. The requirement in paragraph (e)(2)(ii)(B) that contaminated material removed from the work area be placed in a durable, leakproof labeled or color-coded container that is closed before being removed from the work area is to assure there are no accidental spills or other contamination that may place other employees at risk. The requirement of this paragraph closely follows the provisions outlined in the CDC-NIH Publication "Biosafety in Microbiological and Biomedical Laboratories."
The requirement in paragraph (e)(2)(ii)(E) that all activities involving potentially infectious materials be conducted in a biological safety cabinet or equivalent containment is to ensure that material containing virus will be contained and away from the worker's mucous membranes, unprotected skin, and breathing zone (in the case of aerosols).
Paragraphs (e)(2)(ii)(F) and (G) specify personal protective clothing to be worn to prevent contact of the infectious materials with the employee's skin.
The requirements for decontamination of animal wastes, paragraph (e)(2)(ii)(H) and the use of traps on vacuum lines and HEPA or other filters of equivalent or superior efficiency,in paragraph (e)(2)(ii)(I), are to prevent the spread of contamination to other work areas. In response to NIOSH's suggestion, paragraph (e)(2)(ii)(H) was modified to include incineration and autoclaving as additional means of deactivating waste before disposal (Ex. 20-634). These methods are known to destroy bloodborne pathogens. During the hearings, Mr. M. Vincent, President of Arbor Technologies, Inc., testified that HEPA filters are ineffective in humid atmosphere and suggested that vacuum lines be protected with "hydrophobic safety filters" (Tr. 10/17/89, pp. 127-134; Ex.92). Pharmaceutical Manufacturers Association citing Mr. Vincent's article also suggested the use of HEPA filters or "equivalent filtration systems" for vacuum lines (Ex. 20-729). In response to these comments, OSHA decided to supplement the HEPA filters requirement, recommended in the 1988 CDC-NIH biosafety guidelines, by allowing also the use of filters of equivalent or superior efficiency. The requirement for maintenance and replacement of filters and traps was added to paragraph (e)(2)(ii)(I) to ensure "...the efficacy of [these] engineering controls" (Ex. 20-847). OSHA considers engineering controls as the primary method of reducing exposure to toxic and harmful agents. Therefore, filters and traps should be regulatory checked, maintained, and changed if necessary to assure that the capacity of these devices to filter or trap virus has not been exhausted.
Since needlestick injury is one of the most efficient methods of accidental infection, therefore, extreme caution should be used when handling needles and syringes. Paragraph (e)(2)(ii)(J) requires that the use of needles and other sharp objects be kept to a minimum, the sharps handled carefully and disposed of in containers that prevent accidental injury. Containers of used sharps are required to be incinerated, decontaminated or autoclave before being discarded or reused.
Paragraph (e)(2)(ii)(K) requires that all spills must be immediately contained and cleaned up by appropriate professional staff or other employees properly trained and equipped to work with concentrated amounts of potentially infectious materials.
Exposure incidents must be reported (paragraph (e)(2)(ii)(L)) so that post exposure follow-up required by paragraph (f)(3) can be initiated and the circumstances surrounding the exposure incidents can be investigated.
The requirement for a biosafety manual, paragraph (e)(2)(ii)(M), ensures that any necessary additional procedures are developed to address situations that are unique to a particular facility and to provide appropriate protection to potentially exposed employees. The manual should be periodically reviewed and updated annually or more often if necessary.
Paragraph (e)(2)(iii) specifies that specific containment equipment (engineering controls) are required to minimize or eliminate exposure to the viruses. Biological safety cabinets must be certified to ensure that they will provide the proper protection. The American College of Pathologists (Ex. 20-552) and Roche Biomedical Laboratories (Ex. 20-1157) recommended that OSHA adopt the National Sanitation Foundation's (NSF) Standard #49 for certifying biological safety cabinets (BSC). The NSF Standard 49 describes design, construction, and performance criteria for Class II cabinetry. It appears that the NSF Standard 49 specifications are good guidelines for the manufacturers of the Class II BSCs. OSHA standard allows also the use of Class I and Class III BSCs.
Moreover, NSF Standard 49 is subject to the periodic review by the Foundation in order to keep their requirements consistent with new technology. OSHA agrees with this objective, however, incorporating current NSF Standard 49 specifications into the OSHA standard might impede the potential development of different but equally effective products in the future. Some the NSF Standard 49 recommendations are similar to OSHA provisions. For example, the Standard 49 states... "that each cabinet be tested and performance evaluated on site, assuring that all physical containment criteria are met at the time of installation, prior to use, and periodically therefore." NSF Standard 49 also calls for recertification of Class II cabinets at least annually, and when HEPA filters are changed, after maintenance repairs, or relocation of a cabinet. In the OSHA standard, the paragraphs (e)(2)(iii)(A) and (B) have almost identical requirements.
The Agency has decided to retain the provisions for certification as initially proposed without specific reference to the NSF Standard 49. The Agency believes cabinets that are certified by the manufacturer as Class I, II, or III will provide adequate protection to employees.
Paragraph (e)(3) contains requirements specific for HIV and HBV research facilities. This paragraph requires a facility for hand and eye washing, and an autoclave. Handwashing reduces both the likelihood of infection and the contamination of environmental surfaces, and the availability of a handwashing facility near the work area is essential. In response to NIOSH comments, OSHA also added the requirement to the final standard for suitable eye washing facility for quick flushing of the eyes accidentally exposed to the viruses or other materials (Ex 20-634). Such facility should be provided within the work area. The availability of an autoclave is required for inactivating or destroying HIV or HBV in or on a variety of media, including culture fluids, plastic ware, and equipment.
The specific requirements for HIV and HBV production facilities are found in paragraph (e)(4). Paragraph (e)(4)(i) requires that in production facilities work areas be separated from other areas by two sets of doors. This reduces the likelihood of accidental entry into the work area and means that entry into the area is a deliberate action. This further reduces the likelihood that untrained individuals will enter the work area as does the requirement that the doors be self-closing [paragraph (e)(4)(iv)].
The requirement for easy cleaning and decontamination of the work area [paragraph (e)(4)(ii)] is necessary because of the high concentration of the virus that may be present and the need to decontaminate the work area to reduce the possibility of infection.
The requirement for a handwashing sink [paragraph (e)(4)(iii)] is to allow for handwashing prior to exiting the work area and to keep environmental contamination to a minimum by requiring that the sink be foot, elbow and automatically operated. Similarly, as in paragraph (e)(3), OSHA added the requirement for suitable eye washing facility for HIV and HBV production facilities.
The requirement for an autoclave in or very near the work area [paragraph (e)(4)(v)] is necessitated because of the very high concentration of virus in these facilities. Transporting contaminated fluids, plastic ware and other equipment would result in a high potential for accidental exposure to other employees.
The requirement that production facilities have a directional airflow into the work area [paragraph (e)(4)(vi)] is to ensure air is drawn into the work area in order to maintain the containment of the facility.
Paragraph (e)(5) alerts the employees to the special, additional training requirements found in paragraph (g)(2)(ix) for employees in research laboratories and production facilities.
Paragraph (f) HBV Vaccination and Post-Exposure Follow-up
This paragraph of the standard is designed to protect employees from infection caused by bloodborne pathogens by requiring the employer to (1) make Hepatitis B vaccination available to employees to prevent HBV infection and subsequent illness and death and (2) ensure that the employee receives appropriate medical follow-up after an exposure incident. Early intervention, including testing, counseling, and appropriate prophylaxis can reduce the risk of infection, and prevent further transmission should infection occur.
Paragraph (f)(1)(i) calls for hepatitis B vaccination (defined as both the Hepatitis B vaccine and vaccination series) to be made available to all employees who have occupational exposure, and post-exposure evaluation and follow-up to be made available to all employees who have had an exposure incident. Since a single exposure may result in an infection, OSHA believes that pre-exposure Hepatitis B vaccination of all occupationally-exposed employees and post-exposure evaluation and follow-up after each exposure incident helps prevent infection, benefits the health of employees, and is both technologically and economically feasible.
Paragraph (f)(1)(ii)(A) states that the employer shall ensure that all medical evaluations and procedures, including the Hepatitis B vaccine and vaccination series and post-exposure evaluation and follow-up, including prophylaxis, are made available at no cost to the employee. Numerous testimony and comment on the proposed rule stated the necessity that Hepatitis B vaccination and post-exposure evaluation and follow-up be made available by the employer at no cost to the employee (NIOSH, Ex. 20-634; Ms. Clark of Halstead Hospital, Ex. 20-145; Ms. Ahern of Phoenix Camelback Hospital, Ex. 20-311). This is consistent with OSHA policy, as stated in the Occupational Safety and Health Act of 1970 (OSH Act) which defines the employer's duty to furnish "employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees," 29 U.S.C. 644 (a),(1). The American Nurses' Association remarked that the rule "must state that the vaccine shall be furnished to fully informed, consenting employees at no cost to them" (Tr. 9/20/89, p. 78). In addition, some commenters noted that an important factor in successful vaccination programs was providing the vaccination at no cost to the employee (Ms. Clark of Halstead Hospital, Ex. 20-145). The wording in this paragraph was changed from "provided" in the proposed rule to "made available" in the final rule to emphasize the employee's optional choice to participate in the programs. To those employees who consent to participate, the employer will provide Hepatitis B vaccination and post-exposure evaluation and follow-up at no cost to the employee.
Paragraph (f)(1)(ii)(B) requires that all evaluations and procedures, including Hepatitis B vaccine and vaccination series, post-exposure evaluation and follow-up, including prophylaxis, be made available at a reasonable time and place. In order to increase the likelihood that employees will receive the full benefits provided by the standard, evaluations must be convenient to employees. Children's Hospital of San Francisco commented that "providing the vaccine free at a convenient time and place will definitely increase compliance" (Ex. 20-545). OSHA recognizes the need for this provision and has included it in other standards [e.g., EtO, 49 FR 25798 (1984); and Asbestos, 51 FR 22737 (1986)].
Paragraph (f)(1)(ii)(C) states that all medical evaluations and procedures are required to be performed by or under the supervision of a licensed physician or by or under the supervision of another appropriately trained and licensed healthcare professional. Although other OSHA standards require medical evaluations and procedures to be accomplished by or under the supervision of a licensed physician, numerous commenters felt that other trained and licensed healthcare professionals could adequately perform or supervise the requirements of this section. The American Association of Occupational Health Nurses (AAOHN) pointed out that "expert evaluation and follow-up can be and, in fact, is now provided by registered professional nurses in occupational settings", and suggested that evaluations and procedures may be "performed by or under the supervision of a qualified occupational health professional, registered nurse, or physician" (Tr. 9/20/89, pp. 29, 31). The Guthrie Clinic Ltd. urged "that consideration be given to the involvement of other qualified healthcare professionals participating in the post-HBV exposure process" and suggested "a more liberal provision for use of trained healthcare professionals acting under the supervision of a licensed physician" (Ex. 20-1222). Other commenters stated that "physician evaluation of all exposed employees is resource-intensive; once the counseling and testing protocols have been developed, they should be administered by registered nurses with physician backup when needed", and recommended that "a provision for qualified personnel other than physicians be included in this regulation" (Mr. Polheber of Tucson Medical Center, Ex. 20-141; Mr. Hedrick of the University of Missouri Hospital and Clinics, Ex. 20-1117).
OSHA believes that those evaluations and procedures required by this section can be accomplished by or under the supervision of a physician or other healthcare professional licensed to perform or supervise others who perform the procedures specified in paragraph (f). In those states where nurse practitioners are licensed to perform or supervise the evaluations and procedures required by this section, such requirements of this standard can be accomplished by nurse practitioners. Throughout the rest of paragraph (f), the term healthcare professional refers to the physician or other licensed healthcare provider authorized to accomplish or supervise the accomplishment of the evaluations and procedures required by this section.
Paragraph (f)(1)(ii)(D) requires that evaluations and procedures be provided according to recommendations of the U. S. Public Health Service (USPHS), current at the time these evaluations and procedures take place, except as specified by this paragraph (f). The CDC, an agency of the USPHS, follows the epidemiology of bloodborne pathogens, and periodically revises and updates its guidelines and recommendations. At the time of publication of this rule, CDC is the USPHS agency responsible for issuing guidelines and making recommendations regarding infectious agents referred to in this standard as bloodborne pathogens. The proposed rule had specified that evaluations and procedures be done according to standard recommendations for medical practice. The Visiting Nurse Corporation stated that the "provision of effective post-exposure prophylaxis according to standard recommendations for medical practice is too vague" and advised OSHA to "adopt the recommendations of the U. S. Public Health Service" (Ex. 20-1268). The American Medical Association (AMA) noted that OSHA should "defer to the federal scientific agency with the most expertise" and "believes that the best strategy for reducing the risk of occupational transmission of bloodborne disease is implementation of the recommendations of the CDC for prevention of HIV transmission in healthcare settings" (Tr. 12/19/89, p. 982; Ex. 160). The American Association of Critical-Care Nurses commented that "The USPHS recommendations would provide consistency" (Ex. 20-1162).
As noted above, paragraph (f)(1)(ii)(D) specifies that the USPHS recommendations "current" at the time of the evaluation or procedure are to be followed. OSHA recognizes the dynamic nature of medical knowledge relating to bloodborne pathogens, and notes, from a retrospective compliance standpoint, that USPHS recommendations current at the time the standard is published may differ from recommendations current at the time of the evaluation. The AAOHN commented that "current CDC-USPHS recommendations that Hepatitis B vaccination and post-exposure follow-up and HIV post-exposure follow-up and HIV vaccination, should it become available, should be used as the standard of practice" (Tr. 9/20/89, pp. 32, 33). The AMA stated that "the constant new information that is added to our knowledge about HIV and the evolution of the medical response to AIDS requires periodic reassessment and revision of infection control practices. This revision is more readily achievable if the CDC guidelines are incorporated by reference than if the OSHA standard must be modified through the administrative process" (Tr. 12/19/89, p. 982; Ex. 160).
OSHA thus defers specific details of medical practice to the USPHS recommendations, except as specified by paragraph (f). The exception implies that the standard, in certain areas such as employer responsibility and requiring a healthcare professional's written opinion, has set some more specific procedures and requirements than the USPHS recommendations.
Paragraph (f)(1)(iii) requires that all laboratory tests be performed by an accredited laboratory at no cost to the employee. Accreditation by a national accrediting body or its state equivalent means that the laboratory has participated in a recognized quality assurance program. This accreditation process is required to ensure a measure of quality control so that employees receive accurate information concerning their laboratory tests and tends to assure long-term stability and consistency among laboratory test procedures and interpretations of results. OSHA recognizes the need for this requirement and has included it in other standards [e.g., Benzene, 52 FR 34565 (1987)].
(2) Hepatitis B Vaccination
Paragraph (f)(2)(i) requires that Hepatitis B vaccination be made available after the employee has received the training required in paragraph (g)(2)(vii)(I) and within 10 working days of initial assignment to all employees who have occupational exposure. It is the goal of this standard to minimize or eliminate significant risk using vaccination, engineering and work practice controls and personal protective equipment. Because equipment may fail or be defective, employees may be fatigued or distracted by other demands resulting in an exposure incident, or the employee may have unsuspected cuts or dermatitis, infection may follow exposure. OSHA believes that the risk of infection is sufficient to require that the employer make Hepatitis B vaccination available to all employees who have occupational exposure. The information in paragraph (g)(2)(vii)(I) includes the efficacy and safety of the vaccine and benefits of being vaccinated. Therefore, OSHA concludes that it is necessary that such training be accomplished before the employee makes a decision regarding acceptance of the hepatitis B vaccine. Hepatitis B vaccination, defined in this section as both the hepatitis B vaccine and vaccination series, per requirements of section (f)(1)(ii), will be; A) made available at no cost to the employee, B) made available at a reasonable time and place, C) performed by or under the supervision of a licensed physician or another appropriately trained and licensed healthcare professional, and D) provided according to USPHS recommendations current at the time of evaluation.
Hepatitis B vaccination has been recommended by CDC and NIOSH (Exs. 286G; 20-634). The American Dental Association (ADA) has recommended that all dental healthcare workers with possible exposure to blood or direct patient contact obtain Hepatitis B vaccination, and the American College of Obstetricians and Gynecologists has recommended that healthcare workers be vaccinated against HBV (Exs. 11-43; 11-158). The American Association of Critical-Care Nurses (AACN) has endorsed provision of Hepatitis B vaccination by the employer, and the AHA supports "employer-sponsored vaccination of employees for hepatitis B" (Exs. 11-117; 302). The American Nurses' Association (ANA) has recommended that Hepatitis B vaccination be offered at no cost to employees, and SEIU "strongly supports provision of hepatitis B vaccine free of charge to all employees at risk who want to be vaccinated, not just direct patient care workers (Exs. 11-43; 299). AFSCME also "strongly supports OSHA's proposal to vaccinate at-risk employees at management's expense" and stated "for our members who barely earn more than minimum wage, the cost of the vaccine represents a week's wages. Therefore, employees will often refuse the vaccine if they are expected to bear the cost" (Ex. 297).
Extensive testimony and comment emphasized the importance of occupational HBV infection and prevention contrasted to the much higher publicized yet lower risk of occupationally acquired HIV infection. Many commenters noted statistics similar to the CDC estimates of annual HBV infection of 8,700 healthcare workers with occupational exposure, with 2,175 clinical illnesses, 435 hospitalizations, and approximately 194 deaths each year (Exs. 298; 6-392). Groups as diverse as the AMA, who stated "the loss of healthcare workers to hepatitis B virus infection overshadows the risk of AIDS and is almost entirely preventible", to ACTUP who "encourages OSHA to continue to educate workers of their excessive risk of contracting hepatitis B as opposed to their extremely small risk of contracting HIV or AIDS through work place exposure" concur that occupationally acquired Hepatitis B infection affects a far greater number of workers than does occupationally-acquired HIV infection (Tr. 12/19/89, p. 982; Ex. 160; Tr. 11/16/89, p. 767).
OSHA considered whether to require mandatory vaccination of employees, rather than requiring employers to make the vaccine available after providing information about its benefits. This issue was specifically raised and preliminarily addressed in Question 40 of the proposal (54 FR 23045). In that particular question, OSHA stated that although mandatory medical surveillance had never been the Agency's approach, the concept had been explored and rejected in the Lead Standard (43 FR 54450). In the preamble to that standard, the Agency considered such an approach and then abandoned it, concluding that mandating worker participation in such a sensitive area would present an array of religious and privacy concerns. OSHA stated in specific that:
...Attempting to compel workers to subject themselves to detailed medical examinations presents the possibility of clashes with legitimate privacy and religious concerns. Health in general is an intensely personal matter. (54 FR 23045).
As in the lead standard, OSHA's aim in the proposed standard was to encourage rather than to coerce employee cooperation in the vaccination program for Hepatitis B. However, the Agency solicited comments with respect to this question.
A voluntary vaccination program for employees was supported by numerous witnesses and commenters. NIOSH/CDC stated emphatically that a vaccination program should be voluntary for all eligible employees because of the invasive nature of such a procedure. NIOSH/CDC went on to say that a mandatory vaccination program would be inappropriate and objectionable to some persons on religious grounds and that any person who declines vaccination should do so only with full knowledge of the risks of disease, disability, and death that are thereby incurred. "Workers who decline vaccination should also understand that they can reverse that decision at any time and participate in the immunization program at no cost to themselves." (Ex. 20-634).
NIOSH/CDC also commented on the efficacy of the vaccine: Vaccination is the single most effective means of preventing occupational hepatitis B virus (HBV) transmission. However, approximately 5% of individuals given vaccination do not develop an antibody response to the vaccine and remain susceptible to HBV. Even if 100% of workers received the vaccination, this group of nonresponders alone would constitute a large enough group to justify enforcement of mandatory universal precautions (Ex. 29).
Donna Richardson, RN. JD., representing the American Nurses Association, the largest professional organization of registered nurses, stated:
...We wholeheartedly endorse OSHA's requirement that employers provide hepatitis B vaccine to employees. However, we believe OSHA needs to be much more explicit in its mandate. It must state that the vaccine shall be furnished to fully informed, consenting employees at no cost to them. Reports indicate that employees who are thoroughly educated about the vaccine accept it more readily. (Tr. 9/20/89, p.78) (emphasis added).
The Association of Operating Room Nurses also supported a voluntary hepatitis B vaccination program that included informed consent and to further strengthen the program, a requirement that healthcare workers who decline the vaccine do so in writing. (Tr. 9/20/89, p.89). Another commenter who shared the view of a voluntary vaccination program was the Service Employees International Union. It stated that:
Privacy and religious concerns make forced vaccination both illegal and unfair. OSHA should follow its longstanding practice of not forcing invasive medical procedures on workers and should not mandate the hepatitis B vaccine. Of course, as OSHA has recognized in the standard, workers who initially refuse the vaccine but later change their minds should be given the vaccine at a later date. (Ex. 299).
- T. E. Kobrick of the Bethlehem Steel Corporation, stated:
HBV vaccination (or any other vaccination or medical surveillance requirement) should never be made mandatory, as such action would violate legal, medical, and ethical standards and be impossible to enforce. In this matter, OSHA should be consistent with its position in previous standards, which is that employers will "make available" to the employee protective measures, including vaccination. (Ex. 20-110) (emphasis in original).
Along the same line, The Food and Allied Services Trades set forth the following:
We feel that the voluntary approach is the right one to take. Requiring that employees be vaccinated undoubtedly impedes several constitutional protections. Vaccination procedures are inherently intrusive and may be accompanied by civil libertarian and religious concerns associated with requiring any medical procedure.... The best way to minimize the deterrence to vaccination is not to force employees to accept the vaccination, but to encourage education programs, at employer expense, that are designed to allay worker fears and to describe the benefits of the procedure. The ultimate choice concerning vaccination should rest with the individual. (Ex. 20-888) (emphasis in original).
Other interested participants in the rulemaking urged OSHA to keep the vaccination program a voluntary one for any exposed employees (e.g., AFSCME, Ex. 20-985; ServiceMaster Company, Ex. 20-21; Retail, Wholesale and Department Store Union:AFL-CIO, L20-1505; Lutheran General Hospital, Ex. 20-655; Mr. Koch et. al., Sharp Memorial Hospital, Ex. 20-660; The American Board of Orthodontists, Tr. 11/14/89, p. 502; The Florida Nurses Association, Tr. 12/21/89, p. 1395; Ms. Mary Quinn, Tr. 9/18/89, p. 74; The American Nurses Association, Tr. 9/20/89, p. 89).
Few commenters stated that the vaccine should be mandatory for all or some healthcare workers (The American Association of Orthodontists, Tr. 9/22/89, p. 50; Dr. Eugene Blair, Orthodontist, Tr. 10/19/89, p. 582). The American Dental Association considered the issue and specifically stated:
We do not believe that this should be voluntary but rather that it should be a prerequisite for entry into the dental field. The only acceptable reason for not being vaccinated would be a medical condition(s) contraindicating its use. (Ex. 20-665).
The ADA also commented that they did not believe "that the employer should have to pay for the cost of the vaccine for his employees..." (Ex. 20-665).
After reviewing the record, and considering all the above comments OSHA concludes that a voluntary vaccination program is the best approach to foster greater employee cooperation and trust in the system. While the Agency may have the legal authority to require vaccinations as part of the standard, it recognizes that voluntary participation by employees enhances compliance while respecting individuals' beliefs and rights to privacy. Accordingly, OSHA has chosen to require employers to offer Hepatitis B vaccination, but to make participation in the program voluntary.
Many commenters disagreed with the proposed rule's stipulation that Hepatitis B vaccination be based on an average monthly exposure. NIOSH stated that "HBV immunization should be offered to all workers whose jobs involve participation in tasks or activities with exposure to blood or other body fluids in which universal precautions apply. A time-dependent criterion, such as once per month exposure as proposed, invites disputes over actual frequency of exposure" (Tr. 9/14/89, p. 32). AFSCME felt "this arbitrary cut-off would allow too many workers to fall through the cracks" (Ex. 297). The National Association of Children's Hospitals and Related Institutions, Inc., commented that "HBV vaccination might be offered to all hospital employees with the potential for exposure, without linking it to a number of projected exposures" (Ex. 20-1003). The National Foundation for Infectious Diseases agreed that the employer should "make available Hepatitis B vaccine to all employees who have occupational exposure" and that the once per month criterion should be omitted (Tr. 12/19/89, p. 929). Local 1199, the Drug, Hospital and Health Care Employees Union, stated that the "vaccine should be offered to all employees who risk occupational exposure to blood and body fluids, not just those exposed once a month or more" and SEIU stated that the rule should "require free hepatitis B vaccination for all workers with potential exposure, not just workers with monthly exposure" (Tr. 11/14/89, p. 378; Ex. 299). In concurrence with these comments, the final rule deletes references to specific numbers of exposures and requires that Hepatitis B vaccination be made available to all employees who have occupational exposure.
The issue of non-standard routes of Hepatitis B vaccination administration was discussed by some commenters. AFSCME stated that "any non-standard administration of the vaccine to employees should be prohibited by OSHA" (Ex. 297). In their comments, CDC/NIOSH restated the current guidelines that recommend that the vaccine be administered in the deltoid muscle at the specified doses and schedule (Ex. 298). CDC guidelines dated February 9, 1990 state:
The immunogenicity of a series of three low doses (.1 standard dose) of plasma-derived hepatitis B vaccine administered by the intradermal route has been assessed in several studies. The largest studies of adults show lower rates of developing adequate antibody (80%-90%) and twofold to fourfold lower antibody titers than with intramuscular vaccination with recommended doses. Data on immunogenicity of low doses of recombinant vaccines given intradermally are limited. At this time, intradermal vaccination of adults using low doses of vaccine should be done only under research protocol, with appropriate informed consent and with postvaccination testing to identify persons with inadequate response who would be eligible for revaccination. Intradermal vaccination is not recommended for infants or children (Ex. 286G, MMWR. 1990;39[No. RR-2]:12).
Thus the above USPHS guidelines, which are current at the time of publication of this standard, state that the intradermal inoculation of 0.1 of the normal dose of the Hepatitis B vaccine can be done only as a research protocol with informed consent and postvaccination testing. Employees therefore cannot be compelled to participate in a low dose intradermal program in order to receive the vaccine, and OSHA requires employers to make available Hepatitis B vaccination through the standard routes of administration as recommended in USPHS guidelines.
The second part of paragraph (f)(2)(i) indicates that Hepatitis B vaccination need not be made available to employees who have previously received the complete Hepatitis B vaccination series, who have antibody testing revealing immunity, or who have medical contraindications for the vaccine. Decisions on postvaccination testing are to be made in accordance with CDC guidelines current at the time of evaluation. Current CDC guidelines, at the time of this rule publication, do not routinely recommend testing for Hepatitis B immunity after vaccination, but do consider postvaccination testing for persons at occupational risk who may have needle-stick exposures necessitating post-exposure prophylaxis (Ex. 286G).
Paragraph (f)(2)(ii) states that the employer shall not make participation in a prescreening program a prerequisite for receiving Hepatitis B vaccination. OSHA had proposed that Hepatitis B prescreening, that is, prescreening of an individual's antibody status to determine whether there had been previous exposure to either the hepatitis vaccine or virus, be made available to an employee who desired such testing prior to deciding whether to receive Hepatitis B vaccination. Dr. Klees, of the Albert Einstein Medical Center, stated that "mandating prescreening prior to vaccination, allowing employee choice, is admirable" (Ex. 20-838). However, most commenters felt that there should be no requirement for such prescreening programs. The Greater Omaha Area Association for Practitioners in Infection Control stated that "the need for HBV antibody testing, if requested by the employee (prior to Hepatitis B vaccination), is questionable. This could be very costly with no efficacy to support it" (Ex. 20-943). The American Association of Dental Schools suggested "that OSHA eliminate this proposed requirement. This would not prevent employers from offering this service as they see fit" (Ex. 20-876). Stanford University Hospital stated that "offering HBV antibody testing on a routine basis to employees prior to receiving the vaccine is costly. It may be advantageous to offer the antibody testing to employees with a history of hepatitis or from high risk groups as defined by Centers for Disease Control" (Ex. 20-984). The final rule contains no requirement for Hepatitis B vaccination prescreening. However, OSHA acknowledges the merit of many of the comments concerning the possible usefulness of a pre-screening program in certain situations and will not prohibit employers from offering pre-screening programs if they so desire.
CDC has stated that prevaccination screening is usually only cost-effective if both the cost of the vaccine and the Hepatitis B immune prevalence is high (Ex. 286G). If an employer feels that employee prescreening is cost-effective, prevaccination testing may be made available to employees, on a voluntary basis, at no cost to the employee. However, the prescreening program shall not be a prerequisite for receiving Hepatitis B vaccination, so that an employee has the option to decline prevaccination testing and yet accept Hepatitis B vaccination. This provision is also consistent with OSHA's desire to encourage a high percentage of voluntary employee vaccination by making the vaccination process as simple as is medically possible.
The prescreening program in section (f)(2)(ii) is not a screen for medical indications or contraindications to receiving the Hepatitis B vaccine. A determination by a healthcare professional regarding indications and contraindications before receiving Hepatitis B vaccination is an absolute prerequisite for Hepatitis B vaccination, and a healthcare professional's written opinion on indications and contraindications for Hepatitis B vaccination is required per section (f)(5)(i).
Paragraph (f)(2)(iii) requires an employer to make the Hepatitis B vaccination available to an employee who initially declines vaccination, but later decides to accept the vaccination. In this case, the vaccination is still provided by the employer at no cost to the employee and according to the other conditions of paragraph (f)(1)(ii). This provision assures that employees who are initially reluctant to accept vaccination but who later change their minds as the result of information or experience are accorded the opportunity to receive vaccination. The signing of a waiver by the employee does not relieve the employer of the requirement to provide Hepatitis B vaccination at a later date and at no cost if the employee requests vaccination. This is consistent with OSHA's goal of encouraging employees to be vaccinated.
Paragraph (f)(2)(iv) states that the employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the statement in Appendix A. The statement is as follows:
I understand that due to my occupational exposure to blood or other potentially infectious materials I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me.
The purpose of requiring employees to sign a declination is to encourage greater participation in the vaccination program by reiterating that an employee declining the hepatitis B vaccination remains at risk of acquiring hepatitis B. To augment employee understanding of the declination they are signing, OSHA requires per paragraph (f)(2)(i) that employees receive the training specified in paragraph (g)(2)(vii)(I) before being offered the hepatitis B vaccine. The employer will benefit from signed declinations by being able to easily determine who is not vaccinated so that resources can be directed toward improving the acceptance rate of the vaccination program. Moreover, having signed declinations should enable compliance officers to more easily enforce the standard requirements regarding training and vaccination. Such written declination of the hepatitis B vaccine has been recommended by the Association of Operating Room Nurses and the American Nurses' Association, who stated, "If health care workers decline the vaccine, it should be in writing" (Tr. 9/20/89, p.89).
In accordance with Section 4(b)(4) of the OSH Act, the statement of declination of hepatitis B vaccination is not intended to supersede or in any manner affect any workmen's compensation law or to enlarge or diminish or affect in any other manner the common law or statutory rights, duties, or liabilities of employers and employees under any law with respect to injuries, diseases, or death of employees arising out of, or in the course of, employment.
Future hepatitis B vaccination routine booster doses are discussed in paragraph (f)(2)(v) and shall be made available if recommended by USPHS at a future date. Since the plasma-derived Hepatitis B vaccine has been available in the U. S. only since 1982, with recombinant DNA Hepatitis B vaccines licensed in 1986, future follow-up of vaccinees may demonstrate that Hepatitis B antibody levels fall to a level at which they are no longer protective. If a routine booster dose or doses is recommended in the future to help elevate Hepatitis B antibody levels, it shall be provided per the requirements of paragraph (f)(1)(ii). USPHS recommendations current at publication of this rule state "that up to 50% of adult vaccinees who respond adequately to vaccine may have low or undetectable antibody levels by 7 years after vaccination", "for adults and children with normal immune status, booster doses are not routinely recommended within 7 years after vaccination", and that "the possible need for booster doses after longer intervals will be assessed as additional information becomes available" (Ex. 286G). If future USPHS recommendations advise routine prophylactic Hepatitis B vaccination booster doses in previously vaccinated employees who, after time, have low or undetectable antibody levels, the employer will be responsible for providing those booster doses. In accordance with the February 9, 1990, USPHS guidelines, for exposure incidents where the previously vaccinated employee's post-exposure evaluation shows no detectable Hepatitis B antibodies and the source individual is found to be infected with Hepatitis B, a Hepatitis B vaccine booster dose is recommended (Ex. 286G). Responsibility for the latter case of booster dose revaccination is delegated to the employer under the post-exposure prophylaxis reference in (f)(3)(iv).
(3) Post-Exposure Evaluation and Follow-up
Paragraph (f)(3) states that the employer, following a report of an exposure incident, shall make immediately available to the exposed employee a confidential medical evaluation and follow-up. Per paragraph (f)(1)(ii), post-exposure evaluation and follow-up will be; A) made available at no cost to the employee, B) made available at a reasonable time and place, C) performed by or under the supervision of a licensed physician or another appropriately trained and licensed healthcare professional, and D) provided according to USPHS recommendations current at the time of evaluation. Post-exposure medical evaluations have been recommended by NIH/CDC, NIOSH, the National Committee for Clinical Laboratory Standards (NCCLS), the American Hospital Association (AHA), AAOHN, and AFSCME. The American Dental Association (ADA) has stated in their ANPR comment that CDC guidelines should be followed (Exs. 11-187; 11-159; 6-75; 6-153; 11-358; 11-157; 11-43).
The adverb "immediately" is used in this paragraph to re-emphasize the importance of prompt medical evaluation and prophylaxis. Some post-exposure Hepatitis B prophylactic measures should be given as soon as possible after exposure as their value beyond seven days after exposure is unclear, and HIV prophylaxis, if recommended in the future, may need to be accomplished within the first few hours after an incident (Ex. 286G, MMWR. 1990; 39[No. RR-2]:19). Timeliness is therefore an important factor in effective medical prophylaxis and treatment of bloodborne pathogens.
The word "confidential" is included in this paragraph as numerous commenters discussed the importance of confidentiality during post-exposure evaluation and follow-up. AFSCME stated that "it is very important to protect confidentiality, because it is important to encourage workers to report all exposure incidents." The American Association of Forensic Dentists noted that records of "treatment have a high probability of not being kept confidential because of access by non-medical office personnel", and the ADA commented that "the fear of breaching confidentiality in the dental office will be a real disincentive to the reporting of exposure incidents" (Exs. 20-985; 20-109; 20-655). The American Psychiatric Association (APA) stated that they view "the maintenance of strict confidentiality as the cornerstone to viable procedures for workplace exposures", that employees should be told of "the exact limits of confidentiality", and that "it is critical that employees have some guarantee that confidentiality limits cannot be changed at a later date" (Tr. 1/9/90, p. 24). The ANA stated that "reporting procedures must be convenient and afford privacy and confidentiality so that employees are not discouraged from reporting such exposures" and Local 1199 commented that "protection of anonymity would encourage employees to seek testing" (Trs. 9/20/89, pp. 78, 79; 11/14/89, p. 37). OSHA believes that all medical evaluations and follow-up, including the maintenance of required medical records, must be done in a manner that protects the confidentiality of the employee's identity and test results.
As a minimum, paragraph (f)(3) requires a post-exposure evaluation and follow-up to include the following elements: i) Documentation of the route(s) of exposure, and the circumstances under which an exposure incident occurred; ii) Identification and documentation of the source individual; iii) Collection and testing of blood for HBV and HIV serological status; iv) Post-exposure prophylaxis when medically indicated, as recommended by USPHS; v) Counseling; and vi) Evaluation of reported illnesses.
Paragraph (f)(3)(i) requires the route(s) of exposure and the circumstances under which an exposure incident occurred to be documented. This documentation allows the employer to receive feedback regarding the circumstances of employee exposures, and the information collected can then be used to focus efforts on decreasing or eliminating specific circumstances or routes of exposures (e.g., exposure incident documentation may show that protective equipment is not being used because it is uncomfortable and the employer could then provide protective equipment that is more acceptable to and more likely to be used by employees, or training efforts could be increased on certain procedures which seem to be associated with exposure incidents). Both NIH/CDC and NCCLS recommended that institutions develop and maintain post-exposure documentation (Exs. 11-159; 6-312). Such determination and documentation of exposure incidents and circumstances has also been recommended by the American Blood Resources Association (ABRA) (Ex. 11-71), among others.
Identification and documentation of the source individual involved in an exposure incident is required by paragraph (f)(3)(ii), unless the employer can establish that identification is infeasible or prohibited by state or local law. Incidents involving unmarked sharps, or blood samples which may not have been properly labeled may make identification and documentation of the source individual infeasible or even impossible. It is the responsibility of the employer to establish the identification of the source individual or that such identification is infeasible or prohibited by state or local law.
Paragraph (f)(3)(ii)(A) states that the source individual's blood shall be tested as soon as feasible and after consent is obtained in order to determine HBV and HIV infectivity. Testing for a source individual's infectious status provides exposed employees with information that will assist them in decisions regarding testing of their own blood, complying with other elements of post-exposure management, and using precautions to prevent transmission to their sexual partners or, in the case of pregnancy, to their fetuses. In addition, such testing assists the healthcare professional in deciding on appropriate follow-up. The American Red Cross has recommended that "every attempt must be made to evaluate the infectivity of the implicated material by appropriate serologic testing" (Ex. 11-280). The Service Employees International Union (SEIU) stated that it is the right of workers to know the HBV and HIV status of individuals if exposed to their blood or body fluids (Ex. 11-161).
The statement that the source individual's blood will be tested "as soon as feasible" is used instead of "as soon as possible", which connotes extreme immediacy in medical environments. While OSHA does not expect life-threatening procedures to be stopped or delayed in order to obtain testing of a source individual, to be effective the tests must be done in a timely fashion and, therefore, testing "as soon as feasible" is required. The need to obtain the consent of the source individual prior to testing has been recognized. Numerous organizations and associations, including CDC, NIOSH, AAOHN, NCCLS, and AHA support testing of source individuals only after obtaining consent of such individuals (Exs. 6-153; 11-187, 11-358; 11-159; 6-75). Many commenters concurred with the proposed rule's requirement for obtaining the source individual's consent. Dr. McBeath of the American Public Health Association "supports OSHA's position in obtaining the patient's consent before collection and testing of source patient's blood" (Ex. 20-1248). NIOSH stated that "any testing program must have effective provisions to address the necessity of informed consent and confidentiality" (Ex. 11-187). Consistent with the opinion expressed by the CDC and the majority of commenters, OSHA believes that testing of source individuals following an employee exposure incident should be accomplished after consent is obtained from the source individual.
It is to be expected that some individuals will not consent to testing, and OSHA does not expect the employer to test source individuals against their wishes. OSHA recognizes that it is the employer's responsibility to arrange for testing of the source individual, and that employers must make good faith efforts to both identify and obtain consent from the source individual. Paragraph (f)(3)(ii)(A) further states that if consent is not obtained from the source individual, the employer shall establish that legally required consent cannot be obtained. In those states where the source individual's consent is not required by law, the source individual's blood, if available, shall be tested and the results documented. The condition, "if available", applies to blood samples that have been drawn from source individuals for other testing, and OSHA does not expect post-exposure re-drawing of the source individual's blood specifically for HBV and HIV infectivity testing to be performed without obtaining the source individual's consent.
Paragraph (f)(3)(ii)(B) states that when the source individual is already known to be infected with HBV or HIV, testing for the source individual's known infectious status need not be repeated. If, for example, the source individual is known by previous or current medical evaluations to already be infected with HIV, and is therefore considered to be infectious, there is no need to repeat testing for HIV infectiousness. OSHA acknowledges that there are various routinely accepted antibody and antigen tests for HBV, and antibody tests for HIV, with the possibility of routinely accepted HIV antigen tests being available in the future. The specific requirements for source individual testing shall be determined by the employee's healthcare professional, in accordance with USPHS guidelines. If the employee's healthcare professional determines that adequate medical information about the source individual's infectious status is already known, testing for the source individual's known infectious status need not be repeated.
The first half of paragraph (f)(3)(ii)(C) states that results of the source individual's testing shall be made available to the exposed employee. Although the healthcare professional acts as an agent of the employer, the employer does not have a right to know the results of source individual or exposed employee testing. Paragraph (f)(3) states that the employer shall make available to the exposed employee a confidential medical evaluation and [reference paragraph (f)(3)(ii)(C)] results of the source individual's testing shall be made available to the exposed employee. This paragraph does not give the employer authority to be informed of the results of source individual's or exposed employee's testing. OSHA realizes that the boundaries of employer and healthcare professional may be blurred in a medical setting where, for example, a physician is both the employer and evaluating healthcare professional, and that issues of consent and confidentiality are extremely important in encouraging employee participation in post-exposure incident evaluations.
The second half of paragraph (f)(3)(ii)(C) states that exposed employees shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual. Dr. Kantor of San Francisco General Hospital commented that "the standard should recommend a procedure to protect the confidentiality" of the source patient's HIV status, and that "this group of sero-positive people have regularly suffered negative consequences as a result of lack of privacy of this information" (Ex. 20-1029). Dr. Woodard agreed that the source individual "has the right to expect that the results of the test shall remain confidential" (Ex. 20-909). OSHA concurs with this concern related to medical information, but defers guidance to applicable state and federal laws and regulations that specifically cover medical privacy and confidentiality.
Paragraph (f)(3)(iii) states that it is the employer's responsibility, following an exposure incident, to make available to an exposed employee collection and testing of blood for HBV and HIV serological status. Blood from an exposed employee is to be collected as soon as feasible after the exposure incident and tested after consent is obtained for determination of HBV and HIV status. By offering serological testing after an exposure incident, the employer assures that the employee has the opportunity to have baseline testing which can be compared to future test results in order to determine if an infection resulted from an occupational exposure. The offering to exposed employees of voluntary blood collection and testing has been recommended by NIOSH, the Hospital Association of Greater Des Moines, AAOHN, NCCLS, ABRA, and SEIU (Exs. 11-187; 11-23; 11-358; 11-159; 11-71; 11-161). Since post-exposure testing and prophylaxis is a rapidly changing and developing field, it must be, per paragraph (f)(1)(ii)(D), provided according to recommendations of the U. S. Public Health Service current at the time post-exposure testing and prophylaxis take place.
Paragraph (f)(3)(iii)(A) states that the exposed employee's blood shall be collected as soon as feasible and after consent is obtained and tested for HBV and HIV serological status as soon as feasible and after consent is obtained. As with consent and source individual testing, commenters also felt consent was necessary before testing the exposed employee. The APA stated that "testing should require the informed consent of the employee. Informed consent should include at least the following information: (1) the nature of the test to be performed, (2) the benefits and risks of testing, (3) alternatives including the benefits and risks of such alternatives and, (4) the exact limits of confidentiality" (Tr. 1/9/90, pp. 22, 23).
Paragraph (f)(3)(iii)(B) states that if an exposed employee consents to baseline blood collection after an exposure incident, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. In some cases, baseline HBV testing may be indicated and drawn without problem, but the exposed employee, secondary to concerns about confidentiality, employment, prejudice, or lack of medical information, may worry about consenting to baseline HIV testing. If, possibly after counseling, education, or further discussion, and within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing will be done as soon as feasible. Mr. Schmidt, of the Service Master Company, commented that "permitting the employee the option of having blood tested at a later date should increase the likelihood that they will be willing to participate in the post-exposure follow-up program. By giving the employee additional time, if desired, to make a decision, there is an opportunity for the employee to receive counseling and information with which to make an informed decision" (Ex. 20-21). OSHA believes that it is of great importance for employees to have the opportunity to obtain knowledge about baseline serologic testing after exposure incidents, and that this provision of opportunity for future testing rather than a demand for an immediate decision by the employee will encourage employees to consent to blood collection at the time of exposure.
The proposed rule indicated that actual blood testing could be done at a later date, but set no time limits on blood storage. The American Red Cross has recommended in an ANPR comment that employee blood samples be held until the employee requests testing and that samples not tested be held for at least 5 years (Ex. 11-280). Many commenters believed that an unlimited time period for blood storage would burden their institutions. The Gettysburg Hospital commented that "the collection and holding of an employee blood sample for an unstated period of time poses a very real storage problem for most hospitals" and the Association for Practitioners in Infection Control-Virginia stated that "an unspecified time for holding blood sample from exposed employees is logistically difficult from both space-keeping and record-keeping perspectives" (Exs. 20-182; 20-750). The University of Virginia Health Sciences Center commented that "because of space limitations", employee blood samples should "be held for one month" (Ex. 20-977). CDC has stated, "The worker should be advised to report and seek medical evaluation for any acute febrile illness that occurs within 12 weeks after the exposure. Such an illness, particularly one characterized by fever, rash, or lymphadenopathy, may be indicative of recent HIV infection." CDC has further stated that the first 6-12 weeks are "when most infected persons are expected to seroconvert" (Ex. 15, MMWR 1989; 38[No. S-6]:13). The final rule sets a minimum time limitation of 90 days for holding untested baseline blood samples, which includes this 12 week post-exposure period when an acute retroviral illness may develop and affords the employee the opportunity to know immediate post-exposure HIV status even if consent for HIV testing was initially withheld.
Paragraph (f)(3)(iv) states that it is the employer's responsibility, following an exposure incident, to make immediately available to the exposed employee post-exposure prophylaxis, when medically indicated, as recommended by the USPHS. Post-exposure prophylaxis has been recommended by CDC and NIOSH, and a number of other organizations have concurred with CDC recommendations (Exs. 6-153; 20-634; 11-280; 11-358; 11-161; 6-75; 11-71; 11-163; 11-159; 11-157). Since post-exposure prophylactic measures must often be accomplished quickly to increase effectiveness, it is imperative that such measures be accomplished as soon as possible.
Paragraph (f)(3)(v) stipulates that the employer, following an exposure incident, shall make counseling immediately available to the exposed employee. OSHA believes that counseling of exposed employees is a vital component of post-exposure follow-up procedures and that counseling concerning infection status, including results of and interpretation of all tests, will assist the employee in understanding the potential risk of infection and in making decisions regarding the protection of personal contacts. Post-exposure counseling has been recommended by CDC, NIOSH, and other organizations such as ARC, AAOHN, SEIU, AHA, ABRA, AMA, NCCLS, and AFSCME have either directly recommended post-exposure counseling or concurred with CDC recommendations (Exs. 6-153; 20-634; 11-280; 11-358; 11-161; 6-75; 11-71; 11-163; 11-159; 11-157). The APA stated that counseling should "be performed by adequately trained professionals, including psychiatrists" and that "psychiatric follow-up should be made available" (Ex. 20-65).
Paragraph (f)(3)(vi) requires the employer, following an exposure incident, to make available evaluation of reported illnesses. This provision assures that exposed employees will have the benefit of early medical evaluation of such illnesses and can accept in a timely manner any currently recommended treatment and prophylaxis. Illness reporting provisions have been recommended by CDC and ABRA, and other organizations including NIH, AMA, AAOHN, and NCCLS support these CDC recommendations (Ex. 6-153; 11-71; 6-312; 11-163; 11-358; 11-159).
(4) Information Provided to the Healthcare Professional
OSHA believes it is the employer's responsibility to ensure that the healthcare professional responsible for the employee's Hepatitis B vaccination and post-exposure follow-up is informed of the requirements of this standard. This will help assure that the healthcare professional implements the requirements. This provision is included in other OSHA standards [e.g., Benzene, 52 FR 34566, (1987)]. Therefore, paragraph (4)(i) requires the employer to ensure that the healthcare professional responsible for the employee's Hepatitis B vaccination is provided a copy of this regulation.
Paragraph (4)(ii) requires the employer to ensure that the healthcare professional evaluating an employee after an exposure incident is provided; A) a copy of this regulation, B) a description of the exposed employee's duties as they relate to the exposure incident, C) documentation of the route or routes of exposure and circumstances under which the exposure occurred, D) results of the source individual's blood testing, and E) all medical records relevant to the appropriate treatment of the employee, including vaccination status, which are the employer's responsibility to maintain. The purpose of providing this information is to inform the healthcare professional of the requirements of this standard. This information, which represents the minimum necessary for proper followup care, enables the healthcare professional to understand the employee's duties, the circumstances of the exposure incident, the source individual's infectious status, the employee's Hepatitis B vaccination status and other employee medical information. The information provided to the healthcare professional is essential to followup evaluation, so that a determination can be made regarding whether prophylaxis or medical treatment is indicated. The information required in paragraph (f)(4)(ii)(A-C and E) must be provided for each exposure incident. The information required in paragraph (f)(4)(ii)(D), results of the source individual's blood testing, must be provided, obviously, only if it is available. The employer does not have a specific right to know the actual results of the source individual's blood testing, but the employer is responsible for ensuring that the evaluating healthcare professional is provided the results of the testing.
(5) Healthcare Professional's Written Opinion
Paragraph (f)(5) has been changed from "Physician's Written Opinion" in the proposed rule to "Healthcare Professional's Written Opinion" in the final rule in accordance with the change discussed in this summary and explanation under paragraph (f)(1)(ii)(C) relating to the requirement for medical evaluations to be performed by or under the supervision of a licensed physician or another appropriately trained and licensed healthcare professional.
Paragraph (f)(5) states that the employer shall obtain and provide the employee with a copy of the evaluating healthcare professional's written opinion within 15 days of the completion of the evaluation. The employer does have a right to know the information contained in the written opinion and may retain the original written opinion, but must provide the employee with a copy. The 15 day provision assures that the employee is informed in a timely manner regarding information received by the employer and is consistent with other OSHA standards [e.g., Formaldehyde, 52 FR 46295, (1987); and Benzene, 52 FR 34566, (1987)].
The purpose of requiring the employer to obtain a written opinion from the evaluating healthcare professional is (1) to ensure that the employer is provided with documentation that a medical assessment of the employee's ability and indication to receive Hepatitis B vaccination was completed; and (2) to inform the employer regarding the employee's Hepatitis B vaccination status. For post-exposure evaluations, the purpose of requiring a written opinion is to ensure that the employer is provided with documentation that a post-exposure evaluation has been performed, and that the exposed employee has been informed of the results. Some commenters noted that requiring a physician's written opinion "will create a paper work burden for employee health physicians", and that a "written evaluation could prove to be very time consuming" (Ms. Salisbury of Akron General Medical Center, Ex. 20-81; Ms. Borton of Albert Einstein Medical Center, Ex. 20-945). However, OSHA believes that it is important for employers to know if their employees have had evaluations for Hepatitis B vaccination or exposure incidents, and that healthcare professionals, acting as agents for the employer, should provide the employer with written documentation that these evaluations have occurred. This provision requiring a written opinion after a medical evaluation has been included in other OSHA standards [e.g., Occupational Exposures to Hazardous Chemicals in Laboratories, 55 FR 3330, (1990); and Formaldehyde, 52 FR 46295, (1987)].
Paragraph (f)(5)(i) states that the healthcare professional's written opinion for Hepatitis B vaccination shall be limited to whether Hepatitis B vaccination is indicated, and if the employee has received such vaccination. The purpose of limiting the information the employer receives is to encourage employees to participate in the medical evaluation by removing concern that the employer will obtain information about their physical condition and specific medical findings or diagnoses. The American Public Health Association stated that "the worker's right to confidentiality is better protected if the physician's report simply stated whether the worker could receive the vaccine" (Ex. 20-1361). Appropriate written opinions may be as simple as "HBV vaccination indicated for this employee, vaccination not received", "HBV vaccination not indicated for this employee, vaccination not received", or "HBV vaccination indicated for this employee, vaccination received". Since Hepatitis B vaccination is a vaccination series, employers should work directly with the evaluating healthcare professional to develop a method to track and ensure completion of the vaccination series.
Paragraph (f)(5)(ii) states that the healthcare professional's written opinion for post-exposure evaluation of an exposure incident shall be limited to specific information. Paragraph (f)(5)(ii)(A) requires the written opinion to state that the employee has been informed of the evaluation results, while paragraph (f)(5)(ii)(B) requires a statement that the employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment.
Paragraph (f)(5)(iii) states that all other findings or diagnoses shall remain confidential and shall not be included in the written report. The APA stated they view "the maintenance of strict confidentiality as the cornerstone to viable procedures for workplace exposure" (Tr. 1/9/90, pp. 23, 24). OSHA believes that the evaluating healthcare professional has an obligation to view medical information gathered or learned during Hepatitis B vaccination or post-exposure evaluation as confidential medical information, and that successful post-exposure programs must guarantee this confidentiality.
(6) Medical Recordkeeping
Paragraph (f)(6) states that medical records required by this standard shall be maintained in accordance with paragraph (h) of this section. This paragraph is included so that employers, physicians, and other healthcare professionals are made aware that there are requirements for medical recordkeeping elsewhere in this standard. These medical records must be kept confidential.
Paragraph (g) Communication of Hazards to Employees
Paragraph (g), Communication of Hazards to Employees, addresses the issue of transmitting information to employees about the hazards of bloodborne pathogens through the use of labels, signs, and information and training. These provisions apply to all operations where there is occupational exposure to blood and other potentially infectious materials. OSHA's intent here is to ensure that employees will receive adequate warning through labels and signs and training to eliminate or minimize their exposure to bloodborne pathogens.
(1) Labels and Signs.
Paragraph (g)(1) of the Bloodborne Pathogens Standard provides the specific labeling and sign requirements that are required to be used to warn employees of the hazards to which they are exposed. The requirements for labels and signs are consistent with Section 6(b)(7) of the OSH Act, which prescribes the use of labels or other appropriate forms of warning to apprise employees of occupational hazards.
Paragraph (g)(1)(i)(A) requires that labels or other appropriate forms of warning be provided on containers of regulated waste; on refrigerators or freezers that are used to store blood or other potentially infectious materials and on other containers used to store, dispose of, transport or ship either blood or other potentially infectious materials. The purpose of this requirement is to alert employees to possible exposure since the nature of the material or contents will not always be readily identified as blood or other potentially infectious materials under these circumstances. For example, if a refrigerator used to store blood or other potentially infectious materials is not labeled, then employees may be unaware that universal precautions must be observed upon handling the contents in the refrigerator, or that the refrigerator must not be used to store items such as food. Another example would be, if an unlabeled container of blood or potentially infectious material is leaking while being transported, then employees responsible for handling such a container may not be aware that they need to be implementing universal precautions.
Concurring with OSHA's labeling requirement, NIOSH (Ex. 31) states that, "OSHA is correct to require that workers be informed when handling materials or containers of materials that require observation of universal or barrier precautions . . . . the labels required are only for the purpose of advising the workers that barriers precautions are required for the contents of the labeled container."
A number of commenters were opposed to such labeling since universal precautions were in place at their facilities. For instance, Saint Michael's Hospital commented that, "With universal precautions, all laboratory specimens are handled with the same precautions and therefore, specific biohazard labels are unnecessary (Ex. 20-1142)." Harborview Medical Center stated that such labeling would be ". . . redundant within hospitals and laboratories where universal precautions are practiced for all specimens (Ex. 20-346)." Likewise, Georgetown University Hospital commented that, "Specimen labeling requirements are redundant and inconsistent with CDC recommendations (Ex. 20-833)."
OSHA agrees that in work situations in which containers of blood and other potentially infectious materials can be identified by trained employees, then there is no need to label such containers. For instance, when blood is being drawn or laboratory procedures are being performed on blood samples, then the containers housing the blood or other potentially infectious materials would not have to be labeled. Paragraph (d)(2)(xiii)(A) above addresses labelling in facilities where Universal Precautions are observed with respect to all specimen. Under certain circumstances such as transport or shipment, employees may come into contact with these unlabeled substances and not be aware that universal precautions are required (for example, a maintenance worker who is required to clean up an unidentified spill.) In these instances, labels are required.
Several commenters felt that using warning labels on specimens would breach patient confidentiality, and infringe upon the source individual's right to privacy. (See for example, American Health Care Association; Ex. 20-287; Primary Children's Medical Center, Ex. 20-1094; The National Association of Children's Hospitals and Related Institutions, Inc., Ex. 20-1003.) OSHA recognizes that under Universal Precautions, blood and other potentially infectious materials from all source individuals are treated as if they contain HBV or HIV and there is no need for a label that states whether or not the specimen was collected from an individual known to be infected with these viruses. Therefore, OSHA is not requiring that the infection status of source individuals or specimens be identified. The Agency is requiring only that the outermost containers used to store, transport, ship or dispose of blood or other potentially infectious materials from any source individual bear a warning labeling signaling that appropriate barrier precautions must be used if there is occupational exposure. Thus, under this requirement, the source individual's rights to confidentiality and privacy are not violated.
Additionally, OSHA feels that using labels to designate the bloodborne infection status of some individuals and not others sets up a dual system in which employees may take fewer precautions with unlabeled specimens than with those labeled "HIV" or "HBV." There were a number of comments supporting the prohibition of warning labels and signs indicating on individual's bloodborne disease status. For example, CDC/NIOSH stated, "We recommend against using labels to differentiate samples that are known or suspected of being infectious from those not believed to be infectious (Ex. 31)." Likewise, AFSCME stated that, ". . . we are concerned that differential labeling will encourage employees to become lax with samples that are not explicitly marked but that may also be infectious (Ex. 297)." SEIU commented that, ". . . some hospitals follow universal precautions but then use door signs for patients already diagnosed with AIDS or hepatitis B. This inconsistent approach to infection control confuses healthcare workers and discourages compliance with any infection control guidelines (Ex. 299)." However, there were some commenters who felt that employees have the right to know the infection status of specimens and that such labeling should be permitted. For example, The College of American Pathologists commented that, "The College recommends a modification of the strict observance of universal precautions to permit special biohazard labeling of known infectious specimens . . . . there are certain situations where additional precautions should be added (Tr. 11/13/89 pp. 191 & 206)." Dr. Jared Schwartz of Presbyterian Hospital in Charlotte, N.C. stated that it is:
...common sense that if you know of a risk you are obligated to warn others. If you know a lot of ice cream bars are contaminated with Listeria you expect the manufacturer to warn the public which lot is bad. This does not guarantee that the other lots are safe and the public needs to be careful of all bars, but at least you are sure that they are aware of the bars that pose a danger (Ex. 20-641).
Finally, there was support in the record for OSHA's not addressing the issue of the use of labels or signs identifying an individual's infectious status (see, for example, Frankford Hospital, Tr. 12/20/89, pp. 1364; Westmoreland Hospital, Ex. 20-1102; The Bowman Gray School of Medicine, Wake Forest University, Ex. 20-637; and Lutheran General Hospital, Ex. 20-655.) OSHA is not requiring the use of warning signs or labels indicating an individual's bloodborne infectious status. The Agency strongly agrees with the recommendations of CDC/NIOSH against using warning signs indicating such a status. The Agency feels that universal precautions should be implemented which requires that all blood and other potentially infectious materials are treated as if they contain certain bloodborne pathogens. The labeling requirements of paragraph (g)(1)(i)(A) are for the purpose of warning employees only that certain containers are housing blood and other potentially infectious materials. Such warning labels also would inform employees that appropriate barrier precautions would need to be used if occupational exposure occurs. The final Standard includes "containers used to... ship blood..." in addition to containers used to transport blood in order to emphasize that containers in transit by various means either within or between facilities are covered by the labeling requirements.
Paragraph (g)(1)(i)(B) requires that the warning label includes the universal biohazard symbol followed by the term "BIOHAZARD." Any additional appropriate designation or major message, e.g., the term "Regulated Waste", may be included on the label. The provision ensures that appropriate and universally recognized warning is given to employees. The standard does not prevent the inclusion of any other appropriate designation or major message provided that such inclusions do not detract from the impact or visibility of the word "BIOHAZARD", the biohazard symbol or any required information or major message.
The specific requirement to use the word "BIOHAZARD" and the universal biohazard symbol is considered appropriate because epidemiological evidence indicates that HIV and HBV have been transmitted to workers occupationally exposed to blood and other potentially infectious materials. The word "BIOHAZARD" and the universal biohazard symbol indicate the nature of the hazard in a manner readily recognized by many employees exposed to bloodborne pathogens. They warn the employee that universal precautions have to be used when handling the contents of the labeled container. The symbol is placed after the word to reinforce the meaning of the word "BIOHAZARD" and to ensure that the warning of the presence of the hazard is conveyed. Although CDC/NIOSH supported the use of certain warning labels, they recommended that the biohazard symbol not be used (Ex. 298). Rather, they suggested substituting a gloved hand and a graphic representation of spilled liquid. They suggested the label also bear the legend "Universal Precautions." OSHA feels this symbol would be inappropriate for a number of reasons: First of all, the biohazard symbol has been used for a number of year and is effective in warning employees of the presence of biohazards. Secondly, the suggested symbol of a gloved hand and spilled liquid is remarkably similar to three symbols found in ANSI Z129.1-1988 that are use to designate the presence of corrosive chemical. Finally, the Agency has no evidence that such a symbol has ever been tested to determine whether it would convey the appropriate message to workers including those who are illiterate or who cannot read English.
Paragraph (g)(1)(i)(C) requires labels to be fluorescent orange, orange-red or predominantly so with lettering or symbols in a contrasting color. This requirement would ensure that the label attracts the attention of the employee and that the letters and symbols are easily seen. The color requirement is identical to that contained in Appendix A of OSHA's standard for accident prevention tags (29 CFR 1910.145 (f)). Although there were very few comments in the record that addressed this issue of color, at least one company supported standardizing the color of labels (Baxter Health Care Corporation, Tr., 10/20/89, pp. 872). There was no substantial evidence in the record that challenged the color requirements.
Paragraph (g)(1)(i)(D) requires that labels be either an integral part of the container or be affixed as close as feasible to the container by string, wire, adhesive or other methods that prevent their loss or unintentional removal. This ensures that the warning label will not be separated from the container used to store, ship, transport or dispose of the biohazard, so that employees coming in contact with the container will be aware of the hazard. Containers are available that have biohazard labels as an integral part of their structure, but the standard only requires that a label to be affixed to the container. This flexibility is particularly important since objects, such as refrigerators or freezers, will have to be labeled if they house containers of blood or other potentially infectious materials.
There are three exemptions to the labeling requirement of paragraph (g)(1)(i). The first exemption, paragraph (g)(1)(i)(E), allows the substitution of red bags for labels on bags or containers of regulated waste. OSHA believes that employees will be protected where red bags are used because employers will have to comply with paragraph (g)(2)(iv)(M) of the standard which requires that employees be trained to understand the meaning of all color coding used to comply with paragraph (g)(1). This would include information on the meaning of red bags, thus assuring that OSHA's intent, to inform employees of hazards present at their worksite, would be achieved by red bagging.
Paragraph (g)(1)(i)(F) exempts containers of blood, blood components, and blood products labeled as to their contents and released for transfusion or other clinical uses from the labeling provision of this standard. The wording in the final standard has been changed from the proposed standard to clarify the meaning of this provision as suggested by CDC/NIOSH (Ex. 20-634). OSHA's intent is to exempt blood, blood components, and blood products (bearing an identifying label as specified by the FDA) that have been screened for HBV and HIV antibodies and released for clinical use. This exemption is justified because containers having a specific label which identifies blood, blood components, or blood products would provide sufficient information to ensure that additional labeling would be unnecessary. Additional comments in the record supporting this exemption were provided by the American Red Cross, Ex. 20-215; the Department of Defense, the Armed Services Blood Program Office, Ex. 20-161.
Finally, the standard would exempt from the labeling requirement individual containers of blood or other potentially infectious materials that are placed in a labeled container during storage, transport, shipment or disposal. OSHA is not requiring that containers used for collecting or processing blood or other potentially infectious materials be labeled with the biohazard sign during such procedures. Labeling is required only for containers used to store, transport, ship or dispose of blood or other potentially infectious materials. During such times the contents of the containers may not be readily identifiable and employees who come in contact with these substances need to be apprised of the potential for exposure to bloodborne pathogens. For example, during transport a container holding test tubes of blood or other potentially infectious materials would need to be labeled. Also, the potential for breakage or puncture of such containers is of concern especially during shipping and transport and employees who are responsible for clean up procedures need to be warned of the presence of biohazards. Addressing this issue CDC/NIOSH (Ex. 31) states, "The purpose of the label... is to advise the worker that the contents of the container require observance of universal precautions; for example, if the container leaks, is torn or broken, or must be opened for any reason." OSHA has concluded that sufficient warning is provided by labelling the outer container.
Labels required for contaminated equipment (paragraph (g)(1)(i)(H)) that is to be serviced or repaired shall contain the additional information stating which parts of the equipment are contaminated. This will assure that employees who repair, service or otherwise handle this equipment will be warned to take appropriate protective measures.
Paragraph (g)(1)(i)(I) states that regulated waste that has been decontaminated need not be labelled or color-coded. In the proposed standard, OSHA posed the question that if regulated waste (infectious waste) is decontaminated prior to disposal, should the Agency allow the label to be removed from the container? There was strong support in the record for allowing the removal of warning labels from decontaminated regulated waste. (For example, see CDC/NIOSH, Ex. 20-634; American Academy of Family Physicians, Ex. 20-1107; Society of Hospital Epidemiologists of America, Ex. 20-1002, Tr., 10/18/89, pp. 353-354; EPA, Ex. 20-991; American Association of Forensic Dentists, Ex. 20-109; APIC, San Francisco, Ex. 20-654; American Association of Critical Care Nurses, Ex. 20-1162; American Society for Microbiology, Ex. 20-1188; ADA, Ex. 20-665; and Baxter Health Care Corporation, Ex. 20-914.) The American Academy of Family Physicians stated that, "... effective decontamination should allow for removal of the label . . ." (Ex. 20-1107). The Society of Hospital Epidemiologist requested that OSHA allow the removal of the biohazard label "... from anything that has been adequately decontaminated..." (Tr., 11/18/89, pp. 353-354). On the other hand, several commenters felt that OSHA should not allow labels to be removed after the decontamination process as there was no way to ensure that the waste had been decontaminated. Expressing this viewpoint, AFSCME stated that, "Biohazard or other warning labels should remain on infectious waste containers even after decontamination, since studies show that incineration and autoclaving are not guaranteed methods of disinfection" (Tr., 9/15/90, pp. 106). The Visiting Nurses Corporation commented that, OSHA should not allow hazard labels to be removed from waste containers even though such waste has been decontaminated before disposal because "this might create confusion, thereby increasing the risk of exposure" (Ex. 20-1268). The Food and Allied Services Trades (Ex. 20-888) stressed that there is not justification for removing the warning label on infectious waste as it cannot be ensured the waste is decontaminated. There were also a number of commenters who felt that additional labels could be placed on the regulated waste indicating that the waste had been decontaminated. Addressing this issue the Veterans Administration stated, "... the removal of the label, especially if the waste is red bagged would complicate disposal -- suggest that an additional label be attached signifying that decontamination has been performed and that indicates date, time, location and certifying official" (Ex. 20-548d). The American Society of Clinical Pathologists similarly commented, "A label indicating decontamination should be added rather than the original label removed" (Ex. 20-351). The EPA (Ex. 20-991) indicated that although it supports the removing of the warning label once the regulated waste has been "treated," it none the less requires identification of the contents as medical waste using an identification tag.
OSHA recognizes that it is possible to decontaminate regulated waste by a number of methods including incineration, autoclaving or by chemical means. However, in order to ensure that the decontamination process is successful, it must be monitored carefully each time the decontamination process is used. There are several factors which may interfere with or require altering the decontamination process. For example, the denser the load of waste, the more difficult it would be to decontaminate the center of the load. Depending on the configuration of the load, different portions of the load may require variations in the decontamination process for example, greater heating or pressure. Additionally, variation in content or volume of the load may affect the efficacy of the decontamination process. For instance, the greater the organic content of the load, the more difficult it is to decontaminate. Thus, a load of bulk blood or of blood soaked gauzes, may require very different decontamination procedures or conditions than a load of extracted teeth or other body parts.
OSHA has considered all the evidence in the record and has decided not to prohibit the removal of the warning label required by paragraph (g)(1)(i) from decontaminated regulated waste. Of course, the employer who removes the label, covers the red bag or in some other way indicates that regulated waste has been decontaminated must assure that the waste is decontaminated which means that bloodborne pathogens are removed, inactivated, or destroyed to the point where they are no longer capable of producing disease and the surface of an item is rendered safe for handling, use or disposal as defined above in paragraph (b) Definitions.
Paragraph (g)(1)(ii)(A) requires that the entrance to research laboratories or production facilities be posted with signs specifically stating "BIOHAZARD" and showing the universal biohazard symbol. The sign also has to identify the infectious agent and specify any special requirements for entering the area. For example, if personal protective equipment is required, this information would have to be included on the sign. In addition, the name and telephone number of the laboratory director or other responsible person is required to be displayed. Such warning signs would have to be posted at the entrance to a research laboratory or a production facility as defined by paragraph (b) of this standard.
The Agency intends that the posting of these signs will serve as a warning to employees who may otherwise not know they are entering a restricted area. Signs would warn employees not to enter the area unless there is a need, unless the employee has been properly trained, and unless the employee also meets all other appropriate entrance requirements listed on the sign. The standard requires certain wording on the warning signs for regulated areas to assure that appropriate and universally recognized warning is given to employees. The specific requirement to use the word "BIOHAZARD" and the universal biohazard symbol is considered appropriate because epidemiological evidence indicates that HIV and HBV have been occupationally transmitted to laboratory workers in circumstances where these hazards existed. The universal biohazard symbol indicates the nature of the hazard in a manner readily recognized by laboratory workers, and it emphasizes the importance of the message that follows. The requirement that the name of the infectious agent and any special requirements for entering the area be listed on the sign would assure that employees are aware of the specific biohazard involved and of any special measures that need to be taken before entering the restricted area. The provisions for signs in paragraph (g)(1)(i) are virtually identical to the recommendations for signs found in Special Practices for Biosafety Levels 2 and 3 in "Biosafety in Microbiological and Biomedical Laboratories" (Ex. 6-338). The only exceptions are the color requirements and the requirement that the word "BIOHAZARD" be used. OSHA has added the requirement for the word "BIOHAZARD" because some individuals who are present in the general work area may be unfamiliar with the meaning of the biohazard symbol. These individuals may not be covered by the standard and may not have received training required by the standard. Supporting this provision, The Food and Allied Services Trades (Ex. 20-888) commented that OSHA has no way of ensuring the success of a training program to convey this information.
There were commenters who questioned the need for specifying on signs any special requirements for entering a restricted area. Abbot laboratories and the Pharmaceutical Manufacturers Association stated that these requirements may be rather extensive and not easily transferred to a sign (Exs. 20-1227; 20-729). OSHA believes the biohazard symbol alone does not provide sufficient warning to employees who may enter the regulated area. The requirement that the name and telephone number of the laboratory director or other responsible individual be posted on the sign will ensure that, in the event of an emergency or other unforeseen event, the employee will know how to reach a trained and knowledgeable individual who can provide guidance and ensure that procedures are followed to eliminate or minimize exposure.
The proposed standard posed the question of whether it is necessary to require the use of "Danger" or other additional words on biohazard signs in order to warn individuals who may not understand the meaning of "BIOHAZARD". This question generated a substantial response. The majority of those who commented on this issue felt that the word "Danger" should not be added to signs. A number of commenters suggested that posting the word "BIOHAZARD" along with the biohazard symbol would convey appropriate warning provided employees were adequately trained on the meaning of the word "BIOHAZARD." For example, CDC/NIOSH stated, "The word `Danger' or other cautionary words are not necessary. Training required under this regulation should result in employees understanding the significance of the biohazard symbol" (Ex. 20-634). The American Academy of Family Physicians commented that, "`Danger' is certainly more widely used in the U.S. than `Biohazard'... if OSHA feels that the training of employees will be effective, the term biohazard will be sufficient since all concerned persons will have received education in the meaning." (Ex. 20-1107). The Service Master Company commented that:
The use of the term "Biohazard" in combination with the universal biohazard symbol should be sufficient to warn employees of the hazard. It should not be necessary to use the word "danger"... training should properly address the meaning and significance of both the term 'Biohazard' and the biohazard symbol. (Ex. 20-21)
The American Biological Safety Association stated:
The use of the word "Danger" is redundant. The biohazard sign or universal biohazard symbol is indicative of warning of actual or potential hazard. Training of employees to adhere strictly to good laboratory practices and barrier protection is far more effective than posting of inappropriate warning signs which may be ignored if overused. (Ex. 20-241)
Several commenters felt that "Danger" should be added to signs in order to reinforce the meaning of the term "BIOHAZARD" and the biohazard symbol. For example, the American Public Health Association (Ex. 20-1361) suggested that the word "Danger" be added to signs as it is more instructive than "Biohazard". AFSCME (Ex. 20-985) stated, "... the word `Danger' should be on signs for people who may not understand the meaning of `Biohazard'." The Communications Workers of America, AFL-CIO, District 1, (Ex. 20-273) felt that the term "Biohazard" was not a clear enough indicator. Support for including the word "danger" on signs was also provided by Local 1199, Drug Hospital and Healthcare Union (Tr., 11/14/89, p. 380).
Other commenters felt that the word "Danger" is inappropriate since it connotes areas that people should not enter and suggested the word "Caution" be used instead. (Abbott Laboratories, Ex.20-1227; Pharmaceutical Manufacturers Ex. 20-729; Health Industry Manufacturers, Ex.20-795.) OSHA has considered all these comments and has concluded that this final standard should not require use of the word "Danger." However, the employer may use the word "Danger" or "Caution" as long as including the word does not detract from the impact or visibility of the word "BIOHAZARD," the biohazard symbol or any required information or major message.
Consistent with the requirements for labels, signs shall be fluorescent orange-red or predominantly so, with lettering or symbols in a contrasting color.
The hazard warning signs are intended to supplement the training which employees are to receive under the other provisions of paragraph (g)(2), since even trained employees need to be reminded of the location of regulated areas and of the precautions to be taken before entering these hazardous areas.
(2) Employee information and training.
Paragraph (g)(2) requires the employer to provide all employees with occupational exposure to bloodborne pathogens with training about the hazards associated with blood and other potentially infectious materials and the protective measures to be taken to minimize the risk of occupational exposure. Effective training is a critical element of any overall exposure control program. It will ensure that employees understand hazards associated with bloodborne pathogens, the modes of transmission, the exposure control plan, and the use of engineering controls, work practices, and personal protective clothing. Employees are also required to be trained in the appropriate actions to take in an emergency involving exposure to blood and other potentially infectious materials, and they are to be informed of the reasons that they should participate in hepatitis B vaccination and post-exposure evaluation and follow-up.
This training will help reduce the risk of occupational exposure, consequently reducing exposure-related infection, illness, and death. The more than 3,000 comments OSHA received comprise a record that strongly supports the need for employee training programs and endorses the conclusion that employee training should be mandated as an integral part of OSHA's standard on bloodborne pathogens. The comments also provided many suggestions regarding the types of information that should be included in a specific requirement for training, and OSHA relied heavily on these comments in developing the training requirements listed below. (See, for example, CDC/NIOSH, Ex. 11-187; AHA, Ex. 11-233; ANA, Ex. 11-86; AAOHN, Ex. 11-111; ARC, Ex. 11-156, 11-280; SEIU, Ex. 11-161, AFSCME, Tr., 9/15/89, pp. 84; Local 1199-Drug, Hospital and Healthcare Employees Union, Tr., 11/14/89, pp. 380-3.) Typical of the comments received is that of the American Federation of State, County and Municipal Employees (AFSCME) (Ex. 11-157) which addressed the need for training as follows:
A critically important part of preventing injuries or illnesses in the workplace is training workers about potential hazards and safe working conditions. Workers shall have the same right to know about communicable disease hazards to their health that they now have for chemical hazards (Ex. 11-157). All who are potentially exposed must be trained (Tr., 9/15/89, pp. 84).
The Mr.Shirikian, Forensic Scientist, N.Y. State Police, testifying for the SEIU stated that, "Employers and employees alike will be better prepared to protect themselves at the worksite if they have the proper education." (Tr., 11/13/89, pp. 170) The American Dental Association (ADA) noted that such training is already received as part of a dental education. "Dental professionals are trained and educated in the delivery of quality dental care. Training and education include infection control practices" (Ex. 11-43).
Mr. Paul Maniscalco, Vice President of the National Association of Emergency Medical Technicians stated:
Education is the linchpin in this process of protecting EMS workers. Without appropriately delineated training requirements, the necessary behavior modification from the EMT will not be realized and thus, will have no major inpact on reducing the potential for illness or injury. It is imperative that corrective measures be taken immediately to address the inclusion of infection control in all EMS training programs." (Tr. 9/14/89, pp. 122-123)
The training is required to be conducted during working hours, at no cost to the employee and at a reasonable location. These provisions are required implicitly in all OSHA standards that require training so that the employee is not penalized in order to participate in a training program that is required to ensure as far as possible the employee's occupational safety and health. However, the Agency chose to state each provision explicitly in the final standard for Occupational Exposure to Bloodborne Pathogens in order that employers and employees are clearly aware that these requirements exist.
The provisions for employee training are performance oriented, listing categories of information that must be provided to employees. This ensures that important information is communicated to employees while allowing employers the most flexible approach to providing training. The Standard also requires that training records be established and maintained according to section (h)(2). In the proposed standard, OSHA asked whether it is appropriate to substitute some measure of competency in lieu of training for certain individuals. For example, some asserted that infection control practitioners, would be expected to be thoroughly familiar with some of the material in the training program. A number of commenters felt that there would be very few if any employees who would be knowledgeable or have sufficient background in all of the elements of the required training program and therefore there should be no employees exempted from the training requirements. Addressing this issue AFSCME commented that:
Training is critical to the implementation of this standard and no one should be exempted from this requirement... it should not be assumed... that simply because someone has a medical or scientific degree that they are well-versed in infection control techniques, personal protective equipment, emergency procedures, this OSHA standard or other essentials. (Ex. 20-297)
CDC/NIOSH stated that, "... no employees should be exempt from training that pertains to the specific hazards and engineering controls, work practices and PPE associated with their job duties." (Ex. 20-634). Similarly, The Service Master commented that,
Some employees will be thoroughly familiar with some material in the training program. However, they will not be thoroughly familiar with other materials in the program. There should not be a complete exemption from training. Tailoring of the training program... will allow for consideration of professional or technical competency. (Ex.20-21)
On the other hand, SEIU suggests it is appropriate to "exclude diagnosing personnel from the training requirement. Physicians and dentists do not need to be trained in infection control procedures because of their professional education." (Ex. 299) OSHA recognizes that having a professional degree or other credentials does not necessarily ensure that the individual is adequately familiar with all of the provisions of the Bloodborne Pathogens Standard. The Agency realizes also, that depending on one's background, an employee may be somewhat familiar with various elements of the required training program. Therefore, paragraph (g)(2)(i) requires that all employees with occupational exposure participate in a training program; however, the standard allows the employer flexibility in tailoring the program to the employee's background and responsibilities.
In keeping with the proposed standard, OSHA is requiring in paragraph (g)(2)(ii) that training shall be provided at the time of initial employment or within 90 days after the effective date of this standard and at least annually thereafter. In support of this provision, AFSCME pointed out that, "It is also important for training to be provided annually, to reinforce and update information that was provided previously" (Ex. 20-297). The New York Committee for Occupational Safety and Health commented that, "We support the provisions for education and training, in particular the requirements for such at the time of initial employment and then again at least annually" (Tr., 11/13/89, pp. 17).
Bloodborne pathogens constitute a serious hazard which can lead to very serious illness and death after only one exposure. It is extremely important that employees are trained to protect themselves from this hazard before occupational exposure occurs. It is equally important that those employees who have already incurred occupational exposure be trained as soon as possible to eliminate or minimize such exposure in the future. Therefore, the Agency is requiring that the training provisions be among the first requirements implemented after the effective date of the standard.
OSHA has concluded that it is essential for employees to understand the nature of the hazards they may face in the course of their employment and the procedures to follow to minimize or eliminate the risks associated with their exposure to these hazards. Because of the severity of the diseases and the potential to contract them from a single event, it is also important to retrain workers exposed to bloodborne pathogens on an annual basis. Annual retraining reinforces initial training and provides an opportunity to present new information that had not been available at the time of initial training.
The record also indicated that many employees who have occupational exposure have received training and training updates on infection control procedures. In order to avoid duplicating the previous training efforts of employers, the Agency has added a "grandfather" clause to the provision. Paragraph (g)(2)(iii) states that "for employees who have received training on bloodborne pathogens in the year preceding the effective date of the standard, only training on provisions of the standard which were not included need be provided within the 90 days." The annual training for these employees shall be provided within one year of their original training. This allows employers the option of supplementing prior employee training rather than repeating it initially.
There was strong support in the record for such a grandfather clause. For example, the American Hospital Association commented that OSHA should "recognize training in universal precautions that occurred within one year prior to the final publication of the rule as fulfilling the rule's initial training requirements, as long as the employer provides supplemental information to employees about the new rules" (Ex. 20-352). The American Association of Dental Schools stated, "We suggest a training waiver for an employee who has taken a continuing education infection control course within one year prior to the effective date of the final rule - such individual would not need to take the training course until the next year after the rule takes effect." (Ex. 20-651) Mr. Graman, of the University of Rochester School of Medicine commented that, "Many aspects of the required initial training have been covered in recent in-service training on UP and infection control during the past year -- duplication of effort should be avoided." (Ex. 20-1053) The SEIU (Ex. 20-979) felt that OSHA should allow for grandfathering of employees who have gone through training programs.
It is important that employees are trained not only initially and annually but whenever there is a change in an employee's responsibilities, procedures or work situation such that an employee's occupational exposure is affected. Therefore, paragraph (g)(2)(v) includes the following additional provision in the final standard:
Employers shall provide additional training when changes such as modification of tasks or procedures or institution of new tasks or procedures affect the employee's occupational exposure. The additional training may be limited to addressing the new exposures created.
Regarding the need for such additional training, AFSCME stated that, "Additional training should be provided annually and whenever a change of working conditions increases potential exposure" (Ex. 38). The American Nurses' Association commented that, "The employer should routinely assess the employee's need for training and provide [it] then and not just on the anniversary date" (Ex. 20-953). The Retail, Wholesale and Department Store Union, AFL-CIO stressed that in addition to annual training all employees must receive training as new scientific information becomes available (Tr., 11/14/89, pp.431).
OSHA is concerned that the training information presented must be understood by the employee; otherwise the training will not be effective. Therefore, Paragraph (g)(2)(vi) requires that employers must include training material that is appropriate in content and vocabulary to the educational, literacy and language background of employees. This will ensure that all employees, regardless of their cultural or education background will receive adequate training on how to eliminate or minimize their occupational exposure.
Many commenters suggested such a provision. For example: Education must be appropriate to education level, literacy and cultural or language background...clarify materials to workers at all levels with varying cultural, ethnic and literacy backgrounds (American Association of Occupational Health Nurses, Ex. 11-111).
...educational training must be designed and presented according to the employee's educational, language and English proficiency... it may be necessary to supplement with bilingual resources." (American Nurses Association, Tr., 9/20/89, pp. 91.) Program depth, content and frequency might vary widely depending on audience characteristics (such as prior training, educational background, job duties, nature and degree of risk) (American Hospital Association, Ex. 11-233).
The Service Employees International Union (SEIU) provided similar suggestions in recommending that the following factors be taken into consideration for training employees exposed to bloodborne pathogens:
[Employee] attitudes and knowledge about these diseases; educational level of workers and potential barriers to training (i.e., language difficulties of non-English speaking workers, limited literacy on the part of some workers ...) (Ex. 11-161).
The final standard requires that employers provide a training program that contains certain minimum information. The first element in paragraph (g)(2)(vii)(A) is a copy of the regulatory text of the final standard and an explanation of the contents. This ensures the employee will know the standard exists and will be familiar with its provisions. OSHA agrees with several commenters who stated that providing a complete copy of the final standard including the preamble as well as the regulatory text to each employee would be unreasonable and burdensome. For example, the State of Connecticut commented that, "Providing an overview of the standard and making a copy available upon request at a central point in the workplace such as a medical library should be permitted. Providing every employee their own personal copy of the standard does not seem productive or necessary" (Ex. 20-796). However, although providing a copy of the entire standard to each employee is not required, the Agency has concluded that each employee needs a copy of the regulatory text so that he or she will know exactly whaat its requirements are.
The second and third elements, (paragraph (g)(2)(vii)(B) and (C)) require that the training program include a general discussion of bloodborne diseases with specific emphasis on the epidemiology, symptomatology and modes of transmission of HBV and HIV. Discussion of the epidemiology, symptomatology and modes of transmission of HIV and HBV is an appropriate component of training for a number of reasons. First, this provision will ensure a basic understanding of the diseases caused by these viruses and the need to observe precautions to prevent disease transmission. There is general agreement in the record that such information would be needed in a training program for bloodborne pathogens. For example, the SEIU envisioned a training program where "[T]here will be sessions on the general epidemiology of diseases as well as a clinical explanation of the disease" (Ex. 11-161). As a more general statement of the same principle, CDC/NIOSH commented that "[w]orkers require complete understanding of the modes of transmission of HBV and HIV to observe properly the protective measures required of them" (Ex. 11-187). Similarly, the State of Maryland (Ex. 11-283), AFSCME (Ex. 11-157), California Nurses Association (Tr., 9/13/89, pp. 68.) and the American Red Cross (ARC) (Ex. 11-280) endorsed the need for training workers to understand the diseases that could be transmitted by exposure.
Second, employees need to be able to recognize the symptoms associated with these diseases. There may be an exposure incident where an employee may not realize that occupational exposure has occurred. For example, an employee may not realize that there was a small perforation in a glove worn while performing a surgical procedure. The employee must understand that if certain symptoms develop, e.g., abdominal pain and jaundice, then these symptoms may be related to hepatitis B.
It is not the Agency's intention in most cases for training programs to provide in depth information or to focus intensely on bloodborne diseases other than HIV and HBV and the other hepatitis viruses. However, it is appropriate to inform employees that there are bloodborne pathogens in addition to HIV and HBV.
OSHA believes that it is important for each worker to recognize how he or she specifically might be occupationally exposed to bloodborne pathogens and under which circumstances infection control precautions will be necessary. Therefore, the fourth element of the training program (paragraph (g)(2)(vii)(D)) requires an explanation of the exposure control plan and of the appropriate methods for recognizing tasks that may involve exposure to blood, and other potentially infectious materials.
Paragraph (g)(2)(vii)(E) of the training program requires the employer to provide an explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials.
Several groups who have commented to OSHA's record on bloodborne pathogens supported this provision and stressed the need for workers to be able to recognize when they may be at risk of exposure. For example, the American Red Cross commented:
Descriptions of staff duties must indicate whether duties routinely involve potential for exposure to infectious agents...whether such exposure might occasionally occur due to extra-ordinary circumstances...or whether duties do not include potential for exposure (Ex.11-280).
Likewise, AFSCME pointed out that "[t]raining should ensure that all workers...can identify tasks that may involve exposure to blood or other potentially infectious body fluids" (Ex. 11-157). In suggesting a specific training program, the SEIU proposed that "...workers will learn the exposure associated with specific occupations and tasks in health care facilities" (Ex. 11-161).
To ensure that employees will be able to identify and implement methods of reducing or preventing occupational exposure to bloodborne pathogens, paragraph (g)(2)(viii)(F) requires an explanation of the use and limitations of appropriate engineering controls, work practice controls, and personal protective equipment. In support of this provision, the State of Maryland commented that no worker should engage in a task involving occupational exposure before receiving training pertaining to standard operating procedures, work practices and PPE for that particular task (Tr., 9/15/89, pp. 173).
Paragraph (g)(2)(vii)(G) and (H) require that employees be provided information on the types, proper use, location, removal, handling, decontamination and/or disposal of personal protective equipment as well as an explanation of the basis for selection and limitations of protective equipment including protective clothing. This will ensure that employees are knowledgeable about the personal protective equipment available to achieve appropriate barrier protection.
Comments in the record support inclusion of information on personal protective equipment and clothing in the training program for employees. For example, AFSCME suggested the following:
Training should ensure that all workers...know where all protective equipment is kept, how to remove, handle, decontaminate, maintain and dispose of contaminated equipment (Ex. 11-157).
The American Red Cross noted that:
Staff must understand ...protective clothing and equipment (is) available and their proper use...all proper practices and pertinent Standard Operating Procedures, including handling, decontamination, and disposal of contaminated clothing and equipment (Ex.11-280).
CDC/NIOSH (Ex. 11-187) stressed the need for employee training on measures to control exposure to bloodborne pathogens, recommending that "[a]ll workers...receive detailed training on engineering controls, personal protective clothing and equipment and work practices required for their duties." According to CDC/NIOSH, this training would have to cover not only the proper use of protective devices, but also the inherent limitations of those devices.
- The Joint Committee on Health Care Laundry Guidelines stated:
Training should include appropriate pi techniques and the use of PPE related to the risk involved (Tr., 10/20/89, pp. 796).
Paragraph (g)(2)(vii)(I) requires that employees be provided with information on the hepatitis B vaccine to ensure that they are aware of its efficacy and safety as well as its benefits and to ensure that employees are aware that the vaccine and vaccination will be offered to them free of charge. OSHA believes informing employees about the HBV vaccine is a critical component of any training program.
The vaccine is the best available means of preventing HBV in the vast majority of workers. Some employees at risk remain unvaccinated, many because of a lack of knowledge about the vaccine including an unfounded fear of contracting HBV or HIV from the vaccine. According to one vaccine manufacturer, Merck, Sharp and Dohme, a number of studies on worker acceptance attribute the "under utilization of the vaccine" to a "lack of information about the disease and the vaccine safety and effectiveness" (Ex. 11-165). In fact, a study conducted at three teaching hospitals found that "the amount of information received concerning the need for and safety of the vaccine correlated significantly with the level of vaccination among employees. Approximately 50% of employees who reported receiving adequate information were vaccinated, whereas fewer than 20% who indicated they did not receive adequate information requested the vaccine (Ex. 11-165)." Merck, Sharp and Dohme concluded that successful vaccination programs combined "proper education about the disease and the vaccine, [with]... active support for employee vaccinations from the managerial staff, and... vaccine(s) without cost to the employees" (Ex.11-165). Among the other supporters of this provision are the American Dental Hygienists Association (Tr., 1/16/90, pp. 569), the International Association of Fire Fighters (Tr., 9/18/89, pp. 139) and Local 1199 Drug, Hospital and Healthcare Union (Tr., 11/14/89, pp. 380-3).
The clause, "to ensure that employees are aware that the vaccine and vaccination will be offered to them free of charge" was added to the final provision to ensure that employees will know that they are in no way responsible for any portion of the cost of the HBV vaccine or vaccination series. Emphasizing this issue, the American Nurses' Association commented that, "... we believe OSHA needs to be much more explicit in its mandate. It must state that the vaccine shall be furnished to fully informed, consenting employees at no cost to them. Reports indicate that employees that are thoroughly educated about the vaccine accept it more readily." (Tr. 9/20/89, p. 78).
Paragraph (g)(2)(vii)(J) requires that employees be provided information on appropriate actions to take and persons to contact in an emergency involving exposure to blood or other potentially infectious materials. This ensures that workers will be prepared for unusual or extraordinary circumstances that include the potential for exposure to bloodborne pathogens. Typical of the support in the record for this provision is the following comment from the American Red Cross:
Staff must understand...actions to be taken when confronted with a situation of potential exposure that had not been anticipated by the employee. Such training might include knowledge of the existence of safety procedures applicable to the situation and the availability of assistance (Ex. 11-280).
It is important that employees understand the actions to be taken if an occupational exposure does occur as well as what medical follow-up is available for exposed individuals to ensure that they seek appropriate medical treatment, prophylaxis and/or post-exposure follow-up. Therefore, paragraph (g)(2)(vii)(K) and (L) require an explanation of the procedure to follow if an occupational exposure to bloodborne pathogens occurs, including the method of reporting the incident and a description of the medical follow-up including counseling that would be made available.
Support for including training about exposure reporting and post-exposure follow-up after an exposure incident was given by several commenters to the record, such as the American Nurses Association stressed that:
Employees must be educated about the necessity for reporting occupational exposures to blood and body fluids. Employees must be confident the reporting does not bring reprisal (Tr. 9/20/90. p.77).
The American Red Cross stated that "[s]taff must understand...proper procedures to be followed in case of an accident or exposure (Ex. 11-280)." Elaborating on this position, AFSCME stated:
Training should ensure that all workers...know the corrective actions to take in the event of...personal exposure to fluids or tissues, the appropriate reporting procedures and the medical monitoring recommended in cases of suspected parenteral exposure. (Ex. 11-157)
The AAOHN took an even more explicit position regarding training on the need for follow-up medical care in stating that:
All health care workers should receive education about the counseling of occupationally exposed individuals, monitoring and surveillance activities, current management of the disease process and legal, ethical issues. (Ex.11-111)
Paragraph (g)(2)(vii)(M) requires an explanation of the required signs and labels, including color codings and "red bagging", to ensure that employees understand the warning messages presented and the need for appropriate infection control procedures.
Paragraph (g)(2)(vii)(N) requires that there be an opportunity for interactive questions and answers with the person conducting the training session. This will ensure that employees have an opportunity to clarify any issues of concern regarding occupational exposure. Supporting this provision, Helen Miramantes, an occupational health nurse who served as OSHA's expert witness on training, (Ex. 29) emphasized that:
Trainers must allocate sufficient time to not only present the information but also to allow for questions and review of materials as needed. The trainer needs to provide an environment in which participants feel sufficiently comfortable in order to ask questions and make comments. Asking questions and discussing various aspect of a training program can clarify information and reinforce important learning objectives (Ex. 29).
Paragraph (g)(2)(viii) requires that the person conducting the training be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address. There was strong support in the record for requiring that training be conducted by a "qualified trainer." The American Nurses' Association commented that educators must be familiar with occupational health programs as well as bloodborne pathogens and that instructors must be competent (Ex. 20-953). Similarly, the American Association of Occupational Health Nurses stated that, "Because of the complex nature of the subject matter and the content of training required, trainers must be qualified; at a minimum, trainers should have knowledge of disease trans-mission and measures to prevent transmission, health surveillance and follow-up..." (Ex. 20-357). Marquette Dental School suggested that, "It is appropriate that the training and/or a measure of competency is required from individuals who are training others in infection control procedures" (Tr., 10/19/89, pp. 589).
Other commenters stressed the need for allowing flexibility regarding what instructor qualifications should be. For example, NIOSH stated that, "Qualifications of the trainer should be specified in general terms; the trainer should have expertise in the subject area, as documented by objective evidence such as satisfactory completion of relevant training courses or degree programs" (Ex. 20-634).
Finally, the record indicated the need for instructors to be knowledgeable regarding how the elements in the training program relate to the workplace that the training will address. Regarding this issue, the Health Industry Manufacturers' Association requested that the final rule emphasize competency-based education and training, utilizing qualified instructors and that educational programs be tailored to individual facilities (Ex. 20-795). Based on these and other comment in the record, OSHA is requiring that the person conducting the training shall be knowledgeable in the subject matter covered by the elements contained in the training program as it relates to the workplace that the training will address.
Employees in HIV/HBV research laboratories and HIV/HBV production facilities may be at especially high risk of infection following occupational exposure because they handle concentrated preparations of these viruses. OSHA has concluded that the risk is sufficiently high to warrant a requirement for additional initial training in the handling of HIV/HBV. Paragraph (g)(2)(ix)(A) of the standard, therefore, requires that employees in such facilities who have occupational exposures demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV/HBV. OSHA understands that many of the employees who would be covered by this provision are highly skilled and experienced laboratorians who have been working with these viruses and carefully following the biosafety guidelines. For this reason, OSHA is specifying that proficiency be demonstrated rather than requiring that all employees be retrained.
Paragraph (g)(2)(ix)(B) requires employees in HIV/HBV research laboratories and HIV/HBV production facilities to be experienced in the handling of human pathogens or tissue cultures prior to working with HIV or HBV. Finally, Paragraph (g)(2)(ix)(C) requires that employees with no prior experience in handling human pathogens have to participate in an on-the-job training program where initial work activities do not include the handling of infectious agents. A progression of work activities is permitted as techniques are learned and proficiency is developed. An employee is permitted to participate in work activities involving infectious agents only after proficiency has been demonstrated to ensure that the worker is able to handle HIV or HBV as safely as possible, thereby minimizing the risk of occupationally related infection and illness.
OSHA's provisions requiring additional training for employees in HIV/HBV research laboratories and HIV/HBV production facilities are patterned after the recommendations made by an expert team convened by the Director of the National Institute of Health (Ex.6-312). This expert team made the following recommendations to help assure a safe and healthful work environment for employees who handle concentrated preparations of HIV:
- A. Strictly adhere to standard microbiologic practices and techniques:
The most important recommendation is to adhere strictly to standard microbiologic practices and techniques. Persons working with HIV must be aware of potential hazards and must be trained and proficient in practice and techniques necessary for self-protection. Employees must be informed that parenteral exposure is the most serious potential hazard for causing a laboratory-acquired infection.
They must be able to recognize how such exposures occur and how they can be prevented. Although on-the-job training is an acceptable approach for learning techniques and practices, it is imperative that proficiency be obtained before virus is actually handled. Initial work activities should not include the handling of virus. A progression of work activities should be assigned as techniques are learned and proficiency is developed.
- B. Assure that workers are proficient in virus-handling techniques:
Selection criteria for employees who will work in production operations or with concentrated preparations of HIV should require experience in the handling of human pathogens or tissue cultures. If an employee has not had such experience, she/he should participate in carefully structured, well supervised on-the-job training programs.
The director or person in charge of the laboratory or production facility must ensure that personnel are appropriately trained and are proficient in practices and techniques necessary for self protection. Initial work activities should not include the handling of virus. A pro- gression of work activities should be assigned as techniques are learned and proficiency is developed. Virus should only be introduced into the work activities after the supervisor is confident it can be handled safely (Ex.6-312).
The employer must assure that the employee is proficient in the standard microbiogical practices and special practices required by this standard that are applicable to the employee's job, and that the employee can perform his or her tasks in a safe manner. Proficiency is achieved by experience and training. The employer is responsible for evaluating the employee's proficiency and for documenting the mechanism used to determine proficiency. For example, the employee's proficiency may be demonstrated by passing a written test and by having his or her techniques observed by the laboratory director or the director's designated representative. The results of the written tests and observations must be documented. OSHA also recognizes that some employees will be scientists who have extensive experience in these practices. Therefore, proficiency may also be demonstrated by a graduate degree in the study of HIV or HBV or another closely related subject area with a period of related laboratory research experience.
OSHA concludes that the requirments for labelling, signs, and employee training are necessary elements in the effort to eliminate or minimize exposure to bloodborne pathogens.
Paragraph (h) Recordkeeping
The final standard requires that employers maintain records related to bloodborne pathogens including exposure incidents, post exposure follow-up, hepatitis B vaccination status and training for all employees with occupational exposure. These recordkeeping requirements are in accordance with the Occupational Safety and Health Act of 1970 (OSH Act). Section 8(c) of the OSH Act authorizes the promulgation of regulations which require an employer to keep necessary and appropriate records. OSHA has determined that, in this context, medical and training records are necessary to assure that employees receive appropriate information on the hazards and effective prevention and treatment measures, as well as to aid in the general development of information on the causes of occupational illnesses and injuries involving bloodborne pathogens. Specifically, OSHA believes that maintenance of medical records is essential because documentation is necessary to insure proper evaluation of the employee's immune status and for proper healthcare management following an exposure incident.
As proposed, paragraph (h)(1) of the final standard requires employers to maintain employee medical records which include: (1) the name and social security number of the employee; (2) a copy of the employee's hepatitis B vaccination status; (3) a copy of all results of examinations, medical testing, and follow-up procedures related to post-exposure evaluation; (4) the employer's copy of the responsible healthcare professional's written opinion; and (5) a copy of the information given to the healthcare provider as required by paragraph (f) of this standard.
The American Federation of State, County and Municipal Employees, AFL-CIO(AFSCME) petitioned OSHA to promulgate a permanent standard, "requir[ing] the employer to keep records on all occupationally related infectious diseases contracted by employees." (Ex. 2A, p. 4). Many commenters supported AFSCME's petition for a recordkeeping provision. Retail, Wholesale and Department Store Union(RWDSU) commented, "[w]e concur with the recordkeeping requirements of the proposed standard. . ." (Ex. 20-1505, p. 6). Monsour Medical Center agreed that such records should be maintained and kept confidential (Ex. 20-158). Providence Hospital and Clearfield Hospital commented that they had no argument or problem with the recordkeeping provision and have already instituted changes in recordkeeping practices (Exs. 20-343; 20-585). Children's Hospital of the King's Daughters stated that "[i]t is appropriate that the employer establish and maintain an accurate health record for each employee in their institution." (Ex. 20-574, p. 5). Finally, Verdugo Hills Hospital and Northwest Center for Occupational Health and Safety agreed that accurate and unified records are important and should be maintained on employees with risks of exposure to bloodborne pathogens (Exs. 20-525; 20-526). However, the overwhelming majority of commenters did not address this paragraph in their comments. OSHA believes that the lack of comment is due, in part at least, to the common understanding that the establishment and maintenance of employee medical records are an integral part of an occupational health program.
Although the majority of the commenters agreed that records must be maintained, some commenters disagreed about who should maintain the record; how long the record should be retained; and how confidentiality of records should be maintained.
Three commenters suggested that the maintenance of medical records should be the responsibility of the employee's treating healthcare professional and not the employer (Exs. 20-350; 20-1004; 20-665). Other commenters believe that the responsibility for maintaining employee medical records on occupational illnesses properly lies with the employer (Exs. 2A; 20-574). OSHA agrees with the latter and this standard, like other OSHA standards, confers the responsibility for recordkeeping upon the employer. However, this standard does not require the employer to maintain possession of the records. For example, an employer may wish to have the records kept in the office of the physician or other licensed healthcare professional with whom he or she has a contract to provide healthcare to his or her employees. On the other hand, many employers, particularly healthcare providers, already maintain employee medical records (i.e. TB tests, vaccinations, physical examinations, etc.). In these instances, the information from this paragraph would simply be added to existing confidential medical files. This standard does not require an additional record, so long as the existing record is considered confidential. Regardless of where the records are kept, the employer bears the responsibility for their creation and maintenance.
Other commenters suggested that state agencies or OSHA should be responsible for maintaining the medical records. (Exs. 20-665; 20-1205; Tr. 9/21/89, p. 165). Reasons for this suggestion ranged from a belief that confidentiality would be increased to a suggestion that errors and losses would be decreased. OSHA believes that the day to day maintenance of individual employee medical records by state agencies or OSHA would be inconsistent with the OSH Act. First, in Section (2)(b)(7) of the OSH Act, Congress intended for OSHA to be responsible for "provid[ing] medical criteria which will assure insofar as practicable that no employee will suffer diminished health, functional capacity, or life expectancy as a result of his work experience." Second, in Section (6)(b)(7) of the Act, Congress intended that OSHA prescribe appropriate controls, including such controls as medical examinations, as may be necessary, for the protection of employees. Finally, Section 8(c) of the Act states clearly who is responsible for recordkeeping: ". . . each employer shall make, keep and preserve and make available. . . such records regarding his activities relating to [the OSH] Act." OSHA has concluded that medical recordkeeping on vaccination and occupational exposure incidents is an appropriate and necessary control for the protection of employees against bloodborne pathogens. Specifically, OSHA concludes that in order for records to be useful in, for example, assessing post exposure follow-up or instituting and directing an HBV vaccine program, they need to be readily available and this is best accomplished when the employer is responsible for the records. Additionally, OSHA believes that it is the employer, as the individual most familiar with his or her workplace, who is in the best position to institute appropriate recordkeeping provisions and to insure compliance, maintenance and confidentiality.
How records of exposure incidents could be maintained in a manner that would provide useful information to the employer, the employees and compliance officers without compromising employees' confidentiality was of concern to a number of commenters. Local 1199, The American Association of Occupational Health Nurses (AAOHN), AFSCME, and The National Institute for Occupational Safety and Health (NIOSH) commented that all needle sticks should be reportable on the OSHA 200 Log (Tr. 11/14/89, p. 379; Exs. 20-357; 297; and 634). OSHA has responded to these concerns by amending 29 C.F.R 1904.7 to require that when a log or a supplementary record contains information related to bloodborne pathogens the employer must assure that personal identifiers are removed prior to granting access to the record. (For a more thorough discussion of the amendment, see Amendment to Part 1904, above).
There was little public comment on what was required to be kept in the medical records, paragraph (h)(1)(ii)(A),(B),(C),(D) and (E). This was not surprising since the information is entirely related to the goal of preventing occupational illnesses caused by exposures to bloodborne pathogens and it is limited to that which is necessary for the employer to administer an effective HBV vaccination program and medical follow-up after an exposure incident, the employee and his or her healthcare provider to render adequate care, and OSHA to enforce the medical provisions of this standard.
Paragraph (h)(1)(iii) of the final standard states that the employer shall assure that the employee's medical record is kept confidential. Jeanette Wilke, R.N., President of the Association for Practitioners in Infection Control (APIC) of Northwestern Wisconsin and others agree that confidentiality of medical records is a universal standard of ethical conduct within the healthcare professions. (APIC, Ex. 20-108; St. John's Riverside Hospital, Ex. 20-783; American Nurses Association, Inc., Ex. 20-953; American Association of Critical Care Nurses, Ex. 20-1162). In addition, Monongahela Valley Hospital, Indiana Hospital, and Allegheny Valley Hospital pointed out that confidentiality of medical records is codified in state and federal regulations. (Exs. 20-270; 20-656; 20-966). This standard does not abridge, enlarge, or alter any existing ethical or statutory code, rather it is a reiteration of existing standards of conduct.
However, despite existing laws and ethical codes, there are many privacy concerns. OSHA has attempted to reduce concerns which may lead to barriers in exposure reporting by requiring that medical records, including all test results, be kept confidential except as otherwise required by law. Fear that co-workers or others may see test results may discourage the reporting of exposure incidents and the seeking of follow-up care. OSHA recognizes the sensitive nature of HIV testing and the possible repercussions should that test be positive.
The American Dental Association (ADA) expressed concern that any medical recordkeeping requirement could lead to breaches in confidentiality, especially in small dental offices. (Exs. 295; 20-665). This concern is based on an assumption that the dentist will physically maintain the complete medical record in his or her office. However, the dentist, like many other employers affected by this standard, would not be expected to be the primary healthcare provider to his or her employees. These employers will likely contract with a healthcare provider for vaccination and follow-up care, including the generation and maintenance of the employee's medical records. Thus, the employer's office files will include only the information required by paragraph (f)(5) above which is limited to a determination of whether an employee can receive the Hepatitis B vaccine; and, following an exposure incident, a statement that the employee has been told of any medical conditions resulting from exposure to blood or other potentially infectious materials which require further evaluation or treatment; and a determination of whether the employee can return to work after an exposure incident.
The College of American Pathologists and The Cleveland Clinic Foundation suggested that the confidentiality requirement is unrealistic where the employer is also the employee's healthcare provider, i.e. a physician or hospital. (Exs. 20-552; 20-563). OSHA believes the mere fact that the patient is an employee does not remove, lessen or make it unreasonable to expect the employer to keep the employee's medical records confidential. The American Society for Medical Technology concurs with OSHA's reasoning, stating that "[e]mployee medical records should be treated with the same respect and assurance of confidentiality as any other medical record." (Ex. 20-990, p. 14) They added that ". . . all medical records should be handled with the same assurance of confidentiality."(emphasis added) (Ex. 20-990, p. 14). OSHA concludes, and APIC of Northwestern Wisconsin and the Veterans Administration Hospital of Hines, Illinois agree that the approach taken by the final standard and existing ethical, legal and accreditation requirements adequately address the issue of confidentiality in the healthcare setting. (Exs. 20-108; 20-961).
NIOSH recommended that an additional paragraph be added which would require employers to develop a written confidentiality plan detailing, among other things, where records would be stored, how records would be secured, and who would have access. (Ex. 20-634). OSHA has considered this recommendation and has declined to adopt it because the Agency believes that this is an area where, because of the great variety of work-places, flexibility in methods of complying with the confidentiality requirement is needed. However, OSHA recognizes that voluntary development of such a plan can provide guidance to an employer; therefore, OSHA encourages employers to create and institute such plans in order to assist them with the confidentiality requirement of this standard.
Paragraph (h)(1)(iv) requires the employer to retain medical records for the duration of the employment plus thirty years. This time period is consistent with Access to Employee Exposure and Medical Records, 29 C.F.R. 1910.20 (d)(i)(1990). Retaining medical records for the period of employment plus thirty years is necessary because hepatocellular carcinoma, which can occur as a result of hepatitis B infection can, and indeed commonly does, take twenty to thirty years to develop. Individuals who become HBV carriers or develop chronic hepatitis are often ill and infected for the rest of their lives. Moreover, OSHA believes this is an appropriate time period, in light of the fact, that 5% of those exposed to HIV infected blood do not seroconvert within six (6) months. Finally, the time period for retention of records is consistent with other OSHA standards requiring retention of occupational medical records.
The comments received in opposition to the retention provision primarily objected to the length of time. The American Red Cross and The Academy of General Dentistry were among those who expressed objections citing that the time period was excessive, impractical and burdensome. (Exs. 20-207; 20-350). OSHA concludes that this provision is neither excessive nor impractical when viewed from the perspective of the employee. Vaccination records are an essential part of an employee's medical history. OSHA believes that retention of these records and exposure incident records is necessary to assist current and future healthcare professionals in assessing an employee's medical history and prescribing medical treatment. Additionally, OSHA believes that this requirement is not unduly burdensome, especially for an industry that is known for its long-term recordkeeping. Dr. David Eggleston, of the California Dental Association testified that the maintenance of the medical records would not be inconvenient for dentists because dental records of patients are literally being kept forever. (Tr. 1/11/90, pp. 329-330). Matilda Babbitz, RN of AAOHN testified in support of the provision, stating that it was also usual and customary for medical records covered by other OSHA standards to be kept for thirty (30) years. (Tr. 9/20/89, p. 47).
Home Health Service and Staffing Association, representing healthcare temporary service employers, suggested that the medical recordkeeping requirement be limited to two types of employees; all occupationally exposed employees who have worked more than 1200 hours per year for the same employer and all exposed employees who have incurred an exposure incident (Ex. 20-878). OSHA has considered these requests and decided not to incorporate them in the final standard because to distinguish between temporary and permanent employees would have defeated the purpose of preventing occupational illnesses among all healthcare workers who may reasonably be exposed to potentially infectious materials. Bloodborne pathogens do not discriminate among temporary, permanent or even full time and part time workers. In effect, this suggestion would allow employers to wait until an employee has worked seven and a half months (1200 hours/40 hours per week) before offering the HBV vaccine and establishing a medical record, unless there was a reported exposure incident. This could leave a substantial number of employees unprotected from potential occupational exposure. In addition, the HBV vaccination status of a substantial number of employees would likely remain unknown to the employer as well as the employee for approximately the first 7.5 months of employment. In effect, an employee's HBV vaccination status could potentially remain unknown for a significantly longer length of time if the employee changes jobs frequently. Finally, if the employee had an exposure incident during the initial 1200 hours of employment, the healthcare provider would be giving follow-up care without first receiving any pre-exposure information. For the aforementioned reasons, OSHA concludes that medical records are necessary for the protection of all employees occupationally exposed, regardless of the length of their employment. Therefore, the final standard requires that the employer maintain an accurate record for each employee with occupational exposure to bloodborne pathogens.
Paragraph (h)(2) of the final standard requires employers to maintain training records which include: (1) the dates of the training sessions, (2) the contents or a summary of the training session, (3) the names and qualifications of the persons conducting the training sessions, and (4) the names and titles of all persons attending the training sessions.
The American Association of Dental Schools(AADS) commented that: "AADS supports this [paragraph (h)(2)] requirement." (Ex. 20-651, p. 8). Monsour Medical Center agreed that "records of training should be kept-date, time, attendance, educator and evaluation of session." (Ex. 20-158, p. 2). Two commenters alluded to the fact that they already keep training records which would comply with this standard. (Frick Community Health Center, Ex. 20-292; High Point Regional Hospital, Ex. 20-1312). One of them, Frick Community Health Center, commented that accredited hospitals are already maintaining records of training sessions, summaries and attendance as required by the Joint Commission for Accreditation of Healthcare Organizations (JCAHO). (Ex. 20-292). Bernard Grothaus, DDS, testified that his practice conducts in-house training and he keeps records of who attended, and a summary of what was presented for three to four years (Tr. 10/19/89, pp. 534-535). The CDC commented that, ". . . training records, indicating dates of training sessions, the content of those training sessions along with the names of all persons conducting the training, and the names of all those receiving training. . ." should be maintained by the employer (Ex. 15, p. 7).
As indicated earlier, the overwhelming majority of the commenters did not address this portion of paragraph (h) in their comments or testimony. Again, OSHA believes that the lack of comment is due, in part, to the common understanding that instituting, maintaining and using training records are essential elements of any exposure control training program. However, a few commenters, although they agreed that training records were necessary, disagreed on the information the record should contain and the length of time the records should be retained.
Two commenters argued that the amount of information requested in the training record was excessive (Exs. 20-680; 20-11). One of the commenters, Laboratory Administrative Scientific Assembly of Northwestern Washington (LASSA NW), suggested that the record be limited to the name of the employee, nature of the training, and the date of training. (Ex. 20-680). This suggestion omits the job titles of the attending employees, and the name and qualifications of the trainer.
OSHA recognizes that employees may perform different tasks and are therefore exposed to risks of occupational illnesses in different ways. In these situations, the level of training will likely need to vary depending on the job. Helen Merie Miramontes, B.A., training consultant, testified that, in order
[t]o be effective, educational and training programs must address the specific needs of the different categories of healthcare workers. As an example, infection control educational needs of registered nurses would be different than the infection control educational needs of housekeepers.(emphasis added) (Tr. 9/13/89, p. 72)
OSHA concurs with Ms. Miramontes and maintains that accurate recordkeeping of the training session, including title of the employees who attended, is necessary to assist the employer and OSHA in determining whether the training program adequately addresses the risks involved in each job. Additionally, OSHA has concluded that requiring employers to list job titles of the employee will enable the employer to easily determine that employees with occupational exposure have received the proper level of training. Moreover, the employer is likely to find this information very useful in tracking the exposure incidents among various jobs with the level of training.
The ADA requested that minimum qualifications for the trainer not be specified in order to allow for training by video or commercial workbooks. (Ex. 20-665). Obviously, if there is no "live" trainer, the name of the trainer cannot be recorded. On the other hand, RWDSU commented that, "[a]udiovisual presentations should not be substituted for "live" training presentations. There must be a knowledgeable trainer available to answer questions and explain area-and-task specific protocols." (emphasis in original) (Ex. 20-1505, p. 7). Although OSHA agrees with the ADA that information can be presented in a variety of ways, including a video tape, the Agency has concluded that the presence of a knowledgeable person who can respond to employee concerns and questions at the training session is essential to the effectiveness of the training program. (See paragraph (g)(2)(vii) above for the criterion for the knowledgeable person). Ms. Miramontes testified, and OSHA agrees, that a qualified trainer is not only needed to disseminate the most current and accurate information, but the trainer is needed to receive feedback, answer questions, and evaluate the adequacy of the training program. (Tr. 9/13/89, pp. 71-72). Jordan Barab, Health and Safety Coordinator for AFSCME, adds that the trainer should also be familiar with the working conditions of the employees attending the training session. (Tr. 9/15/89, p. 85). He also testified that receiving no training is dangerous, but that receiving inaccurate training from an unqualified trainer may be worse because employees will lose trust in the training program. (Tr. 9/15/89, pp. 85-86). OSHA considered requests to specify minimum qualifications for the trainer, but decided instead to put the provision in performance language thereby requiring only that the trainer be knowledgeable in the subject matter. (For a fuller discussion of the trainer, see the explanation to paragraph (g)(2)(vii), above). Requiring the employer to keep a record of the name and qualifications of the knowledgeable person who was available to respond to employees at the training sessions will help ensure that the trainer actually conducted the sessions and will aid the employer in evaluating his or her training program.
Some dentists testified that many small private dental offices conduct informal training. They noted that this training often consists of on-the-job spontaneous discussions. (Tr. 10/19/89, p. 533, 536). While the performance approach of the training requirements allows a great deal of latitude in how and when information is presented to employees, more than informal discussions while work is being done is necessary to ensure workers are properly trained. Each employer will have to see that all the components of the program required by paragraph (g)(2)(vi) are covered in order to ensure that the employee training is complete. Moreover, a critical additional component of training is the maintenance of records which would be difficult, if not impossible to accomplish when informal discussions during work are substituted for a training program.
As noted above, the creation and maintenance of records will enable the employer to assess the content and completeness of the training program in order to ensure that his or her employees have received the required training. High Point Regional Hospital addressed this reason for keeping records when they commented that they already keep training records, and they conduct a review of the attendance records to make sure that all applicable employees have been trained. (Ex. 20-1312).
The time period for retention of training records is three years. These records are not considered to be confidential and may be maintained in any file. AADS and RWDSU, among others, support this portion of the recordkeeping requirement for training records (Exs. 20-651, 20-1505).
A few commenters believed that requiring employers to retain training records for several years is excessive and of questionable utility. (Exs. 20-655; 20-525; 20-39; 20-141). Most of these commenters were under the impression that a special file had to be established for each employee. OSHA did not intend to imply that employers had to establish and maintain individual training files for each employee, although many employers will keep the training records in each employee's personnel file. So long as the records are created and maintained the employer may choose how to keep them, in the employee's file or in a single file. This paragraph only requires that training records be maintained for three years and that they contain the prescribed information.
Of those employers who testified that they currently keep training records or employment records, OSHA learned that they typically retain the records long after the employees leaves. For example, a dentist, Dr. Howard Stone, testified that he has kept employment records for his long term employees of twenty two and nineteen years. (Tr. 10/19/89, p. 532). Dr. Stone further testified that for those "employees that left . . . their records are still in . . . [the] files. . . .[including]. . . [t]he last one that left . . . four years ago." (Tr. 10/19/89, p. 534). OSHA believes that three years is not a burdensome length of time given the fact that many employers already retain records for this period or longer. OSHA has concluded that training records need to be kept for three years to be of use to employer, the employee and OSHA in evaluating the effectiveness and adequacy of the training program.
Paragraph (h)(3) provides that employees shall be afforded unrestricted access to their medical records, in accordance with Access to Employee Exposure and Medical Records, 29 C.F.R. 1910.20(e)(1990), and to their training records in accordance with the Occupational Safety and Health Act of 1970, 8(c). This paragraph does not affect existing legal and ethical obligations concerning maintenance and confidentiality of employee medical records. An employer's access is governed by existing federal, state and local laws and regulations. A few commenters, including AAOHN, suggested that OSHA should include language in this portion of the paragraph expressly limiting employer access. (Abington Memorial Hospital, Ex. 20-557; St. Thomas Hospital, Ex. 20-890; Bethlehem Steel Corporation, 20-1105; Martin Lubin, AFSME, AFL-CIO, Tr. 11/14/89, p. 457). Other commenters believe such language is unnecessary because of existing laws. (Monongahela Valley Hospital, Inc., Ex. 20-270, Indiana Hospital, 20-656, Allegheny Valley Hospital, 20-966, Westmoreland Hospital, 20-1102). OSHA believes that the standard, as written, sufficiently limits employer access to confidential information while allowing the employer access to the information needed to make appropriate decisions regarding the employer's hepatitis B vaccination program, medical follow-up, and training. Paragraph (f) limits the information that can be included in the record and paragraph (h) requires that this information be kept confidential. Finally, there exists no language in this standard that grants an employer access to the confidential information in an employee's medical file.
In paragraph (h)(3)(ii), OSHA retains access to medical records in accordance with 29 C.F.R. 1910.20(e)(3). Monongahela Valley Hospital and San Antonio Community Hospital expressed concerns about the extent of OSHA's access to the employee medical records. (Exs. 20-270; 20-530). In clarification, OSHA's access to personally identifiable medical records is subject to regulations, published in the Rules of Agency Practice and Procedure Concerning OSHA Access to Employee Medical Records, 29 C.F.R. 1913.10 (1990), will protect the privacy concerns of the employees.
As proposed and consistent with other standards, OSHA also retains access to training records as authorized by Section (8)(c) of the Occupational Safety and Health Act of 1970.
Paragraph (h)(4)(i) provides that the employer shall comply with the requirements of 29 C.F.R. 1910.20(h) and Section 8 of the Act regarding the transfer of employee records. If an employer ceases to do business and there is no successor employer, paragraph (h)(4)(ii) requires the employer to notify NIOSH at least three months prior to the disposal of the records and to transmit them to the Director, upon request, for retention. AADS objected to the transfer of the medical records to NIOSH. Dr. John Green representing the AADS, testified that the transfer of records to NIOSH would present numerous problems in maintaining confidentiality. (Tr. 1/11/90, p. 291). AADS suggested that all confidential records on exposed employees should be transferred to the treating healthcare professional. OSHA believes that the goal of improving occupational safety and health will be better served if all occupational illness and training records are transferred to NIOSH, if requested. NIOSH has a vested interest in maintaining records of occupational injuries and illnesses and is in an excellent position to decide how the records can be best used to be of value to the exposed employee, subsequent employers in the field and OSHA. At NIOSH, the records remain confidential as required under 29 C.F.R. 1910.20(e). Thus, only the employee or his or her representative (with the permission of the employee) retains access to the medical records transferred to NIOSH.
Paragraph (i) Dates
The dates for compliance have been adjusted from those listed in the proposed standard. The final rule would become effective ninety (90) days after its publication in the Federal Register. This increase in the effective date is the result of testimony from several commenters that the proposed thirty(30) days was too short to allow for public distribution and to give employers time to familiarize themselves with the standard (Tr. 11/14/89, p.301; Exs. 20-1087; 20-1059, p.20). Although other commenters urged OSHA to implement a standard rapidly, it was felt that these concerns could be met by shortening the phase-in effective dates of the various provisions (Trs. 11/14/89, p. 460; 11/14/89,p.272; 11/14/89, p. 382).
The first phase-in effective date concerns the Exposure Control Plan. The Exposure Control Plan required by paragraph (c) (2) shall be completed within sixty (60) days of the effective date of the final standard. The Exposure Control Plan includes the Exposure Determination. Because the Exposure Determination has been streamlined to require only job classifications or groups of tasks, it is felt that this requirement can be met within this timeframe.
Paragraph (g)(2) Information and Training and paragraph (h) Recordkeeping shall take effect within ninety (90) days of the effective date. Although many commenters testified that more time was required to implement a full training program, provisions have been made in the final standard to recognize training about bloodborne pathogens provided in the year preceding the effective date of the standard and to require only training with respect to the provisions of the standard which were not included (Tr. 1/9/90, p.54; Exs. 20-1092; 20-621; 20-655; 20-556). Subsequent training is required annually thereafter or when changes affect the employee's occupational exposure. Little comment was received regarding the effective dates for implementing the recordkeeping requirements of the standard.
One hundred, twenty days (120) days after the effective date of the standard, the paragraphs regarding Engineering and Work Practice Controls (d) (2), Personal Protective Equipment(d) (3), Housekeeping (d) (4), HIV and HBV Research Laboratories and Production Facilities (e), Hepatitis B vaccination and Post-Exposure Follow-up (f) and Label and Signs (g) (1) shall take effect. Much of the comment revolved around the issue of implementation of the HBV vaccination program. OSHA recognizes that this vaccination series requires six months to complete. The standard requires that the HBV vaccination program be in effect within these dates; although employees may not have completed their series within 120 days after the effective date for the standard.
There were also concerns documented in the record about the time required to complete proposed medical exams (Exs. 20-940 , p.8; 20-217; 20-700, 20-199). These concerns were addressed by changes in the language of the standard regarding Hepatitis B vaccination (f) which allow for the vaccine program to be managed using appropriate healthcare providers. These changes will allow employers to implement this section using a wider variety of protocols and strategies.
A final concern about the effective dates for these sections was related to the availability of HBV vaccine. Although several commenters expressed concern about the vaccine availability, reassurances were received from the primary manufacturer that an adequate supply would be available within the time period (Exs. 20-847; 20-299; 20-154; 20-940).
Little further comment was received regarding the effective dates proposed for the other sections of the standard. It is useful to note that these dates all follow the effective dates for the final standard, which is ninety (90) days after the publication of the standard in the Federal Register. Planning for compliance, therefore, needs to be undertaken with these new dates in mind.
OSHA concludes that these dates provide sufficient time for the employer to become informed about the standard and to implement the provisions of this standard. At the same time, the dates are not excessively long and assure that all of the protection of the standard will be provided as soon as feasible.
The final standard contains an appendix designed to assist employers in implementing the provisions of this standard. Appendix A is incorporated as part of this standard and imposes additional mandatory obligations on employers covered by the standard. Paragraph (f)(2)(iv) of the standard requires the employer to assure that employees who initially decline to be vaccinated sign a statement declining the HB vaccination. Appendix A contains the mandatory language for the declination.
List of Subjects in 29 CFR Part 1910
AIDS, Hepatitis B, Human Immunodeficiency Virus, Hepatitis B Virus, Blood, Blood Diseases, Communicable Disease, Health, Healthcare, Health Professions, Hospitals, Protective Equipment, Immunization, Medical Research, Occupational Safety and Health.
- [56 FR 64004, Dec. 6, 1991; 57 FR 29206, July 1, 1992]
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