OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION
U.S. DEPARTMENT OF LABOR
THE SUBCOMMITTEE ON WORKFORCE PROTECTIONS
HOUSE EDUCATION AND THE WORKFORCE COMMITTEE
Mr. Chairman, Members of the Subcommittee, thank you for inviting me to testify about the Occupational Safety and Health Administration's (OSHA's) revised bloodborne pathogens compliance directive. I am pleased to have this opportunity to explain the directive and to talk about what OSHA is doing to eliminate or minimize the risk of needlesticks and other sharps injuries, and to tell what we learned from our Request for Information (RFI) on the current use of engineering and work practice controls in the workplace.
Bloodborne Pathogens are a Serious Hazard
OSHA published the final bloodborne pathogens standard in 1991 in response to the significant health risk associated with occupational exposure to blood and other potentially infectious materials. At that time, nearly six million workers in health care and related occupations faced exposure to bloodborne diseases. The standard applies to employees who have occupational exposure to the hazard, the presence of blood or other potentially infectious materials, whether or not a needlestick injury has occurred at the worksite. Diseases caused by bloodborne pathogens include, but are not limited to: Hepatitis B (from the Hepatitis B virus (HBV)); Hepatitis C (from the Hepatitis C virus (HCV)); acquired immunodeficiency syndrome (AIDS) (from the human immunodeficiency virus (HIV)); HTLV-I-associated myelopathy (from the human T-lymphotrophic virus Type 1 (HTLV-I)); diseases associated with HTLV-II; and malaria, syphilis, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, Creutzfeldt-Jakob (known as mad-cow) disease, and viral hemorrhagic fever. Many of these diseases are fatal, and at the time the standard was issued, OSHA predicted that each year the standard would prevent 5,058 - 5,781 occupational HBV infections and 113-129 Hepatitis B deaths.
The standard has been an enormous success. Since the standard was promulgated in 1991, the rate of occupationally acquired Hepatitis B infection has declined dramatically. I believe OSHA's standard, among other factors, contributed to the decline -- in particular the standard's requirement that employers provide and pay for Hepatitis B vaccines for employees exposed to blood or other potentially infectious materials. In 1987, there were 8,700 cases of Hepatitis B infection among health care workers. In 1995, just four years after publication of OSHA's standard, only 800 new cases related to occupational exposure were reported by the Centers for Disease Control and Prevention (CDC).
Despite the standard's success in addressing HBV, OSHA always has been and continues to be, concerned about injuries from needles and other sharps that are contaminated with blood or other potentially infectious materials, particularly in health care settings where employees are frequently exposed to needles and sharp instruments. Notably, needlesticks alone account for up to 80% of the occupational exposures to blood (Jagger, J. "Rates of needlestick injury caused by various devices in a university hospital." New England Journal of Medicine. 319(5): 284-8; 1988). The health research community estimates 600,000 to 800,000 needlestick injuries occur annually -- on average that is one incident a year for every seven health care workers. According to the CDC, about half of needlestick injuries go unreported. CDC has stated that an average hospital incurs approximately 30 worker needlestick injuries per 100 beds per year. Most reported needlestick injuries involve nursing staff. However, CDC indicates that laboratory staff, physicians, housekeepers, dental assistants, and other health care workers have also experienced needlestick injuries -- and are still being injured. (National Institute of Occupational Safety and Health (NIOSH) Alert, "Preventing Needlestick Injuries in Health Care Settings" (CDC, 1999)). Because such injuries continue to be the primary source of occupational exposure to bloodborne pathogens, OSHA and other public health agencies are stressing the importance of reducing these risks.
Between 1985 and December 1999, the CDC reported 56 documented cases of occupationally acquired HIV infections in health care workers and an additional 136 cases of possible occupational HIV transmissions. The risk of contracting Hepatitis C, for which there also is no vaccine, and no cure, is far greater.
Before proceeding to discuss the risk faced by health care workers from HCV, I would like to provide some background on this little-known disease. HCV infection often occurs with no symptoms, or only mild symptoms. But, according to the CDC, "chronic infection develops in 75% to 85% of patients, with active liver disease developing in 70%. Of the patients with active liver disease, 10% to 20% develop cirrhosis, and 1% to 5% develop liver cancer." (NIOSH Alert, "Preventing Needlestick Injuries in Health Care Settings"). Population-based studies indicate that 40% of chronic liver disease is HCV-related, resulting in an estimated 8,000-10,000 deaths each year. In addition, HCV-associated end-stage liver disease is the most frequent indication for liver transplantation among adults (MMWR October 16, 1998, Vol. 47 (RR19);1-39).
A health care worker's risk of exposure to HCV is much higher than the risk of exposure to HIV. The risk is increased in part because the frequency of HCV in the population far outstrips the frequency of HIV. According to the CDC, 3.9 million Americans have been infected with HCV (MMWR October 16, 1998, 1-39). In comparison, the number of people living with HIV is estimated to be between 650,000 and 900,000 (CDC Update, "How Many People Have HIV & AIDS," May 1999). Because more Americans have HCV than HIV, health care workers face a greater risk of encountering a patient with HCV than a patient with HIV. Of the total acute Hepatitis C infections that occurred in 1995, the CDC estimates that 2%-4%, or 720-1400, were in health care workers exposed to blood in the workplace. (MMWR October 16, 1998, 1-39). Although we do not know how many of these cases are attributable to needlesticks or others sharps injuries, we do know that the transmission rate for HCV percutaneous injuries is higher than that for HIV: the CDC estimates an average transmission rate of 0.3% per injury for HIV, as compared to an average transmission rate of 1.8% for HCV. Both this higher transmission rate, and the higher frequency of HCV occurrence in the general population, lead to the conclusion that health care workers face a significant threat from HCV through needlestick and sharps injuries.
The Standard (29 CFR 1910.1030)
The bloodborne pathogens standard contains provisions which were designed and written to be performance-oriented. In other words, the goals of the standard are clearly stated, yet many aspects of the rule give employers considerable flexibility in choosing the methods most feasible for accomplishing those goals. Thus, the standard directs employers to use engineering controls and work practices to eliminate or minimize employee exposure to bloodborne pathogens, but it does not list or specify particular engineering controls (such as which medical devices) that employers must use. This approach allows the rule to take into account the continual progress of medical research and technology and the diversity of workplaces and workplace operations and processes, and allows the employer to determine what engineering controls will provide the best protection.
A central provision of the bloodborne pathogens standard clearly demonstrates its flexible, performance-oriented nature: paragraph (c) of 29 CFR Part 1910.1030 requires employers to develop a written exposure control plan (ECP) that addresses, among other things, the site-specific engineering, work practice, and administrative controls the employer will use to prevent exposure to bloodborne pathogens for workers who have an ongoing occupational risk. In other words, the employer creates a plan that is tailored to the conditions of that employer's work place. The ECP must also include the procedures for evaluating circumstances surrounding an exposure incident. The ECP is used to identify exposed or potentially exposed workers, i.e., those who need training, personal protective equipment, access to vaccinations, and treatment if an exposure incident occurs.
OSHA believes the key to preventing needlesticks and other sharps injuries lies in a comprehensive strategy - a programmatic approach through which employers: 1) use the ECP to evaluate the hazards at their specific facility, 2) provide appropriate employee training for the safe and effective use of new equipment, and 3) evaluate the results and make changes accordingly. OSHA has found this strategy to be more successful when employees are involved in the safer device selection process. This overall approach is highlighted in the current compliance directive, which I will discuss in a moment.
OSHA is Addressing the Continuing Risk
Notwithstanding the success of the standard, OSHA recognizes a need to emphasize specifically the continuing problem of needlesticks and other sharps injuries. Prior to OSHA's decision to revise the bloodborne pathogens standard compliance directive, the agency received suggestions to implement an emergency temporary standard mandating the use of safer devices, and to reopen the bloodborne pathogens standard. Additionally, OSHA is currently considering, as recommended by the Senate Appropriations Committee, a revision to the recordkeeping rule to require that all exposure incidents resulting from contaminated needles and other sharps be recorded on OSHA injuries and illnesses logs. Of course, any new rule would be drafted with strong privacy and security safeguards. We are also aware of other Congressional interest in this area. Last year Senator Barbara Boxer and Representatives Pete Stark and Marge Roukema introduced legislation entitled the "Health Care Worker Needlestick Prevention Act" (S. 1140/H.R. 1899). The Department of Labor expressed support for the intent of the bills in October 1999 letters from Secretary Alexis Herman to Chairman Jim Jeffords, Senator Boxer, and Representative Stark.
The Request for Information (RFI)
Since the promulgation of the bloodborne pathogens standard, the agency, along with the medical and scientific community, has been aware of the continuing problem of needlesticks and other sharps injuries. However, concrete data on the penetration, acceptance and effectiveness of engineered sharps injury prevention devices were hard to collect, or even find. Therefore, in the Spring of 1998, OSHA began developing an RFI to gather information and data from the public. OSHA was interested in learning which strategies for reducing injuries associated with transmission of bloodborne pathogens were being successfully implemented in workplaces, and we asked for ideas and recommendations on ways to better protect workers from contaminated needles or other sharp instruments. The RFI solicited information on many aspects of percutaneous (through the skin) injury prevention. Sixteen questions were carefully developed to draw responses about the types of work settings where such injuries occur; percutaneous injury surveillance; use, evaluation, and effectiveness of control methods; and economic factors associated with the control of needlestick and other sharps injuries. The RFI was published in the Federal Register on September 9, 1998, with a 90-day comment period. OSHA received 396 responses. More than 300 health care facilities provided comments, including nursing homes and clinics; acute care, and rehabilitation facilities, and pediatric hospitals. The Department of Veterans' Affairs, the largest health care provider in the Nation, submitted valuable information on its on-going needlestick prevention program. Several organizations submitted combined responses on behalf of members representing more than 130 additional health care facilities. Individual health care workers, researchers, unions, educational institutions, professional and industry associations, and manufacturers of medical devices also responded.
OSHA released a summary of the comments in May 1999. We learned three critical things from the responses we received: 1) a variety of safer devices were already being used in a number of workplaces to protect workers from needlestick and sharps injuries; however, these devices were not being used widely enough to reduce the overall risk substantially; 2) training and education in the use of safer medical devices and safer work practices have proven effective in preventing exposures in these workplaces; and 3) employee involvement in the selection process can play an important role in the acceptance and proper use of safer medical devices.
"Safer devices" refers to the new technology that has been developing in the past several years to reduce the risk of needlesticks and other percutaneous injuries through elimination of the sharp or incorporation of safety features into a conventional sharp device (e.g. hypodermic syringe/needle). OSHA encourages employers to involve employees in the selection of effective engineering controls to improve employee acceptance of the newer devices and to improve the quality of the selection process. Examples of this technology include needleless devices, shielded needle devices, self-sheathing needles, self-blunting needles, and plastic capillary tubes. There are hundreds of these devices on the market, and this industry is constantly developing new devices. However the design quality and practical effectiveness of the devices in reducing injuries vary considerably.
The November 5, 1999, Compliance Directive
Compliance directives guide OSHA's compliance officers in enforcing standards by providing instruction and ensuring that consistent inspection procedures are followed. OSHA recognizes that employers and other members of the public have an interest in the guidance OSHA provides to its compliance staff, and therefore we make such guidance documents available to the public and post them on our website.
OSHA used a thorough and considered review process to develop the revised directive for the bloodborne pathogens standard. Our industrial hygienists, occupational health nurses, occupational physicians, and public health specialists provided a wealth of professional expertise, including wide experience in hazard control. Additionally, OSHA's attorneys reviewed the directive for consistency with the bloodborne pathogens standard. OSHA also drew upon almost 400 responses to the RFI and information from experts at the CDC, the Food and Drug Administration (FDA), and the Training for Development of Innovative Control Technology Project (TDICT).
I want to emphasize that the current directive is a restatement, clarification and further explanation of the requirements of the bloodborne pathogens standard. It does not amend the standard or create new legal duties, obligations or defenses. But while the standard has not changed, control technology and medical treatment have. In the years since the standard was promulgated, the ability to control exposure to, and transmission of, bloodborne pathogens has improved significantly. These developments, along with what we learned from the RFI, provided the impetus to update the compliance directive.
There are five main areas where additional instruction has been incorporated into the new compliance directive. These areas include: an emphasis on the annual review of the ECP; a clarification of how employers must evaluate and implement engineering controls; a description of necessary employee training; new medical recommendations from the CDC; and, an explanation of the applicability of the bloodborne pathogens standard in multi-employer worksites.
Exposure Control Plan [29 CFR 1910.1030 (c)]
Under the standard, employers must review and update their ECP at least annually, which ensures that it remains current with the latest information and scientific knowledge concerning bloodborne pathogens. The ECP requires the employer to identify those tasks and procedures in which occupational exposure may occur, the individual workers who need to receive training, protective equipment, vaccinations and other protections of the standard, including the provision of engineering controls. In light of the increased use and acknowledged feasibility of safer medical devices, the ECP must document the employer's consideration and implementation of appropriate, commercially available and effective engineering controls. The annual review and update of the plan ensures that it, and the employer's efforts, reflect changes in technology, such as the use of effective engineering controls - safer medical devices - that can eliminate or minimize employee exposures at that workplace. The current CPL includes a sample "fill-in-the-blanks" exposure control plan as an appendix.
Engineering Controls and Work Practices [29 CFR 1910.1030 paragraph (d)(2)]
Under the standard, employers are required to institute engineering and work practice controls as the primary means of eliminating or minimizing employee exposure. Employers must use engineering and work practice controls that eliminate occupational exposure or that reduce it to the lowest feasible extent. The CPL clarifies this intent by stating that "where engineering controls will reduce employee exposure either by removing, eliminating or isolating the hazard, they must be used." Through the mandatory exercise of the annual review of the ECP, employers are required to evaluate workplace exposures to bloodborne hazards and make changes to their ECP which include the consideration and implementation of new technology - safer medical devices and safe work practices - where feasible. This requirement was stated in the preamble to the standard in 1991, and also reiterated in the 1992 compliance directive. Where implementation of engineering controls for a particular procedure are found to be infeasible, the employer should document this in the ECP and explain why no controls could be utilized. OSHA does not advocate the use of one particular device over another; however, in light of the increased use and acknowledged feasibility of safer technology, as demonstrated by the responses to OSHA's RFI, it is clear that some form of engineering control use will be feasible to prevent or minimize most workplace sharps exposures.
Training [29 CFR 1910.1030(g)(2)]
The CPL explains that the standard requires initial and annual refresher "interactive" training sessions where employees must be able to ask questions of the person conducting the training, and to receive immediate answers. This type of training may be supplemented with the use of films or videos, as long as employees are provided an opportunity for discussion. Interactive training is important to ensure that new devices are used correctly. Many of those who responded to the RFI confirmed the need for effective and thorough training to achieve successful implementation of safer medical devices.
New Medical Information
The standard [29 CFR 1910.1030 (f)(3)(iv)] requires employers to incorporate the medically indicated recommendations of the U.S. Public Health Service (USPHS) for post-exposure prophylaxis and follow-up. The CDC is the USPHS agency responsible for making these recommendations. The CPL underscores the standard's requirement that employers use CDC guidelines current at the time of the evaluation or procedure. The most recent CDC guidelines included as appendices to the current CPL include: the December 26, 1997, "Immunization of Health-Care Workers: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the Hospital Infection Control Practices Advisory Committee (HICPAC)" addressing Hepatitis B; the May 15, 1998, "Public Health Service Guidelines for the Management of Health-Care Worker Exposures to HIV and Recommendations for Post-Exposure Prophylaxis;" and the October 16, 1998, "Recommendations for Prevention and Control of Hepatitis C Virus (HCV) Infection and HCV-Related Chronic Disease."
The directive also includes instructions on inspection procedures for multi-employer worksites, that are covered by the standard, which may involve, for example, employment agencies, personnel services, home health services, independent contractors, and physicians in independent practice.
In addition to the specific changes in the new directive, I would like to describe our outreach efforts. Since the rule was promulgated, OSHA has made available to the public a large variety of educational materials and technical information, as well as a great deal of guidance to assist employers in complying with the bloodborne pathogens standard. For instance, OSHA has set up a detailed "Technical Links" webpage that allows users to access multiple references from the CDC, the FDA, and other recognized experts in this field such as the University of Virginia's International Healthcare Worker Safety Center (responsible for EPINet, the Exposure Prevention Information Network database) and TDICT. We have continued these efforts by including several helpful resources in the appendices of the revised compliance directive: a list of the typical committees found in health care facilities; sample engineering control evaluation forms; a sample ECP; and an Internet resource list.
OSHA provides additional assistance through our ten Regional Bloodborne Pathogen Coordinators - one located in each of OSHA's regional offices. The Coordinators may be contacted on an individual basis whenever an employer, employee or OSHA staff person has questions. In order to ensure OSHA's compliance personnel were aware of the new emphasis on the importance of updating the ECP and the implementation of existing technology as required by the engineering control sections of the standard, OSHA conducted an all-OSHA training session in February of this year in Atlanta. Over 175 persons attended this training session. Attendees included compliance officers from across the country, Regional Bloodborne Pathogens Coordinators, State Plan personnel, and representatives from OSHA's Consultation programs. It is important for OSHA's Consultation staff to know how OSHA enforces the rule, so that they can share this information with affected employers. OSHA's Consultation program provides free on-site assistance, and conducts numerous training and outreach programs for small employers.
In recent years, along with our outreach and education efforts to reduce needlesticks and other sharps injuries, OSHA has begun to emphasize the enforcement of occupational health and safety standards for health care workers, and in particular, enforcement of the bloodborne pathogens standard.
OSHA identifies high hazard work sites for inspections through our annual Data Initiative, a survey that collects lost workday injury and illness (LWDII) rate data from 80,000 establishments. When the Data Initiative first began, hospitals were not part of the surveyed population; therefore, no comprehensive inspections were scheduled in this sector. A small number of hospitals are being inspected this year under a pilot program involving data from the 1998 survey. This year's Data Initiative Survey, using 1999 data, includes 1,169 hospitals and we expect this to result in a higher number of comprehensive inspections.
We believe that implementation of the new compliance directive will provide our compliance officers with the information they need to effectively enforce the bloodborne pathogens standard, and raise employer awareness of, and compliance with, the standard. I am confident that employers will find the new information in the revised compliance directive to be helpful. With more than 600,000 needlesticks or other sharps injuries each year, OSHA, employers, and employees must be proactive. It is in the country's best interest to care for the people who care for us. Ensuring that health care workers are protected from contracting deadly or debilitating diseases is the goal of our revised compliance directive.