OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) as amended pursuant to the Needlestick Safety and Prevention Act of 2000, prescribes safeguards to protect workers against the health hazards caused by bloodborne pathogens. Its requirements address items such as exposure control plans, universal precautions, engineering and work practice controls, personal protective equipment, housekeeping, laboratories, hepatitis B vaccination, post-exposure follow-up, hazard communication and training, and recordkeeping. The standard places requirements on employers whose workers can be reasonably anticipated to contact blood or other potentially infectious materials (OPIM), such as unfixed human tissues and certain body fluids.
The Needlestick Safety and Prevention Act (the Act) (Pub. L. 106-430) was signed into law on November 6, 2000. Because occupational exposure to bloodborne pathogens from accidental sharps injuries in healthcare and other occupational settings continues to be a serious problem, Congress required modification of OSHA's Bloodborne Pathogens standard (29 CFR 1910.1030) to set forth in greater detail (and make more specific) OSHA's requirement for employers to identify, evaluate and implement safer medical devices such as needleless systems and sharps with engineered sharps protections. The Act also mandated additional requirements for maintaining a sharps injury log and for the involvement of non-managerial healthcare workers in identifying, evaluating and choosing effective engineering and work practice controls. These are workers who are responsible for direct patient care and be potentially exposed to injuries from contaminated sharps.
The Act directed OSHA to revise its Bloodborne Pathogens standard (29 CFR 1910.1030). OSHA published the revised standard in the Federal Register on January 18, 2001; it took effect on April 18, 2001. The requirement to implement the use of engineering controls, which includes safer medical devices, has been in effect since 1992.
States and territories that operate their own OSHA-approved state programs are required to adopt a Bloodborne Pathogens standard that is at least as effective as the Federal OSHA standard.
The 25 states and two territories that operate OSHA-approved state plans are required to enforce an "at least as effective" standard in the public sector. In the remaining states where Federal OSHA has jurisdiction, hospitals in the public sector are required to comply with the Bloodborne Pathogens standard with enforcement by the Centers for Medicare and Medicaid Services (42 U.S.C. 1395cc(a)(1)(V) and (b)(4)).
OSHA's Bloodborne Pathogens standard, including its 2001 revisions, applies to all employers who have an employee(s) with occupational exposure (i.e., reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials (OPIM) that may result from the performance of the employee's duties). These employers must implement the requirements set forth in the standard. Some of the new and clarified provisions in the standard apply only to healthcare settings, but other provisions, particularly the requirements to update the Exposure Control Plan and to keep a sharps injury log, apply to non-healthcare as well as healthcare settings.
The standard states, "engineering and work practice controls shall be used to eliminate or minimize employee exposure." The 2001 revision defines engineering controls as "controls (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps with engineered sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace." Employers who have employees exposed to contaminated sharps must consider and implement appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure. Also, employees with occupational exposure must be trained in the use and limitations of methods that will prevent or reduce exposure, including appropriate engineering controls, work practices and personal protective equipment. Therefore, training must include instruction on any new techniques and practices associated with new engineering controls.
Yes. OSHA standards are intended to be implemented as a means to prevent occupational injuries and illnesses. To most effectively avoid percutaneous injuries from contaminated sharps, employers must implement engineering controls, including safer medical devices, so that employees have them available to use.
Small medical offices may want to seek input from all occupationally exposed employees when making their decisions. Larger facilities are not required to request input from all exposed employees; however, the employees selected should represent the range of exposure situations encountered in the workplace (e.g., pediatrics, emergency department, etc.). Regardless of the number chosen, in order to be included in the process the workers must be responsible for direct patient care and be potentially exposed to injuries from contaminated sharps. The solicitation of employees who have been involved in the input and evaluation process must be documented in the Exposure Control Plan.
No. OSHA does not approve or endorse any product. It is the employer's responsibility to identify and implement appropriate, commercially available and effective safer medical devices for the specific medical procedures being conducted.
A key element in choosing a safer medical device, other than its appropriateness to the procedure and its effectiveness, is its availability on the market. If there is no safer option to the medical device that you are using for a particular procedure, you are not required to adopt a device different from the one currently being used. During your annual review of devices, you must consider new or prospective safer options and document this fact in your written Exposure Control Plan. With advances in medical technology, more devices are becoming available for different procedures. If no engineering control is available, work practice controls shall be used and, if occupational exposure still remains, personal protective equipment must also be used.
If, as an employer, you are required to maintain a log of occupational injuries and illnesses under 29 CFR Part 1904, you must also establish and maintain a sharps injury log for recording percutaneous injuries from contaminated sharps. The sharps injury log must contain, at a minimum, the type and brand of device involved in the injury (if known), the department or work area where the exposure incident occurred, and an explanation of how the incident occurred. The log must be recorded and maintained in a manner that protects the confidentiality of the injured worker (e.g., removal of personal identifiers).
OSHA's Bloodborne Pathogens standard applies to all employers with employees who have occupational exposure to blood or other potentially infectious materials (OPIM), regardless of how many workers are employed. However, the offices and clinics of medical doctors and dentists are exempt from the requirement to keep a log of occupational injuries and illnesses and thus exempt from maintaining a sharps injury log. (See Appendix A to Subpart B of 29 CFR Part 1904.) All other applicable provisions of the Bloodborne Pathogens standard still apply.
The required elements of an ECP are:
Methods of compliance include:
The ECP must 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 positions with occupational exposure.
The employer would not be required to provide a sharps container to an employee using insulin syringes for personal therapeutic reasons. To eliminate potential exposures to other workers, however, the employer could require that the employee provide his or her own workplace sharps container.
OSHA's position is that EPA-registered tuberculocidal disinfectants, diluted bleach solutions and EPA-registered disinfectants that are labeled as effective against both HIV and HBV as well as Sterilants/High-Level Disinfectants cleared by the FDA, meet the requirement in the standard and are "appropriate" disinfectants to clean contaminated surfaces, provided that such surfaces have not become contaminated with agent(s) or volumes of or concentrations of agent(s) for which higher level disinfection is recommended.
It is important to emphasize the EPA-approved label section titled "SPECIAL INSTRUCTIONS FOR CLEANING AND DECONTAMINATION AGAINST HIV-1 AND HBV OF SURFACES\OBJECTS SOILED WITH BLOOD\BODY FLUIDS." These instructions require:
29 CFR 1910.1030(f)(1)(ii)(D) takes into consideration the changing nature of medical treatment relating to hepatitis B. OSHA requires use of the U.S. Public Health Service (USPHS) guidelines current at the time of the evaluation or procedure. The most current guidelines regarding hepatitis B is the Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Postexposure Prophylaxis in MMWR, Vol. 50, No.11, June 29, 2001. The hepatitis B vaccination must be given in the standard dose and through the standard route of administration, as recommended in the guidelines. Employees who have ongoing contact with patients or blood and are at ongoing risk for percutaneous injuries must be tested for antibody to hepatitis B surface antigen, one to two months after the completion of the three-dose vaccination series. Employees who do not respond to the primary vaccination series must be revaccinated with a second three-dose vaccine series and retested. Non-responders to the second series must be medically evaluated.
The Bloodborne Pathogens standard covers all workers in the private sector as well as civilian employees of federal entities. State and local government employees are covered if they are in one of the 25 states and two territories that operate their own OSHA-approved state plans. In the remaining jurisdictions, where Federal OSHA has authority, hospitals operated by state, territorial or local governments are required to provide the protection of the Bloodborne Pathogens standard to their employees with enforcement by the Centers for Medicare and Medicaid Services (42 U.S.C. 1395cc(a)(1)(V) and (b)(4)).
Additionally, the CDC recommends that all vaccination clinics comply with the Bloodborne Pathogens standard's provisions.
There are several resources available for employers and employees with regard to occupational exposures to blood and OPIM. First is the OSHA Bloodborne Pathogens standard (29 CFR 1910.1030). Also available are CPL 2-2.69 (November 2001) Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, and many other related documents. This information can be found on OSHA's Bloodborne Pathogens and Needlestick Prevention Web Page. You may access additional information, such as information from OSHA's Consultation and State Plan State Offices, via OSHA's website or by phone at 1-800-321-OSHA (6742). CDC and the National Institute for Occupational Safety and Health (NIOSH), a CDC agency, also have documents related to the prevention of occupational exposure to blood and OPIM available.
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