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Federal Register / Vol. o. 235 / Friday, December 6, 1991 / (I) Vacuum lines shall be protected with liquid disinfectant traps and high - efficiency particulate air (NEPA) filters or filters of equivalent or superior efficiency and which are checked routinely and maintained or replaced as necessary. ()) Hypodermic needles and syringes shall be used only for parenteral injection and aspiration of fluids from laboratory animals and diaphragm bottles. Only needle -locking syringes or disposable syringe -needle units (i.e., the needle is -integral to the syringe) shall be used for the injection or aspiration of other potentially infectious materials. Extreme caution shall be used when handling needles and syringes. A needle shall not be bent, sheared, replaced in the sheath or guard, or removed from the syringe following use. The needle and syringe shall be promptly placed in a puncture -resistant container and autoclaved or decontaminated before reuse or disposal. (K) All spills shall be immediately contained and cleaned up by appropriate professional staff or others properly trained and equipped to work with potentially concentrated infectious materials. (L) A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person. (M) A biosafety manual shall be prepared or adopted and periodically reviewed and updated at least annually or more often if necessary. Personnel shall be advised of potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them. (iii) Containment equipment. (A) Certified biological safety cabinets (Class I, II, or III) or other appropriate combinations of personal protection or physical containment devices, such as special protective clothing, respirators, centrifuge safety cups, sealed centrifuge rotors, and containment caging for animals, shall be used for all activities with other potentially infectious materials that pose a threat of exposure to droplets, splashes, spills, or aerosols. (B) Biological safety cabinets shall be certified when installed, whenever they are moved and at least annually. (3) HIV and HBV research laboratories shall meet the following criteria: (i) Each laboratory shall contain a facility for hand washing and an eye wash facility which is readily available within the work area. (ii) An autoclave for decontamination of regulated waste shall be available. (4) HIV and HBV production facilities shall meet the following criteria: (i) The work areas shall be separated from areas that are open to unrestricted traffic flow within the building. Passage through two sets of doors shall be the basic requirement for entry into the work area from access corridors or other contiguous areas. Physical separation of the high -containment work area from access corridors or other areas or activities may also be provided by a double-doored clothes -change room (showers may be included), airlock, or other access facility that requires passing through two sets of doors before entering the work area. (ii) The surfaces of doors, walls, floors and ceilings in the work area shall be water resistant so that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination. (iii) Each work area shall contain a sink for washing hands and a readily available eye wash facility. The sink shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area. (iv) Access doors to the work area or containment module shall be self- closing. (v) An autoclave for decontamination of regulated waste shall be available within or as near as possible to the work area. (vi) A ducted exhaust -air ventilation system shall be provided. This system shall create directional airflow that draws air into the work area through the entry area. The exhaust air shall not be recirculated to any other area of the building, shall be discharged to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified (i.e., into the work area). (5) Training Requirements. Additional training requirements for employees in HIV and HBV research laboratories and HIV and HBV production facilities are specified in paragraph (g)(2)(ix). (f) Hepatitis B vaccination and post- exposure evaluation and follow-up—(1) General. (i) The employer shall make available the hepatitis B vaccine and vaccination series to all employees whu have occupational exposure, and post- exposure evaluation and follow-up to all employees who have had an exposure incident. (ii) 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: (A) Made available at no cost to the employee; and Regulations 64179 (B) Made available to the employee at a reasonable time and place; (C) Performed by or under the supervision of a licensed physician or by or under the supervision of another licensed healthcare professional: and (D) Provided according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by this paragraph (f). (iii) The employer shall ensure that all laboratory tests are conducted by an accredited laboratory at no cost to the employee. (2) Hepatitis B Vaccination. (i) Hepatitis B vaccination shall 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 unless the employee has previously received the complete hepatitis B vaccination series, antibody testing has revealed that the employee is immune, or the vaccine is contraindicated for medical reasons. (ii) The employer shall not make participation in a prescreening program a prerequisite for receiving hepatitis B vaccination. (iii) If the employee initially declines hepatitis B vaccination but at a later date while still covered under the standard decides.to accept the vaccination, the employer shall make available hepatitis B vaccination at that time (iv) The employer shall assure that employees who decline to accept hepatitis B vaccination offered by the employer sign the statement in appendix A. (v) If a routine booster dose(s) of hepatitis B vaccine is recommended by the U.S. Public Health Service at a future date, such booster dose(s) shall be made available in accordance with section (3) Post -exposure Evaluation and Follow-up. Following a report of an exposure incident, the employer shall make immediately available to the exposed employee a confidential medical evaluation and follow-up, including at least the following elements: (i) Documentation of the route(s) of exposure, and the circumstances under which the exposure incident occurred; (ii) Identification and documentation of the source individual, unless the employer can establish that identification is infeasible or prohibited by state or local law: (A) The source individual's blood shall be tested as soon as feasible and