THE COLLEGE OF WILLIAM AND MARY Environment, Health, & Safety Office I. INTRODUCTION A. Purpose The Occupational Safety and Health Administration (OSHA) has issued Standard 29 CFR 1910.1030 which mandates the implementation of specific measures to minimize the exposure of employees to human blood and other potentially infectious materials. In order to comply with the OSHA requirement, each employer having employees whose reasonably anticipated duties may result in an occupational exposure to such materials must establish a written infection-control plan based on the standard and designed to minimize or eliminate employee exposure. A copy of this plan must be made available to the Assistant Secretary of Labor for Occupational Safety and Health or a designated representative for examination upon request. The infection control plan must be reviewed and updated as necessary to reflect significant changes in tasks or procedures. Although the OSHA regulation primarily is intended to minimize the risk of exposure to pathogens derived from humans, the operating practices described in the regulation and in this Infection Control Plan are applicable to situations where there is potential for infection from any source. B. Scope The College of William & Mary Bloodborne Pathogens Exposure Control Plan applies to all faculty, staff, and students while engaged in any College officially directed or sponsored research or activity on or off campus which may have the potential to cause occupational exposures as defined in section C below. Individual and managerial responsibility and authority are as stipulated in the basic portion of the College’s Comprehensive Safety and Health Plan. C. Important Definitions 1. Blood - Any human blood, human blood components, or products made from human blood. 2. Bloodborne Pathogens - Pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV). 3. Clinical Laboratory - A workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. 4. Disinfect - Means to inactivate virtually all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g. bacterial endospores) on inanimate objects. 5. Employee - For the purpose of this plan, all VIMS/SMS faculty, staff, and students are considered employees. 6. Engineering Controls - Controls that isolate or remove the hazard from the workplace. 7. Exposure Incident - A specific eye, mouth, other mucous membrane, non-intact skin, or parenteral contact with blood or other potentially infectious materials that results from the performance of an employee's duties. 8. Infectious Waste - Blood and blood products, contaminated sharps, pathological wastes, and microbiological wastes. 9. Occupational Exposure - Any 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. This definition excludes incidental exposures that may take place on the job and that are neither reasonably nor routinely expected to occur in the normal Revision Date: May 30, 2006 1 course of employment. 10.Other Potentially Infectious Material - Semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, and any body fluid that is visibly contaminated with blood. Any unfixed tissue or organ (other than intact skin) from a human (living or dead), or any HBV/HIV infected human or animal tissue, organ, or culture, solution, blood organ, or culture medium. 11. Personal Protective Equipment - Specialized clothing or equipment worn by an employee to protect him/her from a hazard. 12. Sharps - Any object that can penetrate the skin including but not limited to needles, scalpels, and broken glass. 13. Sterilize - The use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. 14. Universal Precautions - A method of infection control in which all human blood and certain human body fluids are treated as if known to be infectious for HBV, HIV, and other bloodborne pathogens. 15. Work Practice Controls - Controls that reduce the likelihood of exposure by altering the manner in which a task is performed. D. Exposure Determination Each employer who has employee's with occupational exposure as defined in paragraph C 9 above must 1. Identify and document those tasks and procedures where occupational exposures may take place. 2. Identify and document all positions with occupational exposure. 3. Make the exposure determination without regard to the use of personal protective equipment. The responsibility for carrying out the requirements of this paragraph rests with the Principle Investigator for the research grant/contract or the respective faculty monitor in the case of students. A list of those personnel who may fall under the criteria set forth in this appendix must be forwarded to the Office of Safety and Environmental Programs. II. METHODS OF COMPLIANCE A. General Universal precautions shall be observed to prevent contact with blood and other potentially infectious materials. B. Engineering and Work Practice Controls Engineering controls are used in conjunction with work practices and must be examined, maintained, or replaced on a scheduled basis to ensure their effectiveness. Use puncture-resistant, leak-proof containers, color-coded red or labeled, according to the standard (see section K) to discard contaminated items such as needles, broken glass, or scalpels that might cause a cut or puncture wound. Store and process reusable contaminated sharps in a way that ensures safe handling. For example, use a mechanical device to retrieve used instruments from soaking pans in decontamination areas. Revision Date: May 30, 2006 2 Work practice controls reduce the likelihood of exposure by altering the manner in which the task is performed. Al procedures shall minimize splashing, spraying, splattering, and generating droplets. Work practice controls include the following: 1: Wash hand immediately or as soon as possible after removal of gloves or other personal protective equipment and hand contact with blood or other potentially infectious material. 2: All personal protective equipment shall be removed following contamination and upon leaving the work area and shall be placed in an appropriately designated area or container for storage, washing, decontamination, or disposal. 3: Provide and make available a mechanism for immediate eye irrigation in the event of an exposure incident. 4: Do not bend, break, recap, or remove contaminated needles unless required to do so by specific medical procedures or the employer can demonstrate that no alternative is feasible. In these instances, use mechanical means such as forceps or a one handed technique to recap or remove contaminated needles. 5: discard contaminated needles and sharp instruments in puncture-resistant, leak-proof, red or biohazard-labeled containers that are accessible, maintained upright, and not allowed to be overfilled. 6: Do not store food or drink in refrigerators or on shelves where blood or potentially infectious materials are present. 7: Do not use mouth pipetting. 8: Do not eat, drink, apply cosmetics, or handle contact lenses is areas of potential occupational exposure. C. Personal Protective Equipment When there is a potential for occupational exposure, supervisors shall provide and ensure that personal protective equipment is used. This includes but is not limited to gloves, gowns, fluidproof aprons, laboratory coats, head and foot coverings, face shields or masks, and eye protection. All personal protective equipment in the appropriate sizes must be readily accessible in the work area or issued as required. Hypoallergenic gloves shall be readily accessible to those personnel who are allergic to the gloves normally provided. The supervisor shall provide for the cleaning, laundering or disposal, and repair or replacement of personal protective equipment needed to ensure compliance with OSHA requirements. Specific instructions regarding the type and use of personal protective equipment follows: 1. Gloves - Gloves shall be worn when the potential exists for the hands to have direct skin contact with blood, other potentially infectious materials, and non-intact skin and when handling items or surfaces soiled with blood or other potentially infectious materials. Disposable (single use) gloves such as surgical or examination gloves shall be replaced as soon as possible when visibly soiled, torn, punctured, or when their ability to function as a barrier is compromised. They shall not be washed or disinfected for re-use. Utility gloves may be disinfected for re-use if the integrity of the glove is not compromised, however they must be discarded if they are cracked, peeling, discolored, torn, punctured, or exhibit other signs of deterioration. 2. Masks, Eye Protection, and Face Shields - Masks and eye protection or chin-length face shields shall be worn whenever splashes, spray, spatter, droplets, or aerosols of blood or other potentially infectious materials may be generated and there is a potential for eye, nose, or mouth contamination. 3. Gowns, Aprons, and Other Protective Body Clothing - The type and characteristics will depend Revision Date: May 30, 2006 3 upon the task and degree of exposure anticipated; however, the clothing selected shall form an effective barrier. Gowns, lab coats, aprons, or similar clothing shall be worn if there is a potential for soiling of clothes with blood or other potentially infectious materials. Fluid-resistant clothing, surgical caps, or hoods shall be worn if there is a potential for splashing, spraying, or splattering of blood or other potentially infectious materials. Fluid-proof clothing and fluid-proof shoe covers shall be worn if there is a potential for clothing or shoes to become soaked or contaminated. D. Housekeeping Supervisors shall ensure that the work area is maintained in a clean and sanitary condition. Each work area shall implement an appropriate written schedule for cleaning and method of disinfection based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed. All equipment and work surfaces shall be cleaned and decontaminated with an appropriate disinfectant after completion of procedures, immediately after any spill of blood or other potentially infectious materials, and at the end of the work day. Equipment which may become contaminated must be cleaned and disinfected prior to any servicing or shipping. Protective coverings such as plastic wrap, aluminum foil or imperviously-backed absorbent paper may be used to cover equipment and environmental surfaces. They shall be replaced as necessary,. All bins, pails, cans, and similar receptacles intended for reuse shall be inspected, cleaned, and disinfected on a regular basis. They shall be cleaned and disinfected immediately or as soon as possible upon visible contamination. 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 a brush and dust pan, a vacuum cleaner, tongs, cotton swabs, or forceps. E. Specimens Specimens of blood or other potentially infectious materials shall be placed in a closable, leakproof container labeled or color-coded according to Section K of this plan prior to being stored or transported. If outside contamination of the primary container is likely, then a second leakproof container that is labeled or color-coded according to Section K shall be placed over the first and closed to prevent leakage during handling, storage, or transport. If puncture of the primary container is likely, it shall be placed within a leakproof, puncture resistant secondary container. F. Infectious Waste, Potentially Infectious Waste, or Human Tissue Disposal All infectious waste, potentially infectious waste, or human tissue destined for disposal shall be placed in closable, leakproof containers or bags that are color-coded or labeled as required by Section K of this plan. If outside contamination of the container or bag is likely to occur then a second leakproof container or bag which is closable and labeled or color-coded as described in Section K of this plan shall be placed over the outside of the first and closed to prevent leakage during handling, storage, and transport. Disposal of all infectious waste shall be in accordance with applicable federal, state, and local regulations. The College has a contract in place for disposal of infectious waste. Each department will coordinate directly with the disposal vendor for pick-up and disposal of their waste. The department shall forward the completed waste manifest to the EH&S Office. Immediately after use, sharps shall be disposed of in closable, puncture resistant, disposable containers which are leakproof on the sides and bottom and that are color-coded according to Revision Date: May 30, 2006 4 section K of this plan. These containers shall be easily accessible to personnel, located in the immediate area of usage, shall be replaced routinely, and not allowed to be overfilled. Needles should never be recapped or intentionally broken. Full "sharps containers" should be sealed and disposed of through the infectious waste disposal vendor. The EH&S Office can assist you with disposal coordination if needed. In addition, the EH&S Office pays for infectious waste disposal costs. G. Laundry Laundry from work areas with personnel covered under this plan that is contaminated with blood or other potentially infectious materials or may contain contaminated sharps shall be treated as if it were contaminated and shall be handled as little as possible and with a minimum of agitation. Contaminated laundry shall be bagged at the location where it was used and placed and transported in bags that are labeled or color-coded as described in Section K of this plan. Whenever this laundry is wet and presents the potential for soak-through of or leakage from the bag, it shall be placed and transported in leakproof bags. It is mandatory that anyone handling this type of laundry wear appropriate personal protective clothing. Contaminated laundry shall be autoclaved before laundering. Professional laundering services, if required, shall be coordinated through the EH&S Office. H. Hepatitis B Vaccination and Post-Exposure Follow-up All medical evaluations and procedures will be performed by or under the supervision of a licensed physician and all laboratory tests will be conducted by an accredited laboratory. The EH&S Office is responsible for coordinating the Hepatitis B vaccination (HBV) program and maintaining related records. The HBV shall be made available to an employee after he/she completes the training in occupational exposure and within 10 working days of initial assignment with occupational exposure unless the employee has a previous HBV vaccination or antibody testing that reveals the employee is immune. See Hepatitis B Vaccination Information brochure. An employee is occupationally exposed if he/she has an exposure on an average of one or more times per month to blood or other potentially infectious materials. An employee who declines the HBV when it is offered will be required to sign an OSHA-required HBV Declination Form. If the employee initially declines HBV vaccination but at a later date, while still covered under this plan, decides to accept the HBV vaccine, it shall be provided. Should a booster dose(s) be recommended at a future date, such booster(s) shall be provided according to standard recommendations for medical practice. HBV antibody testing shall be made available to an employee who desires such testing prior to deciding whether or not to receive HBV vaccination. If found to be immune to HBV by virtue of adequate antibody titer, then the employer is not required to offer the HBV vaccine to that employee. Participation in a pre-screening program shall not be a prerequisite for receiving HBV. The Hepatitis B vaccine/vaccination series and post exposure follow-up shall be made available at no cost to the employee and shall be provided at a reasonable time and place. The employee’s department will be charged for the cost of the vaccine. Post-exposure follow-up will be paid for under the Workers’ Compensation Program. All exposure incidents shall be reported to the Director, EH&S as soon as possible. Incidents shall be investigated by the supervisor and documented. The EH&S Office will assist with the investigation as needed. Following a report of an exposure incident, each employee covered by this plan shall be provided with a confidential medical examination and follow-up that includes at least the following: 1. Documentation of the route(s) of exposure, HBV and HIV antibody status of the source (if known), the circumstances under which the exposure occurred, and the source (if known). 2. Collection of blood from the exposed employee as soon as possible after the exposure incident for the determination of HIV and/or HBV status. Actual antibody or antigen testing of the blood or Revision Date: May 30, 2006 5 serum sample may be done at that time or at a later date if the employee so requests. 3. Follow-up of the exposed employee including antibody or antigen testing, counseling, illness reporting, and safe and effective post-exposure prophylaxis, according to standard recommendations for medical practice. I. Information To Be Provided to the Physician The following information shall be provided to the evaluating physician 1. A copy of the basic OSHA regulation and a copy of this plan. 2. A description of the affected employee's duties as they relate to the employee's occupational exposure. J. Physician's Written Opinion For each evaluation under this plan, the employee will be provided a copy of the evaluating physician's written opinion within 15 working days of the completion of the evaluation. The written opinion shall be limited to the following information 1. The physician's recommended limitations upon the employee's ability to receive hepatitis B vaccination. 2. A statement that the employee has been informed of the results of the medical evaluation and 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. 3. Specific findings or diagnoses which are related to the employee's ability to receive HBV vaccination. Any other findings and diagnoses shall remain confidential. K. Communication of Hazards to Employees Signs shall be posted at the entrance to specified work areas which shall bear the following legend BIOHAZARD (Name of the Infectious Agent) (Special requirements for entering the area) (Name, telephone number of the person responsible or emergency number) Revision Date: May 30, 2006 6 Warning labels shall be affixed to containers of infectious waste, refrigerators and freezers containing blood and other potentially infectious materials, and other containers used to store the same. Labels required by OSHA shall include the following legend BIOHAZARD These labels shall be fluorescent orange or orange-red, with lettering or symbols in a contrasting color. Labels either shall be an integral part of the container or shall be affixed as closely as safely possible to the container by string, wire, adhesive, or other method that prevents their loss or unintentional removal. Red bags or red containers may be substituted for labels on containers of infectious waste. Red bags and/or containers shall not be used for purposes other than infectious materials identification. III. INFORMATION AND TRAINING A. General All employees with occupational exposure to bloodborne pathogens shall participate in a training program. Training shall be provided at the time of initial employment and at least annually thereafter. Material appropriate in content and vocabulary to educational level, literacy, and language background of employees shall be used. B. Training Program Elements Training is provided at the time of initial assignment to tasks where occupational exposure may occur. Refresher training shall be provided annually thereafter. Training shall be tailored to the education and language level of the employee, and offered during the normal work shift. The training will be interactive and cover the following: 1. A copy of the OSHA regulation and this plan and an explanation of their contents. 2. A general explanation of the epidemiology and symptoms of bloodborne diseases. 3. An explanation of the modes of transmission of bloodborne pathogens. 4. An explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials. 5. An explanation of the use and limitations of practices that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment. 6. Information on the types, proper use, location, removal, handling, decontamination and/or disposal of personal protective equipment, plus an explanation of the basis for selection of personal protective equipment. 7. Information on the hepatitis B vaccine, including information on its efficacy, safety, and the benefits of being vaccinated. 8. Information on the appropriate actions to take and persons to contact in an emergency. Revision Date: May 30, 2006 7 9. An explanation of the procedure to follow if an exposure incident occurs, including the method of reporting the incident and the medical follow-up that will be made available. Also, information on the medical counseling that will be provided for exposed individuals. 10. An explanation of the signs and labels and/or color coding being used. The person conducting the training shall be knowledgeable in the subject matter. The EH&S Office can assist with the training upon request and also has training videos available. IV. MEDICAL AND TRAINING RECORDS A. Medical Records Accurate medical records shall be maintained for each employee subject to this plan in accordance with 29 CFR 1910.20. The records shall include 1. The name and social security number of the employee. 2. A copy of the employee's Hepatitis B vaccination records and medical records relative to the employee's ability to receive vaccination or the circumstances of an exposure incident. 3. A copy of all results of physical examinations, medical testing, and follow-up procedures as they relate to the employee's ability to receive vaccination or to post exposure evaluation following an exposure incident. 4. The employer's copy of the physician's written opinion and a copy of the information provided to the physician by the employer. All employee medical records must be kept confidential and are not to be disclosed or resorted to any person within or outside the workplace except as required by this plan and law. This record is maintained by the Occupational Health Clinic providing the vaccination service and/or post exposure follow-up for the duration of employment plus 30 years in accordance with 29 CFR 1910.20. B. Training Records Training records shall include the following information 1. The dates of the training sessions. 2. The contents or a summary of the training sessions. 3. The names of persons conducting the training and the names of all persons attending the training sessions. 4. Training records shall be maintained for 5 years by the EH&S Office. C. Availability The employer shall assure that all records required to be maintained shall be made available upon request for examination and copying to the subject employee, to anyone having written consent of the subject employee, and to the Assistant Secretary in accordance with 29 CFR 1910.20. Note that it can take the clinic up to 10 days to retrieve employee medical records that have been archived. Revision Date: May 30, 2006 8