Clemson University Occupational Exposure to Bloodborne Pathogens I. POLICY: This policy defines Clemson University’s compliance with OSHA Bloodborne Pathogen Standard 29 CFR 1910.1030. OSHA directs an employer with multiple facilities to have a written Exposure Control Plan for each facility or workplace. Therefore each operational unit within Clemson University which anticipates contact with blood or other potentially infectious materials in the performance of an employee's duties must have a written plan designed to eliminate or minimize employee exposure to bloodborne pathogens within that workplace setting. II. PROCEDURE: A. DEFINITIONS 1. Blood means human/non-human blood, blood components, and products made from human/non-human blood. 2. Bloodborne Pathogens (BBP) means pathogenic microorganisms that are present in human/non-human blood and can cause disease in humans. These pathogens include, but are not limited to, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV). 3. Clinical Laboratory means a workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials. 4. Contaminated means the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface. 5. Contaminated Laundry means laundry which has been soiled with blood or other potentially infectious materials or may contain sharps. 6. Contaminated Sharps means any contaminated object that can penetrate the skin including, but not limited to needles, pipettes, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires. 7. Decontamination means 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 rendered safe for handling, use, or disposal. 8. Engineering Controls means 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. 9. ES means Environmental Safety at Clemson University. 10. Exposure Incident means 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. 11. Handwashing Facilities means a facility providing an adequate supply of running potable water, liquid soap and single use towels or hot air drying machines. 12. Licensed Healthcare Professional is a person whose legally permitted scope of practice allows him or her to independently perform the activities required by paragraph (f) of the Federal OSHA Blood Borne Pathogen Standard (“Hepatitis B Vaccination and Post-Exposure Evaluation and Follow-up”). 13. HBV means Hepatitis B Virus. 14. HCV means Hepatitis C Virus. 15. HIV means Human Immunodeficiency Virus. 16. Needleless systems means a device that does not use needles for: a. The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; b. The administration of medication or fluids; or c. Any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps. 17. Occupational Exposure means 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. 18. Other Potentially Infectious Materials (OPIM) means: 1 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. a. The following human/non-human body fluids: semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, pericardial fluid, peritoneal fluid, amniotic fluid, saliva in dental procedures, any body fluid that is visibly contaminated with blood, and all body fluids in situations where it is difficult or impossible to differentiate between body fluids; b. Any unfixed tissue or organ (other than intact skin) from a human (living or dead); and c. 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. Parenteral means piercing mucous membranes or the skin barrier through such events as needlesticks, human bites, cuts, and abrasions. Personal Protective Equipment (PPE) is specialized clothing or equipment worn by an employee for protection against a hazard. General work clothes (e.g., uniforms, pants, shirts or blouses) not intended to function as protection against a hazard are not considered to be personal protective equipment. Regulated Waste means liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials. Research or Teaching Laboratory means any laboratory (excluding diagnostic or clinical) that stores or manipulates HIV or HBV cultures, blood or OPIM. RS means Research Safety at Clemson University. Sharps with engineered sharps injury protections means a non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident. 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. Sterilize means the use of a physical or chemical procedure to destroy all microbial life including highly resistant bacterial endospores. Universal Precautions is an approach to infection control. According to the concept of Universal Precautions, all human/non-human blood and certain human/non-human body fluids are treated as if known to be infectious for HIV, HBV, and other bloodborne pathogens. Work Practice Controls means controls that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique). B. EXPOSURE DETERMINATION 1. Exposure Classification I Employees who may reasonably expect to be exposed to bloodborne pathogens as part of their routine duties include: a. b. c. d. e. f. g. h. i. j. k. l. m. Physicians, Nurse Practitioners, Physician Assistants Nursing personnel Emergency Medical Technicians, Paramedics, and other emergency medical service providers Fire Fighters Law Enforcement personnel (those exposed to blood or OPIM) Veterinarians Veterinary Technicians Biologists (those exposed to blood or OPIM) Microbiologists (those exposed to blood or OPIM) Biology/Microbiology Technicians and Laboratory Aides (those exposed to blood or OPIM) Lab Supervisors and Technicians (those exposed to blood or OPIM) Animal Handlers Chemists and Biochemists (those exposed to blood or OPIM) 2 n. o. p. q. r. s. ES/RS Personnel handling bio-waste Plumbers/plumbing shop personnel Radiology Technicians (those exposed to blood or OPIM) Custodial/housekeeping personnel (those exposed to blood or OPIM) Medical equipment service and repair personnel (those exposed to blood or OPIM)) Other research employees including Principal Investigators, Research Safety Representatives, Building Security Coordinators and Department Safety Representatives (if they enter labs where exposure to BBP is probable) 2. Exposure Classification ll Employees not normally exposed to blood borne pathogens include: a. b. c. d. e. f. Department chairs and above Housekeeping aides Facilities staff (other than plumbers or plumbing shop personnel) ES/RS personnel who do not handle bio-waste Quality Assurance Auditors University faculty and staff not specified above 3. Tasks and procedures that may result in exposure a. b. c. d. e. Sharps pick-up Trash pick-up Biological Safety Cabinet decontamination and certification Processing/handling human body fluids, tissue, and/or cell lines Handling animals, tissues, cell lines, fluids or cultures which may be infected or potentially infected with bloodborne pathogens f. Laundry processing g. Human tissue xenografts h. Processing blood i. Handling emergencies and first aid j. Work with HIV, HBV, HCV or other infectious cultures k. Needle stick l. Cleaning, handling contaminated instruments C. METHODS OF COMPLIANCE 1. Methods of Compliance: a. Assume all human and animal body fluids are infectious (Universal Precautions also known as Standard Precautions). b. Use of engineering & work practice controls to eliminate or reduce employee exposure including Personal Protective Equipment (PPE). c. Personal protective equipment may include gloves, gowns, laboratory coats, face shields or masks and eye protection, and mouthpieces, resuscitation bags, pocket masks, or other ventilation devices; PPE is provided by the Employee’s Department and its use ensured by appropriate supervisor. d. Engineering controls are kept on a regular preventive maintenance schedule. e. Biological safety cabinets are evaluated by an NSF 49 certified technician (or someone working under the direct supervision of an NSF 49 certified technician) at least annually and whenever moved. f. Readily accessible hand washing facilities with liquid soap or antiseptic cleansers and clean towels are in each lab/work area. 3 g. Eye wash facilities are readily available in each lab/work area. h. Employees must wash hands immediately after PPE removal, i.e., gloves, and if there is any contact with blood or infectious material. i. Needles should be used one-time only. Contaminated needles and other sharps shall not be bent, recapped, or removed unless there is no alternative and, in the case of recapping or removal, a one-handed method or mechanical device must be used. j. Contaminated sharps must be disposed of in containers that are puncture resistant, labeled or color-coded properly, leak-proof on sides and bottom, and closable on top. k. Sharps containers are removed and properly autoclaved or discarded by the personnel assigned to that lab/work area whenever full. l. Eating, drinking, smoking, chewing, applying lip balm or cosmetics, and handling contact lenses are prohibited in the labs. m. Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets or on countertops or bench tops where blood or other potentially infectious materials are present. n. Magazines and newspapers will not be taken home if brought into a work area but must be left in the lab and disposed of with the regular lab trash. o. Splashing, spraying, spattering and droplet generation (aerosols) will be minimized by using centrifuge covers and other techniques designed to reduce aerosol formation. p. Mouth pipetting is prohibited. q. Blood specimens or infectious materials are transported and stored in leak-proof containers. r. Equipment is decontaminated with disinfectant included in Clemson University List of Approved Disinfectants for Use against Blood Borne Pathogens prior to servicing. This list is derived from the registered disinfectants that appear on both EPA List E and EPA List F. List of disinfectants can be accessed at http://media.clemson.edu/research/safety/Disinfectants%20for%20BBP.pdf s. Each work area handling bloodborne pathogens must have a written cleaning schedule including autoclaving, decontamination procedure using Clemson University List of Approved Disinfectants for Use against Blood Borne Pathogens, and laundry handling. The supervisor is responsible for this schedule. An autoclave must also be conveniently available. t. Each supervisor is responsible for reviewing the effectiveness of the individual controls, and making corrections to conform to the Bloodborne Pathogens Standard. u. SDS (Safety Data Sheet) is available for every chemical in use in the facility, per OSHA requirement. 2. Cleaning, Laundering, and Disposal: Disposable PPE should be used when possible. The employer shall clean, launder, and dispose of personal protective equipment at no cost to the employee. In no event shall such PPE be taken home for cleaning, laundering, or disposal. The employer shall provide, repair, and replace such PPE as necessary at no cost to the employee. 3. Special Requirements for HIV, HBV Research Labs: Currently, Clemson University has no HIV or HBV research labs. Introduction of such research to Clemson University will require revision of this plan. D. TRAINING 1. Frequency: New employees should be trained at the time of initial assignment to tasks where occupational exposure may take place; all employees will be re-trained annually, and whenever tasks or assignments are changed. Supervisors may request assistance related to this training from either Environmental Safety or the Occupational Health Nurse; research laboratories should contact Research Safety for training assistance. Training records shall be maintained three years from the date training occurred. 4 Supervisors are required to ensure employee proficiency in biological safety practices prior to employee being allowed to work with blood or OPIM and to provide employee training in the handling of human pathogens or tissue prior to employee being allowed to work with blood or OPIM. 2. Components: a. b. c. d. e. f. g. h. i. j. k. l. m. n. o. Explanation of epidemiology, symptoms, and transmission modes of bloodborne diseases. How to recognize bloodborne hazards. How to prevent or reduce exposure. How to minimize aerosol production. Handling needles properly. Information and instruction on Personal Protective Equipment location, selection, removal, decontamination, and disposal. Instruction on hand washing procedures. Information on biological waste handling and disposal. Information on the Hepatitis B vaccine. At initial training, opportunity for interactive questions and answers with a technically-qualified person. Explanation of the contents of Standard 1910.1030. Explanation of and access to the Exposure Control Plan. Information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials. Explanation of color coding and labeling per 1910.1030(g). Handling of biological waste. E. HEPATITIS B VACCINATION 1. Vaccination: New employees, or employees newly assigned to job functions involving exposure to blood or OPIM, will be offered the HBV vaccination within 10 working days of initial assignment to a position requiring work with blood or OPIM. The employee may decline the vaccination by signing the Hepatitis B Vaccine Status Form. The cost(s) of the vaccinations will be borne by the employee’s department. New employees, or employees newly assigned to job functions involving exposure to blood or OPIM, may not work with blood or OPIM until at least 10 days after receiving the first of the three HBV injections or until after signing the declination form. F. POST EXPOSURE FOLLOW-UP 1. Post-Exposure Documentation: a. Initial documentation. The exposure must be immediately reported to the exposed employee’s supervisor, then CompEndium, Clemson University Risk Management, and Environmental Safety or Research Safety as appropriate. b. Medical Assessment. Occupational exposures should be considered urgent medical concerns to ensure timely postexposure management and administration of HBIG, HPV vaccine, and/or HIV postexposure prophylaxis (PEP). The exposed employee will be offered medical evaluation, PEP, blood testing for HIV, HBV, HCV and counseling by a physician as directed by OSHA. These evaluations and procedures shall be conducted according to recommendations of the U.S. Public Health Service current at the time these evaluations and procedures take place, except as specified by OSHA in paragraph (f)(1)(ii)(D) of the BBP Standard. 5 2. Post-Exposure Evaluation and Follow-Up: Procedure: The exposed employee’s supervisor will contact CompEndium giving details of exposure and duties of employee. CompEndium or Clemson University Risk Management will then contact Redfern Health Center. After medical assessment at Redfern Health Center, if incident is determined to be a true exposure the employee will be referred to an infectious disease specialist for post exposure evaluation and treatment. If no follow-up is desired by employee, employee will complete and sign Informed Refusal of Post-Exposure Medical Evaluation. Responsibilities are outlined below for Redfern Health Center, the infectious disease specialist, the employee and Clemson University: a. Redfern Health Center will provide: Initial assessment by RHC provider to determine if exposure occurred from skin, eye, mucous membrane or parenteral contact with blood or other potentially infectious materials. Patient will complete Exposure Incident Report Form which documents job duties related to the exposure, the circumstances under which the exposure occurred, and identification of the source individual, unless identification is infeasible/impossible. If contaminated sharp was involved, documentation will include specific instrument and task. If incident is determined to be true exposure to a bloodborne pathogen, further action will include: i. If source is identified and available, source will be counseled on the need for HBV, HCV and HIV testing. The source has the right to refuse testing. Consent will be documented on Consent for Blood Testing of Source. If consent is given, blood will be drawn, labeled, and stored until order is obtained from infectious disease specialist. Blood will be sent to reference laboratory with order. If consent is not obtained, RHC shall document that consent cannot be obtained. When the law does not require the source individual’s consent, the source individual’s blood, if available, shall be tested, following above procedure. When the source individual is already known to be infected with HBV, HCV or HIV, testing for the source individual’s HBV or HIV status need not be repeated. ii. Referral of exposed employee to infectious disease specialist. Employee will be directed to seek immediate service by this physician, as certain treatments should be initiated within 2436 hours post exposure. iii. Packet of information for exposed employee to present to infectious disease specialist. iv. Complete confidentiality concerning exposure incident. This obligation for confidentiality extends to any employee to whom this information is disclosed/obtained. v. Billing through Clemson University Risk Management. b. Infectious Disease Specialist will provide: i. Agreement to accept patients with bloodborne pathogen exposure from Clemson University. ii. Assessment of exposed employee and bloodborne pathogen incident. iii. Collection and testing of exposed employee’s blood for HBV, HCV and HIV serological status and documentation of employee’s consent. iv. If the employee consents to baseline blood collection, but does not give consent at that time for HIV serologic testing, the sample shall be preserved for at least 90 days. If, within 90 days of the exposure incident, the employee elects to have the baseline sample tested, such testing shall be done as soon as feasible. v. Counseling of exposed employee. Information to exposed employee of the results of the testing of blood from source individual and exposed employee. The employee shall be informed of applicable laws and regulations concerning disclosure of the identity and infectious status of the source individual. vi. Post exposure prophylaxis as recommended by the US Public Health Service. 6 vii. viii. ix. x. If indicated, the Hepatitis B vaccination will be given to employee, if not already administered. Follow-up of test results/post-counseling with source individual, if possible. Evaluation of reported illnesses. Report to employer within 10 days of evaluation; Healthcare Professional’s Written Opinion for Post-Exposure Evaluation. Report is limited to the facts that: a) The employee has been informed of the results of the evaluation. b) The employee has been told about any medical conditions resulting from exposure to blood or other potentially infectious materials that require further evaluation or treatment. c) All other findings or diagnoses shall remain confidential and shall not be included in the written report. xi. Complete confidentiality. No information on test results of source or employee, or medical conditions resulting from exposure will be released to anyone other than exposed employee. xii. Billing through Clemson University Risk Management. c. Exposed employee will provide: i. Completion of Exposure Incident Report Form. ii. Complete confidentiality concerning the results of the blood infectivity of the source. d. Clemson University will provide: i. Agreement to use infectious disease specialist for evaluation/treatment for bloodborne pathogen exposure incidents involving Clemson University referrals. ii. Payment processed through Workers’ Compensation or Clemson University Risk Management for required testing, evaluation and treatment of bloodborne pathogen incident as directed by the Clemson University Exposure Control Plan. iii. Report of incident on OSHA Form 300, without employee’s name. iv. A copy of the infectious disease specialist’s written opinion to the exposed employee within fifteen (15) days of the completion of the evaluation. Healthcare Professional’s Written Opinion for Post-Exposure Evaluation. v. Maintenance of Workers’ Comp file which includes Exposure Incident Report Form; Consent for Blood Testing of Source; Consent for Blood Testing of Exposed Employee; Hepatitis B Vaccination Status; Informed Refusal of Post-Exposure Medical Evaluation if employee refused treatment. Records will be maintained for at least the duration of employment plus thirty years. vi. Investigation of causes. An investigation of the cause(s) of the exposure will be conducted by the exposed employee's supervisor. ES reviews accident/exposure reports from Clemson University Risk Management weekly, and may decide to conduct an independent investigation. vii. Agent identification. If the work involved use of a neat agent, the agent will be reported to the employee’s supervisor, CompEndium, and Clemson University Risk Management at the time of the initial report. viii. Evaluation of the engineering controls. ES may investigate the engineering controls in place, the work practices used, and the PPE and clothing worn at the time of the exposure. ix. Complete confidentiality of any information which is received on blood test results for employee or source, and medical conditions resulting from exposure and treatments, except as required for Workers’ Compensation documentation. Policy responsibility: William R. Newberry, Chief Environmental Safety Officer, University Facilities Revised date: July 1, 2014 7