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      Bloodborne Pathogen Exposure Control Plan

      INTRODUCTION

      WELCOME to the Ohio State University interactive document for compliance with the new OSHA Standard entitled "Occupational Exposure to Bloodborne Pathogens". The Occupational Safety and Health Administration (OSHA) has promulgated this standard to promote the safety of workers who routinely work with and come in contact with materials which may contain infectious agents such as the Human Immunodeficiency Virus (HIV) and the Hepatitis B Virus (HBV).

      COMPLIANCE BRIEF

      The Bloodborne Pathogens (BBP) Standard requires departments whose employees may have occupational exposure to bloodborne pathogens to draft Exposure Control Plans (ECP) containing procedures in policy form which reduce or eliminate the possibility of exposure and/or infection on-the-job. The operative word is "draft". A supervisory person or group of supervisors in each department to which this standard applies must write the policies and procedures SPECIFICALLY addressing the biological hazards of their workplace(s) and exposure prevention. The standard is "performance oriented", which means that specific actions must be taken by specific people at specific times under specific conditions. The ECP requirements are very detailed and will require an significant amount of time to complete per department.

      COMPLIANCE RELIEF

      These compliance policies have essentially been written for you, using non-specific language when referring to departments, groups, or persons. Since the bulk of the writing has been provided for you, the documents require only customization to meet your department's needs. For instance, the term "departmental management" appears quite often throughout the various sections of the ECP. You may want to replace this term, where appropriate, with an actual management job title, such as "the Director of Research". Also, "the department" is used frequently and should be replaced with the name of your specific unit, department, or group. As with all departmental policies, a high-level management signature is required for the General Policy and a line is provided for this purpose.

      VARIABLE VS. NON-VARIABLE PORTIONS

      Federal OSHA requires and intends for your completed ECP to be an easily accessible and easily understood reference source on procedures for all employees. Toward this end, the document must be customized to reflect specific departmental/laboratory needs and norms. However, specific procedures within policy sections on this disk cannot be completely eliminated unless they clearly do not apply. For example, if your group is not an HIV/HBV Research Lab or Production Facility, it is not required that you include Section IV in your ECP. On the other hand, the Hepatitis B Immunization Program found in Section V can only be altered from the standpoint of which person within the department is responsible for overseeing the program. The same applies to Post-Exposure Evaluation and Follow-Up in Section VI. Certain sections contain forms, lists or acknowledgments which may be completed on word processor or printed to hard copy for signature.

      HELP

      If you have any questions concerning this interactive document or the BBP Standard itself, please to not hesitate to contact the Office of Environmental Health and Safety at (614) 292-1284.

      REGULATION:

      OSHA Standard, 29 FR 1910.1030, Dec. 6, 1992
      Occupational Exposure to Bloodborne Pathogens

      TABLE OF CONTENTS

      Section I. General Policy

      • exposure determination
      • hepatitis B immunization program
      • post-exposure evaluation and follow-up
      • annual review and update
      • schedule for implementation
      • methods of compliance
      • HIV/HBV research labs & prod. facilities
      • communication of hazards to employees
      • record keeping

      Section II. Exposure Determination

      • jobs where all employees with exposure
      • jobs where some employees with exposure
      • tasks which constitute exposure

      Section III. Methods of Compliance

      • general administrative controls
      • engineering and work practice controls
      • personal protective equipment
      • housekeeping

      Section IV. HIV and HBV Research Labs and Production Facilities.

      • standard microbiological practices
      • special practices
      • special facility requirements
      • special training requirements

      Section V. Hepatitis B Immunization Program

      • components
      • declination procedure

      Section VI. Post-Exposure Evaluation and Follow-up

      • employee responsibilities
      • departmental supervision responsibilities
      • University responsibilities

      Section VII. Communication of Hazards to Employees

      • labels and signs
      • information and training

      Section VIII. Recordkeeping

      • medical records
      • training records
      • availability
      • transfer

      Section I

      I. TITLE:

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • General Policy

      II. SCOPE:

      This policy applies to all non-hospital departments whose employees may reasonably anticipate contact with potentially infectious materials during the performance of their duties.

      III. POLICY:

      In compliance with 29 CFR 1910.1030, the University requires all departments which fall within the scope of this policy to minimize employee risk from bloodborne pathogens by instituting Exposure Control Plans (ECP) in the form of departmental policy.

      IV. PROCEDURE:

      • EXPOSURE DETERMINATION - Departmental management shall determine which employees are considered occupationally-exposed by reviewing job classifications and specific tasks and procedures according to procedures described in Section II of this Exposure Control Plan. The determination results shall be recorded and may be found in that same section. Employees classified as occupationally-exposed shall qualify for various provisions of this policy addressing exposure control.
      • HEPATITIS B IMMUNIZATION PROGRAM - The hepatitis immunization series shall be provided, free-of-charge, to all employees whose duties fall into category I or II of the exposure determination. The immunization program will be conducted as described in Section V of this Exposure Control Plan.
      • POST-EXPOSURE EVALUATION AND FOLLOW-UP -Evaluation, follow-up and counseling will be provided, free-of-charge, to all employees who sustain an occupational exposure. The evaluation and follow-up program will be conducted as described in Section VI of this Exposure Control Plan.
      • ANNUAL REVIEW AND UPDATE - The Departmental Exposure Control Plan shall be carefully reviewed and updated annually by a qualified supervisory departmental employee or group of employees.
      • SCHEDULE AND METHOD OF IMPLEMENTATION - Compliance with the OSHA Rule on Occupational Exposure to Bloodborne Pathogens, shall be accomplished within departments using procedures described in the standard and implemented as an Exposure Control Plan. The ECP and its various aspects shall be implemented on or before the following compliance dates:
        • Exposure Control Plan - May 5, 1992
        • Training System in place - June 4, 1992
        • Recordkeeping - June 4, 1992
        • Eng./Work Practices - July 6, 1992
        • Personal Protective Equip- July 6, 1992
        • Housekeeping Practices - July 6, 1992
        • HIV/HBV Research Labs - July 6, 1992
        • HBV Vaccinations - July 6, 1992
        • Post-Exposure Evaluations- July 6, 1992
        • Labels and Signs - July 6, 1992
      • METHODS OF COMPLIANCE - Exposure control methods concerning administrative controls, engineering controls, personal protective equipment, and housekeeping shall be implemented within the departments in accordance with the OSHA Standard. Details of the methods and implementation are described in Section III of this Exposure Control Plan.
      • HIV AND HBV RESEARCH LABORATORIES AND PRODUCTION FACILITIES - Specialized control methods shall be instituted within those areas which present an exceptional pathogen risk to employees. The specialized methods address standard and special microbiological practices, containment equipment, special disposal methods, special laboratory practices, additional training and skill requirements. The details of these special control methods are described in Section IV of this Exposure Control Plan.
      • COMMUNICATION OF HAZARDS TO EMPLOYEES - Safety and precautionary information and specific training which addresses the Bloodborne Pathogens Standard and departmental requirements shall be provided to the employees to which the standard applies. The information shall be communicated to the employees in a manner described in Section VII of this Exposure Control Plan.
      • RECORDKEEPING - Employee records concerning training, exposures, physicals, etc. shall be maintained according to the OSHA Bloodborne Pathogens Standard. The details of the recordkeeping procedures are described in Section VIII of this Exposure Control Plan.

      Section II

      I. TITLE:

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • Exposure Determination

      II. SCOPE:

      This policy applies to all non-hospital departments whose employees may reasonably anticipate contact with potentially infectious materials during the performance of their duties.

      III. POLICY:

      In compliance with 29 CFR 1910.1030, the University requires all departments which fall within the scope of this policy to determine the exposure risk of employees, both in terms of position descriptions and specific task categories, and to classify the employees as occupationally-exposed or not exposed for purposes of training, protective equipment, and hepatitis B vaccination.

      IV. PROCEDURE:

      • The occupational exposure risk of employees shall be determined by the following methods:
        • Listing all job/position descriptions/categories/titles in which ALL employees have occupational exposure (Form I)
        • Listing all job/position descriptions/categories/titles in which SOME employees have occupational exposure (Form II)
        • Listing all tasks and procedures or groups of closely related tasks and procedures in which occupational exposure occurs and that are performed by employees in job classifications listed in accordance with method (2) above (Form III)
      • Exposure determination shall be made without regard to the use of personal protective equipment.
      • Employees whose job/position descriptions/ categories/titles are listed under criteria (1) above are entitled to the protection of the Bloodborne Pathogens Standard and this Policy.
      • Employees whose job/position descriptions/ categories/titles are listed under criteria (2) above and perform tasks or procedures listed under criteria (3) above, are entitled to the protection of the Bloodborne Pathogens Standard and this Policy.
      • Research and Clinical employees whose job/position descriptions/categories/titles are not listed under any of the criteria in part (A) above are entitled to protection under other OSHA Standards including, but not limited to:
        • 29 CFR 1910.1000 "Air Contaminants"
        • 29 CFR 1910.1200 "Hazard Communication"
        • 29 CFR 1910.1400 "Laboratory Standard"

      FORM I

      Job/Position Descriptions/Categories/Titles in which ALL employees have Occupational Exposure [FOR COMPLIANCE WITH 20 CFR 1910.1030(c)(2)(i)(A)]

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      FORM II

      Job/Position Descriptions/Categories/Titles in which SOME employees have Occupational Exposure [FOR COMPLIANCE WITH 20 CFR 1910.1030(c)(2)(i)(B)]

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      FORM III

      Closely Related Groups of Tasks and Procedures in which Occupational Exposure Occurs and that are Performed by Employees in Job Classifications Listed on FORM II [FOR COMPLIANCE WITH 20 CFR 1910.1030(c)(2)(i)(C)]

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      Section III

      I. TITLE :

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • Methods of Compliance

      II. SCOPE:

      This policy applies to all non-hospital University  departments whose employees may reasonably anticipate contact with potentially infectious materials during the performance of their duties.

      III. POLICY:

      In compliance with 29 CFR 1910.1030, the University requires all departments which fall within the scope of this policy to minimize employee risk from bloodborne pathogens by instituting methods of compliance in the form of general administrative controls, engineering and work practice controls, personal protective equipment, housekeeping and waste disposal practices.

      IV.PROCEDURE:

      • General Administrative Controls
        • Universal precautions shall be observed to prevent contact with blood or other potentially infectious materials. Universal precautions is an approach by which blood and body fluids from all patients are treated as if they are potentially infectious for bloodborne pathogens.
        • Under circumstances in which differentiation between body fluid types is difficult or impossible, all body fluids shall be considered potentially infectious materials.
        • Body Substance Isolation (BSI) is a method of infection control in which all body fluids and substances are considered to be infectious. Since BSI incorporates not only the fluids and materials covered by the Bloodborne Pathogens Standard, but expands coverage to include all body fluids and substances, BSI is an acceptable alternative to universal precautions provided facilities utilizing BSI adhere to all other provisions of this standard.
        • Departmental management is responsible for ensuring compliance with and enforcement of the provisions of the Bloodborne Pathogens Standard and the departmental compliance policy. Employee non-compliance with departmental safety procedures and practices shall be considered misconduct and the employee shall receive disciplinary action. The supervisor may initiate correction through oral warning, issue a written reprimand, give disciplinary time off, or discharge the employee. The severity of the discipline depends upon the nature of the misconduct and the employee's previous disciplinary record.
      • Engineering and Work Practice Controls
        • Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains, after institution of these controls, personal protective equipment shall also be used.
        • Engineering controls shall be reviewed and updated on a yearly schedule to ensure their effectiveness.
        • Readily accessible handwashing facilities shall be provided to employees.
        • When provision of handwashing facilities is not feasible in a work area, employees shall be provided with either an appropriate antiseptic hand cleanser in conjunction with paper towels or antiseptic towelettes.
        • Supervisors shall ensure that employees wash their hands immediately or as soon as feasible after removal of gloves or other personal protective equipment.
        • Supervisors shall ensure that employees wash any exposed skin with soap and water and flush mucous membranes with water immediately following contact of such body areas with blood or other potentially infectious materials.
        • Contaminated needles and other contaminated sharps shall not be bent, recapped, except under conditions set forth in section (8) below. Shearing or breaking of contaminated needles is prohibited.
        • Under conditions where equipment does not allow single-handed needle disposal into a sharps container, such as dental syringe assemblies, contaminated needles may be recapped or removed through the use of a mechanical device or a one-handed technique.
        • Immediately or as soon as possible after use, contaminated reusable sharps shall be placed in appropriate containers until properly reprocessed. These containers shall be:
          • puncture resistant
          • labeled or color-coded
          • leak-proof on the sides and bottom
          • stored or processed in a manner that does not require employees to reach by hand into the containers
        • Eating, drinking, smoking, applying cosmetics or lip balm, and handling contact lenses are prohibited in work areas where there is a reasonable likelihood of occupational exposure.
        • Food and drink shall not be kept in refrigerators, freezers, shelves, cabinets, or on countertops or benchtops where blood or other potentially infectious materials are present.
        • All procedures involving blood or other potentially infectious materials shall be performed in such a manner as to minimize splashing, spraying, spattering, and generation of droplets of these substances.
        • Mouth pipetting/suctioning of blood or other potentially infectious materials is prohibited.
        • Specimens of blood or other potentially infectious materials shall be placed in a container which prevents leakage during collection, handling, processing, storage, transport, or shipping.
        • When universal precautions are used for handling all specimens within a facility, and the specimens are not destined to leave the facility, the labeling or color-coding of specimen containers as biohazardous is not necessary, provided containers are recognizable as containing specimens.
        • When such specimens and containers are destined to leave the facility, they shall be labeled with the internationally recognized biohazard logo and the word "biohazard".
        • If outside contamination of the primary container occurs, the primary container shall be placed within a second container which prevents leakage and is properly labeled as containing biohazardous materials.
        • If the specimen could puncture the primary container, the container shall be placed within a second container which is puncture-resistant in addition to the above characteristics.
        • Equipment which may become contaminated with blood or other potentially infectious materials shall be examined prior to servicing or shipping and shall be decontaminated as necessary, unless it can be demonstrated that the decontamination of such equipment or portions of such equipment is not feasible.
        • A readily observable label containing the internationally recognized biohazard logo and the work "biohazard" shall be attached to the equipment stating which portions remain contaminated.
        • The departmental management shall ensure that information pertaining to the contamination status of a piece of equipment is conveyed to all affected employees, the servicing representative, and/or the manufacturer, as appropriate, prior to handling, servicing, or shipping, so that appropriate precautions will be taken.
      • Personal Protective Equipment
        • When there is occupational exposure, employees shall be provided, at no cost to the employee, with appropriate personal protective equipment such as, but not limited to gloves, gowns, laboratory coats, face shields or masks and eye protection.
        • Personal protective equipment shall be considered appropriate only if it does not permit blood or other potentially infectious materials to pass through to or reach the employee's work clothes, street clothes, undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions of use.
        • The departmental management shall ensure that employees use appropriate personal protective equipment and that the equipment in the appropriate sizes is readily accessible at the worksite or is issued to employees.
        • Employees who demonstrate sensitivity to certain personal protective items, such as latex gloves, shall be supplied with hypoallergenic versions of the equipment or protective liners or alternative equipment which allows the same level of performance of duties.
        • Cleaning, laundering, and disposal of personal protective equipment shall be provided by the department at no cost to the employees.
        • The department shall repair or replace personal protective equipment as needed to maintain its effectiveness, at no cost to the employees.
        • If a garment is penetrated by blood or other potentially infectious materials, the garment shall be removed immediately or as soon as feasible.
        • All personal protective equipment shall be removed prior to leaving the work area.
        • When personal protective equipment is removed it shall be placed in an appropriately designated area or container for storage, washing, decontamination, or disposal.
        • Gloves shall be worn when it can be reasonably anticipated that the employee may have hand contact with blood, other potentially infectious materials, mucous membranes, or non-intact skin; and when handling or touching contaminated items or surfaces.
        • Disposable (single use) gloves, such as surgical or examination gloves, shall be replaced as soon as practical when contaminated or as soon as feasible if they are torn, punctured, or when their ability to function as a barrier is compromised.
        • Disposable gloves shall not be washed or decontaminated for re-use.
        • Utility gloves may be decontaminated for re-use if the integrity of the glove is not compromised. However, they must be discarded if they are cracked, peeling, torn, punctured.
        • Gloves shall be worn by employees during all phlebotomies they may perform.
        • Masks in combination with eye protection devices, such as goggles or glasses with solid side shields, or chin-length face shields, shall be worn whenever splashes, spray, spatter, or droplets of blood or other potentially infectious materials may be generated.
        • Appropriate protective clothing such as, but not limited to, gowns, aprons, lab coats, clinic jackets, or similar outer garments shall be worn in occupational exposure situations.
        • Surgical caps or hoods and/or shoe covers or boots shall be worn in instances when gross contamination can reasonably be anticipated (e.g. autopsies, infectious animal dissection).
      • Housekeeping and Waste Disposal
        • The departmental management shall ensure that the worksite is maintained in a clean and sanitary condition.
        • The departmental management shall determine and implement an appropriate written schedule for cleaning and method of decontamination based upon the location within the facility, type of surface to be cleaned, type of soil present, and tasks or procedures being performed in the area.
        • All equipment and environmental and working surfaces shall be cleaned and decontaminated after contact with blood or other potentially infectious materials.
        • Contaminated work surfaces shall be decontaminated with an appropriate disinfectant after completion of procedures; immediately or as soon as feasible when surfaces are overtly contaminated or after any spill of blood or other potentially infectious materials; and at the end of the work shift if the surface may have become contaminated since the last cleaning.
        • Protective coverings, such as plastic wrap, aluminum foil, or impervious-backed absorbent paper used to cover equipment and environmental surfaces, shall be removed and replaced as soon as feasible when they become overtly contaminated or at the end of the workshift if they may have become contaminated during the shift.
        • All bins, pails, cans, and similar receptacles intended for reuse which have a reasonable likelihood for becoming contaminated with blood or other potentially infectious materials shall be inspected and decontaminated on a regularly scheduled basis and cleaned and decontaminated immediately or as soon as feasible 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, tongs, or forceps.
        • Reusable sharps that are contaminated with blood or other potentially infectious materials shall not be stored or processed in a manner that requires employees to reach into the containers with their hands.
        • Contaminated sharps waste shall be discarded immediately or as soon as feasible in containers that are:
          • closable
          • puncture-resistant
          • leakproof on sides and bottom
          • labeled with the international biohazard logo and the word "biohazard"
        • During use, containers for contaminated sharps waste shall be:
          • easily accessible
          • located at the point of generation
          • maintained upright throughout use
          • replaced routinely and not allowed to be overfilled
        • When moving containers of contaminated sharps waste from the area of use, the containers shall be:
          • closed prior to removal
          • placed in a secondary container if leakage is possible
        • The secondary container shall be:
          • closable
          • constructed to contain all contents and prevent leakage during handling
          • labeled as biohazardous
        • Reusable containers shall not be opened, emptied, or cleaned manually or in any other manner which would expose employees to the risk of needle sticks or cuts.
        • Non-sharps contaminated waste shall be placed in containers which are:
          • closable
          • constructed to contain all contents and prevent leakage of fluids during handling
          • labeled as biohazardous
          • closed prior to removal.
        • If outside contamination of the waste container occurs, it shall be placed in a second container which meets the criteria listed in (14) above.
        • Biohazardous Waste Stream Flow Chart
        • Disposal of all regulated waste shall be in accordance with applicable federal, state, and local regulations.
        • Contaminated laundry shall be handled as little as possible with a minimum of agitation. It shall be bagged or containerized at the location where it is used and shall not be stored or rinsed in the location of use.
        • Whenever contaminated laundry is wet and presents a reasonable likelihood of soak-through of or leakage from the bag or container, the laundry shall be placed and transported in bags or containers which prevent soak-through and or leakage of fluids to the exterior.
        • The departmental management shall ensure that employees who have contact with contaminated laundry wear protective gloves and other appropriate personal protective equipment.
        • If contaminated laundry is shipped off-site to a facility which does not practice Universal Precautions, such laundry shall be labeled as contaminated and biohazardous.

      Section IV

      I. TITLE :

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • HIV & HBV Research Labs and Production Facilities

      II. SCOPE:

      This policy applies to all non-hospital departments whose employees work in HIV and HBV research laboratories and production facilities engaged in the culture, production, concentration, experimentation and manipulation of HIV and HBV. It does not apply to clinical or diagnostic laboratories engaged solely in the analysis of blood, tissues or organs.

      III. POLICY:

      Employees who work in HIV and HBV research laboratories and production facilities are at increased risk for occupational exposure to bloodborne pathogens. In compliance with 29 CFR 1910.1030, and recommendations of the CDC/NIH Guidelines for Biosafety in Microbiological and Biomedical Laboratories, the University requires all departments which fall within the scope of this policy to reduce employee exposure risk by providing additional administrative controls, protective equipment, information and training beyond that required for research laboratories not involved in such work.

      IV. PROCEDURE:

      • Employees working in HIV and HBV Research Laboratories and Production Facilities will adhere to standard microbiological practices as described in the CDC/NIH Guidelines for Biosafety in Microbiological and Biomedical Laboratories - Section III, Biosafety Level 2, part A. These standard practices offer limited control of hazards associated with microbiological research.
      • The following special practices will be followed in HIV and HBV Research Laboratories and Production Facilities:
        • Before disposal, all contaminated waste shall either be incinerated or decontaminated by a method, such as autoclaving, known to effectively destroy bloodborne pathogens.
        • Laboratory doors shall be kept closed when work involving HIV or HBV is in progress.
        • Contaminated materials that are to be decontaminated at a site away from the work area shall be placed in a durable, leakproof, labeled or color-coded container that is closed before removal from the work area.
        • Access to the work area shall be limited to authorized persons. Only persons who have been advised of the potential biohazard, who meet any specific entry requirement, and who comply with all entry and exit procedures shall be allowed to enter the work areas.
        • A hazard warning sign incorporating the universal biohazard symboland the word "biohazard" shall be posted on all access doors.
        • All activities involving potentially infectious materials shall be conducted in biological safety cabinets or other physical containment devices within the laboratory.
        • Laboratory coats, gowns, smocks, uniforms, or other appropriate protective clothing shall be used in the work area and animal rooms. Protective clothing shall not be worn outside the work area and shall be decontaminated before being laundered.
        • Special care shall be taken to avoid skin contact with potentially infectious materials. Gloves shall be worn when handling infected animals and when making hand contact with potentially infectious materials is unavoidable.
        • Vacuum lines shall be protected with liquid disinfectant traps and high efficiency particulate air (HEPA) 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 or diaphragm bottles. Only needle-locking syringes or disposable syringe-needle units shall be used for 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 routed as waste to an incinerator.
        • 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.
        • A spill or accident that results in an exposure incident shall be immediately reported to the laboratory director or other responsible person.
        • A biosafety manual shall be prepared or adopted and periodically reviewed and updated at least annually. Personnel shall be advised of the potential hazards, shall be required to read instructions on practices and procedures, and shall be required to follow them.
        • All activities or procedures with potentially infectious materials which pose a threat of exposure to droplets, splashes, spills or aerosols require a combination of personal protective equipment and primary containment such a respirator and biological safety cabinet, or special protective clothing and containment caging for animals.
        • Biological safety cabinets shall be certified when installed, when moved, and at least annually.
        • A facility for hand washing and an emergency eyewash station shall be readily available within the work area.
        • An autoclave shall be available within the work area for the decontamination of biohazardous waste.
      • HIV and HBV Production Facilities, in particular, shall meet the following criteria:
        • 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 required for entry into the work area from access corridors or other contiguous areas.
        • Access doors to the work area shall be self-closing.
        • The surfaces of doors, walls, floors, and ceilings shall be water resistant to that they can be easily cleaned. Penetrations in these surfaces shall be sealed or capable of being sealed to facilitate decontamination.
        • The sink for hand washing shall be foot, elbow, or automatically operated and shall be located near the exit door of the work area.
        • The facility shall be serviced by a ducted exhaust-air ventilation system. The system shall created 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 discharge to the outside, and shall be dispersed away from occupied areas and air intakes. The proper direction of the airflow shall be verified in the work area by qualified ventilation engineers.
      • Personnel who work in HIV and HBV Research Laboratories and Production Facilities will receive special training in addition to that required for employees who do not specifically handle known pathogenic agents. This extra training, detailed in Section VII of the Exposure Control Plan, will cover the following areas:
        • proficiency in standard & special microbiological practices
        • prior experience in handling human pathogens
        • training program for employees with no prior experience
          • initial activities do not involve pathogens
          • progression of activities as proficiency develops
          • infectious agents handled only after proficiency is shown

      Section V

      I. TITLE :

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • Hepatitis B Immunization Program

      II. SCOPE:

      This policy applies to all non-hospital departments whose employees may reasonably anticipate contact with potentially infectious materials during the performance of their duties.

      III. POLICY:

      In compliance with 29 CFR 1910.1030, the University requires all departments which fall within the scope of this policy to minimize employee risk from the bloodborne pathogen hepatitis B, by instituting an Immunization Program for exposed employees.

      IV. PROCEDURE:

      • Immunization against Hepatitis B virus (HBV) by means of a vaccination series will be made available to all employees who are determined to be "occupationally-exposed" as defined in Section II of the Exposure Control Plan.
      • Employee participation in the Immunization Program will be on a completely voluntary basis and the Program will be provided at no cost to them.
      • The Immunization Program will consist of the following components as set forth in the CDC Update on Adult Immunization: Recommendations of the Immunization Practices Advisory Committee (ACIP):
        • a series of three intramuscular vaccinations administered at times zero, one month and six months
        • pre-vaccination testing only for employees who have been previously immunized or are part of an employee population with a high rate of seropositivity such as emergency room staff, paramedics, I.V. teams, and dialysis technicians
        • post-vaccination testing for immunity only for persons whose subsequent management depends on knowing their immune status such as emergency room staff, paramedics, I.V. teams, and dialysis technicians
        • testing for immunity five years after the vaccination series, with a booster to restore immunity, for those individuals who no longer exhibit a protective titer of antibody
      • For employees whose positions qualify them for pre-vaccination or post-vaccination testing for protective titer, the following information and procedures apply:
        • an individual is considered immune if their anti-HBV antibody level (titer) is greater than 10 mIU/ml
        • pre-vaccination titer testing shall not be a prerequisite for participating in the Immunization Program
        • if post-vaccination titer testing is called-for, it must be done within 6 months after the vaccination series.
        • if the titer is found to have fallen below the minimum protective level, a booster will be offered to increase the titer up to a protective level
        • if after the initial vaccination series and titer testing the employee is found not to have developed a protective titer against HBV, a fourth vaccination will be offered as a final attempt to instill immunity. If, after the fourth vaccination, the employee still is not able to develop a protective titer, the employee shall be considered "unimmunizable"
      • Vaccination will be made available within 10 working days of initial assignment and after the employees have been given information on the HBV vaccine efficacy, safety, method of administration, the benefits of immunization, and that the vaccination series will be offered free of charge.
      • If the employee consents to participate in the Immunization Program, the vaccinations will be offered at a time and place convenient to the employee.
      • If the employee has previously received the complete HBV vaccination series and/or antibody testing has revealed that the employee is immune or the vaccine is contraindicated for medical reasons, the vaccination series will not be offered.
      • If an occupationally-exposed employee chooses not to participate in the immunization program, he/she is required to acknowledge a mandatory declination included as Appendix (A) in this policy.
      • If the employee initially declines to participate in the HBV immunization program, but at a later date, while still occupationally exposed, decides to become immunized, the vaccination series shall be made available at that time.
      • The vaccination procedures and testing will be performed by or under the supervision of a licensed healthcare professional at an approved healthcare facility.
      • All laboratory tests associated with the Hepatitis B Immunization Program shall be conducted by an accredited laboratory at no cost to the employee.
      • When the employee presents to the healthcare facility for initial vaccination, the attending healthcare professional shall evaluate the employee and make a determination regarding indications and contradictions before administering the vaccination. The determination shall be submitted as a written opinion to the departmental management within 15 days of the completion of the evaluation.

      APPENDIX (A)
      HEPATITIS B VACCINATION PROGRAM

      HEPATITIS B VACCINE DECLINATION FORM (MANDATORY)I understand that due to my occupational exposure to blood or other potentially infectious materials I may be at risk of acquiring hepatitis B virus (HBV) infection. I have been given the opportunity to be vaccinated with hepatitis B vaccine, at no charge to myself. However, I decline hepatitis B vaccination at this time. I understand that by declining this vaccine, I continue to be at risk of acquiring hepatitis B, a serious disease. If in the future I continue to have occupational exposure to blood or other potentially infectious materials and I want to be vaccinated with hepatitis B vaccine, I can receive the vaccination series at no charge to me at that time.

      Employee Name___________________Employee Signature and Date_____________________

      Supervisor Name_______________Supervisor Signature and Date________________________

      Section VI

      I. TITLE :

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • Post-Exposure Evaluation and Follow-up

      II. SCOPE:

      This policy applies to all non-hospital University  departments whose employees may reasonably anticipate contact with potentially infectious materials during the performance of their duties.

      III. POLICY:

      All occupational exposures to biohazardous materials shall be regarded as serious, reported promptly, evaluated by a trained healthcare professional, and treated according to accepted guidelines.

      IV. DEFINITIONS:

      Accepted Guidelines

      • Protection Against Viral Hepatitis - Recommendations of the Immunization Practices Advisory Committee (ACPI), MMWR, Vol. 40, No. RR-12, pg. 32, Nov. 15, 1991.
      • Management of Exposures, MMWR, Aug. 21, 1987.
      • Guidelines for Prevention of Transmission of HIV and HBV to Healthcare/Public-Safety Workers, MMWR, June 23, 1989.
      • 29 CFR 1910.1030 - Bloodborne Pathogens Final Rule, Federal Register, Vol. 56, No. 235, Dec. 6, 1991.
      • Compliance Assistance Guideline for the OSHA Enforcement Procedures for Occupational Exposure to HBV and HIV, U.S. Department of Labor, OSHA, Jan. 1991.
      • Trained Healthcare Professional - A Ohio Licensed medical doctor who has received specific training for and has experience in occupational infection control and infectious exposure evaluation and follow-up.
      • Approved Healthcare Service - Any hospital or clinic which is approved by to provide post-exposure evaluation and follow-up of the employee for the University.
      • HBV - Hepatitis B Virus, a bloodborne pathogen, which causes a form of Viral Hepatitis. A major infectious occupational hazard to healthcare workers.
      • HIV - Human Immunodeficiency Virus, a bloodborne pathogen, which causes Acquired Immunodeficiency Syndrome (AIDS).
      • Bloodborne Pathogens - Pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, HBV and HIV.
      • Biohazardous Material - Human blood or other body fluids and tissues including blood products which may contain bloodborne pathogens. Experimental laboratory liquids containing known infectious agents such as HBV and HIV.
      • Exposure Source - Any woven or fabric saturated with biohazardous material or any potentially contaminated sharps such as hypodermic needles, broken laboratory glassware or broken laboratory plastics which could cause a skin puncture or cut.
      • Occupational Exposure - Contact with an exposure source or biohazardous material through percutaneous inoculation or contact with an open would, non-intact skin, or mucous membrane during the performance of normal job duties.
      • HBA (HBsAg) - Hepatitis B surface antigen; generally positive when the patient/sample is infectious.
      • Hepatitis B Panel - A battery of serologic tests to detect indicators for hepatitis B in the blood.

        •  

         
         
         
         
         

        This panel can indicate no infection, active infection, previous infection with full recovery, or previous infection with conversion to a carrier-state.

      • HIV Ab - Antibody to Human Immunodeficiency Virus; a positive result on this blood test in combination with a positive on a confirmatory test indicates previous exposure and seroconversion to HIV virus.
      • H-BIG - Hepatitis B Immune Globulin; IgG against hepatitis B prepared from plasma of individuals with high titers of antibody to hepatitis B surface antigen; administered intramuscularly to prevent hepatitis B transmission via passive immunity.
      • Recombivax - The newest hepatitis B vaccine. A non-infectious recombinant DNA vaccine used to provide active immunity to Hepatitis B; administered in a series of three intramuscular injections over a period of six months (at baseline, 1 month and 6 months). Confers immunity for an average length of five years.

      V. PROCEDURE:

      • Upon injury from a suspected exposure source, the employee shall attempt to determine the nature of the exposure and any biohazardous material associated with it.
      • The employee shall also attempt to carefully retain the exposure source and any biohazardous materials which may have constituted an exposure.
      • If necessary, first-aid should be administered immediately for any cuts or punctures and any exposed skin should be washed with soap and water. The employee should report the injury to their supervisor within one hour.
      • The supervisor shall assess the situation and determine if the incident constitutes of "occupational exposure" to a "biohazardous material". The supervisor shall then locate and complete any necessary accident forms and refer the employee to an approved healthcare service.
      • The employee shall present at the approved healthcare service as soon as possible, report that they have received an occupational injury of a potentially infectious nature, and provide them with any exposure source samples and accident forms which their supervisor issued to them.
      • The University, through forms sent with the employee, shall provide the healthcare service with incident details, such as:
        • the type of injury the employee received
        • the type and samples of any biohazardous material the employee was exposed to
        • the type and samples of any exposure sources the employee was exposed to
        • circumstances under which the exposure occurred
        • the hepatitis immunization status of the employee
      • Through an approved healthcare service, the University shall provide the employee with a confidential medical evaluation by a trained healthcare professional and follow-up of the incident which conforms with the recommendations of the U.S. Public Health Service and includes:
        • evaluation of the exposure risk of the incident based on the exposure source
        • providing the employee with a written list of recommended options for testing and preventative treatment
        • explaining to the employee the rationale and benefits of these tests and treatments
      • Testing options include HBA and HIV Ab testing of any samples of biohazardous material to which the employee was exposed, and base-line testing of an employee blood sample for Hepatitis Panel and HIV Ab for determination of pre-exposure HBV and HIV status.
      • Preventative treatment options include H-BIG for short-term protection and Recombivax for long-term protection against hepatitis B. For the preventative treatments to be most effective, the H-BIG must be given within 72hours of exposure and Recombivax must be given within seven days of exposure. At present, there is no federally approved preventative treatment for HIV.
      • Employee acceptance of these tests/treatments will be on a completely voluntary basis and services will be provided at no cost to them.

        •  

         
         
         
         
         

        If the employee consents to collection of a baseline blood sample, 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 will be provided by the University as soon as is feasible.

      • The healthcare service shall provide the University with a written opinion, within 7 days of the exposure incident. The opinion report shall detail:
        • that the employee has been information of the results of the evaluation and has been told about any medical conditions resulting from exposure to blood or other biohazardous materials which require further evaluation and treatment
        • whether HBIG or Recombivax was indicated for the employee, and if the employee has received such treatment
        • all other findings or diagnoses shall remain confidential and shall not be included in the report
      • The University shall provide the employee a copy of the healthcare service report within 15 days of the exposure incident. A copy of the report shall be included in the employee's permanent medical records with the University.
      • If the employee eventually become ill or seroconverts as a direct result of occupational exposure to a bloodborne pathogen, the healthcare service shall file a complete report with the University Worker's Compensation office. The report shall be confidential and will be sent to NO other party within the University.
      • If the exposure source sample is positive or not available and the employee is negative for HBA and HIV Ab, follow-up testing will be made available to them at 6 weeks, 12 weeks, and 6 months. If, at the end of 6 months, the employee has not seroconverted, they are at minimal risk of infection from the occupational exposure.
      • If occupational exposure of the employee to a bloodborne pathogen is confirmed, the University shall provide, through the healthcare service, confidential counseling and evaluation of any consequent illness which the employee reports for a period of 12 months.

      Required Healthcare Service Procedures
      for Post-Exposure Counseling and Prophylaxis

      I. If the exposure source sample tests negative for HBA and HIV Ab and the employee tests negative for both of these parameters on their base-line, the employee may still elect to receive preventative treatment against Hepatitis B, although no counseling or follow-up testing is necessary.

      II. If the exposure source sample tests negative for HBA and HIV Ab and the employee tests positive for one or both of these parameters on their base-line, the employee shall be counseled by a trained healthcare professional regarding the following points:

      • the status of their disease
      • the symptomatology of early stages of HBV/HIV infection
      • behavioral precautions to prevent the spread of disease
      • state worker's compensation policy for such situations
      • employee confidentiality rights
      • to seek medical attention through their family physician
      III. If the exposure source sample tests positive for HBA or HIV AB and the employee tests negative to both of these parameters on their base-line, the employee shall be counseled by a trained healthcare professional regarding the following points:
      • the relative risk of infection based on their exposure
      • the benefits of immediate preventative treatment for HBV if the sample was positive for this virus
      • the symptomatology of early stages of HBV/HIV infection
      • behavioral precautions to prevent the spread of disease
      • state worker's compensation policy for such situations
      • employee confidentiality rights
      IV. If the exposure source sample tests positive for HBA or HIV Ab and the employee tests positive for one or both of these parameters on their base-line, the employee shall be counseled by a trained healthcare professional regarding the following points:
      • the status of their disease
      • the symptomatology of early stages of HBV and HIV infection
      • behavioral precautions to prevent the spread of disease
      • the State worker's compensation policy for such situations
      • the employee's confidentiality rights
      • to seek medical attention through their family physician
      • the employee may elect to receive HBV preventative treatment if they did not test positive for HBV on their baseline
      V. If the exposure source sample is not available and the employee tests negative for both HBA and HIV Ab on their base-line, the employee shall be counseled by a trained healthcare professional regarding the following points:
      • the relative risk of infection based on the material or object they were exposed to
      • the benefits of HBV preventative treatment if they have not been previously immunized
      VI. If the exposure source sample is not available and the employee tests positive for HBA or HIV Ab on their base-line, the employee shall be counseled by a trained healthcare professional regarding the following points:
      • the status of their disease
      • the symptomatology of early stages of HBV and HIV infection
      • behavioral precautions to prevent the spread of disease.
      • the State worker's compensation policy for such situations
      • the employee's confidentiality rights
      • to seek medical attention through their family physician
      • the employee may elect to receive HBV preventative treatment if they did not test positive for HBV on their baseline

      Section VII

      I. TITLE :

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • Communication of Hazards to Employees

      II. SCOPE:

      This policy applies to all non-hospital Ohio State University departments whose employees may reasonably anticipate contact with potentially infectious materials during the performance of their duties.

      III. POLICY:

      In compliance with 29 CFR 1910.1030, the University requires all departments which fall within the scope of this policy to reduce employee risk from bloodborne pathogens by communicating information to exposed employees about hazards of bloodborne pathogens through the use of labels, signs, written information and training.

      IV. PROCEDURE:

      • Labels and Signs
        • Warning labels shall be affixed to or printed on containers and bags of biohazardous waste, refrigerators and freezers containing blood or other potentially infectious material; and other containers used to store, transport or ship blood or other potentially infectious materials.
        • Labels shall include the internationally recognized biohazard logo and the word "biohazard"
        • The labels shall be printed on stickers or bags as either: orange-on-white, red-on-white, orange-on-black, or black-on-orange.
        • Labels shall be affixed at a conspicuous location(s) on the container by direct print, adhesive, string, or wire.
        • Exempted from the labeling requirements are blood, blood products, or blood components that are labeled as to their contents and have been released for transfusion or other clinical use; and individual containers of blood or other potentially infectious materials that are placed in a labeled container for storage, transport, shipment or disposal.
        • Contaminated equipment shall be labeled as to which portions are contaminated.
        • Biohazardous waste which has been decontaminated must be labeled as "biosafe" with approved stickers.
        • Signs which include the internationally recognized biohazard logo and the word "biohazard" shall be posted at the entrance of HIV and HBV research laboratories and production facilities.
      • Information and Training
        • The departmental management shall ensure that all employees with occupational exposure, including themselves, participate in a training program which must be provided at no cost to the employees and during working hours.
        • The training shall be provided as follows:
          • at the time of initial assignment to tasks where occupational exposure may occur
          • before June 4, 1992
          • at least annually thereafter
        • For employees who have received training on bloodborne pathogens in the year preceding June 4, 1992, only training with respect to the provisions of the standard and the departmental policy which were not included need be provided.
        • The departmental management shall ensure that additional training is provided when changes such as modification of tasks or institution of new procedures affect employees' occupational exposure.
        • Material appropriate in content and vocabulary to the educational level, literacy, and language of employees shall be used.
        • The bloodborne pathogens training program shall be conducted by a person knowledgeable in the subject matter and shall contain, at a minimum, the following:
          • an accessible copy of the regulatory text of the Bloodborne Pathogens Standard and Departmental Exposure Control Plan (policy on compliance with the Standard)
          • a general explanation of the epidemiology and symptoms of bloodborne diseases
          • an explanation of the modes of transmission of bloodborne pathogens
          • an explanation of the department's Exposure Control Plan and means by which the employee may obtain a copy of the document
          • an explanation of the appropriate methods for recognizing tasks and other activities that may involve exposure to blood and other potentially infectious materials
          • an explanation of the use and limitations of methods that will prevent or reduce exposure including appropriate engineering controls, work practices, and personal protective equipment
          • information on the types, proper use, location, removal, handling, decontamination and disposal of personal protective equipment
          • an explanation of the basis for selection of personal protective equipment
          • information on the hepatitis B immunization program, including information on the efficacy, safety, administration, and benefits of the vaccine and that the vaccine will be offered at no cost to the employees
          • information on the appropriate actions to take and persons to contact in an emergency involving blood or other potentially infectious materials
          • 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
          • information on post-exposure evaluation and follow-up that the department is required to provide for the employee following an exposure incident
          • an explanation of the labels, signs and color-coding pertaining to biohazards required by departmental policy
          • an opportunity for interactive questions and answers with the person conducting the training session
        • Employees in HIV and HBV research labs and production facilities shall receive the following initial training in addition to the above training requirements:
          • management shall assure that employees demonstrate proficiency in standard microbiological practices and techniques and in the practices and operations specific to the facility before being allowed to work with HIV and HBV
          • management shall assure that employees have prior experience in the handling of human pathogens or tissue cultures before working with HIV or HBV
          • management shall provide a training program to employees who have no prior experience in handling human pathogens. Initial work activities shall not include the handling of infectious agents. A progression of work activities shall be assigned as techniques are learned and proficiency is developed
          • management shall assure that employees participate in work activities involving infectious agents only after proficiency has been demonstrated.

      Section VIII

      I. TITLE :

      OSHA Bloodborne Pathogens Rule
      • Exposure Control Plan
        • Recordkeeping

      II. SCOPE:

      This policy applies to all non-hospital departments whose employees may reasonably anticipate contact with potentially infectious materials during the performance of their duties.

      III. POLICY:

      In compliance with 29 CFR 1910.1030, the University requires that medical and training records be maintained for employees with occupational exposure.

      IV. PROCEDURE:

      • Medical Records
        • The University, through an approved healthcare provider, shall establish and maintain an accurate record for each employee with occupational exposure. This record shall include:
          • the name and social security number of the employee
          • a copy of the employee's hepatitis B immunization status including the dates of all the hepatitis B vaccinations and any medical records relative to the employee's ability to receive vaccination as required in Section V.
          • a copy of all results of examinations, medical testing, and exposure incident follow-up procedures as required in Section VI.
          • the University's copy of the healthcare professional's written opinion concerning hepatitis B vaccination and post-exposure evaluation and follow-up as required in Section VI.
          • a copy of the information provided to the healthcare professional concerning exposure incidents as required in Section VI.
        • The University shall ensure that the employee medical records are kept confidential and are not disclosed or reported without the employee's express written consent to any person within or outside the workplace except as required by availability provisions included in this Section VIII.
        • The University, through an approved healthcare provider, shall maintain the employee medical records for at least the duration of employment plus 30 years in accordance with 29 CFR 1910.20
      • Training Records
        • Training records shall be maintained by departmental management and shall include the following:
          • the dates of the training sessions
          • the contents or a summary of the training sessions
          • the names and qualifications of persons conducting the training
          • the names and job titles of all persons attending the training sessions
        • The departmental management shall maintain the training records for a period of 3 years after the training occurred.
      • Availability
        • The University shall ensure that all medical records shall be made available upon request to the Assistant Secretary of the Department of Labor and the Director of the Department of Labor for examination and copying.
        • The University shall ensure that all medical records shall be provided upon request for examination and copying to the subject employee and to anyone having written consent of the subject employee.
        • The departmental management shall ensure that all training records shall be made available upon request to the Assistant Secretary of the Department of Labor and the Director of the Department of Labor for examination and copying.
        • The departmental management shall ensure that all training records are provided upon request for examination and copying to employees and to employee representatives.
        • The University shall comply with the requirements of 29 CFR 1910.20(h) involving transfer of employee records.