Appendix K: Bloodborne Pathogen Standard

Avoiding occupational exposure to human blood, body fluids, and tissues is the primary way to prevent transmission of bloodborne pathogens. The goal of the initial and annual standard precautions training is to present information on how to prevent such exposures by

• administrative controls,
• workplace engineering controls,
• proper work practices,
• personal protective equipment,
• and a hepatitis B vaccine immunization program.

Personnel can be exposed to bloodborne pathogens by being stuck with contaminated needles, lacerations from contaminated sharp instruments, or being splashed with blood or body fluids on the mucous membrane of the eye, nose or mouth, or on abraded, non-intact skin (e.g., chapped skin or skin affected by dermatitis). Any direct contact (e.g., contact without barrier protection) to concentrated hepatitis B, hepatitis C, HIV, or any other infectious virus in a research laboratory or production facility is considered an exposure that requires clinical evaluation. All employees working with human cell cultures should be offered hepatitis B vaccination and be evaluated if an exposure occurs. Hepatitis B viral infection is one of the most frequent laboratory-associated infections, and laboratory personnel are recognized as a high-risk group for acquiring this infection (Centers for Disease Control and Prevention).

The OSHA Bloodborne Pathogens Standard applies to all employees who might come into contact with blood or other bodily fluids, including:

• Human blood
• Human blood components
• Products made from human blood, or other potentially infectious materials (OPIM) such as the following human body fluids:
  • Semen
  • Vaginal secretions
  • Cerebrospinal fluid
  • Synovial fluid
  • Peritoneal fluid
  • Amniotic fluid
  • Saliva in dental procedures
  • 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.
• Any unfixed tissue or organ (other than intact skin) from human (living or dead)
• HIV-containing cell or tissue cultures, organ cultures, and HIV-, HBV- or HCV-containing culture medium or other solutions; and blood, organs, or other tissues from experimental animals with HIV, HBV or HCV.

Program Elements

The Bloodborne Pathogens Standard requires that an Exposure Control Plan be written and implemented. The Exposure Control Plan must have the following elements:

• Policies and procedures for elimination or minimization of exposure
• Evaluation of employee exposure potentials
• Medical surveillance program
• Routine testing

The following is a general outline of the BU Exposure Control Plan.

Roles and Responsibilities

PI/ Laboratory Director/Employee Supervisor

The PI/laboratory director/employee supervisor must identify employees under his or her supervision who may be at risk. Upon identifying these employees, the supervisor must:

• Reduce potential risk by providing personal protective clothing and equipment;
• Provide HBV vaccinations at no cost to the employee;/li>
• Complete the OSHA-required Bloodborne Pathogen Training;
• Train the employees;
• Ensure that the BU Exposure Control Plan manual is adopted by the lab and develop an effective hazard communication program;
• Ensure appropriate PPE, engineering controls, such as a biological safety cabinet or sharps container are available and used;
• Develop safe work practices and procedures, as well as internal notification procedures to report accidents;
• Review and evaluate safe alternatives for use of sharps with lab personnel;
• Ensure that all observation cited by EHS during lab inspection are addressed and closed-out;
• In conjunction with the academic department, review the list of at-risk employees on an annual basis to ensure that the list is current.

Laboratory Worker

• Complete required Bloodborne Pathogen Training initially on hire and annually thereafter;
• Complete training provided by the PI;
• Use required PPE when working in the lab;
• Report and follow procedures in the event of accidental exposure;
• Accept or decline the HBV vaccination upon offer. Complete the declination form when declining. Inform the PI and ROHP should the individual decide to take the vaccination previously offered at any time during employment;
• Review the lab Exposure Control Plan manual.

Environmental Health and Safety

• Inspect laboratories to verify the lab compliance with the OSHA Bloodborne Pathogen requirements;
• Review lab SOPs upon request by the lab;
• Conduct follow up investigation of exposure and incidents, Determine the root cause and provide recommendations to prevent or minimize the incident from recurring;
• Act as a liaison during inspections and visits by regulatory agencies;
• Prepare, maintain and implement the OSHA-required Bloodborne Pathogen Training for completion by the PI and lab personnel.

Key Definitions

Other potentially infectious materials (OPIM) are those listed above.

Regulated waste means liquid or semi-liquid blood or other potentially infectious materials and contaminated items that would release blood or other potentially infectious material 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.

Sharps waste means any device having acute rigid corners, edges, or protuberances capable of cutting or piercing, including, but not limited to, all of the following:

• Hypodermic needles, syringes, blades, and needles with attached tubing
• Broken glass items, such as Pasteur pipettes and blood vials contaminated with other medical waste

At-Risk Employee Identification

The Exposure Control Plan requires each employer to identify in writing all tasks, procedures, and job classifications where occupational exposure to blood may occur and to document the methods of compliance that will minimize the potential of occupational exposure.

Incident Reporting

All incidents must be documented and a copy be kept in the laboratory and a copy forwarded to EHS. Accident response procedures are described in Chapter 8: Biohazardous Spill Response Written Policies and Procedures.

Written Policies and Procedures

This manual is intended to act as a primary source of policies and procedures designed to eliminate, or minimize, potential employee exposure to all biological materials, regardless of their hazard level. Employees are required to read and implement all sections of this manual that are relevant to their work environment and be fully familiar with standard precautions. Each PI must further develop site-specific SOPs to address local programmatic needs.

Medical Surveillance

The OSHA Bloodborne Pathogens Standard requires that all personnel with potential exposure to bloodborne pathogens be offered immunization against the hepatitis B virus.

• HBV vaccinations must be offered to an employee within 10 days of assignment.
• Personnel must indicate their consent or declination for the Hepatitis B Vaccine using the ROHP Consent or Declination forms. Both forms are available from ROHP. The ROHP must retain this form on file for the duration of the employee’s employment plus thirty (30) years.
• An employee who declines hepatitis B vaccination may, at any time thereafter, change his or her mind and receive the vaccine. The acceptance statement must be signed at that time.
• The PI/laboratory supervisor must not make participation in a prescreening program a prerequisite for receiving the vaccination.
• The HBV vaccination is available at no cost to the employee.
• ROHP conducts thorough evaluation for risk of exposure to other blood borne pathogens such as HIV and HCV.

BPHC must also be notified of all presumptive exposures (See Appendix P for BPHC Medical Surveillance Reporting requirements.)

• The PI must ensure that all employees with the potential for occupational exposure participate in a training program provided by EHS at no cost to the employee during working hours.
• Training must be given in accordance with the Bloodborne Pathogens Standard upon initial assignment, on an annual basis thereafter, or whenever modification of an existing job description may affect the employee’s potential for occupational exposure.
• HIV/HBV research laboratories must ensure that their employees demonstrate proficiency in standard microbiological procedures prior to being allowed to work in the laboratory.
• Training must include a comprehensive discussion of this standard, including
  • epidemiology, symptoms, and transmission of bloodborne diseases;
  • the Exposure Control Plan;
  • the uses, limitations of, and procedures for using personal protective equipment;
  • a discussion of the HBV vaccination (including the benefits of vaccination and efficiency of the vaccine to prevent disease);
  • emergency procedures involving blood exposure or contamination and post-exposure follow-up procedures;
  • hazard communication;
  • and a question-and-answer discussion opportunity.

EHS provides Bloodborne Pathogens training on a regularly scheduled basis. For more information and scheduling, call (617) 358-7840 on the BU Medical Campus and 617-358-4094 on the Charles River Campus.

PI Responsibilities for Occupational Health Issues

In keeping with the OSHA Bloodborne Pathogen Standard, this policy requires annual standard precautions training, a hepatitis B immunization program, and a post-exposure medical management program.

It is the PI’s responsibility to ensure that researchers, technicians, students, or volunteers who work in the laboratory and who have contact with animals, infectious agents, or bloodborne pathogens are medically evaluated prior to starting work and that anyone working with bloodborne pathogens is offered the hepatitis B vaccination series administered by ROHP in compliance with the Bloodborne Pathogen Exposure Policy. PIs are required to complete the Hepatitis B Vaccine Authorization available on ROHP’s website.

An appointment can be made with a medical provider by calling BU’s ROHP at (617) 358-7647. If the research project is located at a facility at another institution, such as the VA Hospital or the Framingham Heart Study, the researcher should contact ROHP for assistance at 617-358-7647.

It is the PI’s responsibility to ensure that any person present in a BU laboratory who has an incident involving potential exposure to an infectious agent is offered immediate access to a medical evaluation by or through the ROHP (listed below). An immediate evaluation is important, as efficacy of post-exposure medication for HIV and other infectious agents may be less effective if the initiation of treatment is delayed. Personnel working with non-human primates or their tissues may also require evaluation for post-exposure prophylaxis against herpes B virus.

If at any time, any employee has an exposure to bloodborne pathogens, they MUST immediately contact the ROHP at (617) 358-ROHP (7647). An immediate evaluation is important, as efficacy of post-exposure medication for HIV may be less effective if the initiation of treatment is delayed. For more information, call BU’s ROHP at (617) 358-ROHP (7647).

Contacting the ROHP

ROHP is located on the Boston University Medical Campus at 72 East Concord Street, 8th Floor, Room 825. Our normal hours of operation are Monday through Friday from 8:00am to 4:30pm. Our phone number is (617) 358-7647 (ROHP) and is available and supported by medical staff 24 hours per day/7 days per week to triage and evaluate laboratory exposures and related illnesses. Based on injury severity, location and time of day, ROHP will refer people to the appropriate health care location.

• For lab exposures (e.g., needle stick, bite, cut, scratch, splash) involving animals or infectious agents on the Medical Campus or Charles River Campus, call the ROHP 24/7 hour number (1-617-358-ROHP (7647) or 4-ROHP (7647) if calling from a Medical Campus location) to be connected with the BU ROHP medical officer.
• For unexplained symptoms or illness call the ROHP 24/7 hour number ((617) 358-ROHP (7647), or 4-ROHP (7647) if calling from a Medical Campus location) to be connected with the BU ROHP medical officer.

When referred to a health care location under any of these scenarios, always inform the physician of your work in the laboratory and the agent(s) that you work with. If you have been given a wallet-size agent ID card, provide the agent ID card to the physician.

References

OSHA Bloodborne Pathogen Program

Centers for Disease Control and Prevention/National Institutes of Health: Biosafety in Microbiological and Biomedical Laboratories, U.S. Department of Health and Human Services, 6th, 6th edition, June 2020.

CDC: “Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HBV, HCV, and HIV and Recommendations for Post-exposure Prophylaxis,”
Morbidity and Mortality Weekly Report, June 29, 2001/Vol. 50/ No. RR-11.

Kuhar DT, Henderson DK, Struble KA, Heneine W, Thomas V, Cheever LW, Gomaa A, Panlilio AL; US Public Health Service Working Group. Updated US Public Health Service guidelines for the management of occupational exposures to human immunodeficiency virus and recommendations for postexposure prophylaxis. Infect Control Hosp Epidemiol. 2013 Sep;34(9):875-92.

Institute of Laboratory Research (ILAR): Occupational Health in the Care and Use of Research Animals, National Academy Press, 1997.

U.S. Department of Labor/OSHA: “Bloodborne Pathogens and Needlestick Prevention.”

CDC Guidance for Evaluating Health-Care Personnel for Hepatitis B Virus Protection and for Administering Postexposure Management.

Different Types of HIV Tests. i-base. (2019, December 1).

Garcia, J., & Vega, C. P. (2020, September 14). New! HCV Guidance for Healthcare Workers by CDC. Medscape.

Jack, B., & Graziano, F. (2010, April). Blood-borne Pathogen Exposure and Post-Exposure Prophylaxis in Global Health Field Sites.

Kuhar, D. T., Henderson, D. K., Struble, K. A., Heneine, W., Thomas, V., Cheever, L. W., … Panlilio, A. L. (2013). Updated US Public Health Service Guidelines for the Management of Occupational Exposures to Human Immunodeficiency Virus and Recommendations for Postexposure Prophylaxis. Infection Control & Hospital Epidemiology, 34(9), 875–892.

National Clinician Consultation Center. (2021, June 18). PEP Quick Guide for Occupational Exposures.

Prevention of Hepatitis B Virus Infection in the United States: Recommendations Of the Advisory Committee on Immunization Practices.