RPM | REQUIREMENTS AND POLICIES MANUAL

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    Title:

    Immunization against Biosafety Hazards

    Publication date:

    4/8/2022

    Effective date:

    11/30/2008

    BRIEF

    Policy Summary

    Lawrence Berkeley National Laboratory (Berkeley Lab) encourages and promotes the safe use of vaccines to prevent occupational infections. The goal is to increase the safety of research with biological etiologic agents.
    Note:

    1. Bloodborne pathogens are covered in the ES&H Manual, Chapter 26, Section 26.5.4, Bloodborne Pathogens and Human Materials, due to different regulatory requirements. Immunizations against bloodborne pathogens are also offered under that policy.
    2. Immunizations are also offered through the Health Promotion Program at Berkeley Lab, outside of this policy.

    Who Should Read This Policy

    • All Laboratory employees at risk of infection with biological etiologic agents
    • Members of the Laboratory's Institutional Biosafety Committee (IBC)
    • The Laboratory Biosafety Officer
    • The Laboratory Medical Director
    • Laboratory work leads or managers conducting research with biological etiologic agents, or using environmental samples reasonably suspected of containing biological etiologic agents

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page

    To Read the EH&S Program Details, Go To:

    Contact Information

    Health Services(510) 486-6266
    https://ehs.lbl.gov/service/health-services/
    or
    Biosafety Officer
    EH&S Division
    [email protected]


    Title:

    Immunization against Biosafety Hazards

    Publication date:

    4/8/2022

    Effective date:

    11/30/2008

    POLICY

    A. Purpose

    Lawrence Berkeley National Laboratory (Berkeley Lab) encourages and promotes the safe use of vaccines to prevent occupational infections. The goal is to increase the safety of research with biological etiologic agents.
    Note:

    1. Bloodborne pathogens are covered in the ES&H Manual, Chapter 26, Section 26.5.4, Bloodborne Pathogens and Human Materials, due to different regulatory requirements. Immunizations against bloodborne pathogens are also offered under that policy.
    2. Immunizations are also offered through the Health Promotion Program at Berkeley Lab, outside of this policy.

    B. Persons Affected

    • All Laboratory employees at risk of infection with biological etiologic agents
    • Members of the Laboratory's Institutional Biosafety Committee (IBC)
    • The Laboratory Biosafety Officer
    • The Laboratory Medical Director
    • Laboratory work leads or managers conducting research with biological etiologic agents, or using environmental samples reasonably suspected of containing biological etiologic agents

    C. Exceptions

    None

    D. Policy Statement

    1. See the Biosafety Manual for:
      1. Pre-approval of work with biological agents.
      2. Internal procedures of the IBC.
    2. The IBC is required to:
      1. Invite the Laboratory Medical Director to all IBC meetings.
      2. Solicit immunization recommendations of the Laboratory Medical Director.
        1. When the Site Occupational Medical Director (SOMD) or his/her designee is not present at IBC meetings, the Laboratory Biosafety Officer is responsible for getting the SOMD's recommendations.
    3. The following events trigger an appointment with Health Services to evaluate an employee's exposure to biohazards:
      1. A vaccine is recommended by the SOMD as potentially protective for a given exposure.
      2. Medical evaluations are needed to determine whether immunizations are appropriate or personal medical conditions are contraindicated for working with biological etiologic agents.
    4. Principal investigators or employees should call Health Services to schedule the appointment for 3.a or 3.b, above. At that appointment, Health Services will determine whether the risks of exposure are sufficient to warrant vaccination.
    5. Health Services will provide information to the employee about the characteristics of the vaccine and whether the vaccine's potential benefits outweigh its risks.
    6. The recommendation for vaccine usage may apply only to subgroups of employees, based on their health status and/or the contraindications of the vaccine.
    7. Recommended vaccines are provided at no cost to the employee.
    8. Medical records must be maintained for vaccinated employees in accordance with medical record guidelines.

    E. Roles and Responsibilities

    Role

    Responsibility

    Work leads or safety line managers (conducting research using biological etiologic agents)
    • Ensure that research with biohazardous materials or agents is documented, reviewed, and preauthorized by the IBC prior to beginning work.
    • Ensure that workers complete the Work Planning and Control process.
    • Ensure that safety controls (e.g., immunizations) are implemented prior to the start of work.
    • Direct their workers to attend appointments in Health Services for health evaluations and/or immunization when advised by the Biological Use Authorization.
    • Assist Health Services in arranging appointments for affected managers and their workers.
    • Prevent workers, students, and affiliates from working with biological etiologic agents until the employees are approved for such work by Health Services.

    Institutional Biosafety Committee (IBC)
    • Reviews proposed work with biohazardous materials and/or biological etiologic agents in accordance with ES&H Manual Chapter 26.
    • Seeks input from the Laboratory Medical Director or the Laboratory Medical Director designee on ways to reduce the risk of infection, when protocols anticipate work with biological etiologic agents or unknown environmental samples reasonably suspected of containing biological etiologic agents. This input includes the availability and advisability of the use of vaccines in preventing occupational infections. Normally, this input is received during the IBC meeting.

    Biosafety Officer
    • Ensures that every protocol reviewed by the Biosafety Committee is reviewed by the Laboratory Medical Director or Laboratory Medical Director designee for consideration of the use of vaccines to protect the workers.
    • Refers to the SOMD and applicable IBC standards or guidelines regarding vaccination relative to the proposed work.

    Laboratory Medical Director
    • Consults with the Laboratory Biosafety Officer, Institutional Biosafety Committee, and others to evaluate the risk of occupational infection from Laboratory research using biohazardous materials or biological etiologic agents.
    • Identifies and reviews applicable standards or guidelines regarding vaccination relative to the proposed work.
    • Recommends for or against the use of vaccination for some or all workers as a means to reduce the risk of occupational infection.
    • Serves as the Laboratory Subject Matter Expert on health aspects of the Laboratory' s vaccination policy and its application to specific work and workers.
    • Recommends other means, as appropriate, for reducing the risk of occupational infection.

    F. Definitions/Acronyms

    See ES&H Manual Chapter 3 and Chapter 26 for technical terms related to the details of this policy and its implementation.

    Term

    Definition

    Biohazardous Material

    		 Environmental materials reasonably suspected of containing biological etiologic agent(s)

    Biological Etiologic Agent

    A microorganism, virus, or toxic protein (biologic toxin or prion) known to cause human disease

    SOMD

    Site Occupational Medical Director

    Workers at Risk of Infection with Biological Etiologic Agents

    Laboratory employees, affiliates, or students working with biological etiologic agents in a manner that may expose them to the risk of infection from the organism/protein

    G. Recordkeeping Requirements

    Role

    Recordkeeping Requirement

    Health Services

    Maintains medical records for vaccinated employees in accordance with medical record guidelines

    Biosafety Officer

    Records that immunization recommendations have been developed during the biosafety protocol review. The immunization recommendations will be attached to the approved protocol.

    H. Implementing Documents

    Document Number

    ES&H Manual Reference

    Title

    Type

    02.13.002.001

    Chapter 3

    Health Services

    Program

    07.07.004.001

    Chapter 26

    Biosafety

    Program

    I. Contact Information

    Health Services(510) 486-6266
    https://ehs.lbl.gov/service/health-services/
    or
    Biosafety Officer
    EH&S Division
    https://ehs.lbl.gov/contact/
    [email protected]

    J. Revision History

    Date

    Revision

    By Whom

    Revision Description

    Section(s) Affected

    Change Type

    4/8/2022

    1.2

    T. Durrani

    Periodic review

    All

    Minor

    8/8/2013

    1.1

    P. Lichty

    Review completed 7/24/13, no changes; update next review date

    –

    Minor

    1/2/2012

    1

    P. Lichty

    Rewrite for RPM

    All

    Minor

    DOCUMENT INFORMATION

    Title:

    Immunization against Biosafety Hazards

    Document number

    07.05.001.000

    Revision number

    1.2

    Publication date:

    4/8/2022

    Effective date:

    11/30/2008

    Next review date:

    4/8/2027

    Policy Area:

    Health Services Programs

    RPM Section (home)

    ESH

    RPM Section (cross-reference)

    None

    Functional Division

    EH&S

    Prior reference information (optional)

    ES&H Manual , Chapters 3 and 26

    Source Requirements Documents

    10 CFR 851, Appendix A, Worker Safety and Health Functional Areas

    Implementing Documents

    Document Number

    ES&H Manual Reference

    Title

    Type

    02.13.002.001

    Chapter 3

    Health Services

    Program

    07.07.004.001

    Chapter 26

    Biosafety

    Program



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