Immunization against Biosafety Hazards

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:

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.
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
biosafety@lbl.gov

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:

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.
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

See the Biosafety Manual for:
1. Pre-approval of work with biological agents.
2. Internal procedures of the IBC.
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.
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.
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.
Health Services will provide information to the employee about the characteristics of the vaccine and whether the vaccine's potential benefits outweigh its risks.
The recommendation for vaccine usage may apply only to subgroups of employees, based on their health status and/or the contraindications of the vaccine.
Recommended vaccines are provided at no cost to the employee.
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/
biosafety@lbl.gov

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

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

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