Research Safety Plan VA Long Beach Healthcare System/Research and Development
VA Long Beach Healthcare System
Research and Development
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Research Safety Plan
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Replaces version dated: 04/08/2015
Review: Annually by SRS and R&D committee
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Neil Hoa., SRS, Vice-Chair Approval Date
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Steven Schreiber, MD., R&D Vice-Chair Approval Date
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Research Safety Plan VA Long Beach Healthcare System/Research and Development
Research Safety Plan
Table of Contents
Purpose...... 3
Definition of Hazard Categories...... 3
Biohazards...... 3
Hazardous Chemicals and Waste...... 3
Physical Hazards...... 3
Scope...... 4
Biohazards...... 4
Hazardous Chemicals and Waste...... 5
Physical Hazards...... 5
Facility Responsibilities...... 6
Medical Center Director (Responsible Official [RO])...... 6
Alternate Responsible Officer (ARO)...... 8
Engineering and Facilities Operations (E&FOS)...... 9
Employee Health (Occupational Health)...... 10
Research Healthcare Group Responsibilities...... 11
Associate Chief of Staff (ACOS)...... 11
Administrative Officer (AO)...... 12
Committee Responsibilities...... 12
Research & Development Committee (RDC)...... 12
Subcommittee on Research Safety (SRS)...... 13
Institutional Biosafety Committee (IBC)...... 13
Support Staff Responsibilities...... 13
Safety Coordinator...... 13
Safety Officer Responsibilities...... 15
Biological Safety Officer (BSO)...... 15
Chemical Hygiene Officer (CHO)...... 15
Facility Safety Officer (FSO)...... 16
Research Compliance Officer (RCO)...... 16
Investigator Responsibilities...... 17
General Lab...... 17
Recombinant DNA...... 19
Select Agents & Toxins...... 22
Laboratory Staff Responsibilities...... 24
References...... 25
Research Safety Plan
VA Long Beach Healthcare System
1. PURPOSE
Ensuring personnel safety in Veterans Health Administration (VHA) research necessitates oversight at the national and local levels. This Plan prescribes local procedures involving the use of potential hazards encountered in these settings, including, but not limited to:
a. Biohazards, such as:
(1) Pathogens and etiologic agents corresponding to Biosafety Levels (BSL) 1-4, and
(2) Organisms and viruses containing recombinant deoxyribonucleic acid (DNA) molecules.
(3) Select Agents and Toxins
b. Chemical hazards.
c. Physical hazards.
2. DEFINITION OF HAZARD CATEGORIES
A.Biohazards. Biohazards include, but are not limited to, the following:
(1) Pathogens and etiologic agents, human and non-human primate tissues including blood and body secretions, and human cell lines corresponding to BSL 1-4 (see subpar. 10a);
(2) Toxins produced by microbial organisms (see subpar. 10a);
(3) Poisonous, toxic, parasitic, and venomous animals or plants;
(4) Recombinant DNA molecules (see subpar. 6g.);
(5) Select agents, as specified in Title 42 Code of Federal Regulations (CFR) Part 73; 7 CFR 331; and 9 CFR 121; and
(6) Animals experimentally or naturally exposed to any of the preceding (see subpar. 10a).
B.Chemical Hazards. Chemical hazards include any substance or mixture of substances with properties capable of producing adverse effects on the health and safety of humans. Chemical hazard categories include, but are not limited to, the following:
(1) Corrosives;
(2) Toxic substances (poisons, irritants, asphyxiates);
(3) Sensitizers;
(4) Carcinogens, mutagens, and teratogens;
(5) Flammables; and
(6) Explosives.
C.Physical Hazards. Physical hazards include, but are not limited to, the following:
(1) Ionizing and non-ionizing radiation (see App. D),
(2) Noise,
(3) Vibration,
(4) Extremes of temperature and pressure,
(5) Explosive hazards,
(6) Electrical hazards, and
(7) Mechanical hazards.
3. SCOPE
Research laboratories are included in the medical center-wide written occupational safety and health program. The role and responsibilities of the Research Office is defined within this program. Research offices must maintain a Research Safety Program that is consistent with VA policies, Federal statutes and regulations from Occupational Safety and Health Administration (OSHA), the Environmental Protection Agency (EPA), the Nuclear Regulatory Commission (NRC), etc., and any applicable State and local requirements. All applicable National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC) guidelines must be
followed. This Research Safety Plan describes the implementation of the safety program at VALBHS. The Research Plan must be updated, reviewed, and approved annually by the Subcommittee on Research Safety (SRS) and forwarded to the Research and Development (R&D) Committee for approval.
A.Biohazards. The research office has developed service-wide safety
Policies and procedures that include:
(1)A description of biohazard controls (e.g., engineering, procedures, and
personal protective equipment). These are described within the Chemical Hygiene Plan.
(2)Emergency proceduresand an emergency cascade phone listspecific to the facility.These are described within the ResearchService Emergency Preparedness Plan.
(3)Laboratories that work at BSL 3 containment maintain a separate, written, regularly updated laboratory manual that includes standard operating procedures and emergency procedures, and includes, but is not limited to a: spill, power outage, or breach of security. These are described in the BSL-3 SOP.
Blood-borne Pathogens
The risk of exposure to blood borne pathogens will be minimizedin the research setting by ensuring that all research personnel are aware of, and utilize, universal precautions in the handling of biologic fluids of any type according to the specifications of the Bloodborne Pathogen Standard. Similarly, the risk of exposure to airborne pathogens such as Mycobacterium tuberculosis will be minimized and strict adherence to all applicable Federal statutes, regulations, policies and guidelines must be rigorously upheld. At VALBHS, all employees are required to have a PPD, TB skin test annually. The Occupational Health Office performs and monitors TB tests and may require x-rays or treatment, as medically warranted for those who are sero-positive.
Recombinant DNA Research
- VA investigators planning to conduct recombinant DNA research must comply with the most current Guidelines for Research involving Recombinant DNA Molecules regardless of the source of research funding. Specific responsibilities are described below under the section for Investigator Responsibilities.
- VA investigators should note that all funded and unfunded projects and proposals must be reviewed and approved according to the procedures described in the most current NIH Guidelines for Research involving Recombinant DNA Molecules. Review policies and procedures are described in the Institutional Biosafety Committee (IBC) SOP.
- Local SRS and R&D Committee approvals are also required as described in the SRS SOP and the R&D Committee SOP.
B.Hazardous Chemicals and Waste
The laboratory program must ensure that all Federal and State occupational safety and health, transportation and shipping, and environmental regulations are adequately addressed. Federal regulations require the development of a “chemical hygiene plan” and the administration of this plan by a “chemical hygiene officer.” This disposal of hazardous chemicals and waste are described in the Chemical Hygiene Plan. The Chemical Hygiene Officer administers the Chemical Hygiene Plan.
C.Physical Hazards
Physical hazards are reviewed by the SRS tominimize risk and ensure regulatory compliance. Routine laboratory inspections by facility safety personnel and research personnel must include a review of all potential physical hazards. As needed, inspections must be coordinated with program managers and technical experts such as the Radiation Safety Officer. The SRS reviews findings from:
- Quarterly Environment of Care Inspections
- Annual Workplace Evaluations (AWE)
- Annual City Medical Waste Inspections
- Annual City Hazardous Waste Inspections
- Annual ORO Inspections
The Radiological Safety Officer, the Industrial Hygienist, the Safety Officer and the Safety Coordinatorare members of the EOC team, as well as the SRS, and participate in EOC inspections.
The SRS also reviews evaluations made by:
- The Safety Coordinator
- The Research Compliance Officer
- The Subcommittee on Animal Studies
4. FACILITY RESPONSIBILIES
- Medical Center Director
The term Medical Center Director is synonymous with the Facility Director or Chief Executive Officer of a medical center or health care system. The Medical Center Director is the Responsible Official (RO) for the facility.
The facility Director is responsible for:
(1)Certification:
Institutional Biosafety Committee (IBC) is registered with the National Institutes of Health (NIH).
(2)Support:
(i.) Ensuring that the research safety program is staffed adequately and that resources are available to maintain full compliance with all applicable regulations and standards of safety.
- Ensuring that resources are provided to identify, evaluate and control
chemical hazards associated with existing and proposed protocols performed at the VA Long Beach Healthcare System Research Facility.
(ii.) Ensuring that all Research personnel who handle animals are included in the facility Occupational Safety and Health program and that research space is included in annual workplace inspections.
NOTE: Research personnel must be covered by all other facility safety programs (e.g., the Respiratory Protection program, the Fire Safety program, etc.)
(iii.) Ensuring the resolution of any facilities-related deficiencies identified in inspections.
(iv.) Providing engineering support in conducting ventilation maintenance and validation of required specifications.
(v.) Providing support to the Engineering Control Element of the Safety Plan with maintenance and validation of required specifications.
(vi.) Ensuring that the research wide safety program is integrated with the medical center safety program and for the overall implementation and enforcement of the Research Safety Plan.
(vii.) Providing the technical assistance of facility safety and health professionals as needed.
(viii.) In cooperation with the Associate Chief of Staff (ACOS) for R&D, ensuring that measures for the security of the research laboratories and surrounding space is developed.
(ix.) Providing adequate administrative support for SRS, including:
- Space sufficient to provide privacy for conducting sensitive duties related to biosafety,
- The personnel to support the review and record-keeping functions of SRS, and
- Support for the timely preparation of investigator correspondence and other documents.
(x.) Granting requests for authorization for access to research areas (BSL-3 laboratories, other laboratories, or storage areas) in which select agents or toxins are used or stored after reviewing the recommendation of the R&D Committee in compliance with the USA Patriot Act and other applicable criteria, regulations, and policies.
3. Appointments:
(i.) The Medical Center Director is responsible for appointing the members of the Research & Development Committee and its subcommittee’s.
(ii.) The Medical Center Director is responsible for appointing the following Officers who assist in the administration and implementation of the Safety Plan:
- Alternate Responsible Official (ARO)
- Facility Safety Officer or Facility Safety Manager
- Radiological Safety Officer
- Research Compliance Officer
4. Delegation:
The Medical Center Director may appoint one or more Alternate Responsible Official(s) (ARO) to assist in administering this program. At LBVAHS the ACOS R&D serves as the ARO. The ARO(s) acting in the absence of the RO may conduct all activities required by the RO related to the facility’s Hazardous Agents Program. If the facility uses or stores select agents or toxins the RO and ARO must meet all the qualifications as found in 42 CFR 73.9, 7 CFR 331.9, and 9 CFR 121.9.
The Medical Center Director, as RO, may delegate the following responsibilities to the ARO(s), but remains the institutional official responsible for the overall VA research laboratory Hazardous Agents Control Program and compliance with all applicable regulations and policies. The RO is responsible for:
(i.) Ensuring that the facility’s research program is in compliance with current VA and Federal regulations, with current policies relating to prevention of terrorist events and with the security of hazardous agents, including select agents, toxins and associated sensitive materials.
(ii.) Delegating authority and responsibility to the ARO(s) to ensure that all applicable regulations and policies are met at the institution in the absence of the RO.
(iii.) Ensuring that all specifications for personnel, facility security and law enforcement contained in VA Handbook 0730, VHA Handbook 0730/1, and VHA Handbook 0710 are adhered to by facility staff, patients, visitors, and guests.
(iv.) Ensuring that the facility’s policies and standard operating procedures address all requirements in this Handbook.
(v.) Ensuring that changes in facility security procedures are made known to the research service, the other appropriate medical center personnel, and ARO(s).
(vi.) Ensuring that the ARO(s) possess expertise in the areas of physical security of facilities, safety of personnel working in both VA research laboratories and when applicable, working with select agents, toxins and hazardous agents.
B.RO and ARO(s). If select agents or non-exempt quantities of toxins are used or stored for research purposes, the RO and ARO(s) must have an approved Security Risk Assessment as required in 42 CFR 73.7, or if agents or toxins are regulated by APHIS, in compliance with 7 CFR 331.7, or 9 CFR 121.7, as applicable. The RO and ARO(s) must:
(1) Be familiar with all applicable regulations, policies, and guidance and be able to perform all duties required for this position.
(2) Oversee the development, implementation, and evaluation of all components of the VA Research Laboratory Hazardous Agents Control Program as required by this Plan and applicable VA and Federal regulations. This requires:
- Developing and implementing safety, containment, security, and emergency response plans.
- Allowing only authorized individuals to have access to select agents or toxins.
- Providing appropriate training for safety, containment, security, and emergency response.
- Maintaining, using, purchasing, transferring, and destroying select agents or toxins in accordance with applicable regulations and policies, including the regulations and policies of the agencies listed in subparagraph 2c.
- Providing timely notice of any theft, loss, or release of a select agent or toxin in accordance with 42 CFR 73.19, 7 CFR 331.19, and 9 CFR 121.19, as applicable.
- Maintaining detailed records of information necessary to give a complete accounting of all activities related to select agents or toxins.
- Conducting annual inspections of VA research laboratories, including BSL-3 laboratories and laboratories where select agents or toxins are used or stored to ensure compliance with all policies, procedures and protocols including plans for safety, security, and incident response.
The inspections must be conducted at least annually and after each incident. Findings must be documented and any deficiencies corrected.
- Conducting drills or exercises, at least annually, to test and evaluate the effectiveness of the safety, security and incidence response plans. The drills or exercises must be documented and any deficiencies corrected.
- Completing the annual vulnerability assessment of VA research areas and informing appropriate facility personnel of the assessment results and correcting any deficiency.
- Notifying CDC or APHIS when an individual’s access to select agents or toxins is terminated and the reason why it was terminated.
- Immediately notify CDC or APHIS if a facility using or storing select agents or toxins looses the services of its RO. To continue use of the select agents or toxins, the facility must appoint another person as RO who already has an approved Security Risk Assessment.
NOTE: In facilities using or storing select agents or toxins the ARO may act as the RO if the RO is unavailable
(3) The RO will establish and maintain a health surveillance program for personnel engaged in animal research involving viable recombinant DNA-containing
microorganisms that require BSL-3 or greater containment in the laboratory.
NOTE: Animal studies at VALBHS do not currently require BSL3 or greater containment.
C. Engineering and Facilities Operations Service (E&FOS)
(i.) Ensuring that laboratory control and emergency equipment (e.g., ventilation systems, detectors, shutoff devices, and emergency eyewash and safety showers) are designed, installed, commissioned, and function-tested in accordance with applicable codes and guidance provided by the hospital.
(ii.) Providing a proactive preventive maintenance and repair program to
ensure that laboratory control and emergency equipment (including:
(a.) Laboratory equipment
(b) Research ventilation systems,
(c) Chemical fume hoods,
(d) Biological safety cabinets,
(e) Autoclaves, -80°C Freezers
(f) Detectors, shutoff devices, and emergency eyewash and safety
showers
(g) Laboratory Sinks are in proper operating condition in accordance
with applicable codes and guidance.
(h) Informing on-site construction/equipment contractors of the presence
and identity of hazardous materials in their immediate work areas.
(i) Notifying the research office to inform building occupants of testing,
demolition, construction, and renovation activities and their related
hazards prior to initiation.
(j) Coordinating with the research office to ensure that all chemicals,
radiological material, and wastes are removed and that all visible
residues are cleaned before demolition, construction, or renovation
activities are initiated in the research
(k) Responding to spills and other emergencies involving hazardous
materials.
(l) Providing Fire Extinguisher Trainingfor research staff
(m) Conducting periodic fire drill for VALBHS research facility (building 138)
D. Occupational Health Service will:
(i.) Provide medical consultation and examinations for individuals who are exposed or potentially exposed to hazardous materials.
(ii.) Provide consultation to women of child-bearing age with respect to
reproductive toxins.
(iii.) Perform routine screening for Tuberculosis.
5. RESEARCH HEALTH CARE GROUP RESPONSIBILITIES
- Associate Chief of Staff (ACOS) for R&D. The ACOS for R&D is responsible for:
(i.) All activities in the Research Service, including the implementation of all requirements set forth in this Plan.
(ii.) Addressing specific needs with regard to the safe handling and storing of
hazardous chemicals specifically for Research Service Health Care Group
(HCG) laboratories.
(iii.) Making certain that all research activities involving the use of hazardous
chemicals are conducted safely.
(iv.) Ensuring continuous evaluation of performance standards of the Research
Safety program.
(v.) Appointing, or serving as, the designated research point of contact for interacting with facility security personnel, health and safety staff, Medical Center Director-RO, ARO, and oversight committees (e.g., R&D Committee, Subcommittee on Research Safety (SRS), Radiation Safety Committee). The ACOS designates that the AO for R&D will serve as the designated point of contact at VALBHS.