Environmental Health & Safety Manual (EHS)

Effective: 1/1/2006

Revised: 3/1/2015

EHS 114: Biosafety Serum Storage Program

Purpose

To establish and maintain ASU’s Biosafety Serum Storage Program, which involves the collection of reference baseline serum samples from personnel working with hazardous research material based on their job responsibilities

Background

The ASU Biosafety Serum Storage Program represents research best practices as recommended by the Centers for Disease Control and Prevention and the National Institutes of Health

Sources

7 Code of Federal Regulations § 331, Animal and Plant Health Inspection Service, Plant Protection and Quarantine (Possession, Use, and Transfer of Select Agents and Toxins)

9 Code of Federal Regulations § 121, Animal and Plant Health Inspection Service, Veterinary Services (Possession, Use, and Transfer of Select Agents and Toxins)

42 Code of Federal Regulations §§ 73, 1003, Public Health Service, Department of Health and Human Services (Possession, Use, and Transfer of Select Agents and Toxins)

Centers for Disease Control & Prevention/National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories. 5th Ed. December, 2009

Department of Health and Human Services. National Institutes of Health. Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. November, 2013

Arizona State University Biosafety Manual

Applicability

ASU academic, research, and other operations employees working in areas deemed to be high risk and as otherwise recommended by the campus Biosafety Officer and/or the Institutional Biosafety Committee (IBC) in consultation with ASU Health Services.

Policy

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Responsibilities of the University

ASU has instituted and maintains a biosafety program for the possession, use, transfer, and storage of biohazards and for employees who may be exposed to biohazards during the performance of their duties. The biosafety program is designed to promote and achieve regulatory compliance and provides a means for personnel to be better informed about and protected from biohazards. Whenever occupational exposure to human pathogens is a risk, ASU will offer the ability to collect and store a serum specimen prior to the initiation of work with the agent. The serum sample may be used to establish baseline sero-reactivity. At a minimum, serum banking is offered to personnel with agents classified as Biosafety Level (BSL)-3/Animal Biosafety Level (ABSL)-3 or when using certain agents classified as BSL-2/ABSL-2.

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Responsibilities of the Department of Environmental Health & Safety

The university Biosafety Officer (BSO) is responsible for providing assistance to the IBC, in consultation with ASU Health Services, for the purpose of risk assessment, identification, and recommendation for participation in the Serum Storage Program.

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Responsibilities of the Institutional Biosafety Committee (IBC)

The IBC is a resource to the university community for supporting the responsible conduct of biohazardous research and oversees research and teaching activities involving the use of infectious materials and microoganisms in research and teaching. The IBC is registered with the National Institutes of Health Office of Biotechnology Activities (OBA) and is responsible for university compliance with the Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). The IBC reports to the senior vice president for Knowledge Enterprise Development. More information on the committee can be found on the Reseach Itegrity and Assurance website.

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Responsibilities of ASU Health Services

ASU Health Services is responsible for drawing the sera for research and operations personnel and maintaining all records associated with the samples. No clinical or diagnostic testing will be requested at the time of the initial banking. Specimens will be processed in accordance with recommendations of the College of American Pathology. Access, inventory, and control of the sera is defined in the “Procedures” section of this document. ASU Health Services will dispose of the samples as medical waste 30 years from date of collection, or after notification that the individual left the university at least 10 years ago, or at the individual’s request.

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Responsibilities of Departments and Units

Deans, Directors, and Chairs

Deans, directors, and chairs of colleges, departments, and other units have the primary responsibility for the biosafety and biosecurity of people, animals, and the environment within their jurisdiction.

Principal Investigators

Principal Investigators (PI) using or storing biohazardous materials are responsible for taking all reasonable and practicable action to protect the health and safety of those working with the materials. The researcher must complete and submit registration forms to the IBC for all research proposals involving the use of biohazards and develop specific biosafety standard operating procedures for each biohazard used in the laboratory.

The PI should take all reasonable and practicable action to:

1. ensure laboratory personnel participate in the necessary medical surveillance program, including identifying positions for which this program is applicable and including the serum storage recommendation in appropriate department or research documentation
2. ensure laboratory personnel sign the consent for participation or acknowledge their declination
3. refer eligible personnel to the ASU Health Services to have their blood drawn
4. provide training and instruction specific to the research hazards as well as safe practices and protocols, including, at a minimum, training in aseptic techniques and biology of the organism(s) being used
5. ensure laboratory personnel are trained in accidental exposures, emergency response procedures, and reporting

   and

6. confirm compliance with applicable statutes, rules, regulations, standards, university policies, and granting requirements.

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Responsibilities of Laboratory/Operations Personnel

Laboratory/operations personnel who use or may contact biohazards during the performance of their duties should take all reasonable and practicable action to:

1. participate in appropriate training and instruction
2. be knowledgeable of the biohazards being used or stored in the laboratory and the potential risks associated with exposure
3. follow all laboratory practices and protocols and comply with all applicable statutes, rules, regulations, standards, university policies and granting requirements
4. participate in medical surveillance as required
5. read and sign the consent/declination form for serum banking and available immunizations
6. be trained in accidental exposures, emergency response procedures, and reporting

   and

7. report all thefts, security incidents, accidents, spills, or contamination incidents to their supervisor.

Procedures

The procedures for the Biosafety Serum Storage Program are available in the ASU Biological Safety Manual.

Cross-Reference

For more information, see the Police Department Policies and Procedures Manual—PDP 104–01, “Laboratory Emergencies.”

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