Environmental Health & Safety Manual (EHS)

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Effective: 1/1/2006

Revised: 7/1/2007

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EHS 114: Biosafety Serum Storage Program

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Purpose

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

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Background

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

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Sources

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7 Code of Federal Regulations § 331
9 Code of Federal Regulations § 121
42 Code of Federal Regulations §§ 73, 1003
Centers for Disease Control & Prevention/National Institutes of Health. Biosafety in Microbiological and Biomedical Laboratories. 4th Ed. May, 1999
Department of Health and Human Services. National Institutes of Health. Guidelines for Research Involving Recombinant DNA Molecules. May 7, 1986
Arizona State University Biosafety Manual

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Applicability

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ASU academic, research, and other operations employees working in areas deemed to be high risk and as recommended by the campus Biosafety Officer and/or the Institutional Biosafety Committee. This may apply to high hazard activities involving:

  1. live viruses, bacterial, fungal, parasitic, or other potentially infectious agents at Biosafety Level 2+ or 3

    and

  2. biohazard exposure to research animals.

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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 laboratory 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 laboratory personnel to be better informed about and protected from biohazards.

A medical surveillance component, including serum banking, is in place to protect the health of employees who may be exposed to biohazards during the performance of their duties


Responsibilities of the Department of Environmental Health & Safety

The university Biosafety Officer (BSO) is responsible for providing assistance to the Institutional Biosafety Committee for the purpose of risk assessment, identification, and recommendation for participation in the Serum Storage Program.


Responsibilities of the Institutional Biosafety Committee

The Institutional Biosafety Committee (IBC) analyzes university operations and facilities involving, or proposing to be involved in, biohazardous activities. The IBC is appointed by and responsible to the vice president of research and economic affairs and recommends actions necessary to maintain and/or improve biosafety. Tasks of the IBC include:

  1. review and approve research proposals involving recombinant DNA and biohazards, including select agents and toxins, and approve those that comply with NIH and CDC guidelines and university policy
  2. adopt policies supporting the safe use of biohazards and the elimination or reduction of exposure to biohazards

    and

  3. with the campus Biosafety Officer, participate in a risk assessment of identified research protocols to determine the recommended participation in the Serum Storage Program or other medical surveillance as deemed necessary by a campus health physician.

Responsibilities of Campus Health Service

Draw the sera for research and operations personnel. 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.

Campus Health will be responsible for the inventory and storage of the baseline sera. Access and control of the stored sera is defined in the “Procedures” section of this document.

Campus Health will dispose of the samples as medical waste 30 years from date of collection or 10 years after the individual leaves the university or at the individual’s request.


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 of people, animals, and the environment within their jurisdiction.

Principal Investigators

Principal Investigators (PI) iin charge of biohazardous activities are responsible for using all reasonable care to protect the health and safety of those working with the materials. The researcher must complete and submit registration forms to the Institutional Biosafety Committee 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 must:

  1. provide laboratory personnel with any necessary medical surveillance, including identifying positions for which this program is applicable and including the serum storage recommendation in appropriate department or research documentation
  2. identify personnel who meet the above eligibility requirements and provide counseling regarding participation in this program. Supervisors will ask the individuals to sign the consent for participation or to acknowledge their declination
  3. refer eligible personnel to the Campus Health Service to have their blood drawn
  4. provide training and instruction specific to the research hazard as well as safe practices and protocols, including, at a minimum, training in aseptic techniques and biology of the organism(s) being used

    and

  5. confirm compliance by laboratory personnel with applicable statutes, rules, regulations, standards, and university policy.

Responsibilities of Laboratory/Operations Personnel

Laboratory/operations personnel who use or may contact biohazards during the performance of their duties must:

  1. participate in appropriate training and instruction
  2. become familiar with biohazards being used 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, and university policy
  4. participate in medical surveillance as required
  5. read and sign the consent/declination form for serum banking and available immunizations

    and

  6. report all thefts, security incidents, accidents, spills, or contamination incidents to the laboratory supervisor.

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Procedures

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Upon recommendation of either the campus Biosafety Officer (BS0) or the Institutional Biosafety Committee (IBC), participation in the program is open to all personnel for whom a specific risk of occupational exposure to potentially biohazardous material has been identified.

All personnel referred to the Serum Storage Program will be asked to sign “Consent for Drawing Baseline Serum Specimen” and provide a serum baseline donation as a recommended condition of participation in research, if their work involves any of the following:

  1. human immunodeficiency virus (HIV)
  2. tuberculosis
  3. select agents
  4. any other microorganisms classified at Biosafety Level 3

    and

  5. as recommended by the campus Biosafety Officer and/or the IBC.

All personnel working with these agents will be offered the opportunity to have a baseline serum sample drawn. If these individuals decline to have a baseline serum sample drawn, they must sign the Serum Storage Program Declination Form.

Collection

Serum samples will be drawn for eligible personnel if the campus Biosafety Officer and/or the IBC determines that it is necessary before initiating or continuing work with a new infectious or other biohazardous agent. A serum sample may be collected following an exposure to an infectious or other biohazardous agent (e.g., percutaneous or mucous membrane exposure to a body fluid or an animal bite) or at the conclusion of the work with the particular agent.

Additional serum samples (in addition to the baseline sample) may be collected if requested by the individual or the supervisor based on a risk assessment or documented occupational exposure. These samples will not be processed through a clinical laboratory for the purposes of diagnostic reporting unless there is an occupational exposure or the individual leaves ASU. Additional consent must be obtained.

Laboratory Process

  1. One 8.5 ml vial of blood will be obtained via venipuncture by an ASU Campus Health Service phlebotomist. Becton-Dickinson tiger-top serum separator tubes should be used for this process. Once drawn, the specimen should be left to sit for 30 minutes. Subsequently, the clotted specimen should be centrifuged so that serum is separated from the cellular elements.
    1. One milliliter (1 ml.) of serum is then pipetted into each of two cryo vial tubes with an O ring on top. These tubes should be labeled with a unique identification number rather than the worker’s personal information. This identifier will be linked with a log kept by the Occupational Health Nurse that states the worker’s name and work location.

      and

    2. The two (2) labeled specimens are placed in the −80o Celsius freezer in separate trays (i.e., the specimens are “split,” so that, should it be decided in the future to store one of the samples off-site as a back-up, one tray can be moved to this location).
  1. The sera will be retained by ASU for purposes of this program for 30 years or for 10 years after the individual leaves the university.
    1. The Occupational Health Nurse will be responsible for compliance with all regulations related to the collection, storage, and release of medical information. Any information gained from testing a baseline serum sample will not be used for discrimination purposes or for any reason not addressed in the consent.
    2. Specimens will be stored in accordance with recommendations of the American College of Clinical Pathologists by ASU’s Campus Health Service under the supervision of the Occupational Health Nurse. The specimens will be stored at −80o Celsius or lower, in a secure and confidential freezer. The Campus Health building has back-up emergency generator capabilities. Storage of employee serum samples in laboratory freezers is not appropriate.
  1. Storage and Retrieval Procedures. The Occupational Health Nurse will be permitted to release stored specimens in the following instances and only if appropriate consent has been obtained:
    1. in the event of an exposure to an infectious or other biohazardous agent
      Note: As stated above, the worker will be asked to sign a consent form allowing an aliquot of his or her serum to be released for testing.
    2. during a public health emergency potentially associated with the laboratory
      Note: The county or state health department may request information from ASU under such circumstances. For the purposes of public health emergencies, obtaining consent is not legally required.

      and

    3. if the worker requests that an aliquot of his/her sera be released to assist in providing medical care.
      Note: A written request by the worker must be made in such situations.
  1. Specimens obtained for the purposes of this program will become the property of Arizona State University. Once the individual has provided the specimen, the individual will have no access to it unless there is a written request from a medical provider and the worker’s signed consent.

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Cross-Reference

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


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