EHS 114: Biosafety Serum Storage Program
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
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
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
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:
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
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.
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:
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.
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 (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:
Laboratory/operations personnel who use or may contact biohazards during the performance of their duties must:
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:
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.
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.
|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.|
|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.|
|Note:||A written request by the worker must be made in such situations.|
For more information, see the Police Department Policies and Procedures Manual— PDP 104–01, “Laboratory Emergencies.”
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