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Last Updated: 03/29/16

Biosafety

Laboratories and biospecimen resources that handle biospecimens expose their employees to risks involving infectious agents and chemicals as well as the general dangers of a laboratory. A predictable yet small percentage of biospecimens will pose a risk to biospecimen resource personnel who process them. Consequently, all biospecimens should be treated as biohazards [57]. In addition to taking biosafety precautions, biospecimen resources should adhere to key principles of general laboratory safety. See ISBER Best Practices [15] Appendix A for additional internet references concerning laboratory and biobank biosafety. Also see the NIH Office of Science Policy’s Biosafety Guidance web site [58]

B.4.1. Biohazard Precautions

B.4.1.1.

Laboratories and biospecimen resources should assume that all human specimens are potentially infective and biohazardous [57]. For example, OSHA regulations [54] (29 CFR § 1910.1030(f)(1)(i)), as applicable, require that employers “make available the hepatitis B vaccine and vaccination series to all employees who have occupational exposure, and post-exposure evaluation and follow-up to all employees who have had an exposure incident.” Dried blood, tissue, urine, saliva, cerebrospinal fluid, dura mater brain tissue and other biospecimens should be handled according to standard precautions and labeled according to applicable OSHA requirements. Biospecimen resource work practices should be based on standard precautions similar to those used in laboratories and clinical settings. Two basic safety precautions should be followed in laboratories and biospecimen resources that handle biospecimens: (1) Wash hands frequently, and (2) always wear face protection and gloves when handling biospecimens or working within or around freezers [59]. Additional good general laboratory work practices are outlined by Grizzle and Fredenburgh and in the NIH biosafety guidelines [57, 58].

B.4.1.2.

A biospecimen resource should establish clear policies regarding the inclusion or exclusion of biospecimens with varying levels of risk. For example, depending on the potential for exposure by splash or aerosol, human specimens of unknown infectivity should be handled according to biosafety level-2 (BSL-2) conditions, as outlined in the Centers for Disease Control and Prevention (CDC)/National Institutes of Health (NIH) booklet “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) [59]. At BSL-2, when biospecimen containers are opened for processing, they should be handled in a BSL-2 biological safety cabinet (hood). All biospecimen resources that handle human specimens should operate under the applicable OSHA bloodborne pathogens standard and develop an exposure control plan [54] (29 CFR § 1910.1030). Additional precautions should be applied, as outlined in the BMBL. Some activities, such as droplet-based sorting procedures [60], may require higher containment, but in other cases, less stringent practices may be acceptable. Therefore, biospecimen resource staff members should be trained to perform risk assessments and determine appropriate levels of containment.

B.4.1.3.

Biospecimen resources should establish policies consistent with the CDC’s “Select Agents and Toxins” regulation [61] (42 CFR Part 73), as applicable. This regulation implements provisions of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, setting forth the requirements for possession, use, and transfer of select agents and toxins. The biological agents and toxins listed as Select Agents and Toxins (e.g., botulinum neurotoxins, Ebola virus) have the potential to pose a severe threat to public health and safety, to animal health, and to animal products.

B.4.2. Biosafety Best Practices

B.4.2.1.

Biospecimen resources should be familiar with governmental and accrediting agency requirements regarding biohazards and sources of current information concerning laboratory biosafety for use in developing an overall program in safety and associated training programs (see CDC/NIH documents referenced in Section B.4.1, Biohazard Precautions).

B.4.2.2.

Biospecimen resources should identify risks and other general issues of biosafety. Frequent biospecimen resource activities should be identified, safety issues involved with each activity analyzed, and suitable controls implemented.

B.4.2.3.

Written working guidelines that are based on Federal and State requirements, experience, and published information should be developed to improve biosafety. These guidelines should be reviewed and updated regularly and modified in response to problems or if they prove ineffective.

B.4.2.4.

A training program should be developed and implemented. Each employee should receive training in relevant areas of biosafety before beginning work, and the training should be updated annually. Training for biorepository personnel should include any site- and/or building-specific emergency procedures.

B.4.2.5.

Biospecimen resources should record and arrange for treatment in response to all incidents where personnel are exposed to biohazards or are potentially infected.

B.4.3. General Laboratory Safety

In addition to biosafety, biospecimen resources should follow strict general safety regulations and procedures regarding chemical, electrical, fire, physical, and radiological safety (ISBER 2012 Best Practices [15], Appendix A; OSHA General Industry Standards [62] 29 CFR 1910).