Policy IBC1A – Handling Human Blood, Tissue or Fluids

Purpose
Applicability
Definitions
Background
Policy
References

This policy is designed to provide assurance that personnel collecting or handling human blood, tissue or fluids use the proper precautions to protect themselves from bloodborne diseases.

This policy is applicable to all individuals, conducting research activities under the auspices of the University. The policy applies to all University locations, excluding the College of Medicine at Hershey, which maintains separate assurances regarding the use of biohazardous materials.

Human Blood, Tissues or Fluids
For the purpose of this policy, human blood, tissues or fluids are any biologic of human origin.

Institutional Biosafety Committee –
This committee is appointed to review proposed uses of genetically modified materials and hazardous agents by the University. Proposed projects are reviewed for compliance to the NIH guidelines.

Numerous projects have been received for review by the human participants Institutional Review Board (IRB) and the Institutional Biosafety Committee (IBC), which involve the collection and subsequent analysis of human blood or other body fluids. Some proposals may even involve the use of human tissues. The IRB and IBC require that trained phlebotomists obtain blood samples and certified medical personnel obtain tissue samples.

The IBC is responsible for ensuring that University laboratory personnel are aware of the potential hazards of handling human blood and/or tissues and use the proper precautions to protect themselves from bloodborne diseases.

University Policy SY-24 defines human blood and blood products, human body fluids and human tissues as biohazardous materials. If an investigator decides to conduct research involving the aforementioned materials, the following steps must be taken.

1. Submit a completed Application for the Use of Biohazardous Materials and supporting documentation to the Office for Research Protections (ORP), 201 Kern Graduate Building, for review and approval by the IBC.
2. Prior to approval, the Environmental Health and Safety Office (EHS) must inspect the laboratory where blood and/or tissues will be handled.
3. Contact EHS for a copy of the “Universal Precautions” which addresses specific work practices to be followed when working with human blood and/or tissues.
4. Arrange for ALL laboratory personnel who will handle human blood and/or tissues to receive Bloodborne Pathogen Training from EHS. Laboratory personnel will be offered the opportunity to be vaccinated against Hepatitis B. If an individual does not wish to be vaccinated against Hepatitis B, a declination form must be signed.
   • Bloodborne Pathogen Training is required for all principal investigators and/or advisors of studies involving human blood, blood products, human body fluids, and/or human tissues. The training must be completed by these individuals who oversee the study, even if they will not handle the clinical materials.
   • Personnel, other than the principal investigator and/or advisor, who are involved in the study but do not handle human blood, blood products, human body fluids, and/or human tissue are not required to complete Bloodborne Pathogen Training.
   • Bloodborne Pathogen Training is not required when the clinical materials have been prescreened and proven to be clear of pathogens. This prescreening must be stated on the IBC application.

If you have additional questions about the use of human blood and/or tissues, DEP infectious waste disposal regulations or other biosafety-related issues, please contact EHS at 865-6391.

For further information concerning this Policy, please contact ORP at 865-1775.

Penn State University Policy SY24– Use of Biohazardous Materials

Policy IBC1A, Last Revised by the IBC on 11/12/2007, Last Approved by the IBC on 11/12/2007