The use of fresh blood drawn from company employees is sometimes required when timelines in experiments are too tight to use an outside blood supply vendor. That said, it is considered to be preferable from a safety standpoint, and often a logistical one as well, that an outside blood supply vendor be used rather than establishing an in-house program.
When research needs require establishing an in-house blood donation program, there are numerous considerations to take into account including:
- Involvement of the legal department to develop an informed consent form for voluntary blood donation. This form should include an explanation of the risks associated with participating in the program, confidentiality concerns, and compensation for program participation, if any.
- An evaluation of the need to establish an Institutional Review Board. If your company receives federal funding and/or the blood collected is being used to support an FDA submission, it’s very important to determine the need for IRB review and the applicability of 45 CFR 46 (Protection of Human Subjects).
- The need for a certified phlebotomist− either through an occupational health provider or an employee that is certified.
- Development of a questionnaire for each donation. This should include questions of the donor including: Are you are feeling well? Are you aware of any risk that your blood may pose to your co-workers? When was the last time you donated blood? etc.
- Establishment of an SOP for drawing blood, including where the draws will occur (must be done in a private non-lab area), PPE required during drawing and transport to the lab, how often donations are allowed (must be within Red Cross guidelines) etc.
These considerations should be addressed early on in the program implementation process. One additional important factor for any in-house blood donation program is never to allow a researcher to work with their own blood in the laboratory if the blood has been manipulated in any way. If a researcher is exposed to their modified blood, their body would likely not recognize it as foreign material. For this reason, some companies do not allow laboratory employees to participate in the blood donation program.
The latest issue of Safety Partners’ Incidents, Accidents, and Near Misses in Laboratory Research (Volume 4) includes a real-life story of what can happen when some critical factors are missed in the planning process for an in-house blood donation program.
For more information on in-house blood donation programs, or to receive a copy of Incidents, Accidents, and Near Misses in Laboratory Research (Volume 4), please email [email protected].