Written by: Mediware Consulting and Analytics on Thursday, August 4, 2011 Posted in: Blood Management

The July supplement to Transfusion, the Journal of Blood Services Management, contains an excellent and quite provocative article surrounding the knowledge of the Food and Drug Administration (FDA) reportable deviations.1

For those outside the highly regulated world of the blood donor center or hospital transfusion service, the FDA biologic product deviations (BPDs) are likely unfamiliar.  Specific regulations were defined by FDA in Nov., 2000, which included BPDs and “near-miss” events.2 Blood establishments and transfusion services are thus responsible for reporting events that could potentially affect the safety, purity, or potency of distributed blood components.  The key element here is the word potential for direct patient harm is not a requirement.

This article seeks to identify if blood center and transfusion service personnel comprehend what constitutes reportable BPDs.  Using a survey containing eight well-defined case scenarios, respondents were asked to identify which should be reportable events (essentially by asking “yes” or “no”).  Respondents, totaling 176, represented various levels of training, including transfusion service medical technologists, supervisors, and directors.  Hospital size ranged from <100-bed facilities to those with >500 beds.

The results of this survey study revealed only 10 of 176 (5.7%) of respondents answered all eight cases correctly.  The job experience, title, size or type of establishment was not associated with knowledge base.  I myself, reviewed these cases as a personal “test” and answered only five of eight correctly. ( I have been, until recently, the Transfusion Medicine Director of a very large complex facility for 20 years!  I have since passed this on to the TSO for my prior service to use an  educational tool.)

As mentioned, this study is quite interesting and provocative for it highlights that even in the highly regulated environment of the blood center or transfusion service, the majority of us do not possess a clear or complete comprehension of the requirements for FDA BPDs.

Very often, the emphasis of safe transfusion therapy is placed on physician/nursing ordering or administration practices.  This article serves to broaden our scope, reminding those of us on the blood center or transfusion service side, that we are also primary stakeholders in providing for the safety, purity, and potency of distributed blood products.  The devil is in the details!

Irrespective of our position, training, title or “real estate”, we all must collaborate in our quest to ensure safe and effective transfusion practices.  All of these efforts direct us to provide (as we say at SHG):

The right product

To the right patient

At the right time

For the right reason.



  1. Transfusion 2011;51:1619-1623
  2. U.S. Food and Drug Administration. Guidance for industry: biologic product deviation reporting for blood and plasma establishments. Washington, D.C.: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Biologics Evaluation and Research (CBER); 2006 October, Available from: URL:http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm073455.htm