A colleague from New Zealand reports that they have a number of centers where they collect plasma from donors using automated plasmapheresis technology, and that they are looking at standardizing the acceptance criteria of their frequent donors when they undergo annual blood tests. The New Zealander is aware that in the United States, the AABB Standards and FDA regulations distinguish between infrequent and frequent plasmapheresis programs, and that according to the AABB Standard 5.5.2.2 (PDF excerpt) "In a "frequent" plasmapheresis program, in which plasma is donated more frequently than once every 4 weeks, the FDA requirements for donor testing and evaluation by a physical exam shall be followed. Please see the FDA Memorandum dated March 10, 1995 "Revision of FDA Memorandum of August 27, 1982: Requirements for Infrequent Plasmapheresis Donors" (PDF) for additional guidance. This is further defined in the US Code of Federal Regulations; 21 CFR 640.65. The New Zealand colleague points out that their practice is to perform tests for total protein, albumin, IgG, IgM levels and a serum protein electrophoresis on an annual basis for their frequent plasmapheresis donors. Not infrequently, a donor may have slightly abnormal values. The action taken by the collection center to these abnormal values is variable, which is what they are trying to standardize in New Zealand. The New Zealander comments that some decisions are easy (e.g. the donor’s total protein < 6g/dl) but other decisions are less clear (e.g. the donor’s IgM is 0.3; normal 0.4-2.5 g/L). The New Zealander was wondering if there existed guidelines to help him and his colleagues in New Zealand address this donor qualification issue?

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator