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Documentation of lot numbers for supplies used in the collection of blood products

A blood banker in Texas reports that after a recent on-site audit by the FDA, the FDA field investigator reportedly issued a Form 483 Notice of Inspectional Observations for failure to document lot numbers of all supplies used in the collection of blood. The FDA field investigator reportedly wanted to see lot numbers of every single item used in the collection of a unit of blood linked to that unit. The inquiring colleague reports that her facility was documenting the lot number of the blood bags that they used, but acknowledges that they were not documenting the lot numbers of EDTA tubes, red top tubes, gauze, etc. The inquiring colleague would like to know if other facilities achieve this degree of documentation for lot numbers and how they link that information to each blood bag.

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

W. Tait Stevens, MD
CBBS e-Network Forum Assistant Editor & Moderator
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Posted: Aug. 3, 2006

Addenda:

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