Is it a requirement for donor reactions to be investigated to determine a probable cause?

A transfusion medicine physician wonders if it is a requirement that donor reactions must be investigated to determine a probable cause. Presumably determination of a cause would help prevent future reactions in that donor. The reason that he asks this question of the e-Network Forum is that it was raised by an inspector during a recent FDA inspection of their blood bank and donor center.

Editor's Note: The following e-Network Forum discussions below are germane to the present discussion:

• Policy for management of reactions developing after a blood donor leaves the collection site
• Possible reaction following automated double red cell collection
• When is a very slow pulse rate in a fit elderly blood donor a cause for concern?
• Questionnaires to identify donors or staff who might have latex allergy
• Donor deferral for allergy symptoms?
• Eligibility to donate blood if a prospective blood donor is confined to a wheelchair
• Can We Use Lidocaine for Numbing a Donor Phlebotomy Site Without a Physician's Prescription?

The following comments have been received.

1. A colleague who is very familiar with the Code of Federal Regulations (CFR) comments that there are regulations in the CFR governing the investigation of donor reactions. The first concerns SOPs, 21 CFR 606.100 (b) (9). Paraphrasing, it says written SOPs shall include, but are not limited to, procedures for investigating adverse donor and recipient reactions. In the Records section, 21 CFR 606.160 (b)(1) (iii) again paraphrasing, Records shall be maintained that include, but are not limited to, the following when applicable: Donor adverse reaction complaints and reports, including results of all investigations and follow-up. Finally, 21 CFR 606.170 (a) entitled, Adverse reaction file: Records shall be maintained of any reports of complaints of adverse reactions regarding each unit of blood or blood product arising as a result of blood collection or transfusion. A thorough investigation of each reported adverse reaction shall be made. A written report of the investigation of adverse reactions, including conclusions and follow-up, shall be prepared and maintained as part of the record for that lot or unit of final product by the collecting or transfusing facility. etc. Then there is fatality reporting under 21CFR 606.170 (b) which also applies to donors.

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

W. Tait Stevens, MD
CBBS e-Network Forum Editor & Moderator

Elizabeth M. St. Lezin, MD
CBBS e-Network Forum Associate Editor & Moderator