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Recalls and Significant Blood Safety Violations

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to testing (failure to perform anti-HIV 1/2 testing correctly).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

10/30/09:
Recalled 1 Red Blood Cells Leukocytes Reduced Product due to donor eligibility (incorrect gender assigned; incorrect Blood Donation Record gender-specific questions were answered).

The following excerpt is from page 1 of this 2-page FDA Inspection Report:

Failure to assure that personnel have the necessary training in and a thorough understanding of the operations which they perform.

Specifically,
While conducting employee observations, I observed Collection employee [REDACTED TEXT] conducting the Uniform Donor History Questionnaire. When asked the question, "In the last 12 months have you had an accidental needle stick", the donor, a healthcare worker, stated yes, she had been stuck by a used needle within the past 12 mos. She couldn't remember the exact date,but stated it was in October 2009. Staff person [REDACTED TEXT] entered Oct. 1, 2009 into the electronic [REDACTED TEXT]system, and stated that they were told to use the first day of the month when they didn't know the exact date. I explained to her that it should be Oct. 31st to include all of October into the deferral period as using the first day of the month would shorten the deferral to possibly 11 months.

I talked to the Collection Supervisor who also stated it should be the first of the month until I explained to her why it shouldn't.

Download the pdf file to read the complete inspection report.