FDA 483 - American National Red Cross - September 24, 2010

The FDA Form 483 details significant deficiencies in the National Donor Deferral Registry (NDDR) and donor management systems. The primary issue is the failure to accurately identify deferred donors due to limitations in the NDDR "pushed tables." These tables only contain current donor information, omitting prior last names and not effectively handling hyphenated names due to soundex algorithm issues. This means donors who previously donated under different names or variations of hyphenated names may not be identified as deferred during registration.

Furthermore, investigations into potential duplicate donors are incomplete or poorly documented. The rationale for determining false matches is often not specified, even when critical donor information is similar. Migration of donor information from prior computer systems to the current NBCS system resulted in inaccurate or incomplete data for deferred donors, including missing addresses and phone numbers, and incorrect gender assignments (female donors transferred as male). These data integrity issues hinder the identification of potential duplicate donors.

Several donor merges were not thoroughly investigated, with instances of unaddressed third last names and failures to identify duplicate donors due to procedural deficiencies in checking prior names. Inaccurate birth dates and unexplained phone number changes in NBCS further compromise data accuracy. Record-keeping is also inadequate, with procedures allowing for the shredding of eBDRs, potentially leading to incomplete donor histories. Finally, Blood Donor Records (BDRs) lack sufficient documentation for health historians to properly assess donor eligibility, particularly concerning travel history for vCJD risk, as specific exposure dates and