American National Red Cross (The), Lewis and Clark Region – FDA 483, May 23, 2008

This FDA Form 483 documents multiple deficiencies at American Red Cross Blood Services. An ongoing trend of "Records: Inappropriate review of ones work" (BPD code (b)(4)) has been observed from March 2006, with multiple corrective actions failing effectiveness checks through February 2008. These included assigning a dedicated reviewer, having the charge person review all Blood Donation Records (BDRs) with a secondary check, and implementing three corrective actions in January 2007 involving policy review, strict adherence to corrective actions, and a multi-step BDR review process. A new trend exception report (b)(4)) for the same BPD code was opened in March 2008.

Additionally, a trend in "Collection Site Set-Up Daily Function Check Form Incorrect/Incomplete" (BPD code (b)(4)) was identified in December 2006, but a timely corrective action was not implemented until August/September 2007. The facility also failed to implement preventative measures for an ongoing trend of "travel to malaria endemic area/history of malaria" (BPD code (b)(4)) since February 2006.

Quality system issues include corrective action plans not always being submitted to the Quality Assurance (QA) Department within 30 days (5 out of 89 reviewed), and QA reviews not being completed within 5 business days (21 out of