Mercy Medical Center, Cedar Rapids, IA, June 14 (Kansas City, KS).After a March 11 inspection, FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. inspectors found several violations in the blood bank's donor screening process. Violations included failure to follow the center's standard operating procedure standard operating procedure Medtalk A technique, method or therapy performed 'by the book,' using a standard protocol meeting internally or externally defined criteria; a formal, written procedure that describes how specific lab operations are to be performed. (SOP), failure to make and record a thorough investigation, conclusion and follow-up of any unexplained unexplained Adjective strange or unclear because the reason for it is not known Adj. 1. unexplained - not explained; "accomplished by some unexplained process" discrepancies; and failure to provide adequate space for private and accurate examinations for potential donors. For example, the SOP required the center to complete health history screening and defer a donor when certain health history information was provided. The agency stated the center, nevertheless, accepted numerous donors whose health screenings were incomplete or contained potentially disqualifying dis·qual·i·fy tr.v. dis·qual·i·fied, dis·qual·i·fy·ing, dis·qual·i·fies 1. a. To render unqualified or unfit. b. To declare unqualified or ineligible. 2. in formation. For example, several donors had stated they had traveled outside of the U.S., yet Mercy accepted the donors without determining whether the travel was to areas that represented a high risk of infection. Furthermore, donor cards donor card n. A card, usually carried on one's person, authorizing the use of one's bodily organs for transplantation in the event of one's death. contained unanswered questions and quality review procedures had not been completed. The agency acknowledged receipt of the center's April 4 response, but deemed it inadequate because it did not address all of the observations listed. BiMo, QC/QS; Doc. 13531W |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion