Lee Memorial Health System.

Company: Lee Memorial Health System
Date: 8/27/01
Product: Blood bank

The inspection revealed failure of your blood bank to adequately determine the suitability of persons to serve as whole blood donors. One donor (unit _____) tested repeatedly reactive for HIV 1-2 in screening tests performed on March 21, 2001 and was never placed in deferral. Donor deferral records maintained electronically failed to contain the names of all donors who were determined unacceptable for donation based on donor suitability questions. At least ten donors answered yes to donor screening questions on a mobile unit that resulted in temporary and/or permanent deferral on manual registration records. However, these donors were not found in the electronic deferral records. In addition, nine of these donors were not found in the donor base as ever being registered. If any of these donors presented themselves for donation at your blood bank at a later date, they could be registered in your computer as first time donors with no past deferral history and accepted for donation.

Florida District Office

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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