South Florida Blood Bank

South Florida Blood Bank 8/12/99

The inspection revealed that complete and accurate donor deferral records are not being maintained. A deferred donor that tested repeatedly reactive HBsAg on February 12, 1998 (Unit #2251435) was improperly re-entered for donation on August 12, 1998 without a neutralization test being performed. This donor should have remained in deferral. However, the reactive test result in your computer system for Unit #2251435 was manually changed to a negative test result for re-entry purposes and this unsuitable donor was accepted for donation on three subsequent occasions (Units #7896092, #7974043, and #7993801) . Unsuitable blood components prepared from those units were issued by your blood bank for transfusion purposes.

The investigator documented that positive viral marker test results for HBsAg and HCV, originally entered in your computer system resulting in donor deferrals, are routinely being manually changed to negative test results in what appears to be a work around the system to allow for the re-entry of qualified donors. Your written procedures fail to contain specific instructions for changing these electronic test results. We believe this practice contributed to the above incident and fails to ensure the integrity of the electronic testing data in your computer system.
The inspection further revealed inadequate computer security to assure data integrity and failure to correct a deviation cited during our previous inspection. Our investigator observed an employee hired in January 1999 gaining access to your computer system using the same generic password provided to all new employees during training, and documented continued failure to recalibrate the blood collection scales on mobile units used in multiple blood drives on the same day.

SoftwareCPR keywords: Blood Establishment

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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FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:

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