Somerset Medical Center Blood Bank

Somerset Medical Center Blood Bank 5/29/96

1. The validation of the Meditech Computer System is incomplete and/or inadequate for the following reasons:

a. Computer documentation did not include testing procedures, system requirements, and system specifications which were specified to Somerset Medical Center.

b. There is no assurance that all program changes resulting from the software upgrade (Version NPR 4.3) were identified and tested prior to the 7/31/95 implementation.

c. Validation documentation for changes made to the [purged word] computer system was not available. For example, a calculation hook to quarantine units was created and implemented in 8/95; there was no validation documentation for this change.

d. Testing was incomplete in that it did not always include invalid and/or “worst case scenario” entries. For example, the testing documentation for the unit status issue routine did not include the attempt to issue “contaminated” and “quarantined” units.

e. Testing documentation did not always include supporting documentation as required by the LIS Validation Testing Protocol. For example, the computer validation form dated 4/11/95 indicated that the ability to reuse social security numbers was tested and acceptable; no documentation supporting this conclusion was attached to the form.

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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