St. Joseph’s Blood Bank

St. Joseph’s Hospital and Medical Center Blood Bank 3/16/00″…6. Inadequate computer security in that employees have access to functions they are not qualified to perform. For example, Technical Assistants (TA) have access to the Blood Order Processing function, Blood Label Check function and Blood Product Testing function, although they are not qualified to perform the tasks in these functions. Additionally, Technologists have access to functions that are only to be performed by Senior Technologists or Supervisors. For example, on February 24, 1999,results for an antibody screen were entered into the computer under a Technical Assistant’s code, although the TA is not qualified to perform this test. ”
SoftwareCPR keyword: CBER, Blood Banks, biologics

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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