Cabrini Medical Center Blood Bank

Cabrini Medical Center Blood Bank 2/8/96

14. Failure to maintain written standard operating procedures for the blood bank’s computer system that include: integration of the computer into daily operations; reverting to manual operations when the system is not functioning; control of changes in hardware and software; security procedures to prevent unauthorized access; and maintenance procedures for hardware and software. Further, the blood bank uses Hemocare software version 4.1. However, the user manual available at the blood bank is for version 4.0. The computer training records for the blood bank technologists do not indicate which software version they were trained to use.

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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