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.

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
Instructors:  Brian Pate, John F. Murray, Jr
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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