Central Washington Hospital – Blood Bank computer

3d) Standard operating procedure Routine Release of Crossmatched Blood and
Blood Products has not been updated to include computter operations utilizing xxx
Blood Bank and Blood Donor Computer System versionyyyy. Specifically, the procedure does not include what type of second verification of information entered into the computer should be performed when blood products are released from the blood bank. In addition, the current procedure for release of product requires that persons removing a blood product from the blood bank must verify the correct product is being issued. During three of four product releases observed during the
inspection this verification step was not performed.

e) Standard operating procedure Standard Methodology Blood Bank Procedures
has not been updated to reflect the use of xxx Blood Bank and Blood Donor System.

5. Failure to adequately train employees to assure competent performance of their
assigned functions [21 CFR 606.20(b)] in that:

a) Blood bank employees reported they began utilizing xxx Blood Bank and Blood Donor System version yyyy March 2, 1999. Training records indicate training on the new computer system occurred on April 30, 1999, May 3, 1999, and May 4, 1999.
Employees operated a computer system that performs control functions related to the release of blood products for approximately two months before records indicate they were trained.

b) Two employees indicated on their assessment forms for the xxx Blood Bank and Blood Donor System version yyyy that they did not know how to perform several blood banking procedures that are included in their responsibilities. There are no records to show that these employees were retrained.

SoftwareCPR Keywords: Blood Establishment, Blood Bank, software validation

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.

What’s New

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:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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