Can somebody share your computer crossmatch validation plan?

 

Thank you.

There are 3 key pieces of the validation process you must inspect and "validate": 

 

1) Your hardware : printers, code readers, etc..

2) software: (your bloodbank and/or laboratory information systems)

3) User performance: mechanism to test the user's ability to understand and correctly operate your electronic crossmatch process.

 

I attached an old copy of the FDA guidance for computer crossmatch. Good luck. 

FDA-Guidance-Computer-Crossmatch.pdf

On 6/6/2022 at 11:21 AM, SbbPerson said:

There are 3 key pieces of the validation process you must inspect and "validate": 

 

1) Your hardware : printers, code readers, etc..

2) software: (your bloodbank and/or laboratory information systems)

3) User performance: mechanism to test the user's ability to understand and correctly operate your electronic crossmatch process.

 

I attached an old copy of the FDA guidance for computer crossmatch. Good luck. 

FDA-Guidance-Computer-Crossmatch.pdf 138.1 kB · 9 downloads

Thank you very much.

We started using the computer crossmatch in the old Hemocare system in 1997. Back then you had to apply for a variance from FDA. FDA made me jump through hoops before they would grant the variance. They did not publish the guidance until 6 months after we applied. Had to prove the system would not you set up and issue an incompatible product, i.e., issue an A to an O or AB, etc.; that you could not perform an EC on someone with an antibody; that there were two ABO/Rhs on file.  We had to send them the evidence that we crossmatched every ABO group against every ABO group to prove the above. The next year I guess they decided that we were not killing people and so you did not have to apply for a variance anymore, but, had to have your validation available. Have to redo the validation with every software upgrade.

LIMS validation checklist -

- that it won't let you issue ABO incompatible units

- that it alerts you if you are issuing ABOD discrepant units

- your antibody flags alterts

- that it won't let you electronic issue if the patient has antibodies (it would issue as uncrossmatched not EI)

- that it won't let you issue expired units

- that it wont let you issue on one sample

-  that it wont let you issue on an expired sample

Much of this may already be in place but will need revalidating specifically to the electronic issue process. If any of these fail, or are not possible on your system them you shouldn't electronically issue.

Keep  a copy of the initial validation handy for CAP inspections. I was asked by an inspector to see it years after we had gone live. I had to dig through previous computer files from my previous boss to find it. It was my first inspection as a lead and made me so nervous. I think she was just messing with me to make me more of a basket case than I already was. 

Also anytime you have a major computer upgrade, you need to test all the computer elements again to prove the rules still work as expected.  It doesn't take too long after you have the initial work down. 

Here is my old validation.   Hope it helps

 

Validation of the Electronic Crossmatch at the GGH - signed.pdf

Meditech provided a validation guide that complied with everything @SbbPerson listed above. This was several years ago however. We kept all the screen shots of each validation step on a network drive in a folder to show inspectors. Still have them to this day. Most CAP inspectors will only ask for records for the period covering your last biennial inspection so no one ever asks to see that anymore (unless there was a significant change of course).