HELP--ABO titer validation plan

[new2BB 11]

Hello everyone.  We are going to start doing ABO titers at our facility and I have been asked to prepare the validation plan for this new procedure.  The problem is that I have NEVER written a validation plan.  What information do I need to include in the plan?  Does anyone have a template for a new procedure validation plan, and willing to share??? 

[David Saikin 1,181]

I've attached my process validation plan.  Let me know if you need more info.

Process Validation Template.doc

[Carrie Easley 77]

Here's the one our entire lab uses.

Validation Plan and Results Review.docm

[new2BB 11]

David and Carrie, thank you SO much for your help.  I really appreciate it!

[Baby Banker 33]

Both of these are good examples.

We do our validation in three parts:  Installation Qualification, Operational Qualification, and Production Qualification.

The IQ just shows how it was installed.  For a piece of equipment it could be the installation checklist.  For a test it could be screen shots of whatever was changed in the computer to create the test.

Operational Qualification shows that a piece of equipment does what the manufacturer says it will do.  What I do for a test is build it in my Validation Environment and test it there.  If that passes, I build it in the Production Environment and test it again.  I can't move a computer build from one environment to another.  So the testing method for OQ and PQ for a test is usually the same.

However you validate, be sure to get your Medical Director to sign off on it.

[new2BB 11]

Thank you so much for replying Baby Banker.  I appreciate it.

[Tabbie 5]

https://www.b-s-h.org.uk/guidelines/guidelines/validation-and-qualification-including-change-control-for-hospital-transfusion-laboratories/

This document has templates at the back and risk assessment info too

Allard_et_al-2012-Transfusion_Medicine_Validation_guidelines.pdf