New Blood bank validation

[jjocom26]

Can anyone please help me. I am currently opening a new blood bank. There is no existing lab. So therefore no current method as well. I have the Galileo Echo and tube method. do I need to correlate the echo with my tube method?

Thanks!!! Needed help badly :'(

[Immunohematologist]

I believe you will need to correlate both methods with another source. I am not sure where you live, but in my state they are very strict with basically everything. If you never did testing at all before, you may have to do testing and send some samples to another lab to prove they are correct. Once one method is tested and validated, you can use that to test the other method.

[David Saikin]

I think you should validate your tube testing first as it is classic (may even be the standard). It's not like you are doing a chemistry/hem analyzier. Once you prove your tube reagents work you can validate and compare your results to the automation. There is no need to send anything out. In your validation process you state what you are going to validate, how you are going to do it, the resullts you expect, the results you get, any corrective actions and repeat studies based on your corrrections and then the acceptance/rejection of the procedure. Make certain that if you are going to use differenct enhancement media (albumin, LISS, PeG, etc) that you validate all in the manner they will be used.

Validation just proves the reagents/instrument you are using works in the manner that you anticipate. You can determine how many samples you need to run - a lot of places run 20 . . . but that call is yours.

Enjoy and make certain to save the results for your first inspection/assesment.

[DOGLOVER]

You will need to find out the state requirements for your area. Also, are you planning on being AABB and/or CAP inspected? Check their standards. Does your local blood supplier have a reference lab that would be willing to let you have some known samples? Also is this a part of a whole new facility or is the facility part of a system? If you are part of a system and are using same procedures and equipment you are in luck. This is quite a challenge, but should be very rewarding. Your vendor for the Gallileo should also be able to help you.

[tbostock]

Every 6 months, we correlate all of our methods (solid phase, gel, tube).

[Immunohematologist]

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Edited September 28, 2012 by Immunohematologist
wrong post

[kirkaw]

You will need to find out the state requirements for your area. Also, are you planning on being AABB and/or CAP inspected? Check their standards. Does your local blood supplier have a reference lab that would be willing to let you have some known samples? Also is this a part of a whole new facility or is the facility part of a system? If you are part of a system and are using same procedures and equipment you are in luck. This is quite a challenge, but should be very rewarding. Your vendor for the Gallileo should also be able to help you.

I am in this exact same situation - we are opening another 'campus' of our hospital but I do not think it will have it's own tax ID #.  Does this affect what the state's requirements might be? And when you say state requirements, where do I look for those, Health and Human services?

I feel that I can validate by testing samples at our main campus and then at this new campus. We will not be using automation, just manual gel and tube testing at the new campus.

[goodchild]

And when you say state requirements, where do I look for those, Health and Human services?

That sounds about right, what state are you in?  Here in Maryland it's the Department of Health and Mental Hygiene. Maryland is lazy, the state requirements are literally "See AABB Standards."

[AMcCord]

If you are CAP inspected, you will have to correlate your tube testing vs Echo testing at least twice a year.

 

Another place to check is CLIA standards. If you receive Medicare payments, you must comply with CLIA. Our CLIA inspections are by deemed status with CAP and verified by the state (random visits to CAP inspected labs post-CAP inspection) - I'm guessing that might be true everywhere. Anyone out there know about who does the CLIA inspections in your state?