Accrediting a new blood bank

[bemarine]

Hello, I was wondering when a new blood bank lab opens. How do they go about getting accreditation? If you are from a big hospital system to you automatically ineherit that or do you prepare everything and then call the agencies to come inspect?

Thanks everyone.

Bettina

[David Saikin]

Who do you want to be accredited by? I would call them and ask what they would like. It seems you should have a copy of the AABB standards and go from there. CAP uses these as the basis for their checklist. Have all your procedures and policies in place to be compliant with whoever's standards you are going to comply with, Then . . . good luck with your inital inspection. The agencies will be very helpful (at least they should) when it comes to explaining any deficiencies and the how's of compliance.

[tbostock]

I agree with David; make sure you check with all possible agencies that regulate your Blood Bank: your state DOH, the Joint Commission, CAP, AABB, FDA, etc to make sure all of your bases are covered. If you forget to notify one of them, you could face issues later.

[bemarine]

Can you still be issuing products and perform testing without any of these accredidations? If so, is there a time line established that you must be accredited by?

[tbostock]

Can you still be issuing products and perform testing without any of these accredidations? If so, is there a time line established that you must be accredited by?

Well, CAP, AABB, and Joint Commission are optional accreditations, so if your hospital is not accredited by them now, no need to worry. However, you would still have to comply with your state regs and the FDA, and I'm sure that they would want to inspect before you started doing any testing or issuing blood.

[L106]

I agree with Terri. I'm sure state laws will vary, but I know that in our state they have to come and inspect any new services as well as most significant changes. (Example: We recently moved our "23-hour Observation Unit" to a different area of the hospital, and the state had to come inspect it before we could start using it.) So I am sure that a new Blood Bank Lab would be a pretty important event.

I had to apply for FDA Registration and notify them when we started collecting autologous donor units. You need to get a copy of the current CFR (Code of Federal Regulations) and make sure you are following all the FDA "rules", but frankly, I don't know what you need to do in regard to notifying FDA when you first open up (if you are not collecting donors or processing/modifying/irradiating donor units.) Surely someone else can answer that question?