Is it required to have a contract with reference laboratories to perform Blood Bank workups? Or is it adequate to have documentation that the reference lab is CMS and AABB or equivalent accrediting body certified? Bottom line-Can a hospital transfusion service perform an ABID for another hospital without any written agreement??...State department is questioning a "sister" hospital as to their process citing AABB Std 4.2 which I have interpreted more as relating to the Blood Supplier Contract, etc..Thanks to anyone that can clarify!

I concur with your interpretation (and I do AABB and CAP assessments). I have never seen a contract with a reference lab. We use the red cross for our blood supplier and will utilizie their reference service if something is beyond our capability. I do work for other institutions; they just need our CMS certification for documentation for their inspections.

I think that the intent of the AABB Standard 4.0 is that you have P/P/P to evaluate the ability of the reference lab to meet your specifications. You dont necessarily need a contract, but you should have it spelled out somewhere how you came to choose XYZ lab as opposed to another one. That's what I look for when I do assessments/ inspections.

We approve all reference labs to which we send specimens for testing, whether it's for BB or Gen Lab. Part of the approval system is to obtain a copy of their CLIA certificate, directory of services, a mechanism to get updates to it, etc, etc.

Our BB reference lab agreement is part of our blood supplier agreement.

Thanks everyone for your quick response! I'll forward information to our state inspector so he understands the intent.

If you intend to bill for the tests, you may want to check the CMS requirements. See 42CFR482.27 for laboratory services.

"482.27(Standard: Adequacy of laboratory services. The hospital shall have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets requirements of part 493 of this chapter." [emphasis added]

As someone else mentioned, if you're referring samples to your blood provider, the testing services are likley covered in the same service agreement used for products.