Validation and revalidation required for performance of the electronic crossmatch

Currently CAP Laboratory Accreditation Checklist item TRM.40660 asks: "If the facility performs electronic crossmatches, is there documentation of on-site validation prior to implementation, at the time of each alteration that may affect function, and at least annually? NOTE: Without alteration of the system, the electronic crossmatch function would be expected to operate successfully. However, given the importance of this function, periodic (at least annual) challenges of the system are necessary, to verify detection of clinically important incompatibilities."

The e-Network Forum Editor has learned that the additional wording was added in the 6/15/09 Checklist Edition, the note was meant to clarify that “challenges of the system are necessary, to verify detection of clinically important incompatibilities.” The intent here apparently was not for a total re-validation annually, rather, the number and extent of challenges would be at the Medical Director’s discretion. Reportedly, the CAP Transfusion Medicine Resource Committee will be asked to discuss TRM.40660 with regards to further clarification of the intent in the body of the question itself.

With regards to the Editor's question about other revalidation requirements, there appear to currently be no others in the pre-transfusion testing area. However, in GEN.43875 the wording to challenge the autoverification process reads as follows: GEN.43875 - Phase II: Is there documentation that the autoverification process was validated initially, and is tested at least annually and whenever there is a change to the system that could affect the autoverification logic? NOTE: The range of results for which autoverification is acceptable must be defined for all patient tests subject to auto-verification.

The following comments have been received in response.

ADDENDA Oct. 28, 2009

1. A colleague in the Pacific Northwest comments that the CAP checklist requirement that periodic (at least annual) challenges of the system are necessary to verify detection of clinically important incompatibilities is NOT helpful unless the word ANNUAL is eliminated from the requirement.

ADDENDA Nov. 7, 2009

2. Suzanne H. Butch, MA, MT(ASCP)SBB of the Blood Bank & Transfusion Service at the University of Michigan (attribution used with permission), and a recognized expert in the electronic crossmatch, comments that she attended the 2009 annual meeting of the AABB where she spoke with Kathleeen Passarelli, MT(ASCP)SBB, a technical specialist with the Laboratory Accreditation section of the CAP. According to Suzanne, Ms. Passarelli indicated that there had been much discussion by the CAP about the annual validation requirement, and that there might be some modification or further explanation of that requirement in the next revision of the CAP Checklist. Apparently, this is a requirement that has come out of the 'General Laboratory" section and relates to auto verification and "rules" based actions.
   
   Suzanne comments that on the one hand, it seems reasonable to verify that no one has tampered with the rules. On the other hand, actions in the software related to the electronic crossmatch are frequently more "hard coded" and not open to laboratory modification. If this is necessary for the electronic crossmatch, it should be a requirement of the serologic crossmatch as well. The software that validates the ABO and Rh compatibility of the donor red cells and patient serum operates using the same rules and tables for both kinds of crossmatches - serologic or electronic - and in some cases for just reserving a product for a patient. So, if this is important, it is important to do it for the serologic crossmatch as well.
   
   Suzanne concludes saying "In my humble opinion, it is not useful or necessary to do the validation annually - only initially and after a change".

ADDENDA Nov. 11, 2009

3. A very experienced transfusion medicine physician who has served in the past on the CAP Transfusion Medicine Resource Committee, and who has served as a member of the leadership of the AABB accreditation program asks: What evidence is there that on-site validation of an electronic crossmatch at least annually is necessary? Does the committee have published or unpublished information to support the change in language? What problem is being addressed?

ADDENDA Nov. 19, 2009

4. Robin Nozick, CTO of R.F. Nozick and Associates (attribution used with permission) agrees with Suzanne Butch that ensuring that no one has tampered with rules and customizations is one of the reasons the FDA's regulations specify that Validation of the BECS should occur periodically, however they don't specify how frequently. In the case of Electronic Crossmatch, Ms. Nozick also agrees with Suzanne Butch, all of the rules are hardcoded by the Vendor of the BECS. Therefore Ms. Nozick thinks that just re-validating the Electronic Crossmatch is probably not the most effective way to show that a system is under control. In Ms. Nozick's opinion, a more meaningful idea would be the FDA mandating that the vendor prove no one has tampered with the code that is behind the Electronic Crossmatch at least anually.

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Ira A. Shulman, MD
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W. Tait Stevens, MD
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