Blood Banker here asking about some very LAB specific quality issue. Hope you can help! There is a recent push to have all of the Blood Bank SOPs signed by the CLIA stated lab director every two years. Ths is in addition to our SOPs being signed by our own Blood Bank medical director every year. The BB director is NOT on the CLIA cert.

Supposedly this is a CMS/CLIA issue that is filtering down thr AABB/CAP. Has anyone else incorporated the signing of ALL Blood Bank SOPs by the Pathologist stated on CLIA cert?

I have not encountered this Y - E - T

The CLIA regs are very clear in who must sign the SOPs. In most blood banks only the medical director will qualify and they must be signed annually by the person listed on the CLIA certificate.

There was some discussion about this on one of the AABB audioconferences. It seems pretty clear that the person on the CLIA certificate will have to sign off on all new and significantly revised procedures for the entire lab ("more than a full time job, if you ask me, which no one did," says Eeyore). My own CLIA director is very resistant at this point, so I am not sure how we will implement this. The CLIA director does not have to sign the annual review, only new and revised procedures. The blood bank medical director can do the annual review of unchanged procedures.

Yes this is correct. My blood bank pathologist shared the notice with me. It is in effect beginning July 1st 2011 and it states that it is for revisions and new procedures only.