I have been in Albuquerque for 9 months and can't figure out why we do so much QC on our reagents. It is a "supposed" CLIA regulation that everytime you switch out reagents, even when they are the same lot number, you have to QC them. I cannot find anywhere in the CMS/CLIA regs that state this. All I can find is to do what the manufacturer recommends, which is once daily.

We used to have an Immucor ABS2000 and now we have 2 Ortho ProVues, and we switch out all reagents every 12 hours (the diluent is good for only 16 hours at RT) and we rerun all of our QC. Or if on our manual rack, we run out of a vial (of Anti-A for example) we redo QC even if it is the same lot.

I personnally think we are going overboard with our QC, wasting QC material and gel cards and wanting to stop duplicating our efforts.

All the labs in the area only perform QC once a day, so if you could please offer some insight for me, I would greatly appreciate it!

Thanks,

QC'd to death!

We do daily QC on gel, Provue and tube method. If we open a vial of anti-A from same lot# we do not repeat QC. We rotate our reagent every shift on ProVue.

We QC each reagent rack, but do not QC every newly-open vial of the same lot.

I sleep better at night following manufacturer's product insert recommendations, which must be CLIA- and FDA-approved.

Most blood bank reagents are extremely stable. The manufacturers must have stability data to support the performance of the reagents over the expiration dating period. The definition of a lot is that the material was once a single large batch. The large batch is filled into multiple single units. Based on this type of manufacturing what is in vial number 1 is the same material that is in vial number 2000 and so on. As long as individual vials are stored in the same manner they will all perform the same. Therefore performing reagent QC on each newly open vial would be a waste of time and costly reagent. Performing QC once a day on a lot should be sufficient.

CLIA has no such reg. As a rule, the regulating agencies do not get that granular but usually have language along the lines of "...evey 24 hours or as per manufacturers instructions..."

As the compliance guy at my facility, whenever someone trots one of these zingers out I always ask for the citation so that I can verify it myself. You would be surprised how often they suddenly cannot find the citation or how quickly they change their minds about it.

We were just sited for this at our recent JCAHO inspection. We were told that it is not acceptable to JCAHO to test just one open vial of the lot number that we have to check all open vials if they are being used. The inspector made reference to a CLIA regulation but I was not able to find one, however the JCAHO standard is very specific. We are not CAP accredited.

Standard number: QC.5.220 states :"each opened vial of antisera, reactive cells, and reagents is tested for reactivity on each day of use and when a new lot of reagents is first used".