Reagent QC

[ABQ bloodbanker]

I have been trying to reduce the amount of QC we do on reagents, so I've been investigating the requirements that the regulatory agencies have for performing reagent QC.

Currently we run QC daily, and repeat it when we switch out reagents or run out of a vial and open a new one, even if it is the same lot number.

On our ProVues, we switch out cells and diluents every 12 hours.

All of the responses I have received so far have been to just do what the manufacturers recommendations are, which is do only perform on day of use and when switching to a new lot #s.

I have just discovered that JACHO, which inspects the hospital we are located in, has a standard QC.5.220 C stating "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.":cries:

How is it that most labs are getting by with only performing QC once a day?

This is what I would like to go to, but do not want to get "dinged" if the hospital inspectors look in the lab at our QC.

[Cliff]

Our facility used to do most of the racks we had in use, and were cited for not doing each open vial each days of use. It's added a significant amount of work for us.

[David Saikin]

CAP only requires that the lot is tested each day of use NOT each open vial of the same lot.

[KKidd]

We perform QC daily on each rack in use and on any vial that is opened during the day. If I have vial that will probably run out during that day, I will go ahead and QC a new vial with the rest of the daily QC. This saves time. On our last JC visit, the inspector checked for this.

[Likewine99]

I have my "day of use" defined in my SOP's as "every 24 hours", this was suggested when we went to the ProVue by our installation consultant. All of the gel cards are QC'd on the Provue, by the night shift every night.

The eveing shift QC's the tube reagent rack (only one rack) every evening, this covers my "every 24 hour" rule. I would explain to an inspector that any new lot of tube reaget that was opened, even if it was opened at the beginning of the evening shift gets QC'd the next evening which covers the every 24 hour rule.

I've had 3 successful CAP inspections and hope this flies next spring when they are due again.

[donellda]

We do QC on the lot in use. We used to have 2 different reagent racks and we QCd both racks until about a year ago. Now that we have started using gel, I only have one rack in use per day. The racks are rotated daily.

[VACASE]

We do not repeat QC on a newly-opened vial if it is of the same lot number that we've already QC'd that day.

I would like to ask how people are QC'ing their panels.

[Likewine99]

We do not QC panels, we d/c'd that about 10 years ago. We QC the gel cards that are used to perform the panel and we QC the screening cells that were used that gave the pos absc.

The theory here is that the panel is an "extended ab screen" and you are using it to "confirm" what was suggested in the absc.

If any of the compliance gurus in the group think that my organization should revisit this pls let me know, we are CAP accredited but not AABB.

[LaraT23]

The way I read TRM.31400, It states" Do records docment...qc.... each cell used for antibody detection must be checked each day of use for reactivity of at least one antigen using antisera of 1+ or greater avidity". We use Ortho panel A and the insert says, that it should be checked periodically with weak antibodies. We do QC on the panel each day of use, using the Cor Qc system. I have actually cited a deficiency myself in the past for not doing panel QC. But like all CAP standards, it is really a matter of interpretation.

[David Saikin]

I qc my panels using weak antibodies when they come in. My interp for antibody detection cells is the screening set. Detection vs identificiation. I think some panel qc in indicated by the feds, not necessarily day of use.