Acceptance Testing of Reagents

[Leisa]

We were recently cited during a Quality Inspection for not performing acceptance testing of reagents upon receipt. We have a procedure for receiving reagents into the lab, verifying the appearance, checking the package insert for important changes, etc. However, we do not test each reagent in a shipment to verify performance. QC is performed each day of use.

The AABB Technical Manual is vague on this issue. I was wondering what other blood banks are doing.

[Lcsmrz]

Acceptance testing differs with every site and with every reagent, so it's important that your criteria be documented for each item defined as a critical material. We do this as part of our initial validation paperwork and add it to the receipt process. Since each item has its own acceptance criteria, every item in a shipment is verified on-reciept against these, and this is documented in the receipt log.

We don't test each reagent in a shipment either, but we QC each reagent vial on opening and daily thereafter. Don't get me started on the usefulness of daily QC testing, though ...

[John C. Staley]

I'm curious, who did this "Quality Inspection" and what did they base their citing on? We haven't done acceptance testing for years and it was our corporate transfusion QA group who told us we could stop and they are the most conservative bunch you would ever hope to meet.

[Lcsmrz]

John:

In their standards, both the AABB and CAP require some thought about acceptance testing of incoming supplies. CAP specifically comments that reagents and kits need to be checked before being placed into use, while the AABB verbage allows you to work it into your system. A brief look at ISO regs finds a requirement as well.

Maybe we're talking about two different things ...

Acceptance testing could be as little as a visual inspection of the container for leaks, or as much as parallel testing against the previous kit. It's whatever your facility defines as acceptable for that material. Both the criteria for acceptance and the incoming inspection need to be documented.

For example, when a reagent shipment arrives, what do you do and how do you document it ??

[John C. Staley]

We document what arrived, when it arrive, how much arrived and if the package insert has changed. If there is something wrong like broken bottles or anything thing else that is immediately apparent steps are taken as outlined in the reagent receiving SOP. No testing is done until the lot is first put into service, then daily QC is performed.

Maybe it's just a matter of semantics but to me when some one says "acceptance testing" then some form of testing is involved and that entails test tubes, centrifuges, etc.

[QDeb]

Wow,

I would ask the assessor or group that the assessor came from to provide more information on what it is that they are looking for...specifically! Ask them to explain the intent of the standard or expectation. Until you know what it is that they are looking for, it would be hard to meet their requirement. Look at what you do and answer one thing...do you meet the standard/requirement? If you feel as if you do meet the standard/requirement then challenge it. Believe it or not assessors are human too...

[mtheriault]

On routine reagent antisera and cells, staff performs QC testing before use to ensure appropriate reactivity.

[luhubert]

We do exactly what mtheriault does. What we're getting and when we get it is maintained through our purchasing department. Lot numbers are maintained when doing QC. The appearance and acceptability is noted when the first QC is done before being placed into use. We have a statement on our spreadsheet for Blood BAnk QC that says "Reagent appearance acceptable? ___ Y/N"

If No, document problem and resolution below.

I personally don't think we need more than that.