Tracking every reagent bottle/cartridge loaded onto you chemistry analyzer

Hi to all,

I need some help. As a key operator of one of our chemistry analyzer i need to help get prepared for our CAP inspection which is due in less than a year. As all of you working techs know, documentation is paramount in passing the inspection so my question is:

Is it a CAP requirement/regulation to keep track of every single bottle/cartridge that is loaded on your chemistry analyzer. As far as i know only reagent lot numbers are supposed to be kept track of, as well as their calibration, lot-to-to comparison, problem/troubleshooting.

I am trying to get rid of unecessary paperwork for our inspection so it wont be to hard to prepare, documentation wise, for our inspection.

Thanks in advance to all that will reply to my post.

To prepare for the CAP inspection, it's better to use the CAP checklist specifically for Chemistry. Go through each requirement one by one to see if you are following it. For reagents with a new lot loaded, it's necessary to do a parallel with a patient specimen or QC from old lot to new lot of reagents. Just have some kind of parellel binder that documents this.

As far as keeping track of every single bottle, I don't think there is a specific checklist requirement for that. The instrument keeps track of what goes on and when it expires usually, so in my opinion, an open date and initials on opened reagents should suffice.

I had the pleasure of being a CAP inspector of a lab in chemistry a few months ago. It was my first time, and all I did was go through each requirement to see if it was met. The other inspectors I went with were more experienced so didn't specifically go through each requirement. They had it mostly in their heads. If you're going to be deficient in something, the inspector has to point to a particular requirement, ding you on that, and explain why you didn't follow it. To me, the most important thing to look at is to make sure you have good documentation showing what you did to troubleshoot and correct proficiency testing that was out of the peer group ranges.

As an inspector, I myself was pretty lenient. As long as I saw some documentation supporting the requirement, I let it go. However, I know some inspectors will be hard asses and nitpick every detail. In that case, it's better to go overboard in following the requirements.

thanks for the very quick reply.

I will ask our lab supervisor for the CAP checklist for chemistry.

Actually we already have a log for the parallel studies (lot-to-lot) of each new reagent lot. we run and compare at least a QC run and at least 2 patient samples to determine if our lot-to-lot comparisons are within CLIA limits. The issue that i have is that we also have log/s that the techs in our lab should fill-out whenever they load a new bottle of reagent on our analyzers; which sad to say, are not being filled out.

The log that i am talking about requires us to document the reagent lot number, bottle number, calibrator lot number(if required), and other information for every reagent bottle that we load.I talked to my co-workers to get for some feedback and a frequent response is that they are to busy get our analyzers back online for testing that they believe that they do not have the time to fill-out one form for a reagent let alone 8-10. I actually agree with them on this point. One of my concerns is that if a CAP inspector asks to see this log, they might notice that there are holes in the documentation and actually ding us for it.

So i guess my point is that i want to get rid of this log if it is not a CAP requirement as to not only lessen the possibilities of us getting dinged when our inspection comes but also lessen the required work of my fellow techs and possibly boost morale.

i need as much information on this as possible because my chemistry tech specialist is under the impression that it is a cap regulation/requirement to keep track of every bottle loaded on the analyzer and believes that it is a good lab practice to keep doing so. My argument to this is diminishing returns. My belief is that there comes a point when too much documentation is bad; not only does it become a chore/morale killer, especially in a short-staffed lab, but it might become a source of issue to any inspection that we might undergo.

I agree with you. There are a few issues on that. I'm pretty sure it is NOT a CAP requirement to document every reagent put on the instrument. That is overkill. If I was the supervisor in your lab, I'd throw the binder away. My department does not have such a binder. It is good that you have the parallel binder because that is enough. Even in my lab, sometimes CLSs don't fill that parallel binder out because they're "too busy."

Something to think about though, is if it is written in your chemistry procedures that the CLS has to write in the log every reagent put on the instrument. If an inspector reads that in your procedures and sees that it's not being done, it is possible that you could be dinged. However, to cite a deficiency, the inspector would have to find the requirement that you are not fulfilling. It is possible that the general lab checklist might have a requirement where the lab must follow what's written in your procedures. I do not know if such a requirement exists. In that instance, your CLSs aren't following your procedure so you could be cited for that.

The best thing would be for your supervisor to edit the procedure to delete the portion of putting new reagents in the log, and throw away that reagent log binder. I'm a chemistry supervisor myself, and that's what I would do. I prefer to make things easier for my CLSs while increasing efficiency.