Documentation that QC was performed on new test strip vial.
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We just had a mock TJC survey and the inspectors wanted to know how we verify that QC is being performed when a new vial of test strips is opened. Currently, we have in our glucose procedure, on the glucose quiz and on the glucose skills checklist that QC must be performed when opening a new vial of test strips. The inspectors said that was fine but we need a way to document that this is actually being done. We cannot do it by lot number because we buy in bulk and our lot number is sequestered for 6 months at a time. We also cover 4 campuses and have about 160 glucometers.
Has anyone else encountered this and what if anything did you do to become compliant. Any input is welcome.
Thanks!
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We also sequester lots for 6 months at a time. When a new lot arrives in tht warehouse, they notify us to pick up a vial of the new lot. Our POC testing staff perform the lot-to-lot comparison according to policy and then activate the new lot on all meters through cobas infinity. We keep a copy of the comparison on file.
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We have Nova StatStrip Meters. TJC wants documentation that QC is being performed on every test vial that is opened, not just when the test strip vials arrive at the warehouse.
Has anyone else encountered this?
Hi Sherri,
Is it possible that TJC wants you to document that QC is performed on every glucose test vial opened because that is the way you have it written in your policy, quiz, and checklist?
We have Accuchek Test strips and the manufacturers instructions say that QC needs to be done on every test strip bottle when it is opened, not just the lot number. We have it listed in our policy and have educated our nurses, but I am not sure how to track this, either. I am interested to know how other facilities are accomplishing this! Thanks for bringing it up!
If you have anything written in a policy and the surveyor reads it and you are not doing it, they will site you for (I believe a leadership standard) because you are not following your own policy.
Jeremy Williford, PBT(ASCP)CM
Laboratory Services Coordinator
Laboratory
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Sent: Tuesday, December 10, 2019 8:26:50 PM
To: Williford, Samuel 'Jeremy'
Subject: [POCT Listserv] Re: Documentation that QC was performed on new test strip vial.
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The lot-to-lot QC is performed by the POC staff for our Accuchek test strips, but QC is performed by each unit on each vial opened.
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How do you prove it, though?
We have Accu-Chek Inform II test Strips, and included the "must QC every newly opened Test Strip vial" in our P&P. We use a Comment "QC 4 new Strip vial" that must be used when they perform QC for this purpose; however I honestly don't think they run Controls every time they open a new vial. TJC and CAP have never inquired about this, but I take the requirement very seriously. The challenge is that it's virtually impossible to make it happen 100% of the time.
I've heard of places that mandate each vial be dated and time stamped when they're opened, so that you can audit the process.
Like Susana said, it is in the procedure that all new bottles of strips must be QC'ed, dated and initialed. They must all document in the meter that it was done. They also at their yearly competency training it is gone over and they answer a question on a quiz about this, that way if they ever got caught by an inspector and they say they were never informed, I can pull all the info for this.
I do have some units that do extremely well and others who seems to just not care. Whether its just coincidence or not, it the areas that are the most deficient tend to be the areas that have the most temp nurses.
I can follow how well we do through RAL's, I would be happy with Hospital wide at 80-90% when in reality we sit at 70%, and that's with some areas that go overboard on the QC by doing all meters when they change, some of them just have a hard time understanding
dave
I follow the manufacturer's ( we have NOVA meters) requirement. Nowhere in the product insert do I see that I have to QC every vial. Unless I am going blind. Someone tell me where it is. I don't have it in my policy either so I don't have to have the users do it. How can you guarantee they do it! You can't unless you are up in the units every time they open one. That is ridiculous!
Now disinfecting the meter is another matter. How do you guarantee they do it all the time. You can't either. I hope that they do. I just remind them that we can always tell who did glucoses on the patient at the time he/she contracted the hospital acquired infection, if any. That scare the wits out of them.
Can you imagine the expense if you have to do QC on each vial! We have units that use 2-3 vials a day. We do not require them to QC every vial. It is a single use strip. How can you guarantee that doing the QC makes the other strips okay too.
We do QC once every 24 hours and I explain to the users that if some results are suspect that they can do QC anytime. Would you believe I get called when they have patients that are running around 100mg/dl. They tell me they did QC to check and they were okay. I guess they are paying attention.
We do the same QC as Pet. Although now, I will most likely scrutinize the manufacturer's inserts.
Its a Roche Inform thing, they put it in there suggested things to do and then New York State picked up on it and they are checking NYS labs to see if they are following there recommendations
dave
We use Accuchek and RALS. A template comment in the glucometer is added to the QC result obtained when performing QC on a newly opened vial. The comments show on the RALS QC reports. Additionally, "QC checked" is written on the lid of the vial.
When we used canister-based test strips (Lifescan), we had these custom labels created for the canister lid. It was an endless battle to achieve compliance, as you might imagine. But at least we were able to show our awareness of the issue and a mechanism for compliance. Fortunately I was never challenged very hard on the issue during surveys. Nonetheless, one of the reasons I was very glad to sunset these meters and move to the Abbott line (individually-wrapped strips) where this requirement was no longer an issue.