Istat precision.
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So we got cited for not doing precision on istats when we got new ones. We were under the assumption that we didn’t need to. So it is com 40310. We have 90 meters spread throughout multiple locations. Would you go back and do precision on all meters? Or just new ones?
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Andre,
Call me....I just finished the write up for the same thing.......
210-297-9657
Deanna Bogner
I would challenge that as it says for “Each test”, not each analyzer. With that being said, we do a mini-precision for each new analyzer.
We tried that but even abbot says at start up if a new meter we should do a precision of two levels of qc 2 days in a row. We even chalegened it with cap and they said the same thing.
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Shawn,
I second Andrea. The Abbott stuff says "recommended but you must follow the inspection agency of choice."
CAP requires it on a new ISTAT as if the method was never validated. I just got my accreditation letter today on what I sent. we did a full validation.
This is one reason we are looking at TJC for POCT. for a 6 hospital system, this is really expensive and totally unnecessary.
Deanna Bogner 210-297-9657
We started to kill two birds with one stone - every 6 months when we do the CLEW update, we run one level of QC for every analyte on every iSTAT, then crunch that as both our iSTAT to iSTAT method comparison, and our precision. If we have any new iSTATs they get thrown into that mix. Perhaps not quite meeting the intention, but so far has worked well for us.
When I get a replacement or new analyzer I do the electronic simulator for 2 days along with QC of the analytes that the analyzer will be doing against another analyzer doing those same cartridges. I list that as my precision based off of our lab policy and I've been good so far. I do like Silka's plan but so far I only have 8 istats but more are coming. I usually run QC after I do the CLEW updates as well but its just to have monthly QC done as per our lab policy. Maybe I'll call that my comparison and precision!
Inga, I am cheap - I worked for an organization that constantly was forcing us to cut costs and looking at ways to cut out unnecessary QC or other processes before looking into cutting staff. in order to save the jobs of my POC team, I was more than willing to combine steps and reduce cartridge use as much as possible, haha
Inga,
Beware....I was cited for something similar. They wanted accuracy and precision and Cal Ver for a replacement instrument. To answer the citation, I had to do a full validation as if the method was brand new.
(Cal ver, accuracy, precision for two days with two lots and accuracy as per POCT policy)
I have 90 ISTAT and yes....more are coming.
Deanna Bogner 210-297-9657
to all,
Yep...I am where Silka is now....looking to preserve cartridges and tech time before people are cut. For us, it may mean an inspection agency move.
Deanna Bogner 210-297-9657
We get on average 3-5 replacement iSTAT's per month. The 2 day QC precision run is the one thing we've never done since the "tests" have already been validated. We rarely send them to the floor right away so use them to QC the S/O every month. I have never had CAP challenge me on this. Looks like I may have to start; very disheartening since our Docs are demanding expanding our iSTAT fleet. Ivy
Ivy, maybe we all need to call CAP today and bombard them about this topic to support our POC colleagues - this is nonsense. I too have never been cited for that, and also have never done it. It is not fair that some labs get cited and others don't.
I had my boss say after we were cited on the ISTAT precision and accuracy "I don't know why we can't make CAP understand that this does not need to be done."
My reply: "Boss, if they understood, they would not have cited us."
Also, I called CAP during this process. The person that answered the phone said " Wow, I have no notes about the ISTAT for these standards. Maybe your inspector over-reached."
But....the CAP person that was reviewing the citations said "Do the full validation."
You can try to call them....but Good luck! CAP does not have to listen in my experience.
My guess is that the calls will not sway CAP. They just want us to check another (expensive) box......
We talked to multiple people at cap and always got the answer it needs to be done. They supposedly sent us to the poct expert and she said it needed to be done.
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This all sounds like a good reason to consider switching from CAP accreditation to Joint Commission. That should get CAP's attention, but it might be too late to help all of you. They are not the only game in town.
I have been down both roads for mod-complex accreditation - JC and CAP. We had JC for non-laboratory sites that did near-patient testing - cath lab, Resp, OP clinics, etc. I would not go back to JC. While you will get on-site expertise at the time of your survey (i.e., typically 'taking it back to the experts' is not necessary because the folks doing your inspection are JC inspectors) - they are extremely thorough and will leave no stone unturned. We came across as many, if not more, struggles with JC standards that were difficult fits for the world of POC. In my mind, both organizations desperately need to update their standards for the fast-moving world of POC that is moving farther and farther away from the structure of the conventional, centralized lab (what both organizations designed their standards around).