Inspection agency question
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To all,
I am curious......
Has anyone considered switching inspection agencies due to costs of items that are required by CAP-specifically for the ISTAT?
I have about 100 ISTAT and the cost of validation is getting to be scary.
I just wondered if anyone else has looked at "When is it not worth it to spend all of this money?" or if there was an "Enough is Enough" moment. If so, what was it? FTE, reagent costs, lack of value add for the patient?
I understand that there are some places that corporate says "You will do this."
If you do not want to post, give me a call.
Thanks to all.
Deanna Bogner 210-297-9657
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I just started using the iSTAT this year in the ED only (slowly rolling out the device and test to be performed). I have 10 iSTAT's w/ more coming (Platform) Cath Lab/OR/DI that will replace Hemochron/ABL80, etc. Currently we are inspected by NYSDOH and DNV but next year we will be adding CAPS. What is the added expense w/ CAPS? I also did an IQCP for the tests that I use on the iSTAT, I am concerned currently of the cost of the cartridge's "14 Day" expiration (a lot of waste - and still working on PAR levels).
We do an initial validation on all meters when we first get them. After that we have a statement stating the istat is the reader and the cartridge does the testing therefor we do not need to validate every meter just a grouping of them every 6 months. There is no way we could do it on all of them for cost alone. Also we do them for all of our locations (3 off sites).
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Initial validation is performed on all meters prior to releasing them to the units along w/ IQCP. Having a valid IQCP allows me to perform QC monthly by an end user (RN- High complexity) which I rotate the devices and end users. The electronic grouping (eVAS) JAMS/CLEWS q 6 months for software update is downloaded.