Replacement Instrument Evaluations
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I know this has been asked before but what do you all do to evaluate replacements for broken instruments that are replaced by the vendor, i.e. iStats, Epocs? Do you do anything different for waived vs moderately complex instruments?
We are currently trying to balance the Regulations against the reality of cost and time. And we are CAP.
I get so much good information from everyone on this listserve so I thank everyone in advance for their help.
Liz
P.S. Good luck on the exam! I wish I could join your study group just to hear what you are discussing. I am sure there will be a lot of great info
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I do CAL/VER and controls on every replacement I-Stat, in addition I do hyperbaric and hypoxic pO2 levels, and a low TCO2 calver. I then follow up by running control. Is this sufficient? I don't see a need to run patient correlations since I am running the span of my reportable range. I've missed most of the prior conversations but am wondering if I am missing something. I do find these step essential because I have had replacement I-Stat analyzers fail my cal/vers and had to be sent back. I do run patient correlations with our Chemistry analyzers every 6 months.
Also has anyone had any bad replacement analyzers lately, we've had three die within a week of being released on our floor. I'm just worried if the quality of replacements are decreasing.
According to our Lab's Quality dept., Abbott has a document that is not in the iSTAT manual or on their website that has suggested protocols for both initial validations - and replacement instrument validations. It includes doing a patient comparison test
with the replacement iSTAT vs an existing iSTAT. So we had to start doing that. I think they and maybe CAP are viewing this document as mfg. "recommended" protocol, though how anyone would know about it is beyond me. Maybe it is provided to their implementation
reps but I've never found it in their public published material. And how would we know if it was updated or changed; it doesn't seem very helpful to me.
Cathy
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Cathy, it is a technical Bulletin
Pet Maniquis, MPA, MT(ASCP) POCS (AACC)
Laboratory Point-of Care Coordinator
Providence Medical Center/ Saint John Hospital
8929 Parallel Parkway, Kansas City, KS 66112
Ph: 913-596-4727; Fax: 913-596-4728
PManiquis@primehealthcare.com
From: Cathy Owens via POCT Listserv (Groupsite) [mailto:users+1166662@poct.groupsite.com]
Sent: Wednesday, October 03, 2018 11:10 AM
To: Perpetua Maniquis (PMC)
Subject: [POCT Listserv] Re: Replacement Instrument Evaluations
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I assumed that document was not on the website because it is no longer applicable.
If you call and ask they will send it to you.
Sent via Groupsite Mobile.
Yes, it does seems like the quality of replacement iSTATs are decreasing. We had one lately that worked fine until we took it out on the floor and then it went to crap. Had to revalidate another. There were a couple that we were able to fix. I would love to have a service contract but when we counted the number of istats that used to break, the contract severely didn't pay off. Now that more are breaking, it would make the contract a bit easier to sell to the hospital but it is getting extremely difficult to get money for anything.
Curious to see what everyone is doing about the memo sent out from Abbott to replace all wireless iSTAT's or turn off the wireless due to the KRACK vulnerability?
We are going to replace our wireless i-STATs. We have only 18 wireless i-STATs.
Just talked with our IT and the vulnerability has been "patched" from our end. The only way to make sure all is safe is to replace all wireless analyzers. I am surprised that Sherri thinks that 18 is a minute number when speaking of validating all replacement analyzers. (Precision, accuracy and patient correlation on them all.) This is time consuming and costly...
I wonder if Abbott will send a representative to validate our analyzers and reimburse us for the cost of QC, calibration verification, and cartridges for all the analytes on the analyzers affected...
First I cried, then I tried to quit, and then I realized that I am going to have to suck it up and validate a whole slew of new i-STAT's. I am going to reserve a conference room when they come in and line them up and go for it. Not my idea of a good time, but there is no way our ED will give up their wireless.
We are waiting for our IT security to let us know if our infrastructure is adequate and we do not have to replace. The risk is quite low from what I understand and there are many medical devices that have the risk not just I-STAT. Because the recall is voluntary and not FDA mandated I do not believe there is any monetary compensation for validation of the replacements.
I have spoke with our IT, as long as your wireless network is ready for it no further action is required. I also called Abbott and they concurred as well that if your facility is equipped and has taken the action to prevent KRACK it is not necessary to replace devices.
We have 9 I-Stats to replace due to the Krack wifi fix. As part of the validations, what number of patient results does your medical director require? We compare 10 I-Stat/lab results. It seems this number is quite variable.
Our medical director requires us to do 5 patient samples for all analytes tested.
We follow the Abbott analyzer workup recommendations of 1-2 patients on a comparative method or previously verified ISTAT. If you email me I can send you the protocol. It may also be in some other strand in this POC group. It has been talked about before.