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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For our I-stats (all of our test are moderately complex)- we just had our cap inspection and was cited for not doing precision and accuracy. So I have just been working on our procedure
We are doing a cal verification, a whole blood patient comparison comparing the new meter and the lab analyzer for accuaracy, and for precision two level of control in duplicate for two days.
It is a long process but talking to Abbott and cap that is what we have come up with. Though don’t ask Abbott too much they claim you don’t have to do it and they don’t recommend it but the regiulatory agency does so I guess you have to do it.
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For iSTAT we just run the call ver one time per level, for all analyses that will be tested on that handheld. Typically that would look like this:
1. Warm up 7 CG4 and 6 CHEM8 cartridges plus one set of the 5 level cal ver, one vial eurotrol hypoxic, one vial eurotrol hyperbaric, and one vial Abbott CHEM8 1b
2. Set up the new iSTAT in linearity mode and scan in the first CG4 cartridge.
3. Shake level 1 vial to mix the gas with the liquid, crack open, and run the first CG4, set vial aside.
4. Repeat for all remaining gas samples
5. Run all remaining chem samples using the same vials as before as long as its within 30 minutes of opening.
6. Crunch data for each analyte in EP Evaluator using the linearity study, but be sure to also select calibration verification, and precision so that you get all three studies in one. We always use the CAP ranges for Total Allowable Error.
7. Review that each analyte is in range and the study says PASS.
8. Done and Done
How are you getting away without dooming precision and accuracy. We just got dinged for that on our inspection. And called cap multiple times and lost the battle with everyone we talked to. Including their poc person.
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Silka,
How does the process that you have outlined cover the accuracy part of the standard?
When you use EP Evaluator and choose the Linearity study, under Report Options you can either just check "Calibration Verification", or you have the option to check additional reports such as "Confirm Linearity", "Confirm Accuracy", and "Confirm Reportable Range". That way you get all three in one. I realize now that I misspoke about precision. We do precision semi-annually after the CLEW update on our fleet, which also counts as our iSTAT to iSTAT method comparison.
If CAP is now citing labs for not doing a new method accuracy and precision validation for each replacement handheld, that is new, and over the top. By that logic, every time you change lot numbers of iSTAT cartridges you should have to do this because the cartridge combined with a handheld equals the "test system". The total test system should have had a primary validation to include accuracy and precision when the method was first introduced to the facility. I am shocked to hear that CAP has reversed their standing on this issue - do they have a new person in charge of Point of Care? That is complete nonsense and a giant waste of time and resources. Usually CAP is reasonable about that - hence the separate checklist for Point of Care.
This is all great, thank everyone so much. At this point we are doing the Cal Vers , run three patient comparisons and do a within run precision. Hearing this discussion we will probably add a day to day to the mix.
One last question. How do you document/test the "Portability" of the analyzer?
I think there is confusion between the method preparing a new device for use and performing the actual accuracy/precision which is done during the six month updates.
Andrea, were you cited for not performing accuracy/precision from the start (and also every six months) or were you cited for not performing accuracy/precision for new units put to use?
Thanks!! And hi Liz!
We were cited for new/replacement meters being brought into the hospital.
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What agency is requiring you to do accuracy and precision every 6 months?!
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Tracy and Robert,
Andrea and I were both cited by CAP. Unfortunately, there may be confusion at CAP about what is needed for a replacement ISTAT....but it does not matter. I had to do full validations.
Tracy, they did not require this every 6 months, just when a new/replacement ISTAT was received.
Deanna Bogner 210-297-9657
Abbott does not require full validation on additional or replacement handheld.
If you look at this Technical Bulletin from Abbott 720619 Rev D, dated 6/22/16, on page 8, Verification of Additional New or Replacement Handheld does not require Full Validation. Full validation is only required if the test involved has not been validated before. If you already do Chem8+ but want to add ABG in your I-STAT menu, you have to do full validation on ABG analytes. If you want to add Troponin to your menu, you have to do full validation on Troponin. If you want to add creatinine because Xray want it in their MRI area, but you already have Chem8+, you do not have to do full validation on it since it has already been validated as part of Chem8+ before.
Test 3 levels of calibration material - low mid and high
Comparison for accuracy- test one or more patient samples only, not 20 or 50
Precision - run controls in duplicate for 2 days.
But cap is saying you have to do more. We called talked to multiple people and got the same answer
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Andrea,
What standard were you cited for regarding the replacement meter validation?
Terry
Terry and Robert,
Andrea and I have been chatting about this. She was cited on COM 40310 for precision and I was cited for both COM 40300 (accuracy) and COM 40310 (Precision)
I was also cited for COM 40250 -not following manufacturers instructions for a new instrument. Yes, Abbott has no requirements, all of their documentation states it is up to the accrediting agency. BUT...we like Andrea, spoke with several people at CAP and CAP said "CAP requires a full validation on these analyzers. Do it and turn it in." Trust me....there is no confusion when CAP says this.
I agree with everyone on the string. The standard should not apply to readers like the ISTAT. The ISTAT can be equated to the monitor on your computer. The CPU does the work....the monitor shows you the answer. But as per usual, CAP is going to make us check a box. In this case, that CAP check box has NOTHING to do with good patient care.
I am working on 7 of the validations of replacement ISTAT right now. We have 4 more to do after these 7 are done. 4 of them were multiple cartridge types on the same instrument. (CHEM8/Lactate or CG8/ACT)
Pretty expensive....time and cartridges and time the instrument is out of patient service. By the time we send it in, get it back, have the reagent ordered, have time to do the work, find the patient samples for the needed tests, do the paperwork, and get the signatures, it can be 6 weeks or more. We send back 20-30 a year because I have a lot of them. I will hit 100 of them by the end of the year.
Deanna Bogner
210-297-9657
We're in the same boat. About 20/year/almost 2 every month get replaced and need the validation - it takes us about 2 complete days of testing to get it all done if we have staff that can spend all day doing it, longer if not. It just seems like we're doing
lots of extra QC/Cal Ver on the already validated cartridges and repeating patient comparisons every month instead of every 6 mos. Then there's no quick way to calculate the precision stats, have to export the data, sort, add calculations - very time consuming.
I am not a fan of this process. I feel it could be shortened to maybe just QC and simulator/thermal check.
Regards,
A. Owens, MT(ASCP)
Point of Care Testing | Carilion Roanoke Memorial Hospital
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