iSTAT AQ-A CAP survey with BUN failure (iSTAT 6+)

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Has anyone received CAP AQ-A survey with BUN (on iSTAT 6+ cartridge) failure? 


 

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Yes! And this is our 2nd in a row for the BUN on 6+. We had this issue a few years ago but then it seems to have resolved itself up until these last two surveys. We are just now starting our investigation. We did call Abbott to report the issue, but of course that could take weeks to months for them to come back with any sort of answer. What have you investigated so far?

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We are having the same problem with BUN on the 6+.  Issues with BUN last year, resolved, issues again with Survey A.  Everyone should report the problems to Abbott so they identify there is an issue.  What cartridge lot did you use?

What survey number is your failure? Is it AQI-A2 on the BUN?

Anyone have trouble with the gases on this survey? Sample #4 in particular.


We had trouble with the blood gases.  But when I repeated the remaining  ampule, the results were in.


We never had a wrong answer on the ABG since I started doing POC in 2001.


I had wrong results  with:  AQI-#2- pH, pCO2, pO2; AQI-#4- pCO2 and pO2.


I thought the wrong ampules were switched but the results did not make sense.


How can anyone screw up i-STAT. I can see the pO2 going up after the ampule


    was opened too long before testing but hardly had problem with  pH and pCO2.


We failed 1 BUN on surveys AQI-C 2015, ACI-A 2016 and AQi-C 2016. We also failed 2 BUN on AQI-C 2018 and AQI-A 2019 (Sample 2 and 4). This issue has been reported to Abbott.  We were using Lot # K18257 and #18275. Both Q.C. and patient correlation on these lot number seems to be ok.  Interestingly, I ran Sample 2 on Chem 8 cartridge and on 6+; chem8 BUN result was acceptable but 6+ BUN was out of range.

We failed BUN on samples 2 and 4. We used the 6+ cartridge lot K 18295. I will be reporting to Abbott also.


 

Cynthia and Pet,


We had trouble with AQI-04 for PCO2 (low)  & pH (high). 


 


Susan,


Our results were AQI-#2  pH is 6.64  ( 6.53-6.62)  slightly above the upper limit;


AQI #2- pCO2 low 83  ( 89-106) ; pO2 high 82 ( 19-76).  


AQI #4 – pCO2 low  72-  ( 73-87); pO2 is high  -  81 ( 24- 80)


Never had results like these before.


I hope the next PT samples do not give me bad results again.


We cannot afford to not do ABG in house.



I just wonder if something  happened to the samples.


We experienced the same thing with two surveys in the past.  The most recent 2018 AQI-C.  We did an extensive investigation.  The data is clear that there is a matrix effect between the 6+ and G cartridges vs. the Chem 8+.


Since the CAP does not sort the peer data by cartridge (like API does), those of us reporting the 6+ will remain outside of the mean  (positive bias) unless CAP evaluates the data by true cartridge peer group. 


We reported this to CAP and even asked that they sort the data by cartridge type (after all even the Abbott QC has different ranges by cartridge types).  The person who received out email at the CAP refused send our data to the Chemistry Committee for review.


We switched to the API survey since they report out data according to cartridge type specifically because there is a matrix difference with aqueous material on these cartridges.


 


 


 

We use the CG8 cartridge and on sample AQI-04 our PCO2 was 72 (73-87), and our pH was 6.82 (6.72-6.81).  Is everyone else who had problems with gases on AQI-04 using the CG8 cartridge?


We use CG8+ because we use  i-STAT for our Open Heart surgery  ABG, K and iCa.


If there is anyone out there who is willing to share their 2018 AQI-C results and what cartridge they were reported on, I will glad share ours and show the bias that exists.


In 2017, CAP admitted that they prepare their survey material based on the Chem8+ cartridge.


There is no bias on whole blood between the cartridge, only on aqueous QC and survey material. 


I did a thorough study by running 6+ along side of Chem8+ and was able to clearly demonstrate the bias.  This is not really an Abbott issue as much as a CAP issue with their material and how they evaluate the results.


Abbott should contact the CAP and compel them to change how they evaluate the peer group.


 

Diana, would you mind sharing your data or summarize the info that clued you into the matrix effect?  I am suspicious of matrix effect, but not quite sure how to prove it to document it on the survey as the potential source of error.


 


Thank you


Penny Gooch


penny.gooch@va.gov

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