Epoc QC Testing Question

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We have Epocs in our Anesthesia department and testing is performed by CRNAs and anesthesiologist.  They have been complaining about performing the weekly liquid QC.  They are trying to say that is the only equipment within their scope where they are assigned responsibility for ongoing quality assurance.  But they are using the excuse that they do not ensure things like the ultrasound or other equipment they use are working properly.  But those aren't testing devices. They are stating they have "staffing" challenges which makes it difficult for them to perform the QC.  I know we have offered to change the day QC is required.  They even wanted to train Anesthesia techs, which I know would only be to have them run the QC and not the patient tests, so they wouldn't have to perform the QC testing.   

They want us (lab/POCT staff) to perform the weekly QC.  We are Joint Commission inspected.  We used to be CAP, but are now only Joint Commission accredited.  I know with CAP there was a specific requirement that QC testing was performed by testing personnel, which would mean it is a requirement for them to perform the testing, not us.  Is this still true for Joint Commission?  Or am I missing something?  And if so, can someone please provide me where to look for this documentation so I can present it?   Knowing how to perform QC is part of the 6 elements of competency, so if they aren't running it, they won't know how to perform during their competency assessment.  Can someone please tell me I'm not going crazy and missing something?  

8 Replies

Regardless of your accreditation/inspection agency, they all follow CLIA regulations. It must be testing personnel performing the QC.  Maybe you should consider adjusting your IQCP for this device and move it from weekly to monthly. Maybe if they didn't have to perform it so frequently they would be more compliant. Our EPOCs are QC'd monthly.  When in doubt go back to package inserts, manufacturer guidelines and CLIA regulations.

This comes up once in a while and is easily resolved.

Show them the regulation that states that the staff that perform thes testing are the same staff that must perform the QC.  I would also include the regulation that states this same QC must be rotated through the testing personal.  Then give them the option (politely and professionally): do the QC as required *OR* they can stop doing the testing and it will be shifted to another group.
If you expect more resistance, I would also include your laboratory MD in this for additional weight on it.  It's their license that is on the line for this being completed correctly.

Good Morning - Our institution was inspected by JC back in December and it was specifically mentioned by our surveyor that QC testing must be performed by testing personnel, this was directed towards our i-STAT program.  Looking in the JC Comprehensive Accreditation Manual, I see under Standard QSA.02.09.02, elements of performance, #2 "Staff who perform patient testing test quality control materials in the same manner as they test patient specimens".  

Hope this helps,

Matt T

We use epoc testing devices in many areas of our system. The IFU states that external liquid QC is only required with new shipment and new lot. I agree with Kristin and would suggest to make a QC frequency update to your IQCP. You can use historical QC data to show that the system is stable longer than weekly. The epoc does have internal QC that occurs with every test to verify the system is good. Some POCCs use monthly QC and some follow the IFU only, with years of data to show test card stability. I am CAP and can only speak to what CAP and our IQCP allows us to do. We do by lot number and shipment. 

The CLIA reg specifically calls it out, so regardless of your accrediting agency or IQCP it must be performed by those performing the test, and not just the same ones every time either. We fight this battle too. https://www.ecfr.gov/current/title-42/section-493.1256 https://www.ecfr.gov/current/title-42/part-493#p-493.1256(d)(7)    https://www.ecfr.gov/current/title-42/part-493#p-493.1256(c)(2)

Hey Kelly, 

I know of a friend who was a supervisor for the Point of Care department and he was cited by the Joint Commission for running the QC for the epocs. His rationale was that the regulation was silly and believe the surveyor would just be satisfied that QC was run; unfortunately the assumption was wrong. 

For CAP and the Joint Commission, the ones who run the test are responsible for running the QCs. 

My advice would be to talk to your lab director and see if you could update your IQCP to have you only required to run QCs monthly. We used eurotrol GAS ISE 1,2,3 and hematocrit A, and B. I believe the minimum is running a high and low so it would be GAS ISE 1,3 and hematocrit A, and B. 

You can also incorporate the QC runs in their competency which would count as well. 

The Joint Commission also informed us that their expectation of Quality controlling the epoc is that the current lot of the epoc cards are to be QCed as the card is the testing apparatus and not the reader. The reader, just reads the cards which matches Siemen's theory of operation.

So if you were to take my advice above, the minimum that the Joint Commission would be for you to run the 4 levels of controls monthly if you can convince your lab director to change your IQCP. I'm assuming you have a weekly IQCP for the epoc. With this change, you can definitely convince them to run the QC 


Kelly, we run external QC monthly with rotating testing personnel and Epocs. We adjusted our IQCP according to historical data. This means we run monthly external QC on one EPOC monthly and when we receive a new lot # of cards. The anesthesiology staff may be more receptive if the QC frequency is cut back to once a month. 

Our site follows the same process as Lisa stated, we have an IQCP which allows us to run QC monthly. We in POC runs cal verfier's and qc on all new lot of cards, we also have the device set up to lock out patient testing if qc is not ran by a certain day in the month. 

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Kelly Greenlee
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