CAP Competency on Non-Waived POC Devices
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Hello,
I currently have 30+ non-lab users in my NICU and CV Lab using an iSTAT with non-waived cartridges.
I am looking for some recommendations on how others may be working through the CAP competency for the non-lab users. I have a online quiz module that they perform at hire, 6-months, and yearly.
The area where I am struggling the most wrapping my head around is the observation portion.
Open to any recommendations or suggestions. I am new to the point of care role but come from a laboratory chemistry background. The CAP part is definitely not new to me and has haunted me for years ;)
Thank you,
Cassie
I currently have 30+ non-lab users in my NICU and CV Lab using an iSTAT with non-waived cartridges.
I am looking for some recommendations on how others may be working through the CAP competency for the non-lab users. I have a online quiz module that they perform at hire, 6-months, and yearly.
The area where I am struggling the most wrapping my head around is the observation portion.
Open to any recommendations or suggestions. I am new to the point of care role but come from a laboratory chemistry background. The CAP part is definitely not new to me and has haunted me for years ;)
Thank you,
Cassie
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Direct observation of patient testing is the most difficult component of competency assessment in the lab. In POCT it becomes almost impossible to figure out. On top of that, the 2025 CLIA personnel qualification updates makes it basically impossible to find any RNs that qualify to serve as a delegated/designated Technical Consultant for competency assessment purposes.
Been trying to figure this exact problem out for six years and feeling completed defeated.
I've got over 200 staff on five different non-waived systems with only 3 RNs "qualified" to help. When those RNs leave or retire, I will be unable to replace them and it will just be me again, like when I started as POCC.
Best of luck, though. Hope others are doing better in this area.
Not sure what you mean about "the CAP part." The fact you have non-waived specimens mean you'll have to use the 6 elements of competency, not just a paper and pencil test. But the good thing is you can spread out the elements i.e. you don't have to check everything on an operator at once. You can also have several people do a task like maintenance at once. You can observe several staff run QC or the same patient sample sequentially and check them all off. Involving them so they own the process also helps: they offer to demonstrate a task or have you watch them test just to have their checklist completed. I am not sure if you need something more specific.
Our institution have over 800 istat users and I have about 10 educators who are grandfathered in to the new CLIA rule helping us out to do the competency assessment. We are finding ways to do online non waived competency but because of the observation element we have not came across one yet. I have quiz and training elements paper based and they run blind sample as observed element and have right result on competency paper, for which I basically make syringes with "blindsample" barcode as patient ID using the blue QC material which get's observed by approved educators by our lab director. Once we receives competency paper from educator, we verify all information on the form & match the result for blind sample in order to grant them access. You can keep quiz part online as it is and just have operator run blind sample as observation element, for us since we have big staff running the device doing all at once is easier to track initial, 6 month and annual competency.
The patient observation is one of the harder of the 6 elements to cover. We had one of our sites get inspected by CLIA after our regular CAP inspection. We were just one of the lucky ones! YAY... They looked VERY closely at our competencies and one of our findings was that we did not do direct patient observations at the time. We had been using a blind sample, but our CLIA inspector told us that did not count for element 1 and it had to be a real patient test. The volume of testing performed at this site is extremely low, so it has been extremely difficult to maintain competencies.
Non Waive requires 6 methods of validation for competency assessment based on CLIA and your regulatory agency, it is not just quiz. Effective this year a person who can sign competency need to meets the qualification of the Technical Supervisor with a Bachelors degree in Sciences. BSN do not meet the requirements because the number of Science course they have will not meet the requirements. Check on the new requirements with CLIA regulation.
Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt
Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
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• alma.calzadoknudson@enloe.org
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