How Do you Perform Direct Patient Observation for Moderate Complexity POC tests?

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How does your program perform direct patient observation for moderate complexity testing in POC?
(I would especially love to hear examples for blood gas, amniotest and ACT testing. These have large user bases and smaller test volumes, which makes this task especially difficult)

If you use non-lab staff as competency assessors, are you confident that they are actually observing patient testing that could be pulled on a tracer to go with their competency documentation? And if so, how do you ensure confidence of compliance on this very specific competency requirement?

10 Replies

Shannon Walden

Mon Sep 26, 2022 at 2:09PM

Ken-
Which agency requires this?
Thank you,
Shannon Walden

Dawn Grose

Mon Sep 26, 2022 at 2:12PM

I am more than interested to hear what people say about this. It is a large challenge to observe patient testing in point of care. My sites are JC accredited and I have submitted questions to obtain clarification. They have historically said if there is a patient privacy issue you may review some items verbally or perhaps use QC materials, but it continues to be discussed during survey inspections. We do have non-lab staff as technical consultants and we do teach them how to approach the direct observation and I believe they document the truth, although again, QC is sometimes used.

Ken Charpie

Mon Sep 26, 2022 at 2:14PM

CLIA in section 1413, paragraph eight, item one.
I just got lectured for more than two days by our JCAHO inspector on this one.
I wish we still used CAP for our accreditation.

Lois Schultz

Mon Sep 26, 2022 at 3:56PM

I use QC material for ACT and blood gas testing and have the operator run it under a dummy patient MRN. I count this for the direct observation and the blind sample. There is a record of the patient test they performed that can be pulled for an inspector (I have my non-lab assessors record the date and time of the test so I can go back and pull it if needed). For the Amniotest you could either save a QC log they filled out or document a de-identified patient test they performed.

Diana Meyer

Mon Sep 26, 2022 at 4:19PM

We have the educator of that area that meets the TC requirements, do the direct observation part of the competency. It is different for each test. Currently for ROM+ , they run QC and the date time and lot number are recorded. EPOC documentation is by either QC or patient, puts the QC information or patient case number and date on the form.
I sign off the educator annually. I agree that this is very difficult to get completed especially
with the initial, 6month and annual for new employees. We are on the struggle bus if anyone has
ideas for tracking and completing in addition to the other 5 requirements for competency we would love to overhaul our procedures.

Danyel Olson

Mon Sep 26, 2022 at 4:31PM

My program is now under COLA and was previously under CAP. For ACT in cath lab and CVOR, that's a small group for me so I have usually observed a PT sample or I will observe QC or QC as a fake patient. For ACT in ECMO with a larger user group, we do use RNs with a 4 year degree/2 years experience to do observations. They are provided a "script" and a check off sheet with exactly what is required as an observer - what the operator needs to perform independently and what they can teach or coach on.
We have iSTAT for blood gases - we tackle this at our annual competency fair and also use non lab TC qualifying staff. We do use QC as a fake sample but treat it as real and observe sample handling and testing. We have not had an issue with this under COLA.

Shana Gaug

Mon Sep 26, 2022 at 7:55PM

We were cited for not having direct observation for microscopy maintenance for PPMP. My colleague and I, directly observed microscopy cleaning or placing a cover over the scope for most of the providers. We are working on a peer to peer process for that will also capture direct observation for the testing process which was previously done by chart audits.
For other nonwaived platforms-we have a select few that qualify as TC to help with direct observations that are trained with a script, otherwise its just my colleague and I. We use QC and PT specimens for Amnisure/Nitrazine. We also have a "Virginia" (the vagina from our L&D Noelle mannequin simulator)for them to demonstrate collection, these are done at a didactic lecture/skills fair. For blood gasses & chemistries, its mostly real/live patient observations-otherwise we defer to calibration material/QC ran as patient.

Adonica Wilson

Tue Sep 27, 2022 at 8:32AM

For our TEG, Istat and Sig Elite we have the operators do a fake patient using QC (Level 2 for Istat because we don't use that one and either an abnormal or normal level for ACT and TEG). The POCT superuser from the unit will observe them do the tests and verify the patient results are within the acceptable range. We print out cards with the correct values on them and keep them with the fake patient samples. They also have to do a real QC sample and dock the meters. The operators have to do a module in our learning system (NU) that says they completed the samples and that they have gone over the critical value pictures (if applicable) along with a troubleshooting question with the superuser. The superuser signs them off as complete in NU and we get the report the next day with their name and the modules they completed. When we get the report we verify the samples are within the correct range and the QC is done, then we update them in QML.

Donna Armstrong

Thu Oct 13, 2022 at 8:08AM

We have annual recertification classes for Radiometer (blood gas) and iSTAT, during which we have operators run an unknown (linearity or qc sample).

Ken Charpie

Wed Oct 19, 2022 at 11:27AM

Well.... I'm trying to figure out how to perform actual direct patient observations for moderate complexity testing in our POC program with skills fairs in progress already... It appears I may be the only person in our facility that meets a strict interpretation of 42 CFR 493.1411 (4) for competency assessment for about 200 moderate complexity users.

It sounds like no one else is fully compliant, either. I haven't heard from anyone that is, yet. I appreciate hearing from those of you that have encountered these citations (for education/experience of assessor and also direct patient observation) and how you are struggling to fulfill it.

Most of CLIA was written before most POC testing existed; extensive moderate complexity testing on nursing units was not something considered when these education/experience criteria were set for a "technical consultant" conducting competency assessment that must include an "observed traceable patient result." (the words of our inspector, which match with the wording of CLIA). We all know this is completely unreasonable because it is impossible for any facility (with significant moderate complexity POC testing anyway) to be fully compliant with the way 42 CFR 493.1411 and 493.1413 are worded on these two issues. This section of CLIA is in desperate need of revision to address the current state of point of care testing. It truly felt like our inspector had a vendetta against POC testing in general, and provider-performed POC testing especially. In conversation where I pointed out the impossibility of compliance with these requirements, the inspector acknowledged how impossible it truly was... but still cited us.

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How Do you Perform Direct Patient Observation for Moderate Complexity POC tests?