POC.06910 Competency Assessment - Nonwaived Testing

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Hi,
Just curious if anyone has a written statement from CAP that says we can use fake samples or previously run samples for the direct observation of routine patient testing. We had a site that received a deficiency a while back for not directly observing actual patient testing.

Thanks,
Brian

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Following......
I'd be curious about this as well. The nature of some POC testing is STAT, immediate testing, and it would be hard for me as POCC to be able to observe that. I generally observe operators running a "fake" blood sample, and we discuss the preanalytical steps. So far, so good with our inspections.

In 2018, I posed this question to CAP: For the purposes of fulfilling competency element #1, direct observation of patient testing, is it allowed to set up a hands on simulation using, i.e., QC materials for the patient sample? The simulation would require that the caregiver verbalize patient ID steps, scan/enter patient ID into the analyzer, and perform testing as though it is a patient?
CAP responded: The intent of the direct observation of testing requirement for competency assessment is to ensure that testers are actually testing as they have been trained. Best practice is to observe patient testing. If the direct observation that you implement for competency assessment utilizes the patient testing process, and your laboratory director approves it, then it meets the intent of the requirement.
 

The statement is not just patient testing, but   1.     Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing

I would challenge by their own definition the inclusion of patient identification, preparation, specimen collection, handling, etc...would mean there are other means to track that the patient testing process is being monitored.  Additionally it goes into detail about the Test System used to produce patient results and then goes on to define what a Test System includes.  I monitor patient tests and review monthly, I also include any flagged results and email operators for proper patient identification.  Pre-analytic test performance such as collection and handling can be monitored by looking through criticals and comparing them to follow up lab tests.  Reviewing QC is another method to monitor performance by running patient equivalent quality control materials.

I do use a dummy patient ID number and a previously run patient during annual evals for non-waived, but I think expecting Point of Care Coordinators to be able to view each and every operator during their routine testing is not realistic and doesn't really meet the intent behind the standard.  Read through the last paragraph where it gives options on how to monitor.  I think if you have a solid program to get annual evaluations done, a good exam that includes a checklist of all these aspects you would be covered.

Brian, great question.

I’m in Lori’s camp (and not just because I admire her action figure self!).

I see this as “stand by your written policy” for your training & competency assessment program). That way if an inspector leans to preferring “real” rather than simulated/fake/no patient present scenarios, it gives them the opportunity to view your complete program, in writing to final, signed off by LD.



Thank you all for your responses. I will just need to spell it out in our policy on how we do our direct observations. 

Brian

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Brian Wittkop
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