HEMOCHRON 100 ACT-LR Competency Physical Observation Suggestion
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Does anyone have a suggestion for doing Direct Observations on Hemochron 100? In general how do you go about completing #1 of the 6 required elements: The six required elements of competency assessment include but are not limited to: 1. Direct observations of routine patient test performance, including, as applicable, patient identification and preparation; and specimen collection, handling, processing and testing. Do you actually go watch them run a patient sample from start to finish or do you have them do an explanation of how they collect the specimen and process it. How do you watch them run a sample and how do you document that for CAP inspectors?
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I've notified management that I will have to schedule time in the OR and other floors/depts next year to accomplish this. Seems like an impossible task for one POCC.
That's the problem; QC doesn't satisfy the direct observation requirement for moderate complexity training. If you read the quoted bold text, its VERY specific. And TJC is now citing everyone for it. Fun to watch the new posts as we all get inspected...
Having been to many inspection and Inspector - I believe “DIRECT OBSERVATION” means Direct observation.
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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CLIA 2025 made an impossible situation more impossible. It's just that not everyone in the field knows it yet. TJC sure is working on that.
Yes. I am directly watching them mix and run the QC or one of my technical consultants do. It's not just having them run it and going off a log. The ref range I was saying is just to help gauge that they mixed it appropriately. If they fail it I remediate and have them repeat and show them how they are mixing wrong. This way they know how to properly run a PT sample since they are the same technique. Unless what you are saying is even watching them directly with QC is still not accepted. Our current technical consultants are grandfathered in before the Dec 28 cutoff. I haven't found anyone that meets the criteria to replace ones that have transferred or left the org. So far no inspector has said anything and I explain watching them run the sample. I was just inspected in May with no deficiencies and they looked at several of my sign offs and the form. I would be interested to know if the direct observation of QC doesn't count. I definitely don't want to get cited in the future and would happily change processes to comply. We are CAP certified.
CAP inspected... I'm not sure if their inspectors are citing this like TJC inspectors are.
But TJC is.
Until several inspections ago. That inspection turned my whole POCT program upside down.
The direct patient observation requirement alone makes POCT so incredibly difficult. I had to completely re-do all of my competency assessment materials and how I worked with clinical educators. Maintenance and function checks are also direct observation, btw.
Moderate complexity assessment is no joke.
With the recent CLIA change and the impossible situations where these types of tests are taking place (Amnisure at L&D - no one wants an extra body in the exam room, Heparin Assay/iSTAT testing/ACT testing in the CVOR and Cath Lab - no space for QA staff, Flight situations (no space for QA staff in the Helicopter/Plane, etc..) it is not reasonable for an accrediting agency to want/need Direct Observations on actual patient tests.
To avoid an inspector pushing back on whatever process you choose, I would recommend reaching out to your accreditation agency by email and getting a pre-clearance response in writing as a go-ahead on your process.