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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Ken, looking at that wording the phrase I keyed in on was "as applicable"; that would mean to me that you could create a specific policy for competency of operators using non-waived testing with test specific language to state exactly what you are doing and why.
Have you reached out directly to the regulatory agency by phone/email? I did that, and it helped quite a bit in finding what to do (If you state the question to them in a way that they are not giving you direct advice on how to run your program) something like: For test "X", it is only performed during life flights and there is no way for a Laboratory observer to attend the testing process, would wording like "Due to the testing environment, direct observation with an actual patient test may not have been observed. Direct observation may have been satisfied by using a control sample." on the competency paperwork meet the intent of the inspection point?
It is worth your time to reach out to the regulatory agency directly and explain your situation.