Built-in Reference Intervals in Cath Lab Charting System

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Hello!
I recently validated the Aoximeter 1000E devices for oxyhemoglobin saturation for my Cath Lab. My medical director approved the use of published reference intervals since a reference interval study was not practical.

The Cath Lab documents the results in their charting system, which then sends the full report to the EHR. The issue is that the charting system has built-in reference intervals that technical support says cannot be changed to the ones approved by my medical director. They also cannot provide documentation showing how they were validated.

Has anyone else encountered this issue? If so, how did you handle it?

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Creating a reference range for the Avoximeter required a different approach because no manufacturer-provided reference range was available for use in our middleware. To establish an appropriate range, I collected and analyzed patient sample results to develop a reference interval that could be entered into the middleware. This step was necessary to enable auto-verification, since the middleware requires a reference range before results can be automatically released.
Although the Avoximeter transmits test results directly to the electronic medical record (EMR), those results do not display with a reference range. In our organization, the Cardiac Catheterization Laboratory documents and interprets the results within the EMR, so the lack of a displayed reference range has not affected patient care. However, without a reference range in the middleware, every result required manual review. Establishing a validated reference range improved workflow efficiency by allowing appropriate results to auto-verify while maintaining oversight of abnormal or unexpected values.

We were concerned about this very issue after our last Joint Commission survey. Our Cath Lab documents the results in McKesson, with no reference range associated with it. We were able to work with our IT people who manage the charting/McKesson and they 'built' a task that the transcriber is able to select which has defined reference ranges attached to the task. So for instance, the RN would select the 'co-ox' task and then a line is added to the McKesson report which has the defined fields for the nurse to enter the results and in parentheses is the reference range. It was quite a task and I am not 100% sure that they all do it, but we are trying to get them to be more compliant. Our AVOX is not interfaced so everything is documented as dictation during the case. 



Our CVL had told us the same thing but further digging and additional
pressure proved that the edits could be made.
We didn't accept the first "NO". I don't remember the name of the program
but it is the procedural software where they enter everything concerning
the procedure in real time.
They were also able to enter a statement indicating that the provider in
the room is directly/verbally notified of the ACT or Blood Gas result and
it also posts the address of the Lab/Hospital.

AVOX devices are able to be interfaced through typical POC middleware systems such as Telcor or RALS; that way you can report directly to the EMR like any interfaced POC test and not rely on the cath lab's charting system.  Of course you cannot stop them from reporting within their system as they currently do, but your direct reporting to the EMR should be what regulatory agencies evaluate as the official reporting.

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Sarah Spaulding
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