POC testing versus Core Lab testing

Is there a CAP guideline that addresses using POC instruments and different core lab instruments with different methodologies on the same lab orderable?  So the information in the chart all flows together without allowing for any differences to be noted.  I would think this falls under a rigorous validation study to show there are no significant clinical differences if you want to lump these together.  How does CAP handle this concern?  I want to separate POC testing from core lab testing in the EMR, but not getting any support. 

 

Malinda Feinauer MT(ASCP), | Laboratory Technical Specialist - POCT




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Multiple arguments:

1) I would start with the potential for billing fraud.  Since different methodologies can potentially have different billing codes (CPT codes) applicable to the methodology.  Ifyour HIS/LIS system triggers the billing code when a test is resulted, and the system cannot discern the difference between testing methodologies, then you may be billing incorrectly (fraudulently).

2) Different methodologies create the potential for different reference ranges as you pointed out.  Our reference range for a Sodium on the i-STAT is different than on our main lab chemistry analyzer.

3) Different testing platforms will have different reportable ranges.  A Whole Blood Glucose by the Hemocue will have a more restrictive reportable range than the main chemistry analyzer.

4) How do you track testing volume by testing platform?

5)  How do you manage good financial tracking/accounting of your testing so that an accurate calculation of cost/reportable or cost/billable can be made?  Does your lab have a metrix that your financial is measured against (internal or external?

Best wishes!

Thanks Gregory Olsen!




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Malinda,

  Greg made all excellent points; I'll just add to that.

  We are a large health system here with a single EMR.  We faced (and continue to face) similar obstacles with mapping of lab results from different platforms into the same result field in the EMR.  At first that also seemed to make sense to us, because the whole point of a thorough method evaluation is to ensure that you do not have significant variations across platforms and, for example, a sodium is a sodium is a sodium.  However, as time goes by, we have identified reasons why separating values from different platforms makes sense.  To give one example, we had a physician complaint about sodium values performed on a blood gas sample (whole blood) vs sodium values from our central lab (plasma).  One uses direct ISE, the other indirect ISE.  We discovered that in certain patient populations (especially critical care) varying protein concentrations in the patient sample introduced a bias to the indirect ISE method that we were previously unaware of.  In some patients, the difference was as much as 6-9 mmol.  This did not show up in our typical method validation because we validated old blood gas analyzer to new blood gas analyzer and it also did not show up in our  q6-month method comparisons.

  The problem was making the case to the EMR team (typically not under the lab's jurisdiction) to separate the values.  We had to really petition the EMR group to make the changes, in the interest of better patient care.  As lab professionals, we should be able to make that call and make it happen easily, without the obstacles that many of us are coming across.  To me, the manipulation of laboratory data in downstream systems that are not under the laboratory's control is an increasingly concerning issue.  Hopefully conversations like these will start the process for change.

You hit the nail on the head.  Thanks for your information and example.  Malinda.




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One other example of manipulated lab data that sort of gives me a chuckle, in spite of being a serious issue.

  Within the EMR, physicians typically pull "fishbone labs" into their progress notes. 

  Not only are there no reference ranges or units, the name of the test isn't even specified.  And this is probably used diagnostically more than the "lab data" area of the chart ever is.

  When you think about all the regulatory requirements necessary for a lab report (units, reference range, etc.) and then realize what they are actually USING, it's almost laughable.  

  fishbone example.JPG  

James, I almost spit out my drink!  When I started working at a Hem/Onc clinic 15 years ago, one of the doctors would ask use to draw the fishbone skeleton alongside the vitals we wrote in the chart.  It was a good 6 months before I understood what he was doing with that "skeleton!" 

Are fishbone labs a type of view in Epic?  I cannot access all of the different ways a provider can see results, but in Epic, it is in chart form that can change to a graph




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Yes, it is the same in Cerner/PowerChart (the chart & graph), but the "fishbone" is apparently a way that patient data can be pulled into free-texted physician documentation notes.  I am not sure exactly how it is done, but it pulls just the values sans any supporting information like ranges, flags, units or comments.  I see it very often in summary notes.

On a conference call with a very knowledgeable Joint Commission inspector in Feb of 2017, he brought up this very topic.  He stated this was a hot topic with both CMS and TJC surveyors for all of the reasons already cited (strips collect time, date, units of measure, reference ranges, interpretative comments) as it presents a patient safety issue.  He stated that the "Official Report" by definition is "any report that can be used for the treatment or diagnosis of patients."  I suspect this may be a target during inspections in the near future based on that conversation.  I have mentioned this in some high-level meetings here only to receive looks as if I had asked providers to chop off their right hand. 

I'll bet you did, Sonya!

I am wondering if many facilities would argue that this is the physician's interpretation of the "official report" rather than the official report itself.  I wonder if that would be acceptable to TJC/CMS.

Edited Thu, Oct 12, 2017 6:21 PM

Because I am at a small, rural hospital I wear more than one hat.  As the POCT Coordinator AND the LIS Coordinator I was involved in the build for our upgrade to Meditch 6.14 last year.  We built all our Point of Care tests as individual lab tests, complete with their own reference ranges, etc.  We use the Nova StatStrip for bedside glucose testing and also use the meter's capability for manual test documentation so all our POC results flow through the same system.  FYI, currently we do not use any other bedside analyzers.  Anyway, because these are built as separate lab tests they appear in the EMR with all the other lab results but under their own tab of POC.  This keeps them visible with all the other lab results in the EMR but they aren't confused with the tests performed here in the lab.  Because Lab personnel build and maintain the lab module, we can make sure the tests are resulted correctly.  It seems odd to me that the lab would have to justify or petition for labs to be built and resulted according to the proper standards.

Yup, and it is odd that we should have to.  And when we were basically in control of the whole reporting process, it wasn't a problem to control what our output looked like.  But it can evolve to this before you know it.  The problem is, the larger the institution or health system is, the further removed those decisions become from the staff that have the expertise.  Add to that the fact that in a large system, you are likely to have LIS support from staff that are not necessarily laboratory professionals.  Add to that "well, this is what we did at a sister facility, so that's what we'll do for your facility", with the complete assumption that the decisions for the sister facility were initially sound.  And therein lies the slippery slope to where some of us are now.

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