PPM testing

I believe you need a test order. Also physician notes don't indicate all the CLIA required information, such as normal values.

Here are some direct citations from CLIA:

https://www.law.cornell.edu/cfr/text/42/493.1241

The laboratory must have a written or electronic request for patient testing from an authorized person.

https://www.law.cornell.edu/cfr/text/42/493.1291

(c) The test report must indicate the following:

(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number.

(2) The name and address of the laboratory location where the test was performed.

(3) The test report date.

(4) The test performed.

(5) Specimen source, when appropriate.

(6) The test result and, if applicable, the units of measurement or interpretation, or both.

(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability.

(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results.

The physician notes in EPIC EMR do include all the required CLIA information except the reference values.  I had talked with our LIS team and EPIC does have the capability of creating "smart phrases" that when a physician says that a vaginal wet prep is negative (for instance) it would automatically come with a reference range for that requirement. 

What I can not get clarification on however is if a patient test result has to actually be resulted as a "test" or if a test report can just be found in a physician notes.

Has anyone had experience with this?

Hi Laura,

Per TJC you need to be able to create a functional audit trail. I went through this last year with my clinics. I basically went in and did my own audit and sent them the standards that they would have been cited on if TJC had did the audit.

DC.01.02.01: The laboratory performs testing based on written(paper or electronic) laboratory test orders.

DC.02.03.01: The laboratory report is complete and is in the patient’s medical record.

These are two that you can use to get started. Physicians don’t often understand the importance of ordering something that they will perform themselves, but since it is a standard they don’t have a choice. DC.02.03.01 address what needs to be included in the laboratory report. This must include reference ranges. Also don’t forget that because PPM is moderately complex all of the QSA standards apply as well.

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Hi Laura,

I would investigate the "smart phrase" solution a little more. We also use Epic and if the nomenclature is the same then a Smart Phrase is simply a shortened way of typing out a long phrase or description (ex: they would type ".ACA" and it would lengthen to "Acute appendicitis"). If that is what your LIS is talking about then it's not the best solution to your problem.

Does your Epic have the option of ordering a BOLB - back office lab order?  We use EPIC  and BOLB's are built with reference ranges, normal ranges, etc for POCT that is manually entered by providers, nurses, MA's, or anyone performing non-interfaced manual POCT.

Is it true that you need a test order and result to bill for the test and service?  If the providers are not using an auditable test order and result, how are they getting paid for their work.  A CPT code is built into a test order to complete the reimbursement cycle.  Isn't that also required for the CLIA permit to perform moderately complex testing?  I am asking because I am learning the moderately complex PPM portion of the POC program at my health system and all the regulatory nuances.  

Just a couple of things but I can't answer entirely.

In my opinion it gets much more complicated for PPMP as moderate complex tests compared to those which are not PPMPs but are moderate tests.

For sure one needs a CLIA to cover the PPMPs even if one is not billing for the test.

What I don't know for a fact is if one 'can' bill for a PPMP that's done as part of a procedure and then the CPT code goes in for billing as part of the office visit. Using our EMR these days where I work, the provider and nursing staff as well input much of the 'billable codes' into the 'documentation' of the visit/encounter. What I lack is the info if it's reimbursed with proper coding but no 'test order' is in that EMR visit record...for example, our wet preps/KOH in ObGyn are resulted using a flowsheet (not as an enter/edit into the POC order). Are the providers 'ordering'? I don't know. I know that we built in wet prep/KOH orders but don't know when/how frequently they are used.