Friday, March 15, 2013

Promoting Laboratory Result Exchange through CLIA

Last week, ONC announced an RFI (Request for Information) on Advancing Interoperability and Health Information Exchange.  Comments are due by 4/22 (my youngest daughter's birthday).  There are nine questions for which they ask for detailed answers, and each question is in several parts.  Question 9 included the following:
What specific HHS policy changes would significantly increase standards based electronic exchange of laboratory results?
This has been an interesting challenge for interoperability, since labs aren't given any incentive dollars to use standards under the Meaningful Use regulation.  In my naive world view (which includes the technical, rather than political issues), I think there's a pretty straight-forward solution.

Currently, laboratories covered under CLIA do not receive incentives for using standards specified under meaningful use. One of the requirements of clinical laboratories under CLIA is the production of a test report that meets requirements under 42 CFR 493, subsection 1291.

One possible way to promote use of the standards would be to providing a deeming clause in subsection 1291 such that if transmission of test results is performed with Health Information technology that has been certified to conform to the criteria in 45 CFR 170, subsection 314(b)(6) (see below for text) could be an incentive for laboratories to use those standards.  A similar approach was used in the Stark Relaxation rule with respect to interoperable Health IT a few years back.  In that regulation, an EHR that had been certified was deemed to be interoperable.

My suggested addition to 42 CFR 493.1291(d) would be:

(d) Electronic Health Technology that has been certified as conforming to 45 CFR 170.314(b)(6) and is connected to a receiving system that is electronic health technology certified as conforming to 45 CFR 170.314(b)(5) is deemed to be an adequate electronic system to ensure test results and patient specific data are accurately and reliably sent from the laboratory to the receiving system.

That deeming clause could greatly simplify for CLIA covered laboratories what they need to do to ensure that test reports are accurately and reliably sent to receiving systems.  It wouldn't eliminate their need to certify interfaces for those providers who aren't using certified EHR's, but it would make it easier for them to deal with providers who are using certified technology, and could greatly reduce the interfacing and certification costs they bear in order to comply with the CLIA regulations.  That might just be the incentive that they need.


  1. Your suggested deeming clause is a good strategy but as a tactic it is insufficient by itself because the simple presence of certified technology is unlikely to significantly reduce ORU delivery complexity. In my day job I wrestle constantly with the chaos that exists between CLIA certified labs and the delivery of ORUs to Certified EHRs. Incentivizing use of CEHRT at both ends of the transaction may be an improvement over the current lack of incentive for CEHRT at the lab end of the transaction. But there are still two major loose ends to tie up. First, LIS software (certified or not) can be easily configured to produce bad or non-normative ORUs that cannot be consumed correctly by CEHRT. And second, CEHRT as utilized by an Eligible Provider is equally capable of failing to correctly consume normative HL7 ORUs. I feed ORUs to one CEHRT installation that correctly receives the first two microorganisms in a microbiology ORU and then consistently fails to report any additional microorganism even when they are reported in the ORU. Also, the generic EHR certification process is a weak hurdle; really it's more busy work than a rigorous test of software functionality. Just because CEHRT can correctly produce or consume specified data types during a bench test provides little assurance to a user that the software will actually work in field conditions. What we really need are massively scalable ORU field validators that can flag malformed HL7 messages. If we had these, then we would have an active way to troubleshoot ORUs.

  2. You brought @Farzad_ONC's retweet of this post to my attention, and I've blogged about it here: Electronic Exchange of Lab Results: A social-media-prompted response to the ONC RFI on interoperability (HealthBlawg) –

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