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March 17, 2013

Electronic Exchange of Lab Results: A social-media-prompted response to the ONC RFI on interoperability

The final question posed in the recent request for information posted by ONC reads as follows:

What specific HHS policy changes would significantly increase standards based electronic exchange of laboratory results?

Keith Boone, aka @motorcycle_guy, self-proclaimed GE standards geek and fellow member of the Society for Participatory Medicine, blogged about his thoughts on the subject in a post entitled: Promoting Laboratory Result Exchange through CLIA. Farzad Mostashari, aka @Farzad_ONC, the National Coordinator of Health IT, tweeted a link to Keith's post, asking lawyers whether this would work:

Jodi Daniel (Director of the Office of Policy Planning at ONC) and Keith (among others) retweeted the request, and Keith tweeted it directly to me, so I thought I'd weigh in on the question.

Keith observes in his post that labs do not receive any meaningful use incentive payments for making their reports standards-compliant, and suggests that other incentives might be useful:

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) [ . . . ] could be an incentive for laboratories to use those standards.

I have a three-part response:

1.    ONC, in its RFI, specifically requested suggestions for sub-regulatory policy changes that could catalyze interoperability of EHRs. Keith's suggestion is a regulatory amendment.  However, since Farzad and Jodi have expressed an interest in this suggestion, and since there is a long-pending proposed rulemaking process out there connected to lab test results (see Lab Results for All! Of Data Liberation, Participatory Medicine, and Government 2.0), this flaw is not fatal, and the recommended change could be made through that rulemaking. In fact, it could help move that rulemaking along (it's been stalled since late 2011) by identifying a mechanism through which the lab test results may be communicated.

2.    The basic suggestion, which is to deem compliance with one standard to be compliance with another standard, is a reasonable one - assuming that the meaningful use standard for lab results applicable to inpatient EHRs (LOINC v. 2.40 + HL7 v. 2.5.1 + S&I Framework Lab Results Interface) referenced in 45 CFR 170.314(b)(6) is substantially equivalent to the lab test report standard in 42 CFR 493.1291. I would ask Keith to confirm that the two are substantially equivalent, or to explain in layman's terms the differences and why they are unimportant. 

3.    Related to item 2, the practical question remains: Given that labs are not provided a financial incentive by HHS to comply with interoperability standards, will the proposed deeming clause make it easier for them to do so? Are the meaningful use standards easier to meet than the lab test report standard? In other words, is the deeming clause enough of an incentive to motivate labs to conform to the meaningful use standard for lab results? I would want to know more about the current compliance profile of the clinical lab community. If labs are complying with the existing CLIA regulation lab test report standard, then perhaps we would want to flip the deeming around so that compliance with 42 CFR 1291 (CLIA) is deemed to satisfy 45 CFR 170.314(b)(6) (Meaningful Use). I'd be interested in feedback on this point from the clinical labs out there and the health care providers that deal with them on a regular basis on the issue of data transfer.

If the proposed change could increase the number of labs that are meaningful use standards compliant, and the labs could therefore significantly increase standards based exchange of lab results, then that would be a win.

I look forward to continuing the conversation with Keith and others and submitting a joint comment on the RFI to Farzad and Jodi. While they've asked for input via Twitter -- which I think is fantastic -- I assume they need to receive the input the old fashioned way so it can be made part of the record and all that.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting  


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Yes, they are substantially equivalent. A set of requirements for each of the the two predecessors to the LRI Guide called out in the MU regs was to ensure that CLIA requirements for content were incorporated into them.


There is an interesting comment on Keith's post regarding the technical difficulties that have yet to be overcome, and expressing doubt that deeming alone will help ... see:

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