Lab Tech Standards, With Benefits

Is your laboratory thinking about Meaningful Use yet? In all the hubbub over ONC's mammoth incentive program (and the penalties that follow in a few short years if you don't get on board), technology changes affecting every medical lab will provide their own benefits to healthcare's bottom line.

It's been a long time coming.

As far back as the 1960s, it was already understood that a standardized vocabulary for the multitude of lab tests performed in this country was lacking. Those lab tests now amount to about 30-billion-per-year.

While the industry argues about which version of ICD to agree upon in the diagnostic code area, and just how we would get physicians to agree upon these diagnosis codes, information about lab tests were always more amenable to being digitized. A serum sodium test is a serum sodium test, and once a lab test standard exists, there's no reason not to bake it right into the diagnostic equipment itself.

And yet, as of today, there is no government requirement for labs or healthcare providers to present each other with lab tests coded in a standard way. Regrettably, labs have built their own mini Tower of Babel using proprietary or home-grown codes.

This means that sending results from one system to another, part of that continuity of care we're always talking about, can involve lots of expensive, time-consuming recoding of lab test codes from one system to another.

Meaningful Use stage 1 didn't do very much to move toward standardization. According to Regenstrief Institute Investigator Daniel Vreeman, if a laboratory sent an electronic health record system digital lab test results encoded with LOINC, that EHR had to retain those LOINC codes.

Backing up for a moment, LOINC stands for Logical Observation Identifiers Names and Codes. It is a universal code system for identifying laboratory and clinical observations. In Meaningful Use stage 2, LOINC has become a full-fledged menu item. It's still not a core requirement for an EHR, though if the past is any indication, it will be required in the core when we get to Meaningful Use stage 3 in 2017.

But as with many technologies, moving to a standard early can position your organization for productivity gains that could give you an edge over a competitor that lags behind on LOINC.

To understand why, I recently spoke with Robert Coli, MD, a retired gastroenterologist who seems to know everything and everybody connected to laboratory information systems. He is a committed member of the Standards and Interoperability Framework, a public/private group that spearheads the standards embraced in Meaningful Use.

"If you're reporting the test as fragmented data, using infinitely variable reporting formats that change every time a new test is added, the ability to follow the trends over time becomes impossible for the human brain," Coli says.

Fair enough, but now realize that this has bothered Coli since he was interning from 1963 to 1965, and you get an idea of how long forward thinkers in laboratory information sciences have been waiting for a solution.

Since 1979, Coli and others have been trying to standardize the format of lab results "as clinically integrated, actionable information, not incomplete, fragmented, almost raw data," Coli says.

When I spoke with Coli, he revealed that LOINC-compliant interfaces are now in pilot testing at nine major sites. S&I Framework participants, including lab giants Quest and LabCorp, have created implementation guides and reference implementations, and these have been balloted with HL7, the nonprofit organization whose standardizing messaging undergirds most of the communications between disparate health IT systems today.

Through these pilots and EHRs that support LOINC, lab results can flow into EHRs in doctors' offices and hospitals and be understood with no recoding necessary.

Why you should care deeply about all this is the opportunity it presents to commoditize the currently (in Coli's words) "exceptionally lucrative business" of writing custom interfaces for every laboratory information system to EHR. We're talking thousands of dollars for each new custom interface developed today. And the EHR vendor is not required to sell the interface any more cheaply to the second, third or later customers of that same interface.

In that sense, Meaningful Use stage 2 is exceptionally good news for healthcare executives: For the first time, EHR vendors will be required by regulation to disclose the costs of these custom interfaces before you, the customer are required to purchase them.

But commoditization of these interfaces goes further still. According to Coli, the cost of such interfaces will be "remarkably reduced" by standardization on LOINC.

There's also a precedent for widespread adoption of LOINC, and that is the Direct Project, an agreed-upon protocol for securely transmitting records from one disparate EHR to another. Created by the same S&I Framework team, it is an absolute requirement for every EHR that plans to be Meaningful Use stage 2 compliant, and in the U.S., that would be every EHR that wants to remain in business.

Direct's rapid adoption curve will begin to prove that EHR technology providers can compete more completely on the virtues of their products' features, and not on customer lock-in to a particular set of data formats. Direct's creators hope to see a similar commoditization of EHR technology, all the more remarkable because a number of Direct's creators were the vendors themselves.

Putting Direct and LOINC in perspective goes a long way to explain the immense pressure on the industry to solve other pressing technology interoperability challenges, such as patient identification matching, the main impetus of the CommonWell Health Alliance announced at HIMSS.

CommonWell has the industry atwitter, dominating a portion of the most recent HIT Policy Committee meeting with both skepticism and perhaps wishful thinking as we all wait for the actionable details.

But while we wait to see what fruit CommonWell produces, the payoffs of Direct and LOINC are within our grasp. I asked Vreeman what some of the benefits of LOINC vocabulary being everywhere would provide.

"From a provider standpoint, this movement towards electronic health records and health information exchanges is all about having the data follow the patient," Vreeman says. "Their results, their medical record information, follow the patient wherever they go throughout the healthcare ecosystem. And so, having LOINC codes allows for that to happen between independent systems, but also for say a primary care provider to sort of take in data that might have been originated from several other different sites."

When we can spare a moment to look up from the immediate benefits, standards such as LOINC have an even brighter future. "There are many secondary uses as well," Vreeman says. Among them:

• Pooling data for electronic quality initiatives
• Writing decision support rules
• CMS reporting
• Reporting to public health agencies trying to track STDs or other diseases on the public health radar

One other bit of good news Vreeman shared with me: Some independent labs are already able to include LOINC codes with the results they return to providers.

To me, that's a remarkable testimony to the power of standards whose time has come. As far as I'm aware, independent labs are not eligible for Meaningful Use incentive money. They are vilified as money mills who are happy to crank out the next duplicate test result.

To me, it's the power of the market—that's the power of you, the reader—finally, relentlessly convincing the sellers to listen to the buyers, to deliver the actionable data they demand. As we move further toward patient-centered care, and further toward value-driven care, that's where technology should be headed, and apparently, already is.