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New hope for lab data interoperability

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Anne Paxton

November 2021—Interoperability, a problem of long standing in health care, has a new push and new prospects.

Interoperability has become a front-burner issue because it has become increasingly urgent to bring the standardized communication of health care data up to speed. Since the 2009 Affordable Care Act, significant resources have been directed to bringing widespread use of electronic health record systems. But interoperability among those EHRs has been held up by the lack of mechanisms and standards to ensure interoperability of laboratory data, which has drawn special concern during the pandemic.

An initiative led by federal agencies could turn that shortage of standards for laboratory data around. The key is a public/private initiative called SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data), launched in 2016 by the Food and Drug Administration. Starting early in 2022, the profile of lab data interoperability should rise as SHIELD takes major public steps forward.

Led by Gregory Pappas, MD, PhD, associate director of national device surveillance for the FDA’s Center for Devices and Radiological Health, SHIELD has brought together more than 70 stakeholders, among them the CAP, federal agencies (NIH, ONC, CMS, VA), public health (CDC), IVD manufacturers, EHR vendors, and others to determine how to standardize coding of IVD laboratory tests and results. The goal of SHIELD is to improve the quality, utility, and portability of IVD laboratory data through the harmonized implementation of semantic data standards. CAP members were appointed to seven of the SHIELD project’s eight subcommittees, with two CAP Informatics Committee members included in SHIELD’s implementation subcommittee.

“When we look at the clinical side, we can move the laboratory data around very nicely with EHRs in a single institution,” says Walter Scott Campbell, PhD, MBA, an implementation subcommittee member and director of pathology laboratory informatics at the University of Nebraska Medical Center. Laboratories, in fact, were the groundbreakers in figuring out how to do that as far back as the 1970s, to make their jobs much easier, he says. “But now you have laboratory data coming in from multiple places via disparate EHRs and laboratories.” Instruments from two different vendors can supply two different results of the same test within the same institution.

Dr. Campbell

SHIELD describes interoperability as the ability to “Describe the same test the same way, every time.” An interoperable coded message, the FDA says, occurs when a specific IVD asks a question of a specimen taken from a human body, gets an answer to that question, and the entire process can be represented by standardized semantic codes.

How usefully one test can be compared with another is the problem now, Dr. Campbell explains. D-dimer tests at two different laboratories, for instance, could have a five- to 10-fold difference in the breakpoint to identify whether a patient has a clot.

That’s one example, Dr. Campbell and other members of the CAP Informatics Committee suggest, of why the absence of interoperability is critical and why CAP members are helping the SHIELD team make interoperability happen. The situation is not necessarily worse than it was 20 years ago. But “I think we all expected to have it worked out by now,” he says. “In so many ways it’s as difficult as it’s ever been and perhaps even more complex because we do more complex things.”

“Laboratory data is really confusing in a certain way, because you could pick any part of the laboratory and say you need to peel back the onion about 14 layers to get to exactly what you are trying to say with that test,” Dr. Campbell says. “What we—especially the CAP members—have been trying to do as part of SHIELD is to create a unique ‘fingerprint’ for any test performed on any piece of equipment with any test kits or reagents that go with it.”

Harmonization, in which an internationally agreed-upon standard would normalize references to any particular test, is also a part of SHIELD, and harmonization would be sufficient to ensure comparability of those test results. INR is one example of a harmonized test, but fewer than 100 other tests are clinically completely harmonized, he points out.

Part of SHIELD is to come up with a reference standard when there is no internationally agreed-upon harmonization. “It’s to answer the need to let clinicians know that two results can be safely compared or safely put in the same row in an EHR. While there’s still risk in this approach, you’re starting to minimize the risk,” Dr. Campbell says.

Such interoperability could benefit the IVD vendors. “If vendors are able to come into an environment where they know there is a standard way to communicate their information, that takes a burden off them,” he says. “They can say this is how you bring our device on and incorporate the information from our device. And we don’t have to customize that for every hospital in every different information technology environment.”

The FDA, too, has a specific interest in interoperability. “They want to be able to see these types of data in such a way that they can give provisional approvals to manufacturers.” Typically, Dr. Campbell notes, the time from invention to implementation in the medical space is 10 to 15 years. “Interoperability is one way the FDA might shorten that time frame.”

His institution’s experience with research shows another value of SHIELD. “As a researcher, I want to know that I can logically aggregate and make decisions from these very large observational data we are looking at” in patient-centered outcomes research. “We’re dumping our EHR data into shared data repositories and trying to apply data standards and metadata to that. But when you get into lab data, as we’re starting to find out, not all apples are the same type of apple.”

Whether the goal is to aggregate data sets to make decisions about cancer or COVID-19, “laboratory data are important. Laboratory data related to cardiac function and respiratory function are particularly important in COVID. These types of labs in particular are often not normalized, but we’re aggregating them. Now, are we at risk of reaching incorrect conclusions from our research data? I would argue we are.”

The role of COVID-19 testing during the pandemic shed clarity on this problem, Dr. Campbell says. “If you’ve got an Abbott machine, and you’ve got a Beckman Coulter, and somebody else has a Roche, how do we know we’re getting positive results for COVID-19 and that each device is as reliable as the next device? We were pushing technology and tests out as fast as we could, and we saw with the antigen tests a lot of questioning about whether you can know you’re not getting false-positives or false-negatives. It underscores that we’re not tracking enough information to really know that ourselves, let alone to exchange information” with other institutions.

These limitations could stall the development of rich and beneficial technologies. For example, “There’s no way we can support enough clinical trials to vet all the different versions of liquid biopsy—a promising new technology. It would take you forever and be really expensive to fund the clinical trials necessary to get the evidence we need. But if we can begin to provide an environment to enable us to start collecting this type of information in vivo, we might be able to get to conclusions faster.”

“We’ve been living this data nightmare for a very long time. In general, it’s gotten pretty small and a pandemic is pretty big. And we’re moving lots of data about lots of things that we didn’t know and people in the government didn’t know.” All of that shows, he says, “that we were weak in terms of the type of information we capture. So how do you start to look at this data world in a different way? I think CMS has been trying to come up with answers but not realizing how disjointed our systems are.”

But with the FDA providing its backing and clout through SHIELD, the laboratory world may be nearer to gaining a system of standardized coding. “The FDA would love to see a pilot started, running, and generating momentum at the end of three years and somehow be more broadly adopted in the next five to six years,” Dr. Campbell says. The pilot could be no greater than two separate institutions such as the University of Nebraska Medical Center and the nearby VA Nebraska-Western Iowa Health Care System.

With the differences between the two institutions, he says, “you’ve got a microcosm of what the rest of our world is going through in the U.S.—two major EHR vendors, different laboratory information systems, a whole cast of characters of in vitro devices.” Together the university and the VA could function more like a prototype project for interoperability, and perhaps that prototype would be enough to test an interoperability plan without 10 or 20 pilots at different hospitals at much greater cost.

Dr. Campbell is of the view that SHIELD has developed its concept into a tangible, doable, sustainable model: “We’ve put the right frameworks together to get on the right pathway to data interoperability in the laboratory.”

The SHIELD initiative is poised to start making its recommendations public in 2022. The SHIELD subcommittees have submitted their recommendations to a small working group, which is compiling those submissions into a draft to go out for public comment before publication. “The authors are working on a short timeline. To finish by the end of the first quarter of next year is probably realistic,” says Monica E. de Baca, MD, a member of the CAP Board of Governors and the CAP Informatics Committee.

Dr. de Baca

Once the interoperability specifications are fairly far along, the project will likely turn to a pilot IVD data hub project. “Depending on how the pilot evolves, there would be a subsequent expansion into a national IVD data hub. It is my understanding,” Dr. de Baca says, “that, in theory, that is something there is agreement on among HHS, FDA, ONC, CDC, and others.”

Trained in both ophthalmology and in pathology, Dr. de Baca has a clear window on the comparative stakes of following proper procedures in those specialties. Her perspective on interoperability is based on the Hippocratic Oath.

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