New hope for lab data interoperability

As a surgeon, she says, “the risk of harm I could do was limited to the number of patients I could directly treat on a given day. Now I’m a pathologist and coming through the laboratory are thousands of patients’ samples; my understanding of the data, data flow, and downstream data usage can affect each sample. As a result, in the clinical laboratory there is the potential of harm to thousands of patients a day. It’s our job to focus on quality and safety—to make sure we know the risks, foresee potential data errors, and mitigate error that could cause harm.”

There are multiple goals for SHIELD, says Dr. de Baca, founder of MDPath LLC and director of hematopathology, Pacific Pathology Partners, Seattle. The major objective is the creation of the IVD data hub, which would enable the FDA and industry to work together to use real-world evidence as a pathway for industry to earn FDA approval. But “SHIELD offers the possibility of complete clinical interoperability—that data from any one patient can be used for that patient, in as many ways as possible, in as many places as possible, knowing there is as much retained context as possible and as little error as possible.”

Luckily that goal is now in sight, she believes, because the federal government has decided that it isn’t going to happen without new force, and the FDA is supplying that force by leading SHIELD.

From the 40,000-foot level, Dr. de Baca says, “We still don’t have seamless functional data flow among institutions allowing colleagues at other sites access to actionable information they can implement to help a mutual patient. What does this mean practically? If you’re on an anticoagulant and you land in a hospital 500 miles from home in a coma and with a broken leg, currently it is unlikely that the institution can access your data from your home institution or, if they can see it, know that the PT/PTT they see on their screen is absolutely equivalent to the values they’d have measured in their laboratory. If data assumptions lead to incorrect therapy, the results could be devastating.”

In short, she says, communication is always “hugely contextual.” If spoken conversations are context free, they become “merely a meaningless word or a string of words—or in the case of laboratory data, communicating a series of numbers could, in the wrong context, become very dangerous.”

The notion of a conversion factor is too limited to bring about interoperability because of the complexity of the variables involved, in her view. By way of analogy, “When cooking, it’s not just looking at a recipe written in French, and it says X grams of butter. I must know that French butter is cultured, has a different fat content, and is unsalted as opposed to my butter, which may or may not be cultured or have salt. Conversions or harmonizations—similar but not equal concepts—where possible, both require context.”

Numerous sets of standards already exist, such as SNOMED CT, HL7, and DICOM, Dr. de Baca says. “In very broad strokes, SHIELD will create a guideline that considers existing standards and provides guidance about what items must be included for each test, each set of reagents, and for each instrument,” thereby ensuring that the context required to know what is behind each piece of information as it comes through is provided.

In an earlier time, interoperability would have been the single paper-based chart—a binder with paper documents from all patient interactions, with all the information in it for the treatment team to see. “Information provenance was much more limited. Now we have both more input sources and more complex downstream data needs. The number of tangles in our ball of yarn gets bigger,” Dr. de Baca says, noting, “It is ever more apparent that we need to evolve to meet the data demands.”

The pandemic put a spotlight on that need, she says. “There was an imperative to use laboratory test result data for national epidemiology in a way that hasn’t ever existed. With COVID-19, every one of our systems became overwhelmed, ironically, while living in an information society. People expect information flow to occur the way they think it should. The pandemic showed our expectations and reality aren’t aligned—we have some serious Rubicons we need to cross.”

Although currently fewer than 100 laboratory tests have complete clinical interoperability, the prospects for the remainder of the tests to reach that stage are good, she believes. “Someday we’re going to get there. The question is what’s our definition of ‘someday.’ The SHIELD initiative gives me hope that the horizon to someday just got closer.”

Most of the western countries are using LOINC or SNOMED for coding, and “there is recognition that no one code is adequate to fully convey the depth of meaning required to have interoperability of laboratory data,” says Hung S. Luu, PharmD, MD, a member of the CAP Informatics Committee and SHIELD implementation subcommittee. “That’s why the SHIELD initiative going forward is different from that,” he says.

But one of the main obstacles to achieving interoperability is the lack of understanding, shared by analysts and others, of laboratory processes and the fact that for the vast majority of tests you can get different results that are not interchangeable, says Dr. Luu, director of clinical pathology at Children’s Health in Dallas. Prior initiatives sometimes included people who understood one piece of the puzzle but may not have understood the other complexities that needed to be solved, he says.

The past five years, however, have led to a tipping point because the ability to exchange data between institutions has progressed immensely. Meanwhile, data aggregation has shifted from mainly a public health perspective—i.e. how many people tested positive for flu, whether it was via a molecular instrument or point-of-care device—to a clinical care issue.

“SHIELD has done an immense amount of good work at getting people to the table. The vendors are now more engaged than they’ve ever been,” Dr. Luu says. “Five or 10 years ago, sending data from institution to institution as easily as it is done today wasn’t imagined.” Now, “Most of the people on SHIELD recognize that the future of medicine should be harmonized values.” The pandemic, too, has been helpful by pulling together different players who might not have interacted before, he adds.

Strangely, when lab results were delivered via paper or fax, it was easier to pinpoint the lab that produced them. The new absence of test provenance in digital test results has created a problem in an era in which results come from a wide range of sources, Dr. Luu says. Formerly, “You had a standardized format with required elements. Now, with digital, it’s much harder to determine provenance.” The pandemic showed this vividly because as COVID testing got underway, “unless you had a laboratory-developed test of your own, you had to use one of the referral labs.” In his case, a test might go to the Quest facility in North Dallas. “That facility would be listed as the performing lab, but the testing for COVID is not performed there. It’s performed in North Carolina.”

That information is lost—as is the name of the ordering provider most of the time, he says—“because the interface is a blunt instrument.” To minimize duplicate testing and conserve reagents, one of Dr. Luu’s duties during the early days of the pandemic was to determine if COVID testing performed by outside institutions should be mapped into the Children’s Health EHR. Mapping meant the EHR would recognize the external results as equivalent to those performed at Children’s Health. The external tests could then be used to fulfill admission and pre-procedural screening requirements. Because “there’s no standard out there for what information needs to cross over the vendor interface,” he says, an outside COVID test could have minimal metadata and provenance information. One piece of information frequently missing was the specimen type. Often, “I won’t know if it is a nasal pharyngeal swab or a saliva specimen, and that has an impact on the sensitivity of a COVID test.”

“The true goal of SHIELD, where we’re setting up milestones for achievability,” Dr. Luu says, “is going to be, first, the interoperability of laboratory data and, second, setting up an IVD data hub to be able to provide real-world evidence for the approval of tests by the FDA, as well as a harmonization indicator to tell laboratories if a test has been harmonized across platforms.”

How likely is it that SHIELD could bring about comprehensive harmonization? “Harmonization is a goal of SHIELD and it’s definitely on the radar,” Dr. Luu says, “but it depends on the vendors, so it’s not something that is easily achievable. It’s unlikely that the FDA will get more prescriptive about imposing baseline harmonization standards, and SHIELD alone doesn’t have the authority to make the manufacturers accomplish harmonization.”

First, under ISO guidelines, there must be a standardized reference material that’s available for the assay to calibrate to, and the vendors would have to calibrate their instruments to that reference material. “If the laboratories aren’t clamoring for this, then the vendors don’t see a need.” Moreover, there are some tests for which people have been working on developing a reference material for years without success, he points out.

That limitation would primarily affect the quantitative tests, though. “When you’re talking about infectious diseases and microbiology, harmonization becomes less important,” he says. In general, “The important thing is to make sure we define and code those tests to let a receiver of the result know the platform the test was performed on so they can determine if that is something equivalent to what they’re doing.”

Partial clinical harmonization will probably be achieved first because the information gulfs to be dealt with can be wide. “Obviously we want to walk before we run. Right now, I can’t even tell from the result information crossing over if the D-dimer performed in my lab is performed on the same platform as those from Duke University. The information is just not there.”

Harmonization “is the brass ring,” Dr. Luu says. “It’s where we’re all going to go—hopefully. But probably not in the near future.” By contrast, prospects for interoperability are good. “There is a lot more movement and a lot more investment in interoperability than I’ve ever seen. So, I think this is probably our best chance right now.” But, he says, “we also are trying to make sure that SHIELD minimizes the burden on laboratories so they are not having to invest resources they don’t have into the initiative. We’re trying to streamline the process and make it automated as much as possible so there’s more of a systemic solution in place.”

Along with the Biden White House, Dr. de Baca says, the HHS, FDA, CDC, and other agencies all consider interoperability a priority. “It’s very important to recognize that CAP has been invited to bring the resources and talent our member subject matter experts have to the table. I think pathologists are far and away the best people to help in this conversation,” she says, “and ensure that interoperability can be achieved at the highest quality level—and with patient safety the top priority.”

Anne Paxton is a writer and attorney in Seattle.