FDA nudges standards adoption in electronic reporting

A study by Dr. Luu, based on responses to a questionnaire attached to a CAP Survey, confirms that laboratories find LOINC far from perfect for practical use. “We found that there is a lot of variation in how laboratories are assigning LOINC codes to their testing,” often with different LOINC codes being used for the same assay. “Part of the reason is that it takes quite a bit of expertise and an understanding of the local menu and hierarchies for LOINC, and I think that is very confusing for U.S. laboratories,” says Dr. Luu, who is the CAP’s liaison to the LOINC effort. “Even for a given manufacturer, laboratories are assigning different codes to them. In some cases they are incorrect. In some cases they are different in level of specificity.”

The questionnaire findings revealed only two-thirds of respondents were using LOINC. For those who do, his study’s look at activated partial thromboplastin time (APTT) showed the majority of laboratories were using code 14979-9 for that assay, which corresponds to APTT in platelet poor plasma by coagulation assay. Others used other LOINC codes such as 3173-2, which is the code for APTT in blood by coagulation assay.

“That’s not technically wrong, but one term is more specific and the other term is more general, so they’re not going to map to each other,” Dr. Luu explains. “The whole purpose of LOINC is to aggregate all these data. So all of these laboratories, if they were in a common database, would not be mapping to the same place. It would not be recognized as the same result.”

This is one example of the fact that “laboratories are struggling because there are so many options and it is unclear to them which to choose,” he says. “This has not gone unnoticed by the FDA, and the FDA put a memo out in November 2017 [“Recommendations for the Submission of LOINC Codes in Regulatory Applications to the U.S. Food and Drug Administration”] indicating that starting on March 15, 2020, it is going to require that regulated research, such as research that results in an application to the FDA for new drug applications, abbreviated new drug applications, and biologics license applications must include LOINC codes for the testing.”

The industry is not ready for that, Dr. Luu says. In fact, the FDA already recognized this by pushing out the original rollout date to 2020. But the industry has had some degree of response to the FDA request for assigning LOINC codes to their tests. “The IICC has developed the LIVD standard where if a lab consumer asks their laboratory instrument sales representative, the lab can be provided with a spreadsheet of the tests on the instrument that are pre-mapped to LOINC codes. That does remove some of the variability,” he says.

The FDA’s SHIELD program is trying to harmonize not only the LOINC codes across manufacturers but also the result codes that come with them, Dr. Luu adds. The FDA has also commissioned manuals that will provide a step-by-step coding of LOINC terms for microbiology. At the CDC, the opioid epidemic has stoked interest in unified data for multiple laboratories; the agency also wants to aggregate and look at microbiology data and susceptibility patterns nationwide.

In the private sector, Epic Systems has launched a program called Cosmos, creating a voluntary process whereby if a user of its software chooses to join a cooperative, the user would upload de-identified lab results to a database and the results would be accessible across all participating labs. All who choose to upload their results would have access to everyone else’s results. “You can imagine that if this takes off, you would have this massive wealth of testing data that you could dissect and break down, for a given diagnosis, what are the most commonly ordered lab tests, how do turnaround times compare, those kinds of things,” Dr. Luu says.

This falls apart, however, “if codes are not assigned consistently. You may have inaccurate data because people are using the wrong LOINC codes.” Dr. Luu does not expect this initiative to take off rapidly unless there is synergy at the instrument-vendor level whereby the linkage of LOINC with tests becomes more automated, ensuring that the mapping is not the responsibility of the small labs.

But he sees high levels of cooperation in the industry. “I have been extremely surprised by the development of LIVD. This already shows what can be accomplished if the different vendors come together.”

LOINC and SNOMED evolved separately, and W. Scott Campbell, PhD, MBA, director of pathology informatics and public health informatics and senior director of research information technologies at the University of Nebraska Medical Center, believes that legacy has created political difficulties affecting the potential usefulness of the FDA guidance. “The LOINC folks drove the conversation with the FDA, and it was not until just before they issued the first round of recommendations that the other standards organizations, mainly SNOMED, were brought into the conversation. So the conversation was well intended but not well informed.”

SNOMED, Dr. Campbell says, has a much more robust information content model underneath it—“We call it description logic in the IT world”—and allows for more in-depth linkages of data than LOINC, though LOINC is good at defining the terms of what is being measured, the units being used, and so on.

“The problem is LOINC does not help tell us how the parts relate to one another. That has been a problem since day one,” he says. He notes that there are more than 600 LOINC codes for serum glucose measurements but no way to logically aggregate “like” terms. Without such a mechanism, for example, a clinician cannot easily determine if a diabetic patient has had any form of blood sugar testing done, regardless of result interpretation, without enumerating the entire list of LOINC terms.

The United Kingdom and Scandinavian countries have rejected LOINC, Dr. Campbell says, because of its insufficient granularity and insufficient description of relationships among concepts. “The U.K. has been a SNOMED country for 20 years,” he says, “so they would have to retool their electronic health record infrastructure to accommodate LOINC as a standard.” But any company trying to sell something to the United States is going to have to use LOINC in the laboratory world, he points out.

Ideally, Dr. Campbell says, there should be grouping concepts that bring together logically the LOINC codes for separate flu tests, if they are testing the same thing. Infectious diseases, in fact, are a good example of why national and international cooperation to coordinate LOINC and SNOMED is increasing. “Influenza has no borders and no respect for borders, so it’s important that we get a read on these things and share our information across the globe,” he says.

Between Georgia and Nebraska alone, the lack of standardization presents problems. “In the public health space as well as in the hospital space, it’s a huge deal if we cannot figure out that two states are experiencing the same kind of flu, as Georgia and Nebraska were. Data indicating that different strains are showing up can easily be masked because we have chosen different terminology and there’s no way to blend that data. This is still an issue,” Dr. Campbell says.

His colleagues have addressed the terminology gap by developing a format known as LOINC-on-OWL, taking every laboratory term represented in LOINC, marrying it to the SNOMED concept model, and applying all the logical rules that apply in SNOMED to LOINC. “This allows us now to easily look at lab data and nonlab data and realize real conclusions. How many times have patients shown up in the emergency department, had an opioid test performed, and had a positive test result? Those things could not have been determined prior to this because there was no connectivity between LOINC terms and SNOMED or other medical information.”

This “universal translator” that he and his colleagues have developed lets LOINC and SNOMED work together, and the challenge now, Dr. Campbell says, is just a matter of getting everyone to agree on implementing it.

“We need to recognize that LOINC is not going away in North America. It is part of the fiber of our health care infrastructure. LOINC is almost 100 percent supported by the U.S. government and SNOMED by roughly half that percentage. We should be telling our leaders that these two need to talk, for public safety and public health, for general patient care, and finally so we can collaborate with our international partners on translational science and new discoveries.”

Dr. Luu is reserved in predicting success in the near term. In assessing the 2018–19 flu season, for example, the medical community could experience a repeat of the familiar pattern of having too much fragmentation of data to have a clear picture of the outbreak, he says. But there is hope, he adds, and the government clearly sees standardization as a priority.

“Unified data is the future,” Dr. Luu says. “Being able to pool data across laboratories, whether for research or to better address public health issues, is the future of medicine. What we need to realize is that the tools we have currently are imperfect. I don’t know if that means improving LOINC or partnering LOINC with SNOMED or playing to the strengths of different coding systems. But improvement definitely needs to be made to realize the benefits of unified data. That is clear to everyone.”

Anne Paxton is a writer and attorney in Seattle.