FDA nudges standards adoption in electronic reporting

Anne Paxton

March 2019—An interesting medical informatics moment occurred post-9/11 with the delivery of anthrax-poisoned letters to several congressional and news media offices.

“There was not a single anthrax test order communicated to the CDC electronically,” says Steven H. Hinrichs, MD, chair of the Department of Pathology and Microbiology at the University of Nebraska Medical Center and director of the Nebraska Public Health Laboratory. “Everything was on paper. That was when it was finally understood what public health needed to do.”

Soon after, the Centers for Disease Control and Prevention set up the National Electronic Disease Surveillance System as its first effort to do electronic reporting and made great progress by providing a tool to share and analyze information, Dr. Hinrichs says.

But adopting a common vocabulary is central to electronic reporting. To date, standardized, commonly shared codes for electronic reporting across the health system have remained out of reach, as federal agencies and the diagnostics industry jockey for authority over standard-setting.

With a recent action, however, the Food and Drug Administration has raised hopes of new momentum in the electronic reporting standardization quest. On June 15, 2018, the agency published a final guidance document on LOINC (Logical Observation Identifiers Names and Codes), a universal code system for identifying laboratory and clinical observations.

In the document, “LOINC for In Vitro Diagnostic Tests,” the FDA encourages adoption of a consensus standard: the IVD Industry Connectivity Consortium’s LIVD (LOINC to IVD) format for distributing LOINC codes. “The FDA recognizes LIVD as a consensus standard that contributes to greater semantic interoperability within and across laboratories,” the consortium said in announcing the guidance. LIVD ensures that laboratory personnel will select the appropriate LOINC codes for IVD tests used by their laboratory. It also allows laboratory information systems to automatically map the correct IVD vendor test result to a LOINC code, according to the consortium.

This FDA recognition is a strong start toward a unified data system, Dr. Hinrichs says, and other experts agree. Hung S. Luu, PharmD, MD, director of clinical pathology at Children’s Health and chief of service for pathology at Children’s Medical Center Plano, UT Southwestern Medical Center, applauds the FDA guidance as an advance toward standardization. “The fact that the FDA has recognized there is a need for greater participation on the part of the vendors in assigning LOINC codes to their tests is a very recent development. We haven’t seen anything like that for the past 10 years, so this is brand new,” Dr. Luu says, adding that public health laboratories are probably ahead of everyone else in wanting unified data.

Unified data for all was the aim when, in 2011, the Office of the National Coordinator for Health Information Technology and the Centers for Medicare and Medicaid Services began phasing in minimum U.S. government-set standards for electronic health records through meaningful use, relabeled as interoperability in 2018. But actual interoperability has not been achieved.

It’s a problem, Dr. Hinrichs says, because a common vocabulary is critical to providing care and maximizing the usefulness of health care data, and it can optimize the value of medical research. “If researchers think they are looking at apples but they’re looking at oranges because they are using English words as opposed to standard codes that have all been linked and curated, then the research itself is questionable,” he says.

LOINC is only part of the solution to standardizing electronic reporting because, aside from being a voluntary standard, it is designed mainly for test orders; the standard for reporting test results is SNOMED CT. “LOINC provides codes for the questions,” Dr. Luu says. “It is just a way of assigning a number to a test so you can track it, the way a barcode does.”

“SNOMED is the computable language of the result in all of its complexity,” Dr. Hinrichs says, meaning that computers can understand and analyze SNOMED vocabulary. While efforts are underway to reengineer LOINC, it’s a language that falls short of SNOMED, in his view. “LOINC will not be a satisfactory solution long term because it does not have sufficient structure to address the complexity of results, particularly as you integrate anatomic pathology or next-generation sequencing with LOINC.”

Having LOINC and SNOMED working together from the start would help a great deal, in his view. “When the CDC had to make the next-generation test for influenza, we saw that as a great opportunity to provide coding with the test up front, so all the public health partners would use the same codes for all the influenza tests out there. There are molecular tests, antigen tests, and antibody tests for influenza, so if you don’t code them correctly, you don’t know what actual information the test is providing.” The influenza pandemic in 2008 and 2009 was the first time that new laboratory tests had LOINC and SNOMED codes linked to them. “Instead of having every laboratory in the country go and find out which LOINC or SNOMED codes to use, those codes were provided up front,” Dr. Hinrichs says.

But coding other areas of testing is less advanced. “What we have now is post-coordinated coding,” he says. “This means that after I see a test result, I put a code on it. It would be much better if the laboratory test result could be encoded prior to its being transmitted. LOINC needs to incorporate the full richness of result reporting, and it would be much better if both LOINC and SNOMED codes were incorporated into package inserts.”

The diagnostics industry has expressed opposition to mandates by the FDA on interoperability requirements. AdvaMed told the FDA in 2015 that requiring LOINC codes on instruments or product inserts would be difficult for manufacturers to implement, posed an excessive regulatory and administrative burden, and could freeze product innovation. However, up-front coding and package inserts are what the laboratory community wants, Dr. Hinrichs says. “We realize the commercial entities are not willing to do it at this point, but that is what we are asking for.”

The FDA guidance on LOINC does highlight the importance of having a common vocabulary to identify IVD test results, says Ed Heierman, PhD, chief technology officer for the IVD Industry Connectivity Consortium and a product software architect for Abbott. “That is what initiated the FDA workshops and the industry collaboration to establish the need for a common vocabulary. As an industry, we wanted all the manufacturers of IVD instruments to provide LOINC for the tests their instruments perform.” And among the manufacturers, “There was alignment on the importance of providing LOINC codes because that’s what allows upstream laboratory systems or systems performing automated analysis to know that they could compare a result from instrument A with a result from instrument B.”

The seeds were planted with the Office of the National Coordinator for Health IT and meaningful use, he says, because there were items of meaningful use that required certain vocabularies, with LOINC among them. “So laboratories were already facing the requirement of ‘I have to start publishing results that come out of my laboratory and identifying them with LOINC.’ The vendors like Epic that are providing the EHR and EMR, the IVD instrument manufacturers, and the LIS and middleware vendors—ultimately all of these entities will have to handle that requirement.”

The FDA’s SHIELD program (Systemic Harmonization and Interoperability Enhancement for Lab Data) is the next evolution of the workshops that led to LIVD on which the FDA LOINC guidance document is based, Dr. Heierman says. “SHIELD is focused on real-world evidence and real-world data. That means being able to collect real data from a population of patients or regions of the country or even specific instruments to perform a big-data analysis. You need these test results in a consistent format that is aligned on vocabulary.”

But whether it is big data, or the health record of an individual who may have received multiple IVD test results from different facilities, or information about a particular instrument to help move along its approval process, “You can see that having data use a common vocabulary is a way the diagnostics industry—the government agencies, the laboratories, and the manufacturers—can open up a lot of possibilities,” Dr. Heierman says.

A mandate from the FDA is not the way forward, he contends. There is leeway in the FDA’s guidance document, and Dr. Heierman thinks that is helping manufacturers with publishing LOINC codes. “After thoughtful discussion, we made an intentional decision to keep the LOINC codes out of the package inserts, and one of the biggest reasons is it is not as useful for laboratories that need to use it to identify the appropriate LOINC code because it is in a PDF or paper format. It is not in an electronic format that their laboratory systems can consume.”

Updating digital content will be much more efficient than updating package inserts, Dr. Heierman says. “Long term, we are looking toward systems that are automated. So [the decision against package insert LOINC codes] has taken away an obstacle that might have slowed some of this down.”

Dr. Heierman is hopeful that the manufacturers, having made progress by collaborating voluntarily, can get industry as a whole to promote and adopt standardized codes instead of waiting for FDA regulations. “I think this is a case where the industry can solve it itself, and I believe that is what the FDA would prefer. The support from the FDA came in the LOINC guidance document they published recommending LIVD as a way to LOINC mapping. As to how it is done, they have left that open.”

The manufacturers are taking the FDA recommendations to heart, he says. “The recommendations are almost as strong as a mandate but without the regulations behind them. The manufacturers are producing mapping tables for LOINC and giving thought to how the content can be automated. We are trying to remove the burden of laboratories having to figure out the LOINC code by giving them instead information to accurately and efficiently perform mappings: If we are running this test from this manufacturer and our lab is configured this way, this is the right LOINC code.”

The diagnostics manufacturers have embraced the FDA guidance because they were the primary players at the table, Dr. Hinrichs says. “They were very much against having standardized codes in the package inserts.” However, “I am so anxious for progress [on interoperability] that any move forward is progress. I wish it would happen faster and, of course, that is where federal mandates can accelerate things.”