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For TRUU-Lab Initiative, test naming a work in progress

February 2022—Ask TRUU-Lab founder Ila Singh, MD, PhD, what’s in a name and she will provide an answer that differs greatly from that of Shakespeare’s Juliet Capulet. According to Dr. Singh, the answer can be too much information, not enough information, or ambiguous terminology—when referring to lab test names, that is.

Through the TRUU-Lab Initiative, Dr. Singh, who is chief of laboratory medicine and chief of pathology informatics at Texas Children’s Hospital, Houston, has joined forces with like-minded medical professionals and others to create easy-to-understand, standardized lab test names, with the goal of reducing errors in test ordering. Among the initiative’s more than three dozen members are representatives of hospital pathology departments, reference labs, electronic medical record companies, industry associations, U.S. federal agencies, and international organizations. “What’s great is that people from agencies like CMS, FDA, CDC, and others join our meetings,” Dr. Singh says.

TRUU-Lab (Test Renaming for Understanding and Utilization in the Laboratory) is developing more precise names for commonly confused tests, which it plans to use to develop consensus guidelines for naming most laboratory tests within the next few years. In contrast to the Regenstrief Institute, which created and maintains machine-readable LOINC codes to identify tests, Dr. Singh is focusing on names “that humans would understand.” To that end, TRUU-Lab is not only developing guidelines but formulating plans to analyze proposed test names in a simulated test-ordering environment, with assistance from the initiative’s EMR vendor members.

“What I would like [EMR vendors] to do—and they have agreed to it—is build mock EMRs,” Dr. Singh says. Vendors would populate the mock EMRs with some of the test names reached through a consensus of TRUU-Lab members to determine if clinicians make fewer mistakes ordering lab tests when using the new names, she explains.

TRUU-Lab member Nick Trentadue, project director for Beaker Laboratory, Epic’s laboratory information system, told CAP TODAY that “there is no reason we couldn’t, for those who have access to Epic, prop up an environment to take a look at what the test names would look like.” Epic clients already have access to a foundation system environment, he adds.

Due to proprietary intellectual property concerns, each vendor would need to build a mock EMR for its own customers, says Trentadue. (Cerner and Sunquest are also among the TRUU-Lab members.) Testing the names on various systems is important, adds Dr. Singh, because the names can often appear differently based on the EMR used.

“Every EMR has its own rules,” she explains. “Some allow 40 characters for a display name. Others, like Epic, have more lenient rules and you can build very long names, so we would have to try out [the names] with multiple vendors.”

It’s crucial that after the mock EMR phase, vendors add TRUU-Lab–recommended names to their base offerings, Dr. Singh says. “EMRs bring you a foundation build that comes with their base level. One way that we can make it easy [to adopt new test names] is by having these EMR vendors say here are all the preferred names in the foundation build.” So far, she notes, TRUU-Lab member vendors are supportive of the plan. “It would save the vendors and hospitals implementing or upgrading their systems both time and resources,” Dr. Singh emphasizes.

“Whether it’s an entire nomenclature or taking the 10 most commonly confused tests and starting from there,” Trentadue says, “we will take action. We have committed to build it out in our foundation system.” Epic will incorporate TRUU-Lab test names into the Epic EMR and Beaker Laboratory LIS since test name clarity is an issue that affects ordering clinicians and the laboratory team, he adds.

Once new names are built into foundation systems, health care institutions will not only be able to access them when they install new EMR systems but also when they upgrade their existing EMRs, Dr. Singh says. But, she notes, discussing test name accessibility is putting the cart before the horse.

For nearly two years, TRUU-Lab has been comprehensively surveying clinicians to assess how well they understand test names and determine what information they would like included in such names. The surveys are funded through a grant from the Centers for Disease Control and Prevention. The initiative is currently conducting a series of clinician surveys in partnership with Brand Institute, a branding company with extensive experience naming pharmaceuticals.

The surveys are necessary, Dr. Singh explains, as indicated by discussions she held with members of the laboratory medicine committee at Texas Children’s Hospital, because the information pathologists consider important in lab test names may not be relevant to clinicians. For example, some test names reflect the type or sensitivity of the assay, but clinicians may prefer test names that describe what the test should target. “We are giving them information that we would like to see but not what they need to see,” she says.

Brand Institute is sending the surveys to clinicians in its database. Respondents enter a portal and answer the questions. TRUU-Lab is seeking responses from clinicians in various specialty areas who order tests frequently, Dr. Singh says. As the survey captures results from a predetermined number of clinicians in one specialty area, it closes to respondents from that specialty.

Because the CDC grant is specifically earmarked for surveying ordering clinicians, TRUU-Lab is conducting separate but similar surveys of pathologists and other lab professionals who are members of the American Society for Clinical Pathology. Comparing the two types of surveys will help TRUU-Lab better understand different perspectives on lab names and, thereby, inform the guidelines, Dr. Singh says.

TRUU-Lab has yet to determine how many test names it will try to standardize because the process is labor intensive and time-consuming, Dr. Singh notes. It’s possible the group may finalize test-naming guidelines, apply them to commonly confused or misunderstood tests, and then offer the guidelines as a framework that hospitals or other health care institutions can use to resolve specific test-naming issues they encounter.

Test names are only one component of the test-ordering process that needs to be standardized, Dr. Singh says. Even if two institutions use the same lab test name and EMR vendor, they may have set up their tests with different units or reference ranges, she explains. Therefore, TRUU-Lab is cooperating with other groups working on related lab test-ordering standardization efforts where possible. For example, representatives of the FDA’s SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) project have joined TRUU-Lab and share feedback about that collaborative’s standardization efforts.

Yet Dr. Singh emphasizes that “the names themselves are going to keep us busy. I wanted to make it all about comprehension, correct use, and eliminating confusion.”

In the end, she concludes, “there are many different standardization endeavors that are targeting different things. And it really would be great if we could combine all of our findings into one thing that can be used by all.”—Renee Caruthers

ONC releases framework for health information exchange

The Office of the National Coordinator for Health Information Technology has launched the Trusted Exchange Framework and Common Agreement.

TEFCA is a set of nonbinding principles that support data exchange across health information networks nationwide. The ONC’s goals for the framework are to establish a universal policy and technical baseline for nationwide interoperability, make it easier for organizations to share information securely, and allow all Americans to compile their health care information.

The ONC’s recognized coordinating entity, the Sequoia Project, will sign a legal contract, called the Common Agreement, with each qualified health information network. The networks, in turn, will execute corresponding connectivity policies within their institutions.

The ONC is also working with the Sequoia Project to create a Fast Healthcare Interoperability Resource roadmap that outlines how FHIR eventually will be incorporated into TEFCA.

Educational resources and information on how to participate in TEFCA are available at https://rce.sequoiaproject.org.

Indica Labs receives CE-IVD certification for AP system

Indica Labs announced that it has received a CE mark for its Halo AP anatomic pathology software, allowing the product to be used for primary diagnosis in the European Economic Area, Switzerland, and the United Kingdom.

“With APIs [application programming interfaces] to support connections to LIS/LIMS or other third-party systems, as well as flexible on-premise and cloud-deployment options, Halo AP can integrate seamlessly within any organization’s existing IT infrastructure,” according to an Indica Labs press release. “For laboratories without an existing LIS/LIMS, Halo AP can act as a fully functional, standalone case- and image-management system.”

In addition to primary diagnoses, the platform supports secondary consults, tumor boards, clinical trials, synoptic reporting, quantitative analytics, and artificial intelligence.

Halo AP has been commercially available in the United States since 2019.

Indica Labs, 505-492-0979

New partnership addresses AI standardization and education

Duke Health and the Mayo Clinic, among others, have established the Health AI Partnership, an endeavor to standardize industry best practices for deploying artificial intelligence software and to develop an open-source AI curriculum.

The group plans to undertake a 12-month project in which it will engage various delivery systems and other stakeholders to analyze the medical industry’s use of artificial intelligence. It will build on the AI advances made by the participating delivery systems relative to laboratory diagnostics, therapeutics, and medical devices. The project will seek and incorporate feedback from technology users, regulators, policy experts, and payers.

“Key insights and best practices will then be aggregated to develop an online professional education curriculum that will empower delivery systems to bolster medical AI procurement, integration, and lifecycle management activities,” according to a blog post from the Duke Institute for Health Innovation. The guidance and curriculum will be made available as open-source offerings.

Among the other members of the partnership are the University of California, Berkeley, the law firm DLA Piper, and a community representative. The program is funded by the Gordon and Betty Moore Foundation.

Dr. Aller practices clinical informatics in Southern California. He can be reached at raller@usc.edu. Dennis Winsten is founder of Dennis Winsten w& Associates, Healthcare Systems Consultants. He can be reached at dwinsten.az@gmail.com.