The universal standard for identifying health measurements, observations, and documents

An Overview and Background

Background and Motivations

At the Regenstrief Institute, Inc., we imagine a world where health is optimized for all through a seamless network of healthcare information systems. Optimal health requires an ecosystem of electronic interoperability: where data such as labs, vitals signs, and clinical documents, can be exchanged and understood by systems made by many vendors. But data producers have different ways of identifying the same test or measurement. We have effectively created isolated data islands, which limits the potential of clinicians, consumers, and caregivers to improve and manage health.

LOINC was created in 1994 by Clem McDonald, MD to make health data more portable and understandable to different computer systems. Now, more than 20 years later, Regenstrief continues to serve as the standards development organization for LOINC as it has grown significantly in scope and adoption worldwide.

A rich trove of standardized variables

LOINC is a large catalog of standardized variables for clinical tests and observations, from lab to lifestyle and genetics to environment.

In June 2017, Regenstrief will publish the 59th release of LOINC containing over 84,00 variables.

Laboratory content (observations on a specimen) includes chemistry, microbiology, drug/tox, hematology, molecular pathology, etc.

Clinical content (observations about people, populations, and the environment) includes vital signs, clinical measures, radiology procedures, document titles, patient-reported outcomes, etc.

LOINC contains extensive metadata about each term, including display names, example units of measure, structured answer lists, synonyms, and more. LOINC has codes for discrete observations plus collections of terms like laboratory panels and patient assessment instruments.[PMID: 22899966]There are now 11,000+ carefully crafted term descriptions like the example below:

LOINC grows because users ask

LOINC uses a community-driven development approach, and users continue to request new content in many domains.

The diagnostic testing industry continues to innovate and new lab tests are always emerging. Many requests now come directly from test manufacturers. Public health continue requesting codes for emergent issues, surveillance, and case reports. Genetic tests for detecting inherited human disorders, somatic mutations (cancer), and the presence of infectious organisms have burgeoned. In the last decade, we increased by four fold the number of molecular pathology terms in LOINC, and have been active in Health Level 7 (HL7)’s work to define new data models for reporting genetic test results. Other growing areas include social determinants of health, patient-reported outcomes, clinical document titles, and structured pathology reporting for cancer.

LOINC is a growing global community

LOINC is used in diverse settings: reference labs, radiology centers, federal agencies, health care organizations, professional societies, data exchange networks, insurance companies, health IT vendors, in vitro diagnostic vendors, and more.

More than 6,000 new users register each year.

Use in the United States

Federal regulations in the EHR “Meaningful Use” program have required LOINC in electronic quality measures, messages reporting lab tests, exchanging medical summaries, and sending data to cancer registries and public health agencies. The Food and Drug Administration uses LOINC in structured product labeling, and will require it for lab data in clinical trials effective March 2018. The Centers for Disease Control and Prevention uses LOINC in electronic laboratory reporting, case reporting, and other national systems. The ONC’s 2017 Interoperability Standards Advisory lists LOINC for many interoperability needs, including functional status, laboratory tests, imaging diagnostics, nursing observations, vital signs, and social determinants of health. The Centers for Medicaid and Medicare Services adopted LOINC for the patient assessment instruments required in post acute care settings. Large scale research networks such as PCORnet, OHDSI, and the FDA’s Mini-Sentinel all use LOINC. LOINC has been endorsed by the College of American Pathologists, the American Nurses Association, American Academy of Nursing, and other professional bodies.

*See Appendix A for additional detail on LOINC’s U.S. federal collaborations.

International use

LOINC is also flourishing internationally. Fueled by an innovative process, there are translations into 18 variants of 12 languages.[PMID: 22285984] It is an official national standard in more than 30 countries. A recent Organisation for Economic Cooperation and Development study highlighted it as the international standard for lab results. LOINC is used in national patient record programs (e.g. Australia, Austria, Italy), maternal health programs (e.g. Rwanda), surveillance networks for antibiotic resistance (e.g. Netherlands), national insurance programs (e.g. Saudi Arabia), patient summaries for cross-border care, reporting lab results (e.g. Turkey, Qatar), and more.

We’re committed to working together with other standards developers

Health Level Seven (HL7)

Regenstrief and HL7 have a long-standing relationship to develop complementary health data standards. A few joint work highlights include: clinical genomics guides, claims attachments specifications, and approaches for representing vocabulary standards in FHIR terminology services.

SNOMED International

In 2013, Regenstrief and SNOMED International (formerly IHTSDO) formed a landmark long-term collaborative relationship to link the rich clinical semantics of SNOMED CT to LOINC, which provide extensive coverage of laboratory tests and clinical measurements.

IEEE Standards Association

Regenstrief Institute, developers of LOINC, and the IEEE Standards Association, developers of the 11073™standards, have signed a memorandum of understanding to enhance the interoperability of traditional medical devices and personal health devices.

IVD Industry Connectivity Consortium (IICC)

Regenstrief worked with the IICC on a new specification for publishing vendor IVD tests associated with a set of LOINC codes that identify the distinct observations produced by the test. This standard will greatly improve the efficiency and consistency with which laboratories can deploy LOINC.

Radiological Society of North America (RSNA)

Regenstrief and the RSNA are unifying the RadLex™Playbook and LOINC radiology terms to produce a single, comprehensive standard for radiology procedures with a shared governance.

Health Standards Collaborative (HSC)

Regenstrief is an active member of the HSC, which provides an executive forum for senior leadership of the U.S. healthcare standards development community to improve interoperability.

Many tools for LOINC implementers

Regenstrief develops and makes available at no cost a large toolbox of resources for implementers.

Regenstrief LOINC Mapping Assistant (RELMA)

RELMA is the “gold standard” desktop mapping program for linking local test codes to LOINC.

Online Search App (search.loinc.org)

Search the latest version of LOINC from your browser – fast. No software install necessary.

Community and Educational Resources

The LOINC website is loaded with resources, including a tutorials, videos, user forum, and more.

Other LOINC-related software

Regenstrief also hosts a FHIR vocabulary server of LOINC subsets, open source data capture widget software developed by NLM called LHC-Forms, and a community mapping repository.

Key funding support from HHS and others

As a non-profit, Regenstrief is able to develop and make LOINC available at no cost because of key financial support from many, including the National Library of Medicine, Regenstrief Foundation, NIDDK, NIBIB, NCCIH, ASPE/CTSA, CMS, bioMérieux, and the LOINC community.

The road ahead

Undoubtedly, LOINC is improving healthcare within the U.S. and around the world by making health data more fluid and understandable to different computer systems. Regenstrief remains committed to developing LOINC openly and making it available at no cost. As new users and new content requests continue to grow, standards like LOINC are at risk for suffering from the tragedy of the commons. Yet, such standards are essential infrastructure for the health ecosystem and necessary ingredients for true and meaningful interoperability. Federal support and adoption of clinical vocabulary standards remains vital for progress towards the vision of optimal health.

Appendix A. Many successful collaborations with federal partners

Regenstrief has a long history of collaborating with and supporting the efforts of federal agencies. We have worked extensively with the VA and DoD about LOINC laboratory, radiology, and clinical document codes. We worked with the Indian Health Service as they mapped all of the laboratory data from its 250 facilities to LOINC. The CDC has many programs that are implementing LOINC. We have worked with many U.S. federal agencies and NIH institutes that are using LOINC to catalog their common data elements.

A brief summary is included below.