Why laboratory contribution is key
Healthcare is inching towards a more interoperable system with the end goal being the ability to access patient health records from any location to expedite treatments and reduce errors. Interoperability means that different information systems, regardless of vendor or application, can communicate—more specifically, exchange data and use the shared data. The idea is that all information and communications technologies (ICT) will be able to work together to support more effective delivery of healthcare and support patient care and population health improvement goals. Yet, we struggle to reach the “nirvana” of healthcare interoperability.
The Lab’s Role in Interoperability
Because laboratories manage a large amount of data, they are a big part of the interoperability puzzle (Figure 1). Providers need access to lab data to be able to make timely care decisions. However, to make interoperable healthcare a reality, we require standardized transmission and languages as well as structured data so that information systems can properly communicate and data can be understood.
Medicare Quality Payment Program Pushes Toward Interoperability
Among government regulations that are a driving force for interoperability, October 2016 brought the final rule for the new Medicare Quality Payment Program (QPP), part of the Medicare Access and CHIP Reauthorization Act (MACRA). The QPP defines how providers will be reimbursed for quality and gives providers two options: the Merit-based Incentive Payment System (MIPS) or the Advanced Alternative Payment Models (APMs). Intended to be implemented in stages, MACRA’s QPP is the next step in the transition to value-based payment models and will consolidate Meaningful Use (MU), the Physician Quality Reporting System (PQRS), and the Value-based Payment Modifier into MIPS. Those who qualify may choose to participate in Advanced APMs. In either case, one of the major objectives of the QPP is to incentivize interoperability.
Types of Healthcare Interoperability
There are three levels of interoperability: foundational, structural, and semantic. Healthcare’s overall goal is to reach the semantic level (Figure 2). But we have to take one step at a time. The simplest level—foundational interoperability—is when data is sent from one system to another, but the data is not interpreted on the receiving end.
A laboratory interface may be an example of the second level, structural interoperability, where the data exchanged is structured and formatted in discrete fields so that the data’s meaning is not lost in transmission and can be interpreted on the receiving end at the data field level. It is at the structured level that standardized languages such as Logical Observation Identifiers Names and Codes (LOINC) and Systematized Nomenclature of Medicine-Clinical Terms (SNOMED CT) become important.
Semantic interoperability, the most desirable level, involves data transmission between information systems where the data can be interpreted and used by the receiving system, such as in a clinical decision support system (CDSS). To accomplish this level, data must not only be structured, but codified as well so that the receiving system can understand what the data means. The semantic level is the gold standard healthcare is striving for, where electronic exchange among all healthcare parties and between any disparate information systems, medical devices, or mobile technologies can be achieved.1 It is easy to understand how this level of data exchange could be leveraged in our healthcare system to improve population health, quality and safety, cost effectiveness, and access to care.
Interoperability Standards Advisory to Track Progress
In December 2015, the Office of the National Coordinator (ONC) unveiled the 2016 Interoperability Standards Advisory (ISA), which details both current and emerging interoperability standards required for each area of healthcare (e.g., lab, imaging, medications, etc.).2 The ISA is a follow-up to the ONC’s Interoperability Roadmap and will help track progress as standards and implementation specifications are updated over time. ONC intends to update the ISA annually to stay up-to-date with the fast-pace changes taking place in health information technology (HIT).
HL7 2.5.1 Has Interoperability as Its Goal
Health Level Seven International (HL7) is the global authority on HIT interoperability standards and provides standards for the exchange, integration, sharing, and retrieval of electronic health information. HL7 transmission standards are used to format the way lab orders are transmitted and how lab results are received. Additionally, HL7 standards are used to support:
- the transmission of a laboratory’s directory of services (DOS)
- the reporting of antimicrobial use and resistance information to public health agencies
- the reporting of cancer cases to public health agencies
- the transmission of reportable lab results to public health agencies
- the reporting of syndromic surveillance to public health entities3
Additionally, HL7 released an implementation guide that standardizes transmission of a laboratory DOS from the LIS to the EHR. Electronic delivery of the lab DOS can assist in the ordering process and potentially improve patient care based on real-time delivery of DOS updates (including specimen collection and transportation requirements) and error reduction.4
Data Semantics for Labs: LOINC & SNOMED CT
To facilitate interoperability, information systems must be able to understand each other’s language; this is accomplished by using standardized vocabularies. By now, laboratories should be familiar with the terminology standards that have been adopted for lab data transmission: LOINC and SNOMED CT. LOINC is used for the transmission of numerical lab results and SNOMED is used for instances in microbiology and pathology where LOINC is not granular enough to identify a specific test or test result. SNOMED CT, used for much more than laboratory reporting (e.g., CDSSs, emergency room charting, cancer reporting, etc.), is the most comprehensive clinical terminology, and was specifically designed to promote electronic health information exchange (Figure 3).
UCUM & UDI
Additionally, Unified Code for Units of Measure (UCUM) and the Unique Device Identification (UDI) system are standardized vocabularies required to promote interoperable laboratory data exchange. UCUM (adopted by HL7) is a code system that standardizes all scientific units of measure for electronic communication of specific units accompanying measured analytes. UDIs are used to uniquely identify medical devices throughout their distribution and use, and are expected to be phased in over the next several years with final compliance expected in 2020.
Collaborative Efforts to Advance Lab Interoperability
The Centers for Disease Control and Prevention (CDC) are encouraging the development of training aids to help laboratories implement LOINC and understand the importance of reporting data in a structured manner. The ONC, the National Institute of Standards and Technology (NIST), the Centers for Medicare and Medicaid Services (CMS), the CDC, and the Food and Drug Administration (FDA) are working together to advance laboratory data interoperability. These agencies are collaborating to define interoperability specifications that support CLIA and other regulatory compliance and to establish requirements for application programming interfaces (APIs) that meet CLIA requirements for laboratory ordering and reporting.
Current Limitations in Laboratory Interoperability
In spite of progress, there are still limitations to lab interoperability. Even when LOINC are used, there are inconsistencies. For quantitative tests, these are problems with units (e.g., inconsistent units of measure, unrecognized synonyms, units that result in different magnitudes of the numeric quantity, and missing units). For non-quantitative tests, the most frequent problems are acronyms and synonyms, different classes of elements in enumerated lists, and the use of free text.5 Furthermore, as genomic tests continue to increase and are needed for use in CDSSs, this complex data will also need to be standardized.
Goal: Anywhere, Anytime Access to Patient Data
Our healthcare system is working toward having electronically-accessible patient records that include a complete longitudinal picture of patients’ health rather than single episodes of care, where unnecessary testing is eliminated because clinical data is available and where public health agencies have access to data that supports population-wide healthcare improvements. As the ONC’s Interoperability Roadmap describes, we are striving for a “learning health system” (see Figure 4) where patient data is available to providers anywhere and anytime throughout the entire patient care continuum from any type of interconnected information system. An interoperable healthcare system would enable better informed healthcare decisions, give patients to access their data, and support improvements in the overall health of our population. Currently, our healthcare system is making great strides with interoperability, but we still have a long way to go. Clinical and anatomic pathology labs that stay abreast of these changes and up-to-date on use of interoperability standards and languages are doing their part to contribute to healthcare interoperability.
- What is interoperability? Available at: www.himss.org/library/interoperability-standards/what-is-interoperability
- ONC-HIT. 2016 interoperability standards advisory. Available at: healthit.gov/sites/default/files/2016-interoperability-standards-advisory-final-508.pdf
- ONC-HIT. Connecting health and care for the nation: A shared nationwide interoperability roadmap. Available at: healthit.gov/sites/default/files/hie-interoperability/nationwide-interoperability-roadmap-final-version-1.0.pdf
- Posnack S, Sparkman T. Highlighting a way to advance interoperability and reduce costs for lab tests. Available at: healthit.gov/buzz-blog/interoperability/highlighting-advance-interoperability-reduce-costs-lab-tests/?utm_source=feedburner&utm_medium=email&utm_campaign=Feed%3A+healthitbuzzblog+%28Health+IT+Buzz+Blog%29
- Lin M, Vreeman DJ, Huff SM. Investigating the semantic interoperability of laboratory data exchanged using LOINC codes in three large institutions. Available at: ncbi.nlm.nih.gov/pmc/articles/PMC3243154/