Adoption of the latest laboratory connectivity standards offers wide-ranging benefits
By Serge Jonnaert and Ed Heierman, PhD
Over the past decade, industry, government, and standards organizations have participated in unprecedented collaboration with the intent of developing well-defined, practical, modularized, and easy-to-implement interoperability standards. Nevertheless, the adoption of such standards by clinical laboratories has lagged significantly. Most laboratories that are installing new instruments follow specifications from guidance documents that are now more than 20 years old and no longer meet the data interoperability and security needs of contemporary laboratories.1,2
With an alphabet soup of organizations involved in developing and promoting connectivity standards, it’s not surprising that clinical laboratory directors may sometimes be confused about which organizations’ guidance documents should be followed (see companion article “Key Players”). But a closer look reveals that the major industry groups and smaller standards organizations—including an FDA-sponsored workgroup on harmonization and interoperability—are now mostly collaborating to achieve the unified goal of synergistic interoperability standards. These new function-specific standards are mature and very well defined—a reflection on the lessons learned from past incomplete and often ambiguous standards such as ASTM E1381.3
Adoption of the new standards has broad benefits for all stakeholders in the healthcare ecosystem. Laboratory leaders should not only become familiar with them; they should demand support of the standards from their IT organizations and vendors. As described below, payback will be immediate.
For clinical laboratories, adoption of the new standards will result in a significant reduction in the time and costs required to deploy, connect, and update laboratory instruments by eliminating the need for vendor-customized connectivity implementations that can easily cost several thousand dollars per instrument. Standards-based interoperability also reduces the risk of errors and improves the integrity of patient data. The new standards support the federal guidelines of the Medicare Access and CHIP Reauthorization Act (MACRA) as well as those of the Centers for Medicare and Medicaid Services merit-based incentive payment system (MIPS) for laboratories that provide services to eligible hospitals and physicians.4,5
For in vitro diagnostic (IVD) manufacturers, adoption of the new standards will reduce the time and costs associated with deploying instrument interfaces to laboratory information systems (LISs) and middleware, as well as related post-deployment support. Customers will favor IVD vendors that support the standards, resulting in cost savings. Most standards are freely available to IVD vendors and do not require licensing or fees for implementation.
For government bodies, the new standards bring about standardized coding of laboratory results and the resolution of related semantic and interoperability issues for the aggregation of big health data. In turn, such standards support the promise of improved real-time epidemiology, the analysis of comprehensive and geo-specific population health data, and the analysis of non-obvious multicorrelates that can lead to new discoveries. The result is overall cost savings to the public healthcare system.
Following is a summary of recently approved and published standards for clinical laboratory interoperability, as well as pending industry standards, with notes about the organizations that collaborated on their development.
The IVD Industry Connectivity Consortium (IICC) creates and encourages the adoption of unified connectivity standards (see Table 1). It is the main sponsor and facilitator behind the laboratory analytical workflow (LAW) profile and the digital format for publication of logical observation identifiers names and codes (LOINC) to vendor test results (LIVD) standards described below.
- Laboratory Analytical Workflow (LAW) Profile. The LAW profile standardizes the physical connections, message definitions, and workflow definitions necessary to achieve plug-and-play connectivity among instruments, middleware, and LISs in the laboratory.6 The profile’s message definitions are based on the messaging standard developed by HL7, which is the standard specified in US meaningful use requirements for electronic laboratory reporting.7 IICC collaborated with the IHE pathology and laboratory medicine (PALM) domain to develop the LAW profile. The LAW profile will also provide the basis for the forthcoming CLSI Auto 16 standard for next-generation IVD instrument interfaces.8 LAW is currently being implemented by major IVD companies, including Abbott, BD, Beckman Coulter, BioMérieux, Orchard Software, Ortho Clinical Diagnostics, Roche Diagnostics, Siemens Healthineers, Sunquest, and many others.
- Digital Format for Publication of LOINC to Vendor Test Results (LIVD). Prepared by IICC, the LIVD specification outlines an industry-defined format to facilitate the digital publication and exchange of IVD test results together with their associated logical observation identifiers names and codes (LOINCs).9 LOINCs are required with laboratory results reporting and on demand from physician laboratory customers. The LIVD specification assists laboratory personnel with the selection of appropriate LOINCs for their IVD test results. It reduces variability in the mapping and maintenance of LOINCs, reducing time and effort of laboratory professionals. It is also defined to allow LISs to automatically map IVD vendor test results to the appropriate LOINCs.
Integrating the Healthcare Enterprise (IHE) promotes the coordinated use of established standards to address specific clinical needs. The organization’s pathology and laboratory medicine (PALM) domain covers standards related to the representation and exchange of digital structured data related to the testing of patient specimens, as well as standards related to biobanking and transfusion medicine. Specialty areas within the domain include anatomic pathology, clinical pathology, and molecular pathology. As described here, PALM committees have developed a number of profiles that can be adopted by clinical laboratories and IVD manufacturers to improve their use of integrated information technologies.
- Laboratory Testing Workflow (LTW). The LTW profile integrates the ordering, scheduling, processing, and results-reporting activities associated with in vitro diagnostic tests performed by clinical laboratories in healthcare institutions.10 It maintains the consistency of patient and order information from registration through ordering, scheduling, preanalytical processing, testing, and technical and clinical validation, to results-reporting and use of laboratory observations and comments by healthcare providers.
- Sharing Laboratory Reports (XD-LAB). The XD-LAB profile describes the content of an electronic clinical laboratory report, and provides a document-sharing profile that permits laboratory reports to be shared as electronic documents in both human- and machine-readable format with electronic health records (EHRs) or personal health records (PHRs) accessible to a community of healthcare providers.11 This profile is currently in use only in Europe.
- Laboratory Device Automation (LDA). This profile covers the exchanges between a laboratory information system (LIS) or laboratory automation system (LAS) and automation subsystems in order to process a work order, perform ordered tests on the pertinent specimens, and retrieve their results.12 Processing performed under this profile includes in-lab preanalytical processing of specimens (eg, sorting, centrifugation, aliquoting, transportation, decapping), the analytical process itself (specimen analysis resulting from ordered tests), and in-lab postanalytical processes (eg, recapping, transportation, rerun, storage, and retrieval).
- Laboratory Barcode Labeling (LBL). This profile specifies methods for the automated identification of specimen containers using a bar-coded label representing the patient, test order, and specimen data received from another system (eg, a clinical information system, hospital information system, or laboratory information system, depending on the region).13
- Laboratory Code Sets Distribution (LCSD). This EU-specific profile defines the distribution of managed sets of clinical laboratory codes (battery, test, and observation codes) and nomenclatures, shared across different systems in the laboratory.14
- Interlaboratory Workflow (ILW). This profile definesthe workflow for orders, payer information, and results between a requesting lab that provides the specimens and order information and a subcontracting lab that performs the test and reports its results to the originating laboratory.15 The structured results may be accompanied by an electronic copy of the performing lab report in portable document format (pdf).
Health Level Seven International (HL7) is a standards-developing organization accredited by the American National Standards Institute (ANSI). HL7 standards focus on the exchange, integration, sharing, and retrieval of electronic health information, and are widely adopted.
- Electronic Directory of Services (eDOS). This US-specific standard from HL7 defines the distribution of managed sets of clinical laboratory codes (order/battery, test result, and result values/observations) with their corresponding terminology codes, as well as other important testing information such as specimen, container, transport, and expected turnaround time.16 The eDOS standard supports updates to the compendium and has an appendix dedicated to common ask-at-order-entry (AOE) questions. It is designed to work in concert with HL7’s standards for laboratory orders and laboratory results interfaces (LOI and LRI).
- Laboratory Orders Interface (LOI). This US-specific implementation guide defines methods to support the transmission of new, appended, or canceled orders between ambulatory care providers and laboratories in the US, including valueset definitions.17 It is designed to work in concert with HL7’s eDOS and LRI standards.
- Laboratory Results Interface (LRI). This US realm guide defines methods for the exchange of results between ambulatory providers and laboratories in the United States, including valueset definitions.18 It is designed to work in concert with HL7’s eDOS and LOI standards.
In addition to the standards described above, the following new initiatives are under development and worth mentioning.
- Devices on FHIR (DoF). Still in its early stages of development, this standard will define the consistent use of fast healthcare interoperability resources (FHIR; pronounced ‘fire’) to represent data acquired from analytical devices, including point-of-care and clinical laboratory instruments.19 The standard will accommodate IICC’s LIVD format. FHIR itself is getting broad industry attention and is poised to dramatically change how healthcare sector entities exchange data in all clinical systems—not just in electronic health records.
- Healthcare Services Platform Consortium (HSPC). This group undertakes initiatives to simplify the development and implementation of healthcare information systems in order to provide specific decision support over highly refined, standards-based, encoded data.20 The group was established in 2013 by Intermountain Healthcare, Louisiana State University, and the US Department of Veterans Affairs, and now numbers more than 270 contributors. The intent of the consortium is to define an open, standards-based, services-oriented architecture platform that integrates the terminologies of the systematized nomenclature of medicine–clinical terms (SnoMed CT), logical observation identifiers names and codes (LOINC), and RxNorm (collectively, SOLOR), to cover the essential domains necessary for healthcare.
The Role of Government Entities
Several US government entities have played active roles in defining, facilitating, and recommending interoperability standards. Most notable are the healthcare advisory committee and the health IT interoperability standards advisory maintained by the Office of the National Coordinator for Health Information Technology (ONC), and the FDA-sponsored systemic harmonization and interoperability enhancement for lab data (SHIELD) workgroup.
The ONC health IT interoperability standards advisory is meant to provide industry with a single, public list of the standards and implementation specifications that can be used to achieve a specific clinical health information interoperability purpose. The advisory also prompts dialogue, debate, and the development of consensus among industry stakeholders when more than one standard or implementation specification could be listed as the best available.
ONC’s shared nationwide interoperability roadmap anticipates that both federal and state healthcare agencies will begin incorporating technical standards and certification requirements in the terms of their grants and contracts that fund health IT adoption, including Medicaid incentives for certified IT systems.
FDA’s SHIELD workgroup is an effort led by Michael Waters, PhD, of the agency’s Office of In Vitro Diagnostics and Radiological Health. The workgroup brings together representatives of five federal agencies, IVD manufacturers, key healthcare systems, and 10 related international industry and standards-development groups. The workgroup takes a very direct, pragmatic approach to tackling healthcare’s lingering interoperability challenges by fostering open dialogue among all relevant stakeholders. The progress made by this workgroup exemplifies its government and industry collaboration.
Connectivity in the European Union. The European Union has selected 27 integration profiles from IHE to become part of the eHealth European Interoperability Framework.21 Selected standards include the LAW profile from IHE and IICC; and the profiles for LCSD, XD-LAB, and LTW, all from the IHE PALM domain. It is expected that public agencies will reference the profiles in their public procurement tenders for European health systems.
It is understandable that many laboratorians find the realm of connectivity and interoperability confusing, and yearn to have all of the pertinent standards bundled together in a single master schedule that has been agreed upon by industry, the laboratory community, and government stakeholders. The Office of the National Coordinator for Health Information Technology is working to accomplish this goal through its interoperability standards advisory (ISA), which coordinates identification, assessment, and public awareness about interoperability standards and implementation specifications used by the healthcare industry, in order to address specific interoperability needs. ISA is updated on an annual basis. While the information it provides is not exhaustive, it can help users to identify the minimum standards that should be adopted as best practices for creating a broader interconnected healthcare ecosystem.
Smart laboratories will evaluate the tangible benefits that the aforementioned standards offer their operations, and will work with vendors to collectively adopt and implement them. Short of being mandated by government regulations, these new standards will not see broad adoption without a progressive effort by more laboratories in the United States and abroad.
Adoption of the new generation of connectivity standards represents an opportunity that should not be missed. Laboratories owe it not only to the general public, but also to the hundreds of highly qualified volunteers who have contributed thousands of hours to define the industry’s best-ever standards, all for the common good of improving patient healthcare.
Serge Jonnaert is vice president for technology mergers and acquisitions at the Corum Group Ltd, president of the IVD Industry Connectivity Consortium, former board member at large of Integrating the Healthcare Enterprise International, and a member of the FDA-sponsored systemic harmonization and interoperability enhancement for lab data (SHIELD) workgroup. Ed Heierman, PhD, is a product software architect at Abbott Laboratories, chief technology officer of the IVD Industry Connectivity Consortium, chair of the CLSI automation and informatics expert panel, and a member of the SHIELD workgroup. For further information, contact CLP chief editor Steve Halasey via [email protected].
- Specification for Low-Level Protocol to Transfer Messages between Clinical Laboratory Instruments and Computer Systems. NCCLS Standard LIS1-A, ed. 1. Wayne, Pa: National Committee for Clinical Laboratory Standards, 2003. Available at: https://infostore.saiglobal.com/store/details.aspx/details.aspx?productid=801014. Accessed January 2, 2019.
- Specification for Transferring Information between Clinical Instruments and Computer Systems. NCCLS Standard LIS2-A2, ed 2. Wayne, Pa: National Committee for Clinical Laboratory Standards, 2004. Available at: https://infostore.saiglobal.com/store/details.aspx/details.aspx?productid=801050. Accessed January 2, 2019.
- Standard Specification for Low-Level Protocol to Transfer Messages between Clinical Laboratory Instruments and Computer Systems. [Withdrawn standard ASTM E1381-02]. West Conshohocken, Pa: ASTM International, 2002. Available at: www.astm.org/standards/e1381.htm. Accessed January 2, 2019.
- Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). Pub.L. 114-10.
- The Merit-Based Incentive Payment System (MIPS). Baltimore: Centers for Medicare and Medicaid Services, 2016. Available at: www.cms.gov/medicare/quality-initiatives-patient-assessment-instruments/value-based-programs/macra-mips-and-apms/quality-payment-program-mips-nprm-slides.pdf. Accessed January 2, 2019.
- Integrating the Healthcare Enterprise Pathology and Laboratory Medicine Technical Framework Supplement: Laboratory Analytical Workflow (LAW). Rev 1.5. Oak Brook, Ill: Integrating the Healthcare Enterprise, 2016. Available at: http://ivdconnectivity.org/wp-content/uploads/delightful-downloads/2016/03/ihe_palm_suppl_law.pdf. Accessed December 31, 2018.
- Meaningful Use: Electronic Laboratory Reporting (ELR) [online]. Atlanta: Centers for Disease Control and Prevention, 2016. Available at: www.cdc.gov/ehrmeaningfuluse/elr.html. Accessed December 31, 2018.
- CLSI begins development of a document on next-generation IVD instrument interface [press release, online]. Wayne, Pa: Clinical and Laboratory Standards Institute, 2015. Available at: https://ivdconnectivity.org/clsi-begins-development-of-a-document-on-next-generation-ivd-instrument-interface. Accessed December 31, 2018.
- Digital Format for Publication of LOINC to Vendor IVD Test Results [online]. San Clemente, Calif: IVD Industry Connectivity Consortium, 2017. Available at: http://ivdconnectivity.org/wp-content/uploads/delightful-downloads/2017/06/iicc_livd_digital_format_2017_06_01_r2.pdf. Accessed January 1, 2019.
- Laboratory Testing Workflow [online]. Oak Brook, Ill: Integrating the Healthcare Enterprise, 2017. Available at: https://wiki.ihe.net/index.php/laboratory_testing_workflow. Accessed January 2, 2019.
- Sharing Laboratory Reports [online]. Oak Brook, Ill: Integrating the Healthcare Enterprise, 2017. Available at: https://wiki.ihe.net/index.php/sharing_laboratory_reports. Accessed January 2, 2019.
- Laboratory Device Automation [online]. Oak Brook, Ill: Integrating the Healthcare Enterprise, 2017. Available at: https://wiki.ihe.net/index.php/laboratory_device_automation. Accessed January 2, 2019.
- Laboratory Barcode Labeling [online]. Oak Brook, Ill: Integrating the Healthcare Enterprise, 2017. Available at: https://wiki.ihe.net/index.php/laboratory_barcode_labeling. Accessed January 2, 2019.
- Laboratory Code Sets Distribution [online]. Oak Brook, Ill: Integrating the Healthcare Enterprise, 2017. Available at: https://wiki.ihe.net/index.php/laboratory_code_sets_distribution. Accessed January 2, 2019.
- Interlaboratory Workflow [online]. Oak Brook, Ill: Integrating the Healthcare Enterprise, 2017. Available at: https://wiki.ihe.net/index.php/inter_laboratory_workflow. Accessed January 2, 2019.
- HL7 Version 2.5.1 Implementation Guide: S&I Framework Laboratory Test Compendium Framework (eDOS). Release 2, Standard for Trial Use 3, US Realm. Ann Arbor, Mich: Health Level Seven International, 2017. Available at: www.hl7.org/documentcenter/public_temp_0aa7864e-1c23-ba17-0c73a66a8941c797/standards/dstu/v2_ig_ltcf_r2_stu_r3_2018jun.pdf. Accessed January 2, 2019.
- HL7 Version 2.5.1 Implementation Guide: Laboratory Orders from EHR (LOI). Release 1, Standard for Trial Use 3, US Realm. Ann Arbor, Mich: Health Level Seven International, 2018. Available at: www.hl7.org/documentcenter/public_temp_09c2a6fb-1c23-ba17-0cdefb3f592ef5d7/standards/dstu/v251_ig_laborders_r1_stu_r3_2018jun.pdf.Accessed January 4, 2019.
- HL7 Version 2.5.1 Implementation Guide: Lab Results Interface (LRI). Release 1, Standard for Trial Use 3, US Realm. Ann Arbor, Mich: Health Level Seven International, 2018. Available at: www.hl7.org/documentcenter/public_temp_0a4bfa12-1c23-ba17-0cd467671ce5589b/standards/dstu/v251_ig_lri_r1_stu3_2018jun.pdf. Accessed January 4, 2019.
- Devices on FHIR [online]. Ann Arbor, Mich: Health Level Seven International, 2018. Available at: http://wiki.hl7.org/index.php?title=Devices_on_FHIR. Accessed January 2, 2019.
- SOLOR and Informatics Architecture [online]. No loc: Healthcare Services Platform Consortium, 2018. Available at: https://healthservices.atlassian.net/wiki/spaces/solor/overview.Accessed January 2, 2019.
- eHealth Network: Refined eHealth European Interoperability Framework. Brussels: eHealth Network, 2015. Available at: https://ec.europa.eu/health/sites/health/files/ehealth/docs/ev_20151123_co03_en.pdf. Accessed January 2, 2019.