In July 2010, the Department of Health and Human Services released the final regulation defining “meaningful use” of electronic health records (EHRs) based on which clinicians and hospitals can qualify for incentive payments authorized by the Health Information Technology for Economic and Clinical Health Act (HITECH). The regulation, which goes into effect in January 2011, portends a change in the way clinical labs consider connectivity and their role in healthcare.
To understand the relationship between connectivity and meaningful use, be aware that the incentive payments are tied not merely to adoption of EHRs but also the more significant goal of improving the healthcare process and patient outcomes. Toward this end, the regulation defines a “menu set” of 10 objectives, out of which a provider must select five to implement by 2011-2012 to qualify. The menu-set objective (to “incorporate clinical laboratory results into EHRs as structured data”) and the corresponding measurement (“more than 40% of clinical laboratory test results where results in positive/negative or numerical format are incorporated into EHRs as structured data”) open the door for a more complete integration of clinical diagnostics into patient care. This challenges clinical labs to build the long-awaited bridge between the lab and the clinician, which will allow labs to fully participate in day-to-day patient management.
The flow of information depends on common languages and unified communication protocols. In the U.S., the use of Health Level Seven International (HL7), a data protocol/connectivity standard used throughout the world, is required for an EHR to be certified under HITECH. Thus, HL7 is a central component of health information technology (IT) in the U.S. In fact, HL7 has been adopted widely throughout the health system — but not in the clinical lab.
In the clinical lab, the American Society for Testing and Materials (ASTM) standard established almost 30 years ago dominates instrument interfaces and is the prevailing data protocol today. ASTM interfaces serve the lab well but do not integrate with the rest of healthcare, which is converging toward HL7. This means lab results stand on their own and are difficult to integrate with other patient information (e.g., vital signs and medication lists). It is estimated that fewer than 40% of currently installed clinical lab instruments use the HL7 standard. With no connectivity standard, interfacing instruments and data systems from different vendors is difficult and costly, and can be prone to errors and gaps in information.
The task of integrating discrete pieces of information about the patient’s status falls largely on the physician at the point of care. The lack of a two-way flow of information between the lab and the EHR makes it difficult for clinicians to access critical patient information provided by the lab, and it deters labs from putting test results in context to help guide interpretation or to follow up on abnormal or unexpected values.
To address the need for standardization, the IVD Industry Connectivity Consortium (IICC) was founded in 2008 to create and encourage the adoption of a unified connectivity standard, with the goal of reducing the cost and variability of data exchange between IVD devices and health IT. IICC member organizations include major instrument manufacturers and software vendors with the support of the clinical lab community. IICC announced in March 2010 the selection of HL7 2.x as the baseline standard for next-generation laboratory connectivity.
Importantly, HL7 is not only the de facto standard in healthcare, it also supports logical observation identifiers names and codes (LOINC), a database to facilitate exchange and pooling of results for clinical care, outcomes management, and research within the context of existing HL7. The laboratory portion of LOINC contains categories such as chemistry, hematology, serology, and microbiology, as well as categories for drugs, cell counts, and antibiotic susceptibilities. The clinical portion includes entries for vital signs, hemodynamics, intake/output, and EKG, as well as imaging data, survey instruments, and clinical observations. Not surprisingly, major healthcare systems, reference labs, and public-health entities have embraced LOINC.
To build the bridge between the lab and the rest of the health system, clinical labs must educate themselves and become IT-conversant. As IT continues to expand its role in healthcare, today’s clinical lab professionals must go beyond biology and chemistry to embrace IT rather than relegate IT to the specialists. And they must reach out beyond the lab — to the pharmacy, imaging, and clinical departments — to take ownership and leadership in developing a patient-centric IT infrastructure. Doing so will elevate clinical diagnostics’ status in healthcare. The converse will paint labs further into a corner, where their output will be nothing more than discrete analytical results that the rest of the healthcare system must find ways to interpret. And as clinicians increasingly look to the lab for more real-time information and decision support, labs will need to use standard HL7 messaging to be “interoperable” with other departments and the EHR. Labs should begin demanding that manufacturers and software vendors accelerate the migration toward HL7, which they can do by supporting and participating in groups such as IICC (http://ivdconnectivity.org). In doing so, clinical diagnostic professionals will become a more effective voice for patients and a more direct contributor to improved healthcare efficiency and outcomes.
Jay B. Jones, PhD, D(ABCC), is director of the Chemistry and Regional Labs Division of Laboratory Medicine at Geisinger Health System, Danville, PA. He is a board member and chair of the Provider Review Committee of the IVD Industry Connectivity Consortium.
