MMI 405 HIT Integration, Interoperability & Standards

Information Exchange Case

LOINC is a common language (set of identifiers, names, and codes) for clinical and

laboratory observations. LOINC is a rich catalog of measurements, including laboratory tests,

clinical measures like vital signs and anthropomorphic measures, standardized survey

instruments, and more. LOINC enables the exchange and aggregation of clinical results for care

delivery, outcomes management, and research by providing a set of universal codes and

structured names to unambiguously identify things you can measure or observe (Loinc, 2016) . 1

LOINC provides universal codes and names that provides the global lingua franca for identifying

tests and observations.

According to Levy, B (2015), the average clinician is not aware of LOINC during their

daily work of ordering, receiving, reviewing labs. LOINC can improve and benefit clinical and

laboratory environments alike, beyond what is needed by meaningful use. When we analyze 2

the laboratory data is often derived from any different sources. Lab results can come from

diverse sites using local lab code and then map local codes to LOINC as required to support

meaningful use. Without the mapping, it can be challenging to present all of the patient’s lab

tests in a consistent manner to the clinicians. 3

Clinical diagnostic laboratories come under the oversight of the U.S. Department of

Health and Human Services (HHS) specifically under a provision known as the Clinical

1 Loinc.Org. What LOINC is?. About LOINC. 2016. Retrieved from https://loinc.org/background 2 Levy, B. Why LOINC Promotes Semantic Interoperability ? Wolters Kluwer Health Language Blog. September 2015. Retrieved from http://blog.healthlanguage.com/an-advanced-course-in-loinc-mapping 3 Levy, B. Why LOINC Promotes Semantic Interoperability ? Wolters Kluwer Health Language Blog. September 2015. Retrieved from http://blog.healthlanguage.com/an-advanced-course-in-loinc-mapping

Laboratory Improvement Amendments of 1988. Clinical diagnostic laboratories need to be

certified under CLIA. CLIA’s make sure quality laboratory testing. 4

Clinical labs use a laboratory information system (LIS) that is a software program that

provides the functionality that often include patient check-in, order entry, results entry, patient

demographics, specimen processing, and some level of reporting ability. Due to current

business requirements and meaningful use, LIS requires an ability to interface with the

institution’s electronic medical record (EMR), whether the institution is a physician’s office,

clinic, larger laboratory, hospital or health center. In addition, the LIS needs to interface with the

laboratory’s instrumentation, to allow test results move directly into the database, then to the

electronic medical record. In addition, to the LIS and the EMR we need to consider the personal

health record (PHR), which is a health record controlled and maintained by the patient; HL7,

which is the international group that determines standards for the interoperability of health

information technology; and the instruments interface, which allow laboratory instrument,

whether it is a hematology analyzer or a cytogenetics imaging and karyotyping system to

communicate with the LIS. 5

When we talk about LOIC and interoperability we say that is semantic interoperability.

CPT is used to order lab tests, whereas LOINC is used to report the lab results. CPT-to-LOINC

mapping enables querying whether the patient actually had the lab test that was ordered and if

the right lab test was performed. Some characteristics of LOINC are already familiar to those

4 Terry, M. Transferring Laboratory Data into the Electronic Medical Record. DARK. Daily Laboratory and Pathology News. darkdaily.com 2011. 5 Terry, M. Transferring Laboratory Data into the Electronic Medical Record. DARK. Daily Laboratory and Pathology News. darkdaily.com 2011.

who know SNOMED CT. Work continues to be done to map LOINC to SNOMED CT, to

further enable seamless semantic interoperability (Levy, 2015) . 6

Today clinical diagnostics is complicated because interacts with patients, physicians,

insurers, other laboratories and other healthcare organizations. Laboratories in the U.S needs to

meet CLIA standards and state licensing and inspection. LIS and interoperability have some

challenges such as LIS cost, integration, adapting workflow, laboratory specialities, database

interfaces, instrumentation interfaces, data storage, host interfaces, EMR, PHRs, among others.

Legacy LIS integration make interoperability a big challenge because in earliest

programming languages there was an inability or difficulty in interfacing with modern

instrumentation and more difficult to interface with modern EMRs and/or difficulty to interface

with web browser-based systems. It is important to adapt the laboratory workflows, because

there is no laboratory identical and each has its own unique workflows based on speciality areas.

When having the proper integration, database interfaces, and instrument interfaces the lab

information can be share with other labs and EMRs as well to PHRs. This proper integration can

be through the use of middlewares. According to Levy (2015), “middleware is a type of

software that sits in the middle between software components and applications. This allows

several different processes that run on several machines to communicate and interact across a

network. In the context of clinical diagnostics and clinical laboratories and laboratory

information systems, middleware is “used to connect laboratory information systems (LIS) with

the analyzers that do the actual lab testing. It’s an interface between the two.” Middleware 7

6 Levy, B. Why LOINC Promotes Semantic Interoperability ? Wolters Kluwer Health Language Blog. September 2015. Retrieved from http://blog.healthlanguage.com/an-advanced-course-in-loinc-mapping 7 Terry, M. Transferring Laboratory Data into the Electronic Medical Record: MiddleWare. DARK. Daily Laboratory and Pathology News. darkdaily.com 2011.

common functions include messaging, automation, inspection preparedness/compliance and

quality control.

By the use of interoperability we can distribute laboratory related activities between the

LIS and the EMR systems. LIS runs the laboratory operations, workflow, instrument interfaces,

outreach client interfaces, support for molecular and genetic testing and digital pathology. The

EMR will display results formats, by integrating data from multiple laboratories and at-home

testing, provide decision support at order entry and provide the ability for patient portals. 8

Patient portals are typically not an LIS function. Patients generally want to see the

summary of their health care data, which includes laboratory results, radiology reports,

cardiology reports, and medications and appointments, among others.

The Lab Interoperability Cooperative Final Report (2013), mentioned that the Lab

Interoperability Cooperative has built a strong foundation of resources and expertise. Their

initiative recruited over 1,200 hospital meeting 240% of program objectives, they delivered

terminology education and technical assistance, developed tools, resources, and communications,

and collaborate with public health agencies to provide added value to hospital participants. At

the end, information needs to be shared to improve health outcomes and to let the patient to make

its own health decisions with the right information. Interoperability is key for that so patients

can get their results on time in any place.

8 Sinard, J. H., Castellani, W. J., Wilkerson, M. L., & Henricks, W. H. (2015). Stand-alone laboratory information systems versus laboratory modules incorporated in the electronic health record. Arch Pathol Lab Med, 139(3), 311-318.