Our clinical terminology consulting services at JPSYS cover many facets of Federal healthcare EHR systems. Terminology work includes terminology matching, terminology data models, development of terminology data standards, the curation of data sets and values, maintenance of data sets and many other services.
If you have term mapping needs, we can help with LOINC and SNOMED CT maps. J P Systems offers LOINCing services whether you are an academic medical center, a community hospital, a biotechnology company, research organization, or an IVD vendor. Our subject matter experts are here to help you with LOINC mapping or submissions. Research labs, commercial labs, and IVD vendors are now being held responsible for mapping their testing to LOINC by the FDA. For research labs it is a mandate by 2020, for other it is strongly suggested by the FDA.
The Healthcare Information Technology (HIT) standards development process is the result of a world-wide effort of Standards Development Organizations (SDOs). Many representatives from governments, private corporations, and non-profit organizations meet weekly in SDO work groups to determine the data formats for information exchange. Here the groups reach a consensus on which data values will be associated with specific fields as a standard value set. These values become the standard ones used for transmission in messages sent between healthcare providers, so that all recipients can utilize the data and derive precise meanings. The underlying problem is that the actual bits and bytes in the data files of a given healthcare providers' database files are NOT interoperable with a different hospital system's EHR data files. This is true even if the two hospitals have the same EHR system.
The data values stored in a hospital's EHR data fields are coded in different ways for a given type of data field. For example, for a field such as blood type, one EHR might store a coded number (9253) while others might store text ('O+'). One way to solve this is an expensive study of every single data element in every data file and the creation and validation of maps between the systems. If they want to share data, years of work has to be done. Every time one adds a new exchange partner, years of work has to be done. The solution then is to instead have each hospital or providers' EHR system map to a worldwide common set of data fields and values. Then the data can be sent unambiguously. The international sets of values are referred to as standardized Reference Terminologies. SNOMED CT is one famous and widely used international clinical terminology. LOINC is another terminology used to assign codes for laboratory tests. MED-RT is a new terminology for prescription drugs and is organized by drug names and classes.
LOINC is owned by the Regenstrief Institute is a dynamic, people-centered research organization driven by a mission to connect and innovate for better health. They envision a world where better information empowers people to improve healthcare, and they pursue this vision through research and development.
They report that “Regulated clinical research is carried out and supported across multiple sectors including academic medical centers, biopharmaceutical companies, biotechnology companies, clinical research organizations, federal agencies, information technology vendors and others. The FDA will soon begin requiring the inclusion of a medical laboratory and observation terminology coding system, Logical Observation Identifiers Names and Codes (LOINC®). While this requirement will help align semantics between healthcare and regulated clinical research, readiness for this requirement and understanding of LOINC can vary dramatically across these sectors.
In January 2017, the FDA convened a Committee, including FDA, NIH, CDISC, and Regenstrief Institute, to evaluate the use of terminology standards, with a particular focus on LOINC. The Committee formed a LOINC Working Group to: (1) review the relationship between the CDISC laboratory codes and the Regenstrief LOINC laboratory codes, (2) address the concerns raised by the CDISC community in the 2017 survey, and (3) develop recommendations for the submission of LOINC within the CDISC data exchange format in applications to the FDA.” Source: Regenstrief Institute.