Standards
The Standards Working Group of the the Association for Diagnostics & Laboratory Medicine (formerly AACC) LISMI Division was formed in 1984 to first coordinate voluntary consensus standards projects relating to the clinical laboratory. ASTM Technical Committee E-31 produced ASTM E-1238 “Standard Specification For Exchanging Clinical Laboratory Observations between Independent Computer Systems” (now NCCLS LIS-5A) which was later expanded to include Clinical Observations. That standard became a basis for HL7's message formats through agreements between ASTM and HL7. In 1986, as a result of discussions at the the Association for Diagnostics & Laboratory Medicine (ADLM) Annual Meeting, ASTM Subcommittee E-31.14 on Instrument and Computer Interfacing was formed. It developed two standards: ASTM E-1381 “Standard Specification for the Low-level Protocol for Transfer messages Between Clinical Laboratory Instruments and Computer Systems” (Now NCCLS LIS 1A) and E-1394 Standard Specitifcation for Transferring Informtion between Clinical Instruments and Compter Systems (Now NCCLS LIS-2A) for the message format based upon E-1238. The original E-31 standard was E-792 “Standard Guide for Selection of a Clinical Laboratory Information Management System (CLIMS)” (now NCCLS LIS-3A) and it has been revised several times to reflect information systems Life Cycle Processes. In 1995, a “Standard Guide for the Functional Requirements for Clinical Laboratory Information Management Systems (ASTM E-1639 now NCCLS LIS-8A) was completed, has been revised several time prior to transfer to NCCLS.
In the 1980s the LISMID Standards Working Group began work on what became ASTM Specification E-1712 for Representing Clinical Laboratory Procedure and Analyte Names which is now the basis for the Logical Observation Identifier Names and Codes (LOINC) project and database; this document was withdrawn in 2002 after the LOINC Project took over responsibility for the terminology. The Laboratory LOINC vocabulary has been designated one of the federal CHI Initiative standard vocabularies. The LOINC project has ADLM participation.
In 1989 an ASTM E-31.13 subcommittee project began on a standard bar-code for clinical laboratory specimen tubes and ASTM E-1466 “Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory” (now NCCLS LIS-7A) was completed in 1991 with continuing interest by the ADLM LISMI Division. The NCCLS AUTO-2A by its Area Committee on Automation and Informatics has emerged as a child of that work and the two standards will likely be combined. In addition the recent work on the NCCLS AUTO 7A “Content of Data for Specimen Identification” will augment these two earlier standards.
The standards for integrating the clinical laboratory information domain with that of the Electronic Health Record (EHR) into an interoperable domain have led to the ASTM E-2118 “Standard Guide "Coordination of Clinical Laboratory Services in an Electronic Health Record Environment and Networked Architectures" (now NCCLS LIS-9A). The Enterprise Information Architecture Planning concepts in that standard that are now being pursued by both commercial enterprises as well as the federal government will be actively addressed with respect to the clinical laboratory by the ADLM LISMI Division as part of ADLM’s Strategic Plan to also be consistent with the ANSI HISB Strategic Plan. These efforts will enable the integration of the “Connectivity” standards (NCCLS AUTO-6A/POCT-1A) that resulted from the industry driven “Connectivity Industry Consortium” that delivered this standard in the 1999-2001 time frame. It was clear that instrument connectivity needed to be clearly understood from an enterprise context but that standards effort consciously limited its efforts to the technical connectivity tasks. These now need to be placed in the broader context and LISMID will work with other ADLM Divisions to produce that documentation.
In addressing the full aspects of implementation, the LISMI Division will be working with the IEEE Computer Society to define the applications of ISO and IEEE standards on Life Cycle processes directed at best-recommended practices for engineering quality software for the clinical laboratory. These efforts are part of the coordination of IEEE standards with those of the ANSI Health Informatics Standards Board (ANSI HISB), of which ADLM is a voting member.
Recent standards work is directed at the application of Extended Markup Language (XML) to the content of existing messages (HIPAA, HL7, DISA X12, NCCLS) as part of a rich formal and semantically exact notation for conveying information among health information domains/sub-domainds in order to build clinical decision support capabilities. This work will need to involve standards input from not only ADLM LISMI but also other specialty Divisions.
Education
In order to address the informatics professional competency issues resulting from the Institute of Medicine’s “Health Professions Education: A Bridge to Quality” 2003 report, an LISMI Education Work Group is being formed to participate in the general professional education and competency oversight activities that ADLM will be engaged in as part of its new Strategic Plan. This may involve participation in the general effort to document a “Guide to the Health Informatics Body of Knowledge” with a directed project to formulate those concepts relevant to the clinical laboratory. These concepts will then become the basis for future ADLM LISMI Division education programs for the full ADLM membership. Contact LISMI Division Chair to participate in this Division Working Group.
Liaison
Working groups of LISMI Division members who are active in other Divisions are being formed to link the content areas of each of these Divisions to the information services that support those clinical laboratory specialty perspectives. Of particular interest is an Industry Working Group. Contact LISMI Division Chair.