American Association for Clinical Chemistry
Better health through laboratory medicine
March 2000
The Way Forward! 1999-2000
Arden W Forrey PhD
Chair, Standards Working Group LISMI Division

Informatics Initiatives

The NACB Meeting on "The Laboratory and the Modern Electronic Medical Record - Issues and Opportunities" 15-16 September 2000 in Philadelphia is one forum in which Division members have participated in organizing and which the Division will make effort to publicize. The importance of the clinical laboratory to healthcare was demonstrated by the recent presentation, in June 1999, to the ANSI Healthcare Informatics Standards Board (ANSI HISB), and subsequently repeated at the LISMI Division Annual meeting during the AACC's Annual meeting in New Orleans in July, of request by the Laboratory Healthcare Partnership, of which AACC is a member, to HISB for a set of informatics standards that would help document the value of clinical laboratory testing to healthcare. The original observations for such documentation will come from the Electronic Health Record (EHR) and must be translated into measures of improved health status of individuals as a result of laboratory services. Such measures must have a valid methodologic basis that uses the recorded observation from the EHR. One of the topics included in the NACB program will develop how the EHR observations can be identified, transformed into scale free measures of both status and conditioned for use in either individual clinical decision support views or population-based clinical/health services research measures of person health status for correlation with clinical laboratory services related data. Briefly, ASTM Technical Committee E-31 has in advanced draft a "Standard Practice for Rating Scale Measures Related to the Electronic Health Record". It is to be coordinated with another "Standard Practice for Conducting Interlaboratory Studies to Determine the Precision of Psychosocial Test Methods", now also in draft. Those interested in these topics should contact Dr. William P Fisher ( Dept. of Biometry LSU Medical Center 1901 Perdido St New Orleans LA 70112 where these methods are now being used within programs at that institution.

At the 6-12 May 2000 Toward an Electronic Patient Record (TEPR) Conference in San Francisco CA, during the Laboratory Track, a number of topics will be presented that relate to definition and implementation of "Domain Information Models" in health care that involve the clinical laboratory. These models bring together the clinical care and resource management ("business") perspectives to the information relevant to the laboratory. As introduced at the 1999 TEPR, the concept of a Clinical Laboratory Domain Information Model (CLDIM) will be explored in terms of definition, implementation approaches and techniques, education of healthcare professional disciplines, and research and analysis. This track will complement other tracks on the uses and the implementation considerations of the EHR which will be organized by ASTM E-31 Technical Committee on Health Informatics and the American Health Information Management Association. The laboratory implications of these topics will be coordinated with the American Health Information Management Association (AHIMA) by the AACC LISMI Division and will complement the planned events at the AACC Annual Meeting 2000, also in San Francisco, in July and the NACB meeting on the EHR in September. Moreover, these forums will also complement the work of the AACC Point-of-Care Testing Division and its associated Open Industry Consortium directed at Point-of-Care Connectivity.

Other important currents include an international ASTM E-31.25, HL7, CEN meeting on XML access techniques for implementation of access to the EHR and to Clinical Laboratory Information Management Systems (CLIMS), which was held in concert with the Massachusetts Medical Society 4-5 October 1999 in Waltham MA. These access methods will enable network (internet, intranet) access to not only Point-of-Care but also to distributed and automated laboratory testing settings and the integration of EHR data with that from measurement devices. ASTM Technical Subcommittee E-31.25 on XML, together with E31.13 on CLIMS and E-31.14 on Instrument, Computer Interfacing, have now in draft form a complementary new standard on tag-value (XML) methods for exchange of clinical laboratory data; This standard, through standards coordination via ANSI Health Informatics Standards Board (ANSI HISB) and these ASTM E-31 efforts, will complement the existing US National (HL7, X12N) messaging standards efforts and the International (ISO TC-215 WG2) work. The tag-value messaging standards work (ASTM, HL7) will strengthen the Domain Information Model that has in advanced draft in ASTM E-31.13 a "Guide for Coordination of Clinical Laboratory Services in an Electronic Health Record Environment and Networked Architecture" which will help bring together all of the pieces that must be considered in assembling an integrated Enterprise Architecture. Those interested should contact ASTM E-31 Staff Manager Teresa Cendrowska either by phone (610-832-9718) or by e-mail

All of these efforts will complement the efforts of NCCLS, which is also an ANSI HISB Standards Developer Organization (SDO) member, that include: 1) The Laboratory Automation Initiative with its five new provisional documents; 2) TC-212 Secretariat and its Working Group 2 on Measurement Traceability; 3) The POCT Working Group. The AACC LISMI Division will be working with NCCLS and the other HISB SDOs to forge aggressive coordination of US National Healthcare Informatics Standards in support of the clinical laboratory roles through the primary representation of AACC on the HISB by Dr. Jay Jones (Penn State Geisinger Health Systems in Danville PA) through the LISMI Division.

The Division has for 15 years been active in promoting and developing not only the healthcare informatics standards that currently exist but also the posture for national and international collaboration in the education of clinical laboratorians about these subjects. The Division is pursuing publication of collected articles on data issues from the American Clinical Laboratory and a possible compendium of ASTM standards relevant to the clinical laboratory as two mechanisms for getting information about this area into the hands of the working laboratorian. Further forums are being discussed with the Software Engineering disciplines regarding best recommended implementation practices for developing verified quality software products and services for support of the clinical laboratory. These publications and forums will be the subject of additional newsletters.