American Association for Clinical Chemistry
Better health through laboratory medicine
September 2000
From the Gates of Troy: Rising to the Challenge!
Arden W. Forrey PhD
Chair Standards Working Group LISMI Division

During the past several years in this newsletter I have referred to our informatics situation in the Clinical Laboratory metaphorically using The Gates of Troy as the paradigm which I continue in this Newsletter. This allegory of the traditional role of the clinical laboratorian facing a new future is quite analogous to the situation of Troy which was fighting to retain its status against the new waves of migration that were populating Europe of that time. Recently, the National Committee on Vital and Health Statistics has issued a "Report on the Uniform Data Standards for Patient Medical Record Information" , released 6 July 2000 (http://ncvhs.hhs.gov/hipaa000706.pdf) which emphatically makes the point that "the lack of complete and comprehensive PMRI Standards is a major constraint on the ability of our healthcare system to enhance quality, improve productivity, manage costs and safeguard data". The AACC has been active in the areas of both clinical laboratory and Electronic Health Record (EHR) Standards since the formation of the LISMI Division in 1984. Since the LISMID began its initiative, a number of key standards have been created and are available that deal with both of these areas of interest. By the time that you read this Newsletter item, the joint LISMID meeting with the NACB on the EHR and the Lab will have taken place where the current status of issues regarding the role of the clinical laboratory in the EHR domain will have been outlined. The real work will then begin. The existence of Standards (Common Conventions) for the EHR and the lab only sets the stage for the work in getting the large proportion of healthcare practitioner disciplines of all specializations to master the skills regarding the information that we produce in the clinical laboratory and provide for the care practitioners to use in their interactions with patients. The value of this information, and the skills needed to produce and manage it, has clearly been unappreciated in the healthcare sector judging from the state of the job market for clinical laboratorians. Only education in the information framework that supports healthcare and the contribution of Information and Communication Technology (ICT in the vernacular) to managing the amount and complexity of that information now needed to conduct healthcare can make major progress in solving the application aspect of the problem. While development of new standards must accelerate, the educational programs in the meaning of all of this must increase by an order of magnitude as these programs are now losing in the tailchase of application activities, thus resulting in the dismal state of affairs noted in the NCVHS report. More on the history, definition, participants, events and links relating to the EHR and its potential impacts for the clinical lab can be found in the Web site http://www.ehrweb.org in which the LISMI Division is collaborating in order to create an informational resource to help laboratorians appreciate the scope and impact of what has been done, what is needed and what is yet to be achieved.

With regard to standards development, two ASTM E-31.13 Subcommittee on Clinical Laboratory Information Management standards are moving forward. First, a new standard "Coordination of Clinical Laboratory Services in an Electronic Health Record Environment and Networked Architecture" is just finishing the ballot process and should receive final approval shortly. A revision of the Standard Guide for Requirements for Clinical Laboratory Information Management Systems (CLIMS) E-1639 has been sent to Subcommittee ballot; it contains new model graphics and tables for the Clinical Laboratory Information Domain, particularly that in common with the demographic segments of the Electronic Health Record. This EHR standard, E-1715 Standard Practice for "An Object-Oriented Model for Registration, Admitting, Discharge and Transfer (RADT) Functions in Electronic Health Record Systems", is an anchor point for the EHR that is the source and destination domain for messaging activity in system architectures. Thus, commonality with the conceptual objects used in the CLIMS sets the stage for interoperability of the clinical laboratory and EHR in clinical decision support functions that are described in the new standard. These concepts then must be included in the education of healthcare professionals.

Toward the educational end I have prepared a proposal to the Division Chair for formation of a Project Team to collaborate with the Engineering Professional Disciplines in drawing on their Software Engineering Body of Knowledge (SWEBOK) project, now two years underway towards creating a Guide to this engineering core body of knowledge ( see: http://www.swebok.org), to help create a corresponding Guide for healthcare. This engineering Guide document will provide part of the core knowledge areas needed by Health Informatics in joining the health conceptual content with the principles of implementation of that content in order to create a Guide for Healthcare Informatics. The Clinical Laboratorians will work to assemble the Clinical Laboratory View of both of those domains in Health Informatics that will help lead to a complete Guide to the Health Informatics Body Of Knowledge (HIBOK). Such a Guide will represent consensus resource about the dimensions of ICT applied to healthcare in a way such that the various educational programs can organize curricula in this subject to fit their needs in teaching how the various disciplines can achieve mastery of these skills and knowledge in support of that discipline. The NCVHS report clearly highlights the responsibility of the healthcare disciplines to do this.

Thus AACC LISMI Division, in concert with other AACC Divisions and the NACB will also be moving forward to discharge this educational responsibility and to tell not only our profession but also the NCVHS what we are doing, why we are doing it and what the benefits to healthcare will be because of it. But the education must also extend to the industrial community in order to ensure that the Suppliers of information products and services clearly understand the demand that the specialty Acquirers will be making of them as they gain increasing mastery of these skills and knowledge. To that end we in the LISMID will be preparing, hopefully in concert with the AACC Industry Division, and other AACC Divisions, a variety of common forums that will give industry a clear vision of the needed capabilities of informatics products and services so that Industry has a clear picture that it can use in developing the needed informatics products and services that have these capabilities. The message about the need for synergism between the professions and Industry was clear in the NCVHS report and it has also been clear for sometime in the ANSI Health Informatics Standards Board's draft Strategic Plan as well as in the various articles and comments in current trade magazines. The effort to produce these forums will be part of the profession's response to that challenge and it will need to involve many individuals.

Those interested in helping shape either the Industry forums or participating in the HIBOK definition can contact me at forraw@u.washington.edu.