LABORATORY SERVICES ARE so closely linked with patient care that any hope for a computer-based patient record (CPR) system must tie the two systems tightly together. Arden Forrey’s colleagues in clinical chemistry don’t think that most clinical laboratory information management systems (CLIMS) do a very good job of receiving clinical orders for laboratory services--and most of that he attributes to a lack of standards. A biochemist and representative of the American Association for Clinical Chemistry (AACC) in standards, Forrey, PhD, research associate in the School of Dentistry at the University of Washington in Seattle, is an active member of the standards community. In the absence of standardized vocabularies, even Health Level Seven (HL7) interfaces for the CLIMS tend to be individual, he notes, particularly for procedure-associated test directories.
A fairly new universal code system, The Logical Observation Identifier Names and Codes (LOINC) can cut through the problems of variables associated with clinical observations. LOINC does not stand alone. It provides standard codes and nomenclature to identify laboratory and clinical terms and can be used in ASTM E1238, HL7, DICOM and CEN TC251 observation report messages for data transmissions. Adoption of LOINC codes is a giant step in providing a common context for clinical and laboratory variables. Moreover, its developers are committed to universal adoption. The LOINC database is freely available for download, as is the Regenstrief LOINC Mapping Assistant program tool for mapping local names and codes to the universal LOINC codes database. (See http://www.mcis.duke.edu/standards/termcode/loinc.htm)
In addition to results reporting, work is also under way on laboratory automation standards. Efforts of the American Society for Testing and Materials (ASTM) for CLIMS components and instrument interfacing and communications are complemented by the National Committee for Clinical Laboratory Standards (NCCLS) of Wayne, Pa. Joint efforts between the two organizations also are tackling problems of specimen bar coding, messaging and instrument control.
Good news/bad news
The vision is in place. The ASTM E31.13 draft document, "Coordination of Laboratory Services in a CPR Environment and Networked Architecture," provides a global view but "much remains to be done for interoperable solutions," says Forrey. Work groups within ASTM are in the process of reviewing clinical views with corresponding clinical laboratory subviews in four specialty areas--emergency medicine, diabetes, obstetrics and gynecology/prenatal, and occupational health. And a coordinated effort from CORBAmed, HL7 and ASTM is focusing on the master patient index--a core function for all activities.
More good news for laboratory standards comes via the Arden Syntax for Medical Logic Modules, now under the HL7 umbrella. A language for encoding medical information, this standard for writing clinical reminders, alerts, interpretations and diagnoses is expected to define knowledge-based conventions needed by laboratory systems as well as for other clinical information systems. However, the bad news is that few laboratory systems currently support the standard. Furthermore, few laboratorians understand the interoperation of CLIMS and CPR domains. Both developmental and educational efforts loom.
The complexity of clinical and laboratory data as well as that of data collection, generation and transmission pathways to, from and within the laboratory present unique standardization challenges. Reference laboratories--early to confront many of the issues surrounding results reporting--have been leaders in the adoption of standards. And LOINC developers have made a major barrier surmountable.
Charlene Marietti is senior technology writer at Healthcare Informatics.