Abstract
The National Committee on Clinical Laboratory Standards Executive Advisory Meeting was held in Arlington, Virginia on March 13, 1996. NCCLS President Charles Galanaugh, in his opening remarks, stressed the strategic importance of developing prospective worldwide standards for “interconnected” clinical laboratory automation.
Emery Stephans, President of Enterprise Analysis Corporation and Chairholder of NCCLs' Subcommittee on Data Management, gave a presentation, “The Case for Prospective Standards for Laboratory Automation,” in which he estimated that implementation of standards in clinical laboratory testing could have a positive economic impact in the range of 10%, or $2 billion, per year. Stephans predicted that the standardization effort would require an investment of $1–3 million, and suggested that a time frame of 18 months would be reasonable for developing standards in the first of five standards areas identified by the Clinical Testing Automation Standards Steering Committee (CTASSC). Stephans presented a workflow diagram (Figure 1) that depicts proposed interrelationships between NCCLS, its new Area Committee on Automation, the CTASSC, and the Executive Advisory Group.
Workflow Diagram (courtesy of Enterprise Analysis Corporation)
Dr. Rodney Markin, University of Nebraska and recently appointed Chairholder of NCCLs' new Area Committee on Automation, discussed the “Recommendation of the Clinical Testing Automation Standard Steering Committee and Formation of the NCCLS Area Committee on Automation.” According to Markin, the initial focus areas for standardization will include automated specimen identification, specimen carrier, specimen container, communications between instrument and computer (including error and exception handling), mechanical interface, and system status/ performance information.
In discussions following Markin's presentation, the following were identified as the major problems to be faced in standardizing laboratory automation:
Unique identification of patient specimens
The linkage of specimens to patients
The linkage between laboratory information systems and laboratory automation
The error rate in reading bar codes
Later discussions dealt with the impact of standards and technical considerations in the development of standards. It was noted that innovation is a fundamental issue in industry; therefore, attention should be given to avoiding the potential to “squelch” innovation through standardization. In addition, it was recommended that aspects of laboratory automation that are common and do not inhibit a vendor's differentiation should be identified, Technical considerations deemed to be particularly important include the development of a standardized approach to the processing of information from the sample to the instrument and from the instrument to the laboratory information system, as well as the adoption of a standardized “point-in-space” approach for accessing the sample delivered to the instrument.
In the concluding discussions it was recognized that there is general agreement on the need for prospective standardization in the area of clinical laboratory automation, and that the perceived sense of urgency requires standards development on a relatively fast track.