NCCLS: Standardization in Clinical Laboratory Automation and Information Systems

The need for standardization in the field of clinical laboratory automation and information systems has been generally agreed upon by those in the laboratory industry. NCCLS, following a request by the Clinical Testing Automation Standards Steering Committee (CTASSC) in November 1995, agreed to coordinate the development of automation standards through its unique voluntary consensus process. NCCLS is an accredited standards-development organization and is the world leader in developing standards and guidelines for the medical healthcare and science community. NCCLS formed an Area Committee on Automation to manage the standards-development program. The area committee is chaired by Rodney S. Markin, M.D., Ph.D., of the University of Nebraska Medical Center. Paul J. Mountain, M.Sc., M.T. (ASCP), of MDS Laboratories, is the area committee's vice chairholder. There are currently five specific standardization projects in development with subcommittee chairholders that were nominated and approved by the area committee.

Subcommittees

Specimen Container/ Specimen Carrier

Specimen Identification

Communications with Automated Systems

Electromechanical Interfaces

System Status

Chairholders

Paul Orsulak, Ph.D., VA Medical Center, Dallas

David Chou, M.D., Univ. of Washington Medical Center

Charles Hawker, Ph.D., ARUP Laboratories

Richard McPherson, M.D., Medical College of Virginia Hospital

Russell Tomar, M.D., University of Wisconsin Hospitals & Clinics

The intent of this program is to create a body of standards and guidelines to assure the interconnectivity of instrumentation in a way that enhances innovation and encourages design commitment. These standards are intended to address essential requirements of interconnectivity and to allow manufacturers and suppliers to develop interconnected systems. Project development includes a broad participation of providers (integrated networks, hospitals, commercial laboratories, professionals), suppliers (systems, instruments, reagents, supplies, and laboratory information systems), and government on a worldwide scale.

Scope of Projects in Development:

• Specimen Container/Specimen Carrier-To establish standard designs of the specimen container and its carrier that function optimally in laboratory automation systems (LAS), and facilitate compatibility of sample carrier design with specimen containers.

• Specimen Identification-This project is intended to assure that specimen identification is useful in automated systems.

• Communications with Automated Systems-This project focuses on communication of data between systems.

• Electromechanical Interfaces-Define a standard compatible connection between instruments and automated technology to create an automated laboratory environment that functions optimally for the individual laboratory.

• System Status-To define information needs of automated systems in order to provide continuous uninterrupted operation with appropriate human intervention.

Laboratory Automation Development Fund NCCLS is pursuing a fast-track approach to take the in vitro diagnostic sector from project initiation to achieving consensus on the standards. A budget has been developed to identify the commitment and resources needed to complete the projects. NCCLS established a funding mechanism to obtain financial commitments from a broad spectrum of organizations and created a ‘Designated Development Fund’ to manage the contributions received. These projects have been strongly supported, in public forums, by leading representatives of NCCLS member and nonmember organizations in all constituencies. This effort provides an opportunity for executive leaders of these organizations to verify their level of interest and priority by commitment of funds.

NCCLS Meetings Meeting of the five subcommittees of the Area Committee on Automation have been scheduled on Saturday and Sunday, 1–2 August 1998.

These meetings will be held in conjunction with the American Association for Clinical Chemistry (AACC)/American Society for Clinical Laboratory Science (ASCLS) Annual Meetings and Clinical Laboratory Exposition in Chicago.

The purpose of these meetings will be to discuss all voting comments received on the respective subcommittee draft documents during subcommittee vote and prepare the documents for the area committee voting period. The objective will be to publish Proposed Level Documents for distribution and broad review within the NCCLS consensus process by the 4^th quarter of 1998.

The NCCLS Area Committee on Automation and its five subcommittees have held meetings in conjunction with the Association for Laboratory Automation's (ALA) LabAutomation'98, The 1^st Cherry Blossom Symposium (Kochi, Japan), and the Annual Meeting of the Clinical Laboratory Management Association (CLMA).

The area committee will report on the status of the laboratory automation standardization efforts at EuroLabAutomation'98 to be held in Oxford, England in September 1998. For further information, please contact Marc R. Schlank, M.T. (ASCP), M.S. at the NCCLS Executive Offices (610.688.0100 times123, [e-mail]). Mr. Schlank is an Assistant Standards Administrator responsible for managing the Area Committee on Automation's efforts through the NCCLS's consensus process and providing support for the standards committees and volunteers.

Also, please visit the NCCLS website at http://www.nccls.org