Clinical and Laboratory Standards Institute: Integrating a Global Perspective
Clinical and Laboratory Standards Institute (CLSI) develops consensus standards that serve the needs of industry, government, and the professions, and advance quality in health care worldwide. Through the work of our volunteer experts, our organization develops and harmonizes standards that respond to the specific needs of medical communities around the world.
By integrating a number of strategies into its global organization, CLSI makes the notion of cooperation and harmonization throughout the global healthcare field a reality. Membership is open to any organization regardless of geographic location. Seven percent of CLSI’s 180 active member organizations, and nearly one quarter of its 1500 corresponding and associate active members, are from outside the U.S. As CLSI’s membership base grows, the organization continues to develop its global presence in the healthcare community.
Healthcare professionals around the world rely on CLSI’s best practices to carry out their responsibilities with efficiency, effectiveness, and the reassurance of global acceptance. CLSI embodies a vast international network of organizational partnerships designed to cultivate harmonized global standards. The consensus documents it produces are purchased and used in over 77 countries around the world. CLSI’s unique cross-cultural consensus process maximizes available resources in addressing standardization issues, promotes new cooperative ventures, and inherently ensures that CLSI products meet the diverse needs of the global medical community.
CLSI’s organizational objective is to promote quality and best practices for laboratories and healthcare services. Recent efforts to inject this overarching goal with a global perspective include:
— Revision of the CLSI Quality Management Systems documents: A Quality Management System Model for Health Care (HS1-A2); Application of a Quality Management System Model for Laboratory Services (GP26-A3); and Continuous Quality Improvement: Integrating Five Key Quality System Components (GP22-A2) to be harmonized with ISO 15189 Medical laboratories – Particular requirements for quality and competence, ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories, and other identified standards
— Active recruitment and appointment of global participants on standards-developing committees
— Identification and cataloging of International Organization for Standardization (ISO) and other international standards on a cross-reference matrix, to serve as a resource for CLSI subcommittees in harmonizing terminology and methodology
— Implementation of processes to update and expand the Harmonized Terminology Database to be in parallel with the ISO, European Committee for Standardization (CEN), and CLSI/NCCLS documents
— Effective management of the ISO/TC 212 consensus process
— Formation of a Task Group on Resource-Limited Laboratories with defined goals to: simplify relevant CLSI documents; develop basic work instruction documents; develop educational programs to accompany the documents; and partner with organizations and donor agencies
— Designation of a specific representative to identify harmonization issues during document development
This is just a sampling of the broad array of global program initiatives underway to diversify input and reduce barriers in the development of CLSI’s global standards. By evolving from the National Committee for Clinical Laboratory Standards (NCCLS) into Clinical and Laboratory Standards Institute, CLSI has adopted an organizational name which better reflects not only its worldwide membership base, but also its true strengths and the scope of its work. By removing “national” from its name, CLSI renews what has already been a longstanding commitment to international cooperation and harmonization. Having freshly established its global identity, CLSI looks forward to new opportunities to develop and disseminate high quality resources, products, and services more effectively around the world in the years to come.
