Clinical and Laboratory Standards Institute (CLSI)

March 17, 2005 15:00 ET

Clinical and Laboratory Standards Institute: Integrating a Global Perspective



MARCH 17, 2005 - 15:00 ET

Clinical and Laboratory Standards Institute:
Integrating a Global Perspective

WAYNE, Pa.--(CCNMatthews - Mar 17, 2005) -

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.


Contact Information

    Clinical and Laboratory Standards Institute (CLSI)
    Timothy Roscoe, 610-688-0100 ext 129