CLSI Promotes Global Harmonization of Clinical Laboratory Practices
The Clinical and Laboratory Standards Institute (CLSI) is a
proven leader in the field of laboratory standards and
guidelines-dedicated to developing best practices in clinical and
laboratory testing and promoting their use throughout the world.
CLSI is a volunteer-driven, membership-supported, nonprofit
organization that promotes the development and use of voluntary
standards and guidelines through a unique consensus process that
involves stakeholders from health care professions, government,
education, and industry. CLSI links professionals from around the
world with a common purpose and mission.
Ferruccio Ceriotti, MD, of Diagnostica E Ricerca San Raffaele in
Milan, Italy, an International Federation of Clinical Chemistry and
Laboratory Medicine (IFCC) member and CLSI volunteer, agrees that
the CLSI consensus process is valuable. He says, "I think the
international participation on CLSI committees is important because
it ensures that perspectives that may be different from those of
the United States are represented. CLSI manages the process of
collaboration and consensus quite well, which is reflected in the
excellence of the results."
CLSI documents serve the medical laboratory community in several
ways. The guidelines outline a pathway to standardization of
laboratory practices that serves to improve quality, safety, and
consistency, and at the same time, contains costs. Quality patient
care begins with an accurate lab test, and CLSI documents lay the
foundation for meeting that objective. Laboratory professionals use
CLSI guidelines to meet requirements for regulatory compliance and
accreditation. This is possible because regulatory agencies and
accrediting bodies recognize the value of implementing CLSI
standards and guidelines in establishing best practices that meet
regulatory requirements. In addition, CLSI volunteers participate
in Global Health Partnerships with the goal of improving health
care around the world-specifically in resource-constrained
countries that are bearing a heavy burden of disease.
CLSI documents do more than just serve as instruction manuals
for laboratories; they also provide scientific explanations for
procedures, and connect theory to practice for professionals. They
also help professionals keep current with new technologies in areas
such as molecular methods and point-of-care testing. Graham White,
Associate Professor, SA Pathology, Flinders Medical Centre,
Australia, and a CLSI volunteer, explains, "The regular appearance
of new topics and updated editions of published documents in the
CLSI library highlights the rapid pace of expansion and change
taking place in laboratory medicine. CLSI documents provide theory
and evidence that underpin the practical guidance. In this way,
CLSI documents are not just recipe manuals for the bench, but they
also educate laboratorians with a scientific understanding of the
'why' as well as the 'how.'"
International Focus and Shared Goals
IFCC and CLSI are proud of their nearly decade-long partnership
aimed at promoting global harmonization of clinical laboratory
practices. The partnership has lead to the development of several
consensus standards and guidelines that meet the goals of all CLSI
documents to reflect a global perspective, help to improve the
quality of laboratory results, and ultimately improve patient
care.
The partnership of IFCC and CLSI grew out of the recognition of
shared goals and a mutual focus of interest. IFCC's involvement in
CLSI's projects is one of the many important relationships with
organizations and societies in the health care field that CLSI
supports to ensure that a broad international perspective is
maintained in its products and services. In addition, both
organizations are dedicated to assisting developing countries in
improving analytical results and helping those nations learn about
better and more efficient approaches to clinical chemistry and
laboratory practice.
Graham White notes the growing importance of consistency in
clinical laboratories worldwide, saying, "Increasing mobility of
patients and doctors within and between health care systems, and
expanding use of international clinical guidelines for diagnosing
and managing disease, are increasing the need for clinical
laboratories to provide, for any given test, high quality results
that are comparable over time, regardless of the method and
laboratory used. The collaborations between CLSI and IFCC bring
together the broadest available expertise to generate unified best
practice evidence-based guidelines, procedures, and documents that,
when widely implemented, provide the practical framework for
achieving high quality consistency across routine clinical
laboratories, wherever they are located."
IFCC and CLSI have also partnered with the National Institute of
Standards and Technology (NIST) to sponsor the
IFCC/NIST/CLSI Robert Schaffer Award for Outstanding
Achievements in the Development of Standards for Use in Laboratory
Medicine. Professor Lothar Siekmann, PhD, was selected to
receive the first award, which honors an individual who has made
unique contributions to the advancement of reference methods and/or
reference materials for laboratory medicine. Dr. Siekmann is
Professor of Clinical Chemistry of the Medical Faculty of the
University of Bonn, Germany, and Director of the Reference
Laboratory I of the German Society of Clinical Chemistry
(DGKL).
IFCC/CLSI Documents
There are several joint IFCC/CLSI documents in the CLSI library
that demonstrate the benefits of an international approach to
clinical chemistry. Examples include the following:
C28-A3 - Defining, Establishing, and Verifying Reference
Intervals in the Clinical Laboratory; Approved Guideline-Third
Edition contains guidelines for determining reference values
and reference intervals for quantitative clinical laboratory
tests.
C49-A - Analysis of Body Fluids in Clinical Chemistry;
Approved Guideline provides guidance for the application of
widely available measurement procedures for testing body fluids and
for reporting and interpreting those results.
X05-R - Metrological Traceability and Its Implementation; A
Report provides guidance to manufacturers for establishing and
reporting metrological traceability.
EP17-A - Protocols for Determination of Limits of Detection
and Limits of Quantitation; Approved Guideline
provides guidance for determining the lower limit of detection of
clinical laboratory methods, for verifying claimed limits, and for
the proper use and interpretation of the limits.
This is just a partial list of the types of useful projects that
IFCC and CLSI have produced.
Become a Member of CLSI
There are many ways to become a part of the CLSI membership
community. CLSI has several membership options to meet the needs of
organizations, professional societies, and associations. CLSI
members consist of organizations rather than individual members.
Membership in CLSI ensures that members' needs are addressed in the
standards and guidelines they use daily. Additionally, membership
provides the opportunity to network with representatives from
government, industry, and the health care professions, as well as
colleagues in related disciplines while working collaboratively to
develop solutions to relevant issues. Membership dues help support
standards and guidelines that directly impact the delivery of
quality patient care. All members receive a savings of up to 50% on
standards and guidelines.
Volunteering with CLSI is a way to join the more than 2, 000
experts from around the world involved in the development of
documents using the consensus process. Graham White believes his
time as a CLSI volunteer has been rewarding, adding, "The value of
an individual's expertise can remain local unless harnessed and
made available to the global clinical laboratory community, and
major enablers of this are professional societies such as CLSI and
IFCC. By offering volunteers many opportunities to contribute their
expertise in participating in the development and/or revision of
consensus standards and guidelines, commenting on draft documents,
participating in presentations on implementation of best laboratory
practices, and in many other ways, laboratorians can significantly
contribute to the advancement of their professional discipline and
the improvement of global health."
Visit www.clsi.org for more information about
membership and to learn more about the more than 200 products
offered by CLSI.