Clinical and laboratory standards institute addressing

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Clinical and Laboratory Standards Institute: Addressing POCT Needs; The Good, The

Bad, and The Risky

Marcy Anderson MS, MT(ASCP) Director, Education

3 Rivers POCT Network June 7, 2012

Today's Presentation

? Discuss who CLSI is by providing background, membership, and document information.

? Define the relationship CLSI has with the ISO, the College of American Pathologists, and The Joint Commission.

? Outline POCT growth for the past 20 years, and provide insight on POCT futures.

? Detail CLSI POCT documents and products how they can meet the many POCT needs.

? Discuss the new EP23 document on risk management


CLSI Background

? Established in 1968 ? Nonprofit corporation based in the United

States ? Accredited standards developing

organization ? Volunteer-driven through our governance

? Structure and technical operations ? An organization of organizations

? No individual memberships


CLSI Today

? 45 employees ? 2000 member organizations ? Nearly 2300 active volunteers ? Consensus standards and guidelines ? > 75 000 documents each year




To be the leader in clinical and laboratory standards to improve the quality of medical care.



To develop best practices in clinical and laboratory testing and promote their use throughout the world,

using a consensus-driven process that balances the viewpoints of industry, government, and the

health care professions.


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