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

2

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

3

CLSI Today

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

distributed

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Vision

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

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Mission

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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