CLSI Speakers Toolkit

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CLSI Speakers Toolkit

• Slides about CLSI for use as needed in your
  presentation

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(No Transcript)
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History

• Incorporated
• National Committee for Clinical
  Laboratory Standards (NCCLS)
• Name changed
• Clinical and Laboratory Standards
• Institute (CLSI)

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Why Name Change?

• From National to global in scope
• From Committee to Institute
• From Clinical Laboratory to Clinical and
  Laboratory

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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 throughout
  the world, using a consensus-driven process that
  balances the viewpoints of industry, government,
  and the healthcare professions.

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Values

• Excellence
• CLSI strives to continuously improve upon its
  tradition of technical excellence and superior
  quality.
• Responsiveness
• CLSI seeks input and addresses issues important
  to customers, communicating the results in a
  timely manner.

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Values

• Inclusiveness
• CLSI encourages the involvement and association
  of all parties with interest in its programs and
  products.
• Fairness
• CLSI preserves its reputation for integrity,
  trust, and openness by committing to high
  standards of responsibility and objectivity.

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Why Standards Matter

• Raise levels of quality, safety, reliability,
  efficiency and interchangeability
• Lower trade barriers
• Act as a base for legislation (or avoid the need
  for legislation)
• Aid in technology transfer
• Provide easy access to best-in-class practices
• Deliver benefits at an economical cost

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CLSI Scope Reach

• Global with 30 of membership outside North
  America, and increasing
• Comprised of gt2,000 member organizations and gt
  2,000 volunteers
• Produce over 160 voluntary consensus standards,
  primarily in the clinical laboratory areas
• Distribute over 75,000 documents per year

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Members and Volunteers
Diverse representation from

• Industry
• IVD Manufacturers
• LIS Vendors
• Startup Companies
• Suppliers
• Trade Organizations

• Government
• Public Health Agencies
• Regulatory Bodies
• Accrediting Organizations
• others

• Professions
• Professional Societies
• Educational Institutions
• Healthcare Delivery Systems
• Hospitals Laboratories

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Members and Volunteers

• Iran
• Israel
• Italy
• Japan
• Korea
• Mexico
• Netherlands
• PR China

• Geographical reach includes
• Argentina
• Australia
• Belgium
• Brazil
• Bulgaria
• Canada
• France
• Germany
• Hong Kong
• India

• Saudi Arabia
• South Africa
• Spain
• Sweden
• Taiwan
• Trinidad
• Turkey
• United Kingdom
• United States

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The CLSI Consensus Process
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The CLSI Consensus Process

• 22-month model for document creation
• Balance between rapid response and integrity of
  consensus process

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CLSI Area Committees

• Immunology Ligand Assay
• Microbiology
• Molecular Methods
• Point-of-Care Testing
• Quality Systems Laboratory Practices

• Automation Informatics
• Clinical Chemistry Toxicology
• Evaluation Protocols
• Hematology

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CLSI Area Committees

• Identify prioritize projects
• Oversee development review of documents
• Complete final technical review before publishing
  proposed level document
• Submit to Board for approval to publish at
  approved level

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CLSI Products Used Worldwide

• International standards
• Government regulations
• Professional practice
• Translations include
• Japanese
• Portuguese
• Russian
• Spanish
• Turkish
• German

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CLSI Products

• Standards
• Guidelines
• Collections
• Reports
• Videos
• Toolkits
• Electronic products
• ISO documents

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Quality Toolkits

• Streamline development of documents, procedures,
  training assessment
• Support quality management systems
• Procedure Manual Toolkit
• Quality System Toolkit
• Training and Competence Assessment Toolkit

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Communications

• Shop online
• 24x7 access to purchase documents
• Electronic subscription service
• eNews
• Monthly electronic newsletter
• Recently published documents, standards status,
  news, events, exhibits, articles

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Communications (cont.)

• Members-only website
• Membership directory, delegate guidebook,
  membership renewal
• Harmonized terminology database

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Whats New at CLSI

• Cooperative Agreement
• Grant from US Dept. of Health and Human Services,
  Centers for Disease Control (HHS/CDC)
• Funded by Presidents Emergency Relief Plan for
  AIDS Relief (PEPFAR)
• CLSI will provide guidance to improve laboratory
  capacity in nations most affected by HIV/AIDS

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International Organization for Standardization
(ISO)

• ISO Worlds largest developer of standards
• CLSI Secretariat of ISO Technical Committee
  212 Clinical laboratory testing and in vitro
  diagnostic test systems and its working groups

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ISO (cont.)

• ISO provides
• Forum for countries to harmonize standards
• One country, one vote consensus process
• Standards that impact product manufacturing
  address needs of international regulators
• Mechanism to address international commerce
  issues

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ISO vs. CLSI

• Complimentary not conflicting roles
• ISO provides broad standard requirements
• CLSI provides detailed best practices, standards
  and practical guidance for implementation

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How to Get Involved with CLSI?

• Volunteer for a committee
• Propose a project
• Contribute to CLSI eNews
• Co-author an article
• Make a presentation
• Become a member

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Contact CLSI
www.clsi.org
610.688.0100
customerservice_at_clsi.org