Area Committee Orientation Program

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Area Committee Orientation Program
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Clinical and Laboratory Standards Institute
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History

• Established in 1967
• 31 clinicians and laboratory scientists
  representing 15 organizations

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Our New Name
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Contribution to Health Care

• Development and dissemination of consensus
  documents
• Unique consensus process

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What is our mission?
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What is our structure?
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Organizational Chart
Executive Offices
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Standards Development Organizations
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Clinical and Laboratory Standards Institute

• Accredited developer of global voluntary
  consensus standards
• ANSI-accredited
• Secretariat for ISO/TC 212
• Secretary for U.S. Technical Advisory Groups for
  ISO/TC 212 and ISO/TC 76

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American National Standards Institute (ANSI)

• Founded in 1918
• Private, non-profit organization 501(c)(3) that
  administers and coordinates the U.S. voluntary
  standardization and conformity assessment system
• Comprised of approximately 1000 company,
  organization, government agency, institutional
  and international members

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International Organization for Standardization
(ISO)

• Established in 1947
• Non-governmental organization
• Worldwide federation of national standards bodies
  from more than 140 countries

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Why Standards?
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Why Standards Matter

• Raise levels of quality, safety, reliability,
  efficiency and interchangeability
• Lower trade barriers
• Base for legislation
• Aid in technology transfer
• Safeguard Provide such benefits at an economical
  cost

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Voluntary Standards

• U.S. participation
• Global participation

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CLSIs Approach to Standards Development

• Voluntary Consensus

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Voluntary Consensus

• Facilitates the inter-relationships
• Substantial agreement (not necessarily unanimous)
• All relevant objections considered

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The Area Committee

• CLSIs Consensus Body

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General Information

• Balanced membership
• Serves as a management group
• Oversight of subcommittees

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Composition and Size

• 6 to 8 members, plus the chairholder
• Balanced membership
• industry, professions, government are represented
  by two (or more) members
• no constituency has a voting majority

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The Area Committee Chairholder
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The Chairholder

• Appointed by the President
• Appointed to a one-year term with the possibility
  of being reconfirmed for a total of six
  consecutive terms

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Requirements for Appointment

• needed constituency for balance
• proven ability to function and manage in the
  consensus process
• CLSI volunteer experience
• expertise in the area committees technical
  responsibility
• global participation
• skill in conducting mediation
• project management experience and
• demonstrated responsiveness.

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Activities of the Area Committee
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Area Committee Planning

• Identify needs within its field of interest
• Prioritizes needs
• Determines resource requirements for projects
• Review the work of the subcommittee to ensure its
  scientific and technical quality

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Area Committee Responsibilities

• Review the work of the subcommittee to ensure its
  scientific and technical quality
• Effect on each constituency
• Adherence to CLSI format and procedural
  requirements
• Relevance to identified need

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Responsibilities (continued)

• Develop technical objectives
• Prepare project proposals
• Report to the Board of Directors

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Global Harmonization

• Harmonization of existing practices is key in
  developing a standard for global application
• CLSI has adopted an Organizational Policy and
  Operational Plan on Harmonization

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The Quality System Approach to Document
Development

• Define document structure
• Identify gaps

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The Consensus Process
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Project Assessment/Authorization
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The Project Idea
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Project Proposal
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Elements of the Project Proposal

• Submitter
• Title
• Product type
• Description
• Proposed subcommittee membership
• Area Committee review and recommendation

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Project Description

• Rationale
• Scope
• Table of Contents
• Other factors for consideration

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Proposed Membership

• Describe the specific expertise needed in
  subcommittee members
• Provide list of nominees

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Review and Recommendation

• Comment on intended users, impact on health care,
  and priority of project
• Chairholder sign-off

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Project Assessment
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Internal Idea Assessment

• Project idea is consistent with the mission and
  goals of CLSI
• Perceived need for the project

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Volunteer Recruitment

• Nomination via interested party
• Self-nomination
• Call for Nominations
• Update
• Website
• Just for letters

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External Interest Assessment

• Qualitative Assessment
• Business Plan
• Quantitative Assessment

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Business Plan (Maximum 4-month Timeline)

• Financial analysis (Multi-year budgets)
• Document development timeline
• - companion products
• - subcommittee membership
• - path of workflow

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Multi-Year Budgets

• Projects authorized for document generation
  include a multi-year budget to ensure funding
  through approved-level publication.

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Multi-Year Budgets (continued)

• Each multi-year budget includes a document
  development timeline and related expenses.
• Delayed projects are flagged for management
  intervention at the proposed and approved levels
  if committee voting has not occurred according to
  the budgeted timeline.

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Subcommittee Formation
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Subcommittee members chosen based on

• representation among professional, government,
  and industry and any other affected
  constituencies
• ability to function in consensus process
• financial support of volunteers organization for
  participation in CLSI activities
• global participation relative to the project
• submission of proper paper work (e.g., curriculum
  vitae, disclosure of interest form)
• member-organization representation, with
  appropriate balance of new constituency
  representation (will be considered but is not a
  requirement)
• appropriate balance of experienced and new
  volunteers and
• a history of tracked on-time contributions to
  other subcommittees.

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Project Authorization
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Authorization

• Chairholders Council (at least quarterly) can
• - accept project with work commencing
  immediately
• - reject
• - commit to fund a project, but schedule a
  delayed
• start (limited application)
• All proposed projects will be presented for
  review regardless of staff/market research
  recommendation

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Subcommittee Appointment
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Subcommittee Appointment

• by the Executive Director, on behalf of the Area
  Committee Chairholder and President-elect

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Inaugural Subcommittee Meetings
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Document Development
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Timeline
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Voting
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Voting Process
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Comment Resolution
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Area Committees Role in Comment Resolution

• To ensure that comments have been resolved and
  that consensus has been reached

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Document Revision
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Action on Approved Documents

• Postpone review
• Reaffirm
• Revise
• Amendment
• Moderate revision
• Extensive revision
• Consolidation
• Withdrawal

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Standards Application Products
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Administrative Considerations
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Tripartite Participation

• Professions
• Government
• Industry
• Other constituencies
• Subcommittee
• Area committees
• Board of Directors

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Antitrust Compliance

• Meeting and conference call arrangements
• Notice and Agenda
• Conduct of meetings
• Forbidden discussion topics
• Competitive disadvantage
• Minutes, reports, and publications

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Disclosure of Interests

• Principles
• Fair and open discussion
• Adequate scientific expertise
• Vested interests
• Voting records
• Disclosure Process
• Disclosure Form
• Undisclosed Interests

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Am I protected from liability?
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Indemnification Policy

• Indemnification policy dovetails with CLSIs
  insurance by covering officers, directors,
  employees, and committee members.
• Intended to be a very positive element in CLSIs
  overall program of supporting its volunteers and
  staff.
• Purpose is to assure volunteers and staff that,
  in a litigious situation, CLSI will stand behind
  them and pledges its assets to do so.
• Key element/limitation of the policy is that
  indemnification does not extend to actions that
  do not adhere to CLSIs policies and procedures.

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Reimbursement
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Frequently Asked Questions
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Who are our members?
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Active Member Organizations

• 29 Professional Societies
• 22 Government Agencies
• 2 Trade Organizations
• 6 Startup Companies
• 52 Industry Organizations (Gross Sales up to
  US50 Million)
• 20 Industry Organizations (Gross Sales over US50
  Million)
• 15 Multiple Sites
• 21 Consultants

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Associate Active, Corresponding, and Education
Members

• 150 Healthcare Delivery Systems
• 1,733 Hospitals and Laboratories
• 45 Educational Institutions

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Quality System Resources

• HS1, A Quality Management System Model for
  Healthcare
• GP26, Application of a Quality Management System
  Model for Laboratory Services

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Harmonization Resources

• Database of terms and definitions (based on
  NRSCL8-A and a compilation of terms in ISO/TC212
  and CEN/TC140)