Dr. Ana Leticia Maselli President

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Latin American Confederation of Clinical
Chemistry COLABIOCLI Guatemalan Society of Clin
ical Chemists

• Dr. Ana Leticia Maselli President

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• Latin-America

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The Latin American Confederation of Clinical
Chemistry (COLABIOCLI)

• Has identified two important problems that
  deserved a major effort
  
• Incorporation of a continuous quality program to
  ensure results of the laboratories. which will
  contribute to the health of the population
  
• Fulfillment management of the laboratories,
  including registration and licensing quality
  assessment (internal and external) and
  accreditation.

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Purposes

• Improvement of the quality performance of the
  clinical laboratories in Latin American
  
• Establishing of an External Quality Assessment
• Initiation of Quality Management System in
  every country.
  
• Developing of Quality indicators in the clinical
  laboratories

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Activities

• Since 1990 COLABIOCLI, WHO,PAHO and other
  Institutions have developed the follow activities
  
  
• Courses and workshops on Quality.
• Edition of two books on Quality Assurance.
• Visits to the different Health Institutions to
  stimulate their interest in our programs.
  
• Providing control material and courses to
  elaborate them.
  
• Seminars on management of External Quality
  Assessment
  
• Training courses for tutor on Quality Management
  System.
  
• Participation in National Congresses and
  organization of Latin American Congresses
  
• Financing visiting lecturers according to local
  needs.

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Quality Management System Basic components

• Standard operatives procedures
• Laboratory Documents
• Internal Quality Control
• External Quality Assessment
• Internal and External audits
• Capacitation and continuous education program.
• Biosafety regulations.
• Preventive and corrective maintenance of the
  equipment.
  
• Ethical compromise of the institution and
  professional.

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Survey realized in 2007 in Latin American
countries
Number of registered laboratories in the region
8
Countries with External Quality Assessment
9
Accreditation Program
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Goals achieved

• Registration
• Register procedure up to date
• Bolivia
• Chile
• Costa Rica
• Colombia
• Guatemala
• México
• Paraguay

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External Quality Assessment

• Recent implementation of the program
• Costa Rica
• Ecuador
• Honduras
• Nicaragua
• Venezuela

• Continuous improvement of External Quality
  Assessment
  
• Argentina
• Bolivia
• Brasil
• Chile
• Guatemala
• México
• Paraguay
• Uruguay

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Preparation of control samples

• Argentina
• Brasil
• Colombia
• Guatemala

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Establishment of a Quality System

• Quality Management System Course
• Workshop for national tutors in 20 countries of
  the region
  
• Training 150 National Tutors
• Courses given in the following countries
• Argentina (80)
• Bolivia (60)
• Brasil (150)
• Colombia (80)
• El Salvador (40)
• Guatemala (170)
• México (90)
• Panamá (35)

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Accreditation (ISO 15189)

• Brasil
• Argentina
• Chile
• Colombia
• Costa Rica
• Guatemala
• México
• Uruguay

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Strategies and goals

• Completion the license procedures in all
  countries.
  
• Innovation of the External Quality Program
• Developing professional resources to manufacture
  reference materials.
  
• Continuing with the efforts for the establishment
  of a quality control program in the Latin
  American Countries.
  
• Achieve the active participation of all the
  health authorities.
  
• Continuation of local and distance learning
  programs.
  
• Application of the guide for local accreditation
  program, according to their possibilities.