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CLSI page Friday, December 05, 2008
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CLSI - Clinical and Laboratory Standards Institute

The Clinical and Laboratory Standards Institute (CLSI) is a global, nonprofit, standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community. We are recognized worldwide for the application of our unique consensus process.   CLSI is based on the principle that consensus is an efficient and cost-effective way to improve patient testing and services. Read more >>

Recommended articles on Quality Standards and Guidelines

  • Statistical Quality Control for Quantitative Measurement procedures: Principles and Definitions; Approved Guideline – Third Edition (C24-A3) - This guideline provides definitions of analytical intervals; planning of quality control procedures; and guidance for quality control applications. Get article >>
  • Laboratory Documents: Development and Control; Approved Guideline – Fifth Edition (GP2-A5) -
    The guideline presents the important components of writing and managing documents for the clinical laboratory. This guideline describes common and specific section for inclusion in laboratory documents. Several examples of process and procedure documents for preexamination, examination and postexamination laboratory activities are provided. Get article >>
  • Training and Competence Assessment; approved Guideline – Second Edition (GP21-A2) -
    This document provides background and recommended processes for the development of training and competence assessment programs that meet quality/regulatory objectives. Get article >>
  • Continuous Quality Improvement: Integrating Five Key Quality System Components; Approved Guideline—Second Edition (GP22-A2) -
    This guideline considers continuous quality improvement (CQI) as five integrated quality system components, which include Quality Planning, Quality Teamwork, Quality Monitoring, Quality Improvement, and Quality Review. Get article >>
  • Application of a Quality Management System Model for Laboratory Services; Approved Guideline-Third Edition (GP-26-A3) -
    This guideline describes the clinical laboratory’s path of workflow and provides information for laboratory operations that will assist the laboratory in improving its processes and meeting government and accreditation requirements. Get article >>
  • A Quality Management System Model for Health Care; Approved Guideline – Second Edition (HS1-A2) -
    This document provides a model for healthcare services that will assist with implementation and maintenance of effective quality management systems. Get article >>

Recommended articles on Quality Toolkits

  • Procedure Manual Toolkit (GP2-A5-C) - This toolkit presents the major concepts of document development and control in a user-friendly format that is easy to read and implement. Nine templates with illustrative examples provide the framework for developing procedures, communicating and organizing information. Get CD >>
  • Quality System Toolkit (HS1-A2-C) -
    Included in this toolkit is useful information for designing, implementing and maintaining an effective quality management system. It lays the foundation for developing quality policies, outlining quality processes, controlling documents and reporting and tracking occurrences. Get article >>
  • Training and Competence Assessment Toolkit (GP21-A2-C) -
    This toolkit provides useful information for the development of training and competence assessment programs to verify that staff demonstrates the knowledge and skills necessary for their assigned work processes and procedures. Get CD >>

Quality Specialty Collections

  • Quality Basics (SC30-L) - This collection of four documents provides medical laboratories with specific tactics for implementing quality guidelines. Get article >>
  • Quality Series (SC24-L) - This collection contains a series of nine documents intended for healthcare managers who wish to improve their programs through quality management activities. Guidelines are for statistical quality control, training verification, continuous quality improvement, a quality system model, and using proficiency testing. Get article >>
  • Regulatory Compliance (SC31-L) - This collection contains a series of documents that will help laboratories comply with regulatory requirements. Get article >>
  
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