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  • 1 - Laboratory Quality Management (Compatibility Mode)

    Загружено:

    Haytham Hagrass
    231 просмотров14 страниц
    This document discusses laboratory quality management. It explains that laboratory quality management is a method or process to ensure consistent and efficient production of laboratory results. It also discusses the 12 quality system essentials defined by CLSI, which fall under three categories: laboratory structure, laboratory process, and laboratory outcome. Laboratory structure covers organization, facilities, personnel and procedures. Laboratory process includes quality control, documentation, information management, and testing methods. Laboratory outcome focuses on data management, incident reporting, quality assurance through indicators, proficiency testing and process improvement. The document provides examples of information that should be included in a laboratory quality manual to define these quality systems.

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    1- Laboratory Quality Management [Compatibility Mode]

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    This document discusses laboratory quality management. It explains that laboratory quality management is a method or process to ensure consistent and efficient production of laboratory results. It also discusses the 12 quality system essentials defined by CLSI, which fall under three categories: laboratory structure, laboratory process, and laboratory outcome. Laboratory structure covers organization, facilities, personnel and procedures. Laboratory process includes quality control, documentation, information management, and testing methods. Laboratory outcome focuses on data management, incident reporting, quality assurance through indicators, proficiency testing and process improvement. The document provides examples of information that should be included in a laboratory quality manual to define these quality systems.

    Авторское право:

    Attribution Non-Commercial (BY-NC)
    Скачайте в формате PDF, TXT или читайте онлайн в Scribd
    Отметить как неприемлемый контент
    231 просмотров14 страниц

    1 - Laboratory Quality Management (Compatibility Mode)

    Загружено:

    Haytham Hagrass
    This document discusses laboratory quality management. It explains that laboratory quality management is a method or process to ensure consistent and efficient production of laboratory results. It also discusses the 12 quality system essentials defined by CLSI, which fall under three categories: laboratory structure, laboratory process, and laboratory outcome. Laboratory structure covers organization, facilities, personnel and procedures. Laboratory process includes quality control, documentation, information management, and testing methods. Laboratory outcome focuses on data management, incident reporting, quality assurance through indicators, proficiency testing and process improvement. The document provides examples of information that should be included in a laboratory quality manual to define these quality systems.

    Авторское право:

    Attribution Non-Commercial (BY-NC)
    Скачайте в формате PDF, TXT или читайте онлайн в Scribd
    Отметить как неприемлемый контент
    из 14

    Laboratory Q lit M L b t Quality Management t

    SAMER DAHSHI, MS, MT (ASCP), CLS Head of Laboratory Services King Faisal Specialist Hospital and Research Center

    Lab QM CBAHI Oct 2010

    Laboratory Quality Management


    L b QM Lab QM:
    Is a Method or a Process of activities to ensure effective and efficient production of laboratory results consistently.* y y

    CBAHI Oct

    Laboratory Quality Management


    Quality in laboratory is a comprehensive process that requires the utilization of many tools ! C you name a f ? Can few?

    CBAHI Oct

    Quality System Essentials (QSE)


    I t International i tit t such as CAP C ll ti l institutes h College of f American Pathologists, AABB American Association of Blood Banking ISO Banking, International Organization for Standardization, and CLSI - Clinical and Laboratory Standard Institute have set guideline and a structure to define and develop Laboratory q p y quality system. y y CLSI called this program Quality System Essentials.

    CBAHI Oct

    Quality System Essentials


    The 12 QSE fall into three major categories: g
    I. Lab Structure II. Lab Process III. Lab Outcome

    Lab QM CBAHI Oct 2010

    Quality System Essentials y y


    I. Lab Structure (Pre-analytical): (Pre Organization Facilities and Safety Personal

    CBAHI Oct

    Quality System Essentials


    II. Process (Analytical):
    Process Control (QC, QI) Document Control g Information Management

    CBAHI Oct

    Quality System Essentials y y


    III. Outcome (Post-analytical): (Post Event Management ( g (OVR & RCA) ) Assessment (Indicators, Proficiency Testing) Process Improvement (PI & QA) Satisfaction Surveys

    CBAHI Oct

    I. Lab Structure
    Administrative Pre-Analytical Factors Pre-

    Laboratory Operation Manual (OM) should contain:


    Administrative Manual Technical Manual

    Lab QM CBAHI Oct 2010

    I. Lab Structure - Administrative Manual


    Administrative manual includes but not limited to:
    Organizational Structure Job Descriptions Scope of Service & Plan of Care Quality Management Program Continuing Education and Training Safety & Facility Management* Etc see attached example (handout)

    CBAHI Oct

    I. Lab Structure - Technical Manual


    T h i l manual i l d b t not li it d Technical l includes but t limited to:
    Quality Control Program Critical Value Policy y Proficiency Testing Policy Method Validation and Comparison Stat Test Protocol Etc see attached example (handout) Etc.

    Lab QM CBAHI Oct 2010

    II. Lab Process


    Analytical Factors

    Quality M Q lit Management Program tP Quality Control Program y g Method Validation Instrument Calibration and Maintenance Method Comparison Documentation & Charts Document Review & Document Control Training and Competencies
    CBAHI Oct

    III. Lab Outcome


    PostPost-analytical Factors

    Data Management and Presentation Incidence Reporting (Non-Punitive) (Non Punitive) Root Cause Analysis Quality Assurance Program
    Quality Indicators Proficiency Testing (internal & external) S lit sample t ti Split l testing

    CBAHI Oct

    Thank You

    14 Lab QM CBAHI Oct 2010

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