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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

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Laboratory Quality Management


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

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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.

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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

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Quality System Essentials


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

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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

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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
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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