بسم اهللا الرحمن الرحيمبسم اهللا الرحمن الرحيمL b t Q lit M tL b t Q lit M tLaboratory Quality ManagementLaboratory Quality Management

SAMER DAHSHI, MS, MT (ASCP), CLSSAMER DAHSHI, MS, MT (ASCP), CLSHead of Laboratory Services

King Faisal Specialist Hospital and Research Center

١Lab QM CBAHI Oct 2010

Laboratory Quality ManagementLaboratory 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 ManagementLaboratory Quality Management

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

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Quality System Essentials (QSE)Quality System Essentials (QSE)

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

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Quality Quality System EssentialsSystem Essentials

•• The The 12 12 QSE fall into three major QSE fall into three major categories:categories:gg

I.I. Lab StructureLab StructureII.II. Lab ProcessLab ProcessII.II. Lab ProcessLab ProcessIII.III. Lab OutcomeLab Outcome

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Quality System EssentialsQuality System Essentialsy yy y

I. Lab Structure (PreI. Lab Structure (Pre--analytical):analytical):•• OrganizationOrganization•• Facilities and SafetyFacilities and Safety•• PersonalPersonal

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Quality System EssentialsQuality System Essentials

II. Process (Analytical):II. Process (Analytical):•• Process Control (QC, QI)Process Control (QC, QI)•• Document ControlDocument Control•• Information ManagementInformation Managementgg

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Quality System EssentialsQuality System Essentialsy yy y

III. Outcome (PostIII. Outcome (Post--analytical):analytical):–– Event Management (OVR & RCA)Event Management (OVR & RCA)g ( )g ( )–– Assessment (Indicators, Proficiency Testing)Assessment (Indicators, Proficiency Testing)

Process Improvement (PI & QA)Process Improvement (PI & QA)–– Process Improvement (PI & QA)Process Improvement (PI & QA)–– Satisfaction SurveysSatisfaction Surveys

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I. Lab StructureI. Lab StructureAdministrativeAdministrative PrePre--Analytical FactorsAnalytical Factors

• Laboratory Operation Manual (OM) shouldLaboratory Operation Manual (OM) should contain:

– Administrative Manual– Technical Manual

٩Lab QM CBAHI Oct 2010

I. Lab Structure I. Lab Structure -- Administrative Administrative ManualManual

• 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*Safety & Facility Management*–– Etc… see attached example (handout)Etc… see attached example (handout)

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I. Lab Structure I. Lab Structure -- Technical Technical ManualManual

T h i l l i l d b t t li it d• Technical manual includes but not limited to:– Quality Control Program– Critical Value Policyy– Proficiency Testing Policy– Method Validation and ComparisonMethod Validation and Comparison– Stat Test Protocol

Etc see attached example (handout)– Etc. see attached example (handout)

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II. Lab ProcessII. Lab ProcessII. Lab ProcessII. Lab ProcessAnalytical Analytical FactorsFactors

Q lit M t P• Quality Management Program• Quality Control Programy g• Method Validation• Instrument Calibration and Maintenance• Instrument Calibration and Maintenance• Method Comparison • Documentation & Charts• Document Review & Document ControlDocument Review & Document Control• Training and Competencies

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III. Lab III. Lab OutcomeOutcomePostPost--analytical analytical FactorsFactors

• Data Management and Presentation • Incidence Reporting (Non-Punitive)Incidence Reporting (Non Punitive)• Root Cause Analysis• Quality Assurance Program

– Quality IndicatorsQuality Indicators– Proficiency Testing (internal & external)

S lit l t ti– Split sample testing

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Thank You

Lab QM CBAHI Oct 201014