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Introduction. Laboratory Quality Management System Introduction. Laboratory Quality Management System

Learning Objectives At the end of this activity, participants will be able to: n Learning Objectives At the end of this activity, participants will be able to: n n Explain the importance of a quality management system List the quality system essential elements Describe the history of development of quality principles Discuss relationship of this quality model to ISO and CLSI standards Introduction Laboratory Quality Management System-Module 1 2

The Quality Management System Organization Personnel Equipment Purchasing & Inventory Process Control Information Management The Quality Management System Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Introduction Laboratory Quality Management System-Module 1 Facilities & Safety 3

What is Quality? Introduction Laboratory Quality Management System-Module 1 4 What is Quality? Introduction Laboratory Quality Management System-Module 1 4

Achieving a 99% level of quality means accepting a 1% error rate 1% Introduction Achieving a 99% level of quality means accepting a 1% error rate 1% Introduction Laboratory Quality Management System-Module 1

In France a 1% error rate would mean everyday n 14 minutes without water In France a 1% error rate would mean everyday n 14 minutes without water or electricity n 50, 000 parcels lost by postal services n 22 newborns falling from midwives’ hands n 600, 000 lunches contaminated by bacteria n 3 bad landings at Orly Paris airport Introduction Laboratory Quality Management System-Module 1 6

Result: 1% failure Introduction Laboratory Quality Management System-Module 1 Result: 1% failure Introduction Laboratory Quality Management System-Module 1

Essential to all aspects of health care laboratory results that are § accurate, § Essential to all aspects of health care laboratory results that are § accurate, § reliable, and § timely Introduction Laboratory Quality Management System-Module 1 8

Laboratory errors cost in time personnel effort patient outcomes Introduction Laboratory Quality Management System-Module Laboratory errors cost in time personnel effort patient outcomes Introduction Laboratory Quality Management System-Module 1 9

Organization How do we achieve excellent performance in the laboratory? Personnel Equipment Purchasing & Organization How do we achieve excellent performance in the laboratory? Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Introduction Laboratory Quality Management System-Module 1 Facilities & Safety 10

Quality Management System Definition Coordinated activities to direct and control an organization with regard Quality Management System Definition Coordinated activities to direct and control an organization with regard to quality (ISO, CLSI). All aspects of the laboratory operation need to be addressed to assure quality; this constitutes a quality management system. Introduction Laboratory Quality Management System-Module 1 11

Complexity of a Laboratory System Reporting Patient/Client Prep Sample Collection Personnel Competency Test Evaluations Complexity of a Laboratory System Reporting Patient/Client Prep Sample Collection Personnel Competency Test Evaluations • Data & Laboratory Management • Safety • Customer Service Sample Receipt and Accessioning Record Keeping Quality Control Testing Introduction Laboratory Quality Management System-Module 1 Sample Transport 12

Path of Workflow THE PATIENT Test selection Sample Collection Preexamination Phase Sample Transport Laboratory Path of Workflow THE PATIENT Test selection Sample Collection Preexamination Phase Sample Transport Laboratory Analysis Examination Phase Report Transport Result Interpretation Report Creation Postexamination Phase Introduction Laboratory Quality Management System-Module 1 13

WHY is the Path of Workflow essential to consider in health laboratories? The entire WHY is the Path of Workflow essential to consider in health laboratories? The entire process of managing a sample must be considered: § the beginning: sample collection § the end: reporting and saving of results § all processes in between. Introduction Laboratory Quality Management System-Module 1 14

Laboratory tests are influenced by § laboratory environment § knowledgeable staff § competent staff Laboratory tests are influenced by § laboratory environment § knowledgeable staff § competent staff § reagents and equipment § quality control § communications § process management § occurrence management § record keeping Introduction Laboratory Quality Management System-Module 1 15

Twelve Quality System Essentials set of coordinated activities that function as building blocks for Twelve Quality System Essentials set of coordinated activities that function as building blocks for quality management Organization Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Introduction Laboratory Quality Management System-Module 1 Facilities & Safety 16

Organization Purchasing & Inventory Personnel Process Control Equipment Information Management Path of Workflow Documents Organization Purchasing & Inventory Personnel Process Control Equipment Information Management Path of Workflow Documents & Records Occurrence Management Process Improvement Customer Service Assessment Introduction Laboratory Quality Management System-Module 1 Facilities & Safety 17

Organization Responsibilities, Authorities Quality Policy Provision of resources Introduction Laboratory Quality Management System-Module 1 Organization Responsibilities, Authorities Quality Policy Provision of resources Introduction Laboratory Quality Management System-Module 1 Communication 18

Personnel § human resources § job qualifications § job descriptions § orientation § training Personnel § human resources § job qualifications § job descriptions § orientation § training § competency assessment § professional development § continuing education Introduction Laboratory Quality Management System-Module 1 19

Equipment § acquisition § installation § validation § maintenance § calibration § troubleshooting § Equipment § acquisition § installation § validation § maintenance § calibration § troubleshooting § service and repair § records Introduction Laboratory Quality Management System-Module 1 20

Purchasing and Inventory §vendor qualifications §supplies and reagents §critical services §contract review §inventory management Purchasing and Inventory §vendor qualifications §supplies and reagents §critical services §contract review §inventory management Introduction Laboratory Quality Management System-Module 1 21

Process Control §quality control §sample management §method validation §method verification Introduction Laboratory Quality Management Process Control §quality control §sample management §method validation §method verification Introduction Laboratory Quality Management System-Module 1 22

Information Management § confidentiality § requisitions § logs and records § reports § computerized Information Management § confidentiality § requisitions § logs and records § reports § computerized laboratory information systems (LIS) Introduction Laboratory Quality Management System-Module 1 23

Documents creation revisions and review control and distribution Introduction Laboratory Quality Management System-Module 1 Documents creation revisions and review control and distribution Introduction Laboratory Quality Management System-Module 1 Records collection review storage retention 24

Occurrence Management §complaints §mistakes and problems §documentation §root cause analysis §immediate actions §corrective actions Occurrence Management §complaints §mistakes and problems §documentation §root cause analysis §immediate actions §corrective actions §preventive actions Introduction Laboratory Quality Management System-Module 1 25

Laboratory Assessment External Internal Proficiency testing (EQA) Inspections Accreditations Introduction Laboratory Quality Management System-Module Laboratory Assessment External Internal Proficiency testing (EQA) Inspections Accreditations Introduction Laboratory Quality Management System-Module 1 26

Process Improvement §opportunities for improvement (OFIs) §stakeholder feedback §problem resolution §risk assessment §preventive actions Process Improvement §opportunities for improvement (OFIs) §stakeholder feedback §problem resolution §risk assessment §preventive actions §corrective actions Introduction Laboratory Quality Management System-Module 1 27

Customer Service § customer group identification § customer needs § customer feedback Introduction Laboratory Customer Service § customer group identification § customer needs § customer feedback Introduction Laboratory Quality Management System-Module 1 28

Facilities and Safety § safe working environment § transport management § security § containment Facilities and Safety § safe working environment § transport management § security § containment § waste management § laboratory safety § ergonomics Introduction Laboratory Quality Management System-Module 1 29

Implementing Quality Management does not guarantee an ERROR-FREE Laboratory But it detects errors that Implementing Quality Management does not guarantee an ERROR-FREE Laboratory But it detects errors that may occur and prevents them from recurring Introduction Laboratory Quality Management System-Module 1 30

Organizatio n Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Organizatio n Personnel Equipment Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Manageme nt Assessmen t Process Improvement Customer Service Laboratories not implementing a quality management system guarantees UNDETECTED ERRORS Facilities & Safety Introduction Laboratory Quality Management System-Module 1 31

Laboratory Quality Management System Coordinated activities to direct and control an organization with regard Laboratory Quality Management System Coordinated activities to direct and control an organization with regard to quality. ISO 9000: 2000 Introduction Laboratory Quality Management System-Module 1 32

Innovators of Quality Walter Shewhart 1891 -1967 Joseph Juran 1904 -2008 (103 years) Philip Innovators of Quality Walter Shewhart 1891 -1967 Joseph Juran 1904 -2008 (103 years) Philip Crosby 1926 -2001 Introduction Laboratory Quality Management System-Module 1 W. Edwards Deming 1900 -1993 Robert Galvin b. 1922 33

A Brief History of Quality Management is not new. Innovator Date Cycle Walter A. A Brief History of Quality Management is not new. Innovator Date Cycle Walter A. Shewhart 1920 s Statistical Process Control W. Edwards Deming 1940 s Continual Improvement Joseph M. Juran Quality Toolbox Philip B. Crosby 1950 s 1970 s Robert W. Galvin 1980 s Micro Scale Error Reduction Introduction Laboratory Quality Management System-Module 1 Quality by Requirement 34

Standards Organizations ISO International Organization for Standardization CLSI Clinical and Laboratory Standards Institute (formerly Standards Organizations ISO International Organization for Standardization CLSI Clinical and Laboratory Standards Institute (formerly known as NCCLS) Standards, guidelines, and Guidance for quality in manufacturing and service best practices for quality in medical laboratory testing industries Broad applicability; used by many kinds of organizations Detailed; applies specifically to medical laboratories Uses consensus process in developing standards Introduction Laboratory Quality Management System-Module 1 35

ISO Documents - Laboratory ISO 9001: 2000 Quality Management System Requirements Model for QA ISO Documents - Laboratory ISO 9001: 2000 Quality Management System Requirements Model for QA in design, development production, installation, and servicing ISO/IEC 17025: 2005 General requirements for the competence of testing and calibration laboratories ISO 15189: 2007 Quality management in the clinical laboratory Introduction Laboratory Quality Management System-Module 1 36

ISO 15189: 2007 n The foundation of international medical laboratory quality management n Medical ISO 15189: 2007 n The foundation of international medical laboratory quality management n Medical laboratories–Particular requirements for quality and competence Introduction Laboratory Quality Management System-Module 1 37

CLSI Quality Documents HS 1 -A 2 A Quality Management System Model for Health CLSI Quality Documents HS 1 -A 2 A Quality Management System Model for Health Care §describes quality system model, 12 essentials §aligns to ISO 15189 and parallels ISO 9000 §applies to all health care systems GP 26 -A 3 Application of Quality Management System Model for Laboratory Services §describes laboratory application of quality system model §relates the path of workflow to the quality system essentials §assists laboratory in improving processes §relates to HS 1 -A 2 and ISO 15189 Introduction Laboratory Quality Management System-Module 1 38

In summary n Quality management is not new. n Quality management grew from the In summary n Quality management is not new. n Quality management grew from the good works of innovators who defined quality over a span of 80 years. n Quality management is as applicable for the medical laboratory as it is for manufacturing and industry. Introduction Laboratory Quality Management System-Module 1 39

Key Messages n n A laboratory is a complex system and all aspects must Key Messages n n A laboratory is a complex system and all aspects must function properly to achieve quality. Approaches to implementation will vary with local situation. Start with the easiest, implement in stepwise process. Ultimately, all quality management system elements must be addressed. Introduction Laboratory Quality Management System-Module 1 40

Organization Personnel Equipment Questions? Purchasing & Inventory Process Control Information Management Documents & Records Organization Personnel Equipment Questions? Purchasing & Inventory Process Control Information Management Documents & Records Occurrence Management Assessment Process Improvement Customer Service Comments? Facilities & Safety Introduction Laboratory Quality Management System-Module 1 41