introduction to laboratory quality management
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Introduction to Laboratory Quality Management. Learning Objectives. At the end of this activity, you will be able to: Relate the importance of a laboratory quality system Define the principal terms used in the field of quality List the essential elements of a laboratory quality system - PowerPoint PPT PresentationTRANSCRIPT
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Introduction to Laboratory Quality Management
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At the end of this activity, you will be able to: Relate the importance of a laboratory quality
system Define the principal terms used in the field of
quality List the essential elements of a laboratory
quality system Describe the development of quality
principles during the last centuries
Learning Objectives
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What is Quality?
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99%: High Quality level?
Accepting 1% non-quality, means everyday in France :
-- 14 minutes without water or electricity -- 50 000 parcels lost by postal services -- 4 bad landings at Orly Paris airport -- 20 newborns falling from midwives’ hands -- 600 000 lunches contaminated by bacteria
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1% of non quality?
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A laboratory occurrence and its consequences
A 83 year old male was admitted to hospital with fever, weight loss and cough being investigated for possible tumor. Sputum was reported to be positive for tuberculosis, but on later review, found to be false positive culture due to in-laboratory contamination. Further investigation found 14 additional patients with falsely positive TB culture
Delay in correct diagnosis Unnecessary treatment Treatment complications. Pattern of other contaminations discovered Problem resolution required 6 months of investigation, contacting of more
than 200 patients, many requiring culture and X-Ray re-examination. Revision of laboratory procedures eradicated the problem.
Laboratory errors cost in time, energy, moneypersonnel and patient outcomes
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Laboratory Quality Management
Coordinated activities to direct and control an organization with
regard to quality
ISO 9000:2000
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ReportTransport
ResultInterpretation
SampleTransport
Sample Collection
Laboratory Analysis
ReportCreation
ThePatient
Path
Of
Workflow
Examination Phase
Post-Examination
Phase
Pre-Examinatio
n Phase
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Why the Path of Workflow is essential to consider in health laboratories
A sample that is damaged or altered as a result of improper collection, or without consideration of the effects of transport will always result in an inaccurate result.
A medical report that is delayed, or lost, or sent to the wrong clinician, or written in a method that results in misinterpreted negates all the time and energy and finances that were spent in collecting, transporting and performing the examination properly
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There are many factors that influence whether laboratory tests will be performed accurately
and in a timely manner.
Competentstaff
Reagentsand equipment
Laboratoryenvironment
Knowledgeablestaff
Qualitycontrol
Communications
OccurrenceManagement
Process Management
Records keeping
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Twelve QualitySystem Essentials
Quality system essentials
Set of coordinated activities that function as building blocks for quality management.
Process Control
(Quality Control & Specimen
Management)
Purchasing & Inventory
AssessmentOccurrence
Management
Information Management
Process Improvement
Customer Service
Facilities & Safety
Organization Personnel Equipment
Documents & Records
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Process Control
(Quality Control & Specimen
Management)
Purchasing & Inventory
AssessmentOccurrence
Management
Information Management
Process Improvement
Customer Service
Facilities & Safety
Organization Personnel Equipment
Documents & Records
Path of Workflow
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The Laboratory shall be legally identifiable
NameAddress
Medical Director Contact Information
TelephoneFacsimile Electronic
Path of WorkflowPatients know to whom to complain about inconvenience
Clinician know to whom to call about late reports
Workers know to whom to complain about late salary cheques
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A Brief History of Laboratory Quality Management
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Quality Management is not newWalter Shewhart
W. Edwards Deming Joseph Juran
Phillip CrosbyRobert Galvin
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A Short History of Quality Management
Innovator Date Cycle Walter A Shewhart 1920’s Statistical Process Control
W Edwards Deming 1940’s Continual Improvement
Joseph Juran 1950’s Quality Toolbox
Phillip Crosby 1970’s Quality by Requirement
Robert Galvin 1980’s Micro Scale Error Reduction
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Walter Shewhart
Statistical Process Control Chart
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W. Edwards Deming
DO
CHECK
PLAN
ACT
The Deming Cycle
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Joseph Juran
Juran Cost of Quality Curve
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Joseph Juran
Juran Defect-Cost Curve (modified)
DEFECTS
COSTS
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Philip Crosby
1. Quality is defined as conformance to requirements, not as 'goodness' or 'elegance'.
2. The system for causing quality is prevention, not appraisal.
3. The performance standard must be Zero Defects, not "that's close enough".
4. The measurement of quality is the Price of Nonconformance, not indices.
Absolutes of Quality
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Robert Galvin
Six Sigma
MEASURE
CONTROL
DEFINE
IMPROVE
ANALYSE6∑
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Six SigmaA modern tool that blends statistical process control and structured project planning
Total Error ErrorPercent
Process Sigma
1,000,000 100,000 10% 2.78
1,000,000 10,000 1% 3.83
1,000,000 5,000 0.5% 4.08
1,000,000 1,000 0.1% 4.59
1,000,000 500 0.05% 4.79
1,000,000 100 0.01% 5.22
1,000,000 50 0.005% 5.39
1,000,000 10 0.001% 5.76
1,000,000 5 0.0005% 5.92
1,000,000 1 0.0001% 6.25
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The March of Quality Management
1942-52 US Military develop requirements for contractors for shell, aircraft, missile suppliers (Quality without 100% inspection)
1959 US Department of Defense established MIL-Q-9858 quality management
1963 MIL-Q-9858 is internationalized as an ABCA standard
1968 NATO adopts MIL-Q-9858A as Allied Quality Assurance Publication 1 (AQAP-1)
1979 British Standards Institute (BSI) developed AQAP-1 for civilian use BS 5750
1987 ISO modifies and adopts BC5750 for international civilian use ISO 9000
1994-2000
ISO issued ISO 9000:1994 and follows with ISO 9000:2000.
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The 30 year March of Quality Management
MIL-Q-98581959
NATO AQAP-11968
BSI 57501979
ISO 90001987
1967, 1988
2004US Military Replaces Mil-Q-9858 with ISO
9000:2000
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ISO 15189:2003Medical laboratories –Particular requirements for quality and competence
ISO 15189:2003 today’s cornerstone of international
Medical Laboratory Quality Management
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Development of ISO 15189
ISO17025:1999 ISO
15189:2003
ISO9001:2000
ArgentinaAustraliaAustria Belgium Brazil Canada Chile China Czech Republic Denmark
Finland FranceGermany Iran,Ireland Israel Italy Jamaica Japan Korea
Mexico Netherlands New Zealand Norway PortugalSingapore Spain Sweden Switzerland Turkey United KingdomUnited States
QualityManagementSystems
General requirements for the competence of testing and calibration laboratories
Medical laboratories – Particular requirements for quality and competence
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ISO 15189:2003Management Requirements Organization Quality Management System
Document controlContract reviewReferral laboratoriesSupplier reviewComplaint resolutionIdentification of NonconformitiesControl of NonconformitiesPreventive ActionsCorrective ActionsManagement reviewContinual Improvement
Technical Requirements Personnel authorities and
responsibilities Accommodation and
Environment Equipment and supplies
Testing Cycle Events•Pre-Examination procedures•Examination procedures
Standard Operating Procedures
Quality Control
External Quality Assessment
•Post-Examination proceduresReporting
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ISO 15189 Family of Documents
ISO 15189:2003Medical laboratories -- Particular requirements for quality and competence
ISO 15190:2003Medical laboratories -- Requirements for safety
ISO 22870:2006Point-of-care testing (POCT) -- Requirements for quality and competence
ISO/TR 22869:2005Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003
ISO/WD TS 22367Medical laboratories -- Reduction of error through risk management and continual improvement
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CLSI Essential DocumentsNational Committee for Clinical Laboratory Standards
Clinical and Laboratory Standards Institute
HS01-A2 2004
A Quality Management System Model for Health Care
GP26 – A32004
Application of a Quality Management System Model for Laboratory Services;
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CLSI Beginning
Started in 196731 clinicians and laboratory scientists representing 15 organizations met:
to discuss ways of improving patient care to develop a formal consensus process for
standardization.
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CLSI Today
Today, 40 years laterA committed forum for laboratory improvement through consensus, guidelines, and standardization.International in scope and participation
World Health Organization Collaborating Centre Secretariat – ISO Technical Committee2.12
Ten area committees addressing the full range of laboratory activities.Current catalogue contains over 180 titles that address the quality and competence of practice in the medical laboratory.
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ISO and Medical Laboratory Quality Quality and Competence Laboratory Safety Point of Care Testing Risk Management
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Summary
Quality management is not new. Quality management grew from the good
works of innovators who defined quality over a spam of 80 years.
Quality management is applicable for the medical laboratory as it is for manufacturing and industry.
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Summary
Through the good works of organizations including WHO, ISO, CLSI, and others…
Laboratories benefitHealth care benefits
Patients benefit