Introduction to Laboratory Quality Management

2

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