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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

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learning objectives
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
  • Describe the development of quality principles during the last centuries
99 high quality level
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
a laboratory occurrence and its consequences
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

laboratory quality management
Laboratory Quality Management

Coordinated activities to direct and control an organization with regard to quality

ISO 9000:2000

slide8

Path

Of

Workflow

Post-

Examination

Phase

Pre-

Examination

Phase

Examination Phase

why the path of workflow is essential to consider in health laboratories
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
slide10
There are many factors that influence whether laboratory tests will be performed accurately and in a timely manner.

Laboratoryenvironment

Reagentsand equipment

Qualitycontrol

Knowledgeablestaff

Communications

Competentstaff

Process Management

OccurrenceManagement

Records keeping

slide11

Organization

Personnel

Equipment

Information Management

Process Control (Quality Control & Specimen Management)

Purchasing & Inventory

Occurrence Management

Assessment

Documents & Records

Process Improvement

Customer Service

Facilities & Safety

Twelve Quality

System Essentials

Quality system essentials

Set of coordinated activities that function as building blocks for quality management.

slide12

Organization

Personnel

Equipment

Information Management

Process Control (Quality Control & Specimen Management)

Purchasing & Inventory

Occurrence Management

Assessment

Documents & Records

Process Improvement

Customer Service

Facilities & Safety

Path of Workflow

the laboratory shall be legally identifiable
The Laboratory shall be legally identifiable

Name

Address

Medical Director

Contact Information

Telephone

Facsimile

Electronic

Path of Workflow

Workers know to whom to complain about late salary cheques

Clinician know to whom to call about late reports

Patients know to whom to complain about inconvenience

slide14
A Brief History of

Laboratory Quality Management

quality management is not new
Quality Management is not new

Walter Shewhart

W. Edwards Deming

Joseph Juran

Robert Galvin

Phillip Crosby

walter shewhart
Walter Shewhart

Statistical Process Control Chart

w edwards deming
W. Edwards Deming

The Deming Cycle

joseph juran
Joseph Juran

Juran Cost of Quality Curve

joseph juran1
Joseph Juran

COSTS

DEFECTS

philip crosby
Philip Crosby
  • Quality is defined as conformance to requirements, not as 'goodness' or 'elegance'.
  • The system for causing quality is prevention, not appraisal.
  • The performance standard must be Zero Defects, not "that's close enough".
  • The measurement of quality is the Price of Nonconformance, not indices.

Absolutes of Quality

six sigma
Six Sigma

A modern tool that blends statistical process control and structured project planning

the 30 year march of quality management

1967, 1988

The 30 year March of Quality Management

2004

US Military Replaces Mil-Q-9858 with ISO 9000:2000

MIL-Q-9858

1959

NATO AQAP-1

1968

BSI 5750

1979

ISO 90001987

iso 15189 2003 today s cornerstone of international medical laboratory quality management
ISO 15189:2003 today’s cornerstone of international Medical Laboratory Quality Management

ISO 15189:2003

Medical laboratories –Particular requirements for quality and competence

development of iso 15189

General requirements for the competence of testing and calibration laboratories

Medical laboratories – Particular requirements for quality and competence

Development of ISO 15189

ISO9001:2000

QualityManagementSystems

ISO17025:1999

ISO

15189:2003

iso 15189 2003
Management Requirements

Organization

Quality Management System

Document control

Contract review

Referral laboratories

Supplier review

Complaint resolution

Identification of Nonconformities

Control of Nonconformities

Preventive Actions

Corrective Actions

Management review

Continual Improvement

Technical Requirements

Personnel authorities and responsibilities

Accommodation and Environment

Equipment and supplies

ISO 15189:2003
  • Testing Cycle Events
  • Pre-Examination procedures
  • Examination procedures
    • Standard Operating Procedures
    • Quality Control
    • External Quality Assessment
  • Post-Examination procedures
    • Reporting
iso 15189 family of documents
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
clsi essential documents
CLSI Essential Documents

National Committee for Clinical Laboratory Standards

Clinical and Laboratory Standards Institute

HS01-A2

2004

A Quality Management System Model for Health Care

GP26 – A3

2004

Application of a Quality Management System Model for Laboratory Services;

clsi beginning
CLSI Beginning

Started in 1967

31 clinicians and laboratory scientists representing 15 organizations met:

  • to discuss ways of improving patient care
  • to develop a formal consensus process for standardization.  
clsi today
CLSI Today

Today, 40 years later

  • A 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.
iso and medical laboratory quality
ISO and Medical Laboratory Quality
  • Quality and Competence
  • Laboratory Safety
  • Point of Care Testing
  • Risk Management
summary
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.
summary1
Summary

Through the good works of organizations including WHO, ISO, CLSI, and others…

Laboratories benefit

Health care benefits

Patients benefit