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? • 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 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 Coordinated activities to direct and control an organization with regard to quality ISO 9000:2000
Path Of Workflow Post- Examination Phase Pre- Examination Phase Examination Phase
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
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
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.
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 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
A Brief History of Laboratory Quality Management
Quality Management is not new Walter Shewhart W. Edwards Deming Joseph Juran Robert Galvin Phillip Crosby
Walter Shewhart Statistical Process Control Chart
W. Edwards Deming The Deming Cycle
Joseph Juran Juran Cost of Quality Curve
Joseph Juran COSTS DEFECTS
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
6∑ Robert Galvin Six Sigma
Six Sigma A modern tool that blends statistical process control and structured project planning
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 Medical laboratories –Particular requirements for quality and competence
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
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 15189:2003Medical 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 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 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 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 • Quality and Competence • Laboratory Safety • Point of Care Testing • Risk Management
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.
Summary Through the good works of organizations including WHO, ISO, CLSI, and others… Laboratories benefit Health care benefits Patients benefit