From Good Laboratory Practice to Total Quality Management in Medical Laboratories : The Perspective October, 2002 S Cheng
What is Quality • Quality is the entity of a product ( service ) which fulfils the defined and expected requirement • The customer checks if the product meet the requirements
Quality in Medical Laboratory Testing • The right test result, at the • Right time, on the • Right specimen, from the right patient, with result interpretation based on • Correct reference data, and at the • Right price
Evolution of Quality Management Philosophy 1930 – 60, Q.C. ( Cure ) 1970 – 80, Q.A. ( Preventive ) To-day, TQM ( Holistic involvement )
Quality Management System • Achieving customer satisfaction by meeting customer’s expectation and preventing non-conformity at all stage of process from design to service. • Enhance the performance of the organization through internal and external audit
Why Quality Management is everybody’s darling • Quality costs, but poor Quality costs more • Regulator : reduces workload, ( manpower ) • Blood Industry Officials: makes the environment transparent • Hospitals : reduces responsibility to patients
Demings chain Improvement of quality Improvement of productivity Market-share Price-reduction Cost-reduction Secure position Secure jobs
Demings chain in Laboratory Service Improvement of quality Improvement of productivity Market-share Price-reduction Cost-reduction Secure position Secure jobs
My problems with the definitions of quality • Does the customer have all the information he needs to qualify the products? Service? • Is it his responsibility to check the quality or standards? • Is’nt there a discrepancy between customer’s expectations and requirements ?
It is our ethical responsibility to define the level of quality • A patient is not able to figure all transfusion risks. He might be unconscious on intensive care. • We know all about transfusion risk and must be responsible for the safety. • A perfect balance is the major support for a good quality management.
Flawless quality management:( Error Management ) • Quality management has to be flawless. Discovery of errors in documents, or problems must lead to the consideration to end, or change the process.
Quality Layers • Minimal requirements “ Bad Quality” • Functional Requirement “Quality” • Non-functional requirements “Good Quality” • Far ahead of customer expectations “Excellence”
Should’nt we achieve excellence ? Quality = Excellence Excellence begins in your mind
Quality Planning • Part of Quality management focused on setting quality objectives and specifying necessary processes and related resources to fulfil the quality objective
3 E in quality • Effectiveness ( doing the right things) - extent to which planed activities are realized and planed results achieved • Efficiency ( doing things right ) - relationship between the result achieved and the resources used • Excellence - Doing the right things right !!
The 8 columns of excellence Orientation on results Responsibility for the community Orientation of customers Building partnerships Continuous learning Leadership & consequences of goals Involvement of employees Management of processes & facts
Achieved By Good Practices • GLP – Good Laboratory Practice • GCL – Good Clinical Practice • GMP – Good Manufacturing Practice • GTP – Good Transportation Practice • GDP – Good Distribution Practice • GAMP – Good Automated Manufacturing Practice • GRP- Good Regulatory Practice
Medical laboratory quality system • A quality system is essential in the laboratory to ensure the correct results for the correct patient / donor • By Good Laboratory Practice ( GLP )
Good Laboratory Practice( GLP ) • Main areas of GLP - Organization and personnel • Facilities • Equipment • Reagent / test kits • Documentation • Inter-laboratory comparison
Organization and Personnel • Quality management system On Accountability -Responsibilities -Authorities • Training - Competency based
Facilities • Appropriate infrastructure • Safety measures • Hygiene measures
Equipment • Validated - Does it do what you want it to do ? • Maintained • Calibrated
Reagents / Test Kits • Evaluated • Methodology validated • Test run validated - Kit / reagent controls - Internal control
Documentation (1) • Testing strategies / protocols - Specimen identification - Confidentiality • SOPs - Sample processing - Test performance and result interpretation - Inspection of incoming goods - Validation - Equipment maintenance and calibration - Safety
Documentation (2) • Records - Test results - Equipment maintenance - Equipment calibration - Control charts - Validation - Training
Inter-laboratory comparison • External Quality Assurance Scheme ( Proficiency Test , P.T. )
By Other Quality Management System International Standards e.g. ISO 9000 series, ISO/IEC 17025:1999 ( General Requirements for the Competence of Testing and Calibration Laboratories )
In 1985 JCAHO published its 10-step QA monitoring process. • Assign responsibility for QA plan. • Define scope of patient care. • Identify important aspects of care. • Construct indicators. • Define thresholds for evaluation. • Collect and organize data. • Evaluate data. • Develop corrective action plan. • Assess action; document improvement. • Communicate relevant information.
JCAHO has also established nine dimensions of performance that must be included and measured in the design of the organization’s quality assessment and performance improvement plan:
Nine Dimension • Efficacy • Appropriateness • Availability • Timeliness • Effectiveness • Continuity • Safety • Efficiency • Care and Respect
National Accreditation Scheme • CAP Laboratory Accreditation Programm ( LAP ), USA • CPA , Clinical Pathology Accreditation ( UK) Ltd., Standards for the Medical Laboratory
ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration Laboratories ( Based on ISO9001:1994 ) • An international standard for recognising competence in testing & calibration laboratories
ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration Laboratories con’t • Sets out basic quality system requirements in accordance with ISO9001 or 9002 • Laboratories carrying out calibration and testing activities and meeting the requirements will therefore also operate accordance with the ISO 9000 series quality system
Management and Technical criteria for Accreditation • Compliance with criteria in Section 4, Management Requirements; • Compliance with the criteria in Section 5, Technical Requirements of Technical Criteria for Laboratory Accreditation HKLAS 003 • Compliance with HKLAS 002 – regulations governing the administration of HOKLAS and the obligations of accredited laboratories.
UNCERTAINTY OF MEASUREMENT Calibration Laboratories • Accredited for calibrations under the “Calibration Service” Test category • Refer to ISO “Guide to Expression of Uncertainty in Measurement” (GUM) • Refer to EA-4/02, for application of GUM website:www.european-accreditation.org
Testing Laboratories • Required to estimate the uncertainty of measurement in accordance with 184.108.40.206 of the HKLAS 003
Asia Pacific Laboratory Accreditation Cooperation (APLAC) • Established in 1992, Secretary Office in Australia • MRA, Mutual Recognition Agreement • Members consisted of 7 countries, 13 Laboratory accredition bodies (December, 1999 figure) • China, China Taipei, China Hong Kong • Australia • New Zealand • Korea • Singapore • United State • Japan
The Hong Kong Laboratory Accreditation Scheme (HOKLAS) • Found in 1985 • Function : identifying and recognising competent testing & calibration laboratories in Hong Kong • Expanded in 1998, forming Hong Kong Accreditation Service (HKAS)
HKLAS – Scope of Accreditation • Electrical and Electronic Products • Textiles and Garments • Toys and children product • Food • Calibration service • Construction materials • Environmental testing • Chemical testing • Miscellaneous Other Test Categories may be added when significant needs are identified.
Pathology Laboratory Accreditation in Hong Kong • In year 2003 • Mandatory or Voluntary ?? Based on which standard (S ) ??
4.1 Organizaton 4.2 Quality system 4.3 Document control 4.4 Review of request, tenders or contract 4.5 Subcontracting of tests and calibrations 4.6 Purchasing services and supplies 4.7 Service to the client 4.8 Complaints 4.9 Control of NC Testing and/or calibration work 4.10 Corrective action 4.11 Preventive action 4.12 Control of records 4.13 Internal audits 4.14 Management Reviews Technical Criteria – ISO/IEC17025:1999 4. Management Requirements
5.1 General 5.2 Personnel 5.3 Accommodation & environment conditions 5.4 Tests & calibration methods and methods validation 5.5 Equipment 5.6 Measurement traceability 5.7 Sampling 5.8 Handling of test and calibration items 5.9 Assuring the quality of test 5.10 Reporting the results 5. Technical Requiremnts