From Good Laboratory Practice to Total Quality Management in Medical Laboratories : The Perspective

1. From Good Laboratory Practice to Total Quality Management in Medical Laboratories : The Perspective October, 2002 S Cheng

2. 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

3. 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

4. Evolution of Quality Management Philosophy 1930 – 60, Q.C. ( Cure )  1970 – 80, Q.A. ( Preventive )  To-day, TQM ( Holistic involvement )

5. Evolution of Quality Systems

6. Overview on the Functions of The Medical Laboratory

7. Clinical Specimen Adulteration

8. 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

9. QM, QA and QC inter-relationships

10. 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

11. Cost of Quality

12. Demings chain Improvement of quality Improvement of productivity Market-share Price-reduction Cost-reduction Secure position Secure jobs

13. Demings chain in Laboratory Service Improvement of quality Improvement of productivity Market-share Price-reduction Cost-reduction Secure position Secure jobs

14. 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 ?

15. 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.

16. 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.

17. Quality Layers • Minimal requirements “ Bad Quality” • Functional Requirement “Quality” • Non-functional requirements “Good Quality” • Far ahead of customer expectations “Excellence”

18. Should’nt we achieve excellence ? Quality = Excellence Excellence begins in your mind

19. Quality Planning • Part of Quality management focused on setting quality objectives and specifying necessary processes and related resources to fulfil the quality objective

20. 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 !!

21. 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

22. 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

23. 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 )

24. Good Laboratory Practice( GLP ) • Main areas of GLP - Organization and personnel • Facilities • Equipment • Reagent / test kits • Documentation • Inter-laboratory comparison

25. Organization and Personnel • Quality management system On Accountability -Responsibilities -Authorities • Training - Competency based

26. Facilities • Appropriate infrastructure • Safety measures • Hygiene measures

27. Equipment • Validated - Does it do what you want it to do ? • Maintained • Calibrated

28. Reagents / Test Kits • Evaluated • Methodology validated • Test run validated - Kit / reagent controls - Internal control

29. 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

30. Documentation (2) • Records - Test results - Equipment maintenance - Equipment calibration - Control charts - Validation - Training

31. Inter-laboratory comparison • External Quality Assurance Scheme ( Proficiency Test , P.T. )

32. 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 )

33. ISO1/IEC 17025, ISO15189 Development History

34. 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.

35. 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:

36. Nine Dimension • Efficacy • Appropriateness • Availability • Timeliness • Effectiveness • Continuity • Safety • Efficiency • Care and Respect

37. National Accreditation Scheme • CAP Laboratory Accreditation Programm ( LAP ), USA • CPA , Clinical Pathology Accreditation ( UK) Ltd., Standards for the Medical Laboratory

38. 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

39. 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

40. ISO9001:1994 – The Role and Function of 20 Elements

41. 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.

42. 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

43. Testing Laboratories • Required to estimate the uncertainty of measurement in accordance with 5.4.6.2 of the HKLAS 003

44. 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

45. 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)

46. 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.

47. Pathology Laboratory Accreditation in Hong Kong • In year 2003 • Mandatory or Voluntary ?? Based on which standard (S ) ??

48. 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

49. 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

50. Quality Policy – determined and issued by the Top Management