2. 1 From Good Laboratory Practice to Total Quality Management in Medical Laboratories : The Perspective October, 2002 S Cheng

3. 2 What is Quality b Quality is the entity of a product ( service ) which fulfils the defined and expected requirement b The customer checks if the product meet the requirements

4. 3 Quality in Medical Laboratory Testing b The right test result, at the b Right time, on the b Right specimen, from the right patient, with result interpretation based on b Correct reference data, and at the b Right price

5. 4 Evolution of Quality Management Philosophy 1930 – 60, Q.C. ( Cure )  1970 – 80, Q.A. ( Preventive )  To-day, TQM ( Holistic involvement )

6. 5 Evolution of Quality Systems

7. 6 Overview on the Functions of The Medical Laboratory

8. 7 Clinical Specimen Adulteration

9. 8 Quality Management System b Achieving customer satisfaction by meeting customer’s expectation and preventing non-conformity at all stage of process from design to service. b Enhance the performance of the organization through internal and external audit

10. 9 QM, QA and QC inter- relationships

11. 10 Why Quality Management is everybody’s darling b Quality costs, but poor Quality costs more b Regulator : reduces workload, ( manpower ) b Blood Industry Officials: makes the environment transparent b Hospitals : reduces responsibility to patients

12. 11 Cost of Quality

13. 12 Demings chain Improvement of quality Improvement of productivity Cost-reductionPrice-reduction Market-share Secure position Secure jobs

14. 13 Demings chain in Laboratory Service Improvement of quality Improvement of productivity Cost-reductionPrice-reduction Market-share Secure position Secure jobs

15. 14 My problems with the definitions of quality b Does the customer have all the information he needs to qualify the products? Service? b Is it his responsibility to check the quality or standards? b Is’nt there a discrepancy between customer’s expectations and requirements ?

16. 15 It is our ethical responsibility to define the level of quality b A patient is not able to figure all transfusion risks. He might be unconscious on intensive care. b We know all about transfusion risk and must be responsible for the safety. b A perfect balance is the major support for a good quality management.

17. 16 Flawless quality management: ( Error Management ) b Quality management has to be flawless. Discovery of errors in documents, or problems must lead to the consideration to end, or change the process.

18. 17 Quality Layers 1. Minimal requirements “ Bad Quality” 2. Functional Requirement “Quality” 3. Non-functional requirements “Good Quality” 4. Far ahead of customer expectations “Excellence”

19. 18 Should’nt we achieve excellence ? Quality = Excellence Excellence begins in your mind

20. 19 Quality Planning b Part of Quality management focused on setting quality objectives and specifying necessary processes and related resources to fulfil the quality objective

21. 20 3 E in quality b Effectiveness ( doing the right things) - extent to which planed activities are realized and planed results achieved - extent to which planed activities are realized and planed results achieved b Efficiency ( doing things right ) - relationship between the result achieved and the resources used - relationship between the result achieved and the resources used b Excellence - Doing the right things right !! - Doing the right things right !!

22. 21 The 8 columns of excellence Orientation on results Orientation of customers Leadership & consequences of goals Management of processes & facts Involvement of employees Continuous learning Building partnerships Responsibility for the community

23. 22 Achieved By Good Practices b GLP – Good Laboratory Practice b GCL – Good Clinical Practice b GMP – Good Manufacturing Practice b GTP – Good Transportation Practice b GDP – Good Distribution Practice b GAMP – Good Automated Manufacturing Practice b GRP- Good Regulatory Practice

24. 23 Medical laboratory quality system b A quality system is essential in the laboratory to ensure the correct results for the correct patient / donor b By Good Laboratory Practice ( GLP ) ( GLP )

25. 24 Good Laboratory Practice( GLP ) b Main areas of GLP - Organization and personnel - Organization and personnel - Facilities - Equipment - Reagent / test kits - Documentation - Inter-laboratory comparison

26. 25 Organization and Personnel b Quality management system On Accountability On Accountability -Responsibilities -Responsibilities -Authorities -Authorities b Training - Competency based - Competency based

27. 26 Facilities b Appropriate infrastructure b Safety measures b Hygiene measures

28. 27 Equipment b Validated - Does it do what you want it to do ? - Does it do what you want it to do ? b Maintained b Calibrated

29. 28 Reagents / Test Kits b Evaluated b Methodology validated b Test run validated - Kit / reagent controls - Kit / reagent controls - Internal control - Internal control

30. 29 Documentation (1) b Testing strategies / protocols - Specimen identification - Specimen identification - Confidentiality - Confidentiality b SOPs - Sample processing - Sample processing - Test performance and result interpretation - Test performance and result interpretation - Inspection of incoming goods - Inspection of incoming goods - Validation - Validation - Equipment maintenance and calibration - Equipment maintenance and calibration - Safety - Safety

31. 30 Documentation (2) b Records - Test results - Test results - Equipment maintenance - Equipment maintenance - Equipment calibration - Equipment calibration - Control charts - Control charts - Validation - Validation - Training - Training

32. 31 Inter-laboratory comparison b External Quality Assurance Scheme ( Proficiency Test, P.T. ) ( Proficiency Test, P.T. )

33. 32 By Other Quality Management System International Standards e.g. ISO 9000 series, ISO/IEC 17025:1999 ISO/IEC 17025:1999 ( General Requirements for the Competence of Testing and Calibration Laboratories ) ( General Requirements for the Competence of Testing and Calibration Laboratories )

34. 33 ISO1/IEC 17025, ISO15189 Development History ISO1/IEC 17025, ISO15189 Development History

35. 34 In1985 JCAHO published its 10-step QA monitoring process. 1. Assign responsibility for QA plan. 2. Define scope of patient care. 3. Identify important aspects of care. 4. Construct indicators. 5. Define thresholds for evaluation. 6. Collect and organize data. 7. Evaluate data. 8. Develop corrective action plan. 9. Assess action; document improvement. 10. Communicate relevant information.

36. 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:

37. 36 Nine Dimension b Efficacy b Appropriateness b Availability b Timeliness b Effectiveness b Continuity b Safety b Efficiency b Care and Respect

38. 37 National Accreditation Scheme b CAP Laboratory Accreditation Programm ( LAP ), USA b CPA, Clinical Pathology Accreditation ( UK) Ltd., Standards for the Medical Laboratory ( UK) Ltd., Standards for the Medical Laboratory

39. 38 ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration Laboratories ( Based on ISO9001:1994 ) b An international standard for recognising competence in testing & calibration laboratories

40. 39 ISO/IEC 17025:1999- General Requirements for the Competence of Testing & Calibration Laboratories con’t b Sets out basic quality system requirements in accordance with ISO9001 or 9002 b Laboratories carrying out calibration and testing activities and meeting the requirements will therefore also operate accordance with the ISO 9000 series quality system

41. 40 ISO9001:1994 – The Role and Function of 20 Elements

42. 41 Management and Technical criteria for Accreditation b Compliance with criteria in Section 4, Management Requirements; b Compliance with the criteria in Section 5, Technical Requirements of Technical Criteria for Laboratory Accreditation HKLAS 003 b Compliance with HKLAS 002 – regulations governing the administration of HOKLAS and the obligations of accredited laboratories.

43. 42 UNCERTAINTY OF MEASUREMENT Calibration Laboratories b Accredited for calibrations under the “Calibration Service” Test category b Refer to ISO “Guide to Expression of Uncertainty in Measurement” (GUM) b Refer to EA-4/02, for application of GUM website:www.european-accreditation.org

44. 43 Testing Laboratories b Required to estimate the uncertainty of measurement in accordance with 5.4.6.2 of the HKLAS 003

45. 44 Asia Pacific Laboratory Accreditation Cooperation (APLAC) b Established in 1992, Secretary Office in Australia b MRA, Mutual Recognition Agreement b Members consisted of 7 countries, 13 Laboratory accredition bodies (December, 1999 figure) 1. China, China Taipei, China Hong Kong 2. Australia 3. New Zealand 4. Korea 5. Singapore 6. United State 7. Japan

46. 45 The Hong Kong Laboratory Accreditation Scheme (HOKLAS) b Found in 1985 b Function : identifying and recognising competent testing & calibration laboratories in Hong Kong b Expanded in 1998, forming Hong Kong Accreditation Service (HKAS)

47. 46 HKLAS – Scope of Accreditation b Electrical and Electronic Products b Textiles and Garments b Toys and children product b Food b Calibration service b Construction materials b Environmental testing b Chemical testing b Miscellaneous Other Test Categories may be added when significant needs are identified.

48. 47 Pathology Laboratory Accreditation in Hong Kong b In year 2003 b Mandatory or Voluntary ?? Voluntary ?? Based on which standard (S ) ??

49. 48 Technical Criteria – ISO/IEC17025:1999 4. Management Requirements 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

50. 49 5. Technical Requiremnts 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

51. 50 Quality Policy – determined and issued by the Top Management

52. 51 Documentation Structure : hierarchy Documentation Structure : hierarchy

53. 52 Documentation System Documentation System

54. 53 Document Control Document Control

55. 54 Benefits of Quality Systems b Consistently achieve ‘customers’ requirements b Minimize errors, “waste” and complaints b Improve efficiency b Reduces - negative impact on customers - negative impact on customers - likelihood of litigation - likelihood of litigation - communication breakdown - communication breakdown

56. 55 Con’t b Improve safety and morale b Standardization b Ensure adequacy of resources b Build-in improvement tools b Facilitates changes & easier problem solving

57. 56 ISO 15189 Medical Laboratories – Particular requirements for quality and competence ( Based on ISO9001:2000) ISO 15189 Medical Laboratories – Particular requirements for quality and competence ( Based on ISO9001:2000) 4 Management requirement 4.1 Organisation and management 4.2 Quality management system 4.3 Document control 4.4 Review of requests and contracts 4.5 Examination by referral laboratories 4.6 External services and supplies 4.7 Advisory services

58. 57 Medical Laboratories – Particular requirements for quality and competence (con’t) 4.8 Resolution of complaints 4.9 Identification and control of nonconformities 4.10 Continual improvement 4.11 Corrective action 4.12 Preventive action 4.13 Quality and technical records 4.14 Internal audits 4.15 Management review

59. 58 Medical Laboratories – Particular requirements for quality and competence (con’t) 5 Technical requirements 5.1 Personnel 5.2 Accommodation and environmental conditions 5.3 Laboratory equipment 5.4 Pre-examination procedures 5.5 Examination procedures 5.6 Assuring the quality of examination procedures 5.7 Post-examination process 5.8 Reporting of results 5.9 Alterations and amendments of reports

60. 59 Continual Improvement Continual Improvement

61. 60 Deming Cycle (Plan, Do, Check & Act) Deming Cycle (Plan, Do, Check & Act)

62. 61 Seven Determinants in TQM

63. 62

64. 63 Model for Medical Laboratories with Patient / Client as “Customer”

65. 64 New Rules of the Game….. b Diminishing Resources b Lowering of staff level b Increasing Accountability b Increasing Regulation b Complex Relationships b Rate of changes b New value Systems The Age of Innocence is over The Age of Innocence is over

66. 65 The Drive for Public Sector Efficiencies b The quest for balanced Budgets b Monopolies and monopsonies b Privatisation b Regionlization b Price signals

67. 66 Some Common Goals b Standardize Business System b Standardize System Performance b Strengthen the Skills of our People

68. 67 Customers Focus and Expectation continue for Good Price for Best Quality

69. Model of process-based quality management system Overview of ISO 9001:2000 Resource management Measurement, analysis & improvement Product Realization Continual Improvement of the Quality Management System Input Output Management responsibility Customers (and other interested parties) Requirements Customers (and other interested parties) Satisfaction

70. 69 Quality Standard Compliance Triangle & Quality System Accreditation/Certification

71. 70 “The system approach begins when first you see the world through the eyes of another” C.W. Churchman 1968