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Role of Laboratory Services in TB Control Part - I C N Paramasivan Tuberculosis Research Centre Indian Council Of Medic

2. Role of Laboratory Services in TB Control. Organization of laboratory servicesRole of smear microscopyQAP of smear microscopyOrganization of QAPRole of culture/ DSTOrganization of DRS. 3. PDF Documents. WHOLABORATORY SERVICES IN TUBERCULOSIS CONTROLORGANIZATION AND MANAGEMENTSmear microscopyCultureGlobal DRS Report IIIWHO IUATLD DRS GuidelinesGeneric DRS protocol of IndiaAPHLS, CDC, WHO etc EQA GuidelinesRNTCP EQA Guidelines.

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Role of Laboratory Services in TB Control Part - I C N Paramasivan Tuberculosis Research Centre Indian Council Of Medic

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    1. Role of Laboratory Services in TB Control Part - I C N Paramasivan Tuberculosis Research Centre Indian Council Of Medical Research Chennai , India

    2. 2 Role of Laboratory Services in TB Control Organization of laboratory services Role of smear microscopy QAP of smear microscopy Organization of QAP Role of culture/ DST Organization of DRS

    3. 3 PDF Documents WHO LABORATORY SERVICES IN TUBERCULOSIS CONTROL ORGANIZATION AND MANAGEMENT Smear microscopy Culture Global DRS Report III WHO IUATLD DRS Guidelines Generic DRS protocol of India APHLS, CDC, WHO etc EQA Guidelines RNTCP EQA Guidelines

    4. 4

    5. 5 National Laboratory Infrastructure

    6. 6

    7. 7

    8. 8

    9. 9

    10. 10

    11. 11

    12. 12

    13. 13

    14. 14

    15. 15 Desirable Features

    16. 16

    17. 17 Aims of sputum microscopy

    18. 18 Advantages of sputum microscopy

    19. 19 Diagnosis of pulmonary tuberculosis

    20. 20 Three sputum smears are optimal

    21. 21 A good smear

    22. 22 False negative results

    23. 23 Consequences of false negative smear results

    24. 24 False positive results

    25. 25 Consequences of false positive results

    26. 26 Comparison of flourescence microscopy & Ziehl-Neelson staining in culture positive cases

    27. 27 Spot & collection specimens: smear & culture results of various combinations

    28. 28 Consistency of smear results in duplicate specimens from sm+ve pts.

    29. 29 Schedule of sputum examinations

    30. 30

    31. QAP IN SPUTUM SMEAR MICROSCOPY

    32. 32 COMPONENTS OF QAP Quality Control Quality Improvement Proficiency Testing

    33. 33

    34. 34 The Quality System

    35. 35

    36. 36 QUALITY CONTROL A process of effective & systematic monitoring of laboratory performance Ensures that the laboratory results are accurate, reliable and reproducible Ensures the competency of diagnostic services

    37. 37

    38. 38

    39. 39 Ensures Detection of errors Prompt and corrective measures Preventive maintenance Continuous training of staff Documentation Coordination Timely feedback QAP

    40. 40

    41. 41

    42. 42

    43. 43

    44. 44

    45. 45

    46. 46 Specificity and Sensitivity Specificity Set at 100% Any false positive should trigger action. Sensitivity Ability of LTs to detect AFB relative to the Controllers Recommended Sensitivity = 75-90%

    47. 47 FALSE POSITIVE AND FALSE NEGATIVE False positive Permissible ERROR rate of close to ‘0’ False Negative Are to be expected with ‘Scanty smears’.

    48. 48 EQA METHOD CONSIDERATIONS “The focus of EQA is on the identification of laboratories where there may be serious problems resulting in poor performance, not on the identification of individual slide errors or the validation of individual patient diagnoses” Three methods to evaluate laboratory performance: On-site evaluation Panel Testing Blinded rechecking

    49. 49 Observation of Worker performance under actual conditions Condition of Equipment Laboratory Safety Adequacy of supplies Processing Smearing Staining Reading Reporting Problem Solving On site Evaluation

    50. 50 On-site visit by personnel should make sure Availability of: Written standard operating procedure An adequate supply of reagents within expiration dates Proper, well functioning equipment and an adequate supply of consumables such as a functional Microscope, slides etc. Internal QC is performed at the required intervals. Laboratory Safety practices are observed. Record keeping is accurate and consistent with requirements of NTP Results are promptly reported to treatment centers or physicians Staff have received adequate training with refresher courses.

    51. 51

    52. 52 Panel Testing A system for sending stained and/ or unstained slides from the central laboratory to the peripheral sites for reading and interpretation at regular intervals is recommended as the minimum requirement to assess proficiency Least expensive and resource intensive of the 3 methods of EQA Limitation: Checks only Technicians ability to stain and/ or read smears not a useful means to assess routine laboratory performance

    53. 53 Panel Testing Panel Testing is useful to: Supplement rechecking program Provide some preliminary data on peripheral laboratory capabilities prior to implementing a rechecking program Assess current status of performance or to quickly detect problems associated with very poor performance Evaluate proficiency of laboratory technicians following training Monitor performance of individuals when adequate resources are not available to implement a rechecking program.

    54. 54

    55. 55 Blinded Rechecking Blinded rechecking / rereading- Best Method Peripherals Sites- Controller High level lab. A country wide program for blinded rechecking of slides at regular intervals should be the long term goal for optimal EQA.

    56. 56 Classification of Errors

    57. 57

    58. 58 QUALITY IMPROVEMENT Process by which laboratory services are analyzed continuously to improve reliability, efficiency & utilization Achieved by anticipating & preventing problems rather than by identifying & correcting problems after their occurrence Most efficient during on-site visits

    59. 59 LQAS Lot Quality Assurance Sampling Optimal sample size Statistically acceptable samples Assesses work quality of Laboratory technicians

    60. 60 VARIABLES USED IN DETERMINING SAMPLE SIZE LOT Results in a economical and statistically valid sample. Total number of negative slides per year, per quarter, per month. importance of choosing time interval.

    61. 61 Critical value An upper threshold of the proportion of false negatives To be chosen from an estimate Historical false negative rates Calculation based on; Prevalence of positives Expected parameters of sensitivity and specificity comparing to controller.

    62. 62

    63. 63

    64. 64

    65. 65

    66. 66 FOLLOW-UP ACTION

    67. 67

    68. 68

    69. 69 Summary Establishment of a Laboratory network is an important function of a National level Program Manager Internal Quality Control and External Quality Assurance are essential for ensuring proper diagnosis by sputum smear microscopy

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