QUALITY CONTROL DR ASR - PREFINAL ppt for

Quality control and quality assurance

1. Quality control & ASSURANCE Dr. S ANAND DR S ANAND

2. Disclaimer – not my objective

3. OVERVIEW OF CONTENTS Quality assurance and its components QUALITY CONTROLS STEPS OF QC – PRE ANALYTICAL/ ANALYTICAL/POST ANALYTICAL AUDIT Total quality management INTERNAL PARAMETERS EXTERNAL PARAMETERS Q PROBE Q TRACK CONTINUOUS DAILY MONITORING

4. OVERVIEW OF CONTENTS EQAS-PROFICIENCY TESTING (PANEL TESTING/RECHECKING & RETESTING/ONSITE SUPEREVISION] ADVANTAGES & DISADVANTAGES OF EACH PROCESS SITUATIONAL ANALYSIS SIX SIGMA – FORERUNNER NABL IQAS SQC- STATISTICS DOCUMEMTATION & RECORDS IN QC/QA MICROBIOLOGICAL KEY PERFORMANCE INDICATORS IOM QC – TESTAMENT TO EXCELLENCE

5. REFERENCES

6. Quality standards

7. Neighbours envy, nations pride

8. Need for quality

9. Need for quality

10. Primary objective Minimizing Variations With a Standard Benchmark Achieving Uniformity & Best result

11. DEFINITION The degree of adherence to predetermined standards. Conformance to the requirements. Doing right things, right way, first time and every time. Fitness for use. Measuring its attributes. Minimizing the variations. Meeting and Surpassing the Customer’s Expectation.

12. QUALITY ASSURANCE FRAMEWORK Benchmarked Responsive/ Patient Centred Equitable Safe Effective Efficient Eco-friendly

13. QUALITY ASSURANCE FRAMEWORK EFFECTIVENESS achieving outcomes as supported by scientific evidence. EFFICIENCY Relates to maximizing the quality of health care delivered or health benefit achieved for a given unit of health care resources used. EQUITY Relates to providing health care of equal quality to those who may differ in personal characteristics PATIENT CENTEREDNESS Relates to meeting patients' needs and preferences and providing education and support. SAFETY Relates to actual or potential bodily harm. TIMELINESS Relates to obtaining needed care while minimizing delays.

14. Evolution of quality Revaluation Evidence based Sustainable and Scientific QUALITY Interventions

15. Assurance Comprehensive control measures & assessment done regularly – lab Should aim for the highest standards OF ALL PROCEDURES AND maintain consistently QA=QC+IQA+EQA Level of assurance – effort put in QC and IQA. EQA IS REFLECTION OF QC+IQA

16. FATHER OF HEALTH CARE - QUALITY A classical approach to developing measures s + p = o Structure + Process = Outcomes

17. HEALTH CARE - QUALITY

18. Lilleyman – summarized object of QUALITY IN LABORATORY as ensuring: ‘

19. Lilleyman – summarized object of QUALITY as ensuring RIGHTS : the right result, from the right tests, done for the right reasons , on the right specimens , from the right patients, with the right interpretations to the right clinicians, at the right time, and at the right cost ’

20. GARVIN – QUALITY AS MULTI DIMENSIONAL :

21. TERMINOLOGIES Quality control : Ongoing , systematic assessment of work to ensure that final products conforms to previously established tolerance limits of precision & accuracy. QC only one facet among larger arena or umbrella of QA. First QC program -1965 Quality- comprises of “TQM+CQI+PI” QC- involves intangible items such as common sense , good judgement ,constant attention to detail , dedication to time Organized – well defined objectives & metrics- to monitor , improve & rectify if needed.

22. QC QA is the method by which the overall process of infectious disease diagnosis is reviewed: Includes three steps: Pre analytic Analytic Post analytic

23. 1 . Pre analytic : Ordering of test by the clinician EXPLANATION OF THE PROCEDURE INFORMED ORAL/WRITTEN CONSENT Processing of test request by the clerical staff APPROPRIATE PROCEDURE , EQUIPMENT, PATIENT & LAB STAFF SAFETY, CONTAINERS AS PER SOP FOR EACH TEST Collection of specimen by health care providers COMPLETE LABELLING OF THE SPECIMEN Transport of specimen to the laboratory Initial processing of specimen in the laboratory STORAGE OF THE SPECIMEN WHEN EVER NECESSARY

24. Quality of report depend on : Quality of specimen Nature & timing of specimen Sampling methods and transport Use of transport media Transit time Adequacy of information given SPECIMEN = PATIENTS LIFE READING

25. Pre analytic : - Table adapted from bailey& scott t

26. Pre analytic :

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33. II. Analytic Interpretation of specimen results by the microbiologist Examination and workup of culture by the microbiologist INTERPRETATION OF SPECIMENT RESULT BY MICROBIOLOGIST

34. III. Post analytic Formulation of a written or printed report by the microbiologist Communication of the microbiologist’s conclusions to the clinician in written or printed format Interpretation of report by the clinician Institution of appropriate therapy by the clinician

35. QA audits: QA audits are planned EXCERCISES , conducted byFINE examining OF the three stages of ANY testing PROCEDURE. Clinical audit topic do not need Ethics committee approval but adheres and abides to ethical framework . Clinical audit refers to specific activity that measures existing clinical care against audit standards / criteria . AIM: The analysis of how the system works and how it can be improved.

36. SCOPE OF AUDIT Aspects of microbiology considered for audit are: Administration Specimen control Processing and reporting Clinicians use of the services SAFE LAB PRACTICES Participation with others in medical audit Audit of antibiotic usage Infection control MORTALITY AUDIT Peer review of services

37. AUDIT OUTCOME - CAPA Corrective action is that action which should be used to stop the occurrence of non-conformities. Preventive action is that which should give the opportunity to prevent potential nonconformities STEPS INVOLVED Reviewing and defining the problem or non-conformity. Finding the cause of problem. Develop an action plan to correct the problem and prevent the recurrence. Implementing the plan. Evaluating the effectiveness of the correction in preventing the problem.

38. total quality improvement/QUALITY MANAGEMENT Quality improvement or total quality MANAGEMENT has given way to Quality assurance BEING “Continuous improvement ” PROCESS Constantly examined – improve performance - ADEQUACY & ACCURACY QM- Internal or External program

39. Risk assessment tools and techniques Implementing Total Quality management does not guarantee an ERROR – FREE Service . Tool – Failure Mode and Effect analysis ( FMEA ) Failure modes ( what could go wrong ?) Failure causes ( Why would the failure happen ?) Failure effects ( What could be the consequences of each failure ?) Failure Correction (How to rectify?)

40. Internal activities: Documentation , verification, validation. Utilization of lab services by clinician . Documentation of performance of technical personnel . Comparing THE observation on same task done by different personnel. Formal evaluation of competencies

41. External activities: Performance evaluated – comparing with peer- External Quality assurance program CAP- 2 programs – Q probes and Q tracks Parameter chosen for evaluation – ‘Indicator’ Lab performance – judged against peers – participation in “ Proficiency testing.”

42. Q probes: Short-term, external peer-comparison studies that provide a one-time comprehensive assessment of key processes - quality improvement. Developed and administered by CAP. Build and improve data collection and analysis processes that contribute to quality of care, patient safety, and outcomes. CAP selects topics to be audited and provides instructions and worksheets for the collection of data. Data collected for specific period and returned to CAP for analysis CAP shows results in form of summary in comparison with peer labs – ‘Benchmarking’ Designated for all areas of laboratory medicine

43. Q-TRACKS Long term studies that allow for continuous/ repetitive monitoring of useful laboratory indicator - performance improvement. Q-TRACKS - evaluate the quality of processes both within and beyond the laboratory - impact test results and patient outcomes .

44. Continuous daily monitoring Aim of microbiologist to ensure best patient care: Example in culture monitoring - (1) comparing results of morphotypes seen on direct examinations with what grows on the culture to ensure that all organisms have been recovered (2) checking antimicrobial susceptibility reports to verify that profiles match those expected from a particular species (3) studying culture and susceptibility reports for clusters of patients with unusual infections or multiple-drug–resistant organisms.

45. Continuous Internal Assessment HOSPITAL DISTRICT STATE NATIONAL Quarterly Assessment by DQAU Periodic Assessment & certification by SQAU National Certification NHSRC Continual Quality Improvement

46. PROFICIENCY TESTING(PT) QA measure used to monitor laboratory analytic performance To compare & judge performance among peer groups First provided by CAP – educational tool for improving laboratory performance Introduction of CLIA(Clinical Laboratory Improvements Amendments) law (1988)- PT became mandated part of doing business in laboratory medicine

47. Laboratories are required to participate in a PT program for each analyte “Blind unknowns” - unknowns are to be treated – routine specimens- from entering in logbook through till reporting of results – signed by director after completion PT specimens establish the accuracy and reproducibility - laboratory’s day-to-day performance. AIM: laboratory’ procedures, reagents, equipment, and personnel are all checked at same time . Errors on PT - point out deficiencies, and - education of the staff- lead to overall improvements- laboratory quality.

48. When grades come back critiques – discussed with the entire technical team. Corrective action taken – documented like changes in procedures, retraining of personnel or the purchase of alternative media and reagents. System of internal PT in addition to those received from external agencies

49. Internal PT done by: Seeding a simulated specimen and labelling it as an autopsy specimen so that no one panics if a pathogen is recovered Splitting a routine specimen for workup by two different technologists Sending part of a specimen to a reference laboratory to compare and confirm the laboratory’s result.

50. OVERVIEW OF EXTERNAL QUALITY ASSESSMENT

51. External Quality Assessment (EQA) A system for objectively checking the laboratory’s performance using an external agency or facility Ensures customers (physicians, patients and health authorities) that the laboratory can produce reliable AND VALIDATED results An indispensable part of a laboratory quality management system EQA Is not coercive or punitive, but competitive and corrective

52. 55 The Quality System ESSENTIALS/QUALITY MANAGEMENT EXTERNAL QUALITY ASSESSMENT Set of coordinated activities that function as building blocks for quality management

53. ISO 15189:2012 Requirements Regarding EQA The laboratory should participate in interlaboratory comparisons such as those organized by EQA schemes The lab management shall monitor the results of EQA and participate in the implementation of corrective actions

54. EQA Benefits Allows inter-lab comparison of performance Serves as an early warning system Identifies systematic problems Provides objective evidence of laboratory quality Serves as an indicator for focusing improvement efforts Identifies training needs Source of continuing education Source of material EVIDENCE for practice

55. EQA Methods External Quality Assessment (EQA) – a process to assess laboratory performance; allows to assess labs’ capabilities and performances by comparing their results with those obtained in other labs in the network On-site supervision Panel testing Blinded rechecking

56. Panel Testing Process Sputum afb as an example NRL sends out sets of stained and/or unstained sputum smears for testing Laboratory technicians analyze smears and return results to NRL Results are evaluated, scores are sent to participants Appropriate corrective actions are undertaken (and documented), if needed

57. National reference laboratory Intermediate laboratory Peripheral laboratories A POSSIBLE SCHEME OF A PANEL TESTING ROUND Peripheral laboratories

58. 61 Panel Testing ADVANTAGES DISADVANTAGES: Low workload for a peripheral center Improves laboratory credibility Rapid response countrywide possible Use of stained and unstained smears can help to identify the source of a problem May lead to identification of faulty equipment Does not measure routine performance High workload for NRL May not be motivating to improve daily performance

59. Blinded - Rechecking/retesting Random sampling of routine slides from a peripheral laboratory for rechecking by a higher-level laboratory The widely used system for rechecking of “10% of negative and 100% of positive smear” is no more recommended The proposed blinded rechecking method is based on the Lot Quality Assurance System (LQAS)

60. 63 Blinded Rechecking ADVANTAGES DISADVANTAGES: Low workload for a peripheral laboratory Motivates to improve daily performance Reflects reality of routine performance Higher workload for a higher level center Needs close adherence to elaborated procedures Can not be used with very low positivity rates The best method for evaluating lab performance Countrywide use Ongoing and permanent

61. On-Site Supervision Periodic visits to the laboratory to assess laboratory practices : Obtain a realistic picture of laboratory practices Provide assistance with problem areas, including training Laboratory experts WITH supervisors When planning site visits, to consider: Frequency Use of checklists Follow-up visits Monitoring corrective actions Training

62. 65 On-Site Supervision ADVANTAGES DISADVANTAGES: Direct personal contact Motivating to staff Observation of actual work Identifies causes of errors Permits verification of equipment quality and function Usually poor coverage Labor intensive Costly Needs very good supervisors Complementary to rechecking and panel testing Implementation and monitoring of quality improvement measures Data collection and flow of information - Benchmark

63. EQA methods: Which one is better? Advantages and drawbacks for all types Influencing factors: goals set up for laboratory sERVICE MORBIDITY/MORTALITY PREVALENCE (MAGNITUDE OF DISEASE) Resources available and projected MAN MATERIAL MONEY METHOD MACHINE TIME

64. Situational Analysis: How to Identify the Most Feasible EQA method(s) For a place? a collection of methods that use to analyze an organization's internal and external environment to understand the organization's capabilities Customers NEED & SATISFACTION OUTPUT MEASURES AND DEVICES METHODS FLEXIBLE/SUITABLE TO THE ORGANIZATION BASED ON ESTABILISHED BENCHMARKS 5C analysis, SWOT analysis and Porter's five forces analysis

65. All quality control programs – one aim –positive patient outcomes Reduced length of stay Reduced cost of stay Reduced turnaround time for diagnosis of infection Change to appropriate antimicrobial therapy Customer (physician or patient) satisfaction

66. TQM Vs SIX SIGMA Six Sigma - new concept TQM. Six Sigma originated in 1986 Aim: quality improvements for achieving near perfection - by restricting the number of possible defects -making precise measurements, identifying problems- measurable solutions. Six Sigma is based on DMAIC (define, measure, analyze , improve, control) The main difference between TQM and Six Sigma is the approach. TQM tries to improve quality by ensuring conformance to internal requirements Six Sigma focuses on improving quality by reducing the number of defects and impurities.

67. Advantages of SIX SIGMA: Reduce operational costs by focusing on reducing defects Minimize turnaround time Trimming the costs. Fact based, data-driven, and results-oriented. Provide quantifiable & measurable bottom-line results Related to customer requirements.

68. Effect of these principles on QC management : Increases: Quality Efficiency Capacity Better patient care Decreases: Cost Inventory space Lead time

69. NABL – dream of labs to become cream in competition

70. NABL - SCOPE

71. NABL - process

72. NABL – ACCREDITATION BENEFITS Customers can search and identify the laboratories accredited by NABL for their specific requirements from the NABL website or directory of accredited laboratories. Increased confidence in reports The customers get services by credential staff. Savings in terms of time and money as it reduces or eliminates the need of re-testing Use of NABL symbol Recognition Satisfaction of the staff Continuous improvement Systematic Control of lab work Better control of laboratory operations and feedback to laboratories Benchmark with best laboratories Rise in Productivity [E & E] 

73. Internal Quality Assessment

74. Benefits of IQA: Regular examinations of rare unusual pathogens Problem with QC,IQA,EQA- noted & resolved All sections can participate regularly media , equipment & procedures – CHANGES assessed Efficacy of training and communication – evaluated Various sections – compared Awareness & competence of staffs – assessed New test , procedures, equipments – checked Influence of arrival time – judged STRICTLY Reporting practices of different teams – compared

75. Iqa – example - amst Quality control of the Inoculum • Quality control ofthe Media • Quality control of the ( antibioticdiscs ) • Incubation condition • End point measurement • Education of the skilled personnel • QC Reference strains • Correctiveand Preventive Action • Trouble shooting

76. Iqa – example – inoculum & mha media qc

77. Turnaround times Important –labs competing for contracts & accreditation Value of reports depend on their timing Other specimens – telephoned according to departmental policy Urgent reports & findings – telephoned at significant stages –assures clinician and patients to get important information without delay & EARLY INITIATION OF RIGHT TREATMENT

78. SQC - STATISTICS

79. SQC - STATISTICS Analytical errors – Accuracy Precision Sensitivity specificity NPV & PPV MEASURES OF DISTRIBUTION – MEAN MEDIAN MODE Standard deviation Coefficient of variation Sd - index

80. SQC – STATISTICS - The Levey-Jennings Control Chart A Levey–Jennings chart is a graph that   quality control   data is plotted on to give a visual indication of precision of lab test The distance from the mean is measured in standard deviations. The date and time, or more often the number of the control run, is plotted on the x-axis. A mark is made indicating how far the actual result was from the mean, which is the expected value for the control. Lines run across the graph at the mean, as well as one, two and three standard deviations to either side of the mean.

81. SQC – STATISTICS - The Westgard rules Westgard rules are used to define specific performance limits for a particular assay (test) and can be used to detect both random and  systematic errors Set of statistical patterns, each being less likely to occur by random variability, thereby raising a suspicion of faulty  accuracy or precision   of the measurement system. Used for  laboratory quality control , in "runs" consisting of measurements of multiple samples Westgard rules are programmed into  automated analyzers   to determine when an analytical run should be rejected.

82. SQC - STATISTICS

83. DOCUMENTS AND records IN QC :

84. Components Of Quality Control Manual : Details of all Qc practises – procedures & schedules fro monitoring Process for monitoring all media and reagents, expiry date , reaction patterns All proficiency testing results. Designed forms with numbers, graphs, diagrams – diagnose any problems & rectify Documentation of the corrective measures taken

85. Maintenance of QC records: CAP – Inspection checklist for laboratories- valuable guideline – point by point assessment of QC needs . RegulAtions – reviewed and revised constantly New ongoing change – New QC control plan by CMS- IQCP( Individualised Quality Control Plan) Minimal QC standards & daily monitoring / surveillance – quality control coordinator QC coordinator – maintain QC manual .

86. Maintenance of QC records: All QC results should be recorded - include a review of the effectiveness of corrective actions Revision of policies and procedures necessary to prevent recurrence of problems Discussion with appropriate staff If temperature is adjusted or a biochemical test is repeated- new readings listed Supervisor reviews and initials all forms weekly & director monthly QC records should be maintained for at least 2 years - On equipment saved for lifetime

87. Key performance indicators

88. Key performance indicators

89. PREREQUISITES - KPI Which data you want to capture? How the data can be capture? Where data can be capture? Who will capture data? See how much data already available? Check Accuracy of Data available! Standardise the format to accurately capture Disseminate format Assign the person to capture data Capture data at periodic interval Analyse the data Plan action Product and Service quality 30 % Customer satisfaction 25 % Operational performance 20 % Employee satisfaction 5 % Financial performance 10 % Supplier performance 5 % Safety /environment /public responsibility 5 % Baldrige Award Criteria - Clinical Microbiology Proficiency Testing, Canada)

90. donts Non- specified/undetermined can waste thousands of work hours if it is analyzing wrong measurements leading to inaccurate decision making. Better to be restricted to the minimal useful indicators. Monitoring more than 10-12 indicators is rarely successful. (Mark Graham Brown, 1996).

91. QC IN IOM – TESTAMENT TO EXCELLENCE

92. QC IN IOM – DIAGNOSTICS Blood section & serology Pus section

93. QC IN IOM – DIAGNOSTICS Sputum, fluids, throat and faeces Urine mycology

94. QC IN IOM – vrdl TESTS POSTIVE CONTROL NEGATIVE CONTROL CALIBRATOR EQAS

95. QC IN IOM – hepatitis & Leptospira TESTS POSTIVE CONTROL NEGATIVE CONTROL CALIBRATOR EQAS

96. QC IN IOM – IRL [NTEP] TESTS POSTIVE CONTROL NEGATIVE CONTROL CALIBRATOR EQAS

97. QC IN IOM – HIV [NACP] TESTS POSTIVE CONTROL NEGATIVE CONTROL CALIBRATOR EQAS NABL

98. QC IN IOM – HLA LAB TESTS POSTIVE CONTROL NEGATIVE CONTROL CALIBRATOR EQAS NABL

99. DOYEN OF QUALITY’S DEPARTING WORDS