QA, QC and TQM in MTB Diagnosis
- 1. Total Quality Management Quality Assurance and Quality Control in Tuberculosis Diagnosis Mr. Shankar Shahi Lab Technician (CMLT ,B.Sc. MLT, M.Sc. TQM) Province public Health Laboratory Bagmati Province Mob. 9841467187 Email: shahishankar69@gmail.com
- 2. Quality: The degree of excellence, characteristics which act to satisfy a need Control: A person or thing used as a standard of comparison for checking the results of a survey or experiment.
- 3. What is Quality Control ??? •Quality Control is the process of ensuring manufactured product or performed service to meet the requirements of the client or customer expectations.
- 4. Quality Control in Laboratory: •Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process that produces patient results. •The goal of Quality control is to detect the errors and minimize them. •These errors includes all the errors arising from the sample collection to the dispatched of the report.
- 5. Why ???
- 6. Quality is.... • invisible when GOOD • impossible to ignore when BAD 6
- 7. HOW To Maintain QC ??? By Using 5M Method: Manpower: Trained, Qualified, Competent Machines : Standard, Stable, Technical/user Friendly Materials: Stable, Efficient, Desired qt. & Validated Methods : Standard, sensitive and specific, validated Management: Supportive, Motivate, measurable Follow PDCA cycle to improve service
- 8. 8 QualityAssurance External Quality Assessment Internal Quality Control Pre analytical Analytical Post analytical
- 9. 9 Internal Quality Control •IQC should be carried as part of everyday routine work. •Includes instrument, slides, pencil, marker, forms and checking new lots of staining solutions •EQA is a process to assess laboratory performance. •Allows participating laboratories to assess their capabilities by comparing their results with those in other laboratories in the network
- 10. 10 Key Elements of Internal Quality Control •Laboratory arrangement and Administration •Laboratory Equipment •Specimens and Request Form •Staining Reagents •Staining and Smear Examination •Reporting
- 11. 11 Laboratory Arrangement and Administration: •Perform Sputum microscopy in a secure, dedicated work space •Provide appropriate staff training and monitor their performance •Methods must comply with NTP guidelines
- 12. 12 Laboratory Equipment •Maintain all laboratory equipment in a good working condition •Keep dated service records for all equipment •Monitor microscopes and balances regularly to ensure consistent performance
- 13. 13 Specimens and Request forms •Ensure request forms are completed and specimens correctly labeled. (register---Container---Form) •Reject specimens that are incorrectly labeled, leaking, or in broken containers. •Record the date specimens arrive in the laboratory. •Evaluate the quality of sputum specimens. •Record and monitor the number of salivary specimens received by the laboratory.
- 14. 14 Staining Reagents: • Label all reagents with the name, date of preparation, and the date first opened. • Indicate date received, if staining reagents are prepared in another laboratory . • Any material found to be unsatisfactory should be recorded as such and removed from the laboratory immediately so it is not used. • Limit stocks for six month supply. Rotate stock to ensure that oldest material is used first.
- 15. 15 Staining and Smear Examination • Filter carbol fuchsin regularly. • Include positive and negative controls at least weekly. • Read control slides before patient smears. • Record the results of control smears
- 16. 16 Recording and Reporting • Report microscopy results as soon as specimen is received. • Record all work performed in standard format into the Laboratory Register • Analyze microscopy results on monthly basis to detect changes which may indicate problems.
- 18. 18 What is External Quality Assessment (EQA)? •A process to assess laboratory performance. •EQA allows participating laboratories to assess their capabilities by comparing their results with those in other laboratories in the network.
- 19. 19 Why EQA? •Identifies errors and is used to improve performance across the laboratory network •An important tool for communicating with and motivating staff •Designed to resolve problems and not to punish staff
- 20. 20 EQA: Conducted at All Levels of Testing NRL: National Lab IL: Intermediate Lab PL: Peripheral lab IL PL PL PL PL PL PL IL PL PL PL PL PL PL PL NRL PL
- 22. 22 What is On-site Evaluation? Periodic site visits to assess laboratory practices • Learn “where we are?” • Identifies what is ‘good’ and what areas need improving • Collect information for • Planning & implementation • Monitoring • Continuous improvement Panel Testing On-site Evaluation Blinded Rechecking
- 23. 23 Panel Testing What is Panel Testing? Panel testing is conducted to improve and maintain proficiency in AFB smear examination in all peripheral laboratories that provide sputum microscopy service. Panel slide preparation • Sputum specimen used for panel slide preparation is not more than 2 days old. Panel slides prepared are of negative and positive of different grades. Characterization of panel slides • Each panel set consists of 10 known smears; five ZN stained and five unstained. Both stained and unstained comprises of negative and positive slides of different grades with code numbers. Dispatch of panel slides • Panel slides are packed in slide boxes and sent to districts. • Laboratories are given one month deadline for reporting the result to PHL from the date of panel slides receipt. On-site Evaluation Blinded Rechecking
- 24. Instruction for test laboratories • Standardized form for reporting and recording of panel results are provided to the technicians in the peripheral laboratories. • Panel slides must be examined individually and not as part of a group effort. Feedback : • The reference laboratory must provide feedback to the peripheral laboratory, including scoring for accuracy of the results.
- 25. 26 Blinded Rechecking What is Blinded Rechecking? • Based on Lot Quality Assurance Sampling (LQAS): • A random selection of specimens are collected from the routine workload at the test site and sent to the reference laboratory for validation • Used to confirm that a laboratory meets national performance goals • Detects errors Panel Testing On-site Evaluation
- 26. 27 Why use Blinded Rechecking? • The only EQA method to provide reliable assurance that a country has an effective AFB microscopy network • Reflects reality of routine performance by checking: specimen quality smear technique stain performance accuracy of reading • Provides motivation to staff
- 27. 28 How is Blinded Rechecking Done? 1. Test lab stores all smears 2. Random sample collected 3. Sampled slides sent to control lab 4. Slides rechecked in blind reading 5. Results analysed 6. Report prepared for test lab 7. Follow-up site visit (if indicated)
- 28. 29 Technicians’ Responsibilities Be a willing participant in the EQA program Ensure all slides are stored in correct order Maintain EQA records within the laboratory Communicate outcomes to supervisors Implement recommended corrective actions promptly
- 29. 30
- 30. 31 Scenario A FAMOUS football player has agreed to train with your National Football team. However, upon arrival, the player admits that he has had a cough for one month. Sputum samples are sent to your lab and you send out results of 2+ AFB on two consecutive specimens. His doctor does not believe your results! How can you show your results are correct?
- 31. 32 Correct Result Correct Test • Laboratory has procedures to perform microscopy Qualified Staff • Microscopist trained • Lab register signed by tester Correct Equipment • Microscope in good working order • Maintenance and cleaning records available Quality Control •Reagents working properly as evidenced by QC records of stains •Current SOPs readily available EQA • Laboratory’s work is checked by another laboratory Correct Specimen • Labeled with unique ID • Completed request • Specimen ID match Request
- 32. Monitoring the Quality of Lab TQM Quality policy QA Good laboratory practice Quality control ……………………………… IQC EQA
Editor's Notes
- #32: Consider that the process should be similar to an on-site evaluation because the doctor is looking for the same type of information and evidence