Laboratories And EQA for effective Tuberculosis Control Programe

1. Laboratories And EQA for effective Tuberculosis Control Programe Gokarna Raj Ghimire Senior Medical Technologist National Tuberculosis Center

2. Introduction • The global burden of TB is high • Untreated smear positive cases are highly infectious • Nepal has steady case finding rate (75%) • Treatment success rate (90 %) • Slide positivity rate still on average 10 % • DO NOT miss diagnosis • DO CORRECT TREATMENT FULL DOSE FULL PERIOD OF TIMR

3. Laboratories and lab networks are a fundamental component of NTP. • It provides testing for diagnosis, treatment monitoring, evaluating the success of treatment and surviellance. • Laboratory should do: • New Initiatives • Strengthen the lab capacity including HR • Implement rapid and new diagnostic tests • Implement quality system and safety system

4. Strength of lab network reflects the success of NTP • Good quality microscopic centers (ZN technique) • Fluorescence Microscopy (Auramine techniques) • Culture and DST (Solid and Liquid) • Molecular techniques, (Gene Xpert, LPA) • Trained staff • Good Quality management System

5. Microscopy • Microscopy remains mainstay of rapid, cheap, easy method of TB case detection • ZN smear is still the most common test. • Low sensitivity, so look for advanced method • FM has high sensitivity • Concentrated technique with FM has more higher sensitivity • Monocular microscope-binocular-fluoresence microscope

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7. Culture and DST • Confirmed diagnostic test • Need high quality lab infrastructure, equipments and HR • Useful diagnostic tools for EP cases, childhood TB cases, HIV-TB cases, MDR-TB Cases, XDR-TB cases • FLD/SLD DST • Facilities are available at NRL/NTC and GENETUP • Purposed places: BPKIHS Dharan, RTC Pokhara, Mid west Surkhet

8. Mycobacterial Colonies on Egg based Culture Medium (LJ medium) 8

9. Nucleic Acid Amplification tests • Gene Xpert : Fully Automated, Cartridge based, Real Time, Nucleic Acid Amplification Test (NAAT) • LPA: Manual PCR, Detection by Hybridization strip,

10. Specimen Transportation 10

11. EXTERNAL QUALITY ASSESSMENT (EQA) IN NEPAL FOR SPUTUM MICROSCOPY

12. External Quality Assessment (EQA) • A system for objectively checking the laboratory’s performance using an external agency or higher authority • Ensures customers (physicians, patients and health authorities) that the laboratory can produce reliable results • An indispensable part of a laboratory quality management system

13. The Quality System Quality System Essentials (QSE) Set of coordinated activities that function as building blocks for quality management EXTERNAL QUALITY ASSESSMENT

14. Requirements Regarding EQA • The laboratory should participate in inter-laboratory comparisons such as those organized by EQA schemes ( Total 554 Microscopy centers are exists in Governmental organization and NGO/INGO/Private institution) • The lab management shall monitor the results of EQA and participate in the implementation of corrective actions

15. 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 for practice

16. EQA for AFB Smear Microscopy Consensus document: External Quality Assessment for AFB Smear Microscopy (2002)

17. QCA at National Quality Control Centre (NTC) QCA at Regional Quality Control Centre DTLO DTLO PMC PMC PMC PMC PMC Current EQA Structure National Problem slides If 100% slides correct If some slides incorrect Regional DTLO holds meeting to discuss results with PMCs District Local =Slides =Feedback

18. Structure of Quality Control System National TB Centre Central level Regional level WDR RTC EDR GoN/BNMT CDR NTC FWDR GoN/FAITH MWDR GoN District level DPHO/DHO Periphery level Microscopy Centre

19. Flow of Quality Control System On Quarterly Basis 2. Send Collected Smear Slides With Form (QC 1) Selecting by using LQAS DTLO 3. Cross Check Assessment (QC 2) 1. Keep all Slides Report Feed-Back (QC 3) Microscopy Centre Regional Quality Control Centre RTLO 5. Supervision Refresher Training

20. 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 Panel testing Blinded rechecking On-site supervision EQA Methods for AFB Smear Microscopy

21. Panel Testing Process • 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

22. Blinded Rechecking • 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)

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

24. EQA methods: Which one is better? • Advantages and drawbacks for all types • Influencing factors: • NTP goals set up for laboratory services development • TB prevalence in the country • Centralization / decentralization of health services • Resources available and projected • Cost, time • Logistical questions

25. Panel Testing

26. Panel Testing: Indications for Use • Minimal first step for EQA with limited resources • Rapid assessment of gross deficiencies • Evaluates proficiency of laboratory technicians prior to and following training • A tool during problem-oriented supervision

27. Blinded Rechecking • Indications for use: • The best method for evaluating lab performance • Countrywide • Ongoing and permanent

28. On-Site Supervision

29. On-Site Supervision: Indications for Use • Complementary to rechecking and panel testing for constructive feedback and problem solving • Implementation and monitoring of quality improvement measures • Data collection and flow of information among laboratory levels

30. EQA: Important Issue Blinded rechecking or panel testing should be complemented by very targeted problem-oriented supervision conducted by a trained staff

31. Situational Analysis Of EQA Nepal • Medium Size Population; • Vast different territory • Low Burden of TB • Several hundreds of geographically dispersed peripheral laboratories • RQCC’s (Intermediate laboratories’) infrastructure is not well developed; many intermediate labs experience lack of staff • NRL/NTC is not well equipped and sufficient staffed

32. Key Messages (I): • EQA can be defined as a system for objectively checking the laboratory’s performance using an external agency or facility • EQA for AFB smear microscopy allows participating laboratories to access their capabilities and performances by comparing their results with those in other laboratories in the network • EQA for AFB sputum smear microscopy include three methods: • Panel testing • Blinded rechecking • On-site supervision

33. Key Messages (II): • Effective use of each of EQA methods will highly depend on resources, NTP goals, TB prevalence, health services’ structure and the stage of laboratory quality assurance activities development in the country • Blinded rechecking or panel testing should be complemented by very targeted problem-oriented supervision conducted by a trained staff

34. Thank You