QUALITY ASSURANCE CHALLENGES IN MALARIA CONTROL

1. QUALITY ASSURANCE CHALLENGES IN MALARIA CONTROL Ministry of Health and Family Welfare Government of India Present By Dr. Rajendra S. Shukla, Joint Secretary Dr. G.P.S. Dhillon, Director

2. Outline of Presentation • Introduction • Quality Assurance / Control- Concept • Quality Assurance / Control- Malaria • Diagnosis • Treatment • Vector Control

3. Life Cycle of Malaria Parasite

4. Source: World Malaria Report 2008, WHO

5. Disease burden • 40% of the world’s population lives in endemic areas • 300-500 million clinical cases per year • 1.5-2.7 million deaths (90% Africa) • Increasing problem (re-emerging disease) • resurgence in some areas • drug resistance ( mortality)

6. India’s contribution to malaria in SEA (2007) India contributes to 71% of total malaria cases in the SEA region 6

7. Malaria Endemic Areas *Andhra, Chhattisgarh, Gujarat, Jharkhand, MP, Maharashtra, Orissa, Rajasthan

8. MALARIA SITUATION IN INDIA • National Malaria Control Programme-1953 • National Malaria Eradication Programme-1958 • Country wide Surveillance for malaria established 1961 • Active surveillance • Passive Surveillance

9. Quality Assurance Model Defining Quality QA is a cyclical, interactive process that must be applied flexibly to meet the needs of a specific program Q A Improving Quality Measuring Quality Source: Quality Assurance Project (funded by USAID)

10. Shewhart Cycle: PDCA • Plan: Establish objectives and processes required to deliver the desired results. • Do: Implement the process developed. • Check: Monitor and evaluate the implemented process by testing the results against the predetermined objectives. • Act: Apply actions necessary for improvement if the results require change. Author: Dr. W. Edwards Deming

11. Defining Quality Assurance Dr. Donabedian broadly defines it as  ”all the arrangements and activities that are meant to safeguard, maintain, and promote the quality of care”.  Drs. Ruelas and Frenk, who have conducted extensive QA work in Mexico, define it as  ”a systematic process for closing the gap between actual performance and the desirable outcomes. . . .” Dr. Heather Palmer, a QA expert in U.S. ambulatory care, defines it as a  ”process of measuring quality, analyzing the deficiencies discovered, and taking action to improve performance followed by measuring quality again to determine whether improvement has been achieved. It is a systematic, cyclic activity using standards of measurement”.  Source: Lori DiPrete Brown et al in “QA of health care in developing countries”

12. Quality Assurance Cycle – an example Pre-Analytic Patient/Client Prep Sample Collection Personnel Competency Test Evaluations • Data and Lab Management • Safety • Customer Service Reporting Post-Analytic Sample Receipt and Accessioning Record Keeping Quality Control Sample Transport Testing Analytic

13. Components of QA Programme for Lab Related Tests & Procedures Adhering to Standard Operating Procedures Ensuring correct methods of specimen/sample collection Ensuring quality of reagents used and calibration of equipment Performing tests with proper precision and accuracy Interpreting results correctly Detecting errors in techniques and taking corrective steps Documenting procedures, results, etc. Timely feedback Monitoring and evaluation Coordination and supervision Adequate training and re-training

15. Internal and External Quality Assurance

16. Diagnosis of Malaria • Previously, only microscopy was used for diagnosis • Now it is supplemented by use of Rapid Diagnostic Kits in remote areas of high endemic districts, especially, in project states covering vulnerable populations • to improve diagnosis, and • to provide timely treatment for preventing deaths/ disability due to malaria

17. Blood Examination GOLD STANDARD : Microscopy of JSB-stained thick and thin smears access to quality microscopy services

18. Quality Control: Diagnosis • LABORATORY • Space, work environment • Water supply, Distilled water for stains • Electricity • 2. MICROSCOPE • Specifications: prescribed by NVBDCP • Maintenance through AMC • Spares –Oil immersion lenses • Natural light – Light from north side • 3. PERSONNEL (Technicians) • Qualifications: as prescribed • Induction training • Re-orientation training Contd….

19. Quality Control: Diagnosis • 4. MICROSLIDE • Quality micro-slide as per BIS specifications • Proper cleaning as per NVBDCP guidelines • Proper washing for re-use, not beyond ten time use • 5. IMMERSION OIL • Proper oil – (Liquid paraffin with matching refractive index of glass slide) • Timely replacement • 6. STAIN • Prescribed JSB-I and JSB-II stain • Use of stain as per guidelines • Analytical Grade ingredients • Stain preparation as per guidelines Contd….

20. Quality Control: Diagnosis • A. Slide Preparation • - Blood: 2-3 big drops • - Smear: 10 mm away from the edge. • 10 mm diameter • 10 layer of RCB: newsprint can be read through smear • Uniform • Proper labeling: Slide No., Workers code No. etc. • B. Thin smear • - Blood: 1 drop on the middle of the slides uniform tongue shaped • C. Staining of slide • Proper training by ensuring use of filtered & mature stain • D. Buffer Water • Preparation as per guidelines • E. Slide examination • Always examine thick smear • Examine minimum 100 fields before declaring negative • Refer to thin smear for species identification Contd….

21. Quality Assurance - Microscopy • Regular supervision of LABORATORY BY MO-PHC • CROSS CHECKING • 10% of negative slides (Random number allocation i.e. any ending digit from 0 to 9 as decided by the state HQ) • 8.5% cross checked by State Referral Laboratories • 1.5% by concerned ROH&FW • - All positive slides • 50% cross checked by State Referral Laboratories • 50 % by concerned ROH&FW Contd….

22. Quality Assurance Microscopy • Action on Cross Checking Report • Discrepancy up to 2% warrants no action but further observation • Discrepancy more than 2% - identify the microscopist / performer and impart intensive/reorientation training, and observe

23. Quality Control - RDT Contd….

24. Quality Control - RDT • Specifications of RD Kits • GMP Product • Transportation of RD Kits at proper temperature below 400 C • Storage below 31oC • Training of workers and other personnel - both induction and re-orientation • Ensuring logistics

25. Proposed QA of RDTs • Procurement of validated product with pre- procurement quality evaluation certificate by authorized institution (NIMR) • WHO recommends 95% sensitivity at  200 parasite/l blood, NVBDCP also follows the same specification • Pre-dispatch sampling • Post-dispatch • Batch testing to assess the quality of supplied RDTs, • Lot quality testing to assess any deterioration in the field at quarterly intervals • QC panel prepared from parasitized blood to be used for QA • NVBDCP has developed the SOP for QA (RDT) • Malaria Technical Supervisors to supervise quality of tests done by ASHA/ health worker Contd….

26. QA of RDT has been outsourced to NIMR to implement as an operational research in 16 high endemic states States were sensitized on the QAP: 13th May 09 NVBDCP has trained NIMR on QC panel prep: 26th - 30th May’ 09 QC Panels prepared from Pf culture & wild parasite (Orissa & Karnataka). Training of the Regional labs (6) to be completed by Sept’09 Sensitization of DMOs to be completed by Sept’09 The project will be initiated immediately after the procurement & supply of RDTs to the states - Post dispatch QA for batch testing. QA of RDTs used by ASHA/MPWs will commence Oct’ 09 onwards. Proposed QA of RDTs

27. Quality Control – Treatment • Appropriate drug policy: to ensure use of effective drugs • Use of GMP products • Training of health personnel on drug administration • Guidelines for treatment, referral as well as management of severe cases • The facilities for diagnosis & treatment up to community level through community volunteers like ASHA and other functionaries • Special training of health personnel including community volunteers on diagnosis & treatment and reorientation from time to time Contd….

28. Quality Assurance – Treatment • Regular replenishing system by visit of health workers to community volunteers on the beat day as well as the scheduled visit of malaria technical supervisors (MTS) for checking it • Monitoring of supply chain management right from centre to field level through a special agency • Monitoring of therapeutic efficacy in collaboration with NIMR by conducting 15 studies in a year in different places to ensure that effective drugs are used in the programme • Pharmaco-vigilance study through NIMR for monitoring side- affects of drugs for taking appropriate actions

29. Guidelines and SOP Operational Manual for Implementation of Malaria Programme National Drug Policy for Treatment of Malaria cases Laboratory SOP

30. QA for Insecticides in Use • Quality Certificate by either Govt. Labs (Centre/ States) or independent accredited labs. • Pre-dispatch samples / Post dispatch one or two samples collected within the shelf life • All samples are picked by Govt. Officials • Three samples for each batch • Samples are sealed signed by all stakeholders . One set of samples is kept with manufacturer , another set with Govt. and third is sent to laboratory test • Testing - as per BIS specifications • Monitoring of vector resistance to the insecticides by using WHO susceptibility test kits through NIMR to ensure that effective insecticides are used

31. Quality Control –Indoor Residual Spray • Procurement - as per BIS specifications • Packaging -as per BIS specifications • Stratification of area through village level data/GIS mapping to identify the focus of high malaria endemic areas for intensive IRS activities • The training of spray squad for ensuring quality spraying • Checking of nozzle discharge every day as per specification –(750-840 ml/min) • Checking of spray pumps in advance • Checking of compressor -40 psi at tank & 10 psi at nozzle • Checking of swath (52.5 cm with overlapping of 7.5 cm when the nozzle is kept at 45 cm from the spray surface) • 85% coverage of rooms

32. Quality Assurance for IRS • Concurrent supervision : Regular supervision of spray by malaria supervisor, MTS, MOIC • Special teams deputed by state and Centre Govts. • Consecutive supervision : Assessment of spray quality and coverage during visit of State & NVBDCP Officers during the field visit • Community mobilization : educating the community by health personnel (MPW, ASHA & village health and sanitation committee) about the effect of the IRS and its needs • Advance information regarding spray date for cooperation / compliance. • Preventing contamination of environment, food and other edibles

33. QA/ QC for ITNs / LLINs Procurement of bed-nets as per BIS specifications Re-treatment /distribution of bed-nets before transmission season Distribution norms - 2 per family of 5 members Coverage norms -100 % saturation of target areas Monitoring of usage- at least 80% utilization Replacement of torn nets and replenishment as per population increase

34. Four Tenets of Quality Assurance • Quality Assurance is oriented toward meeting the needs and expectations of the patient and the community. • Quality assurance focuses on systems and processes. • Quality assurance uses data to analyze service delivery processes. • Quality assurance encourages a team approach to problem solving and quality improvement.

35. Three Tiers of Action 35

36. Famous Malariologist Samuel Darling said “If you wish to control mosquitoes you must learn to think like mosquitoes’’ 36

37. Three effective tools which give hope for elimination of malaria RDT LLIN ACT - (2 Years of shelf life)

38. Thankyou