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Quality of Management Issues in Kenya – 2007 AIDS Indicators Survey

Quality of Management Issues in Kenya – 2007 AIDS Indicators Survey. Bangkok, Thailand March 4, 2009 . Mireille Kalou, MD, MPH On Behalf of the KAIS Lab TWG. Outline. Planning for KAIS Field Laboratory Testing Laboratory Support Supervision Laboratory logistics Challenges.

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Quality of Management Issues in Kenya – 2007 AIDS Indicators Survey

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  1. Quality of Management Issues in Kenya – 2007 AIDS Indicators Survey Bangkok, ThailandMarch 4, 2009 Mireille Kalou, MD, MPH On Behalf of the KAIS Lab TWG

  2. Outline • Planning for KAIS • Field Laboratory • Testing Laboratory • Support Supervision • Laboratory logistics • Challenges

  3. KAIS Primary Objectives • Determine HIV, syphilis and HSV-2 prevalence (15-64 yrs) • Determine CD4 counts in HIV positive persons

  4. EA RV NE WE NY CE NA CO Sampling Design • National Household (HH) Survey • 8 provinces • 415 clusters including rural and urban areas • Eligible men and women 15-64 yrs • Target • 10,000 HH • ~19,000 individuals

  5. Planning Survey • Assessment of laboratory capacity (NHRL and KEMRI/CDC) • Purchase of laboratory supplies, reagents and equipments • Validation of existing and new laboratory equipments • Recruitment of laboratory personnel • Training of laboratory personnel • Survey pilot testing

  6. Laboratory Commodities • Supplies delivered by vendors at primary testing lab stores • Supplies were re-packed in small quantities and sent to the field teams upon request • Samples delivered to field teams by courier • The laboratory logistician monitor stock levels both at central stores and field

  7. Field Laboratory • 56 field lab staffs • Obtain informed consent for blood draw • Collect, process and package specimens for transport • Specimens transported to testing laboratory 3X/wk • Provide respondent with voucher to obtain results

  8. Specimen Collection • Blood collection • Venipuncture • Finger prick only if venous draw was refused or difficult to obtain 5ml of whole blood collected onto plain tubes • 3 serum vials (0.5ml, 1ml, 1.5ml) • Clot of red cells • Testing (HIV, HSV-2, Syphilis) • QA • Storage • Clot of red cells 2ml of whole blood collected onto EDTA tubes • CD4 counts • Backup DBS (prepared in the field lab)

  9. Specimens Transportation EDTA and RBC clot specimens packaged and transported to NPHLS in cool box along w/ temperature monitor Serum specimens transported in dry shipper

  10. Testing Laboratory Organization • Team of 40 members • One specimen reception/accessioning area • Four testing benches • HIV • HSV-2 • Syphilis • CD4 • Four data entry stations

  11. Roles of the Testing Laboratory • Receive, analyze, and store specimens • Perform QC on all positive and 5% negative of all specimens • Provide supervision to the field workers • Prepare and provide back lab results for onward transmission to the clusters

  12. Flow of Specimens Reception at Testing Laboratory • Check specimen integrity • Cross check specimens field ID against sample tracking form • Assess for rejection criteria • Accessioning • Assign unique lab number • Forward to HIV testing bench

  13. Specimens Flow at the NPHLS Specimens sent to KEMRI QC lab

  14. Lab Staff Duty Roster • Scheduled rotation • Regardless of the schedule • Samples arriving outside the scheduled days, were accessioned and tested the same day • Any failed test run was repeated the same day

  15. HIV Testing Algorithm Test 1 Vironostika Ab/Ag CD4 count NEG POS Test 3 DNA PCR (KEMRI Lab) Test 2 Murex Ab/Ag DBS (for testing) POS NEG POS NEG Final result Negative Final result Positive Final result Positive Final result Negative

  16. Test 1 TPPA Negative Positive Test 2 RPR Positive Negative Final result Negative Final result Positive Final result Negative Syphilis Testing Algorithm

  17. HSV-2 Testing Algorithm HSV-2 Kalon EIA Negative Positive Final result Negative Final result Positive

  18. Data Management • Team: data entry clerks, data entry supervisor, data manager and IT support • Robust lab information system (LIS) • Unique IDs generated for the field (forms and specimens) and lab (bar-coded labels) • Testing worksheets and QC lists generated by LIS • Data entry errors handled daily • Daily troubleshooting of improper archiving (i.e. difficult to retrieve specimens) • Test results were entered

  19. Quality Assurance • Perform repeat testing using same algorithm • EQA (retesting) performed at the QA lab • All HIV,HSV-2 and Syphilis (RPR) positives and 5% of randomly selected negatives • For discordant results, testing is repeated. If repeatedly discordant, result is reported as indeterminate • Both initial and QA testing results are compared and final results reported to NPHLS • Both labs plot daily QC charts to monitor quality of testing

  20. Preparation for the Pilot • Weekly TWG meetings • Conference calls with CDC/Atlanta • Lab technical meetings (KEMRI and NPHLS) • Lab space re-organized • TAs: CDC (Kenya, Uganda, Atlanta), in country partners, APHL… • Procurement: lab and field supplies • IT & data management • Training: Field supervisors, interviewers, lab technicians • Documentation: Lab SOPs, job aids, training manuals • (field and labs), detailed lab roster

  21. Reporting of Results HIV • Compare test results from NPHLS and KEMRI labs, discordance resolved by PCR Syphilis and HSV-2 • Compare test results from NPHLS and KEMRI labs, discordance reported as indeterminate

  22. Archiving of Repository Specimens • Serum and RBC clot at -80oC • Use of cryo-vial racks • Freezers and racks numbered for easy retrieval when needed • DBS at -20oC • Use zip lock bags with humidity indicator and desiccant bags

  23. Support Supervision Field Teams • Once a month • Use of supervision checklist to assess performance • Technical working group discuss field reports and initiate appropriate action Testing teams • Each lab has 1 lab supervisor • 1 bench supervisor assigned to each testing bench • Weekly meetings for updates from labs and benches

  24. Challenges • Competing priorities for lab and personnel • Complex USG procurement mechanism • Complex supplies and sample transportation mechanisms • Supervision and coordinating of large number of staff • Handling of electronic database for sample management • HSV-2 testing algorithm (>50% retesting) • Limited number of QC materials for CD4 count

  25. Lessons Learned • Building capacity (IT/data mgt, Lab, data analysis,…) • Useful local and regional TAs expertise/experience in AIS • Development and training of staff on use of SOPs • Limited number of QC materials for CD4 count • Future plans for using the 104 dry shippers and 120 cool boxes? • Building trust between stakeholders/partners

  26. Collaborative Effort Kenya Partners • KAIS TWG • KAIS Survey team • All local participating institutions • NASCOP, MOH • NPHLS, MOH • KNBS • KEMRI • NCAPD • NACC • International Partners • CDC Kenya • CDC Atlanta • CDC Uganda • USAID Kenya • UNAIDS/WHO Kenya • DoD/WRP*

  27. Thank You

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