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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

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

outline
Outline
  • Planning for KAIS
  • Field Laboratory
  • Testing Laboratory
  • Support Supervision
  • Laboratory logistics
  • Challenges
kais primary objectives
KAIS Primary Objectives
  • Determine HIV, syphilis and HSV-2 prevalence (15-64 yrs)
  • Determine CD4 counts in HIV positive persons
sampling design

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
planning survey
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
laboratory commodities
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
field laboratory
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

specimen collection
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)
specimens transportation
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

testing laboratory organization
Testing Laboratory Organization
  • Team of 40 members
  • One specimen reception/accessioning area
  • Four testing benches
    • HIV
    • HSV-2
    • Syphilis
    • CD4
  • Four data entry stations
roles of the testing laboratory
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
flow of specimens reception at testing laboratory
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
slide13

Specimens Flow at the NPHLS

Specimens sent

to KEMRI QC lab

lab staff duty roster
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
slide15

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

slide16

Test 1

TPPA

Negative

Positive

Test 2

RPR

Positive

Negative

Final result

Negative

Final result

Positive

Final result

Negative

Syphilis Testing Algorithm

slide17

HSV-2 Testing Algorithm

HSV-2 Kalon EIA

Negative

Positive

Final result

Negative

Final result

Positive

data management
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
quality assurance
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
slide20

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
reporting of results
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
archiving of repository specimens
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
support supervision
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
challenges
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
lessons learned
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
collaborative effort
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*