icap data dissemination meeting september 21, 2010 charon gwynn
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Overview of ICAP Laboratory Data Collection Initiatives. ICAP Data Dissemination Meeting September 21, 2010 Charon Gwynn. Background. ICAP supports >500 clinical testing laboratories - PowerPoint PPT PresentationTRANSCRIPT
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Overview of ICAP Laboratory Data
Collection InitiativesICAP Data Dissemination Meeting
September 21, 2010Charon Gwynn
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BACKGROUND• ICAP supports >500 clinical testing
laboratories• Routine data collection on the number and
type of HIV-related testing being performed, and assessments of laboratory infrastructure can help ensure high quality and effective lab programs
• Laboratory data collection can be used to demonstrate health system strengthening
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DATA COLLECTION INITIATIVES
• Routinely Collected Laboratory Indicators
• Laboratory PFaCTS
• CD4 Database
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PEPFAR DEFINITION OF CLINICAL LABORATORY
TESTING• laboratory that has the capacity (i.e. infrastructure, dedicated lab personnel, and equipment) to:
– Perform testing for the diagnosis of HIV infection with either rapid test, EIA or molecular methods; and,
– Perform clinical laboratory tests in any of the following areas:
• Hematology• Clinical chemistry• Serology• Microbiology• HIV/AIDS care and treatment monitoring with CD4 testing or
HIV viral loads, • TB diagnostic and identification• Malaria infection diagnosis• OI diagnosis
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ROUTINELY COLLECTED LABORATORY INDICATORS
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LAB INDICATORS• Measure the extent to which
laboratory services are expanding to support HIV/AIDS care and treatment services as well as health system strengthening
• Indicators aligned with the Next Generation PEPFAR Indicators
• Rolled out April-June 2010
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ICAP-NY LABORATORY INDICATORS1. Number of ICAP-supported laboratories with capacity to perform clinical laboratory
testing*2. Number of laboratories that are accredited according to national or international
standards*3. Number of laboratories participating in external
quality assurance/proficiency testing (EQA/PT) for CD4 testing4. Number of laboratories participating in external quality assurance/proficiency testing
(EQA/PT) for HIV rapid-testing5. Number of laboratories participating in external quality assurance/proficiency testing
(EQA/PT) performed for AFB smear microscopy6. Number of HIV simple rapid tests conducted7. Number of HIV enzyme immunoassay (EIA) tests conducted 8. Number of PCR tests conducted for infant HIV diagnosis9. Number of CD4 count tests conducted10. Number of CD4 percentage tests conducted11. Number of HIV viral load tests conducted12. Number of smear tests (AFB) conducted13. Number of TB culture tests conducted14. Number of TB drug susceptibility tests (DST) conducted15. Number of malaria smear tests conducted16. Number of syphilis tests conducted17. Number of ALT tests conducted18. Number of creatinine tests conducted19. Number of hematology (CBC) tests conducted20. Number of laboratorians who successfully completed an in-service training program* * PEPFAR Next Generation Indicator
Disaggregated by testing done for
HIV positive versus HIV
negative and unknown patients
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SUPPORTED AND REPORTED FACILITIES AS
OF APRIL-JUNE 2010 Country Supported Reported
Cote d'Ivoire 14 13
Ethiopia 66 0
Kenya 151 139
Mozambique 7 6
Nigeria 33 33
Rwanda 57 56
Tanzania 134 100
Zambia 1 0
Total 536 303
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PROPORTION OF CARE AND TREATMENT SITES WITH CLINICAL LABORATORIES
Cote d'Ivoire Ethiopia Kenya Mozambique Nigeria Rwanda Tanzania Zambia0
20
40
60
80
100
120
N=60 N=69 N=157 N=62 N=33 N=47 N=127 N=2
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Cote d'Ivoire Kenya Mozambique Nigeria Rwanda Tanzania0
20000
40000
60000
80000
100000
HIV-related tests conducted during quarter, by country, April- June 2010*
HIV Simple Rapid
CD4 Count
CD4 %
AFB
*CI and KN did not report AFB, TZ did not report CD4 count or CD4%
# sites= 9 128 21 17 4 5 4 6 33 33 33 33 56 44 43 51 100 98
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11
NUMBER OF OTHER HIV-RELATED TESTS
CONDUCTED, APRIL- JUNE 2010*
*KN did not report any other HIV related test. Nigeria only reported LFT and hematology, Tanzania reported syphilis.
Cote d'Ivoire Mozambique Nigeria Rwanda Tanzania0
10000
20000
30000
40000
50000
60000
70000
Malaria Smear
Syphilis
Liver Funtion Testing
Creatinine
Hematology
# sites= 13 13 12 1 6 4 4 5 33 33 56 54 51 50 53 100
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LABS CONDUCTING EQA AMONG THOSE REPORTING HIV-RELATED
TESTS, APRIL-JUNE 2010*
Rwanda Mozambique Cote d'Ivoire0
20
40
60
80
100
Rapid TestCD4 CountAFB Smear
44
51
4 5 6 9
56
(%)
*Among countries reporting EQA testing
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NEXT STEPS• Analyze trends over time• Add lab indicators to routinely
generated master slide set• Use routinely collected data with other
lab data sources (eg, lab PFaCTS) to evaluate the type of services offered and improve quality
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LABORATORY PFaCTS
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LAB PFaCTS• Facility level survey to capture
information on– infrastructure and equipment– quality assurance activities– supply and procurement chain management– human resources
• Information will be used together with new laboratory indicators for program planning purposes
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PILOT SURVEY DESIGN• Distributed Sept 2009 to Laboratory
Advisors • Piloted in 51 non-randomly selected
sites in 6 countries• 39 questions in eight sections
– General Information– Testing Services & Testing Equipment– Laboratory Testing Network– Protocols, Procedures & Quality Assurance– Data Collection/Reporting Systems– Physical Infrastructure & Equipment
Maintenance– Supply Inventory & Procurement– Human Resources & Training
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PILOT SAMPLECountry N (%)
Cote d’Ivoire 10 (20)
Ethiopia 10 (20)
Rwanda 10 (20)
Tanzania 10 (20)
Nigeria 7 (14)
Lesotho 4 (8)
TOTAL 51 (100)
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TYPE OF SUPPORT PROVIDED
ICAP Laboratory Support N (%)
Training and mentoring of lab personnel 44 (87)
Equipment procurement 44 (86)
Testing kit/reagent procurement 38 (75)
Sample transportation 31 (61)
Phlebotomy and specimen processing supply procurement 29 (57)
Construction/renovation 29 (57)
Human resources 27 (53)
Other 6 (12)
N=51
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AVAILABLE TESTS BY SITE TYPE
Primary Secondary Tertiary Reference Lab0
20
40
60
80
100
Rapid Test
EIA
CD4 Count
CD4 Percent
Infant Diagnosis (PCR)
TB Testing (AFB)
%
N = 18 N = 25 N = 4 N = 4
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Rapid Test EIA CD4 Count CD4 Percent0
20
40
60
80
100
%
QUALITY ASSURANCE/QUALITY CONTROL FOR SELECT HIV-
RELATED TESTS
(N=48) (N=5) (N=35) (N=24)
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RAPID TEST QA/QC – TYPE AND FREQUENCY
(N=37)
0
20
40
60
80
100No/Missing
Yearly
Quarterly
Monthly
Weekly
Daily
%
QA/QC Measure
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0
20
40
60
80
100
No/Missing
Yearly
Quarterly
Monthly
Weekly
Daily
%
CD4 COUNT QA/QC – TYPE AND FREQUENCY
(N=31)
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REASONS FOR SUPPLY SHORTAGES (N=42)
N (%)
National warehouse shortages 30 (71)
Insufficient funds 5 (12)
Vendor shortage 7 (17)
Insufficient time 19 (45)
Complicated procedure 20 (48)
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SUPPLY SHORTAGES PER YEAR (N=39)
< 1
1 - 2
3 - 4
≥ 5
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POWER OUTAGE FREQUENCY
N (%)
Daily 7 (14)
Weekly 13 (25)
Monthly 17 (33)
Less frequently 6 (12)
Missing 9 (18)
Total 51 (100)
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AVAILABILITY OF BACKUP GENERATORS BY OUTAGE
FREQUENCY
Daily Weekly Monthly Yearly0
20
40
60
80
100
%
N=7 N=13 N=17 N=1
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LESSONS LEARNED• Problems highlighted during pilot
– Missing data Solution Offline Computer-based module – Inaccurate data Solution New question order and computer-
based skip pattern• New responses/questions
– Responses commonly written in on paper pilot survey
– Impact of ICAP support on system strengthening
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NEXT STEPS• Finalize computer data entry
module• Launch data collection – Lab
Advisors to complete most of data collection
• Analyze data and disseminate results to country teams
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CD4 DATABASE
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WHY AN ELECTRONIC CD4 DATABASE?
• CD4 counts provide important clinical information used for HIV care and treatment
• Reporting CD4 testing capacity to assess progress toward program goals
• Monitoring test kit usage can be used for supply forecasting
• Electronic systems allow for standardization of data collection and enhancement of data quality
• Many sites have capacity for simple Access database
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COMPONENTS OF THE CD4 DATABASE
Data Elements• Patient demographic information• ART status and follow-up CD4 measures• CD4 count and % results • testing technician and health center information
Key Functionality• Searchable by patient• Automated data quality checks of CD4 test results• Tools to monitor CD4 testing kit inventory
Automated Reporting• Reports of CD4 counts for specific time period and health center• Highlighting of low CD4 values for potential physician follow-up
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PILOT OF CD4 DATABASE
• Piloted database at 4 labs in Kenya in early 2010
• Support for database provided by ICAP staff
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TESTS ENTERED INTO DATABASE DURING
PILOTSite Name CD4 Count or
PercentageCD4 Count CD4 Percentage
Thikka 2170 2153 95Kiambu 947 947 2Nyeri 2003 1999 211Machakos 979 910 107
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Thikka Kiambu Nyeri Machakos0%
20%
40%
60%
80%
100%
MissingWomenMen
GENDER BY SITE, CD4 DATABASE PILOT
N=2170 N=947 N=2003 N=979
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AGE BY SITE, CD4 DATABASE PILOT
Thikka Kiambu Nyeri Machakos0%
20%
40%
60%
80%
100%
Missing>=15yrs<15 yrs
N=2170 N=947 N=2003 N=979
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PATIENT ART STATUS BY SITE
Thikka Kiambu Nyeri Machakos0%
20%
40%
60%
80%
100%
MissingARTPreART
N=2170 N=947 N=2003 N=979
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REASON FOR CD4 TEST BY SITE
Thikka Kiambu Nyeri Machakos0%
20%
40%
60%
80%
100%
MissingOther18 month12 month6 monthBaseline
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CD4 VALUE AMONG PATIENTS WITH CD4 TEST RESULTS
Thikka Kiambu Nyeri Machakos0%
20%
40%
60%
80%
100%
CD4 count >=250CD4 count <250
N=2153 N=947 N=1999 N=910
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NEXT STEPS• Database has been updated to
accommodate additional tests (e.g., viral load, blood chemistry, etc) specified by user
• Country implementation– Provide updated version to Kenya and potentially
expand to additional sites– Database to be piloted in Tanzania this year
• Available as a tool for country teams, however database is most effective as a jointly clinical and M&E activity
• Eventually explore possibility of combining with other electronic databases
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SUMMARY• Availability of quality laboratory testing
is integral to provision of HIV-related services
• New laboratory data collection initiatives are important part of larger effort to capture information necessary to inform programs
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ACKNOWLEDGEMENTS• Country Lab and M&E teams
http://www.mericap.columbia.edu/dashboard.php?dashboard_type=lab&country_id=0&reset=1
• Amilcar Tanuri, Luis Felipe Gonzalez, Stephania Koblavi, Jessica Justman, Allison Goldberg
• Annie Kao, Suzue Saito, M&E Liaisons