Overview of ICAP Laboratory Data

Collection InitiativesICAP Data Dissemination Meeting

September 21, 2010Charon Gwynn

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

DATA COLLECTION INITIATIVES

• Routinely Collected Laboratory Indicators

• Laboratory PFaCTS

• CD4 Database

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

ROUTINELY COLLECTED LABORATORY INDICATORS

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

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

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

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

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

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

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

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

LABORATORY PFaCTS

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

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

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)

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

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

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)

RAPID TEST QA/QC – TYPE AND FREQUENCY

(N=37)

0

20

40

60

80

100No/Missing

Yearly

Quarterly

Monthly

Weekly

Daily

%

QA/QC Measure

0

20

40

60

80

100

No/Missing

Yearly

Quarterly

Monthly

Weekly

Daily

%

CD4 COUNT QA/QC – TYPE AND FREQUENCY

(N=31)

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)

SUPPLY SHORTAGES PER YEAR (N=39)

< 1

1 - 2

3 - 4

≥ 5

POWER OUTAGE FREQUENCY

N (%)

Daily 7 (14)

Weekly 13 (25)

Monthly 17 (33)

Less frequently 6 (12)

Missing 9 (18)

Total 51 (100)

AVAILABILITY OF BACKUP GENERATORS BY OUTAGE

FREQUENCY

Daily Weekly Monthly Yearly0

20

40

60

80

100

%

N=7 N=13 N=17 N=1

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

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

CD4 DATABASE

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

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

PILOT OF CD4 DATABASE

• Piloted database at 4 labs in Kenya in early 2010

• Support for database provided by ICAP staff

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

Thikka Kiambu Nyeri Machakos0%

20%

40%

60%

80%

100%

MissingWomenMen

GENDER BY SITE, CD4 DATABASE PILOT

N=2170 N=947 N=2003 N=979

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

PATIENT ART STATUS BY SITE

Thikka Kiambu Nyeri Machakos0%

20%

40%

60%

80%

100%

MissingARTPreART

N=2170 N=947 N=2003 N=979

REASON FOR CD4 TEST BY SITE

Thikka Kiambu Nyeri Machakos0%

20%

40%

60%

80%

100%

MissingOther18 month12 month6 monthBaseline

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

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

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

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