ICAP-NY DATA DISSEMINATION
WEBINAR
Bereket Alemayehu, Clinical & Training Unit
Charon Gwynn, SI Unit
Laboratory Program and Facility Characteristics Tracking System:
Round One Findings
Please fill out webinar series survey!!!!
http://www.surveymonkey.com/s/WG5JTTG
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information–Health System Strengthening– Quality Assurance–Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
ICAP’S LABORATORY PORTFOLIO
ALGERIA
MAURITANIAMALI
NIGER
LIBYA
CHAD
EGYPT
SUDAN
ETHIOPIA
KENYA
TANZANIA
DEMOCRATIC
CENTRAL
RWANDA
GABON
NIGERIABENIN
SENEGAL
GHANA
CAMEROON
ZAMBIA
MOZAMBIQUE
ZIMBABWE
BOTSWANA
SWAZILAND
LESOTHO
NAMIBIA
ANGOLA
UGANDA
OF THE CONGO
REPUBLIC
COTE
BURKINAGUINE
A
SOUTH
REPUBLIC
AFRICAN
THE
AFRICA
D’IVOIRE
Turkmenistan
Uzbekistan
Kyrgyzstan
Tajikistan
Kazakhstan
LABORATORY PORTFOLIO…..ORGANOGRAM
Clinical &
Training Unit-
NY
Regional lab advisors
Country lab lead & teams
LABORATORY PORTFOLIO …. PROGRAM FOCUS AREAS
System strengthening• Policy & strategy
development• QA/QC• Lab networking• Accreditation
Service strengthening• Physical infrastructure• Equipments• Supplies
Human resource capacity building• Trainings• Mentorship• Supportive
supervisions
LABORATORY PORTFOLIO ….. INTEGRATION OF SUPPORT
HIVTB
Other OIs
Malaria
LABORATORY PFACTS• Laboratory survey that targets all labs across
the tiered levels • Provides information on the scope, diversity,
and comprehensiveness of laboratories
• Qualitative/quantitative information - implementation of lab quality essentials(QEs)– infrastructure and equipment - human resources– quality assurance activities - Facility safety– Supply chain management
RATIONALE FOR LABORATORY PFACTS
• Specific facility laboratory:– Laboratory’s capacity and progress toward
accreditation– Gap analysis and laboratory specific
improvement plan
• ICAP national laboratory program:– Aggregate information to assess capacity and
identify major gaps in implementing QMS across supported labs
– Lab support prioritization and strategy – Program planning and implementation of
improvement plans
PEPFAR DEFINITION OF CLINICAL LABORATORY
Laboratory that has the capacity to:
Perform testing for the diagnosis of HIV infection with either rapid test, EIA or molecular methods; and
Has dedicated laboratory personnel
Perform clinical laboratory tests in any of the following areas:Hematology - Clinical chemistry - Serology Microbiology - CD4 testing - HIV viral loads TB diagnostic - Malaria diagnosis - OI diagnosis
IMPLEMENTATION
Pilot
• Sept 2009• 6 countries and 51 laboratories• Survey tool revised, database developed
Survey
• July - November 2011• 8 countries and 521 ‘PEPFAR clinical labs’• Interview of lab-in-charge by country lab advisors
Report • Data reviewed and entered into the URS with help from country
M&E teams
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information–Health System Strengthening– Quality Assurance–Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings–General Information–Health System Strengthening– Quality Assurance–Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
PROPORTION OF ICAP SUPPORTED LABORATORIES PARTICIPATING IN LABORATORY PFACTS BY
COUNTRY
0
20
40
60
80
100
86
100 100 100 100 9491
7163
% o
f la
bora
tori
es
ICAP SUPPORTED LABORATORIES BY FACILITY TYPE AND COUNTRY (n=521)
Kenya
Tanza
nia
Ethiop
ia
Mozam
bique
Rwanda
Nigeria
Cote d'
Ivoire
DR Con
go0
50
100
150
200
135
76
2641 37
0 51
40
34
46 10 7
32 11 5
0
1
5
2
00 0
1
3
3
Primary Secondary Tertiary Reference lab
Num
ber
of la
bora
tori
es
TYPE OF SUPPORT PROVIDED BY ICAP (n=521)
0
20
40
60
80
100 97
8580 77
6961 58
44 4136 31 31
18
% o
f la
bora
tori
es
TYPE OF HIV-RELATED TESTS PERFORMED (n=521)
0
20
40
60
80
100 96 94 93
71
50 47 4742
31
2420%
of
labo
rato
ries
AVAILABILITY OF HIV RELATED TESTS BY FACILITY
TYPE
Primary (n=321) Secondary (n=185)
Tertiary (n=8) Reference lab (n=7)
0
20
40
60
80
100 96 97
88
57
5
70
100
88
4
46
3843
9297
100
57
0 0
13
57
HIV Rapid test CD4 cell counts CD4 percent TB test (AFB)
% o
f la
bora
tori
es
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
3%
8%
90%
All equip-ment sep-arateSome equipment separateAll equip-ment to-gether
LOCATION OF ICAP SUPPORTED EQUIPMENT (n=378)
Micropipette (n=114) Chemistry analyzer (n=228)
Hemotology analyzer (n=230)
0
20
40
60
80
100 9895 94
% o
f la
bora
tori
es
EQUIPMENT USED FOR HIV AND NON-HIV PROGRAMS
INVENTORY SYSTEMS USED FOR HIV AND NON-HIV
PROGRAMS
0
20
40
60
80
100
84
98 97 97
84
66 66 64
43
% o
f la
bora
tori
es
REQUISITION FORMS USED FOR HIV AND NON-HIV
PROGRAMS
0
10
20
30
40
50
60
70
80
90
100
87
100 10096
9188
79 79 77
% o
f la
bora
tori
es
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
QUALITY ASSURANCE/QUALITY CONTROL (QA/QC) FOR KEY HIV-
RELATED TESTS
Rapid test (n=500)
CD4 cell counts (n=160)
ALT (n=241)
Creatinine (n=247)
0
20
40
60
80
100 96 99 98 99
14
2720 20
53
85
27 24
Testing against internal controls Internal proficiency testingExternal proficiency testing
% o
f la
bora
tori
es
QA/QC FREQUENCY FOR HIV RAPID TEST (n=498)
Testin
g aga
inst i
nter
nal c
ontro
ls
Inter
nal p
roficie
ncy t
estin
g
Extern
al pr
oficie
ncy t
estin
g0
20406080
100
3
8646
94
31 2
1
19
3
10 10
49
None Daily Weekly Monthly Quarterly Yearly
% o
f la
bora
tori
es
QA/QC FREQUENCY FOR CD4 CELL COUNT TEST (n=159)
Testin
g aga
inst i
nter
nal c
ontro
ls
Inter
nal p
roficie
ncy t
estin
g
Extern
al pr
oficie
ncy t
estin
g0
20406080
100
75
723 52 15
372
14
1
82
0 1
None Daily Weekly Monthly Quarterly Yearly
% o
f la
bora
tori
es
QA/QC FREQUENCY OF ALT TEST (n=247)
Testin
g aga
inst i
nter
nal c
ontro
ls
Inter
nal p
roficie
ncy t
estin
g
Extern
al pr
oficie
ncy t
estin
g0
20406080
100
2
80 7391
75 12 111 26
1
None Daily Weekly Monthly Quarterly Yearly
% o
f la
bora
tori
es
QA/QC FREQUENCY OF CREATININE TEST (n=247)
Testin
g aga
inst i
nter
nal c
ontro
ls
Inter
nal p
roficie
ncy t
estin
g
Extern
al pr
oficie
ncy t
estin
g0
20406080
100
1
80 7691
75 10 1
24
None Daily Weekly Monthly Quarterly Yearly
% o
f la
bora
tori
es
AVAILABILITY OF STANDARD OPERATION PROCEDURES FOR
HIV RELATED TESTING
Rapid test (n=495)
CD4 count (n=160)
Hemoglobin (n=488)
ALT (n=247)
0
20
40
60
80
100 95 9891 94
% o
f la
bora
tori
es
REJECTION CRITERIA FOR HIV RELATED TEST FORMS AND
SAMPLES BY COUNTRY
0
20
40
60
80
10090
100 10096
9389
86
25
0
% o
f lab
orat
orie
s
USE OF SAMPLE VALIDATION SYSTEMS BY COUNTRY
0
20
40
60
80
100
31
100
55
34 33
2114
6 6
% o
f la
bora
tori
es
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
STAFF RECEIVING TRAINING FOR HIV RELATED TESTS
HIV rapid test
(n=499)
CD4 count (n=160)
CD4 percent (n=104)
ALT (n=246)
Hemoglobin (n=489)
CBC (n=259)
0
20
40
60
80
100 91
6168
7380
76
47
26
34
24
38
20
Ever Last 12 month
% o
f sta
ff
STAFF RECEIVING TRAINING FOR HIV RELATED TESTS BY COUNTRY
0
20
40
60
80
100
91
100 100 10096
86
71
5552
60
97 95
61
78
57
34
23
31
73
96100
73
96
53
3642
33
80
100 100 10096
67
25
1420
Rapid test CD4 ALT Hemoglobin
% o
f st
aff
STAFF RECEIVING KEY LABORATORY SKILLS TRAINING (n=520)
QA/QC Inventory/supply management
Data management Biosafety0%
20%
40%
60%
80%
63
55
49 48
4035
28
39
Onsite
% o
f st
aff
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
TRACKING OF SPECIMENS AND TEST RESULTS BY COUNTRY
0
20
40
60
80
100
30
41
13
50
63
15
81
0
88 91
100 97 100
88
100
25
100
paper documentation
% o
f la
bora
tori
es
APPROACHES TO TRANSFER TEST RESULTS TO PATIENT CLINICAL RECORDS BY COUNTRY
All cou
ntries
(n=
520)
Tanza
nia (
n=11
2)
Mozam
bique
(n=
53)
Ethiop
ia (
n=80
)
DR Con
go
(n=6)
Kenya
(n=
174)
Nigeria
(n=
32)
Cote d'
Ivoire
(n=
16)
Rwanda
(n=
47)
0
20
40
60
80
100
52
9887
7450
29
0 0 0
24
12
0
1746
59 5032
17
0 11
4 1716 41
4468
4 1 0 6 17 8 0 6 0
Patient retrieves result from labsData capurer from clinic retrieves result from labsLab technician brings resutls to the clinicData capturer from labs transcribes results into patient clinical recordsOther
% o
f la
bora
tori
es
POWER OUTAGE FREQUENCY (n=520)
Daily Weekly Monthly Yearly Less frequently0
20
40
60
80
100
% o
f la
bora
tori
es
BACKUP GENERATOR AVAILABILITY BY POWER
OUTAGE FREQUENCY
Daily (n=177) Weekly (n=149) Monthly (n=143) Yearly (n=12)0
10
20
30
40
50
36
32
16
0
% o
f la
bora
tori
es
LABORATORIES HAVING AT LEAST MONTHLY POWER OUTAGES BY COUNTRY
0
20
40
60
80
10090
100 99 98 96
8374 71
50
% o
f la
bora
tori
es
BACKUP GENERATOR AVAILABILITY AMONG LABORATORIES HAVING POWER OUTAGE AT LEAST MONTHLY BY COUNTRY
0
20
40
60
80
100 90100 99 98 96
8374 71
50
29
97
11
39
13
60
10
74
25
Have power outage at least monthlyHave generator among labs having power outage at least monthly
% o
f la
bora
tori
es
AVERAGE NUMBER OF SUPPLY SHORTAGES IN YEAR BY COUNTRY
0
1
2
3
4
5
6
7
4.7
6.4 6.2
5.35
3.73.3
1.8 1.7
Ave
rage
SUPPLY SHORTAGES BY KEY COMMODITY AND FREQUENCY (n=519)
HIV test kits
Reagents Controls Calibrators Specimen collection materials
Biosafety materials
0
20
40
60
80
100
2432
5674
63 6635
34
25
2026 25
16
2311
27 5
19
8 5 2 3 26 2 2 2 2 1
0 1 2 3 >3
% o
f la
bora
tori
es
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
AVAILABILITY OF BIOSAFETY EQUIPMENT (n=521)
Hand w
ash s
tation
Autoc
lave
Fire ex
tingu
isher
Biosafe
ty ca
binet
Shower
Eye w
ash
0
10
20
30
40
50
60
70
80
90
100 95
32
2115 13 11%
of
labo
rato
ries
AVAILABILITY OF KEY BIOSAFETY EQUIPMENT BY COUNTRY
0
10
20
30
40
50
60
70
80
90
10094
34
12 118 10
19
0
34 33
14
6 4 40 0
72
33
51
69
4
19
33
Fire Extinguisher Biosafety Cabinet Autoclave
% o
f la
bora
tori
es
HAZARDOUS WASTE DISPOSAL METHODS BY COUNTRY
0
20
40
60
80
100 96100 99 100 99 100
9488
83
74
100 98
88 90
36 36
54
0
Sharps Container Biohazard bag
% o
f la
bora
tori
es
HAZARDOUS WASTE INCINERATION METHOD BY COUNTRY
0
20
40
60
80
100
81
100 100
67
98 95 91
64
1317
0 0
31
2.5 3
26
87
2 0 0 1.1 2.3 2.56.3
9.4
0.0
Incinerator at facility Burned & buried Waste is disposed out of facility
% o
f lab
orat
orie
s
AVAILABILITY OF PERSONAL PROTECTIVE EQUIPMENT (n=521)
Lab coat Gloves Detergents/ antiseptics
Protective glasses
Respirator0
20
40
60
80
100100 99 97
20
7.7
% o
f la
bora
tori
es
OUTLINE• ICAP’s Laboratory Portfolio• Rationale for Laboratory PFaCTS• Laboratory PFaCTS Implementation• Findings– General Information– Health System Strengthening– Quality Assurance– Human Resources & Training– Infrastructure & Supply Management– Biosafety
• Summary• Implications
SUMMARY • ICAP supports a wide range of services and
capacity building activities in the countries where we work
• ICAP’s laboratory support contributes to overall health system strengthening through co-location and shared usage of equipment with non-HIV programs
• Routine QA/QC is conducted in most laboratories, however further efforts are required around routine internal and external proficiency testing and sample validation
SUMMARY (CON’T)• Training on HIV Rapid test procedures was
common, however several countries experience limited training on key HIV-related tests among laboratory staff
• Lack of back up generators and frequent shortages of key commodities compromise laboratory services in most ICAP supported laboratories
• Most countries have appropriate biohazard disposal methods available, however key biosafety and personal protective equipment are lacking at many laboratories
IMPLICATIONS• Aggregate findings from Laboratory PFaCTS should
be used to identify and address country level technical support area needs such as QA/QC, human resources and infrastructure
• Facility specific data should also be reviewed to ensure appropriate targeted technical assistance is provided to facilities
• Routine collection of Laboratory PFaCTS data is needed to allow for more rigorous monitoring and strategic planning towards building capacity of ICAP supported laboratories
• Laboratory PFaCTS results should be combined with routinely collected clinical indicators to examine impacts of laboratory capacity on patient outcomes (eg, completion of CD4 testing at baseline and follow-up)
COMING SOON…• PFaCTS Data Collection
– Combined surveys • Care and Treatment - Round 7• Laboratory - Round 2
– August 2012
• Final Laboratory PFaCTS Report• https://www.socialtext.net/icap_data_dissemination/Laboratory%
20PFaCTS%20July%202011
• URS2.0– Facility level and other user defined reports– https://urs2.mericap.columbia.edu/
ACKNOWLEDGEMENTS• Country Laboratory and M&E
Advisors• Amilcar Tanuri, Luis Felipe
Gonzalez, Stephania Koblavi• Abby Hahn, Yingfeng Wu, SI
Specialists
THANK YOU