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Decentralization of Laboratory Testing Capacity in Resource-Limited Settings: 7 Years of Experience in six African Countries
F Marinucci, PhD 1, S Medina-Moreno 1, AD Paterniti 1, M Wattleworth 1 ,RR Redfield, MD 1 1Institute of Human Virology, University of Maryland School of Medicine, Baltimore, 21201 US
Abstract no. WEAD0101
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AIDSRelief Consortium: PEPFAR Track 1.0 IP
Catholic Relief Services (CRS)
University of Maryland School of Medicine – Institute of Human Virology (IHV)
Futures Group (FG)
Catholic Medical Mission Board (CMMB)
IMA World Health (IMA)
Who We Are?
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98
22
44
18
19
28
3
6
Where Do We Work?
246Local
PartnerTreatmentFacilities
(LPTF)+ 184 satellite sites
8
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Who Do We Work With?
• 229 sites with laboratory mostly in underserved areas– Urban 58/229 (25%), Peri-urban 20/229 (9%), Rural 151/229 (66%)
• A majority of non-public sites and mission facilities– 27% public and 73% non-public. The proportion between public and
non-public sites differs by country
• Breakdown by level – 17% primary 80% secondary 3% tertiary
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Laborator
y Level* General Description Location
General
Description
Level IPrimary - Health post and health center laboratories that
primarily serve outpatientsRural Villages
Level IISecondary - Laboratories in intermediate referral facilities for
health centers (e.g. district hospitals)
Peri-
urban
Towns outside
city or regional
towns
Level III
Tertiary - Laboratories in a regional/provincial referral
hospital that may be part of a regional or provincial health
administration
UrbanRegional towns
or city
*In some countries additional tiers may exist
Laboratory levels classification based on Maputo Harmonization (2008)
www.who.int/entity/diagnostics_laboratory/Maputo-Declaration_2008.pdf
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UMSOM-IHV Model of Care Delivery
• Cornerstone: decentralization of care and treatment
• Care and Tx integrated into existing health care system
• Multidisciplinary approach with different areas of intervention
• Adherence as a vital therapeutic intervention
• Defined catchment area
• Highly supported community based adherence follow up
• Medically driven CQI
• Point-of-care laboratory capacity
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Centralized System
Laboratory Approaches
Point-of-Care System
• Key Advantages
– Quality is maintained though less complicated means
– High-throughput, low reagent cost instrumentation is utilized
• Key Disadvantages
– Limits for growth– Specimen or patient transport– Ineffective information systems
• Key Advantages
– Patients’ timely access to diagnostics and results
– No limits for growth
• Key Disadvantages
– Complexity of quality systems– Higher staff turnover– Complexity of instrument service
and support– Infrastructure Challenges
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On-Site Laboratory Capacity
HIV diagnosis: rapid testing Immunological staging: CD4 absolute/percentage Safety monitoring: Hct or Hb, ALT, Creat Major OI diagnosis: AFB, BF malaria, gram staining, CrAg Monitoring of treatment response/treatment failure
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Three-phase model implemented in collaboration with local partners in Nigeria, Tanzania, Kenya, Uganda, Rwanda, and Zambia
Implementation strategy
1. site assessment and improvement (Y1-Y3)
2. appropriate technology selection with capacity building through training and laboratory mentoring (Y1-Y5)
3. quality management system strengthening and continuous quality improvement (Y6-Y7)
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Phase I
o Assessment of site by multidisciplinary teams
o Overall laboratory capacity evaluation
o Development of site-specific work plan for laboratory strengthening
o Laboratory infrastructure refitting
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Phase II
o Appropriate technology selection and advocacy
1. national guidelines on equipment/testing algorithm
2. in-country suppliers able to provide reagents and technical assistance
3. population size of the catchment area of each site
o Capacity building through practical training and laboratory mentoring
1. Onsite: specific needs, integrated into existing work plans 2. Centralized: aimed to develop in-country laboratory network3. HQ training: comprehensive clinical lab training for field staff
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Phase III
Quality management system strengthening
Introduction of new Laboratory Quality Improvement Tools
Improved coordination with MoH, CDC and other stakeholders
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Urban Peri-urban Rural
Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3 Total sites with HIV-LTC Total sites
Nigeria 0/0 (0%) 9/9 (100%) 4/4 (100%) 0/2 (0%) 0/3 (0%) 0/0 (0%) 1/1 (100%) 19/25 (76%) 0/0 (0%) 33/44 (75%) 44/229 (19%)
Tanzania 0/0 (0%) 22/37 (59%) 1/1 (100%) 0/0 (0%) 0/4 (0%) 0/0 (0%) 0/1 (0%) 3/55(6%) 0/0 (0%) 26/98 (27%) 98/229 (43%)
Kenya 0/0 (0%) 1/1 (100%) 0/0 (0%) 2/2 (100%) 5/5 (100%) 0/0 (0%) 1/1 (100%) 19/19 (100%) 0/0 (0%) 28/28 (100%) 28/229 (12%)
Rwanda 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 2/22 (9%) 0/0 (0%) 0/0 (0%) 2/22 (9%) 22/229 (10%)
Uganda 2/2 (100%) 0/0 (0%) 1/1 (100%) 0/1 (0%) 0/0 (0%) 1/1 (100%) 4/4 (100%) 9/9 (100%) 0/0 (0%) 17/18 (94%) 18/229 (8%)
Zambia 2/2 (100%) 1/1 (100%) 0/0 (0%) 2/2 (100%) 0/0 (0%) 0/0 (0%) 0/0 (0%) 11/14 (79%) 0/0 (0%) 16/19 (84%) 19/229 (8%)
4/4 (100%)
33/48 (69%)
6/6 (100%)
4/7 (57%)
5/12 (42%)
1/1 (100%)
8/29 (28%)
61/122 (50%)
0/0 (0%)
122/229 (53%)
229/229
(100%)
Level 1 40/229 (17%) Level 2 182/229 (80%) Level 3 7/229 (3%) Urban 58/229 (25%) Peri-urban 20/229 (9%) Rural 151/229 (66%)
Results
Number of Local Partner Treatment Facilities with HIV-LTC by Level and Location
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Results cont’d
Lab workers (N=1152) trained by topic (EA)
Increase over time of quality of Malaria and AFB microscopy
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Quality of CD4 Testing Capacity (CD4TC) Graded with LQIT by Level and Location
Urban Peri-urban Rural
LQIT gradeLevel 1 Level 2 Level 3 Level 1 Level 2 Level 3 Level 1 Level 2 Level 3
Total (N=92)
Excellent2/28 (7%) 5/28 (18%) 2/28 (7%) 0/12 (0%) 2/12 (17%) 0/12 (0%) 0/52 (0%) 12/52 (23%) 0/52 (0%) 23/92 (25%)
Good3/28 (11%) 7/28 (25%) 0/28 (0%) 0/12 (0%) 2/12 (17%) 0/12 (0%) 2/52(4%) 17/52 (33%) 0/0 (0%) 31/92 (34%)
Satisfactory0/28 (0%) 6/28 (21%) 1/28 (4%) 3/12 (25%) 4/12 (33%) 0/12 (0%) 4/52 (8%) 12/52 (23%) 0/0 (0%) 30/92 (33%)
Unsatisfactory0/28 (0%) 2/28 (7%) 0/28 (0%) 0/12 (0%) 1/12 (8%) 0/12 (0%) 0/52 (0%) 5/52 (9%) 0/0 (0%) 8/92 (8%)
Results cont’d
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AIDSRelief Patients Over Time
0
50000
100000
150000
200000
250000
300000
350000
400000
Year 1 Year 2 Year 3 Year 4 Year 5 Year 6
On TxIn Care
201,697
335,561
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Major achievements
• Low overall LTFU rate 4.2%
• Viral suppression average across 6 countries 88.7%
• Low general mortality rate 8.4%
• Decentralization of comprehensive care and treatment
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Conclusions
• Balancing country-specific and site-specific factors was crucial in adapting this flexible model for decentralizing sustainable HIV-LTC
• Integrated and comprehensive approach
• Harmonization and standardization
• Continuous mentoring of laboratory workers was KEY to support decentralization efforts
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Thank you
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