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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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