An Integrated Tiered Service Delivery Model (ITSDM) Based on Local CD4 Testing Demands Can Improve Turn-Around Times and Save Costs whilst Ensuring Accessible and Scalable CD4 Services across a National Programme

Abstract

BackgroundThe South African National Health Laboratory Service (NHLS) responded to HIV treatment initiatives with two-tiered CD4 laboratory services in 2004. Increasing programmatic burden, as more patients access anti-retroviral therapy (ART), has demanded extending CD4 services to meet increasing clinical needs. The aim of this study was to review existing services and develop a service-model that integrated laboratory-based and point-of-care testing (POCT), to extend national coverage, improve local turn-around/(TAT) and contain programmatic costs.MethodsNHLS Corporate Data Warehouse CD4 data, from 60–70 laboratories and 4756 referring health facilities was reviewed for referral laboratory workload, respective referring facility volumes and related TAT, from 2009–2012.ResultsAn integrated tiered service delivery model (ITSDM) is proposed. Tier-1/POCT delivers CD4 testing at single health-clinics providing ART in hard-to-reach areas (<5 samples/day). Laboratory-based testing is extended with Tier-2/POC-Hubs (processing ≤30–40 CD4 samples/day), consolidating POCT across 8–10 health-clinics with other HIV-related testing and Tier-3/‘community’ laboratories, serving ≤40 health-clinics, processing ≤150 samples/day. Existing Tier-4/‘regional’ laboratories serve ≤100 facilities and process <350 samples/day; Tier-5 are high-volume ‘metro’/centralized laboratories (>350–1500 tests/day, serving ≥200 health-clinics). Tier-6 provides national support for standardisation, harmonization and quality across the organization.ConclusionThe ITSDM offers improved local TAT by extending CD4 services into rural/remote areas with new Tier-3 or Tier-2/POC-Hub services installed in existing community laboratories, most with developed infrastructure. The advantage of lower laboratory CD4 costs and use of existing infrastructure enables subsidization of delivery of more expensive POC services, into hard-to-reach districts without reasonable access to a local CD4 laboratory. Full ITSDM implementation across 5 service tiers (as opposed to widespread implementation of POC testing to extend service) can facilitate sustainable ‘full service coverage’ across South Africa, and save>than R125 million in HIV/AIDS programmatic costs. ITSDM hierarchical parental-support also assures laboratory/POC management, equipment maintenance, quality control and on-going training between tiers.

Programmatic implications of implementing the relational algebraic capacitated location (RACL) algorithm outcomes on the allocation of laboratory sites, test volumes, platform distribution and space requirements

“…1 This confirms the decentralisation of CD4 test requests. Additionally, 14 health districts in South Africa do not have a local in-district CD4 services.…”

“…1 Additionally, 11 Tier 3 laboratories were proposed. For this scenario, testing would be retained at 30 of the existing CD4 laboratories.…”

Options to Expand HIV Viral Load Testing in South Africa: Evaluation of the GeneXpert® HIV-1 Viral Load Assay

“…Based on the Xpert VL assay performance in this study, suggested placement within the proposed South African tiered (also known as level of service facility) laboratory framework could be as follows [3]: Tier 5 could continue to provide high volume, centralized plasma-based testing in reference facilities with current platforms such as Roche and Abbott, with expansion of plasma testing to tier 4 and tier 3 using GeneXpert 48/80/16/4 instruments that are currently placed at regional and district level laboratories and where technical and implementation experience is already in place with this technology. Critical to this potential future implementation, however, is still the analysis of throughput and current GeneXpert utility if this platform is to be optimised for polyvalent testing.…”

“…South Africa has used VL testing preferentially for monitoring of ART since program inception, which, is now also strongly recommended by the World Health Organisation (WHO) [2]. There are currently over 3900 National Department of Health (NDoH) clinics providing ART initiation and monitoring services in South Africa [3]. All VL testing requirements to service these clinics is performed and managed by the National Health Laboratory service (NHLS) with oversight from the National Priority Programme (NPP), through 16 centralised VL laboratories across the 9 provinces.…”

“…To ensure that VL testing volume requirements are met and are within a clinically relevant turn-around time, a hybrid testing model consisting of both laboratory and point of care testing (POCT), as recently proposed for CD4 testing services [3], may be required. Adapting this model for VL testing could require the expansion of existing centralised, high-throughput VL testing capacity, dried blood spot (DBS) specimen transport and testing and extension of VL testing services to lower throughput decentralised sites.…”