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. 2014 Dec 17;9(12):e115420.
doi: 10.1371/journal.pone.0115420. eCollection 2014.

Estimating implementation and operational costs of an integrated tiered CD4 service including laboratory and point of care testing in a remote health district in South Africa

Naseem Cassim  1 , Lindi M Coetzee  1 , Kathryn Schnippel  2 , Deborah K Glencross  3
Affiliations

Estimating implementation and operational costs of an integrated tiered CD4 service including laboratory and point of care testing in a remote health district in South Africa

Naseem Cassim et al. PLoS One. .

Abstract

Background: An integrated tiered service delivery model (ITSDM) has been proposed to provide 'full-coverage' of CD4 services throughout South Africa. Five tiers are described, defined by testing volumes and number of referring health-facilities. These include: (1) Tier-1/decentralized point-of-care service (POC) in a single site; Tier-2/POC-hub servicing processing < 30-40 samples from 8-10 health-clinics; Tier-3/Community laboratories servicing ∼ 50 health-clinics, processing < 150 samples/day; high-volume centralized laboratories (Tier-4 and Tier-5) processing < 300 or > 600 samples/day and serving > 100 or > 200 health-clinics, respectively. The objective of this study was to establish costs of existing and ITSDM-tiers 1, 2 and 3 in a remote, under-serviced district in South Africa.

Methods: Historical health-facility workload volumes from the Pixley-ka-Seme district, and the total volumes of CD4 tests performed by the adjacent district referral CD4 laboratories, linked to locations of all referring clinics and related laboratory-to-result turn-around time (LTR-TAT) data, were extracted from the NHLS Corporate-Data-Warehouse for the period April-2012 to March-2013. Tiers were costed separately (as a cost-per-result) including equipment, staffing, reagents and test consumable costs. A one-way sensitivity analyses provided for changes in reagent price, test volumes and personnel time.

Results: The lowest cost-per-result was noted for the existing laboratory-based Tiers- 4 and 5 ($6.24 and $5.37 respectively), but with related increased LTR-TAT of > 24-48 hours. Full service coverage with TAT < 6-hours could be achieved with placement of twenty-seven Tier-1/POC or eight Tier-2/POC-hubs, at a cost-per-result of $32.32 and $15.88 respectively. A single district Tier-3 laboratory also ensured 'full service coverage' and < 24 hour LTR-TAT for the district at $7.42 per-test.

Conclusion: Implementing a single Tier-3/community laboratory to extend and improve delivery of services in Pixley-ka-Seme, with an estimated local ∼ 12-24-hour LTR-TAT, is ∼ $2 more than existing referred services per-test, but 2-4 fold cheaper than implementing eight Tier-2/POC-hubs or providing twenty-seven Tier-1/POCT CD4 services.

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Conflict of interest statement

Competing Interests: The patent for the laboratory CD4 method currently used in laboratories in the National Health Laboratory Service (#EP 1 405 073 B1, and US patent #7670793, entitled: ‘Cell Enumeration’), is wholly owned by the National Health Laboratory Service. In terms of DKG′s employment contract with the NHLS, any invention made by DKG during the course of employment is automatically deemed to be owned by the NHLS. As such, DKG is named as the inventor but the patentee is the NHLS. Use of this patented CD4 method in NHLS is not automatic and despite that Beckman Coulter have a licensing agreement with the NHLS, BC is still required, through national government procurement policy, to compete in an open public tender to supply CD4 laboratory testing equipment and reagents. The tender is readvertised and renewed after the expiration period specified for the tender. The remaining authors declare no conflicts of interest. The authors confirm that this does not alter their adherence to all PLOS ONE policies on sharing data and materials.

Figures

Figure 1
Figure 1. Breakdown of costs.
Breakdown of individual cost components, i.e. equipment, reagent and staff costs, used to derive cost per test, at baseline error rates per tier (12% for Tier-1; 8% for Tier-2 and 1% for Tiers 3–5). Daily workload is graphically represented. Existing (Tier-4 and Tier-5) and proposed tiers (Tier-1, or Tier-2 or Tier-3) is shown, as well as service tiers that use POC technologies to CD4 deliver services.
Figure 2
Figure 2. Relationship between costs, TAT and volumes.
Comparison of expected laboratory-to-result turnaround-time (LTR-TAT, orange) and annual CD4 workload (test volumes, blue), per tier, versus cost-per-result (in US$). Tier 3, 4 and 5 laboratories with higher volumes have a lower cost but associated longer LTR-TAT, versus the POC tiers (Tiers 1 and 2) with fast TAT but cost 2–4 times more. Tier-3 emerges with the lowest cost despite lower workload but still meets <24-hour LTR-TAT and fulfils NDOH treatment algorithm requirements where patients are requested to return for CD4 results at 7 days. (*Tiers 1, 2 and 3 are proposed services, #Tiers 4 and 5 are existing service tiers).
Figure 3
Figure 3. Sensitivity analysis.
Sensitivity analysis for POC tiers indicating the impact of test volume, error rates and cartridge costs on cost-per-result. (High error rates of 10 and 15% for Tiers 2 and 1 respectively and low error rates of 6 and 9% per POC tier were used). Baseline cost for Tier-1 (upper dotted line), Tier-2 (lower dotted line) and Tier-3 (feint dotted line) is displayed for reference. This analysis confirms that POC cost is dependent upon volume of samples across a national programme and individual cost of cartridges.
Figure 4
Figure 4. Costs per samples tested.
Cost-per-result based on number of samples run per day for Tiers 1 and 2 (line graphs), compared to published POC data (actual reported points as light yellow bar graphs with extrapolated curve) versus baseline cost-per-result for Tier-3 (pale blue dotted line). The ‘+’ at the end of line represents higher capacity of workload of Tier-3 services.
See this image and copyright information in PMC

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