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      Implementation of a new 'community' laboratory CD4 service in a rural health district in South Africa extends laboratory services and substantially improves local reporting turnaround time

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          Abstract

          BACKGROUND: The CD4 integrated service delivery model (ITSDM) provides for reasonable access to pathology services across South Africa (SA) by offering three new service tiers that extend services into remote, under-serviced areas. ITSDM identified Pixley ka Seme as such an under-serviced district. OBJECTIVE: To address the poor service delivery in this area, a new ITSDM community (tier 3) laboratory was established in De Aar, SA. Laboratory performance and turnaround time (TAT) were monitored post implementation to assess the impact on local service delivery. METHODS: Using the National Health Laboratory Service Corporate Data Warehouse, CD4 data were extracted for the period April 2012 - July 2013 (n=11 964). Total mean TAT (in hours) was calculated and pre-analytical and analytical components assessed. Ongoing testing volumes, as well as external quality assessment performance across ten trials, were used to indicate post-implementation success. Data were analysed using Stata 12. RESULTS: Prior to the implementation of CD4 testing at De Aar, the total mean TAT was 20.5 hours. This fell to 8.2 hours post implementation, predominantly as a result of a lower pre-analytical mean TAT reducing from a mean of 18.9 to 1.8 hours. The analytical testing TAT remained unchanged after implementation and monthly test volumes increased by up to 20%. External quality assessment indicated adequate performance. Although subjective, questionnaires sent to facilities reported improved service delivery. CONCLUSION: Establishing CD4 testing in a remote community laboratory substantially reduces overall TAT. Additional community CD4 laboratories should be established in under-serviced areas, especially where laboratory infrastructure is already in place.

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          National consolidated guidelines for the prevention of mother-to-child transmission of HIV (PMTCT) and the management of HIV in children adolescents and adults

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            African regional external quality assessment for CD4 T-cell enumeration: development, outcomes, and performance of laboratories.

            An independent African Regional External Quality Assessment Scheme (AFREQAS) was implemented from Johannesburg. The aim was to establish a network of CD4 laboratories supporting HIV/AIDS anti-retroviral therapy programs and improve the quality of regional CD4 testing with EQA assessment, feedback, remedial action, and technical training. The overall performance from 2002 to 2006 (Trials 1-20) is reported, together with cumulative longitudinal performance of the different CD4 methods used. Stabilized blood samples with "normal" and/or "low" CD4 values were shipped over 20 Trials. Data was analyzed for each trial including trimmed mean, standard deviation, and percentage coefficient of variation (%CV); "Residual" and SDI values were also calculated for each participating laboratory for both absolute CD4 counts (CD4abs) and CD4 percentage of lymphocytes values (CD4%/Ly). Standardized individual laboratory SDI values across 20 trials were analyzed according to CD4 method. Average participation was 91.5%. Overall AFREQAS between-laboratory reproducibility (trimmed %CV) was 10.5% and 9.1% for absolute CD4 and CD4%/Ly, respectively. For the respective CD4abs and CD4%/Ly values in the trials where "normal" material was shipped trimmed %CV of 10.9 and 7.3% were noted, and in "low" value shipments %CV of 13.8% and 12.4% were noted. Cumulative absolute CD4 SDI analysis revealed the best between-laboratory precision amongst FACSCount and PanLeucogating (PLG-CD4) users (both SD of SDI = 12-25%CV and SD(SDI) > 2.2 noted), indicating that additional technical training and/or manufacturer support was required. Participation in an AFREQAS with feedback and remedial action improves the quality of CD4 testing. African laboratory professionals can easily master CD4 counting technologies. However, the introduction of the simplest and most cost-effective methodologies is required to take ownership, and enable the delivery of quality CD4 counts in vast numbers necessary to support expansion of African ART programs. Copyright 2008 Clinical Cytometry Society.
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              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

              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 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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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Journal
                samj
                SAMJ: South African Medical Journal
                SAMJ, S. Afr. med. j.
                Health and Medical Publishing Group
                2078-5135
                January 2016
                : 106
                : 1
                : 82-87
                Affiliations
                [1 ] National Health Laboratory South Africa
                [2 ] University of the Witwatersrand South Africa
                Article
                S0256-95742016000100027
                10.7196/SAMJ.2016.V106I1.10081
                26792313
                909e5342-0e5b-48b7-b070-ee7a276018ff

                This work is licensed under a Creative Commons Attribution-NonCommercial 3.0 International License.

                History
                Product

                SciELO South Africa

                Self URI (journal page): http://www.scielo.org.za/scielo.php?script=sci_serial&pid=0256-9574&lng=en
                Categories
                Health Care Sciences & Services
                Health Policy & Services
                Medical Ethics
                Medicine, General & Internal
                Medicine, Legal
                Medicine, Research & Experimental

                Social law,General medicine,Medicine,Internal medicine,Health & Social care,Public health

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