Piloting a national laboratory electronic programme status reporting system in Ekurhuleni health district, South Africa

Background. The National Health Laboratory Service (NHLS) performs ~4 million CD4 tests per annum for the public health sector at 61 CD4 testing laboratories across South Africa. Currently, CD4 laboratory data captured do not differentiate between antiretroviral treatment (ART) and pre-ART care.Methods. A cross-sectional study was undertaken to evaluate a redesigned Comprehensive Care, Management and Treatment of HIV and AIDS (CCMT) request form, incorporating a two-tick collection procedure linking the CD4 test request to patient CCMT programme status. Field testing was undertaken at three health facilities, where healthcare personnel were required to capture whether the CD4 count requested was a ‘first-ever CD4’, ‘CD4 taken previously, not yet in ART care’ or ‘in ART care’. All data were extracted from the NHLS Corporate Data Warehouse and analysed using Microsoft Excel and Stata-12.Results. A substantial increase in the number of request forms with a CCMT programme status (28.1% v. 84.4%) was reported pre- and post-implementation. Post-implementation data (N=1 004) revealed that 30.8% patients were ART naive (‘first-ever CD4’), with 7.4% ‘not yet on ART’ (median CD4 counts of 150 and 328 cells/μL, respectively). Patients on ART comprised 61.9% of the study group (median CD4 count ~346 cells/μL). Sixty percent of patients were aged between 30 and 44 years, and females predominated (male/ female ratio 0.7:1).Conclusions. A simple modification to the CCMT request form can successfully facilitate collection of programme status. For national implementation, it would be advantageous to have a unique patient identifier to further enhance laboratory-based programmatic monitoring and evaluation

Documented higher burden of advanced and very advanced HIV disease among patients, especially men, accessing healthcare in a rapidly growing economic and industrial hub in South Africa: A call to action

Background. Lephalale Municipality in Limpopo Province, South Africa, has seen significant economic and industrial development owing to expansion of the coal mining and power generation sectors. This development has coincided with substantial population growth of 65% between 2001 and 2016, attributable to largely (migrant) males living in the area who, overall, outnumbered females by ~121:100. The local HIV prevalence is reported to be higher than national rates.Objectives. Anonymised National Health Laboratory Service CD4+ data were used to document increasing laboratory services workload and to establish the burden of advanced (CD4+ count <200 cells/µL) and very advanced (<100 cells/µL) HIV disease among adult patients accessing public healthcare in Lephalale between 2006 and 2015.Methods. A cross-sectional design was used to analyse CD4+ laboratory data. CD4+ outcomes were categorised by volumes of tests, year, health facility type, age categories (15 - 19, 20 - 24, 25 - 29, 30 - 34, 35 - 39, 40 - 44, 45 - 49 and >49 years), CD4+ test range (≤50, 51 - 100, 101 - 200, 201 - 350, 351 - 500 and ≥501 cells/µL) and gender. Median CD4+ counts were calculated.Results. Extracted Lephalale data comprised 57 490 CD4+ results, with a mean patient age of 34 years. Considerably fewer male than female patients had CD4+ counts reported (male/female ratio 0.45:1). CD4+ test volumes showed a five-fold escalation over the study period, increasing from 1 458 tests in 2006 to 8 239 in 2015. A considerable burden of advanced and very advanced HIV disease (exceeding 50% of all cases) was noted in 2006/2007; by 2015 the proportion had fallen, but was still high at 27%. The overall median CD4+ count in 2006 (192 cells/µL) confirmed a high burden of advanced disease, with modest improvement to 289 cells/µL by 2015. Between 2006 and 2015, the median CD4+ count for females increased from 204 to 405 cells/µL, while that for males increased from 126 to 285 cells/µL. Age analysis further revealed that men aged <20 years or >25 years, and specifically those aged 30 - 45 years, had up to 44% more advanced HIV disease.Conclusions. Lower median CD4+ counts and a dramatic increase in volumes of CD4+ tests performed from 2007 onwards revealed a high burden of advanced and very advanced HIV disease in patients accessing care in Lephalale. Viewed together with Statistics South Africa census documentation of a disproportionately high number of males compared with females living in the area, these figures suggest that improved systems are urgently needed to encourage and accommodate access to HIV care for male (migrant worker) patients living and working in emerging industrial centres

Analysis of HIV disease burden by calculating the percentages of patients with CD4 counts

Background. South Africa (SA)’s Comprehensive HIV and AIDS Care, Management and Treatment (CCMT) programme has reduced new HIV infections and HIV-related deaths. In spite of progress made, 11.2% of South Africans (4.02 million) were living with HIV in 2015.Objective. The National Health Laboratory Service (NHLS) in SA performs CD4 testing in support of the CCMT programme and collates data through the NHLS Corporate Data Warehouse. The objective of this study was to assess the distribution of CD4 counts <100 cells/μL (defining severely immunosuppressed HIV-positive patients) and >500 cells/μL (as an HIV-positive ‘wellness’ indicator).Methods. CD4 data were extracted for the financial years 2010/11 and 2014/15, according to the district where the test was ordered, for predefined CD4 ranges. National and provincial averages of CD4 counts <100 and >500 cells/μL were calculated. Data were analysed using Stata 12 and mapping was done with ArcGIS software, reporting percentages of CD4 counts <100 and >500 cells/μL by district.Results. The national average percentage of patients with CD4 counts <100 cells/μL showed a marked decrease (by 22%) over the 5-year study period, with a concurrent increase in CD4 counts >500 cells/μL (by 57%). District-by-district analysis showed that in 2010/11, 44/52 districts had >10% of CD4 samples with counts <100 cells/μL, decreasing to only 17/52 districts by 2014/15. Overall, districts in the Western Cape and KwaZulu-Natal had the lowest percentages of CD4 counts <100 cells/μL, as well as the highest percentages of counts >500 cells/μL. In contrast, in 2014/15, the highest percentages of CD4 counts <100 cells/μL were noted in the West Rand (Gauteng), Vhembe (Limpopo) and Nelson Mandela Bay (Eastern Cape) districts, where the lowest percentages of counts >500 cells/μL were also noted.Conclusions. The percentages of CD4 counts <100 cells/μL highlighted here reveal districts with positive change suggestive of programmatic improvements, and also highlight districts requiring local interventions to achieve the UNAIDS/SA National Department of Health 90-90-90 HIV treatment goals. The study further underscores the value of using NHLS laboratory data, an underutilised national resource, to leverage laboratory test data to enable a more comprehensive understanding of programme-specific health indicators

Compliance to HIV treatment monitoring guidelines can reduce laboratory costs

Background: Panel tests are a predetermined group of tests commonly requested together to provide a comprehensive and conclusive diagnosis, for example, liver function test (LFT). South African HIV antiretroviral treatment (ART) guidelines recommend individual tests for toxicity monitoring over panel tests. In 2008, the National Health Laboratory Services (NHLS) request form was redesigned to list individual tests instead of panel tests and removed the ‘other tests’ box option to facilitate efficient ART laboratory monitoring.Objectives: This study aimed to demonstrate changes in laboratory expenditure, for individual and panel tests, for ART toxicity monitoring.Method: NHLS Corporate Data Warehouse (CDW) data were extracted for HIV conditional grant accounts to assess ART toxicity monitoring laboratory expenditure between 2010/2011 and 2014/2015. Data were classified based on the tests requested, as either panel (LFT or urea and electrolytes) or individual (alanine transaminase or creatinine) tests.Results: Expenditure on panel tests reduced from R340 million in 2010/2011 to R140m by 2014/2015 (reduction of R204m) and individual test expenditure increased from R34m to R76m (twofold increase). A significant reduction in LFT panel expenditure was noted, reducing from R322m in 2010/2011 to R130m in 2014/2015 (60% reduction).Conclusion: Changes in toxicity monitoring guidelines and the re-engineering of the NHLS request form successfully reduced expenditure on panel tests relative to individual tests. The introduction of order entry systems could further reduce unnecessary laboratory expenditure

Using laboratory data to categorise CD4 laboratory turn-around-time performance across a national programme

Background and objective: The National Health Laboratory Service provides CD4 testing through an integrated tiered service delivery model with a target laboratory turn-around time (TAT) of 48 h. Mean TAT provides insight into national CD4 laboratory performance. However, it is not sensitive enough to identify inefficiencies of outlying laboratories or predict the percentage of samples meeting the TAT target. The aim of this study was to describe the use of the median, 75th percentile and percentage within target of laboratory TAT data to categorise laboratory performance.   Methods: Retrospective CD4 laboratory data for 2015–2016 fiscal year were extracted from the corporate data warehouse. The laboratory TAT distribution and percentage of samples within the 48 h target were assessed. A scatter plot was used to categorise laboratory performance into four quadrants using both the percentage within target and 75th percentile TAT. The laboratory performance was labelled good, satisfactory or poor.   Results: TAT data reported a positive skew with a mode of 13 h and a median of 17 h and 75th percentile of 25 h. Overall, 93.2% of CD4 samples had a laboratory TAT of less than 48 h. 48 out of 52 laboratories reported good TAT performance, i.e. percentage within target > 85% and 75th percentile ≤ 48 h, with two categorised as satisfactory (one parameter met), and two as poor performing laboratories (failed both parameters).   Conclusion: This study demonstrated the feasibility of utilising laboratory data to categorise laboratory performance. Using the quadrant approach for TAT data, laboratories that need interventions can be highlighted for root cause analysis assessment

Piloting a national laboratory electronic programme status reporting system in Ekurhuleni health district, South Africa

Background. The National Health Laboratory Service (NHLS) performs ~4 million CD4 tests per annum for the public health sector at 61 CD4 testing laboratories across South Africa. Currently, CD4 laboratory data captured do not differentiate between antiretroviral treatment (ART) and pre-ART care.Methods. A cross-sectional study was undertaken to evaluate a redesigned Comprehensive Care, Management and Treatment of HIV and AIDS (CCMT) request form, incorporating a two-tick collection procedure linking the CD4 test request to patient CCMT programme status. Field testing was undertaken at three health facilities, where healthcare personnel were required to capture whether the CD4 count requested was a ‘first-ever CD4’, ‘CD4 taken previously, not yet in ART care’ or ‘in ART care’. All data were extracted from the NHLS Corporate Data Warehouse and analysed using Microsoft Excel and Stata-12.Results. A substantial increase in the number of request forms with a CCMT programme status (28.1% v. 84.4%) was reported pre- and post-implementation. Post-implementation data (N=1 004) revealed that 30.8% patients were ART naive (‘first-ever CD4'), with 7.4% ‘not yet on ART’ (median CD4 counts of 150 and 328 cells/µL, respectively). Patients on ART comprised 61.9% of the study group (median CD4 count ~346 cells/µL). Sixty percent of patients were aged between 30 and 44 years, and females predominated (male/female ratio 0.7:1).Conclusions. A simple modification to the CCMT request form can successfully facilitate collection of programme status. For national implementation, it would be advantageous to have a unique patient identifier to further enhance laboratory-based programmatic monitoring and evaluation

Siting of HIV/AIDS diagnostic equipment in South Africa: a case study in locational analysis

This paper describes a practical application of locational analysis to the siting of HIV/AIDS diagnostic equipment in laboratories across South Africa. Classical location analytical techniques were extended to ensure that laboratories are sited as close as possible to major centres of demand from hospitals and clinics. A particular advantage of the modified set covering algorithm developed is that choices between laboratory sites are made in a transparent manner. In order to find appropriate numbers and ideal placement of CD4 laboratories, runs were undertaken for various scenarios based on maximum travel time from health facilities to laboratory sites. Results demonstrated to decision makers showed close comparisons with pilot review projects undertaken in four health districts of South Africa. The research has potential to impact health care delivery to HIV sufferers in the poorest rural regions of the country

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

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.

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

Introduction: CD4 testing in South Africa is based on an integrated tiered service delivery model that matches testing demand with capacity. The National Health Laboratory Service has predominantly implemented laboratory-based CD4 testing. Coverage gaps, over-/under-capacitation and optimal placement of point-of-care (POC) testing sites need investigation. Objectives: We assessed the impact of relational algebraic capacitated location (RACL) algorithm outcomes on the allocation of laboratory and POC testing sites. Methods: The RACL algorithm was developed to allocate laboratories and POC sites to ensure coverage using a set coverage approach for a defined travel time (T). The algorithm was repeated for three scenarios (A: T = 4; B: T = 3; C: T = 2 hours). Drive times for a representative sample of health facility clusters were used to approximate T. Outcomes included allocation of testing sites, Euclidian distances and test volumes. Additional analysis included platform distribution and space requirement assessment. Scenarios were reported as fusion table maps. Results: Scenario A would offer a fully-centralised approach with 15 CD4 laboratories without any POC testing. A significant increase in volumes would result in a four-fold increase at busier laboratories. CD4 laboratories would increase to 41 in scenario B and 61 in scenario C. POC testing would be offered at two sites in scenario B and 20 sites in scenario C. Conclusion: The RACL algorithm provides an objective methodology to address coverage gaps through the allocation of CD4 laboratories and POC sites for a given T. The algorithm outcomes need to be assessed in the context of local conditions

The role of simulation in designing for universal access

It is known that the adoption of user-centred design processes can lead to more universally accessible products and services. However, the most frequently cited approach to user-centred design, i.e. participatory design, can be both problematic and expensive to implement., particularly over the difficulty of finding and recruiting suitable participants. Simulation aids offer a potentially cost-effective replacement or complement to participatory design. This paper examines a number of the issues associated with the use of simulation aids when designing for Universal Access. It concludes that simulation aids can play an effective role, but need to be used with due consideration over what insights they provide