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.


Introduction
Diagnostic laboratory services are considered an integral part of the public health system in South Africa. 1 Laboratory testing plays a pivotal role across the HIV continuum of care, including screening of asymptomatic individuals to identify risk for developing disease, detecting disease at the earliest stages, selecting safe and effective treatments, planning disease management strategies, monitoring treatment response throughout the course of care and identifying adverse reactions. 2 The National Health Laboratory Service (NHLS) is the diagnostic pathology service provider to the public health sector as mandated by Act 37 of 2000. 3 The NHLS currently provides laboratory services coverage up to 80% of the population through a national network of over 260 laboratories. Its mandate is to provide diagnostic laboratory services, research, teaching and training. 4 Annual laboratory expenditure has increased by 45% from R3.1 billion in 2010/2011 to R4.5bn by 2013/2014. 4 Annual state price increases during this period accounted for only 18%, the remainder being due to changes in test volumes and test mix. Total laboratory test volumes increased from 80.2 million tests in 2011/2012 to 86 million tests in 2013/2014. This sharp increase in expenditure and test volumes could be attributed to growth in the priority public health programmes, that is, HIV, TB and cervical cancer screening, as well as state price increases. 4 Pressures on public health expenditure therefore require the application of evidence-based laboratory medicine (EBLM) that integrates clinical decision-making and laboratory investigations, to improve patient outcomes and ensure the effective use of healthcare resources. 5  ART can cause a wide range of toxicities, from low-grade intolerance that may be self-limiting to life-threatening side effects. ART toxicity can be monitored clinically, as well as by a limited number of laboratory tests. The South African ART guidelines list the ART regimens used, as well as the routine laboratory tests required for monitoring for drug toxicity. 8 Since 2004, guidelines have recommended individual tests over panel tests. The current 2015 ART guidelines recommend alanine transaminase (ALT) testing to monitor nevirapine (NVP) toxicity and creatinine testing for tenofovir (TDF) toxicity. 9 One of the early challenges was the availability of the 'other tests' option, which healthcare workers to order laboratory tests, including panels, on the CCMT request form. Since 2008, a demand-management strategy was implemented by listing only tests prescribed by the ART guidelines on the CCMT request form and removing the box for 'other tests', to limit the latter practice not prescribed in the ART guidelines.

Objective
The aim of the study is to review HIV & AIDS conditional grant laboratory expenditure for ART toxicity monitoring by comparing expenditure attributable to costs of panel versus individual prescribed test ordering over a 5-year period.

Laboratory billing and expenditure
Conditional grant laboratory expenditure allocation is managed through a dedicated (CCMT) request form. Health facilities use the CCMT request form when tests are requested for screening and ART monitoring. Each province has either one or more 'ZARV' accounts on the NHLS billing systems (based on provincial requirements) to which conditional grant laboratory expenditure is allocated.
Currently, eight provinces are using conditional grants to pay for ART-related toxicity monitoring. However, it was not possible to extract conditional grant expenditure data for the KwaZulu-Natal province as they do not make use of a provincial conditional grant account. Instead, all expenditure is allocated to the health facility without the possibility of flagging CCMT-related toxicity monitoring. Laboratory expenditure data were extracted from the NHLS Corporate Data Warehouse (CDW) for ART (NVP and TDF)-related toxicity monitoring (refer to

Recommendations to achieve further efficiencies
To further reduce laboratory expenditure of panel tests and to facilitate appropriate guideline-based testing, two options are available. The first alternative involves stopping inappropriately requested tests before they reach the laboratory network, unless the panel test is motivated for by a consultant. 10 This will enable clinicians to request the panel test in patients with symptoms suggestive of hepatitis. These preventative strategies involve a focus on education for clinicians and nurses on appropriate test ordering based on the latest ART guidelines. 10 These interventions include healthcare worker training on appropriate test requesting and the inclusion of interpretative comments on laboratory test results, 10 for example, 'An LFT is not indicated for patients on ART, please request an ALT as stipulated by the current ART guidelines'.
The second intervention to manage appropriate test requesting involves the development of Order Entry (OE) applications on existing electronic health records and hospital Source: Corporate data warehouse (CDW) NVP, nevirapine; TDF, tenofovir. information systems, to flag inappropriate test requests before venesection commences at the health facility. This is the most effective option and alerts (and educates) the healthcare worker requesting an inappropriate test, upfront, by offering more appropriate and cost-effective tests.
Westbrook et al. reported that one of the main advantages of computerised OE systems is the ease of extracting and reviewing the impact of laboratory demand-management strategies by using real-time data to feedback to clinicians and nurses. 11 To describe this further, computerised OE refers to an application that enables healthcare workers to order laboratory tests using a computer system at or near patientcare areas. 12 Additionally, OE can provide a platform that streamlines the logistical processes before the samples get to the laboratory, standardises ordering of laboratory tests, promotes adherence to guidelines and delivers decision support alerts. 12 Additional benefits of OE include the reduction of duplicate test orders for same patient. 12,13 The removal of panel tests on the OE screen itself can reduce panel orders and increase individual test orders.
OE systems may be confused with electronic gate keeping (EGK), which in comparison, is a rule-based mechanism employed on laboratory information systems to reject tests based on agreed criteria when they reach the laboratory. The aim of EGK is to prevent or minimise irrational and wasteful use of laboratory services. The challenge with EGK is that tests are rejected at the laboratory, initially unbeknown to the attending clinician, whereas with OE the decision support alerts are generated at the health facility, enabling the healthcare worker to immediately respond. OE also supports the electronic delivery of laboratory results for integration into the patient's record in the hospital information system. 12 OE also saves wasted expenditure by removing the cost associated with pulling the sample and sending it to the laboratory in the first place (approximately R2.58 for the vacutainer tube, specimen plastic bag and request form). Implementing OE systems in South Africa will require adequate information technology (IT) infrastructure, which is currently lacking.
The combination of these interventions could act to unlock additional reductions in laboratory expenditure on toxicity monitoring and meaningfully reduce public health expenditure on providing ART services.

Limitations
Due to the exclusion of the KwaZulu-Natal province, this study is not representative of national toxicity monitoring expenditure.
From the data extract, we were unable to differentiate test orders from hospitals and primary healthcare clinics to assess differences in laboratory expenditure patterns by level of care. Additionally, it was not possible to differentiate between routine toxicity monitoring versus testing following an adverse event. However, hospital expenditure is funded through the provincial Source: Corporate data warehouse (CDW) equitable share and not the HIV conditional grant, and therefore, this bias is not likely to be substantial.

Conclusion
Although there have been significant cost reductions in panel testing reported here following some fairly simple interventions, widespread use of these interventions is necessary to fully exclude unnecessary laboratory expenditure and maximise cost-efficiency in delivering laboratory services required for monitoring ART toxicity. The introduction of an OE system could play a significant role in this regard to reduce inappropriate laboratory test requests and public health expenditure in South Africa. Additionally, the introduction of OE would improve the appropriate utilisation of laboratory services across all disciplines to further reduce public health expenditure.