Problem statement

 Diagnostics is a fundamental pillar of a strong health system. At the patient level they impact the choice, duration, and dose of treatment with the aim of making the patient better faster. At the public health level, they aid in decision-making for early detection, and timely response and containment of outbreaks/epidemics- averting deaths. To ensure the right test gets to the right patient at the right time, requires a well-functioning diagnostic ecosystem built on having a motivated and skilled workforce, well-maintained infrastructure, and a reliable supply of reagents, commodities, and technologies, backed by adequate funding, and evidence-based policies and guidelines. Unfortunately, the diagnostics sector has often been overlooked, despite its fundamental role in clinical and public health decision making. This has led to limited access and availability of affordable and high-quality lab testing. This is evidenced by the limited funding allocated to laboratories within counties, whereby 10% of the health budget i.e., about KSH 288 per person per year is allocated to labs. Moreover, based on the AHDP feasibility study done nationally, only 30% of the demand for laboratory services within our public hospitals is being met. The reasons for this can be categorized into 4 main buckets (below): challenges related to: service delivery, supply chain, data and data use and health financing.

The challenges listed above require to be tackled using a systematic and holistic approach. Our aim as the innovative diagnostics program is to optimize laboratory capabilities, scale up the utilization of diagnostics in clinical decision making and public health surveillance with approaches that gear towards long term sustainability beyond CHAI.

 What are we doing to address these challenges?

The National Essential Diagnostics List

 Having a sound policy landscape that recognizes and advances the importance of integrating diagnostics as an essential component of the health system is pertinent. Over the years, the country has lacked such an underpinning document to guide the decisions we make around diagnostics. To address this challenge CHAI is supporting the Ministry of Health in development of the National Essential diagnostics List. The Essential Diagnostics List establishes a priority diagnostic list that will facilitate decision-making for appropriate selection, quantification, procurement, and resource allocation for priority diagnostics across each level of care. It will be an indispensable tool that provides an anchor to enhance laboratory service delivery at facility level, in a similar manner to the role the essential medicines list plays. Our role as CHAI is providing technical assistance to the MoH in ensuring the alignment of diagnostics needed to address the diseases that heavily burden the country (e.g., reflecting the diagnostic priorities in key national programs such as TB, HIV, Cancer, NTDs, AMR) in addition to having up to date diagnostics reflected in the list (e.g., use of molecular technology and rapid tests). The EDL is planned to be finalized by April 2023.

Next steps

 To discuss the implementation of the EDL process including supporting documents and tools that can be used at facility level to facilitate utilization of the document e.g., checklists.

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Antimicrobial resistance

 The problem

Antibiotic resistance (AMR) is one of the most significant global public health problems and is rising in many countries due to over-use of antibiotics, widespread availability of counterfeit or substandard medicines and poor infection prevention and control measures. Studies across Kenya have demonstrated widespread resistance to commonly used antibiotics such as ampicillin, ceftriaxone and co-trimoxazole across all age groups. Irrational antibiotic prescription across different levels of facilities in the country is at 45-69%, with limited to no use of culture and sensitivity tests to guide prescription. Key to addressing these challenges is having an active surveillance system, that ensure the right information is available at the right time and in the right place to inform patient management and public health decisions. Core to an active surveillance system is a strong connected diagnostics network.

 The Ministry of Health has established 17 sentinel sites for human health, which are submitting AMR data to a central data warehouse at the National public health laboratory. The pathogens of priority include Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pneumoniae, Salmonella spp.,Shigella spp. While progress has been made, challenges persist especially in terms of reagent and consumable stock outs, limited representation of AMR surveillance data, information systems gaps such as poor internet connection, and lack of LIMS, limited interoperability between existing LIMS and HMIS to bridge the clinical lab interface, high turnover of trained laboratory technologists, low utilization of data to inform policies at facility and county level and low demand of bacteriological services by clinicians.

 The approach

 CHAI has conducted a landscape assessment to understand the existing gaps and opportunities to improve the AMR surveillance systems. Based on the findings CHAI is in the process of supporting the MoH in the development of the National action plan that provides the overall strategic areas needed to tackle this threat in the next 5 years. Additionally, we are supporting the revision of the AMR surveillance strategy that provides the how of operationalizing the surveillance system.

 We are looking forward to :

 1.      Supporting the AMR team in strengthening their data and data use systems to ensure it flows back to the patients through, harmonization of AMR reporting tools, leveraging work from Project Stellar(below) to harmonize clinical and lab data.

 2.      Developing demand forecasts and quantification tools for use across sentinel sites to support planning for supplies and thus reduce stockouts

 3.      Increasing visibility of existing diagnostic tools such as molecular platforms, that could be leveraged to conduct AMR tests.

 4.      Incorporation of Neisseria Gonorrhea as a priority pathogen in the AMR surveillance strategy.

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PROJECT STELLAR

The Problem

Diagnostic data in the form of patient results is key in effective patient management, i.e., inform interventions to monitor transmission level, inform public health response and decision making as well as assist track variant of concerns to mitigate the spread of disease thus protecting the health of local, national, or global populations. The availability of an integrated data management system is lacking as there are different versions of systems including the manual registers that need to be streamlined and/or harmonized, an example being the covid registers that were deployed during the pandemic. This variation makes it difficult for the government to plan, allocate and effectively use resources for data management and decision making. Moreover, collating national program indicators in the laboratory services docket is a challenge associated with different types of data systems that have been deployed in the country making aggregation of this data set a challenge at the national level.

 The Approach

To integrate the existing data management systems that can communicate to each other, there are several phases essential to achieve the impact. The approach includes mapping out existing solutions and understanding what opportunity exist that can be leveraged to achieve this. CHAI has provided technical assistance in terms of:

 1.      Landscape analysis to understand and map out the existing data systems that supports both laboratory analytical processes as well as commodities; looking at the current infrastructure, and the partners who support current systems. The findings are being used in determining what opportunities could be leveraged within the defined time period of the grant and what can be incorporated or ruled out as a solution when considering interoperability.

 2.      Costing out the proposed solutions based on the landscape analysis findings including a resource mobilization plan for supporting the lab systems.

3.      Strengthening the policy landscape, which includes the revision and finalization of LIMS guidelines.

Sustainability beyond CHAI

 As part of the landscape analysis, the different existing solution will be matched to a partner support and resource investment required will be identified. This will be used to create a criterion for which costs of duplications can be avoided and resources appropriately utilized to achieve value for money by exploring partner(s) support for the proposed solution.

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African Health Diagnostics Platform aka Clinical laboratory Improvement Project

 Across the counties there is limited funding allocation by the Government to provide accessible , affordable and high-quality laboratory services. To bridge the 70% gap in meeting demand for laboratory services, counties require approximately KES 200 to 300 million. To address this financing gap, in addition to existing laboratory challenges, the Clinical Laboratory Improvement Project (CLIP) seeks to leverage collaboration with the private sector to support the county governments to expand availability of timely, cost effective, and quality diagnostics. CHAI is supporting the county governments by breaking down barriers that hinder public private collaborations in diagnostics services, with the aim of transforming the testing landscape by catalyzing public private collaborations to increase coverage and quality of diagnostics.

 Public-private collaborations provide an opportunity to combine varied skills and resources in innovative ways and allow for the sharing of benefits, risks, and responsibilities between the government and the private partners. Leveraging the Public Procurement and Disposal Act (PPDA), CHAI is supporting county government to outsource laboratory services from private sector partners using a purchasing agreement model. The purchasing agreement contract forms the basis for a county to partner with private laboratory companies by allocating specific roles to both partners. Below are the roles allocated.

It is anticipated through leveraging the efficiencies and modalities of working of private sector labs within the County laboratories, the quality and menu of tests will improve and as a result the demand and revenues generated from the laboratories increase. The CLIP model is designed to allow the county to be self-sufficient in terms of financing their laboratory sector, as additional revenue anticipated to be collected from the agreements could be ploughed back to improving not just their laboratory systems but other sections of health.

 CHAI has successfully supported the County Government of Tharaka Nithi in establishing such an agreement and is in the process of supporting the implementation of the contract. This includes:

 •      Developing the M&E framework for performance management including supporting the county to conduct regular performance reviews.

 •      Finalization of the Facility Improvement Fund regulations that will allow ring fencing of funds generated by the health sector

 •      Developing a communication and demand generation plan