Enabler tools

The toolkit for outsourcing to laboratory services

The Enabler Tools support the Process Steps to allow for a smoother, quicker transition to successful outsourcing. You can find out more about each of these Enabler Tools in the OSTK.

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The purpose of Policy is to offer guidelines to understand the policy, regulatory and legal environment that affects outsourcing. Given the complex and technical nature of laboratory services and the sensitivities of specimens, a thorough understanding of relevant policy guidelines, standards, and regulations is critical to guarantee high-quality laboratory functions that assist optimised diagnostics and disease surveillance. The World Health Organisation (WHO) sets policies and guidelines for laboratories at the international level. After that, countries opt to adopt and adapt these policies to their national laboratory networks. This exercise is informed by the Diagnostic Network Optimisation, which varies in strategy, organisational structure, resources, stakeholders, and outsourcing implementation. Further, national policy standards are vital for central laboratories to receive ISO 15189 accreditation against international standards.

Application to Mozambique

In Mozambique, a National Laboratory Policy document is being drafted and awaiting approval by the Ministry of Health or Central Medical Store (CMAM). It sets clear responsibilities for quality assurance for laboratory facilities at different levels of its healthcare system. From 2011-2015, Mozambique’s National Tuberculosis Reference Laboratory (NTRL) and seven other smaller laboratories embarked on a continuous journey for quality improvement towards international accreditation. This required institutional commitment, laboratory leadership, staff motivation and a comprehension policy plan with clear quality indicators. Accreditation was granted to the NTRL by the Portuguese Board in 2015. Mozambique’s NTRL is now recognised for superior test reliability, operational performance, quality management and competence – if the NTRL chooses to outsource a laboratory function, this superior testing quality will have to be matched by the outsourced partner.

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Advocacy and governance27

The advocacy process is the start of the outsourcing journey, along with examining policy. Advocacy and Governance develop buy-in to and support for the outsourcing process for laboratories from stakeholders. This can be done by:

  1. Establishing commitment from stakeholders early on
  2. Setting up project management and organisational structures such as steering committees and technical working groups
  3. Ways of engagement, platforms for communication, and reporting mechanisms

The advocacy process requires a thorough understanding of each stakeholder’s roles and benefits each stakeholder brings to the laboratory outsourcing project and their timely engagement for critical buy-in to the project. Stakeholders may include ministries of health, central laboratories, relevant disease programmes, donors, implementing partners, and third-party logistics.

Application to Mozambique

In Mozambique, the Last Mile Supply Chain project was an outsourcing arrangement. VillageReach, acting as the fourth-party logistics, partnered with the Ministry of Health and Central Medical Store (CMAM) to outsource specimen transportation to Bolloré (third-party logistics) across two districts in Zambézia province from March to June 2019. The project was a success – Bolloré has now expanded its specimen transportation services across five provinces in Mozambique. This success rested in the strategic advocacy and governance coordination of the project from the start: stakeholders from CMAM and the Zambézia health directorate were engaged early to seek their support. After that, a technical working group was established by VillageReach as the fourth-party logistics, with members including CMAM managers, Zambézia district health officers, VillageReach, Bolloré and donor partners offering financial or technical assistance. The technical working group met regularly to analyse the implementation of the project and make requisite adjustments. This advocacy and governance structure ensured transparent and strategic oversight of the Last Mile Supply Chain project in Mozambique that allowed project visibility for diverse stakeholders and assisted project success.

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The purpose of People is to understand the core competencies required by the laboratory workforce and whether external private sector expertise should be leveraged to provide capacity building services. It further assists the management of organisational change for outsourcing. The laboratory workforce comprises several cadres, including laboratory managers, phlebotomists, technicians, scientists, pathologists, and laboratory support staff. They interface with a range of healthcare professionals, including clinicians, nurses, public health officers, managers, community workers. Outsourced arrangements for laboratories need to consider the members of the laboratory workforce impacted so that the transition to outsourcing is smooth and laboratory service delivery is of a high quality. Similarly, outsourced partners might require training to handle fragile cargo with a high risk of contamination, particularly specimen transport. Outsourcing specimen transportation allows core laboratory staff to concentrate on essential laboratory tasks. In contrast, selected laboratory staff can be trained on logistics operations to support the outsourcing transition and the third- or fourth-party logistics management arrangement.

Application to Uganda

In Uganda, the training of the laboratory workforce has been prioritised in the Uganda National Health Laboratory Services Policy II (2016-2020). This prioritisation stems from Uganda’s strategic decision to centralise laboratory services and retain most functions in-house instead of investing in capacity building for its laboratory workforce. The Policy details multiple training programmes in the country for biosafety and biosecurity, biorisk management, procurement safety of supplies and equipment, and incident management responses for personnel and managers. A training master plan has been developed with standard curricula for thematic areas such as HIV testing, tuberculosis microscopy, Integrated Disease Surveillance and Response, quality assurance, and logistics management.

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The purpose of Technology is to identify current systems and technologies for laboratory services outsourcing arrangements, usually found in the function of specimen transportation, and then choose whether to outsource the system or not. These systems support management functions regarding reporting, visibility, and routing to improve and strengthen laboratory operations. It prioritises technology platforms including (i) Route Optimisation and (ii) Electronic Management Information Systems (e-LMIS). Technology demands a baseline understanding of current reporting processes and data flows through laboratory information systems to review optimised support for demand planning, forecasting, tracking and visibility (or gaps therein). With this information, the user can identify opportunities to outsource technologies or systems to the private sector to close performance gaps.

Application to Laboratory Information Systems

Laboratory Information Systems (LIMs) play a critical role to ensure the requirements for storage, transport, and handling of the specialised commodities that flow through the laboratory supply chain are upheld and reported. Equally, a robust LIM determines how results are reported from the reference laboratory conducting the test back to the clinician to begin the correct patient treatment programme. Parallel information systems remain a considerable challenge for the laboratory supply chain. Often, the government-run laboratory LIM operations are not aligned to the information system used by the logistics company. Thus, sharing tracking data, testing rates, and performance analyses on sample quality becomes increasingly difficult. Linking these different LIM systems requires effort from governments to understand core LIM competency, align stakeholders to the alignment plan (ministries of health, central laboratory, logistics company, donors), and transparently share information. Here, outsourcing of one centralised, neutral LIM could assist.

26Source: Interviews for the Toolkit for Outsourcing Laboratory Services, November 2020; Viegas SO, Azam K, Madeira C, et al. Mozambique’s journey toward accreditation of the National Tuberculosis Reference Laboratory. 2017;6(2), https://ajlmonline.org/index.php/ajlm/article/view/491/814 27Source: Interviews for the Toolkit for Outsourcing Laboratory Services, November 2020.

28Source: Central Public Health Laboratories of the Republic of Uganda. Available: http://cphl.go.ug/about-us/nhlds-units/human-resource

29Source: Interviews for the Toolkit for Outsourcing Laboratory Services, November 2020.