In the first article of this series, we began with a simple but powerful moment: a person receives a laboratory result and trusts that it is correct. In the second article, we explored how accreditation transformed that trust into proof by providing objective evidence that a laboratory can produce accurate, reliable, and timely results against recognised standards.
But as health systems became more complex, another reality became impossible to ignore: evidence of quality in one laboratory, however important, does not automatically create quality across a country.
Many countries have invested in excellent reference laboratories, specialist equipment, trained professionals, and accreditation. These investments matter deeply. Yet national diagnostic impact depends on more than a few high-performing institutions. It depends on whether quality is organised, financed, regulated, monitored, and sustained across the full network of diagnostic service delivery, from community and primary care settings to district, regional, national, and specialised laboratories [1][2].
This article is about that turning point in the quality journey. It is the moment when laboratory quality had to move beyond individual achievement and become a national responsibility.
The question was no longer only: can this laboratory demonstrate quality and competence? The larger question became: can the country create the conditions for quality diagnostic services to be delivered consistently, equitably, and sustainably across all tiers of care [1][2]?
When We Realised One Strong Laboratory Was Not Enough
For many years, laboratory improvement efforts rightly focused on individual facilities. This made sense. If a laboratory could not manage specimens properly, control testing processes, train staff, maintain equipment, document procedures, or participate in external quality assessment, then the first priority was to strengthen that laboratory.
Quality management systems, accreditation, and stepwise improvement programs made an enormous contribution to this journey. In Africa, Strengthening Laboratory Management Toward Accreditation (SLMTA) and the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) helped many laboratories, particularly in resource-constrained settings, move progressively toward stronger quality management systems and accreditation readiness [3][4].
Over time, however, the field learned a critical lesson: improving one laboratory at a time is necessary, but not sufficient.
A country may have one or two accredited reference laboratories and still have many testing sites across community, primary healthcare, district, regional, and private-sector settings operating with limited quality oversight. This matters because most patients do not begin their healthcare journey at a national reference laboratory. They begin at the first point of care, where the initial diagnostic decision is often made.
If quality is poor at that point, the consequences are immediate. A pregnant woman may receive an unreliable screening result. A child with fever may be treated for the wrong condition. A patient with tuberculosis, HIV, malaria, or antimicrobial-resistant infection may enter the wrong care pathway. A specimen referral system may help for complex or confirmatory testing, but it cannot compensate for unreliable results when essential tests are intended to be delivered safely at lower tiers of care.
The issue, therefore, is not only that quality may be uneven. It is also that quality may be fragile, externally dependent, poorly enforced, and disconnected from health outcomes. In many settings, accreditation and quality improvement have been supported by disease-specific programs, development partners, or time-limited technical assistance. These investments can be powerful, but without national mechanisms to maintain and enforce quality requirements, gains may fade once external support declines.
This is why quality has to become a national system concern. Countries need mechanisms that define minimum quality requirements, adapt them to different types and tiers of diagnostic service delivery, enforce them through regulation and oversight, support facilities to comply, and protect patients when minimum standards are not met.
In such situations, quality does not fail because one strong laboratory is absent. It fails because the wider system has not created the conditions for quality to be delivered, maintained, and improved across the whole diagnostic landscape. That realisation changed the question from, “Is this laboratory good?” to, “Can the national laboratory system ensure reliable diagnostic services wherever patients enter the health system?”
That shift changed everything.
From Facility Improvement to a National Quality Mechanism
This is where the idea of a national laboratory quality mechanism becomes essential.
Facility-level quality tools remain indispensable. SLIPTA and SLMTA are familiar to many laboratory professionals in Africa because, for many years, they provided a practical route toward quality management system implementation and accreditation readiness [3][4]. But they were never designed to carry the full burden of national regulation, financing, enforcement, licensing, inspection, and long-term sustainability.
The national question is different. It asks: who sets the quality requirements? Are those requirements appropriate for each tier and type of service delivery? Who has the authority to recognise quality? How are requirements enforced? Are there enough inspectors and supervisors to identify non-compliance? Do facilities have the workforce, equipment, supplies, data systems, and budget needed to implement quality? What happens when minimum requirements are not met? And how do investments in quality translate into better care, stronger surveillance, and value for money [9]?
The Guidance for Establishing a National Laboratory Quality Framework addresses precisely this space. It was developed to support countries in strengthening national laboratory networks and systems so that laboratories can implement, maintain, and improve laboratory quality management systems across all tiers of the network. It also recognises that facility-focused tools such as SLIPTA do not, on their own, provide the regulatory and policy architecture needed from a national perspective [9].
A national quality mechanism turns quality from a project into a public responsibility. It requires a policy and strategic plan, a legal and regulatory framework, quality standards, licensing systems, inspection and oversight functions, external quality assessment programs, workforce development, equipment maintenance and calibration systems, monitoring and evaluation, and clear governance arrangements [9].
The same guidance describes the National Laboratory Quality Infrastructure as a set of practical building blocks: a capable National Accreditation Body, national or international quality standards such as ISO 15189 and ISO/IEC 17025, staged national quality requirements for different types of laboratories, licensing systems linked to compliance, competent workforce development, national external quality assessment, equipment maintenance and calibration, quality indicators, and tiered supervision [9][10][11].
This is the logic that carries LMM Article #3 forward from LMM Article #2. Accreditation remains a breakthrough because it provides evidence of competence. But for accreditation and quality management systems to create population-level impact, they must be embedded in a national quality architecture that reaches beyond isolated facilities and supports the entire diagnostic service delivery system.
Laboratory Networks Need National Systems to Make Quality Work
The first step beyond individual laboratories is the laboratory network.
A laboratory network connects laboratories and testing sites across tiers of the health system. It allows community and primary care sites, district laboratories, regional laboratories, national reference laboratories, and specialised centres to work as part of a coordinated structure. In a functional network, not every laboratory performs every test. Instead, each tier performs the functions appropriate to its role, while specimens, results, data, expertise, supervision, and quality support move through the network [7].
Quality must be present at every tier where testing decisions are made. The reliability of antibiotic susceptibility testing at a reference laboratory matters. So does the reliability of an HIV rapid diagnostic test, a malaria rapid diagnostic test, tuberculosis microscopy, or a urine protein test used in antenatal care at the first point of service delivery. The technical complexity may differ, but the obligation to protect patients from unreliable results remains the same.
This is also critical for outbreak detection. A country may have strong capacity at the central level, but if lower tiers cannot detect, refer, confirm, or report unusual events promptly, the public health response may still be delayed. The West African Ebola outbreak drew attention to weaknesses in public health laboratory networks and the need to rebuild laboratory systems as part of preparedness [5][6]. COVID-19 reinforced the same lesson globally: countries needed connected networks capable of scaling testing, managing data, coordinating supplies, and supporting surveillance [8].
Yet connection alone is not enough. A network map does not guarantee a functioning system. A referral pathway does not guarantee transportation. A quality policy does not guarantee implementation. A laboratory information system does not guarantee data use. A training plan does not guarantee a competent workforce.
This is why the network must be supported by a broader laboratory system. The network describes how diagnostic services are organized across tiers. The system provides the governance, financing, workforce, regulation, quality infrastructure, procurement, maintenance, data management, biosafety, and coordination needed to make that network function, improve, and survive over time [1][9][12].
Put simply: the network connects laboratories; the system makes those connections work.
Africa’s Contribution: From Facility Quality to Network Functionality and System Maturity
Africa has made a major contribution to this evolution in thinking.
For many years, laboratory strengthening in Africa was closely linked to disease-specific priorities such as HIV, tuberculosis, malaria, antimicrobial resistance, and outbreak response. These programs delivered important gains. They brought equipment, training, quality improvement, reference capacity, and external quality assessment. But they also exposed a structural challenge: program success does not automatically translate into system strength.
SLMTA and SLIPTA helped make facility-level quality improvement practical and measurable [3][4]. The LABNET scorecard then addressed a different question: how functional is the national laboratory network? It provided a practical matrix for assessing network functions and helped countries look beyond individual laboratories toward the organization and performance of the network as a public health asset [7].
The National Laboratory Quality Framework added another essential piece: how countries can establish the policy, planning, regulatory, and operational architecture required to sustain laboratory quality management systems across the network [9]. More recent analyses of regional laboratory networks in East and West Africa have also examined how networks contribute to national health security capacities, including during COVID-19 [8].
These tools and frameworks should not be seen as a hierarchy in which one replaces the other. They are complementary. SLIPTA and SLMTA support implementation of quality management systems at the facility level. LABNET helps examine network functionality. A National Laboratory Quality Framework helps countries define and implement a national quality mechanism. LMM examines the maturity of the national laboratory system across multiple dimensions, including quality [3][4][7][9][12].
This distinction matters because confusion between these tools can weaken the message. LMM is NOT a more advanced version of SLIPTA, nor is it a replacement for LABNET. It asks a different question at a different level. Its value is in helping countries understand whether the national laboratory system is mature enough to sustain the functions that all these tools and frameworks aim to strengthen [12].
Where LMM Fits: Maturity, Not Quality Measurement
This point is central to the theoretical framing of LMM: LMM does not measure quality as a stand-alone output. It assesses the maturity of the national laboratory system across 10 dimensions, one of which is quality [12].
If accreditation asks, “Can this laboratory demonstrate quality and competence?” then LMM asks a broader maturity question: “Is the national laboratory system sufficiently mature across its core dimensions, including quality, to support reliable diagnostic services at scale and contribute to better patient care, public health, Universal Health Coverage, the International Health Regulations, and global health security?” [1][12][13][14]
That is a different level of inquiry. It does not replace internal quality control, external quality assessment, quality management systems, SLIPTA, SLMTA, accreditation, licensing, inspection, or network assessments. Instead, it helps countries understand whether the system around these mechanisms is implemented, coordinated, resourced, monitored, and sustainable [12].
From the perspective of the Ministry of Health, the quality dimension is not only about whether some laboratories are accredited. It is about whether national mechanisms are in place to ensure that every testing site can generate reliable results appropriate to its role; whether quality requirements are adapted to the level and model of service delivery; whether compliance is monitored and enforced; whether non-compliance is identified and addressed; whether facilities are supported to improve; whether quality infrastructure is adequately financed; and whether quality investments contribute to better health outcomes and return on investment [9][12].
At the same time, the maturity of quality depends on other system dimensions. A national quality mechanism cannot be sustained if the workforce is insufficient, if financing is unpredictable, if equipment cannot be maintained or calibrated, if supply chains fail, if data systems are fragmented, or if governance and regulation are weak. Conversely, a strong national quality mechanism contributes to the maturity of the wider laboratory system by making performance more reliable, accountable, and useful for clinical and public health decision-making [9][12].
This is where LMM becomes a logical next step in the story. It does not claim that quality begins with LMM. Rather, it helps countries see whether the many components required for quality, network functionality, and system performance are sufficiently mature to deliver impact at the national scale [12].
The Bottom Line
The evolution of laboratory quality has been a progressive widening of the lens.
It began with the reliability of individual test results. It expanded to quality management systems that standardised processes and strengthened continuous improvement [3][4]. It then moved to accreditation, where standards such as ISO 15189 and ISO/IEC 17025 helped demonstrate competence and the validity of results [10][11]. But the next stage required something broader: national mechanisms that make quality possible, enforceable, affordable, and sustainable across the whole diagnostic service delivery system [9].
This is not a simple ladder from one tool to another. It is an ecosystem. Each part plays a role. Internal quality control protects the test run. External quality assessment checks performance beyond the facility. Quality management systems strengthen processes. Accreditation demonstrates competence. National quality frameworks create policy, regulatory, and operational mechanisms. Laboratory networks organise diagnostic services across tiers. LMM examines whether the national laboratory system is mature enough to bring these components together and sustain them over time [3][4][7][9][10][11][12].
Patients do not experience quality as a certificate on a wall. They experience it through timely diagnosis, appropriate treatment, equitable access, confidence in results, and a health system capable of detecting and responding to threats. That is why quality had to move beyond the individual laboratory. It had to become a national system concern.
In Article #4, we will continue this journey by examining how maturity models emerged, why they became useful for complex systems, and how they helped lay the groundwork for Laboratory Systems Maturity Monitoring. Once we accept that quality depends on a national system, the next question becomes unavoidable: how do we know whether that system is actually maturing?
References
[1] World Health Organization Regional Office for Africa. Regional Strategy on Diagnostic and Laboratory Services and Systems 2023–2032 for the WHO African Region. Brazzaville: WHO Regional Office for Africa; 2023.
[2] Fleming KA, Horton S, Wilson ML, Atun R, DeStigter K, Flanigan J, et al. The Lancet Commission on diagnostics: transforming access to diagnostics. The Lancet. 2021;398(10315):1997–2050.
[3] Yao K, McKinney B, Murphy A, Rotz P, Wafula W, Sendagire H, et al. Improving quality management systems of laboratories in developing countries: an innovative training approach to accelerate laboratory accreditation. American Journal of Clinical Pathology. 2010;134(3):401–409.
[4] World Health Organization Regional Office for Africa. Guide for the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) in the WHO African Region. Brazzaville: WHO Regional Office for Africa; 2020.
[5] Nkengasong JN, Skaggs BA. Are post-Ebola reconstruction efforts neglecting public health laboratory systems? The Lancet Global Health. 2015;3(11):e678.
[6] Cancedda C, Davis SM, Dierberg KL, Lascher J, Kelly JD, Barrie MB, et al. A comprehensive district-level laboratory intervention after the Ebola epidemic in Sierra Leone. African Journal of Laboratory Medicine. 2019.
[7] Ondoa P, Datema TAM, Keita-Sow MS, Ndihokubwayo JB, Kiyaga C, Oskam L. A new matrix for scoring the functionality of national laboratory networks in Africa: introducing the LABNET scorecard. African Journal of Laboratory Medicine. 2016;5(3):a498.
[8] League A, Bangure D, Meyer MJ, Salyer SJ, Wanjohi D, et al. Assessing the impact of regional laboratory networks in East and West Africa on national health security capacities. PLOS Global Public Health. 2023;3(5):e0001962.
[9] Africa Centres for Disease Control and Prevention and African Society for Laboratory Medicine. Guidance for Establishing a National Laboratory Quality Framework: To advance implementation of laboratory quality management systems at all tiers of the laboratory network. 1st edition. Addis Ababa: Africa CDC; 2021.
[10] International Organization for Standardization. ISO 15189:2022 Medical laboratories — Requirements for quality and competence. Geneva: ISO; 2022.
[11] International Organization for Standardization. ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories. Geneva: ISO; 2017.
[12] Africa CDC and World Health Organization Regional Office for Africa. Laboratory Systems Maturity Monitoring (LMM) Country Guide 1.0. 2025.
[13] World Health Organization. International Health Regulations (2005), third edition. Geneva: WHO; 2016.
[14] World Health Organization. Joint External Evaluation Tool: International Health Regulations (2005), third edition. Geneva: WHO; 2022.
