Organization, governance, planning
Foundation for quality in medical testingThe foundation for quality in medical testing, including settings beyond traditional laboratories, draws upon internationally recognized standards. The ISO 15189:2022, Medical laboratories, Requirements for quality and competence provides a comprehensive framework for quality management systems in medical laboratories, emphasizing processes, personnel, equipment, and continual improvement (International Organization for Standardization, 2022). While primarily aimed at traditional labs, its principles are adaptable to decentralized testing. |
Framework
In non-laboratory settings, such as health structures without laboratory, community health clinics, and mobile outreach sites, quality is often compromised by the absence of structured oversight. To address this, governance structures must extend beyond laboratory departments, with national laboratory directorates and diagnostic programs ensuring the implementation of QMS policies at all tiers. Coordination efforts should involve multisectoral teams, including clinical programs, logistics units, and community health leaders, with joint planning and monitoring mechanisms.
The successful implementation and sustainability of a quality management system (QMS) for testing in a non-lab setting relies heavily on strong national engagement. When governments lead the development and oversight of quality assurance (QA) practices, it ensures that quality systems are consistently applied across all levels of the health system and are aligned with broader national health priorities. |
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Roles and responsibilities
Roles and responsibilities in non-lab testing settings must be clearly defined.
- Facility managers are responsible for ensuring SOPs and QMS tools are up to date, accessible and in use;
- Professional health workers and clinical officers uphold pre-analytical quality through proper sample collection, documentation, and transport if needed.
- Community health workers and trained lay testers must be trained to conduct internal quality control and participate in external quality assessments (EQA)/proficiency testing.
- District-level supervisors play an essential role in mentoring, conducting site supportive supervision visits, providing on site training and competency-based assessments, and facilitating feedback loops between clinical, laboratory services and non-lab testing sites.
Limited resources for training, supervision, the absence of formal quality assurance structures in community settings, and fragmented data systems will be key challenges for laboratories and programs supporting non-laboratory settings.
QMS governance
To overcome these barriers, good governance should be supported by national diagnostic policies that explicitly include non-lab testing points, integrated quality assurance programs, continuous capacity building, and performance monitoring using routine quality improvement (QI) indicators.
Sustainable quality in diagnostics requires clear role definition, inclusive coordination mechanisms, and investment in local capacity. Ensuring adequate environmental conditions in non-lab settings is essential to ensure diagnostic reliability. Strengthening QMS governance, at each level of the health pyramid, is key to ensure quality of testing wherever testing is performed, support clinical decision-making, and achieve universal health coverage goals in low- and middle-income countries.