Quality Management Systems for non-laboratory settings

Overview

This toolkit provides practical guidance, tools, and resources to support countries in implementing the minimum package of quality management systems (QMS) activities in non-laboratory (non-lab) testing sites.

It focuses on qualitative serological Rapid Diagnostic Tests (RDTs) – such as HIV, hepatitis B and C, and syphilis RDTs – performed in non-lab settings.

It is designed to be used by the testing providers in non-lab settings and key stakeholders, such as national and subnational quality assurance officers and testing site supervisors involved in ensuring the quality of serology testing, particularly in low-resource settings.

Organization, governance and planning

Strategic and management component, including definition of responsibilities and network structure, resource allocation and development of policies and standards.

Tools available: financial planning, regulation of IVDs, non-laboratory settings conditions, coordination mechanisms, national engagement framework. 

Workforce development

An adequate number of qualified and trained staff at all stages of the health pyramid is one of the cornerstones to ensure quality testing. Defining the roles and responsibilities within job profiles for each person within defined national testing and QA networks is crucial to ensure the day-to-day quality of testing.  

Tools available for: Health workforce governance (role, responsibilities, coordination mechanism) and strengthening HR capacities (training, competency-based assessment, and authorization of practice and supervision) 

Supply chain and inventory management

Effective procurement, supply chain, and inventory management, from national logistic centers to testing sites, is essential to ensure timely availability, quality, and efficiency in delivering diagnostic services. A well-managed supply chain can quickly adapt to changes in demand, such as during an outbreak or epidemic, ensuring a rapid response.

Tools available: Defining testing site needs (alert, buffer stock, average monthly consumption calculation, order form template), Managing inventory at testing sites level (stock card, inventory management templates, temperature monitoring log sheet)

Process control and assessment

This pillar outlines the processes for quality control (internal and 3rd party), external quality assessments (Proficiency Testing scheme and site supervision visits), and continuous quality improvement. Data collection, regular review, and analysis in the testing site are also discussed.

Tools available: for implementing quality control measures, external quality assessment programs and continuous quality improvement.

Documents, records and information management

This pillar focuses on the documents and records that should be available in each testing site and provides practical tools for data collection, review, analysis, and use of data in ensuring quality assurance.

Available tools: SOPs, testing registers, indicator forms and M&E forms that should be available in each testing site and practical tools for data collection, review, analysis, and use of data in ensuring quality assurance.

Post-market surveillance

This pillar focuses on the comprehensive documentation of any product problems (e.g., quality, safety, performance) at the testing site to ensure information can be forwarded in a timely manner to manufacturers for post-market surveillance, or to national regulators.