• Introduction

    To assure good quality testing, human and veterinary laboratories and testing sites need to work within an active National Quality Testing Framework that is supported by the Ministry of Health (MOH). Ideally, each country would have strong national public health laboratories (NPHL), empowered and resourced to provide national oversight of the quality of testing, within the Framework.  The NPHL(s) would have well-trained staff, coordinate the national quality activities, provide training to lower tier testing sites, and advise MOH in the licensing of diagnostics, in line with the Framework, international and national strategies.

    Proposed activites

    National Serology Reference Laboratory (NRL), Australia proposes to partner with MOHs and other stakeholders in the WHO SEARO and WPRO regions, to support NPHLs (where appropriate) in the quality management and quality assurance of infectious disease testing in human health and veterinary testing facilities. NRL’s support is focused on supporting key personnel to become ‘Quality Champions’, conducting train-the-trainer programs so that, when funding is finished, these Quality Champions are capable of sustaining and further supporting the Framework. The Quality Champions can be national or regional core groups. NRL aims to work with existing country and regional networks, where they exist.

    Steps to support the framework

    Activities to support the Framework are implemented in a stepwise approach:

    Step 1: Perform a country situational analysis to assess the country programs, laboratories and Point-of-care (PoC) testing sites.

    Step 2: Develop a country-specific work plan that identifies needs and prioritises critical gaps in medium to long-term, in collaboration with funding partners and local MOHs, and in line with WHO and national strategies.

    Step 3: Identify in-country Quality Champions to be trained and mentored for each module of the Framework.

    Step 4: Design and deliver a) Virtual Introductory Training, b) In-country/ Practical Training and c) Mentoring. After each training module, NRL will set out activities designed to re-enforce learning, and assess outcomes to monitor the effectiveness of the training.

    • Module 1: Quality Management Systems – For clinical and animal health laboratories, including laboratory assessments against ISO 15189, ISO 17025, or ISO 9001 requirements.
    • Module 2: Principles of Good Manufacturing Practice (GMP) – For the manufacture of blood/blood components, and in-vitro diagnostic medical devices, including laboratory assessments against cGMP, ISO 13485, or ISO 9001 requirements.
    • Module 3: Test Kit Evaluations – For the development of infrastructure, procedures, sample banks and knowledge to perform test kit evaluations on behalf of MOHs or other national regulatory bodies, to ensure good quality test kits are promoted for use in-country.
    • Module 4: External Quality Assessment Schemes (EQAS) – For the design, development and implementation of national and regional EQAS programs to monitor the testing performance of in-country facilities; including assessments against ISO 17043 requirements.
    • Module 5: Quality Assurance for Point of Care Testing (POC QA) – For the design, development and implementation of POC QA programs to monitor the quality of testing in PoC settings, where traditional quality assurance might not be fit for purpose; including EQA and competency assessment for individual testers.
    • Module 6: Quality Control Methods – For real-time performance monitoring of the analytical process to detect and rectify adverse events before they impact on patient safety. This includes ways and systems to monitor quality controls used for different laboratory sections and is appropriate for more advanced testing settings.
    • Module 7: Train the Trainer – For reinforcing learning by Quality Champions through training on methodologies around training delivery and mentoring. This includes the shadowing of NRL trainers in the delivery of training and mentoring, and eventually using NRL’s Framework Modules to train and mentor independently.

    Step 5: Conduct Mid-term Review to assess the progress of the activities on the workplan, making necessary adjustments to support the program’s effectiveness and sustainability.

    Step 6: Scale up of in-country programs where NRL and Quality Champions support trainees to expand their new programs and methodologies nationally, or regionally.

    Benefits to the SEA and WP regions

    Good quality systems using fit-for-purpose diagnostics in an appropriate manner will lead to better health outcomes for patients, decrease in the spread of disease, create safer blood supplies, accurate understanding of disease prevenance, decrease in morbidity and mortality and ultimately save costs resulting from better use of resources.