External quality assessment (EQA)

EQA is usually presented as a set of 3 different activities: site assessment/on-site supportive supervision visit, Proficiency Testing (PT) program, and cross-checking. 

In this toolkit, we focus on on-site assessment and the EQA/PT program as WHO does not recommend cross-checking for serology testing (See WHO's Consolidated guidelines on differentiated HIV testing services).

EQA/PT scheme

Proficiency testing (PT) is the most common method of external quality assessment. It enables comparison between testing services and provides a good, objective measure for programs to assess the quality of testing, identify areas for improvement, and obtain recommendations to address those areas effectively. Regular PT is important for all types of medical testing including laboratory and non-laboratory-based testing (e.g. serology [antibody and antigen], and nucleic acid testing), with each test type and technique requiring a specific PT methodology to follow. The number of PT rounds per year varies, but more rounds provide better insights into a testing site´s performance. Testing sites in LMICs should aim for at least one round per testing provider per year, and more frequently, whenever feasible.

Figure 1: EQA-PT Program Implemenation Cycle   Click on image to enlarge

On-site supportive supervision visits

Regular on-site supervision visits allow the monitoring of testing quality trends at a testing site and the assessment of individual tester competency. These visits also provide an opportunity to offer timely and appropriate support when needed. Supervisors should conduct these visits using standardized evaluation tools to ensure consistency and objectivity. 

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Quality Control (QC)  

Quality control (QC) verifies that the products and procedures perform as intended. Two types of QCs could be considered: internal and external/third-party. 

Internal Quality Controls (IQC), which the manufacturer designs into their products (e.g., control line, positive and negative test kit controls), and external quality control (EQC) is when 3rd party supplies QC material of known status that is run in the testing site to determine if the test is functioning properly. External QC should be run at defined intervals.  

External QC (Known positive or negative samples) must be tested, at least: 

• with each new batch;
• with each new operator during competencies assessment-based training; and
• if the tests were exposed to environmental conditions other than those prescribed by the manufacturer.

While both internal and external quality control (QC) processes are essential, they do not guarantee that clients always receive correct results. Rather, these QC measures ensure that testing products and procedures are functioning as intended. To maximize result accuracy, QC should be part of a comprehensive quality management system that includes additional measures such as proper training, adherence to standard operating procedures, and regular proficiency testing. 

Monitoring & Evalutation

Data management is crucial at all levels, from patient care to global monitoring. Key elements include efficient data collection, which focuses on gathering essential indicators across all testing sites while minimizing the burden of data collection and reporting.  

Regular review and analysis of this data should be conducted at site, subnational, and national levels to monitor workload, assess quality, and inform decision-making.  

It is important to develop a strategic framework that links quality assurance processes to specific indicators, ensuring that data is utilized effectively for program management and oversight. 

To enhance effectiveness, it is vital to track trends by linking historical data with current activities. Implementing digital systems with unique national sites and tester IDs can support these efforts. Additionally, using automated analysis tools can help reduce the workload at both regional and national levels.  

Conducting multi-level analyses allows for the identification of broader challenges that might be overlooked when focusing solely on individual sites. This comprehensive approach ensures accurate measurement of progress and alignment with program goals while fostering a data-driven decision-making process. 

Continuous quality improvement

Occurrence management and process improvement

Testing services need to identify areas requiring improvement, plan and undertake improvements, and evaluate their effect (Plan, Do, Check, Act cycle) to ensure continuous quality improvement. 

Area of improvement can be detected by identifying and managing any occurrence through regular monitoring quality indicators, analyzing trends in the testing site and EQA/EQC results, conducting site-supportive supervision visits, monitoring client complaints, etc.  

An occurrence is any event, deviation, problem that can affect patient safety, mis-consume resources, or adversely impact the ability to provide quality testing services. Occurrence management refers to processes for detecting, understanding its root cause and implementing necessary measures (corrective and preventive actions/ CAPA) to solve the problem and prevent its recurrence.

A corrective action removes the root cause of a problem or reduces or eliminates the chances that it will recur. A preventive action avoids a possible future problem or reduces the likelihood that it will happen again, usually referring to the subject of the correction.  

Data analysis from QC and EQA/PT activities, on-site supportive supervision visits and routine testing activities data can guide corrective and preventive actions under the mantle of continual process improvement. 

An effective Occurrence Management System facilitates continuous quality improvement by identifying and addressing potential problems affecting testing service quality.