Implementing effective quality assurance in clinical laboratories

• Maintaining quality assurance in a laboratory focuses on ensuring accurate, reliable, and consistent test results
• Quality assurance differs from quality control, but both fall under the same bracket of “quality management"
• Developing a laboratory quality management system that incorporates quality assurance-related components can help laboratories meet high-quality standards and ensure complete regulatory compliance

In the world of healthcare, maintaining high levels of precision and accuracy is crucial. One of the best ways to ensure the lab supports accuracy in healthcare processes is by implementing the right quality assurance strategy.¹ Put simply, without prioritizing quality assurance in the clinical laboratory environment, you could potentially jeopardize the accuracy, reliability, consistency, and integrity of your results.² This, ultimately, can have a knock-on effect on patient health and the overall delivery of care, leaving labs exposed both reputationally and financially.

In other words, prioritizing quality assurance in the laboratory is crucial — and we’re here to tell you how to do it.

Maintaining quality assurance in a laboratory is all about ensuring accuracy, reliability, and consistency in data and test results.³ Practically, this involves implementing processes, guidelines, and procedures to minimize potential errors by lab personnel.³

While quality assurance is similar to quality control in many ways, there are some slight differences.⁴ For example, quality control refers to the set of procedures and protocols designed to monitor and maintain the precision and accuracy of laboratory equipment and testing processes.⁴ Quality assurance takes a slightly broader approach, by focusing on the entire laboratory testing process rather than just the equipment that it uses.⁴ However, both fall under the same bracket of “quality management.”⁵

Quality assurance provides labs with a comprehensive framework that goes beyond technical processes. It also focuses on the organizational and administrative aspects of lab-based processes to ensure complete accuracy and reliability.⁴

The importance of quality assurance in the laboratory is nothing new. Back in 1996, for example, the World Health Organization (WHO) released its “Quality Assurance in Laboratory Practices” document, which recognized quality assurance as “an important element in the provision of quality patient care” and stated a growing need for its implementation in laboratories of all levels.⁶

Fast-forwarding seven years to 2003, the WHO released a status report update on quality assurance in health laboratories, identifying two key areas to prioritize as part of any effective quality assurance strategy.⁷

• Internal quality control – this refers to putting appropriate measures in place to monitor all day-to-day laboratory activities that could influence the outcome of laboratory results.⁷
• External quality assessment scheme – this refers to the need for retrospective adjudication from an independent agency, to cross-compare one laboratory’s results with another to ensure complete consistency.⁷

Jumping to today, as labs are learning to integrate technological advances into their internal processes, the importance of these two areas within quality assurance hasn’t wavered. But, labs need to now consider more than just quality assurance.

When looking to conduct quality assurance activities, many labs now implement what’s known as a laboratory quality management system.² This is designed to guarantee that the service they provide not only meets the high-quality standards expected but also ensures complete regulatory compliance with any appropriate governing bodies.²

These systems typically incorporate processes and software that focus on:^2,3

• Document control and data management (such as electronic health records)
• Data integrity
• Training and certifying lab personnel
• Establishing standard operating procedures
• Proficiency testing
• Equipment calibration and maintenance
• Audit and inspection management
• Regulatory compliance

Delivering quality assurance as part of this laboratory quality management system involves a multifaceted process.³ As such, there are several areas to consider when trying to meet the specific standards and regulatory requirements associated with the world of healthcare:^3,8

• Develop a quality framework: Take some time to create a strategic plan that clearly outlines the objectives you’re looking to achieve, as well as the roles and responsibilities of each lab personnel.
• Document and update your standard operating procedures: Make sure to update all the standard operating procedures you use across lab processes and set up a secure data management system that enables accurate and efficient record-keeping.
• Conduct regular internal audits: Don’t wait for an external quality assessment to spot areas of improvement. Implement internal audits and conduct proficiency testing checks to analyze your lab’s performance and the consistency of your output.
• Implement training programs: Ensure continuous training for all lab personnel and conduct regular competency assessments to verify they’re delivering a consistent level of performance.
• Focus on compliance: Each laboratory quality management system should have regulatory compliance at its center. By keeping on top of any updated guidelines, labs can continuously ensure complete compliance and added peace of mind.

According to research, implementing a laboratory quality management system in this way can deliver several important benefits — whether that be an improved ability to reduce or eliminate errors, or meet customer expectations more effectively.⁹

Quality assurance is one of the key driving forces in ensuring the reliability, accuracy, and efficiency of laboratory-based workflows.^9,10 By taking the time to implement a robust laboratory quality management system that incorporates quality assurance-related measures, clinical laboratories can not only maintain the high standards expected of them but also ensure complete compliance with regulatory standards.