In clinical laboratories, maintaining the highest standards of accuracy and reliability in test results is paramount. Routine internal quality control (QC) checks are integral to this process and are performed after instrument maintenance, reagent calibration, and at regular intervals to ensure the precision and reliability of both analytical instruments and their reagents. These procedures are vital in safeguarding the consistency and reliability of test results, which directly impacts patient care and well-being.

The shift towards third-party quality controls

In recent years, the demand for third-party QC materials has increased, driven by recommendations from regulatory and accreditation bodies such as ISO and CLSI. These organisations highlight the importance of using QC materials produced by independent manufacturers.

For example, ISO 15189 encourages the adoption of third-party QCs with this note: “Use of independent third-party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer.”

Similarly, the CLSI C24-A3 guidelines state: “Control materials need to be different from the calibrator materials to ensure that the QC procedure provides an independent assessment of system performance.”

With these recommendations, more labs are adopting third-party QC materials to ensure their standards are being upheld in accordance with their awarded accreditations.

4 benefits of third-party quality controls

Clinical laboratories face the challenge of managing increasing sample volumes, delivering rapid results, and maintaining the highest quality standards while boosting profitability. Third-party QCs offer significant advantages in enhancing efficiencies and quality assurance through the following benefits:

1. Independent and unbiased assessments: Third-party QC materials provide an objective evaluation of instrument and method performance, ensuring unbiased results
2. Highly consolidated QC materials: These materials enable laboratories to save time, space, and costs by combining multiple controls into a single, efficient solution
3. Ready-to-use solutions: Liquid, ready-to-use third-party QC materials, reduce preparation time and minimise the risk of errors, streamlining the workflow
4. Compliance with ISO 15189 and CLSI standards: Using third-party QCs helps laboratories meet stringent regulatory and accreditation requirements, ensuring high standards of practice

Embracing the changes that come with third-party quality controls

The need for objectivity, enhanced quality assurance, regulatory compliance, and operational efficiency is propelling the adoption of third-party QC materials in medical laboratories. By integrating these controls, laboratories can ensure the reliability and accuracy of test results, ultimately improving patient care and maintaining exemplary laboratory standards while improving the overall efficiency of laboratory operations.