Testing Standards and Compliance Evolving with Growth of POCT

In point-of-care testing (POCT), errors happen if the manufacturer’s instructions are not followed or if staff are unfamiliar with the process. These errors result in inaccurate test results, which can have severe implications for patients, from misdiagnosis to incorrect treatments or procedures. POCT is convenient and allows quick clinical decisions, but the results must be accurate and reliable.

Addressing POCT concerns

The expanding use of POCT is driving organizations responsible for standards to examine it more closely. Clinical Laboratory Improvement Advisory Committee workgroups have expressed strong concerns about testing integrity in physician offices. Test verification and validation standards under the Clinical Laboratory Improvement Amendments (CLIA) include POCT for infectious diseases.

The International Organization for Standardization (ISO) incorporated POCT device regulation into the ISO 15189:2022 standards, bringing it into a broader category that stresses quality management systems and advances patient care and safety. By updating CLIA and ISO to include POCT molecular devices, these organizations have given POCT sites the quality control guidance they need to deliver reliable and accurate results confidently.

The nature of POCT presents unique challenges: varying user education and experience, clinical environment pressures, the number of users, limited oversight, training verification, and more. Quality control (QC) is critical to address these concerns, and a robust program identifies test result variations so they can be addressed quickly.

ISO 15189 states:

Quality Control materials shall be periodically examined with a frequency that is based on the stability of the procedure and the risk of harm to the patient from an erroneous result.

The 2022 update also promotes using 3rd party controls to improve accuracy for all laboratory testing, including POCT.

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.

Quality management & third-party controls

Unlike control materials created by an instrument manufacturer, third-party controls are impartial and better mimic patient samples for an unbiased assessment. These independent materials are not created by manufacturers to assess their instruments. Objective assessment of a testing system's accuracy is essential. Third-party controls more accurately identify positive and negative results and maintain testing compliance and proficiency success.

POCT quality controls can come from the test manufacturer or a third-party vendor. Manufacturers’ controls validate test performance, while third-party quality controls offer several other significant benefits, including:

  • Improved patient care – Accurate test results are necessary for informed clinical decisions and effective patient care. Third-party controls reduce the risk of incorrect test results.
  • Regulatory compliance – Regulatory agencies require analyzing two levels of external quality controls. Third-party controls are an option to meet quality standards.
  • Minimized risk – Laboratories can avoid releasing inaccurate test results, being found non-compliant with regulatory standards, and failing proficiency testing by using third-party controls.

One of our recent blogs includes more information about using third-party controls, including a checklist to compare control materials and vendors.


Safeguarding POCT quality

Managing quality control for POCT instruments presents challenges because there is no universal approach. CLIA and ISO offer some valuable guidance. Focusing on the manufacturer’s recommendations, establishing consistent procedures, using the right quality control materials, and ensuring users have the proper training and capabilities are fundamental for accurate, reliable, high-quality molecular POCT. All of these improve patient care and outcomes.

Find out more about POCT and third-party controls. Download our recent White Paper, Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality by clicking here or on the button below.



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