Point-of-Care Testing Benefits Must Not Overshadow Quality Management

Point-of-care testing (POCT) for infectious diseases has expanded from COVID-19 to influenza and RSV. It brings molecular diagnostics to the patient outside the traditional laboratory setting. This proximity to the patient provides results that can impact immediate clinical decisions, making the accuracy and reliability of results vital for patient safety and effective care.

Challenges to ensuring POCT quality

  • Varied environments—While POC testing in diverse settings like emergency rooms, clinics, and physicians' offices offers many benefits, the conditions in these settings can vary significantly.
  • Inconsistent operator experience—A range of professionals with different levels of training and expertise perform POCT.
  • Quick results—The speed of POCT, which provides immediate results for swift care decisions, can also increase the risk of errors.
  • Additional regulatory requirements—People who conduct testing must be certified, trained, and tested to guarantee consistent quality control practices.

Quality management for POCT

A strong quality program includes standard operating procedures, administrative requirements, and effective corrective actions. Creating and enforcing a program leads to consistent quality and accuracy. Proficiency testing and quality control address POCT challenges in a variety of settings and instill confidence in staff, procedures, and test results.

  • Proficiency testing mimics patient sample analysis to validate method performance and operator competency. It’s conducted several times a year to satisfy CLIA compliance requirements.
  • Quality control procedures detect sample collection errors and deviations in operator performance, identify patterns that can affect accuracy, and maintain compliance. Depending on the manufacturer's recommendations and the site’s practices, they should be undertaken daily, weekly, or monthly.

Find out more about the crucial relationship between POTC and quality—Download our latest White Paper, by clicking here, or on the button below. Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality. 


Impact of POCT regulatory requirements

CLIA technical standards give labs and healthcare providers guidance on procedures for testing verification and validation. The Centers for Disease Control and Prevention and the Centers for Medicare & Medicaid Services update the standards to keep pace with new testing, including POCT for infectious diseases. All laboratory testing requires certification, including that conducted at CLIA-waived sites. While CLIA-waived labs don’t experience regular inspections, some situations, such as a complaint, can trigger a certificate of waiver inspections. An inspection includes a review of documentation and procedures.

The necessary and appropriate CLIA requirements are the foundation for patient safety and accurate test results. They ensure labs consistently employ sound practices, yet compliance has impacts that need to be considered and understood.

  • Resources—Staff time and funding may need to be allocated to cover staff training, equipment maintenance, documentation, and regulatory inspections and audits.
  • Workflow—New protocols for administering tests, interpreting the results, and completing the necessary documentation can result in workflow.

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Patients and physicians enjoy the convenience and speed POCT offers. As this type of testing expands, it’s critical for patient safety and result accuracy that proficiency testing and quality control be prioritized, no matter the setting.

Take a deeper look at today’s POCT compliance and quality guidelines and challenges. Download 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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