The explosive growth of point-of-care testing (POCT) for infectious diseases we saw during the COVID-19 pandemic continues. While high-quality testing in community settings is a valuable tool to support public health, the potential benefits gained are immaterial without defined quality management standards.
POCT teams within physician offices, outpatient clinics, and urgent care facilities need proper training and a system to monitor assay and testing platform performance. Staff with no laboratory background may have knowledge gaps that need to be filled. POCT coordinators and laboratory directors are responsible for ensuring correct practices, regulatory compliance, and testing integrity. If the manufacturer’s instructions aren’t followed, or team members are unfamiliar with each step in the process, errors can happen.
Resources are available to help you develop quality assurance (QA) and quality control (QC) practices customized for your setting. Get actionable insights when you download our latest white paper, Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality, by clicking here, or on the button below.
Design practices for your specific environment
Maintaining compliance and producing reliable results are central to quality management practices. Those practices need to consider your particular setting. What variations do you need to consider? Which compliance standards and certifications apply to you? What are the unique needs of your patients and healthcare providers? Keep in mind that community health settings where only waived testing is conducted are required to have a Clinical Laboratory Improvement Amendments (CLIA) certificate and to follow the manufacturer's instructions.
Your quality management system must include measures to detect errors throughout the process. Meticulous documentation and consistent self-inspections are critical to proactively identifying and correcting problems. The College of American Pathologists (CAP) point-of-care checklist is a comprehensive resource for developing and improving practices.
Explore the role of third-party controls
Objective assessment of a testing system's accuracy is essential. When the demand for COVID testing was high, new testing devices were quickly introduced. These devices used manufacturer-developed controls; some were pulled when their reliability became a concern.
Independent third-party controls more accurately identify positive and negative results, avoiding repeat testing and offering patients a better overall experience. Third-party controls help ensure regulatory compliance and proficiency testing success.
Find out more about third-party control benefits when you download our latest white paper, Point of Care Testing for Infectious Diseases: Navigating CLIA Compliance and Ensuring Quality, by clicking here, or on the button below.
Understand your quality responsibilities
Standard operating procedures, administrative requirements, and effective corrective actions are the fundamental components of a robust QA management program. Designed to ensure consistent testing quality and accuracy, they can determine the success of point-of-care testing programs.
The Centers for Disease Control and Prevention and the Centers for Medicare & Medicaid Services collaborate to update CLIA technical standards. That includes addressing new and evolving testing, including point-of-care for infectious disease. CLIA requires QC procedures for verification and validation when a new testing method is adopted, or reagents are changed. Other circumstances trigger the need for verification or validation, too.
POCT for infectious diseases delivers rapid results, allowing for quick decision-making. The many benefits of this growing testing option in community healthcare settings comes with responsibilities and challenges for lab directors and coordinators. Specific QA and QC measures must be created that ensure patient safety with compliant, high-quality services.
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.