COURSE OVERVIEW:

The meaning of this course lies in the decentralized delivery of laboratory-quality results at the patient’s bedside or in remote field locations. Point-of-Care Testing (POCT) offers the advantage of rapid turnaround time, but it lacks the controlled environment of a central laboratory, introducing unique risks to data accuracy and clinical safety. This program provides the technical and regulatory framework needed to validate POCT devices, ensuring they meet the same rigorous standards as stationary laboratory instrumentation.

The scope of the training focuses on the lifecycle of POC testing validation, from the selection of "Fitness for Purpose" devices to the implementation of "Operator Competency" programs. It addresses the technical requirements of ISO 22870 (Point-of-Care Testing) and the integration of POC data into the "Electronic Health Record" (EHR). Participants will explore the mechanics of "Method Comparison" studies between field devices and central lab analyzers, as well as the management of decentralized quality control.

The coverage includes a comprehensive investigation into the validation of glucose meters, blood gas analyzers, and rapid infectious disease kits. The course emphasizes the importance of "Pre-analytical Variables" in the field, the management of "Reagent Logistics," and the role of the "POCT Coordinator" in maintaining compliance across multiple sites. By mastering these validation protocols, participants will be able to ensure that rapid testing leads to rapid and accurate clinical decisions without compromising patient safety.

COURSE OBJECTIVES:

After completion of this course, the participants will be able to:

• Define the clinical and operational benefits of Point-of-Care Testing (POCT).
• Interpret the requirements of ISO 22870 and local regulatory standards.
• Conduct "Method Comparison" studies between POCT and Central Lab.
• Validate the "Precision" and "Accuracy" of POC devices in the field.
• Implement a robust "Operator Training and Competency" program.
• Design a decentralized "Quality Control" (QC) and "PT" program.
• Manage "Pre-analytical Variables" unique to field-based testing.
• Ensure the "Metrological Traceability" of POC measurement results.
• Integrate POCT data into the "Laboratory Information System" (LIMS).
• Manage "Reagent Storage" and "Inventory" across remote locations.
• Conduct "Internal Audits" of decentralized testing sites.
• Lead the "POCT Committee" in device selection and clinical governance.

TARGET AUDIENCE:

This course is intended for POCT Coordinators, Laboratory Quality Managers, Nursing Supervisors, and Clinical Technicians involved in decentralized testing.

TRAINING COURSE METHODOLOGY:

A highly interactive combination of lectures, discussion sessions, and case studies will be employed to maximize the transfer of information, knowledge, and experience. The course will be intensive, practical, and highly interactive. The sessions will start by raising the most relevant questions and motivating everybody to find the right answers. The attendants will also be encouraged to raise more of their questions and to share in developing the right answers using their analysis and experience. There will also be some indoor experiential activities to enhance the learning experience. Course material will be provided in PowerPoint, with necessary animations, learning videos, and general discussions.

The course participants shall be evaluated before, during, and at the end of the course.

COURSE CERTIFICATE:

National Consultant Centre for Training LLC (NCC) will issue an Attendance Certificate to all participants completing a minimum of 80% of the total attendance time requirement.