This module is designed to provide a review of the technological principles and clinical applications of point of care testing (POCT) in a range of healthcare settings. Students will explore the challenges of translating innovative technology in the complex and regulated environment of healthcare, and the leading role that POCT plays in transforming healthcare delivery.
Point of care testing
The spectrum of point of care testing- Areas of use, analysers and test kits. Technological development – Biosensors, Microsystems and miniaturised detection methods. Factors driving the POCT market/economic drivers – Healthcare personnel; Advances and new applications in POCT; the evolution of personalised medicine and companion diagnostics; emerging markets – infectious and lifestyle diseases. Benefits and challenges of POCT- Cost, accuracy, precision and interpretation of the test, patient care and safety
Legislation and regulatory requirements
Medical device Legislation , role of the Health Products Regulatory Authority and FDA, the role of the manufacturer and user Accreditation standards. In-vitro diagnostic medical devices (IVD) classification, performance characteristics, conformity assessment pathways. In-house manufacture of IVDs. Risk assessment and adverse incident reporting. User training and certification. Competency management
Effective clinical governance
Responsibility for POCT- The role of the laboratory. Organisation of POCT- Management and oversight. POCT steering group-Membership and role. Role of POCT operational teams and the POCT. Coordinator/Administrator. Evaluation for POCT requests- Risks/benefit analysis (cost versus quality of care). Implementing a POCT service. Resources and space. Training and standard operating procedures, device access. Quality assurance- QC and EQA. Competency /proficiency testing of POCT operators. Device management - POCT connectivity, data management systems and remote access Operator management. Inventory management. Maintenance and service. Process for Adverse Incident Reporting
Lectures, tutorials, workshop and on-line resources.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |