Inspection, Regulations and Compliance
Students will delve into the regulatory landscape governing dialysis equipment and water purification systems, including national fire protection standards, electrical safety testing, and accreditation body requirements. Emphasis is placed on practical application of compliance protocols, meticulous maintenance record-keeping, and understanding the processes for equipment recalls and incident reporting. The curriculum integrates hands-on laboratory sessions to develop proficiency in inspection readiness and safety testing, culminating in a capstone project that simulates real-world compliance challenges. Graduates will be equipped to uphold the highest standards of safety, quality, and regulatory adherence in clinical environments, protecting both patients and staff.
InstructorJacob CalhounCourse outline
Lectures, virtual labs, and graded assignments — completed in your browser.
Syllabus
["Week 1: Lesson 1: Introduction to Regulatory Bodies and Compliance Frameworks","Week 2: Lesson 2: Overview of Hemodialysis Machine Regulations and Standards","Week 3: Lesson 3: Reverse Osmosis Water System Regulations and Standards","Week 4: Hands-on Lab: Electrical Safety Testing Fundamentals for Medical Devices","Week 5: Lesson 5: NFPA 99: Health Care Facilities Code - Applied to Dialysis","Week 6: Lesson 6: Documentation and Maintenance Records for Compliance","Week 7: Lesson 7: Joint Commission (TJC) Readiness and Survey Preparation","Week 8: Hands-on Lab: TJC and CMS Survey Readiness Scenarios & Midterm Review","Week 9: Lesson 9: Centers for Medicare & Medicaid Services (CMS) Requirements","Week 10: Lesson 10: Equipment Recalls, Alerts, and Corrective Action Plans","Week 11: Hands-on Lab: Incident Reporting and Root Cause Analysis Simulation","Week 12: Lesson 12: Risk Management and Patient Safety in Dialysis","Week 13: Lesson 13: Continuous Quality Improvement (CQI) in Dialysis Operations","Week 14: Capstone Service Project: Comprehensive Compliance Audit and Remediation Plan"]