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CTM 195
Term 4
3 credits

Inspection, Regulations and Compliance

This advanced course focuses on the critical aspects of inspection, regulatory compliance, and safety for Computed Tomography (CT), Magnetic Resonance Imaging (MRI), and Fluoroscopy systems. Students will gain a deep understanding of relevant national fire protection codes (e.g., NFPA 99), electrical safety testing protocols, and the stringent requirements of healthcare accreditation bodies (e.g., Joint Commission, CMS). The curriculum emphasizes developing robust strategies for inspection readiness, maintaining comprehensive service and maintenance records, and mastering procedures for product recalls and incident reporting. Practical application and hands-on experience will ensure graduates are well-prepared to uphold the highest standards of safety and compliance in medical imaging environments.

InstructorJacob Calhoun

Course outline

Lectures, virtual labs, and graded assignments — completed in your browser.

01Lesson 1: Introduction to Medical Imaging Regulations and Compliance Frameworkslecture
02Lesson 2: NFPA 99: Healthcare Facilities Code - General Requirements & System Specificslecture
03Lesson 3: Electrical Safety Testing for Medical Imaging Equipment (Grounding, Leakage, Dielectric)lecture
04Hands-on Lab: Electrical Safety Testing & Documentationlab
05Lesson 5: Joint Commission and CMS Readiness: Understanding Standards & Survey Processeslecture
06Lesson 6: Quality Control (QC) and Preventative Maintenance (PM) Program Compliancelecture
07Lesson 7: Environmental Safety Considerations: Cryogenics, Magnetic Fields, and Radiation Shieldinglecture
08Hands-on Lab: Regulatory Inspection Simulation & Midterm Reviewlab
09Lesson 9: Record Keeping and Documentation Best Practices for Compliancelecture
10Lesson 10: Medical Device Reporting (MDR) and Incident Reporting Protocolslecture
11Hands-on Lab: Recalls, Alerts, and Incident Report Processinglab
12Lesson 12: Cybersecurity and Data Privacy (HIPAA) in Medical Imaging Systemslecture
13Lesson 13: Continuous Quality Improvement and Compliance Auditslecture
14Capstone Service Project: Comprehensive Compliance Plan Development for an Imaging Modalityassignment

Syllabus

["Week 1: Lesson 1: Introduction to Medical Imaging Regulations and Compliance Frameworks","Week 2: Lesson 2: NFPA 99: Healthcare Facilities Code - General Requirements & System Specifics","Week 3: Lesson 3: Electrical Safety Testing for Medical Imaging Equipment (Grounding, Leakage, Dielectric)","Week 4: Hands-on Lab: Electrical Safety Testing & Documentation","Week 5: Lesson 5: Joint Commission and CMS Readiness: Understanding Standards & Survey Processes","Week 6: Lesson 6: Quality Control (QC) and Preventative Maintenance (PM) Program Compliance","Week 7: Lesson 7: Environmental Safety Considerations: Cryogenics, Magnetic Fields, and Radiation Shielding","Week 8: Hands-on Lab: Regulatory Inspection Simulation & Midterm Review","Week 9: Lesson 9: Record Keeping and Documentation Best Practices for Compliance","Week 10: Lesson 10: Medical Device Reporting (MDR) and Incident Reporting Protocols","Week 11: Hands-on Lab: Recalls, Alerts, and Incident Report Processing","Week 12: Lesson 12: Cybersecurity and Data Privacy (HIPAA) in Medical Imaging Systems","Week 13: Lesson 13: Continuous Quality Improvement and Compliance Audits","Week 14: Capstone Service Project: Comprehensive Compliance Plan Development for an Imaging Modality"]