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LNA 195
Term 4
3 credits

Inspection, Regulations and Compliance

Students will master the critical aspects of regulatory compliance and safety relevant to advanced medical linear accelerator systems. The curriculum covers foundational standards like NFPA 99, detailing specific requirements for medical equipment installation and operation. Emphasis is placed on comprehensive electrical safety testing methodologies, ensuring technician proficiency in verifying system integrity. The course prepares students for inspections by major accrediting bodies, including understanding the nuances of Joint Commission and Centers for Medicare & Medicaid Services (CMS) expectations. Best practices for meticulous maintenance records, efficient recall management, and accurate incident reporting are thoroughly examined, equipping students to uphold stringent safety and quality standards throughout their careers.

InstructorJacob Calhoun

Course outline

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

01Lesson 1: Introduction to Regulatory Compliance and Quality Assurancelecture
02Lesson 2: NFPA 99: Health Care Facilities Code - Part 1 (Electrical Systems)lecture
03Lesson 3: NFPA 99: Health Care Facilities Code - Part 2 (Gas & Vacuum Systems, Emergency Power)lecture
04Hands-on Lab: Electrical Safety Testing for Medical Equipment (IEC 60601-1)lab
05Lesson 5: Advanced Electrical Safety Testing Protocols and Instrumentationlecture
06Lesson 6: Joint Commission Standards: Environment of Care and Life Safetylecture
07Lesson 7: Centers for Medicare & Medicaid Services (CMS) Conditions of Participationlecture
08Hands-on Lab: Facility Inspection Readiness & Midterm Reviewlab
09Lesson 9: Comprehensive Maintenance Records and Documentation Managementlecture
10Lesson 10: Medical Device Recalls: Identification, Communication, and Remediationlecture
11Hands-on Lab: Incident Reporting and Root Cause Analysis Simulationlab
12Lesson 12: Hazard Communications and Material Safety Data Sheet (MSDS) Compliancelecture
13Lesson 13: Quality Control and Performance Monitoring Beyond Routine Maintenancelecture
14Capstone Service Project: Regulatory Compliance Audit and Improvement Plan Developmentassignment

Syllabus

["Week 1: Lesson 1: Introduction to Regulatory Compliance and Quality Assurance","Week 2: Lesson 2: NFPA 99: Health Care Facilities Code - Part 1 (Electrical Systems)","Week 3: Lesson 3: NFPA 99: Health Care Facilities Code - Part 2 (Gas & Vacuum Systems, Emergency Power)","Week 4: Hands-on Lab: Electrical Safety Testing for Medical Equipment (IEC 60601-1)","Week 5: Lesson 5: Advanced Electrical Safety Testing Protocols and Instrumentation","Week 6: Lesson 6: Joint Commission Standards: Environment of Care and Life Safety","Week 7: Lesson 7: Centers for Medicare & Medicaid Services (CMS) Conditions of Participation","Week 8: Hands-on Lab: Facility Inspection Readiness & Midterm Review","Week 9: Lesson 9: Comprehensive Maintenance Records and Documentation Management","Week 10: Lesson 10: Medical Device Recalls: Identification, Communication, and Remediation","Week 11: Hands-on Lab: Incident Reporting and Root Cause Analysis Simulation","Week 12: Lesson 12: Hazard Communications and Material Safety Data Sheet (MSDS) Compliance","Week 13: Lesson 13: Quality Control and Performance Monitoring Beyond Routine Maintenance","Week 14: Capstone Service Project: Regulatory Compliance Audit and Improvement Plan Development"]