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LSR 195
Term 4
3 credits

Inspection, Regulations and Compliance

This course delves into the regulatory landscape governing medical laser systems, focusing on compliance with key standards such as those related to healthcare facility safety and electrical safety. Students will learn how to conduct thorough inspections, perform electrical safety testing, and prepare for external audits by major accreditation bodies. Emphasis is placed on the meticulous creation and maintenance of service records, understanding procedures for product recalls, and the critical importance of accurate incident reporting. Practical exercises and case studies will reinforce theoretical knowledge, ensuring technicians are well-prepared to uphold safety and compliance in diverse clinical settings, safeguarding both patients and personnel.

InstructorJacob Calhoun

Course outline

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

01Lesson 1: Introduction to Medical Laser Regulations and Compliancelecture
02Lesson 2: Overview of NFPA 99 for Healthcare Facilitieslecture
03Lesson 3: Electrical Safety Standards for Medical Equipmentlecture
04Hands-on Lab: Electrical Safety Testing & Documentationlab
05Lesson 5: Understanding Accreditation Body Requirements (e.g., Joint Commission)lecture
06Lesson 6: CMS Regulations and Inspection Readiness for Laser Systemslecture
07Lesson 7: Creating and Maintaining Service and Maintenance Recordslecture
08Hands-on Lab: Maintenance Record Management & Midterm Reviewlab
09Lesson 9: Product Recalls: Identification, Response, and Reportinglecture
10Lesson 10: Incident Reporting and Root Cause Analysis for Laser Eventslecture
11Hands-on Lab: Incident Simulation and Reporting Protocolslab
12Lesson 12: Risk Assessment and Management in Laser Environmentslecture
13Lesson 13: Developing a Comprehensive Compliance Programlecture
14Capstone Service Project: Compliance Audit & Action Plan Developmentassignment

Syllabus

["Week 1: Lesson 1: Introduction to Medical Laser Regulations and Compliance","Week 2: Lesson 2: Overview of NFPA 99 for Healthcare Facilities","Week 3: Lesson 3: Electrical Safety Standards for Medical Equipment","Week 4: Hands-on Lab: Electrical Safety Testing & Documentation","Week 5: Lesson 5: Understanding Accreditation Body Requirements (e.g., Joint Commission)","Week 6: Lesson 6: CMS Regulations and Inspection Readiness for Laser Systems","Week 7: Lesson 7: Creating and Maintaining Service and Maintenance Records","Week 8: Hands-on Lab: Maintenance Record Management & Midterm Review","Week 9: Lesson 9: Product Recalls: Identification, Response, and Reporting","Week 10: Lesson 10: Incident Reporting and Root Cause Analysis for Laser Events","Week 11: Hands-on Lab: Incident Simulation and Reporting Protocols","Week 12: Lesson 12: Risk Assessment and Management in Laser Environments","Week 13: Lesson 13: Developing a Comprehensive Compliance Program","Week 14: Capstone Service Project: Compliance Audit & Action Plan Development"]