Inspection, Regulations and Compliance

This course is designed to equip ultrasound service technicians with the critical understanding and practical skills necessary to navigate the complex landscape of regulatory compliance and safety. Students will delve into national fire protection codes, electrical safety testing methodologies, and preparation strategies for accreditation body inspections. The curriculum covers the meticulous management of maintenance records, understanding and responding to system recalls, and the proper procedures for incident reporting. Emphasis is placed on practical application of standards to ensure patient and operator safety, system reliability, and institutional compliance, preparing students for real-world responsibilities in a healthcare setting.

InstructorJacob Calhoun

Prerequisites

ULS 101 ULS 105 ULS 110

Course outline

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

01Lesson 1: Introduction to Regulatory Compliance in Healthcare Technologylecture

02Lesson 2: National Fire Protection Association (NFPA) 99 Requirements for Medical Systemslecture

03Lesson 3: Electrical Safety Standards for Diagnostic Ultrasound Systemslecture

04Hands-on Lab: Electrical Safety Testing of Diagnostic Ultrasound Systemslab

05Lesson 5: Understanding Accreditation Bodies: General Requirementslecture

06Lesson 6: Preparing for Inspections: Documentation and Environmental Readinesslecture

07Lesson 7: Preventive Maintenance and Quality Assurance Programslecture

08Hands-on Lab: Documentation & Maintenance Recordkeeping & Midterm Reviewlab

09Lesson 9: System Recalls: Identification, Notification, and Remediationlecture

10Lesson 10: Incident Reporting and Investigation Procedureslecture

11Hands-on Lab: Simulating an Accreditation Survey & System Auditlab

12Lesson 12: Data Security, Privacy, and HIPAA Compliance Considerationslecture

13Lesson 13: Ethical Responsibilities and Professional Conductlecture

14Capstone Service Project: Comprehensive Compliance Audit of an Ultrasound Systemassignment

Syllabus

["Week 1: Lesson 1: Introduction to Regulatory Compliance in Healthcare Technology","Week 2: Lesson 2: National Fire Protection Association (NFPA) 99 Requirements for Medical Systems","Week 3: Lesson 3: Electrical Safety Standards for Diagnostic Ultrasound Systems","Week 4: Hands-on Lab: Electrical Safety Testing of Diagnostic Ultrasound Systems","Week 5: Lesson 5: Understanding Accreditation Bodies: General Requirements","Week 6: Lesson 6: Preparing for Inspections: Documentation and Environmental Readiness","Week 7: Lesson 7: Preventive Maintenance and Quality Assurance Programs","Week 8: Hands-on Lab: Documentation & Maintenance Recordkeeping & Midterm Review","Week 9: Lesson 9: System Recalls: Identification, Notification, and Remediation","Week 10: Lesson 10: Incident Reporting and Investigation Procedures","Week 11: Hands-on Lab: Simulating an Accreditation Survey & System Audit","Week 12: Lesson 12: Data Security, Privacy, and HIPAA Compliance Considerations","Week 13: Lesson 13: Ethical Responsibilities and Professional Conduct","Week 14: Capstone Service Project: Comprehensive Compliance Audit of an Ultrasound System"]