Inspection, Regulations and Compliance
This comprehensive course covers the crucial aspects of inspection, regulatory compliance, and safety for clinical laboratory analyzers. Students will delve into foundational standards such as those related to healthcare facilities' electrical safety, understand electrical safety testing procedures, and prepare for inspections by major accreditation and reimbursement bodies. The curriculum emphasizes the importance of meticulous maintenance record-keeping, efficient recall management, and accurate incident reporting to maintain operational integrity and patient safety. Practical sessions provide hands-on experience with compliance checklists and documentation practices, equipping future technicians with the necessary skills to uphold high standards in a regulated laboratory environment.
InstructorJacob CalhounCourse outline
Lectures, virtual labs, and graded assignments — completed in your browser.
Syllabus
["Week 1: Lesson 1: Introduction to Clinical Laboratory Regulations & Compliance Landscape","Week 2: Lesson 2: Overview of NFPA 99: Healthcare Facilities Code & Electrical Safety Principles","Week 3: Lesson 3: Electrical Safety Testing Fundamentals for Analyzer Systems","Week 4: Hands-on Lab: Electrical Safety Testing & Documentation Practice","Week 5: Lesson 5: Understanding Joint Commission Requirements for Laboratory Equipment","Week 6: Lesson 6: CMS & CLIA Regulations Pertaining to Analyzer Operations","Week 7: Lesson 7: Preparing for Regulatory Inspections: Checklists and Audits","Week 8: Hands-on Lab: Inspection Readiness Simulation & Midterm Review","Week 9: Lesson 9: Comprehensive Maintenance Records & Documentation Best Practices","Week 10: Lesson 10: Managing Equipment Recalls & Field Corrective Actions","Week 11: Hands-on Lab: Incident Reporting & Root Cause Analysis","Week 12: Lesson 12: Quality Assurance & Continuous Improvement in Compliance","Week 13: Lesson 13: Ethical Considerations & Professional Responsibility in Regulatory Compliance","Week 14: Capstone Service Project: Developing a Compliance Plan for a Simulated Lab Analyzer"]