Public Safety and Regulations Flashcards
6 cards from real CBET practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 Public Safety and Regulations flashcards as text
What is the primary role of The Joint Commission (TJC) in healthcare?
Answer: Accrediting healthcare organizations by evaluating compliance with patient safety and quality standards
The Joint Commission accredits healthcare organizations by evaluating compliance with standards for patient safety and quality of care.
What does OSHA require regarding bloodborne pathogen exposure protection for biomedical technicians?
Answer: Employers must provide an exposure control plan, training, PPE, hepatitis B vaccination, and post-exposure procedures
OSHA's Bloodborne Pathogens Standard requires comprehensive employer-provided protection for workers with occupational exposure.
What is the purpose of an equipment management plan in a healthcare facility?
Answer: To establish a systematic program for managing medical equipment throughout its lifecycle
An equipment management plan provides a comprehensive approach to managing medical equipment from selection through retirement.
What is the FDA's role regarding medical devices and what is the 510(k) clearance process?
Answer: The FDA regulates safety and effectiveness; 510(k) demonstrates substantial equivalence to a predicate device
The FDA regulates medical devices; 510(k) requires demonstrating substantial equivalence to a legally marketed device.
What are the reporting requirements under the Safe Medical Devices Act when a device causes patient death or serious injury?
Answer: Facilities must report deaths to both FDA and manufacturer, and serious injuries to the manufacturer, within 10 working days
Healthcare facilities must report device-related deaths to FDA and manufacturer, and serious injuries to manufacturer, within 10 working days.
What does NFPA 99 cover and why is it important for biomedical technicians?
Answer: Healthcare facility requirements for electrical systems, medical gas systems, vacuum systems, and other building systems
NFPA 99 establishes criteria for safeguarding patients from fire, explosion, electrical hazards, and medical gas hazards.