CBET Public Safety and Regulations 2

Question 1

What is the primary role of The Joint Commission (TJC) in healthcare?

Accepted Answer

Accrediting healthcare organizations by evaluating compliance with patient safety and quality standards

Answer

The Joint Commission accredits healthcare organizations by evaluating compliance with standards for patient safety and quality of care.

Question 2

What does OSHA require regarding bloodborne pathogen exposure protection for biomedical technicians?

Accepted Answer

Employers must provide an exposure control plan, training, PPE, hepatitis B vaccination, and post-exposure procedures

Answer

OSHA's Bloodborne Pathogens Standard requires comprehensive employer-provided protection for workers with occupational exposure.

Question 3

What is the purpose of an equipment management plan in a healthcare facility?

Accepted Answer

To establish a systematic program for managing medical equipment throughout its lifecycle

Answer

An equipment management plan provides a comprehensive approach to managing medical equipment from selection through retirement.

Question 4

What is the FDA's role regarding medical devices and what is the 510(k) clearance process?

Accepted Answer

The FDA regulates safety and effectiveness; 510(k) demonstrates substantial equivalence to a predicate device

Answer

The FDA regulates medical devices; 510(k) requires demonstrating substantial equivalence to a legally marketed device.

Question 5

What are the reporting requirements under the Safe Medical Devices Act when a device causes patient death or serious injury?

Accepted Answer

Facilities must report deaths to both FDA and manufacturer, and serious injuries to the manufacturer, within 10 working days

Answer

Healthcare facilities must report device-related deaths to FDA and manufacturer, and serious injuries to manufacturer, within 10 working days.

CBET - Certified Biomedical Equipment Technician Practice Test