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

Manufacturing medical devices

Answer

Providing health insurance

Answer

Training biomedical technicians

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

No specific requirements exist

Answer

Only hand washing is required

Answer

Technicians must purchase own PPE

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

To track equipment purchase prices

Answer

To schedule equipment cleaning only

Answer

To manage cafeteria equipment

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 manufactures medical devices

Answer

The FDA only regulates drugs

Answer

510(k) is a hospital quality process

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

No reporting is required

Answer

Only manufacturers report

Answer

Reports only required for recalled devices

Question 6

What does NFPA 99 cover and why is it important for biomedical technicians?

Accepted Answer

Healthcare facility requirements for electrical systems, medical gas systems, vacuum systems, and other building systems

Answer

Fire extinguisher schedules only

Answer

Pharmaceutical manufacturing standards

Answer

Food preparation safety in hospitals