CHSP Regulatory Compliance & Standards 3 — Questions and Answers
Question 1: The Life Safety Code (NFPA 101) distinguishes between 'existing' and 'new' healthcare occupancies primarily to:
- Reduce paperwork for older facilities
- Apply different but appropriate requirements based on construction date (Correct answer)
- Exempt pre-1967 buildings from all fire safety standards
- Accelerate renovation timelines
Correct answer: Apply different but appropriate requirements based on construction date
NFPA 101 recognizes that retrofitting older buildings to meet all new construction standards may be impractical, so it applies separate—but still protective—requirements to existing occupancies.
Question 2: Which standard establishes requirements for the safe handling of compressed medical gases in healthcare facilities?
- NFPA 54
- NFPA 99 (Correct answer)
- OSHA 29 CFR 1910.101
- ANSI Z49.1
Correct answer: NFPA 99
NFPA 99 Health Care Facilities Code Chapter 5 governs gas and vacuum systems, including storage, distribution, and use of medical gases.
Question 3: Under OSHA's Ionizing Radiation Standard (29 CFR 1910.1096), the permissible exposure limit (PEL) for whole-body occupational radiation exposure is:
- 1.25 rem per quarter (5 rem/year) (Correct answer)
- 5 rem per quarter (20 rem/year)
- 0.5 rem per year
- 10 rem per year
Correct answer: 1.25 rem per quarter (5 rem/year)
OSHA's ionizing radiation standard sets a PEL of 1.25 rem per calendar quarter, equating to 5 rem per year for whole-body exposure.
Question 4: A hospital is accredited by The Joint Commission. When a state health department surveyor arrives unannounced, the hospital should:
- Refuse entry until TJC is notified
- Cooperate fully, as state licensure surveys are independent of TJC accreditation (Correct answer)
- Request a 48-hour notice period
- Require the surveyor to coordinate with TJC first
Correct answer: Cooperate fully, as state licensure surveys are independent of TJC accreditation
State licensure and TJC accreditation are independent processes; facilities must cooperate with state surveyors regardless of their TJC accreditation status.
Question 5: The FDA's Medical Device Reporting (MDR) regulation requires healthcare facilities to report device-related serious injuries to the manufacturer within:
- 24 hours
- 10 working days (Correct answer)
- 30 calendar days
- 60 calendar days
Correct answer: 10 working days
Under 21 CFR Part 803, user facilities must submit MDR reports for serious injuries to the device manufacturer within 10 working days of becoming aware of the event.
Question 6: Which of the following is NOT a required element of OSHA's written Exposure Control Plan under the Bloodborne Pathogens Standard?
- Exposure determination listing job classifications
- Schedule for implementing applicable engineering controls
- A list of all employees' vaccination status (Correct answer)
- Procedures for evaluating post-exposure incidents
Correct answer: A list of all employees' vaccination status
OSHA does not require employers to maintain a list of individual employees' vaccination status in the Exposure Control Plan; rather, the plan must describe how vaccination will be offered.
Question 7: The EPA's Resource Conservation and Recovery Act (RCRA) categorizes most chemotherapy waste as which hazardous waste type?
- Universal waste
- Listed hazardous waste (P or U list) (Correct answer)
- Characteristic hazardous waste
- Regulated medical waste
Correct answer: Listed hazardous waste (P or U list)
Many antineoplastic drugs appear on the EPA's P-list (acutely hazardous) or U-list (toxic hazardous), making them RCRA listed hazardous wastes when discarded.
CHSP Regulatory Compliance & Standards 3
The Life Safety Code (NFPA 101) distinguishes between 'existing' and 'new' healthcare occupancies primarily to: