CHT Regulatory Standards & Infection Control 2 — Questions and Answers
Question 1: Which federal agency enforces the Safe Medical Devices Act as it applies to hyperbaric chambers?
- OSHA
- FDA (Correct answer)
- EPA
- CDC
Correct answer: FDA
The FDA regulates hyperbaric chambers as Class II or Class III medical devices under the Safe Medical Devices Act.
Question 2: Under NFPA 99, a monoplace hyperbaric chamber operating with 100% oxygen is classified as which category of hyperbaric facility?
- Category A (Correct answer)
- Category B
- Category C
- Category D
Correct answer: Category A
NFPA 99 Category A hyperbaric facilities use chambers pressurized primarily with oxygen, including monoplace chambers.
Question 3: According to CMS Conditions of Participation, a hospital-based hyperbaric program must maintain treatment records for a minimum of how many years for adult patients?
- 3 years
- 5 years (Correct answer)
- 7 years
- 10 years
Correct answer: 5 years
CMS requires hospital records, including hyperbaric treatment records for adults, to be retained for at least 5 years from the date of discharge.
Question 4: Which organization's Hyperbaric Oxygen Therapy Committee publishes the Undersea and Hyperbaric Medical Society (UHMS) approved indications list?
- American College of Surgeons
- UHMS (Correct answer)
- Joint Commission
- ACEP
Correct answer: UHMS
The UHMS Hyperbaric Oxygen Therapy Committee reviews evidence and publishes the official list of approved HBO2 indications.
Question 5: When must a hyperbaric facility report a serious device malfunction involving patient harm to the FDA?
- Within 24 hours
- Within 30 days
- Within 10 working days (Correct answer)
- Within 60 days
Correct answer: Within 10 working days
The Safe Medical Devices Act requires facilities to report device-related deaths or serious injuries to the FDA within 10 working days.
Question 6: Which document provides the authority for hyperbaric technicians to perform procedures within their scope in most US states?
- UHMS membership card
- State-specific scope of practice laws and facility policies (Correct answer)
- CHT credential alone
- NFPA 99 certificate
Correct answer: State-specific scope of practice laws and facility policies
Scope of practice for hyperbaric technicians is defined by state law and individual facility credentialing policies, not by certification alone.
Question 7: Per OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), which item is required documentation after an employee exposure incident?
- Personal exposure logbook entry only
- Exposure incident report and follow-up medical evaluation (Correct answer)
- Verbal report to supervisor only
- Annual summary only
Correct answer: Exposure incident report and follow-up medical evaluation
OSHA requires a written exposure incident report and mandates that the employer provide confidential follow-up medical evaluation after any bloodborne pathogen exposure.
CHT Regulatory Standards & Infection Control 2
Which federal agency enforces the Safe Medical Devices Act as it applies to hyperbaric chambers?