Regulatory Standards & Infection Control Flashcards
7 cards from real CHT practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Standards & Infection Control flashcards as text
Which federal agency enforces the Safe Medical Devices Act as it applies to hyperbaric chambers?
Answer: FDA
The FDA regulates hyperbaric chambers as Class II or Class III medical devices under the Safe Medical Devices Act.
Under NFPA 99, a monoplace hyperbaric chamber operating with 100% oxygen is classified as which category of hyperbaric facility?
Answer: Category A
NFPA 99 Category A hyperbaric facilities use chambers pressurized primarily with oxygen, including monoplace chambers.
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?
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.
Which organization's Hyperbaric Oxygen Therapy Committee publishes the Undersea and Hyperbaric Medical Society (UHMS) approved indications list?
Answer: UHMS
The UHMS Hyperbaric Oxygen Therapy Committee reviews evidence and publishes the official list of approved HBO2 indications.
When must a hyperbaric facility report a serious device malfunction involving patient harm to the FDA?
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.
Which document provides the authority for hyperbaric technicians to perform procedures within their scope in most US states?
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.
Per OSHA's Bloodborne Pathogens Standard (29 CFR 1910.1030), which item is required documentation after an employee exposure incident?
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.