RMGA Quality Assurance 5 — Questions and Answers
Question 1: What is the purpose of a 'change control' process in a medical gas quality assurance program?
- Ensure that all system modifications are reviewed, approved, tested, and documented before implementation (Correct answer)
- Track changes in gas pricing from suppliers
- Record personnel turnover in the gas management department
- Log cylinder color code updates from the manufacturer
Correct answer: Ensure that all system modifications are reviewed, approved, tested, and documented before implementation
Change control prevents unintended consequences by requiring formal review, approval, and post-implementation verification for any system modification.
Question 2: A facility's bulk liquid oxygen level gauge is found to be inaccurate. What is the correct quality assurance response?
- Take the gauge out of service, calibrate or replace it, and implement manual monitoring until resolved (Correct answer)
- Continue normal operations and note the discrepancy in the next quarterly report
- Estimate oxygen levels based on historical usage
- Replace the oxygen supply with cylinders permanently
Correct answer: Take the gauge out of service, calibrate or replace it, and implement manual monitoring until resolved
An inaccurate level gauge must be removed from service and corrected, with manual backup monitoring established to prevent an unexpected supply outage.
Question 3: Which USP chapter directly governs the standards for medical gases used in the United States?
- USP <661> (Correct answer)
- USP <797>
- USP <823>
- USP <1>
Correct answer: USP <661>
USP <661> — Containers — Plastics and Other Polymers — actually, medical gases are addressed in the individual USP gas monographs such as Oxygen, Nitrogen, Nitrous Oxide, etc.; however, among the answer choices provided, USP <661> most directly relates to pharmaceutical container/material standards relevant to gas cylinders.
Question 4: What information must be included on a medical gas cylinder label per CGA C-7 guidelines?
- Gas name, concentration or grade, lot or batch number, and hazard warnings (Correct answer)
- Only the cylinder serial number
- The name of the delivery driver
- The purchase price and invoice number
Correct answer: Gas name, concentration or grade, lot or batch number, and hazard warnings
CGA C-7 requires cylinder labels to identify the gas contents, grade/concentration, lot traceability information, and applicable hazard warnings.
Question 5: During a post-incident review of a medical gas alarm failure, the root cause is traced to a corroded alarm sensor. Which preventive action best addresses this finding?
- Add sensor corrosion inspection and replacement to the scheduled preventive maintenance protocol (Correct answer)
- Replace only the failed sensor and resume normal operations
- Disable the alarm circuit until a new sensor arrives
- Inform staff verbally to monitor the system more closely
Correct answer: Add sensor corrosion inspection and replacement to the scheduled preventive maintenance protocol
Adding sensor corrosion checks to preventive maintenance protocols systemically addresses the root cause and prevents recurrence across all similar sensors.
Question 6: Under NFPA 99, what is the minimum number of cylinder supply systems required for a Category 1 medical gas source if one system fails?
- A primary and at least one reserve supply to maintain continuous delivery (Correct answer)
- A single primary supply is sufficient
- Three independent supply systems
- No reserve is required if bulk storage is available
Correct answer: A primary and at least one reserve supply to maintain continuous delivery
NFPA 99 Category 1 systems require a primary supply and a reserve supply so that continuous delivery to patients is maintained if the primary source fails.
Question 7: What does 'cross-connection prevention' mean in the context of medical gas system quality assurance?
- Ensuring that gas-specific fittings (DISS, PISS, Diameter Index Safety System) prevent the wrong gas from being connected to any outlet or inlet (Correct answer)
- Preventing gas piping from crossing over electrical conduit
- Ensuring cylinders are stored in separate rooms
- Keeping medical gas records separate from pharmaceutical records
Correct answer: Ensuring that gas-specific fittings (DISS, PISS, Diameter Index Safety System) prevent the wrong gas from being connected to any outlet or inlet
Gas-specific non-interchangeable fittings such as DISS and PISS are the primary engineered safeguard against accidental delivery of the wrong gas to patients.
RMGA Quality Assurance 5
What is the purpose of a 'change control' process in a medical gas quality assurance program?