RMGA Quality Assurance 3 — Questions and Answers
Question 1: What does the term 'lot traceability' mean in the context of medical gas quality assurance?
- The ability to track a specific batch of gas from production through delivery to the end user (Correct answer)
- Logging how many cylinders were ordered each month
- Verifying that a cylinder was filled at a licensed facility
- Recording who signed for each gas delivery
Correct answer: The ability to track a specific batch of gas from production through delivery to the end user
Lot traceability allows identification and recall of any specific production batch if a quality defect or contamination event is discovered.
Question 2: Which test is used to verify that medical air produced on-site meets the carbon monoxide (CO) content requirement of USP Medical Air?
- Electrochemical sensor or colorimetric CO analyzer test (Correct answer)
- pH strip test
- Combustion analysis
- Infrared thermography
Correct answer: Electrochemical sensor or colorimetric CO analyzer test
USP Medical Air requires CO content not exceeding 10 ppm, verified using electrochemical or colorimetric CO detection methods.
Question 3: A quality audit of medical gas records reveals that alarm test results were not documented for three consecutive months. What is the correct corrective action?
- Perform and document the missed tests immediately and conduct a root-cause analysis (Correct answer)
- Back-date the records to fill the gap
- Discard all records from that period
- Report the auditor to management for an unfair finding
Correct answer: Perform and document the missed tests immediately and conduct a root-cause analysis
The proper response is to perform and document the tests now, then investigate the root cause to prevent recurrence, never to falsify records.
Question 4: According to NFPA 99, who is responsible for ensuring that medical gas system additions or modifications meet code requirements before clinical use?
- The authority having jurisdiction (AHJ) and the healthcare facility together (Correct answer)
- Only the installing contractor
- The gas supplier alone
- The insurance company underwriter
Correct answer: The authority having jurisdiction (AHJ) and the healthcare facility together
Both the AHJ and the healthcare facility share responsibility for verifying that any new or modified medical gas work complies with NFPA 99 before patient use.
Question 5: What is the significance of an oxygen analyzer reading of 19.5% in a pipeline oxygen system that should be delivering 99% O₂?
- It indicates a severe cross-connection or contamination requiring immediate shutdown (Correct answer)
- It is within normal tolerance for hospital-grade oxygen
- It means the analyzer needs to be recalibrated
- It suggests the patient census is very high
Correct answer: It indicates a severe cross-connection or contamination requiring immediate shutdown
A reading of 19.5% (near ambient air) in a pipeline that should carry high-purity oxygen indicates a dangerous cross-connection or major leak that demands immediate shutdown.
Question 6: Which ASTM standard governs the performance testing of medical gas flexible hose assemblies?
- ASTM F1962 (Correct answer)
- ASTM C1010
- ASTM D3755
- ASTM E119
Correct answer: ASTM F1962
ASTM F1962 provides the standard guide for use of flexible hose assemblies in medical gas and vacuum systems.
Question 7: In a quality assurance program, what is the purpose of an internal audit compared to an external audit?
- Internal audits allow the facility to self-assess and correct deficiencies before external review (Correct answer)
- Internal audits are conducted by the state health department quarterly
- External audits are less reliable than internal audits
- Internal audits focus only on financial records
Correct answer: Internal audits allow the facility to self-assess and correct deficiencies before external review
Internal audits are self-initiated reviews that identify gaps and drive improvement before an external authority identifies the same issues.
RMGA Quality Assurance 3
What does the term 'lot traceability' mean in the context of medical gas quality assurance?