CBA CBA Healthcare Facility Operations & Safety Standards 1 — Questions and Answers
Question 1: NFPA 99, the Health Care Facilities Code, classifies patient care areas into categories primarily based on:
- The number of beds in the unit
- The risk of harm to patients if utility systems fail (Correct answer)
- The age of the facility construction
- The annual revenue generated by the department
Correct answer: The risk of harm to patients if utility systems fail
NFPA 99 categorizes patient care spaces (Category 1–4) according to the potential risk to patients if critical building utilities such as power or medical gases fail.
Question 2: In a biomedical audit of a hospital's medical gas system, the auditor should verify compliance with:
- NFPA 99 Chapter 5 and ASSE 6000 series standards (Correct answer)
- OSHA 29 CFR 1910.119 (PSM)
- EPA 40 CFR Part 60
- FDA 21 CFR Part 211
Correct answer: NFPA 99 Chapter 5 and ASSE 6000 series standards
NFPA 99 Chapter 5 governs medical gas and vacuum systems in healthcare facilities, and ASSE 6000 standards cover the qualification of medical gas personnel.
Question 3: The CMS Conditions of Participation (CoP) require hospitals to maintain a written plan for:
- Employee fitness programs
- Emergency and disaster preparedness, including utility failures (Correct answer)
- Marketing new service lines
- Executive compensation structures
Correct answer: Emergency and disaster preparedness, including utility failures
CMS CoPs require hospitals to maintain an emergency preparedness plan that addresses how the facility will respond to utility failures, natural disasters, and other emergencies.
Question 4: A biomedical auditor reviewing sterilization processes should reference which standard for steam sterilization validation?
- ISO 11135
- ANSI/AAMI ST79 (Correct answer)
- ISO 14971
- 21 CFR Part 820
Correct answer: ANSI/AAMI ST79
ANSI/AAMI ST79 is the comprehensive US standard providing guidance for steam sterilization and sterility assurance in healthcare facilities.
Question 5: Which federal agency has primary jurisdiction over workplace safety hazards in a hospital's biomedical engineering department?
- FDA
- EPA
- OSHA (Correct answer)
- CMS
Correct answer: OSHA
OSHA has primary authority over workplace safety and health for healthcare workers, including biomedical technicians handling hazardous materials and electrical equipment.
Question 6: When auditing a healthcare facility's management of single-use devices (SUDs) that are being reprocessed, the auditor must verify compliance with:
- FDA's guidance on reprocessing of single-use devices and 21 CFR Part 820 (Correct answer)
- NFPA 101 Life Safety Code
- EPA Resource Conservation and Recovery Act only
- OSHA Bloodborne Pathogen Standard only
Correct answer: FDA's guidance on reprocessing of single-use devices and 21 CFR Part 820
Reprocessing of SUDs in the US requires compliance with FDA guidance and 21 CFR Part 820, as reprocessors are considered device manufacturers subject to FDA oversight.
CBA CBA Healthcare Facility Operations & Safety Standards 1
NFPA 99, the Health Care Facilities Code, classifies patient care areas into categories primarily based on: