CTO Safety Standards & Documentation 4 — Questions and Answers
Question 1: Which type of fire extinguisher is appropriate for an orthotics lab where thermoplastics and electrical equipment are both present?
- ABC dry chemical extinguisher (Correct answer)
- Class D metal fire extinguisher
- Water-based Class A extinguisher
- Class K wet chemical extinguisher
Correct answer: ABC dry chemical extinguisher
ABC extinguishers handle ordinary combustibles (Class A), flammable liquids (Class B), and electrical fires (Class C), covering typical orthotics lab hazards.
Question 2: When completing a work order for a pediatric patient, which additional documentation step is uniquely important?
- Record parental or guardian consent (Correct answer)
- Skip the prescription verification
- Use adult sizing charts
- Omit diagnosis codes for minors
Correct answer: Record parental or guardian consent
Pediatric patients require documented parental or legal guardian consent before device fabrication and delivery.
Question 3: What does the term 'traceability' mean in the context of orthotic device documentation?
- The ability to track a device's history from raw materials through delivery (Correct answer)
- A GPS tracking system for shipped devices
- The patient's movement pattern analysis
- A billing audit trail only
Correct answer: The ability to track a device's history from raw materials through delivery
Traceability in medical device manufacturing means every component and process step can be linked back through documentation to verify compliance and safety.
Question 4: A batch of polypropylene sheets arrives with no manufacturer lot numbers on the packaging. What is the correct response?
- Quarantine the materials and contact the supplier for proper documentation (Correct answer)
- Use the materials immediately to avoid waste
- Apply an internal lot number and proceed
- Dispose of the materials without documentation
Correct answer: Quarantine the materials and contact the supplier for proper documentation
Unidentified raw materials cannot be traced in the event of a recall; they must be quarantined until proper documentation is obtained.
Question 5: Which condition MOST warrants completing an incident report even if no injury occurred?
- A near-miss where a heavy casting block fell near a technician (Correct answer)
- A minor spelling error on a work order
- A patient arriving five minutes late
- A routine tool calibration check
Correct answer: A near-miss where a heavy casting block fell near a technician
Near-miss events indicate hazardous conditions and must be documented to prevent future injuries, per OSHA safety management principles.
Question 6: What information is required on the label of a secondary container holding a transferred solvent in the orthotics lab?
- Product identifier and hazard warnings (Correct answer)
- Technician's name and shift hours
- Patient insurance information
- Vendor invoice number only
Correct answer: Product identifier and hazard warnings
OSHA HazCom 2012 (GHS-aligned) requires secondary containers to be labeled with the product identity and appropriate hazard warnings.
Question 7: Which of the following best describes the purpose of a corrective action plan (CAP) following a documentation audit finding?
- To identify root causes and implement changes to prevent recurrence (Correct answer)
- To punish the technician responsible for the error
- To backdate records to show compliance
- To reduce the frequency of future audits
Correct answer: To identify root causes and implement changes to prevent recurrence
A CAP addresses the root cause of a deficiency and documents steps taken to prevent the issue from recurring, supporting continuous quality improvement.
CTO Safety Standards & Documentation 4
Which type of fire extinguisher is appropriate for an orthotics lab where thermoplastics and electrical equipment are both present?