CTO Safety Standards & Documentation 2 — Questions and Answers
Question 1: Which OSHA standard primarily governs bloodborne pathogen exposure in an orthotics fabrication lab?
- 29 CFR 1910.1030 (Correct answer)
- 29 CFR 1910.134
- 29 CFR 1910.147
- 29 CFR 1910.212
Correct answer: 29 CFR 1910.1030
OSHA 29 CFR 1910.1030 covers bloodborne pathogen standards applicable when technicians handle patient-contact materials.
Question 2: When documenting a device modification requested by a practitioner, what must always be recorded in the work order?
- Practitioner's verbal authorization and date (Correct answer)
- Patient's insurance policy number
- Lab technician's personal opinion on the modification
- The cost estimate for the modification
Correct answer: Practitioner's verbal authorization and date
Work orders must document the authorizing practitioner and date to maintain a clear chain of accountability.
Question 3: What is the correct action when a technician notices a crack in a load-bearing thermoplastic orthosis component during quality inspection?
- Reject the device and document the defect (Correct answer)
- Apply adhesive and pass the device
- Reduce the patient's activity level recommendation
- Return the device without noting the defect
Correct answer: Reject the device and document the defect
Structural defects in load-bearing components are a safety failure; the device must be rejected and the defect documented.
Question 4: Which labeling requirement must appear on every finished orthotic device delivered to a patient in the US?
- Device name, lot/serial number, and manufacturer information (Correct answer)
- Patient's date of birth only
- The technician's personal certification number
- Insurance billing codes only
Correct answer: Device name, lot/serial number, and manufacturer information
FDA and CMS guidelines require device identification labeling including manufacturer info and tracking numbers on delivered orthoses.
Question 5: A technician is grinding carbon fiber components. Which PPE is MOST critical beyond eye protection?
- N95 or P100 respirator (Correct answer)
- Latex gloves only
- Steel-toed boots
- Hearing protection
Correct answer: N95 or P100 respirator
Carbon fiber dust is a pulmonary hazard; respiratory protection rated for fine particulates is essential during grinding.
Question 6: How long must patient orthotic records typically be retained under US federal regulations for Medicare patients?
- 7 years (Correct answer)
- 1 year
- 10 years
- 3 years
Correct answer: 7 years
CMS requires Medicare suppliers to retain patient records for a minimum of 7 years from the date of service.
Question 7: Which document establishes the chain of custody when a raw orthotic shell is transferred between lab stations?
- Internal work order or traveler card (Correct answer)
- Patient's insurance card copy
- Delivery receipt signed by the patient
- The ABC certification directory
Correct answer: Internal work order or traveler card
A traveler card or internal work order tracks the device through each fabrication stage, establishing chain of custody.
CTO Safety Standards & Documentation 2
Which OSHA standard primarily governs bloodborne pathogen exposure in an orthotics fabrication lab?