Safety Standards & Documentation Flashcards

Which OSHA standard primarily governs bloodborne pathogen exposure in an orthotics fabrication lab?

Answer: 29 CFR 1910.1030

OSHA 29 CFR 1910.1030 covers bloodborne pathogen standards applicable when technicians handle patient-contact materials.

When documenting a device modification requested by a practitioner, what must always be recorded in the work order?

Answer: Practitioner's verbal authorization and date

Work orders must document the authorizing practitioner and date to maintain a clear chain of accountability.

What is the correct action when a technician notices a crack in a load-bearing thermoplastic orthosis component during quality inspection?

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.

Which labeling requirement must appear on every finished orthotic device delivered to a patient in the US?

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.

A technician is grinding carbon fiber components. Which PPE is MOST critical beyond eye protection?

Answer: N95 or P100 respirator

Carbon fiber dust is a pulmonary hazard; respiratory protection rated for fine particulates is essential during grinding.

How long must patient orthotic records typically be retained under US federal regulations for Medicare patients?

Answer: 7 years

CMS requires Medicare suppliers to retain patient records for a minimum of 7 years from the date of service.

Which document establishes the chain of custody when a raw orthotic shell is transferred between lab stations?

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.