Safety and Compliance Flashcards

A research assistant is packaging diagnostic blood specimens for ground shipment to a central lab. Which UN number and classification should appear on the outer package?

Answer: UN3373, Biological Substance Category B

Routine diagnostic patient specimens not known to contain high-consequence pathogens ship as UN3373 Biological Substance, Category B.

Under OSHA's Bloodborne Pathogens Standard, within what time frame must an employer offer the hepatitis B vaccine to a newly assigned at-risk employee?

Answer: Within 10 working days of initial assignment

29 CFR 1910.1030 requires the vaccine be made available within 10 working days of initial assignment at no cost.

Immediately after a needlestick injury with a used needle, what should the research assistant do FIRST?

Answer: Wash the site with soap and water

CDC guidance is to wash the wound immediately with soap and water, then report and seek post-exposure evaluation promptly.

A sharps container in the specimen processing area should be closed and replaced when it reaches which fill level?

Answer: About three-quarters full or at the fill line

Overfilling increases needlestick risk, so containers are replaced at about 3/4 full or the marked fill line.

Which federal regulation sets FDA requirements for electronic records and electronic signatures used in clinical trials?

Answer: 21 CFR Part 11

21 CFR Part 11 establishes criteria for trustworthy electronic records and signatures, including audit trails.

A chemical splashes into a coworker's eyes in the lab. How long should the eyes be flushed at the eyewash station?

Answer: At least 15 minutes

ANSI Z358.1 and standard first aid guidance call for flushing for at least 15 minutes.

When correcting an error on a paper case report form, what is the GCP-compliant method?

Answer: Draw a single line through it, write the correct value, initial and date

ALCOA principles require the original entry stay legible, with the change attributed and dated.