Regulatory Standards & Compliance Flashcards
7 cards from real PCR practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Regulatory Standards & Compliance flashcards as text
Under CLIA, how long must a laboratory generally keep test requisitions, test records, and QC records?
Answer: 2 years
CLIA requires most analytic system records, including QC and test records, to be kept for at least 2 years.
Which UN number and category apply when shipping routine diagnostic patient specimens for PCR testing that are not expected to contain Category A pathogens?
Answer: UN3373, Biological Substance Category B
Most diagnostic specimens ship as UN3373 Biological Substance, Category B, in triple packaging.
Which packaging system do DOT and IATA require for infectious substance shipments?
Answer: Triple packaging: leak-proof primary, leak-proof secondary, and rigid outer packaging
Infectious substance shipments need a primary receptacle, a secondary leak-proof packaging with absorbent material, and a rigid outer package.
Under the OSHA Bloodborne Pathogens Standard, how soon must hepatitis B vaccination be offered to a newly assigned at-risk lab worker?
Answer: Within 10 working days of initial assignment, at no cost
29 CFR 1910.1030 requires employers to offer the HBV vaccine free of charge within 10 working days of initial assignment.
Which ISO standard specifies quality and competence requirements for medical laboratories?
Answer: ISO 15189
ISO 15189 is the international standard for quality and competence of medical laboratories.
An FDA-regulated PCR software system stores electronic records and signatures used for regulatory submissions. Which regulation applies?
Answer: 21 CFR Part 11
21 CFR Part 11 sets FDA requirements for trustworthy electronic records and electronic signatures.
How often must CLIA calibration verification generally be performed for quantitative test systems?
Answer: Every 6 months and when certain events occur
CLIA requires calibration verification at least every 6 months and after events such as major maintenance or reagent lot changes.
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