Regulatory Compliance & Standards Flashcards
7 cards from real CSC practice questions. Tap to flip, then mark Knew It or Still Learning โ missed cards come back until you master them.
Read the first 7 Regulatory Compliance & Standards flashcards as text
Which type of collection is required when a donor has a previous verified positive, adulterated, or substituted result under DOT rules?
Answer: Observed collection
DOT regulations require direct observation for return-to-duty and follow-up testing when prior results were positive, adulterated, or substituted.
Under OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030), which item is required in a collector's exposure control plan?
Answer: Engineering and work practice controls
OSHA's Bloodborne Pathogens Standard requires employers to implement engineering controls and work practice controls to minimize occupational exposure.
What action must a collector take if the tamper-evident seal on a specimen bottle is broken upon receipt at the collection site?
Answer: Begin a new collection with a fresh specimen bottle
A compromised seal indicates potential tampering; the collector must discard the specimen and start a new collection with an intact, sealed bottle.
A split specimen (Bottle B) is sent to a second SAMHSA-certified lab for reanalysis. The lab reports the split specimen is invalid. What is the MRO's ruling on the original result?
Answer: Cancel the original test result
When a split specimen cannot be reconfirmed due to invalidity or insufficient volume, the MRO must cancel the entire test result.
Creatinine concentration below 2 mg/dL combined with specific gravity below 1.0010 classifies a specimen as:
Answer: Substituted
SAMHSA criteria classify a specimen as substituted when creatinine is <2 mg/dL and specific gravity is <1.0010, indicating it is not consistent with normal human urine.
Which federal agency's regulations govern the disposal of biohazardous materials generated during specimen collection?
Answer: OSHA and EPA
OSHA (occupational safety) and EPA (environmental protection) jointly regulate the handling and disposal of biohazardous/medical waste from collection sites.
A collector at a clinic is audited and found to lack a current CLIA Certificate of Waiver for urine dipstick testing. The correct regulatory consequence is:
Answer: Immediate suspension of testing until certification is obtained
Performing waived laboratory tests without a valid CLIA Certificate of Waiver is a regulatory violation that requires immediate cessation of testing.