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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
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.