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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 — missed cards come back until you master them.

Read the first 7 Regulatory Compliance & Standards flashcards as text
  1. Under CLIA regulations, which category covers most routine clinical laboratory tests performed by specimen collectors at point-of-care?

    Answer: Waived tests

    Waived tests are simple, low-risk tests cleared by the FDA and exempt from most CLIA requirements, commonly performed at point-of-care.

  2. A collector working in a non-federal workplace drug testing program is primarily governed by which set of standards?

    Answer: State laws and employer policies

    Non-federally mandated drug testing programs are governed by applicable state laws and the employer's own written drug testing policy.

  3. What is the maximum allowable time between urine collection and delivery to the laboratory under standard SAMHSA protocols to maintain specimen integrity?

    Answer: 48 hours

    Specimens should generally be shipped and received by the laboratory within 48 hours of collection to ensure integrity.

  4. Which regulation requires laboratories certified for federal workplace drug testing to be on the SAMHSA-approved list?

    Answer: 49 CFR Part 40

    49 CFR Part 40 mandates that only SAMHSA-certified laboratories may analyze specimens collected under DOT-regulated testing programs.

  5. A donor presents a valid prescription for a controlled substance before providing a urine specimen. How should the collector handle this information?

    Answer: Not accept or record medical information — proceed normally

    Collectors do not accept, record, or act on medical information; prescription review is the sole responsibility of the Medical Review Officer (MRO).

  6. Which organization publishes the Mandatory Guidelines for Federal Workplace Drug Testing Programs?

    Answer: SAMHSA

    SAMHSA (Substance Abuse and Mental Health Services Administration) publishes and updates the Mandatory Guidelines governing federal workplace drug testing.

  7. An employer subject to DOT drug testing rules wants to add a test for a drug not on the standard 5-panel. Under DOT regulations, this is:

    Answer: Not permitted within the DOT testing program

    Employers may not add substances to the standard DOT 5-panel drug test; any additional testing must occur outside the DOT-regulated program.