Practice Test Geeks(CLT) Clinical Laboratory Technologist Certification Practice Test
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Regulatory Compliance & Standards Flashcards

7 cards from real CLT 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 the Hazard Communication Standard (HazCom 2012), which format replaced the Material Safety Data Sheet (MSDS)?

    Answer: Safety Data Sheet (SDS)

    HazCom 2012 (aligned with GHS) replaced the MSDS with the standardized 16-section Safety Data Sheet (SDS).

  2. Which CLSI document provides guidance on the minimum volume of anticoagulant to blood ratio required for coagulation testing?

    Answer: H21-A5

    CLSI H21-A5 addresses collection, transport, and processing of blood specimens for coagulation testing, including tube fill requirements.

  3. A laboratory proficiency testing (PT) sample must be tested in the same manner as patient samples. Which action violates this requirement?

    Answer: Sending PT samples to a reference lab for testing

    Referring PT samples to another laboratory for analysis violates CLIA regulations requiring labs to test PT samples as they would patient samples.

  4. Which type of laboratory incident must be reported to the FDA under the Safe Medical Devices Act?

    Answer: Device malfunction that could cause serious injury or death

    The Safe Medical Devices Act requires reporting device malfunctions that could cause or contribute to serious injury or death.

  5. Which term describes the laboratory process of verifying that a manufacturer's reference interval is appropriate for the lab's patient population?

    Answer: Reference interval verification

    Reference interval verification confirms that the manufacturer's published normal range is applicable to the laboratory's specific patient population.

  6. According to OSHA, how frequently must laboratory staff receive training on the Bloodborne Pathogens Standard?

    Answer: Annually

    OSHA requires annual bloodborne pathogen training for all employees with occupational exposure.

  7. Which CLIA-defined test complexity category includes urine dipstick, blood glucose monitoring, and urine pregnancy tests?

    Answer: Waived

    Waived tests are cleared by FDA as simple tests posing minimal risk of erroneous results, including urine dipstick and home glucose monitors.