CLT Regulatory Compliance & Standards 3 — Questions and Answers
Question 1: Under the Hazard Communication Standard (HazCom 2012), which format replaced the Material Safety Data Sheet (MSDS)?
- Chemical Safety Bulletin (CSB)
- Safety Data Sheet (SDS) (Correct answer)
- Hazardous Materials Information Sheet (HMIS)
- Laboratory Chemical Profile (LCP)
Correct answer: Safety Data Sheet (SDS)
HazCom 2012 (aligned with GHS) replaced the MSDS with the standardized 16-section Safety Data Sheet (SDS).
Question 2: Which CLSI document provides guidance on the minimum volume of anticoagulant to blood ratio required for coagulation testing?
- H3-A6
- H21-A5 (Correct answer)
- EP15-A3
- GP41-A6
Correct answer: H21-A5
CLSI H21-A5 addresses collection, transport, and processing of blood specimens for coagulation testing, including tube fill requirements.
Question 3: A laboratory proficiency testing (PT) sample must be tested in the same manner as patient samples. Which action violates this requirement?
- Testing PT samples in routine batch runs
- Using the same reagent lot as for patients
- Sending PT samples to a reference lab for testing (Correct answer)
- Running PT samples in duplicate
Correct 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.
Question 4: Which type of laboratory incident must be reported to the FDA under the Safe Medical Devices Act?
- Any QC failure
- Device malfunction that could cause serious injury or death (Correct answer)
- Failed proficiency testing event
- Specimen labeling error
Correct 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.
Question 5: Which term describes the laboratory process of verifying that a manufacturer's reference interval is appropriate for the lab's patient population?
- Method validation
- Reference interval verification (Correct answer)
- Analytical measurement range verification
- Calibration verification
Correct answer: Reference interval verification
Reference interval verification confirms that the manufacturer's published normal range is applicable to the laboratory's specific patient population.
Question 6: According to OSHA, how frequently must laboratory staff receive training on the Bloodborne Pathogens Standard?
- Upon hire only
- Annually (Correct answer)
- Every two years
- Every three years
Correct answer: Annually
OSHA requires annual bloodborne pathogen training for all employees with occupational exposure.
Question 7: Which CLIA-defined test complexity category includes urine dipstick, blood glucose monitoring, and urine pregnancy tests?
- Moderate complexity
- High complexity
- Waived (Correct answer)
- Provider-performed microscopy
Correct answer: Waived
Waived tests are cleared by FDA as simple tests posing minimal risk of erroneous results, including urine dipstick and home glucose monitors.
CLT Regulatory Compliance & Standards 3
Under the Hazard Communication Standard (HazCom 2012), which format replaced the Material Safety Data Sheet (MSDS)?