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
Which regulatory body oversees the approval of in vitro diagnostic (IVD) devices before they can be marketed in the United States?
Answer: FDA
The FDA regulates and approves in vitro diagnostic devices under 21 CFR Part 809 before they can be marketed or sold in the US.
A laboratory's PT score falls below the acceptable threshold two consecutive times for the same analyte. According to CLIA, this requires:
Answer: Immediate test suspension and corrective action
Two consecutive PT failures for the same analyte requires the laboratory to cease patient testing for that analyte until corrective action is documented.
According to HIPAA Security Rule, which safeguard category requires workforce training and sanction policies for protecting electronic PHI?
Answer: Administrative safeguards
Administrative safeguards under the HIPAA Security Rule include workforce training, security management, and sanction policies for ePHI protection.
Which term describes the range of analyte concentrations over which a test system can accurately quantify results without modification?
Answer: Analytical measurement range (AMR)
The Analytical Measurement Range (AMR) is the concentration range a method can directly measure without dilution or concentration steps.
A laboratory using a laboratory-developed test (LDT) is NOT subject to FDA premarket review but MUST still meet which requirements?
Answer: CLIA performance standards and full method validation
LDTs must comply with CLIA performance standards—including full method validation for accuracy, precision, and reference intervals—even without FDA clearance.
Which CLSI guideline provides the framework for establishing quality goals using biological variation data?
Answer: C24-ED4
CLSI C24-ED4 (Statistical Quality Control) provides guidelines for establishing quality goals and QC procedures, including use of biological variation data.
Under the Americans with Disabilities Act (ADA), a laboratory must provide reasonable accommodations for employees with disabilities unless doing so would cause:
Answer: Undue hardship to the employer
The ADA requires reasonable accommodations unless they would impose an undue hardship (significant difficulty or expense) on the employer.