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
A laboratory director reviews a delta check flag on a patient's sodium result. Delta checks are used primarily to:
Answer: Detect specimen identification errors and analytical errors
Delta checks compare a patient's current result to a previous result and flag unexpected changes that may indicate specimen mix-up or analytic error.
Which CMS condition requires laboratories to have written policies for handling and disposing of biohazardous waste?
Answer: CLIA condition for quality systems
CLIA quality systems conditions require written policies for pre-analytic, analytic, and post-analytic processes including biohazardous waste handling.
When a new lot of reagents is placed into service, the laboratory must perform which verification to ensure continuity of results?
Answer: Parallel testing or lot-to-lot comparison
Lot-to-lot comparison (parallel testing) confirms new reagent lots perform equivalently to the current lot before routine use.
A laboratory technologist inadvertently releases a positive HIV result to the wrong patient. Under HIPAA, this is classified as a:
Answer: Unauthorized disclosure requiring breach notification
Releasing PHI to the wrong individual constitutes an unauthorized disclosure; if unsecured PHI is involved, breach notification to the patient and HHS is required.
Which standard requires laboratories to establish and document calibration verification at least every 6 months?
Answer: CLIA 42 CFR 493.1255
CLIA regulation 42 CFR 493.1255 requires calibration verification at least every 6 months for moderate and high complexity testing.
Which organization publishes the Clinical and Laboratory Standards Institute (CLSI) EP15-A3 document, used for verifying precision and bias?
Answer: CLSI
CLSI (Clinical and Laboratory Standards Institute) publishes EP15-A3, which provides protocols for user verification of precision and bias.
A laboratory must retain patient test records for a minimum of how many years under CLIA regulations?
Answer: 2 years
CLIA requires laboratories to retain patient test records for a minimum of 2 years from the date of the report, or longer per state law.