Regulatory Standards & Compliance Flashcards
7 cards from real PCR 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 Standards & Compliance flashcards as text
Which federal agency administers the CLIA program, including certification and laboratory inspections?
Answer: Centers for Medicare & Medicaid Services (CMS)
CMS administers CLIA certification, fees, and surveys, while FDA categorizes test complexity and CDC provides technical support.
Under CLIA, how many proficiency testing events per year are generally required for a regulated analyte?
Answer: Three
CLIA requires enrollment in an approved PT program with three testing events per year for regulated analytes.
A lab runs a molecular PCR assay for an analyte not listed in CLIA Subpart I with no PT available. What must it do at minimum?
Answer: Verify test accuracy at least twice per year using an alternative assessment
CLIA requires labs to verify the accuracy of non-regulated tests at least twice annually, e.g., by split-sample comparison.
A technologist sends a proficiency testing sample to a sister laboratory to confirm the result before reporting it. How does CLIA treat this?
Answer: Prohibited PT referral that can lead to certificate revocation
CLIA prohibits PT referral, and violations can result in revocation of the CLIA certificate and director sanctions.
For an unmodified FDA-cleared PCR assay, which performance specifications must a CLIA lab verify before reporting patient results?
Answer: Accuracy, precision, reportable range, and reference intervals
42 CFR 493.1253 requires verification of accuracy, precision, reportable range, and reference intervals for unmodified FDA-approved tests.
Which guideline sets the minimum information to report when publishing quantitative real-time PCR experiments?
Answer: MIQE
The MIQE guidelines (Bustin et al., 2009) list the essential information for transparent, reproducible qPCR publications.
Which two U.S. states are CLIA-exempt because they run their own approved laboratory licensure programs?
Answer: New York and Washington
CMS has granted CLIA exemption to New York and Washington because their state programs are equivalent or stricter.
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