CPC Quality Assurance & Laboratory Procedures Flashcards
6 cards from real CPC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CPC Quality Assurance & Laboratory Procedures flashcards as text
What is the purpose of the laboratory's blind performance testing program under HHS certification requirements?
Answer: To test the laboratory's accuracy by submitting unknown specimens that mimic real donor samples
Blind performance testing involves submitting proficiency specimens to the laboratory as if they were real donor specimens, assessing the lab's accuracy without their knowledge.
Which cutoff concentration must a urine specimen exceed on an immunoassay screen to be reported as a presumptive positive for marijuana metabolites?
Answer: 50 ng/mL
The HHS-mandated initial immunoassay screen cutoff for marijuana metabolites (THC-COOH) is 50 ng/mL; specimens at or above this level proceed to GC-MS confirmation.
What GC-MS confirmation cutoff concentration must be met or exceeded for a marijuana specimen to be reported as a confirmed positive?
Answer: 15 ng/mL of THC-COOH
The GC-MS confirmation cutoff for THC-COOH is 15 ng/mL, which is lower than the initial screen cutoff, ensuring only true positives are confirmed.
What does the laboratory report to the MRO when a specimen is positive on immunoassay but negative on GC-MS confirmation?
Answer: A negative result
If the confirmatory GC-MS test does not meet the cutoff, the specimen is reported as negative, as the confirmatory result governs the final determination.
Which professional is responsible for certifying each batch of test results at an NLCP-certified laboratory?
Answer: A certifying scientist who reviews and signs off on each batch before results are reported
A certifying scientist must review and certify each batch of drug test results before they are reported to the MRO, ensuring quality and accuracy at the laboratory level.
What must the laboratory do if a specimen's primary vial (Bottle A) is accidentally broken before testing?
Answer: The laboratory must notify the MRO, who may direct testing of the split specimen (Bottle B)
If Bottle A is unusable, the MRO can authorize testing of Bottle B under Part 40, preserving the ability to obtain a valid test result.