CSC Regulatory Compliance & Standards 3

Question 1

Under CLIA regulations, which category covers most routine clinical laboratory tests performed by specimen collectors at point-of-care?

Accepted Answer

Waived tests

Answer

Waived tests are simple, low-risk tests cleared by the FDA and exempt from most CLIA requirements, commonly performed at point-of-care.

Question 2

A collector working in a non-federal workplace drug testing program is primarily governed by which set of standards?

Accepted Answer

State laws and employer policies

Answer

Non-federally mandated drug testing programs are governed by applicable state laws and the employer's own written drug testing policy.

Question 3

What is the maximum allowable time between urine collection and delivery to the laboratory under standard SAMHSA protocols to maintain specimen integrity?

Accepted Answer

48 hours

Answer

Specimens should generally be shipped and received by the laboratory within 48 hours of collection to ensure integrity.

Question 4

Which regulation requires laboratories certified for federal workplace drug testing to be on the SAMHSA-approved list?

Accepted Answer

49 CFR Part 40

Answer

49 CFR Part 40 mandates that only SAMHSA-certified laboratories may analyze specimens collected under DOT-regulated testing programs.

Question 5

A donor presents a valid prescription for a controlled substance before providing a urine specimen. How should the collector handle this information?

Accepted Answer

Not accept or record medical information — proceed normally

Answer

Collectors do not accept, record, or act on medical information; prescription review is the sole responsibility of the Medical Review Officer (MRO).

(CSC) Certified Specimen Collector Practice Test

(CSC) Certified Specimen Collector Practice Test

CSC Regulatory Compliance & Standards 3