CSC Regulatory Compliance & Standards 3 — Questions and Answers
Question 1: Under CLIA regulations, which category covers most routine clinical laboratory tests performed by specimen collectors at point-of-care?
- High complexity
- Moderate complexity
- Waived tests (Correct answer)
- Provider-performed microscopy
Correct answer: Waived tests
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?
- DOT 49 CFR Part 40
- SAMHSA federal guidelines
- State laws and employer policies (Correct answer)
- DEA Schedule I regulations
Correct answer: State laws and employer policies
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?
- 24 hours
- 48 hours (Correct answer)
- 72 hours
- 7 days
Correct answer: 48 hours
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?
- 49 CFR Part 40 (Correct answer)
- 42 CFR Part 493
- 21 CFR Part 1301
- 29 CFR 1910.1030
Correct answer: 49 CFR Part 40
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?
- Record the prescription on the CCF
- Refuse to collect the specimen
- Not accept or record medical information — proceed normally (Correct answer)
- Immediately contact the MRO
Correct answer: Not accept or record medical information — proceed normally
Collectors do not accept, record, or act on medical information; prescription review is the sole responsibility of the Medical Review Officer (MRO).
Question 6: Which organization publishes the Mandatory Guidelines for Federal Workplace Drug Testing Programs?
- CDC
- OSHA
- SAMHSA (Correct answer)
- CMS
Correct answer: SAMHSA
SAMHSA (Substance Abuse and Mental Health Services Administration) publishes and updates the Mandatory Guidelines governing federal workplace drug testing.
Question 7: An employer subject to DOT drug testing rules wants to add a test for a drug not on the standard 5-panel. Under DOT regulations, this is:
- Permitted if the employer pays the extra cost
- Permitted only with MRO approval
- Not permitted within the DOT testing program (Correct answer)
- Required for all safety-sensitive employees
Correct answer: Not permitted within the DOT testing program
Employers may not add substances to the standard DOT 5-panel drug test; any additional testing must occur outside the DOT-regulated program.
CSC Regulatory Compliance & Standards 3
Under CLIA regulations, which category covers most routine clinical laboratory tests performed by specimen collectors at point-of-care?