MRO Source Selection & Evaluation 2 — Questions and Answers
Question 1: When an MRO receives a specimen from a laboratory, which HHS-certified laboratory characteristic is MOST critical to verify before accepting results?
- The lab's state business license
- Current HHS certification under 49 CFR Part 40 (Correct answer)
- The lab's ISO 9001 accreditation
- The lab director's board certification
Correct answer: Current HHS certification under 49 CFR Part 40
Only HHS-certified laboratories may perform DOT-regulated drug testing, and the MRO must confirm this certification is current before accepting results.
Question 2: A collector submits a specimen to a lab that lost its HHS certification two days prior to collection. What should the MRO do?
- Accept the result since collection predated the loss
- Cancel the test and require a recollection (Correct answer)
- Report the result as positive
- Report the result as negative
Correct answer: Cancel the test and require a recollection
If the laboratory was not HHS-certified at the time of testing, the result is invalid and the MRO must cancel the test.
Question 3: Which document confirms that a specific laboratory holds current HHS certification for federal workplace drug testing?
- The laboratory's annual financial audit
- SAMHSA's published list of certified laboratories (Correct answer)
- The laboratory's state license renewal
- CLIA waiver certificate
Correct answer: SAMHSA's published list of certified laboratories
SAMHSA publishes and regularly updates the official list of HHS-certified laboratories that MROs may use to verify certification status.
Question 4: An employer wants to use an on-site instant test device for DOT-mandated testing. What is the MRO's correct guidance?
- Permit it if the device is FDA-cleared
- Permit it for pre-employment only
- Prohibit it; DOT requires HHS-certified lab testing (Correct answer)
- Permit it with split specimen backup
Correct answer: Prohibit it; DOT requires HHS-certified lab testing
49 CFR Part 40 prohibits the use of instant or point-of-collection testing devices for DOT-regulated testing; only HHS-certified labs may be used.
Question 5: Which of the following is an acceptable reason for an MRO to reject a laboratory's reported result?
- The donor is a first-time employee
- The chain of custody was completed in blue ink instead of black
- The laboratory is not listed on the current SAMHSA certified lab list (Correct answer)
- The specimen was collected by a female collector for a male donor
Correct answer: The laboratory is not listed on the current SAMHSA certified lab list
An uncertified laboratory renders the test invalid; ink color is not a disqualifying discrepancy under 49 CFR Part 40.
Question 6: When evaluating an initial drug test result, the MRO must ensure the testing laboratory reported results on which form?
- The employer's proprietary reporting form
- The Federal Drug Testing Custody and Control Form (CCF) (Correct answer)
- Any state-approved chain of custody form
- An OSHA incident report
Correct answer: The Federal Drug Testing Custody and Control Form (CCF)
DOT-regulated testing requires use of the federal CCF; results reported on any other form are not acceptable.
Question 7: A laboratory reports an initial positive result but the MRO notices the laboratory's certification expired 30 days after the collection date but before the analysis date. What action should the MRO take?
- Report the positive result to the employer
- Cancel the test; the lab was uncertified at time of analysis (Correct answer)
- Request the lab re-analyze using a backup sample
- Treat the result as negative
Correct answer: Cancel the test; the lab was uncertified at time of analysis
Certification must be active at the time of analysis; if expired before the specimen was tested, the result must be cancelled.
When an MRO receives a specimen from a laboratory, which HHS-certified laboratory characteristic is MOST critical to verify before accepting results?