MRO Performance Monitoring & QA 3 — Questions and Answers
Question 1: Which document provides the primary federal quality standards that HHS-certified laboratories must follow for workplace drug testing?
- DOT 49 CFR Part 40
- HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs (Correct answer)
- SAMHSA Treatment Improvement Protocol 11
- CLIA 88 Regulations
Correct answer: HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs
The HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs establish the specific quality standards laboratories must meet.
Question 2: An MRO receives a laboratory report indicating a specimen was positive for amphetamines but the laboratory's quantitative result was just above the confirmation cutoff. The MRO should:
- Automatically report the result as negative due to proximity to cutoff
- Conduct the standard interview and make a final determination based on all evidence (Correct answer)
- Request the laboratory retest the specimen before interviewing the donor
- Cancel the test and order a recollection
Correct answer: Conduct the standard interview and make a final determination based on all evidence
Even results near the cutoff are handled through the standard MRO interview process; the MRO may not unilaterally reject a valid laboratory-confirmed positive.
Question 3: A key QA indicator for split specimen testing performance is monitoring the rate of:
- Donors who waive their right to split specimen testing
- Split specimens confirmed at the retest laboratory vs. those that fail reconfirmation (Correct answer)
- Employers who request split retests on behalf of donors
- Split specimens that are rejected for insufficient volume
Correct answer: Split specimens confirmed at the retest laboratory vs. those that fail reconfirmation
Tracking the confirmation vs. non-reconfirmation rate of split specimens helps identify potential laboratory performance or procedural issues.
Question 4: Under DOT 49 CFR Part 40, how long must an MRO retain records of positive, adulterated, substituted, and invalid test results?
- 2 years
- 5 years (Correct answer)
- 7 years
- 10 years
Correct answer: 5 years
DOT requires MROs to retain records of positive, adulterated, substituted, and invalid results for a minimum of 5 years.
Question 5: When an MRO's QA review identifies a pattern of collector errors at a specific site, the MOST appropriate action is to:
- Report the site to SAMHSA for federal inspection
- Coordinate with the DER to arrange corrective training for the collectors (Correct answer)
- Refuse to process any further specimens from that site
- Require a supervisor to be present at all future collections
Correct answer: Coordinate with the DER to arrange corrective training for the collectors
Coordinating corrective training through the Designated Employer Representative (DER) is the appropriate channel for addressing collector performance deficiencies.
Question 6: Which scenario represents a validity testing quality control failure that an MRO should flag during record review?
- A specimen tested negative on both immunoassay and validity markers
- A specimen reported as substituted but creatinine and specific gravity results are not both documented (Correct answer)
- A dilute specimen with creatinine between 2 and 20 mg/dL
- A specimen with a pH of 5.5 reported as valid
Correct answer: A specimen reported as substituted but creatinine and specific gravity results are not both documented
A substituted result requires documentation of both creatinine below 2 mg/dL and specific gravity outside 1.0010–1.0200; missing either value is a QC failure.
Question 7: An MRO self-audit reveals that employee interview documentation is inconsistent across cases. The BEST corrective action is to:
- Outsource all donor interviews to a third-party service
- Develop a standardized interview checklist and apply it to all cases going forward (Correct answer)
- Request that laboratories include interview guidance with each report
- Reduce the number of interviews conducted per month
Correct answer: Develop a standardized interview checklist and apply it to all cases going forward
A standardized interview checklist ensures consistent documentation across all cases and supports QA review.
MRO Performance Monitoring & QA 3
Which document provides the primary federal quality standards that HHS-certified laboratories must follow for workplace drug testing?