MRO Performance Monitoring & QA 2 — Questions and Answers
Question 1: Under DOT 49 CFR Part 40, how often must a laboratory submit blind quality control specimens to the HHS-certified laboratory it contracts with?
- At least once per month (Correct answer)
- At least quarterly
- At least annually
- Continuously throughout each testing cycle
Correct answer: At least once per month
DOT regulations require laboratories to submit blind quality control specimens to HHS-certified labs at least once per month to ensure ongoing performance accuracy.
Question 2: An MRO notices that a specific collection site has a 15% specimen rejection rate over three months. The BEST first step is to:
- Terminate the collection site's contract immediately
- Conduct a site visit and review collector training records (Correct answer)
- Report the site to DOT without further investigation
- Accept the trend as within normal variation
Correct answer: Conduct a site visit and review collector training records
A high rejection rate warrants investigation through a site visit and review of collector training before taking punitive action.
Question 3: Which metric is MOST useful for an MRO to track when evaluating the accuracy of their own result reporting?
- Total number of specimens reviewed per month
- Rate of administrative errors on MRO reports sent to employers (Correct answer)
- Average turnaround time from collection to final report
- Number of employee disputes filed per quarter
Correct answer: Rate of administrative errors on MRO reports sent to employers
Tracking administrative error rates on MRO reports directly measures the accuracy of the MRO's own reporting performance.
Question 4: A laboratory's external proficiency testing (PT) result is reported as 'fail' for one analyte. Under HHS Mandatory Guidelines, the laboratory must:
- Immediately cease testing for all analytes pending investigation
- Investigate and submit a corrective action plan to HHS within 30 days (Correct answer)
- Self-suspend that analyte until the next PT cycle passes
- Notify all MROs of the failed analyte within 48 hours
Correct answer: Investigate and submit a corrective action plan to HHS within 30 days
HHS Mandatory Guidelines require a laboratory to investigate a PT failure and submit a corrective action plan to HHS within 30 days.
Question 5: Which practice BEST supports MRO quality assurance when reviewing cancelled test results?
- Always require a recollection to replace every cancelled result
- Document the reason for cancellation and trend cancelled tests over time (Correct answer)
- Notify the employer of every cancellation with the donor's name
- Discard cancelled test documentation after 30 days
Correct answer: Document the reason for cancellation and trend cancelled tests over time
Documenting cancellation reasons and trending them over time enables the MRO to identify systemic collection or laboratory issues.
Question 6: An MRO QA program should include periodic review of cases where the MRO-reported result differed from the laboratory's initial report. This review is primarily intended to:
- Identify donors who may have cheated the test
- Evaluate whether MRO override decisions are consistent and well-documented (Correct answer)
- Satisfy employer requests for statistical data
- Reduce the number of split specimen retests
Correct answer: Evaluate whether MRO override decisions are consistent and well-documented
Reviewing cases where MRO results differ from lab-reported results ensures that override decisions are applied consistently and are properly supported.
Question 7: Under HHS Mandatory Guidelines, which of the following is a required element of a laboratory's internal quality control program for immunoassay screening?
- Running a minimum of 20 calibrators per batch
- Including negative, positive, and cutoff calibrators in each analytical run (Correct answer)
- Testing each specimen in duplicate before reporting any result
- Performing confirmatory GC-MS on all immunoassay negatives
Correct answer: Including negative, positive, and cutoff calibrators in each analytical run
HHS guidelines require that each immunoassay run include negative controls, positive controls, and calibrators at the cutoff concentration.
MRO Performance Monitoring & QA 2
Under DOT 49 CFR Part 40, how often must a laboratory submit blind quality control specimens to the HHS-certified laboratory it contracts with?