MRO Performance Monitoring & QA 4

Question 1

Under HHS Mandatory Guidelines, what action must a laboratory take when an internal QC sample fails during a routine analytical run?

Accepted Answer

Halt reporting of affected specimens and investigate before re-analyzing

Answer

When a QC sample fails, the laboratory must stop reporting affected results and conduct an investigation before re-analyzing those specimens.

Question 2

For MRO performance monitoring, tracking 'time from specimen receipt at laboratory to MRO final report' measures:

Accepted Answer

End-to-end program turnaround time efficiency

Answer

This end-to-end metric captures overall program efficiency including lab processing and MRO review time.

Question 3

A federally-regulated employer asks an MRO for aggregate monthly statistics on positive rates by drug class. The MRO may provide this information:

Accepted Answer

As a general QA report without identifying individual donors

Answer

MROs may share non-individually identifiable aggregate statistics with employers for program management purposes under DOT rules.

Question 4

Which action is OUTSIDE the scope of MRO quality assurance responsibilities?

Accepted Answer

Auditing collector training certification records directly

Answer

Auditing collector training certification records is an employer/DER responsibility, not a direct MRO QA function.

Question 5

Under 49 CFR Part 40, an MRO who identifies a laboratory reporting a non-negative result without a corresponding confirmed GC-MS test should:

Accepted Answer

Cancel the test and report the discrepancy to the laboratory and DOT if unresolved

Answer

A non-negative result without GC-MS confirmation is a regulatory violation; the MRO must cancel the test and escalate to DOT if the lab cannot resolve it.

(MRO) Medical Review Officer Certification Practice Test

(MRO) Medical Review Officer Certification Practice Test

MRO Performance Monitoring & QA 4