Performance Monitoring & QA Flashcards

Under DOT 49 CFR Part 40, how often must a laboratory submit blind quality control specimens to the HHS-certified laboratory it contracts with?

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.

An MRO notices that a specific collection site has a 15% specimen rejection rate over three months. The BEST first step is to:

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.

Which metric is MOST useful for an MRO to track when evaluating the accuracy of their own result reporting?

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.

A laboratory's external proficiency testing (PT) result is reported as 'fail' for one analyte. Under HHS Mandatory Guidelines, the laboratory must:

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.

Which practice BEST supports MRO quality assurance when reviewing cancelled test results?

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.

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:

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.

Under HHS Mandatory Guidelines, which of the following is a required element of a laboratory's internal quality control program for immunoassay screening?

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.