Quality Assurance & Standards Flashcards
7 cards from real MLS practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Quality Assurance & Standards flashcards as text
A laboratory receives proficiency testing results showing a 'not graded' score for a regulated analyte. What is the MOST likely consequence?
Answer: Potential loss of CLIA certification for that test
Unsatisfactory PT performance for regulated analytes can result in CMS enforcement actions, including suspension or revocation of CLIA certification for the affected test.
Which of the following BEST defines the reportable range of a laboratory test?
Answer: The range of values the laboratory can report accurately, including dilutions
The clinical reportable range extends the AMR by incorporating allowable sample dilutions, representing the full range of concentrations the lab can accurately report.
When a new reagent lot is introduced, a laboratory should FIRST:
Answer: Recalibrate the instrument and verify performance with QC
Before releasing patient results with a new reagent lot, the laboratory must recalibrate if required and verify acceptable QC performance to ensure lot-to-lot consistency.
A laboratory's quality indicator shows an increased rate of hemolyzed specimens from the emergency department. The BEST corrective action is to:
Answer: Conduct phlebotomy technique training for ED staff
Increased hemolysis from a specific area typically indicates a phlebotomy technique problem; targeted training addresses the root cause and reduces pre-analytical errors.
The Six Sigma concept of 'defects per million opportunities' (DPMO) in laboratory medicine equates defects to:
Answer: Patient results outside total allowable error per million tests
In laboratory Six Sigma, a defect is any patient result that falls outside the total allowable error limit, and DPMO counts how often this occurs per million tests.
Which action is REQUIRED when a laboratory's QC fails and patient results have already been reported?
Answer: Investigate the failure, notify the medical director, and consider recalling affected results
A retrospective QC failure requires root cause investigation, medical director notification, and assessment of whether reported patient results were clinically impacted.
An IQCP (Individualized Quality Control Plan) allows a laboratory to:
Answer: Customize QC frequency and type based on a risk assessment of the testing process
IQCP enables laboratories to design a quality control plan tailored to their specific testing process by conducting a risk assessment covering specimen, test system, and testing environment.