MLS Quality Assurance & Standards 5

Question 1

A laboratory receives proficiency testing results showing a 'not graded' score for a regulated analyte. What is the MOST likely consequence?

Accepted Answer

Potential loss of CLIA certification for that test

Answer

Unsatisfactory PT performance for regulated analytes can result in CMS enforcement actions, including suspension or revocation of CLIA certification for the affected test.

Question 2

Which of the following BEST defines the reportable range of a laboratory test?

Accepted Answer

The range of values the laboratory can report accurately, including dilutions

Answer

The clinical reportable range extends the AMR by incorporating allowable sample dilutions, representing the full range of concentrations the lab can accurately report.

Question 3

When a new reagent lot is introduced, a laboratory should FIRST:

Accepted Answer

Recalibrate the instrument and verify performance with QC

Answer

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.

Question 4

A laboratory's quality indicator shows an increased rate of hemolyzed specimens from the emergency department. The BEST corrective action is to:

Accepted Answer

Conduct phlebotomy technique training for ED staff

Answer

Increased hemolysis from a specific area typically indicates a phlebotomy technique problem; targeted training addresses the root cause and reduces pre-analytical errors.

Question 5

The Six Sigma concept of 'defects per million opportunities' (DPMO) in laboratory medicine equates defects to:

Accepted Answer

Patient results outside total allowable error per million tests

Answer

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.

(MLS) Medical Laboratory Scientist Practice Test

(MLS) Medical Laboratory Scientist Practice Test

MLS Quality Assurance & Standards 5