What agency approves new test methodologies, instruments, and reagents before they
are available for purchase by consumers? - answerFDA
How often should biological safety hoods be inspected? - answerAnnually
A chain of custody is required for all of the following: - answerLegal blood alcohol, pre-
employment drug screen, and paternity testing
A chain of custody is required for all of the following, EXCEPT: - answerFetal fibronectin
What federal legislation regulates most clinical laboratories? - answerClinical Laboratory
Improvement Amendments (CLIA)
What is the level of complexity of most testing performed in clinical laboratories? -
answerModerately complex
How often does CLIA require clinical laboratories to have inspections? - answerEvery 2
years
Which laboratories are NOT required to participate in proficiency testing? -
answerLaboratories performing waived testing only.
Which proficiency testing (PT) results do not meet the CLIA performance criteria? -
answerFailed the same analyte in two consecutive PT events
Which one of the following is an example of alternate proficiency testing? - answerSplit
samples sent to another facility using the same test method.
All of the following are pre-analytical errors except which one? - answerTranscription
error entering a manual result
All of the following are pre-analytical erros: - answerOrdering a lab test under the wrong
patient number, misidentification of a patient, mislabeling an add-on test
Which one of the following is the most common analytical error? - answerNot checking
specimen integrity
What is the most common post-analytical error? - answerClerical errors
, How often must a procedure be reviewed? - answerAnnual review is required
How often must thermometers be checked against the NIST thermometer? -
answerAnnually
In which manual are the directions for running quality control for a specific assay kept? -
answerOperating procedure manual
Following equipment maintenance, when is quality control suggested? - answerAfter
any preventative maintenance
What is the most common reason for a control value to be outside of 3SD? -
answerRandom error
If one control is outside the 95% confidence limits, then what is the most appropriate
remedial action to take initially? - answerRepeat the same control
Where should an unopened container of methanol be stored? - answerFlammable
safety cabinet
After preventative maintenance by field service, which one of the following is
recommended? - answerVerification of QC results
According to CLIA, who is responsible for specimen processing, test performance, and
reporting test results? - answerTesting personnel
Which one of the following is NOT a job duty of the testing personnel? -
answerInterpretation of highly complex testing
All of the following are job duties of testing personnel: - answerInventory control,
equipment maintenance, and accuracy of reported results
Which one of the following is not required to be kept in the employee's personnel
records? - answerContinuing education documents?
All of the following are required to be kept in the employee's personnel records: -
answerJob competency training checklist, remedial action documentation, and annual
performance appraisal.
Which one of the following statements concerning CEUs is false? - answerCEUs are
mandated by the College of American Pathologists
Who is responsible for monitoring trends for corrected reports in the laboratory? -
answerQuality assurance
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