MLS Quality Assurance & Standards 3

Question 1

Which document type from CLSI provides consensus-based guidelines for laboratory procedures and standardization?

Accepted Answer

EP documents

Answer

CLSI EP (Evaluation Protocol) documents provide standardized methods for evaluating analytical performance characteristics such as precision, accuracy, and interference.

Question 2

A laboratory notices a gradual upward trend in QC values over 10 days. The MOST likely cause is:

Accepted Answer

Reagent degradation

Answer

A gradual upward trend in QC values over time suggests progressive reagent deterioration, which introduces a systematic drift into the results.

Question 3

The term 'medical decision level' in QC refers to:

Accepted Answer

A clinically critical concentration used to place QC materials

Answer

Medical decision levels are clinically important concentrations (e.g., a glucose level indicating hypoglycemia) at which QC materials should ideally be targeted.

Question 4

Which accreditation organization uses the concept of 'deemed status' under CMS to accredit clinical laboratories?

Accepted Answer

CAP

Answer

The College of American Pathologists (CAP) has CMS-deemed status, meaning CAP-accredited laboratories are considered compliant with CLIA requirements.

Question 5

The analytical measurement range (AMR) of an assay defines:

Accepted Answer

The range over which the assay produces accurate results without dilution

Answer

AMR is the range of analyte concentrations that the instrument can directly measure accurately without sample dilution or concentration.

(MLS) Medical Laboratory Scientist Practice Test

(MLS) Medical Laboratory Scientist Practice Test

MLS Quality Assurance & Standards 3