SM Quality Assurance & Compliance 3

Question 1

Under CLIA, which personnel category is authorized to perform high-complexity testing without additional supervision?

Accepted Answer

Medical Laboratory Scientist (MLS) with ASCP certification

Answer

An MLS (ASCP) meets the education and training requirements for performing high-complexity testing under CLIA regulations.

Question 2

What is the purpose of a delta check in clinical microbiology?

Accepted Answer

Compare current result to previous result for the same patient to detect errors

Answer

Delta checks compare a patient's current result with a prior result to flag implausible changes that may indicate specimen mix-up or analytical error.

Question 3

A laboratory's urine culture contamination rate rises from 3% to 12% over one month. Which is the MOST likely source?

Accepted Answer

Poor collection technique or patient instruction

Answer

Rising contamination rates in urine cultures most commonly reflect inadequate patient education on midstream clean-catch collection technique.

Question 4

Which ISO standard is specifically designed for the quality management of medical laboratories?

Accepted Answer

ISO 15189:2022

Answer

ISO 15189 specifies quality management system requirements and competence requirements specifically for medical laboratories.

Question 5

Which of the following is an example of a pre-analytical error in microbiology?

Accepted Answer

Collecting a sputum specimen after the patient rinsed with mouthwash

Answer

Rinsing with mouthwash before sputum collection is a pre-analytical error that can reduce or eliminate oral pathogens and increase contaminating flora.

(SM) Specialist in Microbiology Practice Test

(SM) Specialist in Microbiology Practice Test

SM Quality Assurance & Compliance 3