SM Quality Assurance & Compliance 2

Question 1

Which document provides the primary regulatory framework for clinical laboratory quality in the United States?

Accepted Answer

CLIA 88

Answer

CLIA 88 (Clinical Laboratory Improvement Amendments of 1988) establishes federal quality standards for all U.S. clinical laboratory testing.

Question 2

A clinical microbiology lab receives a proficiency testing (PT) specimen. The technologist suspects the specimen is a PT sample. What is the correct action?

Accepted Answer

Test it using routine procedures only

Answer

PT specimens must be tested using only the routine methods the laboratory uses for patient samples; referral or special handling is prohibited.

Question 3

In a quality control chart, which rule indicates a systematic error when six consecutive QC values fall on the same side of the mean?

Accepted Answer

Westgard 6x rule

Answer

The Westgard 6x rule (six consecutive values on one side of the mean) signals a systematic shift or bias in the analytical process.

Question 4

Which accreditation organization offers the Laboratory Accreditation Program (LAP) specifically used by many clinical microbiology laboratories in the US?

Accepted Answer

College of American Pathologists (CAP)

Answer

The College of American Pathologists (CAP) LAP is widely used for clinical laboratory accreditation and is deemed equivalent to CLIA certification.

Question 5

A new blood culture system is being evaluated against the current gold standard. A specimen grows Staphylococcus aureus in the new system but not the old. This discrepancy is best described as what type of result?

Accepted Answer

False negative on old system

Answer

If the new system detects a true positive that the old system misses, the old system produced a false negative result.

(SM) Specialist in Microbiology Practice Test

(SM) Specialist in Microbiology Practice Test

SM Quality Assurance & Compliance 2