SM Quality Assurance & Compliance 2 — Questions and Answers
Question 1: Which document provides the primary regulatory framework for clinical laboratory quality in the United States?
- CLIA 88 (Correct answer)
- ISO 9001
- CAP Checklist
- OSHA 29 CFR 1910
Correct answer: CLIA 88
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?
- Test it using routine procedures only (Correct answer)
- Refer it to a reference lab for confirmation
- Send it to a supervisory review panel
- Discard it and request a replacement
Correct answer: Test it using routine procedures only
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?
- Westgard 10x rule
- Westgard 6x rule (Correct answer)
- Westgard 2-2s rule
- Westgard R4s rule
Correct answer: Westgard 6x rule
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?
- The Joint Commission (TJC)
- College of American Pathologists (CAP) (Correct answer)
- AABB
- ASHI
Correct answer: College of American Pathologists (CAP)
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?
- False negative on old system (Correct answer)
- False positive on new system
- Systematic bias
- Random error
Correct answer: False negative on old system
If the new system detects a true positive that the old system misses, the old system produced a false negative result.
Question 6: An antimicrobial susceptibility testing QC strain produces an MIC outside the acceptable range for three consecutive days. What is the FIRST corrective action?
- Report results to the medical director and hold patient results
- Check reagent expiration dates and preparation (Correct answer)
- Repeat the test with a fresh QC organism subculture
- Order replacement QC organisms from ATCC
Correct answer: Check reagent expiration dates and preparation
Investigating reagent integrity, including expiration dates and preparation correctness, is the first step in troubleshooting out-of-range QC.
Question 7: Which element is required in a laboratory's procedure manual under CLIA regulations?
- List of all laboratory personnel salaries
- Step-by-step test performance instructions (Correct answer)
- Patient billing codes for each test
- Insurance contract details
Correct answer: Step-by-step test performance instructions
CLIA requires procedure manuals to include step-by-step instructions for performing each test, including specimen requirements, QC, and result interpretation.
SM Quality Assurance & Compliance 2
Which document provides the primary regulatory framework for clinical laboratory quality in the United States?