AACC AACC Laboratory Management & Operations 1 — Questions and Answers
Question 1: Which accreditation body oversees clinical laboratory quality and compliance in the United States under the Clinical Laboratory Improvement Amendments (CLIA)?
- Centers for Medicare & Medicaid Services (CMS) (Correct answer)
- The Joint Commission (TJC)
- College of American Pathologists (CAP)
- American Association for Clinical Chemistry (AACC)
Correct answer: Centers for Medicare & Medicaid Services (CMS)
CMS is the federal agency that oversees CLIA, which regulates all US clinical laboratory testing on human specimens.
Question 2: A laboratory director receives a critical value result. What is the FIRST action that must be taken?
- File it in the patient's record
- Notify the ordering physician or responsible clinician immediately (Correct answer)
- Repeat the test to confirm the value
- Document the result in the laboratory information system
Correct answer: Notify the ordering physician or responsible clinician immediately
Critical values must be communicated immediately to the ordering clinician so that urgent patient care decisions can be made.
Question 3: What is the primary purpose of a laboratory's standard operating procedure (SOP)?
- To record billing codes for insurance
- To provide step-by-step instructions ensuring consistent, reproducible test performance (Correct answer)
- To list all laboratory personnel and their certifications
- To document equipment purchase history
Correct answer: To provide step-by-step instructions ensuring consistent, reproducible test performance
SOPs ensure that all staff perform procedures the same way, reducing variability and supporting quality test results.
Question 4: Under CLIA regulations, how long must laboratories retain records for non-waived tests?
- 1 year
- 2 years (Correct answer)
- 5 years
- 10 years
Correct answer: 2 years
CLIA requires that records for non-waived tests, including patient test records and quality control data, be retained for a minimum of 2 years.
Question 5: Which staffing model assigns a single laboratory professional to perform multiple types of testing across different disciplines?
- Core laboratory model
- Consolidated testing model
- Cross-training model (Correct answer)
- Point-of-care model
Correct answer: Cross-training model
Cross-training allows laboratory staff to be competent in multiple disciplines, improving flexibility and operational efficiency.
Question 6: What document outlines the expected performance characteristics of a laboratory test method before implementation?
- Method validation report (Correct answer)
- Certificate of analysis
- Lot-to-lot verification
- Competency assessment
Correct answer: Method validation report
A method validation report documents accuracy, precision, linearity, and other performance characteristics established before a new test goes into clinical use.
AACC AACC Laboratory Management & Operations 1
Which accreditation body oversees clinical laboratory quality and compliance in the United States under the Clinical Laboratory Improvement Amendments (CLIA)?