ASPT ASPT Quality Assurance & Laboratory Operations 2 — Questions and Answers
Question 1: What is the primary purpose of proficiency testing (PT) in a CLIA-certified laboratory?
- Train new employees
- Evaluate lab performance by testing unknown samples from an external program (Correct answer)
- Set employee performance goals
- Audit patient records for billing
Correct answer: Evaluate lab performance by testing unknown samples from an external program
Proficiency testing requires labs to test unknown samples sent by an external program to evaluate and verify that the lab's results are accurate and consistent with peers.
Question 2: Which term describes the ability of a test to correctly identify those WITH the disease (low false-negative rate)?
- Specificity
- Sensitivity (Correct answer)
- Precision
- Accuracy
Correct answer: Sensitivity
Sensitivity measures a test's ability to correctly identify true positives (patients with the disease), meaning a highly sensitive test has few false negatives.
Question 3: What does 'chain of custody' refer to in specimen handling?
- The sequence of approved couriers for transport
- Documented, unbroken accountability of a specimen from collection to result reporting (Correct answer)
- The storage temperature log for specimens
- The order in which tubes are filled during collection
Correct answer: Documented, unbroken accountability of a specimen from collection to result reporting
Chain of custody is a documented process ensuring unbroken, accountable handling of a specimen — required for legal, forensic, and drug-testing specimens.
Question 4: What is the correct response if a phlebotomist suspects a specimen has been mislabeled?
- Relabel with the correct information and continue
- Discard the specimen and notify the ordering provider
- Recollect the specimen following proper identification procedures (Correct answer)
- Submit the specimen and add a note to the report
Correct answer: Recollect the specimen following proper identification procedures
A mislabeled specimen must be rejected and recollected with proper patient identification to prevent misidentification errors that could harm the patient.
Question 5: Which accreditation body is known for inspecting hospital and clinical laboratories in the US?
- AABB
- CAP (College of American Pathologists) (Correct answer)
- NAACLS
- ASPT
Correct answer: CAP (College of American Pathologists)
The College of American Pathologists (CAP) is a leading accreditation body that inspects labs using peer review to ensure quality, safety, and regulatory compliance.
Question 6: What is the purpose of a laboratory's standard operating procedure (SOP)?
- Provide patient education materials
- Document step-by-step instructions to ensure consistent, standardized performance of procedures (Correct answer)
- List employee contact information
- Track supply inventory levels
Correct answer: Document step-by-step instructions to ensure consistent, standardized performance of procedures
An SOP provides written, step-by-step instructions for performing laboratory procedures consistently and correctly, reducing variability and errors.
What is the primary purpose of proficiency testing (PT) in a CLIA-certified laboratory?