ABPath Laboratory Management 3 — Questions and Answers
Question 1: Which accreditation body offers the deemed-status inspection program most commonly used by U.S. pathology laboratories?
- FDA
- College of American Pathologists (CAP) (Correct answer)
- OSHA
- CDC
Correct answer: College of American Pathologists (CAP)
CAP holds CMS deemed status and inspects labs for CLIA compliance through its accreditation program.
Question 2: The interval between specimen receipt and result reporting is called:
- Analytical sensitivity
- Turnaround time (Correct answer)
- Reference interval
- Lot-to-lot variation
Correct answer: Turnaround time
Turnaround time (TAT) measures elapsed time from specimen receipt to result availability.
Question 3: Delta checks are used primarily to detect:
- Reagent expiration
- Significant changes in a patient's result compared to prior results, flagging possible errors (Correct answer)
- Instrument temperature drift
- Staff scheduling conflicts
Correct answer: Significant changes in a patient's result compared to prior results, flagging possible errors
A delta check compares a current result to the patient's previous value to catch specimen mix-ups or errors.
Question 4: Which document establishes standardized formatting and content for laboratory procedures in the U.S.?
- A CLSI-formatted standard operating procedure (Correct answer)
- A commercial marketing brochure
- The instrument warranty card
- A billing codebook
Correct answer: A CLSI-formatted standard operating procedure
CLSI provides consensus guidelines for writing standardized SOPs used in clinical laboratories.
Question 5: A critical (panic) value should be:
- Reported at the end of the shift
- Communicated immediately to a responsible caregiver with documented read-back (Correct answer)
- Filed without notification
- Reported only if requested
Correct answer: Communicated immediately to a responsible caregiver with documented read-back
Critical values require immediate notification with documented read-back to ensure patient safety.
Question 6: Lean methodology in the laboratory primarily aims to:
- Increase inventory stockpiles
- Eliminate waste and improve workflow efficiency (Correct answer)
- Reduce the number of QC runs
- Add redundant testing steps
Correct answer: Eliminate waste and improve workflow efficiency
Lean focuses on removing non-value-added steps (waste) to streamline laboratory processes.
Question 7: Which of the following is an appropriate corrective action after a QC failure?
- Release patient results immediately
- Halt reporting, investigate, correct the problem, and re-run QC before resuming (Correct answer)
- Ignore the failure if only one level failed
- Change the mean to match the result
Correct answer: Halt reporting, investigate, correct the problem, and re-run QC before resuming
A QC failure requires stopping reporting, investigating the cause, correcting it, and confirming acceptable QC before releasing results.
Which accreditation body offers the deemed-status inspection program most commonly used by U.S. pathology laboratories?