CLINICAL LABORATORY SCIENCE
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
laboratory as a profession
Stem
A new graduate MLS is asked to document competency for a
waived test performed in the microbiology bench area. The
laboratory’s competency policy requires objective evidence
beyond checklist observation. Which approach best meets
professional and regulatory expectations for competency
documentation?
,A. Supervisor signature on a one-time checklist after
observation.
B. Periodic competency assessment including direct
observation, written assessment, and logged patient result
comparison.
C. Self-attestation by the technologist quarterly.
D. Annual department meeting attendance documented on a
roster.
Correct answer: B
Rationale — Correct (B)
Periodic, multi-component competency assessments
(observation, written tests, and comparison to reference
results) provide objective evidence of ongoing competence and
align with professional standards and CLIA requirements. This
approach detects skill decay and ensures technical accuracy.
Rationale — Incorrect
A. One-time checklist is insufficient for ongoing competency
evidence.
C. Self-attestation lacks objective verification and is not
defensible for regulatory purposes.
D. Meeting attendance documents exposure but not
demonstrated hands-on competence.
Teaching point:
Document multi-modal competency regularly (observation,
written, proficiency comparison).
,Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
laboratory program accreditation
Stem
During a CAP inspection (College of American Pathologists) a lab
is cited for inconsistent temperature logs for a reagent
refrigerator. The log shows frequent 2–3°C excursions outside
the manufacturer's recommended range but no corrective
actions documented. What is the most appropriate immediate
corrective action?
A. Replace the refrigerator immediately.
B. Quarantine affected reagents, review logs, identify root
cause, and document corrective actions.
C. Continue using reagents because excursions were small.
D. Note the excursions in the lab meeting minutes without
quarantining reagents.
Correct answer: B
Rationale — Correct (B)
Quarantining reagents until verified stable, investigating root
cause (thermostat, door seal, loading), and documenting
, corrective and preventive actions satisfy CAP requirements and
ensure patient safety.
Rationale — Incorrect
A. Immediate replacement without investigation may be
unnecessary and disrupt service.
C. Small excursions can affect reagent stability; assuming safety
is unsafe.
D. Meeting minutes alone do not meet corrective action
documentation requirements.
Teaching point:
Quarantine suspect reagents, investigate root cause, and
document corrective actions.
Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA
regulations
Stem
A hospital laboratory performs moderate complexity molecular
tests. Under CLIA (Clinical Laboratory Improvement
Amendments) requirements, which personnel and quality
elements must the lab minimally demonstrate before reporting
patient results?
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
laboratory as a profession
Stem
A new graduate MLS is asked to document competency for a
waived test performed in the microbiology bench area. The
laboratory’s competency policy requires objective evidence
beyond checklist observation. Which approach best meets
professional and regulatory expectations for competency
documentation?
,A. Supervisor signature on a one-time checklist after
observation.
B. Periodic competency assessment including direct
observation, written assessment, and logged patient result
comparison.
C. Self-attestation by the technologist quarterly.
D. Annual department meeting attendance documented on a
roster.
Correct answer: B
Rationale — Correct (B)
Periodic, multi-component competency assessments
(observation, written tests, and comparison to reference
results) provide objective evidence of ongoing competence and
align with professional standards and CLIA requirements. This
approach detects skill decay and ensures technical accuracy.
Rationale — Incorrect
A. One-time checklist is insufficient for ongoing competency
evidence.
C. Self-attestation lacks objective verification and is not
defensible for regulatory purposes.
D. Meeting attendance documents exposure but not
demonstrated hands-on competence.
Teaching point:
Document multi-modal competency regularly (observation,
written, proficiency comparison).
,Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
laboratory program accreditation
Stem
During a CAP inspection (College of American Pathologists) a lab
is cited for inconsistent temperature logs for a reagent
refrigerator. The log shows frequent 2–3°C excursions outside
the manufacturer's recommended range but no corrective
actions documented. What is the most appropriate immediate
corrective action?
A. Replace the refrigerator immediately.
B. Quarantine affected reagents, review logs, identify root
cause, and document corrective actions.
C. Continue using reagents because excursions were small.
D. Note the excursions in the lab meeting minutes without
quarantining reagents.
Correct answer: B
Rationale — Correct (B)
Quarantining reagents until verified stable, investigating root
cause (thermostat, door seal, loading), and documenting
, corrective and preventive actions satisfy CAP requirements and
ensure patient safety.
Rationale — Incorrect
A. Immediate replacement without investigation may be
unnecessary and disrupt service.
C. Small excursions can affect reagent stability; assuming safety
is unsafe.
D. Meeting minutes alone do not meet corrective action
documentation requirements.
Teaching point:
Quarantine suspect reagents, investigate root cause, and
document corrective actions.
Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA
regulations
Stem
A hospital laboratory performs moderate complexity molecular
tests. Under CLIA (Clinical Laboratory Improvement
Amendments) requirements, which personnel and quality
elements must the lab minimally demonstrate before reporting
patient results?
