CLINICAL LABORATORY SCIENCE
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Science as a Profession
Stem
A new graduate MLS is creating a competency assessment plan
for bench staff in a 100-bed hospital lab. Institutional
accreditation requires documentation of competency at hire
and periodically. The graduate must prioritize which elements
to include to satisfy regulatory and accreditation expectations
while ensuring patient safety—which plan best meets those
needs?
,A. Annual written exams only, with supervisor signature.
B. Initial demonstration of technique, quarterly direct
observation for 1 year, semiannual proficiency testing, and
documentation retained.
C. One competency demonstration at hire and supervisor trust-
based approval thereafter.
D. Peer review without formal documentation, rotating
responsibilities monthly.
Correct Answer: B
Rationale — Correct (B)
Includes initial demonstration, frequent direct observation,
scheduled proficiency testing, and documentation—aligns with
best practice and accreditation expectations for ongoing
competency and traceability.
Rationale — Incorrect
A. Written exams alone miss observed technique and hands-on
skills.
C. Single demonstration lacks ongoing competence evidence.
D. Peer review without documentation fails accreditation and
regulatory requirements.
Teaching Point:
Competency programs must include demonstration,
observation, PT, and record retention.
Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
,2)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Overview
Stem
A hospital lab director receives an urgent request to perform a
new send-out immunoassay. Before sending patient samples to
a reference lab, which laboratory management action is
required to meet quality and legal obligations?
A. Send samples immediately with minimal paperwork to
expedite patient care.
B. Review and approve the reference lab’s accreditation,
perform method comparison/validation documentation, and
update test requisition/patient consent as needed.
C. Only obtain verbal confirmation from the reference lab that
they can run the assay.
D. Delegate decision to the clinical team without
documentation.
Correct Answer: B
Rationale — Correct (B)
Regulatory and quality standards require validation or method
comparison for send-outs, verification of reference lab
accreditation, and proper documentation (requisitions/consent)
to ensure result reliability and legal traceability.
, Rationale — Incorrect
A. Expediency without due diligence risks invalid results and
legal exposure.
C. Verbal confirmation is insufficient evidence of quality.
D. Clinical delegation without documentation breaches lab
management responsibility.
Teaching Point:
Send-outs require reference lab verification and method
validation documentation.
Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Improvement Amendments (CLIA)
Stem
A small outpatient clinic wants to perform a new moderate-
complexity assay onsite. Under federal regulation, what must
the clinic demonstrate before testing patients?
A. Nothing — any clinic can perform any test.
B. CLIA certification for moderate complexity, personnel
qualifications, QC procedures, and participation in proficiency
testing (if applicable).
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Science as a Profession
Stem
A new graduate MLS is creating a competency assessment plan
for bench staff in a 100-bed hospital lab. Institutional
accreditation requires documentation of competency at hire
and periodically. The graduate must prioritize which elements
to include to satisfy regulatory and accreditation expectations
while ensuring patient safety—which plan best meets those
needs?
,A. Annual written exams only, with supervisor signature.
B. Initial demonstration of technique, quarterly direct
observation for 1 year, semiannual proficiency testing, and
documentation retained.
C. One competency demonstration at hire and supervisor trust-
based approval thereafter.
D. Peer review without formal documentation, rotating
responsibilities monthly.
Correct Answer: B
Rationale — Correct (B)
Includes initial demonstration, frequent direct observation,
scheduled proficiency testing, and documentation—aligns with
best practice and accreditation expectations for ongoing
competency and traceability.
Rationale — Incorrect
A. Written exams alone miss observed technique and hands-on
skills.
C. Single demonstration lacks ongoing competence evidence.
D. Peer review without documentation fails accreditation and
regulatory requirements.
Teaching Point:
Competency programs must include demonstration,
observation, PT, and record retention.
Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
,2)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Overview
Stem
A hospital lab director receives an urgent request to perform a
new send-out immunoassay. Before sending patient samples to
a reference lab, which laboratory management action is
required to meet quality and legal obligations?
A. Send samples immediately with minimal paperwork to
expedite patient care.
B. Review and approve the reference lab’s accreditation,
perform method comparison/validation documentation, and
update test requisition/patient consent as needed.
C. Only obtain verbal confirmation from the reference lab that
they can run the assay.
D. Delegate decision to the clinical team without
documentation.
Correct Answer: B
Rationale — Correct (B)
Regulatory and quality standards require validation or method
comparison for send-outs, verification of reference lab
accreditation, and proper documentation (requisitions/consent)
to ensure result reliability and legal traceability.
, Rationale — Incorrect
A. Expediency without due diligence risks invalid results and
legal exposure.
C. Verbal confirmation is insufficient evidence of quality.
D. Clinical delegation without documentation breaches lab
management responsibility.
Teaching Point:
Send-outs require reference lab verification and method
validation documentation.
Citation:
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Improvement Amendments (CLIA)
Stem
A small outpatient clinic wants to perform a new moderate-
complexity assay onsite. Under federal regulation, what must
the clinic demonstrate before testing patients?
A. Nothing — any clinic can perform any test.
B. CLIA certification for moderate complexity, personnel
qualifications, QC procedures, and participation in proficiency
testing (if applicable).
