CLINICAL LABORATORY SCIENCE
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA
personnel & test complexity
Stem
A 38-year-old hospital hires a new medical laboratory scientist
(MLS) who completed an accredited program but lacks prior
experience in molecular testing. The lab plans to assign the MLS
to perform a newly implemented moderate-complexity
molecular assay. Under CLIA 1988, what is the laboratory’s most
appropriate initial action before allowing independent testing
by the MLS?
,A. Allow immediate independent testing based on accredited
MLS credential
B. Require documented competency assessment and
supervised training specific to the assay
C. Limit the MLS to waived tests only for 6 months, per CLIA
mandatory waiting period
D. Require the MLS to obtain a doctorate before performing
moderate-complexity tests
Correct answer: B
Rationale — Correct (B)
CLIA requires that personnel performing non-waived (moderate
or high complexity) testing have documented initial training and
competency for the specific assay and instrument. Supervised
training and demonstration of competence ensure analytic
validity and patient safety. Documenting competency also
satisfies CLIA inspection requirements and accrediting
organizations’ standards.
Rationale — Incorrect
A. Credential alone doesn’t substitute for assay-specific
competency required under CLIA.
C. CLIA does not impose a universal 6-month waiting period; it
requires competency documentation.
D. A doctorate is not required by CLIA for moderate-complexity
testing and is unnecessary.
,Teaching Point
CLIA: assay-specific training and documented competency are
required for non-waived testing.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Test
complexity & CLIA categories
Stem
A laboratory wishes to introduce a new point-of-care glucose
analyzer classified as waived under CLIA. Which regulatory
implication is true for waived testing sites?
A. They are exempt from all CLIA requirements, including
enrollment and proficiency testing.
B. They must enroll in CLIA, follow manufacturer instructions,
but are not required to perform PT.
C. They must meet the same personnel qualification standards
as high-complexity labs.
D. They must undergo CAP inspections every two years.
Correct answer: B
Rationale — Correct (B)
CLIA-waived tests require the testing site to be enrolled in CLIA
, and follow manufacturer’s instructions, but they are subject to
fewer regulatory requirements; proficiency testing is not
required for waived tests. This reduces regulatory burden while
maintaining minimal oversight.
Rationale — Incorrect
A. Waived tests are not exempt from CLIA enrollment or basic
requirements.
C. Waived testing sites do not need high-complexity personnel
standards.
D. CAP inspections are voluntary and tied to accreditation, not
mandated for waived testing.
Teaching Point
Waived testing: CLIA enrollment and adherence to
manufacturer instructions, but no PT requirement.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Proficiency
testing (PT) and external QA
Stem
During a CAP inspection, the microbiology lab’s proficiency
testing records show two “unsatisfactory” PT events in the past
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA
personnel & test complexity
Stem
A 38-year-old hospital hires a new medical laboratory scientist
(MLS) who completed an accredited program but lacks prior
experience in molecular testing. The lab plans to assign the MLS
to perform a newly implemented moderate-complexity
molecular assay. Under CLIA 1988, what is the laboratory’s most
appropriate initial action before allowing independent testing
by the MLS?
,A. Allow immediate independent testing based on accredited
MLS credential
B. Require documented competency assessment and
supervised training specific to the assay
C. Limit the MLS to waived tests only for 6 months, per CLIA
mandatory waiting period
D. Require the MLS to obtain a doctorate before performing
moderate-complexity tests
Correct answer: B
Rationale — Correct (B)
CLIA requires that personnel performing non-waived (moderate
or high complexity) testing have documented initial training and
competency for the specific assay and instrument. Supervised
training and demonstration of competence ensure analytic
validity and patient safety. Documenting competency also
satisfies CLIA inspection requirements and accrediting
organizations’ standards.
Rationale — Incorrect
A. Credential alone doesn’t substitute for assay-specific
competency required under CLIA.
C. CLIA does not impose a universal 6-month waiting period; it
requires competency documentation.
D. A doctorate is not required by CLIA for moderate-complexity
testing and is unnecessary.
,Teaching Point
CLIA: assay-specific training and documented competency are
required for non-waived testing.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Test
complexity & CLIA categories
Stem
A laboratory wishes to introduce a new point-of-care glucose
analyzer classified as waived under CLIA. Which regulatory
implication is true for waived testing sites?
A. They are exempt from all CLIA requirements, including
enrollment and proficiency testing.
B. They must enroll in CLIA, follow manufacturer instructions,
but are not required to perform PT.
C. They must meet the same personnel qualification standards
as high-complexity labs.
D. They must undergo CAP inspections every two years.
Correct answer: B
Rationale — Correct (B)
CLIA-waived tests require the testing site to be enrolled in CLIA
, and follow manufacturer’s instructions, but they are subject to
fewer regulatory requirements; proficiency testing is not
required for waived tests. This reduces regulatory burden while
maintaining minimal oversight.
Rationale — Incorrect
A. Waived tests are not exempt from CLIA enrollment or basic
requirements.
C. Waived testing sites do not need high-complexity personnel
standards.
D. CAP inspections are voluntary and tied to accreditation, not
mandated for waived testing.
Teaching Point
Waived testing: CLIA enrollment and adherence to
manufacturer instructions, but no PT requirement.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Proficiency
testing (PT) and external QA
Stem
During a CAP inspection, the microbiology lab’s proficiency
testing records show two “unsatisfactory” PT events in the past
