CLINICAL LABORATORY SCIENCE
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Overview / Pre-analytic variables
Stem
A busy outpatient clinic sends a morning batch of blood
specimens collected in EDTA, but the receiving lab notes 12/25
specimens are hemolyzed and several have prolonged transport
times recorded. The technologist must decide which specimens
to accept and what to document before testing. Which choice
best reflects correct laboratory action and documentation?
,A. Accept all specimens; run CBCs and note hemolysis in body
of report only if results are abnormal.
B. Reject grossly hemolyzed specimens for tests affected by
hemolysis and document reason, time of collection and
transport conditions.
C. Accept specimens but request recollection for all hemolyzed
samples without documenting transport times.
D. Proceed with testing on all specimens because pre-analytic
issues are the clinic's responsibility, not the laboratory’s.
Correct answer
B
Rationales
Correct (B): Hemolysis is a pre-analytical interference for many
assays (e.g., potassium, LD). Best practice is to reject specimens
that compromise result validity, document the rejection reason
and transport variables to inform clinicians and QC events.
A: Running tests despite hemolysis risks reporting inaccurate
values; post-hoc note is insufficient.
C: Requesting recollection without documentation and targeted
rejection is poor quality management.
D: The laboratory shares responsibility for specimen integrity
and must act per policy.
Teaching point
Document pre-analytic problems and reject compromised
specimens per policy.
,Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA
regulation & test complexity
Stem
A hospital lab seeks to implement a new molecular PCR assay
for respiratory pathogens. The lab director must classify the
assay under CLIA to determine personnel and QC requirements.
Which factor most influences CLIA complexity classification for
this test?
A. Whether the instrument is FDA-cleared for that analyte.
B. The cost per test.
C. The clinical significance of the pathogen.
D. The lab's accreditation status with CAP.
Correct answer
A
Rationales
Correct (A): CLIA complexity classification is primarily driven by
FDA categorization (waived, moderate, high complexity) and
whether the test/instrument is FDA-cleared; that determines
personnel qualifications and QC.
B: Cost does not determine CLIA complexity.
, C: Clinical significance affects clinical decisions but not CLIA
classification.
D: Accreditation status may impose additional requirements but
does not determine CLIA complexity.
Teaching point
FDA test/instrument clearance dictates CLIA complexity and
associated personnel/QC requirements.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory —
Accreditation organizations
Stem
During a CAP inspection, surveyors cite missing documentation
that certain technologists completed competency assessments
for immunology tests. The lab's QA manager must respond.
Which corrective action best addresses the deficiency and
aligns with accreditation expectations?
A. Submit a dated memo that competencies will be completed
next quarter.
B. Immediately perform and document competency
assessments for affected personnel and implement process to
track future competency documentation.
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Overview / Pre-analytic variables
Stem
A busy outpatient clinic sends a morning batch of blood
specimens collected in EDTA, but the receiving lab notes 12/25
specimens are hemolyzed and several have prolonged transport
times recorded. The technologist must decide which specimens
to accept and what to document before testing. Which choice
best reflects correct laboratory action and documentation?
,A. Accept all specimens; run CBCs and note hemolysis in body
of report only if results are abnormal.
B. Reject grossly hemolyzed specimens for tests affected by
hemolysis and document reason, time of collection and
transport conditions.
C. Accept specimens but request recollection for all hemolyzed
samples without documenting transport times.
D. Proceed with testing on all specimens because pre-analytic
issues are the clinic's responsibility, not the laboratory’s.
Correct answer
B
Rationales
Correct (B): Hemolysis is a pre-analytical interference for many
assays (e.g., potassium, LD). Best practice is to reject specimens
that compromise result validity, document the rejection reason
and transport variables to inform clinicians and QC events.
A: Running tests despite hemolysis risks reporting inaccurate
values; post-hoc note is insufficient.
C: Requesting recollection without documentation and targeted
rejection is poor quality management.
D: The laboratory shares responsibility for specimen integrity
and must act per policy.
Teaching point
Document pre-analytic problems and reject compromised
specimens per policy.
,Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA
regulation & test complexity
Stem
A hospital lab seeks to implement a new molecular PCR assay
for respiratory pathogens. The lab director must classify the
assay under CLIA to determine personnel and QC requirements.
Which factor most influences CLIA complexity classification for
this test?
A. Whether the instrument is FDA-cleared for that analyte.
B. The cost per test.
C. The clinical significance of the pathogen.
D. The lab's accreditation status with CAP.
Correct answer
A
Rationales
Correct (A): CLIA complexity classification is primarily driven by
FDA categorization (waived, moderate, high complexity) and
whether the test/instrument is FDA-cleared; that determines
personnel qualifications and QC.
B: Cost does not determine CLIA complexity.
, C: Clinical significance affects clinical decisions but not CLIA
classification.
D: Accreditation status may impose additional requirements but
does not determine CLIA complexity.
Teaching point
FDA test/instrument clearance dictates CLIA complexity and
associated personnel/QC requirements.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory —
Accreditation organizations
Stem
During a CAP inspection, surveyors cite missing documentation
that certain technologists completed competency assessments
for immunology tests. The lab's QA manager must respond.
Which corrective action best addresses the deficiency and
aligns with accreditation expectations?
A. Submit a dated memo that competencies will be completed
next quarter.
B. Immediately perform and document competency
assessments for affected personnel and implement process to
track future competency documentation.
