CLINICAL LABORATORY SCIENCE
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Overview & Test Complexity
Stem
A clinic orders a rapid point-of-care (POC) glucose by a nurse
using a handheld reflectance meter on a capillary fingerstick.
The meter consistently reports glucose ~30 mg/dL lower than
the central lab plasma hexokinase method on paired venous
samples. The POC device has recent daily QC within
manufacturer limits. Which is the best laboratory action?
,A. Recommend immediate replacement of the central
laboratory reagent lot.
B. Investigate pre-analytical differences and perform a method
comparison using paired specimens.
C. Adjust the POC meter calibration downward to match the
central lab.
D. Report both results and note method differences to the
clinician without further testing.
Correct Answer
B
Rationale — Correct (B)
The discrepancy likely arises from pre-analytical/matrix
differences (capillary whole blood vs venous plasma) or method
bias. A controlled method comparison using paired specimens
(capillary and venous processed appropriately) across the
measurement range will identify systematic bias and whether
the POC or central method is the cause. This approach follows
laboratory validation and verification principles before
corrective action.
Rationale — Incorrect
A. Replacing central reagent lot is premature; no evidence
implicates central reagents.
C. Recalibrating the POC without investigation risks harm and
violates calibration/validation policy.
D. Merely reporting differences without investigation fails to
address patient safety and method performance.
,Teaching Point
Always perform controlled method comparison before
recalibration or reagent changes.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA & Test
Complexity
Stem
A small outpatient clinic performs rapid influenza antigen tests
classified as CLIA-waived. A newly hired assistant performs the
test but occasionally opens the test cassette before the
recommended read time, producing variable faint bands. The
clinic director asks whether this practice requires CLIA
moderate complexity personnel oversight. What is the correct
laboratory interpretation and action?
A. Because tests are waived, no oversight or competency
documentation is necessary.
B. Even for waived tests, supervise competency assessment and
document training per CLIA guidance.
C. Reclassify the test as moderate complexity because user
errors are occurring.
D. Stop testing onsite and send all specimens to a reference lab.
, Correct Answer
B
Rationale — Correct (B)
CLIA-waived tests are simple but still require appropriate
training, documentation of competency, and adherence to
manufacturer instructions. User errors indicate a need for
training, competency assessment, and corrective action; CLIA
does not exempt facilities from basic oversight of waived testing
personnel.
Rationale — Incorrect
A. CLIA-waived does not mean “no oversight”; facilities must
ensure accuracy.
C. User error does not change regulatory complexity
classification of the method.
D. Stopping testing is unnecessary if training and competency
can correct performance.
Teaching Point
Waived testing still requires documented training and
competency assessment.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Clinical
Laboratory Overview & Test Complexity
Stem
A clinic orders a rapid point-of-care (POC) glucose by a nurse
using a handheld reflectance meter on a capillary fingerstick.
The meter consistently reports glucose ~30 mg/dL lower than
the central lab plasma hexokinase method on paired venous
samples. The POC device has recent daily QC within
manufacturer limits. Which is the best laboratory action?
,A. Recommend immediate replacement of the central
laboratory reagent lot.
B. Investigate pre-analytical differences and perform a method
comparison using paired specimens.
C. Adjust the POC meter calibration downward to match the
central lab.
D. Report both results and note method differences to the
clinician without further testing.
Correct Answer
B
Rationale — Correct (B)
The discrepancy likely arises from pre-analytical/matrix
differences (capillary whole blood vs venous plasma) or method
bias. A controlled method comparison using paired specimens
(capillary and venous processed appropriately) across the
measurement range will identify systematic bias and whether
the POC or central method is the cause. This approach follows
laboratory validation and verification principles before
corrective action.
Rationale — Incorrect
A. Replacing central reagent lot is premature; no evidence
implicates central reagents.
C. Recalibrating the POC without investigation risks harm and
violates calibration/validation policy.
D. Merely reporting differences without investigation fails to
address patient safety and method performance.
,Teaching Point
Always perform controlled method comparison before
recalibration or reagent changes.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — CLIA & Test
Complexity
Stem
A small outpatient clinic performs rapid influenza antigen tests
classified as CLIA-waived. A newly hired assistant performs the
test but occasionally opens the test cassette before the
recommended read time, producing variable faint bands. The
clinic director asks whether this practice requires CLIA
moderate complexity personnel oversight. What is the correct
laboratory interpretation and action?
A. Because tests are waived, no oversight or competency
documentation is necessary.
B. Even for waived tests, supervise competency assessment and
document training per CLIA guidance.
C. Reclassify the test as moderate complexity because user
errors are occurring.
D. Stop testing onsite and send all specimens to a reference lab.
, Correct Answer
B
Rationale — Correct (B)
CLIA-waived tests are simple but still require appropriate
training, documentation of competency, and adherence to
manufacturer instructions. User errors indicate a need for
training, competency assessment, and corrective action; CLIA
does not exempt facilities from basic oversight of waived testing
personnel.
Rationale — Incorrect
A. CLIA-waived does not mean “no oversight”; facilities must
ensure accuracy.
C. User error does not change regulatory complexity
classification of the method.
D. Stopping testing is unnecessary if training and competency
can correct performance.
Teaching Point
Waived testing still requires documented training and
competency assessment.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
3
