CLINICAL LABORATORY SCIENCE
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Laboratory
Management & Regulation
Stem
A midsize hospital lab receives notice of a deficiency from an
external inspection citing incomplete personnel competency
records for moderate complexity testing. The lab director
reviews employee files and finds signed initial competency
assessments but no documented annual competency
evaluations for two technologists performing immunoassay
testing on an automated analyzer. Which laboratory action best
,addresses the regulatory deficiency and minimizes risk to
patient testing?
A. File an appeal to the accrediting body and wait for guidance.
B. Immediately suspend the two technologists from moderate-
complexity testing until annual competencies are documented
and retrain them.
C. Document retrospective competency by having the
technologists sign a checklist dated to past months.
D. Add a note to the employee files promising future annual
evaluations.
Correct answer
B
Rationale — Correct (B)
Suspending personnel from performing unverified moderate-
complexity testing and providing retraining followed by
documented competency assessments meets regulatory
expectations for personnel competency and protects patient
safety. CLIA and accreditation standards require documented
periodic competency evaluation, and immediate corrective
action is necessary when records are incomplete.
Rationale — Incorrect (A)
Appealing delays corrective action and does not remedy the
immediate regulatory and patient-safety concern. Accreditation
bodies expect prompt corrective measures.
,Rationale — Incorrect (C)
Backdating competency documentation is fraudulent and
violates regulatory and ethical standards. This does not
establish actual competency.
Rationale — Incorrect (D)
A future promise does not correct the present deficiency or
protect current testing quality. Documentation of performed
competency is required.
Teaching Point
Documented, current competency assessments are required
before staff perform moderate/high complexity testing.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Regulatory
Compliance & Test Complexity
Stem
A primary care clinic plans to introduce a point-of-care urine
dipstick for glucose and ketone screening as a waived test.
Which operational consideration is most important to remain
compliant with CLIA for waived testing at this alternate site?
, A. Ensure that a CAP inspection occurs monthly.
B. Enroll in a formal proficiency testing program for that
dipstick.
C. Maintain documentation of manufacturer instructions and
follow their directions, including QC as specified.
D. Require ASCP-certified personnel to perform the test.
Correct answer
C
Rationale — Correct (C)
For waived tests, CLIA requires following manufacturer's
instructions and performing any QC recommended;
documentation of procedures and test performance is essential.
Waived complexity imposes fewer personnel and proficiency
requirements but still needs adherence to manufacturer
instructions and basic quality practices.
Rationale — Incorrect (A)
CAP inspections are for accredited labs and are not required
monthly for waived testing at a clinic.
Rationale — Incorrect (B)
Proficiency testing is not required for waived tests under CLIA.
Rationale — Incorrect (D)
There is no CLIA mandate that only ASCP-certified personnel
perform waived tests; appropriate training and competency
documentation suffice.
9TH EDITION
• AUTHOR(S)MARY LOUISE
TURGEON
TEST BANK
1)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Laboratory
Management & Regulation
Stem
A midsize hospital lab receives notice of a deficiency from an
external inspection citing incomplete personnel competency
records for moderate complexity testing. The lab director
reviews employee files and finds signed initial competency
assessments but no documented annual competency
evaluations for two technologists performing immunoassay
testing on an automated analyzer. Which laboratory action best
,addresses the regulatory deficiency and minimizes risk to
patient testing?
A. File an appeal to the accrediting body and wait for guidance.
B. Immediately suspend the two technologists from moderate-
complexity testing until annual competencies are documented
and retrain them.
C. Document retrospective competency by having the
technologists sign a checklist dated to past months.
D. Add a note to the employee files promising future annual
evaluations.
Correct answer
B
Rationale — Correct (B)
Suspending personnel from performing unverified moderate-
complexity testing and providing retraining followed by
documented competency assessments meets regulatory
expectations for personnel competency and protects patient
safety. CLIA and accreditation standards require documented
periodic competency evaluation, and immediate corrective
action is necessary when records are incomplete.
Rationale — Incorrect (A)
Appealing delays corrective action and does not remedy the
immediate regulatory and patient-safety concern. Accreditation
bodies expect prompt corrective measures.
,Rationale — Incorrect (C)
Backdating competency documentation is fraudulent and
violates regulatory and ethical standards. This does not
establish actual competency.
Rationale — Incorrect (D)
A future promise does not correct the present deficiency or
protect current testing quality. Documentation of performed
competency is required.
Teaching Point
Documented, current competency assessments are required
before staff perform moderate/high complexity testing.
Citation
Turgeon, M. L. (9th ed.). Clinical Laboratory Science. Ch. 1.
2)
Reference
Ch. 1 — Fundamentals of the Clinical Laboratory — Regulatory
Compliance & Test Complexity
Stem
A primary care clinic plans to introduce a point-of-care urine
dipstick for glucose and ketone screening as a waived test.
Which operational consideration is most important to remain
compliant with CLIA for waived testing at this alternate site?
, A. Ensure that a CAP inspection occurs monthly.
B. Enroll in a formal proficiency testing program for that
dipstick.
C. Maintain documentation of manufacturer instructions and
follow their directions, including QC as specified.
D. Require ASCP-certified personnel to perform the test.
Correct answer
C
Rationale — Correct (C)
For waived tests, CLIA requires following manufacturer's
instructions and performing any QC recommended;
documentation of procedures and test performance is essential.
Waived complexity imposes fewer personnel and proficiency
requirements but still needs adherence to manufacturer
instructions and basic quality practices.
Rationale — Incorrect (A)
CAP inspections are for accredited labs and are not required
monthly for waived testing at a clinic.
Rationale — Incorrect (B)
Proficiency testing is not required for waived tests under CLIA.
Rationale — Incorrect (D)
There is no CLIA mandate that only ASCP-certified personnel
perform waived tests; appropriate training and competency
documentation suffice.
