Answer the following and rationalize

1. A CLIA waived test requires that operators

a. must follow manufacturer’s instructions.
b. must have annual competence assessment.
c. must perform proficiency testing.
d. must perform QC daily.

* following manufacturers' directions, having a procedure manual that specifies how to

perform tests and report results, performing and documenting calibration procedures (or
verifying calibration) at least once every six months.

2. Quality control lockout

a. prevents quality control from being recorded when outside 2 standard deviations.
b. prevents testing when quality control has not been performed.
c. prevents operator s from changing quality control records.
d. prevents the wrong quality control material to be used for a particular test.

*system of maintaining standards in manufactured products by testing a sample of the

output against the specification

3. EQC per CLIA means

a. equivalent.
b. electronic.
c. external.
d. Essential.

* test method complexity or difficulty to perform the testing

4. For laboratories with a provider-performed microscopy procedure CLIA certificate,
which of the following would NOT be approved?
a. Urinalysis
b. Semen analysis
c. Hematology differential
d. Wet prep

*Hematology differential is often part of a complete blood count (CBC). A CBC is used
to measure the following components of your blood: WBC, RBC, platelets, hemoglobin,
hematocrit and so many more.

5. Connectivity for POCT provides the ability to

a. charge meters at docking stations on the hospital units.
b. accept barcode patient identification.
c. perform electronic quality control.
d. transmit patient results to the medical record.
e. prevent password sharing for operator identification.

*Point-of-care testing (POCT) is defined as medical testing at or near the site of patient
care. It is their responsibilities to transmit patient results to the medical record.

6. Which of the following specimens is NOT used for a waived POC test?
a. Urine
b. Whole blood
c. Plasma
d. Eye fluid

*Tests must be coming inside our body and not for the secretions.
7. Competency for non-waived testing
a. is required for the CLIA director.
b. is NOT required for physicians in their specialty.
c. should be performed and documented annually for all operators.
d. should be performed and documented initially after 6 months, then annually thereafter.

*Occurs after patient testing begins, ongoing assessments, and does require use of six
elements for non-waived testing.