Safety & ComplianceQuestion 47 of 100

Which statement about CLIA-waived testing is accurate?

a.Waived tests do not require any manufacturer instructions to be followed
b.Waived status means the facility needs no CLIA certificate at all
c.Waived tests are simple, low-risk methods that must still be run exactly per the manufacturer instructions
d.Waived tests may be reported without patient identification

Explanation

CLIA-waived tests, such as many point-of-care glucose meters, are considered simple with a low risk of error, but the facility still needs a Certificate of Waiver and must follow the manufacturer instructions exactly. Deviating from the instructions voids waived status. Patient identification and result documentation requirements apply to waived testing just as they do to all laboratory testing.

Law Reference: CLIA

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