CMS SOM App. B, Tag G862

(1) If the HHA engages in laboratory testing outside of the context of assisting an

individual in self-administering a test with an appliance that has been cleared for

that purpose by the Food and Drug Administration, the testing must be in

compliance with all applicable requirements of part 493 of this chapter. The HHA

may not substitute its equipment for a patient’s equipment when assisting with self-administered tests.

Interpretive Guidelines §484.100(c)(1)

If an HHA nurse or other HHA employee only assists a patient who has her or his own

glucose meter, then a Clinical Laboratory Improvement Amendment (CLIA) certificate is

not required. If the HHA nurse or HHA employee conducts the test, regardless of

whether the patient’s equipment or the HHA’s equipment is used, then a CLIA certificate

(specifically a Certificate of Waiver) is required.

The HHA may not substitute its equipment for a patient’s equipment when assisting with

self-administered tests, except that an HHA may allow a patient to use HHA testing

equipment for a short, defined period of time until the patient has obtained his or her own

testing equipment. As a part of the care planning process, HHAs are expected to help

patients identify and obtain resources to secure the equipment needed for self-testing.