CMS SOM App. C, Tag D8303

(1) CMS or a CMS agent may conduct subsequent

inspections on a biennial basis or with such other frequency as CMS determines to

be necessary to ensure compliance with the requirements of this part.

(b)(2) CMS bases the nature of subsequent inspections on the laboratory’s

compliance history.

Interpretive Guidelines §493.1777(b)

In any laboratory holding a CLIA certificate, tests listed on the waived list are not subject

to routine surveys. A survey for waived tests may be conducted only when authorized by

CMS in one of the following instances:

• To collect information on waived tests;

• To determine whether the laboratory is testing beyond its certificate;

• If a complaint is alleged; or

• You have information that the performance of such tests poses an imminent and

serious risk that adversely affects patient test results.

When authorized to perform a survey of waived tests, in addition to the requirements in

this subpart, refer to the requirements at §493.15, subpart A, and §§493.35, 493.37 and

493.39, subpart B, of these guidelines.

Section 493.35(d) requires that laboratories performing only waived tests and no other

tests must agree to permit inspections by HHS in order to receive a certificate of waiver.

Make every effort to minimize the impact of the survey on the laboratory operations and

patient care activities. Be flexible; accommodate staffing schedules and workloads as

much as possible. In facilities providing direct patient care, (i.e., physician’s offices,

clinics, residential care facilities, hospitals, etc.), respect patient privacy and do not

interrupt or interfere with patient care. Be well prepared, courteous and make requests,

not demands.