Laboratory Refuses to Allow Survey

6108 - Laboratory Refuses to Allow Survey ((Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Section 353(g) of the PHSA permits authorized officials to make announced or unannounced surveys of laboratories holding any type of CLIA certificate, at any time during the laboratory’s normal hours of operation. If access is refused, the SA documents the identity (name and title) of the individual refusing admission and the reasons given, and submits this documentation immediately to CMS, i.e., by email, telephone, or fax. The CLIA regulations at 42 CFR 493.1771 and 493.1773 permits the SA to cite the laboratory for refusal to allow a survey on a Form CMS-2567. In addition, the regulation at 42 CFR 1001.1301 permits the OIG to exclude a laboratory from the CLIA program if it fails to grant immediate access upon reasonable request. The exclusion may be in effect up to a period equal to the sum of the length of the period during which immediate access was not granted, plus an additional 90 days. CMS will make the referral to the OIG. (See section 6270)