Testing Outside the Certificate Type

6106.1 - Testing Outside the Certificate Type (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) In accordance with 42 CFR 493.1775, if it is verified that the laboratory that has been issued a CoW or a Certificate for PPM Procedures is testing outside of its certificate type, the laboratory is in violation of CLIA. The SA allows the laboratory the opportunity to submit a new Form CMS-116 requesting an appropriate certificate. If the laboratory fails to do so within 30 days, the SA enters a complaint survey into the CLIA Data System and recommends referral to CMS. The SA completes a Statement of Deficiencies and Plan of Correction (Form CMS-2567) to indicate the findings of the survey and solicits a PoC or AoC from the laboratory. The SA attaches any documentation that can be used in the adverse action process to substantiate the recommendation to the survey kit and puts a check mark in the kit as “Forward to RO.” The SA notifies CMS that CMS needs to review the kit for enforcement. The SA refers to section 6014 if the laboratory wants to add nonwaived tests.