Regulatory Exceptions for a Multiple Site Certificate

6010 - Regulatory Exceptions for a Multiple Site Certificate Location (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Each location where laboratory tests are performed must file a separate application, unless it meets one of the following exceptions as outlined in 42 CFR 493.35(b)(1)-(b)(3), 493.43(b)(1)-(b)(3), or 493.55(b)(1)-(b)(3). Caution should be used when determining if an entity can be issued one certificate for multiple sites. Each exception stands alone and must not be combined with another exception.