Laboratories within Hospitals

6010.3 - Laboratories within Hospitals (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Exception (b)(3): Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction may file a single application or multiple applications for CLIA certificate(s) for the laboratory sites within the same physical location or street address. (42 CFR 493.35(b)(3), 493.43(b)(3), or 493.55(b)(3)). • This exception applies only to laboratories within hospitals. This includes teaching hospitals of universities. Other types of entities are not eligible. • “Under common direction” means that all of the multiple site laboratories must be under the direction of the same laboratory director. • “Street address” is the address assigned by the post office and is the physical location of the main laboratory. The street address may be different from the mailing address, which can be a post office box or a billing address. • Where it is unclear whether laboratories in multiple sites on a campus meet the applicable criteria, such as with a hospital occupying multiple buildings on a university campus, the SA consults with CMS to determine if the hospital is eligible for a single certificate. The fact that the laboratory is owned by a hospital does not necessarily make it a hospital laboratory for purposes of the multi-site exception. In many of these cases, a multiple site certificate CANNOT be issued. Additional information should be requested at each requirement under 42 CFR 493.35(b)(3), 493.43(b)(3), or 493.55(b)(3))