Multiple CLIA Certificates at the Same Location

6009 - Multiple CLIA Certificates at the Same Location (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Each CLIA certificate represents a laboratory, and each laboratory is responsible for complying with the applicable CLIA requirements. They are not to be referred to as “shared laboratories.” Entities that have questions concerning Medicare or Medicaid billing (including, but not limited to, the sharing of expenses) should be informed that these are not CLIA quality and safety issues. Multiple laboratories may operate at the same physical location (e.g., same building or suite, as applicable) with separate CLIA numbers, as long as each laboratory can demonstrate that it is operating as a separate and distinct entity. Laboratories that operate at the same physical location and use the same testing personnel and equipment must meet the following conditions: • All records (e.g., quality control, procedure manuals, personnel competency) must be kept separate and distinct for each laboratory and must clearly show that each laboratory is operating independently. • The hours of operation must be specified for each laboratory and be separate and distinct. The times of testing cannot overlap and cannot be simultaneous.