Clarification of the Operation of Multiple Laboratories at the Same Location and the Discontinued Use of the Term Shared Laboratory

The Centers for Medicare & Medicaid Services (CMS) is clarifying the operation of multiple laboratories at the same location and the discontinued use of the term “shared laboratory” related to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certification.
 Multiple laboratories with separate CLIA numbers may operate at one location as long as it can be demonstrated that each laboratory is operating as a separate and distinct entity. They are not to be referred to as “shared laboratories”.
 This memorandum supersedes all prior guidance regarding the registration of shared laboratories for CLIA.