CHA News Article

CMS Issues Guidance on Operating Multiple Laboratories at Same Location

The Centers for Medicare & Medicaid Services (CMS) has issued a memo clarifying existing policies on the operation of multiple laboratories at the same location under the Clinical Laboratory Improvement Amendments of 1988.

The memo reinforces existing guidance on multiple laboratories at the same location. Laboratories operating at the same physical location must operate as separate and distinct entities, and should not be referred to as “shared laboratories.”

Laboratories operating at the same physical location and using the same testing personnel and equipment must keep records separate to show that each is operating independently. Each laboratory must specify its hours of operation; times of testing cannot overlap or be simultaneous.  

Questions about the memo should be directed to LabExcellence@cms.hhs.gov.

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