BOP Program Statement 6370.02 § 6

The CLIA regulations, 42 C.F.R. § 493.35(a), § 493.43(a) and § 493.55(a), require all

laboratories performing waived and non-waived testing to file a separate application for each

laboratory location. 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 it is operating as a separate and distinct entity. Each CLIA certificate represents a

laboratory, and each laboratory is responsible for complying with the applicable CLIA

requirements.

In addition, multiple 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 each laboratory is operating

independently.

 The hours of operation must be specified for each laboratory.

 The hours of operation for each laboratory must be separate and distinct. The times of testing

cannot overlap and cannot be simultaneous.