CMS Issues Clarification of the Operation of Multiple Laboratories at the Same Location and the Discontinued Use of the Term "Shared Laboratory"
The US Centers for Medicare and Medicaid Services (CMS) has provided clarification regarding the operation of multiple laboratories at the same location and use of the term “shared laboratory” as it relates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) Certification.
According to CMS, during the early implementation of the CLIA program in 1993, many laboratories sought to register multiple CLIA numbers at a single location (i.e. a separate CLIA number for each physician financially affiliated with the entity operating at the location). The term “shared laboratory” was used solely for the purpose of identifying and properly registering such laboratories in the CLIA program. The term “shared laboratory” is not found in the CLIA regulations, laboratories are generally required to file a separate application for each laboratory location. Therefore, multiple laboratories at the same location or in the same suite should not be referred to as a “shared laboratory”.
The CLIA regulations [42 CFR §493.35(a), §493.43(a) and §493.55(a)] generally 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 that 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.
The new CMS Memorandum reinforces existing guidance on multiple laboratories at the same location. 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 that 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.
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. Laboratories should refer their questions or concerns to the appropriate Medicare or Medicaid contacts to ensure they meet all appropriate billing requirements.
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