US · guidance
CMS SOM App. A, Tag A-0582
§482.27(a) Standard: - Adequacy of Laboratory Services
The hospital must have laboratory services available, either directly or through a
contractual agreement with a certified laboratory that meets requirements of Part 493 of
this chapter.
Interpretive Guidelines §482.27(a)
The CLIA certification may be accomplished by having one certificate for the entire hospital’s
laboratory services, by having one certificate for each laboratory, or by the hospital having a
mixture. Whatever the arrangement, all laboratory services must be provided in accordance with
CLIA requirements and under a current CLIA certificate, even when those laboratory services
take place outside of a lab.
Survey Procedures §482.27(a)
• Determine which services are provided directly by the facility and which are provided
through contractual agreements.
• Determine if the referral laboratory is CLIA certified for the appropriate test specialty.
• If the hospital provides laboratory services in multiple locations, verify that all laboratory
services are operating under a current CLIA certificate.
• Examine records and determine if the services, including emergency services, are
provided in accordance with the hospital’s policies.
History
Rev. 37, Issued: 10-17-08; Effective/Implementation Date: 10-17-08
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
6552b1e5253d28545c8213c03d952a7ea7e6299645f04f3f5a24c285095e15a7
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