State Operations Manual (Pub. 100-07), Ch. 6 § 6151
Accredited Laboratories - Deemed Status
6151 - Accredited Laboratories - Deemed Status
(Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25)
An accredited laboratory is a laboratory that has voluntarily applied for and been
accredited by a private, nonprofit accreditation organization (AO) approved by CMS. By
virtue of its accreditation, an accredited laboratory that meets the requirements of
§493.61 is deemed to meet CLIA condition-level requirements.