Laboratories Under Direct Federal Jurisdiction

6028 - Laboratories Under Direct Federal Jurisdiction (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) The following facilities may fall under the direct federal jurisdiction if they test human specimens and report out the results for purposes of diagnosis, assessment or treatment of the subject. Where they do, all survey and certification activities are to be performed by CMS staff. • Federal laboratories subject to CLIA • State laboratories within their region • Indian Health Service laboratories Since Indian health tribal facilities may or may not be under federal jurisdiction, CMS determines whether CMS or the SA has jurisdiction. If they are run by the Department of the Interior/Bureau of Indian Affairs, they are considered federal laboratories and therefore are inspected by CMS. (See SOM Chapter 1, section 1018A) CMS is also responsible for designating all federal jurisdictional laboratories as such in the CLIA Data System.