Section R444-1-3 - Administration(1) The department shall assist any facility or laboratory in the state which desires to become approved or maintain approval. Toward this end, the program shall arrange for training, reviews, and the provision of reference materials to any facility or laboratory requesting the service.(2) The department shall approve a facility to operate as a laboratory for particular specialties or subspecialties upon the facility's demonstrating that it has satisfied the requirements for approval, this includes:(a) the facility must hold a valid federal Clinical Laboratory Improvement Act (CLIA) certificate under 42 C.F.R. part 493, 1990 edition, which is incorporated by reference, for the specialty or subspecialty associated with the testing covered by this rule; and(b) a facility must provide the program: (i) the location of the facility;(ii) the director of the proposed laboratory and their qualifications;(iii) the CLIA certificate number; and(iv) the specialties or subspecialties for which the facility has obtained CLIA certification.(3) A facility that is not approved as a laboratory for the particular specialty or subspecialty that it wishes to perform must request a review in writing providing the information required in Subsection R444-1-3(2)(b).Utah Admin. Code R444-1-3
Amended by Utah State Bulletin Number 2024-05, effective 2/22/2024