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 Division of Epidemiology and Laboratory Services within the department 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, as detailed below:

(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.

(b) A facility must provide the Division of Epidemiology and Laboratory Services (1) the location of the facility; (2) the director of the proposed laboratory and his qualifications; (3) the CLIA certificate number; and (4) 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 R444-1-3(2)(b).