Utah Admin. Code 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).
Notes
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