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Utah Administrative Code (Current through November 1, 2019) |
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R444. Health, Disease Control and Prevention, Laboratory Improvement |
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R444-1. Approval of Clinical Laboratories |
| R444-1-1. Definitions |
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(1) "Department" means the Department of Health. (2) "Facility" means a place physically equipped to be a laboratory, but not yet approved to operate as a laboratory for a particular specialty or subspecialty. (3) "Laboratory" means an approved facility that conducts the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. These examinations also include procedures to determine, measure, or otherwise describe the presence or absence of various substances or organisms in the body. (4) "Review" means an evaluation of a laboratory or a facility by an authorized department representative to determine compliance with R444-1. |
| R444-1-2. Authorization |
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(1) Pursuant to Section 26-1-30(m), a facility may not operate as a laboratory for a particular specialty or subspecialty within the state unless first approved by the department. (2) An entity that does not test specimens and only collects or prepares specimens or only serves as a mailing service is exempt from this rule. |
| R444-1-3. Administration |
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(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). |
| R444-1-4. Maintenance of Approval |
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(1) A laboratory wishing to maintain approval must: (a) continue to hold a valid CLIA certificate for the specialty or subspecialty; (b) notify the Division of Epidemiology and Laboratory Services within 30 calendar days of any changes in information provided pursuant to R444-1-3(2)(b); and (c) demonstrate successful performance in a proficiency testing program administered or approved by the department. (2) The department may revoke approval for any specialty or subspecialty for failure to meet the requirements of subsection (1). |
| R444-1-5. Publishing Lists of Approved Laboratories |
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The department shall publish, at least annually, a list of laboratories meeting the minimum standards established under this rule. Included on the list shall be the name and location of the laboratory, the name of the director, and the specialties or subspecialties approved. The department may publish semi-annual amendments to the list in a newsletter. |