Health, Disease Control and Prevention, Laboratory Improvement

Rule R444-1

Approval of Clinical Laboratories

Five-Year Notice of Review and Statement of Continuation

DAR File No.: 35107
Filed: 08/03/2011 12:41:47 PM

NOTICE OF REVIEW AND STATEMENT OF CONTINUATION

Concise explanation of the particular statutory provisions under which the rule is enacted and how these provisions authorize or require the rule:

Authority for the rule is from Subsection 26-1-30(2)(m) which directs the Department of Health to establish and enforce standards for laboratory services which are provided by any laboratory in the state when the purpose of the services is to protect the public health.

Summary of written comments received during and since the last five-year review of the rule from interested persons supporting or opposing the rule:

No written comments were received.

Reasoned justification for continuation of the rule, including reasons why the agency disagrees with comments in opposition to the rule, if any:

Clinical laboratories fall under the jurisdiction of federal law through the Clinical Laboratory Improvement Amendments, 1988. This rule allows Utah to regulate laboratories to the same standard should the need arise. Therefore, this rule should be continued.

The full text of this rule may be inspected, during regular business hours, at the Division of Administrative Rules, or at:

Direct questions regarding this rule to:

• David Mendenhall at the above address, by phone at 801-965-2530, by FAX at 801-965-2544, or by Internet E-mail at davidmendenhall@utah.gov

Authorized by:

David Patton, Executive Director

Effective:

08/03/2011