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ARIZONA STATE SENATE
Fifty-Fourth Legislature, First Regular Session
clinical laboratories; proficiency testing
Purpose
Requires that any complex laboratory test conducted without the authorization of a healthcare provider be provided by a laboratory that participates in proficiency testing through a program approved by the federal Centers for Medicare and Medicaid Services (CMS).
Background
CMS regulates all laboratory testing, except for research, performed on humans in the United States through the federal Clinical Laboratory Improvement Amendments (CLIA) and the Clinical Laboratory Program (Program). The Program is charged with certifying and regulating laboratories that perform clinical laboratory tests for the diagnosis, prognosis, treatment of disease and health screening services of all certified clinical laboratories.
The Advisory Committee on Clinical Laboratories (Committee) advises the Arizona Department of Health Services (DHS) in developing a list of direct-access tests that is available to the public, with certain exceptions. Additionally, the Committee is required to advise DHS on the use and renewal of standing orders (A.R.S. § 36-466).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Establishes that any laboratory test obtained or conducted without a healthcare provider's authorization or request, regardless of complexity as defined under CLIA must only be provided by a laboratory that routinely participates in proficiency testing through a program approved by CMS.
2. Specifies that proficiency testing is not mandated for a laboratory test if proficiency testing is not available from an approved program.
3. Makes technical changes.
4. Becomes effective on the general effective date.
Prepared by Senate Research
February 11, 2019
CRS/AG/kja