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ARIZONA STATE SENATE
Fifty-Fourth Legislature, Second Regular Session
clinical laboratories; proficiency testing
Purpose
Establishes that any clinical laboratory test performed without a health care provider's order must be provided by a laboratory that routinely participates in proficiency testing through a program approved by the 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 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 and health screening services of all certified clinical laboratories (CMS).
Current statute defines an approved proficiency testing program as a proficiency testing program which is approved and conducted by an accredited body approved by the Secretary of the U.S. Department of Health and Human Services to meet the standards of the federal Clinical Laboratory Improvement Amendments of 1988. A person may obtain any clinical laboratory test from a licensed clinical laboratory without a health care provider's request or written authorization if the laboratory offers that laboratory test to the public on a direct-access basis. It is the duty of the person ordering a test without their health care provider's request to act on the test results. Laboratories are restricted from submitting a claim for reimbursement from a third-party payor for a test that was not requested or authorized by a health care provider (A.R.S. §§ 36-451 and 36-468).
There is no anticipated fiscal impact to the state General Fund associated with this legislation.
Provisions
1. Requires any clinical laboratory test performed without a health care provider's order to be provided only by a laboratory that routinely participates in proficiency testing for the offered test through a program approved by CMS.
2. States that the aforementioned requirement does not mandate proficiency testing for a laboratory test if the proficiency testing is unavailable from a CMS-approved program.
3. Makes technical and conforming changes.
4. Becomes effective on the general effective date.
House Action
HHS 1/23/20 DP 9-0-0-0
3rd Read 2/19/20 60-0-0
Prepared by Senate Research
March 2, 2020
CRS/KS/kja