ARIZONA HOUSE OF REPRESENTATIVES

SB 1337: clinical laboratories; proficiency testing

PRIME SPONSOR: Senator Carter, LD 15

BILL STATUS: Health & Human Services

Overview

States that any laboratory test performed, regardless of the test complexity as defined under the federal Clinical Laboratory Improvement Amendments (CLIA) of 1998 may be provided only by a laboratory that routinely participates in proficiency testing for the offered test through a program approved by the Centers for Medicare and Medicaid Services (CMS).

History

A.R.S. § 36-468 which was enacted in 2015 allows a person to obtain any laboratory test from a licensed clinical laboratory on a direct-access basis without a health care provider's request or written authorization if the laboratory offers that test to the public on a direct-access basis without a provider's request or written authorization.

If a laboratory test of a person is conducted by or under the supervision of a person other than a health care provider and not at the request or with the written authorization of a provider, any report of the test results must be provided by the person conducting the test to the person who was the subject of the test. The report must state in bold type that it is the responsibility of the person who was tested to arrange with the person's health care provider for consultation and interpretation of the results. 

CMS regulates all laboratory testing (except research) performed on humans in the U.S. through CLIA. In total, CLIA covers approximately 260,000 laboratory entities. The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.

The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

Provisions

1. States that any laboratory test performed, regardless of the test complexity as defined under CLIA, may be provided only by a laboratory that routinely participates in proficiency testing for the offered test through a program approved by CMS. (Sec. 1)

2. Specifies proficiency testing is not required for a laboratory test if the proficiency testing is not available from an approved program. (Sec. 1)

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6. Fifty-fourth Legislature                       SB 1337

7. First Regular Session                            Version 1: Health & Human Services

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