REFERENCE TITLE: clinical laboratories; proficiency testing

State of Arizona

House of Representatives

Fifty-fourth Legislature

Second Regular Session

2020

HB 2433

Introduced by

Representatives Nutt: Blackman, Carroll, Cobb, Dunn, Fillmore, Longdon, Osborne, Rivero, Shah, Toma

AN ACT

Amending section 36‑468, Arizona Revised Statutes; relating to clinical laboratories.

(TEXT OF BILL BEGINS ON NEXT PAGE)

Be it enacted by the Legislature of the State of Arizona:

Section 1.  Section 36-468, Arizona Revised Statutes, is amended to read:

START_STATUTE36-468. Laboratory testing without health care provider's order; results; report; duty of care; liability; proficiency testing; definition

A.  A person may obtain any laboratory test from a licensed clinical laboratory on a direct access direct-access basis without a health care provider's request or written authorization if the laboratory offers that laboratory test to the public on a direct access direct-access basis without a health care provider's request or written authorization.

B.  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 health care provider, any report of the test results shall be provided by the person conducting the test to the person who was the subject of the test.  The report shall 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 test results.

C.  A health care provider's duty of care to a patient does not include any responsibility to review or act on the laboratory test results of a patient if the health care provider did not request or authorize the laboratory test.  A health care provider is not subject to liability or disciplinary actions for the failure to review or act on the results of a laboratory test of any patient if the health care provider did not request or authorize the laboratory test.

D.  A clinical laboratory may not submit a claim for reimbursement from a third‑party payor for any laboratory test conducted without a health care provider's request or written authorization.

E.  This section does not require that a laboratory test be covered by a health insurance plan or product pursuant to title 20 or by any program administered by the Arizona health care cost containment system administration pursuant to chapter 29 of this title.

F.  Any laboratory test performed under this section, regardless of the test complexity as defined under the federal clinical laboratory improvement amendments of 1988 (P.L. 100-578), 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. This subsection does not mandate proficiency testing for a laboratory test if the proficiency testing is not available from an approved program.

F.  G.  For the purposes of this section, "health care provider" means a person who is licensed pursuant to title 32 and who is authorized to order laboratory testing. END_STATUTE