Ariz. Admin. Code § 9-9-203

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-9-203 - Contracted Services

A licensee of a non-accredited procurement organization shall ensure that:

1. Contracted services are documented by agreement specified in SOPs.

2. If a procurement organization contracts with a laboratory for infectious disease testing of NAM, the contracted laboratory is registered with the Food and Drug Administration as a tissue establishment, specified in 21 C.F.R. § 1271.3, for testing and is either:

a. Certified to perform such testing on human specimens in accordance with Clinical Laboratory Improvement Amendments of 1988 ( 42 U.S.C. § 263a ) and 42 C.F.R. Part 493; or

b. Meets equivalent requirements as determined by the Centers for Medicare and Medicaid Services.

3. A list of contracted service providers is maintained and includes a description of the specific services provided.

Ariz. Admin. Code § R9-9-203

Reserved Section expired on June 30, 1999 under A.R.S. § 41-1056(E) upon receipt of notice from the Governor's Regulatory Review Council (Supp. 99-3). New Section made by final rulemaking at 28 A.A.R. 1517, effective 6/8/2022.