Ariz. Admin. Code § 9-17-404.01

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

Section R9-17-404.01 - Compliance Monitoring

A. Submission of an application for a laboratory registration certificate constitutes permission for:

1. The Department's entry to and inspection of the laboratory, and

2. The Department to conduct proficiency testing according to R9-17-404.02.

B. The Department shall conduct:

1. An initial laboratory inspection; and

2. A follow-up laboratory inspection, at least annually.

C. The Department shall comply with A.R.S. § 41-1009 in conducting a laboratory inspection or investigation.

D. The Department shall not accept allegations of a laboratory's noncompliance with A.R.S. Title 36, Chapter 28.1 or this Chapter from an anonymous source.

E. If the Department receives an allegation of a laboratory's noncompliance with A.R.S. Title 36, Chapter 28.1 or this Chapter, the Department may conduct an unannounced inspection of the laboratory.

F. If the Department determines that a laboratory is not in compliance with the requirements of A.R.S. Title 36, Chapter 28.1, or this Chapter, the Department:

1. Shall provide the owner, according to R9-17-401(A), and technical laboratory director with a written notice that includes the specific rule or statute that was violated; and

2. May:

a. Take an enforcement action as described in R9-17-410; or

b. Require that the technical laboratory director submit to the Department, within 30 calendar days after written notice from the Department, a corrective action plan to address issues of compliance that do not directly affect the health or safety of a qualifying patient or laboratory agent that:

i. Describes how each identified instance of noncompliance will be corrected and reoccurrence prevented, and

ii. Includes a date for correcting each instance of noncompliance that is appropriate to the actions necessary to correct the instance of noncompliance.

G. Under A.R.S. § 41-1009(G) and (I), the Department's decision regarding whether a technical laboratory director may submit a corrective action plan on behalf of a laboratory or whether a deficiency has been corrected or has been corrected within a reasonable period of time is not an appealable agency action as defined by A.R.S. § 41-1092.

Ariz. Admin. Code § R9-17-404.01

Adopted by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020.