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.