Arizona Administrative Code
Title 9 - HEALTH SERVICES
Chapter 14 - DEPARTMENT OF HEALTH SERVICES - LABORATORIES
Article 6 - LICENSING OF ENVIRONMENTAL LABORATORIES
Section R9-14-605 - Compliance Monitoring

Universal Citation: AZ Admin Code R 9-14-605

Current through Register Vol. 30, No. 38, September 20, 2024

A. The Department may conduct a laboratory inspection, investigation, or proficiency testing, or any combination of the three, at any time before or during a laboratory's license period.

B. The Department shall conduct at least an initial laboratory inspection and a follow-up annual laboratory inspection before determining how often to conduct subsequent laboratory inspections, as provided under subsection (C).

C. In determining how often to conduct a laboratory inspection, the Department shall consider:

1. The Department's findings at the last two laboratory inspections;

2. The licensee's adherence to any corrective action plans created as a result of the last two laboratory inspections;

3. Whether there has been a change in ownership or laboratory director since the last laboratory inspection;

4. The extent to which the compliance testing performed at the laboratory has changed since the last laboratory inspection or would change as a result of a renewal application; and

5. Performance on the most recent proficiency testing completed at the laboratory.

D. For a laboratory at which drinking water compliance testing is performed, the Department shall conduct a laboratory inspection at least once every three years or as otherwise required by the EPA.

E. The Department shall comply with A.R.S. § 41-1009 in conducting laboratory inspections and investigations that occur at a laboratory.

F. If the Department determines, based on a laboratory inspection, investigation, or proficiency testing, or any combination of the three, that a laboratory owner, officer, agent, or employee has engaged in conduct described under A.R.S. § 36-495.09(A), the Department shall request that the licensee or applicant submit to the Department a written corrective action plan, unless the Department determines one of the following, in which case the Department may take action under A.R.S. § 36-495.09:

1. That the deficiencies were committed intentionally;

2. That the deficiencies cannot be corrected within a reasonable period of time;

3. That the deficiencies are evidence of a pattern of noncompliance;

4. That the deficiencies are a risk to any person; the public health, safety, or welfare; or the environment; or

5. That there is a reasonable belief, as stated in A.R.S. § 36-495.09(B), that a violation of A.R.S. § 36-495.09(A)(5) has occurred and that the life or safety of the public is immediately affected.

G. Within 30 days after receiving a request for a written corrective action plan, a licensee or applicant shall submit to the Department a written corrective action plan that includes the following for each identified deficiency:

1. A description of how the deficiency will be corrected, and

2. A date of correction for the deficiency.

H. The Department shall accept a written corrective action plan if the plan:

1. Describes how each identified deficiency will be corrected, and

2. Includes a date for correcting each deficiency as soon as practicable based upon the actions necessary to correct the deficiency.

I. If the Department disapproves a corrective action plan, the Department shall send to the licensee or applicant a written notice of disapproval requesting that the licensee or applicant submit to the Department a revised corrective action plan for the items that the Department disapproves.

1. A licensee or applicant shall submit a revised corrective action plan to the Department within 21 days after the date of a written notice of disapproval.

2. If a licensee or applicant does not submit a revised corrective action plan within 21 days after the date of a written notice of disapproval, the Department may take action under A.R.S. § 36-495.09.

J. A licensee or applicant shall notify the Department when corrective action has been completed.

K. Within 30 days after receiving notice that corrective action has been completed, the Department shall determine whether each deficiency has been corrected and whether the corrective action brings the laboratory operations into substantial compliance with A.R.S. Title 36, Chapter 4.3 and this Article.

L. If the Department determines that a licensee or applicant has not corrected a deficiency or that the licensee or applicant has not corrected a deficiency within a reasonable period of time, the Department may take any enforcement action authorized by law as a result of the deficiency.

M. Under A.R.S. § 41-1009(G), the Department's decision regarding whether a licensee or applicant may submit a corrective action plan 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.

Disclaimer: These regulations may not be the most recent version. Arizona may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
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