Ariz. Admin. Code § R9-17-404.02 - Proficiency Testing

A. At least once in each 12-month period, and more often if requested by the Department, a technical laboratory director shall have at least one laboratory agent, selected according to policies and procedures, participate in proficiency testing provided by the Department or a proficiency testing service that:

1. Includes at least one proficiency testing sample, in a matrix similar to the medical marijuana or marijuana products accepted for testing, for each parameter and analyte for which the laboratory has been approved or is requesting approval;

2. Demonstrates the laboratory agent's competence in testing for the parameter; and

3. If the laboratory has been approved or has requested approval to test an analyte by different methods, may use the same proficiency testing sample for each method.

B. If a proficiency testing sample is not available for a specific parameter and analyte, a technical laboratory director shall have at least one laboratory agent, selected according to policies and procedures, participate in accuracy testing for the parameter.

C.B. To demonstrate competence in testing for a parameter, testing results reported for the parameter shall be within acceptance limits established by the Department, according to R9-17-404.03 or R9-17-404.04, or the proficiency testing service, as applicable.

D.C. A technical laboratory director shall ensure that:

1. Each sample for proficiency testing accepted at the laboratory is analyzed at the laboratory;

2. Each sample for accuracy testing is analyzed at the laboratory;

3.2. Each sample for proficiency testing is tested according to R9-17-404.03 or R9-17-404.04, using the same procedures and techniques employed for routine sample testing;

4.3. A proficiency testing service provides the results for each proficiency testing sample directly to the laboratory and the Department;

5.4. If proficiency testing is provided by the Department, the laboratory submits to the Department payment for the actual costs of the materials for proficiency testing;

6.5. If proficiency testing is not provided by the Department, the laboratory selects a proficiency testing service and contracts with and pays the proficiency testing service directly for proficiency testing; and

6. For any analyte not within the acceptance limit established by the Department or the proficiency testing service in subsection (C)(5), as applicable:

a. A corrective action plan:

i. Is submitted to the Department within 10 calendar days after failing to demonstrate competency in proficiency testing,

ii. Describes how each identified instance of failing to demonstrate competency will be corrected, and

iii. Includes a date for correcting the failure to demonstrate competency that is appropriate to the actions necessary to correct the instance of noncompliance; and

b. If the laboratory fails to demonstrate competency in proficiency testing for any analyte twice in a row, the laboratory does not test for the analyte until the laboratory has demonstrated competency in testing for the analyte by repeat proficiency testing.

E.D. The Department may submit proficiency testing samples to a laboratory at any time during the certification period.

Notes

Ariz. Admin. Code § R9-17-404.02

Adopted by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by final rulemaking at 29 A.A.R. 2396, effective 10/1/2023.