Ariz. Admin. Code § 9-17-402.01

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

Section R9-17-402.01 - Applying for Approval for Testing

To apply for approval for testing, an applicant shall submit to the Department, at least 60 calendar days before the expiration of the initial laboratory registration certificate for the laboratory, the following:

1. An application in a Department-provided format that includes:

a. The name and registry identification number of the laboratory;

b. The physical address of the laboratory;

c. The name of the applicant;

d. The name of the technical laboratory director designated according to R9-17-404(3);

e. For each parameter for which approval for testing is being requested:

i. The analyte to be tested for,

ii. The instruments and equipment to be used for testing, and

iii. The software to be used at the laboratory for instrument control and data reduction interpretation;

f. The laboratory's proposed hours of operation;

g. Whether the laboratory agrees to allow the Department to submit supplemental requests for information; h. Whether the laboratory is ready for an inspection by the Department;

i. If the laboratory is not ready for an inspection by the Department, the date the laboratory will be ready for an inspection by the Department;

j. An attestation that the information provided to the Department to apply for approval for testing is true and correct; and

k. The signatures of the owner of the laboratory, according to R9-17-401(A), and the technical laboratory director and the date each signed;

2. For each parameter and analyte listed according to subsection (1)(e):

a. A copy of current accreditation;

b. The limit of quantitation for each matrix, according to R9-17-404.03(I);

c. A copy of a proficiency testing report;

d. A copy of the standard operating procedure; and

e. Documentation of the initial demonstration of capabilities for each matrix, according to R9-17-404.03(D);

3. Policies and procedures that comply with the requirements in this Chapter that include:

a. A quality assurance program and standards,

b. A process to ensure marijuana or marijuana products testing results are accurate, precise, and scientifically valid before reporting the results; and

c. A process to compile testing results into a single laboratory report to be provided to a dispensary; and

4. If different from the building plan submitted according to R9-17-402(A)(8), a building plan drawn to scale of the building where the laboratory is located showing the:

a. Layout and dimensions of each room;

b. Name and function of each room;

c. Fire ratings of the materials used for ceilings, walls, doors, and floors of rooms used to store flammable substances;

d. Location of each fire protection device;

e. Layout of heating, air conditioning, exhaust, and ventilation systems;

f. Location and layout of refrigerated rooms or freezer rooms;

g. Location of each sink, safety shower, other water supply, or plumbing fixture;

h. Location of fixed or movable equipment and instruments that require dedicated electrical, water, vacuum, gas, or other building systems;

i. Location of security equipment to protect from diversion of marijuana or marijuana products; and

j. Means of egress.

Ariz. Admin. Code § R9-17-402.01

Adopted by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by exempt rulemaking at 26 A.A.R. 968, effective 4/20/2020. Amended by final rulemaking at 29 A.A.R. 2396, effective 10/1/2023.