Ariz. Admin. Code § 9-17-404.06

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

Section R9-17-404.06 - Operations

A. A technical laboratory director shall ensure that:

1. A sample of medical marijuana or a marijuana product accepted at the technical laboratory director's laboratory is analyzed:

a. Either:

i. At the laboratory with methods approved by the Department; or

ii. For testing of parameters or analytes that the laboratory is not approved by the Department to conduct, at another laboratory with an approval for testing issued by the Department;

b. As received; and

c. Within 10 calendar days after receipt;

2. If an instrument or equipment used for testing medical marijuana or a marijuana product has a mechanism to track any changes made to testing results, the tracking mechanism is installed and activated;

3. The facility and utilities required to operate equipment and perform testing of medical marijuana or marijuana products are maintained;

4. Environmental controls are maintained within the laboratory to ensure that laboratory environmental conditions do not affect analytical results beyond quality control limits established for the methods performed at the laboratory;

5. Storage, handling, and disposal of hazardous materials at the laboratory are in accordance with all state and federal regulations;

6. The laboratory complies with all applicable federal, state, and local occupational safety and health regulations; and

7. The following information is maintained for all laboratory agents providing supervisory, quality assurance, or analytical functions related to testing of medical marijuana or a marijuana product:

a. A summary of each laboratory agent's education and professional experience;

b. Documentation of each laboratory agent's applicable certifications and specialized training;

c. Information related to the laboratory agent's registry identification card;

d. Documentation of each laboratory agent's review of the quality assurance plan required under R9-17-404.05(B) and the methods and laboratory standard operating procedures for all testing of marijuana or marijuana products performed by the laboratory agent or for which the laboratory agent has supervisory or quality assurance responsibility;

e. Documentation of each laboratory agent's completion of training on the use of equipment and of proper laboratory technique, including the name of the laboratory agent, the name of the instructor, the duration of the training, and the date of completion of the training;

f. Documentation of each laboratory agent's completion of training classes, continuing education courses, seminars, and conferences that relate to the testing procedures used by the laboratory agent for testing of marijuana or marijuana products;

g. Documentation of each laboratory agent's completion of initial demonstration of capability, as required in R9-17-404.03(D)(3) or R9-17-404.04(D)(3), for each approved method performed by the laboratory agent;

h. Documentation of each laboratory agent's performance of proficiency testing; and

i. Documentation of each laboratory agent's completion of training related to instrument calibration that includes:

i. Instruction on each calibration model that the laboratory agent will use or for which the laboratory agent will review data;

ii. For each calibration model in subsection (A)(7)(i)(i), description of the specific aspects of the calibration model that might compromise the data quality, such as detector saturation, lack of detector sensitivity, the calibration model's not accurately reflecting the calibration points, inappropriate extension of the calibration range, weighting factors, and dropping of mid-level calibration points without justification; and

iii. Instruction that a calibration model shall not be used or changed to avoid necessary instrument maintenance.

B. A technical laboratory director shall ensure that:

1. A testing record for marijuana or marijuana products contains:

a. Sample information, including the following:

i. A unique sample identification assigned at the laboratory;

ii. A description of the marijuana or marijuana product from which the submitted sample was taken, including the amount, strain, and batch number;

iii. The sample collection date and time;

iv. The type of testing to be performed, including whether the testing is to satisfy the requirement in R9-17-317.01(A) or for a dispensary's information only; and

v. The analytes to be tested for, as specified by the dispensary, laboratory, qualifying patient, or designated caregiver, identified according to subsection (B)(1)(c), submitting the sample to the laboratory;

b. A color picture of the sample as submitted;

c. The name and registry identification number of the dispensary, qualifying patient, or designated caregiver submitting the sample to the laboratory;

d. If applicable, name and the registry identification number of the dispensary agent submitting the sample to the laboratory on behalf of a dispensary;

e. The date and time of receipt of the sample at the laboratory;

f. The name and registry identification number of the laboratory agent who received the sample at the laboratory;

g. The dates and times of testing, including the date and time of each critical step;

h. Whether testing results related to a sample were changed;

i. If testing results related to a sample were changed, what was changed, the name of the laboratory agent who changed the testing results, the time and date the data were changed, and why the testing results were changed;

j. If testing results were changed due to retesting:

i. What was used or done to the sample, and

ii. The original and changed testing results;

k. The actual results of testing, including all raw data, work sheets, and calculations performed;

l. The actual results of quality control data validating the testing results, including the calibration and calculations performed;

m. The name of each laboratory agent who performed the testing; and

n. A copy of the final report;

2. A testing result for medical marijuana or a marijuana product that is known to be inaccurate is not reported; and

3. Except as specified in subsection (C) or (D) as applicable, a final report of testing of marijuana or marijuana products contains:

a. The name, address, and telephone number of the laboratory;

b. The registry identification number assigned to the laboratory by the Department;

c. Actual scientifically valid and defensible results of testing of a sample of medical marijuana or a marijuana product in appropriate units of measure, obtained in accordance with R9-17-404.03, R9-17-404.04, and the quality assurance plan;

d. As applicable:

i. A statement that testing results were obtained according to requirements in the quality assurance plan in R9-17-404.05, in the applicable standard operating procedure, and in R9-17-404.03 or R9-17-404.04;

ii. A description of any variances from the requirements in the quality assurance plan in R9-17-404.05, the applicable standard operating procedure, R9-17-404.03, or R9-17-404.04 made to ensure scientifically valid and defensible testing results, and the reason for the variance; or

iii. A qualifier, according to R9-17-404.03(P) or (Q) or R9-17-404.04(H), as applicable, located adjacent to the name of the analyte or testing result to which the qualifier pertains;

e. A list of each method used to obtain the reported results;

f. Sample information, including the following:

i. The unique sample identification assigned at the laboratory;

ii. A color picture of the sample as submitted;

iii. A description of the marijuana or marijuana product from which the submitted sample was taken, including the strain and batch number;

iv. The sample collection date and time;

v. The name and registry identification number of the dispensary, laboratory, qualifying patient, or designated caregiver submitting the sample to the laboratory; and

vi. Any changes made to the information recorded according to subsection (B)(1)(a) since sample submission;

g. The date of testing for each parameter reported;

h. The date of the final report; and

i. The technical laboratory director's or designee's signature.

C. If a sample of medical marijuana or a marijuana product accepted at a laboratory is analyzed at another laboratory, as allowed according to R9-17-404.06(A)(1)(a)(ii), a technical laboratory director shall ensure that the final report of testing required in subsection (B)(3) includes a copy of the final report of testing from each laboratory to which the laboratory accepting the sample from a dispensary sent a portion of the sample for testing of parameters or analytes that the laboratory is not approved by the Department to conduct.

D. If a final report of testing issued according to subsection (B)(3) needs to be changed, amended, or reissued, a technical laboratory director shall ensure that a changed, amended, or reissued report of testing is generated by the laboratory and includes:

1. The date of the changed, amended, or reissued report of testing;

2. A statement that the changed, amended, or reissued report is an amendment to the original final report of testing, including any unique number or other designator given by the laboratory to the original final report of testing;

3. If it is necessary to issue a completely new final report of testing, the information required in subsection (B)(3); and

4. The change to the information provided in the original final report of testing and, where appropriate, the reason for the change, located either:

a. Adjacent to the testing result to which the change pertains, or

b. On the same page of the final report of testing with an indicator located adjacent to the testing result to which the change pertains.

E. For a sample of marijuana or a marijuana product accepted at the technical laboratory director's laboratory, a technical laboratory director shall ensure that the final report of testing in subsection (B)(3):

1. For a sample received from a dispensary, is sent to the dispensary within 10 calendar days after receipt of the sample;

2. For a sample received from another laboratory according to subsection (A)(1)(a)(ii), is sent to the other laboratory from which the sample was sent within seven calendar days after receipt of the sample;

3. For a sample received from another laboratory according to R9-17-317.01(C), is sent to the dispensary requesting retesting within seven calendar days after receipt of the sample; and

4. For a sample received from a qualifying patient or designated caregiver as recorded according to subsection (B)(1)(c), is sent to the qualifying patient or designated caregiver within 10 calendar days after receipt of the sample.

Ariz. Admin. Code § R9-17-404.06

Adopted by final exempt rulemaking at 26 A.A.R. 734, effective 4/2/2020. Amended by final exempt rulemaking at 27 A.A.R. 111, effective 1/15/2021. Amended by final rulemaking at 29 A.A.R. 2396, effective 10/1/2023.