Ariz. Admin. Code § 9-17-404

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

Section R9-17-404 - Administration

An owner of a laboratory with a laboratory registration certificate shall:

1. Comply with the:

a. Quality assurance requirements in R9-17-404.05,

b. Operation requirements in R9-17-404.06, and

c. Laboratory records and reports requirements in R9-17-404;

2. Maintain accreditation for each approved parameter and analyte;

3. Designate in writing a technical laboratory director who:

a. Has knowledge and experience in overseeing a laboratory as documented by:

i. A doctoral degree in chemistry, biochemistry, microbiology, or a similar laboratory science;

ii. A master's degree in chemistry, biochemistry, microbiology, or a similar laboratory science and at least two years of experience working in a laboratory and providing laboratory testing; or

iii. A bachelor's degree in chemistry, biochemistry, microbiology, or a similar laboratory science and at least four years of experience working in a laboratory and providing laboratory testing; and

b. Is responsible for:

i. Ensuring that all services and tests provided by the laboratory are performed in compliance with the requirements in this Article;

ii. Directing and supervising services and tests provided by the laboratory;

iii. Overseeing the work of all personnel in the laboratory;

iv. Providing ongoing training to laboratory agents, as applicable to the functions performed by a laboratory agent; and

v. Ensuring safety and hazardous substance control in the laboratory;

4. Notify the Department in writing within 20 business working days after any change in the technical laboratory director, providing the name and contact information for the new technical laboratory director;

5. Develop, document, and implement policies and procedures regarding:

a. Job descriptions and employment contracts, including:

i. Personnel duties, authority, responsibilities, and qualifications;

ii. Personnel supervision;

iii. Ongoing training, applicable to the functions performed by a laboratory agent;

iv. Training in and adherence to confidentiality requirements;

v. Periodic performance evaluations, including proficiency testing on a rotating basis among all laboratory agents performing similar functions; and

vi. Disciplinary actions;

b. Business records, such as manual or computerized records of assets and liabilities, monetary transactions, journals, ledgers, and supporting documents, including agreements, checks, invoices, and vouchers;

c. Inventory control, including:

i. Tracking;

ii. Accepting medical marijuana or marijuana products for testing;

iii. Transferring a portion of a sample prepared or selected according to subsection (5)(e)(v) to another laboratory for testing of parameters or analytes that the laboratory is not approved by the Department to conduct;

iv. Testing medical marijuana and marijuana products;

v. Providing a representative portion of the sample of tested medical marijuana or a marijuana product, which had been prepared or selected according to subsection (5)(e)(v), to up to two other laboratories, with an approval for testing issued by the Department, at the request of a dispensary according to R9-17-317.01(C);

vi. Retaining the residual portion of a sample accepted for testing from a dispensary for at least 14 days after sending the final report of testing required in R9-17-404.06(B)(3) to the dispensary; and

vii. Disposing of medical marijuana or a marijuana product such that the marijuana or marijuana product is unrecognizable or cannot otherwise be used and documenting:

(1) The method of disposal;

(2) Whether the medical marijuana or marijuana product was tested;

(3) If not tested, the reason for not testing;

(4) The laboratory agent overseeing the disposal; and

(5) The date of disposal;

d. Standard operating procedures, including:

i. The review and updating of standard operating procedures;

ii. Requirements for a laboratory agent to review current, new, or updated standard operating procedures applicable to the functions performed by the laboratory agent; and

iii. Documenting the review of standard operating procedures by applicable laboratory agents;

e. Laboratory records, including:

i. Maintenance and monitoring of instruments and equipment;

ii. Acceptance of medical marijuana and marijuana products for testing, including the specification of the analytes to be tested for;

iii. The chain of custody and applicable trip plan, according to R9-17-408, for a sample accepted by the laboratory for testing;

iv. The storage of a submitted sample prior to testing to maintain the integrity of the sample and analyte;

v. The process for ensuring that a homogeneous portion of a submitted sample is prepared or selected for testing, including:

(1) The aseptic removal of a homogeneous portion of the sample for testing according to R9-17-404.04; and

(2) Further preparation of a homogeneous portion of the sample, if necessary, for testing according to R9-17-404.03;

vi. Ensuring testing results are accurate, precise, and scientifically valid before reporting the results;

vii. Reporting of testing results, including:

(1) Testing results obtained from another laboratory for testing of parameters or analytes that the laboratory is not approved by the Department to conduct, or

(2) Testing results provided to another laboratory from which the laboratory had received a portion of a sample for testing of parameters or analytes that the other laboratory is not approved by the Department to conduct;

viii. If applicable, transfer of a portion of a sample, according to subsection (5)(c)(v), to another laboratory with an approval for testing issued by the Department for testing of parameters or analytes that the laboratory is not approved by the Department to conduct, including:

(1) The name and registry identification number of the dispensary from which the sample was obtained,

(2) The name and registry identification number of the laboratory to which the portion of the sample is being transferred,

(3) The date of the transfer,

(4) The amount of sample being transferred,

(5) The name and registry identification number of the laboratory agent receiving the marijuana or marijuana products on behalf of the other laboratory;

(6) The parameters or analytes being tested by the other laboratory, and

(7) The testing results obtained from the other laboratory;

ix. If applicable, transfer of the portion of a sample remaining after testing, according to subsection (5)(c)(v), to no more than two other laboratories with an approval for testing issued by the Department at the request of a dispensary according to R9-17-317.01(C), including:

(1) The name and registry identification number of the dispensary,

(2) The name and registry identification number of the dispensary agent requesting the transfer on behalf of the dispensary,

(3) The date of the request,

(4) The amount of sample being transferred,

(5) The name and registry identification number of each other laboratory, and

(6) The name and registry identification number of the laboratory agent receiving the marijuana or marijuana products on behalf of each other laboratory;

x. Confidentiality; and

xi. Sample retention;

f. A quality assurance program and standards;

g. A records retention process; and

h. Security;

6. Review and document the review of laboratory policies and procedures at least once every 12 months after the issue date of the laboratory registration certificate and update as needed;

7. Ensure that each laboratory agent has the laboratory agent's registry identification card in the laboratory agent's immediate possession when the laboratory agent is working or providing volunteer services related to marijuana or marijuana products testing at the laboratory;

8. Ensure that a laboratory agent accompanies any individual other than another laboratory agent associated with the laboratory when the individual is present in the area of the laboratory where marijuana or marijuana products are being tested or stored for testing;

9. Not allow an individual who does not possess a laboratory agent registry identification card issued under the laboratory registration certificate to:

a. Serve as an owner for the laboratory,

b. Be employed by the laboratory, or

c. Provide volunteer services at or on behalf of the laboratory;

10. Provide written notice to the Department, including the date of the event, within 10 working days after the date, when a laboratory agent no longer:

a. Serves as an owner for the laboratory,

b. Is employed by the laboratory, or

c. Provides volunteer services at or on behalf of the laboratory;

11. Unless otherwise specified, maintain copies of any documentation required in this Chapter for at least two years after the date on the documentation and provide copies of the documentation to the Department for review upon request.

Ariz. Admin. Code § R9-17-404

Adopted by final exempt rulemaking at 25 A.A.R. 2421, effective 8/27/2019. Amended 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.