Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 18 - DEPARTMENT OF HEALTH SERVICES ADULT-USE MARIJUANA PROGRAM › Article 4 - MARIJUANA TESTING FACILITIES › Section R9-18-409 - Quality Assurance

Current through Register Vol. 30, No. 28, July 12, 2024
A. An owner
				of a marijuana testing facility or applicant shall ensure that the analytical
				data produced at the owner's or applicant's marijuana testing facility are of
				known and acceptable precision and accuracy, as prescribed by the method
				criteria for each analyte in
				R9-18-408, and are scientifically
				valid and defensible.
B. An owner
				holding a marijuana testing facility license or applicant shall establish,
				implement, and comply with a written quality assurance plan that contains the
				following and is available at the marijuana testing facility for Department
				review:
1. A title page identifying the
				marijuana testing facility and date of review and including the technical
				laboratory director's signature of approval;
2. A table of contents;
3. An organization chart or list of the
				marijuana testing facility personnel, including names, lines of authority, and
				identification of principal quality assurance personnel;
4. A copy of the current marijuana testing
				facility license and a list of approved parameters;
5. A statement of quality assurance
				objectives, including data quality objectives with precision and accuracy goals
				and the criteria for determining the acceptability of each testing;
6. Specifications for the preservation of
				samples;
7. A procedure for
				documenting receipt of samples by the marijuana testing facility and tracking
				of samples during testing;
8. A
				procedure for analytical instrument calibration, including frequency of
				calibration and complying with the requirements for calibration in subsection
				(D);
9. A procedure for testing
				data reduction and validation and reporting of final results, including the
				identification and treatment of data outliers, the determination of the
				accuracy of data transcription, and all calculations;
10. If using control limits derived by the
				marijuana testing facility as a basis for determining acceptance of a testing
				result, a procedure to ensure that the control limits are:
a. Statistically significant, valid, and
				defensible; and
b. Updated at least
				every 12 months;
11. A
				statement of the frequency of all quality control checks;
12. A statement of the acceptance criteria
				for all quality control checks;
13.
				Preventive maintenance procedures and schedules;
14. Assessment procedures for data
				acceptability, including appropriate procedures for manual integration of
				chromatograms and when manual integration is inappropriate;
15. Corrective action procedures to be taken
				when results from analytical quality control checks are unacceptable, including
				steps to demonstrate the presence of any interference if the precision,
				accuracy, or limit of quantitation of the reported testing result is affected
				by the interference; and
16.
				Procedures for chain-of-custody documentation, including procedures for the
				documentation and reporting of any deviation from the sample handling or
				preservation requirements.