Arizona Administrative Code › Title 9 - HEALTH SERVICES › Chapter 17 - DEPARTMENT OF HEALTH SERVICES - MEDICAL MARIJUANA PROGRAM › Article 4 - LABORATORIES AND LABORATORY AGENTS › Section R9-17-404.05 - Quality Assurance

Current through Register Vol. 30, No. 28, July 12, 2024
A. An owner
				holding a laboratory registration certificate or applicant shall ensure that
				the analytical data produced at the owner's or applicant's laboratory are of
				known and acceptable precision and accuracy, as prescribed by the method
				criteria for each analyte in
				R9-17-404.03 or
				R9-17-404.04, and are
				scientifically valid and defensible.
B. An owner holding a laboratory registration
				certificate or applicant shall establish, implement, and comply with a written
				quality assurance plan that contains the following and is available at the
				laboratory for Department review:
1. A title
				page identifying the laboratory 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
				laboratory personnel, including names, lines of authority, and identification
				of principal quality assurance personnel;
4. A copy of the current laboratory
				registration certificate 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 preservation of
				samples;
7. A procedure for
				documenting laboratory receipt of samples and tracking of samples during
				laboratory 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
				laboratory 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.