Ariz. Admin. Code § 9-17-404.05

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

Section R9-17-404.05 - Quality Assurance

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.

C. An owner holding a laboratory registration certificate or applicant shall ensure that a laboratory's written quality assurance plan is a separate document available at the laboratory and includes all of the components required in subsection (B), but an owner or applicant may satisfy the components required in subsections (B)(3) through (16) through incorporating by reference provisions in separate documents, such as standard operating procedures.

D. An owner holding a laboratory registration certificate or applicant shall:

1. Have available at the laboratory all methods, equipment, reagents, and supplies necessary for the testing for which the owner or applicant is approved or is requesting approval;

2. Use only reagents of a grade equal to or greater than that required by the method criteria in R9-17-404.03 or R9-17-404.04, and document the use of the reagents;

3. Maintain and require each laboratory agent performing testing on medical marijuana or a marijuana product to comply with a complete and current standard operating procedure that meets the requirements for each method, as specified in R9-17-404.03 or R9-17-404.04, which shall include at least:

a. A description of all procedures to be followed, including the recording of the information required according to R9-17-404.06(B)(1)(g) and (k), when the method is performed;

b. A list of the concentrations for calibration standards, check standards, and spikes;

c. Requirements for instrumental conditions and set up;

d. A requirement for frequency of calibration;

e. The quantitative methods to be used to calculate the final concentration of an analyte in samples, including any factors used in the calculations and the calibration algorithm used; and

f. Requirements for preventative maintenance;

4. Calibrate each instrument as required by the standard operating procedure, as specified in R9-17-404.03 or R9-17-404.04, for which the equipment is used;

5. Maintain calibration documentation, including documentation that demonstrates the calculations performed using each calibration model;

6. Develop, document, and maintain a current limit of quantitation, as specified in R9-17-404.03, for each compliance parameter for each instrument;

7. For each parameter and analyte tested at the laboratory use the quality control acceptance criteria specified according to R9-17-404.03, R9-17-404.04, and Table 3.1;

8. Discard or segregate all expired standards or reagents;

9. Maintain a record showing the traceability of reagents; and

10. Ensure that a calibration model is not used or changed to avoid necessary instrument maintenance.

E. Except as provided in subsection (F), an owner holding a laboratory registration certificate or applicant shall ensure that each laboratory standard operating procedure is a separate document available at the laboratory and includes all of the components required in subsection (D)(3).

F. An owner holding a laboratory registration certificate or applicant may satisfy the components required in subsections (D)(3)(e) and (f) through incorporating by reference provisions in separate documents, such as other standard operating procedures.

Ariz. Admin. Code § R9-17-404.05

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.