Ariz. Admin. Code § 9-14-615

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

Section R9-14-615 - Quality Assurance

A. A licensee or applicant shall ensure that the analytical data produced at the licensee's or applicant's laboratory are of known and acceptable precision and accuracy, as prescribed by the approved method for each analysis or as prescribed by the limits described under subsection (C)(8), and are scientifically valid and defensible.

B. A licensee 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 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 license and a list of licensed 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:

a Sample containers,

b. Preparation of sample containers,

c. Preservation of samples, and

d. Maximum holding times allowed;

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 (C);

9. A procedure for compliance 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. A statement of the frequency of all quality control checks;

11. A statement of the acceptance criteria for all quality control checks;

12. Preventive maintenance procedures and schedules;

13. Assessment procedures for data acceptability, including appropriate procedures for manual integration of chromato-grams and when manual integration is inappropriate;

14. 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 compliance testing result is affected by the interference; and

15. Procedures for chain-of-custody documentation, including procedures for the documentation and reporting of any deviation from the sample handling or preservation requirements listed in this Section.

C. A licensee or applicant shall:

1. Have available ant the laboratory all methods, equipment, reagents, and glassware necessary for the compliance testing for which the licensee or applicant is licensed or is requesting a license;

2. Use only reagents of a grade equal to or greater than that required by the approved methods and document the use of the reagents;

3. Maintain and require each analyst to comply with a complete and current standard operating procedure that meets the requirements for each licensed method which shall include at least:

a. A description of all procedures to be

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 each approved method for which the equipment is used, as follows:

a. If a calibration model is specified in the method, using the specified calibration model or, if another calibration model has been approved by the Department as a method alteration, using the calibration model approved as a method alteration;

b. If multiple calibration models are included as options in the method, using one of the included calibration models or, if another calibration model has been approved by the Department as a method alteration, using the calibration model approved as a method alteration; or

c. If the method does not include a calibration model, using the manufacturer's specifications for calibration;

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

6. Develop, document, and maintain a current limit of detection and limit of quantitation for each compliance parameter for each instrument;

7. Develop each limit of detection using:

a. The protocol in the applicable test method;

b. The protocol in the applicable federal regulation; or

c. A process that complies with the guidelines in Section D.1.2 of Chapter 5, Appendix D-Essential Quality Control Requirements, in Key Reference H;

8. For each parameter tested at the laboratory for which quality control acceptance criteria are not specified in the approved method or by EPA or ADEQ:

a. Use default limits provided in Table 6.4; or

b. Statistically develop limits from historical data by:

i. Determining the mean and standard deviation for a minimum of 20 data points not invalidated for cause, excluding statistical outliers;

ii. Setting the limits no more than three standard deviations from the mean and in the detectable range, using as the lower end of the detectable range the limit of quantitation or the lowest standard value represented in the initial calibration; and

iii. Explaining the origin of the lower end of the detectable range in the laboratory's standard operating procedure;

9. Discard or segregate all expired standards or reagents;

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

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

D. A licensee or applicant may submit a written request to the Department for an exemption from subsection (C)(1) for a specific parameter if the licensee or applicant documents:

1. That the approved method has been performed at the laboratory and that the analytical data generated were scientifically valid and defensible and of known and acceptable precision and accuracy; and

2. The licensee's or applicant's ability to obtain the equipment, reagent, or glassware necessary to perform the approved method.

E. The written request for an exemption under subsection (D) shall include:

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

2. The name, address, and telephone number of the licensee or applicant submitting the request;

3. Identification of the parameter and the equipment, reagent, or glassware for which the licensee or applicant is requesting an exemption; and

4. The documentation described in subsections (D)(1) and (2).

F. The Department may approve a request for an exemption under subsection (D) if the Department determines that the:

1. Approved method has been performed at the laboratory;

2. Analytical data generated were scientifically valid and defensible and of known and acceptable precision and accuracy; and

3. Licensee or applicant is able to obtain the equipment, reagent, or glassware necessary to perform the approved method.

G. A licensee 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 a licensee or applicant may satisfy the components required in subsections (B)(3) through (15) through incorporating by reference provisions in separate documents, such as standard operating procedures.

H. Except as provided in subsection (I), a licensee 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 (C)(3).

I. A licensee or applicant may satisfy the components required in subsections (C)(3)(e) and (f) through incorporating by reference provisions in separate documents, such as other standard operating procedures.

Ariz. Admin. Code § R9-14-615

Adopted effective December 20, 1991 (Supp. 91-4). Former Section R9-14-615 renumbered to R9-14-616; new Section R9-14-615 renumbered from R9-14-614 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-615 renumbered to R9-14-617; new Section R9-14-615 renumbered from R9-14-613and amended by final rulemaking at 7 A.A.R. 184, effective December 15, 2000 (Supp. 00-4). Amended by final rulemaking at 12 A.A.R. 4798, effective December 5, 2006 (Supp. 06-4). Amended by final rulemaking at 22 A.A.R. 2683, effective 10/1/2016.