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)(9), and are scientifically valid and defensible.

B.       A licensee or applicant shall have, implement, and comply with a written quality assurance plan that contains the follow- ing 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, line 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 allowable holding times;

7.        A procedure for documenting laboratory receipt of sam- ples and tracking of samples during laboratory testing;

8.        A procedure for analytical instrument calibration, includ- ing 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 determi- nation of the accuracy of data transcription, and all calcu- lations;

10.     A statement of the frequency of all quality control checks;

11.     A statement of the acceptance criteria for all quality con- trol checks;

12.     Preventive maintenance procedures and schedules;

13.     Assessment procedures for data acceptability;

14.     Corrective action procedures to be taken when results from analytical quality control checks are unacceptable, including steps to demonstrate the presence of any inter- ference if the precision, accuracy, or limit of quantitation the reported compliance testing result is affected by the interference; and

15.     Procedures for chain-of-custody documentation, includ- ing 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 at 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 and document the use of only reagents of a grade equal to or greater than that required by the approved methods;

3.        Maintain and require each analyst to comply with a com- plete and current standard operating procedure for each licensed method, which shall include at least:

a.         A requirement that the method be performed in com- pliance with the requirements in the approved method;

b.        A description of all procedures to be followed when the method is performed;

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

d.        Requirements for instrumental conditions and set up;

e.         A requirement for frequency of calibration;

f.         Calculations for the quantitation of the final concen- tration of samples, with the actual sample dilution factors and the calibration algorithm used, which reflect the procedures followed; and

g.        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 Depart- ment 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 cal- ibration models or, if another calibration model has been approved by the Department as a method alter- ation, 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 calibra- tion;

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

6.        Develop, document, and maintain a current limit of detec- tion and limit of quantitation for each compliance param- eter 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 Sec- tion D.1.2 of Chapter 5, Appendix D—Essential Quality Control Requirements, in National Environ- mental Laboratory Accreditation Conference, EPA Pub. No. EPA/600/R-04/003, 2003 NELAC Stan- dard (June 5, 2003), including no future editions or amendments, which is incorporated by reference, on file with the Department, and available from the National Environmental Laboratory Accreditation Conference, US EPA ORD/NERL, Mailcode E243- 05, RTP, NC 27711, or at www.epa.gov/nelac/;

8.        Maintain all compliance testing equipment in proper operating condition;

9.        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 Exhibit II; 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 calibra- tion; and

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

10.     Discard or segregate all expired standards or reagents;

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

12.     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 spe- cific parameter if the licensee or applicant:

1.        Documents 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.        Documents the licensee’s or applicant’s ability to obtain the equipment, reagent, or glassware necessary to per- form 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 it determines:

1.        That the approved method has been performed at the lab- oratory;

2.        That the analytical data generated were scientifically valid and defensible and of known and acceptable preci- sion and accuracy; and

3.        That the license or applicant is able to obtain the equip- ment, 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 sub- section (B), but a licensee or applicant may satisfy the compo- nents required in subsections (B)(3) through (15) through incorporating by reference provisions in separate documents such as standard operating procedures.

H.      A licensee or applicant shall ensure that each laboratory stan- dard operating procedure is a separate document available at the laboratory and includes all of the components required in subsection (C)(3), but a licensee or applicant may satisfy the components required in subsections (C)(3)(f) and (g) through incorporating by reference provisions in separate documents such as other standard operating procedures.

Historical Note

Adopted effective December 20, 1991 (Supp. 91-4). For- mer 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 Sec- tion R9-14-615 renumbered from R9-14-613 and

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).