Section R9-14-617. Laboratory Records and Reports

A licensee or applicant shall ensure that:

1.        Each record and report required to be maintained by this Article is available for inspection and copying by the Department during normal business hours;

2.        The Department is permitted to remove copied records and reports from a laboratory;

3.        The licensee or applicant maintains records and reports of compliance testing for at least five years after the date of compliance testing, with:

a.         All records and reports for at least the most current two years maintained onsite at the laboratory and the remaining records and reports stored in a secure storage facility;

b.        Each hard copy  document containing data either maintained as a hard copy document or scanned into a PDF file or another electronic file format that pre- serves an exact copy of the hard copy data; and

c.         All instrument-generated electronic data maintained in a reproducible format from which reports can be produced and printed;

4.        No portion of a record or report of compliance testing is altered or deleted to hide or misrepresent any part of the data;

5.        The licensee or applicant produces all records and reports requested by the Department within 24 hours after the request or, if the licensee or applicant requests a period longer than 24 hours, a longer period of time agreed upon by the Department;

6.        Upon Department request, the licensee or applicant makes available for inspection and copying the requested data from non-Arizona compliance samples;

7.        A compliance testing record contains:

a.         Sample information, including the following:

i.         A unique sample identification assigned at the laboratory,

ii.        The location or location code of sample collec- tion,

iii.      The sample collection date and time,

iv.       The type of testing to be performed, and

v.        The name of the individual who collected the sample;

b.        The name and address of the client submitting the sample to the laboratory;

c.         The name of the individual who submitted the sam- ple to the laboratory;

d.        The date and time of receipt of the sample at the lab- oratory;

e.         The name of the individual who received the sample at the laboratory;

f.         The dates and times of testing, including the date and time of each critical step;

g.        The actual results of compliance testing, including all raw data, work sheets, and calculations per- formed;

h.        The actual results of quality control data validating the test results, including the calibration and calcula- tions performed;

i.         The name of each analyst or who performed the test- ing; and

j.         A copy of the final report;

8.        A final report of compliance testing contains:

a.         The name, address, and telephone number of the lab- oratory;

b.        The license number assigned to the laboratory by the Department;

c.         Actual scientifically valid and defensible results of compliance testing in appropriate units of measure, obtained in accordance with an approved method and quality assurance plan;

d.        Qualified results of compliance testing not obtained in accordance with an approved method and quality assurance plan;

e.         A list of each approved method used to obtain the reported results;

f.         Sample information, including the following:

i.         The unique sample identification assigned at the laboratory,

ii.        The location or location code of sample collec- tion,

iii.      The sample collection date and time,

iv.       The name of the individual who collected the sample,

v.        The name of the client that submitted the sam- ple to the laboratory, and

vi.       The name of the individual who submitted the sample to the laboratory;

g.        The date of analysis for each parameter reported;

h.        The date of the final report; and

i.         The laboratory director’s or designee’s signature.

Historical Note

Adopted effective December 20, 1991 (Supp. 91-4). For- mer Section R9-14-617 renumbered to R9-14-618; new Section R9-14-617 renumbered from R9-14-616 and amended effective June 20, 1997 (Supp. 97-2). Former Section R9-14-617 renumbered to R9-14-618; new Sec- tion R9-14-617 renumbered from R9-14-615 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).