- 1. Each record and report required to be maintained by this Article is available for inspection and copying by the Department during a laboratory’s 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 preserves 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, the 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 collection,
- 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 sample to the laboratory;
- d. The date and time of receipt of the sample at the laboratory;
- 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 performed;
- h. The actual results of quality control data validating the test results, including the calibration and calculations performed;
- i. The name of each analyst or who performed the testing; and
- j. A copy of the final report; and
8. A final report of compliance testing contains:
- a. The name, address, and telephone number of the laboratory;
- 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 collection,
- 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 sample 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.
A licensee or applicant shall ensure that:
Historical Note
Adopted effective December 20, 1991 (Supp. 91-4). Former 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 Section 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). Amended by final rulemaking at 22 A.A.R. 2683, effective October 1, 2016 (Supp. 16-3).