Ariz. Admin. Code § 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 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.
Notes
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