To obtain an initial or renewal license to
operate a laboratory, an applicant shall submit to the Department, within the
time prescribed in subsection
1. The following
information in a Department-provided format:
1.
a. The name of the
laboratory;
2.
b. The current Arizona license number for the
laboratory, if any;
3.
c. The current EPA certification number for the
laboratory, if any;
d. Whether the
applicant is applying to license:
i. A single
laboratory,
ii. Multiple
laboratories located on contiguous grounds according to subsection (C)(2),
or
iii. One of multiple
laboratories under a single license according to subsection (C)(3);
4.
e. The physical and mailing addresses for each
laboratory for which the application is being submitted;
5.
f. The
telephone number, fax number, and e-mail address for the laboratory;
g. The type of laboratory:
i. Governmental;
ii. Company, performing internal work
only;
iii. Commercial, for profit;
or
iv. Other, with a description of
the type of laboratory operation;
6.
h. For a type of
laboratory specified in subsection (A)(1)(g)(ii) through (iv):
i. The name and address of the owner and of
each additional person that has an ownership interest in the laboratory;
and
7.
ii. For each person specified in subsection
(A)(1)(h)(i), the name of each officer, principal, and statutory agent;
8.
i. The name of the laboratory director;
9. The type of
laboratory:
a.
Governmental;
b.
Company, performing internal work
only;
c.
Commercial, for profit; or
d.
Other, with a description of the type of laboratory
operation;
10.
j. Whether the
applicant is applying for a:
i. Level I
license,
ii. Level II license,
or
iii. Level III license;
11.
Whether the applicant is applying to license a
single laboratory or multiple laboratories;
12.
k. If the applicant is applying to license a mobile
laboratory:
i. The vehicle make, vehicle
identification number, and Arizona vehicle license number of the mobile
laboratory; and
13.
ii. If the mobile laboratory is affiliated with a
non-mobile laboratory, the name of the non-mobile laboratory;
14. The name, title, and
educational background of each individual authorized to sign final reports for
the laboratory;
15.
l. If the application
is for an initial license:
i. A list of the
parameters for which the applicant is requesting to be licensed,
16.
ii. A
list of the instruments and equipment to be used at the laboratory for
compliance testing,
17.
iii. A list of the software to be used at the
laboratory for instrument control and data reduction interpretation,
and
iv. A list of the states in
which the laboratory is licensed or certified and the corresponding license or
certificate number for each state;
m. If the application is for a renewal
license, whether the applicant:
i. Is
requesting to be licensed for the same parameters as on the current license;
ii. Is using the same instruments
and equipment as used under the current license;
iii. Is using the same software as used under
the current license; and
iv. Is
requesting to make payments in installments, as permitted under
R9-14-608, and, if so, an
indication of the monthly, bimonthly, or quarterly schedule for the
payments;
n. If the
information provided according to subsection (A)(1)(m) indicates a change in
parameters, instruments or equipment, or software for a renewal license, the
changes to the:
i. Parameters on the current
license,
ii. Instruments or
equipment used under the current license, or
iii. Software used under the current license;
18.
o. If the applicant is applying for an out-of-state
laboratory, whether the applicant wants to receive technical updates at the
laboratory by fax or by e-mail;
p.
Whether the applicant agrees to allow the Department to submit supplemental
requests for information; and
19.
If an application for an initial
license:
a.
A copy of a proficiency testing report, for the
current or most recently completed year, for the state in which the laboratory
is located or, if that state does not require proficiency testing, for another
state in which the laboratory is licensed or certified, for each of the
parameters for which licensure is requested;
b.
A list of the states in which the laboratory is
licensed or certified and the corresponding license or certificate number for
each state; and
c.
A copy of a current quality assurance plan for the
laboratory;
20.
If an application for a renewal
license:
a.
A copy of a current standard operating procedure,
limit of detection, and proficiency testing report, if available, for each
parameter newly requested on the application; and
b.
If the applicant desires to make payments in
installments, as permitted under R9-14-608,
an indication of this and the monthly, bimonthly, or quarterly schedule for the
payments;
21.
Except as provided in subsection (J), the fees
required under R9-14-607 and R9-14-608, payable to the Arizona Department of
Health Services by credit card; certified check; business check; or money
order; or, if the owner is an Arizona state agency, purchase
order;
22.
Attestation, made under oath, that the owner and the
laboratory director are aware of all applicable requirements in A.R.S. Title
36, Chapter 4.3 and this Article and that the information provided in the
application, including the information in the documents accompanying the
application form, is accurate and complete; and
23.
q.
The dated signature of the laboratory director and:
a.
i. If the owner is an individual, the
individual;
b.
ii. If the owner is a corporation, an officer of the
corporation;
c.
iii. If the owner is a partnership, one of the
partners;
d.
iv. If the owner is a limited liability company, a
manager or, if the limited liability company does not have a manager, a member
of the limited liability company;
e.
v. If the owner is an
association or cooperative, a member of the governing board of the association
or cooperative;
f. If the owner is a joint
venture, one of the individuals signing the joint venture
agreement;
g.
vi. If the owner is a
governmental agency, the individual in the senior leadership position with the
agency or an individual designated in writing by that individual; or
h.
vii.
If the owner is a business organization type other than those described in
subsections (A)(1)(q)(ii) through (v), an individual who is a member of the
business organization;
