To renew a laboratory registration certificate, an applicant
shall submit to the Department, at least 30 calendar days before the expiration
date of the current laboratory registration certificate, but no more than 90
days before the expiration date of the current laboratory registration
certificate, the following:
1. An
application in a Department-provided format that includes:
a. The physical address of the
laboratory;
b. The following
information for the laboratory:
i. The legal
name of the laboratory,
ii. The
registry identification number for the laboratory,
iii. Type of business organization,
iv. Mailing address,
v. Telephone number, and
vi. E-mail address;
c. The name of the owner designated to submit
laboratory agent registry identification card applications on behalf of the
laboratory;
d. The name, residence
address, and date of birth of each owner;
e. The name, residence address, and date of
birth of the technical laboratory director designated according to
R9-17-404(3)
;
f. The name, residence address,
and date of birth of each laboratory agent, if applicable;
g. Whether the applicant is
requesting the same parameters for which the laboratory is currently approved,
including the same:
i. Analytes,
ii. Instruments and equipment to
be used for testing, and
iii. Software to be used at the
laboratory for instrument control and data reduction interpretation;
h. For each new parameter for
which approval for testing is being requested:
i. The type of
sample,
ii. The analyte to be tested
for,
iii. The instruments and equipment
to be used for testing, and
iv. The software to be used at the
laboratory for instrument control and data reduction
interpretation;
i.
g. Whether the laboratory agrees to allow
the Department to submit supplemental requests for information;
j.
h. An
attestation that the information provided to the Department to renew the
laboratory registration certificate is true and correct; and
k.
i. The
signatures of the owner of the laboratory, according to
R9-17-401(A), and
the technical laboratory director and the date each signed;
2. For each owner:
a. An attestation signed and dated by the
owner that the owner has not been convicted of an excluded felony offense as
defined in A.R.S. §
36-2801; and
b. An attestation signed and dated by the
owner that the laboratory will not test medical marijuana and medical marijuana
products for:
i. A dispensary, related medical
marijuana business entity, or management company that the owner has a direct or
indirect familial or financial relationship with or interest in; or
ii. A designated caregiver who the owner has
a direct or indirect familial or financial relationship with;
3. For each current
parameter, documentation of current accreditation;
4. For each new parameter for
which approval for testing is being requested:
a. The limit of
quantitation;
b. A copy of a proficiency testing
report, if applicable, or accuracy testing documentation; and
c. A copy of the standard
operating procedure;
5.
4. If a change has been
made to the standard operating procedure for a current parameter, a copy of the
revised standard operating procedure;
6.
5. If a change has been
made in the quality assurance plan for a current parameter required in
R9-17-404.03 or
R9-17-404.04, a copy of the revised
quality assurance plan; and
7.
6. The applicable fee
in
R9-17-102 for applying to renew a
laboratory registration certificate.
Notes
Ariz. Admin.
Code §
R9-17-403
Adopted by
final exempt rulemaking at
25
A.A.R. 2421, effective 8/27/2019. Amended by final exempt rulemaking at
26
A.A.R. 734, effective 4/2/2020. Amended by exempt rulemaking at
26
A.A.R. 968, effective 4/20/2020.
