Ariz. Admin. Code § 9-14-603

Current through Register Vol. 30, No. 45, November 8, 2024

Section R9-14-603 - License Application and Process; Transferability

A. To obtain an initial or renewal license to operate a laboratory, an applicant shall submit to the Department, within the time prescribed in subsection (B), an application that contains:

1. The following information in a Department-provided format:

a. The name of the laboratory;

b. The current Arizona license number for the laboratory, if any;

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);

e. The physical and mailing addresses for each laboratory for which the application is being submitted;

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;

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

ii. For each person specified in subsection (A)(1)(h)(i), the name of each officer, principal, and statutory agent;

i. The name of the laboratory director;

j. Whether the applicant is applying for a:

i. Level I license,

ii. Level II license, or

iii. Level III license;

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

ii. If the mobile laboratory is affiliated with a non-mobile laboratory, the name of the non-mobile laboratory;

l. If the application is for an initial license:

i. A list of the parameters for which the applicant is requesting to be licensed ,

ii. A list of the instruments and equipment to be used at the laboratory for compliance testing,

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;

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

,

q. The dated signature of the laboratory director and:

i. If the owner is an individual, the individual;

ii. If the owner is a corporation, an officer of the corporation;

iii. If the owner is a partnership, one of the partners;

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;

v. If the owner is an association or cooperative, a member of the governing board of the association or cooperative;

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

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;

2. A notarized attestation in a Department-provided format, made under oath, and signed by the individuals in subsection (A)(1)(q) stating that:

a. The owner and the laboratory director will comply with all applicable requirements in A.R.S. Title 36, Chapter 4.3 and this Article; and

b. The information and documents provided as part of the application are true and accurate;

3. If the application is 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; and

b. A copy of a current quality assurance plan for the laboratory;

4. If the application is for a renewal license, a copy of a current standard operating procedure, limit of detection, and, if available, proficiency testing report for each new parameter specified according to subsection (A)(1)(n)(i); and

5. Except as provided in subsection (I), 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; money order; or, if the owner is an Arizona state agency, purchase order.

B. An applicant shall submit an application:

1. For an initial license for an in-state laboratory, at least 30 days before the applicant intends to begin operating the in-state laboratory;

2. For an initial license for an out-of-state laboratory, at least 60 days before the applicant intends to begin performing Arizona compliance testing;

3. For a renewal license for an in-state laboratory, at least 30 days before the expiration date of the current license; and

4. For a renewal license for an out-of-state laboratory, at least 60 days before the expiration date of the current license.

C. The Department may issue a single laboratory license for:

1. A single laboratory;

2. Multiple laboratories that are located on contiguous grounds and have the same owner, if the applicant submits one application and combined fees for the laboratories; or

3. Multiple laboratories, including mobile laboratories, that have the same owner but are not located on contiguous grounds, if:

a. The applicant submits a separate application and fees for each laboratory,

b. Each non-mobile laboratory is located in Arizona, and

c. Each mobile laboratory has a current and valid Arizona vehicle registration.

D. The Department shall not issue a single laboratory license for multiple laboratories that do not meet the requirements of subsection (D)(2) or (3) (C)(2) or (3).

E. The Department shall not consider an applicant to be in compliance with the requirements for licensure, as provided under A.R.S. § 36-495.09(A)(5), if the applicant does not pay the appropriate fees required under R9-14-607 and R9-14-608.

F. The Department shall process an application as provided in R9-14-621.

G. A laboratory license is valid only for the facility or facilities for which the license is issued and cannot be transferred to another facility.

H. A laboratory license is valid only in the name of the persons to whom it is issued and expires upon a change in laboratory name, laboratory director, or ownership, unless within 20 business days after the change, the Department receives written notice of the change and an application for a new license.

I. The Department shall not charge a fee for a license application submitted under subsection (H) and shall issue a new license reflecting the change upon determining continued compliance with A.R.S. Title 36, Chapter 4.3 and this Article.

Ariz. Admin. Code § R9-14-603

Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-603 repealed, new Section R9-14-603adopted effective December 20, 1991 (Supp. 91-4). Section citation corrected in preceding historical note; Section amended effective June 20, 1997 (Supp. 97-2). 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 10/1/2016.