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 (C), an application completed using a Department-provided form and including:

1.        The name of the laboratory;

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

3.        The current EPA certification number for the laboratory, if any;

4.        The physical and mailing addresses for the laboratory;

5.        The telephone number; fax number; and e-mail address for the laboratory;

6.        The name and address of the owner and of each addi- tional person that has an ownership interest in the labora- tory;

7.        For the owner and each additional business organization with an ownership interest in the laboratory, the name of each officer, principal, and statutory agent;

8.        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.     The license Level for which the applicant is applying;

11.     Whether the applicant is applying to license a single labo- ratory or multiple laboratories;

12.     If the applicant is applying to license a mobile laboratory, the vehicle make, vehicle identification number, and Ari- zona vehicle license number of the mobile laboratory;

13.     If the applicant is applying to license a mobile laboratory that is affiliated with a non-mobile laboratory, the name of the non-mobile laboratory;

14.     The name, title, and educational background of each indi- vidual authorized to sign final reports for the laboratory;

15.     A list of the parameters for which the applicant is request- ing to be licensed or, if an application for a renewal license, an  indication  that the applicant  desires  to be licensed for the same parameters as on the current license;

16.     A list of the instruments and equipment to be used at the laboratory for compliance testing or, if an application for a renewal license, an indication that the applicant is using the same instruments and equipment as used under the current license;

17.     A list of the software to be used at the laboratory for instrument control and data reduction interpretation or, if an application for a renewal license, an indication that the applicant is using the same software as used under the current license;

18.     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 through the Internet;

19.     If an application for an initial license:

a.         A copy of a proficiency testing report, for the cur- rent 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 certifi- cate 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 install- ments 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 labo- ratory 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 applica- tion form, is accurate and complete; and

23.     The dated and notarized signature of the laboratory direc- tor and:

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

b.        If the owner is a corporation, an officer of the corpo- ration;

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

d.        If the owner is a limited liability company, a man- ager or, if the limited liability company does not have a manager, a member of the limited liability company;

e.         If the owner is an association or cooperative, a mem- ber 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.        If the owner is a governmental agency, the individ- ual in the senior leadership position with the agency or an individual designated in writing by that indi- vidual; or

h.        If the owner is a business organization type other than those described in subsections (A)(23)(b) through (f), an individual who is a member of the business organization.

B.       An application may include an agreement between the appli- cant and the Department that the Department may submit sup- plemental requests for additional information.

C.      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 per- forming 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.

D.      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 sub- mits one application and combined fees for the laborato- ries; 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 Ari- zona vehicle registration.

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

F.       The Department shall not consider an applicant to be in com- pliance 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.

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

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

I.        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 busi- ness days after the change, the Department receives written notice of the change and an application for a new license.

J.        The Department shall not charge a fee for a license application submitted under subsection (I) 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.

Historical Note

Adopted effective August 16, 1985 (Supp. 85-4). Former Section R9-14-603 repealed, new Section R9-14-603 adopted effective December 20, 1991 (Supp. 91-4). Sec- tion citation corrected in preceding historical note; Sec- tion 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).