Ariz. Admin. Code § 9-9A-106

Current through Register Vol. 30, No. 50, December 13, 2024

Section R9-9A-106 - Changes Affecting a License

A. A licensee shall notify the Department in writing at least 30 calendar days before the effective date of termination of procurement organization operations, including the following information, in a Department-provided format:

1. The name and license number of the licensee;

2. The name, email address, and telephone number of an individual who may be contacted by the Department;

3. The proposed termination date; and

4. The address and contact information for the location where the procurement organization records will be retained, according to R9-9A-201(B)(1)(b).

B. A licensee of an accredited procurement organization, whose certificate of accreditation has expired or has been revoked, suspended, or denied, shall notify the Department in writing no later than 14 calendar days after expiration or the receipt of a revocation, suspension, or denial.

C. A licensee shall:

1. Notify the Department in writing at least 30 calendar days before a change in the legal name of a procurement organization that does not affect the structure or ownership of the business organization, including the following information:

a. The name and license number of the licensee;

b. The current name of the procurement organization;

c. The proposed name of the procurement organization; and

d. The name, email address, and telephone number of an individual who may be contacted by the Department; and

2. Within seven calendar days after the effective date of the name change, submit to the Department documentation of the name change from the Arizona Corporation Commission that indicates no change in structure or ownership of the procurement organization.

D. A licensee shall:

1. Notify the Department in writing at least 30 calendar days before a change in the legal name of the licensee, which does not affect the structure or ownership of the business organization if the licensee is a business organization, including the following information:

a. The current name and license number of the licensee,

b. The proposed name of the licensee, and

c. The name, email address, and telephone number of an individual who may be contacted by the Department; and

2. Within seven calendar days after the effective date of the name change, submit to the Department either:

a. If the licensee is an individual, documentation of the individual's legal name change; or

b. If the licensee is a business organization, documentation of the name change from the Arizona Corporation Commission that indicates no change in structure or ownership of the business organization.

E. A licensee shall notify the Department in writing no later than 30 calendar days after a change in any of the following, including the name and license number of the procurement organization:

1. The email address or mailing address of the procurement organization, including the new email address or mailing address;

2. The email address or telephone number of the licensee, including the new email address or telephone number;

3. An administrator, including the name, telephone number, and email address of the new administrator;

4. A medical director, including the name, email address, and professional license number of the new medical director; or

5. The name, telephone number, and email address of the individual acting on behalf of the licensee specified in R9-9A-103.

F. A licensee shall notify the Department in writing at least 30 calendar days before the effective date of a proposed modification, which includes a substantial improvement, enlargement, reduction, alteration, or other substantial change in the facility or another structure on the premises at the procurement organization, including;

1. The following information:

a. The name and license number of the licensee;

b. A description of the proposed modification;

c. Whether the modification will comply with local zoning ordinances, building codes, and fire codes;

d. The estimated date of completion of the modification;

e. The date the facility will be ready for a licensing inspection; and

f. The name, email address, and telephone number of an individual who may be contacted by the Department;

2. A floor plan, drawn to scale, of each building in which a change will be made:

a. Showing the function of each room, and

b. Indicating the changes to be made; and

3. A plan for ensuring the quality and security of non-transplant anatomical donations and non-transplant anatomical material are maintained during the modification.

G. For an anticipated change in the address of a procurement organization, a licensee shall:

1. Notify the Department in writing at least 30 calendar days before the anticipated change in the address, including;

a. The name and license number of the licensee;

b. The new address of the procurement organization;

c. The estimated date that the procurement organization plans to suspend acquisition, preparation, and distribution at the current address in anticipation of the change of address; and

d. The estimated date that the procurement organization plans to be ready to begin operations at the new address;

2. Submit to the Department:

a. The application information, documentation, and fee required in R9-9A-104(B);

b. A plan for ensuring the quality and security of non-transplant anatomical donations and non-transplant anatomical material are maintained during the change of location; and

c. Documentation from the Arizona Corporation Commission that shows the change of address and indicates no change in structure or ownership of the procurement organization;

3. Ensure that the quality and security of non-transplant anatomical donations and non-transplant anatomical material are maintained during the change of address; and

4. Not begin procurement organization activities at the new address until a new license has been issued according to subsection (M).

H. For an anticipated change of ownership of a procurement organization:

1. A licensee shall:

a. Notify the Department in writing at least 30 calendar days before the anticipated change of ownership, including the following information, in a Department-provided format:

i. The name and license number of the licensee;

ii. The name, email address, and telephone number of the person who is anticipated to assume ownership of the procurement organization;

iii. The estimated date that the procurement organization plans to suspend acquisition, preparation, and distribution in anticipation of the change of ownership;

iv. The estimated date that the change of ownership will occur;

v. The address and contact information for the location where the procurement organization records will be retained, according to R9-9A-201(B)(1)(b); and

vi. The name, email address, and telephone number of an individual who may be contacted by the Department;

b. If the licensee anticipates that any non-transplant anatomical donations or non-transplant anatomical material in the possession of the licensee will be transferred to the new owner, submit to the Department a plan for ensuring that the quality and security of the non-transplant anatomical donations and non-transplant anatomical material are maintained during the change of ownership; and

c. If the licensee anticipates that any non-transplant anatomical donations or non-transplant anatomical material in the possession of the licensee will not be transferred to the new owner, submit to the Department a plan for final disposition of the non-transplant anatomical donations and non-transplant anatomical material, consistent with the standard operating procedure for the final disposition of non-transplant anatomical donations and non-transplant anatomical material, according to R9-9A-201(B)(8); and

2. The person identified in subsection (H)(1)(b) shall:

a. Submit to the Department the application information, documentation, and fee required in R9-9A-104(B);

b. Ensure that the quality and security of non-transplant anatomical donations and non-transplant anatomical material transferred from the licensee are maintained during the change of ownership; and

c. Not begin procurement organization activities until a license has been issued by the Department to the person according to R9-9A-109(C)(4).

I. If the Department receives the notification of termination of operation in subsection (A) or notice of a change in ownership in subsection (H)(1), the Department shall void the licensee's license to operate a procurement organization as of the termination date specified by the licensee.

J. If the Department receives a notification in subsection (B) of a procurement organization's loss of accreditation, the Department may conduct an inspection of the procurement organization to ensure compliance with the requirements in A.R.S. § 36-851.03 and this Subchapter.

K. If the Department receives a notification in subsection (C) or (D) of a change in the legal name of the procurement organization or licensee, the Department shall:

1. Determine whether the change affects the structure or ownership of the business organization;

2. If the change does not affect the structure or ownership of the business organization, issue to the licensee an amended license showing the new legal name of the procurement organization or licensee and keeping the current license expiration date; and

3. If the change affects the structure or ownership of the business organization:

a. Notify the licensee that the procurement organization is required to suspend acquisition, preparation, and distribution as of the date of the documentation required in subsection (C)(2) or (D)(2)(b), as applicable;

b. Require the licensee to specify the address and contact information for the location where the procurement organization records will be retained, according to R9-9A-201(B)(1)(b);

c. Notify the licensee that the licensee is responsible for ensuring that the quality and security of non-transplant anatomical donations and non-transplant anatomical material are maintained until:

i. A new license is issued under the new structure or ownership of the business organization; or

ii. The licensee no longer possesses any non-transplant anatomical donations or non-transplant anatomical material;

d. If the procurement organization plans to continue operations under the new structure or ownership of the business organization:

i. Require the submission of the application information, documentation, and fee required in R9-9A-104(B);

ii. Conduct an inspection of the procurement organization if appropriate; and

iii. Specify that procurement organization activities may not resume until a new license has been issued by the Department according to R9-9A-109(C)(4); and

e. Terminate the licensee's current license when the Department:

i. Issues a new license to the procurement organization under the new structure or ownership of the business organization, or

ii. Receives notification that the licensee no longer possesses any non-transplant anatomical donations or non-transplant anatomical material.

L. If the Department receives a notification in subsection (F) of a proposed modification, the Department:

1. May conduct an inspection of the premises; and

2. If the procurement organization is compliant with A.R.S. Title 36, Chapter 7, Article 3, and this Subchapter, shall issue to the licensee an amended license that incorporates the modification and retains the expiration date of the existing license.

M. If the Department receives a notification, information, and documentation in subsection (G) for a change of address, regardless of whether the change affects the structure or ownership of the business organization, or a notification in subsection (H) that indicates a change in ownership, the Department:

1. Shall notify the licensee that:

a. The procurement organization is required to suspend acquisition, preparation, and distribution as of the date specified in subsection (G)(1)(c) or (H)(1)(a)(iii), as applicable;

b. The licensee is responsible for ensuring that the quality and security of non-transplant anatomical donations and non-transplant anatomical material are maintained until:

i. A new license is issued to the licensee at the new address or to the new owner, as applicable; or

ii. The licensee no longer possesses any non-transplant anatomical donations or non-transplant anatomical material; and

c. Procurement organization activities may not occur after the date specified in subsection (G)(1)(c) or (H)(1)(a)(iii), as applicable, until a new license has been issued by the Department according to R9-9A-109(C)(4);

2. May conduct an inspection of the procurement organization;

3. If the application is compliant with A.R.S. Title 36, Chapter 7, Article 3, and this Subchapter, shall issue a new license to the applicant according to R9-9A-109(C)(4); and

4. Shall terminate the licensee's current license when the Department:

a. Issues a new license to the procurement organization at the new address or to the new owner, as applicable; or

b. Receives notification that the licensee no longer possesses any non-transplant anatomical donations or non-transplant anatomical material.

Ariz. Admin. Code § R9-9A-106

New Section made by final expedited rulemaking at 30 A.A.R. 3657, effective 11/5/2024.