Ariz. Admin. Code § 9-25-1307

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

Section R9-25-1307 - Designation and Dedesignation (A.R.S. Sections 36-2202(A)(4), 36-2209(A)(2), and 36-2225(A)(4))

A. For initial designation or renewal of designation of a health care institution based on verification, the Department shall, within 45 calendar days after receiving a complete application from an owner:

1. Except as provided in subsection (H)(2), if the application complies with the applicable requirements in this Article, issue a designation for the health care institution that is valid for the duration of the verification; or

2. If the application does not comply with the applicable requirements in this Article, provide a written notice that complies with A.R.S. Title 41, Chapter 6, Article 10, that the Department intends to decline to issue a designation for the health care institution.

B. Except as provided in subsection (F) specifying requirements for renewal of a one-year designation, for initial designation or renewal of designation of a health care institution based on an assessment by a national verification organization, the Department shall, within 60 calendar days after receiving a complete application from an owner, review the application and, if the Department determines that:

1. The application and the health care institution comply with the applicable requirements in this Article, except as provided in subsection (H)(1), issue a designation for the health care institution that is valid for three years from the issue date;

2. The application complies with the applicable requirements in this Article, the health care institution is in substantial compliance with the applicable requirements in this Article, and the Department has accepted a written corrective action plan submitted according to R9-25-1306(E), issue a designation for the health care institution that is valid for one year from the issue date; or

3. The application or the health care institution does not comply with the applicable requirements in this Article, provide a written notice that complies with A.R.S. Title 41, Chapter 6, Article 10, that the Department intends to decline to issue a designation for the health care institution.

C. Except as provided in subsection (F) specifying requirements for renewal of a one-year designation, for initial designation or renewal of designation of a health care institution as a Level III trauma center or a Level IV trauma center based on an assessment by the Department, an owner shall include as part of the application required in R9-25-1303(A):

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

a. The name of the health care institution for which the owner is requesting designation;

b. The services the health care institution is providing or plans to provide as part of the trauma service;

c. The name and title of the liaison to the trauma service from each of the services listed according to subsection (C)(1)(b);

d. If applicable, the name, e-mail address, telephone number, and, if available, fax number of the health care institution's emergency department physician director;

e. If applicable, the name, e-mail address, telephone number, and, if available, fax number of the health care institution's surgical director or co-director;

f. If a multidisciplinary peer review committee is required according to Table 13.1 for the Level of the trauma center, the name and title of each member of the multidisciplinary peer review committee;

g. If the health care institution's trauma registry will be part of a centralized trauma registry, a description of the training provided to the trauma program manager to enable the trauma program manager to comply with R9-25-1308(D)(2);

h. If applicable, for an application for initial designation, a description of the health care institution's plans for the continuing education activities related to trauma care, required in R9-25-1308(G)(4);

i. For renewal of designation, a description of the continuing education activities conducted during the term of the designation;

j. If applicable, the name, e-mail address, telephone number, and, if available, fax number of the health care institution's injury prevention coordinator;

k. A description of the methods by which trauma team personnel members communicate with EMS personnel;

l. A description of the trauma-related training received by registered nurses in the intensive care unit;

m. An attestation that the owner of the health care institution will prohibit:

i. The trauma medical director from serving as trauma medical director for another health care institution; and

ii. A physician on-call for general surgery, neurosurgery, or orthopedic surgery to be on-call or on a back-up call list at another health care institution; and

n. The dated signature of the applicable individual according to R9-25-102;

2. A copy of the policies and procedures required in R9-25-1308(B)(6) for the health care institution's trauma registry;

3. A copy of the policies and procedures required in R9-25-1308(B)(7) for the health care institution's performance improvement program;

4. A copy of the policies and procedures required in R9-25-1308(F)(2) for the health care institution's trauma service;

5. If applicable, a copy of the policies and procedures required in R9-25-1308(F)(9) for operating rooms;

6. A copy of the applicable policies and procedures required in R9-25-1308(H)(4);

7. A copy of the health care institution's clinical practice guidelines, describing the health care institution's capability to resuscitate, stabilize, and transfer pediatric patients;

8. If applicable, a copy of the bylaws of the health care institution's multidisciplinary peer review committee;

9. Copies of the job descriptions for the health care institution's:

a. Trauma program manager;

b. Trauma registrar; and

c. If applicable, injury prevention coordinator;

10. A list of the trauma care parameters the health care institution is or will be monitoring as part of the performance improvement program;

11. A list of trauma team members, including:

a. Name,

b. Title, and

c. Role on the trauma team;

12. If required for an individual listed according to subsection (C)(11), a copy of documentation of the individual's:

a. Board certification or board eligibility,

b. Most recent certification in a trauma critical care course,

c. Pediatric-specific credentials, and

d. Other trauma-related training; and

13. If the trauma medical director is not a member of the trauma team, the applicable documentation required in subsection (C)(12) for the trauma medical director.

D. Except as provided in subsection (F) specifying requirements for renewal of a one-year designation, for initial designation or renewal of designation of a health care institution as a Level I trauma center, Level I Pediatric trauma center, Level II trauma center, or Level II Pediatric trauma center based on an assessment by the Department under R9-25-1302(C), an owner shall include as part of the application required in R9-25-1303(A):

1. A copy of the documentation submitted to the national verification organization as part of an application for verification;

2. If not included in the documentation in subsection (D)(1):

a. Any information or documents required in subsection (C);

b. For an application for initial designation, a description of the health care institution's plans for:

i. Injury prevention activities, required in R9-25-1308(G)(5)(a); and

ii. Educational outreach activities, required in R9-25-1308(G)(5)(b); and

c. For an application for renewal of designation, a description of the injury prevention activities and educational outreach activities conducted during the term of the designation;

3. A copy of the national verification's organization's written report to the health care institution describing the results of the national verification organization's assessment of the health care organization;

4. A copy of the written report in R9-25-1306(G); and

5. If applicable, the written plan to correct instances of non-compliance in R9-25-1306(H).

E. Except for renewal of a one-year designation as provided in subsection (G), for initial designation or renewal of designation of a health care institution based on an assessment by the Department according to subsection (C) or (D), the Department shall, within 90 calendar days after receiving a complete application from an owner, review the application, inspect the health care institution, if applicable, and, if the Department determines that:

2. The application complies with the applicable requirements in this Article, the health care institution is in substantial compliance with the applicable requirements in this Article, and the Department has accepted the document submitted according to R9-25-1306(E) or subsection (D)(5), issue a designation for the health care institution that is valid for one year from the issue date; or

F. For renewal, at the same Level of trauma center, of a one-year designation issued according to subsection (B)(2) or (E)(2), an owner shall include, as part of the application required in R9-25-1303(A), documentation related to the completion of the plan specified in the document accepted by the Department in subsection (B)(2) or (E)(2).

G. The Department shall, within 60 calendar days after receiving from an owner an application submitted according to subsection (F), review the information and documentation, inspect the health care institution if applicable, and:

1. Issue a designation for the health care institution that is valid for two years from the issue date if the Department determines that:

a. The application and the health care institution comply with the applicable requirements in this Article; and

b. The owner has completed the plan specified in the document accepted by the Department in subsection (B)(2) or (E)(2), as applicable; or

2. Provide a written notice that complies with A.R.S. Title 41, Chapter 6, Article 10, that the Department intends to decline to issue a designation for the health care institution if the Department determines that:

a. The application or the health care institution do not comply with the applicable requirements in this Article; or

b. The owner has not completed all of the components of the plan specified in the document accepted by the Department in subsection (B)(2) or (E)(2), as applicable.

H. The Department may:

1. Issue or extend a designation to a health care institution that is longer than three years if:

a. The health care institution would be eligible for designation under R9-25-1302(A)(2)(a)(ii) or (iii), (A)(2)(b)(ii) or (iii), (A)(2)(c)(ii) or (iii), (A)(2)(d)(ii) or (iii), or (A)(2)(e)(ii) with assessment from a national verification organization;

b. The national verification organization either:

i. Will not allow the health care institution to apply for verification within the time-frame necessary to comply with R9-25-1302(C), or

ii. Does not schedule an assessment visit to the health care institution within six months after the date of the health care institution's request;

c. The health care institution and, if applicable, the application comply with the applicable requirements in this Article; and

d. The health care institution provides to the Department documentation supporting subsection (H)(1)(b); or

2. Issue a designation based on verification to a health care institution, according to subsection (A)(1), that is shorter than the duration of the verification if the expiration of the verification is more than five years after the date of issuance.

I. For modification of a designation according to R9-25-1305, the Department shall, within 30 calendar days after receiving a complete application for modification in R9-25-1305(A) from an owner, review the application, inspect the health care institution, if applicable, and:

1. Issue a modified designation for the Level of designation requested for the health care institution that is valid for the duration of the original designation or one year from the issue date, whichever is longer, if the Department determines that:

a. The application and the health care institution comply with the applicable requirements in this Article for the Level of designation requested; or

b. The application complies with the applicable requirements in this Article, the health care institution is in substantial compliance with the applicable requirements in this Article for the Level of designation requested, and the Department has accepted a written corrective action plan submitted according to R9-25-1306(E);

2. Issue a modified designation for a lower Level of designation than the Level of designation requested for the health care institution that is valid for the duration of the original designation or one year from the issue date, whichever is longer, if the Department determines that:

a. The application and the health care institution comply with the applicable requirements in this Article for the lower Level of designation and the health care institution:

i. Does not comply with the applicable requirements in this Article for the Level of designation requested; or

ii. Is in substantial compliance with the applicable requirements in this Article for the Level of designation requested, and the Department has not accepted a written corrective action plan submitted according to R9-25-1306(E); or

b. The application complies with the applicable requirements in this Article, the health care institution is in substantial compliance with the applicable requirements in this Article for the lower Level of designation, and the Department has accepted a written corrective action plan according to R9-25-1306(E); or

3. Provide a written notice that complies with A.R.S. Title 41, Chapter 6, Article 10 that the Department intends to decline to issue a modified designation for the health care institution if the Department determines that the application or the health care institution does not comply with the applicable requirements in this Article.

J. The Department may dedesignate a health care institution as a trauma center if an owner:

1. Has provided false or misleading information to the Department;

2. Is not eligible for designation under R9-25-1302(A) or (B); or

3. Fails to comply with an applicable requirement in A.R.S. Title 36, Chapter 21.1 or this Article.

K. In determining whether to dedesignate a health care institution as a trauma center, the Department shall consider:

1. The severity of each instance relative to public health and safety;

2. The number of instances;

3. The nature and circumstances of each instance;

4. Whether each instance was corrected, the manner of correction, and the duration of the instance; and

5. Whether the instances indicate a lack of commitment to having the trauma center meet the verification standards of a national verification organization or, if applicable, the standards specified in R9-25-1308 and Table 13.1.

L. If the Department intends to dedesignate a health care institution, the Department shall send to the owner a written notice that complies with A.R.S. Title 41, Chapter 6, Article 10.

M. An owner who receives a written notice in subsection (A)(2), (B)(3), (E)(3), (G)(2), (I)(3), or (J) may file a written notice of appeal with the Department that complies with A.R.S. Title 41, Chapter 6, Article 10.

Ariz. Admin. Code § R9-25-1307

New Section made by final rulemaking 11 A.A.R. 4363, effective October 6, 2005 (Supp. 05-4). Amended and renumbered from R9-6-1312 by final rulemaking at 23 A.A.R. 2656, effective 1/1/2018. Amended by final expedited rulemaking at 29 A.A.R. 2321, effective 9/18/2023.