Ariz. Admin. Code § R9-25-1306 - Inspections (A.R.S. Sections 36-2202(A)(4), 36-2209(A)(2), and 36-2225(A)(4))

A. When the Department inspects a health care institution applying for a trauma center designation or a health care institution designated as a trauma center to determine compliance with the applicable requirements in this Article, the Department:

1. Shall use criteria for assessing compliance developed using recommendations from the State Trauma Advisory Board, according to A.R.S. § 36-2222(E)(1); and

2. May:

a. Evaluate the health care institution's equipment and physical plant;

b. Interview the health care institution's personnel members, including any individuals providing trauma care; and

c. Review any of the following:

i. Medical records;

ii. Patient discharge summaries;

iii. Patient care logs;

iv. Rosters and schedules of personnel members and individuals who provide trauma care as part of the trauma service;

v. Performance-improvement-related documents, including quality management program documents required in A.A.C. R9-10-204 or R9-10-1004 as applicable; and

vi. Other documents relevant to the provision of trauma care as part of the trauma service.

B. The Department shall determine whether there is a need for an inspection of a health care institution and which components in subsection (A)(2) to include in an inspection, based on the health care institution's application; previous inspections, if applicable; and the operating history of the health care institution and may conduct an announced inspection of the identified components:

1. Before issuing an initial, renewal, or modified designation to an owner applying for designation of a health care institution as a trauma center;

2. If an owner of a health care institution designated as a trauma center has submitted a corrective action plan under subsection (E); or

3. A health care institution designated as a trauma center is randomly selected to receive an inspection.

C. If the Department has reason to believe that a trauma center is not complying with applicable requirements in A.R.S. Title 36, Chapter 21.1 and this Article, the Department may conduct an announced or unannounced inspection of the trauma center according to subsection (A).

D. Within 30 calendar days after completing an inspection, the Department shall send to an owner a written report of the Department's findings, including, if applicable, a list of any instances of non-compliance identified during the inspection and a request for a written corrective action plan.

E. Within 15 calendar days after receiving a request for a written corrective action plan, an owner shall submit to the Department a written corrective action plan that includes for each identified instance of non-compliance:

1. A description of how the instance of non-compliance will be corrected and reoccurrence prevented, and

2. A date of correction for the instance of non-compliance.

F. The Department shall accept a written corrective action plan if the corrective action plan:

1. Describes how each identified instance of non-compliance will be corrected and reoccurrence prevented, and

2. Includes a date for correcting each instance of non-compliance that is appropriate to the actions necessary to correct the instance of non-compliance.

G. If the Department reviews a health care institution's facility and documentation of capabilities during a national verification organization's assessment according to R9-25-1302(C)(3) and the health care institution is not issued verification from the national verification organization at the Level of designation sought, the Department shall send to an owner of the health care institution, within 30 calendar days after the review, a written report of the Department's findings, including, if applicable, a list of any instances of non-compliance with requirements in R9-25-1308 and Table 13.1 identified during the review.

H. A health care institution receiving a written report in subsection (G), containing a list of instances of non-compliance with requirements in R9-25-1308 and Table 13.1 identified during a review of the health care institution's facility and documentation of capabilities, may submit to the Department a written plan to correct instances of non-compliance that includes:

1. A description of how the health care institution will correct each instance of non-compliance and prevent the reoccurrence, and

2. A date by which the health care institution plans to correct each instance of non-compliance.

Notes

Ariz. Admin. Code § R9-25-1306

New Section made by final rulemaking 11 A.A.R. 4363, effective October 6, 2005 (Supp. 05-4). Amended 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.