Ariz. Admin. Code § 9-25-1308

Current through Register Vol. 30, No. 40, October 4, 2024

Section R9-25-1308 - Trauma Center Responsibilities (A.R.S. Sections 36-2202(A)(4), 36-2208(A), 36-2209(A)(2), 36-2221, and 36-2225(A)(4), (5), and (6))

A. The owner of a trauma center shall ensure that:

1. If designation is based on:

a. Verification, the trauma center meets the applicable standards of the verifying national verification organization; or

b. Meeting the applicable standards specified in this Section and Table 13.1, the trauma center meets the applicable standards for the Level of trauma center for which designation has been issued;

2. The trauma center complies with a written corrective action plan accepted by the Department according to R9-25-1306(F); and

3. The Department has access to:

a. The trauma center and to personnel members present in the trauma center; and

b. Documents that are requested by the Department and not confidential under A.R.S. Title 36, Chapter 4, Article 4 or 5, within two hours after the Department's request.

B. The owner of a trauma center shall ensure that the trauma center:

1. Except as provided in subsection (D), establishes a trauma registry of patients receiving trauma care who meet the criteria specified in subsection (C)(1) that contains the information required in R9-25-1309, as applicable for the specific Level of the trauma center;

2. Appoints an individual to act as trauma registrar to coordinate trauma registry activities;

3. If necessary to comply with subsections (C)(2) and (3), provides sufficient additional individuals to assist with trauma registry activities;

4. Establishes a performance improvement program for the trauma service to develop and implement processes to improve trauma care parameters;

5. If required according to Table 13.1 for the Level of the trauma center, establishes as part of the performance improvement program, established according to subsection (B)(4), a multidisciplinary peer review committee to review the quality of trauma care provided by the trauma center, including information from the trauma registry, and suggest methods to improve the quality of trauma care;

6. Establishes, documents, and implements policies and procedures for the trauma registry established according to subsection (B)(1) that include:

a. Ensuring that individuals responsible for collecting, entering, or reviewing information in the trauma registry have received training in gaining access to, and retrieving information from, the trauma registry;

b. Collection of the information required in R9-25-1309 about the patients specified in subsection (C)(1) receiving trauma care;

c. Submission to the Department of the information required in subsection (C)(2);

d. Review of information in the trauma center's trauma registry; and

e. Performance improvement activities required in R9-25-1310; and

7. Establishes, documents, and implements policies and procedures for the performance improvement program established according to subsection (B)(4), including:

a. A list of the positions of personnel members who have defined roles in the performance improvement program and, if applicable, a list of positions that are dedicated to performance improvement activities for patients receiving trauma care from the trauma center;

b. The qualifications, skills, and knowledge required of the personnel members in the positions specified according to subsection (B)(7)(a);

c. The role each personnel member specified according to subsection (B)(7)(a) plays in the performance improvement program;

d. The trauma care parameters to be reviewed as part of the performance improvement program;

e. The frequency of review of trauma care parameters;

f. If an issue related to trauma care or to trauma care parameters is identified:

i. How a plan to address the issue is developed to reduce the chance of the issue recurring in the future;

ii. How the plan is documented;

iii. The mechanism and criteria by which the plan is reviewed and approved;

iv. How the plan is implemented; and

v. How implementation of the plan and future recurrences are monitored;

g. If applicable, the composition, duties, responsibilities, and frequency of meetings of the multidisciplinary peer review committee established according to subsection (B)(5);

h. If applicable, how the multidisciplinary peer review committee collaborates with the trauma center's quality management program; and

i. How changes proposed by the performance improvement program are reviewed by the trauma center's quality management program.

C. The owner of a trauma center shall ensure that:

1. The trauma registry, established according to subsection (B)(1), includes the information required in R9-25-1309 for each patient with whom the trauma center had contact who meets one or more of the following criteria:

a. A patient with injury or suspected injury who is:

i. Transported from a scene to a trauma center or an emergency department based on the responding emergency medical services provider's or ambulance service's triage protocol required in R9-25-201(E)(2)(b), or

ii. Transferred from one health care institution to another health care institution by an emergency medical services provider or ambulance service;

b. A patient with injury or suspected injury for whom a trauma team activation occurs; or

c. A patient with injury, who is admitted as a result of the injury or who dies as a result of the injury, and whose medical record includes one or more of specific ICD-codes indicating that:

i. At the initial encounter with the patient, the patient had:

(1) An injury or injuries to specific body parts,

(2) Unspecified multiple injuries,

(3) Injury of an unspecified body region,

(4) A burn or burns to specific body parts,

(5) Burns assessed through Total Body Surface Area percentages, or

(6) Traumatic Compartment Syndrome; and

ii. The patient's injuries or burns were not only:

(1) An isolated distal extremity fracture from a same-level fall,

(2) An isolated femoral neck fracture from a same-level fall,

(3) Effects resulting from an injury or burn that developed after the initial encounter,

(4) A superficial injury or contusion, or

(5) A foreign body entering through an orifice;

2. The following information is submitted to the Department, in a Department-provided format, according to subsection (C)(3):

a. The name and physical address of the trauma center;

b. The date the trauma registry information is being submitted to the Department;

c. The total number of patients whose trauma registry information is being submitted;

d. The quarter and year for which the trauma registry information is being submitted;

e. The range of emergency department or hospital arrival dates for the patients for whom trauma registry information is being submitted;

f. The name, title, e-mail address, telephone number, and, if available, fax number of the trauma center's point of contact for the trauma registry information;

g. Any special instructions or comments to the Department from the trauma center's point of contact;

h. The information from the trauma registry for patients identified during the quarter specified according to subsection (C)(2)(d); and

i. Updated information for any patients identified during the previous quarter, including the patient's name, medical record number, and admission date; and

3. The information required in subsection (C)(2) is submitted:

a. For patients identified between January 1 and March 31, so that the information in subsections (C)(2)(a) through (h) is received by the Department by July 1 of the same calendar year;

b. For patients identified between April 1 and June 30, so that the information in subsections (C)(2)(a) through (h) is received by the Department by October 1 of the same calendar year;

c. For patients identified between July 1 and September 30, so that the information in subsections (C)(2)(a) through (h) is received by the Department by January 2 of the following calendar year; and

d. For patients identified between October 1 and December 31, so that the information in subsections (C)(2)(a) through (h) is received by the Department by April 1 of the following calendar year.

D. Trauma centers under the same governing authority, as defined in A.R.S. § 36-401, may establish a single, centralized trauma registry and submit to the Department consolidated information from the trauma registry, according to subsections (C)(2) and (3), if:

1. The information submitted to the Department specifies for each patient in the trauma registry the trauma center that had contact with the patient; and

2. Each trauma center contributing information to the centralized trauma registry is able to:

a. Access, edit, and update the information contributed by the trauma center to the centralized trauma registry; and

b. Use the information contributed by the trauma center to the centralized trauma registry when complying with performance improvement program requirements in this Section.

E. As part of the performance improvement program, the owner of a trauma center shall ensure that the trauma program manager and, if applicable, trauma medical director periodically, according to policies and procedures:

1. Review the information in the trauma center's trauma registry; and

2. Monitor at least the following trauma care parameters, as applicable, for patients in the trauma registry:

a. EMS received by a patient;

b. Length of stay longer than two hours in the emergency department before transfer;

c. Instances of trauma team activation to determine if trauma team activation was timely and appropriate;

d. Instances where trauma care was provided to a patient but trauma team activation did not occur;

e. Time from notification of a surgeon on the trauma team that a patient described in subsection (H)(6)(b)(i) is in the emergency department to when the surgeon arrives in the emergency department;

f. Documentation of the nursing services provided to a patient;

g. Instances and reasons for transfer of a patient;

h. Instances and reasons for transfer to a hospital not designated as a trauma center;

i. For a hospital designated as a Level I trauma center, Level I Pediatric trauma center, Level II trauma center, or Level II Pediatric trauma center, instances and reasons for diversion, as defined in A.A.C. R9-10-201, of a patient requiring trauma care;

j. Instances of and circumstances related to the death of a patient;

k. Instances related to the assessment of child maltreatment;

l. Other patient outcomes;

m. Trauma care parameters for pediatric patients, including pediatric-specific measures; and

n. The completeness and timeliness of trauma data submission.

F. In addition to the requirements in subsections (A) through (E), the owner of a trauma center designated based on meeting the applicable standards specified in this Section and Table 13.1 shall:

1. Ensure that a trauma service is established if required by Table 13.1;

2. Ensure that policies and procedures for the trauma service are established, documented, and implemented that include:

a. The composition of the trauma team;

b. The qualifications, skills, and knowledge required of each personnel member of the trauma team;

c. Continuing education or continuing medical education requirements for each personnel member of the trauma team;

d. The roles and responsibilities of each personnel member of the trauma team;

e. Under what circumstances the trauma team is activated; and

f. How the trauma team is activated;

3. Ensure that the personnel members on the trauma team have the qualifications, skills, and knowledge required in the policies and procedures;

4. If the trauma center is required according to Table 13.1 to have a trauma medical director, appoint a board-certified or board-eligible surgeon as trauma medical director;

5. Prohibit a physician from serving as trauma medical director for the trauma center if the physician is serving as trauma medical director for another health care institution;

6. Ensure that the trauma medical director completes:

a. If the trauma center's designation is for a three-year period, at least 48 hours of external trauma-related continuing medical education during the term of the designation;

b. If the trauma center's designation is for a one-year period, at least 16 hours of external trauma-related continuing medical education during the term of the designation; and

c. If the trauma center is designated as a Level I Pediatric trauma center or Level II Pediatric trauma center, at least 12 of the 48 hours required in subsection (F)(6)(a) or four of the 16 hours required in subsection (F)(6)(b) in pediatric trauma-related continuing medical education;

7. Appoint an individual to act as trauma program manager to coordinate trauma service activities;

8. If the trauma center is required by Table 13.1 to have a multidisciplinary peer review committee, ensure that each surgeon on the trauma team designated according to subsection (F)(3) attends at least 50% of the meetings of the multidisciplinary peer review committee;

9. If the trauma center provides surgical services, ensure that policies and procedures for operating rooms and an operating room team are established, documented, and implemented that include:

a. The availability of an operating room for trauma care;

b. The composition of an operating room team;

c. The qualifications, skills, and knowledge required of each personnel member of an operating room team;

d. The roles and responsibilities of each personnel member of an operating room team;

e. If an operating room team is not on the premises of the health care institution 24 hours a day, under what circumstances the operating room team is notified to come to the trauma center; and

f. How the operating room team is notified;

10. Ensure that the following personnel members on the trauma team:

a. Hold current certification in a trauma critical care course:

i. Trauma medical director, if applicable;

ii. Each emergency medicine physician who is not board-certified or board-eligible; and

iii. Each physician assistant or registered nurse practitioner who is responsible for providing trauma care to patients in an emergency department in the absence of an emergency physician; or

b. Have held certification in a trauma critical care course:

i. Each general surgeon other than the trauma medical director, and

ii. Each emergency medicine physician who is board-certified or board-eligible;

11. If the trauma center is designated as a Level I trauma center, Level I Pediatric trauma center, Level II trauma center, or Level II Pediatric trauma center, ensure that each of the trauma team personnel members required in Table 13.1(C)(2) and (C)(3)(a) through (f) are board-certified or board-eligible;

12. If the trauma center is designated as a Level I Pediatric trauma center, ensure that the following trauma team members are fellowship-trained:

a. The surgeon credentialed for pediatric trauma care required in Table 13.1(C)(2)(a)(iii),

b. The pediatric emergency medicine physician required in Table 13.1(C)(2)(c),

c. The pediatric-credentialed orthopedic surgeon required in Table 13.1(C)(3)(b),

d. The pediatric-credentialed neurosurgeon required in Table 13.1(C)(3)(d), and

e. The pediatric-credentialed critical care medicine physician required in Table 13.1(C)(3)(f);

13. If the trauma center is designated as a Level II Pediatric trauma center, ensure that:

a. The pediatric-credentialed critical care medicine physician required in Table 13.1(C)(3)(f) is fellowship-trained, and

b. A fellowship-trained pediatric emergency medicine physician:

i. Provides direction for pediatric emergency trauma care and oversight of the treatment of pediat-ric patients as part of the performance improvement program, and

ii. Is appointed as a liaison to the multidisciplinary peer review committee established according to subsection (B)(5); and

14. If the trauma center is not designated as a Level I Pediatric trauma center or Level II Pediatric trauma center and annually provides trauma care to 100 or more injured children younger than 15 years of age who meet one or more of the criteria in subsection (C)(1)(c), ensure that the trauma center:

a. Complies with subsection (F)(13) and Table 13.1(C)(2)(a)(iii), (3)(b), (3)(d), and (3)(f) and (F)(2); and

b. Has a:

i. Pediatric emergency department area,

ii. Pediatric intensive care area, and

iii. Pediatric-specific trauma performance improvement program.

G. In addition to the requirements in subsections (A) through (E), the owner of a trauma center designated based on meeting the applicable standards specified in this Section and Table 13.1 shall ensure that the trauma center:

1. Establishes, documents, and implements a patient transfer plan, consistent with A.A.C. R9-10-211, that includes:

a. The criteria for transferring a patient,

b. The health care institution to which a patient meeting specific criteria will be transferred,

c. The personnel members who are responsible for coordinating the transfer of a patient, and

d. The process for transferring a patient;

2. Participates in state, local, or regional trauma-related activities such as:

a. The State Trauma Advisory Board, established by A.R.S. § 36-2222;

b. A regional emergency medical services coordinating council described in A.R.S. § 36-2222(A)(3);

c. Trauma Registry Users Group, established by the Department;

d. Trauma Managers Workgroup, established by the Department; or

e. Injury Prevention Council;

3. Participates in injury prevention programs specific to the trauma center's patient population at the national, regional, state, or local levels;

4. Except for a Level IV trauma center, conducts trauma care continuing education activities for physicians, trauma center personnel members, and EMCTs;

5. If required for the trauma center according to Table 13.1, establishes and maintains:

a. An injury prevention program:

i. Independently or in collaboration with other health care institutions, health advocacy groups, or the Department; and

ii. That includes:

(1) Designating a prevention coordinator who serves as the trauma center's representative for injury prevention and injury control activities;

(2) Carrying out injury prevention and injury control activities, including activities specific to the patient population;

(3) Conducting injury control studies;

(4) Monitoring the progress and effect of the injury prevention program; and

(5) Providing injury prevention and injury control information resources for the public; and

b. An educational outreach program:

i. Independently or in collaboration with other health care institutions, health advocacy groups, or the Department;

ii. That includes providing education to physicians, trauma center personnel members, EMCTs, and the general public; and

iii. That may include education about:

(1) Injury prevention,

(2) Trauma care,

(3) Other topics specific to the patient population,

(4) Criteria for assessing a patient who may require trauma care, and

(5) Criteria for the transfer of a patient requiring trauma care; and

6. If the trauma center holds a designation as a Level I trauma center or Level I Pediatric trauma center:

a. Establishes and maintains, either independently or in collaboration with other hospitals, a residency program or fellowship program that provides advanced medical training in emergency medicine, general surgery, orthopedic surgery, or neurosur-gery;

b. Participates in the provision of a trauma critical care course;

c. Conducts or participates in research related to trauma and trauma care; and

d. Maintains an Institutional Review Board, established consistent with 45 CFR Part 46 , to review biomedical and behavioral research related to trauma and trauma care involving human subjects, conducted, funded, or sponsored by the trauma center, in order to protect the rights of the human subjects of such research.

H. In addition to the requirements in subsections (A) through (E), the owner of a trauma center designated based on meeting the applicable standards specified in this Section and Table 13.1 shall:

1. Ensure the presence of a surgeon at all operative procedures;

2. If the trauma center provides emergency medicine, neurosurgery, orthopedic surgery, anesthesiology, critical care, or radiology as an organized service, ensure that:

a. A physician from the organized service is appointed to act as a liaison between the organized service and the trauma center's trauma service;

b. The physician in subsection (H)(2)(a) completes:

i. If the trauma center's designation is for a three-year period, at least 48 hours of trauma-related continuing medical education during the term of the designation;

ii. If the trauma center's designation is for a one-year period, at least 16 hours of trauma-related continuing medical education during the term of the designation; and

iii. If the trauma center is designated as a Level I Pediatric trauma center or Level II Pediatric trauma center, at least 12 of the 48 hours required in subsection (H)(2)(b)(i) or four of the 16 hours required in subsection (H)(2)(b)(ii) in pediatric trauma-related continuing medical education; and

c. If the trauma center is required by Table 13.1 to have a multidisciplinary peer review committee, ensure the physician in subsection (H)(2)(a) attends at least 50% of the meetings of the multidisciplinary peer review committee;

3. Ensure that, when a physician is on-call for general surgery, neurosurgery, or orthopedic surgery, the physician is not on-call or on a back-up call list at another health care institution;

4. Ensure that policies and procedures are established, documented, and implemented for:

a. Except for a Level IV trauma center, the formulation of blood products to be available during an event requiring multiple blood transfusions for a patient or patients; and

b. For a Level IV trauma center, the expedited release of blood products during an event requiring multiple blood transfusions for a patient or patients;

5. Ensure that the patient transfer plan required in subsection (G)(1) includes processes for transferring a patient needing:

a. Acute hemodialysis or pediatric trauma care to a hospital providing the required service if the trauma center is designated as a:

i. Level III or Level IV trauma center; or

ii. Level II trauma center and does not provide, as applicable, acute hemodialysis or pediatric trauma care;

b. Burn care as an organized service, acute spinal cord management, microvascular surgery, or replant surgery to a hospital providing the required service if the trauma center is designated as a:

i. Level III or Level IV trauma center; or

ii. Level I or Level II trauma center and does not provide, as applicable, burn care as an organized service, acute spinal cord management, microvascular surgery, or replant surgery; or

c. Another service that the trauma center is not authorized or not able to provide to a hospital providing the required service;

6. Except for a Level IV trauma center or as provided in subsection (I), require that:

a. An emergency medicine physician is present in the emergency department at all times;

b. A surgeon on the trauma team is present in the emergency department:

i. For a patient:

(1) If an adult, with a systolic blood pressure less than 90 mm Hg or, if a child, with confirmed age-specific hypotension;

(2) With respiratory compromise, respiratory obstruction, or intubation;

(3) Who is transferred from another hospital and is receiving blood to maintain vital signs;

(4) Who has a gunshot wound to the abdomen, neck, or chest;

(5) Who has a Glasgow Coma Scale score less than 8 associated with an injury attributed to trauma; or

(6) Who is determined by an emergency department physician to have an injury that has the potential to cause prolonged disability or death; and

ii. No later than the following times:

(1) For a Level I trauma center, Level I Pediatric trauma center, Level II trauma center, or Level II Pediatric trauma center, within 15 minutes after notification or at the time the patient arrives in the emergency department, whichever is later; or

(2) For a Level III trauma center, within 30 minutes after notification or at the time the patient arrives in the emergency department, whichever is later; and

c. One of the following anesthesia personnel members is available for an operative procedure on a patient at the indicated time point:

i. For a Level I trauma center, Level I Pediatric trauma center, Level II trauma center, or Level II Pediatric trauma center, an anesthesiologist, anesthesiology chief resident, or certified registered nurse anesthetist is present in the emergency department or in an operating room area awaiting the patient no later than 15 minutes after patient arrival in the emergency department; and

ii. For a Level III trauma center, an anesthesiologist, anesthesiology chief resident, or certified registered nurse anesthetist is present in the emergency department or in an operating room area awaiting the patient no later than 30 minutes after patient arrival in the emergency department;

7. For a clinical capability required for the trauma center according to Table 13.1(C)(3), require that the on-call radiologist, critical care medicine physician, or surgical specialist is available to provide medical services, as applicable to the specialist, for a patient requiring trauma care within 45 minutes after notification; and

8. For personnel members assigned to an operating room team according to subsection (F)(9), require that the personnel members on the operating room team are on the premises of the trauma center while on duty or:

a. For a Level I trauma center, Level I Pediatric trauma center, Level II trauma center, Level II Pediatric trauma center:

i. Are available to provide operative services for a patient requiring trauma care within 15 minutes after notification or patient arrival at the trauma center, whichever is later; and

ii. Have response times and patient outcomes monitored through the performance improvement program; and

b. For a Level III trauma center or Level IV trauma center, if the Level IV trauma center provides surgical services:

i. Are available to provide operative services for a patient requiring trauma care within 30 minutes after notification orpatient arrival at the trauma center, whichever is later; and

ii. Have response times and patient outcomes monitored through the performance improvement program.

I. The Department shall consider a trauma center designated based on meeting the applicable standards specified in this Section and Table 13.1 to be in compliance with subsection (H)(6)(a), (b), or (c), as applicable, if the trauma center has documentation showing that:

1. The individual required to be present at the indicated location and within the indicated time period was present 80% or more of the time, and

2. The trauma center monitors the rate of compliance with subsection (H)(6) and patient outcomes through the performance improvement program.

J. The requirement in subsection (H)(6)(b) applies whether or not the owner of a trauma center allows a surgery resident in the fourth or fifth year of residency training to begin treating a patient described in subsection (H)(6)(b)(i) while awaiting the arrival of the surgeon on the trauma team, as required in subsection (H)(6)(b)(ii)(1) or (2).

K. An ALS base hospital certificate holder that chooses to submit trauma registry information to the Department, as allowed by A.R.S. § 36-2221(A), shall:

1. Include in the ALS base hospital's trauma registry at least the information required in R9-25-1309(A) for each patient who meets one or more of the criteria in subsections (C)(1)(a) through (c), and

2. Comply with the submission requirements in subsections (C)(2) and (3).

Ariz. Admin. Code § R9-25-1308

New Section made by final rulemaking 11 A.A.R. 4363, effective October 6, 2005 (Supp. 05-4). Amended and renumbered from R9-6-1313 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.