Ill. Admin. Code tit. 77 § 515.2030

Current through Register Vol. 48, No. 45, November 8, 2024

Section 515.2030 - Level I Trauma Center Designation Criteria

a) Level I Trauma Centers, under the direction of Level I Trauma Center Medical Directors, shall be responsible for coordinating and managing trauma care in the EMS Region. This responsibility includes obtaining the cooperation of all Level II Trauma Centers, Participating Hospitals, and EMS Systems in the EMS Region. A Level I Trauma Center Medical Director shall be the chairperson of the Regional Trauma Advisory Committee.

b) The Trauma Center Medical Director shall be a trauma surgeon, board certified in surgery, with at least two years of post-residency experience in trauma care and with 24-hour independent operating privileges.

c) The trauma center shall provide a trauma service, separate from the general surgery service, that is an identified hospital service functioning under the designated director and staffed by trauma surgeons with one year of experience in trauma, and who are available in-house 24 hours a day for immediate response.

1) Trauma surgeons shall have 10 hours of trauma-related CME every two years.

2) The trauma surgeon requirement may be fulfilled by residents with a minimum of four years of general surgery residency training with independent operating room privileges and who have current Advanced Trauma Life Support (ATLS) verification.

3) If the resident is fulfilling the trauma surgeon requirement, the attending physician must be consulted within 30 minutes after the patient's being classified as Category I or II.

4) If the resident is fulfilling the trauma surgeon requirement, it is mandatory that an attending be present 30 minutes after the decision to operate is made.

5) The trauma surgeon, resident or surgical subspecialist shall be consulted when the decision is made to admit a Category II patient. The trauma surgeon or appropriate subspecialist shall see the patient within 12 hours after Emergency Department (ED) arrival.

6) A physician with current ATLS verification or who has current competency in the initial resuscitation of the trauma patient as verified by the professional staff competency plan must be present 24 hours per day in the Level I Trauma Center to treat the trauma patient.

7) The hospital's quality improvement program shall monitor compliance with this subsection (c).

8) The trauma center shall have the option of allowing the ED personnel to determine that a trauma patient with an isolated injury may be treated by one of the services listed in subsection (d) of this Section. An isolated injury refers to the transfer of energy to a single specific anatomic body region with no potential for multisystem involvement. The subspecialist is to arrive within the designated time listed in subsection (d) after notification that his or her services are needed at the hospital. When the need for neurosurgical intervention has been identified, the neurosurgeon must arrive and be available in a fully staffed operating room within 60 minutes after the identification of need for operative intervention.

d) The trauma center shall have the following surgical services within the designated times listed below:

1) On call to arrive at the hospital to treat the patient within 30 minutes after notification that their services are needed at the hospital:

A) Cardiothoracic; this requirement may be fulfilled by a cardiothoracic surgeon or a trauma/general surgeon with experience in cardiothoracic surgery for lifesaving procedures; the surgeon must have cardiothoracic privileges;

B) Obstetrics; and

C) Pediatric surgery as designated by Section 515.2035 of this Part or by transfer agreement.

2) On call to arrive at the hospital to treat the patient within 60 minutes after notification that their services are needed at the hospital:

A) Orthopedic;

B) Vascular;

C) Ophthalmologic;

D) Oral-Dental;

E) Otorhinolaryngologic;

F) Plastic/maxillofacial;

G) Urologic;

H) Reimplantation service, or a transfer agreement; and

I) Neurosurgical. When the need for neurosurgical intervention has been identified, the neurosurgeon must arrive and be available in a fully staffed operating room within 60 minutes after the identification of the need for operative intervention.

3) Twenty-four hours a day, or a transfer agreement:

A) Burn center staffed by Registered Nurses trained in burn care; and

B) Acute spinal cord injury management.

e) The trauma center shall provide the following nonsurgical services within the designated times:

1) Emergency Medicine staffed 24 hours a day in the ED by:

A) A physician who has competency in trauma as demonstrated by:

i) Board certification or board eligibility by the American Board of Emergency Medicine (ABEM) or the American Osteopathic Board of Emergency Medicine (AOBEM) of the American Osteopathic Association (AOA); and

ii) Ten hours per year of American Medical Association (AMA) or AOA-approved Category I or II trauma-related CME; or

B) A physician who was working in the emergency department of a trauma center prior to January 1, 2000, and who had completed 12 months of internship, followed by at least 7000 hours of hospital-based Emergency Medicine over at least a 60-month period (including 2800 hours within one 24-month period), and CME totaling 50 hours, 10 of which are trauma related, for each post-internship year in which the physician completed any hospital-based Emergency Medicine hours.

2) Anesthesiology Services:

A) The anesthesiology service or department shall be supervised by anesthesiologists. "Supervise", for the purposes of this subsection, means to manage, control and direct the services performed, including being present in the trauma center and immediately available for consultation while the services are being performed.

B) Anesthesiology services shall be available 24 hours a day in-house.

C) Direct patient care services may be performed by an anesthesiologist or a certified registered nurse anesthetist (CRNA) acting under the direct supervision of an anesthesiologist.

3) Radiology staffed by:

A) A technician with the ability to perform a computerized axial tomography (CAT) scan in-house, 24 hours a day.

B) A radiologist with the ability to read CAT scans and perform angiography available within 30 minutes. This requirement may be met by a Post Graduate Year (PGY) II radiology resident with six months experience in CAT and angiography. Teleradiographic equipment may be used to transmit CAT scans to radiologists off site in lieu of the radiologists' response to the trauma center to read CAT scans. The radiology department shall provide a quality monitoring process to validate the resident's compliance with the time requirements and competency to read CAT scans and perform angiography.

4) Intensive Care Medicine Unit (ICU) having available 24 hours a day in-house:

A) A physician credentialed by the hospital. This requirement may be fulfilled by second and third year residents who have had intensive care training and are under the supervision of a staff physician possessing full intensive care privileges;

B) One Registered Professional Nurse per shift with two years of ICU or critical care experience and four hours of trauma-related critical care continuing education per year; and

C) The following equipment:

i) Airway control and ventilation devices;

ii) Oxygen source with concentration controls;

iii) Cardiac emergency cart;

iv) Electrocardiograph-oscilloscope-defibrillator;

v) Cardiac output monitoring;

vi) Electronic pressure monitoring;

vii) Mechanical ventilator-respirators;

viii) Pulmonary function measuring devices, i.e., pulse oximeter and CO₂ monitoring;

ix) Temperature control devices;

x) Drugs, intravenous fluids, and supplies in accordance with the Hospital Licensing Requirements (77 Ill. Adm. Code 250.1050, 250.2140, and 250.2710);

xi) Intracranial pressure monitoring devices; and

xii) Intra-aortic balloon pump capability.

5) Laboratory 24 hours a day in-house, providing the following:

A) Standard analysis of blood, urine, and other body fluids;

B) Blood typing and cross-matching;

C) Coagulation studies;

D) Comprehensive blood bank or access to a community central blood bank and adequate hospital storage facilities (see Hospital Licensing Requirements (77 Ill. Adm. Code 250.520));

E) Blood gases and pH determinations;

F) Microbiology, to include the ability to initiate aerobic and anaerobic cultures on a 24 hour per day basis; and

G) Drug and alcohol screening.

6) Cardiology -- 60 minutes.

7) Internal Medicine -- 60 minutes.

8) Pediatrics -- 60 minutes.

9) Postanesthetic recovery capabilities 24 hours a day (may be fulfilled by ICU).

10) Acute hemodialysis capability 24 hours a day.

11) The trauma center shall demonstrate an ongoing relationship with its designated organ procurement agency (OPA).

f) The trauma center shall meet the following professional staff requirements:

1) The ED Director shall be a physician board certified by the ABEM or certified by the AOBEM of the AOA;

2) The ED treating the Category I or Category II trauma patient shall be cared for by at least one RN who holds a current nationally recognized trauma nursing certification such as Trauma Certified Registered Nurse (TCRN), Advanced Trauma Certified Nurse (ATCN), or Trauma Nursing Core Course (TNCC); or is currently recognized as a Trauma Nurse Specialist (TNS);

3) A full-time Trauma Coordinator shall be dedicated solely to the Trauma Program;

4) An operating room shall be staffed in-house and available 24 hours a day; and

5) Staff shall include occupational therapy, speech therapy, physical therapy, social work, dietary, and psychiatry.

g) The trauma center shall develop a professional staff competency plan, including but not limited to trauma surgeons and emergency medicine physicians treating the trauma patients. Physicians caring for trauma patients in the Level I Trauma Center must demonstrate the following:

1) Board certification/Board eligibility in their specialty;

2) Successful completion of trauma-related CME requirements as specified in this Section;

3) Ongoing clinical involvement in the care of the trauma patient as evidenced by the routine participation in one or more of the following: trauma call rosters, trauma teams, and attendance at trauma rounds/trauma meetings;

4) Physician specific outcome measurements for high volume/high acuity procedures;

5) For trauma surgeons and emergency medicine physicians only, the successful completion of an ATLS provider course.

h) The trauma center shall provide and maintain the following equipment:

1) Airway control and ventilation equipment including laryngoscopes and endotracheal tubes of appropriate sizes, bag-mask, resuscitator, sources of oxygen, mechanical ventilator, pulse oximetry and CO₂ monitoring;

2) Suction devices and equipment (pulmonary and gastric);

3) Electrocardiograph-oscilloscope-defibrillator;

4) Apparatus to establish central venous pressure monitoring;

5) All standard intravenous fluids and administration devices;

6) Sterile surgical instruments or sets for emergency care, such as cricothyrotomy, tracheostomy, thoracotomy, thoracostomy, cut down, peritoneal lavage, and intraosseous;

7) Drugs and supplies necessary for emergency care;

8) X-ray and CAT scan capability;

9) Spinal immobilization equipment;

10) Temporary pacemaker;

11) Temperature control device; and

12) Specialized pediatric resuscitation cart with measuring device in the emergency area.

AGENCY NOTE: Broselow(TM) Pediatric Tape will meet this requirement.

i)The trauma center must have helicopter landing capabilities approved by State and federal authorities. (Section 3.95(i) of the Act) The helicopter landing capabilities shall:

1) Comply with the Aviation Safety Rules of the Illinois Department of Transportation (92 Ill. Adm. Code 14, specifically 14.790, 14.792, and 14.795);

2) Be covered by a favorable airspace determination letter issued by the Federal Aeronautics Administration pursuant to Sections 307 and 309 of the Federal Aviation Act of 1958, and 14 CFR 157 and 14 CFR 77, Subpart D;

3) Be provided on the campus of the trauma center; and

4) Out-of-state trauma centers are exempt from this subsection but must provide proof of compliance with their state's rules that govern aviation safety.

j) The trauma center shall perform focused outcome analyses of its trauma services on a quarterly basis, and shall provide on site or upon request all minutes related to these reviews to the Department. The analyses shall consist of at least:

1) Review of all patient deaths, excluding dead on arrival (DOA). Patients must be assigned a status of non-preventable death, potentially preventable death, preventable death, or cannot be determined, using the American College of Surgeons "Performance Improvement" (Chapter 16, from "Resources for Optimal Care of the Injured Patient, 1999"). Factors contributing to the death must be included in the review. A cumulative report of these findings should be kept on site and available to the Department upon request.

2) Review of all morbidities. A morbidity is a negative outcome that is the result of the original trauma and/or treatment rendered or omitted. Factors contributing to the morbidity must be included in the review. A cumulative report of these findings must be presented quarterly to the Region.

3) Review of audit filters. An audit filter is a clinical and/or internal resource indicator used to examine the process of care and to identify potential patient care and/or internal resource problems.

4)All information contained in or relating to any medical audit performed of a trauma center's trauma services pursuant to the Act or by an EMSMD or his designee of medical care rendered by system personnel, shall be afforded the same status as is provided information concerning medical studies in Article VIII, Part 21 of the Code of Civil Procedure. (Section 3.110(a) of the Act)

k) Every two years the trauma center shall provide written protocols with the redesignation packet, which shall include the following:

1) Policies for treating patients in the Level I Trauma Center, which include Trauma Category I and Trauma Category II criteria as required in Section 515.Appendices C and F of this Part;

2) Clinical protocols for the management of the trauma patient in basic resuscitation and management of specific injuries, kept on site and available to the Department upon request;

3) The protocols for transferring trauma patients to more specialized care;

4) A policy that a blood alcohol test will be drawn on any motor vehicle crash victim who is believed to have been the driver of the vehicle;

5) A suspension policy for trauma nurse specialists, meeting due process requirements (see Section 515.2200); and

6) A professional staff competency plan in accordance with subsection (g) of this Section.

l) Changes to the Trauma Center Plan must be approved by the Department prior to implementation.

m) The practices of the trauma center shall reflect the protocols and policies of the EMS Region and Trauma Center plan.

n) The resuscitation care of a Trauma Category I or Trauma Category II patient must be documented on a Trauma Flow Sheet, which at minimum contains trauma category classification; time and place of classification (field or in-house); time of arrival of patient to trauma center; notification of surgical specialties and time of arrival to see patient (may exclude isolated injuries for Category II patients).

o) The trauma center shall maintain a job description for the Trauma Center Medical Director that details his/her responsibility and authority for the coordination and management of trauma services.

p) The trauma center shall maintain a job description for the Trauma Coordinator that details his/her responsibility and authority for the coordination and management of trauma services.

q) The trauma service must be identified in the facility's budget, with sufficient funds dedicated to support the trauma director and trauma coordinator's positions and to provide for the operation of the trauma registry.

r) The trauma center shall develop a policy that identifies resource limitations that would result in the diversion of a trauma patient to another facility. The hospital shall also develop a policy that identifies what measures will be taken to avoid requesting a resource limitation/bypass (see Section 515.315).

1) Such diversion must be reported to the Department by telephone if it occurs during business hours or written notification by fax of diversion must be sent within 24 hours following the diversion.

2) Both forms of notification shall include at minimum:

A) The name of the trauma center;

B) Date and time of resource limitation; and

C) The reason for resource limitation.

s) The trauma center shall develop a plan for implementing a program of public information and education concerning trauma care for adult and pediatric patients.

Ill. Admin. Code tit. 77, § 515.2030

Amended at 25 Ill. Reg. 16386, effective December 20, 2001

Amended at 46 Ill. Reg. 20898, effective 12/16/2022