6 Colo. Code Regs. § 1015-4-309

Current through Register Vol. 47, No. 24, December 25, 2024

Section 6 CCR 1015-4-309 - Facility Designation Criteria - Regional Pediatric Trauma Centers

1. Administration and organization criteria. A Regional Pediatric Trauma Center as defined in Section 25-3.5-703(4)(f), C.R.S. shall have a trauma program with:

A. An administrative organizational structure which identifies the institutional support and commitment. The program's location within that structure must be placed so that it may interact with at least equal authority with other departments providing patient care within the facility.

B. Medical staff commitment to support the program demonstrated by a written commitment to provide the specialty care needed to support optimal care of the injured patient and specific delineation of surgical privileges.

C. A Trauma Medical Director who is a board certified pediatric surgeon, credentialed by the facility for pediatric trauma care.

D. A facility-defined Trauma Team, with an identifiable team leader.

E. A facility-defined Trauma Team activation protocol. The protocol shall base activation of the team on the anatomical, physiological, mechanism of injury, and co-morbid factors as outlined in the Pediatric Prehospital Trauma Triage Algorithms as set forth in 6 CCR 1015-4, Chapter One.

F. A facility-defined trauma service comprised of the personnel and resources identified as needed to provide care for the injured patient. All multi-system trauma patients shall be admitted to this service. The Trauma Medical Director shall direct the service and the cadre of residents or other allied health personnel assigned to that service at any given time.

G. A full time registered nurse identified as the Trauma Program Manager, with educational preparation, certification, and clinical experience in care of the injured as defined by the facility. This position is responsible for the organization of services and systems necessary for a multidisciplinary approach to care of the injured patient.

H. A multi-disciplinary Trauma Committee with specialty representation. This committee is involved in the development of a plan of care for the injured patient and is responsible for trauma program performance.

I. A multidisciplinary Peer Review Committee as defined by the facility. This committee is responsible for monitoring compliance to the facility-defined clinical and system standards of care for trauma patients.

J. Hospital departments/divisions/sections:

(1) General Pediatric Surgery;

(2) Neurological Surgery;

(3) Orthopedic Surgery;

(4) Emergency Medicine; and

(5) Anesthesia.

K. Support services/ancillary services, with policies and procedures for access to:

(1) Chemical dependency services;

(2) Child and adult protection services;

(3) Clergy or pastoral care;

(4) Nutritionist services;

(5) Occupational therapy services;

(6) Pediatric therapeutic recreation;

(7) Pharmacy, with an in-house pharmacist;

(8) Physical therapy services;

(9) Psychological services;

(10) Rehabilitation services;

(11) Social services; and

(12) Speech therapy services.

2. Clinical Capabilities Criteria

A. The following services in house and available 24 hours a day with:

(1) Pediatric surgery within five minutes of Trauma Team activation. Coverage shall be provided by:

a. An attending board certified pediatric surgeon credentialed by the facility for pediatric trauma care who may only take call at one facility at any one time or have a published backup call schedule; or

b. A post graduate year four (PGY4) or above surgical resident may initiate evaluation and treatment upon the patient's arrival until the arrival of the attending surgeon. In this case, the attending surgeon shall be available within 20 minutes of request by the resident,

(2) Pediatric neurosurgery. Coverage shall be provided by:

a. the attending board certified neurosurgeon, who may only take call at one facility at any one time or have a published backup call schedule; or

b. a surgeon who has been judged competent by the chief of neurosurgery to initiate measures to stabilize the patient and initiate diagnostic procedures. In this case, the attending neurosurgeon shall be available within 30 minutes of notification or request by the Trauma Team leader,

(3) Pediatric anesthesiology. Coverage shall be provided by:

a. a board certified anesthesiologist in the O.R. at time of arrival of the patient; and

b. a chief resident or fellow within 5 minutes of request by the Trauma Team leader,

(4) Pediatric emergency medicine. Coverage shall be provided by:

a. a physician board certified in pediatric emergency medicine; or

b. a physician in a pediatric emergency medicine fellowship at PGY5 level or higher; or

c. a physician having completed pediatric emergency medicine training within the past five years.

B. The following surgical services on-call and present within 30 minutes of request by the Trauma Team leader:

(1) Cardio/thoracic surgery;

(2) Ophthalmic surgery;

(3) Oral/maxillofacial/ENT surgery;

(4) Orthopedic surgery with a board certified orthopedic surgeon, who may only take call at one facility at any one time or have a published backup call schedule; and

(5) Urologic surgery.

C. The following non-surgical and surgical specialties including:

(1) A pediatric radiologist on call and available for patient service within 30 minutes of request by the Trauma Team leader.

(2) The following services on call and available for patient consultation or management:

a. Cardiology;

b. Infectious disease;

c. Hand surgery;

d. Microvascular surgery;

e. Plastic surgery;

f. Pulmonary medicine;

g. Nephrology; and

h. Hematology.

3. Facilities/Resources/Capabilities Criteria:

A. An emergency department with:

(1) Personnel, to include:

a. A designated physician director who is board certified in pediatric emergency medicine;

b. Physician(s) designated as a member of the Trauma Team, physically present in the emergency department 24 hours a day, who:

i. Are board certified in pediatric emergency medicine; or

ii. Are in a pediatric emergency medicine fellowship at PGY5 level; or

iii. Have completed pediatric emergency medicine training within the past five years.

c. Registered nursing personnel who provide continuous monitoring of the trauma patient until release from the emergency department, who have successfully completed a Trauma Nurse Core Course (TNCC) or equivalent course, and a Pediatric Advanced Life Support (PALS) course.

(2) Equipment for the resuscitation of patients of all ages shall include but not be limited to:

a. Airway control and ventilation equipment including laryngoscopes and endotracheal tubes of all sizes, bag mask resuscitators, and oxygen;

b. Pulse oximetry;

c. End-tidal CO 2 determination;

d. Suction devices;

e. Electrocardiograph and defibrillator with internal paddles - adult and pediatric;

f. Apparatus to establish central venous pressure monitoring;

g. Standard intravenous fluids and administration devices, including large bore intravenous catheters;

h. Sterile surgical sets for:

i. Airway control/cricothyrotomy;

ii. Thorocostomy - needle and tube;

iii. Thoracotomy;

iv. Vascular/intraosseous access;

v. Central line insertion; and

vi. ICP monitoring equipment.

i. Gastric decompression;

j. Drugs necessary for emergency care;

k. X-ray availability, 24 hours a day;

l. Two-way communication with emergency transport vehicles;

m. Spinal immobilization equipment;

n. Arterial catheters;

o. Thermal control equipment for:

i. Patients, and

ii. Blood and fluids;

p. Rapid infuser system; and

q. Length-based emergency tape (LBET).

(3) Protocols/procedures for management of the injured child in the emergency department.

B. An operating room available within 30 minutes of request 24 hours a day with:

(1) Facility-defined operating room team in-house and available within 10 minutes of request of Trauma Team leader.

(2) Equipment for all ages shall include, but not be limited to:

a. Cardiopulmonary bypass capability;

b. Operating microscope and microinstruments;

c. Thermal control equipment for:

i. Patients, and

ii. Blood and fluids;

d. X-ray capability, including C-arm image intensifier;

e. Endoscopes;

f. Craniotomy instruments;

g. Equipment for fixation of long bone and pelvic fracture; and

h. Equipment for spinal immobilization and instrumentation.

C. Postanesthesia Care Unit (surgical intensive care unit is acceptable) with:

(1) Registered nurses available within 30 minutes of request 24 hours a day;

(2) Equipment for the continuous monitoring of temperature, hemodynamics, gas exchange, and intracranial pressure;

(3) Thermal control equipment for:

a. Patients, and

b. Blood and fluids.

(4) Compartmental pressure monitoring equipment.

D. Intensive Care Unit for injured patients with:

(1) Personnel, to include:

a. A surgical director, who:

i. Is responsible for setting policies and administration related to pediatric trauma ICU patients; and

ii. Has obtained critical care training during residency or fellowship and has expertise in the perioperative and post injury care of the injured child.

b. A physician, credentialed in pediatric critical care, or a pediatric intensivist, approved by the Trauma Medical Director, who is in the hospital and available within 30 minutes of notification.

c. Registered nurses with facility-defined trauma education program.

(2) Equipment for monitoring and resuscitation, to include: intracranial pressure monitoring, compartment pressure monitoring, and continuous monitoring of temperature, hemodynamics, and gas exchange.

E. Acute hemodialysis available in house.

F. Radiological services, available 24 hours a day to the trauma patient, with:

(1) The following technicians:

a. In-house radiology technician available within 10 minutes of notification; and

b. In-house CT technician available within 10 minutes of notification.

(2) The following services:

a. MRI, on site without vehicular transfer of the patient;

b. Angiography;

c. Sonography;

d. Computed tomography (CT); and

e. Interventional radiology.

(3) Physician and technical support staff for the services identified above shall be in-house or available within 30 minutes.

G. Clinical laboratory services, to include:

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

(2) Blood typing and cross matching;

(3) Coagulation studies;

(4) Blood and blood components available from in-house, or through community services, to meet patient needs and blood storage capability;

(5) Blood gases and pH determination;

(6) Microbiology;

(7) Serum alcohol and toxicology determination; and

(8) Clinical laboratory technician available in house.

H. Respiratory therapy services, in house.

I. Acute spinal cord management, with surgeons capable of addressing acute spinal cord injury, and with protocols/procedures to address early assessment of the spinal cord injured patient for management or transfer.

J. Organized burn care for those patients identified in Section 308 of this chapter with:

(1) Specialty designation as a burn center; or

(2) Transfer agreements with a facility with a specialty designation as a burn center.

K. Rehabilitation services, with:

(1) Leadership of the service by a physician who is a physiatrist or who specializes in orthopedic or neurologic rehabilitation, and

a. Protocols/procedures for the early assessment of the rehabilitation needs of the injured child;

b. Physical therapy;

c. Occupational therapy;

d. Speech therapy; and

e. Social services.

L. Outreach program, with telephone and on-site consultations with physicians of the community and outlying areas regarding pediatric trauma care.

M. Injury prevention/public education, with:

(1) Injury prevention with:

a. A designated prevention coordinator;

b. Outreach activities and program development;

c. Information resources for the public; and

d. Collaboration with existing national, regional, and state programs.

(2) Injury control research, which may include:

a. Collaboration with other facilities in prevention research;

b. Monitoring progress/effect of prevention programs; and

c. Special surveillance project/data collection projects.

N. Trauma research program, with:

(1) A designated director;

(2) Regular meetings of the research group;

(3) Evidence of productivity, to include:

a. Proposals reviewed by an Internal Review Board (IRB);

b. Presentations at local/regional/national meetings;

c. Publications in peer-reviewed journals; and

d. Peer-reviewed extramural funding for research activities.

O. Continuing medical education (CME), with

(1) In-house CME for:

a. Staff physicians;

b. Nurses;

c. Allied health personnel; and

d. Community physicians.

(2) Physician CME requirements for emergency medicine, trauma surgery, orthopedics, and neurosurgery -16 CME hours annually or 48 CME hours over the three year period preceding any site review, with half outside own facility.

(3) Nursing CME requirements for emergency department and ICU - 8 hours annually or 24 hours over 3 years.

P. Organ/tissue procurement protocols/procedures.

Q. Trauma divert protocols, to include:

(1) A method to report trauma diverts to the Regional Emergency Medical and Trauma Advisory Council (RETAC) for monitoring;

(2) A method for notification of prehospital providers when on divert;

(3) Facility-defined criteria for going on divert, not to exceed those identified in 6 CCR 1015-4, Chapter One; and

(4) A method for monitoring times and reasons for going on divert.

R. Trauma transfer agreements as a transferring and receiving facility, renewed every 3 years.

S. Interfacility consultation protocols/procedures for attending surgeon availability for responding to mandatory consultations and arranging transfers from Level I, II, III, IV, V, and nondesignated trauma centers.

T. A trauma registry as required in 6 CCR 1015-4, Chapter Two and trauma data entry support.

U. A performance improvement process in accordance with Section 303.3.A of this chapter.

V. Participation in RETAC quality improvement programs established in accordance with 6 CCR 1015-4, Chapter Four.

6 CCR 1015-4-309

39 CR 02, January 25, 2016, effective 2/14/2016

40 CR 08, April 25, 2017, effective 5/15/2017

41 CR 22, November 25, 2018, effective 12/15/2018

42 CR 10, May 25, 2019, effective 6/14/2019

43 CR 09, May 10, 2020, effective 6/14/2020

44 CR 10, May 25, 2021, effective 7/1/2021