6 Colo. Code Regs. § 1015-4-303

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

Section 6 CCR 1015-4-303 - Trauma Facility Designation Criteria - Level I and II Facilities

1. Prehospital Trauma Care Integration

A. The facility shall participate in the development and improvement of prehospital care protocols and patient safety programs.

B. The Trauma Medical Director shall be involved in the development of the trauma facility's divert protocol as it affects the trauma service.

C. A trauma surgeon shall be involved in any decision regarding divert as it affects the care of the trauma patient.

D. A liaison from the emergency department shall participate in prehospital peer review/performance improvement.

2. Interfacility Consultation, Transfer Requirements, and Emergent Surgery

A. The facility shall provide on-going consultation, education, and technical support to referring facilities, individuals, or RETACS.

B. Provisions for direct physician-to-physician contact shall be included in the process of transferring a patient between facilities.

C. The decision to transfer a patient shall be based on the clinical needs of the patient. Physicians shall be allowed to transfer when in the best interest of the patient and shall not be encumbered by restrictions to keep patients within a particular healthcare organization or based on the patient's ability to pay.

D. If the facility does not have a burn service, a reimplantation service, a pediatric trauma service, or an acute rehabilitation service, the facility shall have written transfer guidelines for patients in these categories.

E. All Level I and II trauma centers may perform emergent surgery if appropriate resources are available. If after the emergent surgery is performed, the facility does not have the post-operative resources to care for the patient and for potential complications, the facility shall transfer to a trauma center with the necessary resources to meet the patient's needs.

F. Mandatory Transfers

(1) Patients of any age with a traumatic injury requiring resources beyond those available in the facility's scope of care, see 6 CCR 1015-4, Chapter Three, 303.4.B(1), shall be transferred.

(2) Levels I and II trauma centers that only admit children have a single extremity orthopedic fracture or minor head trauma, as determined by best practice guidelines, shall transfer any other pediatric patients, after emergency surgery, as necessary.

(a) Transfer shall be to a Regional Pediatric Trauma Center or to a Level I or II trauma center that admits pediatric trauma patients.

(b) The receiving trauma center must meet the requirements set forth in 6 CCR 1015-4, Chapter Three, Section 303.9.D and have a pediatric intensive care area staffed by a board certified or board eligible pediatric intensivist available for consultation or have a transfer protocol and transfer agreements for pediatric patients requiring intensive care.

(c) The receiving trauma center must have a neurosurgeon on call with qualifications necessary to manage pediatric neurotrauma.

3. Performance Improvement Process

A. General Provisions

(1) The facility shall demonstrate a clearly defined trauma performance improvement program that shall be coordinated with the hospital-wide program.

(2) The facility shall be able to demonstrate that the trauma patient population can be identified for separate review regardless of the institutional performance improvement processes.

(3) Performance improvement shall be supported by a reliable method of data collection that consistently obtains valid and objective information necessary to identify opportunities for improvement. The process of analysis shall include multidisciplinary review and shall occur at regular intervals to meet the needs of the program. The results of analysis shall define corrective strategies and shall be documented.

(4) The facility shall demonstrate that the trauma registry is used to support the performance improvement program.

(5) The performance improvement program shall have defined audit filters based upon a regular review of registry and/or clinical data.

(6) There shall be appropriate, objectively defined standards to determine the quality of care.

(7) If more than 10 percent of injured patients with an Injury Severity Score greater than or equal to nine (excluding isolated hip fractures) are admitted to non-surgical services, the trauma facility shall demonstrate the appropriateness of that practice through the performance improvement program.

(8) Identified problem trends shall undergo peer review by the Peer Review/Performance Improvement Committee.

(9) The facility shall review any diversion or double transfer (from another facility and then transferred for additional acute trauma care) of trauma patients.

(10) The facility shall demonstrate that its graded activation criteria are regularly evaluated by the performance improvement program.

(11) Physician availability to the trauma patient in the ICU shall be monitored by the peer review/performance improvement program.

B. Multidisciplinary Trauma Committee

(1) The facility shall have a multidisciplinary committee to address trauma program operational issues.

(2) A multidisciplinary trauma committee shall continuously evaluate the trauma program's processes and outcomes.

(3) The committee shall include, at a minimum, the Trauma Medical Director or designee and all core surgeons as well as liaisons from orthopedic surgery, neurosurgery, emergency medicine, radiology, and anesthesia. Each of these liaisons shall attend at least 50 percent of the meetings.

(4) The exact format of the committee may be hospital specific, but shall be multidisciplinary and consist of hospital and medical staff members who work to identify and correct trauma program system issues.

(5) The committee minutes shall reflect the review of operational issues and, when appropriate, the analysis and proposed corrective actions. The process shall identify problems and shall demonstrate problem resolution.

(6) The committee shall monitor compliance with all required time frames for availability of trauma personnel including, but not limited to, response times for general surgery, orthopedics, neurosurgery, anesthesiology, radiology, and radiology, MRI, or CT techs.

(7) The availability of anesthesia services and the absence of delays in airway control or operations shall be monitored.

(8) Radiologists shall be involved in protocol development and trend analysis that relate to diagnostic imaging.

(9) The multidisciplinary committee shall review and address issues related to the availability of necessary personnel and equipment to monitor and resuscitate patients in the PACU.

C. Peer Review/Performance Improvement Committee

(1) The facility shall have a Peer Review/Performance Improvement Committee chaired by the Trauma Medical Director or physician designee.

(2) The committee shall include, at a minimum, the core group of general surgeons and a physician liaison from orthopedic surgery, neurosurgery, emergency medicine, radiology, and anesthesia. Each liaison shall attend at least 50 percent of the meetings.

(3) Each liaison shall be available to the Trauma Medical Director for committee issues that arise in his or her department.

(4) The Peer Review/Performance Improvement Committee shall document evidence of committee attendance and participation.

(5) The committee shall review the overall quality of care for the trauma service, selected deaths, complications, and sentinel events with the objective of identifying issues and appropriate responses.

(6) Trauma patient care may be evaluated initially by individual specialties within their usual Departmental review structures; however, identified problem trends shall undergo review within the Peer Review/Performance Improvement Committee.

(7) The facility shall also, in this committee or in another appropriate forum, provide for morbidity and mortality review of trauma cases. All trauma deaths shall be systematically reviewed and categorized as preventable, non-preventable, or potentially preventable or equivalent taxonomy.

(8) When a consistent problem or inappropriate variation is identified, corrective actions shall be taken and documented.

(9) The Trauma Medical Director shall ensure dissemination of committee information to all non-core general surgeons with documentation.

(10) The Peer Review/Performance Improvement Committee shall review and monitor the organ donation rate.

(11) The committee shall demonstrate that the program complies with required surgical response times at least 80 percent of the time.

(12) The peer review/performance improvement program shall monitor changes in interpretation of diagnostic information.

4. Facility Organization and the Trauma Program

A. Facility Governing Body and Medical Staff Commitment

(1) The facility shall demonstrate the commitment of the facility's governing body and medical staff through a written document. The document shall be reaffirmed every three years and be current at the time of the site review.

(2) The administrative structure of the hospital/trauma facility shall include, at a minimum, an administrator, a Trauma Medical Director, and a trauma program manager.

B. Trauma Program

(1) Scope of care: All designated Level I and II trauma centers shall define their scope of care based on the resources that are available at the facility for adult and pediatric patients.

(2) The trauma program members or a representative of the program shall participate in state and regional trauma system planning, development, and operation.

(3) The trauma program shall have authority to address issues that involve multiple disciplines. The Trauma Medical Director shall have the authority and administrative support to lead the program.

C. Trauma Medical Director

(1) The Trauma Medical Director shall be a board certified (not board eligible) surgeon, as those boards are defined under the "Clinical Requirements for General Surgery" as described in Section 303.5.C or shall be a Fellow of the American College of Surgeons with special interest in trauma care, shall take trauma call, and shall remain current in ATLS.

(2) The Trauma Medical Director shall demonstrate membership and active participation in state and either regional or national trauma organizations.

(3) The Trauma Medical Director shall have the authority to correct deficiencies in trauma care and exclude from taking trauma call all trauma team members who do not meet required criteria. Through the performance improvement program and hospital policy, the Trauma Medical Director shall have the responsibility and authority to determine each general surgeon's ability to participate on the trauma panel based on an annual review.

D. Trauma Resuscitation Team

(1) The facility shall define criteria for trauma resuscitation team activation.

(2) The criteria for a graded activation shall be clearly defined and continuously evaluated by the performance improvement program.

E. Trauma Service

(1) A trauma service admission is a patient who is admitted to or evaluated by an identifiable surgical service staffed by credentialed trauma providers.

(2) The facility shall demonstrate or provide documentation that the trauma service has sufficient infrastructure and support to ensure the adequate provision of care.

(3) The trauma service shall maintain oversight of the admitted patient until trauma care is no longer necessary.

(4) Level I only: An adult trauma facility shall demonstrate an annual volume of at least 320 trauma patients with an Injury Severity Score (ISS) of 16 or greater.

F. Trauma Program Manager

The trauma program manager shall, at a minimum, be a registered nurse and demonstrate the following qualifications:

(1) Administrative ability,

(2) Evidence of educational preparation, and

(3) Documented clinical experience.

5. Clinical Requirements for General Surgery

A. Role/Availability

(1) The on-call attending trauma surgeon shall be in the emergency department on patient arrival, as set forth below, for the highest level of activation, with adequate notification from the field. The maximum response time is 15 minutes, tracked from patient arrival, 80 percent of the time. The Multidisciplinary Trauma Committee shall monitor compliance of the attending surgeon's arrival times.

(2) A resident in postgraduate year four or five may begin resuscitation while awaiting arrival of the attending surgeon based on facility-defined criteria.

B. Equipment/Resources

The facility shall provide all of the necessary resources, including instruments, equipment, and personnel, for current surgical trauma care.

C. Qualifications/Board Certification

(1) Except as provided below in subparagraph 2, all general surgeons on the trauma panel shall be fully credentialed in critical care and board certified in surgery by the American Board of Surgery (ABS), the Bureau of Osteopathic Specialists and Boards of Certification, or the Royal College of Physicians and Surgeons of Canada; or shall be board eligible, working toward certification, and less than five years out of residency.

(2) A foreign-trained, non-ABS boarded surgeon shall have the foreign equivalent of ABS certification in general surgery, clinical expertise in trauma care, an unrestricted Colorado license, and unrestricted credentials in surgery and critical care at the facility.

D. Clinical Commitment/Involvement

(1) All general surgeons on the trauma panel shall have general surgical privileges.

(2) The general surgeon on call shall be dedicated to one trauma facility when taking trauma call.

(3) A published general surgery back-up call schedule shall be available. The backup surgeon shall be present within 30 minutes of being requested to respond.

(4) An attending surgeon shall be present at all trauma operations. The surgeon's presence shall be documented.

(5) The performance of all surgeons on the trauma panel shall be reviewed annually by the Trauma Medical Director.

E. Education/Continuing Education: All general surgeons on the trauma panel shall remain current in ATLS.

F. Participation in Statewide Trauma System

Each Level I and II trauma facility shall provide a qualified surgeon as a state reviewer a minimum of one day per year, if requested by the Department.

6. Requirements for Emergency Medicine and the Emergency Department

A. Role/Availability

(1) The facility shall have a designated emergency department physician director supported by additional physicians to ensure immediate care for injured patients.

(2) A physician shall be present in the emergency department at all times.

(3) In facilities with emergency medicine residents, an in-house attending emergency physician shall provide supervision of the residents 24 hours per day.

(4) The facility shall designate an emergency physician to serve as the emergency medicine liaison to the trauma service.

B. Equipment/Resources

The trauma facility shall provide all of the necessary resources, including instruments, equipment, and personnel, for current emergency trauma care.

C. Qualifications/Board Certification

(1) All emergency physicians on the trauma panel shall have successfully completed ATLS at least once.

(2) Physicians providing initial resuscitation in the emergency department shall be:

(a) Board certified in emergency medicine, or

(b) Have current ATLS.

(3) Board certification shall be issued by a certifying entity that is nationally recognized in the United States.

D. Clinical Commitment/Involvement

(1) The roles and responsibilities of the emergency physician shall be defined, agreed on, and approved by the Trauma Medical Director.

(2) Emergency physicians on the call panel shall be regularly involved in the care of the injured patient.

(3) The performance of all emergency physicians on the trauma panel shall be reviewed annually by the emergency medicine liaison or designated representative.

E. Nursing Services

(1) A qualified nurse shall be available 24 hours per day to provide care for patients during the emergency department phase of care. Nursing personnel with special capability in trauma care shall provide continual monitoring of the trauma patient from hospital arrival to disposition in Intensive Care Unit (ICU), Operating Room (OR), or Patient Care Unit (PCU).

(2) The nurse/patient ratio shall be appropriate for the acuity of the trauma patients in the emergency department.

7. Clinical Requirements for Neurosurgery

A. Role/Availability

(1) The facility shall designate a neurosurgeon to serve as the neurosurgical liaison to the trauma service.

(2) The facility shall define criteria for neurosurgical attending response.

(3) Neurosurgical care must be continuously available for all traumatic brain injury and spinal cord injury patients and must be present within 30 minutes, based on the facility's neurosurgical response criteria.

(4) Compliance with the 30 minute response time to neurosurgical presence shall be monitored by the trauma program and presented to the multidisciplinary trauma committee.

(5) Level I availability:

The facility shall provide a neurosurgical on-call schedule, dedicated only to that facility, available 24 hours per day, and either a posted backup call schedule or a contingency plan that includes bypass and transfer guidelines with another designated Level I, or in the event that no other Level I is available, then to a Level II facility with the necessary resources to meet the patient's needs.

(6) Level II availability:

a. The facility shall provide a neurosurgical on-call schedule, dedicated only to that facility, available 24 hours per day, and either a posted backup call schedule or a contingency plan that includes bypass and transfer guidelines with a designated Level I or II facility with the necessary resources to meet the patient's needs; or

b. If neurosurgeons take call at more than one facility (either trauma or non-trauma) at a time, written primary and backup call schedules are required and a contingency plan that includes bypass and transfer guidelines with a designated Level I or II facility.

B. Equipment/Resources

The facility shall provide all of the necessary resources, including instruments, equipment, and personnel for current neurotrauma care.

C. Qualifications

(1) Neurosurgeons must be:

a. Board certified in neurosurgery, or

b. Board eligible and less than seven years from residency, or

c. Have current ATLS, if no longer boarded or board eligible.

(2) All board certifications shall be issued by a certifying entity that is nationally recognized in the United States.

D. Clinical Commitment/Involvement

(1) Neurosurgeons shall be credentialed by the hospital with general neurosurgical privileges.

(2) Qualified neurosurgeons shall be regularly involved in the care of the head and spinal cord injured patients.

(3) The performance of all neurosurgeons on the trauma panel shall be reviewed annually by the liaison or designated representative.

8. Clinical Requirements for Orthopedic Surgery

A. Role/Availability/Specialists

(1) The facility shall designate an orthopedic surgeon to serve as the orthopedic liaison to the trauma program.

(2) The facility shall define criteria for the orthopedic surgeon attending response.

(3) Orthopedic care must be continuously available for patients and must be present within 30 minutes based on the facility's orthopedic response criteria.

(4) Compliance with the 30 minute response time to orthopedic presence shall be monitored by the trauma program and presented to the multidisciplinary trauma committee.

(5) Level I availability:

The facility shall provide an orthopedic on-call schedule, dedicated only to that facility, available 24 hours per day and either a posted backup call schedule or a contingency plan that includes bypass and transfer guidelines with another designated Level I, or in the event that no other Level I is available, then to a Level II facility with the necessary resources to meet the patient's needs.

(6) Level II availability:

a. The facility shall provide an orthopedic on-call schedule, dedicated only to that facility, available 24 hours per day and either a posted backup call schedule or a contingency plan that includes bypass and transfer guidelines with a designated Level I or II facility with the necessary resources to meet the patient's needs; or

b. If orthopedic surgeons take call at more than one facility (either trauma or non-trauma) at a time, written primary and backup call schedules are required and a contingency plan that includes bypass and transfer guidelines with a designated Level I or II facility.

(7) A fully credentialed spine surgeon shall be promptly available, as defined by the facility, 24 hours per day.

(8) Level I only: At least one orthopedic traumatologist with a minimum of six to twelve months of fellowship training (or equivalent) shall be a part of the trauma team.

B. Equipment/Resources

The facility shall provide all of the necessary resources including instruments, equipment, and personnel for current musculoskeletal trauma care.

C. Qualifications

(1) Orthopedic surgeons must be:

a. Board certified, or

b. Board eligible and less than seven years from residency, or

c. Have current ATLS, if no longer boarded or board eligible.

(2) All board certifications shall be issued by a certifying entity that is nationally recognized in the United States.

D. Clinical Commitment/Involvement

(1) Orthopedic surgeons shall be credentialed by the hospital with general orthopedic privileges.

(2) Orthopedic surgeons on the call panel shall be regularly involved in the care of the trauma patient.

(3) The performance of all orthopedic surgeons on the trauma panel shall be reviewed annually by the liaison or designated representative.

9. Pediatric Trauma Care

A. Pediatric trauma care shall refer to care delivered to children under age 15.

B. Level I and II adult trauma facilities can and will receive pediatric trauma patients. All adult Level I and II facilities shall:

(1) Provide evidence of safe pediatric trauma care to include age-specific medical devices and equipment as appropriate for the resuscitation and stabilization of the pediatric patient.

(2) Assure that the physician and nursing staff providing care to the pediatric patient demonstrates competency in the care of the injured child appropriate to the type of injured child.

(3) Demonstrate oversight of the pediatric care provided through a pediatric-specific peer review/performance improvement process.

C. Nonaccidental Trauma

(1) Pediatric patients with suspected or evidence of nonaccidental trauma requiring social or clinical care beyond the facility's resources shall be transferred to a Regional Pediatric Trauma Center or to a Level I or II trauma center with the necessary resources that admits pediatric trauma patients. The receiving trauma center must meet the requirements set forth in 6 CCR 1015-4, Chapter Three, Section 303.9.D.

(2) All Level I-II facilities admitting pediatric patients with nonaccidental traumatic injury shall consult with a specialist in child maltreatment affiliated with a trauma center for diagnostic and care consideration purposes.

D. A Level I or II adult trauma facility that admits children having other than single extremity orthopedic fracture or minor head trauma as determined by best practice guidelines shall meet the following additional criteria:

(1) All physicians providing care to pediatric trauma patients shall be credentialed for pediatric trauma care by the hospital's credentialing body.

(2) The facility shall provide appropriate pediatric medical equipment in the emergency department.

(3) The facility shall provide a pediatric intensive care area staffed by a board certified or board eligible pediatric intensivist available for consultation or have a transfer protocol and transfer agreements for pediatric patients requiring intensive care.

(4) A neurosurgeon on call with qualifications necessary to manage pediatric neurotrauma.

(5) The facility shall provide appropriate pediatric resuscitation equipment in all pediatric care areas.

(6) The facility shall have a pediatric-specific peer review/performance improvement process, which shall include pediatric-specific process filters and outcome measures.

(7) The facility shall assure that the nursing staff providing care to the pediatric patient has specialized training in the care of the injured child.

10. Collaborative Clinical Services

A. Anesthesiology

(1) Role/Availability

a. The facility shall designate an anesthesiologist to serve as the anesthesia liaison to the trauma program.

b. Anesthesiology services shall be promptly available as defined by the facility 24 hours per day for emergency operations and airway problems in the injured patient. Compliance with the facility-defined availability criteria shall be monitored by the Multidisciplinary Trauma Committee.

c. When anesthesiology residents or certified registered nurse anesthetists are used to fulfill availability requirements, the staff anesthesiologist on call shall be notified and be present in the operating department. The process shall be monitored through the performance improvement process.

d. Level I only: Anesthesiology coverage shall be in house.

(2) Qualifications

a. Levels I-II anesthesiologists and nurse anesthetists must be:

i. Board certified, or

ii. Board eligible and less than seven years from residency, or

iii. Have current ATLS, if no longer boarded or board eligible.

b. All board certifications shall be issued by a certifying entity that is nationally recognized in the United States.

c. The performance of all anesthesiologists on the trauma panel shall be reviewed annually by the anesthesiology liaison or designated representative.

B. Operating Room

(1) General Requirements

a. A dedicated operating room team shall always be available.

b. If the primary operating room team is occupied, there shall be a mechanism in place to staff a second operating room.

c. There shall be a facility-defined access policy for urgent trauma cases of all specialties.

(2) Equipment Requirements

a. The facility shall have rapid infusers, thermal control equipment for patients and fluids, intraoperative radiological capabilities, equipment for fracture fixation, equipment for endoscopic evaluation (bronchoscopy and gastrointestinal endoscopy), and other equipment to provide operative care consistent with current practice.

b. The facility shall have the necessary equipment to perform a craniotomy.

c. Level I only: The facility shall have cardiopulmonary bypass equipment and an operating microscope available 24 hours per day.

C. Postanesthesia Care Unit (PACU)

(1) Qualified nurses shall be available 24 hours per day to provide care for the trauma patient, if needed, in the recovery phase.

(2) If the availability of PACU nurses is met with an on-call team from outside the hospital, the availability of the PACU nurses and absence of delays shall be monitored by the peer review/performance improvement program.

(3) The PACU shall provide all of the necessary resources including instruments, equipment, and personnel to monitor and resuscitate patients consistent with the facility-defined process of care.

(4) Recovery of the trauma patient in a critical care (intensive care) unit is also acceptable.

D. Radiology

(1) Role/Availability

a. Qualified radiologists shall be promptly available as defined by the facility for the interpretation of imaging studies and shall respond in person when requested.

b. The facility shall designate a radiologist to serve as the radiology liaison to the trauma program.

c. Interventional Radiology Requirements:

i. Level I: Personnel qualified in advanced neuro, endovascular, and interventional procedures shall be promptly available as defined by the facility 24 hours per day and available in less than 30 minutes when requested by a trauma surgeon.

ii. Level II: Personnel qualified in interventional procedures shall be promptly available as defined by the facility 24 hours per day when requested by a trauma surgeon.

(2) Clinical Commitment/Involvement

a. Diagnostic information shall be communicated in written form in a timely manner as defined by the facility.

b. Critical information that is deemed to immediately affect patient care shall be promptly communicated to the trauma team.

c. The final report shall accurately reflect the chronology and content of communications with the trauma team, including changes between the preliminary and final interpretation.

(3) Radiology Support Services

a. The facility shall have policies designed to ensure that trauma patients who may require resuscitation and monitoring are accompanied by appropriately trained providers during transport to and while in the radiology department.

b. Conventional radiography and computed tomography (CT) shall be promptly available as defined by the facility 24 hours per day and available in less than 30 minutes when requested by a trauma surgeon.

c. An in-house radiographer and in-house CT technologist shall be promptly available as defined by the facility 24 hours per day and available in less than 30 minutes when requested by a trauma surgeon.

d. Conventional catheter angiography and sonography shall be promptly available as defined by the facility 24 hours per day and available in less than 30 minutes when requested by a trauma surgeon.

e. Magnetic resonance imaging capability shall be promptly available as defined by the facility 24 hours per day and available in less than 30 minutes when requested by a trauma surgeon.

f. The peer review/performance improvement program shall review and address any variance from facility-defined response times.

E. Critical Care

(1) Organization of the Intensive Care Unit (ICU)

a. ICU service leadership:

i. Level I: This service shall be led by a qualified surgeon who is board certified in critical care by the American Board of Surgery. The surgical director shall have obtained critical care training during residency or fellowship and shall have expertise in the perioperative and post injury care of injured patients.

ii. Level II: This service shall be directed or co-directed by a qualified surgeon with expertise in the care of injured patients.

b. This service may be staffed by critical care trained physicians from different specialties.

c. Physician coverage of critically ill trauma patients shall be promptly available as defined by the facility 24 hours per day. These physicians shall be capable of rapid response to deal with urgent problems as they arise. Availability shall be monitored by the peer review/performance improvement program.

d. All trauma surgeons shall be fully credentialed by the facility to provide all intensivist services in the ICU. There shall be full hospital privileges for critical care.

e. The trauma surgeon shall retain oversight of the patient while in the ICU.

f. Level I only: A facility-defined team shall provide daily multidisciplinary rounds to patients in the ICU.

(2) Nursing Services

a. A qualified nurse shall be available 24 hours per day to provide care for patients during the ICU phase of care.

b. The nurse/patient ratio shall be appropriate for the acuity of the trauma patients in the ICU.

c. The facility shall assure that the nursing staff providing care to the pediatric patient has specialized training in the care of the injured child.

(3) Equipment

a. The ICU shall have the necessary resources including instruments and equipment to monitor and resuscitate patients consistent with the facility-defined process of care.

b. Arterial pressure monitoring, pulmonary artery catheterization, patient rewarming, intracranial pressure monitoring, and other equipment to provide critical care consistent with current practice shall also be available.

c. Ventilator support shall be available for trauma patients 24 hours per day.

F. Other Surgical Specialties - The facility shall have a full spectrum of surgical specialists on staff including, but not limited to, the following surgical specialties:

(1) Thoracic, peripheral vascular, obstetric, gynecological, otolaryngologic, urologic, ophthalmologic, facial trauma, and plastic.

(2) In addition, Level I only: cardiac, microvascular, and hand.

G. Medical Consultants

(1) The facility shall have the following medical specialists and their respective support teams on staff: cardiology, infectious disease, internal medicine, pulmonary medicine, and nephrology.

(2) A respiratory therapist shall be promptly available to care for trauma patients.

(3) Acute hemodialysis shall be promptly available for the trauma patient.

(4) Services shall be available 24 hours per day for the standard analyses of blood, urine, and other body fluids, coagulation studies, blood gases, and microbiology, including microsampling when appropriate.

(5) The blood bank shall be capable of blood typing and cross-matching and shall have an adequate supply of red blood cells, fresh frozen plasma, platelets, cryoprecipitate, and appropriate coagulation factors to meet the needs of injured patients.

11. Rehabilitation Requirements

A. Rehabilitation services shall be available to the trauma patient:

(1) Within the hospital's physical facilities, or

(2) At a freestanding rehabilitation hospital. In this circumstance, the trauma facility shall have appropriate transfer agreements.

B. The following services shall be available during the trauma patient's ICU and other acute phases of care:

(1) Physical, occupational, and speech therapy, and

(2) Social services.

12. Trauma Registry

A. Trauma registry data shall be collected and analyzed by every trauma facility. It shall contain detailed, reliable, and readily accessible information that is necessary to operate a trauma facility.

B. Trauma data shall be submitted to the National Trauma Data Bank on an annual basis.

C. The facility shall demonstrate that the trauma registry is used to support the performance improvement program.

D. Trauma data shall be submitted to the Colorado Trauma Registry within 60 days of the end of the month during which the patient was discharged.

E. The trauma program shall have in place appropriate measures to assure that trauma data remain confidential.

F. The facility shall monitor data validity.

13. Outreach and Education

A. Public Outreach and Education: The facility shall engage in public education that includes prevention activities, referral, and access to trauma facility resources.

B. Professional Outreach and Education: The facility shall engage in professional outreach and education that include, at a minimum:

(1) Level I:

a. Providing or participating in one ATLS course annually,

b. Providing a continuous rotation in trauma surgery for senior residents that is part of a program accredited by the Accreditation Council for Graduate Medical Education in either general surgery, orthopedic surgery, neurosurgery, or family medicine; or support of a critical care fellowship or an acute care surgery fellowship consistent with the educational requirements of the American Association for the Surgery of Trauma, and

c. Providing a mechanism to offer trauma-related education to nurses involved in trauma care.

(2) Level II: Internal and external trauma-related educational opportunities for physicians, nurses, and allied health professionals.

14. Prevention

A. The facility shall participate in injury prevention. The facility shall provide documentation of the presence of prevention activities that center on priorities based on local data.

B. The facility shall demonstrate evidence of a job description and salary support for an injury prevention coordinator who is a separate person from, but collaborates with, the trauma program manager.

C. The trauma service shall develop an injury prevention program that, at a minimum, incorporates the following:

(1) Selecting a target injury population,

(2) Gathering and analyzing data,

(3) Developing evidenced-based intervention strategies based on local data and best practices,

(4) Formulating a plan,

(5) Implementing the program, and

(6) Evaluating and revising the program as necessary.

D. The facility shall demonstrate collaboration with or participation in national, regional, or state injury prevention programs.

E. The facility shall have a mechanism to identify patients who may have an alcohol addiction. The facility shall also have the capability to provide an intervention for patients identified as potentially having an alcohol addiction.

F. The facility shall collaborate and mentor lower level trauma centers regarding injury prevention.

15. Level I only: Research and Scholarship

A. The facility shall meet one of the following options:

(1) Twenty peer-reviewed articles published in journals included in Index Medicus in a three-year period. These articles shall result from work related to the trauma facility.

a. Of the 20 articles, there shall be at least one authored or coauthored by members of the general surgery trauma team, and

b. There shall be at least one each from three of the following seven disciplines: neurosurgery, emergency medicine, orthopedics, radiology, anesthesia, nursing, or rehabilitation; or

(2) Ten peer-reviewed articles published in journals included in Index Medicus in a three-year period. These articles shall result from work related to the trauma facility.

a. Of the 10 articles, there shall be at least one authored or coauthored by members of the general surgery team, and

b. There shall be at least one each from three of the following seven disciplines: neurosurgery, emergency medicine, orthopedics, radiology, anesthesia, nursing, or rehabilitation; and

c. Four of the following scholarly activities shall be demonstrated:

i. Leadership in major trauma organizations.

ii. Peer-reviewed funding for trauma research.

iii. Evidence of dissemination of knowledge to include review articles, book chapters, technical documents, Web-based publications, editorial comments, training manuals, and trauma-related course materials.

iv. Display of scholarly application of knowledge as evidenced by case reports or reports of clinical series in journals included in MEDLINE.

v. Participation as a visiting professor or invited lecturer at national or regional trauma conferences.

vi. Support of resident participation in facility-focused scholarly activity, including laboratory experiences, clinical trials, or resident trauma paper competitions at the state, regional, or national level.

vii. Mentorship of residents and fellows, as evidenced by the development of a trauma fellowship program or successful matriculation of graduating residents into trauma fellowship programs.

B. The facility shall demonstrate support for the trauma research program by providing such items as basic laboratory space, sophisticated research equipment, advanced information systems, biostatistical support, salary support for basic and social scientists, or seed grants for less experienced faculty.

16. Organ Procurement Activities

A. The facility shall have an established relationship with a recognized organ procurement organization (OPO).

B. The facility shall have a written policy for triggering notification of the regional OPO.

C. The facility shall have written protocols defining clinical criteria and confirmatory tests for the diagnosis of brain death.

17. Disaster Planning and Management

A. The facility shall meet the Emergency Management-related requirements of the U.S. Department of Health and Human Services.

(1) These rules incorporate by reference the 42 CFR § 482.15, "Condition of Participation: Emergency Preparedness Federal Regulations" (eff. November 29, 2019).

(2) Such incorporation does not include later amendments to or editions of the referenced material. The Health Facilities and Emergency Medical Services Division of the Department maintains copies of the complete text of the incorporated materials for public inspection during regular business hours, and shall provide certified copies of any non-copyrighted material to the public at cost upon request. Information regarding how the incorporated materials may be obtained or examined is available from the Division by contacting:

EMTS Branch Chief

Health Facilities and EMS Division

Colorado Department of Public Health and Environment

4300 Cherry Creek Drive South

Denver, CO 80246-1530

These materials are available and may be accessed at:

https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=cd395e8123ef3c266ed31b354bb524f2&ty =HTML&h=L&mc=true&n=pt42.5.482&r=PART#se42.5.482_11

B. Level I only:

(1) A surgeon from the trauma panel shall participate on the hospital's disaster committee.

(2) The facility shall have a disaster preparedness plan in its policy and procedure manual or equivalent.

(3) Hospital drills that test the facility's preparedness plan shall be conducted no less than every six months.

(4) The facility disaster preparedness plan shall be integrated into local, regional, and state disaster preparedness plans.

18. RETAC Integration

The facility shall demonstrate integration and cooperation with its Regional Emergency Medical and Trauma Advisory Council (RETAC). Evidence of such integration may include, but is not limited to: attendance at periodic RETAC meetings, participation in RETAC injury prevention activities, participation in RETAC data and/or quality improvement projects, etc.

6 CCR 1015-4-303

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