††††† RELATES TO: KRS 211.490, 211.492, 211.494, 211.496
††††† STATUTORY AUTHORITY: 211.494(8)
††††† NECESSITY, FUNCTION, AND CONFORMITY: KRS 211.494(8) authorizes the Department for Public Health to promulgate administrative regulations in accordance with KRS Chapter 13A to implement a statewide trauma care system. This administrative regulation establishes the criteria for a Level IV trauma center in the Kentucky Trauma Care System.
††††† Section 1. Level IV Trauma Centers. (1) A hospital that seeks designation as a Level IV trauma center shall meet the criteria established in this subsection.
††††† (a) Trauma program.
††††† 1. A trauma program shall be created with agreement from the hospitalís board of directors, administration, and medical staff.
††††† 2. The board of directors, administration, medical, nursing, and ancillary staff shall commit to provide trauma care at the level for which the facility is seeking trauma center verification.
††††† 3. A board resolution advising of that commitment shall be submitted with the KYTAC1 application incorporated by reference in 902 KAR 28:020, Section 6.
††††† (b) Trauma services medical director.
††††† 1. The trauma services medical director shall be a physician on staff at the facility.
††††† 2. The job description shall include roles and responsibilities for trauma care, including trauma team formation, supervision and leadership, and continuing education.
††††† 3. The medical director shall act as the medical staff liaison to administration, nursing staff, and as the primary contact for that facility with other trauma centers in the region.
††††† 4. The medical director shall maintain certification as an Advanced Trauma Life Support (ATLS) provider if not Board Certified/Board Eligible by the American Board of Emergency Medicine (ABEM) or the American Osteopathic Board of Emergency Medicine (AOBEM). Rural Trauma Team Development Course (RTTDC) participation shall be required for the trauma services medical director.
††††† (c) Trauma services manager.
††††† 1. The facility shall have a trauma services manager who may be referred to as the trauma coordinator.
††††† 2. The manager shall work with the medical director to coordinate and implement the facilityís trauma care response.
††††† 3. The job description of this position shall include time dedicated to the trauma program, separate from other duties the program manager may have at the facility.
††††† (d) Emergency department coverage.
††††† 1. The facility shall have twenty-four (24) hour physician coverage of the emergency department and a designated physician medical director for the emergency department.
††††† 2. A mid-level provider, such as a nurse practitioner or physician's assistant, may serve as the trauma team leader. A designated emergency department physician shall be present for immediate consultation during trauma team activations.
††††† (e) Emergency department physicians. Physicians assigned to the emergency department of a Level IV Trauma Center shall:
††††† 1. Be licensed in the Commonwealth of Kentucky; and
††††† 2.a. Maintain current Advanced Trauma Life Support” (ATLS) provider certification; or
††††† b. Be certified by ABEM or AOBEM.
††††† (f) Surgical staff.
††††† 1. Orthopedic surgery, plastic surgery, and radiology medical staff availability shall be documented by published call schedules.
††††† 2. If surgical services are provided, anesthesia coverage shall be provided.
††††† 3. Surgical staff shall document completion of fifteen (15) hours of annual trauma-related continuing medical education for surgeons completed every three (3) years as part of the CME required by the Kentucky Board of Medical Licensure.
††††† 4. Surgical specialties participating in the trauma team shall have at least one (1) representative of its specialty attend more than half of the hospitalís multi-disciplinary trauma review committee meetings.
††††† (g) Prior to being assigned to the facilityís trauma team, nurses responsible for trauma care at the facility shall have completed one of the following professional education courses specific to trauma care:
††††† 1. Trauma Nursing Core Course (TNCC); or
††††† 2. Advanced Trauma Care for Nurses (ATCN).
††††† (h) Transfer Protocols.
††††† 1. The facility shall have a written transfer protocol describing the method to transfer the trauma patient requiring a higher level of care.
††††† 2. The transfer protocol shall address:
††††† a. Available ground or air transport services;
††††† b. Alternative transport services;
††††† c. Receiving trauma centers and trauma surgeon contact information;
††††† d. What supplies, records, and resources shall be available for use to affect the transfer; and
††††† e. Specific anatomic and physiologic criteria that will immediately initiate transfer to definitive care.
††††† 3. The transfer protocol shall be developed with involvement of each local ground EMS provider and regional air medical provider to assure seamless patient care during transfer and be consistent with the protocol examples found in the Kentucky Trauma Hospital Resource Manual.
††††† (i) Transfer agreements. A Level IV Trauma Center shall have:
††††† 1. A written agreement with a verified Level I, II, or III trauma center or a hospital whose capabilities exceed that of a Level IV facility regarding the transfer and care of adult and pediatric trauma patients;
††††† 2. A written agreement with back-up transfer agreements specifically for burn patients if the primary regional receiving facility does not have the required capacity; and
††††† 3. Transfer plans that shall be defined and consistent with the examples found in the Kentucky Trauma Hospital Resource Manual.
††††† (j) Radiology.
††††† 1. The facility shall have a Radiologic Technologist available on-site twenty-four (24) hours a day to provide basic plain films used in the evaluation of trauma patients.
††††† 2. A twenty (20) minute response time for trauma team activation shall be required. Response times shall be documented and monitored by the trauma coordinator and the facility's process improvement program.
††††† 3. The facility shall have computed tomography and sonography capabilities.
††††† (k) Clinical laboratory.
††††† 1. The facility shall have a lab technician available on duty or on-call twenty-four (24) hours a day to perform basic studies used in the initial evaluation of trauma patients, including Complete Blood Count, typing, coagulation profile, and Arterial Blood Gas.
††††† 2. A twenty (20) minute response time from trauma team activation shall be required for a lab technician. Response times shall be documented and monitored by the trauma coordinator and the facilityís process improvement program.
††††† 3. The lab or facility blood bank shall have at least two (2) units of O-negative blood available for trauma patients, to be infused at the facility or while en-route to definitive care.
††††† 4. Access to blood and blood products during an emergency situation if the lab is not staffed shall be documented.
††††† 5. The facility shall have the capability to conduct micro-sampling.
††††† (l) Respiratory therapy.
††††† 1. The facility shall have a respiratory care practitioner on duty or on-call twenty-four (24) hours a day to respond to the emergency department if the trauma team is activated.
††††† 2. A twenty (20) minute response time from trauma team activation shall be required if a respiratory care practitioner is not on-site. Response times shall be documented and monitored by the trauma coordinator and the facilityís process improvement program.
††††† 3. Other trained health care personnel may fulfill the respiratory care practitionerís role until the designated respiratory care practitioner arrives.
††††† (2) Trauma Team Activation Protocol. A facility designated as a Level IV Trauma Center shall have a written trauma team activation protocol in place that:
††††† (a) Documents the members of the trauma team and their response requirements if activated;
††††† (b) Establishes the criteria based on severity, anatomy, or physiology of the injury for trauma team activation and provides the names of each person authorized to activate the trauma team; and
††††† (c) Is consistent with the examples of trauma team activation protocols found in the Kentucky Trauma Hospital Resource Manual.
††††† (3) Performance improvement.
††††† (a) A facility designated as a Level IV Trauma Center shall develop a performance improvement program that includes:
††††† 1. An in-house trauma registry or a secure on-line trauma registry system; and
††††† 2. A written policy outlining the quality and performance improvement (PI) portion of the trauma program, which shall include:
††††† a. The names of each person responsible for performing PI reviews;
††††† b. The names of the multidisciplinary trauma review committee;
††††† c. The composition by name and position of the morbidity and mortality review committee;
††††† d. The minimum number of cases to be reviewed annually including:
††††† (i) Patients requiring transfer;
††††† (ii) Record of each trauma death;
††††† (iii) Noncompliance of trauma team members to response time requirements;
††††† (iv) Bypasses;
††††† (v) Transfers; and
††††† (vi) Trauma care provided by physicians not meeting minimal education requirements;
††††† e. Frequency of performance improvement meetings;
††††† f. Minimum requirements for member attendance by position;
††††† g. Evidence of a quality assurance program as required by 902 KAR 20:016, Section 3(8)(b)6; and
††††† h. Feedback obtained from patients transferred to a Level I, II, or III trauma center.
††††† (b) Each performance improvement program shall be consistent with the examples in the Kentucky Trauma Hospital Resource Manual.
††††† (4) Level IV Trauma Center emergency department.
††††† (a) Basic and essential equipment and supplies for the care and treatment of both adult and pediatric patients shall be present in a Level IV Trauma Center emergency room.
††††† (b) A Level IV Trauma Center emergency room shall contain items described as the minimum equipment and supply lists found in the Kentucky Trauma Hospital Resource Manual.
††††† (5) Level IV Trauma Center operating room.
††††† (a) Any operating room available and used for the surgical care of victims of trauma shall have the following:
††††† 1. Operating room staff available within thirty (30) minutes of notification;
††††† 2. Anesthesia staff available within thirty (30) minutes of notification; and
††††† 3. Age-specific equipment including thermal control equipment for patients, fluids, and blood products.
††††† (b) C-arm capability shall be required if orthopedic procedures are to be performed.
††††† (c) Post-anesthetic recovery shall contain equipment for monitoring and resuscitation, pulse oximetry, and thermal control.
††††† (d) Required resuscitation equipment shall include:
††††† 1. Airway and ventilation;
††††† 2. Pulse oximetry;
††††† 3. Suction;
††††† 4. Electro Cardiogram;
††††† 5. Defibrillator;
††††† 6. IV administration sets;
††††† 7. Large bore vascular catheters;
††††† 8. Cricothyroidotomy;
††††† 9. Thoracostomy;
††††† 10. Emergency drugs;
††††† 11. Broselow tape;
††††† 12. Fluid warmer,
††††† 13. Qualitative CO2 detector; and
††††† 14. EMS communication equipment.
††††† (6) Trauma diversion.
††††† (a) The Level IV trauma center shall have a policy in place that outlines the circumstances that shall trigger a trauma diversion and the procedures to be followed, including procedures if one (1) or more hospital resources are functioning at maximum capacity or are otherwise unavailable.
††††† (b) This process shall be coordinated with the EMS providers in the service area and potential receiving facilities.
††††† (c) EMS providers shall coordinate diversion plans under the provisions of 202 KAR 7:501, Section 5(3).
††††† (d) Examples of trauma diversion protocols shall be found in the Kentucky Trauma Hospital Resource Manual.
††††† (7) Other Level IV requirements. A facility designated as a Level IV trauma center may:
††††† (a) Host or participate in a joint RTTDC program. Participation by physicians, members of administration, nursing, ancillary support staff, and local prehospital care providers shall be strongly encouraged;
††††† (b) Conduct or participate in local or regional outreach education, specifically ATLS, TNCC, and ITLS/PHTLS courses, and conduct or participate in local or regional presentations of trauma-related CME for physicians, nurses, prehospital staff, and other personnel; and
††††† (c) Participate in injury prevention programs organized by the facility or in cooperation with the Kentucky Injury Prevention Research Center (KIPRC), law enforcement, fire, EMS and other safety organizations. Documentation of injury prevention program activities shall be available for review during the trauma center verification or reverification process.
††††† Section 2. Level IV Site Visits. (1) A hospital may request a site visit from a peer review team for a consultation visit, a verification visit, or a reverification visit.
††††† (a) A consultation visit shall be conducted to assess the facilityís system of trauma care delivery or to prepare for a verification visit.
††††† 1. A consultation visit shall follow the same format as a verification visit.
††††† 2. Site visit reviewers shall provide recommendations to aid a facility in attaining verification readiness.
††††† (b) A verification visit shall be conducted to confirm the facility is performing as a trauma center according to the criteria listed in Section 1 of this administrative regulation.
††††† 1. Site visit reviewers shall provide a report of findings to the KyTAC.
††††† 2. The KyTAC, upon receipt and review of the report, shall recommend to the Commissioner of Public Health that:
††††† a. A Certificate of Verification be issued, and that the Commissioner designate the facility as a Level IV Trauma Center; or
††††† b. The facility be notified of deficiencies in writing and a focus review visit scheduled within six (6) months of the date of the verification visit to identify those deficiencies that can be isolated and correctable.
††††† (c) A reverification visit shall be requested by a facility previously issued a certificate of verification if the facility does not want its certificate of verification and designation to expire.
††††† 1. The facility shall schedule a reverification visit six (6) months prior to the expiration date of its current certificate of verification and designation as a Level IV Trauma Center.
††††† 2. A facility whose current certificate of verification has lapsed due to the facilityís failure to initiate reverification shall submit a new KYTAC1 as required by 902 KAR 28:020 and this administrative regulation.
††††† 3. A reverification visit shall follow the same procedures established in subsection (2) of this section.
††††† (2) Site visit teams.
††††† (a) A site visit team shall be composed of a minimum number of persons as follows:
††††† 1. Consultation visit: Two (2) members;
††††† 2. Verification visit: Three (3) members;
††††† 3. Reverification visit: Three (3) members; or
††††† 4. Focus review visit: Two (2) members, one (1) of whom shall have been on the original verification team.
††††† (b) Each site visit team member shall be a member of either the:
††††† 1. American College of Surgeons; or
††††† 2. American Board of Emergency Medicine.
††††† (c) The Commissioner of Public Health shall solicit from the KyTAC two (2) names for each team member position for the requested visit.
††††† (d) The Commissioner of Public Health shall select the team members from the list provided and notify KyTAC of the team members selected.
††††† (e) Only one (1) of each teamís members may be a KyTAC member.
††††† Section 3. Incorporation by Reference. (1) "Kentucky Trauma Hospital Resource Manual", April, 2012, is incorporated by reference.
††††† (2) This material may be inspected, copied, or obtained, subject to applicable copyright law, at the Kentucky Department for Public Health, Commissionerís Office, 275 East Main Street, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. (26 Ky.R. 668; Am. 1008; eff. 11-15-1999; 38 Ky.R. 1678; 1862; eff. 6-1-2012.)