Requirements

(1) Trauma registry requirements shall include the following: (a) Each trauma center and CRPC shall submit trauma registry data electronically to the trauma registry on all closed patient files. (b) Each trauma center and CRPC shall submit trauma registry data to be received no later than ninety (90) days after the end of each quarter of the year. Trauma centers and CRPC’s shall receive confirmation of successful submission no later than two (2) weeks after submission. (c) Trauma centers and CRPC’s which fail to submit required data to the trauma registry for two (2) consecutive quarters risk not receiving compensation from the Tennessee Trauma Center Fund. (2) Levels of Care (a) Hospital Origination TRAUMA CENTERS CHAPTER 0720-22 1. Trauma Service I II III IV A recognizable program within the hospital which has a qualified trauma surgeon as its director/coordinator/physician in charge. The intent is to ensure the coordination of services and performance improvement for the trauma patient. The service includes personnel and other resources necessary to ensure appropriate and efficient provision of care and will vary according to facility and level of designation. In a Level I and II trauma center, the trauma team shall evaluate seriously injured patients based upon written institutional graded activation criteria and those patients shall be admitted by an identifiable surgical service staffed by credentialed trauma providers. Level I and II trauma centers shall have sufficient infrastructure and support to ensure adequate provision of care for this service. Sufficient infrastructure and support may require additional qualified physicians, residents, or non-physician practitioners. This composite should be determined by the volume of patients requiring care and the complexity of their conditions. In teaching facilities, the requirements of the Residency Review Committee also must be met. Level I trauma centers must care for at least 1200 trauma patients per year or at least 240 pts with an ISS>15 per year. In Level III centers, the center may admit the injured patients to individual surgeons, but the structure of the program must allow the trauma director to have oversight authority for the care of those injured patients. The center shall ensure that there is a method to identify the injured patients, monitor the provision of health care services, make periodic rounds, and hold formal and informal discussions with individual practitioners. It is particularly important for team members to attend trauma committee meetings regularly and participate in peer review activities to maintain cohesion within the service. E E E Written graded activation criteria. Criteria for highest level of activation is clearly defined and evaluated by the performance improvement program (PIPs). E E E E Administration supportive of the trauma program E E E E Evidence of an annual budget for the trauma program E E E E The trauma team may be organized by a qualified physician, but care must be directed by a board certified or board eligible general surgeon on a trauma service that is committed to the care of the injured. All patients with multiple-system or major injury must be initially evaluated by the trauma team, and the surgeon who shall be responsible for overall care of a patient E E E D TRAUMA CENTERS CHAPTER 0720-22 (the team leader) identified. A team approach is required for optimal care of patients with multiple-system injuries. 2. Surgery Departments/Divisions/Services/Sections (each staffed by qualified specialists) Cardiothoracic Surgery E E General Surgery E E E D Neurologic Surgery E E Obstetrics-Gynecologic Surgery E Ophthalmic Surgery E Oral and Maxillofacial Surgery - Dentistry E2 E2 Orthopedic Surgery E E E Otorhinolaryngologic Surgery E2 E2 Pediatric Surgery E3 Plastic Surgery E Urologic Surgery E Surgical Critical Care E D 3. Emergency Department/Division/Service/Section (staffed by qualified specialists) E4 E4 E4 E9 4. Surgical Specialty Availability In-house 24 hours a day General Surgery E5 Neurologic Surgery E6 Neurosurgical evaluation must occur within 30 minutes of request for the following: (i) Severe TBI (GCS less than 9) with head CT evidence of intracranial trauma (ii) Moderate TBI (GCS 9–12) with head CT evidence of potential intracranial mass lesion (iii) Neurologic deficit as a result of potential spinal cord injury (applicable to spine surgeon, whether a neurosurgeon or orthopedic surgeon) (iv) Trauma surgeon discretion Neurosurgery attending must be involved in the clinical decision-making for the care of these patients E E Level I and II trauma centers must have a neurotrauma contingency plan and must implement the plan when E E TRAUMA CENTERS CHAPTER 0720-22 neurosurgery capabilities are encumbered or overwhelmed. Level III and Level IV trauma centers must have a written plan approved by the TMD that defines the types of neurotrauma injuries that may be treated at the center. E E Surgical Critical Care E5 D5 5. Surgical Specialty Availability from inside or outside hospital 24/7/365. All specialists are required for Level I & II centers. Cardiac Surgery E E1 General Surgery E17 E17 D Neurologic Surgery E17 D Microsurgery capabilities E15 E15 Gynecologic Surgery E E Hand Surgery E7 E7 Obstetrics E E Ophthalmic Surgery E E D Oral and Maxillofacial Surgery - Dentistry E2 E2 D Orthopedic Surgery E E E Must have an orthopedic surgeon who has completed Orthopedic Trauma Association fellowship, alternate training criteria. E E19 In trauma centers, an orthopedic surgeon (resident, non- physician practitioner, trauma surgeon with ortho privileges) must be at bedside within 30 minutes of request for the following: (i) Hemodynamically unstable, secondary to pelvic fracture (ii) Suspected extremity compartment syndrome (iii) Fractures/dislocations with risk of avascular necrosis (e.g., femoral head or talus) (iv) Vascular compromise related to a fracture or dislocation trauma surgeon discretion The orthopedic surgeon must be involved in the clinical decision- making for care of these patients E E E Otorhinolaryngologic Surgery E2 E2 D Pediatric Surgery E3 E3 Plastic Surgery E E D TRAUMA CENTERS CHAPTER 0720-22 Thoracic Surgery E E D Urologic Surgery E E D Vascular Surgery E E 6. Non-Surgical Specialty Availability in-hospital 24 hours a day Emergency Medicine E8 E8 E E9 Anesthesiology E E10 E11 7. Non-Surgical Specialty Availability on call from inside or outside hospital Cardiology E E D Chest (pulmonary) Medicine E E Gastroenterology E E Hematology E E D Infectious Diseases E E Internal Medicine E E E Nephrology E E Pathology E12 E12 Pediatrics E E Psychiatry E E Radiology E18 E18 E18 (i) Interventional Radiology response for hemorrhage control E E (ii) Level I & II centers must have necessary human & physical resources continuously available for so that an endovascular or interventional radiology procedure for hemorrhage control can begin within 60 minutes of request. E E Allied Health (i) Respiratory therapy 24/7/365 E E E (ii) Nutrition support E E E (iii) Speech Therapy E E E (iv) Social Worker E20 E20 E21 TRAUMA CENTERS CHAPTER 0720-22 (v) Occupational Therapy E20 E20 E21 (vi) Physical Therapy E20 E20 E21 Intensivists: at least one intensivist must be board certified or board eligible in critical care E E (b) Special Facilities/Resources/Capabilities 1.(i) Emergency Department (ED) – Personnel I II III IV Designated Physician Director E E E E In all trauma centers, emergency medicine physicians must be board certified, board eligible or have been approved through the Alternate Pathway. All emergency medicine physicians must have taken the ATLS course at least once. Physicians who are board certified or board eligible in a specialty other than emergency medicine must hold current ATLS certification. All physicians must be physically present in the ED 24 hours a day. E E E E Full-time emergency department RN personnel 24 hours a day trained in trauma specific education/competencies E E E E Non-physician practitioners that are clinically involved in the initial evaluation and resuscitation of trauma patients during the activation phase must have current ATLS certification. E E E E 1.(ii) Emergency Department – Equipment for resuscitation and to provide support for the critically or seriously injured must include but shall not be limited to: Airway control and ventilation equipment including laryngoscopes and endotracheal tubes of all sizes, bag-mask resuscitator, sources of oxygen, and mechanical ventilator E E E E All trauma centers must have a provider and equipment immediately available to establish an emergency airway. E E E E Suction devices E E E E Electrocardiography defibrillator E E E E Bedside ultrasound capability for FAST examination E E E E Capability for advanced hemodynamic monitoring i.e. central lines, ICP monitoring, arterial lines etc. E E D All standard intravenous fluids and administration devices, E E E E TRAUMA CENTERS CHAPTER 0720-22 including intravenous catheters Sterile surgical sets for procedures standard for ED, such as thoracostomy, cutdown, etc. E E E E Drugs and supplies necessary for emergency care E E E E X-ray capability, 24-hour coverage by in-house technicians E E E E Two-way radio linked with vehicles of emergency medical services E E E E Cervical collars E E E E Long Spine Board E E E E Splinting materials and devices E E E E Helipad or Helicopter Landing Area E E E E End Tidal Carbon Dioxide Monitoring E E E E Tourniquets E E E E Appropriate sized catheters for the performance of needle chest decompression E E E E Appropriate equipment for the performance of interosseous cannulation E E E E A rapid volume infuser for the utilization of transfusion protocol E E E D 2.(i) Intensive Care Units (ICU) for Trauma Patients Designated Surgeon Medical Director. Level I director must be a surgeon boarded in surgical critical care. Level II Director or co-director must be a surgeon boarded in surgical critical care. Level III director or co-director must be a surgeon boarded in general surgery. E E E If admitting traumatically injured patients, director or co- director must be a board certified general surgeon E Physician on duty in ICU 24 hours a day or immediately available from in-hospital (PGY4/5 qualify) E5 E5 E Provider coverage must be available within 30 minutes of request, with a formal plan in place for emergency coverage. E22 Nurse-patient minimum ratio of 1:2 on each shift depending on patient acuity E E E Immediate access to clinical laboratory service E E E TRAUMA CENTERS CHAPTER 0720-22 2.(ii) Equipment: Airway control and ventilation devices E E E E23 Oxygen source with concentration controls E E E E23 Cardiac emergency cart E E E E23 Temporary transvenous pacemaker E E E E23 Electrocardiograph defibrillator E E E E23 Cardiac output monitoring E E D End Tidal Carbon Dioxide Monitoring/Waveform capnography E E E E23 Electronic Arterial pressure monitoring E E E E23 Mechanical ventilator-respirators E E E E23 Patient weighing devices E E E E23 Temperature control devices E E E E23 Drugs, intravenous fluids and supplies E E E E23 Intracranial pressure monitoring devices E E D D A rapid volume infuser for the utilization of transfusion protocol E E E E23 3. Post-anesthetic recovery room (ICU is acceptable) Registered nurses 24 hours a day E E E Monitoring and resuscitation equipment E E E 4. Acute hemodialysis capability E E13 E13 5. Organized burn care: Physician directed burn center/unit staffed by personnel trained in burn care and equipped properly E14 E14 E14 6. Acute spinal cord management capability OR written transfer agreement with a hospital capable of caring for a spinal cord patient E E 7. Acute head injury management capability OR written transfer agreement with a hospital capable of caring for a patient with a head injury E E 8. Radiological Special Capabilities TRAUMA CENTERS CHAPTER 0720-22 Interventional radiology (includes angiography) E E D Angiography of all types E E D Sonography E E E Nuclear scanning E E D In-house computerized tomography. In all trauma centers, documentation of the final interpretation of CT scans must occur no later than 12 hours after completion of the scan. E E E E MRI (magnetic resonance imaging) E E D Must have mechanism to remote view images from referring hospitals in catchment area E E 9. Organ donation protocol E16 E16 E16 E16 (c) Operating suite special requirements 1. Equipment/instrumentation I II III IV Operating room, dedicated to the trauma service, with nursing staff in-house and immediately available 24 hours a day within 15 minutes of notification E E D If first operating room is occupied an additional operating room must be staffed and available. E E Operating room, dedicated to the trauma service, adequately staffed and available within 30 minutes of notification E Must have dedicated operating room prioritized for fracture care in nonemergent orthopedic trauma E E Cardiopulmonary bypass equipment must be immediately available when required, or a contingency plan must exist to provide emergency cardiac surgical care. E1 E1 Operating microscope E E Thermal control equipment for patient E E E Thermal control equipment for blood E E E X-ray capability E E E Endoscopes, all varieties E E E Craniotomy instrumentation E E D TRAUMA CENTERS CHAPTER 0720-22 Monitoring equipment (e.g., ECG, blood pressure monitoring) E E E A rapid volume infuser for the utilization of transfusion protocol E E E (d) Clinical Laboratory Services available 24 hours a day 1. Standard analysis of blood, urine, and other body fluids E E E E 2. Blood typing and cross-matching E E E E 3. Coagulation studies E E E E 4. Blood bank or access to a community central blood bank and hospital storage facilities E E E E 5. Blood gases and pH determinations E E E E 6. Serum and urine osmolality E E E D 7. Microbiology E E E E 8. Drug and alcohol screening E E E E 9. Thromboelastography (TEG) E E 10. Must have transfusion protocol developed collaboratively between the trauma service and blood bank E E E E 11. Must have adequate supply of blood products E E E E (e) Trauma Medical Director 1. A physician board certified in general surgery E E E D In Level IV centers, there must be a Trauma Medical Director who is a physician and has, at a minimum, the following authority and responsibilities: (i) Develop and enforce clinical protocols and practice management guidelines relevant to the care of the injured patient. (ii) Ensure clinicians meet all requirements and adhere to institutional standards of practice related to trauma care. (iii) Work across departments and /or other administrative units to address deficiencies in care. (iv) Determine clinician participation in trauma care, which might be guided by findings from the PIPS process or professional practice reviews. (v) Oversee the structure and process of the trauma PIPS program. (vi) Participate in committees relevant to the regional trauma system. E TRAUMA CENTERS CHAPTER 0720-22 (vii) Chair or co-chair (with the TPM) the committee where discussions/decisions occur related to trauma operations. (viii) Lead discussions pertaining to trauma multidisciplinary case reviews. (ix) Be active in the participation of trauma care in the trauma center. 2. Minimum of three years clinical experience on a trauma service or trauma fellowship training E E D 3. 36 hours of category I trauma/critical care CME every 3 years or 12 hours each year and attend one national meeting whose focus is trauma or critical care E E E Provide evidence of 24 hours of trauma-related continuing medical education (CME/CE) per 3 years E 4. Participates in call E E E 5. Has the authority to manage all aspects of trauma care E E E 6. Authorizes trauma service privileges of the on-call panel E E E 7. Works in cooperation with nursing administration to support the nursing needs of trauma patients E E E E 8. Develops treatment protocols along with the trauma team E E D 9. Coordinates performance improvement and peer review processes E E E E 10. With the assistance of the hospital administrator and the TPM, be involved in coordinating the budgetary process for the trauma program E E E 11. Participates in the Tennessee Chapter of the ACS-COT E E E E 12. Participates in regional and national trauma organizations E E E 13. Retain a current certification of ATLS and participates in the provision of trauma-related instruction to other health care personnel E E E E 14. Is involved in trauma research E D 15. In trauma centers, the shared roles and responsibilities of trauma surgeons and emergency medicine physicians for trauma resuscitation must be defined and approved by the Trauma Medical Director. E E E D (f) Attending General Surgeon on the Trauma Service TRAUMA CENTERS CHAPTER 0720-22 1. Must be currently board certified or board eligible in General Surgery E E E E 2. All attending general surgeons on the trauma service must have taken the ATLS course at least once. E E E E 3. Surgery coverage must be continually available. E E E 4. In Level I and II trauma centers, the trauma surgeon must be dedicated to a single trauma center while on call. E E 5. Level I and II trauma centers must have a published backup call schedule for trauma surgery. E E 6. Trauma surgeon must be present in the operating room for key portions of operative procedures for which they are the responsible surgeon and must be immediately available throughout the procedure. E E E 7. In Level I centers with surgery training programs, they must: (i) Have a trauma rotation with defined objectives and curriculum for PGY3, PGY4, or PGY5 general surgical residents. (ii) General surgery residents must be assigned to the trauma rotation for a minimum of three months during their PGY4 or PGY5 to ensure sufficient exposure to trauma care. For pediatric trauma centers, PGY3 surgical residents are acceptable. (iii) Must have trauma surgery coverage by PGY4 or PGY5 general surgery residents. If the number of PGY4 or PGY5 residents is insufficient to ensure coverage, PGY3 surgical residents and/or fellows are acceptable. All general surgery residents and/or fellows must be from an Accreditation Council for Graduate Medicine Education (ACGME) accredited program. E24 (g) Trauma Program Manager (TPM)/Trauma Nurse Coordinator (TNC) 1. Must have a full-time TPM/TNC dedicated to the trauma program E E E D 2. Must have a part-time TPM/TNC with the trauma program as a major focus of their job description E 3. Must be a Registered Nurse licensed by the Tennessee Board of Nursing in good standing or a licensed Registered Nurse in another state with a multistate privilege to practice in Tennessee E E E E 4. Must possess experience in Emergency/Critical Care Nursing E E E E 5. Must have a defined job description and organizational chart delineating the TNC/TPM role and responsibilities including a E E E E TRAUMA CENTERS CHAPTER 0720-22 reporting structure that includes the TMD 6. Must be provided the administrative and budgetary support to complete educational, clinical, research, administrative and outreach activities for the trauma program E E E 7. Shall attend one national meeting within the 3-year designation cycle, 36 hour continuing education (CE) during the designation cycle, and hold current membership in national organization E E E E (h) Trauma Registrar 1. A full-time equivalent registrar for each 500 patients per year who were admitted and/or who met institutional criteria for trauma team activation and were discharged home from the ED E E E E 2. At least one registrar must be a current CAISS specialist. E E E E 3. Staff members that have a registry role in data abstraction and entry, injury coding, ISS calculation, data reporting, or data validation for the trauma registry must fulfill all of the following requirements: (i) Participate and pass the most current version of the AAAM’s Abbreviated Injury Scale (AIS) course that your center is using (ii) Participate on a trauma registry course that includes all of the following content: (I) Abstraction (II) Data management (III) Reports/report analysis (IV) Data validation (V) HIPAA (iii) Participate in an ICD-10 course or an ICD-10 refresher course every five years E E E E 4. Each trauma registrar must accrue at least 24 hours trauma- related CE during the designation cycle. E E E E (i) Programs for Quality Assurance 1. Medical Care Education Morbidity and Mortality Reviews to encompass all trauma deaths E E E E 2. Trauma Process Improvement (PI) The institution must provide resources to support the trauma process improvement program. E E E E In all trauma centers, the trauma PIPS program must be independent of the hospital or departmental PI program, but it must report to the hospital or departmental PI program. E E E E TRAUMA CENTERS CHAPTER 0720-22 Trauma centers must have a written PIPS plan that: (i) Outlines the organizational structure of the trauma PIPS process, with a clearly defined relationship to the hospital PI program (ii) Specifies the processes for event identification. As an example, these events may be brought forth by a variety of sources, including but not limited to: individual personnel reporting, morning report or daily signouts, case abstraction, registry surveillance, use of clinical guideline variances, patient relations, or risk management. The scope for event review must extend from prehospital care to hospital discharge. (iii) Includes a list of audit filters, event review, and report review that must include, at minimum, those listed as audit filters, events, or report reviews below (iv) Defines levels of review (primary, secondary, tertiary, and/or quaternary), with a listing for each level that clarifies: (I) Which cases are to be reviewed (II) Who performs the review (III) When cases can be closed or must be advanced to the next level (v) Specifies the members and responsibilities of the trauma multidisciplinary PIPS committee (vi) Outlines an annual process for identification of priority areas for PI, based on audit Audit filters, event or report reviews: (i) Surgeon arrival time for the highest level of activation (ii) Delay in response for urgent assessment by the neurosurgery and orthopedic specialists (iii) Delayed recognition of or missed injuries (iv) Compliance with prehospital triage criteria, as dictated by regional protocols (v) Delays or adverse events associated with prehospital trauma care (vi) Compliance of trauma team activation, as dictated by program protocols (vii) Accuracy of trauma team activation protocols (viii) Delays in care due to the unavailability of emergency department physician (Level III) (ix) Unanticipated return to the OR (x) Unanticipated transfer to the ICU or intermediate care (xi) Transfers out of the facility for appropriateness and safety (xii) All nonsurgical admissions (excludes isolated hip fractures) (xiii) Radiology interpretation errors or discrepancies between the preliminary and final reports (xiv) Delays in access to time-sensitive diagnostic or therapeutic interventions (xv) Compliance with policies related to timely access to the OR for urgent surgical intervention (xvi) Delays in response to the ICU for patients with critical needs (xvii) Lack of availability of essential equipment for E E E E TRAUMA CENTERS CHAPTER 0720-22 resuscitation or monitoring (xviii) MTP activations (xix) Significant complications and adverse events (xx) Transfers to hospice (xxi) All deaths: inpatient, died in emergency department (DIED), DOA (xxii) Inadequate or delayed blood product availability (xxiii) Patient referral and organ procurement rates (xxiv) Screening of eligible patients for psychological sequelae (xxv) Delays in providing rehab services (xxvi) Screening of eligible patients for alcohol misuse (xxvii) Pediatric admissions to non-pediatric trauma centers (xxviii)Neurotrauma care at Level III trauma centers (xxix) Neurotrauma diversion Must have a performance improvement coordinator dedicated to the trauma program. 0.5 FTE when annual volume exceeds 500 patients. 1 FTE when annual volume exceeds 1,000 pt. entries E E E E Must have a Trauma Performance Improvement Committee that meets at least quarterly and includes physician liaisons from the following services: Orthopedics, Radiology, Anesthesia, Emergency Medicine, Neurosurgery, Geriatric and core trauma surgeons as well as nursing, pre-hospital personnel and other healthcare providers. The Committee reviews policies and procedures as well as system issues, and its members or designees attend at least 50% of regular Committee meetings. The Trauma Medical Director must attend at least 60 percent of regular Trauma Performance Improvement Committee meetings. Attendance cannot be delegated to the associate Trauma Medical Director. The committee shall: E E E E (i) Monitor team notification times. For highest level of activation trauma attending must be present within 15 minutes of patient arrival 80% of the time. E E D (ii) Monitor team notification times. For highest level of activation, trauma attending must be present within 30 minutes of patient arrival 80% of the time. E All trauma centers must have documented evidence of event identification; effective use of audit filters; demonstrated loop closure; attempts at corrective actions; and strategies for sustained improvement measured over time. E E E E 3. Operational Process Improvement (Evaluation of System Issues) This is a multidisciplinary conference presided over by the Trauma Medical Director and shall include hospital administrative staff over trauma services as well as the staff in charge of all trauma- program related services. This committee addresses, assesses, and corrects global trauma program and system issues, and corrects overall program deficiencies to continue to optimize E E E E TRAUMA CENTERS CHAPTER 0720-22 patient care. This should be held at least quarterly, attendance noted, and minutes recorded. 4. Trauma Bypass Log All trauma centers must not exceed 400 hours of diversion during the reporting period. E E E E 5. Trauma centers must have evidence-based clinical practice guidelines, protocols, or algorithms that are reviewed at least every three years. E E E D 6. Level I and II trauma centers must have the following protocols for care of the injured older adult: (i) Identification of vulnerable geriatric patients (ii) Identification of patients who will benefit from the input of a health care provider with geriatric expertise (iii) Prevention, identification, and management of dementia, depression, and delirium (iv) Process to capture and document what matters to patients, including preferences and goals of care, code status, advanced directives, and identification of a proxy decision-maker (v) Medication reconciliation and avoidance of inappropriate medications (vi) Screening for mobility limitations and assurance of early, frequent, and safe mobility Implementation of safe transitions to home or other health care facility E E D 7. All trauma centers must have a process in place to assess children for nonaccidental trauma. E E E E 8. All trauma centers must have a rapid reversal protocol in place for patients on anticoagulants. E E E E 9. In all trauma centers, the emergency department must evaluate its pediatric readiness and have a plan to address any deficiencies. E E E E 10. Trauma centers must have treatment guidelines for, at minimum, the following orthopedic injuries: (i) Patients who are hemodynamically unstable attributable to pelvic ring injuries (ii) Long bone fractures in patients with multiple injuries (e.g., time to fixation, order of fixation, and damage control versus definitive fixation strategies) (iii) Open extremity fractures (e.g., time to antibiotics, time to OR for operative debridement, and time to wound coverage for open fractures) (iv) Hip fractures in geriatric patients (e.g., expected time to OR) E E E 11. Trauma centers must meet the rehabilitation needs of trauma patients by: E E E TRAUMA CENTERS CHAPTER 0720-22 (i) Developing protocols that identify which patients will require rehabilitation services during their acute inpatient stay (ii) Establishing processes that determine the rehabilitation care, needs, and services required during the acute inpatient stay (iii) Ensuring that the required services during acute inpatient stay are provided in a timely manner 12. Rehabilitation and discharge planning. Trauma centers must have a process to determine the level of care patients require after trauma center discharge, as well as the specific rehabilitation care services required at the next level of care. The level of care and services required must be documented in the medical record. E E E 13. Trauma centers must meet the mental health needs of trauma patients by having a protocol to screen patients at high risk for psychological sequelae with subsequent referral to a mental health provider. E E 14. A process for referral to a mental health provider when required E D 15. Alcohol misuse screening. Trauma centers must screen all admitted trauma patients greater than 12 years old for alcohol misuse with a validated tool or routine blood alcohol content testing. Programs must achieve a screening rate of at least 80 percent. E E E D Alcohol misuse intervention. Trauma centers, at least 80 percent of patients who have screened positive for alcohol misuse must receive a brief intervention by appropriately trained staff prior to discharge. This intervention must be documented. Level III trauma centers must have a mechanism for referral if brief intervention is not available as an inpatient. E E E D 16. Trauma centers must have a written data quality plan and demonstrate compliance with that plan. At minimum, the plan must require quarterly review of data quality. E E E 17. Trauma centers must participate in a risk-adjusted benchmarking program and use the results to determine whether there are opportunities for improvement in patient care and registry data quality. E E D D 18. All nonsurgical trauma admissions must be reviewed by the trauma program. Nonsurgical admissions (NSA) without trauma or other surgical consultation, with ISS > 9, or with identified opportunities for improvement must, at a minimum, be reviewed by the TMD in secondary review. E E E D (j) System Development 1. Level I and II centers shall maintain a commitment to provide ATLS and other educational activities deemed appropriate and E E TRAUMA CENTERS CHAPTER 0720-22 timely to surrounding referral centers. 2. Be involved with local and regional EMS agencies and/or personnel and assist in trauma education, performance improvement, and feedback regarding care E E E 3. All trauma centers shall participate in trauma system planning and development under the auspices of the Trauma Care Advisory Council. E E E E 4. The trauma center shall be involved in community awareness of trauma and the trauma system. E E E E (k) Injury Prevention 1. Participate in statewide trauma center collaborative injury prevention efforts focused on common needs throughout the state E E E E 2. Perform studies in injury control while monitoring the effects of prevention programs. Implement at least two activities over the course of the designation cycle with specific objectives and deliverables that address separate major causes of injury in the community E E D 3. Must have a full-time injury prevention coordinator dedicated to the trauma program to ensure community and regional injury prevention activities are implemented and evaluated for effectiveness E E D D (l) Institutional Commitment 1. Demonstrates knowledge, familiarity, and commitment of upper level administrative personnel to trauma service E E E E 2. Upper level administration participation in multidisciplinary trauma conferences/committees E E E E 3. Evidence of yearly budget for the trauma program E E E E 4. Hospital administration must demonstrate support for research efforts of the Trauma Service E D 5. Must demonstrate the following scholarly activities during the verification (designation) cycle: (i) At least 10 trauma-related research articles (ii) Participation by at least one trauma program faculty member as a visiting professor, invited lecturer, or speaker at a regional, national, or international trauma conference Support of residents or fellows in any of the following scholarly E TRAUMA CENTERS CHAPTER 0720-22 activities: laboratory experience; clinical trials; resident trauma paper competition at the state, regional, or national level; and other resident trauma research presentations (m) Activation Criteria 1. Each center shall have clearly defined graded activation criteria. For the highest level of activation, the trauma team (trauma Chief resident: PGY 4/5 or ED attending) shall be immediately available and the trauma attending available within 15 minutes of patient arrival. E E 2. For the highest level of activation for Level III centers, the trauma attending shall be available within 30 minutes of patient arrival unless the patient is immediately being transferred to a higher level of care. E (n) Disaster Preparedness 1. The trauma program must be a part of the hospital disaster planning process. E E E E A trauma surgeon from the trauma panel must be a part of the disaster planning committee. E E E Ortho trauma surgeon from the trauma panel must be a part of the disaster planning committee. E Trauma programs must participate in two hospital drills/exercise per year. E E E Surgeon liaison to disaster committee must complete DMEP course at least once. E (3) References (a) The following references refer to the superscripts in the Table in paragraph (2) of this rule: 1. If cardiopulmonary bypass equipment is not immediately available, a contingency plan, including immediate transfer to an appropriate center and one hundred percent performance review of all patients transferred must be in place. 2. This requirement may be substituted by a department or division capable of treating maxillofacial trauma as demonstrated by staff privileges. 3. This requirement may be substituted by a current signed transfer agreement with an institution having a Pediatric Surgery Service. TRAUMA CENTERS CHAPTER 0720-22 4. The emergency department staffing must provide immediate and appropriate care for the trauma patient. The emergency department physician must function as a designated member of the trauma team. 5. Requirements may be fulfilled by a Senior Surgical Resident (PGY 4 or higher) capable of assessing emergency situations in trauma patients and initiating proper treatment. A staff surgeon trained and capable of carrying out definitive treatment must be available within 15 minutes of patient arrival. 6. Requirements may be fulfilled by in-house neurosurgeon or neurosurgery resident, senior general surgery resident or trauma attending who has special competence as defined by the hospital, as documented by the Chief of Neurosurgery Service, in the care of patients with neural trauma, and who is capable of initiating measures directed toward stabilizing the patient and initiating diagnostic procedures. An attending neurosurgeon dedicated to the hospital’s trauma service must be available within thirty (30) minutes from notification. 7. This requirement may be substituted by a current signed transfer agreement with an institution having a Hand Surgery Service. 8. Requirements may be fulfilled by senior level (last year in training) Emergency Medicine Residents capable of assessing emergency situations and initiating proper treatment. The staff specialist responsible for the resident must be available within thirty (30) minutes. 9. A non-physician practitioner with current certification as an ATLS provider may fulfill this role. 10. Requirements for Level II Trauma Center may be fulfilled when local conditions assure that a staff anesthesiologist is on call and available within thirty (30) minutes. During the interim period prior to the arrival of a staff anesthesiologist, a Certified Registered Nurse Anesthetist (CRNA) operating under the direction of the anesthesiologist, the trauma team surgeon director or the emergency medicine physician may initiate appropriate supportive care. 11. Requirements for Level III Trauma Center may be fulfilled when local conditions assure that a staff anesthesiologist is on call and available within thirty (30) minutes. However, when there is not an anesthesiologist on the hospital staff, this requirement may be fulfilled by a CRNA operating under the supervision of the surgeon, the anesthesiologist, and/or the responsible physician. 12. Forensic pathologist must be available either as part of the hospital staff or on a consulting basis. 13. This requirement may be substituted by current signed transfer agreement with hospital having hemodialysis capabilities. 14. This requirement may be substituted by current signed transfer agreement with burn center or hospital with burn unit. 15. This requirement may be substituted by a current signed transfer agreement with a hospital having Microsurgical capabilities. 16. Each center must have an organized protocol with a transplant team or service to identify possible organ donors and in procuring organs for donation. TRAUMA CENTERS CHAPTER 0720-22 17. All specialists must be available within thirty (30) minutes from notification. 18. Qualified radiologists must be available within 30 minutes in person or by teleradiology for interpretation of radiographs. 19. This requirement may be substituted by a current signed transfer agreement with a hospital having an orthopedic surgeon who has completed Orthopedic Trauma Association fellowship alternate training criteria. 20. For Level I and II centers, these requirements will/shall be available 7 days a week. 21. For Level III centers, 7 day a week coverage is not required. 22. Coverage may include an intensivist, hospitalist, or non-physician practitioner. The formal plan for emergency coverage should allow for patients’ immediate needs to be met until the attending surgeon is available. For Level IV centers. All equipment is to be required if admitting trauma patients to the ICU, except cardiac output monitoring. 24. Essential only for those Level I centers with surgery training programs. (4) Designation (a) The Commission shall implement and oversee the designation process. (b) The preliminary designation process for facilities aspiring for designation as a Level I, II, III, or IV Trauma Center shall consist of the following: 1. Each facility desiring designation shall submit an application to the Commission; 2. The Commission shall review each submitted application and communicate deemed application deficiencies to the facility in writing; 3 . The facility shall have thirty (30) days to submit required information; and 4 . Arrangements shall be made for a provisional site visit for those facilities meeting application requirements. (c) The site visit team shall consist of the following for Level I and Level II centers: 1. A trauma surgeon medical director or a trauma surgeon who has previously been a medical director from an out-of-state trauma center who shall serve as team leader; If the out-of-state surgeon is not available, he/she may be substituted by an in-state surgeon from a different grand division at the discretion of the center being reviewed. 2. A trauma surgeon from an in-state Level I trauma center; 3. An in-state trauma nurse coordinator/program manager from a Level I trauma center; and 4. The state trauma system director/asst. director. (d) The site visit team shall consist of the following for Level III centers: TRAUMA CENTERS CHAPTER 0720-22 1. A trauma surgeon from an in-state Level I or Level II trauma center; 2. An in-state trauma nurse coordinator/program manager from a Level I trauma center; and 3. The state trauma system director/asst. director. (e) The site visit team shall consist of the following for Level IV centers: 1. An in-state trauma nurse coordinator/program manager from a Level I trauma center; and 2. The state trauma system director/asst. director. 3. If deficiencies are found necessitating a focused visit, a trauma surgeon from an in-state Level I trauma center shall be part of the focused site visit team. (f) The team shall be appointed by the following organizations: 1. The state trauma system director/asst. director shall consult with the State Committee on Trauma of the American College of Surgeons for assistance in identifying the out-of-state surgeon; and 2. The state trauma system director/asst. director, in consultation with the chairman and vice chairpersons of the Tennessee Committee on Trauma, shall select the in-state members of the site visiting team. (g) The team shall conduct a provisional visit to ensure compliance with all criteria required for designation as a Trauma Center with the requested level of designation before the Commission grants an institution designation as a Trauma Center. During the provisional visit, the applicant shall demonstrate that the required mechanisms to meet the criteria for the desired designation level are in place. (h) The team shall identify deficiencies and areas of improvement it deems necessary for designation. (i) If the team does not cite any deficiencies and concludes that the facility is otherwise in compliance with all applicable standards, it shall approve the applicant to function with provisional status for a period of one (1) year. (j) If, during the provisional visit, the team cites deficiencies, it shall not approve provisional status for the applicant to function as a trauma center. Centers with deficiencies shall have fifteen (15) days from report receipt to provide documentation demonstrating compliance. If the facility is unable to correct the deficiencies within fifteen (15) days, the application shall be denied and the applicant may not resubmit an application for trauma center designation for at least one (1) year from the date of denial. (k) Facilities granted provisional status as a trauma center shall adhere to the following: 1. The facility shall be prepared to provide: (i) A description of changes made after the grant of provisional status; TRAUMA CENTERS CHAPTER 0720-22 (ii) A description of areas for improvement cited during the provisional visit; and (iii) A summary of the hospital’s trauma service based on the trauma registry report. 2. The team shall conduct a site visit at the termination of the applicant’s one (1) year provisional designation as a trauma center. 3. During the follow-up visit, the team shall identify the presence of any deficiencies and areas for improvement. (l) Upon completion of the follow-up visit, the team shall submit its findings and designation recommendations to the Commission. 1. If the team cites deficiencies found during its follow-up visit, they shall be included in its report to the Commission. 2. The facility requesting trauma center designation shall be allowed to present evidence demonstrating action taken to correct cited deficiencies to the Commission during the ratification process. (m) The final decision regarding trauma center designation shall be rendered by the Commission. If granted, trauma center designation is applicable for a period of three (3) years. (n) If the Commission denies the applicant trauma center designation, the facility may not reapply for at least one (1) year and will have its provisional status revoked. (o) The facility applying for trauma center designation shall bear all costs of the application process, including costs of a site visit. (p) A facility requesting an American College of Surgeons trauma center consultation/verification site visit shall coordinate with the state trauma system director/ asst. director to ensure his/her attendance at the review. If the state trauma system director/asst. director is unable to attend the site visit, the facility shall share the finalized report from the site visit with the state trauma system director/asst. director for presentation to the Commission if the facility seeks a reciprocal state designation. (q) Denial of Provisional or Full Designation, When the Commission denies provisional or full designation, it must provide the center with a written notification of the action and the basis for the action. The notice will inform the center of the right to appeal and the procedure to appeal the action under the provisions of the Uniform Administrative Procedures Act. (5) Verification (a) Following designation as a trauma center, a verification site visit shall be conducted at the facility every three (3) years. (b) The team shall advise the center of an upcoming verification visit at least sixty (60) days prior to the visit. After the facility receives notice of the upcoming verification site visit, it shall prepare all materials the team requests for submission. (c) The team shall conduct an exit interview with the facility at the conclusion of the verification visit. During the exit interview the team shall communicate the following: TRAUMA CENTERS CHAPTER 0720-22 1. The presence of deficiencies; 2. The facility’s strengths and weaknesses; and 3. Recommendations for improvements and correction of deficiencies. (d) The team shall submit a site visit report within sixty (60) days of completion of the site visit. It shall submit a copy of the report to the Commission, the Chief Executive Officer of the hospital, the Trauma Medical Director and the Trauma Program Manager (TPM). (e) If the team does not cite deficiencies and the center is in compliance with all applicable standards, the team shall recommend that the facility be confirmed at its current level of trauma designation for a period of three (3) additional years. (f) The facility shall bear all costs of the verification process, including the costs of a site visit. (g) If a trauma center already designated by the Commission elects to undergo an American College of Surgeons trauma center consultation/verification site visit, the facility shall coordinate with the state trauma director/asst. director to ensure his/her attendance at the review. If the state trauma director/asst. director is unable to attend the site visit, the finalized report from the site visit shall be shared with the state trauma director/asst. director for presentation to the Commission if a reciprocal state designation is to be granted. (6) Disciplinary Action (a) If during the site visit the team determines that deficiencies exist, the center’s designation shall be placed on provisional status and the center shall have a period not to exceed thirty (30) days to submit a corrective action plan (CAP) that shall include the process for deficiency resolution and a timeline for compliance. A focused review will be scheduled within one (1) year either through a desk review or on-site review to ensure compliance, if deemed necessary by the site review team. Immediate referral for termination of designation may be made by the review team, if the deficiency is determined to be severe and pervasive. (b) Whether a desk review or onsite visit shall be required is dependent upon the scope and severity of the deficiency cited and is within the purview of the site team to make the decision on the type of revisit required. (c) If the team ascertains that deficiencies have not been corrected within one (1) year, whether through desk review or an on-site visit, the center must present an explanation to the Commission at its next scheduled meeting. (d) The Commission may, in accordance with the Uniform Administrative Procedures Act, revoke, suspend, place on probation, or otherwise discipline, a facility’s trauma center designation. (e) The Commission may revoke, suspend, place on probation, or otherwise discipline, the designation or provisional status of a center when an owner, officer, director, manager, employee or independent contractor: 1. Fails or refuses to comply with the provisions of these rules; TRAUMA CENTERS CHAPTER 0720-22 2. Makes a false statement of material fact about the center’s capabilities or other pertinent circumstances in any record or matter under investigation for any purposes connected with these rules; 3. Prevents, interferes with, or attempts to impede in any way, the work of a representative of the Commission; 4. Falsely advertises, or in any way misrepresents the facility’s ability to care for patients based on its designation status; 5. Is substantially out of compliance with these rules and has not rectified such noncompliance; 6. Fails to provide reports required by the trauma registry or the Commission in a timely and complete fashion; 7. Fails to comply with or complete a plan of correction in the time or manner specified; 8. Has engaged in a deliberate and willful violation of these rules; or 9. Acts in a manner that endangers the public’s health, safety, or welfare. (7) Prohibitions (a) It shall be a violation of these regulations for any health care facility to hold out, advertise or otherwise represent itself to be a “trauma center” as licensed by the Commission unless it has complied with the regulations set out herein and the Commission has so licensed it. (b) Any facility the Commission designates as a trauma center, at any level, shall comply with the requirements of EMTALA. The medical needs of a patient and the available medical resources of the facility, rather than the financial resources of a patient, shall be the determining factors concerning the scope of service provided. (c) The term “trauma center” refers to a main hospital campus that has met all requirements to satisfy trauma center rule designation. Off campus sites are excluded in this designation.