SECTION .0900 – TRAUMA CENTER STANDARDS AND APPROVAL
10A NCAC 13P .0901 LEVEL I TRAUMA CENTER CRITERIA
To receive designation as a Level I Trauma Center, a
hospital shall have the following:
(1) A trauma program and a trauma service that have
been operational for at least 12 months prior to application for designation;
(2) Membership in and inclusion of all trauma patient
records in the North Carolina Trauma Registry for at least 12 months prior to
submitting a Request for Proposal;
(3) A trauma medical director who is a board-certified
general surgeon. The trauma medical director must:
(a) Have a minimum of three years clinical
experience on a trauma service or trauma fellowship training;
(b) Serve on the center's trauma service;
(c) Participate in providing care to patients
with life-threatening or urgent injuries;
(d) Participate in the North Carolina Chapter of
the ACS Committee on Trauma as well as other regional and national trauma
organizations;
(e) Remain a provider in the ACS' ATLS Course
and in the provision of trauma-related instruction to other health care
personnel; and
(f) Be involved with trauma research and the
publication of results and presentations;
(4) A full-time TNC/TPM who is a registered nurse,
licensed by the North Carolina Board of Nursing;
(5) A full-time TR who has a working knowledge of
medical terminology, is able to operate a personal computer, and has the
ability to extract data from the medical record;
(6) A hospital department/division/section for general
surgery, neurological surgery, emergency medicine, anesthesiology, and
orthopaedic surgery, with designated chair or physician liaison to the trauma
program for each;
(7) Clinical capabilities in general surgery with
separate posted call schedules. One shall be for trauma, one for general surgery
and one back-up call schedule for trauma. In those instances where a physician
may simultaneously be listed on more than one schedule, there must be a defined
back-up surgeon listed on the schedule to allow the trauma surgeon to provide
care for the trauma patient. If a trauma surgeon is simultaneously on call at
more than one hospital, there shall be a defined, posted trauma surgery back-up
call schedule composed of surgeons credentialed to serve on the trauma panel;
(8) A trauma team to provide evaluation and treatment
of a trauma patient 24 hours per day that includes:
(a) An in-house trauma attending or PGY4 or
senior general surgical resident. The trauma attending participates in
therapeutic decisions and is present at all operative procedures.
(b) An emergency physician who is present in the
Emergency Department 24 hours per day who is either board-certified or prepared
in emergency medicine (by the American Board of Emergency Medicine or the
American Osteopathic Board of Emergency Medicine). Emergency physicians caring
only for pediatric patients may, as an alternative, be boarded or prepared in
pediatric emergency medicine. Emergency physicians must be board-certified within
five years after successful completion of a residency in emergency medicine and
serve as a designated member of the trauma team to ensure immediate care for
the injured patient until the arrival of the trauma surgeon;
(c) Neurosurgery specialists who are never
simultaneously on-call at another Level II or higher trauma center, who are
promptly available, if requested by the trauma team leader, unless there is
either an in-house attending neurosurgeon, a PGY2 or higher in-house
neurosurgery resident or an in-house trauma surgeon or emergency physician as
long as the institution can document management guidelines and annual
continuing medical education for neurosurgical emergencies. There must be a
specified back-up on the call schedule whenever the neurosurgeon is
simultaneously on-call at a hospital other than the trauma center;
(d) Orthopaedic surgery specialists who are
never simultaneously on-call at another Level II or higher trauma center, who
are promptly available, if requested by the trauma team leader, unless there is
either an in-house attending orthopaedic surgeon, a PGY2 or higher in-house
orthopaedic surgery resident or an in-house trauma surgeon or emergency
physician as long as the institution can document management guidelines and
annual continuing medical education for orthopaedic emergencies. There must be
a specified written back-up on the call schedule whenever the orthopaedist is
simultaneously on-call at a hospital other than the trauma center;
(e) An in-house anesthesiologist or a CA3 resident
as long as an anesthesiologist on-call is advised and promptly available if
requested by the trauma team leader; and
(f) Registered nursing personnel trained in the
care of trauma patients;
(9) A written credentialing process established by the
Department of Surgery to approve mid-level practitioners and attending general
surgeons covering the trauma service. The surgeons must have board
certification in general surgery within five years of completing residency;
(10) Neurosurgeons and orthopaedists serving the trauma
service who are board certified or eligible. Those who are eligible must be
board certified within five years after successful completion of the residency;
(11) Written protocols relating to trauma management
formulated and updated to remain current;
(12) Criteria to ensure team activation prior to arrival,
and trauma attending arrival within 15 minutes of the arrival of trauma and
burn patients that include the following conditions:
(a) Shock;
(b) Respiratory distress;
(c) Airway compromise;
(d) Unresponsiveness (GSC less than nine) with
potential for multiple injuries;
(e) Gunshot wound to neck, chest or abdomen;
(f) Patients receiving blood to maintain vital
signs; and
(g) ED physician's decision to activate;
(13) Surgical evaluation, based upon the following
criteria, by the trauma attending surgeon who is promptly available:
(a) Proximal amputations;
(b) Burns meeting institutional transfer
criteria;
(c) Vascular compromise;
(d) Crush to chest or pelvis;
(e) Two or more proximal long bone fractures;
and
(f) Spinal cord injury.
A PGY4 or higher surgical resident, a
PGY3 or higher emergency medicine resident, a nurse practitioner or physician's
assistant, who is a member of the designated surgical response team, may
initiate the evaluation;
(14) Surgical consults for patients with traumatic
injuries, at the request of the ED physician, will conducted by a member of the
trauma surgical team. Criteria for the consults include:
(a) Falls greater than 20 feet;
(b) Pedestrian struck by motor vehicle;
(c) Motor vehicle crash with:
(i) Ejection (includes motorcycle);
(ii) Rollover;
(iii) Speed greater than 40 mph; or
(iv) Death of another individual in the same
vehicle; and
(d) Extremes of age, less than five or greater
than 70 years.
A senior surgical resident may initiate
the evaluation;
(15) Clinical capabilities (promptly available if
requested by the trauma team leader, with a posted on-call schedule), that
include individuals credentialed in the following:
(a) Cardiac surgery;
(b) Critical care;
(c) Hand surgery;
(d) Microvascular/replant surgery, or if service
is not available, a transfer agreement must exist;
(e) Neurosurgery (The neurosurgeon must be
dedicated to one hospital or a back-up call schedule must be available. If
fewer than 25 emergency neurosurgical trauma operations are done in a year, and
the neurosurgeon is dedicated only to that hospital, then a published back-up
call list is not necessary);
(f) Obstetrics/gynecologic surgery;
(g) Opthalmic surgery;
(h) Oral maxillofacial surgery;
(i) Orthopaedics (dedicated to one hospital or
a back-up call schedule must be available);
(j) Pediatric surgery;
(k) Plastic surgery;
(l) Radiology;
(m) Thoracic surgery; and
(n) Urologic surgery;
(16) An Emergency Department that has:
(a) A designated physician director who is
board-certified or prepared in emergency medicine (by the American Board of
Emergency Medicine or the American Osteopathic Board of Emergency Medicine);
(b) 24-hour-per-day staffing by physicians
physically present in the ED such that:
(i) At least one physician on every shift in
the ED is either board-certified or prepared in emergency medicine (by the
American Board of Emergency Medicine or the American Osteopathic Board of
Emergency Medicine) to serve as the designated member of the trauma team to
ensure immediate care until the arrival of the trauma surgeon. Emergency
physicians caring only for pediatric patients may, as an alternative, be
boarded in pediatric emergency medicine. All emergency physicians must be board-certified
within five years after successful completion of the residency;
(ii) All remaining emergency physicians, if not
board-certified or prepared in emergency medicine as outlined in Subitem
(16)(b)(i) of this Rule, are board-certified, or eligible by the American Board
of Surgery, American Board of Family Practice, or American Board of Internal
Medicine, with each being board-certified within five years after successful
completion of a residency; and
(iii) All emergency physicians practice emergency
medicine as their primary specialty.
(c) Nursing personnel with experience in trauma
care who continually monitor the trauma patient from hospital arrival to
disposition to an intensive care unit, operating room, or patient care unit;
(d) Equipment for patients of all ages to
include:
(i) Airway control and ventilation equipment
(laryngoscopes, endotracheal tubes, bag-mask resuscitators, pocket masks, and
oxygen);
(ii) Pulse oximetry;
(iii) End-tidal carbon dioxide determination
equipment;
(iv) Suction devices;
(v) Electrocardiograph-oscilloscope-defibrillator
with internal paddles;
(vi) Apparatus to establish central venous
pressure monitoring;
(vii) Intravenous fluids and administration
devices that include large bore catheters and intraosseous infusion devices;
(viii) Sterile surgical sets for airway
control/cricothyrotomy, thoracotomy, vascular access, thoracostomy, peritoneal
lavage, and central line insertion;
(ix) Apparatus for gastric decompression;
(x) 24-hour-per-day x-ray capability;
(xi) Two-way communication equipment for
communication with the emergency transport system;
(xii) Skeletal traction devices, including
capability for cervical traction;
(xiii) Arterial catheters;
(xiv) Thermal control equipment for patients;
(xv) Thermal control equipment for blood and
fluids;
(xvi) A rapid infuser system;
(xvii) A dosing reference and measurement system to
ensure appropriate age related medical care;
(xviii) Sonography; and
(xix) A doppler;
(17) An operating suite that is immediately available 24
hours per day and has:
(a) 24-hour-per-day immediate availability of
in-house staffing;
(b) Equipment for patients of all ages that
includes:
(i) Cardiopulmonary bypass capability;
(ii) Thermal control equipment for patients;
(iii) Thermal control equipment for blood and
fluids;
(iv) 24-hour-per-day x-ray capability including
c-arm image intensifier;
(v) Endoscopes and bronchoscopes;
(vi) Craniotomy instruments;
(vii) The capability of fixation of long-bone and
pelvic fractures; and
(viii) A rapid infuser system;
(18) A postanesthetic recovery room or surgical intensive
care unit that has:
(a) 24-hour-per-day in-house staffing by
registered nurses;
(b) Equipment for patients of all ages that
includes:
(i) The capability for resuscitation and
continuous monitoring of temperature, hemodynamics, and gas exchange;
(ii) The capability for continuous monitoring of
intracranial pressure;
(iii) Pulse oximetry;
(iv) End-tidal carbon dioxide determination
capability;
(v) Thermal control equipment for patients; and
(vi) Thermal control equipment for blood and
fluids;
(19) An intensive care unit for trauma patients that has:
(a) A designated surgical director for trauma
patients;
(b) A physician on duty in the intensive care
unit 24 hours per day or immediately available from within the hospital as long
as this physician is not the sole physician on-call for the Emergency
Department;
(c) Ratio of one nurse per two patients on each
shift;
(d) Equipment for patients of all ages that includes:
(i) Airway control and ventilation equipment
(laryngoscopes, endotracheal tubes, bag-mask resuscitators, and pocket masks);
(ii) An oxygen source with concentration
controls;
(iii) A cardiac emergency cart;
(iv) A temporary transvenous pacemaker;
(v) Electrocardiograph-oscilloscope-defibrillator;
(vi) Cardiac output monitoring capability;
(vii) Electronic pressure monitoring capability;
(viii) A mechanical ventilator;
(ix) Patient weighing devices;
(x) Pulmonary function measuring devices;
(xi) Temperature control devices; and
(xii) Intracranial pressure monitoring devices.
(e) Within 30 minutes of request, the ability to
perform blood gas measurements, hematocrit level, and chest x-ray studies;
(20) Acute hemodialysis capability;
(21) Physician-directed burn center staffed by nursing
personnel trained in burn care or a transfer agreement with a burn center;
(22) Acute spinal cord management capability or transfer
agreement with a hospital capable of caring for a spinal cord injured patient;
(23) Radiological capabilities that include:
(a) 24-hour-per-day in-house radiology
technologist;
(b) 24-hour-per-day in-house computerized
tomography technologist;
(c) Sonography;
(d) Computed tomography;
(e) Angiography;
(f) Magnetic resonance imaging; and
(g) Resuscitation equipment that includes airway
management and IV therapy;
(24) Respiratory therapy services available in-house 24
hours per day;
(25) 24-hour-per-day clinical laboratory service that
must include:
(a) Analysis of blood, urine, and other body
fluids, including micro-sampling when appropriate;
(b) Blood-typing and cross-matching;
(c) Coagulation studies;
(d) Comprehensive blood bank or access to
community central blood bank with storage facilities;
(e) Blood gases and pH determination; and
(f) Microbiology;
(26) A rehabilitation service that provides:
(a) A staff trained in rehabilitation care of
critically injured patients;
(b) Functional assessment and recommendations
regarding short- and long-term rehabilitation needs within one week of the
patient's admission to the hospital or as soon as hemodynamically stable;
(c) In-house rehabilitation service or a
transfer agreement with a rehabilitation facility accredited by the Commission
on Accreditation of Rehabilitation Facilities;
(d) Physical, occupational, speech therapies,
and social services; and
(e) Substance abuse evaluation and counseling
capability;
(27) A performance improvement program, as outlined in
the North Carolina Chapter of the American College of Surgeons Committee on Trauma
document "Performance Improvement Guidelines for North Carolina Trauma
Centers," incorporated by reference in accordance with G.S. 150B-21.6,
including subsequent amendments and editions. This document is available from
the OEMS, 2707 Mail Service Center, Raleigh, North Carolina 27699-2707, at no cost. This performance improvement program must include:
(a) The state Trauma Registry whose data is
submitted to the OEMS at least weekly and includes all the center's trauma
patients as defined in Rule .0102(68) of this Subchapter who are either
diverted to an affiliated hospital, admitted to the trauma center for greater
than 24 hours from an ED or hospital, die in the ED, are DOA or are transferred
from the ED to the OR, ICU, or another hospital (including transfer to any
affiliated hospital);
(b) Morbidity and mortality reviews including
all trauma deaths;
(c) Trauma performance committee that meets at
least quarterly and includes physicians, nurses, pre-hospital personnel, and a
variety of other healthcare providers, and reviews policies, procedures, and
system issues and whose members or designee attends at least 50 percent of the
regular meetings;
(d) Multidisciplinary peer review committee that
meets at least quarterly and includes physicians from trauma, neurosurgery,
orthopaedics, emergency medicine, anesthesiology, and other specialty
physicians, as needed, specific to the case, and the trauma nurse
coordinator/program manager and whose members or designee attends at least 50
percent of the regular meetings;
(e) Identification of discretionary and
non-discretionary audit filters;
(f) Documentation and review of times and
reasons for trauma-related diversion of patients from the scene or referring
hospital;
(g) Documentation and review of response times
for trauma surgeons, neurosurgeons, anesthesiologists or airway managers, and
orthopaedists. All must demonstrate 80 percent compliance.
(h) Monitoring of trauma team notification
times;
(i) Review of pre-hospital trauma care that
includes dead-on-arrivals; and
(j) Review of times and reasons for transfer of
injured patients;
(28) An outreach program that includes:
(a) Transfer agreements to address the transfer
and receipt of trauma patients;
(b) Programs for physicians within the community
and within the referral area (that include telephone and on-site consultations)
about how to access the trauma center resources and refer patients within the
system;
(c) Development of a Regional Advisory Committee
as specified in Rule .1102 of this Subchapter;
(d) Development of regional criteria for
coordination of trauma care;
(e) Assessment of trauma system operations at
the regional level; and
(f) ATLS;
(29) A program of injury prevention and public education that
includes:
(a) Epidemiology research that includes studies
in injury control, collaboration with other institutions on research,
monitoring progress of prevention programs, and consultation with researchers
on evaluation measures;
(b) Surveillance methods that includes trauma
registry data, special Emergency Department and field collection projects;
(c) Designation of a injury prevention
coordinator; and
(d) Outreach activities, program development,
information resources, and collaboration with existing national, regional, and
state trauma programs.
(30) A trauma research program designed to produce new
knowledge applicable to the care of injured patients that includes:
(a) An identifiable institutional review board
process;
(b) Educational presentations that must include
12 education/outreach presentations offered outside the trauma center over a
three-year period; and
(c) 10 peer-reviewed publications over a
three-year period that could come from any aspect of the trauma program; and
(31) A written continuing education program for staff
physicians, nurses, allied health personnel, and community physicians that
includes:
(a) A general surgery residency program;
(b) 20 hours of Category I or II trauma-related
continuing medical education (as approved by the Accreditation Council for
Continuing Medical Education) every two years for all attending general
surgeons on the trauma service, orthopedists, and neurosurgeons, with at least 50
percent of this being external education including conferences and meetings
outside of the trauma center. Continuing education based on the reading of
content such as journals or other continuing medical education documents is not
considered education outside of the trauma center;
(c) 20 hours of Category I or II trauma-related
continuing medical education (as approved by the Accreditation Council for
Continuing Medical Education) every two years for all emergency physicians,
with at least 50 percent of this being external education including conferences
and meetings outside of the trauma center or visiting lecturers or speakers
from outside the trauma center. Continuing education based on the reading of
content such as journals or other continuing medical education documents is not
considered education outside of the trauma center;
(d) ATLS completion for general surgeons on the
trauma service and emergency physicians. Emergency physicians, if not boarded
in emergency medicine, must be current in ATLS;
(e) 20 contact hours of trauma-related
continuing education (beyond in-house in-services) every two years for the TNC/TPM;
(f) 16 hours of trauma-registry-related or
trauma-related continuing education every two years, as deemed appropriate by
the trauma nurse coordinator/program manager for the trauma registrar;
(g) At least an 80 percent compliance rate for
16 hours of trauma-related continuing education (as approved by the TNC/TPM)every
two years related to trauma care for RN's and LPN's in transport programs,
Emergency Departments, primary intensive care units, primary trauma floors, and
other areas deemed appropriate by the TNC/TPM; and
(h) 16 hours of trauma-related continuing
education every two years for mid-level practitioners routinely caring for
trauma patients.
History Note: Authority G.S. 131E-162;
Temporary Adoption Eff. January 1, 2002;
Eff. April 1, 2003;
Amended Eff. January 1, 2009; January 1, 2004.
