New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTH
Chapter V - Medical Facilities
Subchapter A - Medical Facilities-minimum Standards
Article 2 - Hospitals
Part 405 - Hospitals-Minimum Standards
Section 405.45 - Trauma centers
Universal Citation: 10 NY Comp Codes Rules and Regs ยง 405.45
Current through Register Vol. 46, No. 39, September 25, 2024
(a) Definitions.
The following terms when used in this section shall have the following meanings:
(1)
Trauma patient means a patient at high risk of death or
disability from multiple and severe injuries.
(2)
Trauma care means health
care provided to a trauma patient.
(3)
Level I trauma center
means a facility verified by the American College of Surgeons Committee on
Trauma (ACS-COT), or other entity determined by the Department, and designated
by the Department as a facility that is capable of providing the full range of
services required of trauma patients; conducts trauma research; and provides
training to surgical residents that comports with the ACS-COT's publication
entitled Resources for Optimal Care of the Injured Patient
(2022). The standards set forth in the ACS-COT's publication entitled
Resources for Optimal Care of the Injured Patient (2022) are
hereby incorporated by reference with the same force and effect as if fully set
forth herein. A copy of Resources for Optimal Care of the Injured
Patient (2022) is available for inspection and copying at the
Regulatory Affairs Unit, New York State Department of Health, Corning Tower,
Empire State Plaza, Albany, New York 12237. Copies are also available from the
American College of Surgeons Committee on Trauma, 633 North Saint Clair Street,
Chicago, Illinois 60611. A Level I trauma center shall have a transfer
agreement with at least one pediatric trauma center for trauma patients whose
needs exceed the clinical capabilities of the facility.
(4)
Level II trauma center
means a facility verified by the ACS-COT, or other entity determined by the
department, and designated by the department as a facility that is capable of
providing comprehensive trauma care. A Level II trauma center shall have a
transfer agreement with at least one Level I trauma center and, unless
otherwise designated, at least one pediatric trauma center for trauma patients
whose needs exceed the clinical capabilities of the facility.
(5)
Level III trauma center
means a facility verified by the ACS-COT, or other entity determined by the
department, and designated by the department to serve communities that do not
have immediate access to a Level I or II trauma center that is capable of
providing prompt assessment, resuscitation, emergency operations and
stabilization of trauma patients. A Level III trauma center shall have a
transfer agreement with at least one Level I or Level II trauma center,
whichever is the most appropriate trauma center, and at least one pediatric
trauma center for trauma patients whose needs exceed the clinical capabilities
of the facility.
(6)
Level
IV trauma center means a facility located in a rural area verified by
the ACS-COT, or other entity determined by the department, and designated by
the department as a facility that is capable of providing initial evaluation
and stabilization of trauma patients prior to transfer to a higher level trauma
center. A Level IV trauma center shall have a transfer agreement with at least
one Level I, Level II, or Level III trauma center, whichever is the most
appropriate trauma center, and at least one pediatric trauma center for trauma
patients whose needs exceed the clinical capabilities of the
facility.
(7)
Pediatric
trauma center means a facility verified by the ACS-COT, or other
entity determined by the department, and designated by the department as a
Level I or Level II trauma center and as a facility that is capable of
providing comprehensive pediatric trauma care to pediatric trauma patients. A
pediatric trauma center shall have a transfer agreement with at least one Level
I or Level II trauma center, whichever is the most appropriate trauma
center.
(8)
Region
means a defined geographic area of the State where a regional trauma advisory
committee has been established pursuant to PHL section 3065.
(9)
Regional trauma center
means a Level I or Level II trauma center selected by the department to
coordinate regional trauma performance improvement activities in its region.
The regional trauma center will be selected from facilities in a region that
have been successfully verified by ACS-COT, or other entity determined by the
department, and designated as a trauma center by the department, with a history
of leadership and commitment to the region.
(10)
Transfer agreement
means a written and fully executed agreement between a hospital that has
limited capability to receive and treat trauma patients in need of specialized
emergency care and a designated trauma center that is capable of providing such
care, for the transfer of such patients, that is consistent with the criteria,
policies and procedures set forth in the hospitals' trauma affiliation
agreement with the regional trauma center.
(11)
Trauma affiliation
agreement means a written and fully executed agreement between the
regional trauma center and each of the Level I, Level II, Level III, and Level
IV trauma centers and non-designated hospitals in the regional trauma center's
region. A trauma affiliation agreement shall include provisions for:
(i) criteria, policies and procedures for the
transfer of trauma patients to trauma centers and between levels of trauma
center;
(ii) participation in the
New York State Trauma Registry including the maintenance of confidentiality and
protection of all data provided to the registry;
(iii) cooperation in outreach, education,
training and data collection activities; and
(iv) authority for a representative or
representatives of the regional trauma center to participate in and receive
information from the affiliate hospital's quality assurance committee,
participate in other reviews of the quality of trauma care provided by the
affiliate, and provide recommendations for quality improvement of trauma
care.
(b) General provisions.
(1) The
department may designate a hospital as a designated trauma center if the
hospital demonstrates that it has met the requirements of section
3066 of the
Public Health Law and this Part, to the department's satisfaction.
(2) Only those hospitals designated as trauma
centers by the department shall admit and provide trauma care to trauma
patients; provided, however, that if the existing designated trauma centers
have exceeded their capacity during a state-declared disaster or an emergency
surge, an undesignated hospital, upon approval by the commissioner, may
temporarily provide trauma care.
(3) Any hospital not designated as a trauma
center that receives a trauma patient shall transfer such patient to the most
appropriate trauma center pursuant to a transfer agreement as required under
section 405.19 of this Part. Trauma
centers shall be consulted prior to transfer. Trauma patients requiring trauma
care shall be transported to the most appropriate trauma centers in accordance
with State Emergency Medical Advisory Committee (SEMAC) approved Emergency
Medical Services (EMS) protocols developed and adopted pursuant to subdivision
two of section
3002-a of
the Public Health Law.
(4) No
hospital shall state that it has trauma center status unless so designated by
the department.
(c) Trauma center designation.
(1) A
hospital seeking designation as a trauma center must receive verification by
the American College of Surgeons, Committee on Trauma (ACS-COT), or other
entity determined by the Department. To receive verification, the hospital must
undergo a consultation site visit and verification site visit by the ACS-COT,
or other entity determined by the Department. During the verification site
visit, the hospital must exhibit that it is capable of providing Level I, Level
II, Level III, Level IV or pediatric trauma care in accordance with the trauma
care standards set forth in ACS-COT's publication entitled Resources
for Optimal Care of the Injured Patient (2022).
(i) Consultation site visits. A hospital
seeking designation as a trauma center shall request a consultation site visit
by the ACS-COT, or other entity determined by the department, for the purpose
of providing recommendations and assistance in preparation for verification.
(a) The cost of the consultation site visit
shall be at the facility's own expense.
(b) A hospital shall provide 30 days' notice
to the department prior to any and all consultation site visits.
(c) The department may participate in any
consultation site visits.
(ii) Verification site visit. A hospital
seeking designation as a trauma center shall request an official verification
site visit by the ACS-COT, or other entity determined by the Department, no
later than two years following a hospital's receipt of its consultation site
visit report. The hospital must receive confirmation from the ACS-COT, or other
entity determined by the Department, that the hospital meets the criteria for
trauma center verification in accordance with the criteria outlined in the
ACS-COT's publication entitled Resources for Optimal Care of the
Injured Patient (2022).
(a) The cost
of any verification site visit shall be at the hospital's own
expense.
(b) A hospital shall
provide 30 days' notice to the department prior to any and all verification
site visits.
(c) The department may
participate in any verification site visits.
(d) A hospital seeking Level I, Level II, or
Level III trauma center designation shall require that any verification review
team, as provided by ACS-COT, or other entity determined by the department,
include a nurse reviewer. The hospital shall submit to the department
documentation confirming that a nurse reviewer was a member of the verification
review team.
(e) A hospital shall
submit to the department a copy of all verification site visit reports and
verification certificates issued by the ACS-COT, or other entity determined by
the department, within 10 business days of receipt.
(f) A hospital shall submit to the department
immediately upon receipt any statement of deficiencies found or interim reports
of focused surveys issued by the ACS-COT, or other entity determined by the
department, during a verification review.
(g) A hospital shall notify the department
immediately upon receipt of notice of failure to be verified by the ACS-COT, or
other entity determined by the department. Such notification must be made in
writing to the department by the hospital's chief administrative
official.
(2)
A hospital seeking designation as a trauma center must provide to the
department any additional materials received by the hospital from the ACS-COT,
or other entity determined by the department, upon the department's
request.
(3) A verified trauma
center must be re-verified every three years by the ACS-COT, or other entity
determined by the department, and in accordance with subparagraph (1)(ii) of
this subdivision.
(d) Requirements for operating a trauma center.
(1) Upon designation, a hospital operating a
trauma center shall:
(i) remain subject to the
provisions of this Part and all other applicable requirements of this Title and
of the Public Health Law related to general hospitals;
(ii) comply with the trauma care standards set forth in ACS-COT's publication entitled Resources for Optimal Care of the Injured Patient (2022);
(iii)
have age and size appropriate resuscitation equipment consistent with section
405.19(b) and
this Part;
(iv) participate and
submit information to the New York State Trauma Registry as set forth in
subdivision (f) of this section;
(v) maintain transfer agreements with
non-designated hospitals and the nearest designated Level I, Level II, Level
III and pediatric trauma center, as appropriate for the region, to assure the
timely transfer of trauma patients to the appropriate level of trauma
care;
(vi) participate in the
performance improvement process as set forth in subdivision (g) of this
section;
(vii) submit to the
department any notices of noncompliance issued by the ACS-COT, or other entity
determined by the department, within one business day of receipt;
(viii) provide to the department any
additional materials received by the hospital from the ACS-COT, or other entity
determine by the department, upon the department's request; and
(ix) notify the department immediately of any
inability to meet the capabilities required by its current designation. Such
notification must be made in writing to the department by the hospital's chief
administrative official.
(e) Withdrawal of designation.
(1) The department may withdraw designation
from a hospital if:
(i) the hospital's trauma
center verification certificate lapses;
(ii) the hospital is not issued a certificate
of trauma center verification after a reverification site visit; or
(iii) the hospital fails to comply with
paragraph (d)(1) of this section.
(2) Upon withdrawal of a trauma care
designation, the hospital shall immediately take measures to notify affected
parties and divert trauma patients to designated trauma centers, and within 30
days, provide to the department a written plan describing the specific measures
it has taken to notify affected parties and its process for diversion of trauma
patients to designated trauma centers. In addition, the hospital shall ensure
that it has a transfer agreement with at least one designated Level I, Level II
or Level III trauma center, whichever is the most appropriate trauma center
available, and at least one pediatric trauma center to assure the timely
transfer of trauma patients in need of specialized emergency care, consistent
with section
405.19 of this Part.
(f) New York State Trauma Registry.
Each designated trauma center, and every hospital that treats trauma patients prior to transferring them to a designated trauma center, shall submit information to the New York State Trauma Registry. The data elements that are required to be reported to the New York State Trauma Registry are set forth in the New York State Trauma Registry's data dictionary. Hospitals must submit data to the New York State Trauma Registry at least quarterly and at such other times as the department may require. The hospital shall have in place appropriate measures to ensure the confidentiality of all information provided to the registry.
(g) Performance improvement.
(1) Each designated trauma center shall
participate with the coordinating regional trauma center and other hospitals
and healthcare facilities, EMS agencies and governmental disaster preparedness
programs in regional trauma performance improvement activities that shall
include:
(i) evaluation of the quality and
appropriateness of care provided, including providing referring hospitals with
information on trauma patient outcome;
(ii) analysis of data from the New York State
Trauma Registry, patient care report database and other sources to identify
opportunities for improvement. The regional trauma center shall have in place
appropriate measures to ensure the confidentiality of all data utilized to
conduct this analysis;
(iii)
development of trauma protocols, procedures, guidelines and policies;
(iv) assessment of the regional trauma
system;
(v) utilization of trauma
and EMS data sources to guide public education and injury prevention
efforts;
(vi) provision of
trauma-related/injury prevention education to allied healthcare providers;
and
(vii) participation in
emergency and disaster planning including incorporation of resources and
capabilities into plans to address mass casualty and other disaster
events.
(2) The regional
trauma center in each region will coordinate with each hospital within its
region to participate in regional trauma performance improvement activities.
(i) Each regional trauma center shall enter
into and comply with a trauma affiliation agreement with each hospital in its
region. A representative of the regional trauma center may participate in and
receive information from the affiliate hospital's quality assurance committee,
and may review other reviews of the quality of trauma care provided by the
affiliate hospital, in order to make informed recommendations about improving
trauma care and about the performance improvement process. Each regional trauma
center and each affiliate hospital shall take actions necessary, including but
not limited to, incorporating necessary provisions in the trauma affiliation
agreement, to authorize such participation. For purposes of such participation,
the regional trauma center's representative(s) shall be deemed a member(s) of
the affiliate hospital's quality assurance committee. The regional trauma
center's representative(s) shall only access confidential patient information
for purposes of quality improvement of trauma care. Members of an affiliate
hospital's quality assurance committee shall maintain the confidentiality of
patient information and are subject to all applicable confidentiality laws and
regulations, including subdivision (3) of section
3006 of the
Public Health Law.
(ii) The
regional trauma center shall participate in the review of information and data
for quality improvement purposes as described in the affiliation agreement,
which shall include:
(a) a quarterly review
of all pediatric trauma deaths, delays of three hours or more in transferring
trauma patients to a higher level of trauma care, and any transport and/or
admission of trauma patients to a non-trauma center;
(b) making quality improvement
recommendations for trauma care for the hospitals in its region; and
(c) periodic review, at the department's
request, of potential issues with trauma care in its region identified by the
department during routine analysis of regional data in the New York State
Trauma Registry; and
(d) any other
activities required by the department for quality improvement
purposes.
(iii) The
regional trauma center shall submit to the department on a quarterly basis a
report, in a format determined by the department, describing its quality
improvement reviews of all pediatric trauma deaths, delays of three hours or
more in transferring trauma patients to a higher level of trauma care, any
transport and/or admission of trauma patients to a non-trauma center and any
additional information requested by the department, and a report, in a format
determined by the department, describing any quality improvement
recommendations made to the hospitals in its region.
(iv) The regional trauma center shall
cooperate with the department in regular reviews by the department of the
regional trauma center's quality improvement activities, including providing
medical records and other relevant documents and information on a timely basis
when requested.
Disclaimer: These regulations may not be the most recent version. New York may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
