Current through Reg. 49, No. 38; September 20, 2024
(a) The Office of Emergency Medical Services
(EMS)/Trauma Systems Coordination (office) shall recommend to the Commissioner
of the Department of State Health Services (commissioner) the designation of an
applicant/healthcare facility (facility) as a trauma facility at the level(s)
for each location of a facility the office deems appropriate.
(1) Comprehensive (Level I) trauma facility
designation--The facility, including a free-standing children's facility, meets
the current American College of Surgeons (ACS) essential criteria for a
verified Level I trauma center; meets the "Advanced Trauma Facility Criteria"
in subsection (x) of this section; actively participates on the appropriate
Regional Advisory Council (RAC); has appropriate services for dealing with
stressful events available to emergency/trauma care providers; and submits data
to the Texas EMS/Trauma Registry.
(2) Major (Level II) trauma facility
designation--The facility, including a free-standing children's facility, meets
the current ACS essential criteria for a verified Level II trauma center; meets
the "Advanced Trauma Facility Criteria" in subsection (x) of this section;
actively participates on the appropriate RAC; has appropriate services for
dealing with stressful events available to emergency/trauma care providers; and
submits data to the Texas EMS/Trauma Registry.
(3) Advanced (Level III) trauma facility
designation--The facility meets the "Advanced Trauma Facility Criteria" in
subsection (x) of this section; actively participates on the appropriate RAC;
has appropriate services for dealing with stressful events available to
emergency/trauma care providers; and submits data to the Texas EMS/Trauma
Registry. A free-standing children's facility, in addition to meeting the
requirements listed in this section, must meet the current ACS essential
criteria for a verified Level III trauma center.
(4) Basic (Level IV) trauma facility
designation--The facility meets the "Basic Trauma Facility Criteria" in
subsection (y) of this section; actively participates on the appropriate RAC;
has appropriate services for dealing with stressful events available to
emergency/trauma care providers; and submits data to the Texas EMS/Trauma
Registry.
(b) A
healthcare facility is defined under these rules as a single location where
inpatients receive hospital services or each location if there are multiple
buildings where inpatients receive hospital services and are covered under a
single hospital license.
(1) Each location
shall be considered separately for designation and the Department of State
Health Services (department) will determine the designation level for that
location, based on, but not limited to, the location's own resources and levels
of care capabilities; Trauma Service Area (TSA) capabilities; and the essential
criteria and requirements outlined in subsection (a)(1) - (4) of this section.
The final determination of the level(s) of designation may not be the level(s)
requested by the facility.
(2) A
facility with multiple locations that is applying for designation at one
location shall be required to apply for designation at each of its other
locations where there are buildings where inpatients receive hospital services
and such buildings are collectively covered under a single hospital's
license.
(c) The
designation process shall consist of three phases.
(1) First phase--The application phase begins
with submitting to the office a timely and sufficient application for
designation as a trauma facility and ends when the survey report is received by
the office.
(2) Second phase--The
review phase begins with the office's review of the survey report and ends with
its recommendation to the commissioner whether or not to designate the facility
and at what level(s). This phase also includes an appeal procedure governed by
the department's rules for a contested case hearing and by Government Code,
Chapter 2001.
(3) Third phase--The
final phase begins with the commissioner reviewing the recommendation and ends
with his/her final decision.
(d) For a facility seeking initial
designation, a timely and sufficient application shall include:
(1) the department's current "Complete
Application" form for the appropriate level, with all fields correctly and
legibly filled-in and all requested documents attached, hand-delivered or sent
by postal services to the office;
(2) full payment of the designation fee
enclosed with the submitted "Complete Application" form;
(3) any subsequent documents submitted by the
date requested by the office;
(4) a
trauma designation survey completed within one year of the date of the receipt
of the application by the office; and
(5) a complete survey report, including
patient care reviews, that is within 180 days of the date of the survey and is
hand-delivered or sent by postal services to the office.
(e) If a hospital seeking initial designation
fails to meet the requirements in subsection (d)(1) - (5) of this section, the
application shall be denied.
(f)
For a facility seeking re-designation, a timely and sufficient application
shall include:
(1) the department's current
"Complete Application" form for the appropriate level, with all fields
correctly and legibly filled-in and all requested documents attached,
hand-delivered or sent by postal services to the office one year or greater
from the designation expiration date;
(2) full payment of the designation fee
enclosed with the submitted "Complete Application" form;
(3) any subsequent documents submitted by the
date requested by the office; and
(4) a complete survey report, including
patient care reviews, that is within 180 days of the date of the survey and is
hand-delivered or sent by postal services to the office no less than 60 days
prior to the designation expiration date.
(g) If a healthcare facility seeking
re-designation fails to meet the requirements outlined in subsection (f)(1) -
(4) of this section, the original designation will expire on its expiration
date.
(h) The office's analysis of
the submitted "Complete Application" form may result in recommendations for
corrective action when deficiencies are noted and shall also include a review
of:
(1) the evidence of current participation
in RAC/regional system planning; and
(2) the completeness and appropriateness of
the application materials submitted, including the submission of a
non-refundable application fee as follows:
(A) for Level I and Level II trauma facility
applicants, the fee will be no more than $10 per licensed bed with an upper
limit of $5,000 and a lower limit of $4,000;
(B) for Level III trauma facility applicants,
the fee will be no more than $10 per licensed bed with an upper limit of $2,500
and a lower limit of $1,500; and
(C) for Level IV trauma facility applicants,
the fee will be no more than $10 per licensed bed with an upper limit of $1000
and a lower limit of $500.
(i) When a "Complete Application" form for
initial designation or re-designation from a facility is received, the office
will determine the level it deems appropriate for pursuit of designation or
re-designation for each of the facility's locations based on, but not limited
to: the facility's resources and levels of care capabilities at each location,
TSA resources, and the essential criteria for Levels I, II, III, and IV trauma
facilities. In general, physician services capabilities described in the
application must be in place 24 hours a day/7 days a week. In determining
whether a physician services capability is present, the department may use the
concept of substantial compliance that is defined as having said physician
services capability at least 90% of the time.
(1) If a facility disagrees with the level(s)
determined by the office to be appropriate for pursuit of designation or
re-designation, it may make an appeal in writing within 60 days to the director
of the office. The written appeal must include a signed letter from the
facility's governing board with an explanation as to why designation at the
level determined by the office would not be in the best interest of the
citizens of the affected TSA or the citizens of the State of Texas.
(2) The written appeal may include a signed
letter (s) from the executive board of its RAC or individual healthcare
facilities and/or EMS providers within the affected TSA with an explanation as
to why designation at the level determined by the office would not be in the
best interest of the citizens of the affected TSA or the citizens of the State
of Texas.
(3) If the office upholds
its original determination, the director of the office will give written notice
of such to the facility within 30 days of its receipt of the applicant's
complete written appeal.
(4) The
facility may, within 30 days of the office's sending written notification of
its denial, submit a written request for further review. Such written appeal
shall then go to the Assistant Commissioner, Division for Regulatory Services
(assistant commissioner).
(j) When the analysis of the "Complete
Application" form results in acknowledgement by the office that the facility is
seeking an appropriate level of designation or re-designation, the facility may
then contract for the survey, as follows.
(1)
Level I and II facilities and all free-standing children's facilities shall
request a survey through the ACS trauma verification program.
(2) Level III facilities shall request a
survey through the ACS trauma verification program or through a comparable
organization approved by the department.
(3) Level IV facilities shall request a
survey through the ACS trauma verification program, through a comparable
organization approved by the department, or by a department-credentialed
surveyor(s) active in the management of trauma patients.
(4) The facility shall notify the office of
the date of the planned survey and the composition of the survey
team.
(5) The facility shall be
responsible for any expenses associated with the survey.
(6) The office, at its discretion, may
appoint an observer to accompany the survey team. In this event, the cost for
the observer shall be borne by the office.
(k) The survey team composition shall be as
follows.
(1) Level I or Level II facilities
shall be surveyed by a team that is multi-disciplinary and includes at a
minimum: 2 general surgeons, an emergency physician, and a trauma nurse all
active in the management of trauma patients.
(2) Free-standing children's facilities of
all levels shall be surveyed by a team consistent with current ACS policy and
includes at a minimum: a pediatric surgeon; a general surgeon; a pediatric
emergency physician; and a pediatric trauma nurse coordinator or a trauma nurse
coordinator with pediatric experience.
(3) Level III facilities shall be surveyed by
a team that is multi-disciplinary and includes at a minimum: a trauma surgeon
and a trauma nurse (ACS or department-credentialed), both active in the
management of trauma patients.
(4)
Level IV facilities shall be surveyed by a department-credentialed
representative, registered nurse or licensed physician. A second surveyor may
be requested by the facility or by the department.
(5) Department-credentialed surveyors must
meet the following criteria:
(A) have at
least 3 years experience in the care of trauma patients;
(B) be currently employed in the coordination
of care for trauma patients;
(C)
have direct experience in the preparation for and successful completion of
trauma facility verification/designation;
(D) have successfully completed a
department-approved trauma facility site surveyor course and be successfully
re-credentialed every 4 years; and
(E) have current credentials as follows:
(i) for nurses: Trauma Nurses Core Course
(TNCC) or Advanced Trauma Course for Nurses (ATCN); and Pediatric Advanced Life
Support (PALS) or Emergency Nurses Pediatric Course (ENPC);
(ii) for physicians: Advanced Trauma Life
Support (ATLS); and
(iii) have
successfully completed a site survey internship.
(6) All members of the survey team, except
department staff, shall come from a TSA outside the facility's location and at
least 100 miles from the facility. There shall be no business or patient care
relationship or any potential conflict of interest between the surveyor or the
surveyor's place of employment and the facility being
surveyed.
(l) The survey
team shall evaluate the facility's compliance with the designation criteria,
by:
(1) reviewing medical records; staff
rosters and schedules; process improvement committee meeting minutes; and other
documents relevant to trauma care;
(2) reviewing equipment and the physical
plant;
(3) conducting interviews
with facility personnel;
(4)
evaluating compliance with participation in the Texas EMS/Trauma Registry;
and
(5) evaluating appropriate use
of telemedicine capabilities where applicable.
(m) The site survey report in its entirety
shall be part of a facility's performance improvement program and subject to
confidentiality as articulated in the Health and Safety Code, §
773.095.
(n) The surveyor(s) shall provide the
facility with a written, signed survey report regarding their evaluation of the
facility's compliance with trauma facility criteria. This survey report shall
be forwarded to the facility within 30 calendar days of the completion date of
the survey. The facility is responsible for forwarding a copy of this report to
the office if it intends to continue the designation process.
(o) The office shall review the findings of
the survey report for compliance with trauma facility criteria.
(1) A recommendation for designation shall be
made to the commissioner based on compliance with the criteria.
(2) If a facility does not meet the criteria
for the level of designation deemed appropriate by the office, the office shall
notify the facility of the requirements it must meet to achieve the appropriate
level of designation.
(3) If a
facility does not comply with criteria, the office shall notify the facility of
deficiencies and recommend corrective action.
(A) The facility shall submit to the office a
report that outlines the corrective action(s) taken. The office may require a
second survey to ensure compliance with the criteria. If the office
substantiates action that brings the facility into compliance with the
criteria, the Office shall recommend designation to the commissioner.
(B) If a facility disagrees with the office's
decision regarding its designation application or status, it may request a
secondary review by a designation review committee. Membership on a designation
review committee will:
(i) be
voluntary;
(ii) be appointed by the
office director;
(iii) be
representative of trauma care providers and appropriate levels of designated
trauma facilities; and
(iv) include
representation from the department and the Trauma Systems Committee of the
Governor's EMS and Trauma Advisory Council (GETAC).
(C) If a designation review committee
disagrees with the office's recommendation for corrective action, the records
shall be referred to the assistant commissioner for recommendation to the
commissioner.
(D) If a facility
disagrees with the office's recommendation at the end of the secondary review,
the facility has a right to a hearing, in accordance with the department's
rules for contested cases, and Government Code, Chapter 2001.
(p) The facility shall
have the right to withdraw its application at any time prior to being
recommended for trauma facility designation by the office.
(q) If the commissioner concurs with the
recommendation to designate, the facility shall receive a letter and a
certificate of designation valid for 3 years. Additional actions, such as a
site review or submission of information/reports to maintain designation, may
be required by the department.
(r)
It shall be necessary to repeat the designation process as described in this
section prior to expiration of a facility's designation or the designation
expires.
(s) A designated trauma
facility shall:
(1) comply with the provisions
within these sections; all current state and system standards as described in
this chapter; and all policies, protocols, and procedures as set forth in the
system plan;
(2) continue its
commitment to provide the resources, personnel, equipment, and response as
required by its designation level;
(3) participate in the Texas EMS/Trauma
Registry. Data submission requirements for designation purposes are as follows.
(A) Initial designation--Six months of data
prior to the initial designation survey must be uploaded. Subsequent to initial
designation, data should be uploaded to the Texas EMS/Trauma Registry on at
least a quarterly basis (with monthly submissions recommended) as indicated in
§ 103.19 of this title (relating to Electronic Reporting).
(B) Re-designation--The facility's trauma
registry should be current with at least quarterly uploads of data to the Texas
EMS/Trauma Registry (monthly submissions recommended) as indicated in §
103.19 of this title;
(4)
notify the office, its RAC plus other affected RACs of all changes that affect
air medical access to designated landing sites.
(A) Non-emergent changes shall be implemented
no earlier than 120 days after a written notification process.
(B) Emergency changes related to safety may
be implemented immediately along with immediate notification to department, the
RAC, and appropriate Air Medical Providers.
(C) Conflicts relating to helipad air medical
access changes shall be negotiated between the facility and the EMS
provider.
(D) Any unresolved issues
shall be handled utilizing the nonbinding alternative dispute resolution (ADR)
process of the RAC in which the helipad is located;
(5) within 5 days, notify the office; its RAC
plus other affected RACs; and the healthcare facilities to which it customarily
transfers-out trauma patients or from which it customarily receives trauma
transfers-in if temporarily unable to comply with a designation criterion. If
the healthcare facility intends to comply with the criterion and maintain
current designation status, it must also submit to the office a plan for
corrective action and a request for a temporary exception to criteria within 5
days.
(A) If the requested essential criterion
exception is not critical to the operations of the healthcare facility's trauma
program and the office determines that the facility has intent to comply, a
30-day to 90-day exception period from the onset date of the deficiency may be
granted for the facility to achieve compliancy.
(B) If the requested essential criterion
exception is critical to the operations of the healthcare facility's trauma
program and the office determines that the facility has intent to comply, no
greater than a 30-day exception period from the onset date of the deficiency
may be granted for the facility to achieve compliancy. Essential criteria that
are critical include such things as:
(i)
neurological surgery capabilities (Level I, II);
(ii) orthopedic surgery capabilities (Level
I, II, III);
(iii) general/trauma
surgery capabilities (Level I, II, III);
(iv) anesthesiology (Levels I, II,
III);
(v) emergency physicians (all
levels);
(vi) trauma medical
director (all levels);
(vii) trauma
nurse coordinator/program manager (all levels); and
(viii) trauma registry (all
levels).
(C) If the
healthcare facility has not come into compliance at the end of the exception
period, the office may at its discretion elect one of the following:
(i) allow the facility to request designation
at the level appropriate to its revised capabilities;
(ii) propose to re-designate the facility at
the level appropriate to its revised capabilities;
(iii) propose to suspend the facility's
designation status. If the facility is amenable to this action, the office will
develop a plan for corrective action for the facility and a specific timeline
for compliance by the facility; or
(iv) propose to extend the facility's
temporary exception to criteria for an additional period not to exceed 90 days.
The department will develop a plan for corrective action for the facility and a
specific timeline for compliance by the facility.
(I) Suspensions of a facility's designation
status and exceptions to criteria for facilities will be documented on the
office website.
(II) If the
facility disagrees with a proposal by the office, or is unable or unwilling to
meet the office-imposed timelines for completion of specific actions plans, it
may request a secondary review by a designation review committee as defined in
subsection (o)(3)(B) of this section.
(III) The office may at its discretion choose
to activate a designation review committee at any time to solicit technical
advice regarding criteria deficiencies.
(IV) If the designation review committee
disagrees with the office's recommendation for corrective actions, the case
shall be referred to the assistant commissioner for recommendation to the
commissioner.
(V) If a facility
disagrees with the office's recommendation at the end of the secondary review
process, the facility has a right to a hearing, in accordance with the
department's rules for contested cases and Government Code, Chapter
2001.
(VI) Designated trauma
facilities seeking exceptions to essential criteria shall have the right to
withdraw the request at any time prior to resolution of the final appeal
process;
(6) notify the office; its RAC plus other
affected RACs; and the healthcare facilities to which it customarily
transfers-out trauma patients or from which it customarily receives trauma
transfers-in, if it no longer provides trauma services commensurate with its
designation level.
(A) If the facility
chooses to apply for a lower level of trauma designation, it may do so at any
time; however, it shall be necessary to repeat the designation process. There
shall be a paper review by the office to determine if and when a full survey
shall be required.
(B) If the
facility chooses to relinquish its trauma designation, it shall provide at
least 30 days notice to the RAC and the office; and
(7) within 30 days, notify the office; its
RAC plus other affected RACs; and the healthcare facilities to which it
customarily transfers-out trauma patients or from which it customarily receives
trauma transfers-in, of the change(s) if it adds capabilities beyond those that
define its existing trauma designation level.
(A) It shall be necessary to repeat the
trauma designation process.
(B)
There shall then be a paper review by the office to determine if and when a
full survey shall be required.
(t) Any facility seeking trauma designation
shall have measures in place that define the trauma patient population
evaluated at the facility and/or at each of its locations, and the ability to
track trauma patients throughout the course of their care within the facility
and/or at each of its locations in order to maximize funding opportunities for
uncompensated care.
(u) A
healthcare facility may not use the terms "trauma facility", "trauma hospital",
"trauma center", or similar terminology in its signs or advertisements or in
the printed materials and information it provides to the public unless the
healthcare facility is currently designated as a trauma facility according to
the process described in this section.
(v) The office shall have the right to
review, inspect, evaluate, and audit all trauma patient records, trauma
performance improvement committee minutes, and other documents relevant to
trauma care in any designated trauma facility or applicant/healthcare facility
at any time to verify compliance with the statute and this rule, including the
designation criteria. The office shall maintain confidentiality of such records
to the extent authorized by the Texas Public Information Act, Government Code,
Chapter 552, and consistent with current laws and regulations related to the
Health Insurance Portability and Accountability Act of 1996. Such inspections
shall be scheduled by the office when deemed appropriate. The office shall
provide a copy of the survey report, for surveys conducted by or contracted for
the department, and the results to the healthcare facility.
(w) The office may grant an exception to this
section if it finds that compliance with this section would not be in the best
interests of the persons served in the affected local system.
(x) Advanced (Level III) Trauma Facility
Criteria.
Attached
Graphic
(1) Advanced (Level
III) Trauma Facility Criteria Standards.
Attached
Graphic
(2)
Advanced (Level III) Trauma Facility Criteria Audit Filters.
Attached
Graphic
(y) Basic (Level IV) Trauma Facility
Criteria.
Attached Graphic
(1) Basic (Level IV) Trauma Facility Criteria
Standards.
Attached
Graphic
(2) Basic
(Level IV) Trauma Facility Criteria Audit Filters.
Attached
Graphic
