| (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
Cont'd... |
