Part 1.
DEPARTMENT OF STATE HEALTH SERVICES
Chapter 157.
EMERGENCY MEDICAL CARE
Subchapter G. EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS
The Executive Commissioner of the Health and Human Services Commission,
on behalf of the Department of State Health Services (department), proposes
the repeal of §157.125, new §157.125 concerning requirements for
trauma facility designation; and an amendment to §157.128 concerning
denial, suspension, and revocation of trauma facility designation.
BACKGROUND AND PURPOSE
The amendment, repeal and new section are necessary to comply with Government
Code, §2001.039, that requires each state agency to review and consider
for re-adoption each rule adopted by that agency pursuant to the Government
Code, Chapter 2001 (Administrative Procedures Act). Sections 157.125 and 157.128
have been reviewed and the department has determined that reasons for adopting
the sections continue to exist because rules on this subject are needed.
Additionally, the amendment, repeal and new section are necessary to update,
remove obsolete language, reorganize, and clarify the requirements for meeting
trauma designation standards. The amendment was endorsed by the stakeholder
group, the Governor's Emergency Medical Services (EMS) and Trauma Advisory
Council's Trauma Systems Committee, and department staff after over two years
of discussion and stakeholder input. Proposed changes to the rules are expected
to positively impact the care provided to patients in designated trauma centers
throughout the state. The department also anticipates a positive impact on
hospitals and the organizations that represent them. The proposed rules are
expected to have a positive impact on the department as they propose to trauma
designate hospitals, review survey reports and enforce trauma designation
rules.
SECTION-BY-SECTION SUMMARY
The repeal and new §157.125 provide clarity due to the number of proposed
changes. The new proposed rule better defines the various levels of trauma
designation to include the process for review and designation of healthcare
facilities based on the level of designation deemed appropriate by the department;
the definition of a healthcare facility as it relates to trauma designation;
the three phases of the trauma designation process; and a timely and sufficient
application.
The new proposed rule outlines the process for requesting exceptions to
criteria and for reporting deficiencies. It adds language to address air medical
access to designated landing sites at the healthcare facility and the process
used to implement any changes to designated landing sites.
The new proposed rule also updates the composition of the trauma designation
site survey team as well as designation requirements to include such things
as pediatric-specific education and the use of the American College of Surgeons
or a comparable organization to conduct the trauma designation survey.
The proposed new rule aligns existing rule language with the national standards
of care for trauma facilities set forth by the American College of Surgeons
and applies state standards consistently across all levels of trauma designation
by requiring hospitals that have achieved higher levels of trauma designation
to also meet all required standards for hospitals with lower designation levels,
to include such things as nursing education requirements that are not addressed
by the American College of Surgeons.
The proposed new rule establishes consistent performance standards for
all hospitals seeking Level III trauma facility designation, to include the
requirement for orthopedic surgeons, full-time trauma program managers/trauma
nurse coordinators, and outreach programs.
Amendments to §157.128 provide clarification to the rule, update reference
to a statute, and update the name of the department's program to the "Office
of EMS/Trauma Systems Coordination" which provides rule oversight.
FISCAL NOTE
Kathryn C. Perkins, Section Director, Health Care Quality Section, has
determined that for each year of the first five years that the sections are
in effect, there will be no fiscal implications to state and local governments
as a result of enforcing or administering the sections as proposed unless
a local government operates a healthcare facility and voluntarily chooses
to seek trauma designation. In that case, local governments will be required
to comply with the rules. Once the rules are adopted, local governments that
currently operate or seeks Level III trauma designation may incur costs to
maintain 24/7 orthopedic surgical coverage and to provide one full-time equivalent
position for the trauma nurse coordinator/trauma program manager position.
The current rule only applies these criteria to "lead" Level III trauma facilities,
which effects approximately less than half of the 40 healthcare facilities
designated as a Level III. The new requirements will apply to all Level III
trauma facilities, some of which are already meeting the criteria. The cost
associated with these proposed requirements cannot be determined since the
local market in which the Local Government resides will determined the fiscal
impact on each healthcare facility
SMALL AND MICRO-BUSINESS IMPACT ANALYSIS
Ms. Perkins has also determined that there is no anticipated economic costs
to persons who are required to comply with the sections as proposed. This
was determined by interpretation of the rule that small businesses and micro-businesses
will not be required to alter their business practices in order to comply
with these sections unless they operate a healthcare facility and voluntarily
choose to seek trauma designation. In that case, the small businesses and/or
micro-businesses will be required to comply with the rules. Once the rules
are adopted, small businesses and/or micro-businesses that currently operate
or seeks Level III trauma designation may incur costs to maintain 24/7 orthopedic
surgical coverage and to provide one full-time equivalent position for the
trauma nurse coordinator/trauma program manager position. The current rule
only applies these criteria to "lead" Level III trauma facilities, which affects
approximately less than half of the 40 healthcare facilities designated as
a Level III. The new requirements will apply to all Level III trauma facilities,
some of which are already meeting the criteria. The cost associated with these
proposed requirements cannot be determined since the local market in which
the small businesses and/or micro-businesses resides will determined the fiscal
impact on each healthcare facility. There is no anticipated negative impact
on local employment.
PUBLIC BENEFIT
In addition, Ms. Perkins has also determined that for each year of the
first five years the sections are in effect, the public will benefit from
adoption of the sections. The public benefit anticipated as a result of enforcing
or administering the sections is a strengthening of the Texas EMS/Trauma System
because the proposed rules are expected to positively impact the care provided
to patients in designated trauma centers across the state. The department
also anticipates a positive impact on hospitals and the organizations that
represent them.
REGULATORY ANALYSIS
The department has determined that this proposal is not a "major environmental
rule" as defined by Government Code, §2001.0225. "Major environmental
rule" is defined to mean a rule the specific intent of which is to protect
the environment or reduce risk to human health from environmental exposure
and that may adversely affect, in a material way, the economy, a sector of
the economy, productivity, competition, jobs, the environment or the public
health and safety of a state or a sector of the state. This proposal is not
specifically intended to protect the environment or reduce risks to human
health from environmental exposure.
TAKINGS IMPACT ASSESSMENT
The department has determined that the proposed amendment, repeal and new
rule do not restrict or limit an owner's right to his or her property that
would otherwise exist in the absence of government action and, therefore,
does not constitute a taking under Government Code, §2007.043.
PUBLIC COMMENT
Comments on the proposal may be submitted to Stephen C. Janda, Manager,
Office of EMS/Trauma Systems Coordination, Department of State Health Services,
1100 West 49th Street, Austin, Texas 78756, (512) 834-6700, or by email to
steve.janda@dshs.state.tx.us. Comments will be accepted for 30 days following
publication of the proposal in the
Texas Register
.
LEGAL CERTIFICATION
The Department of State Health Services General Counsel, Cathy Campbell,
certifies that the proposed rules have been reviewed by legal counsel and
found to be within the state agencies' authority to adopt.
25 TAC §157.125
(Editor's note: The text of the following section proposed for
repeal will not be published. The section may be examined in the offices of
the Department of State Health Services or in the Texas Register office, Room
245, James Earl Rudder Building, 1019 Brazos Street, Austin.)
STATUTORY AUTHORITY
The proposed repeal is authorized by the Health and Safety Code, Chapter
773, Emergency Medical Services, which provides the department with the authority
to adopt rules to implement the Emergency Medical Services Act; and Government
Code, §531.0055, and Health and Safety Code, §1001.075, which authorize
the Executive Commissioner of the Health and Human Services Commission to
adopt rules and policies necessary for the operation, provision, and administration
of health and human services by the department and for the administration
of Health and Safety Code, Chapter 1001.
The proposed repeal affects the Health and Safety Code, Chapter 773.
§157.125.Requirements for Trauma Facility Designation.
This agency hereby certifies that the proposal has been
reviewed by legal counsel and found to be within the agency's legal authority
to adopt.
Filed with the Office of
the Secretary of State on May 25, 2006.
TRD-200602914
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: July 9, 2006
For further information, please call: (512) 458-7111 x6972
25 TAC §157.125, §157.128
STATUTORY AUTHORITY
The proposed new rule and amendment are authorized by the Health and Safety
Code, Chapter 773, Emergency Medical Services, which provides the department
with the authority to adopt rules to implement the Emergency Medical Services
Act; and Government Code, §531.0055, and Health and Safety Code, §1001.075,
which authorize the Executive Commissioner of the Health and Human Services
Commission to adopt rules and policies necessary for the operation, provision,
and administration of health and human services by the department and for
the administration of Health and Safety Code, Chapter 1001.
The proposed new rule and amendment affect the Health and Safety Code,
Chapter 773.
§157.125.Requirements for Trauma Facility Designation.
(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 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 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 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
1 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.
Figure: 25 TAC §157.125(x) (.pdf)
(1)
Advanced (Level III) Trauma Facility Criteria Standards.
Figure: 25 TAC §157.125(x)(1) (.pdf)
(2)
Advanced (Level III) Trauma Facility Criteria Audit Filters.
Figure: 25 TAC §157.125(x)(2) (.pdf)
(y)
Basic (Level IV) Trauma Facility Criteria.
Figure: 25 TAC §157.125(y) (.pdf)
(1)
Basic (Level IV) Trauma Facility Criteria Standards.
Figure: 25 TAC §157.125(y)(1) (.pdf)
(2)
Basic (Level IV) Trauma Facility Criteria Audit Filters.
Figure: 25 TAC §157.125(y)(2) (.pdf)
§157.128.Denial, Suspension, and Revocation of Trauma Facility Designation.
(a)
An applicant/healthcare facility's
[
(1) - (3)
(No change.)
(4)
failure
[
(5)
failure to maintain required licenses, designations, and
accreditations or when disciplinary action has been taken against the
healthcare facility
[
(6) - (11)
(No change.)
(b)
Occasional failure of a
healthcare
[
(1)
do not reflect an overall deterioration in quality of [
(2)
are corrected within a reasonable timeframe by the
healthcare
[
(c)
If the
office
[
(1)
A request for a hearing shall
be in writing and submitted to the Office of EMS/Trauma Systems Coordination
and postmarked within 15 days of the date the notice was sent.
[
(2)
If the healthcare facility
fails to timely submit a written request for a hearing, it will be deemed
to have waived the opportunity for a hearing and the proposed action will
be ordered.
[
(d)
Six months after the denial of
an applicant/healthcare
facility's
[
[
(e)
[
This agency hereby certifies that the proposal has been reviewed
by legal counsel and found to be within the agency's legal authority to adopt.
Filed
with the Office of the Secretary of State on May 25, 2006.
TRD-200602913
Cathy Campbell
General Counsel
Department of State Health Services
Earliest possible date of adoption: July 9, 2006
For further information, please call: (512) 458-7111 x6972
A hospital's
] application for designation may be denied or a
healthcare
[
trauma
] facility's
trauma
[
(facility)
] designation
may be suspended or revoked for, but not limited to, the following reasons:
refusal
] to submit data
to the
Texas EMS/Trauma Registry
[
state trauma registry
];
hospital
] by a licensing agency;
hospital
or
] facility to meet designation criteria shall not be grounds for denial,
suspension or revocation by the
Office of EMS/Trauma Systems Coordination
(office)
[
Bureau of Emergency Management (bureau)
], if the
circumstances under which the failure occurred:
and commitment to
] trauma care; and
hospital or
] facility.
bureau
] proposes to
deny, suspend, or revoke a designation, the
office
[
bureau
] shall notify the
healthcare
[
hospital or
] facility
at the address shown in the current records of the department. The notice
shall state the alleged facts that warrant the
proposed
action
and state that the
healthcare
[
hospital or
] facility
has an opportunity to request a hearing in accordance with [
the Administrative
Procedure Act,
] Government Code, Chapter 2001.
(1)
The hospital or facility shall
request a hearing in writing and submit it to the bureau chief within 15 days
after the date of the denial, suspension, or revocation notice.]
(2)
If the hospital or facility
does not request a hearing in writing, after being sent the notice of opportunity
for hearing, it is deemed to have waived the opportunity for a hearing and
the denial, suspension, or revocation decision shall stand.]
a hospital's application for
] designation, the
applicant/healthcare facility
[
hospital
] may reapply for
trauma facility designation as described in §157.125 of this title.
(e)
When a designation has been
suspended, the suspension shall be in effect a minimum of 10 days. Upon completion
of the assigned suspension time, designation shall resume.]
(f)
] One year after the revocation
of a
healthcare facility's
[
facility
] designation, the
healthcare facility
[
hospital
] may reapply for designation
as described in §157.125 of this title. The
office
[
bureau
] may deny designation if the
office
[
bureau
]
determines that the reason for the revocation continues to exist.