| (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
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