| (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.
Cont'd... |
