Response: The department disagrees because the criterium is desired not essential, therefore, if the hospital does not meet it, there are no consequences. No change was made as a result of this comment.

Comment: Concerning §157.125(s), criterium A(5)(a) and §157.125(t), criterium 2(a)(1), one commenter suggested that the term anesthesia care team be defined to assure that CRNAs are included.

Response: The department disagrees because the anesthesia care team is defined and credentialed by the hospital. No change was made as a result of this comment.

Comment: Concerning §157.125(s), criterium B(4)(b), one commenter stated that requiring a physician credentialed in critical care to be available in the hospital 24 hours per day is unrealistic for a Level III trauma facility.

Response: The department disagrees because the criterium allows for that physician to come from anywhere in the hospital, including the emergency department. No change was made as a result of this comment.

Comment: Concerning §157.125(s), criterium A(6)(a) and §157.125(t), criterium 2(a)(2)(b), one commenter supported and multiple commenters objected to the requirement for board-certified emergency physicians at Level III and Level IV trauma facilities to be credentialed in the ATLS course. Additionally, concerning §157.125(t), criterium 2(a)(2)(b), one commenter requested that the requirement for physicians covering emergency medicine at Level IV trauma facilities to be credentialed in the ATLS course be changed from essential to desired.

Response: The department agrees in part and has changed the requirement so that board- certified emergency physicians in Level III and Level IV trauma facilities do not have to meet this criterium unless they participated in the treatment of less than 10 major or severe trauma patients in the previous year and that there shall be/should be a credentialing program for emergency physicians in Level III/Level IV trauma facilities, respectively.

Comment: Concerning §157.125(t), one commenter requested assurance that all criteria currently specified as desired not be changed to essential in the future.

Response: The department agrees in that changes to the criteria can only be made through the rule process, which includes the opportunity for stakeholder input. No change was made as a result of this comment.

Comment: Concerning §157.125(t), one commenter was concerned because there is no reference to General Surgery in the Basic Trauma Facility Criteria.

Response: The department disagrees in that it would be extremely rare for most major and severe trauma patients to receive surgery at a Level IV trauma facility. Section 157.125(t) Basic Trauma Facility Standard #9 refers to the expectation that major and severe patients who are not transferred from a Level IV facility within two hours should receive the same level of care as the highest available in the Trauma Service Area. Additionally, all major and severe trauma patients who receive surgery at a Level IV trauma facility should be reviewed for quality and appropriateness of care as outlined by Basic Trauma Facility Standard Audit Filters #13 and #15. No change was made as a result of this comment.

Comment: Concerning §157.125(t), Basic Trauma Facility Standard #1, one commenter suggested changing the wording from requiring a Level IV trauma facility to participate on "its" regional system to "a" regional system because this would allow a hospital to receive permission to participate on a system that it is not assigned.

Response: The department agrees in part in that it may give approval for a hospital to participate in a different system, however, in that case it would be that hospital's system. No change was made as a result of this comment.

Comment: Concerning §157.125(t), Basic Trauma Facility Standard #5, one commenter suggested eliminating the words "severe and major" because Level IV hospitals also receive non-critical patients and the word "team" because it is not well-defined.

Response: The department disagrees because the emphasis of designation is how a hospital handles the critical/potentially critical (severe and major) trauma patients. Additionally, the hospital is required to identify its trauma team under §157.125(t), criterium 1(b). No change was made as a result of this comment.

Comment: Concerning §157.125(t), Basic Trauma Facility Standard #7, one commenter stated that the criteria for a Level IV trauma facility do not address "treatment within the capability of the facility."

Response: The department disagrees because the Basic Trauma Facility Standards are attached to the criteria document. No change was made as a result of this comment.

Comment: Concerning §157.125(t), Basic Trauma Facility Standard #8, one commenter suggested adding the wording that indicates that disposition decisions are made by a physician and transfers initiated when medically necessary.

Response: The department agrees in part and language referring to the physician's responsibility in determining transfer has been added to §157.125(t), Basic Trauma Facility Standard #8 and §157.125(s), General Trauma Facility Standard #10.

Comment: Concerning §157.125(t), Basic Trauma Facility Standard #9, one commenter suggested substituting the word inappropriately for intentionally, because there may be some situations where a patient is not transferred because of circumstances beyond the hospital's control.

Response: The department agrees and the language has been added to §157.125(t), Basic Trauma Facility Standard #9 and §157.125(s), General Trauma Facility Standard #11.

Comment: Concerning §157.125(t), Basic Trauma Facility Standard #10, one commenter suggested that the word "internally" be added, that "quality of care" be substituted for "appropriateness of care," and that "provided by the facility" be substituted for "throughout the hospital stay."

Response: The department agrees in part and has added clarifying language to §157.125(t), Basic Trauma Facility Standard #10 and §157.125(s), General Trauma Facility Standard #13.

Comment: Concerning §157.125(t), criterium 1(a)(2), two commenters requested that the wording be changed to require only one nurse with trauma training participate in initial trauma resuscitations because it is an unrealistic expectation for a rural hospital to be required to have two such nurses.

Response: The department disagrees because the criterium is desired not essential, therefore, if the hospital does not meet it, there are no consequences. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criterium 1(b), one commenter requested that wording be added to specify that any written protocols should be established by the facility's medical staff.

Response: The department agrees and the language has been added to §157.125(t), criterium 1(b) and to §157.125(s), criterium A(2)(d).

Comment: Concerning §157.125(t), criterium 1(c), one commenter requested that wording be added to specify that the written plan for the acquisition of additional staff as needed should be established by the facility.

Response: The department agrees and the language has been added to §157.125(t), criterium 1(c) and §157.125(s), criterium B(5)(d).

Comment: Concerning §157.125(t), criterium 1(d)(5), one commenter requested that the wording be changed to reflect the ability to establish a central venous line rather that the piece of equipment.

Response: The department disagrees because the criteria 1(d) are a list of equipment, not procedures. Additionally, the criterium 1(d)(5) is desired not essential, therefore, if the hospital does not meet it, there are no consequences. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criteria 1(e)(1)(b) and 1(e)(1)(c), one commenter requested that the requirements for 24 hour coverage by an in-house radiological technician and computerized tomography be removed because they are unrealistic expectations for a rural hospital.

Response: The department disagrees because the criteria are desired not essential, therefore, if the hospital does not meet them, there are no consequences. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criterium 2(a)(4), one commenter requested clarification on what Radiology Physician requirements need to be available.

Response: The department responds that this is up to the hospital and that this criterium is desired not essential, therefore, if the hospital does not meet it, there are no consequences. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criteria 3(e) and (f), one commenter requested re- numbering the criteria to move 3(f) to 3(e)(3) and commented that expecting rural hospitals to have 50% of nurses caring for trauma patients to be certified in their area of specialty is unrealistic.

Response: The department disagrees because 3(e) and 3(f) relate to different educational requirements and because the criterium 3(f) is desired not essential, therefore, if the hospital does not meet it, there are no consequences. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criterium 4(a), one commenter requested that the wording be clarified that the performance improvement program is developed by the hospital. Response: The department agrees and the clarifying language has been added to §157.125(t), criterium 4(a) and §157.125(s), criterium C(1).

Comment: Concerning §157.125(t), criterium 4(a), one commenter questions the inclusion of audit filters regarding admission to the hospital without evaluation by a physician, admission of patients to surgery or the ICU, and transfers to a non-designated facility because they may be medically appropriate.

Response: The department agrees that such actions by a level IV may be medically appropriate, but contends that it is the trauma performance improvement process that makes this determination. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criterium 4(a)(2), one commenter requested that the wording be changed from requiring the hospital to audit trauma charts for "appropriateness of care" to "quality of care."

Response: The department agrees in part and has changed the wording to include quality of care in §157.125(t), criterium 4(a)(2) and §157.125(s), criterium C(5).

Comment: Concerning §157.125(t), criterium 5, one commenter would like the wording requiring trauma facilities to meet RAC requirements for participation to be removed.

Response: The department disagrees because each RAC has defined their participation requirements per the needs of the regional system. Additionally, development of a comprehensive regional system is dependent on participation by all trauma care providers. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criterium 7, two commenters would like the requirement for a Level IV trauma facility to have a program to address the major injury problems with the hospital's service area to be changed from essential to desired.

Response: The department disagrees because prevention programs by individual trauma care providers are a critical element of a trauma system. Additionally, the criterium may be met by participating in a RAC's program. No change was made as a result of this comment.

Comment: Concerning §157.125(t), criterium 8, one commenter objects to requiring a Level IV trauma facility to pay for physicians' continuing education.

Response: The department disagrees that the wording is requiring the hospital to pay for the physicians' continuing education, only to make it available. No change was made as a result of this comment.

No comments were received on the following subsections, but the changes were made by staff to clarify the intent and accuracy of the sections.

Change: Concerning §157.37, in subsections (a), (b)(3), (c)(2)(A), and (d), the department has changed the citations of "Texas Civil Statutes, Article 6252" to "Occupations Code, Chapter 53" due to recodification of the statutes. Other minor changes were made to clarify the intent and improve the accuracy of the wording regarding investigations of criminal history of EMS personnel.

Change: Concerning §157.3(b)(1) and (2), the wording was changed because it was redundant.

Change: Concerning §157.11(l)(4), the wording was changed to reflect withdrawal of §157.34 from adoption.

Change: Concerning §157.16(e)(4), (5), and (6), the numbering was corrected from the incorrect numbering in the proposed rule.

Change: Concerning §157.36(b)(21), language was changed to broaden the scope of reporting obligations.

Change: Concerning §157.44(b)(4), language was included to exempt volunteer instructors from fees.

Change: Concerning §157.37(c)(3)(G), this new paragraph has been added to strengthen the list of offenses which may be considered and reviewed in relation to certification and licensure of EMS personnel.

Change: Concerning 157.37(d), wording was changed to clarify the department position on conduct of EMS personnel with regard to criminal history evaluation.

Change: Concerning §157.43(d)(1), the wording was changed to allow exemption of a fee for volunteers if they receive no compensation for coordinating courses or programs.

Change: Concerning §157.43(d)(8), the wording was changed for clarification. A one- year limit was added, retesting was allowed and a retest fee was specified. Requirements for certification were specified if the requirements were not completed within the one-year period after course completion.

Change: Concerning §157.43(e)(1), wording was added to allow an exemption of a fee for volunteers if they receive no compensation for coordinating training courses.

Change: Concerning §157.43(e)(9), wording was edited for clarity and a one-year limit was added. Allowance for a retest and a retest fee was added was added. If the requirements for certification are not completed within one year, the new requirements are added to the section.

Change: Concerning §157.43(e)(10), the wording for the requirements for a basic coordinator applying for advanced coordinator certification has been added for clarity.

Change: Concerning §157.43(j)(3), clarifying language has been added to the paragraph to prevent stacking of certification periods.

Change: Concerning §157.43(l), reference to the late fee and reference to §157.33 were eliminated.

Change: Concerning §157.43(l), the paragraph was reordered and clarifying language for late recertification has been added.

Change: Concerning §157.44(f)(3), wording has been added to clarify the requirements and to prevent stacking of certification periods.

Change: Concerning §157.44(h), new paragraph (h) has been added from paragraph (g) to clarify the requirements for recertification.

Change: Concerning §157.122, since proposal of the rule Tyler county has re-aligned from Trauma Service Area-R to Trauma Service Area-H. The language has been corrected in (c)(8) and (c)(18).

Change: Concerning §157.125, performance improvement is the current verbiage for quality management or improvement activities, therefore the language has been corrected in (g) (1), (r), (t)criterium 1(e)(2)(e), (t)criterium 2(a)(2)(c), (t)criterium 4, (t)criterium 4(a), (t) criterium 4(a)(4), and (t)criterium 8.

Change: Concerning §157.125(r), the citation regarding Open Records was changed after recodification of the statute.

Change: Concerning §157.128(a)(11), the citation regarding Occupation Code was changed after recodification of the statute.

Change: Concerning §157.128(c)(1), the word postmark was removed for consistency.

The commenters were the Texas Heart Association, Heart of Texas Regional Advisory Council, Texas Ambulance Association, Texas Association of Nurse Anesthetists, Texas College of Emergency Physicians, Texas Organization of Rural and Community Hospitals, Texas Trauma Coordinators Forum, Arlington Memorial Hospital, Baylor College of Medicine, Ben Taub General Hospital, Christus St. Joseph Hospital, Los Colinas Medical Center, Memorial Health System, Memorial Hermann Southeast Hospital, Memorial Hermann Southwest Hospital, Memorial Hermann The Woodlands Hospital, Methodist Healthcare System, North Hills Hospital, Permian General Hospital, Questcare, Republic Emergency Services, Richards Memorial Hospital, Sabine County Hospital, St. Joseph Regional Health Center, Southwest Texas Emergency Physicians Management Service Association, Team Health Southwest, Texas Tech University Health Sciences Center at El Paso, Texoma Medical Center, Third Coast Emergency Physicians, United Regional Health Care System, University of North Texas Health Science Center at Fort Worth, University of Texas Health Science Center at San Antonio, University of Texas Southwestern Medical Center at Dallas, and department staff. In addition, numerous individuals commented. All commenters were not for or against the rules in their entirety, however they expressed affirmatory comments, concerns, asked questions, and/or suggested recommendations for change as discussed in the summary of comments.

The repeals are adopted under the Health and Safety Code, Chapter 773, which provides the Board of Health (board) with the authority to adopt rules to implement the Emergency Medical Services Act; and §12.001, which provides the board with the authority to adopt rules for the performance of every duty imposed by law on the board, the department and the commissioner of health.