The Texas Department of Health (department) adopts the repeal of §§157.1 - 157.3, 157.11 - 157.14, 157.16 - 157.24, 157.32 - 157.35, 157.41 - 157.47, 157.51; 157.53, 157.61 - 157.64, 157.101, and 157.121 - 157.128 and new rules 157.1 - 157.3, 157.11 - 157.14, 157.16, 157.33, 157.36, 157.37, 157.43, 157.44, 157.122 - 157.123, 157.125, and 157.128 concerning emergency medical services (EMS) and trauma systems development. New sections 157.2 - 157.3, 157.11 - 157.14, 157.16, 157.33, 157.36 - 157.37, 157.43 - 157.44, 157.122 - 157.123, 157.125, and 157.128 are adopted with changes to the proposed text as published in the October 29, 1999, issue of the Texas Register (24 TexReg 9534). The repeal of §§157.1 - 157.3, 157.11 - 157.14, 157.16 - 157.24, 157.32 - 157.35, 157.41 - 157.47, 157.51, 157.53, 157.61 - 157.64, 157.101, and 157.121 - 157.128 and new §157.1 are adopted without changes and therefore will not be republished.

The repeal of §157.38, and §157.129, the amendment to §157.40, and new §§157.32, 157.34 and 157.42 which were simultaneously proposed in the October 29, 1999, issue of the Texas Register , are being withdrawn from consideration for permanent adoption.

The department adopts new rules concerning purpose; definitions; processing EMS provider licenses and applications for EMS personnel certification and licensure; requirements for an EMS provider license; rotor-wing air ambulance operations; fixed-wing air ambulance operations; requirements for first responder organization registration; emergency suspension, suspension, probation, revocation or denial of a provider license; criteria for denial and disciplinary actions for EMS personnel and voluntary surrender of a certificate or license; certification or licensure of persons with criminal backgrounds; course coordinator certification; and EMS instructor certification.

The department also adopts new rules concerning trauma service areas; regional EMS/trauma systems; requirements for trauma facility designation; and denial, suspension and revocation of trauma facility designation.

All commenters were not against the rules in their entirety, however they expressed concerns, asked questions and suggested recommendations for change as discussed in the summary of comments. Twelve commenters at the public hearing were in favor of sending the rules through the process with no changes to the text. The following comments were received during the 90-day comment period:

Comment: Concerning §157.2(9), two commenters suggested that the definition of Basic (Level IV) Trauma Facility was too narrow.

Response: The department agrees in part and has removed the word "all" from this section and from the heading section §157.125(t).

Comment: Concerning §157.2(13), three commenters suggested that the definition of Basic Trauma Facility be changed to require that an EMS provider not utilize predetermined triage criteria, but to call the physician on staff or on call at the nearest hospital before that hospital is bypassed to take a patient to another hospital.

Response: The department agrees in part and has added language that requires local physician input into the development of predetermined triage criteria and review of the criteria through the regional system performance improvement process.

Comment: Concerning §157.2(42), two commenters opposed language in the definition regarding industrial ambulances. Both suggested referencing Texas Transportation Code, Chapter 541, §201.

Response: The department agrees and has made the appropriate change.

Comment: Concerning §157.2(47), one commenter suggested that in the definition of major trauma patient, the word "designated" be removed because non-designated trauma facilities may also be capable of treating major trauma patients.

Response: The department agrees because the word "designated" is redundant in the definition - according to the enacting legislation, a hospital is not a trauma facility unless designated by the department. The wording has been corrected in this section and in §157.2(63).

Comment: Concerning §157.2(47), one commenter suggested that in the definition of "major trauma patient," the word "retrospectively" be removed because appropriateness of triage should not be based on retrospective identification.

Response: The department agrees in part and has added clarifying language to this section and §157.2(63) that the injury severity score may be used to evaluate of the appropriateness of triage retrospectively through an individual trauma care provider's and/or a regional performance improvement program.

Comment: Concerning §157.2(73), one commenter suggested that in the definition of "trauma nurse coordinator/trauma program manager" the words "the authority to positively impact care of trauma patients in all areas of the hospital" be removed because they are vague and the trauma coordinator does not need to impact care of patients once they no longer need trauma care.

Response: The department agrees in part and has changed the wording to reflect that the trauma nurse coordinator/trauma program manager should be able to positively impact trauma care of trauma patients.

Comment: Concerning §157.2(74), one commenter suggested that in the definition of "trauma patient" the words "trauma facility" be replaced by "acute care facility" because certain trauma patients may be treated in non-designated facilities.

Response: The department disagrees because the definition of "trauma patient" is directly out of the enacting legislation. No change was made as a result of this comment.

Comment: Concerning §157.11, one commenter recommends inclusion of a drug storage rule.

Response: The department disagrees because the issue is addressed by the Board of Pharmacy regulations. No change was made as a result of this comment.

Comment: Concerning §157.11(i)(1)(M), one commenter opposes the required Automatic External Defibrillators (AEDs) on Basic Life Support units.

Response: The department disagrees because of the availability of AEDs and the public access to AEDs. No change was made as a result of this comment.

Comment: Concerning §157.11(c), one commenter suggested that the language was ambivalent.

Response: The department agrees and has made the appropriate change to include the words "between providers".

Comment: Concerning §157.12(c)(6), one commenter recommended that the rule require submission of current FAA operational certification.

Response: The department agrees and has added that language.

Comment: Concerning §157.12(d), two commenters wanted clarification of the medical director credentials.

Response: The department disagrees. Several air medical providers are based in adjoining states and the language that the medical directors be "approved by the department" is sufficient. No change was made as a result of this comment.

Comment: Concerning §157.13(b), two commenters wanted clarification of the medical director credentials.

Response: The department disagrees. Several air medical providers are based in adjoining states and the language that the medical directors be "approved by the department" is sufficient. No change was made as a result of this comment.

Comment: Concerning §157.13(d)(4), one commenter recommended that the rule require submission of the provider's current Federal Aviation Air Taxi and Commercial Operator Certification.

Response: The department agrees and has added that language.

Concerning §157.14, the following comments were received from one commenter:

Comment: Concerning §157.14, one commenter recommends charging all volunteers a fee for administrative purposes.

Response: The department disagrees because fees and volunteer exemptions are mandated by statute. No change was made as a result of this comment.

Comment: Concerning §157.14, one commenter opposes the requirement that the department be advised of addition or deletion of staff except at the time of renewal of the license.

Response: The department disagrees because it is not required. No change was made as a result of this comment.

Comment: Concerning §157.14(a)(2) and (b)(5)(A), the commenter suggested that we use the word "members" which would include paid or volunteer first responder personnel instead of "employees and/or members."

Response: The department agrees with the need for a change but has changed the word to "personnel" to be consistent with the other uses of that terminology in the rule.

Comment: Concerning §157.14(b)(2), the commenter suggested that the personnel list include the Social Security number and certification level for more complete information.

Response: The department agrees and has made the change for clarity.

Comment: Concerning §157.14(b) and (b)(5)(B), the commenter suggested that "candidate" for registration should be "applicant".

Response: The department agrees and has made the change for clarity.

Comment: Concerning §157.14(c)(1), the commenter suggested that patients are "treated" not always "stabilized" by First Responder personnel.

Response: The department agrees and has changed the wording for clarity.

Comment: Concerning §157.14(c)(1), the commenter felt the agreement should be approved by the responsible person for the "First Responder Organization" not the first responder.

Response: The department agrees and has changed the wording for clarity.

Comment: Concerning 157.14(c)(2)(C), one commenter opposes the requirement for availability schedules.

Response: The department disagrees because the transporting provider should be informed of its First Responders' availability. No change was made as a result of this comment.

Comment: Concerning §157.14(d)(2), one commenter opposes the requirement for individual identification.

Response: The department disagrees because all persons rendering emergency care should be identified to the patient. No change was made as a result of this comment.

Comment: Concerning §157.14(d)(6), the commenter suggested that first responder vehicles do not always belong to the First Responder Organization, so proof of first responder registration should be carried in vehicles "used or operated" by the first responder.

Response: The department agrees and has modified the language.

Note: Due to the significant controversy surrounding the examination requirement for personnel recertification in §157.33(j), and because of the importance of the balance of the proposed rule to establishing certification criteria, including fees and other statute-mandated provisions, staff has deleted the proposed language in subsection (j) and has replaced it with language identical to that contained in the current rule subsection (j) pertaining to recertification.

Comment: Seventy three commenters oppose the reinstatement of the pass/fail requirement on the personnel recertification examination in §157.33(j).

Response: The department recognizes that conflicts between the personnel opposing the requirement and the physician medical directors who are in favor of the requirement will not be resolved in sufficient time to meet the rule submission deadline for the Board of Health meeting and has deleted the controversial section (j) and has replaced it with language identical to that contained in the current rule subsection (j) pertaining to recertification.

Comment: Thirteen commenters are in favor of the reinstatement of the pass/fail requirement on the personnel recertification examination in §157.33(j).

Response: The department recognizes that conflicts between the personnel opposing the requirement and the physician medical directors who are in favor of the requirement will not be resolved in sufficient time to meet the rule submission deadline for the Board of Health meeting and has deleted the controversial section (j).

Comment: Two commenters oppose the requirement for repeating a training course in §157.33(e)(2) following failure of a second retest.

Response: The department disagrees. Currently, only one retest attempt is allowed under the rules. The proposed rule provides for three attempts to successfully complete the credentialing examination. No change was made as a result of this comment.

Comment: Two commenters oppose the increase in late fees as proposed in §157.33(k)(2).

Response: The department disagrees. The increase in late fees is established by statute. No change was made as a result of this comment.

Comment: Two commenters oppose the elimination of the 90-day extension of certification past the expiration date.

Response: The department disagrees. The extension of certification is not a provision of the statute. No change was made as a result of this comment.

Comment: Concerning §157.123, two commenters indicated support for the rule as proposed.

Response: No change was made as a result of this comment.

Comment: Concerning §157.123, two commenters would like to see the Regional Advisory Councils (RACs) more specifically defined as to authority, responsibilities, conduct of business, voting, etc. They went on to express concern that there is no mechanism for assuring that state monies directed to and through the RACs are spent appropriately.

Response: The department disagrees because the RACs cover areas that are so diverse in geographic size, population, and numbers and levels of trauma care providers that defining a specific organizational structure that would meet the needs of all twenty-two Trauma Service Areas would be extremely difficult, which is why they have been allowed to develop a structure that meets the needs of their area. Additionally, staff do evaluate complaints regarding these issues and conduct on-site visits at RAC meetings, providing feedback to the RACs on the conduct of their business. In regards to state funding being directed to and through the RACs, the state will have a contract with each RAC for each different source of funding, which will define the appropriate uses of the funds and require specific reporting as to how all monies are spent. In addition, the RACs will be subject to audit regarding the use of state funds. No change was made as a result of these comments.

Comment: Concerning §157.123(b)(1)(E), one commenter suggested that the wording was vague and therefore not meaningful.

Response: The department agrees and has deleted and added language to clarify the meaning of the section.

Comment: Concerning §157.125, ten commenters indicated support for the rule as proposed.

Response: No change was made as a result of these comments.

Comment: Concerning §157.125, one commenter suggested that language be included that would allow hospitals to file a complaint regarding the conduct of a surveyor and a process for evaluation and resolution of those complaints.

Response: The department agrees and the language has been added as §157.125(d)(7).

Comment: Concerning §157.125(a)(1) and (a)(2), one commenter objected to adoption of the American College of Surgeons criteria regarding anesthesiology requirements for Level I and II trauma facilities because they conflict with state requirements.

Response: The department agrees, however, it is the nature of national standards that they may not always correspond exactly with every state's requirements. Additionally, each hospital may have a different process for meeting the essential criteria. That is why §157.125(k) allows the department to give an exception to criteria. No change was made as a result of this comment.

Comment: Concerning §157.125(d)(5), one commenter suggested that the words "from the department" be added because it is not appropriate for outside observers be allowed to accompany a survey team.

Response: The department agrees in part and has added the wording that a hospital may refuse to allow non-department observers to participate in a survey.

Comment: Concerning §157.125(g)(1), one commenter requested that the wording be clarified that only medical records, etc. specifically relevant to trauma care be reviewed during the survey process.

Response: The department agrees and the language has been added.

Comment: Concerning §157.125(p), one commenter stated a concern that the wording implies that non-designated facilities are inferior and requests that the wording be changed to state only that non-designated facilities cannot represent themselves as designated.

Response: The department disagrees because the wording is directly out of the enacting legislation. No change was made as a result of this comment.

Comment: Concerning §157.125(s) and (t), four commenters indicated support for the General and Basic Trauma Facility criteria as proposed.

Response: No change was made as a result of these comments.

Comment: Concerning §157.125(s), General Trauma Facility Standards and §157.125(s), criterium C(1), one commenter stated concern that there was no standard or standard audit filter related to diversion by trauma facilities.

Response: The department agrees and the language has been added as §157.125(s), General Trauma Facility Standard #4, §157.125(s), criterium C(1), Audit Filter #4, §157.125(t), Basic Trauma Facility Standard #4, and §157.125(t), criterium 4(a) Audit Filter ##4.

Comment: Concerning §157.125(s), criterium A(2)(b), one commenter pointed out that the wording "trauma coordinator" is not consistent with the wording in §157.2(73) or the national standards.

Response: The department agrees and the language has been corrected in §157.125(s), criterium A(2)(b) and §157.125(t), criterium 3(a).

Comment: Concerning §157.125(s), criterium A(2)(e), one commenter stated concern with requiring all trauma patients to be admitted to a surgeon because less than major trauma patients may not require that level of care and because the patient's primary physician may not be notified.

Response: The department agrees. The language of criterium A(2)(e) limits the requirement of admission to an appropriate surgeon to major and severe trauma patients. Additionally, criterium A(6)(b) states that it is essential that a patient's primary care physician be notified. No change was made as a result of this comment.

Comment: Concerning §157.125(s), criterium A(5)(a), one commenter pointed out that national standards require orthopedic surgery in Level III trauma facilities and the proposed criteria do not.

Response: The department agrees in part and has added the language that orthopedic surgery is required in lead facilities.

Comment: Concerning §157.125(s), criterium A(5)(a), one commenter stated that encouraging orthopedic surgeons and neurosurgeons to be credentialed the Advanced Trauma Life Support (ATLS) course is unrealistic and does not improve care.