TITLE 25.HEALTH SERVICES

Part 1. TEXAS DEPARTMENT OF HEALTH

Chapter 1. TEXAS BOARD OF HEALTH

Subchapter N. HISTORICALLY UNDERUTILIZED BUSINESSES

25 TAC §1.171

The Texas Department of Health (department) adopts new §1.171, concerning the Historically Underutilized Business (HUB) Program, without changes to the proposed text as published in the September 22, 2000, issue of the Texas Register (25 TexReg 9360), and therefore the section will not be republished.

The rule adopts by reference the General Services Commission (GSC) rules at Title 1, Texas Administrative Code (TAC) §§111.11-111.27 concerning the Historically Underutilized Business (HUB) Program in order to comply with the legislative requirements of Senate Bill (SB) 178, 76th Legislative Session codified under the Government Code, Chapter 2161. Section 2161.003 requires each agency to adopt the GSC rules as agency rules. The rules are adopted to implement the new requirements of the Government Code, Chapter 2161 regarding the HUB policy statement, procurement utilization goals, agency determination of subcontracting opportunities, HUB subcontracting plans, HUB coordinator responsibilities and the agency forum program. The department, according to the rules and in accordance with the HUB Program's policies and procedures, will maintain the requirements.

The department received no comments on the proposal during the comment period.

The new section is adopted under the Government Code §2161.003, which requires agencies to adopt the GSC rules and the Health and Safety Code, §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.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 18, 2001.

TRD-200100341

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 7, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Chapter 13. HEALTH PLANNING AND RESOURCE DEVELOPMENT

Subchapter B. DATA COLLECTION

25 TAC §§13.13, 13.15, 13.17 - 13.19

The Texas Department of Health (department) adopts amendments to §§13.13, 13.15, 13.17, 13.18, and 13.19, concerning hospital financial and utilization reporting and the reporting of charity care and community benefits data from nonprofit hospitals without changes to the proposed text as published in the October 27, 2000, issue of the Texas Register (25 TexReg 10619), and therefore the sections will not be republished.

The amended sections cover definitions; survey forms and methods of reporting data; duties of nonprofit hospitals under Health and Safety Code, Chapter 311; noncompliance with reporting requirements; and confidential data. The amendments are proposed to update obsolete language, to clarify wording, and to specify alternative methods that hospitals may use to report financial and utilization data.

In accordance with the requirements of the Government Code, §2001.039 and the General Appropriations Act, 76th Legislature, Article IX, §9-10.13, the sections have been reviewed and the department has determined that reasons for adopting the sections continue to exist; however, some of the sections were amended as described in this preamble. Sections 13.11, 13.12, 13.14, 13.16, and 13.20 were proposed for readoption in the proposed preamble and were opened for comment and are readopted without changes because no needed revisions were identified during the review and no comments were received on the proposal.

The department published a Notice of Intention to Review in the Texas Register on February 12, 1999 (24 TexReg 1001). No comments were received.

No comments were received as a result of the publication of the proposed rules.

A readoption notice concerning §§13.11, 13.12, 13.14, 13.16, and 13.20 can be found in the Adopted Rule Reviews under the Rule Review of Agency Rules in the February 2, 2001 issue of the Texas Register.

The amendments and the readopted sections are adopted under the Health and Safety Code, §104.42(a) which authorizes the Board of Health (board) to adopt rules relating to the collection and dissemination of data from health care facilities necessary to facilitate health planning and resource development; §311.032(b) which mandates the adoption of rules on the collection and reporting of hospital financial and utilization data; 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.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 19, 2001.

TRD-200100362

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 8, 2001

Proposal publication date: October 27, 2000

For further information, please call: (512) 458-7236


Chapter 102. DISTRIBUTION OF TOBACCO SETTLEMENT PROCEEDS TO POLITICAL SUBDIVISIONS

25 TAC §102.3

The Texas Department of Health (department) adopts an amendment to §102.3, relating to the distribution of tobacco settlement proceeds to political subdivisions, without changes to the proposed text as published in the October 27, 2000, issue of the Texas Register (25 TexReg 10666), and therefore the section will not be republished.

This rule implements a portion of Acts 1999, 76th Legislature, Chapter 753, Article 2 (House Bill (HB) 1161), which designates the department's responsibilities under the Agreement Regarding Disposition of Tobacco Settlement Proceeds (agreement) filed on July 24, 1998, in United States District Court, Eastern District of Texas, in the case styled The State of Texas v. The American Tobacco Co., et al., No. 5-96CV-91. The department collects information and certifies amounts of the tobacco settlement proceeds for annual distribution to political subdivisions. The term "political subdivision" means a hospital district, another local political subdivision owning or maintaining a public hospital, or a county of the State of Texas responsible for providing indigent health care to the general public. The Texas Health and Safety Code, Chapter 61 defines which entities are responsible for providing indigent health care to the general public.

The amendment improves the procedures for submission of the annual expenditure statement by political subdivisions.

The amendment will allow local governments to deliver a copy of their expenditure statement by fax or electronic mail by or on March 31 and deliver their original statement to the department by or on April 7. The expenditure statement that is delivered by fax or electronic mail on or by March 31 in lieu of the original statement must be an exact facsimile of the original. In contrast, the current rule requires that the original statement be mailed and postmarked by March 31. The additional time allowed in the proposed amendment should help local governments to meet the deadline. Political subdivisions that do not meet the deadline are ineligible to receive any portion of the distribution of tobacco settlement proceeds in that year.

No comments were received concerning the proposal during the comment period.

The amendment is adopted under the Health and Safety Code, Chapter 12, Subchapter J, which provides the Texas Board of Health (board) with the authority to adopt rules concerning the tobacco settlement proceeds; HB 1161, §2.04, which provides the board with the authority to adopt rules relating to the tobacco settlement proceeds in the lump sum trust account; and Health and Safety Code §12.001, which provides the board with authority to adopt rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 18, 2001.

TRD-200100348

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 7, 2001

Proposal publication date: October 27, 2000

For further information, please call: (512) 458-7236


Chapter 128. PERMITS FOR CONTACT LENS DISPENSERS

25 TAC §§128.1, 128.2, 128.6, 128.10

The Texas Department of Health (department) adopts amendments to §§128.1- 128.2 and 128.6 and new §128.10 concerning the regulation of persons filling contact lens prescriptions. Section 128.10 is adopted with changes to the proposed text as published in the August 11, 2000, issue of the Texas Register (25 TexReg 7451). Sections 128.1- 128.2 and 128.6 are adopted without changes, and therefore the sections will not be republished.

The sections cover introduction; definitions; violations, complaints, and disciplinary actions; and fees. The sections are amended to correct citations throughout 25 Texas Administrative Code, Chapter 128 based on House Bill 3155, 76th Legislature, 1999, which compiled relevant laws into the Texas Occupations Code, and new §128.10 is amended to establish a schedule of fees for obtaining a contact lens dispensing permit. The schedule of fees set out in the Contact Lens Prescription Act, Texas Occupations Code, Chapter 353 (the Act) has been used to date; however, the Act authorizes the department to adopt fees in amounts sufficient to cover costs associated with the administration of provisions of the Act.

The following comment was received concerning the proposal during the comment period. Additionally, the department has made a minor grammatical change to §128.10(d) to clarify the intent and improve the accuracy of the subsection.

Comment: Concerning §128.10(a)(3), one commenter stated that the $300 fee for business entities makes it difficult for a small business owner to compete with big businesses because the margins on contacts are small and the big businesses do a larger volume business. The commenter requested the department reconsider raising the fee for business entities.

Response: The department disagrees with the commenter. The Act established a schedule of fees for the department to use until changed by the Texas Board of Health (board). The statutory fee schedule provided a higher fee for business entities and allows business entities to obtain one permit for up to nine locations. Additionally, the Act allows the board to adopt fees sufficient to cover the costs of administering the provisions of the Act. The fees set out in §128.10 reflect the amounts necessary to cover those costs. No change was made as a result of this comment.

The amendments and new section are adopted under Texas Occupations Code, Chapter 353, Chapter 352, and Chapter 53, which provide the Board of Health (board) with the authority to adopt rules; and Health and Safety Code, §12.001, which provides the board with authority to adopt rules to implement every duty imposed by law on the board, the department and the commissioner of health.

§128.10.Fees.

(a)

The annual permit fees are as follows:

(1)

$50 for an optician who has registered with the department under the Opticians' Registry Act, Texas Occupations Code, Chapter 352;

(2)

$75 for an optician who has not registered with the department under the Opticians' Registry Act, Texas Occupations Code, Chapter 352; and

(3)

$300 for a business entity.

(b)

A person whose permit has been expired for 90 days or less may renew the permit by paying to the department a renewal fee that is equal to one and one-half times the normally required annual permit fee.

(c)

A person whose permit has been expired for more than 90 days but less than one year may renew the permit by paying to the department a renewal fee that is equal to two times the normally required annual permit fee.

(d)

A person whose permit has been expired for one year or more may not renew the permit. The person may obtain a new permit by complying with requirements and procedures for an original permit.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 18, 2001.

TRD-200100343

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 7, 2001

Proposal publication date: August 11, 2000

For further information, please call: (512) 458-7236


Chapter 157. EMERGENCY MEDICAL CARE

Subchapter B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES

25 TAC §157.25

The Texas Department of Health (department) adopts an amendment to §157.25 concerning the Out-Of-Hospital Do Not Resuscitate (DNR) identification devices, and is adopted with changes to the proposed text as published in the September 22, 2000, issue of the Texas Register (25 TexReg 9390).

The amendment will give consumers greater choice in DNR devices by allowing more businesses to comply with the department rules in supplying the DNR identification devices. The amendment affects the specifications of DNR identification devices and will allow more businesses to become vendors of the DNR identification devices.

No public comments were received on the rule. However, the department is making the following changes, due to staff comments.

Concerning §157.25(i)(1) and (2), "may be honored" was changed to "shall be honored" to make it consistent with statutory language.

Concerning §157.25(i)(3), new language was added to meet statutory requirements.

The amendment is adopted under the Health and Safety Code, Chapter 166, which provides the Board of Health (board) with the authority to adopt and amend rules to implement the Advanced Directives Act; and §12.001, which provides the board with the authority to adopt and amend rules for the performance of every duty imposed by law on the board, the department, and the commissioner of health.

§157.25. Out-of-Hospital Do Not Resuscitate (DNR) Order.

(a)

Purpose. The purpose of this section shall be to establish a statewide DNR protocol as required in the Health and Safety Code, Title 2, Chapter 166.

(b)

DNR order. A DNR order may be issued by an attending physician for any patient. That attending physician has responsibility for ensuring that the form is filled out in its entirety and that the information regarding the existence of a DNR order is entered into the patient's medical record.

(c)

Protocol development. A DNR protocol in accordance with this section, shall apply to all out-of-hospital settings including cardiac arrests which occur during interfacility transport. The protocol shall include the following:

(1)

a copy of the Texas Department of Health (department) standardized DNR form listing the designated treatments that shall be withdrawn or withheld. Those treatments shall be:

(A)

cardiopulmonary resuscitation;

(B)

advanced airway management;

(C)

artificial ventilation;

(D)

defibrillation; and

(E)

transcutaneous cardiac pacing.

(2)

an explanation of the patient identification process to include an option to use a department-standardized identification device such as a necklace or bracelet; and

(3)

an on-site DNR dispute resolution process which includes contacting an appropriate physician.

(d)

Recordkeeping. Records shall be maintained on each incident in which an out-of-hospital DNR order or DNR identification device is encountered by responding healthcare professionals, and the number of cases where there is an on-site revocation of the DNR order shall be recorded.

(1)

The data documented should include:

(A)

an assessment of patient's physical condition;

(B)

whether an identification device or a DNR form was used to confirm DNR status and patient identification number;

(C)

any problems relating to the implementation of the DNR order;

(D)

the name of the patient's attending physician; and

(E)

the full name, address, telephone number, and relationship to patient of any witness used to identify the patient.

(2)

If the patient is transported, the original DNR order or a copy of the original order will be kept with the patient.

(3)

Copies of the original DNR order may be put on file with concerned parties, and the original order shall remain in the possession of the patient, a legal guardian, or the healthcare facility responsible for the patient's care.

(4)

At the time of relicensure, the out-of-hospital provider shall submit a report to the Bureau of Emergency Management with the following information:

(A)

number of times personnel have been presented with DNR documentation;

(B)

number of times there was a problem and the DNR order could not be honored; and

(C)

any problems that were encountered using the standardized form.

(e)

Out-of-state DNR Orders. Personnel may accept an out-of-hospital DNR order or device that has been executed in any other state, if there is no reason to question the authenticity of the order or device.

(f)

Failure to honor a DNR order. If there are any indications of unnatural or suspicious circumstances, the provider shall begin resuscitation efforts until such time as a physician directs otherwise.

(g)

Pregnant persons. A person may not withhold the designated treatments listed in subsection (c)(1) from a person known by responding healthcare professionals to be pregnant.

(h)

DNR Form. The Bureau of Emergency Management or their appointees shall furnish DNR forms to physicians, clinics, hospitals, nursing homes, hospices and home health agencies throughout the state upon request.

(1)

The form shall contain all the information as prescribed in the Health and Safety Code, Chapter 166.

(2)

The form shall be 8-1/2 inches by 11 inches, printed front and back, and in the format specified by the board as follows.

Figure: 25 TAC §157.25(h)(2) (No change.)

(i)

Identification devices. As an optional means of identification, a patient may obtain, at patient's expense, an Out-of-Hospital (OOH) DNR device. An OOH DNR device, as approved by the Texas Department of Health, must meet the following requirements:

(1)

An intact, unaltered, easily identifiable plastic identification OOH DNR bracelet, with the word "Texas" (or a representation of the geographical shape of Texas and the word "STOP" imposed over the shape) and the words "Do Not Resuscitate", shall be honored by qualified EMS personnel in lieu of an original OOH DNR Order form.

(2)

An intact, unaltered, easily identifiable metal bracelet or necklace inscribed with the words, "Texas Do Not Resuscitate - OOH" shall be honored by qualified EMS personnel in lieu of an OOH DNR Order form.

(3)

The person or entity who provides an OOH DNR identification device to an individual shall send with the identification device a statement with the words, "Pursuant to Texas Health and Safety Code, §166.090 this identification device may only be worn by a person who has executed a valid out-of-hospital DNR order."

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 18, 2001.

TRD-200100342

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 7, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236


Subchapter C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL

25 TAC §157.32

The Texas Department of Health (department) adopts new §157.32 concerning emergency medical services (EMS) education program and course approval with changes to the proposed text as published in the September 22, 2000, issue of the Texas Register (25 TexReg 9397).

In accordance with Health and Safety Code, Chapter 773, 76th Legislature, 1999, the department is required to adopt rules concerning emergency medical services (EMS) education program and course approval.

The following comments were received in regards to the proposal.

Comment: Concerning §157.32(p), two commenters suggested that the "grandfather" provision of exempting preexisting programs from the provisions of the proposed rule did not automatically continue the exemption upon program re-approval.

Response: The department agrees that the exemption language for program re-approval was inadvertently omitted and that language has been added as new language in §157.32(p)(3).

Comment: There were 38 written comments received opposing the proposed requirement in §157.32(h)(2) requiring advanced program sponsorship by a regionally accredited post- secondary educational institution or a health care institution accredited by an organization recognized by the department. The commenters were concerned that the requirement would cause unwarranted fiscal burdens and extended training delays for certain EMS providers by requiring the institutional sponsorships.

Response: The department presented the proposed rule controversy to the Governor's EMS and Trauma Advisory Council (GETAC) on November 20, 2000. Separate recommendations from the EMS Committee and the Medical Director Committee were reviewed and discussed and the council heard 23 public commenters. A motion was made and seconded that the language in §157.32(h)(2) be modified to include "or any other entity meeting standards and criteria for sponsoring advanced EMS courses". The motion passed unanimously. The language recommended by the council has been added to the proposed rule.

Comment: Concerning §157.32(m)(1), the advisory council also suggested that the department may exempt nationally accredited programs from portions of the requirements be changed to "shall exempt".

Response: The department disagrees that all nationally accredited programs should automatically be exempted from the provisions of the rule based on historical problems with certain accredited programs. No change was made as a result of this comment

The following minor change was made to clarify the intent of the section.

Change: Concerning §157.32(j), the word "established" was deleted after "standards".

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. There were 248 written comments received in favor of sending the rule through the process with no changes to the text. The comments were received during the 30-day comment period. The commenters included individuals and the Governor Appointed Emergency Medical Services and Trauma Advisory Council (GETAC) and the subcommittees of GETAC.

The new section is adopted under the Health and Safety Code, Chapter 773, which requires the department to adopt rules concerning emergency medical services (EMS) education program and course approval; 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.

§157.32.Emergency Medical Services Education Program and Course Approval.

(a)

Emergency medical services (EMS) Education Program Standards. The Bureau of Emergency Management (bureau) shall develop and publish an EMS Education and Training Manual (manual) outlining standards for EMS education that address at least the following areas:

(1)

program sponsorship;

(2)

program direction and administration;

(3)

medical direction;

(4)

instructor personnel;

(5)

financial resources;

(6)

physical resources, including classroom and laboratory facilities, equipment and supplies, and learning resources;

(7)

clinical and field internship resources;

(8)

academic and administrative policies, procedures and records requirements;

(9)

program evaluation;

(10)

curriculum; and

(11)

delivery of instruction by distance learning technology.

(b)

Consideration of training standards.

(1)

The Texas Department of Health (department) shall base the manual on applicable standards and guidelines for evaluation and approval of EMS education programs adopted by national accrediting organizations.

(2)

Before implementation or revision of the manual, the department shall ensure adequate time for public review and comment.

(3)

Before implementation or revision of the manual, the department shall present the manual to the advisory council for review.

(c)

Curriculum.

(1)

Emergency Care Attendant (ECA)

(A)

The minimum curriculum shall include all content required by the current national EMS First Responder educational standards and competencies as defined by the United States Department of Transportation (DOT).

(B)

In addition to the minimum curriculum in subparagraph (A) of this paragraph, the curriculum shall include the following subjects:

(i)

recognition and identification of hazardous materials as defined by the Federal Emergency Management Agency curriculum, "Recognizing and Identifying Hazardous Materials";

(ii)

airway/ventilation adjuncts; to include use of the bag-valve mask, oxygen administration and oral suctioning;

(iii)

measurement of baseline vital signs to include pulse, respiration and blood pressure by palpation and auscultation;

(iv)

spinal motion restriction, to include sizing and application of cervical collars and short/long spinal motion restriction devices to supine, seated, and standing patients;

(v)

patient assessment;

(vi)

bandaging, splinting, and traction splinting;

(vii)

cardiac arrest management, including use of the semi- automatic external defibrillator;

(viii)

equipment used to lift and move patients;

(ix)

communications and documentation; and

(x)

ambulance operations, to include emergency vehicle laws.

(C)

The course shall include a minimum of 40 clock hours of classroom and laboratory instruction in the approved curriculum.

(2)

Emergency Medical Technician-Basic (EMT-B).

(A)

The minimum curriculum shall include all content required by the current national EMT-B educational standards and competencies as defined by DOT.

(B)

The course shall include a minimum of 140 clock hours of classroom, laboratory, clinical, and field instruction which shall include supervised experiences in the emergency department, with a licensed EMS provider and in other settings as needed to develop the competencies defined in the minimum curriculum.

(3)

Emergency Medical Technician-Intermediate (EMT-I).

(A)

The minimum curriculum shall include all content required by the portions of the current national paramedic education standards and competencies as defined by DOT which address the following areas:

(i)

roles and responsibilities of the paramedic;

(ii)

well being of the paramedic;

(iii)

illness and injury prevention;

(iv)

medical/legal issues;

(v)

ethics;

(vi)

general principles of pathophysiology;

(vii)

pharmacology;

(viii)

venous access and medication administration;

(ix)

therapeutic communications;

(x)

life span development;

(xi)

patient assessment;

(xii)

airway management and ventilation, including endotracheal intubation; and

(xiii)

trauma.

(B)

The course shall include a minimum of 160 clock hours of classroom, laboratory, clinical, and field instruction which shall include supervised experiences in the emergency department with a licensed EMS provider, and in other settings as needed to develop the competencies defined in the minimum curriculum.

(C)

Certification as an EMT-Basic shall be required prior to beginning field and clinical rotations in an EMT-I course.

(4)

Emergency Medical Technician-Paramedic (EMT-P).

(A)

The minimum curriculum shall include all content required by the current national paramedic education standards and competencies as defined by DOT.

(B)

The course shall include a minimum of 624 clock hours of classroom, laboratory, clinical and field instruction which shall include supervised experiences in the emergency department with a licensed EMS provider and in other settings as needed to develop the competencies defined in the minimum curriculum.

(C)

Certification as an EMT-Basic shall be required prior to beginning field and clinical rotations in an EMT-P course.

(d)

Sponsorship.

(1)

EMS Education programs shall be sponsored by organizations or individuals with adequate resources and dedication to carry out successful educational endeavors.

(2)

Program sponsors shall provide appropriate oversight and supervision to ensure that programs are:

(A)

educationally and fiscally sound; and

(B)

meet the responsibilities listed in subsection (o) of this section.

(e)

Levels of program approval.

(1)

A program may be approved as a basic EMS training program or an advanced training program.

(2)

ECA and EMT training shall be conducted by a basic program and may be conducted by an advanced program.

(3)

EMT-I and EMT-P training shall be conducted by an advanced program.

(4)

An advanced program shall be considered to have met the requirements for approval as a basic program.

(f)

Currently approved programs. Programs that have obtained approval as of the effective date of this rule shall be considered to have met the requirements of subsections (g) or (h) of this section appropriate to their current level of approval.

(g)

Basic approval requirements. To approve a basic program, an applicant shall:

(1)

submit a letter of sponsorship;

(2)

submit letters of intent from qualified providers of clinical and field internship experience appropriate to the level of training;

(3)

have at least one course coordinator certified as an EMT or higher;

(4)

have a program director who contributes an adequate amount of time to assure the success of the program. In addition to other responsibilities, the program director shall be responsible for the development, organization, administration, periodic review and effectiveness of the program. In addition to other duties, the program director may function as a course coordinator if appropriately certified; and shall:

(A)

routinely review student performance to assure adequate progress toward completion of the program;

(B)

review and supervise the quality of instruction provided by the program; and

(C)

document that each graduating student has achieved the desired level of competence prior to graduation;

(5)

have a medical director if appropriate to the level or content of training. The medical director shall be a licensed physician approved by the department with experience in and current knowledge of emergency care. The medical director shall be knowledgeable about educational programs for EMS personnel. In addition to other duties assigned by the program, the medical director shall:

(A)

review and approve the educational content of the program's curricula;

(B)

review and approve the quality of medical instruction provided by the program; and

(C)

attest that each graduating student has achieved the desired level of competence prior to graduation;

(6)

have an advisory committee representing the program's communities of interest (individuals, groups of individuals, or institutions impacted by the program) designated and charged with assisting the program director and medical director in formulating appropriate goals and standards, monitoring needs and expectations and ensuring program responsiveness to change;

(7)

submit a completed application to the appropriate regional office; and

(8)

demonstrate substantial compliance with the EMS education standards by successfully completing the self study/on-site review process outlined in the manual.

(h)

Advanced approval requirements. To approve an advanced program, an applicant shall:

(1)

have successfully operated a basic program;

(2)

submit documentation of sponsorship by a regionally accredited post- secondary educational institution or a health care institution accredited by an organization recognized by the department, or any other entity meeting standards and criteria for sponsoring advanced EMS courses;

(3)

submit letters of intent from qualified providers of clinical and field internship experience appropriate to the level of training offered;

(4)

have at least one advanced course coordinator certified at or above the highest level of training to be offered by the program;

(5)

have a program director who contributes an adequate amount of time to assure the success of the program. In addition to other responsibilities, the program director shall be responsible for the development, organization, administration, periodic review and effectiveness of the program; and shall:

(A)

routinely review student performance to assure adequate progress toward completion of the program; and

(B)

review and supervise the quality of instruction provided by the program; and

(C)

document that each graduating student has achieved the desired level of competence prior to graduation;

(6)

have a medical director who shall be a licensed physician approved by the department with experience in and current knowledge of emergency care. The medical director shall be knowledgeable about educational programs for EMS personnel. In addition to other duties assigned by the program, the medical director shall:

(A)

review and approve the educational content of the program's curricula;

(B)

review and approve the quality of medical instruction provided by the program; and

(C)

attest that each graduating student has achieved the desired level of competence prior to graduation;

(7)

have an advisory committee representing the program's communities of interest (individuals, groups of individuals, or institutions impacted by the program) designated and charged with assisting the program director and medical director in formulating appropriate goals and standards, monitoring needs and expectations and ensuring program responsiveness to change;

(8)

submit a completed application to the appropriate regional office; and

(9)

demonstrate substantial compliance with the EMS education standards by successfully completing the self-study/on-site review process outlined in the manual.

(i)

Provisional approval. If following the department's review of the self-study, the applicant is found to be in substantial compliance with established EMS education standards outlined in the manual, the department shall issue a provisional approval.

(j)

Lack of substantial compliance. If following the department's review of the self- study, the applicant is not found in substantial compliance with EMS education standards outlined in the manual, the program director and sponsor shall receive a written report detailing:

(1)

any deficiencies; and

(2)

specific recommendations for improvement that will be necessary before provisional approval may be granted.

(k)

On-site review. After the completion of a provisionally-approved program's first course, an on-site review shall be conducted as outlined in the manual.

(1)

If the program is found to be in substantial compliance with established EMS education standards and all fees and expenses associated with the self-study and on-site review have been paid, the department shall approve the program for a period of years as set forth in the manual and issue an approval number. The program director and sponsor shall receive a written report of the site-review team's findings, including areas of exceptional strength, areas of weakness and recommendations for improvement.

(2)

If the program is not in substantial compliance with established EMS education standards, the program director and sponsor shall receive a written report detailing deficiencies and specific requirements for improvement. Depending on the nature and severity of the identified deficiencies within the program, the program may or may not be allowed to continue training activities. In all cases the department in consultation with program officials shall devise a remedial plan for the deficiencies.

(3)

Upon completion of a remedial plan a program shall be approved for a period of years as outlined by the manual.

(l)

Exception to sponsorship requirements for advanced programs.

(1)

If an urgent need for an advanced program or an EMS operator instructor program exists in an area and cannot be met by an entity that meets the sponsorship requirements defined in subsection (h)(2) of this section, a licensed EMS provider may request the department to grant an exception to allow the EMS provider to sponsor an advanced program.

(2)

Such request must be submitted in writing and must include the following:

(A)

documentation of the need for an advanced program and of the urgency of the situation;

(B)

documentation that the EMS provider has successfully operated a basic program;

(C)

documentation of attempts by the EMS provider to affiliate with an entity that meets the requirements of subsection (h)(2) of this section;

(D)

a letter from the EMS provider agreeing to assume all responsibilities of advanced program sponsorship;

(E)

letters of intent from qualified providers of clinical and field internship experience appropriate to the level of training to be offered; and

(F)

a letter of intent from a medical director who will agree to perform the responsibilities listed in subsection (h)(6) of this section.

(3)

In determining whether the request for an exception is to be approved or denied, the department shall consider, but not be limited to, the following issues:

(A)

the quality of the basic program previously operated by the EMS provider;

(B)

evidence that the EMS provider possesses the resources and dedication necessary to operate an advanced program that complies with the EMS education standards;

(C)

the efforts of the EMS provider to affiliate with an entity that meets the requirements of subsection (h)(2) of this section;

(D)

the availability of an approved advanced program within a reasonable distance of the affected area;

(E)

the availability of an approved advanced program that will provide training to the affected area by outreach or distance learning technology;

(F)

the probable impact on existing approved advanced programs if the exception is approved; and

(G)

the probable adverse consequences to the public health or safety if the exception is not approved.

(4)

After evaluation by the department, the EMS provider shall be notified in writing of the approval or denial of the request.

(5)

An exception to the requirements of subsection (h)(2) of this section shall meet all other requirements of subsection (h) of this section, including completion of the self-study and the on-site review process, and shall demonstrate substantial compliance with the EMS education standards as outlined in the manual before being granted approval by the department.

(m)

National accreditation.

(1)

If a program has been accredited through a national accrediting organization recognized by the department, the department may exempt the program from the program approval or re-approval process. If a program is denied, the program has an opportunity to request a hearing in accordance with §§1.21-1.34 of this title (relating to Formal Hearing Procedures).

(2)

Nationally accredited programs shall provide the department with copies of:

(A)

the accreditation self study;

(B)

the accreditation letter or certificate; and

(C)

any correspondence or updates to or from the accrediting organization that impact the program's status.

(3)

On request of the department, programs shall permit the department's representatives to participate in site visits performed by national accrediting organizations.

(4)

If the department takes disciplinary action against a nationally accredited program for violations that could indicate substantial noncompliance with a national accrediting organization's essentials or standards, the department shall advise the national accrediting organization of the action and the evidence on which the action was based.

(5)

If a program's national accreditation lapses or is withdrawn, the program shall meet all requirements of subsections (g) or (h) of this section within a reasonable period of time as determined by the department.

(n)

Denial of program approval. A program may be denied approval, provisional approval, or re-approval for, but not limited to, the following reasons:

(1)

failure to meet the requirements established in subsections (g) or (h) of this section;

(2)

failure, or previous failure, to meet program responsibilities as defined in subsection (o) of the this section;

(3)

conduct, or previous conduct, that is grounds for suspension or revocation of program approval as defined in subsection (t) of this section;

(4)

falsifying any information, record, or document required for program approval, provisional approval, or re-approval;

(5)

misrepresenting any requirements for program approval, provisional approval, or re-approval;

(6)

failing or refusing to submit a self-study or a required report of progress toward remediation of a documented program weakness or areas of non-compliance within a reasonable period of time as determined by the department;

(7)

failing or refusing to accept an on-site program review by a reasonably scheduled date as determined by the department;

(8)

issuing a check to the department which is returned unpaid;

(9)

being charged with criminal activity while approved to provide EMS training;

(10)

having disciplinary action imposed by the department on the provider license, personnel certification or licensure, or program for violation of any provision of Health and Safety Code, Chapter 773 or 25 Texas Administrative Code, Chapter 157.

(o)

Responsibilities. A program shall be responsible to:

(1)

plan for and evaluate the overall operation of the program;

(2)

provide supervision and oversight of all courses for which the program is responsible;

(3)

act as liaison between students, the sponsoring organization and the department;

(4)

submit course notifications and approval applications, along with nonrefundable fees if applicable, to the department as described in the manual;

(5)

assure availability of classroom(s) and other facilities necessary to provide for instruction and convenience of the students enrolled in courses for which the program is responsible;

(6)

screen student applications, verify prerequisite certification if applicable and select students;

(7)

schedule classes and assign course coordinators and/or instructors;

(8)

verify the certification, license, or other proper credentials of all personnel who instruct in the program's courses;

(9)

maintain an adequate inventory of training equipment, supplies and audio- visual resources;

(10)

assure that training equipment and supplies are available and operational for each laboratory session;

(11)

secure and maintain affiliations with clinical, and field internship facilities necessary to meet the instructional objectives of all courses for which the program is responsible;

(12)

develop field internship and clinical objectives for all courses for which the program is responsible;

(13)

train and evaluate internship preceptors;

(14)

maintain all course records for a minimum of 5 years;

(15)

along with the course coordinator develop and use valid and reliable written examinations, skills proficiency verifications, and other student evaluations;

(16)

along with the course coordinator, supervise and evaluate the effectiveness of personnel who instruct in the program's courses;

(17)

along with the course coordinator, supervise and evaluate the effectiveness of the clinical and EMS field internship training;

(18)

along with the course coordinator, attest to the successful course completion of all students who meet the programs requirements for completion;

(19)

provide the department with information and reports necessary for planning, administrative, regulatory, or investigative purposes; and

(20)

provide the department with any information that will effect the program's interaction with the department; including but not limited to changes in:

(A)

program director;

(B)

course coordinators;

(C)

medical director;

(D)

classroom training facilities;

(E)

clinical or field internship facilities; and

(F)

program's physical and mailing address.

(p)

Program Re-approval.

(1)

Prior to the expiration of a program's approval period, the department shall send a notice of expiration to the program at the address shown in the current records of the department.

(2)

If a program has not received notice of expiration from the department 45 days prior to the expiration, it is the program's duty to notify the department and request an application for re-approval. Failure to apply for re-approval shall result in expiration of approval.

(3)

Programs that have obtained approval as of the effective date of this rule shall be considered to have met the requirements of subsections (g) or (h) of this section appropriate to their current level of approval.

(4)

To be eligible for re-approval, the program shall meet all the requirements in subsections (g) or (h) of this section as appropriate to the level of approval requested; and

(A)

prepare an update to the program's self-study that addresses significant changes in the program's personnel, structure, curriculum, resources, policies, or procedures;

(B)

document progress toward correction of any deficiencies identified by the program or the department through the self-study and on-site review process; and

(C)

host an on-site review if one is deemed necessary by the department or requested by the program.

(q)

Fees.

(1)

The following nonrefundable fees shall apply:

(A)

$25 for review of a basic self-study, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training;

(B)

$75 for conducting a basic site visit;

(C)

$50 for review of an advanced self-study, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training;

(D)

$200 for conducting an advanced site visit;

(E)

$25 for processing a basic course notification or approval application, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training; and

(F)

$50 for processing an advanced course notification or approval application, except that this nonrefundable fee may be waived if the program receives no remuneration for providing training.

(2)

Program approvals shall be issued only after all required nonrefundable fees have been paid.

(r)

Course Notification and Approval.

(1)

Each course conducted by an approved program shall be approved by notice from the department and the issuance of an assigned course number. A program shall not start a course, advertise a course, or collect tuition and/or fees from prospective students until the course is approved by the department and the assigned course number issued.

(2)

The program director of an approved program shall submit notice of intent to conduct a course and the appropriate fee, if required, to the department on a form provided by the department at least 30 days prior to the proposed start date of the course. The notification shall include the following information:

(A)

training level of course;

(B)

dates and times classes are to be conducted;

(C)

physical location of the classroom;

(D)

identification of clinical sites and internship providers, if required;

(E)

name of principle instructor;

(F)

enrollment status;

(G)

anticipated number of students;

(H)

number of contact hours;

(I)

amount of tuition to be charged;

(J)

proposed ending date of the course; and

(K)

signature of the program director

(3)

A nonrefundable course fee, unless program is not remunerated for the course in any way, shall be submitted as follows:

(A)

$25 for a Basic Course (ECA or EMT);

(B)

$50 for an Advanced Course (EMT-Intermediate or Paramedic);

(C)

$25 for an EMS Instructor Course; and

(D)

$50 for an Emergency Medical Information Operator Instructor Course.

(4)

The department may require submission of a written course approval application, in accordance with the guidelines set forth in the manual, in lieu of the course notification from programs which:

(A)

have not successfully completed a site visit review;

(B)

have proposed courses which do not conform to the approved parameters of the current program standards;

(C)

have not conducted a course of the same level in the previous 12 months; or

(D)

the department has probable cause to suspect are in noncompliance with the provisions of this chapter.

(s)

Denial of a course notification or course approval. A course may be denied for, but not limited to the following:

(1)

submission of an incomplete application;

(2)

failure to meet all requirements outlined in the manual;

(3)

failure of the program to hold current approval to conduct the level of the course proposed;

(4)

failure to follow the guidelines for submission of the course notification or course approval application and supporting documents;

(5)

falsification or misrepresentation of any information required for course notification or course approval; and/or

(6)

issuing a check which is returned unpaid.

(t)

Disciplinary actions.

(1)

Emergency suspension. The bureau chief may issue an emergency order to suspend a program's approval if the bureau chief has reasonable cause to believe that the conduct of the program creates an immediate danger to the public health or safety.

(A)

An emergency suspension shall be effective immediately without a hearing or written notice to the program. Notice to the program shall be presumed established on the date that a copy of the emergency suspension order is sent to the address shown in the current records of the department. Notice shall also be sent to the program's sponsoring entity.

(B)

If a written request for a hearing is received from the program within 15 days of the date of suspension, the department shall conduct a hearing not earlier than the 10th day nor later than the 30th day after the date on which the hearing request is received to determine if the emergency suspension is to be continued, modified, or rescinded. The hearing and appeal from any disciplinary action related to the hearing shall be governed by the Administrative Procedure Act, Government Code, Chapter 2001.

(2)

Non-emergency suspension or revocation. A program's approval may be suspended or revoked for, but not limited to, the following reasons:

(A)

failing to comply with the responsibilities of a program as defined in subsection (o) of this section;

(B)

failing to maintain sponsorship as identified in the program application and self-study;

(C)

failing to maintain employment of at least one course coordinator whose current certifications are appropriate for the level of the program;

(D)

falsifying a program approval application, a self-study, a course notification or course approval application, or any supporting documentation;

(E)

falsifying a course completion certificate or any other document that verifies course activity and/or is a part of the course record;

(F)

assisting another to obtain or to attempt to obtain personnel certification or recertification by fraud, forgery, deception, or misrepresentation;

(G)

failing to complete and submit course notifications or course approval applications and student documents within established time frames;

(H)

offering or attempting to offer courses above the program's level of approval;

(I)

compromising or failing to maintain the integrity of a department- approved training course or program;

(J)

failing to maintain professionalism in a department-approved training course or program;

(K)

demonstrating a lack of supervision of course coordinators or personnel instructing in the program's courses;

(L)

compromising an examination or examination process administered or approved by the department;

(M)

accepting any benefit to which there is no entitlement or benefitting in any manner through fraud, deception, misrepresentation, theft, misappropriation, or coercion;

(N)

failing to maintain appropriate policies, procedures, and safeguards to ensure the safety of students, instructors, or other course participants;

(O)

allowing recurrent use of inadequate, inoperable, or malfunctioning equipment;

(P)

maintaining a passing rate on the examinations for certification or licensure that is statistically and significantly lower than the state average;

(Q)

failing to maintain the fiscal integrity of the program;

(R)

issuing a check to the department which is returned unpaid;

(S)

failing to maintain records for initial or continuing education courses;

(T)

demonstrating unwillingness or inability to comply with the Health and Safety Code and/or rules adopted thereunder;

(U)

failing to give the department true and complete information when asked regarding any alleged or actual violation of the Health and Safety Code or the rules adopted thereunder;

(V)

committing a violation within 24 months of being placed on probation; and/or

(W)

offering or attempting to offer courses during a period when the program's approval is suspended.

(3)

Notification. If the department proposes to suspend or revoke a program's approval, the program shall be notified at the address shown in the current records of the department. The notice shall state the alleged facts or conduct warranting the action and state that the program has an opportunity to request a hearing in accordance with Administrative Procedure Act, Government Code, Chapter 2001.

(A)

The program may request a hearing within 15 days after the date of the notice. This request shall be in writing and submitted to the chief.

(B)

If the program does not request a hearing within 15 days after the date of the notice of opportunity, the program waives the opportunity for a hearing and the department shall implement its proposal.

(4)

Probation. The department may probate any penalty assessed under this section and may specify terms and conditions of any probation issued.

(5)

Re-application.

(A)

Two years after the revocation or denial of approval, the program may petition the department in writing for the opportunity to reapply.

(B)

The department shall evaluate the petition and may allow or deny the opportunity to submit an application.

(C)

In evaluating a petition for permission to reapply, the department shall consider, but is not limited to, the following issues:

(i)

likelihood of a repeat of the violation that led to revocation;

(ii)

the petitioner's overall record as a program;

(iii)

letters of support or recommendation;

(iv)

letters of protest or non-support of the petition; and

(v)

the need for training in the area the program would serve.

(D)

The petitioner shall be notified within 60 days at the address shown in the current records of the department of the decision to allow or deny the submission of an application for re-approval.

(6)

A program whose approval expires during a suspension or revocation period may not petition to reapply until the end of the suspension or revocation period.

This agency hereby certifies that the adoption has been reviewed by legal counsel and found to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 18, 2001.

TRD-200100340

Susan K. Steeg

General Counsel

Texas Department of Health

Effective date: February 7, 2001

Proposal publication date: September 22, 2000

For further information, please call: (512) 458-7236