TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 98. TEXAS HIV MEDICATION PROGRAM

SUBCHAPTER C. TEXAS HIV MEDICATION PROGRAM

DIVISION 2. ADVISORY COMMITTEE

25 TAC §98.121

The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts an amendment to §98.121, concerning the Texas HIV Medication Advisory Committee, without changes to the proposed text as published in the July 22, 2016, issue of the Texas Register (41 TexReg 5323) and, therefore, the section will not be republished.

BACKGROUND AND PURPOSE

The Texas HIV Medication Advisory Committee is mandated under Texas Health and Safety Code, Chapter 85, Subchapter K and advises the Executive Commissioner and the department in the development of procedures and guidelines for the Texas HIV Medication Program, which helps provide medications for the treatment of HIV and its related complications for low-income Texans.

The amendment avoids abolishment of the Texas HIV Medication Advisory Committee by August 1, 2016, as prescribed in the current rule. The purpose of the rule amendment is to extend the date of Texas HIV Medication Advisory Committee abolishment from August 1, 2016, to August 1, 2020, based on the recommendation of the Executive Commissioner to continue the Texas HIV Medication Advisory Committee. A review of department advisory committees was conducted by the commission in the Fall of 2015. The need for continuing the Texas HIV Medication Advisory Committee was established as required in the current rule.

SECTION-BY-SECTION SUMMARY

The amendment to §98.121 changes the expiration date of the Texas Medication Advisory Committee to reflect that the need for the Texas HIV Medication Advisory Committee has been established and that it should continue until August 1, 2020.

COMMENTS

The department, on behalf of the commission, did not receive any comments regarding the proposed rule during the comment period.

LEGAL CERTIFICATION

The Department of State Health Services, General Counsel, Lisa Hernandez, certifies that the rule, as adopted, has been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

STATUTORY AUTHORITY

The amendment is authorized by Texas Health and Safety Code, §85.003, which requires the department to act as lead agency and primary resource for AIDS and HIV policy; Texas Health and Safety Code, §85.016, which allows for the adoption of rules; Texas Health and Safety Code, §85.061, which establishes the Texas HIV Medication Program; Texas Health and Safety Code, §85.272, which establishes the Texas HIV Medication Advisory Committee and its duties; and by Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Texas Health and Safety Code, Chapter 1001.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 20, 2017.

TRD-201700282

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: February 9, 2017

Proposal publication date: July 22, 2016

For further information, please call: (512) 776-6972


CHAPTER 157. EMERGENCY MEDICAL CARE

The Executive Commissioner of the Health and Human Services Commission (commission), on behalf of the Department of State Health Services (department), adopts amendments to §§157.2, 157.5, 157.11 - 157.14, 157.16, 157.32 - 157.34, 157.36, 157.38, 157.43, and 157.44, the repeal of §157.3 and new §157.3, concerning Emergency Medical Services (EMS) provider licensing. The amendments to §§157.2, 157.11 - 157.14, 157.16, 157.32 - 157.34 and new §157.3 are adopted with changes to the proposed text as published in the August 12, 2016, issue of the Texas Register (41 TexReg 5918). The amendments to §§157.5, 157.36, 157.38, 157.43, 157.44 and the repeal of §157.3 are adopted without changes, and therefore, the sections will not be republished.

BACKGROUND AND PURPOSE

The rules are necessary to comply with Health and Safety Code, Chapter 773, Subchapter C, which requires the department to issue EMS provider licenses in accordance with this chapter.

Senate Bill (SB) 8 and House Bill 3556, 83rd Legislation, Regular Session, 2013, added Health and Safety Code, §773.05712, which requires licensed EMS providers to declare an Administrator of Record (AOR).

SB 1899, 84th Legislation, Regular Session, 2015, added Health and Safety Code, §773.05715 and §773.05716 that requires emergency medical service providers to have a permanent physical location as the provider's primary place of business, and to own or obtain a long-term lease for its equipment and vehicles.

SB 219, 84th Legislation, Regular Session, 2015, requires changing the name of an Emergency Medical Technician-Intermediate (EMT-I) to an Advanced Emergency Medical Technician (AEMT). SB 219 also amended Health and Safety Code, Chapter 773 by replacing the outdated references to the "Board of Health" with the rulemaking authority of the "Executive Commissioner" and the "department" due to the department reorganization which occurred in 2004.

SB 1574, 84th Legislation, Regular Session, 2015, added Health and Safety Code, §81.012 that requires entities using emergency response employees or volunteers to have a designated infection control officer to handle an employee's exposure to a reportable diseases through blood or other body fluids.

These and other rules amendments reflect years of input to the department from EMS stakeholders and the Governor's EMS and Trauma Advisory Council (GETAC) on ways to improve the Texas EMS system.

These rules are the product of more than 15 public, statewide stakeholder meetings held between members of the EMS Committee of GETAC and department staff. They represent a grass roots process of feedback and deliberation garnered during more than 100 hours of meetings between emergency medical personnel and state EMS officials. On December 11, 2015, the EMS Committee approved these proposed revisions and made a recommendation to GETAC to approve the proposed rules.

The draft rules were reviewed by GETAC at meetings on January 27, 2016 and February 12, 2016, and GETAC voted unanimously for the proposed draft rules to be presented to the State Health Services Council.

The purpose of these rule revisions is to ensure compliance with new laws and to reflect current state and national trends in the EMS industry. These rules will affect more than 63,000 EMS personnel, 800 EMS Providers and the 4 million patients that the EMS and Trauma system treat and transport annually.

These rules are also in compliance with Government Code, §2001.039, which requires that each state agency review and consider for re-adoption each rule adopted by that agency pursuant to the Government Code, Chapter 2001 (Administrative Procedure Act). Sections 157.2, 157.3, 157.5, 157.11 - 157.14, 157.16, 157.32 - 157.34, 157.36, 157.38, 157.43, and 157.44, have been reviewed, and the department has determined that reasons for adopting the section continue to exist because rules on this subject are needed.

SECTION-BY-SECTION SUMMARY

Section 157.2, Definitions, incorporates modifications to existing rules by adding several new definitions and updating language and terms to reflect current standards.

Section 157.3, Processing EMS Provider Licenses and Applications for EMS Personnel Certification and Licensure, was repealed and rewritten as a new rule to incorporate modifications to existing rules and update language to current terms and practices. This section specifies the time period for the department to review applications for completeness and to process applications, in order to make eligibility determinations for various EMS certifications, licenses and approvals as required by Government Code, Chapter 2001.

Section 157.5, Rule Exemption Requests, incorporates modifications to existing rules to update language to be in alignment with current terms and practices. In addition, bureau chief references are replaced with the department and EMT-Intermediate references were removed to incorporate the use of AEMT.

Section 157.11, Requirements for Emergency Medical Services Provider Licensing, incorporates modifications to existing rules, to current standards, terms, and practices. Amendments to current rules were also added due to new legislation, SB 1899 and SB 1574. The changes required by SB 1899 were based on the ongoing steps being taken to reduce and prevent fraud within the EMS industry in Texas.

Section 157.11(c)(7)(D) prevents entities from adopting a deceptively similar name to a city, county, or Regional Advisory Council.

Section 157.11(c)(7)(F) added language required by SB 1899 requirements for EMS Providers. This additional requirement mandates that an EMS provider declare the address of their main business location, normal business hours, and provide a map of their service area. It also stipulates that only one EMS Provider can occupy a location, and requires the provider to retain that location until the next licensing period, unless otherwise approved by the department.

Section 157.11(c)(7)(G) outlines the educational requirements for the AOR, to include continuing education, as required by SB 8, 83rd Legislature, Regular Session, 2013.

Section 157.11(c)(7)(J) requires that the department is provided a staffing plan that addresses coverage of a service area, to include a process of managing communication after normal business hours have concluded.

Section 157.11(c)(7)(O) states that an EMS provider must provide the department with a list of equipment with identifiable or legible serial numbers at the initial or renewal application for an EMS Provider license.

Section 157.11(c)(7)(Q) states that an EMS provider must attest that each authorized vehicle has its own set of required equipment.

Section 157.11(c)(7)(S) states that an EMS provider will attest or provide documentation that the applicant and/or its management staff participates in the local regional advisory council.

Section 157.11(e)(3) states that ambulance vehicles must meet minimum national ambulance vehicle body type, dimension and safety criteria standards.

Section 157.11(g)(3), states that the staffing plan requires proof that the personnel has completed a jurisprudence examination.

Section 157.11(j)(2) requires all patient equipment to be clean, fully operational, and have a backup power source, if applicable.

Section 157.11(k)(1) - (3) explains the type of patients and level of care that is expected for each type of ambulance.

Section 157.11(k)(2)(F) requires waveform capnography be used when preforming or monitoring endotracheal intubation patients as of January 1, 2018, which is the standard throughout the nation.

Section 157.11(k)(3)(C) requires transmission of 12-lead capability cardiac monitor/defibrillator by January 1, 2020, which is the standard throughout the nation.

Section 157.11(m)(1)(C) requires an EMS provider, who is not the primary provider in an area where it plans to sell subscriptions, to provide to subscription plan participants, a written notice indicating the provider is not the primary provider in that area and requires the provider to give a copy of this notice to the primary provider in the area and to the department within 30 days before it begins the subscription enrollment period.

Section 157.11(n) requires an EMS provider to have a plan established for the ongoing monitoring of the quality of patient care that is given by the EMS provider's personnel and to collect patient care data as required by 25 Texas Administrative Code, Chapter 103, concerning the reporting requirements for EMS providers.

Section 157.11(n)(15) sets standards for the maintenance and location of medical records.

Section 157.11(n)(27)(F) as required by U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, requires each EMS Provider to have an educated designated infection control officer to enhance communication between hospitals, the EMS Provider, and personnel related to an exposure event.

Section 157.11(n)(27)(J) requires a policy explaining the process to secure medications, fluids and controlled substances on ambulances which are in compliance with local, state, and federal laws and rules.

Section 157.11(p) states that a provisional license shall be effective for no more than "30 days" instead of "45 days" from the date of issuance.

Section 157.11(r) outlines the process that the department will use to conduct surveys, inspections and investigations.

Section 157.11(u) outlines the process that the department will use when conducting a complaint investigation.

Section 157.12, Rotor-wing Air Ambulance Operations and 157.13, Fixed-wing Air Ambulance Operations, incorporates modifications to existing rules in order for language and terms to reflect current standards to include ensuring the air unit meets air worthiness statistics per federal regulations. Changes include documentation of the knowledge and experience of the medical director when treating and transporting patients by air. Also, language was removed that required bodily injury and property damage insurance coverage amounts for an aircraft provider because these amounts are established by federal regulations. In addition, rule language was included to require permanently installed climate control equipment to provide an environment appropriate for the medical needs of patients.

Section 157.14, adds requirements for a First Responder Organization License (FRO) to include incorporation of U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136 and SB 1574 requirements for the designation of an infection control officer. Additionally, language was amended to require a FRO License application to include response, dispatch and treatment protocols including an equipment and supply list to treat adult, pediatric and neonatal patients.

Section 157.16, Emergency Suspension, Suspension, Probation, Revocation, Denial of a Provider License or Administrative Penalties, incorporates modifications to existing rule language and adds language and terms to allow the department to take disciplinary action based on an action taken by another state or federal agency. In addition, the rule language was modified to include a notification requirement for the AOR and an EMS Provider license holder of pending disciplinary action by the department.

Section 157.32, Emergency Medical Services Education Program and Course Approval, incorporates modifications into existing rules to meet current national education standards by increasing the minimum required hours needed to complete an Emergency Care Attendant (ECA) course, an EMT-Basic course, an Advanced EMT course and an EMT-Paramedic course. An additional amendment was included to change the name of the "Intermediate EMT-I" to "Advanced EMT" which was required by SB 219 and reflects a national name change.

Language as added in 157.32(d)(2)(C) to ensure that the sponsor of an education program has the required equipment and resources to conduct the program.

New rule language was added as required by U.S. Code, Title 42, Chapter 6A, subchapter XXIV, Part G, to stipulate that EMS Education Program providers must have an educated and designated infection control officer to enhance communication between the program, hospitals and students participating in the program.

Section 157.32(i)(2)(A) provides detailed information regarding the department's expectations regarding a self-study program submitted by an applicant. Throughout this section, new rule language was added to ensure medical oversight is provided during all aspects of the education program.

Section 157.32(p)(25) was added to ensure on-line or distance learning classes meet the same standards as outlined in this rule.

Section 157.33, Certification, incorporates modifications to existing rule language and terms to reflect current standards and includes provisions requiring fingerprinting of EMS personnel as mandated in the Government Code, §411.087 and §411.110 and as required in §157.37 relating to Certification or Licensure of Persons with Criminal Backgrounds. The following responsibilities were added for EMS personnel to:

-complete an accurate patient care record;

-report abuse or injury to a patient;

-follow the medical director's protocols and policies;

-take precautions to prevent misappropriation of medication;

-maintain skills and knowledge of level of certification; and

-notify the department within 30 days of a change of address.

Section 157.34, Recertification, incorporates modifications to existing rule language and terms to reflect current standards and includes the EMS jurisprudence exam as required by SB 1899. The Advanced EMT replaced the EMT-I in this rule.

Section 157.36, Criteria for Denial and Disciplinary Actions for EMS Personnel and Applicants and Voluntary Surrender of a Certificate or License, incorporates modifications into existing rules by clarifying current language and adding additional actions the department may take, including disciplinary actions against EMS personnel certification. Disciplinary action may be taken by the department against a person's certification or license for the following additional reasons:

-failing to report abuse or injury to a patient to employer or legal authority within 24 hours;

-turning over or delegating care to person whom has the lacks of education or skills to treat the patient at the appropriate level required;

-failing to take precautions to prevent misappropriation of medication;

-cheating on a test to gain or renew certification/license by department;

-using drugs or alcohol that could possibly endanger patient health and safety;

-failing to transport the patient to an appropriate medical facility;

-failing to contact medical control when required;

-falsifying an employment application that would affect the hiring process;

-falsifying clinical documentation as a student;

-falsifying required daily check sheets;

-engaging in act(s) of dishonesty which relates to the EMS profession,

-behavior exploiting the EMS personnel- patient relationship in a sexual way;

-falsifying information provided to the department;

-engaging in a pattern of behavior that demonstrates routine response to medical emergencies without being under the medical oversight or with an EMS Provider or FRO; and

-disciplinary action taken by another state, U.S. territory, National Registry of EMT or any other national recognized organization that provides or renews certification/license.

Section 157.38, Continuing Education, incorporates modifications to existing rule language and terms to reflect current standards, by requiring a continuing education program to designate an infection control officer and to verify that physician medical oversight is provided when students are involved in patient care.

Section 157.43, Course Coordinator Certification, incorporates modifications to existing rule language by increasing the teaching experience requirement for a course coordinator to four years of experience in EMS. Additionally, physician medical oversight is required when education is conducted, especially during clinic time or when advance level skills are being provided on an ambulance. Rule language was added to require more detail to be provided to students regarding what to expect from an EMS education program and the requirements necessary to become certified/licensed in Texas. Per SB 1899, rule language was added to require the education of students regarding current Texas EMS laws, rules and policies.

Section 157.43(h)(20) adds language to require a course coordinator to notify the department when leaving employment as the course coordinator for an on-going EMS education program.

Section 157.43(m)(3)(AA) adds language to explain what the department considers unprofessional conduct by the department such as retaliation; discrimination; and verbal or physical abuse; or inappropriate physical or sexual conduct.

Section 157.44(f), Emergency Medical Service Instructor Certification, incorporates modifications to existing rules by requiring an EMS Instructor to observe or provide patient care in an ambulance, hospital or clinic for at least 8 hours every two years, in order to enhance and reinforce the instructors' knowledge of the Texas EMS system.

Section 157.44(i)(2)(W) and (X) allows the department to take disciplinary action against an instructor for failure to notify the department if the instructor learns that a student applicant was arrested, convicted, had deferred adjudication or deferred prosecution.

Section 157.44(i)(2)(Y), provides what is considered unprofessional conduct by the department such as retaliation; discrimination; verbal or physical abuse; or inappropriate physical or sexual conduct.

COMMENTS

The department, on behalf of the commission, held a public hearing on September 9, 2016. It was attended by 23 individuals representing the following agencies and organizations: Association of Texas EMS Professionals (ATEMSP), Allegiance Mobile Health, American Medical Response (AMR), Arlington Fire Department, Association of Texas EMS Professionals (ATEMSP), College of the Mainland, CyFair Volunteer Fire Department, HCA Healthcare, Jeff Davis County Ambulance, One Response EMS, San Angelo Fire Department, Southeast Texas Regional Advisory Council (SETRAC), Texas Department of Public Safety, Texas EMS Alliance (TEMSA), Texas EMS Trauma and Acute Care Foundation (TETAF), and Williamson County EMS. The department, on behalf of the commission, has reviewed and prepared responses to the comments received regarding the proposed rules during the public hearing, which the commission has reviewed and accepts. The department received comments from Arlington Fire Department, College of the Mainland, Jeff Davis County Ambulance, Association of Texas EMS Professionals (ATEMSP), Southeast Texas Regional Advisory Council (SETRAC), and Texas EMS Alliance (TEMSA). The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of comments.

COMMENT: Concerning §157.11(c)(7)(S), Southeast Texas Regional Advisory Council (SETRAC) is concerned that allowing an EMS provider to either attest or provide documentation that the EMS provider met the RAC's participation requirements has the potential to cause an EMS provider to turn in an attestation that is in conflict to what the regional advisory committee shows on record for that provider's participation. SETRAC recommends that the rule require EMS providers to produce documentation from the respected regional advisory committee, stating that the provider has meet the regional advisory committee participation requirements.

RESPONSE: The commission acknowledges the comments; however, the rule allows for newly involved or initial EMS providers to meet the requirement, as written. No change was made to the rule as a result of these comments.

COMMENT: Concerning §157.32(c)(2)(B), Jeff Davis County Ambulance is concerned that the requirement to have a licensed EMS provider in attendance during their emergency department rotation will negatively impact their ability to complete education programs in rural and frontier areas. This statement is also true for §157.32(c)(3)(B) and §157.32(c)(4)(B).

RESPONSE: The commission agrees with the comments and has changed §157.32(c)(2)(B), §157.32(c)(3)(B), and §157.32(c)(4)(B) to state "…shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed…"

COMMENT: Concerning §157.32(c)(4)(B), College of the Mainland is concerned about the amount of hours required to complete a paramedic program.

RESPONSE: The commission acknowledges the comment; however, the rule is sufficient as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning the Jurisprudence Exam in §157.33(a)(4), §157.33(i)(1)(E), §157.33(i)(2)(D), §157.33(j)(2)(D), §157.34(b)(1)(G), §157.34(b)(2)(B), §157.34(b)(3)(B), §157.34(b)(4)(C), and §157.34(b)(5)(D), Arlington Fire Department submits to SB 1899 in the requirement of the exam, however is strongly opposed to any fees associated with the administration of the exam. The City of Arlington recommends and encourages the department to seek alternatives to initiating the jurisprudence exam requirement that result in no costs to the local governments.

Texas EMS Alliance (TEMSA) supports the jurisprudence exam because it provides the certificate holder with an overview of the rules, however is concerned about the impact on EMS agencies regarding the cost of the jurisprudence exam. TEMSA recommends that the department seek other entities that may be able to offer the exam at little to no cost for EMS agencies and EMS professionals or to find other allocated funds to offset the overall cost of the exam, thereby minimizing costs to the certified individuals.

RESPONSE: The commission acknowledges the comments; however, the rule language is sufficient as written and consistent with Health and Safety Code, §773.050(i). The department is finalizing the development of a process which will allow for over 300 continuing education providers to offer this education, as the department does with all continuing education requirements currently. The expected cost for personnel to complete this requirement would range from $0 to as high as $40.00. It is expected that most EMS personnel will have no additional cost to complete the intent of SB 1899. No change was made to the rule as a result of these comments.

COMMENT: Concerning §157.43(e), Jeff Davis County Ambulance stated that the requirement of an Advanced Coordinator to possess, at a minimum, an associate's degree places an undue burden on rural/frontier services.

RESPONSE: The commission acknowledges the comment; the rule is substantial due to the complexity of the advanced education. This is current standard and there has been no proposed changes to this section in this rule packet. No change was made to the rule as a result of this comment.

COMMENT: Association of Texas EMS Professionals (ATEMSP) submitted a comment in support of the proposed rules. ATEMSP believes the new rules will help sustain Texas EMS as the premier leader in out-of-hospital and pre-hospital care in the United States and that the success of EMS is tied directly to the professional success of EMS policy and legislation that will facilitate us in providing the most comprehensive, evidence-based care to our patients in order to lower or prevent disease or morbidity and mortality.

RESPONSE: The commission acknowledges the comments of support.

In addition to the comments received at the public hearing, the department received additional comments during the comment period and are addressed as follows.

The department, on behalf of the commission, has reviewed and prepared responses to the comments received regarding the proposed rules during the comment period, which the commission has reviewed and accepts. The department received comments from ADAPT Pharma, Air Evac Lifeteam, Arlington Fire Department, Brookhaven College, CareFlite, College of the Mainland, Cook Children's Medical Center, Coryell Memorial Healthcare System, Cypress Creek EMS, El Paso Fire Department, Garland Fire Department, Industrial EMS, Jeff Davis County Ambulance, Lake Jackson EMS, Lamar Institute of Technology, Las Colinas Medical Center, Lifeguard Aeromed Inc., PERCOM Online, PHI Air Medical, Terlingua Fire and EMS, Travis County STAR Flight, Williamson County EMS, Association of Texas EMS Professionals (ATEMSP), City of Arlington, Southeast Texas Regional Advisory Council (SETRAC), State Firefighters' and Fire Marshals' Association of Texas (SFFMA), Texas EMS Alliance (TEMSA), and three individuals. The commenters were not against the rules in their entirety; however, the commenters suggested recommendations for change as discussed in the summary of comments.

COMMENT: Concerning §157.2, one individual stated that EMT is defined at §157.2(37) and EMT-P is defined at §157.2(38); however, there is not a definition for ECA or AEMT.

RESPONSE: The commission disagrees with the comment, ECA is defined at §157.2(29) and AEMT is defined at §157.2(5). No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.2(33), department staff recommended adding "emergency medical technician intermediate (EMT-I)" to be consistent throughout the rule.

RESPONSE: The commission agrees with the comment and added "emergency medical technician intermediate (EMT-I)" in §157.2(33)(D).

COMMENT: Concerning §157.2, the City of Arlington recommended adding a definition for "protocols" since it is referenced in several places throughout the rule.

RESPONSE: The commission agrees with the comment and added a definition for "Protocols" in §157.2(68).

COMMENT: Concerning §157.2(52), Licensee, one individual stated that there seems to be a repeat or redundant statement "…to provide EMS and holds a paramedic license from the department" that seems to be covered in the beginning of the definition.

RESPONSE: The commission agrees with the comment and revised §157.2(52).

COMMENT: Concerning §157.2(62), one individual recommended using the State Comptroller's Office (Comptroller) to check names or require that a business be registered with the Comptroller since the Comptroller does not allow repeats or similar names to be registered that are within a certain area.

RESPONSE: The commission acknowledges the comment; for the purpose of these rules, the definition is clear as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(c)(7)(G), the Garland Fire Department recommended leaving the AOR exempt for governmental agencies.

RESPONSE: The commission acknowledges the comment. The rule as written does not change the impact on governmental agencies. No change to the rule was made as a result of this comment.

COMMENT: Concerning §157.11(c)(7)(O), ADAPT Pharma questioned if "naloxone" is addressed in the rules.

RESPONSE: The commission acknowledges the comment. The authority to list supplies, medications, and equipment is the responsibility of the medical director and is not addressed in the rules. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(c)(7)(S), one individual is concerned about what would be required for the attestation and documentation that it and/or its management staff participate in the local regional advisory council.

State Firefighters' and Fire Marshals' Association of Texas (SFFMA) stated that requiring participation is dangerous and could have cost impacts for smaller agencies that must pay varied membership rates across the state. The commenters understand that the desire of this rule change was to insure proper facilities receive proper patients.

Southeast Texas Regional Advisory Council (SETRAC) is concerned that allowing an EMS provider to either attest or provide documentation that the EMS provider met the regional advisory committee's participation requirements has the potential to cause an EMS provider to turn in an attestation that is in conflict to what the regional advisory committee shows on record for that provider's participation. SETRAC recommends that the rule require EMS providers to produce documentation from the respected regional advisory committee, stating that the provider has meet the regional advisory committee participation requirements.

RESPONSE: The commission acknowledges the comments; however, the rule allows for newly involved or initial EMS providers to meet the requirement, as written. No change was made to the rule as a result of these comments.

COMMENT: Concerning §157.11(c)(7)(W)(ii), Cook Children's Medical Center suggested adding language to include captive policies since they are not licensed or deemed eligible by the Texas Department of Insurance.

RESPONSE: The commission agrees with the comment and has added language to include captive policies in §157.11(c)(7)(W)(ii).

COMMENT: Concerning §157.11(e)(1), SFFMA expressed concern for the change requiring neonatal equipment and suggested replacing neonatal equipment with child birth equipment.

RESPONSE: The commission disagrees with the comment; the language is inclusive of child birth equipment as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(e)(3), Coryell Memorial Healthcare System and Garland Fire Department are concerned with ambulances meeting minimum national ambulance safety criteria standards. The most current safety recommendations would eliminate a tremendous number of vehicles from fleets in the state.

Garland Fire Department stated they are against §157.11(e)(3) if the national standard means the adoption of the National Fire Protection Association standard. This minimum standard would make a new ambulance very expensive.

RESPONSE: The commission acknowledges the comments; the rule allows for the recognition of multiple national vehicle construction standards as written. No change was made to the rule as a result of these comments.

COMMENT: Concerning §157.11(e)(5), SFFMA is concerned how field inspectors will address in service and out of service units and the issues that will arise with serial number tracking assigned to units when those units are taken out of service during emergency events or with large agencies rotating units in and out of service status.

RESPONSE: The commission acknowledges the comment; however, this language as written, continues to support the prevention of fraud and abuse in the EMS industry. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(g)(3), El Paso Fire Department stated there is no reason other than the entity administering the jurisprudence exam to gain profit from it. The cost of personnel taking the exam may have a significant fiscal impact on a service and/or department.

Garland Fire Department recommended replacing the jurisprudence examination with required continuing education.

RESPONSE: The department is finalizing the development of a process which will allow over 300 continuing education providers to offer this education, as the department does with all continuing education requirements currently. This will allow for multiple options for the jurisprudence exam in order to comply with the intent of SB 1899. The expected cost for personnel to complete this requirement would range from $0 to as high as $40.00. It is expected that most EMS personnel will have no additional cost to complete the intent of SB 1899. The rule language is sufficient as written and consistent with Health and Safety Code, §773.050(i). No change was made to the rule as a result of these comments.

COMMENT: Concerning §157.11(h)(2), one individual suggested using "AEMT" instead of "EMT-I" to be consistent with the language of the rule.

RESPONSE: The commission agrees with the comment and has added "AEMT" to §157.11(h)(2).

COMMENT: Concerning §157.11(h)(4), department staff recommended adding "or EMT-Intermediate" to be consistent throughout the rule.

RESPONSE: The commission agrees with the comment and added "or EMT Intermediate".

COMMENT: Concerning §157.11(h)(5), one individual and El Paso Fire Department suggested using "AEMT" instead of "EMT-I" to be consistent with the language of the rule.

RESPONSE: The commission agrees with the comments and has added "AEMT" to §157.11(h)(5).

COMMENT: Concerning §157.11(j)(3), one individual suggested that manufacturers should be possessive as well as plural.

RESPONSE: The commission agrees with the comment and has revised §157.11(j)(3).

COMMENT: Concerning §157.11(k)(2)(F), Williamson County EMS expressed strong support for the requirement for waveform capnography during intubation. The commenter understands the fiscal impact that this requirement can have on small departments; it is clearly standard of care for prehospital medicine. It is necessary for safe practice.

RESPONSE: The commission acknowledges the comment of support.

COMMENT: Concerning §157.11(k)(3)(C) and information in the Small and Micro Business Impact Analysis that the cost range of an active 12-lead capability cardiac monitor/defibrillator for each advance life support ambulance by January 1, 2020, will have a cost range between $4000 to $10,000 per device, Lake Jackson EMS stated that most modern such equipment starts at $30,000 per unit, the cost estimate should be reevaluated. These are a must for Mobile Intensive Care Unit ambulances, but cost prohibitive for a Basic Life Support or Advanced Life Support ambulance.

RESPONSE: The commission acknowledges the comment; however the cost in the Small and Micro Business Impact Analysis reflects the additional costs of enhancing existing cardiac monitors and not an entirely new monitor. The Health and Safety Code, §773.052 provides authority to the department to grant variances with a specific hardship in meeting the minimum staffing and equipment standards. A process is already in place to request and grant these variances. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(k)(3)(C), Williamson County EMS expressed strong support for the requirement of 12-lead capability. The commenter understands the fiscal impact that this requirement can have on small departments; it is clearly standard of care for prehospital medicine. It is necessary for safe practice.

RESPONSE: The commission acknowledges the comment of support; the Health and Safety Code, §773.052 provides authority to the department to grant variances with a specific hardship in meeting the minimum staffing and equipment standards. A process is already in place to request and grant these variances. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(k)(7), the City of Arlington, suggested adding ". . . listed above, EMS vehicles must also have:"

RESPONSE: The commission agrees with the comment and has changed §157.11(k)(7) to state "In addition to medical supplies and equipment as defined in subsection (k) of this section, EMS vehicles must also have."

COMMENT: Concerning §157.11(m)(1)(A), one individual suggested using "provide" instead of "provider."

RESPONSE: The commission agrees with the comment and has changed §157.11(m)(1)(A).

COMMENT: Concerning §157.11(n)(10)(A), Las Colinas Medical Center seeks to understand if this means delivered or does this mean provide access to the completed patient care report.

RESPONSE: The commission acknowledges the comment; as written, it is the responsibility of the EMS provider to provide the patient care report. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(n)(10)(B), Las Colinas Medical Center is concerned that the verbal patient care report given by an EMS provider will not meet the intent and if not, an abbreviated report has to be given in writing.

RESPONSE: The commission acknowledges the comment; as written it would allow for a verbal report, but it is the responsibility of the EMS provider to ensure the information is documented. No change to the rule was made as a result of this comment.

COMMENT: Concerning §157.11(n)(10)(C), Garland Fire Department would like to see an allowance for the ability to do an oral hand off report in the event of a taxed system, with the understanding that the actual report will be delivered to the hospital within 24 hours.

Las Colinas Medical Center questioned if the report is in verbal format only, is the department going to ensure that all this information is being given to the emergency department of a health care facility at the time of the patient hand off.

RESPONSE: The commission acknowledges the comments; as written it would allow for a verbal report, this is a patient safety issue and it is the responsibility of the EMS provider to ensure the information is documented. No change was made to the rule as a result of these comments.

COMMENT: Concerning §157.11(n)(15)(E), one individual suggested adding the word "and" between "records maintains."

RESPONSE: The commission agrees with the comment and has revised §157.11(n)(15)(E).

COMMENT: Concerning §157.11(n)(15)(G), one individual suggested revising "medical director must attestation" to "medical director must attest."

RESPONSE: The commission agrees with the comment and has revised §157.11(n)(15)(G).

COMMENT: Concerning §157.11(n)(27)(F), Garland Fire Department seeks to understand if more than one person can be designated as an infection control officer for entities.

RESPONSE: The commission acknowledges the comment; however, SB 1574 only required the naming of a person as the infection control officer, the rule language is sufficient. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.11(n)(27)(J), Garland Fire Department questioned if the security of medication applies to "normal saline?"

RESPONSE: The commission acknowledges the comment; as written, each EMS provider is responsible for developing, implementing, and enforcing their medication security policies. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.12(b)(6)(F), Air EVAC Lifeteam and PHI Air Medical are concerned that the creation of an EMS rule when Federal Aviation Association (FAA) regulations are already in place to address this topic will create unnecessary confusion and conflict between the department staff, the FAA, and Air Medical providers. They recommend revising the rule to state that all equipment and carry-on items shall be secured in the aircraft as required by FAA regulations.

Travis County STAR Flight is concerned that the State would propose specialized rules regarding aircraft configuration and equipment mounts for less than 1% of the patient mix and recommends that the FAA retains oversight for all mounting of equipment in the aircraft.

In addition to the previous comments, four separate letters of support for §157.12(b)(6)(F) were received from a Flight Nurse, Flight Paramedic, Director of Maintenance and Air Clinical Operations with CareFlite.

RESPONSE: The commission acknowledges the comments and has agreed to change §157.12(b)(6)(F) to state "shall assure that all specialized medical equipment is secured throughout transport with adequately engineered designated mounts as approved by FAA."

COMMENT: Concerning §157.13(b)(7), Lifeguard Aeromed Inc. stated that the additional cost to modify aircraft with permanently installed air conditioners, depending on the aircraft, can be extremely expensive modification, exceeding the cost of the aircraft.

RESPONSE: The commission acknowledges the comment; the rule as written specifically addresses the environmental needs of patient medical care. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.13(b)(11), Air EVAC Lifeteam and PHI Air Medical are concerned that the creation of an EMS rule when FAA regulations are already in place to address this topic will create unnecessary confusion and conflict between the DSHS staff, the FAA, and Air Medical providers. They recommend revising the rule to state that all equipment and carry-on items shall be secured in the aircraft as required by FAA regulations.

RESPONSE: The commission acknowledges the comments and has agreed to change §157.13(b)(11) to state "shall assure that all specialized medical equipment is secured throughout transport with an adequately engineered designated mount, as approved by FAA."

COMMENT: Concerning §157.14(e)(20)(C) and (D), the City of Arlington suggested changing the language to be consistent with §157.11(n)(27)(F).

RESPONSE: The commission agrees with the comment and has changed §157.14(e)(20)(C) to state "infection control procedures" and §157.14(e)(20)(D) to state "contact information for the designated infection control officer for whom education based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136 has been documented."

COMMENT: Concerning §157.16(d)(12), SFFMA suggested the removal of any language that has to do with required communication and reporting for individually certified or licensed providers and agencies to the department for an employee that has self-reported or requested assistance for an addictive disease or behaviors related to drugs alcohol, or related substance abuse.

RESPONSE: The commission acknowledges the comment; however, the proposed language was recommended by Texas EMS stakeholders through an extensive vetting process. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.32(c)(2)(B), Jeff Davis County Ambulance is concerned that the requirement to have a licensed EMS provider in attendance during their emergency department rotation will negatively impact their ability to complete education programs in rural and frontier areas. This statement is also true for §157.32(c)(3)(B) and §157.32(c)(4)(B).

Terlingua Fire and EMS stated that §157.32(c)(2)(B) is not clear and recommended "…shall include supervised experiences in the emergency department and supervised experiences with a licensed EMS provider or other settings…"

RESPONSE: The commission agrees with the comments and has changed §157.32(c)(2)(B), §157.32(c)(3)(B), and §157.32(c)(4)(B) to state "…shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed…"

COMMENT: Concerning §157.32(c)(3)(A), Industrial EMS is concerned that there will be confusion regarding the levels name change of "EMT-I" to "AEMT" related to the National Registry.

RESPONSE: The commission acknowledges the comment; however, as written, the rule language is sufficient and consistent with Health and Safety Code, §773.048, as it only recognizes "AEMT." No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.32(c)(4)(B), College of the Mainland is concerned about the amount of hours required to complete a paramedic program.

RESPONSE: The commission acknowledges the comment; all currently approved education programs in Texas already meet the required hours, the rule is sufficient as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.32, Williamson County EMS supports the clarification that medical direction is required throughout an education program.

RESPONSE: The commission acknowledges the comment of support; no change was made to the rule as a result of this comment.

COMMENT: Concerning §157.32(g)(9) and §157.32(h)(10), department staff recommended changing the language by removing "Subpart B of the 1990 Ryan White Comprehensive AIDS Resources Emergency ACT, Public Law 101-381," and replace with "U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136" to be consistent with language in §157.11(n)(27)(F) and throughout the rule.

RESPONSE: The commission agrees with the comment and as a result has revised the rule text in §157.32(g)(9) and §157.32(h)(10) to include "based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136."

COMMENT: Concerning §157.32(p)(22), Brookhaven College is concerned that only CAAHEP/CoAEMSP are named specifically and may not allow for accreditation from some other agency.

RESPONSE: The commission acknowledges the comment; however, the rule as written, allows for other national accrediting organizations to be recognized by the department. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.32(p)(23) - (25), PERCOM Online stated providing a roster of all initial enrollees is misleading as reflective of "student population" for online programs because many "enrollees" get course access and then disappear; but that may not be known in 14 days or even 30 days or so in some cases. In an online program where students don't show up in a classroom, it is much more difficult to gauge until the enrollee actually does coursework.

RESPONSE: The commission agrees with the comment and as a result has revised the rule text in §157.32(p)(23) and §157.32(p)(24) to submit a roster of students when requested by the department.

COMMENT: Concerning the Jurisprudence Exam in §157.33(a)(4), §157.33(i)(1)(E), §157.33(i)(2)(D), §157.33(j)(2)(D), §157.34(b)(1)(G), §157.34(b)(2)(B), §157.34(b)(3)(B), §157.34(b)(4)(C), and §157.34(b)(5)(D), one individual is concerned about who gives the state approved jurisprudence examination and if it has to be done at each renewal.

One individual is concerned about the cost to personnel taking the jurisprudence examination and is opposed to this proposed change.

Arlington Fire Department submits to SB 1899 in the requirement of the exam, however is strongly opposed to any fees associated with the administration of the exam. The City of Arlington recommends and encourages the department to seek alternatives to initiating the jurisprudence exam requirement that result in no costs to the local governments.

Lamar Institute of Technology seeks clarification as to what is the state approved jurisprudence examination.

Texas EMS Alliance (TEMSA) supports the jurisprudence exam because it provides the certificate holder with an overview of the rules, however is concerned about the impact on EMS agencies regarding the cost of the jurisprudence exam. TEMSA recommends that the department seek other entities that may be able to offer the exam at little to no cost for EMS agencies and EMS professionals or to find other allocated funds to offset the overall cost of the exam, thereby minimizing costs to the certified individuals.

SFFMA is concerned that the current proposal for a provider to complete additional continuing education training, and have to pay a separate renewal fee, a 63% increase, is cost-prohibitive to volunteers.

RESPONSE: The commission acknowledges the comments; however, the rule language is sufficient as written and consistent with Health and Safety Code §773.050(i). The department is finalizing the development of a process which will allow for over 300 continuing education providers to offer this education, as the department does with all continuing education requirements currently. This will allow for multiple options for the jurisprudence exam in order to comply with the intent of SB 1899. The expected cost for personnel to complete this requirement would range from $0 to as high as $40.00. It is expected that most EMS personnel will have no additional cost to complete the intent of SB 1899. No change was made to the rule as a result of these comments.

COMMENT: Concerning §157.33(j)(2), one individual is concerned about "equivalency shall."

RESPONSE: The commission acknowledges the comment; however, the rule is sufficient as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.34(a)(4)(B), department staff recommended adding "EMT-Intermediate (EMT-I)" to be consistent throughout the rule.

RESPONSE: The commission agrees with the comment and added "EMT Intermediate (EMT-I)."

COMMENT: Concerning §157.34(b)(4)(C), department staff recommended removing "that the applicant has" as it seems to be repetitious and does not add value.

RESPONSE: The commission agrees with the comment and removed "that the applicant has" from §157.34(b)(4)(C).

COMMENT: Concerning §157.36(b)(11), Lake Jackson EMS stated that this describes some EMS students that show up to ride on their ambulance; and is concerned if they are responsible for the students level of education and skill before they are delegated to.

RESPONSE: The commission acknowledges the comment; however, the authority of delegation of medical practices of the EMS provider personnel is the responsibility of the EMS medical director. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.36(b)(38), Lake Jackson EMS is concerned that the rule's wording mandates transport and there are many reasons why a patient would not be transported; also, seeks the definition of an appropriate medical facility.

RESPONSE: The commission acknowledges the comment; these reasons are addressed in the medical director's criteria for each licensed EMS provider. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.43(e), Jeff Davis County Ambulance stated that the requirement of an Advanced Coordinator to possess, at a minimum, an associate's degree places an undue burden on rural/frontier services.

RESPONSE: The commission acknowledges the comment; the rule is substantial due to the complexity of the advanced education and is not a change from current requirements. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.43(h)(11), PERCOM Online feels that this issue is between the ambulance service and its medical director to agree to as part of their contracted relationship and propose that the rule revision places the burden of responsibility with the service.

RESPONSE: The commission acknowledges the comment; however, the rule supports and meets the intent of the stakeholders and the Governor's EMS and Trauma Advisory Council, as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.43(j)(3)(B), El Paso Fire Department stated it is an unfair burden on a coordinator and/or the service/program/department to mandate recertification. This should be deleted from the rule.

RESPONSE: The commission disagrees with the comment; the rule clarifies and reflects current practices as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.43(m)(3)(Y), El Paso Fire Department stated that this affects instructors as well as coordinators and is concerned that every instructor in a program will need to report this in order to meet the letter and intent of the rule. El Paso Fire Department recommended stating "the program will notify the department…"

RESPONSE: The commission acknowledges the comment; the rule allows for multiple avenues of reporting, as written. No change was made to the rule as a result of this comment.

COMMENT: Concerning §157.44(f)(3)(B), El Paso Fire Department is concerned if this activity cannot be done while on duty, it may have a fiscal impact in that services/programs/departments have to pay overtime in order for the instructors to meet this requirement.

RESPONSE: The commission acknowledges the comment; the rule is not limiting in this capacity, as written. No change was made to the rule as a result of this comment.

COMMENT: The City of Arlington submitted the rules with many editorial comments including grammar, punctuation, word selection, and paraphrasing.

RESPONSE: The commission acknowledges the comments; as a result, the department has accepted several edits to the text based on these editorial comments in the following sections:

§§157.3, 157.11 - 157.13, 157.16, 157.32 and 157.33.

COMMENT: Association of Texas EMS Professionals (ATEMSP) submitted a comment in support of the proposed rules. ATEMSP believes the new rules will help sustain Texas EMS as the premier leader in out-of-hospital and pre-hospital care in the United States and that the success of EMS is tied directly to the professional success of EMS policy and legislation that will facilitate us in providing the most comprehensive, evidence-based care to our patients in order to lower or prevent disease or morbidity and mortality.

Cypress Creek EMS submitted a comment in support of the proposed rules. Cypress Creek EMS stated that the rules seem to be appropriate, thorough, beneficial and an improvement on the currently active rules.

RESPONSE: The commission acknowledges the comments of support.

LEGAL CERTIFICATION

The Department of State Health Services General Counsel, Lisa Hernandez, certifies that the adopted rules have been reviewed by legal counsel and found to be a valid exercise of the agencies' legal authority.

SUBCHAPTER A. EMERGENCY MEDICAL SERVICES - PART A

25 TAC §§157.2, 157.3, 157.5

STATUTORY AUTHORITY

The amendments and new section are authorized by the Health and Safety Code, Chapter 773; and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Health and Safety Code, Chapter 1001. Review of the rules implements Government Code, §2001.039.

§157.2.Definitions.

The following words and terms, when used in these sections, shall have the following meanings, unless the context clearly indicates otherwise:

(1) Abandonment - Leaving a patient without appropriate medical care once patient contact has been established, unless emergency medical services personnel are following medical director's protocols, a physician directive or the patient signs a release; turning the care of a patient over to an individual of lesser education when advanced treatment modalities have been initiated.

(2) Accreditation - Formal recognition by a national association of a provider's service or an education program based on standards established by that association.

(3) Act - Emergency Medical Services Act, Health and Safety Code, Chapter 773.

(4) Administrator of Record (AOR) - The administrator for an EMS provider who meets the requirements of Health and Safety Code, §773.05712 and §773.0415.

(5) Advanced Emergency Medical Technician (AEMT) - An individual who is certified by the department and is minimally proficient in performing the basic life support skills required to provide emergency prehospital or interfacility care and initiating and maintaining under medical supervision certain advanced life support procedures, including intravenous therapy and endotracheal or esophageal intubation.

(6) Advanced life support (ALS) - Emergency prehospital or interfacility care that uses invasive medical acts and which would include ALS assessment. The provision of advanced life support shall be under the medical supervision and control of a licensed physician.

(7) Advanced life support (ALS) vehicle - A vehicle that is designed for transporting the sick and injured and that meets the requirements of §157.11(j)(2) of this title (relating to Requirements for an EMS Provider License) as an advanced life support vehicle and has sufficient equipment and supplies for providing advanced level of care based on national standards and the EMS provider's medical director approved treatment protocols.

(8) Advanced Life Support assessment - Assessment performed by an AEMT or paramedic that qualify as advanced life support based upon initial dispatch information, when it could reasonably be believed that the patient was suffering from an acute condition that may require advanced skills.

(9) Air ambulance provider - A person who operates/leases a fixed-wing or rotor-wing air ambulance aircraft, equipped and staffed to provide a medical care environment on-board appropriate to the patient's needs. The term air ambulance provider is not synonymous with and does not refer to the Federal Aviation Administration (FAA) air carrier certificate holder unless they also maintain and control the medical aspects that are consistent with EMS provider licensure.

(10) Ambulance - A vehicle for transportation of sick or injured person to, from or between places of treatment for an illness or injury, and provide out of hospital medical care to the patient.

(11) Authorized ambulance vehicle - A vehicle authorized to be operated by the licensed provider and that meets all criteria for approval as listed in §157.11(e) of this title.

(12) Basic life support (BLS) - Emergency prehospital or interfacility care that uses noninvasive medical acts. The provision of basic life support will have sufficient equipment and supplies for providing basic level care based on national standards and the EMS provider's medical director approved treatment protocols.

(13) Basic life support (BLS) vehicle - A vehicle that is designed for transporting the sick or injured and that has sufficient equipment and supplies for providing basic life support based on national standards and the EMS provider's medical director approved treatment protocols.

(14) Basic trauma facility - A hospital designated by the department as having met the criteria for a Level IV trauma facility as described in §157.125 of this title (relating to Requirements for Trauma Facility Designation). Basic trauma facilities provide resuscitation, stabilization, and arrange for appropriate transfer of major and severe trauma patients to a higher level trauma facility, provide ongoing educational opportunities in trauma related topics for health care professionals and the public, and implement targeted injury prevention programs.

(15) Bypass - Direction given to a prehospital emergency medical services unit, by direct/on-line medical control or predetermined triage criteria, to pass the nearest hospital for the most appropriate hospital/trauma facility. Bypass protocols should have local physician input into their development and should be reviewed through the regional performance improvement process.

(16) Candidate - An individual who is requesting emergency medical services personnel certification or licensure, recertification or relicensure from the Texas Department of State Health Services.

(17) Certificant - Emergency medical services personnel with current certification from the Texas Department of State Health Services.

(18) Comprehensive trauma facility - A hospital designated by the department as having met the criteria for a Level I trauma facility as described in §157.125 of this title. Comprehensive trauma facilities manage major and severe trauma patients, provide ongoing educational opportunities in trauma related topics for health care professionals and the public, implement targeted injury prevention programs, and conduct trauma research.

(19) Course medical director - A Texas licensed physician approved by the department with experience in and current knowledge of emergency care who shall provide direction over all instruction and clinical practice required in EMS training courses.

(20) Credit hour - Continuing education credit unit awarded for successful completion of a unit of learning activity as defined in §157.32 of this title (relating to EMS Education Program and Course Approval).

(21) Critically injured person - A person suffering major or severe trauma, with severe multi system injuries or major unisystem injury; the extent of the injury may be difficult to ascertain, but which has the potential of producing mortality or major disability.

(22) Current - Within active certification or licensure period of time.

(23) Department - The Texas Department of State Health Services.

(24) Designated infection control officer - A designated officer who serves as a liaison between the employer's employees who have been or believe they have been exposed to a potentially life-threatening infectious disease, through a person who was treated and/or transported, by the EMS provider.

(25) Designation - A formal recognition by the department of a hospital's trauma care capabilities and commitment.

(26) Distance learning - A method of learning remotely without being in regular face-to-face contact with an instructor in the classroom.

(27) Diversion - A procedure put into effect by a trauma facility to ensure appropriate patient care when that facility is unable to provide the level of care demanded by a trauma patient's injuries or when the facility has temporarily exhausted its resources.

(28) Emergency call - A new call or other similar communication from a member of the public, as part of a 9-1-1 system or other emergency access communication system, made to obtain emergency medical services.

(29) Emergency care attendant (ECA) - An individual who is certified by the department as minimally proficient to provide emergency prehospital care by providing initial aid that promotes comfort and avoids aggravation of an injury or illness.

(30) Emergency medical services (EMS) - Services used to respond to an individual's perceived need for medical care and to prevent death or aggravation of physiological or psychological illness or injury.

(31) Emergency medical services (EMS) operator - A person who, as an employee of a public agency, as that term is defined by Health and Safety Code, §771.001, receives emergency calls.

(32) Emergency medical services and trauma care system - An arrangement of available resources that are coordinated for the effective delivery of emergency health care services in geographical regions consistent with planning and management standards.

(33) Emergency medical services (EMS) personnel -

(A) emergency care attendant (ECA);

(B) emergency medical technician (EMT);

(C) advanced emergency medical technician (AEMT);

(D) emergency medical technician intermediate (EMT-I); or

(E) emergency medical technician-paramedic (EMT-P); or

(F) licensed paramedic.

(34) Emergency medical services (EMS) provider - A person who uses, operates or maintains EMS vehicles and EMS personnel to provide EMS. See §157.11 of this title regarding fee exemption.

(35) Emergency medical services (EMS) volunteer provider - An EMS provider that has at least 75% of the total personnel as volunteers and is a nonprofit organization. See §157.11 of this title regarding fee exemption.

(36) Emergency medical services (EMS) volunteer - EMS personnel who provide emergency prehospital or interfacility care in affiliation with a licensed EMS provider or a registered First Responder organization without remuneration, except for reimbursement for expenses.

(37) Emergency medical technician (EMT) - An individual who is certified by the department as minimally proficient to perform emergency prehospital care that is necessary for basic life support and that includes the control of hemorrhaging and cardiopulmonary resuscitation.

(38) Emergency medical technician-paramedic (EMT-P) - An individual who is certified by the department as minimally proficient to provide emergency prehospital or interfacility care in health care facility's emergency or urgent care clinical setting, including a hospital emergency room and a freestanding emergency medical care facility by providing advanced life support that includes initiation and maintenance under medical supervision of certain procedures, including intravenous therapy, endotracheal or esophageal intubation or both, electrical cardiac defibrillation or cardioversion, and drug therapy.

(39) Emergency medical services vehicle -

(A) basic life support (BLS) vehicle;

(B) advanced life support (ALS) vehicle;

(C) mobile intensive care unit (MICU);

(D) MICU rotor wing and MICU fixed wing air medical vehicles; or

(E) specialized emergency medical service vehicle.

(40) Emergency Medical Task Force (EMTF) - A unit specially organized to provide coordinated emergency medical response operation systems during large scale EMS incidents.

(41) Emergency prehospital care - Care provided to the sick and injured within a health care facility's emergency or urgent care clinical setting, including a hospital emergency room and a freestanding emergency medical care facility, before or during transportation to a medical facility, including any necessary stabilization of the sick or injured in connection with that transportation.

(42) Facility triage - The process of assigning patients to an appropriate trauma facility based on injury severity and facility availability.

(43) Fixed location - The address as it appears on the initial and/or renewal EMS provider license application in which the patient care records and administrative offices will be located.

(44) General trauma facility - A hospital designated by the department as having met the criteria for a Level III and Level IV trauma facility as described in §157.125 of this title. General trauma facilities provide resuscitation, stabilization, and assessment of injury victims and either provide treatment or arrange for appropriate transfer to a higher level trauma facility, provide ongoing educational opportunities in trauma related topics for health care professionals and the public, and implement targeted injury prevention programs.

(45) Governmental entity - A county, a city or town, a school district, or a special district or authority created in accordance with the Texas Constitution, including a rural fire prevention district, an emergency services district, a water district, a municipal utility district, and a hospital district.

(46) Health care entity - A first responder, EMS provider, physician, nurse, hospital, designated trauma facility, or a rehabilitation program.

(47) Inactive EMS provider status - The period when a licensed EMS provider is not able to respond or response ready to an emergency or non-emergency medical dispatch.

(48) Industrial ambulance - Any vehicle owned and operated by an industrial facility as defined in the Texas Transportation Code, §541.201, and used for initial transport or transfer of company employees who become urgently ill or injured on company premises to an appropriate medical facility.

(49) Interfacility care - Care provided while transporting a patient between medical facilities.

(50) Lead trauma facility - A trauma facility which usually offers the highest level of trauma care in a given trauma service area, and which includes receipt of major and severe trauma patients transferred from lower level trauma facilities. It also includes on-going support of the regional advisory council and the provision of regional outreach, prevention, and trauma educational activities to all trauma care providers in the trauma service area regardless of health care system affiliation.

(51) Legal entity name - The name of the lawful or legally standing association, corporation, partnership, proprietorship, trust, or individual. Has legal capacity to:

(A) enter into agreements or contracts;

(B) assume obligations;

(C) incur and pay debts;

(D) sue and be sued in its own right; and

(E) to be accountable for illegal activities.

(52) Licensee - A person who holds a current paramedic license from the Texas Department of State Health Services (department) or a person who uses, maintains or operates EMS vehicles and EMS personnel to provide EMS and who holds an EMS provider license from the department.

(53) Major trauma facility - A hospital designated by the department as having met the criteria for a Level II trauma facility as described in §157.125 of this title. Major trauma facilities provide similar services to the Level I trauma facility although research and some medical specialty areas are not required for Level II facilities, provide ongoing educational opportunities in trauma related topics for health care professionals and the public, and implement targeted injury prevention programs.

(54) Major trauma patient - A person with injuries, or potential injuries, severe enough to benefit from treatment at a trauma facility. These patients may or may not present with alterations in vital signs or level of consciousness or obvious significant injuries (see severe trauma patient), but have been involved in an incident which results in a high index of suspicion for significant injury and/or disability. Co-morbid factors such as age and/or the presence of significant medical problems should also be considered. These patients should initiate a system's or health care entity's trauma response, including prehospital triage to a designated trauma facility. For performance improvement purposes, these patients are also identified retrospectively by an injury severity score of 9 or above.

(55) Medical control - The supervision of prehospital emergency medical service providers by a licensed physician. This encompasses on-line (direct voice contact) and off-line (written protocol and procedural review).

(56) Medical Director - The licensed physician who provides medical supervision to the EMS personnel of a licensed EMS provider or a recognized First Responder Organization under the terms of the Medical Practices Act (Occupations Code, Chapters 151 - 165 and rules promulgated by the Texas Medical Board. Also may be referred to as off-line medical control.

(57) Medical oversight - The assistance and management given to health care providers and/or entities involved in regional EMS/trauma systems planning by a physician or group of physicians designated to provide technical assistance.

(58) Medical supervision - Direction given to emergency medical services personnel by a licensed physician under the terms of the Medical Practice Act, (Occupations Code, Chapters 151 - 165) and rules promulgated by the Texas Medical Board pursuant to the terms of the Medical Practice Act.

(59) Mobile intensive care unit (MICU) - A vehicle that is designed for transporting the sick or injured and that meets the requirements of the advanced life support vehicle and which has sufficient equipment and supplies to provide cardiac monitoring, defibrillation, cardioversion, drug therapy, and two-way communication with at least one paramedic on the vehicle when providing EMS.

(60) Off-line medical direction - The licensed physician who provides approved protocols and medical supervision to the EMS personnel of a licensed EMS provider under the terms of the Medical Practices Act (Occupations Code, Chapters 151 - 165) and a rules promulgated by the Texas Medical Board (22 Texas Administrative Code, §197.3).

(61) Online course - A directed learning process, comprised of educational information (articles, videos, images, web links), communication (messaging, discussion forums) with a process and some way to measure students' knowledge.

(62) Operational name - Name under which the business or operation is conducted and presented to the world.

(63) Operational policies - Policies and procedures which are the basis for the provision of EMS and which include, but are not limited to such areas as vehicle maintenance, proper maintenance and storage of supplies, equipment, medications, and patient care devices; complaint investigation, multicasualty incidents, and hazardous materials; but do not include personnel or financial policies.

(64) Out of service vehicle - The period when a licensed EMS Provider vehicle is unable to respond or be response ready for an emergency or non-emergency response.

(65) Person - An individual, corporation, organization, government, governmental subdivision or agency, business, trust, partnership, association, or any other legal entity.

(66) Prehospital triage - The process of identifying medical/injury acuity or the potential for severe injury based upon physiological criteria, injury patterns, and/or high-energy mechanisms and transporting patients to a facility appropriate for their medical/injury needs. Prehospital triage for injury victims is guided by the prehospital triage protocol adopted by the regional advisory council (RAC) and approved by the department.

(67) Practical exam - Sometime referred to as psychomotor, is an exam that assesses the subject's ability to perceive instructions and perform motor responses.

(68) Protocols - A detailed, written set of instructions by the EMS Provider medical director, which may include delegated standing medical orders, to guide patient care or the performance of medical procedures as approved.

(69) Primary EMS provider response area - The geographic area in which an EMS agency routinely provides emergency EMS as agreed upon by a local or county governmental entity or by contract.

(70) Public safety answering point (PSAP) - The call center responsible for answering calls to an emergency telephone number for ambulance services; sometimes called "public safety access point," or "dispatch center."

(71) Quality management - Quality assurance, quality improvement, and/or performance improvement activities.

(72) Regional Advisory Council (RAC) - An organization serving as the Department of State Health Services recognized health care coalition responsible for the development, implementation and maintenance of the regional trauma and emergency health care system within the geographic jurisdiction of the Trauma Service Area. A Regional Advisory Council must maintain §501(c)(3) status.

(73) Regional EMS/trauma system - A network of healthcare providers within a given trauma service area (TSA) collectively focusing on traumatic injury as a public health problem, based on the given resources within each TSA.

(74) Regional medical control - Physician supervision for prehospital emergency medical services (EMS) providers in a given trauma service area or other geographic area intended to provide standardized oversight, treatment, and transport guidelines, which should, at minimum, follow the regional advisory council's regional EMS/trauma system plan components related to these issues and 22 Texas Administrative Code, §197.3(relating to Off-line Medical Director).

(75) Recertification - The procedure for renewal of emergency medical services certification.

(76) Receiving facility - A facility to which an EMS vehicle may transport a patient who requires prompt continuous medical care.

(77) Reciprocity - The recognition of certification or privileges granted to an individual from another state or recognized EMS system.

(78) Relicensure - The procedure for renewal of a paramedic license as described in §157.40 of this title (relating to Paramedic Licensure); the procedure for renewal of an EMS provider license as described in §157.11 of this title.

(79) Response pending status - The status of an EMS vehicle that just delivered a patient to a final receiving facility, and the dispatch center has another EMS response waiting that EMS vehicle.

(80) Response ready - When an EMS vehicle is equipped and staffed in accordance with §157.11 of this title (relating to Requirements for a Provider License) and is immediately available to respond to any emergency call 24 hours per day, seven days per week (24/7).

(81) Scope of practice - The procedures, actions and processes that an EMS personnel are permitted to undertake in keeping with the terms of their professional license or certification and approved by their EMS provider's medical director.

(82) Severe trauma patient - A person with injuries or potential injuries that require treatment at a tertiary trauma facility. These patients may be identified by an alteration in vital signs and/or level of consciousness or by the presence of significant injuries and shall initiate a system's and/or health care entity's highest level of trauma response including prehospital triage to a designated trauma facility. For performance improvement purposes, these patients are also identified retrospectively by an injury severity score of 15 or above.

(83) Shall - Mandatory requirements.

(84) Site survey - An on-site review of a trauma facility applicant to determine if it meets the criteria for a particular level of designation.

(85) Sole provider - The only licensed emergency medical service provider in a geographically contiguous service area and in which the next closest provider is greater than 20 miles from the limits of the area.

(86) Specialized emergency medical services vehicle - A vehicle that is designed for responding to and transporting sick or injured persons by any means of transportation other than by standard automotive ground ambulance or rotor or fixed wing air craft and that has sufficient staffing, equipment and supplies to provide for the specialized needs of the patient transported. This category includes, but is not limited to, water craft, off-road vehicles, and specially designed, configured or equipped vehicles used for transporting special care patients such as critical neonatal or burn patients.

(87) Specialty centers - Entities that care for specific types of patients such as trauma, pediatric, stroke, cardiac hospitals and burn units that have received certification, categorization, verification or other form of recognition by an appropriate agency regarding their capability to definitively treat these types of patients.

(88) Staffing plan - A document which indicates the overall working schedule patterns of EMS personnel.

(89) Standard of care - Care equivalent to what any reasonable, prudent person of like certification level would have given in a similar situation, based on locally, regionally and nationally adopted standard emergency medical services curricula as adopted by reference in §157.32 of this title (relating to Emergency Medical Services Training and Course Approval).

(90) Substation - An EMS provider station location that is not the fixed station and which is likely to provide rapid access to a location to which the EMS vehicle may be dispatched.

(91) Trauma - An injury or wound to a living body caused by the application of an external force or violence, including burn injuries. Poisonings, near-drownings and suffocations, other than those due to external forces are to be excluded from this definition.

(92) Trauma facility - A hospital that has successfully completed the designation process, is capable of stabilization and/or definitive treatment of critically injured persons and actively participates in a regional EMS/trauma system.

(93) Trauma nurse coordinator/trauma program manager - A registered nurse with demonstrated interest, education, and experience in trauma care and who, in partnership with the trauma medical director and hospital administration, is responsible for coordination of trauma care at a designated trauma facility. This coordination should include active participation in the trauma performance improvement program, the authority to positively impact trauma care of trauma patients in all areas of the hospital, and targeted prevention and education activities for the public and health care professionals.

(94) Trauma patient - Any critically injured person who has been evaluated by a physician, a registered nurse, or emergency medical services personnel, and found to require medical care in a trauma facility based on local, regional or national medical standards.

(95) Trauma registry - A statewide database which documents and integrates medical and system information related to the provision of trauma care by health care entities.

(96) Trauma Service Area - An organized geographical area of at least three counties administered by a regional advisory council for the purpose of providing prompt and efficient transportation and/or treatment of sick and injured patients.

(97) When in service - The period of time when an EMS vehicle is at the scene or when enroute to a facility with a patient.

§157.3Processing EMS Provider Licenses and Applications for EMS Personnel Certification and Licensure.

(a) Purpose. The purpose of this section is to set out the time periods by which the Texas Department of State Health Services (department) reviews applications for completeness and processes applications to make an eligibility determination of applicants for various Emergency Medical Services (EMS) certifications, licenses and approvals. This section does not apply to applications for trauma facility designation, but does apply to applications for the following:

(1) EMS Provider License,

(2) First Responder Organization (FRO) license;

(3) EMS Personnel Certifications;

(4) Paramedic Licenses;

(5) EMS Personnel Certification or Paramedic License via Reciprocity;

(6) EMS Personnel Certification or Paramedic License via Upgrade;

(7) EMS Course Coordinator certification;

(8) EMS Instructor Certification;

(9) EMS Information Operator Certification;

(10) Comprehensive Clinical Management Program (CCMP) Approval;

(11) EMS Education Program Approval;

(12) EMS Course Approval;

(13) EMS Continuing Education Provider Approval;

(14) EMS Information Operator Instructor Certification;

(15) EMS Information Operator Training Program Approval, and

(16) EMS Information Operator Instructor Training Program Approval.

(b) Period for Processing Initial or Renewal Application. This period begins on the date the department receives for review and processing a fully completed written initial or renewal application for any of those certifications, licenses or approvals listed in subsection (a)(1) - (16) of this section and ends on the date the department issues the certification or license, or sends a written notice proposing to deny granting the certification, license or approval. The certification, license or approval may be sent to the applicant in lieu of sending a notice of acceptance of an application.

(1) This period will be no more than 60 calendar days.

(2) This period will be no more than 120 calendar days for an EMS provider license initial applicant, seeking a variance from eligibility requirements.

(3) This period may be no more than 180 days for an applicant of whom the department is conducting a criminal background investigation.

(4) If the department receives information from any other person or source that would cause the department to begin a criminal background investigation of an applicant, this period may be no more than 180 days from the date the department sends written notice that it's conducting a criminal background investigation.

(5) This period may be longer than noted periods, if an application is deficient and becomes subject to a continuing review of the application.

(6) This period may be longer than noted periods, if the department proposes to deny the granting of a license, certification or approval and the applicant timely requests an administrative appeal hearing, thus causing a final determination to be made pursuant to timelines relative to Texas Government Code, Chapter 2001 and the department's appeal rules in this chapter.

(c) Period for Continuing Review of an Initial or Renewal Application.

(1) Incomplete Information. If an initial or renewal application is incomplete, the department will send written notice to the applicant that it is deficient and will specify what information is required to cure all deficiencies and make it complete and acceptable for filing. If the department is conducting a criminal background investigation of the applicant during its application review, it may send the applicant a request for information needed for its investigation to determine the applicant's continued eligibility. The department will send such notice, and/or request, by the 30th day of its receipt of a deficient application or receipt of information giving cause for a criminal background investigation. Once an application is subject to a continuing review of the application, the 60 day period for the department either to issue, or propose to deny, the license, certification or approval will be extended based upon the applicant's timeliness in providing the information and other factors related to the department's reviewing and processing the application.

(A) Application Deficiency. If an application deficiency is based upon an absence of information required to make the application complete for filing, the applicant shall provide the required information to the department by the 30th day from the date that the department sent a written request for required information to cure the application's deficiencies.

(B) Eligibility Deficiency. If an application deficiency is based upon the applicant's lack of fulfilling an eligibility requirement(s) that causes an absence of information required to make the application complete for filing, the applicant shall provide written notification to the department of such along with a time estimate as to when such eligibility requirement(s) will be fulfilled and shall do so by the 30th day from the date that the department sent a written request for required information to cure the application's deficiencies.

(C) Criminal Background Investigation. If the department is conducting a criminal background investigation of the applicant during its application review and sends the applicant a request for information needed for its criminal background investigation, the applicant shall provide such requested information by the 30th day from the date that the department sent a written request for the required information.

(2) Second Attempt to Cure Incomplete Information.

(A) Application Deficiency Information. If the applicant timely provides any written information that attempts to respond to a notice of application deficiencies, but which still does not cure said deficiencies, the department will send a second written notice specifying what information is required to cure the deficiencies. The department will send this second written notice by the 30th day from the day it receives the information that attempts to satisfy its earlier request. The applicant shall provide the requested information to the department by the 30th day from the date the department sent its second written request for required information to cure the application's deficiencies.

(B) Criminal Background Information - If the applicant timely provides any written information or documentation that does not completely fulfill an earlier request for information needed for a criminal background investigation, the department will send a second written notice specifying what information is needed for its investigation. The department will send this second written notice by the 30th day from the day it receives the information that attempts to satisfy its earlier request. The applicant shall provide the requested information to the department by the 30th day from the date the department sent its second written request for information needed for its investigation.

(3) Complete Information. If the applicant timely provides information that cures application deficiencies and fully completes the application for filing or satisfactorily provides the requested information needed for a criminal background investigation to determine applicant's continuing eligibility, the department, by the 60th day from the date that the department receives such information, will either issue the certification, license or approval or send a written notice proposing to deny granting the certification, license or approval.

(4) Failure to Cure Initial Application Deficiencies or Provide Complete Information.

(A) If the department does not timely receive from the initial applicant any information in response to the department's first or second written notice of initial application deficiencies and request for curing information, the initial application is deemed to be withdrawn and/or void on the 30th day from the date the department sent its request, and the initial application fee is forfeited.

(B) If the department does not timely receive from the initial applicant the requested information needed for its criminal background investigation to determine the initial applicant's continued eligibility, the department may propose to deny granting the initial certification, license or approval.

(5) Failure to Cure Initial Application Deficiencies Related to Eligibility Requirements.

(A) If an initial application for EMS Personnel Certifications, Paramedic Licenses, EMS Personnel Certification or Paramedic License via Reciprocity, EMS Personnel Certification or Paramedic License via Upgrade, EMS Course Coordinator certification, EMS Instructor Certification, EMS Information Operator Certification, EMS Information Operator Instructor Certification, is deficient because the applicant has not yet fulfilled certain eligibility requirements, outlined in this chapter, and the applicant has timely notified the department of such, the department may withhold making its determination to either grant or propose denying the certification or license for not more than two years after the application's filing date. If the applicant fails to timely provide the department with written substantial proof noting fulfillment of certain eligibility requirements, thus making the application complete for filing, within two years after the application filing date, the application is deemed to be withdrawn and/or void and the application fee is forfeited.

(B) If an initial application for an EMS Provider License, FRO license, EMS Education Program Approval, EMS Course Approval, EMS Continuing Education Provider Approval, EMS Information Operator Training Program Approval, or EMS Information Operator Instructor Training Program Approval, is deficient because the applicant has not yet fulfilled certain eligibility requirements, outlined in this chapter, and the applicant has timely notified the department of such, the department may withhold making its determination to either grant or propose denying the certification, license or approval for not more than six months after the application's filing date. If the applicant fails to timely provide the department with information or written substantial proof noting fulfillment of certain eligibility requirements, thus making the application complete for filing, within six months after the application filing date, the application is deemed to be withdrawn and/or void and the application fee is forfeited.

(d) Timeliness Issues Regarding a Renewal Application.

(1) Continuance of License. If the department receives a sufficiently complete timely filed renewal application along with the full amount of the renewal fee prior to midnight of the expiration date of the certificate, license or approval to be renewed, the certificate, license or approval does not expire, but continues during the department's review of the application for completeness or, if applicable, its criminal background investigation of the applicant and continues during its processing of the application to make a determination either to grant, or propose to deny, the renewal of the certification, license or approval.

(2) Expiration of License. If the department does not timely receive a renewal application and the correct amount of renewal fee, or only receives the application but not the full amount of the renewal fee prior to midnight of the expiration date of the certificate, license or approval to be renewed, then the certificate, license or approval expires at midnight of the expiration date. Even if the applicant untimely files the application with the full amount of the fee, the department will review the application for completeness and if the application is complete or later becomes timely completed, it will then process the application to determine eligibility either to renew, or otherwise to propose to deny the renewal of, the certification, license or approval. During that review and processing period, the person or entity will not be certified, licensed, or approved. If renewal is granted, the renewed license, certification or approval will begin on the date the department grants it, which most likely will not be on the date immediately following the expiration date. An untimely filed EMS provider renewal application will require the applicant to file an initial application and to meet EMS provider license requirements in effect for an initial applicant at that time.

(3) Uncured Application Deficiencies. If the department does not timely receive from the applicant any information in response to the department's first or second written notice(s) of application deficiencies and request(s) for curing information, the department may propose to deny renewal of the license, certification or approval.

(4) Incomplete Requested Criminal Background Information. If the department does not timely receive from the applicant any requested information needed to complete its criminal background investigation to determine the applicant's continued eligibility, the department may propose to deny renewal of the certification.

(5) Proposed Denial of Renewal. If the department proposes to deny renewal for failure to timely provide requested information to cure application deficiencies or requested information to complete a criminal background information or for failure to meet eligibility requirements, and sends, via United States mail, written notice to the applicant proposing to deny renewal of the certification, license or approval and if the department timely receives from the applicant a written request for an administrative appeal hearing, the certificate, license or approval continues past its expiration date until a final determination is made pursuant to Texas Government Code, Chapter 2001 and the department's appeal rules in this chapter.

(e) Notice to Last Known Address. The department will send letters, noting application deficiencies or other correspondence requesting necessary information, via U.S. mail, to the applicant's last known address on file with the department, unless it later changes its manner or policy on its notification process. It is the applicant's responsibility to timely notify the department of any change in its mailing address within ten days of such address change.

(f) Prolonged Application Review Process by the Department. If the application review process is prolonged due to circumstances surrounding a general investigation or criminal background investigation of the applicant or due to any other administrative procedure within the department or other unexpected event, the department may extend the final review period regarding its review of the application and its making a final determination of the applicant's eligibility for initial or renewal certification, license or approval.

(g) Reimbursement of fees.

(1) In the event the application is not processed within the time periods as stated in subsections (b) and (c) of this section, the applicant has the right to request of the director of the Office of EMS and Trauma Systems full reimbursement of all filing fees paid in that particular application process. If the director does not agree that the established periods have been violated or finds that good cause existed for exceeding the established periods, the request will be denied.

(2) Good cause for exceeding the period established is considered to exist if:

(A) the number of applications for licenses, registrations, certifications, and permits as appropriate to be processed exceeds by 15% or more the number processed in the same calendar quarter the preceding year;

(B) another public or private entity utilized in the application process caused the delay; or

(C) other conditions existed giving good cause for exceeding the established periods.

(h) Appeal. If the request for full reimbursement authorized by subsection (g) of this section is denied, the applicant may then appeal to the commissioner of health for a resolution of the dispute. The applicant shall give written notice to the commissioner that it requests full reimbursement of all filing fees paid because its application was not processed within the adopted time period. The director shall submit a written report to the commissioner, with a copy provided to the applicant, of the facts related to the processing of the application and good cause for exceeding the established time periods. The commissioner will review the report and any documentation submitted by the applicant, make the final decision on the matter, and provide written notification of his or her decision to the applicant and the director.

(i) Sufficiently Complete Timely Filed Renewal Application. A renewal application that the department timely has received before the expiration date of a certificate, license or approval that contains all of the following:

(1) correct, legible, dated, and signed by the applicant on either a department approved paper form or on an online form; and

(2) the appropriate amount of application fee that has cleared the applicant's financial institution.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 23, 2017.

TRD-201700315

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: February 12, 2017

Proposal publication date: August 12, 2016

For further information, please call: (512) 776-6972


25 TAC §157.3

STATUTORY AUTHORITY

The repeal is authorized by the Texas Health and Safety Code, Chapter 773 and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Texas Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 23, 2017.

TRD-201700316

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: February 12, 2017

Proposal publication date: August 12, 2016

For further information, please call: (512) 776-6972


SUBCHAPTER B. EMERGENCY MEDICAL SERVICES PROVIDER LICENSES

25 TAC §§157.11 - 157.14, 157.16

STATUTORY AUTHORITY

The amendments are authorized by the Texas Health and Safety Code, Chapter 773 and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Texas Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.

§157.11.Requirements for an EMS Provider License.

(a) Purpose: Acquiring, issuing, and maintaining an EMS Providers License.

(b) EMS in Texas is a delegated practice, as written in Occupations Code, §157.003.

(c) Application requirements for an Emergency Medical Services (EMS) Provider License.

(1) An applicant for an initial EMS provider license shall submit a completed application to the department on the required official forms, following the department's written process.

(2) The nonrefundable application fee of $500 per provider plus $180 for each EMS vehicle to be operated under the license shall accompany the application.

(3) The department will process the EMS provider license application as per §157.3 of this title (relating to Processing EMS Provider Licenses and Applications for EMS Personnel Certification and Licensure).

(4) An EMS provider holding a valid license or authorization from another state; whose service area adjoins the State of Texas; who has in place a written mutual aid agreement, with a licensed Texas EMS provider, and who when requested to do so by a licensed Texas EMS provider, responds into Texas for emergency mutual aid assistance, may be exempt from holding a Texas EMS provider license, but will be obligated to perform to the same medical standards of care required of EMS providers licensed by their home state.

(5) A fixed-wing or rotor-wing air ambulance provider, appropriately licensed by the state governments of New Mexico, Oklahoma, Arkansas, Kansas, Colorado or Louisiana may apply for a reciprocal issuance of a provider license, and the application would not require staffing by Texas EMS certified or licensed personnel. A nonrefundable administrative fee of $500 per provider in addition to a nonrefundable fee of $180 for each EMS aircraft to be operated in Texas under the reciprocal license shall accompany the application.

(6) An applicant for an EMS provider license that provides emergency prehospital care is exempt from payment of department licensing and authorization fees if the firm is staffed with at least 75% volunteer personnel, has no more than five full-time staff or equivalent, and the firm is recognized as a §501(c)(3) nonprofit corporation by the Internal Revenue Service. An EMS provider who compensates a physician to provide medical supervision may be exempt from the payment of department licensing and authorization fees if all other requirements for fee exemption are met.

(7) Required documents that shall accompany a license application.

(A) Document verifying volunteer status, if applicable.

(B) Map and description of service area, a list of counties and cities in which applicant proposes to provide primary emergency service and a list of all station locations with address and telephone and facsimile transmission numbers for each station.

(C) Declaration of organization type and profit status.

(D) Declaration of Provider Name.

(i) The legal name of the EMS provider cannot include the name of the city, county or regional advisory council within or in part, unless written approval is given by the individual city, county or regional advisory council respectively.

(ii) The EMS provider operational name cannot include the name of the city, county or regional advisory council within or in part, unless written approval is given by the individual city, county or regional advisory council respectively. A proposed provider name is deemed to be deceptively similar to an established licensed EMS provider if it meets the conditions listed in the Office of the Secretary of State rule, 1 Texas Administrative Code, §79.39 (relating to Deceptively Similar Name).

(E) Declaration of Ownership.

(F) Declaration of the address for the main location of the business, normal business hours and provide proof of ownership or lease of such location.

(i) The normal business hours must be posted for public viewing.

(ii) A service area map must be provided.

(iii) Only one EMS provider license will be issued to each fixed address.

(iv) The applicant shall attest that no other license EMS provider is at the provided business location or address.

(v) The emergency medical services provider must remain in the same physical location for the period of licensure, unless the department approves a change in location.

(G) Declaration of the administrator of record and any subsequently filed declaration of a new administrator shall declare the following, if the EMS provider is required to have an administrator of record as per Health and Safety Code, §773.0571 or §773.05712.

(i) The administrator of record is not employed or otherwise compensated by another private for-profit EMS provider.

(ii) The administrator of record meets the qualifications required for an emergency medical technician certification or other health care professional license with a direct relationship to EMS and currently holds such certification or license issued by the State of Texas.

(iii) The administrator of record has submitted to a criminal history record check at the applicant's expense as directed in §157.37 of this title (relating to Certification or Licensure of Persons With Criminal Backgrounds).

(iv) The administrator of record has completed an initial education course approved by the department regarding state and federal laws and rules that affect EMS in the following areas:

(I) Health and Safety Code, Chapter 773 and 25 Texas Administrative Code, Chapter 157;

(II) EMS dispatch processes;

(III) EMS billing processes;

(IV) Medical control accountability; and

(V) Quality improvement processes for EMS operations.

(v) The applicant will assure that its administrator of record shall annually complete eight hours of continuing education related to the Texas and federal laws and rules related to EMS.

(vi) An EMS provider that is directly operated by a governmental entity, is exempt from this subparagraph, except for declaration of administrator of record.

(vii) An EMS provider that held a license on September 1, 2013, and has an administrator of record who has at least eight years of experience providing EMS, the administrator of record is exempt from clauses (ii) and (iv) of this subparagraph.

(H) Copies of Doing Business Under Assumed Name Certificates (DBA).

(I) Completed EMS Personnel Form.

(J) Staffing Plan that describes how the EMS provider provides continuous coverage for the service area defined in documents submitted with the EMS provider application. The EMS provider shall have a staffing plan that addresses coverage of the service area or shall have a formal system to manage communication when not providing services after normal business hours.

(K) Completed EMS Vehicle Form.

(L) Declaration of an employed medical director and a copy of the signed contract or agreement with a physician who is currently licensed in the State of Texas, in good standing with the Texas Medical Board, in compliance with Texas Medical Board rules, 22 Texas Administrative Code, Chapter 197, and in compliance with Title 3 of the Texas Occupations Code.

(M) Completed Medical Director Information Form.

(N) Treatment and Transport Protocols and policies addressing the care to be provided to adult, pediatric, and neonatal patients, must be approved and signed by the medical director.

(O) A list of equipment as required on the EMS Provider initial and renewal application, with identifiable or legible serial numbers, supplies and medications; approved and signed by the medical director.

(P) The applicant shall attest that all required equipment is permitted to be used by the EMS provider and provide proof of ownership or hold a long-term lease for all equipment necessary for the safe operation.

(Q) The applicant shall attest that each authorized vehicle will have its own set of equipment required for each authorized vehicle to operate at the level of the service for which the provider is authorized.

(R) Description of how the EMS provider will conduct quality assurance in coordination with the EMS provider medical director.

(S) The applicant shall provide an attestation or provide documentation that it and/or its management staff will or continues to participate in the local regional advisory council.

(T) Plan for how the provider will respond to disaster incidents including mass casualty situations in coordination with local and regional plans.

(U) Copies of written Mutual Aid and/or Inter-local Agreements with EMS providers.

(V) Documentation as required for subscription or membership program, if applicable.

(W) Certificate of Insurance, provided by the insurer, identifying the department as the certificate holder and indicating at least minimum motor vehicle liability coverage for each vehicle to be operated and professional liability coverage. If applicant is a government subdivision, submit evidence of financial responsibility by self-insuring to the limit imposed by the tort claims provisions of the Texas Civil Practice and Remedies Code.

(i) The applicant shall maintain motor vehicle liability insurance as required under the Texas Transportation Code.

(ii) The applicant shall maintain professional liability insurance coverage in the minimum amount of $500,000 per occurrence, or as necessary per state law, with a company licensed or deemed eligible by the Texas Department of Insurance to do business in Texas or acceptable proof of self-insurance or captive insurance in order to secure payment for any loss or damage resulting from any occurrence arising out of, or caused by the care, or lack of care, of a patient.

(X) The applicant shall provide copies of vehicle titles, vehicle lease agreements, copies of exempt registrations if applicant is a government subdivision, or an affidavit identifying applicant as the owner, lessee, or authorized operator for each vehicle to be operated under the license.

(Y) The applicant shall provide documentation of the following, showing that the applicant, including its management staff possesses sufficient professional experience and qualifications related to EMS:

(i) an attestation that its management staff have read the Texas Emergency Healthcare Act and the department's EMS rules in this chapter;

(ii) proof of one year experience or education provided by a nationally recognized organization on emergency medical dispatch processes;

(iii) proof of one year experience or education provided by a nationally recognized organization concerning EMS billing processes;

(iv) proof of one year experience or education provided by a nationally recognized organization on medical control accountability; and

(v) proof of one year experience or education provided by a nationally recognized organization on quality improvement processes for EMS operations.

(Z) A copy of a letter of credit for the obtaining or renewing of an EMS Providers license, issued by a federally insured bank or savings institution:

(i) in the amount of $100,000 for the initial license and for renewal of the license on the second anniversary of the date the initial license is issued;

(ii) in the amount of $75,000 for renewal of the license on the fourth anniversary of the date the initial license is issued;

(iii) in the amount of $50,000 for renewal of the license on the sixth anniversary of the date the initial license is issued;

(iv) in the amount of $25,000 for renewal of the license on the eighth anniversary of the date the initial license is issued;

(v) that shall include the names of all of the parties involved in the transaction;

(vi) that shall include the names of the persons or entity, who owns the EMS provider operation and to whom the bank is issuing the letter of credit;

(vii) that shall include the name of the person or entity, receiving the letter of credit; and

(viii) an EMS provider that is directly operated by a governmental entity is exempt from this subsection.

(AA) A copy of the surety bond in the amount of $50,000 issued to and provided to the Health and Human Services Commission by the applicant, participating in the medical assistance program operated under Human Resources Code, Chapter 32, the Medicaid managed care program operated under Government Code, Chapter 533, or the child health plan program operated under Health and Safety Code, Chapter 62. An EMS provider that is directly operated by a governmental entity is exempt from this subparagraph.

(BB) Documentation evidencing applicant or management team has not been excluded from participation in the state Medicaid program.

(CC) A copy of a governmental entity letter of approval that shall:

(i) be from the governing body of the municipality in which the applicant is located and is applying to provide EMS;

(ii) be from the commissioner's court of the county in which the applicant is located and is applying to provide EMS, if the applicant is not located in a municipality;

(iii) include the attestation that the addition of another licensed EMS provider will not interfere with or adversely affect the provision of EMS by the licensed EMS providers operating in the municipality or county;

(iv) include the attestation that the addition of another licensed EMS provider will remedy an existing provider shortage that cannot be resolved through the use of the licensed EMS providers operating in the municipality or county; and

(v) include the attestation that the addition of another licensed EMS provider will not cause an oversupply of licensed EMS providers in the municipality or county.

(8) Paragraph (7)(CC) of this subsection does not apply to renewal of an EMS provider license or a municipality, county, emergency services district, hospital, or EMS volunteer provider organization in this state that applies for an EMS provider license.

(9) An EMS provider is prohibited from expanding operations to or stationing any EMS vehicles in a municipality or county other than the municipality or county from which the provider obtained the letter of approval under this subsection until after the second anniversary of the date the provider's initial license was issued, unless the expansion or stationing occurs in connection with:

(A) a contract awarded by another municipality or county for the provision of EMS;

(B) an emergency response made in connection with an existing mutual aid agreement; or

(C) an activation of a statewide emergency or disaster response by the department.

(10) Paragraph (9) of this subsection does not apply to renewal of an EMS provider license or a municipality, county, emergency services district, hospital, or EMS volunteer provider organization in this state that applies for an EMS provider license.

(11) Paragraph (9) of this subsection does not apply to fixed or rotor wing EMS providers.

(d) EMS Provider License.

(1) License.

(A) Applicants who have submitted all required documents and who have met all the criteria for licensure will be issued a provider license to be effective for a period of two years from the date of issuance.

(B) Licenses shall be issued in the name of the applicant.

(C) License expiration dates may be adjusted by the department to create licensing periods less than two years for administrative purposes.

(D) An application for an initial license or for the renewal of a license may be denied to a person or legal entity who owns or who has owned any portion of an EMS provider service or who operates/manages or who/which has operated/managed any portion of an EMS provider service which has been sanctioned by or which has a proposed disciplinary action/sanction pending against it by the department or any other local, state or federal agency.

(E) The license will be issued in the form of a certificate which shall be prominently displayed in a public area of the provider's primary place of business.

(F) An EMS Provider License issued by the department shall not be transferable to another person or entity.

(2) Vehicle Authorization.

(A) The department will issue an authorization for each vehicle to be operated by the applicant which meets all criteria for approval as defined in subsection (d) of this section.

(B) A vehicle authorization shall be issued for the following levels of service, and a provider may operate at a higher level of service based on appropriate staffing, equipment and medical direction for that level. A vehicle authorization will include a level of care designation at one of the following levels:

(i) Basic Life Support (BLS);

(ii) BLS with Advanced Life Support (ALS) capability;

(iii) BLS with Mobile Intensive Care Unit (MICU) capability;

(iv) Advanced Life Support (ALS);

(v) ALS with MICU capability;

(vi) Mobile Intensive Care Unit (MICU);

(vii) Air Medical:

(I) Rotor wing; or

(II) Fixed wing; and

(viii) Specialized.

(C) Change of Vehicle Authorization. To change an authorization to a different level the provider shall submit a request with appropriate documentation to the department verifying the provider's ability to perform at the requested level. A fee of $30 shall be required for each new authorization requested. The provider shall allow sufficient time for the department to verify the documentation and conduct necessary inspections before implementing service at the requested authorization level.

(D) Vehicle Authorizations are not required to be specific to particular vehicles and may be interchangeably placed in other vehicles as necessary. The original Vehicle Authorization for the appropriate level of service shall be prominently displayed in the patient compartment of each vehicle:

(E) Vehicle Authorizations are not transferable between providers.

(F) A replacement of a lost or damaged license or authorization may be issued if requested with a nonrefundable fee of $10.

(3) Declaration of Business Operational Name and Administration.

(A) The applicant shall submit a list of all business operational names under which the service is operated. If the applicant intends to operate the service under a name or names different from the name for which the license is issued, the applicant shall submit certified copies of assumed name certificates.

(B) A change in the operational name which the service is operated will require a new application and a prorated fee as determined by the department. A new provider number will be issued.

(C) Name of Administrator of Record must be declared. The applicant shall submit a notarized document declaring the full name of the chief administrator, his/her mailing address and telephone number to whom the department shall address all official communications in regard to the license.

(e) Vehicles.

(1) All EMS vehicles must be adequately constructed, equipped, maintained and operated to render patient care, comfort and transportation of adult, pediatric, and neonatal patients safely and efficiently. A pediatric and neonatal equipment list should be based on endorsed pediatric equipment national standards within the approved equipment list required by the medical director.

(2) EMS vehicles must allow the proper and safe storage and use of all required equipment, supplies and medications and must allow all required procedures to be carried out in a safe and effective manner.

(3) As approved by the department, EMS vehicles must meet a practical efficient minimum national ambulance vehicle body type, dimension and safety criteria standards.

(4) All vehicles shall have an environmental system capable of heating or cooling the patient(s) and staff, in accordance with the manufacturer specifications, within the patient compartment at all times when in service and which allows for protection of medication, according to manufacturer specifications, from extreme temperatures if it becomes environmentally necessary. The provider shall provide evidence of an operational policy which shall list the parenteral pharmaceuticals authorized by the medical director and which shall define the storage and/or FDA recommendations. Compliance with the policy shall be incorporated into the provider's Quality Assurance process and shall be documented on unit readiness reports.

(5) EMS vehicles shall have operational two-way communication capable of contacting appropriate medical resources and as outlined in the current Texas interoperability plan unless the vehicle is designated as being out of service using the form provided by the department.

(6) EMS vehicles shall be in compliance with all applicable federal, state and local requirements unless the vehicle is designated out of service with the form provided by the department.

(7) All EMS vehicles shall have the name of the provider and a current department issued EMS provider license number prominently displayed on both sides of the vehicle in at least 2 inch lettering and in contrasting color. The license number shall have the letters TX prior to the license number. This requirement does not apply to fixed or rotor wing aircraft.

(f) Substitution, replacement and additional EMS vehicles.

(1) The EMS provider shall notify the department within five business days if the EMS provider substitutes or replaces a vehicle. No fee is required for a vehicle substitution or replacement.

(2) The EMS provider shall notify the department if the EMS provider adds a vehicle to the provider's operational fleet prior to making the vehicle response-ready. A vehicle authorization request shall be submitted with a nonrefundable vehicle fee prior to the vehicle being placed into service.

(g) Staffing Plan Required.

(1) The applicant shall submit a completed EMS Personnel Form listing each response person assigned to staff EMS vehicles by name, certification level, and department issued certification/license identification number.

(2) An EMS provider responsible for an emergency response area that is unable to provide continuous coverage within the declared service areas shall publish public notices in local media of its inability to provide continuous response capability and shall include the days and hours of its operation. The EMS provider shall notify all the public safety-answering points and all dispatch centers of the days and hours when unable to provide coverage. The EMS provider shall submit evidence that reasonable attempts to secure coverage from other EMS providers have been made.

(3) The applicant must provide proof at initial and renewal of license that all licensed or certified personnel have completed a jurisprudence examination approved by the department on state and federal laws and rules that affect EMS.

(h) Minimum Staffing Required.

(1) BLS--When response-ready or in-service, authorized EMS vehicles operating at the BLS level shall be staffed at a minimum with two emergency care attendants (ECAs).

(2) BLS with ALS capability--When response-ready or in-service below ALS two ECAs. Full ALS status becomes active when staffed by at least an emergency medical technician (EMT)-Intermediate or AEMT and at least an EMT.

(3) BLS with MICU capability--When response-ready or in-service below MICU two ECAs. Full MICU status becomes active when staffed by at least a certified or licensed paramedic and at least an EMT.

(4) ALS--When response-ready or in-service, authorized EMS vehicles operating at the ALS level shall be staffed at a minimum with one EMT Basic and one AEMT or EMT- Intermediate.

(5) ALS with MICU capability--When response-ready or in-service below MICU shall require one EMT-Intermediate or AEMT and one EMT. Full MICU status becomes active when staffed by at least a certified or licensed paramedic and at least an EMT.

(6) MICU--When response-ready or in-service, authorized EMS vehicles operating at the MICU level shall be staffed at a minimum with one EMT Basic and one certified or licensed EMT-Paramedic.

(7) Specialized--When response-ready or in-service, EMS vehicles authorized to operate for a specialized purpose shall be staffed with a minimum of two personnel appropriately licensed and/or certified as determined by the type and application of the specialized purpose and as approved by the medical director and the department.

(8) For air ambulance staffing requirements refer to §157.12(f) of this title (relating to Rotor-wing Air Ambulance Operations) or §157.13(g) of this title (relating to Fixed- wing Air Ambulance Operations).

(9) When response-ready or in-service, authorized EMS vehicles may operate at a lower level than licensed by the department. When operating at the BLS level with an ALS/MICU ambulance, the EMS provider must have an approved security plan for the ALS/MICU medication as approved by the EMS provider medical director's protocol and/or policy.

(10) As justified by patient needs, providers may utilize appropriately certified and/or licensed medical personnel in addition to those which are required by their designation levels. In addition to the care rendered by the required staff, the provider shall be accountable for care rendered by any additional personnel.

(i) Treatment and Transport Protocols Required.

(1) The applicant shall submit written delegated standing orders for patient treatment and transport protocols and policies related to patient care which have been approved and signed by the provider's medical director.

(2) The protocols shall have an effective date.

(3) The protocols shall address the use of non-EMS certified or licensed medical personnel who, in addition to the EMS staff, may provide patient care on behalf of the provider and/or in the provider's EMS vehicles.

(4) The protocols shall address the use of all required, additional, and/or specialized medical equipment, supplies, and pharmaceuticals carried on each EMS vehicle in the provider's fleet.

(5) The protocols shall identify delegated procedures for each EMS Certification or license level utilized by the provider.

(6) The protocols shall indicate specific applications, including geographical area and duty status of personnel.

(j) EMS Equipment, supplies, medical devices, parenteral solutions and pharmaceuticals.

(1) The EMS provider shall submit a list, approved and signed by the medical director and fully supportive of and consistent with the protocols, of all medical equipment, supplies, medical devices, parenteral solutions and pharmaceuticals to be carried. The list shall specify the quantities of each item to be carried and shall specify the sizes and types of each item necessary to provide appropriate care for all age ranges appropriate to the needs of their patients. The quantities listed shall be appropriate to the provider's call volume, transport times and restocking capabilities.

(2) All patient care equipment, and medical devices must be operational, appropriately secured in the vehicle at the time of providing patient care and response ready, and supplies shall be clean and fully operational. All patient care powered equipment shall have manual mechanical, spare batteries or an alternative power source, if applicable.

(3) All solutions and pharmaceuticals shall be up to date and shall be stored and maintained in accordance with the manufacturer's and/or U.S. Federal Drug Administration (FDA) recommendations.

(4) The requirements for air ambulance equipment and supplies are listed in 157.12(h) of this title or §157.13(h) of this title.

(k) The following equipment shall be present on each EMS in-service vehicle and on, or immediately available for, each response-ready vehicle as specified in the equipment list as required by the medical director's approved equipment list to include all state required equipment. The equipment list shall include equipment required for treatment and transport of adult, pediatric, and neonatal patients.

(1) Basic Life Support (BLS):

(A) Equipment required to administer the BLS scope of practice and incorporates the knowledge, competencies and basic skills of an EMT/ECA and additional skills as authorized by the EMS provider medical director. All BLS ambulances shall be able to perform treatment and transport patients receiving the following skills:

(i) airway/ventilation/oxygenation;

(ii) cardiovascular circulation;

(iii) immobilization;

(iv) medication administration - routes; and

(v) single and multi-system trauma patients.

(B) oropharyngeal airways;

(C) portable and vehicle mounted suction;

(D) bag valve mask units, oxygen capable;

(E) portable and vehicle mounted oxygen;

(F) oxygen delivery devices;

(G) dressing and bandaging materials;

(H) commercial tourniquet;

(I) rigid cervical immobilization devices;

(J) spinal immobilization devices;

(K) extremity splints;

(L) equipment to meet special patient needs;

(M) equipment for determining and monitoring patient vital signs, condition or response to treatment;

(N) pharmaceuticals, as required by the medical director's protocols;

(O) an external cardiac defibrillator appropriate to the staffing level with two sets of adult and two sets of pediatric pads;

(P) a patient-transport device capable of being secured to the vehicle, and the patient must be fully restrained per manufacturer recommendations; and

(Q) an epinephrine auto injector or similar device capable of treating anaphylaxis.

(2) Advanced Life Support (ALS):

(A) equipment required to administer the ALS scope of practice and incorporates the knowledge, competencies and basic and advanced skills of an AEMT and additional skills as authorized by the EMS provider medical director. All ALS ambulances shall be able to perform treatment and transport patients receiving the following skills, including all required BLS equipment to perform treatment and transport patients receiving the following skills:

(i) airway/ventilation/oxygenation;

(ii) cardiovascular circulation;

(iii) immobilization;

(iv) medication administration - routes; and

(v) intravenous (IV) initiation/maintenance fluids.

(B) all required BLS equipment;

(C) advanced airway equipment;

(D) IV equipment and supplies;

(E) pharmaceuticals as required by medical director protocols; and

(F) wave form capnography or state approved carbon dioxide detection equipment must be used after January 1, 2018, when performing or monitoring endotracheal intubation.

(3) MICU:

(A) equipment required to administer the knowledge, competencies and advanced skills of a paramedic, and additional skills as authorized by the EMS provider medical director. All MICU ambulances shall be able to perform treatment and transport patients receiving the following skills:

(i) airway/ventilation/oxygenation;

(ii) cardiovascular circulation;

(iii) immobilization;

(iv) medication administration - routes; and

(v) intravenous (IV) initiation/maintenance fluids.

(B) all required BLS and ALS equipment;

(C) with transmitting 12-lead capability cardiac monitor/defibrillator by January 1, 2020; and

(D) pharmaceuticals as required by medical director protocols.

(4) BLS with ALS Capability:

(A) all required BLS equipment, even when in service or response ready at the ALS level; and

(B) all required ALS equipment, when in service or response ready at the ALS level.

(5) BLS with MICU Capability:

(A) all required BLS equipment, even when in service or response ready at the MICU level; and

(B) all required MICU equipment, when in service or response ready at the MICU level.

(6) ALS with MICU Capability:

(A) all required ALS equipment, even when in service or response ready at the MICU level; and

(B) all MICU equipment, when in service or response ready at the MICU level.

(7) In addition to medical supplies and equipment as defined in subsection (k) of this section, EMS vehicles must also have:

(A) a complete and current copy of written or electronic formatted protocols approved and signed by the medical director; with a current and complete equipment, supply, and medication list available to the crew;

(B) operable emergency warning devices;

(C) personal protective equipment for the EMS vehicle staff, including at least:

(i) protective, non-porous gloves;

(ii) medical eye protection;

(iii) medical respiratory protection must be available per crew member, meeting National Institute for Occupational Safety and Health (NIOSH) approved N95 or greater standards;

(iv) medical protective gowns or equivalent; and

(v) personal cleansing supplies;

(D) sharps container;

(E) biohazard bags;

(F) portable, battery-powered flashlight (not a pen-light);

(G) a mounted, currently inspected, 5 pound ABC fire extinguisher (not applicable to air ambulances);

(H) "No Smoking" signs posted in the patient compartment and cab of vehicle;

(I) a current emergency response guide book, or an electronic version that is available to the crew (for hazardous materials); and

(J) each vehicle will carry 25 triage tags in coordination with the Regional Advisory Council (RAC).

(8) As justified by specific patient needs, and when qualified personnel are available, EMS providers may appropriately utilize equipment in addition to that which is required by their authorization levels. Such equipment must be consistent with protocols and/or patient- specific orders and must correspond to personnel qualifications.

(l) National accreditation. If a provider has been accredited through a national accrediting organization approved by the department and adheres to Texas staffing level requirements, the department may exempt the provider from portions of the license process. In addition to other licensing requirements, accredited providers shall submit:

(1) an accreditation self-study;

(2) a copy of the formal accreditation certificate; and

(3) any correspondence or updates to or from the accrediting organization which impact the provider's status.

(m) Subscription or Membership Services. An EMS provider that operates or intends to operate a subscription or membership program for the provision of EMS within the provider's service area shall meet all the requirements for an EMS provider license as established by the Health and Safety Code, Chapter 773, and the rules adopted thereunder, and shall obtain department approval prior to soliciting, advertising or collecting subscription or membership fees. To obtain department approval for a subscription or membership program, the EMS provider shall:

(1) Obtain written authorization from the highest elected official (County Judge or Mayor) of the political subdivision(s) where subscriptions will be sold. Written authorization must be obtained from each County Judge if subscriptions are to be sold in multiple counties.

(A) The County Judge must provide written authorizations, if subscriptions are to be sold throughout a county.

(B) The Mayor may provide written authorization if subscriptions are sold exclusively within the boundaries of an incorporated town or city.

(C) If an EMS provider is not the primary emergency provider in any area where they are going to sell a subscription plan, written notification must be provided to the participants receiving subscription plan stating that the EMS Provider is not the primary emergency provider in this area. A copy of this documentation should be provided to the primary emergency provider and the department within 30 days before the beginning of any enrollment period.

(2) Submit a copy of the contract used to enroll participants.

(3) The EMS provider shall maintain a current file of all advertising for the service. Submit a copy of all advertising used to promote the subscription service within 30 days before the beginning of any enrollment period.

(4) Comply with all state and federal regulations regarding billing and reimbursement for participants in the subscription service.

(5) Provide evidence of financial responsibility by:

(A) obtaining a surety bond payable to the department in an amount equal to the funds to be subscribed. The surety bond must be on a department bond form and be issued by a company licensed by or eligible to do business in the State of Texas; or

(B) submitting satisfactory evidence of self-insurance an amount equal to the funds to be subscribed if the provider is a function of a governmental entity.

(6) Not deny emergency medical services to non-subscribers or subscribers of non-current status.

(7) Be reviewed at least every year; and the subscription program may be reviewed by the department at any time.

(8) Furnish a list after each enrollment period with the names, addresses, dates of enrollment of each subscriber, and subscription fee paid by each subscriber.

(9) Furnish the department beginning and ending dates of enrollment period(s). Subscription service period shall not exceed one year. Subscribers shall not be charged more than a prorated fee for the remaining subscription service period that they subscribe for.

(10) Furnish the department with the total amount of funds collected each year.

(11) Not offer membership nor accept members into the program who are Medicaid clients.

(n) Responsibilities of the EMS provider. During the license period, the EMS provider's responsibilities shall include:

(1) assuring that all response-ready and in-service vehicles are available 24 hours a day and seven days a week, maintained, operated, equipped and staffed in accordance with the requirements of the provider's license, to include staffing, equipment, supplies, required insurance and additional requirements per the current EMS provider's medical director approved protocols and policies;

(2) each EMS provider shall develop, implement, maintain, and evaluate an effective, ongoing, system-wide, data-driven, interdisciplinary quality assessment and performance improvement program. The program shall be individualized to the provider and shall, at a minimum, include:

(A) the standard of patient care as directed by the medical director's protocols and medical director input into the provider's policies and standard operating procedures;

(B) a complaint management system;

(C) monitoring the quality of patient care provided by the personnel and taking appropriate and immediate corrective action to insure that quality of care is maintained in accordance with the existing standards of care and the provider medical director's signed, approved protocols;

(D) the program shall include, but not be limited to, an ongoing program that achieves measurable improvement in patient care outcomes and reduction of medical errors;

(3) provide an attestation or provide documentation that its management staff will or continue to participate in the local regional advisory council;

(4) when an air ambulance is initiated through any other method than the local 911 system the air service providing the air ambulance is required to notify the local 911 center or the appropriate local response system for the location of the response at time of launch. This would not include interfacility transports or schedule transports;

(5) ensuring that all personnel are currently certified or licensed by the department;

(6) assuring that all personnel, when on an in-service vehicle or when on the scene of an emergency, are prominently identified by, at least, the last name and the first initial of the first name, the certification or license level and the EMS provider's name. A provider may utilize an alternative identification system in incident specific situations that pose a potential for danger if the individuals are identified by name;

(7) assuring the confidentiality of all patient information is in compliance with all federal and state laws;

(8) assuring that Informed Treatment/Transport Refusal forms are signed by all persons refusing service, or documenting incidents when a signed Informed Treatment/Transport Refusal form cannot be obtained;

(9) assuring that patient care reports are completed accurately for all patients and meet standards as outlined in 25 Texas Administrative Code, Chapter 103;

(10) assuring that patient care reports are provided to facilities receiving the patient:

(A) whenever operationally feasible, the report shall be provided to the receiving facility at the time the patient is delivered or a full written or computer generated report shall be delivered to the facility within 24 hours of the delivery of the patient,

(B) if in a response-pending status, an abbreviated documented report shall be provided at the time the patient is delivered and a completed written or computer generated report shall be delivered to the facility within 24 hours of the delivery of the patient;

(C) the abbreviated report shall document, at a minimum, the patient's name, patient's condition upon arrival at the scene; the prehospital care provided; the patient's condition during transport, including signs, symptoms, and responses to treatment during the transport; the call initiation time; dispatch time; scene arrival time; scene departure time; hospital arrival time; and, the identification of the ambulance staff; and

(D) in lieu of subparagraph (C) of this paragraph, personnel may follow the Regional Advisory Council's process for providing abbreviated documentation to the receiving facility.

(11) assuring that all pharmaceuticals are stored according to conditions specified in the pharmaceutical storage policy approved by the EMS provider's medical director;

(12) assuring that staff completes a readiness inspection as written by the EMS provider's policy;

(13) assuring that there is a preventive maintenance plan for vehicles and equipment.

(14) assuring that staff has reviewed policies and procedures as approved by the EMS Provider and the EMS Provider Medical Director;

(15) Maintenance of medical reports.

(A) A licensed EMS provider shall maintain adequate medical reports of a patient for a minimum of seven years from the anniversary date of the date of last treatment by the EMS provider.

(B) If a patient was younger than 18 years of age when last treated by the provider, the medical reports of the patient shall be maintained by the EMS provider until the patient reaches age 21 or for seven years from the date of last treatment, whichever is longer.

(C) An EMS provider may destroy medical records that relate to any civil, criminal or administrative proceeding only if the provider knows the proceeding has been finally resolved.

(D) EMS providers shall retain medical records for a longer length of time than that imposed herein when mandated by other federal or state statute or regulation.

(E) EMS providers may transfer ownership of records to another licensed EMS provider only if the EMS provider, in writing, assumes ownership of the records and maintains the records consistent with this chapter.

(F) Destruction of medical records shall be done in a manner that ensures continued confidentiality.

(G) At the time of initial licensing and at each license renewal, the EMS provider and medical director must attest or provide documentation to the department a plan for the going out of business, selling, transferring the business to ensure the maintenance of the medical record as outlined in subparagraph (E) of this paragraph.

(H) The emergency medical services provider must maintain all patient care records in the physical location that is the provider's primary place of business, unless the department approves an alternate location.

(16) assuring that all requested patient records are made promptly available to the medical director, hospital or department when requested;

(17) assuring that current protocols, equipment, supply and medication lists, and the correct original Vehicle Authorization at the appropriate level are maintained on each response-ready vehicle;

(18) monitoring and enforcing compliance with all policies and protocols;

(19) assuring provisions for the appropriate disposal of medical and/or biohazardous waste materials;

(20) assuring ongoing compliance with the terms of first responder agreements;

(21) assuring that all documents, reports or information provided to the department and hospital are current, accurate and complete;

(22) assuring compliance with all federal and state laws and regulations and all local ordinances, policies and codes at all times;

(23) assuring that all response data required by the department is submitted in accordance with §103.5 of this title (relating to Reporting Requirements for EMS Providers);

(24) assuring that, whenever there is a change in the EMS provider's name or the service's operational assumed name, the printed name on the vehicles are changed accordingly within 30 days of the change;

(25) assuring that the department is notified within 30 business days whenever:

(A) a vehicle is sold, substituted or replaced;

(B) there is a change in the level of service;

(C) there is a change in the declared service area as written on an initial or renewal application;

(D) there is a change in the official business mailing address;

(E) there is a change in the physical location of the business and/or substations;

(F) there is a change in the physical location of patient report file storage, to assure that the department has access to these records at all times; and

(G) there is a change of the administrator of record.

(26) assuring that when a change of the medical director has occurred the department is notified within one business day;

(27) develop, implement and enforce written operating policies and procedures required under this chapter and/or adopted by the licensee. Assure that each employee (including volunteers) is provided a copy upon employment and whenever such policies and/or procedures are changed. A copy of the written operating policies and procedures shall be made available to the department on request. Policies at a minimum shall adequately address:

(A) personal protective equipment;

(B) immunizations available to staff;

(C) infection control procedures;

(D) management of possible exposure to communicable disease;

(E) emergency vehicle operation;

(F) contact information for the designated infection control officer for whom education based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff- 136 has been documented.

(G) credentialing of new response personnel before being assigned primary care responsibilities. The credentialing process shall include as a minimum:

(i) a comprehensive orientation session of the services, policies and procedures, treatment and transport protocols, safety precautions, and the quality management process; and

(ii) an internship period in which all new personnel practice under the supervision of, and are evaluated by, another more experienced person.

(H) appropriate documentation of patient care; and

(I) vehicle checks, equipment, and readiness inspections;

(J) the security of medications, fluids and controlled substances in compliance with local, state and federal laws or rules.

(28) assuring that manufacturers' operating instructions for all critical patient care electronic and/or technical equipment utilized by the provider are available for all response personnel;

(29) assuring that the department is notified within five business days of a collision involving an in-service or response ready EMS vehicle that results in vehicle damage whenever:

(A) the vehicle is rendered disabled and inoperable at the scene of the occurrence; or

(B) there is a patient on board.

(30) assuring that the department is notified within one business day of a collision involving an in-service or response ready EMS vehicle that results in vehicle damage whenever there is personal injury or death to any person;

(31) maintaining motor vehicle liability insurance as required under the Texas Transportation Code;

(32) maintaining professional liability insurance coverage in the minimum amount of $500,000 per occurrence, with a company licensed or deemed eligible by the Texas Department of Insurance to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of, or caused by the care, or lack of care, of a patient;

(33) insuring continuous coverage for the service area defined in documents submitted with the EMS provider application;

(34) responding to requests for assistance from the highest elected official of a political subdivision or from the department during a declared emergency or mass casualty situation according to national, state, regional and/or local plans, when authorized;

(35) providing written notice to the department, RAC and Emergency Medical Task Force, if the EMS provider will make staff and equipment available during a declared emergency or mass casualty situation, for a state or national mission, when authorized;

(36) assuring all EMS personnel receive continuing education on the provider's anaphylaxis treatment protocols. The provider shall maintain education and training records to include date, time, and location of such education or training for all its EMS personnel;

(37) immediately notify the department in writing when operations cease in any service area;

(38) assure that all patients transported by stretcher must be in a department authorized EMS vehicle; and

(39) develop or adopt and then implement policies, procedures and protocols necessary for its operations as an EMS provider, and enforce all such policies, procedures and protocols.

(o) License renewal process.

(1) It shall be the responsibility of the provider to request license renewal application information.

(2) EMS providers shall submit a completed application, all other required documentation and a nonrefundable license renewal fee, no later than 90 days prior to the expiration date of the current license.

(A) When a complete application is received by the department 90 or more days prior to the expiration date of the current license that is to be renewed, the applicant shall submit a nonrefundable application fee of $400 per provider plus $180 for each EMS vehicle.

(B) When a complete application is received by the department 60 or more days, but less than 90 days prior to the expiration date of the current license that is to be renewed, the applicant shall submit a nonrefundable application fee of $450 per provider plus $180 for each EMS vehicle.

(C) When a complete application is received by the department less than 60 days prior to the expiration of the current license, the applicant shall submit a nonrefundable application fee of $500 per provider plus $180 for each EMS vehicle.

(D) If the application for renewal is received by the department after the expiration date of the current license, it is deemed to be untimely filed and that license expires on its expiration date. The EMS provider will be required to file a new initial application and follow the initial application process.

(E) An EMS provider may not operate after its license has expired.

(p) Provisional License. The department may issue an EMS provisional license if an urgent need exists in a service area when the department finds that the applicant is in substantial compliance with the provisions of this section and if the public interest would be served. A provisional license shall be effective for no more than 30 days from the date of issuance.

(1) An EMS provider may apply for a provisional license by submitting a written request and a nonrefundable fee of $30.

(2) A provisional license issued by the department may be revoked at any time by the department, with written notice to the provider, when the department finds that the provider is failing to provide appropriate service in accordance with this section or that the provider is in violation of any of the requirements of this chapter.

(q) Advertisements.

(1) Any advertising by an EMS provider shall not be misleading, false, or deceptive. When an EMS provider advertises in Texas and/or conducts business in Texas by regularly transporting patients from, or within Texas, the provider shall be required to have a Texas EMS Provider License.

(2) An EMS provider shall not advertise levels of patient care which it cannot provide at all times. The provider shall not use a name, logo, art work, phrase or language that could mislead the public to believe a higher level of care is being provided.

(3) An EMS provider that has more than five paid staff, but is composed of at least 75% volunteer EMS personnel may advertise as a volunteer service.

(r) Surveys/Inspections and Investigations.

(1) The department may conduct scheduled or unannounced on-site inspection or investigation of a provider's vehicles, office(s), headquarter(s) and/or station(s) (hereinafter operations), at any reasonable time, including while services are being provided, to ensure compliance with Health and Safety Code, Chapter 773 and this chapter.

(2) An applicant or licensee, by applying for or holding a license, consents to entry and inspection or investigation of any of its operations by the department, as provided for by the Health and Safety Code, Chapter 773 and this chapter.

(3) Department's inspections or investigations to evaluate an EMS provider's compliance with the requirements of the Health and Safety Code, Chapter 773 and this chapter, may include:

(A) initial, prelicensure and change in status inspections for the issuance of a new license;

(B) routine inspection conducted at the departments' discretion or prior to renewal;

(C) follow-up on-site inspection, conducted to evaluate implementation of a plan of correction for deficiencies cited during a department investigation or inspection;

(D) a complaint investigation, conducted in response to a report or complaint, as described in subsection (u) of this section, relating to complaint investigations; and

(E) an inspection to determine if a person, company, or organization is offering or providing EMS service(s) without a license, or to determine if EMS vehicles are being staffed by persons who do not hold Texas EMS certification or license.

(4) The provider and medical director shall cooperate with any department investigation or inspection, and shall, consistent with applicable law, permit the department to examine the provider's grounds, buildings, books, records and other documents and information maintained by or on behalf of the provider, that are necessary to evaluate compliance with applicable statutes, rules, plans of correction and orders with which the EMS provider is required to comply. The EMS provider shall permit the department, consistent with applicable law, to interview members of the governing authority, personnel and patients.

(5) The EMS provider shall, consistent with applicable law, permit the department to copy or reproduce, or shall provide photocopies to the department of any requested records or documents. If it is necessary for the department to remove records or other information (other than photocopies) from the provider's premises, the department will provide the EMS provider's governing authority or designee with a written statement of this fact, describing the information being removed and when it is expected to be returned. The department will make a reasonable effort, consistent with the circumstances, to return the records the same day.

(6) The department will hold an entrance conference with the EMS provider, governing authority or designee before beginning the inspection or investigation, to explain, consistent with applicable law, the nature, scope and estimated time schedule of the inspection or investigation.

(7) Except for a complaint investigation or a follow-up visit, an inspection will include an evaluation of compliance with the Health and Safety Code, Chapter 773 and the rules of this chapter. During the inspection, the department representative will, unless otherwise provided for by law, inform the EMS provider's governing authority or designee of the preliminary findings and give the provider a reasonable opportunity to submit additional facts or other information to the department representative in response to those findings.

(8) When the inspection is complete, the department will hold an exit conference with the provider, unless otherwise provided for by law, to inform the provider, to the extent permitted by law, of any preliminary findings of the inspection or investigation and to give the EMS provider the opportunity to provide additional information regarding the deficiencies cited. If no deficiencies are identified at the time of inspection, a statement indicating this fact may be left with the EMS provider's governing authority or designee. Such a statement does not constitute a department finding or certification that the facility is in compliance.

(9) If deficiencies are cited:

(A) the department will provide the EMS provider's administrator of record and medical director with a written deficiency report no more than 30 calendar days after the exit conference.

(B) The EMS provider's governing authority, designee, or person in charge at the time shall sign an acknowledgement of the inspection and receipt of the written deficiency report and return it to the department. The signature does not indicate the EMS provider's agreement with, or admission to the cited deficiencies unless the agreement or admission is explicitly stated.

(C) No later than 30 calendar days after the EMS provider's receipt of the deficiency report, the EMS provider shall return a written plan of correction to the department for each deficiency, including time frames for implementation, together with any additional evidence of compliance the EMS provider may have, regarding any cited deficiency. The department will determine if the written plan of correction and proposed timeframes for implementation are acceptable. If the plan is not acceptable, the department will notify the provider in writing no later than 30 days after receipt and request a modified plan. The EMS provider shall modify and resubmit the plan of correction no later than 30 calendar days after the EMS provider's receipt of the request. The EMS provider shall correct the identified deficiencies and submit documentation to the department verifying completion of the corrective action within the timeframes set forth in the plan of correction accepted by the department, or as otherwise specified by the department. The provider will be deemed to have received the deficiency report or other department correspondence mailed under this subparagraph three days after mailing.

(D) Regardless of the EMS provider's compliance with this subsection, the department's acceptance of the provider's plan of correction, or the provider's utilization of an informal compliance group review under paragraph (10) of this subsection, the department may, at any time, propose to take action as appropriate under §157.16 of this title (relating to Emergency Suspension, Suspension, Probation, Revocation, Denial of a Provider License or Administrative Penalties).

(10) The department inspector will inform the provider's chief executive officer, designee, or person in charge at the time of the inspection, of the provider's right to an informal compliance group review, when there is disagreement with deficiencies cited by the inspector or investigator, that the provider was unable to resolve through submission of information to the inspector or additional information bearing on the deficiencies cited.

(11) The department shall refer issues and complaints relating to the conduct or actions by licensed professionals to their appropriate licensing boards.

(12) All initial applicants and their medical director shall be required to have an initial compliance survey by the department that evaluates all aspects of the applicant's proposed operations including clinical care components and an inspection of all vehicles prior to the issuance of a license.

(13) At renewal, randomly, or in response to a complaint, the department may conduct an unannounced compliance survey that includes inspection of a provider's vehicles, operations and/or records to ensure compliance with this title at any time, including nights or weekends.

(14) If a re-survey/inspection to ensure correction of a deficiency is conducted, the provider shall pay a nonrefundable fee of $30 per vehicle needing a re-inspection.

(s) Specialty Care Transports. A Specialty Care Transport is defined as the interfacility transfer by a department licensed EMS provider of a critically ill or injured patient requiring specialized interventions, monitoring and/or staffing. To qualify to function as a Specialty Care Transport the following minimum criteria shall be met:

(1) Qualifying Interventions:

(A) patients with one or more of the following IV infusions: vasopressors; vasoactive compounds; antiarrhythmics; fibrinolytics; tocolytics; blood or blood products and/or any other parenteral pharmaceutical unique to the patient's special health care needs; and

(B) one or more of the following special monitors or procedures: mechanical ventilation; multiple monitors; cardiac balloon pump; external cardiac support (ventricular assist devices, etc); any other specialized device, vehicle or procedure unique to the patient's health care needs.

(2) Equipment. All specialized equipment and supplies appropriate to the required interventions shall be available at the time of the transport.

(3) Minimum Required Staffing. One currently certified EMT-Basic and one currently certified or licensed paramedic with the additional training as defined in paragraph (4) of this subsection; or, a currently certified EMT-Basic and a currently certified or licensed paramedic accompanied by at least one of the following: a Registered Nurse with special knowledge of the patient's care needs; a certified Respiratory Therapist; a licensed physician; or, any other licensed health care professional designated by the transferring physician.

(4) Additional Required Education and Training for Certified/Licensed Paramedics: Evidence of successful completion of post-paramedic education, training and appropriate periodic skills verification in management of patients on ventilators, 12 lead EKG and/or other critical care monitoring devices, drug infusion pumps, and cardiac and/or other critical care medications, or any other specialized procedures or devices determined at the discretion of the EMS provider's medical director.

(t) For all initial applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with the initial application and renewal application processing through Texas Online.

(u) Complaint Investigations.

(1) Upon request, all licensed EMS Providers shall make available for a patient or its legal guardian a written statement supplied by the department, identifying the department as the responsible agency for conducting EMS provider and EMS personnel complaint investigations. The statement shall inform persons that they may direct a complaint to the Department of State Health Services, EMS Compliance Group, by phone, or by email. The statement shall provide the most current contact information, including the appropriate department group, address, local and toll-free telephone number, and email address for filing a complaint.

(2) The department evaluates all complaints made against EMS providers and/or EMS personnel. Any complaint submitted to the department shall be submitted by telephone, electronically, or in writing, using the department's current contact information for that purpose, as described in paragraph (1) of this subsection.

(3) The department will document, evaluate and prioritize complaints and information received, based on the seriousness of the alleged violation and the level of risk to patients, personnel and/or the public.

(A) Allegations determined to be within the department's regulatory jurisdiction relating to emergency medical services are authorized for investigation under this chapter. Complaints received that are outside the department's jurisdiction may be referred to another appropriate agency for response.

(B) The investigation is conducted on-site, by telephone and/or through written correspondence.

(4) The department conducts a prompt and thorough investigation of all reports or complaint allegations that may pose a threat of harm to the health and safety of patients or participants. Reports or complaints received by the department concerning alleged abuse, neglect and exploitation will be addressed in accordance with Human Resources Code, Chapter 48 and Family Code, §261.101(d).

(5) The department evaluates complaint allegations that do not pose a significant risk of harm to patients. Based on the nature and severity of the alleged incident, the department determines whether to investigate the complaint directly or to require the provider to conduct an internal investigation and submit its findings and supporting evidence to the department.

(A) The findings of an EMS provider's internal investigation will be reviewed by the department and may result in an additional investigation by the department, a request for a plan of correction to be completed by the provider in accordance with subsection (q) of this section (relating to inspections and investigations) and/or a proposal to take action against the provider under §157.16 of this title.

(B) The EMS provider under investigation shall provide department staff access to all documents, evidence and individuals related to the alleged violation, including all evidence and documentation relating to any internal investigations.

(6) Once an internal EMS provider investigation and/or department investigation is complete, the department reviews the evidence from the investigation to evaluate whether the evidence substantiates the complaint and what corrective action, if any, is needed.

§157.12.Rotor-wing Air Ambulance Operations.

(a) Rotary wing aircraft (helicopters) operated by a licensed emergency medical services (EMS) provider shall be at the mobile intensive care level. Persons or entities operating rotary wing air ambulances must direct and control the integrated activities of both the medical and aviation components. Although the aircraft operator is directly responsible to the Federal Aviation Administration (FAA) for the operation of the aircraft, typically the organization in charge of the medical functions directs the combined efforts of the aviation and medical components during patient transport operations. Licensed rotary wing aircraft must also meet the requirements of §157.11 of this title (relating to Requirements for an EMS Provider License) as long as the Airline Deregulation Act of 1978, 49 U.S.C. §41713 (b)(1) et seq. is not violated.

(b) When being used as an ambulance, the helicopter shall:

(1) be configured so that the medical personnel have adequate access to the patient in order to begin and maintain basic and advanced life support treatment;

(2) have an entry that allows loading and unloading of a patient without excessive maneuvering (no more than 45 degrees about the lateral axis and 30 degrees about the longitudinal axis); and does not compromise functioning of monitoring systems, intravenous (IV) lines, or manual or mechanical ventilation;

(3) have a supplemental lighting system in the event standard lighting is insufficient for patient care that includes:

(A) a self-contained lighting system powered by a battery pack or a portable light with a battery source; and

(B) a means to protect the pilot's night adaptation vision. (Use of red lighting or low intensity lighting in the patient care area is acceptable if not able to isolate the patient care area);

(4) have an electric power outlet with an inverter or appropriate power source of sufficient output to meet the requirements of the complete specialized equipment package without compromising the operation of any electrical aircraft equipment;

(5) have protection of the pilot's flight controls, throttles and radios from any intended or accidental interference by the patient, air medical personnel or equipment and supplies; and

(6) have an internal medical configuration located so that air medical personnel can provide patient care consistent with the scope of care of the air medical service, to include:

(A) the space necessary to ensure the patient's airway is maintained and to provide adequate ventilatory support from the secured, seat-belted position of the air medical personnel;

(B) those aircraft with gaseous oxygen systems have equipment installed so that medical personnel can determine if oxygen is on by in-line pressure gauges mounted in the patient care area. Aircraft using liquid or gaseous oxygen should have equipment installed:

(i) with each gas outlet clearly marked for identification;

(ii) with oxygen flow capable of being stopped at the oxygen source from inside the aircraft; and

(iii) so that the measurement of the liter flow and quantity of oxygen remaining is accessible to air medical personnel while in flight. All flow meters and outlets must be padded, flush mounted, or so located as to prevent injury to air medical personnel; or there shall be an operational policy stating that attendants wear helmets;

(C) hangers/hooks available to secure (IV) solutions in place or a mechanism to provide high flow fluids if needed:

(i) all IV hooks shall be padded, flush mounted, or so located as to prevent head trauma to the air medical personnel in the event of a hard landing or emergency with the aircraft; or an operational policy stating that attendants wear helmets; and

(ii) glass containers shall not be used unless required by medication specifications and properly vented;

(D) provision for medication which allows for protection from extreme temperatures if it becomes environmentally necessary;

(E) secure positioning of cardiac monitors, defibrillators, and external pacers so that displays are visible to medical personnel; and

(F) shall assure that all specialized medical equipment is secured throughout transport with adequately engineered designated mounts as approved by FAA.

(c) An air ambulance provider shall meet the responsibilities of EMS providers as in §157.11 of this title (relating to Requirements for an EMS Provider License) and in addition shall:

(1) submit proof that the rotor-wing aircraft provider carries bodily injury and property damage insurance with a company licensed to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the operation or use of any of the certificate holder's aircraft.

(2) submit proof that the air ambulance provider carries professional liability insurance coverage in the minimum amount of $500,000 per occurrence, with a company licensed to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the care or lack of care of a patient;

(3) submit a list of all aircraft with the registration number or "N" number for the helicopters in the possession of the provider.

(4) submit a letter of agreement that all helicopters shall meet the specifications of subsection (b) of this section, if the aircraft is leased from a pool;

(5) allow visual and physical inspection of each aircraft and of the equipment to be used on each vehicle for the purpose of determining compliance with the vehicle and equipment specifications within this section; and

(6) submit a copy of current Federal Aviation Administration (FAA) carrier, operational, and airworthiness certification, as per U.S, Code of Federal Regulations, Title 14, Subchapter G, Part 135).

(d) The air ambulance provider shall employ a medical director who shall meet the following qualifications:

(1) be a physician approved by the department and in practice;

(2) have knowledge and experience consistent with the transport of patients by air;

(3) be knowledgeable in aeromedical physiology, stresses of flight, aircraft safety, patient care, and resource limitations of the aircraft, medical staff and equipment;

(4) have access to consult with medical specialists for patient(s) whose illness and care needs are outside the medical director's area of practice;

(5) shall comply with the requirements in the Medical Practice Act, Occupations Code, Chapters 151 - 168, and 22 Texas Administrative Code, Chapter 197; and

(6) have knowledge on Texas EMS laws and regulations affecting local, regional and state operations.

(e) The physician shall fulfill the following responsibilities:

(1) ensure that there is a comprehensive plan/policy to address selection of appropriate aircraft, staffing and equipment;

(2) be involved in the selection, hiring, educating, training and continuing education of all medical personnel;

(3) be responsible for overseeing the development and maintenance of a continuous quality improvement program;

(4) ensure that there is a plan to provide direction of patient care to the air medical personnel during transport. The system shall include on-line (radio/telephone) medical control, and/or an appropriate system for off-line medical control such as written guidelines, protocols, procedures, patient specific written orders or standing orders;

(5) participate in any administrative decision making processes that affect patient care;

(6) ensure that there is an adequate method for on-line medical control, and that there is a defined plan or procedure and resources in place to allow off-line medical control;

(7) oversee the review, revision and validation of written medical policies and protocols annually for the treatment and transportation of adult, pediatric, and neonatal patients; and

(8) attest to the following capabilities:

(A) experience consistent with the transport of patients by air;

(B) knowledge of aeromedical physiology, stresses of flight, aircraft safety, resources limitations of the aircraft;

(C) knowledge on Texas EMS laws and regulations affecting local, regional and state operations; and

(D) awareness that the EMS provider has provided safety education for ground emergency services personnel.

(f) There shall be two Texas licensed/certified personnel on board the helicopter when in service. A waiver to the Texas license/certification may be granted for personnel employed by providers in New Mexico, Oklahoma, Arkansas, Kansas, Colorado and Louisiana who respond in Texas and are licensed in their respective state. Staffing of vehicles shall be as follows:

(1) when responding to an emergency scene, at least one of the personnel shall be a paramedic;

(2) when responding for an inter-facility transfer, at least one of the personnel performing patient care duties shall be a certified or licensed paramedic, registered nurse or physician. The qualifications and numbers of air medical personnel shall be appropriate to patient care needs;

(3) when responding as in paragraphs (1) and (2) of this subsection, the second person may be a certified or licensed paramedic, registered nurse, or a physician; and

(4) air medical personnel shall not be assigned or assume the cockpit duties of the flight crew members concurrent with patient care duties and responsibilities.

(g) Documentation of successful completion of education specific to the helicopter transport environment in general and the licensee's operation specifically shall be required. The curriculum shall be consistent with the Department of Transportation (DOT) Air Medical Crew - National EMS Education Standards or equivalent program and each attendant's qualifications shall be documented.

(h) Medical supplies and equipment shall be consistent with the service's scope of care as defined in the protocols/standing orders for adult, pediatric, and neonatal patients. Medical equipment shall be functional without interfering with the avionics nor should avionics interfere with the function of the medical equipment. Additionally, the following equipment, clean and in working order, must be on the aircraft or immediately available for all providers:

(1) one or more stretchers capable of being secured in the aircraft which meet the following criteria:

(A) can accommodate an adult, 6 feet tall, weighing 212 pounds. There shall be restraining devices or additional appliances available to provide adequate restraint of all patients including those under 60 pounds or 36 inches in height;

(B) shall have the head of the primary stretcher, with recommended manufacturer's or FAA approved restraint system in place, capable of being elevated up to 30 degrees. The elevating section shall not interfere with or require that the patient or stretcher securing straps and hardware be removed or loosened;

(C) shall be sturdy and rigid enough that it can support cardiopulmonary resuscitation. If a backboard or equivalent device is required to achieve this, such device will be readily available;

(D) shall have a pad or mattress impervious to moisture and easily cleaned and disinfected according to Occupational Safety and Health Administration (OSHA) bloodborne pathogen requirements; and

(E) shall have a supply of linen for each patient;

(2) adequate amounts of oxygen and masks (for anticipated liter flow and length of flight with an emergency reserve) available for every mission;

(3) one portable oxygen tank;

(4) a back-up source of oxygen (of sufficient quantity to get safely to a facility for replacements). A back-up source may be the required portable tank if the tank is accessible in the patient care area during flight;

(5) airway adjuncts as follows:

(A) oropharyngeal airways in at least five assorted sizes, including for adult, pediatric, and neonatal patients; and

(B) nasopharyngeal airways in at least three sizes with water soluble lubricant;

(6) at least one suction unit which is portable (bulb syringes or foot pump is not acceptable);

(7) the following items in amounts and sizes as specified on a list signed by the medical director:

(A) IV solutions;

(B) IV catheters;

(C) endotracheal tubes;

(D) medications;

(E) any specialized equipment required in medical treatment protocols/standing orders;

(F) pressure bag;

(G) tourniquets, tape, dressings; and

(H) container appropriate to contain used sharp devices (needles, scalpels) which meets OSHA requirements;

(8) assessment equipment as follows:

(A) equipment suitable to determine blood pressure of an adult, pediatric, and neonatal patients during flight;

(B) stethoscope;

(C) penlight/flashlight;

(D) heavy duty bandage scissors;

(E) pulse oximeter;

(F) external cardiac pacing device; and

(G) IV infusion pump capable of strict mechanical control of an IV infusion drip rate. Passive devices such as dial-a-flow are not acceptable;

(9) bandages and dressings as follows:

(A) sterile dressings such as 4x4s, abdominal pads;

(B) bandages such as Kerlix, Kling; and

(C) tape in various sizes;

(10) container(s) and methods to collect, contain, and dispose of body fluids such as emesis, oral secretions, and blood consistent with OSHA bloodborne pathogen requirements;

(11) infection control equipment. The licensee shall have a sufficient quantity of the following supplies for all air medical personnel, and each flight crew member, and all ground personnel with incidental exposure risks according to OSHA requirements which includes but is not limited to:

(A) protective gloves;

(B) protective gowns;

(C) protective eyewear;

(D) protective face masks, National Institute for Occupational Safety and Health (NIOSH) approved N95 or greater;

(E) an approved bio-hazardous waste plastic bag or impervious container to receive and dispose of used supplies; and

(F) handwashing capabilities or antiviral towelettes;

(12) an adequate trash disposal system exclusive of bio-hazardous waste control provisions;

(13) security of medications, fluids, and controlled substances shall be maintained by each air ambulance licensee in compliance with local, state, and federal drug laws;

(14) 12-lead cardiac monitor defibrillator - DC battery powered portable monitor/defibrillator with paper printout, accessories and supplies, with sufficient power supply to meet demands of the mission;

(15) quantity and type of drugs and specialized equipment as specified on the medical director's list;

(16) permanently installed climate control equipment to provide an environment appropriate for the medical needs of patients; and

(17) survival kit which shall include, but not be limited to, the following items which are appropriate to the terrain and environments the provider operates over:

(A) instruction manual;

(B) water;

(C) shelter-space blanket;

(D) knife;

(E) signaling devices;

(F) compass; and

(G) fire starting items.

§157.13.Fixed-wing Air Ambulance Operations.

(a) Fixed wing aircraft operated by a licensed EMS provider shall be at the mobile intensive care level. Persons or entities operating fixed wing air ambulances must direct and control the integrated activities of both the medical and aviation components. Although the aircraft operator is directly responsible to the Federal Aviation Administration (FAA) for the operation of the aircraft, one organization, typically the one in charge of the medical functions, directs the combined efforts of the aviation and medical components during patient transport operations. Licensed fixed wing aircraft must also meet the requirements of §157.11 of this title (relating to Requirements for an EMS Provider License), as long as the rule does not violate the Federal Aviation Act of 1958, 49 U.S.C. §§ et seq. and Airline Deregulation Act of 1978, 49 U.S.C. §41713 (b)(1).

(b) When being used as an ambulance, a fixed wing aircraft shall:

(1) be multi-engine or be a single, turbo-prop engine capable of maintaining cabin pressurization;

(2) maintain a cabin altitude consistent with patient diagnosis, condition, and destination;

(3) be equipped and kept current for instrument flight rules (IFR) flight;

(4) have a door large enough to allow a patient on a stretcher with the manufacturer's recommended or FAA approved stretcher restraint system in place to be enplaned without excessive maneuvering or tipping of the patient which compromises the function of monitoring devices, intravenous (IV) lines or ventilation equipment;

(5) be designed or modified to accommodate at least one stretcher patient with the manufacturer's recommended or FAA approved stretcher restraint system in place;

(6) have a lighting system which can provide adequate intensity to illuminate the patient care area and an adequate method (curtain, distance) to limit the cabin light from entering the cockpit and impeding cockpit crew vision during night operations;

(7) have permanently installed climate control equipment to provide an environment appropriate for the medical needs of the patient(s);

(8) have an interior cabin configuration large enough to accommodate the number of air medical personnel needed to provide care to the patient, as well as an adult stretcher in the cabin area with access to the patient. The configuration shall not impede the normal or emergency evacuation routes;

(9) have an electrical system capable of servicing the power needs of electrically powered on-board patient care equipment;

(10) have all installed and carry-on equipment secured using FAA-approved devices and methods;

(11) shall assure that all specialized medical equipment is secured throughout transport with adequately engineered designated mounts as approved by FAA.

(12) have sufficient space in the cabin area where the patient stretcher is installed so that equipment can be stored and secured with FAA approved devices in such a manner that it is accessible to the air medical personnel; and

(13) have two FAA approved fire extinguishers approved for aircraft use. Each shall be fully charged with valid inspection certification and capable of extinguishing type A, B, or C fires. One extinguisher shall be accessible to the cockpit crew and one shall be in the cabin area accessible to the medical crew member.

(c) An operator of aircraft in an air ambulance program shall be FAA certified as an air taxi and commercial operator (ACTO) with operation specifications allowing air ambulance operations.

(d) The fixed-wing air ambulance provider shall meet the responsibilities of EMS providers as in §157.11 of this title (relating to Requirements for an EMS Provider License) and shall also:

(1) submit proof that the fixed-wing aircraft provider carries bodily injury and property damage insurance with a company licensed to do business in Texas, in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the operation or use of any of the certificate holder's aircraft.

(2) submit proof that the air ambulance provider carries professional liability insurance coverage in the minimum amount of $500,000 per occurrence, with a company licensed to do business in Texas in order to secure payment for any loss or damage resulting from any occurrence arising out of or caused by the care or lack of care of a patient; and

(3) submit a letter of agreement that all fixed-wing aircraft shall meet the specifications of subsection (b) of this section, if the aircraft is leased from a pool; and

(4) submit a copy of current Federal Aviation Administration Air Taxi and Commercial Operator Certification.

(e) The air ambulance provider shall employ a medical director who shall meet the following qualifications:

(1) be a physician approved by the Texas Department of Health and in practice;

(2) have knowledge and experience consistent with the transport of patients by air;

(3) be knowledgeable in aeromedical physiology, stresses of flight, aircraft safety, patient care, and resource limitations of the aircraft, medical staff and equipment;

(4) have access to consult with medical specialists for patient(s) whose illness and care needs are outside the medical director's area of practice; and

(5) shall comply with the requirements in the Medical Practice Act, Occupations Code, Chapters 151 - 168, and 22 Texas Administrative Code, Chapter 197;

(f) The physician shall fulfill the following responsibilities:

(1) ensure that there is a comprehensive plan/policy to address selection of appropriate aircraft, staffing and equipment;

(2) be involved in the selection, hiring, educating, training and continuing education of all medical personnel;

(3) be responsible for overseeing the development and maintenance of a continuous quality improvement program;

(4) ensure that there is a plan to provide direction of patient care to the air medical personnel during transport. The system shall include on-line (radio/telephone) medical control, and/or an appropriate system for off-line medical control such as written guidelines, protocols, procedures, patient specific written orders or standing orders;

(5) participate in administrative decision making processes that affect patient care;

(6) ensure that there is an adequate method for on-line medical control, and that there is a defined plan or procedure and resources in place to allow off-line medical control;

(7) oversee the review, revision and validation of written policies and protocols annually for the treatment and transportation of adult, pediatric, and neonatal patients to include a policy defining the specific instances in which a patient could be accompanied by only one attendant; and

(8) attest to the following capabilities:

(A) experience consistent with the transport of patients by air;

(B) knowledge of aeromedical physiology, stresses of flight, aircraft safety, resources limitations of the aircraft;

(C) knowledge on Texas EMS laws and regulations affecting local, regional and state operations;

(D) awareness that the EMS provider has provided safety education for ground emergency services personnel.

(g) There shall be at least one licensed or certified paramedic, registered nurse, or physician on board an air ambulance to perform patient care duties on that air ambulance. The qualifications and numbers of air medical personnel shall be appropriate to patient care needs. Personnel employed by providers who are based in another state, do not need Texas certification/licensure but shall be certified/licensed in their respective state.

(1) Documentation of successful completion of education specific to the fixed-wing transport environment in general and the licensee's operation specifically shall be required. The curriculum shall be consistent with the Department of Transportation (DOT) Air Medical Crew - National EMS Education Standards, or equivalent program.

(2) Each attendant's qualifications shall be documented.

(3) Air medical personnel shall not be assigned or assume the cockpit duties of the flight crew members concurrent with patient care duties and responsibilities.

(4) The aircraft shall be operated by a pilot or pilots certified in accordance with applicable Federal Aviation Regulations.

(h) Medical supplies and equipment shall be consistent with the service's scope of care as defined in the protocols/standing orders for adult, pediatric, and neonatal patients. Medical equipment shall be functional without interfering with the avionics nor should avionics interfere with the function of the medical equipment. Additionally, the following equipment, clean and in working order, must be on the aircraft or immediately available for all providers:

(1) one or more stretchers installed in the aircraft cabin which meet the following criteria:

(A) can accommodate an adult, 6 feet tall, weighing 212 pounds except for a neonatal stretcher, with recommended manufacturer's or FAA approved restraint system in place, which has been fitted with an isolette. There shall be restraining devices or additional appliances available to provide adequate restraint of all patients including those under 60 pounds or 36 inches in height;

(B) the head of each stretcher, with recommended manufacturer's or FAA approved restraint system in place, shall be capable of being elevated up to 45 degrees. The elevating section must hinge at or near the patient's hips and shall not interfere with or require that the patient or stretcher securing straps and hardware be removed or loosened;

(C) each stretcher, with recommended manufacturer's or FAA approved restraint system in place, shall be positioned in the cabin to allow the air medical personnel clear view of the patient and shall ensure that medical personnel always have access to the patient's head and upper body for airway control procedures as well as sufficient space over the area where the patient's chest is to adequately perform closed chest compression or abdominal thrusts on the patient;

(D) a pad or mattress impervious to moisture and easily cleaned and disinfected according to Occupation Safety and Health Administration (OSHA) bloodborne pathogen requirements;

(E) a device to make the stretcher surface rigid enough if the surface of the stretcher under the patient's torso is not firm enough to support adequate chest compressions; and

(F) shall have a supply of linen for each patient;

(2) an adequate and manually-controlled supply of gaseous or liquid medical oxygen, attachments for humidification, and a variable flow regulator for each patient;

(A) a humidifier, if used, shall be a sterile, disposable, one-time usage item;

(B) the licensee shall have and demonstrate the method used to calculate the volume of oxygen required to provide sufficient oxygen for the patient's needs for the duration of the transport;

(C) the licensee shall have a plan to provide the calculated volume of oxygen plus a reserve equal 1000 liters or the volume required to reach an appropriate airport, whichever is longer;

(D) all necessary regulators, gauges and accessories shall be present and in good working order;

(E) the oxygen system shall be securely fastened to the airframe using FAA approved restraining devices;

(i) a separate emergency backup supply of oxygen of not less than 57 liters with regulator and flow meter;

(ii) one adult, one child, one pediatric, one neonatal size non- rebreathing mask, one adult size nasal cannula and necessary connective tubings and appliances.

(3) an electrically-powered suction apparatus with wide bore tubing, a large reservoir and various sizes suction catheters. The suction system may be built into the aircraft or provided with a portable unit. Backup suction is required and can be a manually operated device. (Bulb syringe not acceptable);

(4) hand operated bag-valve-mask ventilators of adult, pediatric and infant sizes with clear masks in adult, pediatric, and neonatal patients. It shall be capable of use with a supplemental oxygen supply and have an oxygen reservoir;

(5) airway adjuncts as follows:

(A) oropharyngeal airways in at least five assorted sizes, including for adult, pediatric, and neonatal patients; and

(B) nasopharyngeal airways in at least three sizes with water soluble lubricant;

(6) assessment equipment as follows:

(A) equipment suitable to determine blood pressure of the adult, pediatric, and neonatal patients during flight;

(B) stethoscope;

(C) penlight/flashlight;

(D) heavy duty bandage scissors; and

(E) pulse oximeter;

(7) bandages and dressings as follows:

(A) sterile dressings such as 4x4s, ABD pads;

(B) bandages such as Kerlix, Kling; and

(C) tape in various sizes.

(8) container(s) and methods to collect, contain, and dispose of body fluids such as emesis, oral secretions, and blood consistent with OSHA bloodborne pathogen requirements;

(9) urinal and bedpan with toilet tissue;

(10) infection control equipment. The licensee shall have a sufficient quantity of the following supplies for all air medical personnel, each flight crew member, and all ground personnel with incidental exposure risks according to OSHA requirements which includes but is not limited to:

(A) protective gloves;

(B) protective gowns;

(C) protective eyewear;

(D) protective face masks, National Institute for Occupational Safety and Health (NIOSH) approved N95 or greater;

(E) an approved bio-hazardous waste plastic bag or impervious container to receive and dispose of used supplies; and

(F) handwashing capabilities or antiviral towelettes.

(11) an adequate trash disposal system exclusive of bio-hazardous waste control provisions;

(12) the following additional equipment in amounts and sizes specified by the medical director is required for an air ambulance provider to function at the advanced level:

(A) advanced airway management equipment appropriate to the patient's needs;

(B) sterile crystalloid solutions in plastic containers, IV catheters, and administration tubing sets;

(C) hanger for IV solutions;

(D) pressure bag;

(E) tourniquets, tape, dressings;

(F) container appropriate to contain used sharp devices, needles, scalpels which meets OSHA requirements;

(G) a list signed by medical director defining quantities and types of drugs to be carried; and

(H) any specialized equipment required in medical treatment protocols/standing orders.

(13) cardiac monitor defibrillator-DC battery powered portable monitor/defibrillator with paper printout, accessories and supplies, with sufficient power supply to meet demands of the mission; and

(14) survival kit which shall include, but not be limited to, the following items which are appropriate to the terrain and environments the provider operates over:

(A) instruction manual;

(B) water;

(C) shelter-space blanket;

(D) knife;

(E) signaling devices;

(F) compass; and

(G) fire starting items.

(i) A system for security of medications, fluids, and controlled substances shall be maintained by each air ambulance licensee in compliance with local, state, and federal drug laws.

(j) The air ambulance provider shall own the following equipment or shall have a written lease agreement explaining the availability of the equipment for use when the patient's condition indicates the need:

(1) external cardiac pacing device;

(2) IV infusion pump capable of strict mechanical control of an IV infusion drip rate. Passive devices such as dial-a-flow are not acceptable; and

(3) a mechanical ventilator that can deliver up to 100% oxygen concentration at pressures, rates and volumes appropriate for the size of the patient.

§157.14.Requirements for a First Responder Organization License.

(a) A First Responder Organization (FRO) is a group or association of certified emergency medical services personnel that works in cooperation with a licensed emergency medical services provider to:

(1) routinely respond to medical emergency situations;

(2) utilize personnel who are emergency medical services (EMS) certified by the Texas Department of State Health Services (department); and

(3) provide on-scene patient care to the ill and injured and does not transport patients.

(b) Individuals or organizations meeting the description in subsection (a) of this section must comply with the requirements outlined in this section including submission of an application for a license.

(c) Application requirements for an FRO affiliated with a licensed EMS Provider.

(1) A Basic Life Support (BLS) or Advanced Life Support (ALS) First Responder Organization affiliated with a Texas licensed EMS Provider must apply for an FRO license by submitting a completed application to the department. A complete application consists of the following:

(A) provider license application form;

(B) personnel list including social security number or EMS personnel identification (ID) number and certification/licensure level;

(C) description and map of the service area;

(D) staffing plan including days of the week and hours of the day the FRO will be available for response;

(E) written affiliation agreement with the primary licensed EMS provider in the service area. The primary licensed EMS provider must provide a letter attesting that the following items have been reviewed and approved by the director and medical director of the EMS provider:

(i) level(s) of certification/licensure of FRO personnel providing care;

(ii) response, dispatch and treatment protocols including an equipment and supply list approved by the medical director of the licensed EMS provider to treat adult, pediatric and neonatal patients;

(iii) description of how the FRO receives notification of calls;

(iv) patient care reporting procedures;

(v) process for the assessment of care provided by the FRO personnel;

(vi) response code policies for FRO personnel;

(vii) on-scene chain-of-command policies;

(viii) policies regarding FRO personnel canceling en route EMS units;

(ix) policies regarding FRO personnel accompanying patients in EMS providers vehicles including when FRO personnel hold the highest certification or licensure on the scene; and

(x) patient confidentiality.

(F) It is not necessary to submit the individual items in subparagraph (E)(i) - (x) of this paragraph with the application, if each is referenced in the affiliation agreement. All items listed in this paragraph must be immediately available for review by department personnel upon request during unannounced site visits or complaint investigations.

(2) Any FRO which is, or has a contract with, an entity such as a business, corporation or department and whose first responder employees or members are compensated by that entity for providing first responder service shall pay a nonrefundable $60 application fee. If the license is issued for less than 12 months, the nonrefundable fee shall be $30. The FRO personnel described in this paragraph are not exempt from the payment of certification or license application fees.

(3) Applicants that meet all the requirements shall be issued an FRO license. The license may be valid for up to 2 years, but may be issued for less than 2 years for administrative purposes.

(4) Although not required, the FRO license application may be submitted with the license application of the affiliated EMS provider. The FRO is responsible for submitting fees, if applicable.

(5) An affiliation agreement between a licensed EMS provider and a licensed FRO does not automatically imply any legal liability beyond the agreements listed in paragraph (1)(E) of this subsection.

(6) A violation of statute or rule by an FRO will not implicate the affiliated EMS provider unless both organizations are involved in the violation. Likewise, a violation of statute or rule by an affiliated EMS provider does not implicate the FRO unless both organizations are involved in the violation.

(d) Application requirements for an FRO not affiliated with a licensed EMS provider.

(1) A BLS first responder organization not affiliated with a licensed EMS provider may apply for an FRO License by submitting a completed application to the department. A complete application consists of the following:

(A) application form;

(B) personnel list including social security number or personnel ID number and certification/licensure level;

(C) description and map of the service area;

(D) staffing plan including days of the week and hours of the day the FRO will be available for response;

(E) response, dispatch and treatment protocols including an equipment and supply list approved by the FRO medical director;

(F) letter of recognition from the primary licensed 911 EMS Provider or from the highest elected city/county official in the service area and a written explanation why the EMS provider will not enter into an agreement with the FRO;

(G) description of how the FRO receives notification of calls; and

(H) process for the assessment of care provided by the FRO personnel.

(I) The application for a FRO license will be considered incomplete if any items listed in subparagraphs (A) - (H) of this paragraph are not enclosed with the application.

(J) All items listed in subparagraphs (A) - (H) of this paragraph must be immediately available for review by department personnel if requested during unannounced site visits or complaint investigations.

(2) An ALS first responder organization not affiliated with a licensed EMS provider may apply for an FRO License by submitting a completed application to the department. A complete application consists of the following:

(A) application form;

(B) personnel list including social security number or personnel ID number and certification/licensure level;

(C) description and map of the service area; and

(D) staffing plan including days of the week and hours of the day the FRO will be available for response.

(E) The FRO shall have an agreement with all licensed EMS providers and their medical directors who routinely transport patients treated by the FRO's personnel. Each agreement shall be approved by the person responsible for the FRO, director and medical director of each licensed EMS provider. At a minimum, the agreements shall address:

(i) the level(s) of certification/licensure of FRO personnel providing care;

(ii) the response, dispatch and treatment protocols including an equipment and supply list approved by the FRO medical director and a letter of approval from the medical director(s) of the licensed transporting providers with whom the FRO has agreements;

(iii) a description of how the FRO receives notification of calls;

(iv) patient care reporting procedures;

(v) a process for the assessment of care provided by FRO personnel;

(vi) response code policies for FRO personnel;

(vii) on-scene chain-of-command policies;

(viii) policies regarding FRO personnel canceling en route EMS units;

(ix) policies regarding FRO personnel accompanying patients in provider's vehicles including when FRO personnel hold the highest certification or licensure on the scene; and

(x) patient confidentiality.

(F) The application for a FRO license is incomplete if any items listed in this paragraph are not enclosed with the application.

(G) All items listed in this paragraph must be immediately available for review by department personnel if requested during unannounced site visits or complaint investigations.

(3) Any FRO which is, or has a contract with, an entity such as a business, corporation or department and whose first responder employees or members are compensated by that entity for providing first responder services shall pay a nonrefundable $60 application fee. If the license is issued for less than 12 months, the nonrefundable fee shall be $30. The FRO personnel described in this paragraph are not exempt from the payment of certification and license application fees.

(4) Applicants that meet all the requirements for a license shall be issued an FRO license. The license is issued for 2 years. For administrative purposes, it may be issued for less than 2 years.

(e) Responsibilities of the FRO. During the license period the FRO's responsibilities shall include:

(1) assuring ongoing compliance with the terms of all EMS provider agreement(s);

(2) assuring the existence of and adherence to a quality assurance plan which shall, at a minimum, include:

(A) the standard of patient care and the medical director's protocols;

(B) pharmaceutical storage;

(C) readiness inspections;

(D) preventive maintenance of medical equipment and vehicles owned by the FRO;

(E) policies and procedures;

(F) complaint management; and

(G) patient care reporting and documentation;

(3) ensuring that all medical personnel are currently certified or licensed by the department;

(4) assuring that all personnel on the scene of an emergency are prominently identified by, at least, the last name and the first initial of the first name, the certification or license level and the FRO name. An FRO may utilize an alternative identification system in incident specific situations that pose a potential for danger if the individuals are identified by name;

(5) assuring that all vehicles utilized by FRO personnel carry proof of first responder registration or have the name of the FRO prominently displayed and visible from the outside of the vehicle while on the scene of an emergency;

(6) assuring the confidentiality of all patient information is in compliance with all federal and state laws;

(7) developing and adhering to an agreement between the primary transport provider and first responder organization concerning the use of patient refusal forms and documentation for incidents when an informed treatment refusal form cannot be obtained;

(8) developing and adhering to an agreement between the primary transport provider and first responder organization concerning the maintenance of FRO records;

(9) assuring that patient care reports are completed accurately for all patients:

(A) the report shall be accurate, complete and clearly written; and

(B) the report shall document, at a minimum, the patient's name, the patient's condition when first contacted by FRO personnel; the prehospital care provided; the dispatch time; scene arrival time; and the identification of the FRO personnel who provided care to the patient;

(10) assuring that all relevant patient care information is supplied in writing to the licensed EMS provider at the time the patient is transferred to the provider;

(11) assuring that a full written report is provided, upon request, within 1 business day to the transport provider and/or hospital facility where the patient was delivered;

(12) assuring that all requested patient records are made promptly available to the first responder organization's medical director;

(13) assuring that current protocols are available to all certified or licensed personnel;

(14) monitoring and enforcing compliance with all policies;

(15) assuring provisions for the appropriate disposal of medical and/or biohazardous waste materials;

(16) assuring that all documents, reports or information provided to the department are current, accurate and complete;

(17) assuring compliance with all federal and state laws and regulations and all local ordinances, policies and codes at all times;

(18) assuring that the department is notified within 5 business days whenever there is a change:

(A) in the level of service;

(B) in the declared service area;

(C) in the official business mailing address;

(D) in the physical location of the first responder organization;

(E) in the physical location of patient report file storage, to assure that the department has access to these records at all times;

(F) of the administrator;

(G) of the e-mail address; or

(H) of the EMS providers associated with the FRO.

(19) assuring that the department is notified within 1 business day when a change of the medical director has occurred;

(20) assuring the FRO has written operating policies, procedures and medical protocols and provides all medical personnel a copy initially and whenever such policies, procedures and/or medical protocols are changed. A copy of the written operating policies, procedures and medical protocols shall be made available to the department upon request. At a minimum, policies shall adequately address:

(A) personal protective equipment;

(B) immunizations available to personnel;

(C) infection control procedures;

(D) contact information for the designated infection control officer for whom education based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136 has been documented;

(E) management of possible exposure to communicable disease;

(F) credentialing of new response personnel before being assigned to respond to emergencies. The credentialing process shall include, at minimum:

(i) a comprehensive orientation session of the FRO's policies and procedures, safety precautions, and quality management process; and

(ii) an internship period in which all new personnel practice under the supervision of, and are evaluated by, another more experienced person, if operationally feasible; and

(G) appropriate documentation of patient care;

(21) assuring that all documents, reports or information provided to the department are current, truthful and correct;

(22) assuring that the department is notified within 1 business day of a collision involving an FRO vehicle responding to a scene or while at the scene of an emergency and resulting in personal injury or death of any person;

(23) maintaining motor vehicle and professional liability insurance as required by the Texas Transportation Code under Subchapter D, §601.071 and §601.072, for all vehicles owned or operated by the FRO;

(24) providing continuous coverage for the service area as defined in the staffing plan; and

(25) responding to requests for assistance from the highest elected official of a political subdivision or from the department during a declared emergency or mass casualty situation.

(f) License renewal.

(1) The department may notify the FRO at least 90 days before the expiration date of the current license at the address shown in the current records of the department. If a notice of expiration is not received, it is the responsibility of the FRO to notify the department and request license renewal application information.

(2) FROs shall submit a completed application and nonrefundable fee, if applicable, and must verify compliance with the requirements of the license.

(g) License denial. A license may be denied for, but not limited to, the following reasons:

(1) failure to meet requirements for an FRO license in accordance with this section;

(2) previous failure to meet the responsibilities of an FRO as described in this section;

(3) falsifying any information, record or document required for an FRO license;

(4) misrepresenting any requirements for an FRO license or renewal of an FRO license;

(5) history of criminal activity while licensed as an FRO;

(6) history of disciplinary action relating to the FRO license; and/or

(7) issuing a check for application for an FRO license which is subsequently returned to the department unpaid.

(h) License revocation criteria. An FRO license may be revoked or suspended for failure to meet the responsibilities of a licensed FRO as described in this section.

(i) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority to recover costs associated with the application and renewal application processing through Texas Online.

§157.16.Emergency Suspension, Suspension, Probation, Revocation, Denial of a Provider License or Administrative Penalties.

(a) Emergency Suspension. The Texas Department of State Health Services (department), may issue an emergency suspension order to any licensed emergency medical services (EMS) provider if the department has reasonable cause to believe that the conduct of any licensed provider creates an imminent danger to public health or safety.

(1) An emergency suspension issued by the department is effective immediately without a hearing or notice to the license holder. Notice to the license holder shall be presumed established on the date that a copy of the signed emergency suspension order is sent to the individual listed as the administrator of record at the address shown in the current records of the department.

(2) A copy of the emergency suspension order shall be sent to the provider's listed medical director, to the EMS provider, and to all government entities, institutions or facilities with which the license holder is known to be associated to the addresses shown in the current records of the department.

(3)If a written request for a hearing is received from the suspended license holder, the department shall conduct a hearing not earlier than the 10th day nor later than the thirtieth day after the date on which a 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.

(b) Administrative penalty. An administrative penalty may be assessed when an EMS provider is in violation of the Health and Safety Code, Chapter 773, 25 Texas Administrative Code, Chapter 157, or the reasons outlined in subsections (c) and (d) of this section.

(c) Accountability. An EMS provider retains ultimate responsibility for the operation of the service. A licensed EMS provider may not claim a defense when one or more staff members, acting with or without the consent and knowledge of the license holder, commit(s) multiple violations in this section, or perform(s) contrary to EMS standards while on EMS business for the provider. The department shall consider the EMS provider's current policies and procedures when staff violate rules or EMS standards.

(d) Nonemergency suspension or revocation. An EMS provider license may be suspended or revoked for, but not limited to, the following reasons:

(1) failing to comply with any requirement of provider licensure as defined in §157.11 of this title (relating to Requirements for an EMS Provider License);

(2) operating the service while the license is under suspension;

(3) falsifying or altering a license issued by the department;

(4) failing to correct deficiencies as instructed by the department;

(5) obtaining or attempting to obtain or assisting another to obtain a provider license or personnel certification by fraud, forgery, deception, or misrepresentation;

(6) providing false or misleading advertising and/or making false or misleading claims to clients or the public about the service;

(7) failing to operate a subscription service/membership program according to provisions in §157.11 of this title;

(8) failing to maintain patient confidentiality according to standards and department regulations;

(9) discriminating in the provision of services based on national origin, race, color, creed, religion, gender, sexual orientation, age, physical or mental disability;

(10) falsifying a patient care record or any other document or record resulting from or pertaining to EMS Provider responsibilities;

(11) obtaining any fee or benefit by fraud, coercion, theft, deception, or misrepresentation;

(12) failing to give the department true and complete information when asked, regarding any alleged or actual violation of the Health and Safety Code, Chapter 773;

(13) failing to pay an administrative penalty in full within established time frames;

(14) failing to staff each vehicle deemed to be in service or response ready with appropriately and currently certified personnel;

(15) operating, directing, or allowing staff to operate vehicle warning devices unnecessarily or inappropriately;

(16) operating, directing, or allowing any person to operate any vehicle on EMS business while under the influence of any substance that inhibits the mental or physical capacities of that person;

(17) having been found to have operated, directed, or allowed staff to operate any vehicle while on EMS business in a reckless or unsafe manner and/or in a manner that is dangerous to the health or safety of any person;

(18) operating, directing, or allowing staff to operate any vehicle that is not mechanically safe, clean and in good operating condition; and/or

(19) having been found in violation of any local, state, or national code or regulation pertaining to EMS operations or business practices; and/or violating any rule or standard that could jeopardize the health or safety of any person.

(e) Denial of a license. A license may be denied for, but not limited to, the following reasons:

(1) failing to meet the licensing requirements outlined in §157.11 of this title;

(2) one of the owners having a history of a misdemeanor or felony which the department has determined may put the safety of any person; at risk;

(3) previous conduct while holding an EMS provider license which could put any person at risk;

(4) the EMS provider has received disciplinary action in another state or by a federal agency;

(5) falsifying or misrepresenting any fact or requirement on or for an application or related document for a provider license or EMS personnel license/certificate; and/or

(6) issuing a check for application for a provider license which is returned to the department unpaid.

(f) Notification. If the department proposes to deny, suspend, revoke, or probate a license, the EMS provider license holder and the administrator of record shall be notified at the address shown in the current records of the department. The notice shall state the alleged facts or conduct to warrant the proposed action and state that the license holder may request a hearing.

(g) Hearing Request.

(1) A request for a hearing shall be in writing and submitted to the department and postmarked no later than 30 days after the date of the notice. The hearing shall be conducted pursuant to the Administrative Procedure Act, Government Code, Chapter 2001.

(2) If the candidate, applicant or licensee does not request a hearing in writing within 30 days after proper notice, the individual is deemed to have waived the opportunity for a hearing as outlined in the notice.

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

(i) Re-application.

(1) Two years after denial or revocation of a license, or the voluntary surrender of a license while disciplinary action is pending, an individual may petition the department in writing for re-application for licensure. Expiration of a certificate or license during the suspension period shall not affect the two-year waiting period required before a petition can be submitted.

(2) The petitioner bears the burden of proving fitness for licensure.

(3) The department may allow an application for licensure if there is proof that the health, safety, and confidence of the public will be protected.

(4) The department may deny any petitioner if, in the judgement of the department, the reason for the original action continues to exist or if the petitioner has failed to offer sufficient proof that there is no longer a threat to public health, safety, and/or confidence.

(5) If the application is allowed, the petitioner shall be required to meet the requirements as described in §157.11 of this title and in addition shall meet the terms of probation in subsection (h) of this section.

(j) Expiration of a license during suspension. A provider whose license expires during a suspension period shall not reapply for licensure until the end of the suspension period.

(k) Surrender of a license. Surrender of a license shall not deprive the department of jurisdiction in regard to disciplinary action against the license holder. A provider who wishes to surrender his or her license prior to the expiration of the license may do so by:

(1) completing a Surrender of License statement; and

(2) in the event that a disciplinary action is pending or reasonably imminent, the licensee shall acknowledge that the surrender constitutes a plea of "no contest" to the allegations upon which the disciplinary action is predicated, acknowledging that the surrender is a "no contest" plea in the event that a disciplinary action is pending or reasonably imminent.

(l) Notification of disposition. An order of final disposition of any disciplinary action shall be sent to the license holder at the address shown in the current records of the department. A copy of the order shall also be sent to the provider's medical director and to any government entity, institution or facility with which the license holder is known to be associated at the address shown in the current records of the department.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 23, 2017.

TRD-201700317

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: February 12, 2017

Proposal publication date: August 12, 2016

For further information, please call: (512) 776-6972


SUBCHAPTER C. EMERGENCY MEDICAL SERVICES TRAINING AND COURSE APPROVAL

25 TAC §§157.32 - 157.34, 157.36, 157.38

STATUTORY AUTHORITY

The amendments are authorized by the Texas Health and Safety Code, Chapter 773 and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Texas Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.

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

(a) Emergency medical services (EMS) Education Program Standards. An EMS Education Program shall meet national education training standards 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. The department shall base the education and training standards on applicable national standards and guidelines for evaluation and approval of EMS education programs adopted by national accrediting organizations.

(c) Curriculum

(1) Emergency Care Attendant (ECA).

(A) The minimum curriculum shall include all content required by the current national Emergency Medical Responder (EMR) educational standards and competencies as defined in the National EMS Education Standards 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 60 clock hours of classroom and laboratory instruction in the approved curriculum.

(2) Emergency Medical Technician (EMT).

(A) The minimum curriculum shall include all content required by the current national EMT educational standards and competencies as defined in the National EMS Education Standards by DOT.

(B) The course shall include a minimum of 150 clock hours of classroom, laboratory, clinical, and field instruction which shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed to develop the competencies defined in the minimum curriculum.

(3) Advanced Emergency Medical Technician (AEMT).

(A) The minimum curriculum shall include all content required by the current national Advanced Emergency Medical Technician (AEMT) standards and competencies as defined in the National EMS Education Standards by DOT. The following areas must be addressed as outlined in the AEMT national educational standards and the Health and Safety Code, §773.048:

(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 250 clock hours of classroom, laboratory, clinical, and field instruction which shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed to develop the competencies defined in the AEMT national educational standards.

(C) A student shall have a current EMT certification from the department or National Registry prior to beginning and throughout field and clinical rotations in an AEMT 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 in the National EMS Education Standards as defined by DOT.

(B) The course shall include a minimum of 1000 clock hours of classroom, laboratory, clinical and field instruction which shall include supervised experiences in the emergency department and with a licensed EMS provider and in other settings as needed to develop the competencies defined in the minimum curriculum.

(C) A student shall have a current EMT or AEMT certification from the department or current EMT, EMT-I or AEMT certification from the National Registry prior to beginning and throughout 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:

(A) are educationally and fiscally sound;

(B) meet the responsibilities listed in subsection (o) of this section; and

(C) has the required equipment and resources to conduct the program.

(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) AEMT 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.

(5) The education programs must have the authority or ownership to provide the program.

(6) Approval of a program by the department is not transferable.

(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. Paramedic programs must provide proof of accreditation by the Commission on Accreditation of Allied Health Education Programs (CAAHEP)/Committee on Accreditation of Emergency Medical Services Professions (CoAEMSP), or a national accrediting organization recognized by the department. Alternatively, the program may provide a letter of review from CAAHEP/CoAEMSP or a national accrediting organization recognized by the department stating the education program has submitted the appropriate documentation that indicates it being in pursuit of accreditation as defined by that organization.

(g) Basic approval requirements. To receive approval for 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 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;

(8) demonstrate substantial compliance with the EMS education standards by successfully completing the self-study/on site review process; and

(9) provide a name and contact information for the designated infection control officer and document education for the designated infection control officer based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136.

(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;

(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;

(9) demonstrate substantial compliance with the EMS education standards by successfully completing the self-study/on-site review process outlined in the national education and training standards; and

(10) provide a name and contact information for the designated infection control officer and document education for the designated infection control officer based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136.

(i) Self-study requirements.

(1) A self-study is a self-evaluation and compilation of documents that describes the proposed or existing program's overall process. It shall explain and/or document the program's organizational structure, resources, facilities, record keeping, personnel and their qualifications, policies and procedures, text books, course delivery methods used, clinical and field affiliations, student to patient contact matrix, psychomotor competency evaluations, a copy of all advertisements, documents provided to students and describe what is necessary for students to complete the program.

(2) All proposed and/or existing programs must provide a self-study at the basic (ECA and EMT) and/or advanced (AEMT and Paramedic) level. Programs that offer paramedic education may submit a copy of a self-study submitted to national accrediting organizations to meet this requirement. However, they must submit supplemental documentation to demonstrate substantial compliance with the EMS education standards of this section.

(A) Each applicant for an EMS Program must submit a self-study that contains the following items:

(i) an organizational chart;

(ii) a description of the ownership and sponsorship of the proposed or existing program;

(iii) a description of financial resources;

(iv) a description of the record keeping process for maintaining program, course, and student records;

(v) a description of the facilities;

(vi) a description of learning resources;

(vii) a description of equipment and supplies;

(viii) a description of personnel (faculty and staff) and qualifications;

(ix) a description of the instructor /faculty credentialing, evaluation and continuing education process.

(x) a description of the clinical and field internship affiliations;

(xi) a description of the student to patient contact ratio and how it will be tracked and monitored. If an existing program at renewal, include a student patient contact ratio report;

(xii) a description of the text books and curriculum;

(xiii) a description of the psychomotor competency evaluation process;

(xiv) a copy of any policies and procedures used for faculty, staff and students, that address the following:

(I) attendance, tardiness, and participation;

(II) program medical director change;

(III) cheating;

(IV) clinical and field internship;

(V) complaint resolution;

(VI) conduct, safety and health;

(VII) counseling and coaching of students;

(VIII) dress and hygiene requirements;

(IX) grading;

(X) grievance and appeals;

(XI) immunizations;

(XII) policies for the prevention of sexual harassment;

(XIII) policies for the prevention of discrimination based on race, sex, creed, national origin, sexual preference, age, handicap or medical problems;

(XIV) psychomotor competency evaluation;

(XV) record keeping and access to records;

(XVI) student faculty relationships;

(XVII) student screening and enrollment;

(XVIII) test review and makeup; and

(XIX) tuition and/or fee reimbursement.

(XX) Provide a name and contact information for the designated infection control officer, and document education for the designated infection control officer based on U.S. Code, Title 42, Chapter 6A, Subchapter XXIV, Part G, §300ff-136.

(xv) a sample of all advertisements and any documents given to potential students, students and exiting students; and

(xvi) a description of any and all requirements for a student to complete a course.

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

(k) 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, 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.

(l) On-site review. After the completion of a provisionally-approved program's first course, an on-site review shall be conducted. The on-site review process is the department inspector's review of a proposed and/or existing program's records plan, self-study, equipment, facilities and clinical and field internship facilities, and student-to-patient contact ratios.

(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 four years 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 four years.

(m) 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 (d) 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;

(G) the probable adverse consequences to the public health or safety if the exception is not approved; and

(H) the written support by the program medical director.

(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 before being granted approval by the department.

(n) National accreditation for paramedic education/training programs.

(1) In addition to the requirements listed in subsection (h) of this section, all EMS education/training programs currently conducting paramedic education and training must meet the following requirements to receive approval as a paramedic education and training program:

(A) provide proof of accreditation by the CAAHEP/CoAEMSP, or a national accrediting organization recognized by the department; or

(B) provide documentation from CAAHEP/CoAEMSP or a national accrediting organization recognized by the department stating the education program has submitted the appropriate documentation that indicates it being in pursuit of accreditation as defined by the CAAHEP/CoAEMSP or a national accrediting organization recognized by the department. The education/training program that is deemed as pursuing accreditation may be temporarily approved by the department. In order to receive program approval, the education/training program must be accredited and provide proof of their accreditation by the national accrediting organization to the department.

(2) If the education/training program is not accredited or has their accreditation revoked by the national accrediting organization the program will not be allowed to conduct a paramedic education or training course until the program becomes accredited or the program is recognized by the national accrediting organization as being in pursuit of accreditation.

(3) Initial or current education programs that are not accredited and would like to offer paramedic education and training on or after January 1, 2013 must:

(A) be approved by the department as an EMS basic education program, according to subsection (g) of this section;

(B) submit the appropriate application and fees to the department;

(C) meet the accreditation standards set by CAAHEP/CoAEMSP or another department approved national accrediting organization in order for the department to issue the applicant a temporary approval to conduct paramedic education or training courses; and

(D) provide proof of accreditation by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department. If the training program does not become accredited the program will not be allowed to conduct another paramedic education or training course until the program becomes accredited or the department receives notification from the accrediting organization that the program is recognized as being in pursuit of accreditation as defined by the accrediting organization.

(4) If a program has been accredited by CAAHEP/CoAEMSP or a national accrediting organization recognized by the department, the department may exempt the program from the program approval or re-approval process.

(5) Programs accredited by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department 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 national accrediting organization that impact the program's status.

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

(7) 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.

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

(o) 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 subsection (g), (h) or (m) of this section;

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

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

(11) failure of a paramedic program to become accredited or maintain their accreditation by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department.

(p) 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;

(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 based on the National EMS Education Standards, and course medical director;

(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) obtain written acknowledgement from the field internship EMS provider medical director, if students will be conducting advanced-level skills as part of their field internship with that EMS provider;

(15) maintain all course records for a minimum of 5 years;

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

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

(18) along with the course coordinator and medical director, supervise and evaluate the effectiveness of the clinical and EMS field internship training;

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

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

(21) provide the department with any information that will affect 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;

(22) provide proof of accreditation by CAAHEP/CoAEMSP or another national accrediting organization recognized by the department;

(23) submit a roster of all enrolled students when requested by the department;

(24) submit a final student roster when requested by the department; and

(25) online and or distance learning classes, programs and courses must meet the same standards as outlined in this section.

(q) 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 subsection (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), (h) or (m) 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;

(C) host an on-site review if one is deemed necessary by the department or requested by the program; and

(D) a paramedic program must provide documentation of current accreditation from CoAEMSP or another national accrediting organization recognized by the department.

(r) Fees.

(1) The following nonrefundable fees shall apply:

(A) $30 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) $90 for conducting a basic site visit;

(C) $60 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) $250 for conducting an advanced site visit;

(E) $30 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) $60 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.

(s) 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) $30 for a Basic Course (ECA or EMT);

(B) $60 for an Advanced Course (AEMT or Paramedic);

(C) $30 for an EMS Instructor Course; and

(D) $60 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 education and training standards, 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.

(t) 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 as outlined in this section;

(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.

(u) Disciplinary actions.

(1) Emergency suspension. The department may issue an emergency order to suspend a program's approval if the department 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, 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;

(W) offering or attempting to offer courses during a period when the program's approval is suspended;

(X) a paramedic program receiving revocation of their accreditation by CAAHEP/CoAEMSP or any other organization that provides nationally recognized EMS accreditation; and/or

(Y) for starting a course, program or class before receiving official approval from the department.

(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. The request shall be in writing and submitted to the department.

(B) If the program does not request a hearing within 30 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.

(v) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with the application and renewal application processing through Texas Online.

§157.33.Certification.

(a) Certification requirements. A candidate for emergency medical services (EMS) certification shall:

(1) be at least 18 years of age;

(2) have a high school diploma or GED certificate:

(A) the high school diploma must be from a school accredited by the Texas Education Agency (TEA) or a corresponding agency from another state. Candidates who received a high school education in another country must have their transcript evaluated by a foreign credentials evaluation service that attests to its equivalency. A home school diploma is acceptable;

(B) an emergency care attendant (ECA) who provides emergency medical care exclusively as a volunteer for a licensed provider or registered FRO is exempt from paragraph (2) of this subsection.

(3) have successfully completed a Department of State Health Services (department)-approved course; and

(4) The candidate has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(5) submit an application, meeting the requirements in §157.3 of this title (relating to Processing EMS Provider Licenses and Applications for EMS Personnel Certification and Licensing), and the following nonrefundable fees as applicable:

(A) $60 for emergency care attendant (ECA) or emergency medical technician (EMT);

(B) $90 for AEMT or EMT-paramedic (EMT-P); and

(C) EMS volunteer--no fee. However, if such an individual receives compensation during the certification period, the exemption ceases and the individual shall pay a prorated fee to the department based on the number of years remaining in the certification period when employment begins. The nonrefundable fee for ECA or EMT certification shall be $15 per each year remaining in the certification. The nonrefundable fee for AEMT or EMT-P shall be $22.50 per each year remaining in the certification. Any portion of a year will count as a full year;

(6) provide evidence of current active or inactive National Registry certification at the appropriate level. National Registry First Responder certification is considered the appropriate corresponding certification level for an ECA; and

(7) submit fingerprints through the state approved fingerprinting service to undergo an FBI fingerprint criminal history check.

(b) Length of certification. A candidate who meets the requirements of subsection (a) of this section shall be certified for four years beginning on the date of issuance of a certificate and wallet-size certificate. A candidate must verify current certification before staffing an EMS vehicle. Certification may be verified by the applicant's receipt of the official department identification card, by using the department's certification website.

(c) Scheduling authority for certification examinations.

(1) Examinations shall be administered at regularly scheduled times in various locations across the state.

(2) The candidate shall be responsible for making appropriate arrangements for the examination.

(3) The department is not required to set special examination schedules for a single candidate or for a specific group of candidates.

(d) Time limits for completing requirements.

(1) An initial candidate for certification shall complete all requirements for certification no later than two years after the candidate's course completion date. The application will expire two years from the date the mailed application is postmarked, or the date a faxed, online submission or hand-delivered application is received at the department.

(A) The National Registry certification described in subsection (a)(5) of this section must remain current until the final requirement for state certification is met.

(B) The applicant shall update the application if any changes occur between the time of original submission and the time the final requirement for certification is met.

(2) A candidate who does not complete all requirements for certification within two years of the candidate's initial course completion date must meet the requirements of subsection (a) of this section, including the completion of another initial course to achieve certification.

(e) Non-transferability of certificate. A certificate is not transferable. A duplicate certificate may be issued if requested with a nonrefundable fee of $10.

(f) A candidate may apply for a lower level than the level of National Registry certification held.

(g) Voluntary downgrades.

(1) An individual who holds a current Texas EMS certification or paramedic license may be certified at a lower level voluntarily for the remainder of the certification period by submitting an application for the lower level certification and the applicable nonrefundable fee as required in subsection (a)(4) of this section.

(2) On the date the downgrade is final, the previous higher level of certification/license shall be surrendered. To regain the original higher level of certification, the candidate shall follow late recertification procedures according to §157.34(d) of this title (relating to Recertification), within one year after the surrender date.

(h) Inactive certification. A certified EMT, AEMT, or EMT-P may make application to the department for inactive certification at any time during the certification period or within one year after the certificate expiration date.

(1) The request for inactive certification shall be accompanied by a nonrefundable fee of $30 in addition to the regular nonrefundable fee in subsection (a)(4)(A) and (B) of this section. If the final requirement is completed during the one-year period after expiration, the application fees listed in §157.34(d) of this title will be required. Volunteers are not exempt from inactive fees.

(2) Period of inactive certification.

(A) The inactive certification period shall begin upon date of issuance of the notice of inactive certification and remain in effect until the end of the original active certification period for those candidates who are currently certified. The candidate's active certification is surrendered upon issuance of the notice of inactive certification.

(B) If the candidate is within the final year of active certification and chooses to renew with inactive certification, the inactive certification begins on the first day after the expiration of the current active certificate and shall remain in effect for four years.

(C) If the candidate applies during and/or completes the final requirement for inactive certification within one year after the expiration of active certification, the inactive certification period shall remain in effect for four years from the date of issuance of the notice of inactive certification.

(3) While on inactive certification, a person shall not practice other than to act as a bystander rendering first aid or cardiopulmonary resuscitation (CPR) or the use of an Automated External Defibrillator in the capacity of a layperson. Practicing in any other capacity for compensation or as a volunteer shall be cause for denial of reentry and decertification.

(4) An individual shall not simultaneously hold inactive and active certification.

(i) Reciprocity.

(1) A person who is currently certified by the National Registry but did not complete a department-approved course may apply for the equal or lower level Texas certification by submitting a reciprocity application and a nonrefundable fee of $120.

(A) Applicants holding National Registry AEMT certification may be required to submit written verification of proficiency of AEMT skills from an approved education program.

(B) National Registry first responder certification is not eligible for reciprocity at the ECA level.

(C) A candidate will not be eligible for reciprocity if the National Registry certification expires prior to the completion of all requirements for certification as listed in this section.

(D) A candidate who meets the requirements of this section shall be certified for four years beginning on the date of issuance of a certificate and wallet-size certificate.

(E) The candidate has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(2) A person currently certified by another state may apply for equal or lower level Texas certification by submitting a reciprocity application and a nonrefundable fee of $120.

(A) The candidate must pass the National Registry assessment exam.

(B) Applicants holding AEMT out-of-state certification must submit written proof of proficiency on all of the AEMT skills signed by a Texas certified EMS coordinator or instructor.

(C) All applicants shall submit fingerprints through the state approved fingerprinting service to undergo an FBI fingerprint criminal history check.

(D) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(E) Reciprocity is not allowed for the ECA level.

(F) A candidate will not be eligible for reciprocity if the out-of-state certification expires prior to the completion of all requirements for certification as listed in this section.

(G) A candidate who meets the requirements of this section shall be certified for four years beginning on the date of issuance of a certificate and wallet-size certificate.

(3) Personnel receiving department issued certification through reciprocity must recertify prior to the expiration of the certificate by following the requirements in §157.34 of this title.

(j) Equivalency.

(1) Candidates meeting the following criteria may apply for certification only through the equivalency process as described in this subsection:

(A) an individual who completed EMS training outside the United States or its possessions;

(B) an individual who is certified or licensed in another healthcare discipline;

(C) an individual whose department issued EMS certification or license has been expired for more than one year; or

(D) an individual who has held department issued inactive certification for more than four years.

(2) A candidate applying for certification by equivalency shall:

(A) submit a copy of the curriculum and work history completed by the candidate to a regionally accredited post secondary institution approved by the department to sponsor an EMS education program for its review;

(B) obtain a course completion document that verifies that the program is satisfied that all curriculum requirements have been met. Evaluations of curricula conducted by post secondary educational institutions under this subsection shall be consistent with the institution's established policies and procedures for awarding credit by transfer or advanced placement;

(C) the candidate may then apply for initial certification with the department as described in subsection (a) of this section; and

(D) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(k) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.

(l) Responsibilities of the EMS personnel. During the license period, the EMS Personnel responsibilities shall include:

(1) making accurate, complete and/or clearly written patient care reports including documenting a patient's condition upon the EMS personnel's arrival at the scene and patient's status during transport, including signs, symptoms, and responses during duration of transport as per EMS provider's approved policy;

(2) reporting to the employer, appropriate legal authority or the department, of abuse or injury to a patient or the public within 24 hours or the next business day after the event;

(3) following the approved medical director's protocol and policies;

(4) taking precautions to prevent the misappropriation of medications, supplies, equipment, personal items, or money belonging to the patient, employer or any person or entity;

(5) maintaining skill and knowledge to perform the duties or meet the responsibilities required of current level of EMS certification; and

(6) notifying the department of a current and/or valid mailing address within 30 days of any changes.

§157.34.Recertification.

(a) Recertification requirements.

(1) Not later than the 30th day before the date a person's certificate is scheduled to expire, the Department of State Health Services (department) may send to the person a notice of expiration at the address shown in the current records of the department.

(2) If a certificant has not received a notice of expiration from the department 30 days prior to the expiration, it is the duty of the certificant to notify the department and to request an application for recertification or download an application from the Internet.

(3) To maintain certification status without a lapse, an applicant shall submit a completed application for recertification and shall meet all requirements for renewal of the current certification prior to the expiration date of the current certificate, but no earlier than one year prior to the expiration date.

(4) The certificant shall submit the following non-refundable fees as applicable:

(A) $60 for Emergency Care Attendant (ECA) or Emergency Medical Technician (EMT);

(B) $90 for Advanced EMT (AEMT), EMT-Intermediate (EMT-I), or EMT-Paramedic (EMT-P); and

(C) EMS volunteer--no fee. However, if such an individual receives compensation during the certification period, the exemption ceases and the individual shall pay a prorated fee to the department based on the number of years remaining in the certification period when employment begins. The non-refundable fee for ECA or EMT certification shall be $15 per each year remaining in the certification. The non-refundable fee for AEMT or EMT-P shall be $22.50 per each year remaining in the certification. Any portion of a year will count as a full year.

(5) Recertification by voluntary downgrade. An individual who holds a Texas EMS certification or paramedic license may renew at a lower level by meeting the requirements of this subsection. The applicant must meet the requirements for the lower level of certification requested as described in subsection (b) or (f) of this section. On the date the downgrade is final, the previous higher level of certification becomes invalid. To regain the original higher level of certification, the candidate shall meet the late recertification requirements outlined in subsection (f) of this section, within one year after the expiration date.

(6) A certificate is not transferable.

(7) Military personnel. A person certified by the department who is deployed in support of military, security, or other action by the United Nations Security Council, a national emergency declared by the President of the United States, or a declaration of war by the United States Congress is eligible for recertification under timely recertification requirements from the person's date of demobilization until one calendar year after the date of demobilization but will not be certified during that period.

(A) In addition to requirements described in this subsection, the candidate shall submit a copy of deployment and demobilization orders.

(B) The four-year certification will commence on issue date of the certificate.

(b) Recertification options. Upon submission of a completed application for recertification, the applicant shall commit to, and recertify through one of the options described in paragraphs (1) - (5) of this subsection.

(1) Option 1--Written Examination Recertification Process.

(A) The applicant shall pass the National Registry assessment exam. An overall score of 70 is considered to be passing.

(B) If the applicant fails the examination for recertification, the applicant may attempt two retests of the examination after:

(i) submitting a retest application for each attempt at any eligible level; and

(ii) submitting a non-refundable retest fee of $30 for each attempt.

(C) For each subsequent retest attempt, an applicant may apply for and retest at a lower level by complying with paragraph (1)(B) of this subsection, if applicable.

(D) An applicant who selects option 1 and attempts the exam but does not pass the National Registry assessment examination may not gain recertification by any other option and shall not qualify for inactive certification addressed in §157.33(h) of this title (relating to Certification) or subsection (e) or (f) of this section.

(E) An applicant who does not pass the third attempt at the National Registry assessment examination:

(i) shall successfully complete a Formal Recertification Course as described in paragraph (4) of this subsection; and

(ii) shall submit a course completion certificate of the Formal recertification course, reflecting that the course was completed after the 2nd retest failure; and

(iii) shall pass the National Registry assessment examination in accordance with the provisions in subparagraphs (A) - (D) of this paragraph.

(iv) shall not qualify for more than a total of six attempts at the exam, in any combination of levels attempted.

(F) The certification status of an applicant who does not successfully complete the examination recertification process as described in paragraph (1)(A) - (E) of this subsection shall expire on the date of the current certificate.

(G) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(2) Option 2--Continuing Education Recertification Process.

(A) The certificant shall attest to accrual of department approved EMS continuing education as specified in §157.38 of this title (relating to Continuing Education); and

(B) the applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(3) Option 3--National Registry Recertification Process.

(A) The applicant shall attest to and hold current National Registry certification at the time of applying for recertification; and

(B) the applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(4) Option 4--Formal Course Recertification Process. The applicant shall attest to successful completion of a department approved recertification course.

(A) The recertification course shall be a formal structured interactive training course as approved by the department and conducted within the four-year certification period.

(B)The minimum contact hours required for recertification courses are:

Figure: 25 TAC §157.34(b)(4)(B) (No change.)

(C) The applicant has completed a state approved jurisprudence examination to determine the knowledge on state EMS laws, rules, and policies.

(5) Option 5--CCMP Recertification Process. An applicant affiliated with an EMS provider that has a department-approved Comprehensive Clinical Management Program (CCMP) may be recertified if:

(A) the applicant is currently credentialed in the provider's CCMP;

(B) the applicant has been enrolled in the provider's CCMP for at least six continuous months;

(C) the applicant submits to the department a signed written statement by the CCMP's medical director, attesting to the applicant's successful participation in and completion of the provider's CCMP; and

(D) The applicant has completed a state approved jurisprudence examination to determine the knowledge that the applicant has on state EMS laws, rules, and policies.

(6) If a candidate wishes to change options (other than option 1), another application form must be submitted. An additional fee is not required if the candidate completes all requirements within the same time period of the original submission.

(c) After verification by the department of the information submitted by the applicant, that the information is true, correct and complete with regard to the applicant meeting recertification requirements by the certification expiration date, the department shall recertify the applicant for four years, commencing on the day following the expiration date of the most recent certificate. A candidate must verify current certification before staffing an EMS vehicle. Certification may be verified by the applicant's receipt of the official department identification card, by using the department's certification website, or by contacting the department directly.

(d) Late recertification.

(1) The candidate whose certification has expired shall be considered late, non-certified and shall not function in the capacity of an EMS certificant or represent that he is EMS certified until recertification is issued.

(2) A candidate whose certificate has been expired for 90 days or less may renew the certificate by submitting an application accompanied by a non-refundable renewal fee that is equal to 1-1/2 times the normally required application renewal fee for that level as listed in subsection (a)(4) of this section. Applicant shall meet one of the recertification options described in subsection (b)(1) - (5) of this section and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of 1-1/2 times the normally required application renewal fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance.

(3) A candidate whose certificate has been expired for more than 90 days but less than one year may renew the certificate by submitting an application accompanied by a non-refundable renewal fee that is equal to two times the normally required application renewal fee as listed in subsection (a)(4) of this section. Applicant shall meet one of the recertification options described in subsection (b)(2) - (6) of this section and submit verification of skills proficiency from an approved education program. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times the fee shall be necessary.

(4) The applicant shall be recertified for a period of four years beginning on the date of issuance.

(5) A candidate whose certificate has been expired for one year or more may not renew the certificate. The candidate may become certified by complying with the requirements of §157.33(a) or (j) of this title.

(6) A candidate who was certified in this state, moved to another state, and is currently certified or licensed and has been in practice in the other state for two years preceding the date of application may become certified without reexamination. The candidate may gain recertification by:

(A) submitting to the department a non-refundable fee that is equal to two times the normally required renewal fee for certification as listed in subsection (a)(4) of this section; and

(B) attesting to regular practice of emergency medical care in the other state for the two years preceding the date of application.

(e) Renewal of inactive certification.

(1) To renew inactive certification, an applicant holding inactive certification shall submit an application and the non-refundable fee as described in §157.33(a)(4) of this title. The $30 inactive fee is not required for renewal when renewing inactive certification. A candidate who meets requirements for inactive renewal shall be awarded inactive certification for a period of four years beginning on the first day after the expiration of the previous inactive certification.

(2) A candidate whose inactive certification has been expired for 90 days or less may renew the inactive certification during the 90 day period after expiration of the certification upon submitting a fee of 1-1/2 times the normally required renewal fee as described in subsection (a)(4) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to expiration, another application will not be required, but a total of 1-1/2 times the fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance.

(3) A candidate whose inactive certification has been expired more than 90 days but less than one year may renew the inactive certification upon submitting a fee of two times the normally required renewal fee as described in subsection (a)(4) of this section. If the applicant has already submitted an application and fee, but has not met all of the requirements prior to the 90th day after expiration, another application will not be required, but a total of two times the fee shall be necessary. The applicant shall be recertified for a period of four years beginning on the date of issuance.

(4) A candidate whose inactive certificate has been expired more than one year must regain active certification before reapplying for inactive certification as described in subsection (f) of this section.

(f) Inactive to active certification.

(1) An inactive certificant prior to the expiration of the first four-year inactive certification period may obtain active certification by submitting an application and the non-refundable fee to the department, as described in subsection (a)(4) of this section and by completing one of the following options:

(A) Option 1--meet the normal four year continuing education requirement for certification renewal as listed in subsection (b)(2) of this section, submit verification of skills proficiency from an approved education program or recognized physician by the department, and pass the National Registry EMT cognitive assessment exam.

(B) Option 2--complete a department approved recertification course, and pass the National Registry EMT psychomotor (practical) exam and cognitive assessment exam.

(2) A certificant who has held inactive certification for more than four years may return to active certification only by completing requirements described in §157.33(a) or (j) of this title.

(g) For all applications and renewal applications, the department is authorized to collect subscription and convenience fees, in amounts determined by the Texas Online Authority, to recover costs associated with application and renewal application processing through Texas Online.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 23, 2017.

TRD-201700318

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: February 12, 2017

Proposal publication date: August 12, 2016

For further information, please call: (512) 776-6972


SUBCHAPTER D. EMERGENCY MEDICAL SERVICES PERSONNEL CERTIFICATION

25 TAC §157.43, §157.44

STATUTORY AUTHORITY

The amendments are authorized by the Texas Health and Safety Code, Chapter 773 and Government Code, §531.0055, and Health and Safety Code, §1001.075, which authorize the Executive Commissioner of the Health and Human Services Commission to adopt rules and policies necessary for the operation and provision of health and human services by the department and for the administration of Texas Health and Safety Code, Chapter 1001. Review of the rule implements Government Code, §2001.039.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on January 23, 2017.

TRD-201700319

Lisa Hernandez

General Counsel

Department of State Health Services

Effective date: February 12, 2017

Proposal publication date: August 12, 2016

For further information, please call: (512) 776-6972