TO: Health and Human Services Commission Executive Council

DATE: November 14, 2019

FROM: Stephen Pahl, Associate Commissioner Consumer Protection Division

AGENDA ITEM: 2.f

SUBJECT: Emergency Medical Services Personnel and Level IV Trauma Designation

BACKGROUND: ☐ Federal ☒ Legislative ☐ Other: Program Initiative

The Office of EMS/Trauma Systems, in the Consumer Protection Division, is responsible for regulation of emergency medical services (EMS) and the designation of Trauma, Stroke, Neonatal, and Maternal facilities. The office performs inspections, site surveys, investigations, and provides technical assistance related to EMS, Trauma, Stroke, Neonatal, and Maternal designations. The office proposes to amend Title 25, Texas Administrative Code (TAC), Chapter 157, Emergency Medical Care, to implement House Bill (H.B.) 871 and H.B. 1418 from the 86th Legislature, Regular Session, 2019.

H.B. 871 authorizes the use of telemedicine medical services by health care facilities located in a county with a population of less than 30,000 may satisfy a Level IV trauma facility designation physician requirement. Section 157.125 complies with H.B. 871 by adding text in the basic Level IV trauma facility criteria in the Figure for 157.125(y).

H.B. 1418 requires emergency services personnel receive up-to-date information about their immunization status during certification or recertification and also information about certain risks posed when responding to an emergency. During Hurricane Harvey, lack of clarity for first responders concerning their vaccine history caused certain individuals to either duplicate previous vaccinations, or be required to wait for vaccinations due to high demand for the vaccines in the disaster-declared region. Sections 157.33(l) and 157.34(d) comply with H.B. 1418 by adding the applicant’s immunization history, which require DSHS to provide the emergency services personnel their immunization status during certification or recertification. The proposed amendments add that DSHS will provide information about certain vaccine preventable diseases when responding to an emergency that an immunization may prevent. The rule references in Sections 157.33 and 157.34 are also revised to reflect the addition of new text.

ISSUES AND ALTERNATIVES:

None known at this time.

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STAKEHOLDER INVOLVEMENT:

The rule revisions were shared with trauma system stakeholders, including EMS providers and personnel, designated trauma facilities, Regional Advisory Councils, professional organizations, and individuals. Additionally, the rule revisions were presented for recommendations and comments to the Governor’s EMS and Trauma Advisory Council (GETAC) in June 2019.

FISCAL IMPACT:

☒ None

SERVICES IMPACT STATEMENT:

The proposed rules will positively impact the health and human services client population by creating the opportunity for emergency medical service personnel to know their immunization status at certification and recertification and information about certain risks posed when responding to an emergency.

The rules also authorize a hospital located in a county with a population of less than 30,000 to utilize telemedicine medical services to comply with the physician requirement for Level IV Trauma Designation.

RULE DEVELOPMENT SCHEDULE:

September 20, 2019 Publish proposed rules in Texas Register November 14, 2019 Present to HHSC Executive CouncilNovember 2019 Publish adopted rules in Texas RegisterDecember 2019 Effective date

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TITLE 25 HEALTH SERVICESPART 1 DEPARTMENT OF STATE HEALTH SERVICESCHAPTER 157 EMERGENCY MEDICAL CARESUBCHAPTER C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE

APPROVALSUBCHAPTER G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS

PROPOSED PREAMBLE

The Executive Commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §157.33, concerning Certification, §157.34, concerning Recertification, and §157.125, concerning Requirements for Trauma Facility Designation.

BACKGROUND AND PURPOSE

The proposal is necessary to comply with House Bill (H.B.) 871 and H.B. 1418, 86th Legislature, Regular Session, 2019, which requires the adoption of rules to implement the legislation.

H.B. 871, 86th Legislature, Regular Session, 2019, amended Texas Health and Safety Code, §773.1151, which authorizes a hospital located in a county with a population of less than 30,000 to utilize telemedicine medical services to comply with the physician requirement for Level IV Trauma Designation. DSHS is directed to adopt rules not later than December 1, 2019.

H.B. 1418, 86th Legislature, Regular Session, 2019, amended Texas Health and Safety Code, §773.0551, which requires emergency services personnel receive their immunization status during certification or recertification. H.B. 1418 also requires that emergency personnel be provided information about certain risks of exposure to serious or deadly communicable disease when responding to an emergency that an immunization may prevent.

During Hurricane Harvey, lack of clarity for first responders concerning their vaccine history caused certain individuals to either duplicate previous vaccinations or be required to wait for vaccinations due to high demand for the vaccines in the disaster-declared region. DSHS is directed to adopt rules as soon as practicable.

SECTION-BY-SECTION SUMMARY

The proposed amendments to §157.33(l) and §157.34(d) add the applicant’s immunization history, which require DSHS to provide the emergency services personnel their immunization status during certification or recertification. The proposed amendments add that DSHS will provide information about certain vaccine preventable diseases when responding to an emergency that an immunization may prevent. The rule references in §157.33 and §157.34 are also revised to reflect the addition of new text.

The proposed amendment to §157.125 adds text for a hospital located in a county

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with a population of less than 30,000 to utilize telemedicine medical services to comply with the physician requirement for a Level IV trauma facility designation. The new text is added to the basic Level IV trauma facility criteria in the Figure for §157.125(y).

FISCAL NOTE

Donna Sheppard, Chief Financial Officer, has determined that for each year of the first five years that the rules will be in effect, enforcing or administering the rules do not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rules will be in effect:

(1) the proposed rules will not create or eliminate a government program;(2) implementation of the proposed rules will not affect the number of DSHS employee positions;(3) implementation of the proposed rules will result in no assumed change in future legislative appropriations; (4) the proposed rules will not affect fees paid to DSHS; (5) the proposed rules will not create a new rule;(6) the proposed rules will not expand existing rules;(7) the proposed rules will not change the number of individuals subject to the rules; and(8) the proposed rules will not affect the state’s economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Donna Sheppard, has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities. The rules do not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rules.

LOCAL EMPLOYMENT IMPACT

The proposed rules will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to these rules because the rules are necessary to protect the health, safety, and welfare of the residents of Texas; do not impose a cost on regulated persons; and are necessary to implement legislation that does not specifically state that §2001.0045 applies to the rules. Sections 157.33 and 157.34 are being adopted in response to a natural disaster.

PUBLIC BENEFIT AND COSTS

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Stephen Pahl, Associate Commissioner, Consumer Protection Division, has determined that for each year of the first five years that the amended §157.33 and §157.34 are in effect, the public benefit will be the opportunity for emergency medical service personnel to know their immunization status at certification and recertification and also information about certain risks posed when responding to an emergency. For each year of the first five years that the amended §157.125 is in effect, the public benefits by continuing to receive quality trauma patient care directed by a physician who has special competence in the care of critically injured patients in the rural areas of Texas. The rural hospitals may seek or maintain trauma designation and participate in the trauma system to improve patient care and outcomes.

Donna Sheppard, has also determined that for the first five years the rules are in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rules. The amendments to §157.33 and §157.34 require DSHS to provide the emergency services personnel their immunization status during certification or recertification and the cost of certification or recertification is not impacted by these amendments. There also would not be any additional costs based on the amendment to §157.125, as participation in trauma facility designation is voluntary and is not required or mandated.

REGULATORY ANALYSIS

DSHS has determined this proposal is not a "major environmental rule" as defined by Texas Government Code §2001.0225. "Major environmental rule" is defined to mean a rule the specific intent of which is to protect the environment or reduce risk to human health from environmental exposure and that may adversely affect, in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment or the public health and safety of a state or a sector of the state. This proposal is not specifically intended to protect the environment or reduce risks to human health from environmental exposure.

TAKINGS IMPACT ASSESSMENT

DSHS has determined the proposal does not restrict or limit an owner's right to his or her property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal may be submitted to Christina Coleman, Program Specialist, Mail Code 1876, P.O. Box 149347, Austin, Texas 78714-9347, by fax to 512-834-6736 or by email to EMSInfo@dshs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be: (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period to the Exchange Building, EMS/Trauma Systems, 8407 Wall Street, Austin, TX 78754; or (3) faxed or emailed before midnight on the last day of the comment period. If last day to submit

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comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When faxing or emailing comments, please indicate "Comments on Proposed Rules 19R056" in the subject line.

STATUTORY AUTHORITY

The amendments are authorized by Texas Health and Safety Code, Chapter 773; and Texas Government Code §531.0055, which provides that the Executive Commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, including by DSHS. Under Texas Health and Safety Code, Chapter 1001, the DSHS Commissioner is authorized to assist the Executive Commissioner in the development of rules relating to the matters within DSHS jurisdiction.

The amendments implement Texas Health and Safety Code, Chapter 773.

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

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TITLE 25 HEALTH SERVICESPART 1 DEPARTMENT OF STATE HEALTH SERVICESCHAPTER 157 EMERGENCY MEDICAL CARESUBCHAPTER C EMERGENCY MEDICAL SERVICES TRAINING AND COURSE

APPROVAL

§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;

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(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.

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(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(e) §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(e) §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.

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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.

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(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.

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(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) Applicant immunization history.

(1) If the applicant's immunization history is included in the immunization registry as defined by Health and Safety Code §161.007, the department shall provide the applicant notice of the applicant's immunization history using information from the immunization registry.

(2) If the applicant's immunization history is not included in the immunization registry, the department shall provide:

(A) details about the program developed under Health and Safety Code, §161.00707; and

(B) the specific risks to emergency medical services personnel when responding rapidly to an emergency of exposure to and infection by a potentially serious or deadly communicable disease that an immunization may prevent.

(m) (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.

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(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) or (g) (e) 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 (g) (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.

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(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 (f) or (g) (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.

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(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;

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(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) Applicant immunization history.

(1) If the applicant's immunization history is included in the immunization registry as defined by Health and Safety Code, §161.007, the department shall provide notice of the applicant's immunization history using information from the immunization registry.

(2) If the applicant's immunization history is not included in the immunization registry, the department shall provide:

(A) details about the program developed under Health and Safety Code §161.00707; and

(B) the specific risks to emergency medical services personnel when responding rapidly to an emergency of exposure to and infection by a potentially serious or deadly communicable disease that an immunization may prevent.

(e) (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

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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.

(f) (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

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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 (g) (f) of this section.

(g) (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.

(h) (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.

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TITLE 25 HEALTH SERVICESPART 1 DEPARTMENT OF STATE HEALTH SERVICESCHAPTER 157 EMERGENCY MEDICAL CARESUBCHAPTER G EMERGENCY MEDICAL SERVICES TRAUMA SYSTEMS

§157.125. Requirements for Trauma Facility Designation.

(a) The Office of Emergency Medical Services (EMS)/Trauma Systems Coordination (office) shall recommend to the Commissioner of the Department of State Health Services (commissioner) the designation of an applicant/healthcare facility (facility) as a trauma facility at the level(s) for each location of a facility the office deems appropriate.

(1) Comprehensive (Level I) trauma facility designation--The facility, including a free-standing children's facility, meets the current American College of Surgeons (ACS) essential criteria for a verified Level I trauma center; meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate Regional Advisory Council (RAC); has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the Texas EMS/Trauma Registry.

(2) Major (Level II) trauma facility designation--The facility, including a free-standing children's facility, meets the current ACS essential criteria for a verified Level II trauma center; meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the Texas EMS/Trauma Registry.

(3) Advanced (Level III) trauma facility designation--The facility meets the "Advanced Trauma Facility Criteria" in subsection (x) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the Texas EMS/Trauma Registry. A free-standing children's facility, in addition to meeting the requirements listed in this section, must meet the current ACS essential criteria for a verified Level III trauma center.

(4) Basic (Level IV) trauma facility designation--The facility meets the "Basic Trauma Facility Criteria" in subsection (y) of this section; actively participates on the appropriate RAC; has appropriate services for dealing with stressful events available to emergency/trauma care providers; and submits data to the Texas EMS/Trauma Registry.

(b) A healthcare facility is defined under these rules as a single location where inpatients receive hospital services or each location if there are multiple buildings where inpatients receive hospital services and are covered under a single hospital license.

(1) Each location shall be considered separately for designation and the Department of State Health Services (department) will determine the designation

19

level for that location, based on, but not limited to, the location's own resources and levels of care capabilities; Trauma Service Area (TSA) capabilities; and the essential criteria and requirements outlined in subsection (a)(1) - (4) of this section. The final determination of the level(s) of designation may not be the level(s) requested by the facility.

(2) A facility with multiple locations that is applying for designation at one location shall be required to apply for designation at each of its other locations where there are buildings where inpatients receive hospital services and such buildings are collectively covered under a single hospital's license.

(c) The designation process shall consist of three phases.

(1) First phase--The application phase begins with submitting to the office a timely and sufficient application for designation as a trauma facility and ends when the survey report is received by the office.

(2) Second phase--The review phase begins with the office's review of the survey report and ends with its recommendation to the commissioner whether or not to designate the facility and at what level(s). This phase also includes an appeal procedure governed by the department's rules for a contested case hearing and by Government Code, Chapter 2001.

(3) Third phase--The final phase begins with the commissioner reviewing the recommendation and ends with his/her final decision.

(d) For a facility seeking initial designation, a timely and sufficient application shall include:

(1) the department's current "Complete Application" form for the appropriate level, with all fields correctly and legibly filled-in and all requested documents attached, hand-delivered or sent by postal services to the office;

(2) full payment of the designation fee enclosed with the submitted "Complete Application" form;

(3) any subsequent documents submitted by the date requested by the office;

(4) a trauma designation survey completed within one year of the date of the receipt of the application by the office; and

(5) a complete survey report, including patient care reviews, that is within 180 days of the date of the survey and is hand-delivered or sent by postal services to the office.

(e) If a hospital seeking initial designation fails to meet the requirements in subsection (d)(1) - (5) of this section, the application shall be denied.

(f) For a facility seeking re-designation, a timely and sufficient application shall

20

include:

(1) the department's current "Complete Application" form for the appropriate level, with all fields correctly and legibly filled-in and all requested documents attached, hand-delivered or sent by postal services to the office one year or greater from the designation expiration date;

(2) full payment of the designation fee enclosed with the submitted "Complete Application" form;

(3) any subsequent documents submitted by the date requested by the office; and

(4) a complete survey report, including patient care reviews, that is within 180 days of the date of the survey and is hand-delivered or sent by postal services to the office no less than 60 days prior to the designation expiration date.

(g) If a healthcare facility seeking re-designation fails to meet the requirements outlined in subsection (f)(1) - (4) of this section, the original designation will expire on its expiration date.

(h) The office's analysis of the submitted "Complete Application" form may result in recommendations for corrective action when deficiencies are noted and shall also include a review of:

(1) the evidence of current participation in RAC/regional system planning; and

(2) the completeness and appropriateness of the application materials submitted, including the submission of a non-refundable application fee as follows:

(A) for Level I and Level II trauma facility applicants, the fee will be no more than $10 per licensed bed with an upper limit of $5,000 and a lower limit of $4,000;

(B) for Level III trauma facility applicants, the fee will be no more than $10 per licensed bed with an upper limit of $2,500 and a lower limit of $1,500; and

(C) for Level IV trauma facility applicants, the fee will be no more than $10 per licensed bed with an upper limit of $1000 and a lower limit of $500.

(i) When a "Complete Application" form for initial designation or re-designation from a facility is received, the office will determine the level it deems appropriate for pursuit of designation or re-designation for each of the facility's locations based on, but not limited to: the facility's resources and levels of care capabilities at each location, TSA resources, and the essential criteria for Levels I, II, III, and IV trauma facilities. In general, physician services capabilities described in the application must be in place 24 hours a day/7 days a week. In determining whether a physician services capability is present, the department may use the concept of substantial compliance that is defined as having said physician services capability at least 90% of the time.

21

(1) If a facility disagrees with the level(s) determined by the office to be appropriate for pursuit of designation or re-designation, it may make an appeal in writing within 60 days to the director of the office. The written appeal must include a signed letter from the facility's governing board with an explanation as to why designation at the level determined by the office would not be in the best interest of the citizens of the affected TSA or the citizens of the State of Texas.

(2) The written appeal may include a signed letter (s) from the executive board of its RAC or individual healthcare facilities and/or EMS providers within the affected TSA with an explanation as to why designation at the level determined by the office would not be in the best interest of the citizens of the affected TSA or the citizens of the State of Texas.

(3) If the office upholds its original determination, the director of the office will give written notice of such to the facility within 30 days of its receipt of the applicant's complete written appeal.

(4) The facility may, within 30 days of the office's sending written notification of its denial, submit a written request for further review. Such written appeal shall then go to the Assistant Commissioner, Division for Regulatory Services (assistant commissioner).

(j) When the analysis of the "Complete Application" form results in acknowledgement by the office that the facility is seeking an appropriate level of designation or re-designation, the facility may then contract for the survey, as follows.

(1) Level I and II facilities and all free-standing children's facilities shall request a survey through the ACS trauma verification program.

(2) Level III facilities shall request a survey through the ACS trauma verification program or through a comparable organization approved by the department.

(3) Level IV facilities shall request a survey through the ACS trauma verification program, through a comparable organization approved by the department, or by a department-credentialed surveyor(s) active in the management of trauma patients.

(4) The facility shall notify the office of the date of the planned survey and the composition of the survey team.

(5) The facility shall be responsible for any expenses associated with the survey.

(6) The office, at its discretion, may appoint an observer to accompany the survey team. In this event, the cost for the observer shall be borne by the office.

(k) The survey team composition shall be as follows.

(1) Level I or Level II facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum: 2 general surgeons, an emergency

22

physician, and a trauma nurse all active in the management of trauma patients.

(2) Free-standing children's facilities of all levels shall be surveyed by a team consistent with current ACS policy and includes at a minimum: a pediatric surgeon; a general surgeon; a pediatric emergency physician; and a pediatric trauma nurse coordinator or a trauma nurse coordinator with pediatric experience.

(3) Level III facilities shall be surveyed by a team that is multi-disciplinary and includes at a minimum: a trauma surgeon and a trauma nurse (ACS or department-credentialed), both active in the management of trauma patients.

(4) Level IV facilities shall be surveyed by a department-credentialed representative, registered nurse or licensed physician. A second surveyor may be requested by the facility or by the department.

(5) Department-credentialed surveyors must meet the following criteria:

(A) have at least 3 years experience in the care of trauma patients;

(B) be currently employed in the coordination of care for trauma patients;

(C) have direct experience in the preparation for and successful completion of trauma facility verification/designation;

(D) have successfully completed a department-approved trauma facility site surveyor course and be successfully re-credentialed every 4 years; and

(E) have current credentials as follows:

(i) for nurses: Trauma Nurses Core Course (TNCC) or Advanced Trauma Course for Nurses (ATCN); and Pediatric Advanced Life Support (PALS) or Emergency Nurses Pediatric Course (ENPC);

(ii) for physicians: Advanced Trauma Life Support (ATLS); and

(iii) have successfully completed a site survey internship.

(6) All members of the survey team, except department staff, shall come from a TSA outside the facility's location and at least 100 miles from the facility. There shall be no business or patient care relationship or any potential conflict of interest between the surveyor or the surveyor's place of employment and the facility being surveyed.

(l) The survey team shall evaluate the facility's compliance with the designation criteria, by:

(1) reviewing medical records; staff rosters and schedules; process improvement committee meeting minutes; and other documents relevant to trauma care;

23

(2) reviewing equipment and the physical plant;

(3) conducting interviews with facility personnel;

(4) evaluating compliance with participation in the Texas EMS/Trauma Registry; and

(5) evaluating appropriate use of telemedicine capabilities where applicable.

(m) The site survey report in its entirety shall be part of a facility's performance improvement program and subject to confidentiality as articulated in the Health and Safety Code, §773.095.

(n) The surveyor(s) shall provide the facility with a written, signed survey report regarding their evaluation of the facility's compliance with trauma facility criteria. This survey report shall be forwarded to the facility within 30 calendar days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the office if it intends to continue the designation process.

(o) The office shall review the findings of the survey report for compliance with trauma facility criteria.

(1) A recommendation for designation shall be made to the commissioner based on compliance with the criteria.

(2) If a facility does not meet the criteria for the level of designation deemed appropriate by the office, the office shall notify the facility of the requirements it must meet to achieve the appropriate level of designation.

(3) If a facility does not comply with criteria, the office shall notify the facility of deficiencies and recommend corrective action.

(A) The facility shall submit to the office a report that outlines the corrective action(s) taken. The office may require a second survey to ensure compliance with the criteria. If the office substantiates action that brings the facility into compliance with the criteria, the Office shall recommend designation to the commissioner.

(B) If a facility disagrees with the office's decision regarding its designation application or status, it may request a secondary review by a designation review committee. Membership on a designation review committee will:

(i) be voluntary;

(ii) be appointed by the office director;

(iii) be representative of trauma care providers and appropriate levels of designated trauma facilities; and

(iv) include representation from the department and the Trauma Systems

24

Committee of the Governor's EMS and Trauma Advisory Council (GETAC).

(C) If a designation review committee disagrees with the office's recommendation for corrective action, the records shall be referred to the assistant commissioner for recommendation to the commissioner.

(D) If a facility disagrees with the office's recommendation at the end of the secondary review, the facility has a right to a hearing, in accordance with the department's rules for contested cases, and Government Code, Chapter 2001.

(p) The facility shall have the right to withdraw its application at any time prior to being recommended for trauma facility designation by the office.

(q) If the commissioner concurs with the recommendation to designate, the facility shall receive a letter and a certificate of designation valid for 3 years. Additional actions, such as a site review or submission of information/reports to maintain designation, may be required by the department.

(r) It shall be necessary to repeat the designation process as described in this section prior to expiration of a facility's designation or the designation expires.

(s) A designated trauma facility shall:

(1) comply with the provisions within these sections; all current state and system standards as described in this chapter; and all policies, protocols, and procedures as set forth in the system plan;

(2) continue its commitment to provide the resources, personnel, equipment, and response as required by its designation level;

(3) participate in the Texas EMS/Trauma Registry. Data submission requirements for designation purposes are as follows.

(A) Initial designation--Six months of data prior to the initial designation survey must be uploaded. Subsequent to initial designation, data should be uploaded to the Texas EMS/Trauma Registry on at least a quarterly basis (with monthly submissions recommended) as indicated in §103.19 of this title (relating to Electronic Reporting).

(B) Re-designation--The facility's trauma registry should be current with at least quarterly uploads of data to the Texas EMS/Trauma Registry (monthly submissions recommended) as indicated in §103.19 of this title;

(4) notify the office, its RAC plus other affected RACs of all changes that affect air medical access to designated landing sites.

(A) Non-emergent changes shall be implemented no earlier than 120 days after a written notification process.

25

(B) Emergency changes related to safety may be implemented immediately along with immediate notification to department, the RAC, and appropriate Air Medical Providers.

(C) Conflicts relating to helipad air medical access changes shall be negotiated between the facility and the EMS provider.

(D) Any unresolved issues shall be handled utilizing the nonbinding alternative dispute resolution (ADR) process of the RAC in which the helipad is located;

(5) within 5 days, notify the office; its RAC plus other affected RACs; and the healthcare facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in if temporarily unable to comply with a designation criterion. If the healthcare facility intends to comply with the criterion and maintain current designation status, it must also submit to the office a plan for corrective action and a request for a temporary exception to criteria within 5 days.

(A) If the requested essential criterion exception is not critical to the operations of the healthcare facility's trauma program and the office determines that the facility has intent to comply, a 30-day to 90-day exception period from the onset date of the deficiency may be granted for the facility to achieve compliancy.

(B) If the requested essential criterion exception is critical to the operations of the healthcare facility's trauma program and the office determines that the facility has intent to comply, no greater than a 30-day exception period from the onset date of the deficiency may be granted for the facility to achieve compliancy. Essential criteria that are critical include such things as:

(i) neurological surgery capabilities (Level I, II);

(ii) orthopedic surgery capabilities (Level I, II, III);

(iii) general/trauma surgery capabilities (Level I, II, III);

(iv) anesthesiology (Levels I, II, III);

(v) emergency physicians (all levels);

(vi) trauma medical director (all levels);

(vii) trauma nurse coordinator/program manager (all levels); and

(viii) trauma registry (all levels).

(C) If the healthcare facility has not come into compliance at the end of the exception period, the office may at its discretion elect one of the following:

26

(i) allow the facility to request designation at the level appropriate to its revised capabilities;

(ii) propose to re-designate the facility at the level appropriate to its revised capabilities;

(iii) propose to suspend the facility's designation status. If the facility is amenable to this action, the office will develop a plan for corrective action for the facility and a specific timeline for compliance by the facility; or

(iv) propose to extend the facility's temporary exception to criteria for an additional period not to exceed 90 days. The department will develop a plan for corrective action for the facility and a specific timeline for compliance by the facility.

(I) Suspensions of a facility's designation status and exceptions to criteria for facilities will be documented on the office website.

(II) If the facility disagrees with a proposal by the office, or is unable or unwilling to meet the office-imposed timelines for completion of specific actions plans, it may request a secondary review by a designation review committee as defined in subsection (o)(3)(B) of this section.

(III) The office may at its discretion choose to activate a designation review committee at any time to solicit technical advice regarding criteria deficiencies.

(IV) If the designation review committee disagrees with the office's recommendation for corrective actions, the case shall be referred to the assistant commissioner for recommendation to the commissioner.

(V) If a facility disagrees with the office's recommendation at the end of the secondary review process, the facility has a right to a hearing, in accordance with the department's rules for contested cases and Government Code, Chapter 2001.

(VI) Designated trauma facilities seeking exceptions to essential criteria shall have the right to withdraw the request at any time prior to resolution of the final appeal process;

(6) notify the office; its RAC plus other affected RACs; and the healthcare facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in, if it no longer provides trauma services commensurate with its designation level.

(A) If the facility chooses to apply for a lower level of trauma designation, it may do so at any time; however, it shall be necessary to repeat the designation process. There shall be a paper review by the office to determine if and when a full survey shall be required.

27

(B) If the facility chooses to relinquish its trauma designation, it shall provide at least 30 days notice to the RAC and the office; and

(7) within 30 days, notify the office; its RAC plus other affected RACs; and the healthcare facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in, of the change(s) if it adds capabilities beyond those that define its existing trauma designation level.

(A) It shall be necessary to repeat the trauma designation process.

(B) There shall then be a paper review by the office to determine if and when a full survey shall be required.

(t) Any facility seeking trauma designation shall have measures in place that define the trauma patient population evaluated at the facility and/or at each of its locations, and the ability to track trauma patients throughout the course of their care within the facility and/or at each of its locations in order to maximize funding opportunities for uncompensated care.

(u) A healthcare facility may not use the terms "trauma facility", "trauma hospital", "trauma center", or similar terminology in its signs or advertisements or in the printed materials and information it provides to the public unless the healthcare facility is currently designated as a trauma facility according to the process described in this section.

(v) The office shall have the right to review, inspect, evaluate, and audit all trauma patient records, trauma performance improvement committee minutes, and other documents relevant to trauma care in any designated trauma facility or applicant/healthcare facility at any time to verify compliance with the statute and this rule, including the designation criteria. The office shall maintain confidentiality of such records to the extent authorized by the Texas Public Information Act, Government Code, Chapter 552, and consistent with current laws and regulations related to the Health Insurance Portability and Accountability Act of 1996. Such inspections shall be scheduled by the office when deemed appropriate. The office shall provide a copy of the survey report, for surveys conducted by or contracted for the department, and the results to the healthcare facility.

(w) The office may grant an exception to this section if it finds that compliance with this section would not be in the best interests of the persons served in the affected local system.

(x) Advanced (Level III) Trauma Facility Criteria.

Figure: 25 TAC §157.125(x) (No change.)

(1) Advanced (Level III) Trauma Facility Criteria Standards.

Figure: 25 TAC §157.125(x)(1) (No change.)

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(2) Advanced (Level III) Trauma Facility Criteria Audit Filters.

Figure: 25 TAC §157.125(x)(2) (No change.)

(y) Basic (Level IV) Trauma Facility Criteria.

Figure: 25 TAC §157.125(y)Figure: 25 TAC §157.125(y) (Separate Attachment)

(1) Basic (Level IV) Trauma Facility Criteria Standards.

Figure: 25 TAC §157.125(y)(1) (No change.)

(2) Basic (Level IV) Trauma Facility Criteria Audit Filters.

Figure: 25 TAC §157.125(y)(2) (No change.)

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Figure: 25 TAC §157.125(y)

BASIC (LEVEL IV) TRAUMA FACILITY CRITERIA

Basic Trauma Facility (Level IV) - provides resuscitation, stabilization, and arranges for appropriate transfer of major and severe trauma patients to a higher level trauma facility when medically necessary; provides ongoing educational opportunities in trauma related topics for health care professionals and the public, and implements targeted injury prevention programs (see attached standards). The administrative commitment of a Level IV trauma facility includes developing processes that define the trauma patient population evaluated by the facility and track them throughout the course of their stay in order to maximize funding opportunities.

A.        TRAUMA PROGRAM1.      An identified Trauma Medical Director (TMD) who:

is currently credentialed in Advanced Trauma Life Support (ATLS) or an equivalent course approved by the Department of State Health Services (DSHS).

is charged with overall management of trauma services provided by the hospital.

shall have the authority and responsibility for the clinical oversight of the trauma program.  This is accomplished through mechanisms that may include: credentialing of medical staff who provide trauma care; providing trauma care; developing treatment protocols; cooperating with the nursing administration to support the nursing needs of the trauma patients; coordinating the performance improvement (PI) peer review; and correcting deficiencies in trauma care.

a. There shall be a defined job description and organizational chart delineating the TMD's role and responsibilities.

b. The TMD shall be credentialed by the hospital to participate in the resuscitation and treatment of trauma patients using criteria to include such things as board-certification/board-eligibility, trauma continuing medical education, compliance with trauma protocols, and participation in the trauma PI program.

c. The TMD shall participate in a leadership role in the hospital, community, and emergency management (disaster) response committee.

d. The TMD should participate in the development of the regional trauma system plan.

 E 

2.      An identified Trauma Nurse Coordinator/Trauma Program Manager (TNC/TPM) who:

 E 

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is a registered nurse.

has successfully completed and is current in the Trauma Nurse Core Course (TNCC) or Advanced Trauma Course for Nurses (ATCN) or a DSHS-approved equivalent.

has successfully completed and is current in a nationally recognized pediatric advanced life support course ((e.g. Pediatric Advanced Life Support (PALS) or the Emergency Nurse Pediatric Course (ENPC)).

has the authority and responsibility to monitor trauma patient care from emergency department deparment (ED) admission through operative intervention(s), ICU care, stabilization, rehabilitation care, and discharge, including the trauma PI program.

a. There shall be a defined job description and organizational chart delineating the TNC/TPM's role and responsibilities.

b. The TNC/TPM shall participate in a leadership role in the hospital, community, and regional emergency management (disaster) response committee.

c. Trauma programs should have a minimum of .8 FTE dedicated to the TNC/TPM position.

d. The TNC/TPM should complete a course designed for his/her role which provides essential information on the structure, process, organization and administrative responsibilities of a PI program to include a trauma outcomes and performance improvement course ((e.g. Trauma Outcomes Performance Improvement Course (TOPIC) or Trauma Coordinators Core Course (TCCC)).

3.      An identified Trauma Registrar who has appropriate training ((e.g. the Association for the Advancement of Automotive Medicine (AAAM) course, American Trauma Society (ATS) Trauma Registrar Course)) in injury severity scaling.  Typically, one full-time equivalent (FTE) employee dedicated to the registry shall be required to process approximately 500 patients annually.

 D 

4.      Written protocols, developed with approval by the hospital's medical staff, for:

a. Trauma team activation

b. Identification of trauma team responsibilities during a resuscitation

c. Resuscitation and Treatment of trauma patients

d. Triage, admission and transfer of trauma patients

 E 

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B.   PHYSICIAN SERVICES1.      Emergency Medicine - this requirement may be fulfilled by a

physician credentialed by the hospital to provide emergency medical services.

Any emergency physician who is providing trauma coverage shall be credentialed by the TMD to participate in the resuscitation and treatment of trauma patients of all ages to include requirements such as current board certification/eligibility, an average of 9 hours of trauma-related continuing medical education per year, compliance with trauma protocols, and participation in the trauma PI program.

An Emergency Medicine board-certified physician who is providing trauma coverage shall have successfully completed an ATLS Student Course or a DSHS-approved ATLS equivalent course.

Current ATLS verification is required for all physicians who work in the ED and are not board certified in Emergency Medicine.

The emergency physician representative to the multidisciplinary committee that provides trauma coverage to the facility shall attend 50% or greater of multidisciplinary and peer review trauma committee meetings.

 E 

2.      Radiology  D 3.      Anesthesiology - requirements may be fulfilled by a member of the

anesthesia care team credentialed in assessing emergent situations in trauma patients and providing any indicated treatment.

 D 

4.      Primary Care Physician - The patient's primary care physician should be notified at an appropriate time.

 D 

C.     NURSING SERVICES (for all Critical Care and Patient Care Areas)1.      All nurses caring for trauma patients throughout the continuum of care

have ongoing documented knowledge and skill in trauma nursing for patients of all ages to include trauma specific orientation, annual clinical competencies, and continuing education.

 E 

2.      Written standards on nursing care for trauma patients for all units (i.e. ED, ICU, OR, PACU, general wards) in the trauma facility shall be implemented.

 E 

3.      A written plan, developed by the hospital, for acquisition of additional staff on a 24 hour basis to support units with increased patient acuity, multiple emergency procedures and admissions (i.e. written disaster plan.)

 E 

4.      50% of nurses caring for trauma patients should be certified in their area of specialty (e.g. CEN, CCRN, CNRN, etc.)

 D 

D.     EMERGENCY DEPARTMENT1.      Physician on-call schedule must be published.  E 

2.      Physician with special competence in the care of critically injured patients, who is a designated member of the trauma team and who is on-call (if not in-house 24/7) and promptly available within 30 minutes of request from inside or outside the hospital.* *Neither a hospital’s telemedicine medical

 E 

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service telemedical capabilities nor the physical presence of physician assistants (PAs) or clinical nurse specialists/nurse practitioners (CNSs/NPs) shall satisfy this requirement with the exception of the following:

a. A health care facility located in a county with a population of less than 30,000 may satisfy a Level IV trauma facility designation requirement relating to physicians through the use of telemedicine medical service in which an on-call physician who has special competence in the care of critically injured patients provides patient assessment, diagnosis, consultation, or treatment, or transfers medical data to a physician, advanced practice registered nurse, or physician assistants located at the facility.

b. Additionally, PAs/NPs and telemedicine-support physicians who participate in the care of major/severe trauma patients shall be credentialed by the hospital to participate in the resuscitation and treatment of said trauma patients, to include requirements such as board certification/eligibility, an average of 9 hours of trauma-related continuing medical education per year, compliance with trauma protocols, and participation in the trauma PI program.

3.      The physician on duty or on-call to the emergency department (ED)

shall be activated on EMS communication with the ED or after a primary assessment of patients who arrive to the ED by private vehicle for the major or severe trauma patient. Response time shall not exceed thirty minutes from notification (this criterion shall be monitored in the trauma PI program.)

 E 

4.      A minimum of one and preferably two registered nurses who have trauma nursing training shall participate in initial major trauma resuscitations.

 E 

5.      Nurse staffing in initial resuscitation area is based on patient acuity and trauma team composition based on historical census and acuity data.

 E 

6.      At least one member of the registered nursing staff responding to the trauma team activation for a major or severe trauma resuscitation has successfully completed and holds current credentials in an advanced cardiac life support course (e.g. ACLS or hospital equivalent), a nationally recognized pediatric advanced life support course (e.g. PALS or ENPC) and TNCC or ATCN or a DSHS-approved equivalent.

 E 

7.      100% of nursing staff have successfully completed and hold current credentials in an advanced cardiac life support course (e.g. ACLS or hospital equivalent), a nationally recognized pediatric advanced life support course (e.g. PALS or ENPC) and TNCC or ATCN or a DSHS-approved equivalent, within 18 months of date of employment in the ED or date of designation.

 E 

8.      Nursing documentation for trauma patients is systematic and meets the trauma registry guidelines.

 E 

9.      Two-way communication with all pre-hospital emergency medical services vehicles.

 E 

10.    Equipment and services for the evaluation and resuscitation of, and to provide life support for, critically or seriously injured patients of all ages shall include but not be limited to:

 E 

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               a.     Airway control and ventilation equipment including laryngoscope and endotracheal tubes of all sizes, bag-valve-mask devices (BVMs), pocket masks, and oxygen

 E 

               b.     Mechanical ventilator  E                c.     Pulse oximetry  E                d.     Suction devices  E                e.     Electrocardiograph - oscilloscope - defibrillator  E                f.      Supraglottic airway management device (e.g. LMA)  D                g.     Apparatus to establish central venous pressure monitoring

equipment D 

               h.     All standard intravenous fluids and administration devices, including large-bore intravenous catheters and a rapid infuser system

 E 

               i.      Sterile surgical sets for procedures standard for the emergency room such as thoracostomy, venous cutdown, central line insertion, thoracotomy, airway control/cricothyrotomy, etc.

 E 

               j.      Drugs and supplies necessary for emergency care  E                k.     Cervical spine stabilization device  E                l.     Length-based body weight & tracheal tube size evaluation

system (such as Broselow tape) and resuscitation medications and equipment that are dose-appropriate for all ages

 E 

               m.     Long bone stabilization device  E                n.     Pelvic stabilization device  E                o.     Thermal control equipment for patients and a rapid warming

device for blood and fluids E 

               p.     Non-invasive continuous blood pressure monitoring devices  E                q.     Qualitative end tidal CO2 monitor E11.     X-ray capability.  E 

E.     CLINICAL LABORATORY SERVICE (available 24 hours per day)1.    Call-back process for trauma activations available within 30 minutes.

This system shall be continuously monitored in the trauma PI program. E 

2.    Standard analyses of blood, urine, and other body fluids, including microsampling.

 E 

3.    Blood typing and cross-matching.  D 4.    Capability for immediate release of blood for a transfusion and a

protocol to obtain additional blood supply. E 

5.    Coagulation studies.  E 6.    Blood gases and pH determinations.  E 7.    Drug and alcohol screening - toxicology screens need not be

immediately available but are desirable (if available, results should be included in all trauma PI reviews.)

 D 

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F.     RADIOLOGICAL CAPABILITIES (available 24 hours per day)1.    Call-back process for trauma activations available within 30 minutes.

This system shall be continuously monitored in the trauma PI program. E 

2.    24-hour coverage by in-house technician.  D 3.    Computerized tomography.  D 

G.  PERFORMANCE IMPROVEMENT1.     Track record:

             On Initial Designation:  a facility must have completed at least six months of audits on all qualifying trauma records with evidence of “loop closure” on identified issues.  Compliance with internal trauma policies must be evident.

             On Re-designation:  a facility must show continuous PI activities throughout its designation and a rolling current three year period must be available for review at all times.

 E 

2.     Minimum inclusion criteria:  All trauma team activations (including those discharged from the ED), all trauma deaths or dead on arrivals (DOAs), all major and severe trauma admissions; transfers-in and transfers-out; and readmissions within 48 hours after discharge.

 E 

3.     An organized trauma PI program established by the hospital, to include a pediatric-specific component and trauma audit filters (see "Basic Trauma Facility Audit Filters" list.)

 E 

       a.     Audit of trauma charts for appropriateness and quality of care.  E        b.     Documented evidence of identification of all deviations from

trauma standards of care, with in-depth critical review.  E 

       c.     Documentation of actions taken to address all identified issues.  E        d.     Documented evidence of participation by the TMD.  E        e.     Morbidity and mortality review including decisions by the TMD as

to whether or not standard of care was met.  E 

       f.      Documented resolutions “loop closure” of all identified issues to prevent future recurrences.  E 

       g.     Special audit for all trauma deaths and other specified cases, including complications, utilizing age-specific criteria.  E 

       h.     Multidisciplinary hospital trauma PI committee structure in place.  E 4.     Multidisciplinary trauma conferences, continuing education and

problem solving to include documented nursing and pre-hospital participation  D 

5.    Feedback regarding major/severe trauma patient transfers-out from the ED and in-patient units shall be obtained from receiving facilities.  E 

6.     Trauma registry - data shall be forwarded to the state trauma registry on at least a quarterly basis.  E 

7.     Documentation of severity of injury (by Glasgow Coma Scale, revised trauma score, age, injury severity score) and outcome (survival, length of stay,

 E 

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ICU length of stay) with monthly review of statistics.8.     Participation with the regional advisory council’s (RAC) PI program,

including adherence to regional protocols, review of pre-hospital trauma care, submitting data to the RAC as requested including such things as summaries of transfer denials and transfers to hospitals outside of the RAC.

 E 

9.      Times of and reasons for diversion must be documented and reviewed by the trauma PI program.

 E 

H.  REGIONAL TRAUMA SYSTEM1.      Must participate in the regional trauma system per RAC requirements.  E 

I.    TRANSFERS1.     A process to expedite the transfer of major and severe trauma patients

to include such things as written protocols, written transfer agreements, and a regional trauma system transfer plan for patients needing higher level of care or specialty services (i.e. surgery, burns, etc.)

 E 

2.     A system for establishing an appropriate landing zone in close proximity to the hospital (if rotor wing services are available.)

 E 

J.   PUBLIC EDUCATION/INJURY PREVENTION1.     A public education program to address the major injury problems within

the hospital's service area. Documented participation in a RAC injury prevention program is acceptable.

 E 

2.     Coordination and/or participation in community/RAC injury prevention activities.

 E 

K.  TRAINING PROGRAMS1.     Formal programs in trauma continuing education provided by hospital

for staff based on needs identified from the trauma PI program for: E 

       a.     Staff physicians  E        b.     Nurses  E        c.     Allied health personnel, including mid-level providers such as

physician assistants and nurse practitioners E 

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