DAR File No. 43321

Health, Family Health and Preparedness, Emergency Medical Services

Rule R426-9

Trauma and EMS System Facility Designations

Notice of Proposed Rule

(Amendment)

DAR File No.: 43321
Filed: 10/22/2018 10:44:18 AM

RULE ANALYSIS

Purpose of the rule or reason for the change:

These amendments provide requirements for data submission for the stroke and cardiac registries.

Summary of the rule or change:

These amendments are in response to amendments to Sections 26-8d-102 and 103.

Statutory or constitutional authorization for this rule:

• Section 26-8d

Anticipated cost or savings to:

the state budget:

An anticipated fiscal impact to the state budget was included in the new legislation for the creation of the stroke and cardiac registries (see Section 26-8d). The fiscal impact for the enacted bill was on-going at $98,000 per year. The costs are technical costs, and will be used to acquire data from existing health care provider data already submitted for the electronic exchange of clinical health information (see Section 26-1-37). Costs also include the administration of the stroke and cardiac advisory committees.

local governments:

There is no anticipated fiscal impact to local governments because these amendments do not constrain local governments.

small businesses:

There is no anticipated fiscal impact to small businesses. These amendments pertain to hospitals and state functions.

persons other than small businesses, businesses, or local governmental entities:

These rule amendments to R426-9 are not expected to have any fiscal impact on persons other than small businesses, businesses, or local governments because the data collected for the stroke and cardiac registries will be derived by the Department of Health from existing data already submitted by health care providers under existing requirements for the electronic of clinical health information data base (see Section 26-1-37).

Compliance costs for affected persons:

Affected persons (patients) will not have any additional compliance costs.

Comments by the department head on the fiscal impact the rule may have on businesses:

After conducting a thorough analysis, it was determined that these rule amendments will not result in fiscal impact to businesses.

Joseph K. Miner, M.D., Executive Director

The full text of this rule may be inspected, during regular business hours, at the Office of Administrative Rules, or at:

Health
Family Health and Preparedness, Emergency Medical Services
3760 S HIGHLAND DR
SALT LAKE CITY, UT 84106

Direct questions regarding this rule to:

• Jolene Whitney at the above address, by phone at 801-273-6665, by FAX at 801-273-4165, or by Internet E-mail at [email protected]

Interested persons may present their views on this rule by submitting written comments to the address above no later than 5:00 p.m. on:

12/17/2018

This rule may become effective on:

12/24/2018

Authorized by:

Joseph Miner, Executive Director

Appendix 1: Regulatory Impact Summary Table*

Fiscal Costs	FY 2019	FY 2020	FY 2021
State Government	$98,000	$98,000	$98,000
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Person	$0	$0	$0
Total Fiscal Costs:	$98,000	$98,000	$98,000
Fiscal Benefits
State Government	$0	$0	$0
Local Government	$0	$0	$0
Small Businesses	$0	$0	$0
Non-Small Businesses	$0	$0	$0
Other Persons	$0	$0	$0
Total Fiscal Benefits:	$0	$0	$0
Net Fiscal Benefits:	$(98,000)	$(98,000)	$(98,000)

 

*This table only includes fiscal impacts that could be measured. If there are inestimable fiscal impacts, they will not be included in this table. Inestimable impacts for State Government, Local Government, Small Businesses and Other Persons are described in the narrative. Inestimable impacts for Non - Small Businesses are described in Appendix 2.

 

Appendix 2: Regulatory Impact to Non - Small Businesses

These amendments to R426-9 are not expected to have any fiscal impact on non-small businesses revenues or expenditures, because the data collected for the stroke and cardiac registries will be derived by the Department of Health from existing data already submitted by health care providers under existing requirements for the electronic of clinical health information data base (see Section 26-1-37).

 

 

R426. Health, Family Health and Preparedness, Emergency Medical Services.

R426-9. [Trauma and EMS System]Specialty Care Systems Facility Designations.

R426-9-100. Authority and Purpose for [ Trauma System ] Specialty Care Systems Standards.

(1) [Authority - This rule is established under Title 26, Chapter 8a, 252, Statewide Trauma System, which authorizes the Department to:]This rule establishes requirements pursuant to statute for a statewide specialty care systems and related emergency medical systems including the following:

(a) establishes and actively supervise s a statewide trauma system;

(b) establishes, by rule, trauma center designation requirements and model state guidelines for triage, treatment, transport, and transfer of trauma patients to the most appropriate health care facility; and

(c) [designate]allows designation of trauma care facilities consistent with the trauma center designation requirements and verification process established by the Department and applicable statutes.

(2) This rule provides standards for the categorization of all hospitals and the voluntary designation of [T]trauma [C]centers to assist physicians in selecting the most appropriate physician and facility based upon the nature of the patient's critical care problem and the capabilities of the facility.

(3) It is intended that the categorization process be dynamic and updated periodically to reflect changes in national standards, medical facility capabilities, and treatment processes. Also, as suggested by the Utah Medical Association, the standards are in no way to be construed as mandating the transfer of any patient contrary to the wishes of his attending physician, rather the standards serve as an expression of the type of facilities and care available in the respective hospitals for the use of physicians requesting transfer of patients requiring skills and facilities not available in their own hospitals.

 

R426-9-200. Trauma System Advisory Committee.

(1) The [t]Trauma [s]System [a]Advisory [c]Committee[, created pursuant to 26-8a-251,] shall:

(a) be a broad and balanced representation of healthcare providers and health care delivery systems; and

(b) conduct meetings in accordance with committee procedures.

(2) The Department shall appoint committee members to serve terms from one to four years.

(3) The Department may re-appoint committee members for one additional term in the position initially appointed by the Department.

(4) Causes for removal of a committee member include the following:

(a) more than two unexcused absences from meetings within 12 calendar months;

(b) more than three excused absences from meetings within 12 calendar months;

(c) conviction of a felony; or

(d) change in organizational affiliation or employment which may affect the appropriate representation of a position on the committee for which the member was appointed.

 

R426-9-300. Trauma Center Categorization Guidelines.

The Department adopts as criteria for Level I, Level II, Level III, IV and Pediatric trauma center designation, compliance with national standards published in the American College of Surgeons document: Resources for Optimal Care of the Injured Patient 2014.

 

R426-9-400. Trauma Center Review Process.

(1) The Department shall conduct a quality review site visit of trauma centers and applicants to verify compliance with standards set in R426-9-300. In conducting each evaluation, the Department may consult with experts from the following disciplines:

(a) trauma surgery;

(b) emergency medicine;

(c) emergency or critical care nursing; and

(d) hospital administration.

(2) A consultant shall not assist the Department in evaluating a facility in which the consultant is employed, practices, or has any financial interest.

 

R426-9-500. Trauma Center Categorization Process.

The Department shall:

(1) Develop a survey document based upon the Trauma Center Criteria described in R426-9-300.

(2) Periodically survey all Utah hospitals which provide emergency trauma care to determine the maximum level of trauma care which each is capable of providing.

(3) Disseminate survey results to all Utah hospitals, and as appropriate, to Utah licensed ambulance providers.

 

R426-9-600. Trauma Center Designation Process.

(1) Hospitals seeking voluntary designation and all designated Trauma Centers desiring to remain designated, shall apply for designation by submitting the following information to the Department at least 30 days prior to the date of the scheduled site visit:

(a) a completed and signed application and appropriate fees for trauma center verification;

(b) a letter from the hospital administrator of continued commitment to comply with current trauma center designation standards as applicable to the applicant's designation level;

(c) the data specified under R426-9-700 are current;

(d) Level I and Level II Trauma Centers must submit a copy of the Pre-review Questionnaire (PRQ) from the American College of Surgeons in lieu of the application in 1a above;

(e) Level III and Level IV and Level V trauma centers must submit a complete Department approved application.

(2) Hospitals desiring to be designated as Level I and Level II Trauma Centers must be verified by the American College of Surgeons (ACS) within three (3) months of the expiration date of previous designation and must submit a copy of the full ACS report detailing the results of the ACS site visit. A Department representative must be present during the entire ACS verification or consultation visit. Hospitals desiring to be Level III or Level IV Trauma Centers must be designated by hosting a formal site visit by the Department.

(3) Hospitals not previously designated as a Level I or a Level II trauma center, applying for designation after December 31, 2016, will be considered for designation implementing the point system suggested by the American College of Surgeons as follows and using data from the Utah Trauma Registry:

(a) population as defined by the federal Office of Management and Budget total Metropolitan Statistical Area (MSA);

(i) total MSA population of less than 600,000 receives 2 points,

(ii) total MSA population of 600,000 to 1,200,000 receives 4 points,

(iii) total MSA population of 1,200,000 to 1,800,000 receives 6 points,

(iv) total MSA population of 1,800,000 to 2,400,000 receives 8 points,

(v) total MSA population of greater than 2,400,000 receives 10 points.

(b) Median Transport Times (combined air and ground -- scene only no transfer);

(i) median transport time of less than 10 minutes received 0 points,

(ii) median transport time of 10 -- 20 minutes receives 1 points,

(iii) median transport time of 21 -- 30 minutes receives 2 points,

(iv) median transport time of 31 -- 40 minutes receives 3 points,

(v) median transport time of greater than 41 minutes receives 4 points.

(c) Department/System Stakeholder/Community Support;

(i) Department support for a trauma center(if none exist)or an additional trauma center in the MSA -- 5 points,

(ii) Department position that no additional trauma centers are needed -- negative 5 points,

(iii) Trauma System Advisory Committee (or equivalent body) statement of support for a trauma center (if none exist) or an additional trauma center in the MSA -- 5 points,

(iv) community support demonstrated by letters of support from 25- 50% of city and county governing bodies within the MSA -- 1 points,

(v) community support demonstrated by letters of support from over 50% of city and county governing bodies within the MSA -- 2 points.

(d) Severely injured patients (ISS more than 15) discharged from acute care facilities not designated as Level I, II, or III trauma centers;

(i) discharges of 0-200 severely injured patients receives 0 points,

(ii) discharges of 201 -- 400 severely injured patients receives 1 points,

(iii) discharges of 401 -- 600 severely injured patients receives 2 points,

(iv) discharges of 601 -- 800 severely injured patients receives 3 points,

(v) discharges of greater than 800 severely injured patients receives 4 points.

(e) Level I Trauma Centers;

(i) for the existence of each verified Level I trauma center already in the MSA assign 1 negative point,

(ii) for the existence of each verified Level II trauma center already in the MSA assign 1 negative point,

(iii) for the existence of each verified Level III trauma center already in the MSA assign 0.5 negative points.

(f) Numbers of severely injured patients (ISS more than 15) seen in trauma centers (Level I and II) already in the MSA. The expected number of high-ISS patients is calculated as: 500 x (Number of Level I and Level II centers in the MSA) = (Expected Number of high ISS patients);

(i) if the MSA has more than 500 severely injured patients above the expected number assign 2 points,

(ii) if the MSA has 0 - 500 severely injured patients above the expected number assign 1 point,

(iii) if the MSA has 0 - 500 fewer severely injury patients than the expected number assign 1 negative point,

(iv) if the MSA has more than 500 fewer severely injured patients than the expected number assign 2 negative points.

(g) The following scoring system shall be used to allocate trauma centers within the MSAs:

(i) MSAs with scores of 5 points or less shall be allocated 1 Level I or II trauma center;

(ii) MSAs with scores of 6 - 10 points shall be allocated 2 Level I or II trauma centers;

(iii) MSAs with score of 11 - 15 points shall be allocated 3 Level I or II trauma centers;

(iv) MSAs with scores of 16 - 20 points shall be allocated 4 Level I or II trauma centers.

(h) If the number of trauma centers allocated by the model is greater than the existing number of Level I or II trauma centers in the MSA, efforts should be undertaken to recruit and designate additional trauma centers.

(i) If the number of Level I and II trauma centers allocated by the model is less than or equal to the number currently designated, the Department should not designate additional Level I or II trauma centers in the MSA.

 

R426-9-700. Data Requirements for an Inclusive Trauma System.

(1) All hospitals shall collect, and monthly submit to the Department, Trauma Registry information necessary to maintain an inclusive trauma system. Designated trauma centers shall provide such data in a standardized electronic format approved by the Department. The Department shall provide funds to hospitals, excluding designated trauma centers, for the data collection process. In order to ensure consistent patient data collection, a trauma patient is defined as a patient sustaining a traumatic injury and meeting the following criteria:

(a) At least one of the following injury diagnostic codes: ICD10 Diagnostic Codes: S00-S00 with 7th character modifiers of A, B, or C only, T07, T14, T20-T28 with 7th character modifier of A, T30-T32, T79.A1-T79.A9 with 7th character modifier of A excluding the following isolated injuries: S00, S10, S20, S30, S40, S50, S60, S70, S80, S90. Late effect codes, which are represented using the same range of injury diagnosis codes but with the 7th digit modifier code of D through S are also excluded; and

(b) At least one of the following patient conditions:

Stay at a hospital greater than 12 hours (as measured from the Emergency Department arrival to patient discharge); transferred in or out of reporting hospital via EMS transport (including air ambulance); death resulting from the traumatic injury (independent of hospital admission or hospital transfer status.

(c) The Department adopt by reference the National Trauma Data Standard Data Dictionary for 2016 Admissions published by the American College of Surgeons, and the Utah Trauma Registry State Required Elements for 2016 published by the Department.

 

R426-9-800. Trauma Triage and Transfer Guidelines.

The Department adopts by reference the 2009 Resources and Guidelines for the Triage and Transfer of Trauma Patients published by the Utah Department of Health as model guidelines for triage, transfer, and transport of trauma patients. The guidelines do not mandate the transfer of any patient contrary to the judgment of the attending physician. They are a resource for pre-hospital and hospital providers to assist in the triage, transfer and transport of trauma patients to designated trauma centers or acute care hospitals which are appropriate to adequately receive trauma patients.

 

R426-9-900. Noncompliance to Trauma Standards.

(1) The Department may warn, reduce, deny, suspend, revoke, or place on probation a facility designation, if the Department finds evidence that the facility has not been or will not be operated in compliance to standards adopted under R426-9-300.

(2) A hospital, clinic, health care provider, or health care delivery system may not profess or advertise to be designated as a trauma center if the Department has not designated it as such pursuant to this rule.

 

R426-9-1000. Resource Hospital Minimum Designation Requirements.

A Resource Hospital shall meet the following minimum requirements for designation:

(1) Be licensed in Utah or another state as a general acute hospital or be a Veteran's Administration hospital operating in Utah;

(2) Have the ability to communicate with other EMS providers operating in the area;

(3) Provide on-line medical control for all pre-hospital EMS providers who request assistance for patient care, 24 hours-a-day, seven days a week;

(4) Create and abide by written pre-hospital emergency patient care protocols for use in providing on-line medical control for pre-hospital EMS providers;

(5) Train new staff on the protocols before the new staff is permitted to provide on-line medical control and annually review protocols with physician and nursing staff;

(6) Annually provide in-service training on the protocols to all physicians and nurses who provide on-line medical control;

(7) Make the protocols immediately available to staff for reference;

(8) Provide on-line medical control which shall include:

(a) direct voice communication with a physician; or

(b) a registered nurse or physician's assistant, who shall to be licensed in Utah, who is in voice contact with a physician;

(9) Implement a quality improvement process which shall include:

(a) representatives from local EMS providers that routinely transport patients to the resource hospital;

(b) quarterly meetings; and

(c) minutes of the quality improvement meetings which are available for Department review;

(10) Identify a coordinator for the pre-hospital quality improvement process;

(11) Cooperate with the pre-hospital EMS providers' off-line medical directors in the quality review process, including granting access to hospital medical records of patients served by the particular pre-hospital EMS provider;

(12) Participate in local and regional forums for performance improvement; and

(13) Assist the Department in evaluating EMS system effectiveness by submitting to the Department, in an electronic format quarterly data specified by the Department.

(14) Designated Trauma Centers are deemed to meet the Resource Hospital standards and are exempt from requirements outlined in this section.

(15) The resource hospital designation and re-designation shall be for a period of three years.

 

R426-9-1100. Stroke Treatment and Stroke Receiving Facility Minimum Designation Requirements.

(1) A Primary or Comprehensive Stroke Treatment Center or an Acute Stroke Ready Hospital shall be accredited by the Joint Commission or other nationally recognized accrediting body.

(2) A hospital designated as a Stroke Receiving Facility for receiving stroke patients via Emergency Medical Services shall meet the following requirements:

(a) Be licensed as an acute care hospital in Utah;

(b) Require physician response to the emergency department in less than thirty (30) minutes for treatment of stroke patients;

(c) Maintain the ability of physician and nursing staff to utilize a standardized assessment tool for ischemic stroke patients;

(d) Maintain and utilize approved thrombolytic medications for treatment of patients meeting criteria for administration of thrombolytic therapy;

(e) Establish a standardized acute stroke protocol and authorize appropriate emergency department staff to implement the protocol when appropriate;

(f) Have ancillary equipment and personnel available to diagnose and treat acute stroke patients in a timely manner;

(g) Establish patient transport protocols with designated stroke treatment centers;

(h) Have a performance improvement program for acute stroke care and report data as required by the Department; and

(i) Submit to a site visit by representatives of the Department.

(3) Upon designation, the Department may, in consultation with off line EMS medical direction and protocol, recommend direct transport of stroke patients to a Stroke Receiving Center or a Stroke Treatment Center by licensed ambulance provider.

(4) All hospitals shall collect, and submit at least quarterly to the Department, Stroke Registry information necessary to maintain an inclusive stroke system. All hospitals shall provide such data in a standardized electronic format approved by the Department.

(5) The stroke treatment and stroke receiving designation and re-designation shall be for a period of three years.

 

R426-9-1200. Percutaneous Coronary Intervention Center Minimum Designation Requirements.

(1) A Percutaneous Coronary Intervention (PCI) Center, for the purpose of receiving acute ST-elevation myocardial infarction (STEMI) patients via an ambulance, shall meet the following minimum designation requirements:

(a) Be licensed as an acute care hospital in Utah;

(b) Maintain an emergency department staffed by at least one (1) Physician and one (1) Registered Nurse at all times;

(c) Have the ability to receive 12 lead EKG data from licensed ambulance providers transporting patients to the hospital for treatment of ST Segment Elevation Myocardial Infarction (STEMI);

(d) Maintain the ability to provide cardiac catheterization and PCI of STEMI patients within ninety (90) minutes of patient arrival in the emergency department twenty four (24) hours a day and seven (7) days a week;

(e) Maintain a performance improvement program for STEMI care and report data to the Department as required by the Department; and

(f) Submit to a site visit by representatives of the Department.

(2) Upon designation, the Department may, in consultation with offline EMS medical direction and protocol, recommend direct transport of STEMI patients to a STEMI Treatment Center by a licensed ambulance provider.

(3) The PCI designation and re-designation [period ]shall be for a period of three years.

(4) All hospitals shall collect, and submit at least quarterly to the Department, Cardiac Registry information necessary to maintain an inclusive cardiac system. All hospitals shall provide such data in a standardized electronic format approved by the Department.

 

R426-9-1300. Patient Receiving Facility Minimum Designation Requirements.

(1) A Patient Receiving Facility shall meet the following minimum designation requirements:

(a) Have the ability to communicate with licensed and designated EMS providers;

(b) Be staffed or have on-call physician, physician assistant, or nurse practitioner availability during designated hours with a response time of less than 20 minutes;

(c) Have and maintain ACLS and PALS certification;

(d) Attend meetings of the local EMS council, if one exists, to participate in the coordination and operations of local licensed and designated EMS providers;

(e) Abide by off-line protocols approved by the licensed ambulance provider's off-line medical director;

(f) Train staff on protocols used by the licensed ambulance providers who transport patients to the Patient Receiving Facility;

(g) Implement a quality improvement process of all patients received at the patient receiving facility with the local resource hospital or trauma center including access to medical records for patients transported by ambulance;

(h) Maintain equipment, services and medications on-site to provide Advanced Life Support (ALS) intervention and appropriate treatment. Equipment and services shall include:

(i) ECG;

(ii) ACLS medications;

(iii) laboratory services;

(iv) radiology services;

(v) oxygen delivery systems;

(vi) airway support equipment and supplies;

(vii) suction equipment and supplies; and,

(i) Submit to a yearly site visit by representatives of the Department; and

(j) Submit monthly data reports to the Department on all patients received by an ambulance, and in an electronic format provided by the Department.

(2) The Department may recommend the preferential transportation of STEMI patients by ambulance to a Patient Receiving Facility.

 

KEY: emergency medical services, trauma, reporting, trauma center designation

Date of Enactment or Last Substantive Amendment: [February 1, 2017]2018

Authorizing, and Implemented or Interpreted Law: 26-8a-252