DAR File No. 28121

Health, Health Systems Improvement, Emergency Medical Services

R426-5

Hospital Trauma Categorization Standards

NOTICE OF PROPOSED RULE

DAR File No.: 28121
Filed: 08/01/2005, 01:24
Received by: NL

RULE ANALYSIS

Purpose of the rule or reason for the change:

This rulemaking conforms the rule with recent changes to the statute (H.B. 180 (2003)) governing the statewide trauma system. (DAR NOTE: H.B. 180 (2003) is found at UT L 2003 Ch 137, and was effective 05/05/2003.)

Summary of the rule or change:

The changes correct references to statute; replace "EMS Committee" with "Department"; create a section describing Trauma System Advisory Committee as mandated in statute; and conform the mandatory reporting by all hospitals (as opposed to reporting just by trauma centers) to the statutory requirement. The changes also eliminate definitions that will be placed in the definitions rule, Rule R426-11; and provides more options to the Department and trauma centers for violation of the standards.

State statutory or constitutional authorization for this rule:

Section 26-8a-250

Anticipated cost or savings to:

the state budget:

The costs for reporting by non-trauma center hospitals have been covered in appropriations since the statute first required non-trauma center hospitals to report. This rule adds no additional costs beyond what is required by statute.

local governments:

Costs to local governments that operate hospitals have been covered in appropriations since the statute first required non-trauma center hospitals to report.

other persons:

The costs for reporting by non-trauma center hospitals have been covered in appropriations since the statute first required non-trauma center hospitals to report.

Compliance costs for affected persons:

All costs to affected persons have been covered by legislative appropriation since the statute first required non-trauma center hospitals to report.

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

Department personnel have worked closely with the affected businesses to craft a rule that meets the public purpose of the program and is supported by the businesses it regulates. This rule represents that result. Fiscal impact is offset by legislative appropriations. David N. Sundwall, MD, Executive Director

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

Direct questions regarding this rule to:

Jolene Whitney at the above address, by phone at 801-538-6290, by FAX at 801-538-6808, or by Internet E-mail at jrwhitney@utah.gov

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:

09/14/2005

This rule may become effective on:

09/15/2005

Authorized by:

David N. Sundwall, Executive Director

RULE TEXT

R426. Health, Health Systems Improvement, Emergency Medical Services.

R426-5. Statewide [Hospital ]Trauma [Categorization ]System Standards.

R426-5-1. Authority and Purpose.

(1) Authority - This rule is established under [Sections 26-8-4 and 26-8-5]Title 26, Chapter 8a, Part 2A, Statewide Trauma System, which authorizes the Department to:

(a) establish and actively supervise a statewide trauma system;[The Department to develop hospital critical care categorization guidelines and treatment protocols for trauma and]

(b) [The EMS Committee to approve critical care categorization guidelines and treatment protocols]establish, 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 trauma care facilities consistent with the [approved guidelines]the trauma center designation requirements and verification process.

(2) This rule provides standards for the categorization of all hospitals and the voluntary designation of [hospital ]Trauma Centers [which will be of assistance ]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.

R426-5-2. [Definitions]Trauma System Advisory Committee.

[As used in R426-5:

(1) Categorization means the process of identifying and developing a stratified profile of Utah hospital trauma critical care capabilities in relation to the standards defined under R426-5-8.

(2) Department means the Utah Department of Health.

(3) Director means the Executive Director of the Utah Department of Health.

(4) EMS Committee means The State Emergency Medical Services Committee.

(5) Inclusive Trauma System means the coordinated component of the State emergency medical services (EMS) system composed of all general acute hospitals licensed under Title 26, Chapter 21, trauma centers, and prehospital providers which have established communication linkages and triage protocols to provide for the effective management, transport and care of all injured patients from initial injury to complete rehabilitation.

(6) Level of care means the capabilities and commitment to the care of the trauma patient available within a specified facility.

(7) Patient means an individual who, as the result of illness or injury, needs immediate medical attention, whose physical or mental condition presents an imminent danger of loss of life or significant health impairment, or who may be otherwise incapacitated or helpless as a result of a physical or mental condition.

(8) Trauma Center means a hospital or consortium of hospitals that meets the standards set forth in R426-5 and is designated by the EMS Committee to function at a specified categorization level.

(9) Verification means determination by the EMS Committee that trauma centers have maintained and are in compliance with standards set forth in R426-5.](1) The trauma system advisory 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 established by the Department and applicable statutes.

(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.

R426-5-3. Trauma Center Categorization Guidelines.

(1) To establish a basis for trauma center categorization and designation, the Department shall utilize trauma center criteria established in the 1995 Utah Trauma System Plan[ as approved by the EMS committee]. The criteria takes into consideration current national standards for trauma center categorization.

R426-5-4. Trauma Review Committee.

(1) The Department shall appoint a Trauma Review Committee. The committee shall annually evaluate trauma centers and applicants for compliance to standards set in R426-5-2 for verification. The committee shall report results to the [EMS Committee]Department. The committee shall be composed of the following persons:

(a) one surgeon, knowledgeable in trauma;

(b) one emergency physician;

(c) one nurse;

(d) one hospital administrator; and

(e) one Department representative.

(2) With the exception of the Department representative, tenure shall be three years. Initial appointments for the physicians, nurse and hospital administrator shall be for three, two and one year(s), respectively. Committee members may be reappointed. A physician representative shall serve as committee chair.

(3) Trauma Review Committee members shall not review their own hospitals. When this situation arises, the Department shall appoint a temporary alternate member.

R426-5-7. Trauma Center Verification Process.

(1) All designated Trauma Centers desiring to remain designated, shall apply for verification by submitting the following information to the Department at least six months prior to the anniversary date of initial designation:

(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 R426-5-8;

(d) The minutes of pertinent hospital committee meetings for the previous year as specified by the Trauma Review Subcommittee, for example, trauma conferences, surgical morbidity and mortality meetings, emergency department or trauma death audits.

(e) A brief narrative report of trauma outreach education activities for the previous year;

(f) A brief narrative report of trauma research activities for the previous year including protocols and publications.

(2) All trauma centers desiring to apply for verification shall submit the required application and appropriate fees to the Department no later than January 1.

(3) Upon receipt of a verification application from the Department, accompanied by the information specified under R426-5-7(1)(a) through (f), the Trauma Review Committee shall conduct a review and report the results to the [EMS Committee]Department.

(4) Every three years, the Level I and II Trauma Centers must submit written documentation detailing the results of an American College of Surgeons site visit.

(5) Every three years from the date of initial designation or from a date specified by the Department, the Trauma Review Subcommittee shall conduct a formal site visit for each designated Level III, IV, or V trauma center and report the results to the [EMS Committee]Department.

(6) The Department and the Trauma Review Committee may conduct activities with any designated trauma center to verify compliance with designation requirements which may include:

(a) Site visits to observe, unannounced, an actual trauma resuscitation, including the care and treatment of a trauma patient.

(b) Interview or survey prehospital care providers who frequent the trauma center, to ascertain that the pledged level of trauma care commitment is being maintained by the trauma center.

R426-5-8. Data Requirements for an Inclusive Trauma System.

(1) All hospitals[Designated trauma centers] shall collect, and quarterly submit to the Department, Trauma Registry information necessary to maintain an inclusive trauma system until December 31, 2006. The Department shall provide funds to hospitals, excluding designated trauma centers, for the data collection process. The inclusion criteria for a trauma patient is as follows:

(a) ICD9 Diagnostic Codes between 800 and 959.9 (trauma); or

760.5 (fetus or newborn affected by trauma); or

641.8 (antepartum history due to trauma); or

518.5 (pulmonary embolism due to trauma); and

(b) Any of the following patient conditions:

admitted to the hospital for 48 hours or longer; transferred in or out of your hospital; died; all air ambulance transports (including death in transport and patients flown in but not admitted to the hospital).

The information shall be in a standardized electronic format specified by the Department which includes:

(i) Demographics:

Database Record Number

Institution ID number

Medical Record Number

Social Security Number

Patient Home Zip Code

Sex

Date of Birth

Age Number and Units

(ii) Injury:

Date of Injury

Time of Injury

City of Injury

State of Injury

Zip Code of Injury

Blunt, Penetrating, or Burn Injury

Cause of Injury Description

Cause of Injury Code

Cause of Injury E-code

Site/Location of Injury

Work Related Injury (y/n)

(iii) Prehospital:

Name of EMS Service

Transport Origin Scene or Referring Facility

Trip Form Obtained (y/n)

Arrival Time at (First) Hospital

Arrival Date at Hospital

(iv) Referring Hospital:

Transfer from Another Hospital (y/n)

Name or Code

Arrival Date

Arrival Time

Discharge Date

Discharge time

Transfer Mode

Admitted or ER

Procedures

Pulse

Capillary Refill

Respiratory Rate

Respiratory Effort

Blood Pressure

Eye Movement

Verbal Response

Motor Response

Glascow Coma Score Total

Revised Trauma Score Total

(v) Emergency Department Information:

Mode of Transport

Arrival Date

Arrival Time

Discharge Time

Discharge Date

Pulse

Capillary Refill

Respiratory Rate

Respiratory Effort

Blood Pressure

Eye Movement

Verbal Response

Motor Response

Arrival Glascow Coma Score Total

Revised Trauma Score Total

(vi) Emergency Department Treatment:

Procedures Done (pick list)

Paralytics used prior to GCS (y/n)

Disposition

(vii) Admission Information:

Admit from ER or Direct Admit

Admitted from what Source

Time of Hospital Admission

Date of Hospital Admission

(viii) Hospital Diagnosis:

ICD9 Diagnosis Codes

AIS 90 or 95 Used?

AIS Score for Diagnosis (calculated)

Injury Severity Score

(ix) Operations/Procedures:

ICD9 Codes

(x) Quality Assurance Indicators:

None

(xi) Complications:

None

(xii) Outcome:

Discharge Time

Discharge Date

Total Days Length of Stay

Disposition from Hospital

Destination Facility

GCS Outcome Score

(xiii) Charges:

Payment Sources

R426-5-9. Noncompliance to Standards.

(1) The Department may warn, reduce, deny, suspend, revoke, or place on probation a facility designation [to a lower level, or rescind the designation], if the Department finds evidence that the facility has not been or will not be operated [for noncompliance]in compliance to standards adopted in R426-5.

(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.

R426-5-10. Statutory Penalties.

A person who violates this rule is subject to the provisions of Title 26, Chapter 23, which provides for a civil money penalty of up to $5,000 per violation or a Class B misdemeanor on the first offense and a Class A misdemeanor on a subsequent offense.

KEY: emergency medical services

[September 23, 1997]2005

Notice of Continuation December 9, 1997

26-8a

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For questions regarding the content or application of this rule, please contact Jolene Whitney at the above address, by phone at 801-538-6290, by FAX at 801-538-6808, or by Internet E-mail at jrwhitney@utah.gov

For questions about the rulemaking process, please contact the Division of Administrative Rules (801-538-3764). Please Note: The Division of Administrative Rules is NOT able to answer questions about the content or application of these administrative rules.