DEPARTMENT OF HEALTH AND SOCIAL SERVICES

Division of Public Health

Emergency Medical Services

4305 Trauma System

1.0 Purpose

The purpose of this regulation is to establish and define the conditions under which the Delaware Statewide Trauma System functions. The goal of this Trauma System is to assure that every person injured in Delaware receives the same high-quality care, thus decreasing morbidity and mortality from injury.

2.0 Authority

This regulation is promulgated under the authority of 16Del.C.Ch. 97. Emergency Medical Services Systems.

3.0 Definitions

The following words and terms, when used in this regulation, have the following meaning:

"ACEP" means the American College of Emergency Physicians, Delaware Chapter.

"ACS" means the American College of Surgeons.

"Community trauma center" or "Level III" means an acute care facility that provides assessment, resuscitation, stabilization, and triage of all trauma patients, arranging for timely transfer of those patients requiring the additional resources of a regional trauma or specialty center and delivering definitive care to those whose needs match the resources of the community trauma center.

"Definitive care" means a level of medical intervention capable of providing comprehensive services for a patient's injuries and associated conditions.

"Designation" means a process through which a facility is confirmed by the Trauma Center Designation Committee and the Division Director to have the appropriate resources to manage patients with injuries of particular degrees of severity and is granted the authorization to function as a Delaware trauma center. Levels of Trauma Center designation are Level I, Level II, Level III, and Level IV.

"Division" means the Delaware Division of Public Health.

"Division Director" means the Director of the Delaware Division of Public Health.

"Emergency Medical Services" or "EMS" means the arrangement of personnel, facilities, equipment, transportation, and communication to provide for the effective and coordinated delivery of medical care in emergency situations resulting from injuries, illnesses, or natural disasters.

"Interfacility transfer" means the transfer of a patient from 1 facility to another facility.

"Level I" - See the definition for Regional Level I Trauma Center.

"Level II" - See the definition for Regional Level II Trauma Center.

"Level III" - See the definition for "community trauma center".

"Level IV" - See the definition for "participating facility".

"Participating facility" or "Level IV" means an acute care facility which transfers trauma patients with moderate or severe injuries to trauma centers after initial resuscitation. When necessary, this facility may provide care to trauma patients with minor injuries. Participating facilities contribute data to the Delaware Trauma System Registry and Quality Improvement Program.

"Pediatric trauma centers" means children's facilities which meet the standards for a particular classification of trauma center within Delaware'sPediatric Trauma Standardsand the corresponding classification in Delaware'sAdult Trauma Standards.

"Performance improvement" or "PI" means a process of measuring the outcome of a particular component, process, procedure, or treatment within the trauma care continuum, then modifying the process or procedure to improve patient care. PI is often interchanged with the term "quality improvement" or "QI".

"Performance improvement and patient safety" or "PIPS" means processes for identifying adverse events and implementing subsequent corrective action plans.

"Prevention" means efforts to decrease the numbers and severity of traumatic injuries.

"Protocols" means written standards for clinical practice in a variety of situations within the Trauma System.

"Quality improvement" or "QI" see definition for "performance improvement".

"Severe injuries" means those patients with an Injury Severity Score greater than 15.

"Specialty center" means a facility and staff that meet minimum standards established under the program and are designated by the board for program use in the comprehensive diagnostic and treatment services for a specific medical condition. This may include pediatric centers, burn centers, and others.

"Transfer agreement" means a formal written agreement between hospitals which provides for the acceptance of patients in transfer.

"Trauma" means any bodily injury. Injury is the result of an act that damages, harms, or hurts; unintentional or intentional damage to the body resulting from acute exposure to mechanical, thermal, electrical, or chemical energy or from the absence of such essentials as heat or oxygen.

"Trauma center" means an acute care facility that has received and maintains current state designation as a trauma center and is distinguished by the immediate availability of specialized surgeons, physician specialists, anesthesiologists, nurses, and resuscitation and life support equipment on a 24-hour basis to provide care for severely injured patients or those at risk for severe injury.

"Trauma Medical Director" or "TMD" means the physician responsible for and who has the authority to develop and enforce policies and procedures relevant to the care of the injured patient and to oversee the structure and process of the trauma PIPS program. Each trauma center is required by the ACS to have a TMD.

"Trauma Program Manager" or "TPM" means the individual with the daily responsibility for process and performance improvement activities as they relate to nursing and ancillary personnel involved in the care of trauma patients. The TPM's role includes partnering with the TMD in the development of policies and oversight of the program. Each trauma center is required by ACS to have a TPM.

"Trauma registry" means a database to provide information for analysis and evaluation of the quality of patient care, including epidemiological and demographic characteristics of trauma patients. The 'Expanded' data set provides a basis for the facility's Trauma Quality Program; the 'Minimal' data set collects largely demographic information.

"Triage" means the sorting of patients in terms of priority need for care, so that appropriate treatment, transportation, and destination decisions can be made according to predetermined protocols.

"Verification" means a process in which the trauma care capability and performance of a facility are evaluated by the American College of Surgeons Committee on Trauma, Verification Review Consultation (ACS COT VRC) Committee. Centers can be verified by the ACS COT VRC as Level I, Level II, or Level III.

4.0 Trauma System Committee ("TSC")

1. 4.1 Membership. The minimum membership requirements of the Trauma System Committee membership are defined by16Del.C.§9704(f).

2. 4.2 Purpose. The TSC shall act as an advisory group to the Division Director under16Del.C.§9704(g)and shall:

   1. 4.2.1 Maintain a system-wide perspective and communicate with other committees to encourage system-wide open dialogue and problem solving;
   2. 4.2.2 Model a collaborative approach between Trauma System Committee members and Division of Public Health/Office of Emergency Medical Services (OEMS) personnel; and
   3. 4.2.3 Provide coordination, oversight, and guidance for all components of the Trauma System in Delaware and with the support of the Trauma System of Care Coordinator and shall be responsible for the development and maintenance of the Trauma System Plan.

3. 4.3 Committee Leadership. The Division Director shall appoint a Trauma System Committee and, as necessary, Subcommittee chairpersons for 4-year terms. Chairpersons may be appointed to subsequent terms and shall:

   1. 4.3.1 Collaborate with OEMS or OEMS contractors to develop meeting agendas, presentations, and minutes; and
   2. 4.3.2 Preside at respective committee meetings and perform related administrative duties according to Robert's Rules of Order.

4. 4.4 Trauma System of Care Medical Advisor

   1. 4.4.1 The Trauma System of Care Medical Advisor shall serve as a non-voting member of the TSC and must have the following qualifications:

      1. 4.4.1.1 A minimum of 1 year of active involvement in state Trauma System development or management;
      2. 4.4.1.2 Be a Board-certified trauma or trauma subspecialty surgeon or Emergency Medicine physician; and
      3. 4.4.1.3 Experience in medical leadership in a role such as physician, chairperson, or medical director.

   2. 4.4.2 The Trauma System of Care Medical Advisor shall:

      1. 4.4.2.1 Serve as an advisor on both specific and general trauma clinical and patient care issues which are brought to the TSC or its subcommittees;
      2. 4.4.2.2 Assist the TSC and its subcommittees in developing clinical-oriented trauma system policies and protocols;
      3. 4.4.2.3 Serve as a leader in injury prevention and injury control activities;
      4. 4.4.2.4 Serve as a liaison to the Trauma System Quality Evaluation Committee for medical issues requiring physician input; and
      5. 4.4.2.5 Serve as moderator of the Trauma System Quality Educational Forum.

5. 4.5 Standing Committees and Subcommittees

   1. 4.5.1 Trauma System Quality Evaluation Committee ("Quality Committee")

      1. 4.5.1.1 The Quality Committee is a standing subcommittee of the TSC and shall focus on trauma system performance improvement.
      2. 4.5.1.2 Membership consists of representatives from each component of the statewide Trauma System.
      3. 4.5.1.3 Standing members shall be available for frequent working meetings and have access to the quality management process of the agency which they represent. The Quality Committee and Division may designate ad hoc quality management project members as needed.
      4. 4.5.1.4 After 3 unexcused absences in a calendar year, a member will be automatically removed from the Quality Committee and the Division will name a replacement.
      5. 4.5.1.5 Specific tasks and duties of the Quality Committee are as listed in subsection 8.7 of this regulation.

   2. 4.5.2 Trauma Center Designation Subcommittee ("Designation Committee")

      1. 4.5.2.1 The Designation Committee shall review reports of Trauma Center site visits and make recommendations through the Trauma System Coordinator to the Division Director on state Trauma Center designation.

      2. 4.5.2.2 The Designation Committee membership shall consist of the following:

         1. 4.5.2.2.1 One member from the Delaware Healthcare Association;
         2. 4.5.2.2.2 One anesthesiologist or intensivist from the Medical Society of Delaware;
         3. 4.5.2.2.3 One member from the ACS, Delaware Chapter, Committee on Trauma;
         4. 4.5.2.2.4 One member from ACEP;
         5. 4.5.2.2.5 One member from the Delaware Emergency Nurse Association;
         6. 4.5.2.2.6 One member from the Delaware Society of Orthopedic Surgeons;
         7. 4.5.2.2.7 One member from American Association of Critical Care Nurses, Delaware Chapter;
         8. 4.5.2.2.8 One member who shall be a pediatric care specialist; and
         9. 4.5.2.2.9 One member from the American Neurosurgery Association, Delaware Chapter.
      3. 4.5.2.3 The Division Director shall appoint Designation Committee members who provide geographic and institutional diversity. Designation Committee members shall serve at the pleasure of the Division Director, until the member submits a letter of resignation, the member’s organization requests to replace them, or the member is absent from meetings for a period of 1 year, which shall be cause for dismissal.
      4. 4.5.2.4 Designation Committee members shall be chosen by the Division Director to participate in each Designation Committee assignment, with the selections designed to optimize impartiality and avoid conflict of interest related to the current action.
      5. 4.5.2.5 In the event a Designation Committee member retires, resigns, or is removed, the nominating committee shall request 2 names from the appropriate Delaware organization or chapters and submit those names to the Division Director for consideration of appointment.
      6. 4.5.2.6 All Designation Committee proceedings shall be confidential. Information discussed at meetings and the records thereof shall be confidential and privileged and shall be protected from direct or indirect means of discovery, subpoena, or admission into evidence in any judicial or administrative proceeding. All meeting attendees shall be required to sign confidentiality statements, and all written information distributed during the meetings shall be collected prior to adjournment. Any documented breach of confidentiality shall be referred to the Division for appropriate action.

   3. 4.5.3 Trauma Registrar Network

      1. 4.5.3.1 The Trauma Registrar Network is a standing committee of the TSC, and its membership consists of trauma registrars from designated trauma centers in Delaware.

      2. 4.5.3.2 The Trauma Registrar Network shall:

         1. 4.5.3.2.1 Ensure timely and accurate trauma registry data submissions;
         2. 4.5.3.2.2 Provide trauma registry-related education to the trauma registrars; and
         3. 4.5.3.2.3 Refer trauma registry data and quality issues identified through the Trauma Registrar Network to the Quality Committee for consideration and potential action.

   4. 4.5.4 Delaware Coalition for Injury Prevention ("Coalition")

      1. 4.5.4.1 The Delaware Coalition for Injury Prevention is a standing committee of the TSC, and its membership consists of volunteers from agencies involved with injury prevention.
      2. 4.5.4.2 The Coalition's primary purpose is to decrease death and disability from injury through public education.
      3. 4.5.4.3 The Coalition shall support statewide injury prevention efforts and develop the prevention component of the Delaware State Trauma System Plan.
   5. 4.5.5 Ad hoc subcommittees and work groups.

5.0 Delaware Trauma Center Designation Process

1. 5.1 Trauma System Participation

   1. 5.1.1 To be considered a participant in Delaware's Prehospital Trauma Triage Scheme and receive injured patients, an inpatient acute care facility must be designated as a trauma center by the Division Director.
   2. 5.1.2 An out-of-state facility must be granted reciprocity as a trauma center by the State of Delaware, which requires verification of current trauma center designation and compliance with trauma standards that are substantially equivalent to those established by the state, to be considered a participant in Delaware’s Prehospital Trauma Triage Scheme.
   3. 5.1.3 All acute care inpatient facilities in Delaware which receive traumatically injured patients shall be required to contribute to the State Trauma Registry program by collecting and recording electronic data into the facility registry system, following the patient criteria described in the currentDelaware Trauma Registry Inclusion Criterialocated on the Trauma System of Care webpage (https://dhss.delaware.gov/dph/ems/trauma/),and any subsequent revisions. All designated trauma facilities must complete the Trauma Registry Form available within the trauma registry software, which includes patient information and facility-specific quality assurance and financial data elements.

   4. 5.1.4 Each designated trauma center shall have a contractual agreement with the Division.

      1. 5.1.4.1 In the contract, the trauma center agrees to maintain commitment and resources commensurate with the standards of its designation level and to notify the Division in writing of intent to function at any other level of designation, no less than 30 days prior to that change becoming effective.
      2. 5.1.4.2 This contract shall also serve as the mechanism by which a facility receives permission to publicly refer to itself as a Delaware trauma center.

2. 5.2 Responsibilities of the Division of Public Health. The Division shall:

   1. 5.2.1 Provide staff support for the trauma center designation process;
   2. 5.2.2 Coordinate and provide staff for Level IV verification visits;
   3. 5.2.3 Develop and disseminate a timeline for the designation process;
   4. 5.2.4 Provide support and consultation as requested, to assist a facility in preparing for an American College of Surgeons (ACS) Committee on Trauma’s (COT) Verification, Review and Consultation (VRC) visit or corrective action visit.

3. 5.3 Responsibilities of Delaware Facilities

   1. 5.3.1 Cost. Facility fees for verification visits shall include all ACS and Division-appointed surveyor fees.
   2. 5.3.2 The facility shall coordinate site visits, surveyor accommodations, transportation, and preparatory information to facilities as needed.

4. 5.4 Verification Process

   1. 5.4.1 All Level I, Level II, and Level III trauma centers must be verified by the ACS COT prior to being designated as a Delaware trauma center.
   2. 5.4.2 Level IV (Participating Facility) trauma centers shall be verified by designees appointed by the Division Director as detailed in subsection 5.4.3.4 of this regulation.

   3. 5.4.3 Minimum Requirements of Verification Team Composition

      1. 5.4.3.1 For all Levels:

         1. 5.4.3.1.1 Familiarity with similar size geographical region and facilities; and
         2. 5.4.3.1.2 No conflicts of interest.

      2. 5.4.3.2 For Regional Trauma Centers Levels I and II:

         1. 5.4.3.2.1 Two trauma surgeons (ACS COT VRC requirement);
         2. 5.4.3.2.2 One trauma registered nurse (ACS COT VRC requirement);
         3. 5.4.3.2.3 One emergency medicine physician (Division requirement);
         4. 5.4.3.2.4 A neurosurgeon shall be utilized for all initial verification visits and for reverification of facilities where there has been a documented neurosurgical care or coverage issue since the last site visit; and
         5. 5.4.3.2.5 Subspecialty reviewers may be added to any review on request of the American College of Surgeons, the Trauma System Designation Committee, the facility, or the Division Director. Movement to a new level of designation is considered an initial review visit.

      3. 5.4.3.3 For Community Trauma Centers (Level III):

         1. 5.4.3.3.1 Two trauma surgeons (ACS COT VRC requirement); and
         2. 5.4.3.3.2 One emergency medicine physician (Division requirement).
         3. 5.4.3.3.3 In addition, for first-time Level III verification, or an increase to Level III from a Level IV, 1 trauma registered nurse approved by the ACS COT VRC.

      4. 5.4.3.4 Participating (Level IV) Trauma Centers shall be verified by Division-appointed designees, including:

         1. 5.4.3.4.1 The Delaware Trauma System Coordinator;
         2. 5.4.3.4.2 One out-of-state emergency department physician;
         3. 5.4.3.4.3 One trauma registered nurse; and
         4. 5.4.3.4.4 The Delaware Trauma System of Care Medical Advisor.
      5. 5.4.3.5 Pediatric Trauma Centers. Pediatric trauma centers shall have equivalent verification teams to the corresponding level of adult trauma center.

5. 5.5 Designation Process. The Designation Committee shall make recommendations to the Division Director on the category of trauma center designation for which each facility has qualified, based on its review of the ACS site visit report (Levels I, II, III) or the Delaware Level IV verification team site visit report and application of Delaware's correlational template.

   1. 5.5.1 Any facility not receiving the full ACS verification shall be offered the opportunity for a representative to address the Designation Committee for no more than 10 minutes prior to their deliberation.
   2. 5.5.2 The Division Director shall designate a trauma center based on the Designation Committee's recommendations.

6. 5.6 Categories of State Designation and Timeframes

   1. 5.6.1 Full designation may be awarded for 3 years.

   2. 5.6.2 Provisional designation may be awarded for 1 year.

      1. 5.6.2.1 Non-compliant standards defined by ACS must be corrected and verified by the ACS within this period.
      2. 5.6.2.2 The Division may require interim reports or on-site progress evaluations as a condition of approval of the written plan of correction. This plan of correction may be required by the Designation Committee within 6 months after the provisional designation has been awarded. Facilities shall be informed whether their plan for correction is acceptable.

   3. 5.6.3 Non-designation

      1. 5.6.3.1 Facilities not receiving full or provisional designation must notify the Division within 30 days of status notification of their intent to correct non-compliant standards or to accept non-designation. A written plan of correction including timeframes must be submitted to the Division with the notice of intent if the facility chooses to pursue designation.
      2. 5.6.3.2 All corrections must be completed and verified within 1 year from the date of status notification. Facilities shall be informed whether their plan for correction is acceptable.

   4. 5.6.4 Lower Designation

      1. 5.6.4.1 The Trauma Center Designation Committee may offer a facility a provisional lower designation level than originally applied for if the facility does not qualify for the higher level. If the facility accepts the lower designation level, the facility must submit a letter to the Trauma Center Designation Committee accepting the lower level and documenting the intent to obtain ACS/state verification at this level within the provisional period as determined by the Director.
      2. 5.6.4.2 A facility may voluntarily request a designation at a lower level than its current designation. To do so, the facility must submit a formal letter to the Trauma Center Designation Committee no less than 30 days prior to the requested effective date. This letter must clearly state the facility’s intent to operate at a lower designation, its commitment to apply for and obtain the applicable ACS/state verification and designation requirements, and the process by which it will maintain compliance with the ACS/state verification and designation standards, as outlined in Section 6.0 of16DE Admin. Code4305. If a facility subsequently chooses to pursue a higher designation level, it must submit an application and complete the full ACS/state verification and designation process in accordance with subsection 5.6.5 of this regulation.
      3. 5.6.4.3 Upon receipt of the ACS/state verification, the Delaware Trauma Center Designation Committee shall make a recommendation to the Division Director regarding the center’s eligibility for the lower designation. If approved, OEMS shall notify prehospital and facility agencies of the change in status after a start date has been agreed upon by the facility and the Director.

   5. 5.6.5 A trauma facility seeking to be designated at a higher level shall:

      1. 5.6.5.1 At its discretion, apply for verification at a higher trauma designation level at any time the trauma facility deems itself prepared. Alternatively, the trauma facility may elect to maintain its current, lower-level designation. Should the trauma facility undergo verification and subsequent reverification at the lower level prior to the expiration of the current verification period, the trauma facility may retain that designation in accordance with applicable regulatory requirements.
      2. 5.6.5.2 Meet with the Trauma System Coordinator to review compliance with the standards of the higher-level trauma center.
      3. 5.6.5.3 In the event that a trauma center previously held a higher-level designation but subsequently failed to meet the applicable standards, the trauma center shall initiate the process for provisional designation by submitting a written request to the Delaware Trauma Center Designation Committee. This request must include a corrective action plan addressing the identified non-compliant standards, and a formal statement of intent to obtain verification from the ACS within 1 year of the provisional designation. Upon receipt of the request, the Delaware Trauma Center Designation Committee shall review the submission and make a recommendation to the Division Director regarding the center’s eligibility for provisional status. If approved, OEMS shall notify prehospital and facility agencies of the change in status after a start date has been agreed upon.

7. 5.7 Redesignation

   1. 5.7.1 Trauma facilities must schedule ACS reverification visits every 3 years if the trauma facility prefers to continue their trauma center status.
   2. 5.7.2 Re-designation categories and timeframes shall be the same as those for initial designation.

8. 5.8 Initiation of Revocation of Trauma Center Designation Process

   1. 5.8.1 Consideration of revocation of a trauma center's designation shall be initiated when a documented violation of an applicable Delaware Trauma Center Standard is identified.

   2. 5.8.2 Identification may occur through 1 of the following mechanisms:

      1. 5.8.2.1 Expiration of a trauma center's designation period with failure of the facility to successfully complete an ACS reverification visit;
      2. 5.8.2.2 A corrective action visit which results in a not verified status;
      3. 5.8.2.3 A Trauma System Quality Evaluation Committee recommendation; or
      4. 5.8.2.4 A written complaint that prompts investigation by the facility and the Trauma System Quality Evaluation Committee. The facility must report the findings of its investigation to the Quality Evaluation Committee.

9. 5.9 Investigation of Identified Violation of Standard

   1. 5.9.1 The identifying agent (report of site visit or Quality Evaluation Committee) shall provide written notification of the violation to the Division of Public Health, including supporting documentation.
   2. 5.9.2 The Division Director shall select the Designation Committee members to be assigned to the ad hoc investigation committee.
   3. 5.9.3 The involved trauma center shall be notified of the investigation in writing with a request for its written response.
   4. 5.9.4 The assigned investigation committee shall conduct an appropriate follow-up investigation.

   5. 5.9.5 The investigation committee shall submit its report and recommendation for 1 of the following to the Division Director:

      1. 5.9.5.1 Probation until the deficiency is remedied and accepted by the Division. The investigation committee shall include a timeframe and method by which the facility must demonstrate compliance with the standard.
      2. 5.9.5.2 Designation change to lower level until the deficiency is remedied and accepted by the Division.
      3. 5.9.5.3 Revocation of trauma center designation.
      4. 5.9.5.4 Continuation of current trauma center designation.
   6. 5.9.6 If probation or revocation of designation is recommended, the investigation committee report shall include recommended steps necessary for reinstatement. This shall include verification of adequate correction by an in-state or out-of-state review team and may include interim reports or on-site progress evaluations. In cases of revocation, a full or focused ACS site visit may be recommended.
   7. 5.9.7 If probation or revocation of designation is not recommended, the investigation committee may recommend follow-up monitoring or reporting.
   8. 5.9.8 The Division Director shall decide the action to be taken after consideration of the investigation committee's report. Written notification of the action shall be forwarded to the facility.

   9. 5.9.9 If a facility is unable to demonstrate compliance in the specified timeframe, it must submit a written progress report and request for a deadline extension to the Division Director. Failure to comply within the specified timeframe without requesting such an extension shall result in change of status from probationary status to a level that is commensurate with verified resource capabilities, which may include a change in designation level or the loss of designation.

      1. 5.9.9.1 If a facility fails to comply with an extended timeframe, the Division Director may require a full ACS verification site visit for a facility to be reinstated at its former level of designation.
      2. 5.9.9.2 A facility may relinquish its trauma center designation through written notification to the Division Director if it chooses not to pursue correction of a deficiency.

10. 5.10 Appeal Process

    1. 5.10.1 The involved trauma center shall have the right to appeal any decision of the Division of Public Health regarding initial or subsequent designation or a change in designation status.
    2. 5.10.2 Written notification of the intent to appeal must be made to the Division Director within 30 days of notification of action. Written notice shall comply with29Del.C.§10122.
    3. 5.10.3 The Division Director shall name an impartial panel to hear the facility's case and make recommendations. The panel shall consist of 3 members of the Trauma System Committee who have no relationship with the appealing facility and have not been involved in the case. At least 1 of these members shall be affiliated with a Delaware trauma center in a different county from the appealing facility.
    4. 5.10.4 The appeal hearing shall be scheduled to occur no later than 45 days following receipt of the facility's request for appeal by the Division.
    5. 5.10.5 Information pertinent to the case shall be presented to the panel by a member of the ad hoc investigation committee (or assigned Designation Committee task force in the case of appeal of a designation decision following site visit) and a representative of the facility. The presentations shall be audio-recorded and transcribed by the Division.
    6. 5.10.6 The panel shall make a recommendation to the Division Director that the original decision stand, be reversed, or be modified, and specific recommendations for the modification shall be outlined.
    7. 5.10.7 The Division Director shall provide a written notification of the decision within 30 days of the hearing's conclusion.

11. 5.11 Reinstatement Process

    1. 5.11.1 When a facility has corrected a problem which resulted in probation or revocation of designation, it shall notify the Division in writing to request reinstatement.
    2. 5.11.2 The Designation Committee will submit its recommendation to the Division Director for final determination.

    3. 5.11.3 Outcomes of the review are for the facility to:

       1. 5.11.3.1 Return to the previous level of designation or end of probation;
       2. 5.11.3.2 Designate at a lower level until reverified by ACS; or
       3. 5.11.3.3 Remain at a (Level IV) Participating Facility until reverified by ACS.
12. 5.12 A facility may relinquish its trauma center designation through written notification of their intent to the Division Director no less than 30 days prior to the effective date.

6.0 State of Delaware Trauma Center Standards

1. 6.1 At a minimum, Delaware Trauma Center Standards must meet the requirements and trauma standards set forth in the current ACS COT VRCResources for Optimal Care of the Injured Patient, 2006 Standardsand all subsequent updates for verification and designation.

   1. 6.1.1 The Division may modify existing ACS COT Standards to increase the level of the requirement.
   2. 6.1.2 American College of Surgeons Trauma Standards may not be modified to decrease the level of the requirement.

   3. 6.1.3 The process for modifying an existing American College of Surgeons Standard is as follows:

      1. 6.1.3.1 The Trauma System Committee shall discuss and vote to recommend to the Division Director that a modification should be made.
      2. 6.1.3.2 If approved by the Division Director, the existing Delaware Trauma System regulations (16DE Admin. Code4305) shall be revised under 29Del.C.Ch. 101.
   4. 6.1.4 Copies of the current ACSResources for Optimal Care of the Injured Patientmay be obtained by contacting the ASC Publication Orders Department at 633 N. Saint Clair Street in Chicago, IL, 60611 or by telephone at 312-202-5000. Copies can also be found athttps://www.facs.org/quality-programs/trauma/quality/verification-review-and-consultation-program/.

2. 6.2 Facility Requirements

   1. 6.2.1 Facility administration and medical staff must demonstrate commitment to the trauma program, including:

      1. 6.2.1.1 Development and adoption of written resolution of support from both the facility Board of Trustees and the medical staff;
      2. 6.2.1.2 Establishment of written policies and procedures to provide and maintain the services for trauma patients as outlined in Delaware's Trauma Center Standards;
      3. 6.2.1.3 Demonstrated evidence of budgetary support of the facility's trauma program such as facility-funded positions for Trauma Medical Director (TMD), Trauma Program Manager (TPM), trauma registry personnel or Trauma Quality Improvement Program personnel;
      4. 6.2.1.4 Active participation and attendance of trauma leadership staff in the Delaware Trauma System Committee and Trauma Quality Evaluation Committee;
      5. 6.2.1.5 Adherence to State Trauma Registry requirements for providing facility trauma registry data to the State Trauma Registry for utilization in trauma system management and quality improvement activities;
      6. 6.2.1.6 Establishment and maintenance of written transfer procedures and agreements with appropriate trauma centers, specialty centers, and facilities, providing for movement of both critical and convalescing patients within the trauma system. Compliance with these procedures is to be monitored by the quality improvement process in each facility. Each receiving facility is responsible for providing timely feedback to transferring facilities on the status and outcome of all patients received; and
      7. 6.2.1.7 Designated trauma system facilities shall continue to function in accordance with the Trauma Facility - Division of Public Health Memoranda of Agreement signed upon designation.

   2. 6.2.2 Facilities must incorporate the following trauma services procedures:

      1. 6.2.2.1 Written protocols and standards of care for the major trauma patient, including definitions of response and turnaround times as well as team participant roles; and
      2. 6.2.2.2 Written trauma activation procedures.

3. 6.3 Trauma Program Manager (TPM)

   1. 6.3.1 Facilities must retain a TPM who shall have the following qualifications and responsibilities:

      1. 6.3.1.1 The TPM shall work with the Trauma Medical Director (TMD) and shall be responsible for the organization of services and systems necessary for an interdisciplinary approach throughout the continuum of trauma care. The TPM role has the following components:

         1. 6.3.1.1.1 Clinical;
         2. 6.3.1.1.2 Educational;
         3. 6.3.1.1.3 Registry/quality improvement/research;
         4. 6.3.1.1.4 Administrative; and
         5. 6.3.1.1.5 Liaison.
      2. 6.3.1.2 In Level I, II, and III trauma centers, the TPM must have 1 full-time equivalent (FTE) commitment to the trauma program.
      3. 6.3.1.3 The TPM is not required to be a full-time (1 FTE) position for Level IV centers.
      4. 6.3.1.4 The TPM must be certified in Trauma Nursing Core Course (TNCC).
      5. 6.3.1.5 The TPM must attend a minimum of 36 hours of trauma-related continuing education during the verification cycle, and records must be available documenting these trauma-specific continuing education hours.
      6. 6.3.1.6 The TPM must actively participate in and attend meetings of the Delaware Trauma System Committee and Trauma Quality Evaluation Committee.

4. 6.4 Trauma Medical Director (TMD)

   1. 6.4.1 Facilities must retain a Trauma Medical Director (TMD). The TMD shall have the following qualifications and responsibilities:

      1. 6.4.1.1 Levels I, II, III: The TMD shall be a board-certified or board-eligible surgeon or emergency department physician.
      2. 6.4.1.2 Level IV: May be a board-certified or board-eligible surgeon or emergency department physician.
      3. 6.4.1.3 Through the quality improvement process, the TMD shall have responsibility for all trauma patients and administrative authority for the facility's Trauma Program.
      4. 6.4.1.4 The TMD must attend a minimum of 8 trauma-related hours of continuing education annually and records must be available documenting these trauma-specific continuing education hours.
      5. 6.4.1.5 Additional qualifications for the TMD shall include regular involvement in the care of injured patients and participation in trauma-related educational activities.
      6. 6.4.1.6 The TMD shall maintain current Advanced Trauma Life Support certification.
      7. 6.4.1.7 The TMD must actively participate in and attend meetings of the Delaware Trauma System Committee and Trauma Quality Evaluation Committee.

5. 6.5 Delaware State Trauma Registry

   1. 6.5.1 Facility Participation

      1. 6.5.1.1 All acute care inpatient facilities in Delaware which receive traumatically injured patients shall be required to contribute to the State Trauma Registry program by collecting and recording electronic data into the facility registry system, following the patient criteria described in the current and subsequent updated versions of the Delaware Trauma Registry Inclusion Criteria located on the Trauma System of Care webpage (https://dhss.delaware.gov/dph/ems/trauma/).

         1. 6.5.1.1.1 The Trauma Registry software to be used by facilities shall be specified by the Division in conjunction with the Trauma System Quality Evaluation Committee, with input from all data-contributing facilities. Technical support shall be provided to all Delaware acute care facilities by the Division or its designee.
         2. 6.5.1.1.2 Facilities shall collect the required data and submit it to the System Trauma Registry Coordinator as soon as possible, but no more than 90 days after the close of each quarter.
      2. 6.5.1.2 Each contributing facility shall designate an individual with the authority, responsibility, and accountability for directing and maintaining the facility trauma registry and its data submission to the State Trauma Registry.
      3. 6.5.1.3 Each contributing facility shall identify a primary data entry individual and allow adequate time and resources for this individual to perform assigned tasks. This individual shall be required to participate in a Delaware trauma registrars Network, which shall facilitate communications among trauma registrars and provide educational information to improve data quality. It is encouraged that all trauma registrars attend scheduled Network meetings and workshops, with a minimum of 1 registrar per facility.
      4. 6.5.1.4 Both the individual contributing facilities and the state shall be responsible for data integrity and confidentiality.

   2. 6.5.2 Data Set/Data Dictionary

      1. 6.5.2.1 To ensure consistent data collection across Delaware, data is entered into the National Trauma Data Bank according to the National Trauma Data Standards, which are provided in the current and subsequent updated versions of the Delaware Trauma System Data Dictionary, located on the Trauma System of Care webpage (https://dhss.delaware.gov/dph/ems/trauma/).
      2. 6.5.2.2 Data collected from contributing acute care facilities shall form the State's Trauma System Registry. Registry data shall be used in the process of formulating Trauma System reports for the purposes of quality improvement, data linkage, and research and prevention activities. Researchers may request data for analysis by completing the Trauma System Registry Data Use Agreement.
      3. 6.5.2.3 The Trauma Registry data set and dictionary shall be reviewed annually by the Trauma Registrar Network and the Trauma System Quality Evaluation Committee and the Division for any necessary additions, deletions, or modifications.

6. 6.6 Performance Improvement and Patient Safety Program (PIPS). Each facility must have a Performance Improvement and Patient Safety (PIPS) Program that conducts the following:

   1. 6.6.1 In accordance with subsection 6.5.1.1 of this regulation, provide facility trauma registry data to the State Trauma Registry for utilization in trauma system management and quality improvement activities;
   2. 6.6.2 Special audits for all trauma deaths;
   3. 6.6.3 Morbidity and mortality reviews;
   4. 6.6.4 Nursing performance improvement reviews;
   5. 6.6.5 Reviews of prehospital trauma care;
   6. 6.6.6 Documentation of times of and reasons for trauma-related bypass;
   7. 6.6.7 Reviews of trauma patients admitted to medical services (non-surgical service admissions); and

   8. 6.6.8 Establishment of a Trauma Program Performance Improvement Committee, which shall:

      1. 6.6.8.1 Meet regularly for the purpose of peer-review and trauma center performance;
      2. 6.6.8.2 Be chaired by the Trauma Medical Director;
      3. 6.6.8.3 Have representation from the major services and applicable specialists that were involved in the treatment of the reviewed trauma patient with membership including the Trauma Program Manager, emergency medicine physician, and if applicable the surgeon and anesthesiologist; and
      4. 6.6.8.4 Conduct the following tasks: critically review, evaluate, and discuss the quality and appropriateness of care in cases of adverse outcome (complications and deaths, particularly unexpected deaths), monitor complication trends, identify well-managed cases which can be utilized as teaching cases, and designate focused audits.

7. 6.7 Transfer Agreements

   1. 6.7.1 Written transfer procedures and agreements with appropriate trauma centers, specialty centers, and facilities, providing for timely movement of both critical and convalescing patients within the Trauma System, must be established and maintained. Compliance with these procedures is to be monitored by each facility's PIPS program.

   2. 6.7.2 Transfer agreements are required for the following:

      1. 6.7.2.1 Regional trauma resources/capabilities, or specialty centers;
      2. 6.7.2.2 Recognized burn centers; and
      3. 6.7.2.3 Tertiary pediatric referral center with critical care capabilities.

8. 6.8 Rehabilitative Services

   1. 6.8.1 Consultation with appropriate rehabilitative services shall be made early in the patient's hospitalization. Patients with rehabilitative needs shall have access to early rehabilitative evaluation and bedside therapy during the acute phase of their care. Optimal time for rehabilitation consult is within 72 hours of admission.
   2. 6.8.2 There must be identifiable evidence of early and adequate discharge planning for patients, including assessment of function to assure that all trauma patients have access to the inpatient or outpatient services that may be required post-acute care discharge.
   3. 6.8.3 Facilities that do not have in-house trauma rehabilitation services must have a transfer agreement with a rehabilitation facility.

7.0 State of Delaware Triage, Transport, and Transfer Protocols

1. 7.1 Prehospital Trauma Triage Guidance

   1. 7.1.1 Due to the dynamic nature of identification and evolution of best practices in prehospital care, the prehospital trauma triage guidance shall be found solely in the current State of Delaware, Department of Health and Social Services, Division of Public Health, Office of Emergency Medical Services, Statewide Standard Treatment Protocols, Guidelines, Policies, and Paramedic Standing Orders and Statewide Standard Treatment Protocols and Basic Life Support Standing Orders. The Trauma System Committee shall be asked for input by the State EMS Medical Director through the Trauma System Manager during every Standing Orders revision process.
   2. 7.1.2 If transport time between 2 trauma centers is relatively equal, critically injured trauma patients should be transported directly to the higher-level trauma center. Patients with significant head trauma as evidenced by a Glasgow Coma Score of 8 or less, or spinal cord trauma as evidenced by new onset limb paralysis or weakness should be transported directly to a Level I or Level II Trauma Center with an available neurosurgeon when possible. Availability of air transport will impact these time and distance decisions and may potentially save the patient the time required for later interfacility transfer as well as keep the helicopter available for scene medevac work.
2. 7.2 Out-of-State Facility. In order to be considered a participant in Delaware's Trauma System, an out-of-state facility must receive Delaware reciprocity as a trauma center by demonstrating current trauma center designation status and adherence to equivalent trauma standards.

3. 7.3 Air Transport Guidelines

   1. 7.3.1 Utilization of aeromedical services has become a nationally accepted standard for the rapid evacuation and transportation of critically injured patients to the most appropriate medical facility for definitive medical care. In order to make the best decisions about the most appropriate mode of transport for a particular patient, multiple factors must be considered. Clinical factors relate to the patient and are described in the Delaware Paramedic and Basic Life Support Standing Orders. Operational factors relate to the transport process and include helicopter availability and location measured against ground transport time. Weather, traffic, ground unit availability, and scene accessibility are other operational factors which must be considered on a case-by-case basis.
   2. 7.3.2 Air transportation from the scene is appropriate for a seriously injured trauma patient. These decisions shall be based on current State of Delaware, Department of Health and Social Services, Division of Public Health, Office of Emergency Medical Services, Statewide Standard Treatment Protocols, Guidelines, Policies, and Paramedic Standing Orders and Statewide Standard Treatment Protocols and Basic Life Support Standing Orders.
   3. 7.3.3 To avoid excessive time spent on scene awaiting arrival of the aircraft, the helicopter should be dispatched at the time of initial ALS dispatch or immediately upon arrival of the first units on scene. It is in the patient's best interest for the aircraft to be dispatched early rather than to wait for ground unit request when available information suggests a major incident. When appropriate, consideration may be given to rendezvous.

4. 7.4 Interfacility Transfer Decisions

   1. 7.4.1 The most appropriate mode of transportation to be utilized when an interfacility transfer is being arranged is a decision made by the referring physician. Operational factors as well as clinical factors must be considered in arriving at the best transport decision in each circumstance.
   2. 7.4.2 See the current and subsequent updatedDelaware Interfacility Transfer Protocollocated on the Trauma System of Care webpage (https://dhss.delaware.gov/dph/ems/trauma) for guidance on the interfacility transfer of trauma patients.

8.0 State of Delaware Trauma System Performance Improvement Plan

1. 8.1 Purpose

   1. 8.1.1 The State of Delaware Trauma System is committed to provision of optimal care for all injured persons. In order to attain this goal, the Division coordinates all medical services provided to trauma patients based on national standards for trauma care as set forth by the Joint Commission (TJC) on Accreditation of Health Care Organizations (JCAHO), the current ACS COT'sResources for Optimal Care of the Injured Patient(1993 Standards), the current ACEP'sTrauma Care System Guidelinesand current Health Resources and Services Administration'sThe Model Trauma Care System Planand subsequent revisions of these documents. This Performance Improvement Plan seeks to enable the Trauma System to meet and exceed these standards, both administratively and clinically, through promotion and achievement of continuous improvement in all aspects of the statewide trauma program's organization and associated activities.
   2. 8.1.2 The State of Delaware Trauma System's Quality Improvement Plan describes the framework for designing, measuring, assessing, and improving the organizational functions related to the provision of medical services to injured patients within the State. It promotes performance improvement through education, facilitation of inter- and intra-facility communication, and systems coordination. The plan integrates all prehospital, medical staff, nursing, ancillary services, and operational performance improvement activities through systematic monitoring and evaluation of the appropriateness of patient care, the measurement of outcomes, and the identification of opportunities for improvement.
   3. 8.1.3 The goals of the Trauma System's Quality Improvement Plan are to monitor the process and outcome of patient care, to ensure the quality and timely provision of such care, to improve the knowledge and skills of trauma care providers, and to provide the structure and organization to promote quality improvement within the State.

2. 8.2 Objectives. Based on national standards for Facility Quality Improvement set forth in ACSResources for Optimal Care of the Injured Patientand the JCAHO Recommendations for Improving Organizational Performance and for System Quality Improvement as outlined in the ACEP Trauma Care System Guidelines, the Trauma System's Quality Improvement Plan describes the framework for use in designing, measuring, assessing, and improving the Delaware Trauma System's organization, functions, and services. This is accomplished by a collaborative approach with the appropriate facilities, services, and disciplines involved, utilizing the following objectives:

   1. 8.2.1 Systematic measurement on a continuing basis to understand and maintain the stability of systems and processes;
   2. 8.2.2 Measurement of patient and systems outcomes to help determine priorities for improving systems and processes; and
   3. 8.2.3 Assessment of system competence and performance.

3. 8.3 Authority

   1. 8.3.1 The Division of Public Health has the ultimate authority and responsibility for assuring the delivery of quality trauma care throughout the State.
   2. 8.3.2 The Division has the authority for system data collection, review, and the authority to recommend corrective action in all aspects of trauma care throughout the continuum from injury to rehabilitation.
   3. 8.3.3 The Division shall provide guidance as needed to individual trauma facilities in the development and implementation of the Quality Improvement Programs.
   4. 8.3.4 The care of the trauma patient is monitored and evaluated at both the facility and Trauma System levels, and maintenance of patient confidentiality is the joint responsibility of evaluators at the both the facility and Trauma System levels.

4. 8.4 Prehospital Evaluation

   1. 8.4.1 The Division of Public Health shall work with the State Fire Prevention Commission to address improvements regarding prehospital care of the injured patient. The ACEP's Trauma Care System Guidelines shall provide a basis for prehospital trauma care evaluation. There shall be an ongoing evaluation of all aspects of trauma care from the receipt of the call at central dispatch to the patient's arrival at the medical facility. Evaluation shall document quality of care provided and compliance with protocols.

   2. 8.4.2 Areas to be reviewed by the agency's PI staff include the following:

      1. 8.4.2.1 Access to the system;
      2. 8.4.2.2 Efficacy of field therapy;
      3. 8.4.2.3 Scene time;
      4. 8.4.2.4 Transport decisions;
      5. 8.4.2.5 Transport time;
      6. 8.4.2.6 Transport to the appropriate facility;
      7. 8.4.2.7 Under/over triage; and
      8. 8.4.2.8 Documentation.

   3. 8.4.3 Delaware shall follow national standards for prehospital data collection.

      1. 8.4.3.1 The Division shall collaborate with the State Fire Prevention Commission to determine the minimum data sets to be collected by Basic and Advanced Life Support providers. Data used for evaluation of prehospital care must be consistent with the design of the Delaware Trauma Registry, as collected by the medical facilities and analyzed by the Division.

      2. 8.4.3.2 Data to be reviewed shall include:

         1. 8.4.3.2.1 Completion of primary patient assessment;
         2. 8.4.3.2.2 Appropriate care of life-threatening conditions;
         3. 8.4.3.2.3 Trip sheet completion and availability at facility;
         4. 8.4.3.2.4 Scene time within accepted guidelines;
         5. 8.4.3.2.5 Proper triage/determination of facility type needed by patient; and
         6. 8.4.3.2.6 Transportation to appropriate facility within an acceptable time frame.

   4. 8.4.4 Performance Improvement ("PI")

      1. 8.4.4.1 PI measures shall be determined by the Trauma System Evaluation Committee based on Delaware prehospital protocols and national and Delaware standards of care.
      2. 8.4.4.2 A completed prehospital patient care record must be provided to the medical receiving facility for inclusion in the patient's emergency room or facility medical record. Facilities and prehospital providers are strongly encouraged to establish a mechanism for exchange of information, including provision of feedback to prehospital providers on triage decisions made. Additionally, the facility's trauma registrar shall include this record's data in the facility's trauma registry for outcome evaluation.
      3. 8.4.4.3 A PI program model shall be developed by the Division or its designee for the use of Basic Life Support and Advanced Life Support agencies. Recommendations for changes in educational curricula, patient care protocols, etc. shall be based on analysis of information obtained through the prehospital evaluation process. The Division shall also develop a mechanism for prehospital providers to have input into quality assurance issues, including the identification of educational needs and methods of addressing them.

5. 8.5 Trauma Center Evaluation

   1. 8.5.1 All designated trauma facilities shall design a performance improvement plan which meets the standards and requirements established by the Division. The Division shall utilize the current ACSResources for Optimal Care of the Injured Patientand subsequent revisions as guidelines. Facility performance improvement plans shall be verified during site survey and quality improvement visits.

   2. 8.5.2 When new processes or systems are developed within a facility, the design shall be based on the following:

      1. 8.5.2.1 Up-to-date sources of information about designing processes and systems including practice guidelines, clinical pathways, professional standards, and regulatory standards;
      2. 8.5.2.2 The needs and expectations of internal and external consumers; and
      3. 8.5.2.3 The performance of the processes and systems and their outcomes including internal and external (benchmarking) comparison data.
   3. 8.5.3 Performance Measures. Performance measures (audit filters) shall be based on nationally recognized guidelines set forth by the ACS. Performance measures are established to evaluate process or outcome of the care or services provided or to determine the level of performance of existing processes and the outcomes resulting from these processes. Data collection and measurement shall be systematic, relate to relevant standards of care, and prioritized according to high volume, high risk, or problem-prone areas. In addition, the needs, expectations, and feedback from patients and their families, employees, results of ongoing monitoring activities (e.g., infection control), safety of the patient care environment, utilization, and risk management findings shall be included.

   4. 8.5.4 Data collection

      1. 8.5.4.1 Data collection shall be designed to:

         1. 8.5.4.1.1 Assess new or existing processes;
         2. 8.5.4.1.2 Measure the level of performance and stability of important existing processes;
         3. 8.5.4.1.3 Set performance improvement priorities;
         4. 8.5.4.1.4 Establish benchmarks of performance to identify potential opportunities for improvement;
         5. 8.5.4.1.5 Identify patterns and trends that may require focused attention;
         6. 8.5.4.1.6 Provide comparative performance data to use for performance improvements; and
         7. 8.5.4.1.7 Evaluate whether changes have improved the processes.

      2. 8.5.4.2 Performance measures (audit filters) may:

         1. 8.5.4.2.1 Measure events or phenomena that are expected to occur at some level of frequency;
         2. 8.5.4.2.2 Relate data about either a process or an outcome;
         3. 8.5.4.2.3 Relate data about occurrences that are either desirable or undesirable;
         4. 8.5.4.2.4 Relate data that guide the Trauma Program in improving norms of performance instead of focusing exclusively on censoring or eliminating individual outliers; and
         5. 8.5.4.2.5 Identify serious events which may trigger an opportunity for improvement and require further data collection.

   5. 8.5.5 Focused audits shall be used to periodically examine the process of care as recommended by ACS or the State of Delaware Trauma Quality Evaluation Committee and may include the following:

      1. 8.5.5.1 Noncompliance with facility criteria for trauma center designation;
      2. 8.5.5.2 Trauma attending surgeon arrival times for Trauma Codes; and
      3. 8.5.5.3 The absence of documentation of required information or patient assessment findings on trauma care records.

   6. 8.5.6 After data collection, the data shall be analyzed to determine the following:

      1. 8.5.6.1 Whether design specifications for new processes were met;
      2. 8.5.6.2 The level of performance and stability of existing processes;
      3. 8.5.6.3 Priorities for possible improvement of existing processes;
      4. 8.5.6.4 Actions and strategies to improve the performance of processes; and
      5. 8.5.6.5 Whether changes in the processes resulted in improvement.
      6. 8.5.6.6 Data analysis shall be accomplished using statistical quality control techniques and tools, comparative benchmarking data such as TRISS, review of the Trauma Program's processes and outcomes over time, and other reference material as appropriate. Intensive assessment shall be used when measurement indicates that potential performance or system related opportunities for improvement exist, a single serious event occurs, the control limits are met, or when undesirable variation in performance has occurred or is occurring.
      7. 8.5.6.7 The data analysis process shall be interdisciplinary and interdepartmental depending upon the process or outcome under review.

   7. 8.5.7 When an opportunity for improvement is identified or when the measurement of an existing process identifies the need to redesign a process, a systematic approach, such as the Find, Organize, Clarify, Understand, Select and Plan, Do, Check, Act (FOCUS-PDCA) Model, shall be implemented. This model is the ongoing process used to promote continuous improvement as described below:

      1. 8.5.7.1 Find process improvement opportunity:

         1. 8.5.7.1.1 Develop an opportunity statement; and
         2. 8.5.7.1.2 Identify the process.

      2. 8.5.7.2 Organize a team that knows the process:

         1. 8.5.7.2.1 Identify employees who work closest with the process; and
         2. 8.5.7.2.2 Identify internal and external consumers and their expectations.

      3. 8.5.7.3 Clarify current knowledge of the process:

         1. 8.5.7.3.1 Identify sound areas of the process;
         2. 8.5.7.3.2 Determine if team members are appropriate to assess the process;
         3. 8.5.7.3.3 Identify the process flow; and
         4. 8.5.7.3.4 Identify problems or redundancies which can be eliminated to make the flow more efficient.

      4. 8.5.7.4 Uncover causes of process variation:

         1. 8.5.7.4.1 Identify variation in the process;
         2. 8.5.7.4.2 Identify measurable process characteristics;
         3. 8.5.7.4.3 Identify if the variation has a common or unique cause; and
         4. 8.5.7.4.4 Identify the effect the variation has on other facility systems.

      5. 8.5.7.5 Start the improvement cycle:

         1. 8.5.7.5.1 Determine what changes can be made to improve the process; and
         2. 8.5.7.5.2 Start a description of the process to be improved.

      6. 8.5.7.6 Plan the improvement and data collection:

         1. 8.5.7.6.1 Identify what improvements are to be made and in what order;
         2. 8.5.7.6.2 Assign responsibility for making the change;
         3. 8.5.7.6.3 Determine when the change will be effective; and
         4. 8.5.7.6.4 Determine what data will be collected to measure changes.

      7. 8.5.7.7 Make the improvement:

         1. 8.5.7.7.1 Initiate the change (pilot study period); and
         2. 8.5.7.7.2 Collect data.

      8. 8.5.7.8 Check the results:

         1. 8.5.7.8.1 Analyze the results of the data collection; and
         2. 8.5.7.8.2 Draw conclusions.

      9. 8.5.7.9 Act in process and theory:

         1. 8.5.7.9.1 Standardize the change;
         2. 8.5.7.9.2 Determine ongoing measurement of the process and reevaluation of implemented changes (effectiveness monitored for a minimum of 3 months following corrective action);
         3. 8.5.7.9.3 Policy and procedure development/revision;
         4. 8.5.7.9.4 Education and communication of new process; and

         5. 8.5.7.9.5 Following identification and documentation of a specific problem in patient care or system performance by the peer-review process, corrective action is taken through 1 of the following mechanisms:

            1. 8.5.7.9.5.1 Change of existing policies and procedures that govern or define the standard of care;
            2. 8.5.7.9.5.2 Professional education: Cases may be selected for discussion at the trauma service conferences; deficits in knowledge can be addressed through education of the whole group of providers or of specific providers;
            3. 8.5.7.9.5.3 Counseling: Review of a specific case or cases is conducted by the Trauma Medical Director, chief of the service, or the supervisor, with the individual; or
            4. 8.5.7.9.5.4 Credentialing process: Information from quality improvement activities may be reported through the facility's QI System for consideration at the time of credentialing, delineation of privileges, or evaluation.

6. 8.6 Trauma System Evaluation

   1. 8.6.1 Evaluation of the Delaware Trauma System encompasses the entire scope of care provided to injured patients within the State of Delaware from injury through rehabilitation.

   2. 8.6.2 Division of Public Health responsibilities are:

      1. 8.6.2.1 Implement and monitor the State Trauma System Quality Improvement Program.

      2. 8.6.2.2 Trauma System Registry Coordinator responsibilities are as follows:

         1. 8.6.2.2.1 Review Trauma Registry data submitted for completeness;
         2. 8.6.2.2.2 Provide educational support for trauma registrars;
         3. 8.6.2.2.3 Assure maintenance of all minutes and records related to Trauma System continuous improvement activities; and
         4. 8.6.2.2.4 Function as staff for Quality Evaluation Committee.

7. 8.7 Trauma System Quality Evaluation Committee ("Quality Committee")

   1. 8.7.1 The Quality Committee is established under subsection 4.5.1 of this regulation.

   2. 8.7.2 The Quality Committee shall provide recommendations, advice, and assistance to the Division in its ongoing evaluation of the Delaware Trauma System based on ACS standards and nationally accepted Continuous Quality Improvement guidelines. Specific functions may include the following:

      1. 8.7.2.1 Support the Trauma System Registry Coordinator in the supervision of the State Trauma Registry;
      2. 8.7.2.2 Assess trauma care standards and recommend actions for the development and implementation of statewide policies and procedures that guide and support the provision of trauma care or services;
      3. 8.7.2.3 Assess resources needed to support and sustain the Delaware State Trauma System;
      4. 8.7.2.4 Evaluate the coordination and integration of prehospital, inter-facility, intra-facility, and ancillary services;
      5. 8.7.2.5 Monitor the incidence of adverse outcomes on a regular basis with comparison to regional and national norms;
      6. 8.7.2.6 Recommend action for identified problems or opportunities for improvement in patient care services;
      7. 8.7.2.7 Report Quality Improvement activities to the Division on an annual basis;
      8. 8.7.2.8 Sponsor ongoing education regarding ACS, ACEP, and TJC standards and provide a multidisciplinary educational forum for presentation and discussion of interesting, difficult, or controversial trauma patient management cases;
      9. 8.7.2.9 Evaluate effectiveness of actions taken and determine follow-up;
      10. 8.7.2.10 Meet a minimum of 4 times per year, and as determined by the Committee or the Division;
      11. 8.7.2.11 Assess other sources of data to combine into a comprehensive database for evaluation of the continuum of trauma care in Delaware;
      12. 8.7.2.12 Develop operational guidelines for the Committee's functioning; and
      13. 8.7.2.13 Perform any other function deemed necessary by the Division of Public Health.
   3. 8.7.3 The Quality Committee, with administrative assistance from the Systems of Care Program, will document identified issues using theDelaware Trauma System QE Issue Documentation Tool, which is located on the Trauma System of Care webpage (https://dhss.delaware.gov/dph/ems/trauma/)

   4. 8.7.4 The Quality Committee shall report aggregate findings and activities of the Quality Committee including:

      1. 8.7.4.1 The incidence of adverse or positive outcomes with comparison to regional and national norms;
      2. 8.7.4.2 Trend analyses of systems components;
      3. 8.7.4.3 Recommendations for action when opportunities for improvement are identified;
      4. 8.7.4.4 Evaluation of effectiveness of actions taken and methodologies for follow-up; and
      5. 8.7.4.5 Publication of reports to support trauma prevention, research, and systems activities, or helping others to publish reports.

   5. 8.7.5 Major areas of Trauma System review shall include:

      1. 8.7.5.1 Triage;
      2. 8.7.5.2 Inter-facility transfer;
      3. 8.7.5.3 Facility performance;
      4. 8.7.5.4 Impact of system;
      5. 8.7.5.5 Integrity of Trauma Registry data; and
      6. 8.7.5.6 Prevention trends.

8. 8.8 Confidentiality

   1. 8.8.1 As used in this Section, "records" means the recordings of interviews and all oral or written reports, statements, minutes, memoranda, charts, data, statistics, and other documentation generated by the Quality Committee, its subcommittees, and the State Trauma Registry for the stated purpose of trauma system medical review or quality care review and audit.
   2. 8.8.2 All quality management proceedings shall be confidential. Records of the Quality Committee, its subcommittees, the State Trauma Registry, and attendees at meetings held for stated purposes of trauma system medical review or quality care review and audit shall be confidential and privileged and shall be protected from direct or indirect means of discovery, subpoena, or admission into evidence in any judicial or administrative proceeding.
   3. 8.8.3 All studies, reports, and minutes will include only the patient trauma registry number with all other identifying information encoded or kept in locked files. Access to qualified researchers may be granted based on state, federal, and municipal statutes, bylaws, rules, regulations, and policies. All meeting attendees will be required to sign confidentiality statements. Any documented breach of confidentiality will be referred to the Division of Public Health for appropriate action.
9. 8.9 The Trauma System Performance Improvement Plan shall be reviewed at least annually by the Division and the Quality Committee.

9.0 Severability

In the event any clause or Section of these regulations should be declared invalid or unconstitutional by any court of competent jurisdiction, the remaining portions shall remain in full effect.

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)

5 DE Reg. 632 (09/01/01)

17 DE Reg. 523 (11/01/13)

27 DE Reg. 529 (01/01/24)

29 DE Reg. 704 (02/01/26)