16 Del. Admin. Code § 4305-5.0

Current through Register Vol. 28, No. 7, January 1, 2025

Section 4305-5.0 - Delaware Trauma Center Designation Process

5.1 Trauma System Participation

5.1.1 To be considered a participant in Delaware's Prehospital Trauma Triage Scheme and receive injured and trauma patients, an acute care facility must be designated as a trauma center by the Division Director.

5.1.2 To be considered a participant in Delaware's Prehospital Trauma Triage Scheme, 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.

5.1.3 All acute care in-patient 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 Delaware System Trauma Plan, July 2023 Version, and any subsequent revisions. All designated trauma facilities must use the complete trauma registry form, which includes patient information and facility-specific quality assurance and financial data elements.

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

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.

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.

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

5.2.1 Prepare for verification visits;

5.2.2 Provide staff support for the trauma center designation process;

5.2.3 Coordinate and provide staff for Level IV verification visits;

5.2.4 Develop and disseminate a timeline for the designation process;

5.2.5 Establish partnerships to hold educational and informational forums about the verification process and facility role, including mock surveys upon request or as necessary.

5.3 Responsibilities of Delaware Facilities.

5.3.1 Cost. Facility fees for verification visits shall include all ACS and surveyor fees.

5.3.2 Application form. The facility must submit a completed ACS application to ACS and the Division.

5.3.3 The facility shall coordinate site visits, surveyor accommodations, transportation, and preparatory information to facilities as needed.

5.4 Verification Process

5.4.1 All Level I, Level II, and Level III trauma centers must be verified by the ACS Committee on Trauma prior to being designated as a Delaware trauma center.

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.

5.4.3 Requirements of verification team composition.

5.4.3.1 For all Levels:

5.4.3.1.1 Familiarity with similar size geographical region and facilities; and

5.4.3.1.2 No conflicts of interest.

5.4.3.2 For Regional Trauma Centers Levels 1 and 2:

5.4.3.2.1 Two trauma surgeons;

5.4.3.2.2 One trauma registered nurse;

5.4.3.2.3 One Emergency Medicine physician;

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

5.4.3.2.5 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.

5.4.3.3 For Community Trauma Centers (Level III):

5.4.3.3.1 One Trauma Surgeons; and

5.4.3.3.2 One Emergency Medicine physician.

5.4.3.3.3 In addition, for first-time Level III verification, or an increase to Level III from a Level IV, one trauma registered nurse from the ACS Committee on Trauma's Verification, Review and Consultation (VRC) Committee.

5.4.3.4 Participating Facilities (Level IV) Trauma Centers shall be verified and designated by Division-appointed designees, including:

5.4.3.4.1 One Delaware Trauma System Coordinator

5.4.3.4.2 One out-of-state Emergency Department Physician;

5.4.3.4.3 One trauma registered nurse; and

5.4.3.4.4 The Delaware Trauma System of Care Medical Advisor.

5.4.3.5 Pediatric Trauma Centers. Pediatric trauma centers shall have equivalent verification teams to the corresponding level of adult trauma center.

5.4.4 In any case where the ACS does not provide the scope necessary to include a particular facility in its verification process, the Division Director may decide to allow that facility to participate in the Delaware Trauma System under special circumstances. In this case, that facility is encouraged to utilize the ACS to the extent to which applicable services are available, and the Division shall arrange for a comparable verification visit by national trauma experts under individual contract with the Division. Fees and site visit reports of this team shall be handled in the same manner as those of the ACS.

5.5 Timeframe.

5.5.1 The facility shall determine when it is adequately prepared to begin the verification process.

5.5.2 The Division shall hold periodic designation cycles for facilities to apply for trauma center designation.

5.6 Designation Process.

5.6.1 The Designation Committee shall make recommendations to the Division on the category of trauma center designation for which each facility has qualified, based on its review of the ACS site visit report and application of Delaware's correlational template.

5.6.1.1 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.

5.6.1.2 The Division Director shall designate a trauma center based on the Designation Committee's recommendations.

5.6.2 Categories of state designation and timeframes.

5.6.2.1 Full designation may be awarded for 3 years.

5.6.2.2 Provisional designation may be awarded for 1 year.

5.6.2.2.1 Deficiencies defined by ACS must be corrected and verified by the ACS within this period.

5.6.2.2.2 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.

5.6.2.2.3 The Division may require interim reports or on-site progress evaluations as a condition of approval of the written plan of correction 1 year after the provisional designation has been awarded.

5.6.2.3 Non-designation

5.6.2.3.1 Facilities not receiving full designation must notify the Division within 30 days of status notification of their intent to correct deficiencies or to accept non-designation. A written plan of correction including timeframes must be submitted to the Division if the facility chooses to pursue designation.

5.6.2.3.2 All corrections must be completed and verified within one year from the date of status notification. Facilities shall be informed whether their plan for correction is acceptable.

5.6.2.4 Lower designation

5.6.2.4.1 Facilities may be offered a lower designation level than originally applied for if they do not qualify for the higher level. If they accept the lower designation level, they may apply again for a verification visit at the higher level at any time that they are ready or may elect to remain at the designated level.

5.6.2.4.2 A facility seeking to be designated at a higher level shall:

5.6.2.4.2.1 Meet with the Trauma System Coordinator to review compliance with the standards of the higher-level trauma center.

5.6.2.4.2.2 Request provisional designation in writing from the Division of Public Health, providing documentation of intent to obtain ACS verification within the year of provisional designation.

5.6.2.4.2.3 If approved, the Office of EMS shall notify prehospital and facility agencies of the change in status after a start date has been agreed upon.

5.7 Designation Committee

5.7.1 The Division Director shall maintain an impartial Trauma Center Designation Committee. The Designation Committee members are appointed from each of the following Delaware organizations or chapters as follows:

5.7.1.1 One member from the Delaware Healthcare Association;

5.7.1.2 One member from the Delaware Organization of Nurse Leaders;

5.7.1.3 One anesthesiologist or intensivist from the Medical Society of Delaware;

5.7.1.4 One member from the American College of Surgeons, Delaware Chapter, Committee on Trauma;

5.7.1.5 One member from the American College of Emergency Physicians, Delaware Chapter;

5.7.1.6 One member from the Delaware Emergency Nurse Association;

5.7.1.7 One member from the Delaware Society of Orthopedic Surgeons

5.7.1.8 One member from American Association of Critical Care Nurses, Delaware Chapter;

5.7.1.9 One member who shall be a pediatric care specialist; and

5.7.1.10 One member from the American Neurosurgery Association, Delaware Chapter who shall serve in advisory, non-voting role.

5.7.2 The Division Director shall make an effort to appoint committee members who provide geographic and institutional diversity. Members shall serve at the pleasure of the Division Director, until they submit a letter of resignation, their organization requests to replace them, or they are absent from meetings for a period of 1 year, which shall be cause for dismissal.

5.7.3 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.

5.7.4 In the event a 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.

5.7.5 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 of Public Health for appropriate action.

5.8 Redesignation

5.8.1 ACS reverification visits must be scheduled every three years for facilities wishing to continue their trauma center status.

5.8.2 Subsequent site visits shall focus heavily on quality management and patient care issues.

5.8.3 Re-designation categories and timeframes shall be the same as those for initial designation.

5.9 Initiation of Revocation of Trauma Center Designation Process

5.9.1 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.

5.9.2 Identification may occur through one of the following mechanisms:

5.9.2.1 Expiration of a trauma center's designation period with failure of the facility to successfully complete an American College of Surgeons (ACS) reverification visit;

5.9.2.2 An interim quality improvement site visit;

5.9.2.3 A Trauma System Quality Evaluation Committee recommendation; or

5.9.2.4 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.

5.10 Investigation of Identified Violation of Standard

5.10.1 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.

5.10.2 The Division Director shall select the Designation Committee members to be assigned to the ad hoc investigation committee.

5.10.3 The involved trauma center shall be notified of the investigation in writing with a request for its written response.

5.10.4 The assigned investigation committee shall conduct an appropriate follow-up investigation.

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

5.10.5.1 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.

5.10.5.2 Status change to Participating Facility until the deficiency is remedied and accepted by the Division (revocation of trauma center designation).

5.10.5.3 Continuation of current trauma center designation.

5.10.6 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.

5.10.7 If probation or revocation of designation is not recommended, the investigation committee may recommend follow-up monitoring or reporting.

5.10.8 The Division Director shall make a decision on the action to be taken after consideration of the investigation committee's report. Written notification of the action shall be forwarded to the facility.

5.10.9 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.

5.10.9.1 If a facility fails to comply with an extended timeframe, the Division Director may require a full American College of Surgeons verification site visit for a facility to be reinstated at its former level of designation.

5.10.9.2 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.

5.11 Appeal Process

5.11.1 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.

5.11.2 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 with 29 Del.C. § 10122, as far as practicable.

5.11.3 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.

5.11.4 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 of Public Health.

5.11.5 Information pertinent to the case shall be presented to the panel by a member of the ad hoc investigation committee (or assigned Designation Committee taskforce 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.

5.11.6 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.

5.11.7 The Division Director shall make a decision based on the panel's recommendation within 30 days of the hearing's conclusion and shall provide written notification of the action to the facility.

5.12 Reinstatement Process

5.12.1 When a facility has corrected a problem which resulted in probation or revocation of designation, it shall notify the Division of Public Health in writing, requesting reinstatement.

5.12.2 Based on the reinstatement steps recommended by the Designation Committee, the Division shall arrange a review to verify resolution of the problem.

5.12.3 Outcomes of the review are for the facility to:

5.12.3.1 Return to previous level of designation or end of probation;

5.12.3.2 Designate at lower level until reverified by ACS; or

5.12.3.3 Remain at Participating Facility level until reverified by ACS.

5.13 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.

16 Del. Admin. Code § 4305-5.0

27 DE Reg. 529( 1/1/2024) (Final)