10A NCAC 13P .0904       INITIAL DESIGNATION PROCESS

(a)  For initial Trauma Center designation or changing the level of Trauma Center designation, the hospital shall request a consult visit by OEMS and the consult shall occur within one year prior to submission of the RFP.

(b)  A hospital interested in pursuing Trauma Center designation shall submit a letter of intent 180 days prior to the submission of an RFP to the OEMS. The letter shall define the hospital's primary trauma catchment area. Simultaneously, Level I or II applicants shall also demonstrate the need for the Trauma Center designation by submitting one original and three copies of documents that include:

(1)           the population to be served and the extent that the population is underserved for trauma care with the methodology used to reach this conclusion;

(2)           geographic considerations, to include trauma primary and secondary catchment area and distance from other Trauma Centers; and

(3)           evidence the Trauma Center will admit 1200 or more trauma patients annually or show that its trauma service will be taking care of at least 240 trauma patients with an ISS greater than or equal to 15 yearly. These criteria shall be met without compromising the quality of care or cost effectiveness of any other designated Level I or II Trauma Center sharing all or part of its catchment area or by jeopardizing the existing Trauma Center's ability to meet this same 240-patient minimum.

(c)  The hospital shall be participating in the State Trauma Registry as defined in Rule .0102 of this Subchapter, and submit data weekly to the OEMS of 12 months or more prior to application that includes all the Trauma Center's trauma patients as defined in Rule .0102 of this Subchapter who are:

(1)           diverted to an affiliated hospital;

(2)           admitted to the Trauma Center for greater than 24 hours from an ED or hospital;

(3)           die in the ED;

(4)           are DOA; or

(5)           are transferred from the ED to the OR, ICU, or another hospital (including transfer to any affiliated hospital).

(d)  OEMS shall review the regional Trauma Registry data from both the applicant and the existing trauma center(s), and ascertain the applicant's ability to satisfy the justification of need information required in Paragraph (b) of this Rule. The OEMS shall notify the applicant's primary RAC of the application and provide the regional data submitted by the applicant in Paragraph (b) of this Rule for review and comment. The RAC shall be given 30 days to submit written comments to the OEMS.

(e)  OEMS shall notify the respective Board of County Commissioners in the applicant's primary catchment area of the request for initial designation to allow for comment during the same 30 day comment period.

(f)  OEMS shall notify the hospital in writing of its decision to allow submission of an RFP. If approved, the RAC and Board of County Commissioners in the applicant's primary catchment area shall also be notified by the OEMS that an RFP will be submitted.

(g)  Once the hospital is notified that an RFP will be accepted, the hospital shall complete and submit an electronic copy of the completed RFP with signatures to the OEMS no later than 45 days prior to the proposed site visit date.

(h)  The RFP shall demonstrate that the hospital meets the standards for the designation level applied for as found in Rule .0901 of this Section.

(i)  If OEMS does not recommend a site visit based upon failure to comply with Rule .0901 of this Section, the OEMS shall send the written reasons to the hospital within 30 days of the decision. The hospital may reapply for designation within six months following the submission of an updated RFP. If the hospital fails to respond within six months, the hospital shall reapply following the process outlined in Paragraphs (a) through (h) of this Rule.

(j)  If after review of the RFP, the OEMS recommends the hospital for a site visit, the OEMS shall notify the hospital within 30 days. The hospital and the OEMS shall agree on the date of the site visit.

(k)  Except for OEMS representatives, reviewers for a Level I or II visit shall be from outside the local or adjacent RAC, unless mutually agreed upon by the OEMS and the trauma center seeking designation where the hospital is located. The composition of a Level I or II site survey team shall be as follows:

(1)           one trauma surgeon who is a Fellow of the ACS, experienced as a site surveyor, who shall be the primary reviewer;

(2)           one emergency physician who currently works in a designated trauma center, is a member of the American College of Emergency Physicians or American Academy of Emergency Medicine, and is boarded in emergency medicine by the American Board of Emergency Medicine or the American Osteopathic Board of Emergency Medicine;

(3)           one trauma surgeon;

(4)           one trauma program manager; and

(5)           OEMS Staff.

(l)  All site team members for a Level III visit except for the OEMS representatives, shall be from outside the local or adjacent RAC where the hospital is located. The composition of a Level III state site survey team shall be as follows:

(1)           one trauma surgeon who is a Fellow of the ACS and shall be the primary reviewer;

(2)           one emergency physician who currently works in a designated trauma center and is boarded in emergency medicine by the American Board of Emergency Medicine or the American Osteopathic Board of Emergency Medicine;

(3)           one trauma program manager; and

(4)           OEMS Staff.

(m)  The hospital shall make available all requested patient medical charts.

(n)  The primary reviewer of the site review team shall give a verbal post-conference report representing a consensus of the site review team. The primary reviewer shall complete and submit to the OEMS a written consensus report within 30 days of the site visit.

(o)  The report of the site survey team and the staff recommendations shall be reviewed by the State Emergency Medical Services Advisory Council at its next regularly scheduled meeting following the site visit. Based upon the site visit report and the staff recommendation, the State Emergency Medical Services Advisory Council shall recommend to the OEMS that the request for Trauma Center designation be approved or denied.

(p)  All criteria defined in Rule .0901 of this Section shall be met for initial designation at the level requested.

(q)  Hospitals with a deficiency(ies) resulting from the site visit shall be given up to 12 months to demonstrate compliance. Satisfaction of deficiency(ies) may require an additional site visit. The need for an additional site visit shall be determined on a case-by-case basis based on the type of deficiency. If compliance is not demonstrated within the time period set by OEMS, the hospital shall submit a new application and updated RFP and follow the process outlined in Paragraphs (a) through (h) of this Rule.

(r)  The final decision regarding Trauma Center designation shall be rendered by the OEMS.

(s)  The OEMS shall notify the hospital in writing of the State Emergency Medical Services Advisory Council's and OEMS' final recommendation within 30 days of the Advisory Council meeting.

(t)  If a trauma center changes its trauma program administrative structure such that the trauma service, trauma Medical Director, trauma program manager, or trauma registrar are relocated on the hospital's organizational chart at any time, it shall notify OEMS of this change in writing within 30 days of the occurrence.

(u)  Initial designation as a trauma center shall be valid for a period of three years.

History Note:        Authority G.S. 131E-162; 143-508(d)(2);

Temporary Adoption Eff. January 1, 2002;

Eff. April 1, 2003;

Amended Eff. January 1, 2009;

Readopted Eff. January 1, 2017;

Amended Eff. April 1, 2024; July 1, 2018.