(b) Site survey.

1. (1) Upon the review and approval by the Trauma Section of the application materials submitted pursuant to subsection (a) of this section, an on-site survey of the facility shall be scheduled.
2. (2) All costs associated with conducting an on-site survey shall be the responsibility of the applicant.
3. (3) The on-site survey shall be conducted based upon the standards described in 20 CAR § 80-501 et seq., or 20 CAR § 80-601 et seq., as applicable.
4. (4) All requirements, including CMEs, meeting attendance (e.g., operations, peer review, TRAC), and certifications (e.g., TNCC, ATLS, RTTDC) shall be verified as met or not met at the time of the site survey visit.
5. (5) No additional documentation will be accepted after the visit and used in consideration of the determination of compliance with criteria.
6. (6) The survey team and the TAC Designation Committee shall not consider any activities or certifications that may occur after the site survey.
7. (7) The survey team shall consist of members approved by the Trauma Section as outlined in subsection (c) of this section.
8. (8) The survey team shall submit a comprehensive report to the Trauma Section and the TAC Designation Committee, which will review the findings and report its recommendation to the TAC.
9. (9) The TAC, in turn, shall submit the recommendation to the Trauma Section.

10. (10) The Trauma Section shall review the survey findings, in conjunction with the recommendation, and issue a decision to implement one (1) of the following options:

    1. (A) Full designation. Designation level requested by the applicant for a period of three (3) years;
    2. (B) Provisional designation.

(c) (c) It shall be the hospital’s responsibility to correct the deficiencies and complete a focused review prior to the end of the provisional year.

1. (ii)

(b) (b) Therefore, the facility shall submit all paperwork and undergo an on-site visit (if one is required) at least six (6) weeks prior to the expiration of its provisional designation at one (1) year.

1. (c) (c) All requirements, including CMEs, meeting attendance (e.g., operations, peer review, TRAC) and certifications (e.g., TNCC, ATLS, RTTDC) shall be met at the time of the site survey visit.

   1. (d) (d) There will be no automatic extension of the provisional designation while awaiting the outcome of a focused review.

(e)

1. (1) (e)(1) During the focused review, all deficiencies and weaknesses will be addressed by the review team.
2. (2) (2) Additional deficiencies and weaknesses may be cited if discovered and verified during the focused review process.

(h) (h) Consideration will be given to facilities for which the failure to meet the corrective action prescribed is beyond their immediate control.

1. (i) (i) At the conclusion of the second provisional term, if the facility has not met the department’s requirements, the provisional designation shall be revoked and the facility shall reapply for trauma center designation.

(k) (k) It does not have to repay previously received funding but is not eligible for continued funding unless designated at a later date;

1. (C) Designation at a different level. Full or provisional designation at a different level of designation as recommended by the Trauma Section based upon the facility’s current capabilities as determined by the Trauma Section’s review of the on-site survey; or

   1. (D) Approval denied or suspended/revoked.

      1. (i) The facility shall resubmit a new application.
      2. (ii) This cannot be done earlier than six (6) months after the denial or suspension/revocation.
      3. (iii) The facility has the option to designate at a lower level with the approval of the department at the time of suspension/revocation.

2. (11) If an application for designation is denied or not approved at the desired level, please see 20 CAR § 80-403 for the appeal process.

   1. (c) Trauma center site survey team.

3. (1) Purpose.

   1. (A) As part of the trauma center designation process, following a successful application, an on-site survey of the prospective trauma center shall be conducted to evaluate the quality of the applicant’s compliance with the standards outlined in 20 CAR § 80-501 et seq., and 20 CAR § 601 et seq.
   2. (B) The survey of hospitals for trauma center designation shall include interviews with designated hospital staff, a review of the physical plant and equipment, and a review of records and documents as deemed necessary to ensure compliance with the requirements of the rules set forth in this part.
   3. (C) The cost of the site survey shall be paid by each applicant hospital or renewing trauma center unless otherwise stated by the Trauma Section.

4. (2)

   1. (A) The survey team will be selected by the Trauma Section and consist of individuals who are disinterested both politically and financially from the facility to be surveyed.
   2. (B) Each team member shall have past experience and/or special training related to trauma designation site surveys.

5. (3)

   1. (A) The following individuals shall comprise the survey team.
   2. (B) As noted in subdivision (c)(4) of this section, the actual composition of the team is dependent upon the level of trauma center designation sought by the hospital.

   3. (C) The individuals are:

      1. (i) General surgeon (pediatric surgeon for pediatric specialty facility) who:

(b) (b) Is a FACS or a member of the ACOS;

1. (ii) Emergency physician (pediatric emergency physician for pediatric specialty facility) who:

(b) (b) Is board-certified in EM or approved by the Trauma Section;

1. (iii) TPM who is a RN with responsibility for monitoring and evaluating nursing care of trauma patients and for the coordination of the QI and patient safety programs of the trauma center in conjunction with the TMD; and

   1. (iv) Trauma Section representative who has a regular working relationship with the TAC.

2. (4)

   1. (A) The survey team shall be comprised of the following for the designation levels set forth below:

      1. (i) Level I.

(b) (b) The majority of the clinical review team shall be out-of-state reviewers;

1. (ii) Level II.

(b) (b) At least one (1) member of the clinical review team shall be an out-of-state reviewer;

1. (iii) Level III.

(b) (b) Both clinicians may be from within the state but shall be from another region or regions of the state; and

1. (iv) Level IV.

(b) (b) The clinician reviewer shall be from another region of the state.

1. (B) In the event that in-state reviewers are not available, out-of-state reviewers may be substituted at the facility’s cost.
2. (5) All team members, with the exception of the Trauma Section representative, shall be active in the management of trauma patients.

3. (6)

   1. (A) Additional team members may be assigned at the discretion of the Trauma Section, based on previous performance, concerns, or complaints.
   2. (B) The additional cost shall be the responsibility of the facility.

4. (7) The survey team shall evaluate the quality of each applicant’s compliance with the standards set forth in 20 CAR § 80-501 et seq., and 20 CAR § 80-601 et seq., by:

   1. (A) Conducting interviews with hospital personnel;
   2. (B) Examining equipment, touring the physical plant; and
   3. (C) Reviewing medical records, staff rosters and schedules, operations and peer review committee meeting minutes, trauma registry data, and other documents relevant to trauma care.
5. (8) Findings of the survey team shall be forwarded to the Trauma Section within two (2) weeks of the survey date.

6. (9)

   1. (A) An out-of-state hospital shall be surveyed under the same criteria by which in-state facilities are verified.
   2. (B) However, if the out-of-state applicant is designated as a trauma center in an adjacent state with an established trauma system, the standards of review meet or exceed Arkansas’s standards, and there is no competition for designation at that level, the Trauma Section may use the administrative findings, conclusions, and decisions of the adjacent state’s or ACS’s verification process to make the decision to designate.
   3. (C) Additional information may be requested by the Trauma Section to make a final decision.

   4. (D) Out-of-state facilities wishing to exercise this option shall notify the department Trauma Section at least six (6) months prior to the anticipated site survey.

      1. (d) Certification of an approved trauma center.
7. (1) Upon approval by the Trauma Section of all application requirements as set forth in subsections (a) and (b) of this section, a certificate of trauma center designation shall be issued identifying the facility as an Arkansas-certified provider of trauma care.
8. (2) This certificate shall be enforced for a time period not to exceed three (3) years from the date of issue or, if provisional, shall be reviewed by the end of the one-year provisional period.

(e)

1. (1) Trauma centers are required to notify the Trauma Section of administrative and trauma team staff changes.

2. (2)

   1. (A) Notification of administrative changes include the facility’s president, CEO, COO, and/or administrator.
   2. (B) Trauma centers are required to notify the Trauma Section within thirty (30) days of a status change by submitting the administrative/trauma team staff change notification form.

3. (3)

   1. (A) Notification of trauma team staff changes include the TMD, TPM, and/or registrar.
   2. (B) Trauma centers are required to notify the Trauma Section immediately of a status change by submitting the administrative/trauma team staff change notification form.
4. (4) The Trauma Section reserves the right to perform an on-site evaluation of the facility if the changes are felt to be substantial, may change the commitment to the Trauma Program, or change the clinical or administrative performance of the program.

(f) Denial of trauma center designation. A trauma center’s designation may be denied for, but not limited to, any one (1) of the following reasons:

1. (1) Failure to comply with applicable sections within this part and/or the Rules for Hospitals and Related Institutions in Arkansas, 20 CAR pt. 41;
2. (2) Failure to provide care consistent with the facility’s capability and capacity;
3. (3) Willful preparation or filing of false reports or records;
4. (4) Fraud or deceit in obtaining or attempting to obtain designation status;
5. (5) Failure to submit data to the trauma registry as described in 20 CAR § 80-901 et seq.;
6. (6) Failure to have appropriate staff or equipment required for designation as described in 20 CAR § 80-501 et seq., and 20 CAR § 80-601 et seq., as applicable;
7. (7) Unauthorized disclosure of medical or other confidential information;
8. (8) Alteration or inappropriate destruction of medical records; or

9. (9) Refusal to render care because of a patient’s:

   1. (A) Race;
   2. (B) Ethnicity;
   3. (C) Sex;
   4. (D) Creed;
   5. (E) National origin;
   6. (F) Sexual preference;
   7. (G) Gender identity;
   8. (H) Age;
   9. (I) Disability;
   10. (J) Medical problem; or
   11. (K) Inability to pay.