(1) A Montana health care facility that is not currently verified by the American College of Surgeons as meeting the American College of Surgeons' criteria to qualify for verification as a trauma facility and that wishes a designation or renewal of designation as a Montana trauma facility must submit to the department an application for trauma facility designation, supplied by the department.

(2) The application must:

(a) specify the level of designation for which the facility is applying; and

(b) provide information about the facility's compliance with the Montana Trauma Facility Designation Criteria of the State Trauma Plan that are required for that level of trauma facility.

(3) The department will review the application for completeness and within 30 days, after receiving the application, notify the health care facility that:

(a) the application is complete; or

(b) the application is incomplete and request additional information.

(4) When the application is complete, the department will:

(a) select a site review team; and

(b) with a minimum of 60 days advance notice, notify the facility of the scheduled dates for the site survey and of the site review team members.

(5) The health care facility must:

(a) notify the department in writing within ten working days if it objects to one or more members of the site review team due to a perceived conflict of interest, and provide documentation of clear and convincing evidence for its concern including, but not limited to, the member's past or potential financial or personal gain, past or potential employment, or gain from the use of confidential information; and

(b) prohibit its administration, faculty, medical staff, employees, and representatives from having any contact with site review members prior to the site survey, except as directed by the department.

(6) The site review team will:

(a) review the commitment and capabilities of the applicant health care facility to meet the resource criteria described in the Montana Trauma Facility Designation Criteria of the State Trauma Plan for the level of designation sought, based upon consideration of all pertinent information, including:

(i) review of the application for designation;

(ii) inspection of the facility and required equipment;

(iii) interview with appropriate individuals;

(iv) review of medical records;

(v) review of inpatient logs and hospital emergency department logs;

(vi) review of hospital trauma registry entries and reports;

(vii) review of documentation of trauma performance improvement;

(viii) review of call rosters, staffing schedules, and meeting minutes;

(ix) review of injury prevention and education programs; and

(x) other documentation as necessary to assess the facility's compliance with these rules;

(b) make a verbal report of its findings through an exit interview to the applicant upon completion of the site survey and prior to leaving the facility; and

(c) make a written report of its findings and recommendations to the department within 30 days following the on-site survey of the facility.

(7) The department will review the report of the site review team and forward a copy to the designation subcommittee.

(8) The designation subcommittee will review the report of a site review team at the next quarterly State Trauma Care Committee meeting and make a recommendation to the department regarding the trauma designation of the applicant facility.

(9) The department must:

(a) determine the final designation of the facility based on consideration of the application, the recommendations of the site review team, and the recommendations of the designation subcommittee; and

(b) notify the applicant of its decision in writing within 30 days after receiving the recommendation from the designation subcommittee.

(10) The department will take one of the following actions:

(a) designate the applicant as qualifying for the trauma facility level requested, providing there is compliance with the trauma facility resource criteria in the Montana Trauma Facility Designation Criteria of the State Trauma Plan;

(b) issue a provisional designation to the applicant provided:

(i) there are deficiencies noted but the facility is substantially compliant with the resource criteria and any deficiencies will not have an immediate detrimental impact on trauma patient care; and

(ii) the applicant has submitted to the site review team a corrective action plan, acceptable to the team, for the correction of the identified deficiencies;

(c) designate the applicant as a trauma facility at a different level from that for which the applicant applied, provided that:

(i) the applicant meets all of the requirements of the alternative trauma facility designation level; and

(ii) the applicant agrees to be designated at the alternative trauma facility designation level; or

(d) deny any trauma facility designation if:

(i) there is substantial noncompliance with the requirements; or

(ii) the deficiencies are fundamental or may have an immediate detrimental impact on trauma patient care.