64J-2.016. Site Visits and Approval

(1) As used in this rule, the term “applicant” includes a hospital seeking selection as a trauma center, a current verified trauma center seeking a change or redesignation in status, or a current verified trauma center seeking renewal. Each applicant will receive an on-site evaluation to determine the quality of trauma care and whether the applicant is in substantial compliance with standards published in DHP 150-9, January 2010, Trauma Center Standards, which is incorporated by reference in Rule 64J-2.011, F.A.C.

(2) The on-site evaluation will be conducted by a review team of out-of-state reviewers with knowledge of trauma patient management as evidenced by experience in trauma care at a trauma center approved by the governing body of the state in which they are licensed. Prospective out-of-state reviewers must disclose to the department and to the applicant under review any conflict of interest that may affect or be perceived to affect their findings.

(3) All applicants will receive a site visit no later than one year following the submission of a renewal application or beginning operations as a trauma center. Applicants that submit a completed Trauma Center Application to Renew, Form DH 2032R, more than 14 months before expiration of the current certification will receive an initial on-site survey not less than 100 days from the date the current certification expires.

(4) The reviewers will assess each applicant’s compliance with the standards published in DHP 150-9, Trauma Center Standards, and the quality of trauma patient care and patient management by direct observation, review of call schedules, patient charts, hospital trauma mortality data, trauma case summaries, and minutes of trauma quality management committee meetings.

(5) Evaluation of the Quality of Trauma Patient Care and Trauma Patient Management:

(a) The reviewers will assess the quality of trauma patient care and the quality of trauma patient management by analyzing each applicant’s trauma patient care and trauma patient outcomes, by reviewing trauma patient charts and by evaluating the effectiveness of the trauma quality management program through reviews of trauma case summaries and minutes of trauma quality management committee meetings.

(b) Evaluations of trauma patient care and trauma patient management will also be conducted using trauma patient data collected from the hospital trauma registry and the Florida Trauma Registry from a period of time between the date that the applicant began operations through the date of the onsite review. Trauma patient data may also be collected from the emergency department patient log, audit filter log, or quality management committee minutes.

(c) Patient charts to be reviewed will be selected by the department from cases meeting the criteria listed in Standard XVIII B.2., published in DHP 150-9, Trauma Center Standards. A minimum of 75 cases will be selected for review. If the case total is less than 75, all cases are subject to review.

(d) Patient charts will be reviewed to identify factors related to negative patient outcome or compromised patient care. When such factors are identified, trauma case reviews by the medical director of the trauma service or the trauma nurse coordinator, as well as minutes of trauma quality management committee meetings, will be reviewed to determine if corrective action was taken by the trauma service and appropriate peer review committees.

(e) Reviewers will study the trauma case reviews and trauma quality management committee meeting minutes to evaluate the overall effectiveness of the quality management program.

(6) The reviewers will rate applicants as either acceptable, acceptable with corrections, or unacceptable. The rating will be based on substantial compliance with the standards published in DHP 150-9, Trauma Center Standards, and upon the performance of each applicant in providing acceptable trauma patient care and trauma patient management which results in acceptable patient outcomes.

(7) The department will notify each applicant by electronic mail to the email address of record for the hospital’s chief executive officer or equivalent of the results of the site visit within 45 days from site visit completion. The department will include in the notice any problems that the applicant was informed of at the conclusion of the department’s site visit. If the applicant desires to provide additional information regarding the results of the site visit to the department to be considered during the final evaluation, the information must be provided in writing and be received by the department within 45 days of the applicant’s receipt of the department’s notice. If the applicant fails to timely respond to the department’s notice, the department will make the final determination of approval or denial based solely on information collected during the site visit.

(8) Site visits will be conducted at any reasonable time at the discretion of the department at any applicant or trauma center by the department staff or reviewers to:

(a) Verify information provided pursuant to subsection (7); and

(b) Ensure each trauma center maintains substantial compliance with trauma center standards, quality of trauma patient care, and quality of trauma patient management.

(9) Section 395.4025(13), F.S., makes confidential and exempt from the provisions of Section 119.07(1), F.S., not only patient care, transport or treatment records and patient care quality assurance proceedings, but also records or reports made or obtained pursuant to Sections 119.07(3)(v), 395.3025(4)(f), 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.404, 395.4045, and 395.405, F.S. The department identifies the confidential and exempt records included within the authority of these laws to be the following:

(a) Patient care, transport or treatment records;

(b) Patient care quality assurance proceedings, records, or reports;

(c) Any site survey instrument of the department, its agents, or surveyors in any form;

(d) Any site survey findings of the department; and,

(e) An applicant’s response to the department’s site survey findings.

Rulemaking Authority 395.401(1), (2), 395.4025, 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS. History–New 8-3-88, Amended 12-10-92, 10-2-94, 12-10-95, Formerly 10D-66.112, Amended 8-4-98, 2-20-00, 6-3-02, 6-9-05, 3-5-08, Formerly 64E-2.028, Amended 11-5-09, 4-20-10, 3-4-20.