64J-2.016. Site Visits and Approval  


Effective on Tuesday, April 20, 2010
  • 1(1) Each Provisional trauma center shall receive an on-site evaluation to determine whether the hospital is in substantial compliance with standards published in DHP 150-9, Trauma Center Standards, which is incorporated by reference in Rule 6437J-2.011, 38F.A.C., 39and available from the department, as defined by subsection 6449J-50251.00152(53454), F.A.C., 56and to determine the quality of trauma care provided by the hospital.

    68(2) The on-site evaluation shall 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

    112(3) All Provisional trauma center shall receive a site visit between October 1 of each year and June 1 of the following year.

    135(4) The reviewers shall assess each applicant hospital’s compliance with the standards published in DHP 150-9, by means of direct observation, review of call schedules, and review of patient charts. Reviewers also shall assess the quality of trauma patient care and trauma patient management by reviewing facility trauma mortality data, by reviewing patient charts and by reviewing trauma case summaries and minutes of trauma quality management committee meetings pursuant 204to Standard XVIII of DHP 150-9210.

    211(5) Evaluation of the Quality of Trauma Patient Care and Trauma Patient Management:

    224(a) The reviewers shall judge the quality of trauma patient care and the quality of trauma patient management in each Provisional trauma center by analyzing each facility’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.

    288(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 the time the hospital received provisional trauma center status through the date of the on-site review. Trauma patient data may also be collected from the emergency department patient log, audit filter log, or quality management committee minutes. The patient population for review shall be selected on the basis of Injury Severity Scores (ISS). The ISS shall be determined using Abbreviated Injury Scaling (AIS-90). If the Provisional trauma center has an in-hospital trauma registry which computes the ISS using the International Classification of Disease, 9th Revision, Clinical Modification (ICD-9-CM), the computer program shall contain AIS-90 as a component of the program.

    418(c) Patient charts to be reviewed shall be selected by the department from cases meeting the criteria listed in Standard XVI439II B.2., published in DHP 150-9445. A minimum of 75 cases shall be selected for review in each facility. If the cases total less than 75, then all cases are subject to review.

    473(d) Patient charts shall 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, shall be reviewed to determine if corrective action was taken by the trauma service and appropriate peer review committees within the facility.

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

    569(6) The reviewers shall rate a Provisional trauma center which they have reviewed as either acceptable, acceptable with corrections, or unacceptable. The rating shall be based on each facility’s substantial compliance with the st603andards published in DHP 150-9, 608and upon the performance of each Provisional trauma center in providing acceptable trauma patient care and trauma patient management which resulted in acceptable patient outcomes.

    633(7) The department shall evaluate the results of the site visit review and the in-depth application review of each Provisional trauma center between June 1 and July 1. All applicant hospitals shall be notified simultaneously of their approval or denial to become a trauma center on or before July 1. The department’s selection will be based on the results of the site visit and the in-depth application review. In those situations in which there are more trauma centers or Provisional trauma centers than available positions in the TSA, the criteria in subsection (11) of this section shall be applied for final selection.

    735(8) The department shall notify each Provisional trauma center of the results of the site visit within 30 working days from completion of the site visit. The department shall include in the notice any problems that the Provisional trauma center was informed of at the conclusion of the department’s in-depth application review. If the Provisional trauma center desires to provide additional information regarding the results of the site visit or in-depth application review to the department to be considered during the final evaluation between June 1 and July 1, the information must be provided in writing and be received by the department within 30 calendar days of the hospital’s receipt of the department’s notice. If the Provisional trauma center elects not to respond to the department’s notice within 30 calendar days, the department shall make the final determination of approval or denial based solely on information collected during the applicant’s site visit and in-depth application review.

    891(9) Site Visits may be conducted at any reasonable time at the discretion of the department at any Provisional trauma center or trauma center by the department staff or reviewers to:

    922(a) Verify information provided pursuant to subsection (8); and

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

    954(10) Section 956395.4025(12), F.S., 958makes confidential and exempt from the provisions of Section 967119.07(1), F.S., 969not only patient care, transport or treatment records and patient care quality assurance proceedings, but also records or reports made or obtained pursuant to Sections 994119.07(3)(v), 995395.3025(4)(f), 996395.401, 997395.4015, 998395.402, 999395.4025, 1000395.403, 1001395.404, 1002395.4045, 1003and 1004395.405, F.S. 1006The department identifies the confidential and exempt records included within the authority of these laws to be the following:

    1025(a) Patient care, transport or treatment records;

    1032(b) Patient care quality assurance proceedings, records, or reports;

    1041(c) Any site survey instrument of the department, its agents, or surveyors in any form;

    1056(d) Any site survey findings of the department; and

    1065(e) A hospital’s response to the department’s site survey findings.

    1075(11) If the number of Provisional trauma centers found eligible for selection by the department in a given TSA exceeds the number permitted, as provided in subsection 641103J-2.0101104(3), F.A.C., the following criteria shall be applied independently and consecutively to all Provisional trauma centers in the TSA until application of the criteria results in the number of trauma centers authorized in subsection 641139J-2.0101140(3), F.A.C., for that TSA. When that occurs, the remaining criteria shall not be considered. The criteria to be applied are as follows:

    1163(a) A hospital recommended to be a trauma center in the department-approved local or regional trauma agency plan pursuant to subparagraph 641185J-2.0071186(2)(d)3., F.A.C., shall be given approval preference over any hospital which was not recommended.

    1200(b) A hospital shall be given selection preference based on the level of service they intend to provide according to the following sequence:

    12231. A Provisional Level I trauma center will be given preference over a Provisional Level II trauma center with pediatrics, a Provisional Level II trauma center, and a Provisional pediatric trauma center;

    12552. A Provisional Level II trauma center with pediatrics will be given preference over a Provisional Level II trauma center and a Provisional pediatric trauma center; and

    12823. A Provisional Level II trauma center will be given preference over a Provisional pediatric trauma center in TSA having only one allocated trauma center position, and in a TSA with more than one allocated trauma center position if there already exists an approved Level I trauma center, Level II trauma center with pediatrics, or a pediatric trauma center, or if in the instant selection process a Level I trauma center, Level II trauma center with pediatrics, or pediatric trauma center is to be selected.

    1367(c) An applicant hospital in a geographic location that is most conducive to access by the greatest number of people to be served within a TSA shall be given preference for selection.

    1399(d) A hospital representing the best geographic distribution with respect to terrain, population served and projected service population in a given TSA shall be given preference for selection.

    1427(e) A hospital which, according to the most recent complete year of Agency for Health Care Administration data, shows a higher level of commitment of care to the service area, as evidenced by the ratio of non-paying to paying patients, shall be given preference for approval.

    1473(12) The department shall inform in writing each Provisional trauma center denied approval as a trauma center of its opportunity to request a hearing in which to contest the denial in accordance with Section 1507120.57, F.S.

    1509Rulemaking 1510Authority 1511395.4025, 1512395.405 FS. 1514Law Implemented 1516395.401, 1517395.4015, 1518395.402, 1519395.4025, 1520395.404, 1521395.4045, 1522395.405 FS. 1524History–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, 15373-5-08, 1538Formerly 153964E-2.028, 1540Amended 11-5-09, 4-20-10.

Rulemaking Events:

Historical Versions(2)

Select effective date to view different version.