To amend rule language as necessary to ensure that all rules conform to statutory requirements, repeal obsolete rules, delete unnecessary and obsolete language, update references to incorporated material, and implement Florida Session Law 2018-66 ...

 

DEPARTMENT OF HEALTH

Division of Emergency Preparedness and Community Support

RULE NOS.:RULE TITLES:

64J-2.001Definitions

64J-2.009Trauma Agency Implementation and Operation Requirements

64J-2.010Allocation of Trauma Centers Among the Trauma Service Areas (TSAs)

64J-2.013Extension of Application Period

64J-2.015Process for Renewal of Trauma Centers

64J-2.016Site Visits and Approval

64J-2.017Application by Hospital Denied Approval

64J-2.019Funding for Verified Trauma Centers

PURPOSE AND EFFECT: To amend rule language as necessary to ensure that all rules conform to statutory requirements, repeal obsolete rules, delete unnecessary and obsolete language, update references to incorporated material, and implement Florida Session Law 2018-66 related to definitions, trauma service areas, numbers, allocation and selection of trauma centers.

SUMMARY: Proposed changes are related to statutory change, terminology clarification, revised business practices, and reduction in duplicative statutory language. Rules related to trauma center allocation are obsolete due to statutory changes and are therefore repealed. In addition, the statutory changes to the trauma center application and designation process outlined in Section 395.4025, F.S., require the repeal and amendment of related rules in this chapter.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Through its analysis of regulatory costs required as a part of the SERC analysis, the Department has determined this rule will not require legislative ratification pursuant to Section 120.541(3), F.S. No other statute requires legislative ratification for this rule.

Any person who wishes to provide information regarding a statement of estimated regulatory costs or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 395.4001(13), (17), 395.401(1), (2), 395.4025, 395.4036, 395.4045, 395.405 FS.

LAW IMPLEMENTED: 381.0205, 395.1031, 395.3025(4)(f), 395.40(3)-(6), 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.4036, 395.404, 395.4045, 395.405 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Michael Leffler, Trauma Section Manager at [e-mail] or by phone at [phone].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64J-2.001 Definitions.

(1) Abbreviated Injury Score (AIS-90) – means a consensus derived, anatomically based system that classifies individual injuries by body region on a 6-point ordinal severity scale ranging from 1 to 6. The methodology for determining AIS-90 Code is found in the “Abbreviated Injury Scale 1990 – Update 98,” which is incorporated by reference and is available from the Association for the Advancement of Automotive Medicine, P. O. Box 4176, Barrington, IL 60011-4176.

(2) through (6) renumbered (1) through (5) No change.

(7) ICD-9-CM – means the “International Classification of Disease, 9th Revision, Clinical Modification,” March, 1989, U.S. Department of Health and Human Services Publication No. (PHS) 89-1260; an internationally applied method by which diseases or groups of medical conditions or injuries are coded for the purpose of statistical analyses. This book is incorporated by reference and available for purchase from the American Hospital Association, Central Office on ICD-9-DM, 1(800)242-2626, AHA, Post Office Box 92683, Chicago, IL 60675-2683.

(8) through (17) renumbered (6) through (15) No change.

Rulemaking Authority 381.0011(13), 395.4001(13), (17), 395.401(1), (2), 395.4025(7), (9), (10) (13), 395.4036(1), 395.4045(3), (4), (5), (8), 395.405(8), 401.45(5) FS. Law Implemented 381.0205, 395.1031, 395.3025(4)(f), 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.4036, 395.404, 395.4045, 395.405, 401.30, 401.35, 401.45, 765.401 FS. History–New 11-5-09, Amended ________.

 

64J-2.009 Trauma Agency Implementation and Operation Requirements.

(1) Each trauma agency must shall operate the trauma system in accordance with the department-approved plan., and shall:

(2) Each trauma agency must:

(a) Conduct reviews of trauma center applications from any hospital within the defined geographic area of the trauma agency. Results of the trauma agency’s review shall be submitted to the department no later than April 7 of each year, in order to be considered by the department.

(a)(b) Conduct annual performance evaluations and submit annual reports on the status of the trauma agency’s trauma system to the department to be included in the department’s Florida Trauma System annual reports.

(b) Submit tThe trauma agency annual report shall be submitted by May 1 following the end of the previous calendar year, and. This evaluation shall include at least the following:

1. through 5. No change.

(c)(2) Trauma agencies shall every five years Ssubmit to the department every five years for approval an updated plan in accordance with Section 395.401(1)(n), F.S.

Rulemaking Authority 395.401(1), (2), 395.405, 401.35 FS. Law Implemented 395.401, 395.4015, 395.4025, 395.404, 395.4045, FS. History–New 12-10-92, Formerly 10D-66.1065, Amended 8-4-98, 11-19-01, 11-24-02, 6-9-05, Formerly 64E-2.021, Amended 3-25-09, 9-5-16, ________.

 

64J-2.010 Allocation of Trauma Centers Among the Trauma Service Areas (TSAs)

Rulemaking Authority 395.402, 395.405 FS. Law Implemented 395.402 FS. History–New 12-10-92, Formerly 10D-66.1075, Amended 6-9-05, 12-18-06, Formerly 64E-2.022, Amended 7-29-14, Repealed _________.

 

64J-2.013 Extension of Application Period.

Rulemaking Authority 395.405 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS. History–New 12-10-92, Amended 12-10-95, Formerly 10D-66.1095, Amended 8-4-98, 2-20-00, 6-3-02, 6-9-05, 3-5-08, Formerly 64E-2.025, Amended 11-5-09, 4-20-10, Repealed _________.

 

64J-2.015 Process for Renewal of Trauma Centers.

(1) At least 14 months prior to the expiration of the trauma center’s certification, the department will shall send, by electronic mail to the email address of record for the hospital’s chief executive officer or equivalent of each trauma center that is eligible to renew a blank DH Form 2032R, January 2010, Trauma Center Application to Renew, which is incorporated by reference and available at Florida Department of Health, Office of Trauma, 4052 Bald Cypress Way, Bin C-18, Tallahassee, Florida 32399-1738, http://www.floridahealth.gov/licensing-and-regulation/trauma-system/_documents/form-dh-2032R.pdf and at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX from the department, as defined by subsection 64J-2.001(4), F.A.C., in accordance with the provisions of this section. Within 15 calendar days after receipt, the trauma center choosing to renew its certification shall submit to the department Tthe completed DH Form 2032R must be returned to the department via electronic mail or certified mail within 15 days of receipt to apply to renew the certification.

(2) All renewing trauma centers will shall receive an on-site survey after the department’s receipt of the completed DH Form 2032R. The department will shall notify each trauma center of the results of the site survey within 45 30 working days from completion of the site survey. If the trauma center desires to provide additional information regarding the results of the site survey to the department to be considered, the information must be provided in writing and be received by the department within 45 30 calendar days of the trauma center’s hospital’s receipt of the department’s notice. If the trauma center fails elects not to timely respond to the department’s notice within 30 calendar days, the department will shall make the final determination of approval or denial based solely on information collected during the site survey.

(3) No later than At least 45 10 days prior to the expiration of the certification, the department will shall simultaneously notify each trauma center facility in writing of its their approval or denial  by electronic mail to the email address of record for the hospital’s chief executive officer or equivalent to renew. If the department determines that the trauma center meets the requirements for renewal of its trauma center designation approved, the department may issue an approval and renewal certification immediately upon completion of the site survey process as outlined in subsection (2) of this rule. The this renewal certification will shall be for a period of 7 years beginning the day after the current certification expires.

(4) A trauma center which does not desire to be re-approved shall follow the notification provisions of Section 395.4025(8), F.S.

Rulemaking Authority 395.4025, 395.405 FS. Law Implemented 395.401, 395.402, 395.4025, 395.404, 395.4045, 395.405 FS. History–New 8-3-88, Amended 12-10-92, 1-23-96, Formerly 10D-66.111, Amended 3-15-98, 2-20-00, 6-9-05, 3-5-08, Formerly 64E-2.027, Amended 11-5-09, 4-20-10,________.

 

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 Provisional trauma center will shall receive an on-site evaluation to determine the quality of trauma care and whether the applicant hospital 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., and available at Florida Department of Health, Office of Trauma, 4052 Bald Cypress Way, Bin C-18, Tallahassee, Florida 32399-1738, http://www.floridahealth.gov/licensing-and-regulation/trauma-system/_documents/trauma-center-standards-pamphlet.pdf and at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXX from the department, as defined by subsection 64J-2.001(4), F.A.C., and to determine the quality of trauma care provided by the hospital.

(2) The on-site evaluation will 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. 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 Provisional trauma center will shall 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, DH Form 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 between October 1 of each year and June 1 of the following year.

(4) The reviewers will shall assess each applicant’s applicant hospital’s compliance with the standards published in DHP 150-9, Trauma Center Standards, and the quality of trauma patient care and patient management by means of direct observation, review of call schedules, and review of patient charts, hospital. 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 to Standard XVIII of DHP 150-9.

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

(a) The reviewers will assess shall judge the quality of trauma patient care and the quality of trauma patient management in each Provisional trauma center by analyzing each applicant’s 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.

(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 the time between the date that the applicant hospital received provisional trauma center began operations status 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. 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.

(c) Patient charts to be reviewed will shall 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 shall be selected for review in each facility. If the case cases total is less than 75, then all cases are subject to review.

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

(e) Reviewers will shall 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 shall rate applicants a Provisional trauma center which they have reviewed as either acceptable, acceptable with corrections, or unacceptable. The rating will shall be based on each facility’s substantial compliance with the standards published in DHP 150-9, Trauma Center Standards, and upon the performance of each applicant Provisional trauma center in providing acceptable trauma patient care and trauma patient management which results resulted in acceptable patient outcomes.

(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 rule, shall be applied for final selection.

(7)(8)The department will shall notify each applicant Provisional trauma center 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 30 working days from site visit completion of the site visit. The department will shall include in the notice any problems that the applicant Provisional hospital or trauma center was informed of at the conclusion of the department’s site visit in-depth application review. If the applicant 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 45 30 calendar days of the applicant’s hospital’s receipt of the department’s notice. If the applicant Provisional trauma center fails elects not to timely respond to the department’s notice within 30 calendar days, the department will 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.

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

(a) Verify information provided pursuant to subsection (7)(8); and,

(b) No change.

(9)(10) Section 395.4025(123), 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) through (d) No change.

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

(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 64J-2.010(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 64J-2.010(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:

(a) A hospital recommended to be a trauma center in the department-approved local or regional trauma agency plan pursuant to subparagraph 64J-2.007(2)(d)3., F.A.C., shall be given approval preference over any hospital which was not recommended.

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

1. 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,

2. 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,

3. 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.

(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.

(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.

(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.

(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 120.57, F.S.

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,________.

 

64J-2.017 Application by Hospital Denied Approval.

Rulemaking Authority 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, 12-10-95, Formerly 10D-66.113, Amended 2-20-00, 6-9-05, 3-5-08, Formerly 64E-2.029, Amended 11-5-09, 4-20-10, Repealed _______.

 

64J-2.019 Funding for Verified Trauma Centers.

(1)(a) through (b) No change.

(c) “International Classification Injury Severity Score” (ICISS) means a mathematical system of risk stratification based on anatomic diagnosis of trauma patients as initially defined and validated in the following reference: “Osler T, Rutledge R, Deis J, Bedrick E., ICISS: an international classification of disease-9 based injury severity score, Journal of Trauma. 1996 Sep:41(3):380-6; discussion 386-8.” an International Classification of Diseases (ICD)-based multiplicative prediction model that calculates the likelihood of survival of an injured patient based on the assumption that all injuries contribute to the overall severity. The department will calculate the ICISS score for each injured patient in the most recent complete year of the Agency for Health Care Administration's Hospital Discharge Data Set based upon the multiplicative product of all Survival Risk Ratios (SRR) associated with each ICD code listed in the patient’s record.

(d) No change.

(e) “Year” – means the most recent complete calendar year for which trauma caseload volume is available from the Agency for Health Care Administration trauma registry.

(f) As used in this rule, “trauma caseload volume” means all patients treated at trauma centers that are identified as “trauma” in the “Priority of Admission” field in the Agency for Health Care Administration’s Hospital Inpatient Data File.   

(2) Funds governed under this rule will shall be distributed to verified trauma centers in the quarter following deposit into the Ddepartment’s trust funds.

(a) All distribution will shall be consistent with subsection (2), or upon resolution of all relevant administrative and judicial challenges, whichever is later.

(b) Funds collected under Section 318.14(5), F.S., governed under this rule will shall be distributed to the verified trauma centers as follows:

[(.5 x funds)/Current total number of verified trauma centers)] + [(.5 x funds) x (Trauma caseload volume for the verified trauma center for the year/The sum of trauma caseload volume for all verified trauma centers during the year)].

(c) Funds collected under Sections 318.18(15), 316.0083(1)(b)3.a. and 316.0083(1)(b)3.b., F.S., governed under this rule and deposited in accordance with Section 395.4036(1), F.S., will shall be distributed as follows:

1. through 3. No change.

(d) Funds collected under Sections 318.18(5)(c) and (20), F.S., governed under this rule will shall be distributed as follows.

1. through 3. No change.

(3) Hospitals that are not subject to audit pursuant to Section 215.97 F.S., and operate a verified trauma center that receives proceeds under Section 395.4036, F.S., must annually submit to the department an attestation stating the proceeds received by the hospital were used in compliance with Section 395.4036(3)(a), F.S.

Rulemaking Authority 395.4036 FS. Law Implemented 395.4036 FS. History–New 4-25-06, Amended 1-9-07, Formerly 64E-2.040, Amended 10-22-09, 12-22-10, 12-21-15,________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kate Kocevar, Trauma Section Administrator

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Scott Rivkees, MD, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD:  November 20, 2019

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR:  April 15, 2019