Review these rules and amend rule language as necessary to ensure that all rules conform to statutory requirements, delete unnecessary and obsolete language and update reference material.

 

DEPARTMENT OF HEALTH

Division of Emergency Preparedness and Community Support

RULE NO.:RULE TITLE:

64J-2.006Trauma Registry and Trauma Quality Improvement Program

64J-2.007Trauma Agency Formation, Continuation, and Plan Requirements

64J-2.008Trauma Agency Plan Approval and Denial Process

64J-2.009Trauma Agency Implementation and Operations Requirements

64J-2.019Funding for Verified Trauma Centers

64J-2.020Acute Care Hospital Trauma Registry

PURPOSE AND EFFECT: Review these rules and amend rule language as necessary to ensure that all rules conform to statutory requirements, delete unnecessary and obsolete language and update reference material.

SUMMARY: Proposed changes are related to terminology clarification, revised document updates, and reduction in duplicative statutory language.

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: 395.401(2), 395.405, 401.35 FS.

LAW IMPLEMENTED: 395.401, 395.4015, 395.402, 395.4025, 395.403, 395.4036, 395.404, 395.4045 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 THIS RULE IS:  Susan Bulecza, DNP, RN, PHCNS-BC, Trauma Program Administrator, 4052 Bald Cypress Way, Bin #A20, Tallahassee, Florida 32399-1722

 

THE FULL TEXT OF THE PROPOSED RULES ARE:

 

64J-2.006 Trauma Registry and Trauma Quality Improvement Program.

(1) The Florida Trauma Registry Manual, Data Dictionary January 1, 2016 edition is an extention of the ACS NTDB National Trauma Data Standard: Data Dictionary 2016 Admissions, Release date July, 2015, which is incorporated by reference and available from the American College of Surgeons at http://www.ntdsdictionary.org/dataElements/datasetDictionary.html. Instructions for completing and submitting data are defined in the Florida Trauma Registry Manual, and  Data Dictionary January 1, 2016 edition January 2014, which is incorporated by reference and available from the department, as defined by subsection 64J-2.001(4), F.A.C., or at http://www.flrules.org/Gateway/reference.asp?No=Ref-03327.

(2) Level I and Level II verified trauma centers must maintain participation in the American College of Surgeons Trauma Quality Improvement Program. PROPOSED EFFECTVE DATE: January 1, 2016.

Rulemaking Authority 395.401(2), 395.405 FS. Law Implemented 395.401(2), 395.4025(9), 395.404 FS. History–New 8-3-88, Amended 12-10-92, 11-30-93, Formerly 10D-66.103, Amended 7-14-99, 11-19-01, 6-3-02, 6-9-05, 4-25-06, 7-8-08, Formerly 64E-2.018, Amended 11-5-09, 1-1-14, 7-1-14, Amended_______.

 

64J-2.007 Trauma Agency Formation, Plan Approval and Denial Process Continuation, and Plan Requirements.

(1) The geographic boundaries of To form a regional trauma agency service area , a county or counties (if regional), or an entity with which the county or counties contract for the purpose of trauma service administration shall: shall be consistent with boundaries of a trauma region as defined in section 395.4015 Florida Statutes.

(a) Obtain formal authority to create the agency from the county commission of each of the counties in which the agency plans to operate.

(b) Establish interlocal agreements between county governments if the proposed agency shall provide service to more than one county.

(2) To form a trauma agency, an entity shall demonstrate compliance with the requirements of section 395.401 (1), Florida Statutes by submitting an application to the department. For the formation and for continuation of a trauma agency, a county or counties, or an entity with which the county or counties contract for the purpose of trauma agency service administration, shall submit a trauma agency plan initially and an update at five-year intervals thereafter to the department for approval. Prior to the submission of the trauma agency plan or five-year plan update to the department, the county or counties, an entity with which the county or counties contract or the existing trauma agency shall:

(a) Hold a public hearing at least 60 days prior to the submission of the plan to the department, and give adequate notice of the hearing to the public in the defined geographic area to be served by the trauma agency. Adequate notice shall consist of publishing the notice, at least 30 days prior to the public hearing, in at least one newspaper of general circulation in each affected county. If a newspaper is not published in a county in which the trauma agency shall operate, adequate notice may be given by publishing the notice in at least one newspaper of general circulation in adjoining affected counties.

(b) Develop and submit an electronic copy of the trauma agency plan or five-year plan update to the department for review and approval.

(3) The department shall, within 30 days of receipt of the initial trauma agency application or update, review the trauma agency’s trauma system plan and notify the trauma agency that the plan is complete, or that there are omissions. If there are omissions, the department shall request the required additional information to be submitted by the trauma agency.

(3) The trauma agency initial plan or five-year plan update shall contain the following information in the following order:

(a) Table of Contents;

(b) Population and Geographic Area to be Served.

1. Describe the population and defined geographic area to be served by the trauma agency;

2. Include a map showing the defined geographic area of the trauma agency, each major geographical barrier, all medical facilities, all prehospital ground and air facilities, and all other significant factors that affect the determination of the geographic area boundaries; and

3. Describe the historical patient flow, patient referral, and transfer patterns used to define the geographic areas of the trauma agency.

(c) Organizational Structure:

1. Provide a detailed description of the managerial and administrative structure of the proposed agency;

2. Include a table of organization, the names of the board of directors and each member’s affiliation, and identify the individuals who will administer or operate the trauma agency, if known;

3. Provide the names, job descriptions and responsibilities of officials who shall be directly responsible for trauma agency personnel, and the names, job descriptions and responsibilities of individuals who shall be responsible for managing and operating the trauma agency on a daily basis; and

4. Describe in detail the specific authority that trauma agency personnel shall have in directing the operation of prehospital and hospital entities within the purview of the trauma agency, if approved, be it a single or multi-county trauma agency.

(d) Trauma System Structure:

1. Describe the operational functions of the system; the components of the system; the integration of the components and operational functions; and the coordination and integration of the activities and responsibilities of trauma centers, hospitals, and prehospital EMS providers; and

2. Include a list of all participating and non-participating trauma care resources within the defined geographical area of the trauma agency and documentation showing that these entities have been given the opportunity to participate in the system. Trauma care resources shall include, but are not limited to, hospitals, trauma centers, EMS providers, training centers, emergency medical dispatch, and planning entities; and

3. Include the trauma agency’s recommendation and justification for the number and location of trauma centers required to serve its defined geographical area.

(e) Objectives, Proposed Actions, and Implementation Schedule. Provide a description of the objectives of the plan, a detailed list of the proposed actions necessary to accomplish each objective, and a timetable for the implementation of the objectives and action.

(f) Describe the source of income and anticipated expenses by category for the trauma agency;

(g) Describe the trauma agency’s fiscal impact on the trauma system which includes a description of any increased costs related to providing trauma care.

(h) Transportation System Design:

1. Describe the EMS ground, water, and air transportation system design of the trauma system; and

2. Include trauma patient flow patterns, emergency inter-hospital transfer agreements and procedures, and the number, type, and level of service of the EMS providers within the trauma system.

(i) TTPs:

1. Provide confirmation that existing department-approved TTPs for each EMS provider, within the defined geographical area of the trauma agency, are accurate and shall be adopted by the trauma agency, pending department approval of the plan;

2. A trauma agency may develop uniform TTPs for department approval that shall be adhered to by all EMS providers that serve the geographical area of the trauma agency. If uniform TTPs are submitted to the department for approval, the TTPs shall include the name of each EMS provider that shall operate according to the uniform TTPs, and proof of consultation with each EMS provider’s medical director. TTPs developed and submitted by a trauma agency shall be processed in accordance with Rule 64J-2.003, F.A.C.; and

3. The trauma agency shall provide a copy of any county ordinance governing the transport of trauma patients within the defined geographic area of the trauma agency.

(j) Medical Control and Accountability. Identify and describe the qualifications, responsibilities and authority of individuals and institutions providing off-line (system) medical direction and on-line (direct) medical control of all hospitals and EMS providers operating under the purview of the trauma agency.

(k) Emergency Medical Communications:

1. Describe the EMS communication system within the trauma agency’s trauma service area; and

2. Verify that the existing communications within the trauma agency’s trauma service area meet all the requirements for compliance with the Florida Emergency Medical Services Communications Plan, Volume I – March 2004 and Volume II – July 2008, to include all hospitals with emergency departments. The Florida Emergency Medical Services Communications Plan (Volumes I and II) is incorporated by reference and a copy of the document can be obtained by mail from the Department of Management Services, Division of Telecommunications, 4030 Esplanade Way, Suite 180, Tallahassee, Florida 32399; or electronically through the following web link: http://dms.myflorida.com/suncom/public_safety/radio_communications/ radio_communication_plans.

(l) Data Collection. Describe the trauma data management system developed for the purpose of documenting and evaluating the trauma systems operation.

(m) Trauma System Evaluation. Describe the methodology by which the trauma agency shall evaluate the trauma system.

(n) Mass Casualty and Disaster Plan Coordination. Describe the trauma agency’s role with local and/or regional emergency management entities in the coordination of the prehospital and hospital component’s mass casualty and disaster plan for the defined geographic area it represents.

(o) Public Information and Education. Describe the trauma agency’s programs designed to increase public awareness of the trauma system and public education programs designed to prevent, reduce the incidence of, and care for traumatic injuries within the defined geographic area it represents.

(p) Attachments. Include the following:

1. A sample of each type of contract and agreement entered into by the trauma agency for the benefit and operation of the trauma system. A description of these agreements may be substituted.

2. Documentation showing that the county commission of the county or counties in the geographic area to be served by the trauma agency have endorsed the initial plan or five-year plan update, pending department approval of the same; and

3. A copy of the public hearing notice and minutes of the hearing for the initial plan or five-year plan update.

(4) The trauma agency shall submit the requested additional information to the department within 30 days of receipt of the notice of omissions.

(5) The department shall deem the plan complete upon receipt of the additional information or the expiration of the 30-day time period, whichever occurs first.

(6) The department shall review the plan to determine compliance with Chapter 395, Florida Statutes, within 60 days of receipt of the additional information or of the plan being deemed complete and notify the applicant of the department’s approval or denial of the plan.

Rulemaking Specific Authority 395.401, 395.405, 401.35 FS. Law Implemented 395.401, 395.40 ,395.402, 395.4025, 395.405, 401.35 FS. History–New 8-3-88, Amended 12-10-92, Formerly 10D-66.104, Amended 11-24-02, 6-9-05, Formerly 64E-2.019, Amended 3-25-09,_____.

 

64J-2.008 Trauma Agency Plan Approval and Denial Process.

Rulemaking Specific Authority 395.401, 395.405, 401.35 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.405, 401.35 FS. History–New 8-3-88, Amended 12-10-92, Formerly 10D-66.106, Amended 11-24-02, Formerly 64E-2.020, Amended 3-25-09, Repealed________.

 

64J-2.009 Trauma Agency Implementation and Operation Requirements.

(1) To implement a trauma system, a department-approved trauma agency shall:

(a) Implement the trauma system in accordance with its department-approved planned timetable for implementation.

(b) Submit proposed changes to the department-approved plan to the department for approval, as provided in Rule 64J-2.008, F.A.C. The trauma agency may, at its own risk, institute proposed changes to the plan and submit a request for department approval within 30 days after a change is instituted if a delay in approval would have an adverse impact on the current level of care. The trauma agency’s request shall explain how the delay in approval would have adversely affected the current level of care. Each request shall document that affected trauma care resources within the defined geographical area of the agency concur with these proposed changes.

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

(a) Conduct reviews of trauma center applications from any hospital within the defined geographic area of the trauma agency. Submission of a trauma center’s application to the trauma agency by a hospital seeking approval shall be in accordance with the time frames described in paragraph 64J-2.012(1)(c), F.A.C. The department will coordinate the prospective trauma center’s application development and review process with the relevant trauma agency to facilitate sufficient time to increase familiarity with the application and conduct the final review. 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.

(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. The trauma agency annual report shall be submitted by May 1 following the end of the previous calendar year. This evaluation shall include at least the following:

1. Description of any funding sources and any other related issues, such as: the fiscal impact on the trauma agency’s system, including increased costs related to providing trauma care, the reduction or increase in budget or human resources, specialty physician coverage, etc.

2. Description of whether Documentation that all trauma centers in the geographic area of the trauma agency participate in the trauma agency’s quality assurance and improvement activities.

3. through 5. No change

(2) Trauma agencies shall every five years submit to the department for approval an updated plan in accordance with section 395.401(1)(n) Florida Statutes.

(3) Each trauma agency shall have personnel or arrange for management service personnel with clear authority and responsibility to operate the trauma agency. The administrative function of the trauma agency shall not be carried out or performed under the direct supervision of any individual who administers or operates any health care entity in the trauma system, whether a single or multi-county system.

Rulemaking Specific Authority 395.401, 395.405, 401.35 FS. Law Implemented 395.401, 395.4015, 395.402, 395.4025, 395.405, 401.35 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,_________.

 

64J-2.019 Funding for Verified Trauma Centers.

(1) For purposes of Sections 318.14, 318.18 and 395.4036, F.S., and this rule, in addition to those terms defined by in the Florida Trauma Registry Manual, February 2008, (see Rule 64J-2.006, F.A.C.) and elsewhere in these rules, the following definitions also apply:

(a)  No change.

(b) “Certified trauma center”, “Vverified trauma center” and “trauma center” – all means mean a Level I, Level II or Pediatric Verified Trauma Center not operating as a provisional trauma center.

(c) “Caseload volume”, “trauma caseload volume”, and “volume of trauma cases” – all mean the number of verified trauma patients served by a trauma center during a calendar year, after 2004, on whom data timely supplied by the trauma center to the trauma registry satisfies the Florida Trauma Registry Manual, February 2008, reporting requirements for determining trauma caseload volume (see page 6 of the manual).

(c) (d) No change.

(e) “Public hospital” – means a hospital licensed under Chapter 395, Part I, F.S., which is owned by a state or local government, or local healthcare tax district.

(d) (f)  No change

(g) “Verified Trauma Patient” means a patient treated at a state verified certified trauma center with at least one ICD-9-CM discharge diagnosis between 800 and 959.9 with a Survival Risk Ratio (SRR) <1 whose data is used by the trauma registry to determine caseload volume. SRRs for each diagnosis code will be determined from analysis of data in the trauma registry by the Department consistent with ICISS and shall be published by the Department.

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

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

(a) No change.

(b) Funds collected under Section 318.14(5), F.S., governed under this rule 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 Section 318.18(15), 316.0083(1)(b)3.a. and 316.003(1)(b)3.b., F.S., governed under this rule and deposited in accordance with Section 395.4036(1), F.S., shall be distributed as follows:

1. To each verified trauma center in a region receiving a local funding contribution as of December 31 of the previous year: (.2 x funds) x (Trauma caseload volume for the verified trauma center for the year/The sum of trauma caseload volume for the year for all verified trauma centers receiving funding under subparagraph (2)(c)1. of this rule).

2. To each verified trauma center: (.4 x funds) x (Trauma caseload volume of the verified trauma center during the year/The sum of trauma caseload volume for all verified trauma centers during the year).

3. To each verified trauma center: (.4 x funds) x (The total number of severe injury patients served by the verified trauma center for the year/The total number of all severe injury patients served by all verified trauma centers for the year).

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

1. To each Level II trauma center operated by a public hospital that provides an attestation certifying that the hospital is governed by an elected board of directors as of December 31, 2008:

(.30 x funds). 

2. To each verified trauma center: (.35 x funds) x (Trauma caseload volume of the verified trauma center during the year/The sum of trauma caseload volume for all verified trauma centers during the year).

3. To each verified trauma center: (.35 x funds) x (The total number of severe injury patients served by the verified trauma center for the year/The total number of all severe injury patients served by all verified trauma centers for the year).

(3) No change.

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,________.

 

64J-2.020 Acute Care Hospital Trauma Registry.

Each hospital as defined by Section 395.002(12), F.S., except for a long term care hospital as defined in Section 408.032, F.S., shall document and submit to the department patient care data in accordance with the format and time frame specified in the Florida Acute Care Trauma Registry Manual Data Dictionary, January 1, 2016 edition 2014, which is incorporated by reference and available from the department, or at _____DOS link________.

PROPOSED EFFECTIVE DATE: January 1, 2016.

Rulemaking Authority 395.405 FS. Law Implemented 395.404 FS. History‒New 6-17-14., Amended,_______.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Susan Bulecza, DNP, RN, PHCNS-BC, Trauma Program Administrator.

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: John H. Armstrong, M.D., FACS.

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 31, 2015.

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 13, 2015.