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House Bill 0895c1

Florida House of Representatives - 1997 CS/HB 895 By the Committee on Health Care Standards & Regulatory Reform and Representatives Dawson-White, Lippman, Casey, Thrasher, Miller, Jones, Healey, Arnall and Peaden 1 A bill to be entitled 2 An act relating to trauma centers; amending s. 3 395.402, F.S.; providing legislative 4 recognition of pediatric trauma referral 5 centers; providing legislative intent regarding 6 factors to be considered in devising planning 7 guidelines; prescribing the number and types of 8 patients to be treated at pediatric trauma 9 referral centers; amending s. 395.4025, F.S.; 10 providing for the selection of state-approved 11 trauma centers and pediatric trauma referral 12 centers; revising procedures for renewing 13 verification; requiring the formation of a task 14 force on pediatric trauma; providing for 15 membership, duties, and responsibilities of the 16 task force members; requiring a report to the 17 Legislature; providing an effective date. 18 19 Be It Enacted by the Legislature of the State of Florida: 20 21 Section 1. Subsections (1) and (2) of section 395.402, 22 Florida Statutes, are amended, subsection (3) is renumbered as 23 subsection (4), and a new subsection (3) is added to said 24 section, to read: 25 395.402 Trauma service areas; number and location of 26 trauma centers.-- 27 (1) The Legislature finds that it is appropriate to 28 recognize as a trauma patient someone with an injury severity 29 score (ISS) of 9 or greater. The Legislature also recognizes 30 that Level I and Level II trauma centers and pediatric trauma 31 referral centers should each be capable of annually treating a 1 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 minimum of 1,000, and 500, and 150 patients, respectively, 2 with an injury severity score of 9 or greater. Further, the 3 Legislature finds that, based on the numbers and locations of 4 trauma victims with these injury severity scores, there should 5 be 19 trauma service areas in the state, and, at a minimum, 6 there should be at least one trauma center in each service 7 area. 8 (2) It is the intent of the Legislature that, as a 9 planning guideline, Level I and Level II trauma centers and 10 pediatric trauma referral centers should generally each 11 provide care annually to approximately a minimum of 1,000, and 12 500, and 150 patients, respectively, as provided in subsection 13 (1). It is the further intent of the Legislature that, as a 14 planning guideline, factors such as geography, relative 15 population density, and other factors that ensure access to 16 trauma care may be considered. Level II trauma centers in 17 counties of more than 500,000 population are expected to be 18 able to care for 1,000 patients per year, as a planning 19 guideline. 20 (3) For purposes of subsections (1) and (2), adult 21 patients who are treated at a Level I or Level II trauma 22 center may not be considered to be pediatric trauma patients. 23 Section 2. Subsections (1), (2), (4), (6), and (13) of 24 section 395.4025, Florida Statutes, 1996 Supplement, are 25 amended, subsections (7) through (13) are renumbered as 26 subsections (8) through (14), respectively, and a new 27 subsection (7) is added to said section, to read: 28 395.4025 Selection of state-approved trauma centers.-- 29 (1) For purposes of developing a system of 30 state-approved trauma centers, the department shall use the 19 31 trauma service areas established in s. 395.402. Within each 2 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 service area and based on the state trauma system plan, the 2 local or regional trauma services system plan, recommendations 3 of the local or regional trauma agency, and the 1990 Report 4 and Proposal for Funding State-Sponsored Trauma Centers, the 5 department shall establish the approximate number of 6 state-approved trauma centers needed to ensure reasonable 7 access to high-quality trauma services. Using the guidelines 8 and procedures outlined in the 1990 report, except when in 9 conflict with those prescribed in this section, or when in 10 conflict with the local or regional trauma agency plan as 11 approved by the department, the department shall select those 12 hospitals that are to be recognized as state-approved trauma 13 centers and shall include all trauma centers verified as of 14 October 1, 1990, and subsequently, subject to specific 15 programmatic and quality of care standards. 16 (2)(a) The department shall annually notify each acute 17 care general hospital and each local and each regional trauma 18 agency in the state that the department is accepting letters 19 of intent from hospitals that are interested in becoming 20 state-approved trauma centers. In order to be considered by 21 the department, a hospital that operates within the geographic 22 area of a local or regional trauma agency must submit written 23 certification by the local or regional trauma agency that the 24 verification of the hospital as a Level I or Level II trauma 25 center or as a pediatric trauma referral center, together with 26 its letter of intent, certify that its intent to operate as a 27 state-approved trauma center is consistent with the trauma 28 services plan of the local or regional trauma agency, as 29 approved by the department, if such agency exists. Letters of 30 intent must be submitted to the department and to the local or 31 regional trauma agency, if one exists, and must be postmarked 3 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 no later than midnight October 1 of the year in which the 2 letter of intent is filed. The department may not consider the 3 letter of intent or application of any hospital that has not 4 timely filed both a letter of intent and a written 5 confirmation of consistency with the local or regional agency 6 plan as required by this section. This paragraph does not 7 apply to any hospital that is a provisional or verified trauma 8 center on January 1, 1992. 9 (b) By October 15, the department shall send to all 10 hospitals that submitted a letter of intent an application 11 package that will provide the hospitals with instructions for 12 submitting information to the department for selection as a 13 state-approved trauma center. The standards for verification 14 of trauma centers and pediatric trauma referral centers 15 provided for in s. 395.401(3), as adopted by rule of the 16 department, shall serve as the basis for these instructions. 17 (c) In order to be considered by the department, 18 applications from those hospitals seeking selection as 19 state-approved trauma centers or state-approved pediatric 20 trauma referral centers, including those current verified 21 trauma centers that seek to be state-approved trauma centers 22 or state-approved pediatric trauma referral centers, must be 23 received by the department and, for any hospital that operates 24 within the geographic area of a local or regional trauma 25 agency, by the local or regional trauma agency, no later than 26 the close of business on April 1. The department shall conduct 27 a provisional review of each application for the purpose of 28 determining that the hospital's application is complete and 29 that the hospital has the critical elements required for a 30 state-approved trauma center. The local or regional trauma 31 agency shall conduct a preliminary review of the application 4 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 for the purposes of this paragraph and shall submit comments 2 or recommendations to the department no later than the close 3 of business on April 7. In reviewing the application, the 4 department shall consider the comments or recommendations 5 submitted by the local or regional trauma agency. If the 6 department makes a finding of fact or determination regarding 7 the application which is counter to the comments or 8 recommendations submitted by the local or regional trauma 9 agency, the department must provide to the local or regional 10 trauma agency, in writing, its reasons for its findings, item 11 by item. This critical review conducted by the department and 12 by the local or regional trauma agency must will be based on 13 trauma center verification standards and must shall include, 14 but is not be limited to, a review of whether the hospital 15 has: 16 1. Equipment and physical facilities necessary to 17 provide trauma services. 18 2. Personnel in sufficient numbers and with proper 19 qualifications to provide trauma services. 20 3. An effective quality assurance process. 21 4. Submitted written confirmation by the local or 22 regional trauma agency that the verification of the hospital 23 as a state-approved trauma center is consistent with the plan 24 of the local or regional trauma agency, as approved by the 25 department, if such agency exists. This subparagraph applies 26 to any hospital that is not a provisional or verified trauma 27 center on January 1, 1992. 28 29 Any application that is submitted by a hospital that has 30 failed to comply with the requirements of paragraph (a) must 31 5 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 be rejected and may not be considered by the department or by 2 the local or regional trauma agency. 3 (d)1. Notwithstanding other provisions in this 4 section, the department may grant up to an additional 18 5 months to a hospital applicant that is unable to meet all 6 requirements as provided in paragraph (c) at the time of 7 application if the number of applicants in the service area in 8 which the applicant is located is equal to or less than the 9 service area allocation, as provided by rule of the 10 department. An applicant that is granted additional time 11 pursuant to this paragraph shall submit a plan for 12 departmental approval which includes timelines and activities 13 that the applicant proposes to complete in order to meet 14 application requirements. Any applicant that demonstrates an 15 ongoing effort to complete the activities within the timelines 16 outlined in the plan shall be included in the number of 17 state-approved trauma centers at such time that the department 18 has conducted a provisional review of the application and has 19 determined that the application is complete and that the 20 hospital has the critical elements required for a 21 state-approved trauma center. 22 2. Timeframes provided in subsections (1)-(9) (1)-(8) 23 shall be stayed until the department determines that the 24 application is complete and that the hospital has the critical 25 elements required for a state-approved trauma center. 26 (4) Between May 1 and October 1 of each year, the 27 department and, for any hospital that operates within the 28 geographic area of a local or regional trauma agency, the 29 local or regional trauma agency shall conduct an in-depth 30 evaluation of all applications found acceptable in the 31 provisional review. The local or regional trauma agency shall 6 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 conduct an in-depth evaluation of the application and shall 2 submit comments and recommendations to the department no later 3 than the close of business on June 1 of the year in which the 4 application was submitted. In reviewing the application, the 5 department shall consider the comments and recommendations 6 submitted by the local or regional trauma agency. If the 7 department makes a finding of fact or determination regarding 8 the application which is counter to the comments or 9 recommendations submitted by the local or regional trauma 10 agency, the department must provide to the local or regional 11 trauma agency, in writing, its reasons for its findings, item 12 by item. The applications must shall be evaluated against 13 criteria enumerated in the application packages as provided to 14 the hospitals by the department. 15 (6) Based on recommendations from the review team, the 16 department shall select state-approved trauma centers by July 17 1. An applicant for designation as a state-approved trauma 18 center or a state-approved pediatric trauma referral center 19 may request an extension of its provisional status if it 20 submits a corrective action plan to the department. The 21 corrective action plan must demonstrate the ability of the 22 applicant to correct deficiencies noted during the applicant's 23 onsite review conducted by the department between the previous 24 October 1 and June 1. The department may extend the 25 provisional status of an applicant for designation as a 26 state-approved trauma center or a state-approved pediatric 27 trauma referral center through December 31 if the applicant 28 provides a corrective action plan acceptable to the 29 department. The department or a team of out-of-state experts 30 assembled by the department shall conduct an onsite visit on 31 or before November 1 to confirm that the deficiencies have 7 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 been corrected. The provisional state-approved trauma center 2 or the provisional state-approved pediatric trauma referral 3 center is responsible for all costs associated with the onsite 4 visit in a manner prescribed by rule of the department. By 5 January 1, the department must approve or deny the application 6 of any provisional applicant granted an extension. Each 7 state-approved trauma center shall be granted a 7-year 8 verification period during which time it must continue to 9 maintain trauma center verification standards and acceptable 10 patient outcomes as determined by department rule. A 11 verification, unless sooner suspended or revoked, 12 automatically expires 7 years after the date of issuance, but 13 and is renewable upon application for renewal, if the 14 applicant continues to meet prescribed verification standards 15 as prescribed by rule of the department. An application for 16 renewal must be filed with the department at least 90 days 17 before the verification period ends, on forms provided by the 18 department. The forms must be limited to requesting 19 confirmation of the applicant's desire to renew its 20 verification for another 7-year period, and the applicant's 21 certification of continued compliance with trauma center 22 verification standards for trauma center facilities, staffing, 23 equipment, and programs. The timely filing of an application 24 for trauma center verification renewal shall toll the 25 verification period until final agency action is taken on the 26 verification renewal application, so that the applicant can 27 continue operating as a verified trauma center during the 28 department's review of the application and during any 29 administrative hearing held with respect to the verification 30 renewal application. After July 1, 1992, Only those hospitals 31 8 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 selected as state-approved trauma centers may operate as 2 trauma centers. 3 (7) Any time the local or regional trauma agency makes 4 comments or recommendations to the department, and any time 5 the department provides a response to the comments or 6 recommendations made by the local or regional trauma agency, 7 as required by this section, a copy of such shall be provided 8 to the applicant hospital. 9 (14)(13) The department may adopt, by rule, the 10 procedures and process by which it will select state-approved 11 trauma centers. Such procedures and process must be used in 12 annually selecting state-approved trauma centers and must be 13 consistent with subsections (1)-(9) (1)-(8) except in those 14 situations in which it is in the best interest of, and 15 mutually agreed to by, all applicants within a service area 16 and the department to reduce the timeframes. 17 Section 3. Within 60 days after the effective date of 18 this act, the Department of Health shall convene a task force 19 on pediatric trauma. Task force members who are to be 20 appointed by the department must include representatives of 21 health care facilities, emergency medical services providers, 22 and health care practitioners, all of whom have special 23 expertise or experience in the area of pediatric trauma care; 24 representatives of facilities providing trauma care and 25 pediatric referral or transport; representatives from local 26 and regional trauma agencies and health planning councils, and 27 representatives from the Division of Children's Medical 28 Services of the department. Representatives from the Agency 29 for Health Care Administration who have special expertise in 30 health planning, hospital regulation, and children's health 31 care are to be appointed by the Agency for Health Care 9 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 Administration. Consistent with its state planning 2 requirements as provided in s. 395.4015, Florida Statutes, the 3 department shall draft a planning document for pediatric 4 trauma care and shall submit the document to the chairs of the 5 health care and fiscal committees of each house of the 6 Legislature by December 1, 1998. The planning document must 7 address the establishment of minimum pediatric trauma patient 8 case number planning guidelines and must be based on a 9 consideration of other factors relevant to the planning of 10 pediatric trauma care, including, at a minimum: 11 (1) The injury severity level for which pediatric 12 trauma care is required. 13 (2) A proposal for a minimum patient care number 14 planning guideline that is based on a consideration of 15 geographic factors, relative population density of urban and 16 rural areas, and other factors important to ensuring adequate 17 geographic access to care. 18 (3) A proposal for a minimum number or range of 19 numbers of pediatric trauma cases which should be used as a 20 pediatric trauma planning guideline. In arriving at such a 21 number, the task force should consider the number of pediatric 22 trauma cases which should be treated at a pediatric trauma 23 referral center in order to maintain skill proficiencies 24 consistent with high-quality outcomes; to contribute to 25 teaching, research, and education; and to ensure training of 26 future pediatric trauma physicians and other pediatric trauma 27 professional specialists. 28 (4) The acceptable range of elapsed time between the 29 occurrence of pediatric trauma injury and the provision of 30 definitive care. In arriving at the acceptable range of 31 elapsed time, the task force must consider what constitutes 10 CODING: Words stricken are deletions; words underlined are additions. Florida House of Representatives - 1997 CS/HB 895 601-118-97 1 appropriate travel time from accident locations to a pediatric 2 trauma referral center and what constitutes appropriate 3 lengths of time for interfacility transfer between 4 nonpediatric trauma facilities and pediatric trauma referral 5 centers. 6 (5) The existing level of facilities available 7 throughout the state as resources for pediatric trauma care. 8 (6) The appropriate distribution of pediatric referral 9 centers relative to adult trauma centers throughout the state. 10 11 Members of the task force, excluding state employees, shall 12 serve without compensation and without reimbursement for 13 travel expenses. The activities of the task force must be 14 accomplished within existing resources and appropriations. 15 Section 4. This act shall take effect upon becoming a 16 law. 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 11