Florida Senate - 2019                        COMMITTEE AMENDMENT
       Bill No. SB 7078
                              LEGISLATIVE ACTION                        
                    Senate             .             House              

       Appropriations Subcommittee on Health and Human Services
       (Harrell) recommended the following:
    1         Senate Amendment (with title amendment)
    3         Between lines 495 and 496
    4  insert:
    5         Section 9. Present subsections (9) through (12) of section
    6  395.1055, Florida Statutes, are amended, and new subsections
    7  (10), (13), and (14) are added to that section, to read:
    8         395.1055 Rules and enforcement.—
    9         (9) The agency shall establish a pediatric cardiac
   10  technical advisory panel, pursuant to s. 20.052, to develop
   11  procedures and standards for measuring outcomes of pediatric
   12  cardiac catheterization programs and pediatric cardiovascular
   13  surgery programs.
   14         (a) Members of the panel must have technical expertise in
   15  pediatric cardiac medicine, shall serve without compensation,
   16  and may not be reimbursed for per diem and travel expenses.
   17         (b) Voting members of the panel shall include: 3 at-large
   18  members, and 3 alternate at-large members with different program
   19  affiliations, including 1 cardiologist who is board certified in
   20  caring for adults with congenital heart disease and 2 board
   21  certified pediatric cardiologists, neither of whom may be
   22  employed by any of the hospitals specified in subparagraphs 1.
   23  10. or their affiliates, each of whom is appointed by the
   24  Secretary of Health Care Administration, and 10 members, and an
   25  alternate for each member, each of whom is a pediatric
   26  cardiologist or a pediatric cardiovascular surgeon, each
   27  appointed by the chief executive officer of the following
   28  hospitals:
   29         1. Johns Hopkins All Children’s Hospital in St. Petersburg.
   30         2. Arnold Palmer Hospital for Children in Orlando.
   31         3. Joe DiMaggio Children’s Hospital in Hollywood.
   32         4. Nicklaus Children’s Hospital in Miami.
   33         5. St. Joseph’s Children’s Hospital in Tampa.
   34         6. University of Florida Health Shands Hospital in
   35  Gainesville.
   36         7. University of Miami Holtz Children’s Hospital in Miami.
   37         8. Wolfson Children’s Hospital in Jacksonville.
   38         9. Florida Hospital for Children in Orlando.
   39         10. Nemours Children’s Hospital in Orlando.
   41  Appointments made under subparagraphs 1.-10. are contingent upon
   42  the hospital’s maintenance of pediatric certificates of need and
   43  the hospital’s compliance with this section and rules adopted
   44  thereunder, as determined by the Secretary of Health Care
   45  Administration. A member appointed under subparagraphs 1.-10.
   46  whose hospital fails to maintain such certificates or comply
   47  with standards may serve only as a nonvoting member until the
   48  hospital restores such certificates or complies with such
   49  standards. A voting member may serve a maximum of two 2-year
   50  terms and may be reappointed to the panel after being retired
   51  from the panel for a full 2-year term.
   52         (c) The Secretary of Health Care Administration may appoint
   53  nonvoting members to the panel. Nonvoting members may include:
   54         1. The Secretary of Health Care Administration.
   55         2. The Surgeon General.
   56         3. The Deputy Secretary of Children’s Medical Services.
   57         4. Any current or past Division Director of Children’s
   58  Medical Services.
   59         5. A parent of a child with congenital heart disease.
   60         6. An adult with congenital heart disease.
   61         7. A representative from each of the following
   62  organizations: the Florida Chapter of the American Academy of
   63  Pediatrics, the Florida Chapter of the American College of
   64  Cardiology, the Greater Southeast Affiliate of the American
   65  Heart Association, the Adult Congenital Heart Association, the
   66  March of Dimes, the Florida Association of Children’s Hospitals,
   67  and the Florida Society of Thoracic and Cardiovascular Surgeons.
   68         (d) The panel shall meet biannually, or more frequently
   69  upon the call of the Secretary of Health Care Administration.
   70  Such meetings may be conducted telephonically, or by other
   71  electronic means.
   72         (e) The duties of the panel include recommending to the
   73  agency standards for quality of care, personnel, physical plant,
   74  equipment, emergency transportation, and data reporting for
   75  hospitals that provide pediatric cardiac services.
   76         (f) Beginning on January 1, 2020, and annually thereafter,
   77  the panel shall submit a report to the Governor, the President
   78  of the Senate, the Speaker of the House of Representatives, the
   79  Secretary of Health Care Administration, and the State Surgeon
   80  General. The report must summarize the panel’s activities during
   81  the preceding fiscal year and include data and performance
   82  measures on surgical morbidity and mortality for all pediatric
   83  cardiac programs.
   84         (g) Members of the panel are immune from any civil or
   85  criminal liability for events resulting from their good faith
   86  performance of duties assigned to them by the Secretary of
   87  Health Care Administration.
   88         (10) The Secretary of Health Care Administration shall
   89  consult the pediatric cardiac technical advisory panel for an
   90  advisory recommendation on all certificate of need applications
   91  to establish pediatric cardiac surgical centers.
   92         (11)(10) Based on the recommendations of the pediatric
   93  cardiac technical advisory panel in subsection (9), the agency
   94  shall adopt rules for pediatric cardiac programs which, at a
   95  minimum, include:
   96         (a) Standards for pediatric cardiac catheterization
   97  services and pediatric cardiovascular surgery including quality
   98  of care, personnel, physical plant, equipment, emergency
   99  transportation, data reporting, and appropriate operating hours
  100  and timeframes for mobilization for emergency procedures.
  101         (b) Outcome standards consistent with nationally
  102  established levels of performance in pediatric cardiac programs.
  103         (c) Specific steps to be taken by the agency and licensed
  104  facilities when the facilities do not meet the outcome standards
  105  within a specified time, including time required for detailed
  106  case reviews and the development and implementation of
  107  corrective action plans.
  108         (12)(11) A pediatric cardiac program shall:
  109         (a) Have a pediatric cardiology clinic affiliated with a
  110  hospital licensed under this chapter.
  111         (b) Have a pediatric cardiac catheterization laboratory and
  112  a pediatric cardiovascular surgical program located in the
  113  hospital.
  114         (c) Have a risk adjustment surgical procedure protocol
  115  following the guidelines established by the Society of Thoracic
  116  Surgeons.
  117         (d) Have quality assurance and quality improvement
  118  processes in place to enhance clinical operation and patient
  119  satisfaction with services.
  120         (e) Participate in the clinical outcome reporting systems
  121  operated by the Society of Thoracic Surgeons and the American
  122  College of Cardiology.
  123         (13)(a) The Secretary of Health Care Administration may
  124  request announced or unannounced site visits to any existing
  125  pediatric cardiac surgical center or facility seeking licensure
  126  as a pediatric cardiac surgical center through the certificate
  127  of need process, to ensure compliance with this section and
  128  rules adopted hereunder.
  129         (b) At the request of the Secretary of Health Care
  130  Administration, the pediatric cardiac technical advisory panel
  131  shall recommend in-state physician experts to conduct an on-site
  132  visit. The Secretary may also appoint up to two out-of-state
  133  physician experts.
  134         (c) A site visit team shall conduct an on-site inspection
  135  of the designated hospital’s pediatric medical and surgical
  136  programs, and each member shall submit a written report of his
  137  or her findings to the panel. The panel shall discuss the
  138  written reports and present an advisory opinion to the Secretary
  139  of Health Care Administration which includes recommendations and
  140  any suggested actions for correction.
  141         (d) Each on-site inspection must include all of the
  142  following:
  143         1. An inspection of the program’s physical facilities,
  144  clinics, and laboratories.
  145         2. Interviews with support staff and hospital
  146  administrators.
  147         3.A review of:
  148         a. Randomly selected medical records and reports,
  149  including, but not limited to, advanced cardiac imaging,
  150  computed tomography, magnetic resonance imaging, cardiac
  151  ultrasound, cardiac catheterization, and surgical operative
  152  notes.
  153         b.The program’s clinical outcome data submitted to the
  154  Society of Thoracic Surgeons and the American College of
  155  Cardiology pursuant to s. 408.05(3)(k).
  156         c.Mortality reports from cardiac-related deaths that
  157  occurred in the previous year.
  158         d. Program volume data from the preceding year for
  159  interventional and electrophysiology catheterizations and
  160  surgical procedures.
  161         (14) The Surgeon General shall provide quarterly reports to
  162  the Secretary of Health Care Administration consisting of data
  163  from the Children’s Medical Services critical congenital heart
  164  disease screening program for review by the advisory panel.
  165         (15)(12) The agency may adopt rules to administer the
  166  requirements of part II of chapter 408.
  168  ================= T I T L E  A M E N D M E N T ================
  169  And the title is amended as follows:
  170         Between lines 73 and 74
  171  insert:
  172         395.1055, F.S.; authorizing the reimbursement of per
  173         diem and travel expenses to members of the pediatric
  174         cardiac technical advisory panel, established within
  175         the Agency for Health Care Administration; revising
  176         panel membership to include certain alternate at-large
  177         members; providing term limits for voting members;
  178         providing immunity from civil and criminal liabilities
  179         to members of the panel; requiring the Secretary of
  180         Health Care Administration to consult the panel for
  181         advisory recommendations on certain certificate of
  182         need applications; authorizing the secretary to
  183         request announced or unannounced site visits to any
  184         existing pediatric cardiac surgical centers or
  185         facilities seeking licensure as a pediatric cardiac
  186         surgical center through the certificate of need
  187         process; providing a process for the appointment of
  188         physician experts to a site visit team; requiring each
  189         member of a site visit team to submit a report to the
  190         panel; requiring the panel to discuss such reports and
  191         present an advisory opinion to the secretary;
  192         providing requirements for an on-site inspection;
  193         requiring the Surgeon General of the Department of
  194         Health to provide specified reports to the secretary;
  195         amending s.