Florida Senate - 2019                                    SB 1126
       By Senator Harrell
       25-01272-19                                           20191126__
    1                        A bill to be entitled                      
    2         An act relating to the Pediatric Cardiac Technical
    3         Advisory Panel; amending s. 395.1055, F.S.;
    4         authorizing the reimbursement of per diem and travel
    5         expenses to members of the pediatric cardiac technical
    6         advisory panel, established within the Agency for
    7         Health Care Administration; revising panel membership
    8         to include certain alternate at-large members;
    9         providing term limits for voting members; providing
   10         immunity from civil and criminal liabilities to
   11         members of the panel; requiring the Secretary of
   12         Health Care Administration to consult the panel for
   13         advisory recommendations on certain certificate of
   14         need applications; authorizing the secretary to
   15         request announced or unannounced site visits to any
   16         existing pediatric cardiac surgical centers or
   17         facilities seeking licensure as a pediatric cardiac
   18         surgical center through the certificate of need
   19         process; providing a process for the appointment of
   20         physician experts to a site visit team; requiring each
   21         member of a site visit team to submit a report to the
   22         panel; requiring the panel to discuss such reports and
   23         present an advisory opinion to the secretary;
   24         providing requirements for an on-site inspection;
   25         requiring the Surgeon General of the Department of
   26         Health to provide specified reports to the secretary;
   27         providing an effective date.
   29  Be It Enacted by the Legislature of the State of Florida:
   31         Section 1. Present subsections (9) through (12) of section
   32  395.1055, Florida Statutes, are amended, and new subsections
   33  (10), (13), and (14) are added to that section, to read:
   34         395.1055 Rules and enforcement.—
   35         (9) The agency shall establish a pediatric cardiac
   36  technical advisory panel, pursuant to s. 20.052, to develop
   37  procedures and standards for measuring outcomes of pediatric
   38  cardiac catheterization programs and pediatric cardiovascular
   39  surgery programs.
   40         (a) Members of the panel must have technical expertise in
   41  pediatric cardiac medicine, shall serve without compensation,
   42  and may not be reimbursed for per diem and travel expenses.
   43         (b) Voting members of the panel shall include: 3 at-large
   44  members, and 3 alternate at-large members with different program
   45  affiliations, including 1 cardiologist who is board certified in
   46  caring for adults with congenital heart disease and 2 board
   47  certified pediatric cardiologists, neither of whom may be
   48  employed by any of the hospitals specified in subparagraphs 1.
   49  10. or their affiliates, each of whom is appointed by the
   50  Secretary of Health Care Administration, and 10 members, and an
   51  alternate for each member, each of whom is a pediatric
   52  cardiologist or a pediatric cardiovascular surgeon, each
   53  appointed by the chief executive officer of the following
   54  hospitals:
   55         1. Johns Hopkins All Children’s Hospital in St. Petersburg.
   56         2. Arnold Palmer Hospital for Children in Orlando.
   57         3. Joe DiMaggio Children’s Hospital in Hollywood.
   58         4. Nicklaus Children’s Hospital in Miami.
   59         5. St. Joseph’s Children’s Hospital in Tampa.
   60         6. University of Florida Health Shands Hospital in
   61  Gainesville.
   62         7. University of Miami Holtz Children’s Hospital in Miami.
   63         8. Wolfson Children’s Hospital in Jacksonville.
   64         9. Florida Hospital for Children in Orlando.
   65         10. Nemours Children’s Hospital in Orlando.
   67  Appointments made under subparagraphs 1.-10. are contingent upon
   68  the hospital’s maintenance of pediatric certificates of need and
   69  the hospital’s compliance with this section and rules adopted
   70  thereunder, as determined by the Secretary of Health Care
   71  Administration. A member appointed under subparagraphs 1.-10.
   72  whose hospital fails to maintain such certificates or comply
   73  with standards may serve only as a nonvoting member until the
   74  hospital restores such certificates or complies with such
   75  standards. A voting member may serve a maximum of two 2-year
   76  terms and may be reappointed to the panel after being retired
   77  from the panel for a full 2-year term.
   78         (c) The Secretary of Health Care Administration may appoint
   79  nonvoting members to the panel. Nonvoting members may include:
   80         1. The Secretary of Health Care Administration.
   81         2. The Surgeon General.
   82         3. The Deputy Secretary of Children’s Medical Services.
   83         4. Any current or past Division Director of Children’s
   84  Medical Services.
   85         5. A parent of a child with congenital heart disease.
   86         6. An adult with congenital heart disease.
   87         7. A representative from each of the following
   88  organizations: the Florida Chapter of the American Academy of
   89  Pediatrics, the Florida Chapter of the American College of
   90  Cardiology, the Greater Southeast Affiliate of the American
   91  Heart Association, the Adult Congenital Heart Association, the
   92  March of Dimes, the Florida Association of Children’s Hospitals,
   93  and the Florida Society of Thoracic and Cardiovascular Surgeons.
   94         (d) The panel shall meet biannually, or more frequently
   95  upon the call of the Secretary of Health Care Administration.
   96  Such meetings may be conducted telephonically, or by other
   97  electronic means.
   98         (e) The duties of the panel include recommending to the
   99  agency standards for quality of care, personnel, physical plant,
  100  equipment, emergency transportation, and data reporting for
  101  hospitals that provide pediatric cardiac services.
  102         (f) Beginning on January 1, 2020, and annually thereafter,
  103  the panel shall submit a report to the Governor, the President
  104  of the Senate, the Speaker of the House of Representatives, the
  105  Secretary of Health Care Administration, and the State Surgeon
  106  General. The report must summarize the panel’s activities during
  107  the preceding fiscal year and include data and performance
  108  measures on surgical morbidity and mortality for all pediatric
  109  cardiac programs.
  110         (g) Members of the panel are immune from any civil or
  111  criminal liability for events resulting from the good faith
  112  performance of duties assigned to them by the Secretary of
  113  Health Care Administration.
  114         (10) The Secretary of Health Care Administration shall
  115  consult the pediatric cardiac technical advisory panel for an
  116  advisory recommendation on all certificate of need applications
  117  to establish pediatric cardiac surgical centers.
  118         (11)(10) Based on the recommendations of the pediatric
  119  cardiac technical advisory panel in subsection (9), the agency
  120  shall adopt rules for pediatric cardiac programs which, at a
  121  minimum, include:
  122         (a) Standards for pediatric cardiac catheterization
  123  services and pediatric cardiovascular surgery including quality
  124  of care, personnel, physical plant, equipment, emergency
  125  transportation, data reporting, and appropriate operating hours
  126  and timeframes for mobilization for emergency procedures.
  127         (b) Outcome standards consistent with nationally
  128  established levels of performance in pediatric cardiac programs.
  129         (c) Specific steps to be taken by the agency and licensed
  130  facilities when the facilities do not meet the outcome standards
  131  within a specified time, including time required for detailed
  132  case reviews and the development and implementation of
  133  corrective action plans.
  134         (12)(11) A pediatric cardiac program shall:
  135         (a) Have a pediatric cardiology clinic affiliated with a
  136  hospital licensed under this chapter.
  137         (b) Have a pediatric cardiac catheterization laboratory and
  138  a pediatric cardiovascular surgical program located in the
  139  hospital.
  140         (c) Have a risk adjustment surgical procedure protocol
  141  following the guidelines established by the Society of Thoracic
  142  Surgeons.
  143         (d) Have quality assurance and quality improvement
  144  processes in place to enhance clinical operation and patient
  145  satisfaction with services.
  146         (e) Participate in the clinical outcome reporting systems
  147  operated by the Society of Thoracic Surgeons and the American
  148  College of Cardiology.
  149         (13)(a) The Secretary of Health Care Administration may
  150  request announced or unannounced site visits to any existing
  151  pediatric cardiac surgical centers or facilities seeking
  152  licensure as a pediatric cardiac surgical center through the
  153  certificate of need process, to ensure compliance with this
  154  section and rules adopted hereunder.
  155         (b) At the request of the Secretary of Health Care
  156  Administration, the pediatric cardiac technical advisory panel
  157  shall recommend in-state physician experts to conduct an on-site
  158  visit. The Secretary may also appoint up to two out-of-state
  159  physician experts.
  160         (c) A site visit team shall conduct an on-site inspection
  161  of the designated hospital’s pediatric medical and surgical
  162  programs, and each member shall submit a written report of its
  163  findings to the panel. The panel shall discuss the written
  164  reports and present an advisory opinion to the Secretary of
  165  Health Care Administration which includes recommendations and
  166  any suggested actions for correction.
  167         (d) Each on-site inspection must include all of the
  168  following:
  169         1. An inspection of the program’s physical facilities,
  170  clinics, and laboratories.
  171         2. Interviews with support staff and hospital
  172  administration.
  173         3.A review of:
  174         a. Randomly selected medical records and reports,
  175  including, but not limited to, advanced cardiac imaging,
  176  computed tomography, magnetic resonance imaging, cardiac
  177  ultrasound, cardiac catheterization, and surgical operative
  178  notes.
  179         b.The program’s clinical outcome data submitted to the
  180  Society of Thoracic Surgeons and the American College of
  181  Cardiology pursuant to s. 408.05(3)(k).
  182         c.Mortality reports from cardiac-related deaths that
  183  occurred in the previous year.
  184         d. Program volume data from the preceding year for
  185  interventional and electrophysiology catheterizations and
  186  surgical procedures.
  187         (14) The Surgeon General shall provide quarterly reports to
  188  the Secretary of Health Care Administration consisting of data
  189  from the Children’s Medical Services critical congenital heart
  190  disease screening program for review by the advisory panel.
  191         (15)(12) The agency may adopt rules to administer the
  192  requirements of part II of chapter 408.
  193         Section 2. This act shall take effect July 1, 2019.