Florida Senate - 2021                              CS for SB 362
       By the Committee on Health Policy; and Senator Harrell
       588-02183-21                                           2021362c1
    1                        A bill to be entitled                      
    2         An act relating to pediatric cardiac care; amending s.
    3         395.1055, F.S.; revising requirements for members of
    4         the pediatric cardiac technical advisory panel;
    5         specifying that time spent as an alternate member does
    6         not count toward panel member term limits; revising
    7         the frequency with which the panel must meet;
    8         requiring the panel’s chair and vice chair, in
    9         consultation with the Agency for Health Care
   10         Administration, to develop panel meeting agendas;
   11         requiring a certain annual report composed and
   12         submitted by the panel to be signed by the panel’s
   13         chair and vice chair; extending sovereign immunity to
   14         apply to all individuals who are members of a site
   15         visit review team; requiring pediatric cardiac
   16         programs to include certain cases in the program’s
   17         required surgical volume; authorizing site visit teams
   18         to conduct virtual site inspections during a declared
   19         state of emergency; authorizing the panel to alter
   20         certain requirements for virtual site inspections;
   21         providing that pediatric cardiac surgical centers that
   22         are deemed by the panel to be noncompliant with
   23         certain standards must come into compliance with those
   24         standards within a specified timeframe; authorizing
   25         the panel to make a certain recommendation to the
   26         Secretary of Health Care Administration if a center
   27         does not come into compliance within such timeframe;
   28         authorizing the Secretary for Health Care
   29         Administration to accept or modify the panel’s
   30         recommendations and requiring enforcement of the
   31         agency’s standards accordingly;
   32         requiring certain data submitted by the Surgeon
   33         General to the Secretary of Health Care Administration
   34         to follow specified guidelines and suggestions;
   35         providing an effective date.
   37  Be It Enacted by the Legislature of the State of Florida:
   39         Section 1. Paragraphs (b), (d), (f), and (g) of subsection
   40  (10), paragraph (c) of subsection (13), paragraph (c) of
   41  subsection (14), and subsection (15) of section 395.1055,
   42  Florida Statutes, are amended, and paragraphs (e) and (f) are
   43  added to subsection (14) of that section, to read:
   44         395.1055 Rules and enforcement.—
   45         (10) The agency shall establish a pediatric cardiac
   46  technical advisory panel, pursuant to s. 20.052, to develop
   47  procedures and standards for measuring outcomes of pediatric
   48  cardiac catheterization programs and pediatric cardiovascular
   49  surgery programs.
   50         (b) Voting members of the panel shall include the following
   51  individuals appointed in the following manner:
   52         1.Three 3 at-large members, and three 3 alternate at-large
   53  members, each with different program affiliations, including one
   54  1 cardiologist who is board-certified board certified in caring
   55  for adults with congenital heart disease and two 2 board
   56  certified pediatric cardiologists, none neither of whom may be
   57  employed by any of the hospitals specified in subparagraph 2.
   58  subparagraphs 1.-10. or their affiliates of those hospitals, and
   59  each of whom is appointed by the Secretary of Health Care
   60  Administration.
   61         2.One member, and 10 members, and one an alternate for
   62  each member, from each of the following hospitals, each of whom
   63  is a pediatric cardiologist or a pediatric cardiovascular
   64  surgeon, each appointed by the chief executive officer of their
   65  respective hospital the following hospitals:
   66         a.1. Johns Hopkins All Children’s Hospital in St.
   67  Petersburg.
   68         b.2. Arnold Palmer Hospital for Children in Orlando.
   69         c.3. Joe DiMaggio Children’s Hospital in Hollywood.
   70         d.4. Nicklaus Children’s Hospital in Miami.
   71         e.5. St. Joseph’s Children’s Hospital in Tampa.
   72         f.6. University of Florida Health Shands Hospital in
   73  Gainesville.
   74         g.7. University of Miami Holtz Children’s Hospital in
   75  Miami.
   76         h.8. Wolfson Children’s Hospital in Jacksonville.
   77         i.9. Florida Hospital for Children in Orlando.
   78         j.10. Nemours Children’s Hospital in Orlando.
   79         3. For each member and corresponding alternate member
   80  appointed under subparagraph 2., one must be a pediatric
   81  cardiologist and the other must be a pediatric cardiovascular
   82  surgeon. Appointments made under subparagraph 2. subparagraphs
   83  1.-10. are contingent upon the hospital’s compliance with this
   84  section and rules adopted thereunder, as determined by the
   85  Secretary of Health Care Administration. A member appointed
   86  under subparagraph 2. subparagraphs 1.-10. whose hospital fails
   87  to comply with such standards may serve only as a nonvoting
   88  member until the hospital complies with such standards. A voting
   89  member may serve a maximum of two 2-year terms and may be
   90  reappointed to the panel after being retired from the panel for
   91  a full 2-year term. Time spent serving as an alternate member on
   92  the panel does not count toward a member’s term limits.
   93         (d) The panel shall meet quarterly biannually, or more
   94  frequently upon the call of the Secretary of Health Care
   95  Administration. Such meetings may be conducted telephonically,
   96  or by other electronic means. The chair and vice chair of the
   97  panel, in consultation with the agency, shall develop the
   98  agendas for panel meetings.
   99         (f) Beginning on January 1, 2020, and annually thereafter,
  100  the panel shall compose a report signed by the chair and vice
  101  chair of the panel and submit the a report to the Governor, the
  102  President of the Senate, the Speaker of the House of
  103  Representatives, the Secretary of Health Care Administration,
  104  and the State Surgeon General. The report must summarize the
  105  panel’s activities during the preceding fiscal year and include
  106  data and performance measures on surgical morbidity and
  107  mortality for all pediatric cardiac programs.
  108         (g) Panel members and all members of a site visit review
  109  team are agents of the state for purposes of s. 768.28
  110  throughout the good faith performance of the duties assigned to
  111  them by the Secretary of Health Care Administration.
  112         (13) A pediatric cardiac program shall:
  113         (c) Have a risk adjustment surgical procedure protocol
  114  following the guidelines established by the Society of Thoracic
  115  Surgeons. The program’s cardiac surgical volume must include
  116  cases involving children younger than 18 years of age with any
  117  type of acquired or congenital heart disease and adults with
  118  congenital heart disease. Cases involving open surgical
  119  placement of a pacing wire count toward the surgical volume.
  120         (14)
  121         (c) A site visit team shall conduct an onsite inspection of
  122  the designated hospital’s pediatric medical and surgical
  123  programs, and each member shall submit a written report of his
  124  or her findings to the panel. During a declared state of
  125  emergency, a site visit team may conduct a virtual site
  126  inspection in lieu of an onsite inspection. The panel shall
  127  discuss the written reports and present an advisory opinion to
  128  the Secretary of Health Care Administration which includes
  129  recommendations and any suggested actions for correction.
  130         (e)For virtual site inspections conducted during a
  131  declared state of emergency, the panel may alter the
  132  requirements for the patient-specific data to be reviewed
  133  virtually as appropriate to comply with the Health Insurance
  134  Portability and Accountability Act and other laws governing the
  135  electronic sharing of protected medical information.
  136         (f)Following a site inspection, if the panel deems the
  137  information contained in the submitted reports to establish that
  138  the pediatric cardiac surgical center under inspection is
  139  noncompliant with the agency’s standards for pediatric cardiac
  140  programs, the center has 24 consecutive months to come into
  141  compliance with such standards. If at the end of the 24-month
  142  period, the panel deems the center is still noncompliant with
  143  the standards, the panel may recommend to the Secretary of
  144  Health Care Administration that the center have its license to
  145  perform congenital cardiac surgery revoked. The Secretary of
  146  Health Care Administration may accept or modify the panel’s
  147  recommendations and shall enforce compliance with the agency’s
  148  standards accordingly.
  149         (15) The Surgeon General shall provide quarterly reports to
  150  the Secretary of Health Care Administration consisting of data
  151  from the Children’s Medical Services’ critical congenital heart
  152  disease screening program for review by the advisory panel. Data
  153  submitted must follow the guidelines and suggestions established
  154  by the Cardiac Subcommittee of the Children’s Medical Services’
  155  Genetics and Newborn Screening Advisory Council in consultation
  156  with the panel.
  157         Section 2. This act shall take effect July 1, 2021.