Florida Senate - 2016                             CS for SB 1518
       By the Committee on Health Policy; and Senator Grimsley
       588-03240-16                                          20161518c1
    1                        A bill to be entitled                      
    2         An act relating to cardiovascular services; creating
    3         s. 391.224, F.S.; providing legislative findings and
    4         intent; creating the Pediatric Cardiac Advisory
    5         Council; determining the chair of the advisory
    6         council; establishing the membership of the advisory
    7         council; identifying the duties of the advisory
    8         council; setting the minimum qualifications for the
    9         designation of a facility as a Pediatric and
   10         Congenital Cardiovascular Center of Excellence;
   11         requiring a report to the Governor, the Legislature,
   12         and the State Surgeon General; requiring the
   13         Department of Health to develop rules relating to
   14         pediatric cardiac services and facilities in the
   15         Children’s Medical Services Network; authorizing the
   16         department to adopt rules relating to the council and
   17         the designation of facilities as Pediatric and
   18         Congenital Cardiovascular Centers of Excellence;
   19         authorizing and preserving until amended specified
   20         rules relating to pediatric cardiac services and
   21         facilities; amending s. 408.0361, F.S.; expanding
   22         rulemaking criteria for the Agency for Health Care
   23         Administration for licensure of hospitals performing
   24         percutaneous cardiac intervention procedures;
   25         providing an effective date.
   27  Be It Enacted by the Legislature of the State of Florida:
   29         Section 1. Section 391.224, Florida Statutes, is created to
   30  read:
   31         391.224 Pediatric Cardiac Advisory Council.—
   33         (a) The Legislature finds significant benefits in the
   34  continued coordination of activities by several state agencies
   35  regarding access to pediatric cardiac care in this state. It is
   36  the intent of the Legislature that the Department of Health, the
   37  department’s cardiac consultants, and the Agency for Health Care
   38  Administration maintain their long-standing interagency teams
   39  and agreements for the development and adoption of guidelines,
   40  standards, and rules for those portions of the state cardiac
   41  care system within the statutory authority of each agency. This
   42  coordinated approach will continue to ensure the necessary
   43  continuum of care for the pediatric cardiac patient. The
   44  department has the leadership responsibility for this activity.
   45         (b) It is further the intent of the Legislature to
   46  establish the Pediatric Cardiac Advisory Council, a statewide,
   47  inclusive council within the department.
   49         (a) The State Surgeon General shall appoint the Pediatric
   50  Cardiac Advisory Council for the purpose of advising the
   51  department on the delivery of cardiac services to children.
   52         (b) The chair of the council shall be elected from among
   53  the council members every 2 years and may not serve more than
   54  two consecutive terms.
   55         (c) The council shall meet upon the call of the chair or
   56  two or more voting members or upon the call of the State Surgeon
   57  General, but must meet at least quarterly. Council meetings must
   58  be conducted by teleconference or through other electronic means
   59  when feasible.
   60         (d) The council shall be composed of no more than 13 voting
   61  members with technical expertise in cardiac medicine. Members
   62  shall be appointed by the State Surgeon General for staggered
   63  terms of 4 years. An employee of the department or a contracted
   64  consultant paid by the department may not serve as an appointed
   65  member or ex officio member of the council. Council members
   66  shall include the following voting members:
   67         1. Pediatric cardiologists or pediatric cardiovascular
   68  surgeons who have been nominated by their respective chief
   69  executive officers and approved by the State Surgeon General
   70  from the following facilities for as long as such facilities
   71  maintain their pediatric certificates of need:
   72         a. All Children’s Hospital in St. Petersburg;
   73         b. Arnold Palmer Hospital for Children in Orlando;
   74         c. Joe DiMaggio Children’s Hospital in Hollywood;
   75         d. Nicklaus Children’s Hospital in Miami;
   76         e. St. Joseph’s Children’s Hospital in Tampa;
   77         f. University of Florida Health Shands Hospital in
   78  Gainesville;
   79         g. University of Miami Holtz Children’s Hospital in Miami;
   80  and
   81         h. Wolfson Children’s Hospital in Jacksonville.
   83  A hospital with a certificate of need for a pediatric cardiac
   84  program that meets state and national standards as determined by
   85  the council following an onsite visit by a panel from the
   86  council shall have one of its pediatric cardiologists or
   87  pediatric cardiovascular surgeons who has been nominated by its
   88  chief executive officer and approved by the State Surgeon
   89  General appointed to the council as a new voting member. The
   90  voting privilege of a voting member of the council appointed
   91  pursuant to this subparagraph shall be suspended if the facility
   92  he or she represents no longer meets state and national
   93  standards as adopted by the council. Such individual may remain
   94  a member of the council in an advisory capacity but shall
   95  relinquish voting privileges until his or her facility meets
   96  such standards.
   97         2. Two physicians at large, not associated with a facility
   98  that has a representative appointed as a voting member of the
   99  council, who are pediatric cardiologists or subspecialists with
  100  special expertise or experience in dealing with children or
  101  adults with congenital heart disease. These physicians shall be
  102  selected by the State Surgeon General in consultation with the
  103  Deputy Secretary for Children’s Medical Services and the
  104  Director of Children’s Medical Services.
  105         3. One community physician who has ongoing involvement with
  106  and special interest in children with heart disease and who is
  107  not associated with a facility represented in subparagraph 1. or
  108  one community-based medical internist having experience with
  109  adults with congenital heart disease. The community physician
  110  shall be selected by the State Surgeon General in consultation
  111  with the Deputy Secretary of Children’s Medical Services and the
  112  Director of the Division of Children’s Medical Services.
  113         (e) The State Surgeon General may appoint nonvoting
  114  advisory members to the council in consultation with the Deputy
  115  Secretary for Children’s Medical Services and the Director of
  116  Children’s Medical Services. Among such nonvoting advisory
  117  members appointed to the council shall be one representative
  118  from a pediatric health advocacy group. Such members may
  119  participate in council discussions and subcommittees created by
  120  the council, but may not vote.
  121         (f) The duties of the council include, but are not limited
  122  to:
  123         1. Recommending standards for personnel, diagnoses,
  124  clinics, and facilities rendering cardiac services to the
  125  department and the Division of Children’s Medical Services.
  126         2. Analyzing reports on the periodic review of cardiac
  127  personnel, diagnoses, clinics, and facilities to determine if
  128  established state and national standards for cardiac services
  129  are met.
  130         3. Making recommendations to the Director of Children’s
  131  Medical Services as to the approval or disapproval of reviewed
  132  cardiac care personnel, diagnoses, clinics, and facilities.
  133         4. Making recommendations as to the intervals for
  134  reinspection of approved personnel, diagnoses, clinics, and
  135  facilities for cardiac care.
  136         5. Reviewing and inspecting hospitals upon the request of
  137  the hospitals, the department, or the Agency for Health Care
  138  Administration to determine if established state and national
  139  standards for cardiac services are met.
  140         6. Providing input on all aspects of the state’s Children’s
  141  Medical Services cardiac programs, including rulemaking.
  142         7. Addressing all components of the care of adults and
  143  children with congenital heart disease and children with
  144  acquired heart disease, as indicated and appropriate.
  145         8. Abiding by the recognized state and national
  146  professional standards of care for children with heart disease.
  147         9. Making recommendations to the State Surgeon General for
  148  legislation and appropriations for children’s cardiac services.
  149         10. Providing advisory opinions to the Agency for Health
  150  Care Administration before the agency approves a certificate of
  151  need for children’s cardiac services.
  152         (g) A council member shall serve without compensation, but
  153  is entitled to reimbursement for per diem and travel expenses in
  154  accordance with s. 112.061.
  155         (h) At the recommendation of the Pediatric Cardiac Advisory
  156  Council and with the approval of the Director of Children’s
  157  Medical Services, the State Surgeon General shall designate
  158  facilities meeting the council’s approved state and national
  159  professional standards of care for children with heart disease
  160  as “Pediatric and Congenital Cardiovascular Centers of
  161  Excellence.” The designation is withdrawn automatically if a
  162  particular center no longer meets such standards.
  163         1. The council shall develop and recommend to the State
  164  Surgeon General measurable performance standards and goals for
  165  determining whether a facility meets the requirements for
  166  designation as a “Pediatric and Congenital Cardiovascular Center
  167  of Excellence.”
  168         2. The council shall develop and recommend to the State
  169  Surgeon General evaluation tools for measuring the goals and
  170  performance standards of the facilities seeking and receiving
  171  the “Pediatric and Congenital Cardiovascular Center of
  172  Excellence” designation.
  173         (3) ANNUAL REPORT.—The council shall submit an annual
  174  report to the Governor, the President of the Senate, the Speaker
  175  of the House of Representatives, and the State Surgeon General
  176  by January 1 of each year, beginning in 2017. The report must
  177  summarize the council’s activities for the preceding fiscal year
  178  and include data and performance measures for all pediatric
  179  cardiac facilities that participate in the Children’s Medical
  180  Services Network relating to surgical morbidity and mortality.
  181  The report must also recommend any policy or procedural changes
  182  that would increase the council’s effectiveness in monitoring
  183  the pediatric cardiovascular programs in the state.
  184         (4)RULEMAKING.—The department, in coordination with the
  185  Agency for Health Care Administration, shall develop rules
  186  related to pediatric cardiac facilities that participate in the
  187  Children’s Medical Services Network. The rules may establish
  188  standards relating to the training and credentialing of medical
  189  and surgical personnel, facility and physician minimum case
  190  volumes, and data reporting requirements for monitoring and
  191  enhancing quality assurance. The department may adopt rules
  192  relating to the establishment, operations, and authority of the
  193  Pediatric Cardiac Advisory Council and the establishment, goals,
  194  performance standards, and evaluation tools for designating
  195  facilities as Pediatric and Congenital Cardiovascular Centers of
  196  Excellence. The rules relating to pediatric cardiac services and
  197  facilities in effect on October 1, 2015, are authorized pursuant
  198  to this subsection and shall remain in effect until amended
  199  pursuant to this subsection.
  200         Section 2. Paragraph (b) of subsection (3) of section
  201  408.0361, Florida Statutes, is amended to read:
  202         408.0361 Cardiovascular services and burn unit licensure.—
  203         (3) In establishing rules for adult cardiovascular
  204  services, the agency shall include provisions that allow for:
  205         (b) For a hospital seeking a Level I program, demonstration
  206  that, for the most recent 12-month period as reported to the
  207  agency, it has provided a minimum of 300 adult inpatient and
  208  outpatient diagnostic cardiac catheterizations or, for the most
  209  recent 12-month period, has discharged or transferred at least
  210  300 inpatients with the principal diagnosis of ischemic heart
  211  disease and that it has a formalized, written transfer agreement
  212  with a hospital that has a Level II program, including written
  213  transport protocols to ensure safe and efficient transfer of a
  214  patient within 60 minutes. However, a hospital located more than
  215  100 road miles from the closest Level II adult cardiovascular
  216  services program does not need to meet the 60-minute transfer
  217  time protocol if the hospital demonstrates that it has a
  218  formalized, written transfer agreement with a hospital that has
  219  a Level II program. The agreement must include written transport
  220  protocols to ensure the safe and efficient transfer of a
  221  patient, taking into consideration the patient’s clinical and
  222  physical characteristics, road and weather conditions, and
  223  viability of ground and air ambulance service to transfer the
  224  patient. At a minimum, the rules for adult cardiovascular
  225  services must require nursing and technical staff to have
  226  demonstrated experience in handling acutely ill patients
  227  requiring intervention based on the staff members’ previous
  228  experience in dedicated cardiac interventional laboratories or
  229  surgical centers. If a staff member’s previous experience is in
  230  a dedicated cardiac interventional laboratory at a hospital that
  231  does not have an approved adult open-heart-surgery program, the
  232  staff member’s previous experience qualifies only if, at the
  233  time the staff member acquired his or her experience, the
  234  dedicated cardiac interventional laboratory:
  235         1. Had an annual volume of 500 or more percutaneous cardiac
  236  intervention procedures;
  237         2. Achieved a demonstrated success rate of 95 percent or
  238  greater for percutaneous cardiac intervention procedures;
  239         3. Experienced a complication rate of less than 5 percent
  240  for percutaneous cardiac intervention procedures; and
  241         4. Performed diverse cardiac procedures, including, but not
  242  limited to, balloon angioplasty and stenting, rotational
  243  atherectomy, cutting balloon atheroma remodeling, and procedures
  244  relating to left ventricular support capability.
  245         Section 3. This act shall take effect July 1, 2016.