Florida Senate - 2019 COMMITTEE AMENDMENT
Bill No. SB 7078
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
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
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
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
114 (c) Have a risk adjustment surgical procedure protocol
115 following the guidelines established by the Society of Thoracic
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
143 1. An inspection of the program’s physical facilities,
144 clinics, and laboratories.
145 2. Interviews with support staff and hospital
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
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
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.