Florida Senate - 2024 SB 1612
By Senator Brodeur
10-01555-24 20241612__
1 A bill to be entitled
2 An act relating to adult cardiovascular care
3 standards; amending s. 395.1055, F.S.; deleting the
4 requirement for the Agency for Health Care
5 Administration to adopt certain rules for adult
6 inpatient diagnostic cardiac catheterization programs;
7 revising standards for rules relating to adult
8 cardiovascular services; requiring the agency to
9 update its rules as often as necessary to remain
10 consistent with new standards and guidelines published
11 by certain entities; providing an effective date.
12
13 Be It Enacted by the Legislature of the State of Florida:
14
15 Section 1. Subsections (16), (18), and (19) of section
16 395.1055, Florida Statutes, are amended to read:
17 395.1055 Rules and enforcement.—
18 (16) Each provider of diagnostic cardiac catheterization
19 services shall comply with rules adopted by the agency which
20 establish licensure standards governing the operation of adult
21 inpatient diagnostic cardiac catheterization programs. The rules
22 must ensure that such programs:
23 (a) Comply with the most recent guidelines of the American
24 College of Cardiology and American Heart Association Guidelines
25 for Cardiac Catheterization and Cardiac Catheterization
26 Laboratories.
27 (b) Perform only adult inpatient diagnostic cardiac
28 catheterization services and will not provide therapeutic
29 cardiac catheterization or any other cardiology services.
30 (c) Maintain sufficient appropriate equipment and health
31 care personnel to ensure quality and safety.
32 (d) Maintain appropriate times of operation and protocols
33 to ensure availability and appropriate referrals in the event of
34 emergencies.
35 (e) Demonstrate a plan to provide services to Medicaid and
36 charity care patients.
37 (18) In establishing rules for adult cardiovascular
38 services, the agency shall include provisions that provide allow
39 for all of the following:
40 (a) The establishment of two hospital program licensure
41 levels, a Level I program that authorizes the performance of
42 adult percutaneous cardiac intervention without onsite cardiac
43 surgery, including rotational or other atherectomy devices,
44 electrophysiology, and treatment of chronic total occlusions,
45 and a Level II program that authorizes the performance of
46 percutaneous cardiac intervention with onsite cardiac surgery.
47 (b)1. For A hospital seeking a Level I program must have a,
48 demonstration that, for the most recent 12-month period as
49 reported to the agency, the hospital has provided a minimum of
50 300 adult inpatient and outpatient diagnostic cardiac
51 catheterizations or, for the most recent 12-month period, has
52 discharged or transferred at least 300 patients with the
53 principal diagnosis of ischemic heart disease and that it has a
54 formalized, written transfer agreement with a hospital that has
55 a Level II program, including written transport protocols to
56 ensure safe and efficient transfer of a patient within 60
57 minutes.
58 2.a. A hospital located more than 100 road miles from the
59 closest Level II adult cardiovascular services program is not
60 required to meet the diagnostic cardiac catheterization volume
61 and ischemic heart disease diagnosis volume requirements in
62 subparagraph 1. if the hospital demonstrates that it has, for
63 the most recent 12-month period as reported to the agency,
64 provided a minimum of 100 adult inpatient and outpatient
65 diagnostic cardiac catheterizations or that, for the most recent
66 12-month period, it has discharged or transferred at least 300
67 patients with the principal diagnosis of ischemic heart disease.
68 2.b. A hospital located more than 100 road miles from the
69 closest Level II adult cardiovascular services program must have
70 a does not need to meet the 60-minute transfer time protocol
71 requirement in subparagraph 1. if the hospital demonstrates that
72 it has a formalized, written transfer agreement with a hospital
73 that has a Level II program which includes. The agreement must
74 include written transport protocols to ensure the safe and
75 efficient transfer of a patient, taking into consideration the
76 patient’s clinical and physical characteristics, road and
77 weather conditions, and viability of ground and air ambulance
78 service to transfer the patient.
79 3. At a minimum, the rules for adult cardiovascular
80 services must require nursing and technical staff to have
81 demonstrated experience in handling acutely ill patients
82 requiring intervention, based on the staff member’s previous
83 experience in dedicated cardiac interventional laboratories or
84 surgical centers. If a staff member’s previous experience is in
85 a dedicated cardiac interventional laboratory at a hospital that
86 does not have an approved adult open heart surgery program, the
87 staff member’s previous experience qualifies only if, at the
88 time the staff member acquired his or her experience, the
89 dedicated cardiac interventional laboratory:
90 a. Had an annual volume of 500 or more percutaneous cardiac
91 intervention procedures.
92 b. Achieved a demonstrated success rate of 95 percent or
93 greater for percutaneous cardiac intervention procedures.
94 c. Experienced a complication rate of less than 5 percent
95 for percutaneous cardiac intervention procedures.
96 d. Performed diverse cardiac procedures, including, but not
97 limited to, balloon angioplasty and stenting, rotational
98 atherectomy, cutting balloon atheroma remodeling, and procedures
99 relating to left ventricular support capability.
100 (c) For a hospital seeking a Level II program,
101 demonstration that, for the most recent 12-month period as
102 reported to the agency, the hospital has performed a minimum of
103 1,100 adult inpatient and outpatient cardiac catheterizations,
104 of which at least 400 must be therapeutic catheterizations, or,
105 for the most recent 12-month period, has discharged at least 800
106 patients with the principal diagnosis of ischemic heart disease.
107 (d) Compliance with the most recent guidelines of the
108 American College of Cardiology, and the American Heart
109 Association, and the Society for Cardiac Angiography and
110 Intervention guidelines for staffing, physician training and
111 experience, operating procedures, equipment, physical plant, and
112 patient selection criteria, to ensure patient quality and
113 safety.
114 (e) The establishment of appropriate hours of operation and
115 protocols to ensure availability and timely referral in the
116 event of emergencies.
117 (f) The demonstration of a plan to provide services to
118 Medicaid and charity care patients.
119 (g) For a hospital licensed for adult diagnostic cardiac
120 catheterization that provides Level I or Level II adult
121 cardiovascular services, demonstration that the hospital is
122 participating in the American College of Cardiology’s National
123 Cardiovascular Data Registry or the American Heart Association’s
124 Get with the Guidelines–Coronary Artery Disease registry and
125 documentation of an ongoing quality improvement plan ensuring
126 that the licensed cardiac program meets or exceeds national
127 quality and outcome benchmarks reported by the registry in which
128 the hospital participates. A hospital licensed for Level II
129 adult cardiovascular services must also participate in the
130 clinical outcome reporting systems operated by the Society for
131 Thoracic Surgeons.
132 (19) The agency may adopt rules to administer the
133 requirements of part II of chapter 408 and shall update agency
134 rules as often as necessary to remain consistent with new
135 standards and guidelines published by federal health agencies
136 and nationally recognized medical organizations.
137 Section 2. This act shall take effect July 1, 2024.