Florida Senate - 2018 SB 144 By Senator Grimsley 26-00116-18 2018144__ 1 A bill to be entitled 2 An act relating to adult cardiovascular services; 3 amending s. 408.0361, F.S.; establishing criteria that 4 must be included by the Agency for Health Care 5 Administration in rules relating to the licensure of 6 certain hospitals performing percutaneous coronary 7 intervention procedures; providing an effective date. 8 9 Be It Enacted by the Legislature of the State of Florida: 10 11 Section 1. Paragraphs (a) and (b) of subsection (3) of 12 section 408.0361, Florida Statutes, are amended to read: 13 408.0361 Cardiovascular services and burn unit licensure.— 14 (3) In establishing rules for adult cardiovascular 15 services, the agency shall include provisions that allow for: 16 (a) Establishment of two hospital program licensure levels: 17 a Level I program authorizing the performance of adult 18 percutaneous coronary
cardiacintervention without onsite 19 cardiac surgery and a Level II program authorizing the 20 performance of percutaneous coronary cardiacintervention with 21 onsite cardiac surgery. 22 (b) For a hospital seeking a Level I program, demonstration 23 that, for the most recent 12-month period as reported to the 24 agency, it has provided a minimum of 300 adult inpatient and 25 outpatient diagnostic cardiac catheterizations or, for the most 26 recent 12-month period, has discharged or transferred at least 27 300 inpatients with the principal diagnosis of ischemic heart 28 disease and that it has a formalized, written transfer agreement 29 with a hospital that has a Level II program, including written 30 transport protocols to ensure safe and efficient transfer of a 31 patient within 60 minutes. However, a hospital located more than 32 100 road miles from the closest Level II adult cardiovascular 33 services program does not need to meet the 60-minute transfer 34 time protocol if the hospital demonstrates that it has a 35 formalized, written transfer agreement with a hospital that has 36 a Level II program. The agreement must include written transport 37 protocols to ensure the safe and efficient transfer of a 38 patient, taking into consideration the patient’s clinical and 39 physical characteristics, road and weather conditions, and 40 viability of ground and air ambulance service to transfer the 41 patient. At a minimum, the rules for adult cardiovascular 42 services must require nursing and technical staff to have 43 demonstrated experience in handling acutely ill patients 44 requiring intervention based on the staff members’ previous 45 experience in dedicated cardiovascular interventional 46 laboratories or surgical centers. If a staff member’s previous 47 experience is in a dedicated cardiovascular interventional 48 laboratory at a hospital that does not have an approved adult 49 open-heart surgery program, the staff member’s previous 50 experience qualifies only if, at the time the staff member 51 acquired his or her experience, the dedicated cardiovascular 52 interventional laboratory: 53 1. Had an annual volume of 500 or more percutaneous 54 coronary intervention procedures; 55 2. Achieved a demonstrated success rate of 95 percent or 56 greater for percutaneous coronary intervention procedures; 57 3. Experienced a complication rate of less than 5 percent 58 for percutaneous coronary intervention procedures; and 59 4. Performed diverse cardiac procedures, including, but not 60 limited to, balloon angioplasty and stenting, rotational 61 atherectomy, cutting balloon atheroma remodeling, and procedures 62 relating to left ventricular support capability. 63 Section 2. This act shall take effect July 1, 2018.