HB 1665

1	A bill to be entitled
2	An act relating to certificates of need; amending s.
3	408.036, F.S; exempting from review certain projects
4	involving percutaneous coronary intervention; providing
5	requirements by which certain hospitals may obtain an
6	exemption; providing exemption limitations; providing an
7	effective date.
8
9	Be It Enacted by the Legislature of the State of Florida:
10
11	Section 1.  Paragraphs (j), (k), (l), (m), (n), (o), (p),
12	(q), (r), (s), and (t) of subsection (3) of section 408.036,
13	Florida Statutes, are redesignated as paragraphs (k), (l), (m),
14	(n), (o), (p), (q), (r), (s), (t), and (u), respectively, and a
15	new paragraph (j) is added to said subsection, to read:
16	408.036  Projects subject to review; exemptions.--
17	(3)  EXEMPTIONS.--Upon request, the following projects are
18	subject to exemption from the provisions of subsection (1):
19	(j)  For the provision of percutaneous coronary
20	intervention for patients presenting with emergency myocardial
21	infarctions in a hospital without an approved adult open-heart-
22	surgery program. In addition to any other documentation required
23	by the agency, a request for an exemption submitted under this
24	paragraph must comply with the following:
25	1.  The applicant must certify that it will meet and
26	continuously maintain the requirements adopted by the agency for
27	the provision of these services. These licensure requirements
28	shall be adopted by rule pursuant to ss. 120.536(1) and 120.54
29	and must be consistent with the guidelines published by the
30	American College of Cardiology and the American Heart
31	Association for the provision of percutaneous coronary
32	interventions in hospitals without adult open-heart services. At
33	a minimum, the rules shall require the following:
34	a.  Cardiologists must be experienced interventionalists
35	who have performed a minimum of 75 interventions within the
36	previous 12 months.
37	b.  The hospital must provide a minimum of 36 emergency
38	interventions annually in order to continue to provide the
39	service.
40	c.  The hospital must offer sufficient physician, nursing,
41	and laboratory staff to provide the services 24 hours a day, 7
42	days a week.
43	d.  Nursing and technical staff must have demonstrated
44	experience in handling acutely ill patients requiring
45	intervention based on previous experience in dedicated
46	interventional laboratories or surgical centers.
47	e.  Cardiac care nursing staff must be adept in hemodynamic
48	monitoring and Intra-aortic Balloon Pump (IABP) management.
49	f.  Formalized written transfer agreements must be
50	developed with a hospital with an adult open-heart-surgery
51	program, and written transport protocols must be in place to
52	ensure safe and efficient transfer of a patient within 60
53	minutes. Transfer and transport agreements must be reviewed and
54	tested, with appropriate documentation maintained at least every
55	3 months.
56	g.  Hospitals implementing the service must first undertake
57	a training program of 3 to 6 months, which includes establishing
58	standards and testing logistics, creating quality assessment and
59	error management practices, and formalizing patient-selection
60	criteria.
61	2.  The applicant must certify that it will use at all
62	times the patient-selection criteria for the performance of
63	primary angioplasty at hospitals without adult open-heart-
64	surgery programs issued by the American College of Cardiology
65	and the American Heart Association. At a minimum, these criteria
66	would provide for the following:
67	a.  Avoidance of interventions in hemodynamically stable
68	patients who have identified symptoms or medical histories.
69	b.  Transfer of patients who have a history of coronary
70	disease and clinical presentation of hemodynamic instability.
71	3.  The applicant must agree to submit a quarterly report
72	to the agency detailing patient characteristics, treatment, and
73	outcomes for all patients receiving emergency percutaneous
74	coronary interventions pursuant to this paragraph. This report
75	must be submitted within 15 days after the close of each
76	calendar quarter.
77	4.  The exemption provided by this paragraph does not apply
78	unless the agency determines that the hospital has taken all
79	necessary steps to be in compliance with all requirements of
80	this paragraph, including the training program required under
81	sub-subparagraph 1.g.
82	5.  Failure of the hospital to continuously comply with the
83	requirements of sub-subparagraphs 1.c.-f. and subparagraphs 2.
84	and 3. will result in the immediate expiration of this
85	exemption.
86	6.  Failure of the hospital to meet the volume requirements
87	of sub-subparagraphs 1.a.-b. within 18 months after the program
88	begins offering the service will result in the immediate
89	expiration of the exemption.
90
91	If the exemption for this service expires under subparagraph 5.
92	or subparagraph 6., the agency may not grant another exemption
93	for this service to the same hospital for 2 years and then only
94	upon a showing that the hospital will remain in compliance with
95	the requirements of this paragraph through a demonstration of
96	corrections to the deficiencies that caused expiration of the
97	exemption. Compliance with the requirements of this paragraph
98	includes compliance with the rules adopted pursuant to this
99	paragraph.
100	Section 2.  This act shall take effect July 1, 2004.

CODING: Words stricken are deletions; words underlined are additions.