Senate Bill sb0182
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2004 SB 182
By Senator Atwater
25-112-04
1 A bill to be entitled
2 An act relating to certificates of need;
3 amending s. 408.036, F.S., relating to
4 health-care-related projects subject to review
5 for a certificate of need; exempting certain
6 projects involving percutaneous coronary
7 intervention from review; providing
8 requirements by which certain hospitals may
9 obtain an exemption; providing an effective
10 date.
11
12 Be It Enacted by the Legislature of the State of Florida:
13
14 Section 1. Present paragraphs (j), (k), (l), (m), (n),
15 (o), (p), (q), (r), (s), and (t) of subsection (3) of section
16 408.036, Florida Statutes, are redesignated as paragraphs (k),
17 (l), (m), (n), (o), (p), (q), (r), (s), (t), and (u),
18 respectively, and a new paragraph (j) is added to that
19 subsection, to read:
20 408.036 Projects subject to review; exemptions.--
21 (3) EXEMPTIONS.--Upon request, the following projects
22 are subject to exemption from the provisions of subsection
23 (1):
24 (j) For the provision of percutaneous coronary
25 intervention for patients presenting with emergency myocardial
26 infarctions in a hospital without an approved adult
27 open-heart-surgery program. In addition to any other
28 documentation required by the agency, a request for an
29 exemption submitted under this paragraph must comply with the
30 following:
31
1
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2004 SB 182
25-112-04
1 1. The applicant must certify that it will meet and
2 continuously maintain the requirements adopted by the agency
3 for the provision of these services. These licensure
4 requirements shall be adopted by rule pursuant to ss.
5 120.536(1) and 120.54 and must be consistent with the
6 guidelines published by the American College of Cardiology and
7 the American Heart Association for the provision of
8 percutaneous coronary interventions in hospitals without adult
9 open-heart services. At a minimum, the rules shall require the
10 following:
11 a. Cardiologists must be experienced
12 interventionalists who have performed a minimum of 75
13 interventions within the previous 12 months.
14 b. The hospital must provide a minimum of 36 emergency
15 interventions annually in order to continue to provide the
16 service.
17 c. The hospital must offer sufficient physician,
18 nursing, and laboratory staff to provide the services 24 hours
19 a day, 7 days a week.
20 d. Nursing and technical staff must have demonstrated
21 experience in handling acutely ill patients requiring
22 intervention based on previous experience in dedicated
23 interventional laboratories or surgical centers.
24 e. Cardiac care nursing staff must be adept in
25 hemodynamic monitoring and Intra-aortic Balloon Pump (IABP)
26 management.
27 f. Formalized written transfer agreements must be
28 developed with a hospital with an adult open-heart-surgery
29 program, and written transport protocols must be in place to
30 ensure safe and efficient transfer of a patient within 60
31 minutes. Transfer and transport agreements must be reviewed
2
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2004 SB 182
25-112-04
1 and tested, with appropriate documentation maintained at least
2 every 3 months.
3 g. Hospitals implementing the service must first
4 undertake a training program of 3 to 6 months, which includes
5 establishing standards and testing logistics, creating quality
6 assessment and error management practices, and formalizing
7 patient-selection criteria.
8 2. The applicant must certify that it will use at all
9 times the patient-selection criteria for the performance of
10 primary angioplasty at hospitals without adult
11 open-heart-surgery programs issued by the American College of
12 Cardiology and the American Heart Association. At a minimum,
13 these criteria would provide for the following:
14 a. Avoidance of interventions in hemodynamically
15 stable patients who have identified symptoms or medical
16 histories.
17 b. Transfer of patients who have a history of coronary
18 disease and clinical presentation of hemodynamic instability.
19 3. The applicant must agree to submit a quarterly
20 report to the agency detailing patient characteristics,
21 treatment, and outcomes for all patients receiving emergency
22 percutaneous coronary interventions pursuant to this
23 paragraph. This report must be submitted within 15 days after
24 the close of each calendar quarter.
25 4. The exemption provided by this paragraph does not
26 apply unless the agency determines that the hospital has taken
27 all necessary steps to be in compliance with all requirements
28 of this paragraph, including the training program required
29 under sub-subparagraph 1.g.
30 5. Failure of the hospital to continuously comply with
31 the requirements of sub-subparagraphs 1.c.-f. and
3
CODING: Words stricken are deletions; words underlined are additions.
Florida Senate - 2004 SB 182
25-112-04
1 subparagraphs 2. and 3. will result in the immediate
2 expiration of this exemption.
3 6. Failure of the hospital to meet the volume
4 requirements of sub-subparagraphs 1.a.-b. within 18 months
5 after the program begins offering the service will result in
6 the immediate expiration of the exemption.
7
8 If the exemption for this service expires under subparagraph
9 5. or subparagraph 6., the agency may not grant another
10 exemption for this service to the same hospital for 2 years
11 and then only upon a showing that the hospital will remain in
12 compliance with the requirements of this paragraph through a
13 demonstration of corrections to the deficiencies that caused
14 expiration of the exemption. Compliance with the requirements
15 of this paragraph includes compliance with the rules adopted
16 pursuant to this paragraph.
17 Section 2. This act shall take effect July 1, 2004.
18
19 *****************************************
20 SENATE SUMMARY
21 Provides an exemption from certificate-of-need review for
the provision of pertaneous coronary intervention to
22 patients who have emergency myocardial infarctions in a
hospital without an approved adult open-heart-surgery
23 program.
24
25
26
27
28
29
30
31
4
CODING: Words stricken are deletions; words underlined are additions.