HB 1029 2003
1	A bill to be entitled
2	An act relating to notification of an adverse incident
3	provided to the Agency for Health Care Administration;
4	amending s. 395.0197, F.S.; eliminating the requirement of
5	a hospital, ambulatory surgical center, or mobile surgical
6	facility licensed under ch. 395, F.S., to notify the
7	Agency for Health Care Administration of the occurrence of
8	specified adverse incidents; correcting cross references;
9	repealing s. 395.0198, F.S., which provides an exemption
10	from public records requirements for information contained
11	in a notification of an adverse incident provided to the
12	Agency for Health Care Administration by a hospital,
13	ambulatory surgical center, or mobile surgical facility
14	licensed under ch. 395, F.S.; providing an effective date.
15
16	Be It Enacted by the Legislature of the State of Florida:
17
18	Section 1. Subsections (7) of section 395.0197, Florida
19	Statutes, is amended, subsections (13), (14), and (15) are
20	renumbered as subsections (12), (13), and (14), and amended, and
21	subsections (8), (9), (10), (11), (12), (16), (17), (18), (19),
22	and (20) are renumbered as subsections (7) (8), (9), (10), (11),
23	(15), (16), (17), (18), and (19), respectively, to read:
24	395.0197 Internal risk management program.--
25	(7) The licensed facility shall notify the agency no later
26	than 1 business day after the risk manager or his or her
27	designee has received a report pursuant to paragraph (1)(d) and
28	can determine within 1 business day that any of the following
29	adverse incidents has occurred, whether occurring in the
30	licensed facility or arising from health care prior to admission
31	in the licensed facility:
32	(a) The death of a patient;
33	(b) Brain or spinal damage to a patient;
34	(c) The performance of a surgical procedure on the wrong
35	patient;
36	(d) The performance of a wrong-site surgical procedure; or
37	(e) The performance of a wrong surgical procedure.
38
39	The notification must be made in writing and be provided by
40	facsimile device or overnight mail delivery. The notification
41	must include information regarding the identity of the affected
42	patient, the type of adverse incident, the initiation of an
43	investigation by the facility, and whether the events causing or
44	resulting in the adverse incident represent a potential risk to
45	other patients.
46	(13) In addition to any penalty imposed pursuant to this
47	section, the agency shall require a written plan of correction
48	from the facility. For a single incident or series of isolated
49	incidents that are nonwillful violations of the reporting
50	requirements of this section, the agency shall first seek to
51	obtain corrective action by the facility. If the correction is
52	not demonstrated within the timeframe established by the agency
53	or if there is a pattern of nonwillful violations of this
54	section, the agency may impose an administrative fine, not to
55	exceed $5,000 for any violation of the reporting requirements of
56	this section. The administrative fine for repeated nonwillful
57	violations shall not exceed $10,000 for any violation. The
58	administrative fine for each intentional and willful violation
59	may not exceed $25,000 per violation, per day. The fine for an
60	intentional and willful violation of this section may not exceed
61	$250,000. In determining the amount of fine to be levied, the
62	agency shall be guided by s. 395.1065(2)(b). This subsection
63	does not apply to the notice requirements under subsection (7).
64	(14) The agency shall have access to all licensed facility
65	records necessary to carry out the provisions of this section.
66	The records obtained by the agency under subsection (6),
67	subsection (7)(8), or subsection (9)(10)are not available to
68	the public under s. 119.07(1), nor shall they be discoverable or
69	admissible in any civil or administrative action, except in
70	disciplinary proceedings by the agency or the appropriate
71	regulatory board, nor shall records obtained pursuant to s.
72	456.071 be available to the public as part of the record of
73	investigation for and prosecution in disciplinary proceedings
74	made available to the public by the agency or the appropriate
75	regulatory board. However, the agency or the appropriate
76	regulatory board shall make available, upon written request by a
77	health care professional against whom probable cause has been
78	found, any such records which form the basis of the
79	determination of probable cause, except that, with respect to
80	medical review committee records, s. 766.101 controls.
81	(15) The meetings of the committees and governing board of
82	a licensed facility held solely for the purpose of achieving the
83	objectives of risk management as provided by this section shall
84	not be open to the public under the provisions of chapter 286.
85	The records of such meetings are confidential and exempt from s.
86	119.07(1), except as provided in subsection (13)(14).
87	Section 2. Section 395.0198, Florida Statutes, is
88	repealed.Section 3. This act shall take effect upon becoming a
89	law.