Amendment
Bill No. 1041

Amendment No. 573463

CHAMBER ACTION
Senate		House
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1	Representative(s) Gannon offered the following:
2
3	Amendment (with title amendment)
4	Remove everything after the enacting clause and insert:
5	Section 1.  This act may be cited as the "People's Health
6	and Safety Act."
7	Section 2.  Section 458.338, Florida Statutes, is created
8	to read:
9	458.338  Powers of agency; rules; disposal of human
10	tissue.--
11	(1)  The Department of Health shall have the authority to
12	develop and enforce rules for the health, care, and treatment of
13	persons in physicians' or osteopathic physicians' offices or
14	clinics and for the safe operation of such offices or clinics.
15	(a)  The rules shall be reasonably related to the
16	preservation of the health of the patients.
17	(b)  The rules may not impose an unconstitutional burden on
18	a patient's privacy rights including a woman's freedom to decide
19	whether to terminate her pregnancy.
20	(c)  The rules shall provide for:
21	1.  The performance of surgical procedures only by a
22	licensed physician.
23	2.  The making, protection, and preservation of patient
24	records, which shall be treated as medical records under this
25	chapter.
26	(2)  For clinics that perform abortions in the first
27	trimester of pregnancy only, these rules shall be comparable to
28	rules that apply to all surgical procedures requiring
29	approximately the same degree of skill and care as the
30	performance of first trimester abortions.
31	(3)  For offices and clinics in which abortions and other
32	surgical procedures having patient risks similar to or greater
33	than abortions performed after the first trimester of pregnancy,
34	the agency shall adopt rules pursuant to ss. 120.536(1) and
35	120.54 to implement the provisions of this chapter, including
36	the following:
37	(a)  Rules for a physician's or osteopathic physician's
38	office or clinic's physical facilities. At a minimum, these
39	rules shall prescribe standards for:
40	1.  Adequate private space that is specifically designated
41	for interviewing, counseling, and medical evaluations.
42	2.  Dressing rooms for staff and patients.
43	3.  Appropriate lavatory areas.
44	4.  Areas for preprocedure hand washing.
45	5.  Private procedure rooms.
46	6.  Adequate lighting and ventilation for the procedures.
47	7.  Surgical or gynecological examination tables and other
48	fixed equipment.
49	8.  Postprocedure recovery rooms that are equipped to meet
50	the patients' needs.
51	9.  Emergency exits to accommodate a stretcher or gurney.
52	10.  Areas for cleaning and sterilizing instruments.
53	11.  Adequate areas for the secure storage of medical
54	records and necessary equipment and supplies.
55	12.  The display in the office or clinic, in a place that
56	is conspicuous to all patients, of the physician's or
57	osteopathic physician's and the clinic's current license issued
58	by the department.
59	(b)  Rules to prescribe office or clinic supplies and
60	equipment standards, including supplies and equipment that are
61	required to be immediately available for use or in an emergency.
62	At a minimum, these rules shall:
63	1.  Prescribe required clean and sterilized equipment and
64	supplies, including medications, required for the conduct, in an
65	appropriate fashion, of any procedure that the medical staff of
66	the office or clinic anticipates performing and for monitoring
67	the progress of each patient throughout the procedure and
68	recovery period.
69	2.  Prescribe required equipment, supplies, and medications
70	that shall be available and ready for immediate use in an
71	emergency and requirements for written protocols and procedures
72	to be followed by staff in an emergency, such as the loss of
73	electrical power.
74	3.  Prescribe equipment and supplies for required
75	laboratory tests and requirements for protocols to calibrate and
76	maintain laboratory equipment or equipment operated by office or
77	clinic staff at the office or clinic.
78	4.  Require ultrasound equipment in those facilities that
79	provide abortions after 12 weeks' gestation.
80	5.  Require that all equipment is safe for the patient and
81	the staff, meets applicable federal standards, and is checked
82	annually to ensure safety and appropriate calibration.
83	(c)  Rules relating to medical office or clinic personnel.
84	At a minimum, these rules shall require that:
85	1.  A clinic designate a medical director who is licensed
86	to practice medicine and surgery in the state and who has
87	admitting privileges at an accredited hospital in the state that
88	is within 50 miles of the clinic.
89	2.  If a physician is not present after a procedure is
90	performed, a registered nurse, licensed practical nurse,
91	advanced registered nurse practitioner, or physician assistant
92	shall be present and remain at the clinic to provide
93	postoperative monitoring and care until the patient is
94	discharged.
95	3.  Surgical assistants receive training in counseling,
96	patient advocacy, and the specific responsibilities associated
97	with the services the surgical assistants provide.
98	4.  Volunteers receive training in the specific
99	responsibilities associated with the services the volunteers
100	provide, including counseling and patient advocacy as provided
101	in the rules adopted by the director for different types of
102	volunteers based on their responsibilities.
103	(d)  Rules relating to the medical screening and evaluation
104	of each patient. At a minimum, these rules shall require:
105	1.  A medical history including reported allergies to
106	medications, antiseptic solutions, or latex; past surgeries; and
107	an obstetric and gynecological history.
108	2.  A physical examination, including a bimanual
109	examination estimating uterine size and palpation of the adnexa
110	if an abortion procedure is to be performed.
111	3.  The appropriate laboratory tests, including:
112	a.  For an abortion in which an ultrasound examination is
113	not performed before the abortion procedure, urine or blood
114	tests for pregnancy performed before the abortion procedure.
115	b.  A test for anemia.
116	c.  Rh typing, unless reliable written documentation of
117	blood type is available.
118	d.  Other tests as indicated from the physical examination.
119	4.  An ultrasound evaluation for all patients who elect to
120	have an abortion after 12 weeks' gestation. The rules shall
121	require that if a person who is not a physician performs an
122	ultrasound examination, that person shall have documented
123	evidence that he or she has completed a course in the operation
124	of ultrasound equipment as prescribed in rule. The physician,
125	registered nurse, licensed practical nurse, advanced registered
126	nurse practitioner, or physician assistant shall review, at the
127	request of the patient, the ultrasound evaluation results,
128	including an estimate of the probable gestational age of the
129	fetus, with the patient before the abortion procedure is
130	performed.
131	5.  That the physician is responsible for estimating the
132	gestational age of the fetus based on the ultrasound examination
133	and obstetric standards in keeping with established standards of
134	care regarding the estimation of fetal age as defined in rule
135	and shall write the estimate in the patient's medical history.
136	The physician shall keep original prints of each ultrasound
137	examination of a patient in the patient's medical history file.
138	(e)  Rules relating to the surgical procedure. At a
139	minimum, these rules shall require:
140	1.  That a physician, registered nurse, licensed practical
141	nurse, advanced registered nurse practitioner, or physician
142	assistant is available to all patients throughout the surgical
143	procedure.
144	2.  Standards for the safe conduct of surgical procedures
145	that conform to medical standards in keeping with established
146	standards of care.
147	3.  Appropriate use of general and local anesthesia,
148	analgesia, and sedation if ordered by the physician or
149	osteopathic physician.
150	4.  Appropriate precautions, such as the establishment of
151	intravenous access where medically appropriate.
152	5.  Appropriate monitoring of the vital signs and other
153	defined signs and markers of the patient's status throughout the
154	surgical procedure and during the recovery period until the
155	patient's condition is deemed to be stable in the recovery room.
156	(f)  Rules that prescribe minimum recovery room standards.
157	At a minimum, these rules shall require that:
158	1.  Postprocedure recovery rooms are supervised and staffed
159	to meet the patients' needs.
160	2.  Immediate postprocedure care consists of observation in
161	a supervised recovery room for as long as the patient's
162	condition warrants.
163	3.  The office or clinic arranges hospitalization if any
164	complication beyond the medical capability of the staff occurs
165	or is suspected.
166	4.  A registered nurse, licensed practical nurse, advanced
167	registered nurse practitioner, or physician assistant who is
168	trained in the management of the recovery area and is capable of
169	providing basic cardiopulmonary resuscitation and related
170	emergency procedures remains on the premises of the office or
171	clinic until all patients are discharged.
172	5.  A physician shall sign the discharge order and be
173	readily accessible and available until the last patient is
174	discharged to facilitate the transfer of emergency cases if
175	hospitalization of the patient is necessary.
176	6.  A physician discusses Rho(D) immune globulin with each
177	patient for whom it is indicated and ensures that it is offered
178	to the patient in the immediate postoperative period or that it
179	will be available to her within 72 hours after completion of the
180	abortion procedure. If the patient refuses the Rho(D) immune
181	globulin, a refusal form approved by the department shall be
182	signed by the patient and a witness and included in the medical
183	record.
184	7.  Written instructions with regard to post-procedure
185	coitus, signs of possible problems, and general aftercare are
186	given to each patient. Each patient shall have specific written
187	instructions regarding access to medical care for complications,
188	including a telephone number to call for medical emergencies.
189	8.  There is a specified minimum length of time that a
190	patient remains in the recovery room by accepted medical
191	standards.
192	9.  The physician or osteopathic physician ensures that a
193	registered nurse, licensed practical nurse, advanced registered
194	nurse practitioner, or physician assistant makes a good faith
195	effort to contact the patient by telephone, with the patient's
196	consent, within 24 hours after surgery to assess the patient's
197	recovery.
198	10.  Equipment and services are located in the recovery
199	room to provide appropriate emergency resuscitative and life
200	support procedures pending the transfer of the patient to the
201	hospital.
202	(g)  Rules that prescribe standards for followup care. At a
203	minimum, these rules shall require that a post-surgery medical
204	visit that includes a medical examination and a review of the
205	results of all laboratory tests is offered and, if requested,
206	scheduled for 2 to 3 weeks after the procedure.
207	(h)  Rules to prescribe minimum office or clinic incident
208	reporting. At a minimum, these rules shall require that:
209	1.  The office or clinic records each incident that results
210	in serious injury to a patient and shall report an incident in
211	writing to the department within 10 days after the incident
212	occurs. For the purposes of this paragraph, "serious injury"
213	means an injury that occurs at an office or clinic and that
214	creates a serious risk of substantial impairment of a major
215	bodily organ or bodily function.
216	2.  If a patient's death occurs, other than a fetal death
217	properly reported pursuant to law, the office or clinic reports
218	it to the department not later than the next department workday.
219	3.  Incident reports are filed with the department and
220	appropriate professional regulatory boards.
221	(4)  The department shall not release personally
222	identifiable patient or physician information.
223	(5)  The rules adopted pursuant to this section shall not
224	limit the ability of a physician to advise a patient on any
225	health issue.
226	(6)  The provisions of this section and the rules adopted
227	pursuant hereto shall be in addition to any other laws, rules,
228	and regulations which are applicable to facilities where
229	surgical procedures are performed.
230	(7)  The agency may adopt and enforce rules, in the
231	interest of protecting the public health, to ensure the prompt
232	and proper disposal of human tissue resulting from the
233	procedure.
234	(8)  If any owner, operator, or employee of an office or
235	clinic fails to dispose of human tissue in a manner consistent
236	with accepted medical standards in a competent professional
237	manner, the license of such office or clinic may be suspended or
238	revoked, and such person is guilty of a misdemeanor of the first
239	degree, punishable as provided in s. 775.082 or s. 775.083.
240	Section 3.  If any provision of this act or the application
241	thereof to any person or circumstance is held invalid, the
242	invalidity shall not affect other provisions or applications of
243	the act which can be given effect without the invalid provision
244	or application. To this end, the provisions of this act are
245	declared severable.
246	Section 4.  This act shall take effect July 1, 2005.
247
248	================= T I T L E  A M E N D M E N T =================
249	Remove the entire title and insert:
250	A bill to be entitled
251	An act relating to people's health and safety; providing a
252	popular name; creating s. 458.338, F.S.; authorizing the
253	Department of Health to develop and enforce rules for the
254	health, care, and treatment of persons in physicians' or
255	osteopathic physicians' offices or clinics and for the safe
256	operation of such offices or clinics; specifying the scope
257	of such rules; providing minimum requirements for such
258	rules; prohibiting the department from releasing certain
259	information; prohibiting the limitation of a physician's
260	ability to advise patients; providing for the continued
261	applicability of current laws, rules, and regulations
262	applicable to certain facilities; authorizing the Agency
263	for Health Care Administration to adopt and enforce certain
264	rules relating to the disposal of human tissue; providing a
265	ground for discipline relating to the disposal of human
266	tissue; providing severability; providing an effective
267	date.

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