Amendment
Bill No. 1041
Amendment No. 128679
CHAMBER ACTION
Senate House
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1Representative(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
6and Safety Act."
7     Section 2.  Section 459.0124, Florida Statutes, is created
8to read:
9     459.0124  Powers of agency; rules; disposal of human
10tissue.--
11     (1)  The Department of Health shall have the authority to
12develop and enforce rules for the health, care, and treatment of
13persons in physicians' or osteopathic physicians' offices or
14clinics and for the safe operation of such offices or clinics.
15     (a)  The rules shall be reasonably related to the
16preservation of the health of the patients.
17     (b)  The rules may not impose an unconstitutional burden on
18a patient's privacy rights including a woman's freedom to decide
19whether to terminate her pregnancy.
20     (c)  The rules shall provide for:
21     1.  The performance of surgical procedures only by a
22licensed physician.
23     2.  The making, protection, and preservation of patient
24records, which shall be treated as medical records under this
25chapter.
26     (2)  For clinics that perform abortions in the first
27trimester of pregnancy only, these rules shall be comparable to
28rules that apply to all surgical procedures requiring
29approximately the same degree of skill and care as the
30performance of first trimester abortions.
31     (3)  For offices and clinics in which abortions and other
32surgical procedures having patient risks similar to or greater
33than abortions performed after the first trimester of pregnancy,
34the agency shall adopt rules pursuant to ss. 120.536(1) and
35120.54 to implement the provisions of this chapter, including
36the following:
37     (a)  Rules for a physician's or osteopathic physician's
38office or clinic's physical facilities. At a minimum, these
39rules shall prescribe standards for:
40     1.  Adequate private space that is specifically designated
41for 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
48fixed equipment.
49     8.  Postprocedure recovery rooms that are equipped to meet
50the 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
54records and necessary equipment and supplies.
55     12.  The display in the office or clinic, in a place that
56is conspicuous to all patients, of the physician's or
57osteopathic physician's and the clinic's current license issued
58by the department.
59     (b)  Rules to prescribe office or clinic supplies and
60equipment standards, including supplies and equipment that are
61required to be immediately available for use or in an emergency.
62At a minimum, these rules shall:
63     1.  Prescribe required clean and sterilized equipment and
64supplies, including medications, required for the conduct, in an
65appropriate fashion, of any procedure that the medical staff of
66the office or clinic anticipates performing and for monitoring
67the progress of each patient throughout the procedure and
68recovery period.
69     2.  Prescribe required equipment, supplies, and medications
70that shall be available and ready for immediate use in an
71emergency and requirements for written protocols and procedures
72to be followed by staff in an emergency, such as the loss of
73electrical power.
74     3.  Prescribe equipment and supplies for required
75laboratory tests and requirements for protocols to calibrate and
76maintain laboratory equipment or equipment operated by office or
77clinic staff at the office or clinic.
78     4.  Require ultrasound equipment in those facilities that
79provide abortions after 12 weeks' gestation.
80     5.  Require that all equipment is safe for the patient and
81the staff, meets applicable federal standards, and is checked
82annually to ensure safety and appropriate calibration.
83     (c)  Rules relating to medical office or clinic personnel.
84At a minimum, these rules shall require that:
85     1.  A clinic designate a medical director who is licensed
86to practice medicine and surgery in the state and who has
87admitting privileges at an accredited hospital in the state that
88is within 50 miles of the clinic.
89     2.  If a physician is not present after a procedure is
90performed, a registered nurse, licensed practical nurse,
91advanced registered nurse practitioner, or physician assistant
92shall be present and remain at the clinic to provide
93postoperative monitoring and care until the patient is
94discharged.
95     3.  Surgical assistants receive training in counseling,
96patient advocacy, and the specific responsibilities associated
97with the services the surgical assistants provide.
98     4.  Volunteers receive training in the specific
99responsibilities associated with the services the volunteers
100provide, including counseling and patient advocacy as provided
101in the rules adopted by the director for different types of
102volunteers based on their responsibilities.
103     (d)  Rules relating to the medical screening and evaluation
104of each patient. At a minimum, these rules shall require:
105     1.  A medical history including reported allergies to
106medications, antiseptic solutions, or latex; past surgeries; and
107an obstetric and gynecological history.
108     2.  A physical examination, including a bimanual
109examination estimating uterine size and palpation of the adnexa
110if 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
113not performed before the abortion procedure, urine or blood
114tests for pregnancy performed before the abortion procedure.
115     b.  A test for anemia.
116     c.  Rh typing, unless reliable written documentation of
117blood type is available.
118     d.  Other tests as indicated from the physical examination.
119     4.  An ultrasound evaluation for all patients who elect to
120have an abortion after 12 weeks' gestation. The rules shall
121require that if a person who is not a physician performs an
122ultrasound examination, that person shall have documented
123evidence that he or she has completed a course in the operation
124of ultrasound equipment as prescribed in rule. The physician,
125registered nurse, licensed practical nurse, advanced registered
126nurse practitioner, or physician assistant shall review, at the
127request of the patient, the ultrasound evaluation results,
128including an estimate of the probable gestational age of the
129fetus, with the patient before the abortion procedure is
130performed.
131     5.  That the physician is responsible for estimating the
132gestational age of the fetus based on the ultrasound examination
133and obstetric standards in keeping with established standards of
134care regarding the estimation of fetal age as defined in rule
135and shall write the estimate in the patient's medical history.
136The physician shall keep original prints of each ultrasound
137examination of a patient in the patient's medical history file.
138     (e)  Rules relating to the surgical procedure. At a
139minimum, these rules shall require:
140     1.  That a physician, registered nurse, licensed practical
141nurse, advanced registered nurse practitioner, or physician
142assistant is available to all patients throughout the surgical
143procedure.
144     2.  Standards for the safe conduct of surgical procedures
145that conform to medical standards in keeping with established
146standards of care.
147     3.  Appropriate use of general and local anesthesia,
148analgesia, and sedation if ordered by the physician or
149osteopathic physician.
150     4.  Appropriate precautions, such as the establishment of
151intravenous access where medically appropriate.
152     5.  Appropriate monitoring of the vital signs and other
153defined signs and markers of the patient's status throughout the
154surgical procedure and during the recovery period until the
155patient's condition is deemed to be stable in the recovery room.
156     (f)  Rules that prescribe minimum recovery room standards.
157At a minimum, these rules shall require that:
158     1.  Postprocedure recovery rooms are supervised and staffed
159to meet the patients' needs.
160     2.  Immediate postprocedure care consists of observation in
161a supervised recovery room for as long as the patient's
162condition warrants.
163     3.  The office or clinic arranges hospitalization if any
164complication beyond the medical capability of the staff occurs
165or is suspected.
166     4.  A registered nurse, licensed practical nurse, advanced
167registered nurse practitioner, or physician assistant who is
168trained in the management of the recovery area and is capable of
169providing basic cardiopulmonary resuscitation and related
170emergency procedures remains on the premises of the office or
171clinic until all patients are discharged.
172     5.  A physician shall sign the discharge order and be
173readily accessible and available until the last patient is
174discharged to facilitate the transfer of emergency cases if
175hospitalization of the patient is necessary.
176     6.  A physician discusses Rho(D) immune globulin with each
177patient for whom it is indicated and ensures that it is offered
178to the patient in the immediate postoperative period or that it
179will be available to her within 72 hours after completion of the
180abortion procedure. If the patient refuses the Rho(D) immune
181globulin, a refusal form approved by the department shall be
182signed by the patient and a witness and included in the medical
183record.
184     7.  Written instructions with regard to post-procedure
185coitus, signs of possible problems, and general aftercare are
186given to each patient. Each patient shall have specific written
187instructions regarding access to medical care for complications,
188including a telephone number to call for medical emergencies.
189     8.  There is a specified minimum length of time that a
190patient remains in the recovery room by accepted medical
191standards.
192     9.  The physician or osteopathic physician ensures that a
193registered nurse, licensed practical nurse, advanced registered
194nurse practitioner, or physician assistant makes a good faith
195effort to contact the patient by telephone, with the patient's
196consent, within 24 hours after surgery to assess the patient's
197recovery.
198     10.  Equipment and services are located in the recovery
199room to provide appropriate emergency resuscitative and life
200support procedures pending the transfer of the patient to the
201hospital.
202     (g)  Rules that prescribe standards for followup care. At a
203minimum, these rules shall require that a post-surgery medical
204visit that includes a medical examination and a review of the
205results of all laboratory tests is offered and, if requested,
206scheduled for 2 to 3 weeks after the procedure.
207     (h)  Rules to prescribe minimum office or clinic incident
208reporting. At a minimum, these rules shall require that:
209     1.  The office or clinic records each incident that results
210in serious injury to a patient and shall report an incident in
211writing to the department within 10 days after the incident
212occurs. For the purposes of this paragraph, "serious injury"
213means an injury that occurs at an office or clinic and that
214creates a serious risk of substantial impairment of a major
215bodily organ or bodily function.
216     2.  If a patient's death occurs, other than a fetal death
217properly reported pursuant to law, the office or clinic reports
218it to the department not later than the next department workday.
219     3.  Incident reports are filed with the department and
220appropriate professional regulatory boards.
221     (4)  The department shall not release personally
222identifiable patient or physician information.
223     (5)  The rules adopted pursuant to this section shall not
224limit the ability of a physician to advise a patient on any
225health issue.
226     (6)  The provisions of this section and the rules adopted
227pursuant hereto shall be in addition to any other laws, rules,
228and regulations which are applicable to facilities where
229surgical procedures are performed.
230     (7)  The agency may adopt and enforce rules, in the
231interest of protecting the public health, to ensure the prompt
232and proper disposal of human tissue resulting from the
233procedure.
234     (8)  If any owner, operator, or employee of an office or
235clinic fails to dispose of human tissue in a manner consistent
236with accepted medical standards in a competent professional
237manner, the license of such office or clinic may be suspended or
238revoked, and such person is guilty of a misdemeanor of the first
239degree, punishable as provided in s. 775.082 or s. 775.083.
240     Section 3.  If any provision of this act or the application
241thereof to any person or circumstance is held invalid, the
242invalidity shall not affect other provisions or applications of
243the act which can be given effect without the invalid provision
244or application. To this end, the provisions of this act are
245declared 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
251An act relating to people's health and safety; providing a
252popular name; creating s. 459.0124, F.S.; authorizing the
253Department of Health to develop and enforce rules for the
254health, care, and treatment of persons in physicians' or
255osteopathic physicians' offices or clinics and for the
256safe operation of such offices or clinics; specifying the
257scope of such rules; providing minimum requirements for
258such rules; prohibiting the department from releasing
259certain information; prohibiting the limitation of a
260physician's ability to advise patients; providing for the
261continued applicability of current laws, rules, and
262regulations applicable to certain facilities; authorizing
263the Agency for Health Care Administration to adopt and
264enforce certain rules relating to the disposal of human
265tissue; providing a ground for discipline relating to the
266disposal of human tissue; providing severability;
267providing an effective date.


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