HB 1041

1
A bill to be entitled
2An act relating to women's health care; providing a
3popular name; amending s. 390.012, F.S.; revising
4requirements for rules of the Agency for Health Care
5Administration relating to abortion clinics performing
6abortions after the first trimester of pregnancy;
7requiring rules that prescribe standards for physical
8facilities, supplies and equipment, personnel, screening
9and evaluation, the abortion procedure, recovery, follow-up
10care, and incident reporting; providing that rules
11regulating abortion clinics may not impose an
12unconstitutional burden rather than a legally significant
13burden on a woman's right to choose to terminate her
14pregnancy; providing for severability; providing an
15effective date.
16
17     WHEREAS, abortion is an invasive surgical procedure that
18can lead to numerous and serious medical complications,
19including, but not limited to, bleeding, hemorrhage, infection,
20uterine perforation, blood clots, cervical tears, incomplete
21abortion and retained tissue, failure to actually terminate the
22pregnancy, free fluid in the abdomen, missed ectopic
23pregnancies, cardiac arrest, sepsis, respiratory arrest,
24reactions to anesthesia, fertility problems, emotional problems,
25and even death, and
26     WHEREAS, the state has a legitimate interest in ensuring
27that abortions, like any other medical procedure, be performed
28under circumstances that ensure maximum safety for the patient,
29and
30     WHEREAS, the risks for abortion are greater after the first
31trimester of pregnancy, and
32     WHEREAS, the risk of hemorrhage, in particular, is greater
33after the first trimester of pregnancy, and the resultant
34complications may require a hysterectomy, other reparative
35surgery, or a blood transfusion, NOW, THEREFORE,
36
37Be It Enacted by the Legislature of the State of Florida:
38
39     Section 1.  This act may be cited as the "Women's Health
40and Safety Act."
41     Section 2.  Section 390.012, Florida Statutes, is amended
42to read:
43     390.012  Powers of agency; rules; disposal of fetal
44remains.--
45     (1)  The agency shall have the authority to develop and
46enforce rules for the health, care, and treatment of persons in
47abortion clinics and for the safe operation of such clinics.
48These rules shall be comparable to rules which apply to all
49surgical procedures requiring approximately the same degree of
50skill and care as the performance of first trimester abortions.
51     (a)  The rules shall be reasonably related to the
52preservation of maternal health of the clients.
53     (b)  The rules shall be in accordance with s. 797.03 and
54may not impose an unconstitutional a legally significant burden
55on a woman's freedom to decide whether to terminate her
56pregnancy.
57     (c)  The rules shall provide for:
58     1.(a)  The performance of pregnancy termination procedures
59only by a licensed physician.
60     2.(b)  The making, protection, and preservation of patient
61records, which shall be treated as medical records under chapter
62458.
63     (2)  For clinics that perform abortions in the first
64trimester of pregnancy only, these rules shall be comparable to
65rules that apply to all surgical procedures requiring
66approximately the same degree of skill and care as the
67performance of first trimester abortions.
68     (3)  For clinics that perform or claim to perform abortions
69after the first trimester of pregnancy, the agency shall adopt
70rules pursuant to ss. 120.536(1) and 120.54 to implement the
71provisions of this chapter, including the following:
72     (a)  Rules for an abortion clinic's physical facilities. At
73a minimum, these rules shall prescribe standards for:
74     1.  Adequate private space that is specifically designated
75for interviewing, counseling, and medical evaluations.
76     2.  Dressing rooms for staff and patients.
77     3.  Appropriate lavatory areas.
78     4.  Areas for preprocedure hand washing.
79     5.  Private procedure rooms.
80     6.  Adequate lighting and ventilation for abortion
81procedures.
82     7.  Surgical or gynecological examination tables and other
83fixed equipment.
84     8.  Postprocedure recovery rooms that are equipped to meet
85the patients' needs.
86     9.  Emergency exits to accommodate a stretcher or gurney.
87     10.  Areas for cleaning and sterilizing instruments.
88     11.  Adequate areas for the secure storage of medical
89records and necessary equipment and supplies.
90     12.  The display in the abortion clinic, in a place that is
91conspicuous to all patients, of the clinic's current license
92issued by the agency.
93     (b)  Rules to prescribe abortion clinic supplies and
94equipment standards, including supplies and equipment that are
95required to be immediately available for use or in an emergency.
96At a minimum, these rules shall:
97     1.  Prescribe required clean and sterilized equipment and
98supplies, including medications, required for the conduct, in an
99appropriate fashion, of any abortion procedure that the medical
100staff of the clinic anticipates performing and for monitoring
101the progress of each patient throughout the procedure and
102recovery period.
103     2.  Prescribe required equipment, supplies, and medications
104that shall be available and ready for immediate use in an
105emergency and requirements for written protocols and procedures
106to be followed by staff in an emergency, such as the loss of
107electrical power.
108     3.  Prescribe equipment and supplies for required
109laboratory tests and requirements for protocols to calibrate and
110maintain laboratory equipment or equipment operated by clinic
111staff at the abortion clinic.
112     4.  Require ultrasound equipment.
113     5.  Require that all equipment is safe for the patient and
114the staff, meets applicable federal standards, and is checked
115annually to ensure safety and appropriate calibration.
116     (c)  Rules relating to abortion clinic personnel. At a
117minimum, these rules shall require that:
118     1.  The abortion clinic designate a medical director who is
119licensed to practice medicine in this state and who has
120admitting privileges at a licensed hospital in this state or has
121a transfer agreement with a licensed hospital within reasonable
122proximity of the clinic.
123     2.  If a physician is not present after an abortion is
124performed, a registered nurse, licensed practical nurse,
125advanced registered nurse practitioner, or physician assistant
126shall be present and remain at the clinic to provide
127postoperative monitoring and care until the patient is
128discharged.
129     3.  Surgical assistants receive training in counseling,
130patient advocacy, and the specific responsibilities associated
131with the services the surgical assistants provide.
132     4.  Volunteers receive training in the specific
133responsibilities associated with the services the volunteers
134provide, including counseling and patient advocacy as provided
135in the rules adopted by the director for different types of
136volunteers based on their responsibilities.
137     (d)  Rules relating to the medical screening and evaluation
138of each abortion clinic patient. At a minimum, these rules shall
139require:
140     1.  A medical history including reported allergies to
141medications, antiseptic solutions, or latex; past surgeries; and
142an obstetric and gynecological history.
143     2.  A physical examination, including a bimanual
144examination estimating uterine size and palpation of the adnexa.
145     3.  The appropriate laboratory tests, including:
146     a.  For an abortion in which an ultrasound examination is
147not performed before the abortion procedure, urine or blood
148tests for pregnancy performed before the abortion procedure.
149     b.  A test for anemia.
150     c.  Rh typing, unless reliable written documentation of
151blood type is available.
152     d.  Other tests as indicated from the physical examination.
153     4.  An ultrasound evaluation for all patients who elect to
154have an abortion after the first trimester. The rules shall
155require that if a person who is not a physician performs an
156ultrasound examination, that person shall have documented
157evidence that he or she has completed a course in the operation
158of ultrasound equipment as prescribed in rule. The physician,
159registered nurse, licensed practical nurse, advanced registered
160nurse practitioner, or physician assistant shall review, at the
161request of the patient, the ultrasound evaluation results,
162including an estimate of the probable gestational age of the
163fetus, with the patient before the abortion procedure is
164performed.
165     5.  That the physician is responsible for estimating the
166gestational age of the fetus based on the ultrasound examination
167and obstetric standards in keeping with established standards of
168care regarding the estimation of fetal age as defined in rule
169and shall write the estimate in the patient's medical history.
170The physician shall keep original prints of each ultrasound
171examination of a patient in the patient's medical history file.
172     (e)  Rules relating to the abortion procedure. At a
173minimum, these rules shall require:
174     1.  That a physician, registered nurse, licensed practical
175nurse, advanced registered nurse practitioner, or physician
176assistant is available to all patients throughout the abortion
177procedure.
178     2.  Standards for the safe conduct of abortion procedures
179that conform to obstetric standards in keeping with established
180standards of care regarding the estimation of fetal age as
181defined in rule.
182     3.  Appropriate use of general and local anesthesia,
183analgesia, and sedation if ordered by the physician.
184     4.  Appropriate precautions, such as the establishment of
185intravenous access at least for patients undergoing post-first
186trimester abortions.
187     5.  Appropriate monitoring of the vital signs and other
188defined signs and markers of the patient's status throughout the
189abortion procedure and during the recovery period until the
190patient's condition is deemed to be stable in the recovery room.
191     (f)  Rules that prescribe minimum recovery room standards.
192At a minimum, these rules shall require that:
193     1.  Postprocedure recovery rooms are supervised and staffed
194to meet the patients' needs.
195     2.  Immediate postprocedure care consists of observation in
196a supervised recovery room for as long as the patient's
197condition warrants.
198     3.  The clinic arranges hospitalization if any complication
199beyond the medical capability of the staff occurs or is
200suspected.
201     4.  A registered nurse, licensed practical nurse, advanced
202registered nurse practitioner, or physician assistant who is
203trained in the management of the recovery area and is capable of
204providing basic cardiopulmonary resuscitation and related
205emergency procedures remains on the premises of the abortion
206clinic until all patients are discharged.
207     5.  A physician shall sign the discharge order and be
208readily accessible and available until the last patient is
209discharged to facilitate the transfer of emergency cases if
210hospitalization of the patient or viable fetus is necessary.
211     6.  A physician discusses Rho(D) immune globulin with each
212patient for whom it is indicated and ensures that it is offered
213to the patient in the immediate postoperative period or that it
214will be available to her within 72 hours after completion of the
215abortion procedure. If the patient refuses the Rho(D) immune
216globulin, a refusal form approved by the agency shall be signed
217by the patient and a witness and included in the medical record.
218     7.  Written instructions with regard to postabortion
219coitus, signs of possible problems, and general aftercare are
220given to each patient. Each patient shall have specific written
221instructions regarding access to medical care for complications,
222including a telephone number to call for medical emergencies.
223     8.  There is a specified minimum length of time that a
224patient remains in the recovery room by type of abortion
225procedure and duration of gestation.
226     9.  The physician ensures that a registered nurse, licensed
227practical nurse, advanced registered nurse practitioner, or
228physician assistant from the abortion clinic makes a good faith
229effort to contact the patient by telephone, with the patient's
230consent, within 24 hours after surgery to assess the patient's
231recovery.
232     10.  Equipment and services are readily accessible to
233provide appropriate emergency resuscitative and life support
234procedures pending the transfer of the patient or viable fetus
235to the hospital.
236     (g)  Rules that prescribe standards for followup care. At a
237minimum, these rules shall require that:
238     1.  A postabortion medical visit that includes a medical
239examination and a review of the results of all laboratory tests
240is offered.
241     2.  A urine pregnancy test is obtained at the time of the
242followup visit to rule out continuing pregnancy.
243     3.  If a continuing pregnancy is suspected, the patient
244shall be evaluated and a physician who performs abortions shall
245be consulted.
246     (h)  Rules to prescribe minimum abortion clinic incident
247reporting. At a minimum, these rules shall require that:
248     1.  The abortion clinic records each incident that results
249in serious injury to a patient or a viable fetus at an abortion
250clinic and shall report an incident in writing to the agency
251within 10 days after the incident occurs. For the purposes of
252this paragraph, "serious injury" means an injury that occurs at
253an abortion clinic and that creates a serious risk of
254substantial impairment of a major bodily organ.
255     2.  If a patient's death occurs, other than a fetal death
256properly reported pursuant to law, the abortion clinic reports
257it to the department not later than the next department workday.
258     (4)  The rules adopted pursuant to this section shall not
259limit the ability of a physician to advise a patient on any
260health issue.
261     (5)  The provisions of this section and the rules adopted
262pursuant hereto shall be in addition to any other laws, rules,
263and regulations which are applicable to facilities defined as
264abortion clinics under this section.
265     (6)(2)  The agency may adopt and enforce rules, in the
266interest of protecting the public health, to ensure the prompt
267and proper disposal of fetal remains and tissue resulting from
268pregnancy termination.
269     (7)(3)  If any owner, operator, or employee of an abortion
270clinic fails to dispose of fetal remains and tissue in a manner
271consistent with the disposal of other human tissue in a
272competent professional manner, the license of such clinic may be
273suspended or revoked, and such person is guilty of a misdemeanor
274of the first degree, punishable as provided in s. 775.082 or s.
275775.083.
276     Section 3.  If any provision of this act or the application
277thereof to any person or circumstance is held invalid, the
278invalidity shall not affect other provisions or applications of
279the act which can be given effect without the invalid provision
280or application. To this end, the provisions of this act are
281declared severable.
282     Section 4.  This act shall take effect July 1, 2005.


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