1 | A bill to be entitled |
2 | An act relating to women's health care; providing a |
3 | popular name; amending s. 390.012, F.S.; revising |
4 | requirements for rules of the Agency for Health Care |
5 | Administration relating to abortion clinics performing |
6 | abortions after the first trimester of pregnancy; |
7 | requiring rules that prescribe standards for physical |
8 | facilities, supplies and equipment, personnel, screening |
9 | and evaluation, the abortion procedure, recovery, follow-up |
10 | care, and incident reporting; providing that rules |
11 | regulating abortion clinics may not impose an |
12 | unconstitutional burden rather than a legally significant |
13 | burden on a woman's right to choose to terminate her |
14 | pregnancy; providing for severability; providing an |
15 | effective date. |
16 |
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17 | WHEREAS, abortion is an invasive surgical procedure that |
18 | can lead to numerous and serious medical complications, |
19 | including, but not limited to, bleeding, hemorrhage, infection, |
20 | uterine perforation, blood clots, cervical tears, incomplete |
21 | abortion and retained tissue, failure to actually terminate the |
22 | pregnancy, free fluid in the abdomen, missed ectopic |
23 | pregnancies, cardiac arrest, sepsis, respiratory arrest, |
24 | reactions to anesthesia, fertility problems, emotional problems, |
25 | and even death, and |
26 | WHEREAS, the state has a legitimate interest in ensuring |
27 | that abortions, like any other medical procedure, be performed |
28 | under circumstances that ensure maximum safety for the patient, |
29 | and |
30 | WHEREAS, the risks for abortion are greater after the first |
31 | trimester of pregnancy, and |
32 | WHEREAS, the risk of hemorrhage, in particular, is greater |
33 | after the first trimester of pregnancy, and the resultant |
34 | complications may require a hysterectomy, other reparative |
35 | surgery, or a blood transfusion, NOW, THEREFORE, |
36 |
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37 | Be It Enacted by the Legislature of the State of Florida: |
38 |
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39 | Section 1. This act may be cited as the "Women's Health |
40 | and Safety Act." |
41 | Section 2. Section 390.012, Florida Statutes, is amended |
42 | to read: |
43 | 390.012 Powers of agency; rules; disposal of fetal |
44 | remains.-- |
45 | (1) The agency shall have the authority to develop and |
46 | enforce rules for the health, care, and treatment of persons in |
47 | abortion clinics and for the safe operation of such clinics. |
48 | These rules shall be comparable to rules which apply to all |
49 | surgical procedures requiring approximately the same degree of |
50 | skill and care as the performance of first trimester abortions. |
51 | (a) The rules shall be reasonably related to the |
52 | preservation of maternal health of the clients. |
53 | (b) The rules shall be in accordance with s. 797.03 and |
54 | may not impose an unconstitutional a legally significant burden |
55 | on a woman's freedom to decide whether to terminate her |
56 | pregnancy. |
57 | (c) The rules shall provide for: |
58 | 1.(a) The performance of pregnancy termination procedures |
59 | only by a licensed physician. |
60 | 2.(b) The making, protection, and preservation of patient |
61 | records, which shall be treated as medical records under chapter |
62 | 458. |
63 | (2) For clinics that perform abortions in the first |
64 | trimester of pregnancy only, these rules shall be comparable to |
65 | rules that apply to all surgical procedures requiring |
66 | approximately the same degree of skill and care as the |
67 | performance of first trimester abortions. |
68 | (3) For clinics that perform or claim to perform abortions |
69 | after the first trimester of pregnancy, the agency shall adopt |
70 | rules pursuant to ss. 120.536(1) and 120.54 to implement the |
71 | provisions of this chapter, including the following: |
72 | (a) Rules for an abortion clinic's physical facilities. At |
73 | a minimum, these rules shall prescribe standards for: |
74 | 1. Adequate private space that is specifically designated |
75 | for 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 |
81 | procedures. |
82 | 7. Surgical or gynecological examination tables and other |
83 | fixed equipment. |
84 | 8. Postprocedure recovery rooms that are equipped to meet |
85 | the 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 |
89 | records and necessary equipment and supplies. |
90 | 12. The display in the abortion clinic, in a place that is |
91 | conspicuous to all patients, of the clinic's current license |
92 | issued by the agency. |
93 | (b) Rules to prescribe abortion clinic supplies and |
94 | equipment standards, including supplies and equipment that are |
95 | required to be immediately available for use or in an emergency. |
96 | At a minimum, these rules shall: |
97 | 1. Prescribe required clean and sterilized equipment and |
98 | supplies, including medications, required for the conduct, in an |
99 | appropriate fashion, of any abortion procedure that the medical |
100 | staff of the clinic anticipates performing and for monitoring |
101 | the progress of each patient throughout the procedure and |
102 | recovery period. |
103 | 2. Prescribe required equipment, supplies, and medications |
104 | that shall be available and ready for immediate use in an |
105 | emergency and requirements for written protocols and procedures |
106 | to be followed by staff in an emergency, such as the loss of |
107 | electrical power. |
108 | 3. Prescribe equipment and supplies for required |
109 | laboratory tests and requirements for protocols to calibrate and |
110 | maintain laboratory equipment or equipment operated by clinic |
111 | staff at the abortion clinic. |
112 | 4. Require ultrasound equipment. |
113 | 5. Require that all equipment is safe for the patient and |
114 | the staff, meets applicable federal standards, and is checked |
115 | annually to ensure safety and appropriate calibration. |
116 | (c) Rules relating to abortion clinic personnel. At a |
117 | minimum, these rules shall require that: |
118 | 1. The abortion clinic designate a medical director who is |
119 | licensed to practice medicine and surgery in the state and who |
120 | has admitting privileges at an accredited hospital in the state |
121 | that is within 50 miles of the abortion clinic. |
122 | 2. If a physician is not present after an abortion is |
123 | performed, a registered nurse, licensed practical nurse, |
124 | advanced registered nurse practitioner, or physician assistant |
125 | shall be present and remain at the clinic to provide |
126 | postoperative monitoring and care until the patient is |
127 | discharged. |
128 | 3. Surgical assistants receive training in counseling, |
129 | patient advocacy, and the specific responsibilities associated |
130 | with the services the surgical assistants provide. |
131 | 4. Volunteers receive training in the specific |
132 | responsibilities associated with the services the volunteers |
133 | provide, including counseling and patient advocacy as provided |
134 | in the rules adopted by the director for different types of |
135 | volunteers based on their responsibilities. |
136 | (d) Rules relating to the medical screening and evaluation |
137 | of each abortion clinic patient. At a minimum, these rules shall |
138 | require: |
139 | 1. A medical history including reported allergies to |
140 | medications, antiseptic solutions, or latex; past surgeries; and |
141 | an obstetric and gynecological history. |
142 | 2. A physical examination, including a bimanual |
143 | examination estimating uterine size and palpation of the adnexa. |
144 | 3. The appropriate laboratory tests, including: |
145 | a. For an abortion in which an ultrasound examination is |
146 | not performed before the abortion procedure, urine or blood |
147 | tests for pregnancy performed before the abortion procedure. |
148 | b. A test for anemia. |
149 | c. Rh typing, unless reliable written documentation of |
150 | blood type is available. |
151 | d. Other tests as indicated from the physical examination. |
152 | 4. An ultrasound evaluation for all patients who elect to |
153 | have an abortion after the first trimester. The rules shall |
154 | require that if a person who is not a physician performs an |
155 | ultrasound examination, that person shall have documented |
156 | evidence that he or she has completed a course in the operation |
157 | of ultrasound equipment as prescribed in rule. The physician, |
158 | registered nurse, licensed practical nurse, advanced registered |
159 | nurse practitioner, or physician assistant shall review, at the |
160 | request of the patient, the ultrasound evaluation results, |
161 | including an estimate of the probable gestational age of the |
162 | fetus, with the patient before the abortion procedure is |
163 | performed. |
164 | 5. That the physician is responsible for estimating the |
165 | gestational age of the fetus based on the ultrasound examination |
166 | and obstetric standards in keeping with established standards of |
167 | care regarding the estimation of fetal age as defined in rule |
168 | and shall write the estimate in the patient's medical history. |
169 | The physician shall keep original prints of each ultrasound |
170 | examination of a patient in the patient's medical history file. |
171 | (e) Rules relating to the abortion procedure. At a |
172 | minimum, these rules shall require: |
173 | 1. That a physician, registered nurse, licensed practical |
174 | nurse, advanced registered nurse practitioner, or physician |
175 | assistant is available to all patients throughout the abortion |
176 | procedure. |
177 | 2. Standards for the safe conduct of abortion procedures |
178 | that conform to obstetric standards in keeping with established |
179 | standards of care regarding the estimation of fetal age as |
180 | defined in rule. |
181 | 3. Appropriate use of general and local anesthesia, |
182 | analgesia, and sedation if ordered by the physician. |
183 | 4. Appropriate precautions, such as the establishment of |
184 | intravenous access at least for patients undergoing post-first |
185 | trimester abortions. |
186 | 5. Appropriate monitoring of the vital signs and other |
187 | defined signs and markers of the patient's status throughout the |
188 | abortion procedure and during the recovery period until the |
189 | patient's condition is deemed to be stable in the recovery room. |
190 | (f) Rules that prescribe minimum recovery room standards. |
191 | At a minimum, these rules shall require that: |
192 | 1. Postprocedure recovery rooms are supervised and staffed |
193 | to meet the patients' needs. |
194 | 2. Immediate postprocedure care consists of observation in |
195 | a supervised recovery room for as long as the patient's |
196 | condition warrants. |
197 | 3. The clinic arranges hospitalization if any complication |
198 | beyond the medical capability of the staff occurs or is |
199 | suspected. |
200 | 4. A registered nurse, licensed practical nurse, advanced |
201 | registered nurse practitioner, or physician assistant who is |
202 | trained in the management of the recovery area and is capable of |
203 | providing basic cardiopulmonary resuscitation and related |
204 | emergency procedures remains on the premises of the abortion |
205 | clinic until all patients are discharged. |
206 | 5. A physician shall sign the discharge order and be |
207 | readily accessible and available until the last patient is |
208 | discharged to facilitate the transfer of emergency cases if |
209 | hospitalization of the patient or viable fetus is necessary. |
210 | 6. A physician discusses Rho(D) immune globulin with each |
211 | patient for whom it is indicated and ensures that it is offered |
212 | to the patient in the immediate postoperative period or that it |
213 | will be available to her within 72 hours after completion of the |
214 | abortion procedure. If the patient refuses the Rho(D) immune |
215 | globulin, a refusal form approved by the agency shall be signed |
216 | by the patient and a witness and included in the medical record. |
217 | 7. Written instructions with regard to postabortion |
218 | coitus, signs of possible problems, and general aftercare are |
219 | given to each patient. Each patient shall have specific written |
220 | instructions regarding access to medical care for complications, |
221 | including a telephone number to call for medical emergencies. |
222 | 8. There is a specified minimum length of time that a |
223 | patient remains in the recovery room by type of abortion |
224 | procedure and duration of gestation. |
225 | 9. The physician ensures that a registered nurse, licensed |
226 | practical nurse, advanced registered nurse practitioner, or |
227 | physician assistant from the abortion clinic makes a good faith |
228 | effort to contact the patient by telephone, with the patient's |
229 | consent, within 24 hours after surgery to assess the patient's |
230 | recovery. |
231 | 10. Equipment and services are readily accessible to |
232 | provide appropriate emergency resuscitative and life support |
233 | procedures pending the transfer of the patient or viable fetus |
234 | to the hospital. |
235 | (g) Rules that prescribe standards for followup care. At a |
236 | minimum, these rules shall require that: |
237 | 1. A postabortion medical visit that includes a medical |
238 | examination and a review of the results of all laboratory tests |
239 | is offered. |
240 | 2. A urine pregnancy test is obtained at the time of the |
241 | followup visit to rule out continuing pregnancy. |
242 | 3. If a continuing pregnancy is suspected, the patient |
243 | shall be evaluated and a physician who performs abortions shall |
244 | be consulted. |
245 | (h) Rules to prescribe minimum abortion clinic incident |
246 | reporting. At a minimum, these rules shall require that: |
247 | 1. The abortion clinic records each incident that results |
248 | in serious injury to a patient or a viable fetus at an abortion |
249 | clinic and shall report an incident in writing to the agency |
250 | within 10 days after the incident occurs. For the purposes of |
251 | this paragraph, "serious injury" means an injury that occurs at |
252 | an abortion clinic and that creates a serious risk of |
253 | substantial impairment of a major bodily organ. |
254 | 2. If a patient's death occurs, other than a fetal death |
255 | properly reported pursuant to law, the abortion clinic reports |
256 | it to the department not later than the next department workday. |
257 | (4) The rules adopted pursuant to this section shall not |
258 | limit the ability of a physician to advise a patient on any |
259 | health issue. |
260 | (5) The provisions of this section and the rules adopted |
261 | pursuant hereto shall be in addition to any other laws, rules, |
262 | and regulations which are applicable to facilities defined as |
263 | abortion clinics under this section. |
264 | (6)(2) The agency may adopt and enforce rules, in the |
265 | interest of protecting the public health, to ensure the prompt |
266 | and proper disposal of fetal remains and tissue resulting from |
267 | pregnancy termination. |
268 | (7)(3) If any owner, operator, or employee of an abortion |
269 | clinic fails to dispose of fetal remains and tissue in a manner |
270 | consistent with the disposal of other human tissue in a |
271 | competent professional manner, the license of such clinic may be |
272 | suspended or revoked, and such person is guilty of a misdemeanor |
273 | of the first degree, punishable as provided in s. 775.082 or s. |
274 | 775.083. |
275 | Section 3. If any provision of this act or the application |
276 | thereof to any person or circumstance is held invalid, the |
277 | invalidity shall not affect other provisions or applications of |
278 | the act which can be given effect without the invalid provision |
279 | or application. To this end, the provisions of this act are |
280 | declared severable. |
281 | Section 4. This act shall take effect July 1, 2005. |