| 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 in this state and who has |
| 120 | admitting privileges at a licensed hospital in this state or has |
| 121 | a transfer agreement with a licensed hospital within reasonable |
| 122 | proximity of the clinic. |
| 123 | 2. If a physician is not present after an abortion is |
| 124 | performed, a registered nurse, licensed practical nurse, |
| 125 | advanced registered nurse practitioner, or physician assistant |
| 126 | shall be present and remain at the clinic to provide |
| 127 | postoperative monitoring and care until the patient is |
| 128 | discharged. |
| 129 | 3. Surgical assistants receive training in counseling, |
| 130 | patient advocacy, and the specific responsibilities associated |
| 131 | with the services the surgical assistants provide. |
| 132 | 4. Volunteers receive training in the specific |
| 133 | responsibilities associated with the services the volunteers |
| 134 | provide, including counseling and patient advocacy as provided |
| 135 | in the rules adopted by the director for different types of |
| 136 | volunteers based on their responsibilities. |
| 137 | (d) Rules relating to the medical screening and evaluation |
| 138 | of each abortion clinic patient. At a minimum, these rules shall |
| 139 | require: |
| 140 | 1. A medical history including reported allergies to |
| 141 | medications, antiseptic solutions, or latex; past surgeries; and |
| 142 | an obstetric and gynecological history. |
| 143 | 2. A physical examination, including a bimanual |
| 144 | examination 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 |
| 147 | not performed before the abortion procedure, urine or blood |
| 148 | tests for pregnancy performed before the abortion procedure. |
| 149 | b. A test for anemia. |
| 150 | c. Rh typing, unless reliable written documentation of |
| 151 | blood type is available. |
| 152 | d. Other tests as indicated from the physical examination. |
| 153 | 4. An ultrasound evaluation for all patients who elect to |
| 154 | have an abortion after the first trimester. The rules shall |
| 155 | require that if a person who is not a physician performs an |
| 156 | ultrasound examination, that person shall have documented |
| 157 | evidence that he or she has completed a course in the operation |
| 158 | of ultrasound equipment as prescribed in rule. The physician, |
| 159 | registered nurse, licensed practical nurse, advanced registered |
| 160 | nurse practitioner, or physician assistant shall review, at the |
| 161 | request of the patient, the ultrasound evaluation results, |
| 162 | including an estimate of the probable gestational age of the |
| 163 | fetus, with the patient before the abortion procedure is |
| 164 | performed. |
| 165 | 5. That the physician is responsible for estimating the |
| 166 | gestational age of the fetus based on the ultrasound examination |
| 167 | and obstetric standards in keeping with established standards of |
| 168 | care regarding the estimation of fetal age as defined in rule |
| 169 | and shall write the estimate in the patient's medical history. |
| 170 | The physician shall keep original prints of each ultrasound |
| 171 | examination of a patient in the patient's medical history file. |
| 172 | (e) Rules relating to the abortion procedure. At a |
| 173 | minimum, these rules shall require: |
| 174 | 1. That a physician, registered nurse, licensed practical |
| 175 | nurse, advanced registered nurse practitioner, or physician |
| 176 | assistant is available to all patients throughout the abortion |
| 177 | procedure. |
| 178 | 2. Standards for the safe conduct of abortion procedures |
| 179 | that conform to obstetric standards in keeping with established |
| 180 | standards of care regarding the estimation of fetal age as |
| 181 | defined in rule. |
| 182 | 3. Appropriate use of general and local anesthesia, |
| 183 | analgesia, and sedation if ordered by the physician. |
| 184 | 4. Appropriate precautions, such as the establishment of |
| 185 | intravenous access at least for patients undergoing post-first |
| 186 | trimester abortions. |
| 187 | 5. Appropriate monitoring of the vital signs and other |
| 188 | defined signs and markers of the patient's status throughout the |
| 189 | abortion procedure and during the recovery period until the |
| 190 | patient's condition is deemed to be stable in the recovery room. |
| 191 | (f) Rules that prescribe minimum recovery room standards. |
| 192 | At a minimum, these rules shall require that: |
| 193 | 1. Postprocedure recovery rooms are supervised and staffed |
| 194 | to meet the patients' needs. |
| 195 | 2. Immediate postprocedure care consists of observation in |
| 196 | a supervised recovery room for as long as the patient's |
| 197 | condition warrants. |
| 198 | 3. The clinic arranges hospitalization if any complication |
| 199 | beyond the medical capability of the staff occurs or is |
| 200 | suspected. |
| 201 | 4. A registered nurse, licensed practical nurse, advanced |
| 202 | registered nurse practitioner, or physician assistant who is |
| 203 | trained in the management of the recovery area and is capable of |
| 204 | providing basic cardiopulmonary resuscitation and related |
| 205 | emergency procedures remains on the premises of the abortion |
| 206 | clinic until all patients are discharged. |
| 207 | 5. A physician shall sign the discharge order and be |
| 208 | readily accessible and available until the last patient is |
| 209 | discharged to facilitate the transfer of emergency cases if |
| 210 | hospitalization of the patient or viable fetus is necessary. |
| 211 | 6. A physician discusses Rho(D) immune globulin with each |
| 212 | patient for whom it is indicated and ensures that it is offered |
| 213 | to the patient in the immediate postoperative period or that it |
| 214 | will be available to her within 72 hours after completion of the |
| 215 | abortion procedure. If the patient refuses the Rho(D) immune |
| 216 | globulin, a refusal form approved by the agency shall be signed |
| 217 | by the patient and a witness and included in the medical record. |
| 218 | 7. Written instructions with regard to postabortion |
| 219 | coitus, signs of possible problems, and general aftercare are |
| 220 | given to each patient. Each patient shall have specific written |
| 221 | instructions regarding access to medical care for complications, |
| 222 | including a telephone number to call for medical emergencies. |
| 223 | 8. There is a specified minimum length of time that a |
| 224 | patient remains in the recovery room by type of abortion |
| 225 | procedure and duration of gestation. |
| 226 | 9. The physician ensures that a registered nurse, licensed |
| 227 | practical nurse, advanced registered nurse practitioner, or |
| 228 | physician assistant from the abortion clinic makes a good faith |
| 229 | effort to contact the patient by telephone, with the patient's |
| 230 | consent, within 24 hours after surgery to assess the patient's |
| 231 | recovery. |
| 232 | 10. Equipment and services are readily accessible to |
| 233 | provide appropriate emergency resuscitative and life support |
| 234 | procedures pending the transfer of the patient or viable fetus |
| 235 | to the hospital. |
| 236 | (g) Rules that prescribe standards for followup care. At a |
| 237 | minimum, these rules shall require that: |
| 238 | 1. A postabortion medical visit that includes a medical |
| 239 | examination and a review of the results of all laboratory tests |
| 240 | is offered. |
| 241 | 2. A urine pregnancy test is obtained at the time of the |
| 242 | followup visit to rule out continuing pregnancy. |
| 243 | 3. If a continuing pregnancy is suspected, the patient |
| 244 | shall be evaluated and a physician who performs abortions shall |
| 245 | be consulted. |
| 246 | (h) Rules to prescribe minimum abortion clinic incident |
| 247 | reporting. At a minimum, these rules shall require that: |
| 248 | 1. The abortion clinic records each incident that results |
| 249 | in serious injury to a patient or a viable fetus at an abortion |
| 250 | clinic and shall report an incident in writing to the agency |
| 251 | within 10 days after the incident occurs. For the purposes of |
| 252 | this paragraph, "serious injury" means an injury that occurs at |
| 253 | an abortion clinic and that creates a serious risk of |
| 254 | substantial impairment of a major bodily organ. |
| 255 | 2. If a patient's death occurs, other than a fetal death |
| 256 | properly reported pursuant to law, the abortion clinic reports |
| 257 | it to the department not later than the next department workday. |
| 258 | (4) The rules adopted pursuant to this section shall not |
| 259 | limit the ability of a physician to advise a patient on any |
| 260 | health issue. |
| 261 | (5) The provisions of this section and the rules adopted |
| 262 | pursuant hereto shall be in addition to any other laws, rules, |
| 263 | and regulations which are applicable to facilities defined as |
| 264 | abortion clinics under this section. |
| 265 | (6)(2) The agency may adopt and enforce rules, in the |
| 266 | interest of protecting the public health, to ensure the prompt |
| 267 | and proper disposal of fetal remains and tissue resulting from |
| 268 | pregnancy termination. |
| 269 | (7)(3) If any owner, operator, or employee of an abortion |
| 270 | clinic fails to dispose of fetal remains and tissue in a manner |
| 271 | consistent with the disposal of other human tissue in a |
| 272 | competent professional manner, the license of such clinic may be |
| 273 | suspended or revoked, and such person is guilty of a misdemeanor |
| 274 | of the first degree, punishable as provided in s. 775.082 or s. |
| 275 | 775.083. |
| 276 | Section 3. If any provision of this act or the application |
| 277 | thereof to any person or circumstance is held invalid, the |
| 278 | invalidity shall not affect other provisions or applications of |
| 279 | the act which can be given effect without the invalid provision |
| 280 | or application. To this end, the provisions of this act are |
| 281 | declared severable. |
| 282 | Section 4. This act shall take effect July 1, 2005. |