2016 Florida Statutes
Powers of agency; rules; disposal of fetal remains.
Powers of agency; rules; disposal of fetal remains.
390.012 Powers of agency; rules; disposal of fetal remains.—
(1) The agency may develop and enforce rules pursuant to ss. 390.011-390.018 and part II of chapter 408 for the health, care, and treatment of persons in abortion clinics and for the safe operation of such clinics.
(a) The rules shall be reasonably related to the preservation of maternal health of the clients.
(b) The rules shall be in accordance with s. 797.03 and may not impose an unconstitutional burden on a woman’s freedom to decide whether to terminate her pregnancy.
(c) The rules shall provide for:
1. The performance of pregnancy termination procedures only by a licensed physician.
2. The making, protection, and preservation of patient records, which shall be treated as medical records under chapter 458. When performing a license inspection of a clinic, the agency shall inspect at least 50 percent of patient records generated since the clinic’s last license inspection.
3. Annual inspections by the agency of all clinics licensed under this chapter to ensure that such clinics are in compliance with this chapter and agency rules.
4. The prompt investigation of credible allegations of abortions being performed at a clinic that is not licensed to perform such procedures.
(2) For clinics that perform abortions in the first trimester of pregnancy only, these rules must be comparable to rules that apply to all surgical procedures requiring approximately the same degree of skill and care as the performance of first trimester abortions and must require:
(a) Clinics to have a written patient transfer agreement with a hospital within reasonable proximity to the clinic which includes the transfer of the patient’s medical records held by the clinic and the treating physician to the licensed hospital; or
(b) Physicians who perform abortions at the clinic to have admitting privileges at a hospital within reasonable proximity to the clinic.
(3) For clinics that perform or claim to perform abortions after the first trimester of pregnancy, the agency shall adopt rules pursuant to ss. 120.536(1) and 120.54 to implement the provisions of this chapter, including the following:
(a) Rules for an abortion clinic’s physical facilities. At a minimum, these rules shall prescribe standards for:
1. Adequate private space that is specifically designated for interviewing, counseling, and medical evaluations.
2. Dressing rooms for staff and patients.
3. Appropriate lavatory areas.
4. Areas for preprocedure hand washing.
5. Private procedure rooms.
6. Adequate lighting and ventilation for abortion procedures.
7. Surgical or gynecological examination tables and other fixed equipment.
8. Postprocedure recovery rooms that are equipped to meet the patients’ needs.
9. Emergency exits to accommodate a stretcher or gurney.
10. Areas for cleaning and sterilizing instruments.
11. Adequate areas for the secure storage of medical records and necessary equipment and supplies.
12. The display in the abortion clinic, in a place that is conspicuous to all patients, of the clinic’s current license issued by the agency.
(b) Rules to prescribe abortion clinic supplies and equipment standards, including supplies and equipment that are required to be immediately available for use or in an emergency. At a minimum, these rules shall:
1. Prescribe required clean and sterilized equipment and supplies, including medications, required for the conduct, in an appropriate fashion, of any abortion procedure that the medical staff of the clinic anticipates performing and for monitoring the progress of each patient throughout the procedure and recovery period.
2. Prescribe required equipment, supplies, and medications that shall be available and ready for immediate use in an emergency and requirements for written protocols and procedures to be followed by staff in an emergency, such as the loss of electrical power.
3. Prescribe equipment and supplies for required laboratory tests and requirements for protocols to calibrate and maintain laboratory equipment or equipment operated by clinic staff at the abortion clinic.
4. Require ultrasound equipment.
5. Require that all equipment is safe for the patient and the staff, meets applicable federal standards, and is checked annually to ensure safety and appropriate calibration.
(c) Rules relating to abortion clinic personnel. At a minimum, these rules shall require that:
1. The abortion clinic designate a medical director who is licensed to practice medicine in this state, and all physicians who perform abortions in the clinic have admitting privileges at a hospital within reasonable proximity to the clinic, unless the clinic has a written patient transfer agreement with a hospital within reasonable proximity to the clinic which includes the transfer of the patient’s medical records held by both the clinic and the treating physician.
2. If a physician is not present after an abortion is performed, a registered nurse, licensed practical nurse, advanced registered nurse practitioner, or physician assistant be present and remain at the clinic to provide postoperative monitoring and care until the patient is discharged.
3. Surgical assistants receive training in counseling, patient advocacy, and the specific responsibilities associated with the services the surgical assistants provide.
4. Volunteers receive training in the specific responsibilities associated with the services the volunteers provide, including counseling and patient advocacy as provided in the rules adopted by the director for different types of volunteers based on their responsibilities.
(d) Rules relating to the medical screening and evaluation of each abortion clinic patient. At a minimum, these rules shall require:
1. A medical history including reported allergies to medications, antiseptic solutions, or latex; past surgeries; and an obstetric and gynecological history.
2. A physical examination, including a bimanual examination estimating uterine size and palpation of the adnexa.
3. The appropriate laboratory tests, including:
a. Urine or blood tests for pregnancy performed before the abortion procedure.
b. A test for anemia.
c. Rh typing, unless reliable written documentation of blood type is available.
d. Other tests as indicated from the physical examination.
4. An ultrasound evaluation for all patients. The rules shall require that if a person who is not a physician performs an ultrasound examination, that person shall have documented evidence that he or she has completed a course in the operation of ultrasound equipment as prescribed in rule. The rules shall require clinics to be in compliance with s. 390.0111.
5. That the physician is responsible for estimating the gestational age of the fetus based on the ultrasound examination and obstetric standards in keeping with established standards of care regarding the estimation of fetal age as defined in rule and shall write the estimate in the patient’s medical history. The physician shall keep original prints of each ultrasound examination of a patient in the patient’s medical history file.
(e) Rules relating to the abortion procedure. At a minimum, these rules shall require:
1. That a physician, registered nurse, licensed practical nurse, advanced registered nurse practitioner, or physician assistant is available to all patients throughout the abortion procedure.
2. Standards for the safe conduct of abortion procedures that conform to obstetric standards in keeping with established standards of care regarding the estimation of fetal age as defined in rule.
3. Appropriate use of general and local anesthesia, analgesia, and sedation if ordered by the physician.
4. Appropriate precautions, such as the establishment of intravenous access at least for patients undergoing post-first trimester abortions.
5. Appropriate monitoring of the vital signs and other defined signs and markers of the patient’s status throughout the abortion procedure and during the recovery period until the patient’s condition is deemed to be stable in the recovery room.
(f) Rules that prescribe minimum recovery room standards. At a minimum, these rules must require that:
1. Postprocedure recovery rooms be supervised and staffed to meet the patients’ needs.
2. Immediate postprocedure care consist of observation in a supervised recovery room for as long as the patient’s condition warrants.
3. A registered nurse, licensed practical nurse, advanced registered nurse practitioner, or physician assistant who is trained in the management of the recovery area and is capable of providing basic cardiopulmonary resuscitation and related emergency procedures remain on the premises of the abortion clinic until all patients are discharged.
4. A physician sign the discharge order and be readily accessible and available until the last patient is discharged to facilitate the transfer of emergency cases if hospitalization of the patient or viable fetus is necessary.
5. A physician discuss Rho(D) immune globulin with each patient for whom it is indicated and ensure that it is offered to the patient in the immediate postoperative period or will be available to her within 72 hours after completion of the abortion procedure. If the patient refuses the Rho(D) immune globulin, she and a witness must sign a refusal form approved by the agency which must be included in the medical record.
6. Written instructions with regard to postabortion coitus, signs of possible problems, and general aftercare which are specific to the patient be given to each patient. The instructions must include information regarding access to medical care for complications, including a telephone number for use in the event of a medical emergency.
7. A minimum length of time be specified, by type of abortion procedure and duration of gestation, during which a patient must remain in the recovery room.
8. The physician ensure that, with the patient’s consent, a registered nurse, licensed practical nurse, advanced registered nurse practitioner, or physician assistant from the abortion clinic makes a good faith effort to contact the patient by telephone within 24 hours after surgery to assess the patient’s recovery.
9. Equipment and services be readily accessible to provide appropriate emergency resuscitative and life support procedures pending the transfer of the patient or viable fetus to the hospital.
(g) Rules that prescribe standards for followup care. At a minimum, these rules shall require that:
1. A postabortion medical visit that includes a medical examination and a review of the results of all laboratory tests is offered.
2. A urine pregnancy test is obtained at the time of the followup visit to rule out continuing pregnancy.
3. If a continuing pregnancy is suspected, the patient shall be evaluated and a physician who performs abortions shall be consulted.
(h) Rules to prescribe minimum abortion clinic incident reporting. At a minimum, these rules shall require that:
1. The abortion clinic records each incident that results in serious injury to a patient or a viable fetus at an abortion clinic and shall report an incident in writing to the agency within 10 days after the incident occurs. For the purposes of this paragraph, “serious injury” means an injury that occurs at an abortion clinic and that creates a serious risk of substantial impairment of a major bodily organ.
2. If a patient’s death occurs, other than a fetal death properly reported pursuant to law, the abortion clinic reports it to the department not later than the next department workday.
(4) The rules adopted pursuant to this section shall not limit the ability of a physician to advise a patient on any health issue.
(5) The provisions of this section and the rules adopted pursuant hereto shall be in addition to any other laws, rules, and regulations which are applicable to facilities defined as abortion clinics under this section.
(6) The agency may adopt and enforce rules, in the interest of protecting the public health, to ensure the prompt and proper disposal of fetal remains and tissue resulting from pregnancy termination.
(7) If an owner, operator, or employee of an abortion clinic fails to dispose of fetal remains and tissue in a sanitary manner pursuant to s. 381.0098, rules adopted thereunder, and rules adopted by the agency pursuant to this section, the license of such clinic may be suspended or revoked, and such person commits a misdemeanor of the first degree, punishable as provided in s. 775.082 or s. 775.083.
(8) Beginning February 1, 2017, and annually thereafter, the agency shall submit a report to the President of the Senate and the Speaker of the House of Representatives which summarizes all regulatory actions taken during the prior year by the agency under this chapter.
History.—s. 2, ch. 78-382; s. 1, ch. 80-413; s. 1, ch. 86-286; ss. 1, 4, 5, ch. 88-97; s. 65, ch. 91-224; s. 4, ch. 91-429; s. 5, ch. 97-151; s. 2, ch. 2005-95; s. 15, ch. 2007-230; s. 96, ch. 2008-4; s. 2, ch. 2011-224; s. 2, ch. 2015-118; s. 4, ch. 2016-150.