State of Arizona
Second Regular Session
SENATE BILL 1324
Amending section 36‑449.03, Arizona Revised Statutes; relating to abortion clinics.
(TEXT OF BILL BEGINS ON NEXT PAGE)
Be it enacted by the Legislature of the State of Arizona:
Section 1. Section 36-449.03, Arizona Revised Statutes, is amended to read:
36-449.03. Abortion clinics; rules; civil penalties
A. The director shall adopt 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 gynecologic examination tables and other fixed equipment.
8. Postprocedure recovery rooms that are supervised, staffed and 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 department.
B. The director shall adopt 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 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. Require that the number or amount of equipment and supplies at the clinic is adequate at all times to assure sufficient quantities of clean and sterilized durable equipment and supplies to meet the needs of each patient.
3. 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.
4. Prescribe required equipment and supplies for required laboratory tests and requirements for protocols to calibrate and maintain laboratory equipment at the abortion clinic or operated by clinic staff.
5. Require ultrasound equipment.
6. 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. The director shall adopt rules relating to abortion clinic personnel. At a minimum these rules shall require that:
1. The abortion clinic designate a medical director of the abortion clinic who is licensed pursuant to title 32, chapter 13, 17 or 29.
2. Physicians performing abortions are licensed pursuant to title 32, chapter 13 or 17, demonstrate competence in the procedure involved and are acceptable to the medical director of the abortion clinic.
3. A physician is available:
(a) For a surgical abortion who has admitting privileges at a health care institution that is classified by the director as a hospital pursuant to section 36‑405, subsection B and that is within thirty miles of the abortion clinic.
(b) For a medication abortion who has admitting privileges at a health care institution that is classified by the director as a hospital pursuant to section 36‑405, subsection B.
4. If a physician is not present, a registered nurse, nurse practitioner, licensed practical nurse or physician assistant is present and remains at the clinic when abortions are performed to provide postoperative monitoring and care, or monitoring and care after inducing a medication abortion, until each patient who had an abortion that day is discharged.
5. Surgical assistants receive training in counseling, patient advocacy and the specific responsibilities of the services the surgical assistants provide.
6. Volunteers receive training in the specific responsibilities of 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. The director shall adopt 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 the following:
(a) Reported allergies to medications, antiseptic solutions or latex.
(b) Obstetric and gynecologic history.
(c) Past surgeries.
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 the person completed a course in the operation of ultrasound equipment as prescribed in rule. The physician or other health care professional shall review, at the request of the patient, the ultrasound evaluation results with the patient before the abortion procedure is performed, including the probable gestational age of the fetus.
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. The director shall adopt rules relating to the abortion procedure. At a minimum these rules shall require:
1. That medical personnel 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 local anesthesia, analgesia and sedation if ordered by the physician.
4. The use of appropriate precautions, such as the establishment of intravenous access at least for patients undergoing second or third trimester abortions.
5. The use of 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.
6. That any medication, drug or other substance used to induce an or cause a medication abortion, as defined in section 36‑2151, is administered in compliance with the Mifeprex final printing label protocol that is authorized approved by the United States food and drug administration and that is outlined in the final printing labeling instructions for that medication, drug or substance and in effect as of December 31, 2015.
F. The director shall adopt rules that prescribe minimum recovery room standards. At a minimum these rules shall require that:
1. For a surgical abortion, immediate postprocedure care, or care provided after inducing a medication abortion, consists of observation in a supervised recovery room for as long as the patient's condition warrants.
2. The clinic arrange hospitalization if any complication beyond the management capability of the staff occurs or is suspected.
3. A licensed health professional who is trained in the management of the recovery area and is capable of providing basic cardiopulmonary resuscitation and related emergency procedures remains on the premises of the abortion clinic until all patients are discharged.
4. For a surgical abortion, a physician with admitting privileges at a health care institution that is classified by the director as a hospital pursuant to section 36‑405, subsection B and that is within thirty miles of the abortion clinic remains on the premises of the abortion clinic until all patients are stable and are ready to leave the recovery room and to facilitate the transfer of emergency cases if hospitalization of the patient or viable fetus is necessary. A physician shall sign the discharge order and be readily accessible and available until the last patient is discharged.
5. A physician discusses RhO(d) immune globulin with each patient for whom it is indicated and assures it is offered to the patient in the immediate postoperative period or that it will be available to her within seventy‑two hours after completion of the abortion procedure. If the patient refuses, a refusal form approved by the department shall be signed by the patient and a witness and included in the medical record.
6. Written instructions with regard to postabortion coitus, signs of possible problems and general aftercare are given to each patient. Each patient shall have specific instructions regarding access to medical care for complications, including a telephone number to call for medical emergencies.
7. There is a specified minimum length of time that a patient remains in the recovery room by type of abortion procedure and duration of gestation.
8. The physician assures that a licensed health professional from the abortion clinic makes a good faith effort to contact the patient by telephone, with the patient's consent, within twenty‑four hours after a surgical abortion to assess the patient's recovery.
9. Equipment and services are located in the recovery room to provide appropriate emergency resuscitative and life support procedures pending the transfer of the patient or viable fetus to the hospital.
G. The director shall adopt rules that prescribe standards for follow‑up visits. At a minimum these rules shall require that:
1. For a surgical abortion, a postabortion medical visit is offered and, if requested, scheduled for three weeks after the abortion, including a medical examination and a review of the results of all laboratory tests. For a medication abortion, the rules shall require that a postabortion medical visit is scheduled between one week and three weeks after the initial dose of for a medication abortion to confirm the pregnancy is completely terminated and to assess the degree of bleeding.
2. A urine pregnancy test is obtained at the time of the follow‑up visit to rule out continuing pregnancy. If a continuing pregnancy is suspected, the patient shall be evaluated and a physician who performs abortions shall be consulted.
H. The director shall adopt rules to prescribe minimum abortion clinic incident reporting. At a minimum these rules shall require that:
1. The abortion clinic records each incident resulting in a patient's or viable fetus' serious injury occurring at an abortion clinic and shall report them in writing to the department within ten days after the incident. 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 body organ and includes any injury or condition that requires ambulance transportation of the patient.
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 work day.
3. Incident reports are filed with the department and appropriate professional regulatory boards.
I. The director shall adopt rules relating to enforcement of this article. At a minimum, these rules shall require that:
1. For an abortion clinic that is not in substantial compliance with this article and the rules adopted pursuant to this article or that is in substantial compliance but refuses to carry out a plan of correction acceptable to the department of any deficiencies that are listed on the department's state statement of deficiency, the department may do any of the following:
(a) Assess a civil penalty pursuant to section 36‑431.01.
(b) Impose an intermediate sanction pursuant to section 36‑427.
(c) Suspend or revoke a license pursuant to section 36‑427.
(d) Deny a license.
(e) Bring an action for an injunction pursuant to section 36‑430.
2. In determining the appropriate enforcement action, the department considers consider the threat of to the health, safety and welfare of the abortion clinic's patients or the general public, including:
(a) Whether the abortion clinic has repeated violations of statutes or rules.
(b) Whether the abortion clinic has engaged in a pattern of noncompliance.
(c) The type, severity and number of violations.
J. The department shall not release personally identifiable patient or physician information.
K. The rules adopted by the director pursuant to this section do not limit the ability of a physician or other health professional to advise a patient on any health issue.
Sec. 2. Rulemaking exemption
For the purposes of this act, the department of health services is exempt from the rulemaking requirements of title 41, chapter 6, Arizona Revised Statutes, for one year after the effective date of this act.
APPROVED BY THE GOVERNOR MARCH 30, 2016.
FILED IN THE OFFICE OF THE SECRETARY OF STATE MARCH 31, 2016.