SB1361 - 502R

Be it enacted by the Legislature of the State of Arizona:

Section 1. Section 36-2311, Arizona Revised Statutes, is amended to read:

START_STATUTE36-2311. Definitions

In this article, unless the context otherwise requires:

1. "Assisted reproductive technology" means any procedure, treatment or medical or scientific intervention provided for the purpose of formation of a human embryo with the intent to produce a live birth.

1. 2. "Destructive human embryonic stem cell research" means any research that involves the disaggregation of any human embryo for the purpose of creating human pluripotent stem cells or human pluripotent stem cell lines.

3. "Gamete" means a human egg or human spermatozoon.

4. "Gamete donor" means an egg donor or a person unrelated by marriage to the recipient who provides or agrees to provide gametes for the purposes of treating human infertility.

2. 5. "Human-animal hybrid" means any of the following:

(a) A human embryo into which a nonhuman cell or cells, or any component part of a nonhuman cell or cells, have been introduced.

(b) A hybrid human-animal embryo produced by fertilizing a human egg with a nonhuman sperm.

(d) An embryo produced by introducing a nonhuman nucleus into a human egg.

(e) An embryo produced by introducing a human nucleus into a nonhuman egg.

(f) An embryo containing at least haploid sets of chromosomes from both a human and a nonhuman life form.

(g) A nonhuman life form engineered so that human gametes develop within the body of a nonhuman life form.

(h) A nonhuman life form engineered so that it contains a human brain or a brain derived wholly or predominantly from human neural tissues.

3. 6. "Human embryo" means a living organism of the species homo sapiens through the first fifty-six days of its development, excluding any time during which its development has been suspended.

4. 7. "In vitro" means outside the human body.

5. 8. "Purchase or sell" includes an exchange of cash, an in-kind payment or any other valuable financial or nonfinancial consideration. Purchase or sell does not include payment of costs related to donation of a human embryo for the purpose of implantation in the body of a woman. END_STATUTE

Sec. 2. Title 36, chapter 23, article 2, Arizona Revised Statutes, is amended by adding sections 36-2314, 36-2315 and 36-2316, to read:

START_STATUTE36-2314. Assisted reproductive technology; informed consent; unprofessional conduct

A. A physician providing assisted reproductive technologies, at least twenty-four hours before the physician obtains a signed contract for services, must provide patients with the following information in writing and obtain a signed informed consent form before services commence:

1. A description of the procedure.

2. The likelihood that the patient will become pregnant, based on experience of that particular physician with patients of comparable age and medical conditions.

3. If the physician operates out of a facility, statistics on the facility's success rate, including the total number of live births, the number of live births as a percentage of completed retrieval cycles, the rates for clinical pregnancy and delivery per completed retrieval cycle bracketed by age groups consisting of women under thirty years of age, women who are thirty through thirty-four years of age, women who are thirty-five through thirty-nine years of age and women who are at least forty years of age.

4. A description of alternative therapies and treatments, including adoption and natural cycling.

5. The likelihood of the patient having a live-born child based on a forthright assessment of her particular age, circumstances and embryo transfer options.

6. A statement that the patient retains the right to withhold or withdraw consent at any time before transfer of gametes or embryos without affecting her right to future care or treatment or risking the loss or withdrawal of any program benefits to which the patient would otherwise be entitled.

7. A description of the known and potential risks, consequences and benefits of assisted reproductive technology, including psychological risks associated with all drugs and procedures considered, the inherent risk of embryo loss due to aneuploidy, failure of implantation or thawing, the risks associated with the use of hormones and other drugs that may be used, egg retrieval, multiple pregnancies and selective reduction.

8. The most recent statistics reported by the facility to federal and state agencies, along with information on where to obtain reported statistics from all other fertility facilities in the state and national statistics as reported to the United States centers for disease control and prevention, along with an explanation of the relevance of the statistics.

9. The anticipated price to the patient of all procedures, including any charges for procedures and medications not covered in the standard fee.

10. The average cost to patients of a successful assisted pregnancy.

11. The likelihood that selective reduction might be recommended as a response to multiple gestation, along with a clear explanation of the nature of selective reduction and the associated risks for the mother and any surviving child.

12. Information about embryo conception and transfer, including the patient's right to determine the number of embryos or oocytes to conceive and transfer and the most recent scientific information on the number of embryos needed to be transferred for a successful pregnancy.

13. If the patient is using donor gametes, the psychological screening and the testing protocol used to ensure that gamete donors are free from known infection, including human immunodeficiency viruses, and free from carriers of known genetic and chromosomal diseases.

14. If the patient is using donor gametes, notice that use of an anonymous gamete donor will affect the genetic child and may have negative effects on the child, including tension, confusion and distress about the child's origins and ancestry.

15. The availability of embryo adoption for untransferred embryos and information on agencies in the state that process or facilitate embryo adoption.

16. The risks of cryopreservation for embryos, including information concerning the current feasibility of freezing eggs rather than embryos, and any influence that may have on the likelihood of a live birth.

17. A description of the facility's practice regarding selecting embryos as viable to transfer, including whether embryos will be deemed not viable for transfer and the outcome for those embryos, including whether those embryos will be destroyed, used for training or used for research.

18. The current law governing disputes concerning untransferred embryos.

19. Information concerning disposition of untransferred embryos that may be chosen by the patient, the rights of patients regarding that disposition and the need to state their wishes and intentions regarding disposition.

20. The effect on treatment, embryos and the validity of informed consent of clinic closings, divorce, separation, failure to pay storage fees for untransferred embryos, failure to pay treatment fees, inability to agree on the fate of embryos, the death of a patient or others, withdrawal of consent for transfer after fertilization but before cryopreservation, incapacity, unavailability of agreed on disposition of embryos or loss of contact with the facility.

21. That there may be foreseen or unforeseen legal consequences and that it is advisable to seek legal counsel.

22. That all existing confidentiality protections apply and what these confidentiality protections are.

23. That a patient has access to all of the patient's medical information to the extent the law allows.

B. A patient must be informed of the option of additional counseling throughout future procedures, even if counseling was refused in the past.

C. Each time a new cycle is undertaken, informed consent must be obtained and information provided to the patient with the latest statistics and findings concerning the patient's status.

D. The provider must document informed consent in a record for each participant that must:

1. Be in plain language.

2. Be dated and signed by the provider and by the participant.

3. State that disclosures have been made pursuant to this section.

4. Specify the length of time the consent remains valid.

5. Advise the party signing the informed consent document of the right to receive a copy of the record.

E. Except in an emergency, the record must be signed by the parties before informed consent is valid or the commencement of any assisted reproductive technology.

F. This section does not require a physician to provide additional information or obtain additional informed consent if the physician's current practices relating to informed consent already meet the standards prescribed by subsections a through d of this section.

G. A physician who knowingly violates this section commits an act of unprofessional conduct and is subject to license suspension or revocation pursuant to title 32, chapter 13 or 17. END_STATUTE

START_STATUTE36-2315. Assisted reproductive technology; required disclosures

A. Before each retrieval and each transfer, a physician must disclose to all participants the following possible dispositions of embryos, together with a statement as to which are allowed under applicable law:

1. Storage, including length of time, costs and location.

2. Transfer.

3. Donation as follows:

(a) To a known individual for transfer.

(b) To an anonymous individual for transfer.

(c) For scientific or clinical research, including the institution conducting the research and the intended nature of the research, if known.

4. Destruction.

B. A physician is not required to offer all possible dispositions, but the physician must inform the patient that other providers may offer other options and that the patient has the right to transport embryos to other providers.

C. Before each transfer cycle, the provider must provide each intended parent with the following information in a record, where applicable:

1. The method used to achieve fertilization and the results of semen analysis, including, at a minimum, motility, count and morphology.

2. The number of eggs retrieved.

3. For the retrieval and transfer of fresh embryos:

(a) The number created.

(b) The number viable for transfer.

(d) The number to be transferred.

(e) The number preserved.

(f) The quality of each embryo transferred.

(g) The quality of each embryo preserved.

4. For the transfer of preserved embryos:

(a) The number of embryos thawed.

(b) The number of embryos viable for transfer after thawing.

5. A statement that failure to adhere to drug administration schedules may affect the outcome of the treatment. END_STATUTE

START_STATUTE36-2316. Assisted reproductive technology facilities; reporting requirements; unprofessional conduct; violations; classification

A. All assisted reproductive technology facilities must confidentially collect and maintain the following information pertaining to the particular facility and confidentially submit a report, on a form and in a manner prescribed by the department, not later than February 1 following the year the procedures were performed:

1. The rates of success, as defined as the total number of live births achieved, the percentage of live births per completed cycle of egg retrieval and the numbers of both clinical pregnancy and actual delivery as ratios against the number of retrieval cycles completed. The programs must break down these statistics into the following age groups:

(a) Women who are under thirty years of age.

(b) Women who are thirty through thirty-four years of age.

(d) Women who are at least forty years of age.

2. The rate of live births per transfer.

3. The number of live births per ovarian stimulation, broken down into the following age groups:

(a) Women who are under thirty years of age.

(b) Women who are thirty through thirty-four years of age.

(d) Women who are at least forty years of age.

4. Information regarding the safekeeping of embryos, including:

(a) The storage location, if stored.

(b) If transferred to another facility, the location to which it was relocated.

(d) The total number of embryos deemed not viable for transfer or preservation and destroyed.

(e) The total number of embryos deemed not viable for transfer or preservation and used for training.

(f) The total number of embryos deemed not viable for transfer or preservation and used for research.

(g) The total number of preserved embryos destroyed.

(h) The total number of preserved embryos used for research.

(i) The total number of preserved embryos donated to any person for research.

(j) The total number of preserved embryos donated to another individual for transfer.

5. The percentage usage of types of assisted reproductive technology, including in vitro fertilization, gamete intrafallopian transfer and zygote intrafallopian transfer.

6. The percentage of pregnancies resulting in multi-fetal pregnancies, broken down by number of fetuses.

7. The percentage of live births having multiple infants.

8. The number of selective reductions performed broken down by the number of embryos transferred before the reduction.

9. the percentage of transferred embryos that implant.

10. The percentage of premature births per singleton and multiple births.

11. The use of preimplantation genetic diagnosis, if used, including data on its safety and efficacy.

12. The percentage of birth defects per singleton and multiple births.

13. The percentage of selective reductions that resulted in a miscarriage.

B. A report filed pursuant to this section must be filed electronically at an internet website that is designated by the department unless the person required to file the report applies for a waiver from electronic reporting by submitting a written request to the department.

C. A report required by this section shall not contain the name of the patient, common identifiers, such as the woman's social security number, driver license number or insurance carrier identification numbers, or any other information or identifiers that would make it possible to identify in any manner or under any circumstances a woman who has undergone an egg donation procedure.

D. The department shall collect all assisted reproductive technology reports and prepare a comprehensive annual statistical report based on the data gathered in the reports. The statistical report shall not cause the disclosure of the identity of any person about whom a report is filed. The department shall make the statistical report available on its website and for public inspection and copying.

E. Original copies of all reports filed pursuant to this section are available to the Arizona medical board and the Arizona board of osteopathic examiners in medicine and surgery for use in the performance of their official duties. The Arizona medical board and the Arizona board of osteopathic examiners in medicine and surgery must maintain the confidentiality of any patient who is identified in reports obtained pursuant to this subsection.

F. A person who is required by this section to file a report, keep any records or supply any information and who wilfully fails to file that report, keep records or supply information as required by law is guilty of unprofessional conduct and is subject to disciplinary action, including license suspension or revocation.

G. A person who wilfully delivers or discloses to the department any report, record or information known by that person to be false commits a class 1 misdemeanor.

H. In addition to the penalties prescribed by subsections F and G of this section, an organization or facility that wilfully violates the reporting requirements of this article is subject to disciplinary action by the department, including civil penalties as prescribed in section 36‑431.01. END_STATUTE