HB2307 - 522R

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

Section 1. Section 36-414, Arizona Revised Statutes, is amended to read:

START_STATUTE36-414. Health services licensing fund; exemption

A. The health services licensing fund is established consisting of monies deposited pursuant to sections 36‑405, 36‑851.01, 36‑882, 36‑897.01 and 36‑1903. The department of health services shall administer the fund.

B. Monies in the fund are subject to legislative appropriation.

C. Monies in the fund are exempt from the provisions of section 35‑190 relating to lapsing of appropriations. END_STATUTE

Sec. 2. Section 36-841, Arizona Revised Statutes, is amended to read:

START_STATUTE36-841. Definitions

In this article, unless the context otherwise requires:

1. "Adult" means an individual who is at least eighteen years of age.

2. "Agent" means an individual who is either:

(a) Authorized to make health care decisions on the principal's behalf pursuant to a health care power of attorney.

(b) Expressly authorized to make an anatomical gift on the principal's behalf pursuant to any other record signed by the principal.

3. "Anatomical gift" means a donation of all or part of a human body to take effect after the donor's death for the purpose of transplantation, therapy, research or education.

4. "Decedent" means a deceased individual whose body or part is or may be the source of an anatomical gift. Decedent includes a stillborn infant and, subject to restrictions imposed by any other law, a fetus.

5. "Disinterested witness" means a witness other than the spouse, child, parent, sibling, grandchild, grandparent or guardian of the individual who makes, amends, revokes or refuses to make an anatomical gift, or another adult who exhibited special care and concern for the individual. Disinterested witness does not include a person to which an anatomical gift could pass pursuant to section 36‑850.

6. "Document of gift" means a donor card or other record that is used to make an anatomical gift. Document of gift includes a statement or symbol on a driver license, identification card or donor registry.

7. "Donor" means an individual whose body or part is the subject of an anatomical gift.

8. "Donor registry" means a database that contains records of anatomical gifts.

9. "Driver license" means a license or permit that is issued pursuant to title 28 to operate a vehicle, whether or not conditions are attached to the license or permit.

10. "Eye bank" means a person that is licensed or regulated under federal or state law or and that is accredited by a nationally recognized accrediting agency to engage in the recovery, screening, testing, processing, storage or distribution of human eyes or portions of human eyes.

11. "Guardian" means a person who is appointed by a court to make decisions regarding the support, care, education, health or welfare of an individual. Guardian does not include a guardian ad litem.

12. "Hospital" means a facility that is licensed as a hospital under the laws of any state or that is operated as a hospital by the United States, a state or a subdivision of a state.

13. "Identification card" means an a nonoperating identification card license that is issued by the motor vehicle division of the department of transportation.

14. "Know" means to have actual knowledge.

15. "Minor" means an individual who is under eighteen years of age.

16. "Organ procurement organization" means a person that is licensed under state law, that is accredited by a nationally recognized accrediting agency and that is designated by the secretary of the United States department of health and human services as an organ procurement organization.

17. "Parent" means a parent whose parental rights have not been terminated.

18. "Part" means an organ, eye or tissue of a human being. Part does not include the whole body.

19. "Person" means an individual, corporation, business trust, estate, trust, partnership, limited liability company, association, joint venture, public corporation, government or governmental subdivision, agency or instrumentality, or any other legal or commercial entity.

20. "Physician" means an individual who is licensed as a physician pursuant to title 32, chapter 13 or 17.

21. "Principal" means a person who is the subject of a health care power of attorney.

22. "Procurement organization" means any of the following that is licensed pursuant to section 36‑851.01:

(a) An organ procurement organization.

(b) A tissue bank for the recovery of tissues for transplantation, therapy, research or education.

(d) A storage facility that is licensed, accredited or approved under federal law or the laws of any state by a nationally recognized accrediting agency to engage in the recovery, screening, testing, processing, storage or distribution of human bodies or parts.

23. "Prospective donor" means an individual who is dead or near death and who has been determined by a procurement organization to have a part that could be medically suitable for transplantation, therapy, research or education. Prospective donor does not include an individual who has made a refusal.

24. "Reasonably available" means able to be contacted by a procurement organization without undue effort and willing and able to act in a timely manner consistent with existing medical criteria necessary for the making of an anatomical gift.

25. "Recipient" means an individual into whose body a decedent's part has been or is intended to be transplanted.

26. "Record" means information that is inscribed on a tangible medium or that is stored in an electronic or other medium and is retrievable in perceivable form.

27. "Refusal" means a record created pursuant to section 36‑846 that expressly states an intent to bar other persons from making an anatomical gift of an individual's body or part.

28. "Sign", with respect to the present intent to authenticate or adopt a record, means either:

(a) To execute or adopt a tangible symbol.

(b) To attach to or logically associate with the record an electronic symbol, sound or process.

29. "State" means a state of the United States, the District of Columbia, Puerto Rico, the United States Virgin Islands or any territory or insular possession subject to the jurisdiction of the United States.

30. "Technician" means an individual who is determined to be qualified to remove or process parts by an appropriate organization that is licensed or regulated under federal or state law or is accredited by a nationally recognized accrediting agency. Technician includes an enucleator.

31. "Tissue" means all or a portion of the human body other than blood, an organ or an eye unless the blood, organ or eye is donated for the purpose of transplantation, research or education.

32. "Tissue bank" means a person that is licensed or regulated under federal or state law or and that is accredited as a tissue bank by a nationally recognized accrediting agency organization to engage in the recovery, screening, testing, processing, storage or distribution of tissue for transplantation, therapy, research or education.

33. "Transplant hospital" means a hospital that furnishes organ transplants and other medical and surgical specialty services required for the care of transplant patients. END_STATUTE

Sec. 3. Section 36-848, Arizona Revised Statutes, is amended to read:

START_STATUTE36-848. Who may make anatomical gift of decedent's body or part

A. Subject to the requirements of subsections B and C of this section, and unless barred pursuant to section 36‑846 or 36‑847, an anatomical gift for transplantation, therapy, research or education may be made by any member of the following classes of persons who is reasonably available, in the order of priority listed:

1. An agent of the decedent at the time of death who could have made an anatomical gift pursuant to section 36‑843 immediately before the decedent's death.

2. The decedent's spouse.

3. The decedent's adult children.

4. The decedent's parents.

5. If the decedent is unmarried, the decedent's domestic partner, if another person had not assumed financial responsibility for the decedent.

6. The decedent's adult siblings.

7. The decedent's adult grandchildren.

8. The decedent's grandparents.

9. An adult who exhibited special care and concern for the decedent.

10. The persons who were acting as the guardians of the person of the decedent at the time of death.

11. Any other person who has the authority to dispose of the decedent's body.

B. If there is more than one member of a class that is listed in subsection A, paragraph 1, 3, 4, 5, 6, 7, 8 or 10 of this section who is entitled to make an anatomical gift, an anatomical gift may be made by a member of the class unless that member or a person to which the gift may pass pursuant to section 36‑850 knows of an objection by another member of the class. If an objection is known, the gift may be made only by a majority of the members of the class who are reasonably available.

C. A person may not make an anatomical gift if, at the time of the decedent's death, a person in a prior class pursuant to subsection A of this section is reasonably available to make or to object to the making of an anatomical gift.

D. If the decedent's body is not within the custody of the county medical examiner, the county health officer may release and permit the removal of any part from the body in the county health officer's custody for transplantation, therapy, education or research if the requirements of section 36‑860, subsection A, B are met. END_STATUTE

Sec. 4. Section 36-850, Arizona Revised Statutes, is amended to read:

START_STATUTE36-850. Persons who may receive anatomical gifts; purpose of anatomical gift

A. An anatomical gift may be made to the following named in the document of gift:

1. An organ procurement organization.

2. A hospital, accredited medical school, dental school, college, university, or procurement organization or any other appropriate person, for research or education.

3. Subject to the requirements of subsection B of this section, an individual designated by the person making the anatomical gift if the individual is the recipient of the part.

4. An eye bank or a tissue bank.

B. If an anatomical gift to an individual pursuant to subsection A, paragraph 3 of this section cannot be transplanted into the individual, the part passes pursuant to subsection G H of this section in the absence of an express contrary indication by the person making the anatomical gift.

C. If an anatomical gift of one or more specific parts or of all parts is made in a document of gift that does not name a person described in subsection A of this section but that identifies the purpose for which an anatomical gift may be used, the gift passes:

1. To the appropriate eye bank if the part is an eye and the gift is for the purpose of transplantation or therapy.

2. To the appropriate tissue bank if the part is tissue and the gift is for the purpose of transplantation or therapy.

3. To the organ procurement organization as custodian of the organ if the part is an organ and the gift is for the purpose of transplantation or therapy.

4. To the appropriate procurement organization if the part is an organ, an eye or tissue and the gift is for the purpose of research or education.

D. If an anatomical gift is suitable for transplantation and the procurement organization is unable or unwilling to recover the tissue, the procurement organization shall refer the gift and all relevant donation information to another procurement organization in a manner that ensures the gift is recovered for transplantation.

D. E. For the purposes of subsection C of this section, if there is more than one purpose of an anatomical gift stated in the document of gift but the purposes are not stated in any priority, the gift must be used for transplantation or therapy, if suitable. If the gift cannot be used for transplantation or therapy, the gift may be used for research or education.

E. F. If an anatomical gift of one or more specific parts is made in a document of gift that does not name a person described in subsection A of this section and does not identify the purpose of the gift, the gift may be used only for transplantation or therapy and the gift passes pursuant to subsection G H of this section.

F. G. If a document of gift specifies only a general intent to make an anatomical gift by words such as "donor", "organ donor" or "body donor", or by a symbol or statement of similar import, the gift may be used only for transplantation or therapy and the gift passes pursuant to subsection G H of this section.

G. H. For the purposes of subsections B, E F and F G of this section:

1. If the part is an eye, the gift passes to the appropriate eye bank.

2. If the part is tissue, the gift passes to the appropriate tissue bank.

3. If the part is an organ, the gift passes to the organ procurement organization as custodian of the organ.

H. I. An anatomical gift of an organ for transplantation or therapy, other than an anatomical gift pursuant to subsection A, paragraph 3 of this section, passes to the organ procurement organization as custodian of the organ.

I. J. If an anatomical gift does not pass pursuant to subsection A, B, C, D, E, F, G, or H or I of this section or the decedent's body or part is not used for transplantation, therapy, research or education, custody of the body or part passes to the person who is under an obligation to dispose of the body or part pursuant to section 36‑831.

J. K. A person may not accept an anatomical gift if the person knows that the gift was not effectively made pursuant to section 36‑844 or 36‑849 or if the person knows that the decedent made a refusal pursuant to section 36‑846 that was not revoked. For the purposes of this subsection, if a person knows that an anatomical gift was made in a document of gift, the person is deemed to know of any amendment of the gift, revocation of the gift or refusal to make an anatomical gift in the same document of gift.

K. L. Except as otherwise provided in subsection A, paragraph 3 of this section, this article does not affect the allocation of organs for transplantation or therapy. END_STATUTE

Sec. 5. Title 36, chapter 7, article 3, Arizona Revised Statutes, is amended by adding sections 36-851.01 and 36‑851.02, to read:

START_STATUTE36-851.01. Procurement organizations; licensure; renewal; fees; penalties

A. A person may not act as a procurement organization in this state unless the person is licensed by the department of health services as a procurement organization. The person shall apply in writing to the director of the department on a form specified by the director, shall include all information requested in the application and shall pay the fees prescribed by the director.

B. The director shall grant a procurement organization license to a person If the organization either is registered or regulated by the federal government and is subject to inspection or meets the requirements prescribed in section 36‑851.02 and the rules adopted by the department.

C. A license under this section is valid for two years and must be renewed every two years. A person shall file an application for renewal at least thirty days before the expiration of the current license.

D. Each procurement organization applying for licensure or renewal under this section shall pay all applicable fees as prescribed by the director. All fees collected pursuant to this section for the licensure and renewal of procurement organizations shall be deposited in the health services licensing fund established by section 36‑414.

E. The director may sanction, impose civil penalties on or, pursuant to title 41, chapter 6, article 10, suspend or revoke, in whole or in part, the license of any procurement organization if any person who is an owner, officer, agent or employee of the procurement organization is in or continues to be in violation of this article or the rules of the department of health services adopted pursuant to this article.END_STATUTE

START_STATUTE36-851.02. Procurement organizations; requirements; records

Each procurement organization shall do all of the following:

1. Designate a medical director who is a physician licensed pursuant to title 32, chapter 13 or 17 and who provides medical guidance to determine donor eligibility.

2. Employ a director who holds at least a bachelor's degree in a related science from an accredited university and who is responsible for all licensed activities of the organization.

3. Implement and maintain all of the following:

(a) Standard operating procedures for all licensed functions of the organization.

(b) A safety awareness and blood‑borne pathogen training program that complies with state and federal law.

4. Provide a designated area for tissue recovery that:

(a) Is open to inspection by the department of health services with or without notice.

(b) Does not operate in a funeral establishment for the recovery of whole bodies for medical research and education.

5. Properly track donors and label tissue by doing both of the following:

(a) Assigning a unique identifying number to each donor and using this number for all tissue from that donor that is recovered and distributed.

(b) Affixing labels with the following information on all nontransplant tissue specimens:

(i) A statement that universal precautions will be used.

(ii) A statement that the specimen is not for transplant or clinical use.

(iii) Any condition or limitation regarding the use of the specimen.

(iv) Contact information for the procurement organization.

6. Maintain the following records for ten years after the last date of tissue distribution:

(a) A copy or recorded consent of the donation authorization.

(b) A copy of the donor's death certificate and transit permit issued by the state where the death occurred.

(d) A copy of the donor's serological results, when applicable.

(e) A copy of all documentation relating to tissue recovery, storage and distribution activities. END_STATUTE

Sec. 6. Section 36-852, Arizona Revised Statutes, is amended to read:

START_STATUTE36-852. Rights and duties of procurement organizations and others

A. When a hospital refers an individual who is at or near death to an organ procurement organization, the organization shall make a reasonable search of the records of any donor registry that it knows exists for the geographical area in which the individual resides to determine if the individual has made an anatomical gift.

B. A procurement organization must be allowed reasonable Direct access to all of the information in the records of the donor registry to determine if an individual who is at or near death is a donor.

C. When a hospital refers an individual who is at or near death to an organ procurement organization, the organ procurement organization or the appropriate eye bank or tissue bank may conduct any reasonable examination necessary to ensure the medical suitability of a part that is or could be the subject of an anatomical gift for transplantation, therapy, research or education from a donor or a prospective donor. During the examination period, measures necessary to ensure the medical suitability of the part may not be withdrawn unless the hospital or procurement organization knows that the individual expressed a contrary intent.

D. Unless otherwise prohibited by law, at any time after a donor's death, the person to which a part passes pursuant to section 36‑850 may conduct any reasonable examination necessary to ensure the medical suitability of the body or part for its intended purpose.

E. Unless otherwise prohibited by law, an examination pursuant to subsection C or D of this section may include an examination of all medical and dental records of the donor or prospective donor.

F. On the death of a minor who was a donor or who had signed a refusal, unless a procurement organization knows the minor is emancipated, the appropriate procurement organization shall conduct a reasonable search for the parents of the minor and provide the parents with an opportunity to revoke or amend the anatomical gift or revoke the refusal.

G. On referral by a hospital pursuant to subsection A of this section, the appropriate procurement organization must make a reasonable search for any person listed in section 36‑848 who has priority to make an anatomical gift on behalf of a prospective donor. If a procurement organization receives information that an anatomical gift to any other person was made, amended or revoked, it the organization shall promptly advise the other person of all relevant information.

H. Subject to the requirements of section 36‑850, subsection I J and section 36‑861, the rights of the person to which a part passes pursuant to section 36-850 are superior to the rights of all others with respect to the part. The person may accept or reject an anatomical gift in whole or in part. Subject to the terms of the document of gift and this article, a person who accepts an anatomical gift of an entire body may allow embalming, burial or cremation and use of remains in a funeral service. If the gift is of a part, the person to which the part passes pursuant to section 36‑850, on the death of the donor and before embalming, burial or cremation, shall cause the part to be removed without unnecessary mutilation.

I. The physician who attends the decedent at death and the physician who determines the time of the decedent's death may not participate in the procedures for removing or transplanting a part from the decedent.

J. A physician or technician may remove a donated part from the body of a donor that the physician or technician is qualified to remove. END_STATUTE

Sec. 7. Section 36-853, Arizona Revised Statutes, is amended to read:

START_STATUTE36-853. Coordination of procurement and use

A. Each hospital in this state shall enter into one or more agreements or affiliations a contract with all procurement organizations in this state that request a contract for the coordination of procurement and use of anatomical gifts to ensure that all donation opportunities are recovered.

B. If there has been an anatomical gift, the institution where the removal of any donated parts occurs shall notify the funeral director or the person acting in that capacity who first assumes custody of the body about the removal of the body parts. END_STATUTE

Sec. 8. Section 36-860, Arizona Revised Statutes, is amended to read:

START_STATUTE36-860. County medical examiners; authorization

A. Each county medical examiner in this state shall enter into a contract with all procurement organizations in this state that request a contract for the coordination of procurement and use of anatomical gifts to ensure that all donation opportunities are recovered.

A. B. The medical examiner or individual legally delegated that authority may release and permit the removal of a part from or all of a body within the custody of that official for transplantation, therapy, research or education pursuant to title 11, chapter 3, article 12 if the part is the subject of an anatomical gift and:

1. A request has been received from a procurement organization.

2. The organ procurement organization has made a reasonable effort, taking into account the useful life of the part, to locate and examine the decedent's medical records and, if the decedent has not executed a document of gift or has not refused to make an anatomical gift, inform persons listed in section 36-848, subsection A, of the person's option to make or object to making an anatomical gift.

3. The official does not know of a refusal by the decedent or an objection by a person having priority to act as listed in section 36-848, subsection A.

4. The removal will be by a physician, surgeon or trained technician.

5. The removal will be in accordance with accepted medical standards.

6. The removal will not interfere with any death investigation.

7. Cosmetic restoration will be done, if appropriate.

B. C. An official who releases and permits the removal of a part shall maintain a permanent record of the name of the decedent, the person making the request, the date and purpose of the request, the part requested and the person to whom it was released. END_STATUTE

Sec. 9. Department of health services; rulemaking exemption

For the purposes of implementing this act, the department of health services shall adopt rules relating to the licensure of procurement organizations and enforcement of those provisions. The department is exempt from the rulemaking requirements of title 41, chapter 6, Arizona Revised Statutes, for one year after the effective date of this act.