Arizona-2016-HB2307-Chaptered

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 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 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:

(a) An organ procurement organization.

(b) A tissue bank.

(d) A storage facility that is licensed, accredited or approved under federal law or the laws of any state to engage in the recovery, screening, testing, processing, or 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 research or education.

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

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. Title 36, chapter 7, article 3, Arizona Revised Statutes, is amended by adding sections 36-851.01, 36‑851.02 and 36‑851.03, to read:

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

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 accredited by a nationally recognized accrediting agency that is approved by the department of health services and maintains full accreditation with the accrediting agency or meets the requirements prescribed in section 36‑851.03 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 license 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 license 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.

F. This section does not apply to any of the following:

1. An organ procurement organization as described� by 42 United States Code section 273 that is designated for this state by the secretary of the United States department of health and human services pursuant to 42 United States Code section 1320b‑8.

2. A procurement organization that is regulated by the United States food and drug administration in connection with the recovery of human tissue intended for transplantation pursuant to 21 Code of Federal Regulations part 1270.

3. A procurement organization as defined in section 36‑841, paragraph 22, subdivision (d).

4. A procurement organization that is affiliated with an accredited educational institution in connection with the education of students enrolled in a degree-granting program for health professionals.

5. A procurement organization that is affiliated with an accredited hospital as defined in section 36‑401 for the recovery of anatomical gifts for research, education, quality improvement or quality assurance. END_STATUTE

START_STATUTE36-851.02. Procurement organizations; deemed status; requirements; inspection

A procurement organization that is licensed pursuant to section 36‑851.01 by virtue of its accreditation status:

1. Is deemed to meet health and safety requirements that are equivalent to those set forth in section 36‑851.03 and is not required to meet the requirements prescribed in section 36-851.03 except as specified in paragraph 2 of this section if the procurement organization maintains its accredited status with the accrediting agency.

2. Shall comply with all of the following as adopted in rule by the department of health services:

(a) The proper use and maintenance of donor consent forms.

(b) the implementation and maintenance of Proper identification systems for bodies and disarticulated items.

(c) The implementation and maintenance of protocols and materials for procedures used by the procurement organization to properly screen end users.

(d) The proper documentation and disclosure of the disease status of tissue specimens to end users.

(e) Labeling, packaging, transport and distribution policies and procedures.

(f) Final disposition procedures.

3. Shall provide a designated area for tissue recovery that does not operate in a funeral establishment for the recovery of whole bodies for medical research and education.

4. Is subject to inspection by the department of health services at any time with respect to compliance with the requirements of paragraph 2 of this section. END_STATUTE

START_STATUTE36-851.03. Procurement organizations; requirements; records; rules; inspection

A. Except as provided in section 36‑851.02, each procurement organization that is required to be licensed pursuant to section 36‑851.01 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. Comply with all of the following as adopted in rule by the department of health services:

(a) The proper use and maintenance of donor consent forms.

(b) The implementation and maintenance of proper identification systems for bodies and disarticulated items.

(c) The implementation and maintenance of protocols and materials for procedures used by the procurement organization to properly screen end users.

(d) The proper documentation and disclosure of the disease status of tissue specimens to end users.

(e) Labeling, packaging, transport and distribution policies and procedures.

(f) Final disposition procedures.

4. 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.

5. 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.

6. 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.

7. 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.

B. The department of health services shall adopt rules that follow, as nearly as practicable, the requirements on equivalent subjects specified in subsection A of this section that are set forth in the accreditation requirements of a nationally recognized� accrediting agency that is approved by the department.

C. A procurement organization that is subject to the requirements of this section is subject to inspection by the department of health services at any time to evaluate the compliance by the procurement organization with the requirements of this article and the rules adopted by the department. END_STATUTE

Sec. 4. 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.