SB3604 103RD GENERAL ASSEMBLY

LRB103 37007 CES 69616 b

103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
SB3604

Introduced 2/9/2024, by Sen. Mary Edly-Allen

SYNOPSIS AS INTRODUCED:

See Index

Creates the Consensual Non-Transplant Donation Regulation Act. Provides for licensing of non-transplant anatomical donation organizations by the Department of Public Health. Sets forth requirements for licensed non-transplant anatomical donation organizations, including application and renewal fees, penalties for failing to comply with the Act, and enforcement of the Act's provisions. Provides for deposit of licensing and renewal fees in the Public Health Licensing Fund, a special fund created in the State treasury. Provides that fines accruing from a conviction under the Act shall be paid into the common school fund of the county in which the offense was committed. Sets forth conditions under which a licensee must update a license or license application. Sets forth conditions under which the Department may deny, suspend or revoke, a license, or assess a civil penalty against a licensee. Provides for a universal donor consent form and sets forth requirements for the form. Sets forth requirements for donor records and record retention policies. Sets forth requirements for labeling and packaging the non-transplant anatomical donation. Provides for final disposition of a non-transplant anatomical donation. Sets forth general responsibilities and environmental standards for licensees. Provides for transportation standards while transporting non-transplant anatomical donations. Provides screening standards for end users by licensees. Makes conforming changes in the State Finance Act, Vital Records Act, Illinois Vehicle Code, and Illinois Anatomical Gift Act. Effective immediately.

A BILL FOR

AN ACT concerning regulation.

Be it enacted by the People of the State of Illinois, represented in the General Assembly:

Section 1. Short title. This Act may be cited as the Consensual Non-Transplant Donation Regulation Act.

Section 5. Definitions. As used in this Act:

"Accrediting body" means a nationally recognized agency approved by the Department that provides certification for a business organization operating a non-transplant anatomical donation organization.

"Arranger" means the individual who is talking with, coordinating with, facilitating, or presenting the option of non-transplant anatomical donation to a potential donor, donor's family, or responsible authorizing agent on behalf of a non-transplant anatomical donation organization. With regards to the Secretary of State's role in non-transplant anatomical donation under Section 6-117 of the Illinois Vehicle Code, the Secretary of State shall not be considered the arranger.

"Chain of custody documentation" means a record that establishes the continuous location and control of a dead body, body parts, or human remains, which includes: (i) the deceased's unique identifier; (ii) a list of each death care provider that came in contact with the dead body; (iii) a list of each service performed detailing the provider, location, and date; and (iv) the signature of the individual who executes final disposition.

"Department" means the Department of Public Health.

"Director" means the Director of Public Health.

"Distribution" means a process that includes selection and evaluation of intended use of non-transplant anatomical material or a non-transplant anatomical donation, a human body, or human body part for release to an education facility or a research facility according to State law.

"Donor" means a person who has knowingly consented in accordance with applicable law to the transfer of a person's deceased body or body part, not for use in transplantation, for education, research, or the advancement of medical, dental, or mortuary science.

"Donor's family" means the next of kin to the donor with the legal authority to consent to non-transplant anatomical donation on behalf of the donor in accordance with Section 5-5 of the Illinois Anatomical Gift Act.

"End user" means the education or research institution that receives the non-transplant anatomical donation from a licensed non-transplant anatomical donation organization.

(1) A "primary end user" is the donor's, donor's family's, or the responsible authorizing agent's first in priority choice of an education or research institution to receive the non-transplant anatomical material under this Act.

(2) A "secondary end user" is the donor's, donor's family's, or the responsible authorizing agent's second in priority choice of an education or research institution to receive the non-transplant anatomical material under this Act.

"Entity" means a non-transplant anatomical donation organization that is accredited, licensed, or approved under federal law or the laws of this State to engage in the recovery, screening, testing, processing, distribution, or storage of human bodies or body parts.

"Exceptional release" means non-transplant anatomical material that is approved for usage before a donor acceptability assessment or by a researcher requesting non-transplant anatomical material that would not normally meet the established acceptability criteria.

"Environmental services" means activities such as housekeeping, laundry, facility maintenance, or equipment maintenance.

"Final disposition" means the final disposal of non-transplant anatomical material or a non-transplant anatomical donation through incineration, cremation, bio-cremation, burial, full depletion by virtue of a particular use, or by another legal means.

"Education" means the use of a human body or body parts for teaching or training individuals, including, but not limited to, medical, dental, or mortuary science students or professionals, with regard to the anatomy and characteristics of the human body, disease detection, and such other uses as may be specified by the Department by rule.

"Human body" means a deceased human body or non-transplant anatomical donation.

"Human body part" or "body part" means an organ, tissue, eye, bone, blood vessel, or any other portion of a human body that is subject to an anatomical gift or other transfer made under State law. "Human body part" does not include blood drawn for medical purposes or a growing cell line.

"Institution" means a facility established by law for the purpose of education, research, or the advancement of medical, dental, or mortuary science.

"Licensee" means a person to whom the Department has issued a license to operate a non-transplant anatomical donation organization.

"Misuse" means to use non-transplant anatomical material and non-transplant anatomical donations for purposes other than education or research.

"Non-transplant anatomical donation" means a donation of a whole body, organ, or tissue authorized and used for education and research prior to release to distribution inventory.

"Non-transplant anatomical material" means a whole body or part of a body donated for use in education or research that has been prepared, packaged, labeled, and released to distribution inventory.

"Non-transplant anatomical donation organization" means an entity that is accredited, licensed, or approved under federal law or State law to engage in the recovery, screening, testing, processing, distribution, or storage of human bodies or body parts for purposes of education, research or the advancement of medical, dental, or mortuary science.

"Research" does not include an autopsy or examination conducted as part of a criminal investigation.

"Responsible authorizing party" means an individual with the legal authority to consent to non-transplant anatomical donation on behalf of a donor in accordance with Section 5-5 of the Illinois Anatomical Gift Act.

"Secondary specific use consent" means the opportunity for a donor's family or responsible authorizing agent to modify the specific use the donor, the donor's family, or responsible authorizing agent consented to in the universal donor consent form.

"Specific use" means the specified purpose, whether education or research related, consented to by the donor, the donor's family, or a responsible authorizing agent to a specified end user consented to by the donor, the donor's family, or a responsible authorizing agent within the universal donor consent form.

"Storage" means a designated area that contains equipment, instruments, and supplies necessary to maintain non-transplant anatomical donations or non-transplant anatomical material until distribution or final disposition.

"Transfer" means to move from a non-transplant anatomical donation organization to an institution.

"Unique identifier" means providing the deceased with individual identification, through tagging, numbering, QR code, or other individualized means, that is affixed to the dead body, the body bag, and any body part, organ, or tissue separated from the deceased to be used in non-transplant anatomical donation in order to prevent misidentification of human remains.

"Universal donor consent form" means the legal record of a gift of non-transplant anatomical material permitting and defining acquisition and specific use of non-transplant anatomical material for education and research.

Section 10. License required. Except as provided by this Act, no person shall open, manage, conduct, offer, maintain, or advertise as a non-transplant anatomical donation organization without a valid license issued by the Department. A non-transplant anatomical donation organization established by law to conduct business in the State of Illinois that acquires or transfers a human body or human body part for education, research, or the advancement of medical, dental, or mortuary science, and not for use in human transplantation, shall register and be licensed by the Department at such time and in such manner as the Department may require. All non-transplant anatomical donation organizations in existence on the effective date of this Act shall obtain a valid license to operate within 2 years after the adoption of rules by the Department to implement this Act.

Section 15. Contents of license application. An applicant for a license or license renewal under this Section shall submit an application to the Department containing such information as the Department may require by rule on the activities to be carried out pursuant to licensure. Unless otherwise set forth by administrative rule, the application shall include:

(1) the name of the applicant, including all trade names under which the applicant conducts business;

(2) the date on which the applicant first began or will begin commencing activities described in this Act;

(3) a list of all addresses at which the applicant conducts business;

(4) a description of the premises and equipment used by the applicant;

(5) a description of the types of service provided by the applicant;

(6) identification of all officers and administrators of the applicant;

(7) an attestation that the applicant will keep records, including, but not limited to, the chain of custody documentation, in accordance with the requirements of this Act;

(8) an attestation that the applicant will use the universal donor consent form in accordance with the requirements of this Act;

(9) an attestation that the applicant will label and package all human bodies or human body parts with a unique identifier in accordance with the requirements of this Act; and

(10) an acknowledgment that the Department will be permitted to inspect the premises and records of the applicant as to the items and in the manner prescribed in this Act.

Section 20. Accreditation; licensure; renewal; fees; penalties; enforcement.

(a) An entity may not act as a non-transplant anatomical donation organization in this State unless the entity is accredited and licensed by the Department as a non-transplant anatomical donation organization. The entity shall apply in writing to the Department on a form specified by the Director, which shall include all information requested in the application, and shall pay the fees prescribed by the Department by rule.

(b) The Director shall grant a license to an entity if:

(1) the organization is accredited by a nationally recognized accrediting agency that is approved by the Department and maintains full accreditation with the accrediting agency; and

(2) the entity meets other requirements prescribed by the Department by rule.

(c) Each non-transplant anatomical donation organization applying for a license or license renewal shall pay all applicable fees as prescribed by the Department by rule. All fees collected for the license and license renewal of non-transplant anatomical donation organizations shall be deposited in the Public Health Licensing Fund, a special fund created in the State treasury, to be used by the Department for the administration and enforcement of this Act.

(d) The Director may sanction, impose civil penalties on, suspend the license of, or revoke the license of a non-transplant anatomical donation organization and may sanction or impose civil penalties on any person who is an owner, officer, agent, or employee of a non-transplant anatomical donation organization if the person is in or continues to be in violation of this Act or rules adopted by the Department under this Act.

(e) Any person or entity operating as a non-transplant anatomical donation organization without proper accreditation or licensure in this State shall be subject to criminal prosecution and civil penalties as provided under Section 85 and any applicable rules.

Section 25. Other fees.

(a) The Department shall establish a fee for licensure under Section 10 and renewal under Section 30.

(b) The Department shall determine the amount of licensing fees under this Act, taking into consideration, among other things, the projected implementation, enforcement, and inspection costs associated with this Act.

(c) Every fine accruing from a conviction under this Act shall be paid into the common school fund of the county in which the offense was committed.

Section 30. License renewal. The Department shall require that the license of an applicant be renewed by the applicant every 2 years.

Section 35. Change of information.

(a) Not later than 30 days after any change of any information listed under Section 15, an applicant or licensee shall notify the Department of the change in writing as prescribed by the Department.

(b) A licensee shall notify the Department in writing at least 30 calendar days before the date of:

(1) termination of operation, including, but not limited to, the proposed termination date and the address and contact information for the location where the non-transplant anatomical donation organization records will be retained, if applicable;

(2) a proposed modification that alters the area for tissue recovery, if applicable;

(3) a change in the non-transplant anatomical donation organization's legal name;

(4) a change in the legal name of a licensee, including the licensee's new name; and

(5) a change in the address of the non-transplant anatomical donation organization, including the new address.

(c) A licensee shall notify the Department in writing no later than 30 calendar days after the date of:

(1) a change in the non-transplant anatomical donation organization's email address or mailing address, including the new email address or mailing address of the non-transplant anatomical donation organization;

(2) a change in the email address or telephone number of the licensee, including the new email address or telephone number;

(3) a change in an administrator or medical director, including his or her name and email address; and

(4) a change in the name or contact information of an officer affiliated with the licensee, including the name and contact information of the new officer.

(d) If the Department receives notification of termination of operation, the Department shall void the licensee's license to operate a non-transplant anatomical donation organization on the termination date specified by the licensee.

(e) If the Department receives notification of a proposed modification that alters the area for tissue recovery, the Department:

(1) may conduct an inspection of the premises; and

(2) shall issue to the licensee an amended license that incorporates the modification and retains the expiration date of the existing license, if the non-transplant anatomical donation organization is in compliance.

(f) If the Department receives a notification of a legal name change for a non-transplant anatomical donation organization, the Department shall issue to the licensee an amended license showing the licensee's changed legal name.

(g) If the Department receives notice of a change in the legal name of a licensee, the Department shall void the licensee's license to operate and issue a new license to operate with the licensee's changed legal name.

(h) If the Department receives notice for a change in the address of a non-transplant anatomical donation organization, the Department shall require and review an amended application for a license.

(i) An individual or business organization planning to assume operation of an existing non-transplant anatomical donation organization shall obtain a new license before beginning operation.

Section 40. Denial; suspension; revocation; enforcement.

(a) The Department may:

(1) deny a license;

(2) suspend or revoke a license; or

(3) assess a civil penalty against a licensee.

(b) The Department may deny an application or suspend or revoke a license to operate a non-transplant anatomical donation organization if:

(1) an applicant or licensee does not meet the application requirements;

(2) a licensee does not comply with any statutory requirements or requirements of the Department;

(3) a licensee does not correct a deficiency identified during an inspection according to the plan of correction;

(4) an applicant or licensee provides false or misleading information as part of an application or inspection; or

(5) the nature or number of violations revealed by any type of inspection or investigation of a non-transplant anatomical donation organization pose a direct risk to the life, health, or safety of individuals on the premises or the public at large.

(c) In determining which action is appropriate, the Department may consider:

(1) repeated violations of statutes or rules;

(2) a pattern of violations;

(3) the severity of violations; and

(4) the number of violations.

(d) The Department may suspend or revoke a non-transplant anatomical donation organization's license if the Department receives notice from the organization's accrediting body that the organization's accreditation has been suspended or revoked. An applicant or licensee may seek administrative review of the Department's determination.

Section 45. Inspections. The Department shall inspect a licensee's premises at least annually and any time after it receives a complaint or notice of a violation.

Section 50. Universal donor consent form; non-transplant anatomical donation. The Department shall create a universal donor consent form that allows a donor, the donor's family, or responsible authorizing agent to consent to non-transplant anatomical donation.

(1) The universal donor consent form shall include:

(A) the name of the donor and name of the donor's family member or responsible authorizing agent, if applicable;

(B) the contact information for donor, donor's family, or responsible authorizing agent;

(C) the definitions of "education" and "research" as provided in Section 5 of this Act;

(D) the specific use consented to by the donor, donor's family, or responsible authorizing agent of the non-transplant anatomical material;

(E) uses of non-transplant anatomical material that the donor, donor's family, or responsible authorizing agent does not consent to;

(F) the end user or list of end users the donor, donor's family, or authorizing agent consents to;

(G) a description of how, if the specific use consented to by the donor, donor's family, or responsible authorizing agent cannot be executed, the donor's family or responsible authorizing agent shall be contacted to execute secondary specific use consent in accordance with the procedure provided in Section 60 of this Act;

(H) the contact information for the individual with the authority to execute secondary specific use consent;

(I) an explanation of how remains would be returned, if applicable;

(J) the name, phone number, and license number for the arranger;

(K) a statement that provides the donor, donor's family, or responsible authorizing agent with information regarding who to direct questions to;

(L) a statement that the non-transplant anatomical material will be treated with dignity at all times; and

(M) a statement that the non-transplant anatomical material may require international export to an end user; and

(2) The universal donor consent form shall direct a potential donor, the donor's family, or responsible authorizing agent to websites that:

(A) answer frequently asked questions;

(B) allow a potential donor, the donor's family, or responsible authorizing agent to verify whether a specific non-transplant anatomical donation organization holds a valid license with the Department; and

(C) provide a resource to contact if the donor, the donor's family, or responsible authorizing agent alleges a violation of this Act.

Section 55. Specific use.

(a) The Department shall establish rules, regarding the donor's, donor's family's, or responsible authorizing agent's consented specific use of the non-transplant anatomical material, in accordance with the procedures provided for in this Section.

(b) When the donor, donor's family, or responsible authorizing agent consent to the gift of a non-transplant anatomical donation, the donor, donor's family, or responsible authorizing agent shall be provided the opportunity to consent to the specific use of the non-transplant anatomical material.

(c) On the universal donor consent form, the donor, donor's family, or responsible authorizing agent shall be permitted to consent to the non-transplant anatomical donation for the following purposes:

(1) education purposes, including, but not limited to, the training of new doctors;

(2) research purposes, including, but not limited to, military advancements, vehicle safety, specific medical research such as curing a specified ailment held by the donor; or

(3) a specific education or research purpose.

(d) On the universal donor consent form, the donor, donor's family, or responsible authorizing agent shall be permitted to specify that the donor, donor's family, or responsible authorizing agent does not consent to the non-transplant anatomical donation for the following purposes:

(1) education purposes, including, but not limited to, the training of new doctors; or

(2) research purposes, including, but not limited to, military advancements, vehicle safety, or specific medical research such as curing a specified ailment held by the donor; or

(3) a specific education or research purpose.

(e) On the universal donor consent form, the donor, donor's family, or responsible authorizing agent shall be permitted to specify a primary end user who the donor, donor's family, or responsible authorizing agent consents may receive the donor's non-transplant anatomical material. The donor, donor's family, or responsible authorizing agent shall be permitted to specify a secondary end user who the donor, donor's family, or responsible authorizing agent consents may receive the donor's non-transplant anatomical material if the primary end user is unable to accept the non-transplant anatomical donation for any reason, including that the primary end user cannot satisfy the donor, donor's family, or responsible authorizing agent's consented purpose in subsections (c) and (d) of this Section.

(f) If the specific use, including the consented purpose and end user, that the donor, donor's family, or responsible authorizing agent has consented to cannot be satisfied for any reason, the Department shall establish rules that require a licensee under this Act to contact the donor, donor's family, or responsible authorizing agent to execute secondary specific use consent in accordance with Section 60 of this Act. At this time, the licensee is required to notify the donor's family or responsible authorizing agent that if the consented secondary specific use cannot be satisfied, the donor's family or responsible authorizing agent is responsible for final disposition as the donation will not be accepted.

(g) If the licensee can honor the secondary specific use consented to by the donor's family or responsible authorizing agent, the licensee may transfer the non-transplant anatomical material to the end user.

(h) If the licensee cannot satisfy the secondary specific use consented to by the donor's family or responsible authorizing agent, the licensee may not transfer the non-transplant anatomical material to an end user. The licensee shall preserve the decedent's body and no donation shall be made.

Section 60. Secondary specific use consent.

(a) The Department shall establish rules regarding the donor's, donor's family's, or responsible authorizing agent's secondary specific use consent of the non-transplant anatomical material, in accordance with the procedures provided for in this Section.

(b) If the specific use, including the consented purpose and end user, that the donor, donor's family, or responsible authorizing agent has consented to cannot be satisfied for any reason, the donor's family or responsible authorizing agent shall be given an opportunity from the licensee to provide secondary specific use consent.

(c) A licensee shall notify the donor's family or responsible authorizing agent that the specific use consented to in the universal donor consent form cannot be satisfied. The licensee may provide the donor's family or responsible authorizing agent with options for secondary specific use consent based on the current demand for non-transplant anatomical material for specific uses and specific end users. The licensee may provide the donor's family or responsible authorizing agent with the ability to provide secondary specific use consent for any education or research purpose to any end user. The licensee shall notify the donor's family or responsible authorizing agent that if the secondary specific use consented to by the donor's family or responsible authorizing agent cannot be satisfied, the licensee shall preserve the body and no donation shall be made.

(d) If the licensee can honor the secondary specific use consented to by the donor's family or responsible authorizing agent, the licensee may transfer the non-transplant anatomical material to the end user.

(e) If the licensee cannot satisfy the secondary specific use consented to by donor's family or responsible authorizing agent, the licensee may not transfer the non-transplant anatomical material to an end user. The licensee shall preserve the decedent's body and no donation shall be made.

Section 65. Donor records.

(a) A non-transplant anatomical donation organization shall maintain a legible, reproducible record for each donor from whom it releases non-transplant anatomical material for at least 10 years after the date of final disposition.

(b) To ensure traceability of a non-transplant anatomical donation and non-transplant anatomical material, a non-transplant anatomical donation organization shall:

(1) document each procedure performed on a non-transplant anatomical donation and non-transplant anatomical material related to processing and storing non-transplant anatomical donations and non-transplant anatomical material;

(2) for each document created under paragraph (1), include:

(A) the donor's unique identifier;

(B) the date, time, and location for each procedure completed; and

(C) the name of the technician who performed the procedure; and

(3) submit or have a contracted funeral home submit information required to register the death of a non-transplant anatomical donation within 7 calendar days after receiving the non-transplant anatomical donation, if applicable.

(c) A donor record shall be:

(1) confidential;

(2) kept in a location with controlled access;

(3) stored in a manner to prevent unauthorized access; and

(4) maintained in a manner to preserve the donor record's completeness and accuracy.

(d) A donor record shall include at least the following:

(1) donor information that includes:

(A) the donor's name;

(B) the donor's unique identifier;

(C) the donor's date of birth and date of death; and

(D) the name and contact information of the person responsible for a donor's anatomical gift, if applicable;

(2) an executed universal consent form that contains the consented to specific use of the non-transplant anatomical material;

(3) a secondary specific use consent, if applicable;

(4) a document of authorization, which is a legal record of the gift, to take place postmortem, permitting and defining the scope of the postmortem acquisition and use of non-transplant anatomical material for education and research, signed or otherwise recorded by the authorizing person;

(5) a document of anatomical gift, which is the donor's legal record of the gift of non-transplant anatomical material permitting and defining the scope of the postmortem acquisition and use of non-transplant anatomical material for education and research;

(6) an authorization of gift, which must be signed or otherwise recorded by an individual authorized by law to make a gift during the donor's lifetime;

(7) the donor's death record;

(8) the human remains release form, if applicable;

(9) information for a death record, if applicable for transporting human remains into the State;

(10) a disposition transit permit, if applicable;

(11) a medical examiner's release of information, if applicable;

(12) chain of custody documentation;

(13) medical records, including:

(A) a donor's physical assessment;

(B) a risk assessment questionnaire;

(C) pathology and laboratory testing and reports;

(D) physician summaries, if applicable;

(E) transfusion or infusion information, if applicable; and

(F) plasma dilution calculations if applicable;

(14) information from the donor referral source;

(15) donor eligibility;

(16) a donor acceptability assessment;

(17) a physical assessment questionnaire;

(18) documentation related to distribution;

(19) serological results, if applicable;

(20) a cremation authorization document;

(21) documentation related to non-transplant anatomical material recovery, storage, and distribution activities;

(22) final disposition documentation, including all records demonstrating chain of custody; and

(23) documentation of the suspected misuse or harm to the donor, if any.

(e) A donor's record shall be accessible to:

(1) an agent legally authorized to have access, or an individual designated at the time a donor gives consent;

(2) an individual appointed by a court or authorized by State law;

(3) an individual of a non-transplant anatomical donation organization as identified by policies and procedures;

(4) an individual from an approved accrediting body, if applicable; and

(5) an individual from the Department or other regulatory agency authorized by State or federal laws or rules adopted by the Department.

(f) Except for a donor record that must be maintained for a period of 10 years after final disposition, a non-transplant anatomical donation organization shall maintain documentation required under this Act for at least 3 years after the date of the documentation and shall provide copies of the documentation to the Department for review upon request.

Section 70. Recordkeeping.

(a) A licensee shall compile or maintain a record for each case in which the licensee acquires a human body, human body part, or non-transplant anatomical donation.

(b) A record shall contain the following information and any additional information required by the Department:

(1) documentation that the donor has knowingly consented to the transfer of the human body or human body part, not for use in transplantation, for education, research, or the advancement of medical, dental, or mortuary science in accordance with all applicable laws pertaining to the final disposition of human remains;

(2) documentation that the donor has been informed of the obligation of the licensee as to the proper disposal of the human body or human body part;

(3) the date and time of the donation or transfer from the donor;

(4) the name of the person, including any trade or business name, who transferred the human body or human body part to the licensee, if applicable;

(5) the full name and most recent address of the donor;

(6) a description of the human body or human body part being acquired or transferred;

(7) the medical history of the donor, including the autopsy report if any autopsy was conducted;

(8) the identity and address of each person who has been in possession of the human body or human body part prior to the registrant, including any funeral home, coroner, hospital, organ procurement organization, or tissue bank;

(9) documentation of the use and final disposition of each human body or human body part by the licensee;

(10) documentation of the name and address of each person to whom the licensee transfers the human body or human body part; and

(11) the implementation and maintenance of protocols and materials for procedures to properly screen end users.

(c) A licensee shall maintain the following records for 10 years after the last date of tissue distribution:

(1) a copy of recorded consent of the donation authorization;

(2) a copy of the donor's death certificate and transit permit issued by the state where the death occurred;

(3) a copy of the donor's physical assessment and risk assessment questionnaire;

(4) a copy of the donor's serological results, if applicable; and

(5) a copy of all documentation relating to tissue recovery, storage, and distribution activities.

Section 75. Labeling and packaging.

(a) A licensee shall ensure that all human bodies and human body parts in the possession of, or transferred by, the licensee are labeled and packaged in accordance with this Section.

(b) Unless the Department specifies otherwise by rule, all anatomical material in a licensee's possession shall be affixed with a unique identifier. Each body part, organ, or tissue of the deceased that is separated from the body shall have its own additional identification that corresponds to the unique identifier of the deceased.

(c) A licensee shall ensure the unique identifier affixed to the anatomical materials or the packaging of the anatomical materials corresponds to the donor's file, which includes the following information:

(1) the proper name of the donor;

(2) a description of the contents of the package indicating whether it is a human body or human body parts, including a list of all human body parts;

(3) the name, address, and license and registration number of the person transferring the human body or human body part;

(4) the tissue types of the human body or human body part;

(5) the cause of death of the donor, if applicable and known;

(6) serological test results, if any results exist;

(7) any known infectious disease agents of the human body or human body part;

(8) a statement about the use of personal protective equipment and universal precautions when handling a human body or human body part as required by law; and

(9) the statement "not for transplantation".

(d) Unless the Department specifies otherwise by rule, each human body or human body part under this Section shall be wrapped and packaged in a manner that:

(1) mitigates potential contamination and cross contamination;

(2) mitigates potential safety hazards;

(3) is sealed to prevent leakage; and

(4) ensures the integrity of the human body or human body part.

(e) The Department shall enforce the unique identifier requirement on all licensees under its jurisdiction that are required to fulfill this requirement.

Section 80. Final disposition. A licensee shall ensure the proper final disposition of a human body, human body part, or non-transplant anatomical material, in accordance with applicable federal and State law, by:

(1) returning the human body, human body part, non-transplant anatomical material, or cremains to the donor's family or responsible authorizing agent of the donor within a time frame designated by the non-transplant anatomical donation organization at the time donation is established;

(2) carrying out the final disposition of the human body or human body part as set forth in Section 4 of the Cadaver Act; or

(3) if the licensee is releasing the human body or human body part to another institution, contracting with the institution to assume the obligations described in this Act.

Section 85. Violations.

(a) Any person, entity, officer, or administrator who violates a requirement of this Act shall be guilty of a Class 4 felony.

(b) The Department may suspend or revoke the license of any licensee found to be in violation of this Act.

(c) It is a violation of this Act for any person or entity to alter or falsify any information on a label required under Section 75.

Section 90. General responsibilities.

(a) A licensee shall provide a copy of a renewed accreditation to the Department within 30 calendar days after the date of issuance.

(b) A licensee shall ensure that a non-transplant anatomical donation organization facility is in a building that provides a separate and designated area for tissue recovery.

(c) A licensee shall ensure policies and procedures are established, documented, and implemented that cover:

(1) labeling;

(2) packaging, including a packaging insert form that discloses the disease status of tissue to end users;

(3) transport;

(4) distribution; and

(5) final disposition.

Section 95. General plant standards; environmental services. A licensee shall ensure that a non-transplant anatomical donation organization:

(1) has preparation rooms that:

(A) are maintained in a clean and sanitary condition at all times;

(B) are only used for examining and preparing a non-transplant anatomical donation;

(C) contain equipment, instruments, and supplies necessary for examining and preparing a non-transplant anatomical donation and are disinfected or sterilized, as applicable, after each use to protect the health and safety of technicians and personnel members;

(D) have sanitary flooring, drainage, and ventilation;

(E) have proper and convenient receptacles for refuse, bandages, and all other waste materials; and

(F) are thoroughly cleansed and disinfected with a 1% solution of chlorinated soda, or other suitable and effective disinfectant, immediately after examining and preparing each non-transplant anatomical material; and

(2) has equipment at the non-transplant anatomical donation organization that is:

(A) sufficient to support the service;

(B) maintained in working condition;

(C) maintained in a clean and sanitary condition;

(D) used according to the manufacturer's recommendations;

(E) if used during an examination or preparation of a non-transplant anatomical donation, cleaned and sanitized after every use; and

(F) if applicable, tested and calibrated according to the manufacturer's recommendations or, if there are no manufacturer's recommendations, according to policies and procedures approved by the Department.

Section 100. Transportation standards.

(a) If a non-transplant anatomical donation organization owns and maintains a vehicle for transporting non-transplant anatomical material, an administrator shall ensure that the vehicle is:

(1) not used for a purpose other than transporting non-transplant anatomical donations and non-transplant anatomical material or conducting non-transplant anatomical donation organization business;

(2) only operated by a procurement organization technician or designated individual authorized to transport non-transplant anatomical donations or non-transplant anatomical material;

(3) maintained in clean and sanitary condition; and

(4) locked and secured at all times during transport of non-transplant anatomical donations or non-transplant anatomical material.

(b) If using a vehicle other than the vehicle described under subsection (a) for transporting a non-transplant anatomical donation or non-transplant anatomical material, an administrator shall ensure that the vehicle:

(1) is properly equipped for the transportation of non-transplant anatomical material;

(2) is compliant with all State and federal laws and rules pertaining to transporting humans remains; and

(3) if transport is by air, complies with applicable standards established by the International Air Transport Association and Transportation Security Administration.

(c) An administrator shall ensure that non-transplant anatomical donations and non-transplant anatomical material transported into the State have information of death documentation prior to transport.

Section 105. End user.

(a) A licensee shall establish, document, and implement policies and procedures to properly screen an end user that include:

(1) a written request for non-transplant anatomical material, including:

(A) the name, address, and affiliation of educators or research institutions accepting responsibility for the acceptance, use, and final disposition of the non-transplant anatomical material;

(B) a description of the intended use;

(C) the date and the approximate duration of non-transplant anatomical material use;

(D) a description of the venue in which the non-transplant anatomical material will be used and the security measures for the safe and ethical utilization of the venue;

(E) an assurance that precautions will be used when handling non-transplant anatomical material;

(F) the proposed final disposition of the non-transplant anatomical material;

(G) an agreement to comply with the licensee's policies, if applicable;

(H) an outline of proposed materials to be disseminated in connection with the use of non-transplant anatomical material, if applicable; and

(I) other supporting documentation that is relevant to the request; and

(2) the criteria for approving requested non-transplant anatomical material for use, including:

(A) the acceptability of the educator and researcher for non-transplant anatomical material utilization;

(B) the appropriateness of the intended use;

(C) the type of venue in which the non-transplant anatomical material will be used; a licensee shall determine that a hotel or other building held out to the public to be a place where lodging is offered for consideration to travelers and guests is not a suitable venue for the use of non-transplant anatomical material.

(D) the proposed final disposition of the non-transplant anatomical material, unless returned to the non-transplant anatomical donation organization; and

(E) proposed research materials.

(b) A licensee shall establish, document, and implement a procedure that allows end users to request an exceptional release of non-transplant anatomical material.

Section 900. The State Finance Act is amended by adding Section 5.1015 as follows:

(30 ILCS 105/5.1015 new)

Sec. 5.1015. The Public Health Licensing Fund.

Section 905. The Vital Records Act is amended by changing Sections 1 and 21.7 as follows:

(410 ILCS 535/1) (from Ch. 111 1/2, par. 73-1)

Sec. 1. As used in this Act, unless the context otherwise requires:

(1) "Vital records" means records of births, deaths, fetal deaths, marriages, dissolution of marriages, and data related thereto.

(2) "System of vital records" includes the registration, collection, preservation, amendment, and certification of vital records, and activities related thereto.

(3) "Filing" means the presentation of a certificate, report, or other record provided for in this Act, of a birth, death, fetal death, adoption, marriage, or dissolution of marriage, for registration by the Office of Vital Records.

(4) "Registration" means the acceptance by the Office of Vital Records and the incorporation in its official records of certificates, reports, or other records provided for in this Act, of births, deaths, fetal deaths, adoptions, marriages, or dissolution of marriages.

(5) "Live birth" means the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy, which after such separation breathes or shows any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles, whether or not the umbilical cord has been cut or the placenta is attached.

(6) "Fetal death" means death prior to the complete expulsion or extraction from the uterus of a product of human conception, irrespective of the duration of pregnancy, and which is not due to an abortion as defined in Section 1-10 of the Reproductive Health Act. The death is indicated by the fact that after such separation the fetus does not breathe or show any other evidence of life such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles.

(7) "Dead body" means a lifeless human body or parts of such body or bones thereof from the state of which it may reasonably be concluded that death has occurred.

(8) "Final disposition" means the burial, cremation, or other disposition of a dead human body or fetus or parts thereof.

(9) "Physician" means a person licensed to practice medicine in Illinois or any other state.

(10) "Institution" means any establishment, public or private, which provides in-patient medical, surgical, or diagnostic care or treatment, or nursing, custodial, or domiciliary care to 2 or more unrelated individuals, or to which persons are committed by law.

(11) "Department" means the Department of Public Health of the State of Illinois.

(12) "Director" means the Director of the Illinois Department of Public Health.

(13) "Licensed health care professional" means a person licensed to practice as a physician, advanced practice registered nurse, or physician assistant in Illinois or any other state.

(14) "Licensed mental health professional" means a person who is licensed or registered to provide mental health services by the Department of Financial and Professional Regulation or a board of registration duly authorized to register or grant licenses to persons engaged in the practice of providing mental health services in Illinois or any other state.

(15) "Intersex condition" means a condition in which a person is born with a reproductive or sexual anatomy or chromosome pattern that does not fit typical definitions of male or female.

(16) "Homeless person" means an individual who meets the definition of "homeless" under Section 103 of the federal McKinney-Vento Homeless Assistance Act (42 U.S.C. 11302) or an individual residing in any of the living situations described in 42 U.S.C. 11434a(2).

(17) "Advanced practice registered nurse" means: (i) an advanced practice registered nurse with full practice authority; or (ii) an advanced practice registered nurse with a collaborative agreement with a physician who has delegated the completion of death certificates.

(18) "Certifying health care professional" means a physician, physician assistant, or advanced practice registered nurse.

(19) "Physician assistant" means a physician assistant who practices in accordance with a written collaborative agreement that includes the completion of death certificates.

(20) "Unique identifier" means providing the deceased with individual identification, through tagging, numbering, QR code, or other individualized means, that is affixed to the dead body, the body bag, and any body part, organ, or tissue separated from the deceased to be used in non-transplant anatomical donation in order to prevent misidentification of human remains as described in the Consensual Non-Transplant Donation Regulation Act.

(Source: P.A. 101-13, eff. 6-12-19; 102-257, eff. 1-1-22; 102-844, eff. 1-1-23.)

(410 ILCS 535/21.7)

Sec. 21.7. Temporary removal of a dead body. No permit for transportation signed by the local registrar is required prior to transporting a dead human body out of the State of Illinois, at the direction of a federally designated organ procurement organization, for the purpose of organ or tissue donation. The dead human body being transported for the purpose of organ or tissue donation shall be accompanied by a self-issued permit in accordance with rules adopted by the Department of Public Health. The dead human body being transported shall have the deceased's unique identifier affixed to the deceased, the body bag, and any body part, organ, or tissue separated from the deceased to be used in non-transplant anatomical donation. This self-issued permit shall be completed by an Illinois-licensed funeral director and embalmer or Illinois-licensed funeral director and shall serve as notification to the county medical examiner or coroner of the jurisdiction or county in which the death occurred that the dead human body is being transported out of Illinois for a period not to exceed 36 hours. This Section applies only to instances in which the dead human body is to be returned to Illinois prior to disposition. This Section does not affect any rights or responsibilities held by county medical examiners or coroners under the Local Governmental and Governmental Employees Tort Immunity Act. The Department of Public Health shall adopt rules to implement this Section.

(Source: P.A. 99-262, eff. 1-1-16.)

Section 910. The Illinois Vehicle Code is amended by changing Section 6-117 as follows:

(625 ILCS 5/6-117) (from Ch. 95 1/2, par. 6-117)

Sec. 6-117. Records to be kept by the Secretary of State.

(a) The Secretary of State shall file every application for a license or permit accepted under this Chapter, and shall maintain suitable indexes thereof. The records of the Secretary of State shall indicate the action taken with respect to such applications.

(b) The Secretary of State shall maintain appropriate records of all licenses and permits refused, cancelled, disqualified, revoked, or suspended and of the revocation, suspension, and disqualification of driving privileges of persons not licensed under this Chapter, and such records shall note the reasons for such action.

(c) The Secretary of State shall maintain appropriate records of convictions reported under this Chapter. Records of conviction may be maintained in a computer processible medium.

(d) The Secretary of State may also maintain appropriate records of any crash reports received.

(e) The Secretary of State shall also maintain appropriate records of any disposition of supervision or records relative to a driver's referral to a driver remedial or rehabilitative program, as required by the Secretary of State or the courts. Such records shall only be available for use by the Secretary, the driver licensing administrator of any other state, law enforcement agencies, the courts, and the affected driver or, upon proper verification, such affected driver's attorney.

(f) The Secretary of State shall also maintain or contract to maintain appropriate records of all photographs and signatures obtained in the process of issuing any driver's license, permit, or identification card. The record shall be confidential and shall not be disclosed except to those entities listed under Section 6-110.1 of this Code.

(g) The Secretary of State may establish a First Person Consent organ and tissue donor registry in compliance with subsection (b-1) of Section 5-20 of the Illinois Anatomical Gift Act, as follows:

(1) The Secretary shall offer, to each applicant for issuance or renewal of a driver's license or identification card who is 16 years of age or older, the opportunity to have his or her name included in the First Person Consent organ and tissue donor registry. The Secretary must advise the applicant or licensee that he or she is under no compulsion to have his or her name included in the registry. An individual who agrees to having his or her name included in the First Person Consent organ and tissue donor registry has given full legal consent to the donation of any of his or her organs or tissue upon his or her death. A brochure explaining this method of executing an anatomical gift must be given to each applicant for issuance or renewal of a driver's license or identification card. The brochure must advise the applicant or licensee (i) that he or she is under no compulsion to have his or her name included in this registry and (ii) that he or she may wish to consult with family, friends, or clergy before doing so.

(2) The Secretary of State may establish additional methods by which an individual may have his or her name included in the First Person Consent organ and tissue donor registry.

(2.5) Not later than 2 years after the effective date of this amendatory Act of the 103rd General Assembly, the Secretary of State shall provide each applicant under this Section the universal donor consent form established by the Department of Public Health in Section 50 of the Consensual Non-Transplant Donation Regulation Act.

(3) When an individual has agreed to have his or her name included in the First Person Consent organ and tissue donor registry, the Secretary of State shall note that agreement in the First Person consent organ and tissue donor registry. Representatives of federally designated organ procurement agencies and tissue banks and the offices of Illinois county coroners and medical examiners may inquire of the Secretary of State whether a potential organ donor's name is included in the First Person Consent organ and tissue donor registry, and the Secretary of State may provide that information to the representative.

(4) An individual may withdraw his or her consent to be listed in the First Person Consent organ and tissue donor registry maintained by the Secretary of State by notifying the Secretary of State in writing, or by any other means approved by the Secretary, of the individual's decision to have his or her name removed from the registry.

(5) The Secretary of State may undertake additional efforts, including education and awareness activities, to promote organ and tissue donation.

(6) In the absence of gross negligence or willful misconduct, the Secretary of State and his or her employees are immune from any civil or criminal liability in connection with an individual's consent to be listed in the organ and tissue donor registry.

(Source: P.A. 102-982, eff. 7-1-23.)

Section 915. The Illinois Anatomical Gift Act is amended by changing Sections 1-10, 5-5, 5-12, 5-20, 5-25, 5-27, and 5-47 and by adding Section 5-6 as follows:

(755 ILCS 50/1-10) (was 755 ILCS 50/2)

Sec. 1-10. Definitions. In this Act:

"Close friend" means any person 18 years of age or older who has exhibited special care and concern for the decedent and who presents an affidavit to the decedent's attending physician, or the hospital administrator or his or her designated representative, stating that he or she (i) was a close friend of the decedent, (ii) is willing and able to authorize the donation, and (iii) maintained such regular contact with the decedent as to be familiar with the decedent's health and social history, and religious and moral beliefs. The affidavit must also state facts and circumstances that demonstrate that familiarity.

"Death" means, for the purposes of the Act, when, according to accepted medical standards, there is (i) an irreversible cessation of circulatory and respiratory functions; or (ii) an irreversible cessation of all functions of the entire brain, including the brain stem.

"Decedent" means a deceased individual and includes a stillborn infant or fetus.

"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. The term does not include a person to whom an anatomical gift could pass under Section 5-12.

"Document of gift" means a donor card or other record used to make an anatomical gift. The term includes a donor registry.

"Donee" means the individual designated by the donor as the intended recipient or an entity which receives the anatomical gift, including, but not limited to, a hospital; an accredited medical school, dental school, college, or university; an organ procurement organization; an eye bank; a tissue bank; for research or education, a non-transplant anatomic bank; or other appropriate person.

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

"Hospital" means a hospital licensed, accredited or approved under the laws of any state; and includes a hospital operated by the United States government, a state, or a subdivision thereof, although not required to be licensed under state laws.

"Non-transplant anatomic bank" means any facility or program operating or providing services in this State that is accredited by the American Association of Tissue Banks and that is involved in procuring, furnishing, or distributing whole bodies or parts for the purpose of medical education. For purposes of this Section, a non-transplant anatomic bank operating under the auspices of a hospital, accredited medical school, dental school, college or university, or federally designated organ procurement organization is not required to be accredited by the American Association of Tissue Banks.

"Non-transplant anatomical donation organization" means an entity that is licensed under the Consensual Non-Transplant Donation Regulation Act to engage in the recovery, screening, testing, processing, distribution, or storage of human bodies or body parts for purposes of education, research, or the advancement of medical, dental, or mortuary science.

"Organ" means a human kidney, liver, heart, lung, pancreas, small bowel, or other transplantable vascular body part as determined by the Organ Procurement and Transplantation Network, as periodically selected by the U.S. Department of Health and Human Services.

"Organ procurement organization" means the organ procurement organization designated by the Secretary of the U.S. Department of Health and Human Services for the service area in which a hospital is located, or the organ procurement organization for which the Secretary of the U.S. Department of Health and Human Services has granted the hospital a waiver pursuant to 42 U.S.C. 1320b-8(a).

"Part" means organs, tissues, eyes, bones, arteries, blood, other fluids and any other portions of a human body.

"Person" means an individual, corporation, government or governmental subdivision or agency, business trust, estate, trust, partnership or association or any other legal entity.

"Physician" or "surgeon" means a physician or surgeon licensed or authorized to practice medicine in all of its branches under the laws of any state.

"Procurement organization" means an organ procurement organization or a tissue bank.

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

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

"State" includes any state, district, commonwealth, territory, insular possession, and any other area subject to the legislative authority of the United States of America.

"Technician" means an individual trained and certified to remove tissue, by a recognized medical training institution in the State of Illinois.

"Tissue" means eyes, bones, heart valves, veins, skin, and any other portions of a human body excluding blood, blood products or organs.

"Tissue bank" means any facility or program operating in Illinois that is accredited by the American Association of Tissue Banks, the Eye Bank Association of America, or the Association of Organ Procurement Organizations and is involved in procuring, furnishing, donating, or distributing corneas, bones, or other human tissue for the purpose of injecting, transfusing, or transplanting any of them into the human body or for the purpose of research or education. "Tissue bank" does not include a licensed blood bank. For the purposes of this Act, "tissue" does not include organs or blood or blood products.

(Source: P.A. 98-172, eff. 1-1-14; 98-756, eff. 7-16-14.)

(755 ILCS 50/5-5) (was 755 ILCS 50/3)

Sec. 5-5. Persons who may execute an anatomical gift.

(a) An anatomical gift of a donor's body or part that is to be carried out upon the donor's death may be made during the life of the donor for the purpose of transplantation, therapy, research, or education by:

(1) the donor, if the donor is an adult, an emancipated minor, or 16 or 17 years of age and registered in the First Person Consent organ and tissue donor registry under subsection (g) of Section 6-117 of the Illinois Vehicle Code if the First Person Consent was executed prior to 2 years after the effective date of this amendatory Act of the 103rd General Assembly;

(1.5) the donor, if the donor is an adult, an emancipated minor, or 16 or 17 years of age and registered in the First Person Consent organ and tissue donor registry under subsection (g) of Section 6-117 of the Illinois Vehicle Code and executed the universal donor consent form in accordance with Section 50 of the Consensual Non-Transplant Donation Regulation Act, if the First Person Consent was executed later than 2 years after the effective date of this amendatory Act of the 103rd General Assembly;

(2) an agent of the donor, unless the power of attorney for health care or other record prohibits the agent from making an anatomical gift;

(3) a parent of the donor, if the donor is an unemancipated minor; or

(4) the donor's guardian.

(b) If no gift has been executed under subsection (a), an anatomical gift of a decedent's body or part for the purpose of transplantation, therapy, research, or education may be made at the time of the decedent's death, or when death is imminent, by a member of the following classes of persons who is reasonably available for the giving of authorization or refusal, in the order of priority listed, when persons in prior classes are not available for the giving of authorization or refusal and in the absence of actual notice of contrary intentions by the decedent:

(1) an individual acting as the decedent's agent under a power of attorney for health care;

(2) the guardian of the person of the decedent;

(3) the spouse or civil union partner of the decedent;

(4) an adult child of the decedent;

(5) a parent of the decedent;

(6) an adult sibling of the decedent;

(7) an adult grandchild of the decedent;

(8) a grandparent of the decedent;

(9) a close friend of the decedent;

(10) the guardian of the estate of the decedent; and

(11) any other person authorized or under legal obligation to dispose of the body.

(b-5) If there is more than one member of a class listed in item (2), (4), (5), (6), or (7) of subsection (b) of this Section 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 under Section 5-12 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 for the giving of authorization or refusal.

(b-10) A person may not make an anatomical gift if, at the time of the decedent's death, a person in a higher priority class under subsection (b) of this Section is reasonably available for the giving of authorization or refusal.

(c) A gift of all or part of a body authorizes any blood or tissue test or minimally invasive examination necessary to assure medical acceptability of the gift for the purposes intended. The hospital shall, to the extent possible and in accordance with any agreement with the organ procurement organization, non-transplant anatomical donation organization, or tissue bank, take measures necessary to maintain the medical suitability of the part until the procurement organization has had the opportunity to advise the applicable persons as set forth in this Act of the option to make an anatomical gift or has ascertained that the individual expressed a contrary intent and has so informed the hospital. The results of tests and examinations under this subsection shall be used or disclosed only for purposes of evaluating medical suitability for donation, to facilitate the donation process, and as required or permitted by existing law.

(d) The rights of the donee created by the gift are paramount to the rights of others except as provided by Section 5-45(d).

(e) If no gift has been executed under this Act, then no part of the decedent's body may be used for any purpose specified in this Act.

(Source: P.A. 100-41, eff. 1-1-18.)

(755 ILCS 50/5-6 new)

Sec. 5-6. Universal donor consent form. Two years after the effective date of this amendatory Act of the 103rd General Assembly, the execution of a gift under this Act shall be accompanied by the universal donor consent form provided for in Section 50 of the Consensual Non-Transplant Donation Regulation Act to consent to non-transplant anatomical donation.

(755 ILCS 50/5-12)

Sec. 5-12. Persons who may receive an anatomical gift; purpose of anatomical gift.

(a) An anatomical gift may be made to the following persons named in the document of gift:

(1) for research or education, a hospital; an accredited medical school, dental school, college, or university; an organ procurement organization; or other appropriate person;

(2) subject to subsection (b) of this Section, an individual designated by the person making the anatomical gift if the individual is the recipient of the part;

(3) an eye bank or tissue bank; or

(4) for research or education, a non-transplant anatomical donation organization licensed by the Department of Public Health anatomic bank.

(b) If an anatomical gift to an individual under item (2) of subsection (a) of this Section cannot be transplanted into the individual, the part passes in accordance with subsection (g) of this Section unless there is an express, contrary indication by the person making the anatomical gift or the universal donor consent form provides the contrary indication.

(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 identifies the purpose for which an anatomical gift may be used, the following rules apply:

(1) If the part is an eye and the gift is for the purpose of transplantation or therapy, the gift passes to the appropriate eye bank.

(2) If the part is tissue and the gift is for the purpose of transplantation or therapy, the gift passes to the appropriate tissue bank.

(3) If the part is an organ and the gift is for the purpose of transplantation or therapy, the gift passes to the appropriate organ procurement organization as custodian of the organ.

(4) If the part is an organ, an eye, or tissue and the gift is for the purpose of research or education, the gift passes to the appropriate non-transplant anatomical donation organization procurement organization.

(d) For the purpose of subsection (c) of this Section, if there is more than one purpose of an anatomical gift set forth in the document of gift but the purposes are not set forth in any priority, and if the gift cannot be used for transplantation or therapy, the gift may be used for research or education, provided that the universal donor consent form does not stipulate a purpose to the contrary.

(e) 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 or research, and the gift passes in accordance with subsection (g) of this Section.

(f) 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 or research, and the gift passes in accordance with subsection (g) of this Section.

(g) For purposes of subsections (b), (e), and (f) of this Section, the following rules apply:

(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 appropriate organ procurement organization or non-transplant anatomical donation organization as custodian of the organ.

(h) An anatomical gift of an organ for transplantation or therapy, other than an anatomical gift under item (2) of subsection (a) of this Section, passes to the organ procurement organization as custodian of the organ.

(i) If an anatomical gift does not pass under 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 under obligation to dispose of the body or part.

(j) A person may not accept an anatomical gift if the person knows that the gift was not effectively made under Section 5-5 or subsection (e) or (e-5) of Section 5-20 or if the person knows that the decedent made a refusal under Section 5-43 that was not revoked.

(k) Except as otherwise provided in item (2) of subsection (a) of this Section, nothing in this Act affects the allocation of organs for transplantation or therapy.

(Source: P.A. 98-172, eff. 1-1-14.)

(755 ILCS 50/5-20) (was 755 ILCS 50/5)

Sec. 5-20. Manner of executing anatomical gifts.

(a) A donor may make an anatomical gift:

(1) by authorizing a statement or symbol indicating that the donor has made an anatomical gift to be imprinted on the donor's driver's license or identification card;

(2) in a will;

(3) during a terminal illness or injury of the donor, by any form of communication addressed to at least 2 adults, at least one of whom is a disinterested witness; or

(4) as provided in subsection (b) and (b-1) of this Section.

(b) A donor or other person authorized to make an anatomical gift under subsection (a) of Section 5-5 may make a gift by a donor card or other record signed by the donor or other person making the gift or by authorizing that a statement or symbol indicating that the donor has made an anatomical gift be included on a donor registry. If the donor or other person is physically unable to sign a record, the record may be signed by another individual at the direction of the donor or other person and must:

(1) be witnessed by at least 2 adults, at least one of whom is a disinterested witness, who have signed at the request of the donor or the other person; and

(2) state that it has been signed and witnessed as provided in paragraph (1) of this subsection (b).

(b-1) A gift under Section 5-5 (a) may also be made by an individual consenting to have his or her name included in the First Person Consent organ and tissue donor registry maintained by the Secretary of State under Section 6-117 of the Illinois Vehicle Code. An individual's consent to have his or her name included in the First Person Consent organ and tissue donor registry constitutes full legal authority for the donation of any of his or her organs or tissue for purposes of transplantation, therapy, or research. Consenting to be included in the First Person Consent organ and tissue donor registry is effective without regard to the presence or signature of witnesses.

(b-5) Revocation, suspension, expiration, or cancellation of a driver's license or identification card upon which an anatomical gift is indicated does not invalidate the gift.

(b-7) Not later than 2 years after the effective date of this amendatory Act of the 103rd General Assembly, the Secretary of State shall provide all donors with the universal donor consent form in accordance with Section 6-117 of the Illinois Vehicle Code.

(b-10) An anatomical gift made by will takes effect upon the donor's death whether or not the will is probated. Invalidation of the will after the donor's death does not invalidate the gift.

(c) The anatomical gift may be made to a specified donee or without specifying a donee. If the gift is made to a specified donee who is not available at the time and place of death, then if made for the purpose of transplantation, it shall be effectuated in accordance with Section 5-25.

(d) The donee or other person authorized to accept the gift pursuant to Section 5-12 may employ or authorize any qualified technician, surgeon, or physician to perform the recovery.

(e) A person authorized to make an anatomical gift under subsection (b) of Section 5-5 may make an anatomical gift by a document of gift signed by the person making the gift or by that person's oral communication that is electronically recorded or is contemporaneously reduced to a record and signed by the individual receiving the oral communication.

(e-5) An anatomical gift by a person authorized under subsection (b) of Section 5-5 may be amended or revoked orally or in a record by a member of a prior class who is reasonably available for the giving of authorization or refusal. If more than one member of the prior class is reasonably available for the giving of authorization or refusal, the gift made by a person authorized under subsection (b) of Section 5-5 may be:

(1) amended only if a majority of the class members reasonably available for the giving of authorization or refusal agree to the amending of the gift; or

(2) revoked only if a majority of the class members reasonably available for the giving of authorization or refusal agree to the revoking of the gift or if they are equally divided as to whether to revoke the gift.

(e-10) A revocation under subsection (e-5) is effective only if, before an incision has been made to remove a part from the donor's body or before invasive procedures have been commenced to prepare the recipient, the procurement organization, non-transplant anatomic bank, transplant hospital, or physician or technician knows of the revocation.

(f) When there is a suitable candidate for organ donation and a donation or consent to donate has not yet been given, procedures to preserve the decedent's body for possible organ and tissue donation may be implemented under the authorization of the applicable organ procurement organization, at its own expense, prior to making a donation request pursuant to Section 5-25. If the organ procurement organization does not locate a person authorized to consent to donation or consent to donation is denied, then procedures to preserve the decedent's body shall be ceased and no donation shall be made. The organ procurement organization shall respect the religious tenets of the decedent, if known, such as a pause after death, before initiating preservation services. Nothing in this Section shall be construed to authorize interference with the coroner in carrying out an investigation or autopsy.

(Source: P.A. 100-41, eff. 1-1-18.)

(755 ILCS 50/5-25)

Sec. 5-25. Notification; authorization.

(a) Each hospital in this State shall enter into agreements or affiliations with procurement organizations for coordination of procurement and use of anatomical gifts. Within 2 years after the effective date of this amendatory Act, each hospital in the State shall enter into agreements or affiliations with non-transplant anatomical donation organizations licensed by the Department of Public Health for the purposes of coordinating non-transplant anatomical donations.

(b) Hospitals shall proceed in accordance with the applicable requirements of 42 CFR 482.45 or any successor provisions of federal statute or regulation, as may be amended from time to time, with regard to collaboration with procurement organizations to facilitate organ, tissue, and eye donation.

In making a request for organ or tissue donation, the hospital or the hospital's federally designated organ procurement organization or tissue bank shall request any of the persons, in the order of priority stated in items (1) through (11) below, when persons in prior classes are not available and in the absence of (i) actual notice of contrary intentions by the decedent, (ii) actual notice of opposition by any member within the same priority class, and (iii) reason to believe that an anatomical gift is contrary to the decedent's religious beliefs, to authorize the gift of all or any part of the decedent's body for any purpose specified in Section 5-12:

(1) an individual acting as the decedent's agent under a power of attorney for health care;

(2) the guardian of the person of the decedent;

(3) the spouse or civil union partner of the decedent;

(4) an adult child of the decedent;

(5) a parent of the decedent;

(6) an adult sibling of the decedent;

(7) an adult grandchild of the decedent;

(8) a grandparent of the decedent;

(9) a close friend of the decedent;

(10) the guardian of the estate of the decedent; and

(11) any other person authorized or under legal obligation to dispose of the body.

(c) (Blank).

(d) (Blank).

(Source: P.A. 98-172, eff. 1-1-14.)

(755 ILCS 50/5-27) (was 755 ILCS 60/3.5)

Sec. 5-27. Notification of patient; family rights and options after circulatory death.

(a) In this Section, "donation after circulatory death" means the donation of organs from a patient whose death is declared based upon cardiopulmonary, and not neurological, criteria, following the implementation of the decision to withdraw life support.

(b) If (i) a potential organ donor, or an individual given authority under subsection (b) of Section 5-25 to consent to an organ donation, expresses an interest in organ donation, (ii) there has not been a certification of brain death for the potential donor, and (iii) the potential donor is a patient at a hospital that does not allow donation after circulatory death, then the organ procurement organization shall inform the patient or the individual given authority to consent to organ donation that the hospital does not allow donation after circulatory death.

(c) In addition to providing oral notification, the organ procurement organization shall develop a written form that indicates to the patient or the individual given authority to consent to organ donation, at a minimum, the following information:

(1) That the patient or the individual given authority to consent to organ donation has received literature and has been counseled by (representative's name) of the (organ procurement organization name).

(2) That all organ donation options have been explained to the patient or the individual given authority to consent to organ donation, including the option of donation after circulatory death.

(3) That the patient or the individual given authority to consent to organ donation is aware that the hospital where the potential donor is a patient does not allow donation after circulatory death.

(4) That the patient or the individual given authority to consent to organ donation has been informed of the right to request a patient transfer to a facility allowing donation after circulatory death.

(5) That the patient or the individual given authority to consent to organ donation has been informed of another hospital that will allow donation after circulatory death and will accept a patient transfer for the purpose of donation after circulatory death; and that the cost of transferring the patient to that other hospital will be covered by the organ procurement organization, with no additional cost to the patient or the individual given authority to consent to organ donation.

The form required under this subsection must include a place for the signatures of the patient or the individual given authority to consent to organ donation and the representative of the organ procurement organization and space to provide the date that the form was signed.

(d) Within 2 years after the effective date of this amendatory Act of the 103rd General Assembly, if the potential donor's gift is for the purpose of research or education, the patient or the individual given authority to consent to organ donation shall be provided the universal donor consent form.

(Source: P.A. 98-172, eff. 1-1-14.)

(755 ILCS 50/5-47)

Sec. 5-47. Rights and duties of procurement organizations and others.

(a) When a hospital refers an individual at or near death to a procurement organization, the organization shall make a reasonable search of the records of the Secretary of State and any donor registry that it knows exists for the geographical area in which the individual resides to ascertain whether the individual has made an anatomical gift.

(b) A procurement organization shall be allowed reasonable access to information in the records of the Secretary of State to ascertain whether an individual at or near death is a donor. If the individual is a donor who is an unemancipated minor, the procurement organization shall conduct a reasonable search for a parent or guardian of the donor and shall provide the parent or guardian with an opportunity to amend or revoke the anatomical gift of the donor's body.

(c) Unless prohibited by law other than this Act, at any time after a donor's death, the person to which a part passes under Section 5-12 may conduct any reasonable examination necessary to ensure the medical suitability of the body or part for its intended purpose.

(d) Unless prohibited by law other than this Act, an examination under subsection (c) may include an examination of all medical and dental records of the donor or prospective donor.

(e) Upon referral by a hospital under subsection (a) of this Section, a procurement organization shall make a reasonable search for any person listed in subsection (b) of Section 5-5 having 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 shall promptly advise the other person of all relevant information.

(f) Subject to subsection (i) of Section 5-12, the rights of the person to which a part passes under Section 5-12 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 Act, 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 under Section 5-12, upon the death of the donor and before embalming, burial, or cremation, shall cause the part to be removed without unnecessary mutilation.

(g) Neither the physician who attends the decedent at death nor the physician who determines the time of the decedent's death may participate in the procedures for removing or transplanting a part from the decedent.

(h) A physician or technician may remove a donated part from the body of a donor that the physician or technician is qualified to remove.

(i) Not later than July 1, 2020, the Secretary of State shall create a database consisting of all individuals who have consented to having their names included in the First Person Consent organ and tissue donor registry maintained by the Secretary of State pursuant to Section 6-117 of the Illinois Vehicle Code. This database shall include identifying information for each individual, including, where available, the individual's name, address, gender, date of birth, driver's license or identification card number, social security number only if the donor does not have a driver's license or identification card number, and date of consent to join the registry. The Secretary of State shall update the database not less often than every 7 days. Upon executing a data access agreement with the Secretary of State, an organ procurement organization, as defined in this Act, providing services in the State of Illinois shall be granted online access to the database for the purpose of determining whether a potential organ and tissue donor is included in the First Person Consent organ and tissue donor registry.

(j) Not later than 2 years after the effective date of this amendatory Act of the 103rd General Assembly, the Department of Public Health shall create a database consisting of all universal donor consent forms.

The organ procurement organization shall indemnify and hold harmless the State of Illinois, its officials, and employees for any judgments, assessments, damages, fines, fees, and legal costs arising out of the acts, omissions, decisions, or other conduct of the organ procurement organization and its officials, employees, and agents in the use of the database.

(Source: P.A. 100-41, eff. 1-1-18; 101-179, eff. 1-1-20.)

Section 999. Effective date. This Act takes effect upon becoming law.