SB0363 102ND GENERAL ASSEMBLY

LRB102 03894 CPF 13909 b

102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
SB0363

Introduced 2/19/2021, by Sen. Patricia Van Pelt

SYNOPSIS AS INTRODUCED:

New Act
30 ILCS 105/5.935 new

Creates the Non-Transplant Organ Donation Regulation Act. Requires non-transplant organ donation organizations that acquire or transfer human bodies or human body parts for education, research, or the advancement of medical, dental, or mortuary science to register with the office of the Secretary of State and be licensed by the Department of Public Health. Contains requirements for license application, accreditation, renewal, and fees. Provides that the Department may deny, suspend, or revoke a license; assess civil penalties; and perform inspections under the Act. Provides requirements for donor consent forms, identification of donated human bodies or human body parts, and other records. Contains requirements regarding the labeling, packaging, and final disposition of human bodies or human body parts under the Act. Provides disciplinary action for violation of the Act. Contains other provisions. Effective immediately.

CORRECTIONAL BUDGET AND IMPACT NOTE ACT MAY APPLY

FISCAL NOTE ACT MAY APPLY

A BILL FOR

AN ACT concerning health.

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 Non-Transplant Organ 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 organ donation organization.

"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 consent form" means a legal record of a gift of non-transplant anatomical material permitting and defining acquisition and use of non-transplant anatomical material for education and research, such as a document of authorization, gift, or gift and authorization.

"Entity" means a non-transplant organ 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:

(1) blood drawn for medical purposes; or

(2) 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 organ 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 organ 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.

"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 organ donation organization to an institution.

Section 10. Registration. A non-transplant organ 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 with the office of the Secretary of State and be licensed by the Department at such time and in such manner as the Department may require.

Section 15. Contents of license application. An applicant for licensure or renewal of license 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 registration. 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 in accordance with the requirements of this Act;

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

(9) 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 organ donation organization in this State unless the entity is accredited and licensed by the Department as a non-transplant organ 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 organ donation organization applying for licensure or license renewal shall pay all applicable fees as prescribed by the Department by rule. All fees collected for the licensure and license renewal of non-transplant organ donation organizations shall be deposited in the Public Health Licensing Fund 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 organ donation organization and may sanction or impose civil penalties on any person who is an owner, officer, agent, or employee of a non-transplant organ 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 organ donation organization without proper accreditation or licensure in this State shall be subject to criminal prosecution and civil penalties as provided under Section 80 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 annually.

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 organ 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 organ 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 organ 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 organ donation organization's email address or mailing address, including the new email address or mailing address of the non-transplant organ 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 organ donation organization as of 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 organ donation organization is in compliance.

(f) If the Department receives a notification of a legal name change for a non-transplant organ 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 organ 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 organ 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 organ 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 organ 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 organ 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. Donor consent forms; non-transplant anatomical donation and non-transplant anatomical material identification. A non-transplant organ donation organization must establish donor consent and ensure that:

(1) a donor consent form includes:

(A) the intended use of the non-transplant anatomical material;

(B) how the non-transplant anatomical material may not be used;

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

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

(2) the donor consent form is maintained in the donor's record and retained for at least 10 years after the date of final disposition;

(3) an electronic identification system for donors is established and maintained that:

(A) assigns a unique identifier using a combination of letters, numbers, or symbols for a non-transplant anatomical donation and non-transplant anatomical material;

(B) tracks the complete history of all non-transplant anatomical material; and

(C) records the date and staff member involved in each significant step of the operation from the time of a non-transplant anatomical donation acquisition through final disposition; and

(4) the information required to register the death of a non-transplant anatomical donation is submitted within 7 calendar days after receiving the non-transplant anatomical donation.

Section 55. Donor records.

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

(b) To ensure traceability of a non-transplant anatomical donation and non-transplant anatomical material, a non-transplant organ 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 date, time, and location for each procedure completed; and

(B) 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 identifying number;

(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; and

(2) an informed consent record or documentation of authorization for an anatomical gift;

(3) 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;

(4) 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;

(5) 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;

(6) the donor's death record;

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

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

(9) a disposition transit permit, if applicable;

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

(11) all documents and permits that establish the chain of custody and identifies the individuals and organizations that had physical custody of the non-transplant anatomical material;

(12) 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; and

(13) information from the donor referral source;

(14) donor eligibility;

(15) a donor acceptability assessment;

(16) a physical assessment questionnaire;

(17) documentation related to distribution;

(18) serological results, if applicable;

(19) a cremation authorization document;

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

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

(22) 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 organ 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 organ 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 60. 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 or 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 65. 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, a label shall include the following:

(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".

(c) 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.

Section 75. 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 a relative or personal representative of the donor within a time frame designated by the non-transplant organ 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 80. 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 in a label required under Section 65.

Section 85. 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 organ 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 90. General plant standards; environmental services. A licensee shall ensure that a non-transplant organ 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 organ 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 95. Transportation standards.

(a) If a non-transplant organ 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 organ 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 time 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 100. 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;

(D) the proposed final disposition of the non-transplant anatomical material, unless returned to the non-transplant organ 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 125. The State Finance Act is amended by adding Section 5.935 as follows:

(30 ILCS 105/5.935 new)

Sec. 5.935. The Public Health Licensing Fund.

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