Illinois General Assembly - Full Text of SB3419
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Full Text of SB3419  101st General Assembly




State of Illinois
2019 and 2020


Introduced 2/14/2020, by Sen. Patricia Van Pelt


New Act
30 ILCS 105/5.930 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.

LRB101 20120 CPF 69655 b






SB3419LRB101 20120 CPF 69655 b

1    AN ACT concerning health.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 1. Short title. This Act may be cited as the
5Non-Transplant Organ Donation Regulation Act.
6    Section 5. Definitions. As used in this Act:
7    "Accrediting body" means a nationally recognized agency,
8approved by the Department, that provides certification for a
9business organization operating a non-transplant organ
10donation organization.
11    "Department" means the Department of Public Health.
12    "Director" means the Director of Public Health.
13    "Distribution" means a process that includes selection and
14evaluation of intended use of non-transplant anatomical
15material or a non-transplant anatomical donation, a human body,
16or human body part for release to an education facility or a
17research facility according to State law.
18    "Donor" means a person who has knowingly consented in
19accordance with applicable law to the transfer of a person's
20deceased body or body part, not for use in transplantation, for
21education, research, or the advancement of medical, dental, or
22mortuary science.
23    "Donor consent form" means a legal record of a gift of



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1non-transplant anatomical material permitting and defining
2acquisition and use of non-transplant anatomical material for
3education and research, such as a document of authorization,
4gift, or gift and authorization.
5    "Entity" means a non-transplant organ donation
6organization that is accredited, licensed, or approved under
7federal law or the laws of this State to engage in the
8recovery, screening, testing, processing, distribution, or
9storage of human bodies or body parts.
10    "Exceptional release" means non-transplant anatomical
11material that is approved for usage before a donor
12acceptability assessment or by a researcher requesting
13non-transplant anatomical material that would not normally
14meet the established acceptability criteria.
15    "Environmental services" means activities such as
16housekeeping, laundry, facility maintenance, or equipment
18    "Final disposition" means the final disposal of
19non-transplant anatomical material or a non-transplant
20anatomical donation through incineration, cremation,
21bio-cremation, burial, full depletion by virtue of a particular
22use, or by another legal means.
23    "Education" means the use of a human body or body parts for
24teaching or training individuals, including, but not limited
25to, medical, dental, or mortuary science students or
26professionals, with regard to the anatomy and characteristics



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1of the human body, disease detection, and such other uses as
2may be specified by the Department by rule.
3    "Human body" means a deceased human body or non-transplant
4anatomical donation.
5    "Human body part" or "body part" means an organ, tissue,
6eye, bone, blood vessel, or any other portion of a human body
7that is subject to an anatomical gift or other transfer made
8under State law. "Human body part" does not include:
9        (1) blood drawn for medical purposes; or
10        (2) a growing cell line.
11    "Institution" means a facility established by law for the
12purpose of education, research, or the advancement of medical,
13dental, or mortuary science.
14    "Licensee" means a person to whom the Department has issued
15a license to operate a non-transplant organ donation
17    "Misuse" means to use non-transplant anatomical material
18and non-transplant anatomical donations for purposes other
19than education or research.
20    "Non-transplant anatomical donation" means a donation of a
21whole body, organ, or tissue authorized and used for education
22and research prior to release to distribution inventory.
23    "Non-transplant anatomical material" means a whole body or
24part of a body donated for use in education or research that
25has been prepared, packaged, labeled, and released to
26distribution inventory.



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1    "Non-transplant organ donation organization" means an
2entity that is accredited, licensed, or approved under federal
3law or State law to engage in the recovery, screening, testing,
4processing, distribution, or storage of human bodies or body
5parts for purposes of education, research or the advancement of
6medical, dental, or mortuary science.
7    "Research" does not include an autopsy or examination
8conducted as part of a criminal investigation.
9    "Storage" means a designated area that contains equipment,
10instruments, and supplies necessary to maintain non-transplant
11anatomical donations or non-transplant anatomical material
12until distribution or final disposition.
13    "Transfer" means to move from a non-transplant organ
14donation organization to an institution.
15    Section 10. Registration. A non-transplant organ donation
16organization established by law to conduct business in the
17State of Illinois that acquires or transfers a human body or
18human body part for education, research, or the advancement of
19medical, dental, or mortuary science, and not for use in human
20transplantation, shall register with the office of the
21Secretary of State and be licensed by the Department at such
22time and in such manner as the Department may require.
23    Section 15. Contents of license application. An applicant
24for licensure or renewal of license under this Section shall



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1submit an application to the Department containing such
2information as the Department may require by rule on the
3activities to be carried out pursuant to registration. Unless
4otherwise set forth by administrative rule, the application
5shall include:
6        (1) the name of the applicant, including all trade
7    names under which the applicant conducts business;
8        (2) the date on which the applicant first began or will
9    begin commencing activities described in this Act;
10        (3) a list of all addresses at which the applicant
11    conducts business;
12        (4) a description of the premises and equipment used by
13    the applicant;
14        (5) a description of the types of service provided by
15    the applicant;
16        (6) identification of all officers and administrators
17    of the applicant;
18        (7) an attestation that the applicant will keep records
19    in accordance with the requirements of this Act;
20        (8) an attestation that the applicant will label and
21    package all human bodies or human body parts in accordance
22    with the requirements of this Act; and
23        (9) an acknowledgment that the Department will be
24    permitted to inspect the premises and records of the
25    applicant as to the items and in the manner prescribed in
26    this Act.



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1    Section 20. Accreditation; licensure; renewal; fees;
2penalties; enforcement.
3    (a) An entity may not act as a non-transplant organ
4donation organization in this State unless the entity is
5accredited and licensed by the Department as a non-transplant
6organ donation organization. The entity shall apply in writing
7to the Department on a form specified by the Director, which
8shall include all information requested in the application, and
9shall pay the fees prescribed by the Department by rule.
10    (b) The Director shall grant a license to an entity if: (1)
11the organization is accredited by a nationally recognized
12accrediting agency that is approved by the Department and
13maintains full accreditation with the accrediting agency; and
14(2) the entity meets other requirements prescribed by the
15Department by rule.
16    (c) Each non-transplant organ donation organization
17applying for licensure or license renewal shall pay all
18applicable fees as prescribed by the Department by rule. All
19fees collected for the licensure and license renewal of
20non-transplant organ donation organizations shall be deposited
21in the Public Health Licensing Fund to be used by the
22Department for the administration and enforcement of this Act.
23    (d) The Director may sanction, impose civil penalties on,
24suspend the license of, or revoke the license of a
25non-transplant organ donation organization and may sanction or



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1impose civil penalties on any person who is an owner, officer,
2agent, or employee of a non-transplant organ donation
3organization if the person is in or continues to be in
4violation of this Act or rules adopted by the Department under
5this Act.
6    (e) Any person or entity operating as a non-transplant
7organ donation organization without proper accreditation or
8licensure in this State shall be subject to criminal
9prosecution and civil penalties as provided under Section 80
10and any applicable rules.
11    Section 25. Other fees.
12    (a) The Department shall establish a fee for licensure
13under Section 10 and renewal under Section 30.
14    (b) The Department shall determine the amount of licensing
15fees under this Act, taking into consideration, among other
16things, the projected implementation, enforcement, and
17inspection costs associated with this Act.
18    (c) Every fine accruing from a conviction under this Act
19shall be paid into the common school fund of the county in
20which the offense was committed.
21    Section 30. License renewal. The Department shall require
22that the license of an applicant be renewed by the applicant



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1    Section 35. Change of information.
2    (a) Not later than 30 days after any change of any
3information listed under Section 15, an applicant or licensee
4shall notify the Department of the change in writing as
5prescribed by the Department.
6    (b) A licensee shall notify the Department in writing at
7least 30 calendar days before the date of:
8        (1) termination of operation, including, but not
9    limited to, the proposed termination date and the address
10    and contact information for the location where the
11    non-transplant organ donation organization records will be
12    retained, if applicable;
13        (2) a proposed modification that alters the area for
14    tissue recovery, if applicable;
15        (3) a change in the non-transplant organ donation
16    organization's legal name;
17        (4) a change in the legal name of a licensee, including
18    the licensee's new name; and
19        (5) a change in the address of the non-transplant organ
20    donation organization, including the new address.
21    (c) A licensee shall notify the Department in writing no
22later than 30 calendar days after the date of:
23        (1) a change in the non-transplant organ donation
24    organization's email address or mailing address, including
25    the new email address or mailing address of the
26    non-transplant organ donation organization;



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1        (2) a change in the email address or telephone number
2    of the licensee, including the new email address or
3    telephone number;
4        (3) a change in an administrator or medical director,
5    including his or her name and email address; and
6        (4) a change in the name or contact information of an
7    officer affiliated with the licensee, including the name
8    and contact information of the new officer.
9    (d) If the Department receives notification of termination
10of operation, the Department shall void the licensee's license
11to operate a non-transplant organ donation organization as of
12the termination date specified by the licensee.
13    (e) If the Department receives notification of a proposed
14modification that alters the area for tissue recovery, the
16        (1) may conduct an inspection of the premises; and
17        (2) shall issue to the licensee an amended license that
18    incorporates the modification and retains the expiration
19    date of the existing license, if the non-transplant organ
20    donation organization is in compliance.
21    (f) If the Department receives a notification of a legal
22name change for a non-transplant organ donation organization,
23the Department shall issue to the licensee an amended license
24showing the licensee's changed legal name.
25    (g) If the Department receives notice of a change in the
26legal name of a licensee, the Department shall void the



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1licensee's license to operate and issue a new license to
2operate with the licensee's changed legal name.
3    (h) If the Department receives notice for a change in the
4address of a non-transplant organ donation organization, the
5Department shall require and review an amended application for
6a license.
7    (i) An individual or business organization planning to
8assume operation of an existing non-transplant organ donation
9organization shall obtain a new license before beginning
11    Section 40. Denial; suspension; revocation; enforcement.
12    (a) The Department may:
13        (1) deny a license;
14        (2) suspend or revoke a license; or
15        (3) assess a civil penalty against a licensee.
16    (b) The Department may deny an application or suspend or
17revoke a license to operate a non-transplant organ donation
18organization if:
19        (1) an applicant or licensee does not meet the
20    application requirements;
21        (2) a licensee does not comply with any statutory
22    requirements or requirements of the Department;
23        (3) a licensee does not correct a deficiency identified
24    during an inspection according to the plan of correction;
25        (4) an applicant or licensee provides false or



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1    misleading information as part of an application or
2    inspection; or
3        (5) the nature or number of violations revealed by any
4    type of inspection or investigation of a non-transplant
5    organ donation organization pose a direct risk to the life,
6    health, or safety of individuals on the premises or the
7    public at large.
8    (c) In determining which action is appropriate, the
9Department may consider:
10        (1) repeated violations of statutes or rules;
11        (2) a pattern of violations;
12        (3) the severity of violations; and
13        (4) the number of violations.
14    (d) The Department may suspend or revoke a non-transplant
15organ donation organization's license if the Department
16receives notice from the organization's accrediting body that
17the organization's accreditation has been suspended or
18revoked. An applicant or licensee may seek administrative
19review of the Department's determination.
20    Section 45. Inspections. The Department shall inspect a
21licensee's premises at least annually and any time after it
22receives a complaint or notice of a violation.
23    Section 50. Donor consent forms; non-transplant anatomical
24donation and non-transplant anatomical material



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1identification. A non-transplant organ donation organization
2must establish donor consent and ensure that:
3        (1) a donor consent form includes:
4            (A) the intended use of the non-transplant
5        anatomical material;
6            (B) how the non-transplant anatomical material may
7        not be used;
8            (C) a statement that the non-transplant anatomical
9        material will be treated with dignity at all times; and
10            (D) a statement that the non-transplant anatomical
11        material may require international export to an end
12        user; and
13        (2) the donor consent form is maintained in the donor's
14    record and retained for at least 10 years after the date of
15    final disposition;
16        (3) an electronic identification system for donors is
17    established and maintained that:
18            (A) assigns a unique identifier using a
19        combination of letters, numbers, or symbols for a
20        non-transplant anatomical donation and non-transplant
21        anatomical material;
22            (B) tracks the complete history of all
23        non-transplant anatomical material; and
24            (C) records the date and staff member involved in
25        each significant step of the operation from the time of
26        a non-transplant anatomical donation acquisition



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1        through final disposition; and
2        (4) the information required to register the death of a
3    non-transplant anatomical donation is submitted within 7
4    calendar days after receiving the non-transplant
5    anatomical donation.
6    Section 55. Donor records.
7    (a) A non-transplant organ donation organization shall
8maintain a legible, reproducible record for each donor from
9whom it releases non-transplant anatomical material for at
10least 10 years beyond the date of final disposition.
11    (b) To ensure traceability of a non-transplant anatomical
12donation and non-transplant anatomical material, a
13non-transplant organ donation organization shall:
14        (1) document each procedure performed on a
15    non-transplant anatomical donation and non-transplant
16    anatomical material related to processing and storing
17    non-transplant anatomical donations and non-transplant
18    anatomical material;
19        (2) for each document created under paragraph (1),
20    include:
21            (A) the date, time, and location for each procedure
22        completed; and
23            (B) the name of the technician who performed the
24        procedure; and
25        (3) submit or have a contracted funeral home submit



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1    information required to register the death of a
2    non-transplant anatomical donation within 7 calendar days
3    after receiving the non-transplant anatomical donation, if
4    applicable.
5    (c) A donor record shall be:
6        (1) confidential;
7        (2) kept in a location with controlled access;
8        (3) stored in a manner to prevent unauthorized access;
9    and
10        (4) maintained in a manner to preserve the donor
11    record's completeness and accuracy.
12    (d) A donor record shall include at least the following:
13        (1) donor information that includes:
14            (A) the donor's name;
15            (B) the donor's unique identifying number;
16            (C) the donor's date of birth and date of death;
17        and
18            (D) the name and contact information of the person
19        responsible for a donor's anatomical gift, if
20        applicable; and
21        (2) an informed consent record or documentation of
22    authorization for an anatomical gift;
23        (3) a document of authorization, which is a legal
24    record of the gift, to take place postmortem, permitting
25    and defining the scope of the postmortem acquisition and
26    use of non-transplant anatomical material for education



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1    and research, signed or otherwise recorded by the
2    authorizing person;
3        (4) a document of anatomical gift, which is the donor's
4    legal record of the gift of non-transplant anatomical
5    material permitting and defining the scope of the
6    postmortem acquisition and use of non-transplant
7    anatomical material for education and research;
8        (5) an authorization of gift, which must be signed or
9    otherwise recorded by an individual authorized by law to
10    make a gift during the donor's lifetime;
11        (6) the donor's death record;
12        (7) the human remains release form, if applicable;
13        (8) information for a death record, if applicable for
14    transporting human remains into the State;
15        (9) a disposition transit permit, if applicable;
16        (10) a medical examiner's release of information, if
17    applicable;
18        (11) all documents and permits that establish the chain
19    of custody and identifies the individuals and
20    organizations that had physical custody of the
21    non-transplant anatomical material;
22        (12) medical records, including:
23            (A) a donor's physical assessment;
24            (B) a risk assessment questionnaire;
25            (C) pathology and laboratory testing and reports;
26            (D) physician summaries, if applicable;



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1            (E) transfusion or infusion information, if
2        applicable; and
3            (F) plasma dilution calculations if applicable;
4        and
5        (13) information from the donor referral source;
6        (14) donor eligibility;
7        (15) a donor acceptability assessment;
8        (16) a physical assessment questionnaire;
9        (17) documentation related to distribution;
10        (18) serological results, if applicable;
11        (19) a cremation authorization document;
12        (20) documentation related to non-transplant
13    anatomical material recovery, storage, and distribution
14    activities;
15        (21) final disposition documentation, including all
16    records demonstrating chain of custody; and
17        (22) documentation of the suspected misuse or harm to
18    the donor, if any.
19    (e) A donor's record shall be accessible to:
20        (1) an agent legally authorized to have access, or an
21    individual designated at the time a donor gives consent;
22        (2) an individual appointed by a court or authorized by
23    State law;
24        (3) an individual of a non-transplant organ donation
25    organization as identified by policies and procedures;
26        (4) an individual from an approved accrediting body, if



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1    applicable; and
2        (5) an individual from the Department or other
3    regulatory agency authorized by State or federal laws or
4    rules adopted by the Department.
5    (f) Except for a donor record that must be maintained for a
6period of 10 years after final disposition, a non-transplant
7organ donation organization shall maintain documentation
8required under this Act for at least 3 years after the date of
9the documentation and shall provide copies of the documentation
10to the Department for review upon request.
11    Section 60. Recordkeeping.
12    (a) A licensee shall compile or maintain a record for each
13case in which the licensee acquires a human body, human body
14part, or non-transplant anatomical donation.
15    (b) A record shall contain the following information and
16any additional information required by the Department:
17        (1) documentation that the donor has knowingly
18    consented to the transfer of the human body or human body
19    part, not for use in transplantation, for education,
20    research, or the advancement of medical, dental, or
21    mortuary science in accordance with all applicable laws
22    pertaining to the final disposition of human remains;
23        (2) documentation that the donor has been informed of
24    the obligation of the licensee as to the proper disposal of
25    the human body or human body part;



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1        (3) the date and time of the donation or transfer from
2    the donor;
3        (4) the name of the person, including any trade or
4    business name, who transferred the human body or human body
5    part to the licensee, if applicable;
6        (5) the full name and most recent address of the donor;
7        (6) a description of the human body or human body part
8    being acquired or transferred;
9        (7) the medical history of the donor, including the
10    autopsy report if any autopsy was conducted;
11        (8) the identity and address of each person who has
12    been in possession of the human body or human body part
13    prior to the registrant, including any funeral home,
14    coroner, hospital, organ procurement organization, or
15    tissue bank;
16        (9) documentation of the use and final disposition of
17    each human body or human body part by the licensee;
18        (10) documentation of the name and address of each
19    person to whom the licensee transfers the human body or
20    human body part; and
21        (11) the implementation and maintenance of protocols
22    and materials for procedures to properly screen end users.
23    (c) A licensee shall maintain the following records for 10
24years after the last date of tissue distribution:
25        (1) a copy or recorded consent of the donation
26    authorization;



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1        (2) a copy of the donor's death certificate and transit
2    permit issued by the state where the death occurred;
3        (3) a copy of the donor's physical assessment and risk
4    assessment questionnaire;
5        (4) a copy of the donor's serological results, if
6    applicable; and
7        (5) a copy of all documentation relating to tissue
8    recovery, storage, and distribution activities.
9    Section 65. Labeling and packaging.
10    (a) A licensee shall ensure that all human bodies and human
11body parts in the possession of, or transferred by, the
12licensee are labeled and packaged in accordance with this
14    (b) Unless the Department specifies otherwise by rule, a
15label shall include the following:
16        (1) the proper name of the donor;
17        (2) a description of the contents of the package
18    indicating whether it is a human body or human body parts,
19    including a list of all human body parts;
20        (3) the name, address, and license and registration
21    number of the person transferring the human body or human
22    body part;
23        (4) the tissue types of the human body or human body
24    part;
25        (5) the cause of death of the donor, if applicable and



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1    known;
2        (6) serological test results, if any results exist;
3        (7) any known infectious disease agents of the human
4    body or human body part;
5        (8) a statement about the use of personal protective
6    equipment and universal precautions when handling a human
7    body or human body part as required by law; and
8        (9) the statement "not for transplantation".
9    (c) Unless the Department specifies otherwise by rule, each
10human body or human body part under this Section shall be
11wrapped and packaged in a manner that:
12        (1) mitigates potential contamination and cross
13    contamination;
14        (2) mitigates potential safety hazards;
15        (3) is sealed to prevent leakage; and
16        (4) ensures the integrity of the human body or human
17    body part.
18    Section 75. Final disposition. A licensee shall ensure the
19proper final disposition of a human body, human body part, or
20non-transplant anatomical material, in accordance with
21applicable federal and State law, by:
22        (1) returning the human body, human body part,
23    non-transplant anatomical material, or cremains to a
24    relative or personal representative of the donor within a
25    time frame designated by the non-transplant organ donation



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1    organization at the time donation is established;
2        (2) carrying out the final disposition of the human
3    body or human body part as set forth in Section 4 of the
4    Cadaver Act; or
5        (3) if the licensee is releasing the human body or
6    human body part to another institution, contracting with
7    the institution to assume the obligations described in this
8    Act.
9    Section 80. Violations.
10    (a) Any person, entity, officer, or administrator who
11violates a requirement of this Act shall be guilty of a Class 4
13    (b) The Department may suspend or revoke the license of any
14licensee found to be in violation of this Act.
15    (c) It is a violation of this Act for any person or entity
16to alter or falsify any information in a label required under
17Section 65.
18    Section 85. General responsibilities.
19    (a) A licensee shall provide a copy of a renewed
20accreditation to the Department within 30 calendar days after
21the date of issuance.
22    (b) A licensee shall ensure that a non-transplant organ
23donation organization facility is in a building that provides a
24separate and designated area for tissue recovery.



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1    (c) A licensee shall ensure policies and procedures are
2established, documented, and implemented that cover:
3        (1) labeling;
4        (2) packaging, including a packaging insert form that
5    discloses the disease status of tissue to end users;
6        (3) transport;
7        (4) distribution; and
8        (5) final disposition.
9    Section 90. General plant standards; environmental
10services. A licensee shall ensure that a non-transplant organ
11donation organization:
12        (1) has preparation rooms that:
13            (A) are maintained in a clean and sanitary
14        condition at all times;
15            (B) are only used for examining and preparing a
16        non-transplant anatomical donation;
17            (C) contain equipment, instruments, and supplies
18        necessary for examining and preparing a non-transplant
19        anatomical donation and are disinfected or sterilized,
20        as applicable, after each use to protect the health and
21        safety of technicians and personnel members;
22            (D) have sanitary flooring, drainage, and
23        ventilation;
24            (E) have proper and convenient receptacles for
25        refuse, bandages, and all other waste materials; and



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1            (F) are thoroughly cleansed and disinfected with a
2        1% solution of chlorinated soda, or other suitable and
3        effective disinfectant, immediately after examining
4        and preparing each non-transplant anatomical material;
5        and
6        (2) has equipment at the non-transplant organ donation
7    organization that is:
8            (A) sufficient to support the service;
9            (B) maintained in working condition;
10            (C) maintained in a clean and sanitary condition;
11            (D) used according to the manufacturer's
12        recommendations;
13            (E) if used during an examination or preparation of
14        a non-transplant anatomical donation, cleaned and
15        sanitized after every use; and
16            (F) if applicable, tested and calibrated according
17        to the manufacturer's recommendations or, if there are
18        no manufacturer's recommendations, according to
19        policies and procedures approved by the Department.
20    Section 95. Transportation standards.
21    (a) If a non-transplant organ donation organization owns
22and maintains a vehicle for transporting non-transplant
23anatomical material, an administrator shall ensure that the
24vehicle is:
25        (1) not used for a purpose other than transporting



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1    non-transplant anatomical donations and non-transplant
2    anatomical material or conducting non-transplant organ
3    donation organization business;
4        (2) only operated by a procurement organization
5    technician or designated individual authorized to
6    transport non-transplant anatomical donations or
7    non-transplant anatomical material;
8        (3) maintained in clean and sanitary condition; and
9        (4) locked and secured at all time during transport of
10    non-transplant anatomical donations or non-transplant
11    anatomical material.
12    (b) If using a vehicle other than the vehicle described
13under subsection (a) for transporting a non-transplant
14anatomical donation or non-transplant anatomical material, an
15administrator shall ensure that the vehicle:
16        (1) is properly equipped for the transportation of
17    non-transplant anatomical material;
18        (2) is compliant with all State and federal laws and
19    rules pertaining to transporting humans remains; and
20        (3) if transport is by air, complies with applicable
21    standards established by the International Air Transport
22    Association and Transportation Security Administration.
23    (c) An administrator shall ensure that non-transplant
24anatomical donations and non-transplant anatomical material
25transported into the State have information of death
26documentation prior to transport.



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1    Section 100. End user.
2    (a) A licensee shall establish, document, and implement
3policies and procedures to properly screen an end user that
5        (1) a written request for non-transplant anatomical
6    material, including:
7            (A) the name, address, and affiliation of
8        educators or research institutions accepting
9        responsibility for the acceptance, use, and final
10        disposition of the non-transplant anatomical material;
11            (B) a description of the intended use;
12            (C) the date and the approximate duration of
13        non-transplant anatomical material use;
14            (D) a description of the venue in which the
15        non-transplant anatomical material will be used and
16        the security measures for the safe and ethical
17        utilization of the venue;
18            (E) an assurance that precautions will be used when
19        handling non-transplant anatomical material;
20            (F) the proposed final disposition of the
21        non-transplant anatomical material;
22            (G) an agreement to comply with the licensee's
23        policies, if applicable;
24            (H) an outline of proposed materials to be
25        disseminated in connection with the use of



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1        non-transplant anatomical material, if applicable; and
2            (I) other supporting documentation that is
3        relevant to the request; and
4        (2) the criteria for approving requested
5    non-transplant anatomical material for use, including:
6            (A) the acceptability of the educator and
7        researcher for non-transplant anatomical material
8        utilization;
9            (B) the appropriateness of the intended use;
10            (C) the type of venue in which the non-transplant
11        anatomical material will be used;
12            (D) the proposed final disposition of the
13        non-transplant anatomical material, unless returned to
14        the non-transplant organ donation organization; and
15            (E) proposed research materials.
16    (b) A licensee shall establish, document, and implement a
17procedure that allows end users to request an exceptional
18release of non-transplant anatomical material.
19    Section 125. The State Finance Act is amended by adding
20Section 5.930 as follows:
21    (30 ILCS 105/5.930 new)
22    Sec. 5.930. The Public Health Licensing Fund.
23    Section 999. Effective date. This Act takes effect upon
24becoming law.