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.


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CORRECTIONAL BUDGET AND IMPACT NOTE ACT MAY APPLY
FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

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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
16body, or human body part for release to an education facility
17or a research 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,
21for education, research, or the advancement of medical,
22dental, or mortuary 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
17maintenance.
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
22particular use, 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
15issued a license to operate a non-transplant organ donation
16organization.
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,
4testing, processing, distribution, or storage of human bodies
5or body parts for purposes of education, research or the
6advancement of medical, 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
9    will 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
13    by 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
19    records 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,
9and shall 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
23annually.
 

 

 

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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,
18    including the licensee's new name; and
19        (5) a change in the address of the non-transplant
20    organ 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
15Department:
16        (1) may conduct an inspection of the premises; and
17        (2) shall issue to the licensee an amended license
18    that incorporates the modification and retains the
19    expiration date of the existing license, if the
20    non-transplant organ donation organization is in
21    compliance.
22    (f) If the Department receives a notification of a legal
23name change for a non-transplant organ donation organization,
24the Department shall issue to the licensee an amended license
25showing the licensee's changed legal name.
26    (g) If the Department receives notice of a change in the

 

 

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1legal name of a licensee, the Department shall void the
2licensee's license to operate and issue a new license to
3operate with the licensee's changed legal name.
4    (h) If the Department receives notice for a change in the
5address of a non-transplant organ donation organization, the
6Department shall require and review an amended application for
7a license.
8    (i) An individual or business organization planning to
9assume operation of an existing non-transplant organ donation
10organization shall obtain a new license before beginning
11operation.
 
12    Section 40. Denial; suspension; revocation; enforcement.
13    (a) The Department may:
14        (1) deny a license;
15        (2) suspend or revoke a license; or
16        (3) assess a civil penalty against a licensee.
17    (b) The Department may deny an application or suspend or
18revoke a license to operate a non-transplant organ donation
19organization if:
20        (1) an applicant or licensee does not meet the
21    application requirements;
22        (2) a licensee does not comply with any statutory
23    requirements or requirements of the Department;
24        (3) a licensee does not correct a deficiency
25    identified during an inspection according to the plan of

 

 

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

 

 

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1    Section 50. Donor consent forms; non-transplant anatomical
2donation and non-transplant anatomical material
3identification. A non-transplant organ donation organization
4must establish donor consent and ensure that:
5        (1) a donor consent form includes:
6            (A) the intended use of the non-transplant
7        anatomical material;
8            (B) how the non-transplant anatomical material may
9        not be used;
10            (C) a statement that the non-transplant anatomical
11        material will be treated with dignity at all times;
12        and
13            (D) a statement that the non-transplant anatomical
14        material may require international export to an end
15        user; and
16        (2) the donor consent form is maintained in the
17    donor's record and retained for at least 10 years after
18    the date of final disposition;
19        (3) an electronic identification system for donors is
20    established and maintained that:
21            (A) assigns a unique identifier using a
22        combination of letters, numbers, or symbols for a
23        non-transplant anatomical donation and non-transplant
24        anatomical material;
25            (B) tracks the complete history of all
26        non-transplant anatomical material; and

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1applicable federal and State law, by:
2        (1) returning the human body, human body part,
3    non-transplant anatomical material, or cremains to a
4    relative or personal representative of the donor within a
5    time frame designated by the non-transplant organ donation
6    organization at the time donation is established;
7        (2) carrying out the final disposition of the human
8    body or human body part as set forth in Section 4 of the
9    Cadaver Act; or
10        (3) if the licensee is releasing the human body or
11    human body part to another institution, contracting with
12    the institution to assume the obligations described in
13    this Act.
 
14    Section 80. Violations.
15    (a) Any person, entity, officer, or administrator who
16violates a requirement of this Act shall be guilty of a Class 4
17felony.
18    (b) The Department may suspend or revoke the license of
19any licensee found to be in violation of this Act.
20    (c) It is a violation of this Act for any person or entity
21to alter or falsify any information in a label required under
22Section 65.
 
23    Section 85. General responsibilities.
24    (a) A licensee shall provide a copy of a renewed

 

 

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1accreditation to the Department within 30 calendar days after
2the date of issuance.
3    (b) A licensee shall ensure that a non-transplant organ
4donation organization facility is in a building that provides
5a separate and designated area for tissue recovery.
6    (c) A licensee shall ensure policies and procedures are
7established, documented, and implemented that cover:
8        (1) labeling;
9        (2) packaging, including a packaging insert form that
10    discloses the disease status of tissue to end users;
11        (3) transport;
12        (4) distribution; and
13        (5) final disposition.
 
14    Section 90. General plant standards; environmental
15services. A licensee shall ensure that a non-transplant organ
16donation organization:
17        (1) has preparation rooms that:
18            (A) are maintained in a clean and sanitary
19        condition at all times;
20            (B) are only used for examining and preparing a
21        non-transplant anatomical donation;
22            (C) contain equipment, instruments, and supplies
23        necessary for examining and preparing a non-transplant
24        anatomical donation and are disinfected or sterilized,
25        as applicable, after each use to protect the health

 

 

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1        and safety of technicians and personnel members;
2            (D) have sanitary flooring, drainage, and
3        ventilation;
4            (E) have proper and convenient receptacles for
5        refuse, bandages, and all other waste materials; and
6            (F) are thoroughly cleansed and disinfected with a
7        1% solution of chlorinated soda, or other suitable and
8        effective disinfectant, immediately after examining
9        and preparing each non-transplant anatomical material;
10        and
11        (2) has equipment at the non-transplant organ donation
12    organization that is:
13            (A) sufficient to support the service;
14            (B) maintained in working condition;
15            (C) maintained in a clean and sanitary condition;
16            (D) used according to the manufacturer's
17        recommendations;
18            (E) if used during an examination or preparation
19        of a non-transplant anatomical donation, cleaned and
20        sanitized after every use; and
21            (F) if applicable, tested and calibrated according
22        to the manufacturer's recommendations or, if there are
23        no manufacturer's recommendations, according to
24        policies and procedures approved by the Department.
 
25    Section 95. Transportation standards.

 

 

SB0363- 24 -LRB102 03894 CPF 13909 b

1    (a) If a non-transplant organ donation organization owns
2and maintains a vehicle for transporting non-transplant
3anatomical material, an administrator shall ensure that the
4vehicle is:
5        (1) not used for a purpose other than transporting
6    non-transplant anatomical donations and non-transplant
7    anatomical material or conducting non-transplant organ
8    donation organization business;
9        (2) only operated by a procurement organization
10    technician or designated individual authorized to
11    transport non-transplant anatomical donations or
12    non-transplant anatomical material;
13        (3) maintained in clean and sanitary condition; and
14        (4) locked and secured at all time during transport of
15    non-transplant anatomical donations or non-transplant
16    anatomical material.
17    (b) If using a vehicle other than the vehicle described
18under subsection (a) for transporting a non-transplant
19anatomical donation or non-transplant anatomical material, an
20administrator shall ensure that the vehicle:
21        (1) is properly equipped for the transportation of
22    non-transplant anatomical material;
23        (2) is compliant with all State and federal laws and
24    rules pertaining to transporting humans remains; and
25        (3) if transport is by air, complies with applicable
26    standards established by the International Air Transport

 

 

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1    Association and Transportation Security Administration.
2    (c) An administrator shall ensure that non-transplant
3anatomical donations and non-transplant anatomical material
4transported into the State have information of death
5documentation prior to transport.
 
6    Section 100. End user.
7    (a) A licensee shall establish, document, and implement
8policies and procedures to properly screen an end user that
9include:
10        (1) a written request for non-transplant anatomical
11    material, including:
12            (A) the name, address, and affiliation of
13        educators or research institutions accepting
14        responsibility for the acceptance, use, and final
15        disposition of the non-transplant anatomical material;
16            (B) a description of the intended use;
17            (C) the date and the approximate duration of
18        non-transplant anatomical material use;
19            (D) a description of the venue in which the
20        non-transplant anatomical material will be used and
21        the security measures for the safe and ethical
22        utilization of the venue;
23            (E) an assurance that precautions will be used
24        when handling non-transplant anatomical material;
25            (F) the proposed final disposition of the

 

 

SB0363- 26 -LRB102 03894 CPF 13909 b

1        non-transplant anatomical material;
2            (G) an agreement to comply with the licensee's
3        policies, if applicable;
4            (H) an outline of proposed materials to be
5        disseminated in connection with the use of
6        non-transplant anatomical material, if applicable; and
7            (I) other supporting documentation that is
8        relevant to the request; and
9        (2) the criteria for approving requested
10    non-transplant anatomical material for use, including:
11            (A) the acceptability of the educator and
12        researcher for non-transplant anatomical material
13        utilization;
14            (B) the appropriateness of the intended use;
15            (C) the type of venue in which the non-transplant
16        anatomical material will be used;
17            (D) the proposed final disposition of the
18        non-transplant anatomical material, unless returned to
19        the non-transplant organ donation organization; and
20            (E) proposed research materials.
21    (b) A licensee shall establish, document, and implement a
22procedure that allows end users to request an exceptional
23release of non-transplant anatomical material.
 
24    Section 125. The State Finance Act is amended by adding
25Section 5.935 as follows:
 

 

 

SB0363- 27 -LRB102 03894 CPF 13909 b

1    (30 ILCS 105/5.935 new)
2    Sec. 5.935. The Public Health Licensing Fund.
 
3    Section 999. Effective date. This Act takes effect upon
4becoming law.