Bill Amendment: IL HB1335 | 2015-2016 | 99th General Assembly
NOTE: For additional amemendments please see the Bill Drafting List
Bill Title: RIGHT TO TRY ACT
Status: 2015-08-05 - Public Act . . . . . . . . . 99-0270 [HB1335 Detail]
Download: Illinois-2015-HB1335-House_Amendment_001.html
Bill Title: RIGHT TO TRY ACT
Status: 2015-08-05 - Public Act . . . . . . . . . 99-0270 [HB1335 Detail]
Download: Illinois-2015-HB1335-House_Amendment_001.html
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| 1 | AMENDMENT TO HOUSE BILL 1335
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| 2 | AMENDMENT NO. ______. Amend House Bill 1335 as follows:
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| 3 | on page 4, above line 9, by inserting the following:
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| 4 | "Section 80. The Nursing Home Care Act is amended by | ||||||
| 5 | changing Section 2-104 as follows:
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| 6 | (210 ILCS 45/2-104) (from Ch. 111 1/2, par. 4152-104)
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| 7 | Sec. 2-104.
(a) A resident shall be permitted to retain the | ||||||
| 8 | services
of his own personal physician at his own expense or | ||||||
| 9 | under an individual or
group plan of health insurance, or under | ||||||
| 10 | any public or private
assistance program providing such | ||||||
| 11 | coverage. However, the facility is
not liable for the | ||||||
| 12 | negligence of any such personal physician. Every
resident shall | ||||||
| 13 | be permitted to obtain from his own physician or the
physician | ||||||
| 14 | attached to the facility complete and current information
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| 15 | concerning his medical diagnosis, treatment and prognosis in | ||||||
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| 1 | terms and
language the resident can reasonably be expected to | ||||||
| 2 | understand. Every
resident shall be permitted to participate in | ||||||
| 3 | the planning of his total
care and medical treatment to the | ||||||
| 4 | extent that his condition permits. No
resident shall be | ||||||
| 5 | subjected to experimental research or treatment
without first | ||||||
| 6 | obtaining his informed, written consent. The conduct of
any | ||||||
| 7 | experimental research or treatment shall be authorized and | ||||||
| 8 | monitored
by an institutional review board appointed by the | ||||||
| 9 | Director. The
membership, operating procedures and review | ||||||
| 10 | criteria for the institutional
review board shall be prescribed | ||||||
| 11 | under rules and regulations of the
Department and shall comply | ||||||
| 12 | with the requirements for institutional review boards | ||||||
| 13 | established by the federal Food and Drug Administration. No | ||||||
| 14 | person who has received compensation in the prior 3 years from | ||||||
| 15 | an entity that manufactures, distributes, or sells | ||||||
| 16 | pharmaceuticals, biologics, or medical devices may serve on the | ||||||
| 17 | institutional review board. | ||||||
| 18 | The institutional review board may approve only research or | ||||||
| 19 | treatment that meets the standards of the federal Food and Drug | ||||||
| 20 | Administration with respect to (i) the protection of human | ||||||
| 21 | subjects and (ii) financial disclosure by clinical | ||||||
| 22 | investigators. The Office of State Long Term Care Ombudsman and | ||||||
| 23 | the State Protection and Advocacy organization shall be given | ||||||
| 24 | an opportunity to comment on any request for approval before | ||||||
| 25 | the board makes a decision. Those entities shall not be | ||||||
| 26 | provided information that would allow a potential human subject | ||||||
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| 1 | to be individually identified, unless the board asks the | ||||||
| 2 | Ombudsman for help in securing information from or about the | ||||||
| 3 | resident. The board shall require frequent reporting of the | ||||||
| 4 | progress of the approved research or treatment and its impact | ||||||
| 5 | on residents, including immediate reporting of any adverse | ||||||
| 6 | impact to the resident, the resident's representative, the | ||||||
| 7 | Office of the State Long Term Care Ombudsman, and the State | ||||||
| 8 | Protection and Advocacy organization. The board may not approve | ||||||
| 9 | any retrospective study of the records of any resident about | ||||||
| 10 | the safety or efficacy of any care or treatment if the resident | ||||||
| 11 | was under the care of the proposed researcher or a business | ||||||
| 12 | associate when the care or treatment was given, unless the | ||||||
| 13 | study is under the control of a researcher without any business | ||||||
| 14 | relationship to any person or entity who could benefit from the | ||||||
| 15 | findings of the study. | ||||||
| 16 | No facility shall permit experimental research or | ||||||
| 17 | treatment to be conducted on a resident, or give access to any | ||||||
| 18 | person or person's records for a retrospective study about the | ||||||
| 19 | safety or efficacy of any care or treatment, without the prior | ||||||
| 20 | written approval of the institutional review board. No nursing | ||||||
| 21 | home administrator, or person licensed by the State to provide | ||||||
| 22 | medical care or treatment to any person, may assist or | ||||||
| 23 | participate in any experimental research on or treatment of a | ||||||
| 24 | resident, including a retrospective study, that does not have | ||||||
| 25 | the prior written approval of the board. Such conduct shall be | ||||||
| 26 | grounds for professional discipline by the Department of | ||||||
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| 1 | Financial and
Professional Regulation. | ||||||
| 2 | The institutional review board may exempt from ongoing | ||||||
| 3 | review research or treatment initiated on a resident before the | ||||||
| 4 | individual's admission to a facility and for which the board | ||||||
| 5 | determines there is adequate ongoing oversight by another | ||||||
| 6 | institutional review board. Nothing in this Section shall | ||||||
| 7 | prevent a facility, any facility employee, or any other person | ||||||
| 8 | from assisting or participating in any experimental research on | ||||||
| 9 | or treatment of a resident, if the research or treatment began | ||||||
| 10 | before the person's admission to a facility, until the board | ||||||
| 11 | has reviewed the research or treatment and decided to grant or | ||||||
| 12 | deny approval or to exempt the research or treatment from | ||||||
| 13 | ongoing review.
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| 14 | The institutional review board requirements of this | ||||||
| 15 | subsection (a) do not apply to investigational drugs, | ||||||
| 16 | biological products, or devices used by a resident with a | ||||||
| 17 | terminal illness as set forth in the Right to Try Act. | ||||||
| 18 | (b) All medical treatment and procedures shall be | ||||||
| 19 | administered as
ordered by a physician. All new physician | ||||||
| 20 | orders shall be reviewed by the
facility's director of nursing | ||||||
| 21 | or charge nurse designee within 24 hours
after such orders have | ||||||
| 22 | been issued to assure facility compliance with such orders.
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| 23 | All physician's orders and plans of treatment shall have | ||||||
| 24 | the authentication of the physician. For the purposes of this | ||||||
| 25 | subsection (b), "authentication" means an original written | ||||||
| 26 | signature or an electronic signature system that allows for the | ||||||
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| 1 | verification of a signer's credentials. A stamp signature, with | ||||||
| 2 | or without initials, is not sufficient. | ||||||
| 3 | According to rules adopted by the Department, every woman | ||||||
| 4 | resident of
child-bearing age shall receive routine | ||||||
| 5 | obstetrical and gynecological
evaluations as well as necessary | ||||||
| 6 | prenatal care.
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| 7 | (c) Every resident shall be permitted to refuse medical | ||||||
| 8 | treatment
and to know the consequences of such action, unless | ||||||
| 9 | such refusal would
be harmful to the health and safety of | ||||||
| 10 | others and such harm is
documented by a physician in the | ||||||
| 11 | resident's clinical record. The
resident's refusal shall free | ||||||
| 12 | the facility from the obligation to
provide the treatment.
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| 13 | (d) Every resident, resident's guardian, or parent if the | ||||||
| 14 | resident
is a minor shall be permitted to inspect and copy all | ||||||
| 15 | his clinical and
other records concerning his care and | ||||||
| 16 | maintenance kept by the facility
or by his physician. The | ||||||
| 17 | facility may charge a reasonable fee for
duplication of a | ||||||
| 18 | record.
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| 19 | (Source: P.A. 96-1372, eff. 7-29-10; 97-179, eff. 1-1-12.)"; | ||||||
| 20 | and
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| 21 | on page 4, line 9, by replacing "Section 30." with "Section | ||||||
| 22 | 90.".
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