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Public Act 097-0179 | ||||
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AN ACT concerning health facilities.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 5. The Nursing Home Care Act is amended by changing | ||||
Section 2-104 as follows:
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(210 ILCS 45/2-104) (from Ch. 111 1/2, par. 4152-104)
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Sec. 2-104.
(a) A resident shall be permitted to retain the | ||||
services
of his own personal physician at his own expense or | ||||
under an individual or
group plan of health insurance, or under | ||||
any public or private
assistance program providing such | ||||
coverage. However, the facility is
not liable for the | ||||
negligence of any such personal physician. Every
resident shall | ||||
be permitted to obtain from his own physician or the
physician | ||||
attached to the facility complete and current information
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concerning his medical diagnosis, treatment and prognosis in | ||||
terms and
language the resident can reasonably be expected to | ||||
understand. Every
resident shall be permitted to participate in | ||||
the planning of his total
care and medical treatment to the | ||||
extent that his condition permits. No
resident shall be | ||||
subjected to experimental research or treatment
without first | ||||
obtaining his informed, written consent. The conduct of
any | ||||
experimental research or treatment shall be authorized and | ||||
monitored
by an institutional review board appointed by the |
Director. The
membership, operating procedures and review | ||
criteria for the institutional
review board shall be prescribed | ||
under rules and regulations of the
Department and shall comply | ||
with the requirements for institutional review boards | ||
established by the federal Food and Drug Administration. No | ||
person who has received compensation in the prior 3 years from | ||
an entity that manufactures, distributes, or sells | ||
pharmaceuticals, biologics, or medical devices may serve on the | ||
institutional review board. | ||
The institutional review board may approve only research or | ||
treatment that meets the standards of the federal Food and Drug | ||
Administration with respect to (i) the protection of human | ||
subjects and (ii) financial disclosure by clinical | ||
investigators. The Office of State Long Term Care Ombudsman and | ||
the State Protection and Advocacy organization shall be given | ||
an opportunity to comment on any request for approval before | ||
the board makes a decision. Those entities shall not be | ||
provided information that would allow a potential human subject | ||
to be individually identified, unless the board asks the | ||
Ombudsman for help in securing information from or about the | ||
resident. The board shall require frequent reporting of the | ||
progress of the approved research or treatment and its impact | ||
on residents, including immediate reporting of any adverse | ||
impact to the resident, the resident's representative, the | ||
Office of the State Long Term Care Ombudsman, and the State | ||
Protection and Advocacy organization. The board may not approve |
any retrospective study of the records of any resident about | ||
the safety or efficacy of any care or treatment if the resident | ||
was under the care of the proposed researcher or a business | ||
associate when the care or treatment was given, unless the | ||
study is under the control of a researcher without any business | ||
relationship to any person or entity who could benefit from the | ||
findings of the study. | ||
No facility shall permit experimental research or | ||
treatment to be conducted on a resident, or give access to any | ||
person or person's records for a retrospective study about the | ||
safety or efficacy of any care or treatment, without the prior | ||
written approval of the institutional review board. No nursing | ||
home administrator, or person licensed by the State to provide | ||
medical care or treatment to any person, may assist or | ||
participate in any experimental research on or treatment of a | ||
resident, including a retrospective study, that does not have | ||
the prior written approval of the board. Such conduct shall be | ||
grounds for professional discipline by the Department of | ||
Financial and
Professional Regulation. | ||
The institutional review board may exempt from ongoing | ||
review research or treatment initiated on a resident before the | ||
individual's admission to a facility and for which the board | ||
determines there is adequate ongoing oversight by another | ||
institutional review board. Nothing in this Section shall | ||
prevent a facility, any facility employee, or any other person | ||
from assisting or participating in any experimental research on |
or treatment of a resident, if the research or treatment began | ||
before the person's admission to a facility, until the board | ||
has reviewed the research or treatment and decided to grant or | ||
deny approval or to exempt the research or treatment from | ||
ongoing review.
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(b) All medical treatment and procedures shall be | ||
administered as
ordered by a physician. All new physician | ||
orders shall be reviewed by the
facility's director of nursing | ||
or charge nurse designee within 24 hours
after such orders have | ||
been issued to assure facility compliance with such orders.
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All physician's orders and plans of treatment shall have | ||
the authentication of the physician. For the purposes of this | ||
subsection (b), "authentication" means an original written | ||
signature or an electronic signature system that allows for the | ||
verification of a signer's credentials. A stamp signature, with | ||
or without initials, is not sufficient. | ||
According to rules adopted by the Department, every woman | ||
resident of
child-bearing age shall receive routine | ||
obstetrical and gynecological
evaluations as well as necessary | ||
prenatal care.
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(c) Every resident shall be permitted to refuse medical | ||
treatment
and to know the consequences of such action, unless | ||
such refusal would
be harmful to the health and safety of | ||
others and such harm is
documented by a physician in the | ||
resident's clinical record. The
resident's refusal shall free | ||
the facility from the obligation to
provide the treatment.
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(d) Every resident, resident's guardian, or parent if the | ||
resident
is a minor shall be permitted to inspect and copy all | ||
his clinical and
other records concerning his care and | ||
maintenance kept by the facility
or by his physician. The | ||
facility may charge a reasonable fee for
duplication of a | ||
record.
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(Source: P.A. 96-1372, eff. 7-29-10.)
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