| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
| ||||||||||||||||||||
1 | AN ACT concerning regulation.
| |||||||||||||||||||
2 | Be it enacted by the People of the State of Illinois, | |||||||||||||||||||
3 | represented in the General Assembly:
| |||||||||||||||||||
4 | Section 5. The Nursing Home Care Act is amended by changing | |||||||||||||||||||
5 | Section 2-104 as follows:
| |||||||||||||||||||
6 | (210 ILCS 45/2-104) (from Ch. 111 1/2, par. 4152-104)
| |||||||||||||||||||
7 | Sec. 2-104.
(a) A resident shall be permitted to retain the
| |||||||||||||||||||
8 | the services
of his own personal physician at his own expense | |||||||||||||||||||
9 | or under an individual or
group plan of health insurance, or | |||||||||||||||||||
10 | under 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
| |||||||||||||||||||
15 | concerning his medical diagnosis, treatment and prognosis in | |||||||||||||||||||
16 | terms and
language the resident can reasonably be expected to | |||||||||||||||||||
17 | understand. Every
resident shall be permitted to participate in | |||||||||||||||||||
18 | the planning of his total
care and medical treatment to the | |||||||||||||||||||
19 | extent that his condition permits. No
resident shall be | |||||||||||||||||||
20 | subjected to experimental research or treatment
without first | |||||||||||||||||||
21 | obtaining his informed, written consent. The conduct of
any | |||||||||||||||||||
22 | experimental research or treatment shall be authorized and | |||||||||||||||||||
23 | monitored
by an institutional review board appointed by the |
| |||||||
| |||||||
1 | Director. The
membership, operating procedures and review | ||||||
2 | criteria for the institutional
review board shall be prescribed | ||||||
3 | under rules and regulations of the
Department and shall comply | ||||||
4 | with the requirements for institutional review boards | ||||||
5 | established by the federal Food and Drug Administration. No | ||||||
6 | person who has received compensation in the prior 3 years from | ||||||
7 | an entity that manufactures, distributes, or sells | ||||||
8 | pharmaceuticals, biologics, or medical devices may serve on the | ||||||
9 | institutional review board. | ||||||
10 | The institutional review board may approve only research or | ||||||
11 | treatment that meets the standards of the federal Food and Drug | ||||||
12 | Administration with respect to (i) the protection of human | ||||||
13 | subjects and (ii) financial disclosure by clinical | ||||||
14 | investigators. The Office of State Long Term Care Ombudsman and | ||||||
15 | the State Protection and Advocacy organization shall be given | ||||||
16 | an opportunity to comment on any request for approval before | ||||||
17 | the board makes a decision. Those entities shall not be | ||||||
18 | provided information that would allow a potential human subject | ||||||
19 | to be individually identified, unless the board asks the | ||||||
20 | Ombudsman for help in securing information from or about the | ||||||
21 | resident. The board shall require frequent reporting of the | ||||||
22 | progress of the approved research or treatment and its impact | ||||||
23 | on residents, including immediate reporting of any adverse | ||||||
24 | impact to the resident, the resident's representative, the | ||||||
25 | Office of the State Long Term Care Ombudsman, and the State | ||||||
26 | Protection and Advocacy organization. The board may not approve |
| |||||||
| |||||||
1 | any retrospective study of the records of any resident about | ||||||
2 | the safety or efficacy of any care or treatment if the resident | ||||||
3 | was under the care of the proposed researcher or a business | ||||||
4 | associate when the care or treatment was given, unless the | ||||||
5 | study is under the control of a researcher without any business | ||||||
6 | relationship to any person or entity who could benefit from the | ||||||
7 | findings of the study. | ||||||
8 | No facility shall permit experimental research or | ||||||
9 | treatment to be conducted on a resident, or give access to any | ||||||
10 | person or person's records for a retrospective study about the | ||||||
11 | safety or efficacy of any care or treatment, without the prior | ||||||
12 | written approval of the institutional review board. No nursing | ||||||
13 | home administrator, or person licensed by the State to provide | ||||||
14 | medical care or treatment to any person, may assist or | ||||||
15 | participate in any experimental research on or treatment of a | ||||||
16 | resident, including a retrospective study, that does not have | ||||||
17 | the prior written approval of the board. Such conduct shall be | ||||||
18 | grounds for professional discipline by the Department of | ||||||
19 | Financial and
Professional Regulation. | ||||||
20 | The institutional review board may exempt from ongoing | ||||||
21 | review research or treatment initiated on a resident before the | ||||||
22 | individual's admission to a facility and for which the board | ||||||
23 | determines there is adequate ongoing oversight by another | ||||||
24 | institutional review board. Nothing in this Section shall | ||||||
25 | prevent a facility, any facility employee, or any other person | ||||||
26 | from assisting or participating in any experimental research on |
| |||||||
| |||||||
1 | or treatment of a resident, if the research or treatment began | ||||||
2 | before the person's admission to a facility, until the board | ||||||
3 | has reviewed the research or treatment and decided to grant or | ||||||
4 | deny approval or to exempt the research or treatment from | ||||||
5 | ongoing review.
| ||||||
6 | (b) All medical treatment and procedures shall be | ||||||
7 | administered as
ordered by a physician. All new physician | ||||||
8 | orders shall be reviewed by the
facility's director of nursing | ||||||
9 | or charge nurse designee within 24 hours
after such orders have | ||||||
10 | been issued to assure facility compliance with such orders.
| ||||||
11 | According to rules adopted by the Department, every woman | ||||||
12 | resident of
child-bearing age shall receive routine | ||||||
13 | obstetrical and gynecological
evaluations as well as necessary | ||||||
14 | prenatal care.
| ||||||
15 | (c) Every resident shall be permitted to refuse medical | ||||||
16 | treatment
and to know the consequences of such action, unless | ||||||
17 | such refusal would
be harmful to the health and safety of | ||||||
18 | others and such harm is
documented by a physician in the | ||||||
19 | resident's clinical record. The
resident's refusal shall free | ||||||
20 | the facility from the obligation to
provide the treatment.
| ||||||
21 | (d) Every resident, resident's guardian, or parent if the | ||||||
22 | resident
is a minor shall be permitted to inspect and copy all | ||||||
23 | his clinical and
other records concerning his care and | ||||||
24 | maintenance kept by the facility
or by his physician. The | ||||||
25 | facility may charge a reasonable fee for
duplication of a | ||||||
26 | record.
|
| |||||||
| |||||||
1 | (Source: P.A. 96-1372, eff. 7-29-10.)
|