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(210 ILCS 25/Art.
I heading)
ARTICLE I. SHORT TITLE,
LEGISLATIVE INTENT AND APPLICATION OF ACT
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(210 ILCS 25/1-101) (from Ch. 111 1/2, par. 621-101)
Sec. 1-101. Short
title. This Act may be cited as the Illinois Clinical
Laboratory and Blood Bank Act.
(Source: P.A. 87-1269.)
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(210 ILCS 25/1-102) (from Ch. 111 1/2, par. 621-102)
Sec. 1-102. Purposes.
The operation of clinical laboratories and blood
banks in the State of Illinois is declared to affect the public health, safety and welfare.
It is further declared that the purpose of this Act
is to supplement federal regulation of clinical laboratories
to provide for the better protection of public health.
This Act shall be liberally construed to carry out
these objects and purposes.
(Source: P.A. 87-1269.)
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(210 ILCS 25/1-103) (from Ch. 111 1/2, par. 621-103)
Sec. 1-103. Application
of Act. This Act applies to clinical laboratories
and blood banks, except clinical laboratories operated
by the United States Government. In addition, this
Act shall not be construed to apply to tests classified
as waivered tests under federal regulations adopted
for the Clinical Laboratory Improvement Act of 1988.
(Source: P.A. 86-853; 86-1292; 87-467;
87-600; 87-895; 87-1269.)
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(210 ILCS 25/Art.
II heading)
ARTICLE II. DEFINITIONS
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(210 ILCS 25/2-101) (from Ch. 111 1/2, par. 622-101)
Sec. 2-101. For the
purposes of this Act, the words and phrases defined
in Sections after this Section and preceding Section
3-101 have the meanings ascribed to them unless
the context otherwise requires.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-102) (from Ch. 111 1/2, par. 622-102)
Sec. 2-102. "Person" means
any individual, firm, partnership, association, corporation,
whether organized for profit or not, or any other
form of business enterprise.
(Source: Laws 1965, p. 3256.)
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(210 ILCS 25/2-103) (from Ch. 111 1/2, par. 622-103)
Sec. 2-103. "Clinical
laboratory" or "laboratory" means
a facility which performs laboratory tests or issues
reports resulting from such tests and is certified
under the Clinical Laboratory Improvement Act of
1988.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-104) (from Ch. 111 1/2, par. 622-104)
Sec. 2-104. The "director
of clinical laboratory" means an individual
who administers the technical and scientific operation
of a clinical laboratory, including the reporting
of the findings of clinical laboratory tests.
(Source: P. A. 76-1000.)
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(210 ILCS 25/2-105) (from Ch. 111 1/2, par. 622-105)
Sec. 2-105. "Department" means
the Department of Public Health of the State of Illinois.
(Source: Laws 1965, p. 3256.)
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(210 ILCS 25/2-116) (from Ch. 111 1/2, par. 622-116)
Sec. 2-116. "Physician" means,
unless otherwise indicated in this Act, (a) a person
licensed by the Department of Professional Regulation,
pursuant to the requirements of the Medical Practice
Act of 1987; or (b) a person licensed as a physician
under the laws of another state or territory of the
United States.
(Source: P.A. 85-1025.)
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(210 ILCS 25/2-117) (from Ch. 111 1/2, par. 622-117)
Sec. 2-117. "Test" means
laboratory examinations and issuance of reports resulting
from the biological, microbiological, serological,
chemical, immunohematological, radioimmunological,
hematological, biophysical, cytological, pathological,
toxicological or other examination of materials derived
from the human body for the purposes of providing
information for the diagnosis, prevention or treatment
of any disease or impairment of, or the assessment
of, the health of humans including determining drug
use by humans.
(Source: P.A. 85-1025.)
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(210 ILCS 25/2-120) (from Ch. 111 1/2, par. 622-120)
Sec. 2-120. "Health
screening" means those tests or categories of
tests set forth in the regulations adopted under
this Act that are performed for the purpose of assessing
a phase of the general state of health of human subjects.
(a) All health screenings
must be conducted under a protocol approved by a physician licensed
to practice medicine in all its branches that includes, but is
not limited to, provisions concerning disclosure of the purpose
and limitations of the screening tests to test subjects, proper
collection of samples and administration of tests including staffing,
staff training and equipment monitoring, adequate procedures
for protecting the confidentiality of test subjects and test
results, and appropriate referrals for medical attention.
(b) Health screening protocols
under this Section shall be exempt from the provisions of Sections
7-101 and 7-102 of this Act.
(Source: P.A. 87-600; 87-1269.)
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(210 ILCS 25/2-124) (from Ch. 111 1/2, par. 622-124)
Sec. 2-124. "Blood
bank" means any institution, building, or place
that provides, through its ownership or operation,
a system for the collection, processing, storage,
distribution, or administration of whole human blood
or its component parts.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-125) (from Ch. 111 1/2, par. 622-125)
Sec. 2-125. "Medical
Director of a blood bank" means an individual
who administers the technical and scientific operation
of a blood bank, including the reporting of the findings
of blood bank tests.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-126) (from Ch. 111 1/2, par. 622-126)
Sec. 2-126. "Dentist" means
a person licensed in Illinois to practice dentistry.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-127) (from Ch. 111 1/2, par. 622-127)
Sec. 2-127. "Podiatrist" means
a person licensed in Illinois to practice podiatry.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-127.5)
Sec. 2-127.5. Therapeutic
optometrist. "Therapeutic optometrist" means
a person who is licensed in Illinois to practice
optometry and who is therapeutically certified.
(Source: P.A. 90-322, eff. 1-1-98.)
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(210 ILCS 25/2-128) (from Ch. 111 1/2, par. 622-128)
Sec. 2-128. "Blood" means
whole human blood or components of human blood, including
plasma, that are prepared from whole human blood
by physical rather than chemical processes, but does
not include blood derivatives manufactured or processed
for industrial use.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-129) (from Ch. 111 1/2, par. 622-129)
Sec. 2-129. "Volunteer
donor" means a person from whom blood is withdrawn
for which he receives no monetary consideration in
any form, whether he presents himself for the withdrawal
of blood on his own initiative or on the initiative
of another person.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-130) (from Ch. 111 1/2, par. 622-130)
Sec. 2-130. "Paid
donor" means a person from whom blood is withdrawn
for which he receives a monetary consideration in
any form, whether he presents himself for the withdrawal
of blood on his own initiative or on the initiative
of another person.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-131) (from Ch. 111 1/2, par. 622-131)
Sec. 2-131. "Industrial
use" means a use of blood in which the blood
is modified by physical or chemical means to produce
derivatives for therapeutic or pharmaceutic biologicals
and laboratory reagents or controls.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-132) (from Ch. 111 1/2, par. 622-132)
Sec. 2-132. "Transfusion" means
a use of blood in which the blood is administered
to a human being for treatment of sickness or injury.
(Source: P.A. 87-1269.)
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(210 ILCS 25/2-133) (from Ch. 111 1/2, par. 622-133)
Sec. 2-133. "Nonreplacement
fee" means a fee charged by any blood bank or
other entity for nonreplacement of blood units received
by patients.
(Source: P.A. 87-1269.)
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(210 ILCS 25/Art.
IV heading)
ARTICLE IV. POWERS AND DUTIES OF THE DEPARTMENT
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(210 ILCS 25/4-101) (from Ch. 111 1/2, par. 624-101)
Sec. 4-101. Rules.
The Department shall prescribe and enforce reasonable
rules and regulations as are necessary to carry out
the purposes of this Act.
(Source: P.A. 87-1269.)
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(210 ILCS 25/4-102) (from Ch. 111 1/2, par. 624-102)
Sec. 4-102. Inspections.
The Department is authorized to inspect the premises
and operations of all clinical laboratories and blood
banks subject to this Act for enforcement purposes.
(Source: P.A. 87-1269.)
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(210 ILCS 25/4-104) (from Ch. 111 1/2, par. 624-104)
Sec. 4-104. Reports.
The Department may require the owners and directors
of laboratories and blood banks to submit reports
under oath that contain information and data concerning
the technical operation of the laboratory or blood
bank.
(Source: P.A. 87-1269.)
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(210 ILCS 25/Art.
V heading)
ARTICLE V. ADVISORY BOARD
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(210 ILCS 25/5-101) (from Ch. 111 1/2, par. 625-101)
Sec. 5-101. Advisory
board. The Governor shall appoint a Clinical Laboratory
and Blood Bank Advisory Board to consult with the
Department. The Board shall be composed of 2 pathologists,
at least one of whom shall be certified by the American
Board of Pathology in Clinical Pathology, one physician
who is not a pathologist, two laboratory directors
who are not physicians, one individual, not a physician,
having an earned doctorate degree, who holds a professorial
rank in a department of medical basic science in
a university medical school in Illinois, one physician
actively engaged in blood bank management at a free-standing
blood bank, one individual actively engaged in blood
bank management at a free-standing blood bank,
and one individual qualified as a general supervisor
and employed at a clinical laboratory or blood bank.
The pathologists and physicians appointed to this
Board shall be persons licensed to practice medicine
in all its branches in the State of Illinois.
The Director of Public Health
shall be a member of the Board, ex officio.
Each member shall hold office
for a term of 3 years except that the 6 members first appointed
under this Act shall be appointed for the following terms: 2
for 1 year, 2 for 2 years and 2 for 3 years as designated by
the Governor at the time of appointment, unless sooner removed
by the Governor. No member shall be eligible for reappointment
for more than 3 full terms and any appointment to fill a vacancy
shall be for the unexpired portion of the term. The Governor
may remove any member for cause at any time prior to expiration
of his term.
(Source: P.A. 87-1269.)
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(210 ILCS 25/5-102) (from Ch. 111 1/2, par. 625-102)
Sec. 5-102. Members
of the Advisory Board shall serve without pay, but
they shall receive reimbursement for actual and necessary
expenses incurred in the performance of their duties.
(Source: Laws 1965, p. 3256.)
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(210 ILCS 25/5-103) (from Ch. 111 1/2, par. 625-103)
Sec. 5-103. The Advisory
Board shall consult with the Department in matters
of policy affecting the administration of this Act
and in the development, revision and enforcement
of the rules and regulations adopted under this Act.
The Advisory Board shall meet as frequently as the
Director of Public Health deems necessary; however,
upon request of 2 members of the Advisory Board,
it shall be the duty of the Director of Public Health
to call a meeting of the Board.
(Source: P.A. 87-600.)
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(210 ILCS 25/Art.
VI heading)
ARTICLE VI. QUALIFICATIONS OF THE DIRECTOR OF A CLINICAL LABORATORY
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(210 ILCS 25/Art.
VII heading)
ARTICLE VII. ACCEPTANCE, COLLECTION, IDENTIFICATION AND EXAMINATION
OF
SPECIMENS, AND REPORTS OF FINDINGS
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(210 ILCS 25/7-101) (from Ch. 111 1/2, par. 627-101)
Sec. 7-101. Examination
of specimens. A clinical laboratory shall examine
specimens only at the request of (i) a licensed physician,
(ii) a licensed dentist, (iii) a licensed podiatrist,
(iv) a therapeutic optometrist for diagnostic or
therapeutic purposes related to the use of diagnostic
topical or therapeutic ocular pharmaceutical agents,
as defined in subsections (c) and (d) of Section
15.1 of the Illinois Optometric Practice Act of 1987,
(v) a licensed physician assistant in accordance
with the written guidelines required under subdivision
(3) of Section 4 and under Section 7.5 of the Physician
Assistant Practice Act of 1987, (v-A) an advanced
practice nurse in accordance with the written collaborative
agreement required under Section 15-15 of the
Nursing and Advanced Practice Nursing Act, or (vi)
an authorized law enforcement agency or, in the case
of blood alcohol, at the request of the individual
for whom the test is to be performed in compliance
with Sections 11-501 and 11-501.1 of
the Illinois Vehicle Code. If the request to a laboratory
is oral, the physician or other authorized person
shall submit a written request to the laboratory
within 48 hours. If the laboratory does not receive
the written request within that period, it shall
note that fact in its records. For purposes of this
Section, a request made by electronic mail or fax
constitutes a written request.
(Source: P.A. 90-116, eff. 7-14-97;
90-322, eff. 1-1-98; 90-655, eff. 7-30-98;
90-666, eff. 7-30-98; 90-742, eff. 8-13-98;
91-357, eff. 7-29-99.)
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(210 ILCS 25/7-102) (from Ch. 111 1/2, par. 627-102)
Sec. 7-102. Reports
of test results. The result of a test shall be reported
directly to the licensed physician or other authorized
person who requested it. No interpretation, diagnosis
or prognosis or suggested treatment shall appear
on the laboratory report form except that a report
made by a physician licensed to practice medicine
in Illinois, a dentist licensed in Illinois, or a
therapeutic optometrist may include such information.
Nothing in this Act prohibits the sharing of information
as authorized in Section 2.1 of the Department of
Public Health Act.
(Source: P.A. 93-829, eff. 7-28-04.)
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(210 ILCS 25/7-104) (from Ch. 111 1/2, par. 627-104)
Sec. 7-104. No person
other than a licensed physician or one authorized
by law shall manipulate a person for the collection
of specimens except that technical personnel of a
clinical laboratory may collect blood, or remove
stomach contents, or collect material for smears
and cultures, under the direction or upon the written
request of a licensed physician or dentist.
(Source: P.A. 87-600.)
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(210 ILCS 25/7-108) (from Ch. 111 1/2, par. 627-108)
Sec. 7-108. Duties
of blood banks. A blood bank shall:
(a) Collect, process, and
provide for use blood or blood components from a blood donor
only upon the consent of that donor and under the direction or
delegated direction of the blood bank Medical Director.
(b) Transfuse blood or blood
components upon the request of a physician licensed to practice
medicine in all its branches, a dentist, or a podiatrist who
is on the medical staff of a hospital and has permission from
the medical staff to make such a request. If the request is oral,
the physician or other authorized person shall submit a written
request to the blood bank within 48 hours. If the blood bank
does not receive the written request within that period, it shall
note that fact in its records.
(Source: P.A. 87-1269.)
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(210 ILCS 25/7-109) (from Ch. 111 1/2, par. 627-109)
Sec. 7-109. Designated
donors.
(a) Each blood bank shall
allow a recipient of blood to designate a donor of his choice,
for the purpose of receiving red cells, under the following conditions:
(1)
the recipient, or someone on his behalf, has
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(2)
the designated donor consents the donation;
(3)
the designated donor's blood may be obtained in
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sufficient time to meet the health
care needs of the recipient;
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(4)
the designated donor is qualified to donate
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blood under the criteria for donor
selection promulgated by the federal Food
and Drug Administration; and
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(5)
the blood of the donor is acceptable for the
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(b) Blood donated
for designated use shall be reserved for the designated
recipient; however, if it has not been used within
7 days from the day of donation, it may be used for
any other medically appropriate purpose.
(c) This Section shall not
limit other procedures blood banks may establish to enable directed
donations.
(Source: P.A. 87-1269.)
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(210 ILCS 25/7-110) (from Ch. 111 1/2, par. 627-110)
Sec. 7-110. Blood
labeling. Every person who withdraws blood from an
individual or separates blood into components by
physical processes shall affix to each container
of blood or blood components a label that includes
the appropriate donor classification, "volunteer
donor" or "paid donor", in no less
prominence than the word "blood" or the
name of the blood component.
Any person who receives
blood or blood components in this State from a federally licensed
blood bank in another state shall not be required to relabel
a container of blood or blood components if the container of
blood or blood components is labeled with the appropriate donor
classification, "volunteer donor" or "paid donor",
in no less prominence than the word "blood" or the
name of the blood component.
(Source: P.A. 87-1269.)
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(210 ILCS 25/7-111) (from Ch. 111 1/2, par. 627-111)
Sec. 7-111. Administration
of labeled blood. No person may administer blood
by transfusion in this State or transfer or offer
to transfer blood for transfusion purposes by any
type of transaction unless the container of the blood
is labeled as required by Section 7-110.
When blood is administered
by transfusion in this State, the identification number of the
unit of blood shall be recorded in the patient's medical record
and the label on the container of the blood shall not be removed
before or during the administration of that blood by transfusion.
(Source: P.A. 87-1269.)
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(210 ILCS 25/7-112) (from Ch. 111 1/2, par. 627-112)
Sec. 7-112. Blood
from paid donor; transfusions. No blood initially
acquired from a paid donor may be administered by
transfusion in Illinois unless the physician licensed
to practice medicine in all its branches, the dentist,
or the podiatrist who is on the medical staff of
a hospital and has permission from the medical staff
to request a transfusion, who is in charge of the
treatment of the patient to whom the blood is to
be administered, has directed that blood acquired
from a paid donor be administered to that patient
and has specified in the patient's medical record
his reason for this action.
Blood acquired from a paid
donor shall be transferred for transfusion purposes in this State
only as expressly permitted by rules promulgated by the Illinois
Department of Public Health.
(Source: P.A. 87-1269.)
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