(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.
"Podiatric physician" means a person licensed in Illinois to practice
podiatry.
(Source: P.A. 98-214, eff. 8-9-13.)
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(210 ILCS 25/2-127.5)
Sec. 2-127.5. Optometrist. "Optometrist" means a
person who is licensed in Illinois to practice optometry.
(Source: P.A. 98-185, eff. 1-1-14.)
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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 25/2-134) Sec. 2-134. Health care operations. "Health care operations" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(Source: P.A. 98-1046, eff. 1-1-15.) |
(210 ILCS 25/2-135) Sec. 2-135. HIPAA. "HIPAA" means the Health Insurance Portability and Accountability Act of 1996, Public Law 104-191, as amended by the Health Information and Technology for Economic and Clinical Health Act of 2009, Public Law 111-05, and any subsequent amendments thereto and any regulations promulgated thereunder.
(Source: P.A. 98-1046, eff. 1-1-15.) |
(210 ILCS 25/2-136) Sec. 2-136. Payment. "Payment" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(Source: P.A. 98-1046, eff. 1-1-15.) |
(210 ILCS 25/2-137) Sec. 2-137. Treatment. "Treatment" has the meaning ascribed to it under HIPAA, as specified in 45 CFR 164.501.
(Source: P.A. 98-1046, eff. 1-1-15.) |
(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 podiatric physician, (iv) a licensed
optometrist,
(v) a licensed
physician assistant,
(v-A) a licensed advanced practice registered nurse,
(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, (vii) a genetic counselor with the specific authority from a referral to order a test or tests pursuant to subsection (b) of Section 20 of the Genetic Counselor Licensing Act, or (viii) a pharmacist in accordance with Section 43.5 of the Pharmacy Practice Act.
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. 102-1051, eff. 1-1-23.)
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(210 ILCS 25/7-102) (from Ch. 111 1/2, par. 627-102)
Sec. 7-102. Reports of test results. (a) Clinical laboratory test results may be reported or transmitted to: (1) the licensed physician or other authorized person | ||
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(2) any health care provider who is providing | ||
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(3) an electronic health information exchange for the | ||
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(4) a pharmacist in accordance with Section 43.5 | ||
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(b) 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 an optometrist licensed in Illinois may
include such information. (c) 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. 102-1051, eff. 1-1-23.)
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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 podiatric physician
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. 98-214, eff. 8-9-13.)
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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 may 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 to the donation;
(3) the designated donor's blood may be obtained in | ||
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(4) the designated donor is qualified to donate blood | ||
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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. 100-201, eff. 8-18-17.)
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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 podiatric physician 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. 98-214, eff. 8-9-13.)
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(210 ILCS 25/7-113) (from Ch. 111 1/2, par. 627-113)
Sec. 7-113.
Nonreplacement fees.
The assessment of nonreplacement
fees with respect to blood is prohibited.
(Source: P.A. 87-1269.)
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(210 ILCS 25/7-114) (from Ch. 111 1/2, par. 627-114)
Sec. 7-114.
Industrial uses; volunteer or paid donor.
Blood and blood
components, including salvage plasma, may be used and transferred for
industrial uses without regard to whether its original acquisition was from
a volunteer donor or a paid donor.
(Source: P.A. 87-1269.)
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(210 ILCS 25/7-115) (from Ch. 111 1/2, par. 627-115)
Sec. 7-115.
HIV testing; rules.
(a) The Department shall by rule provide for the testing of blood for
evidence of exposure to the human immunodeficiency virus (HIV) and any
other identified causative agent of acquired immunodeficiency syndrome
(AIDS). These rules shall require the disposal of any blood showing
evidence of exposure to HIV or any other identified causative agent of
AIDS, unless a research facility requests, in writing, the use of this
blood for AIDS research. The rules shall also provide for the personal and
confidential notification of the donor if the tests required by the
Department yield a positive result. No person shall incur any civil or
criminal liability for making this notification, if it is made in good
faith and in accordance with the rules of the Department.
(b) No blood may be withdrawn from any individual in this State for
transfusion or industrial use without (i) giving the individual notice that
the blood withdrawn will be subjected to testing for evidence of exposure
to the causative agent of AIDS and (ii) giving the individual an
opportunity to refuse to consent to the withdrawal of blood.
(c) In a medical emergency constituting an imminent threat to the life
of a potential transfusion recipient, if blood that has been subjected to
the testing required under subsection (a) is not available, the testing and
notification requirements of subsections (a) and (b) shall not apply.
(Source: P.A. 87-1269.)
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(210 ILCS 25/8-108) (from Ch. 111 1/2, par. 628-108)
Sec. 8-108.
The provisions of the Illinois Administrative Procedure Act are
hereby expressly adopted and shall apply to all administrative rules and
procedures of the Department of Public Health under this Act, except that in
case of conflict between the Illinois Administrative Procedure Act and this Act
the provisions of this Act shall control, and except that Section 5-35 of the
Illinois Administrative Procedure Act relating to procedures for rule-making
does not apply to the adoption of any rule required by federal law in
connection with which the Department is precluded by law from exercising any
discretion.
(Source: P.A. 88-45.)
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(210 ILCS 25/Art. IX heading) ARTICLE IX.
OFFENSES AND PENALTIES
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(210 ILCS 25/9-101) (from Ch. 111 1/2, par. 629-101)
Sec. 9-101.
Prohibited acts.
It is unlawful for any person to do any
of the following:
(a) Accept specimens for tests from and make reports to persons
other than those authorized to submit specimens and receive
reports under Section 7-101 of this Act. However, this does not prohibit
the referral of specimens from one clinical laboratory to another clinical
laboratory provided the report indicates clearly the name and address of the
clinical laboratory performing the test and the name of the director of such
laboratory.
(b) Violate any provision of this Act or any rule or regulation
adopted by the Department under this Act.
(Source: P.A. 87-600; 87-1269.)
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(210 ILCS 25/9-102) (from Ch. 111 1/2, par. 629-102)
Sec. 9-102.
The performance of any of the acts specified in Section 9-101
shall constitute a business offense subject to a fine of not less
than $200 nor more than $1,000 and each day's violation shall constitute
separate offenses.
(Source: P.A. 81-1509.)
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(210 ILCS 25/9-103) (from Ch. 111 1/2, par. 629-103)
Sec. 9-103.
Penalties and fines.
The Department is empowered to
assess penalties or fines against a clinical laboratory or blood bank for
violations of this Act and the regulations adopted under this Act, under
regulations for penalties established by the Department. In no circumstance
will the penalties or fines exceed $1,000 per day for each day the clinical
laboratory or blood bank remains in violation.
(Source: P.A. 87-600; 87-1269.)
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(210 ILCS 25/Art. X heading) ARTICLE X.
INJUNCTIONS
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(210 ILCS 25/10-101) (from Ch. 111 1/2, par. 630-101)
Sec. 10-101.
Nuisance; injunction.
The operation or maintenance of a clinical
laboratory or blood bank in violation of this Act is declared a nuisance
inimical to the public health, welfare and safety. The Director of the
Department, in the name of the people of the State, through the Attorney
General, may, in addition to other remedies herein provided, bring an action
for an injunction to restrain such violation or to enjoin the future operation
or maintenance of any such clinical laboratory or blood bank, until compliance
with the provisions of this Act has been obtained.
(Source: P.A. 87-1269.)
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(210 ILCS 25/Art. XA heading) ARTICLE XA.
SEVERABILITY OF THE ACT
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(210 ILCS 25/10A-101) (from Ch. 111 1/2, par. 630A-101)
Sec. 10A-101.
If any article, section, subsection, sentence, clause, phrase, or
requirement of this Act is for any reason held to be unconstitutional, such
decision shall not affect the validity of the remaining portions of this
Act. The legislature hereby declares that it would have passed this Act,
and each article, section, subsection, sentence, clause, phrase, and
requirement thereof irrespective of the fact that any one or more articles,
sections, subsections, sentences, clauses, phrases or requirements be
declared unconstitutional.
(Source: P.A. 76-1000.)
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(210 ILCS 25/Art. XI heading) ARTICLE XI.
MISCELLANEOUS PROVISIONS
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(210 ILCS 25/11-103) (from Ch. 111 1/2, par. 631-103)
Sec. 11-103.
The "Illinois Clinical Laboratory Registration Act", approved
August 21, 1963, is repealed.
(Source: Laws 1965, p. 3256.)
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