210 ILCS 25/ Illinois Clinical Laboratory and Blood Bank Act.

(210 ILCS 25/Art. I heading) ARTICLE I. SHORT TITLE, LEGISLATIVE INTENT AND APPLICATION OF ACT

(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.)

(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.)

(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.)

(210 ILCS 25/Art. II heading) ARTICLE II. DEFINITIONS

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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

(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.)

(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.)

(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.)

(210 ILCS 25/Art. V heading) ARTICLE V. ADVISORY BOARD

(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.)

(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.)

(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.)

(210 ILCS 25/Art. VI heading) ARTICLE VI. QUALIFICATIONS OF THE DIRECTOR OF A CLINICAL LABORATORY

(210 ILCS 25/Art. VII heading) ARTICLE VII. ACCEPTANCE, COLLECTION, IDENTIFICATION AND EXAMINATION OF SPECIMENS, AND REPORTS OF FINDINGS

(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.)

(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 who requested the test, their designee, or both;

(2) any health care provider who is providing treatment to the patient;

(3) an electronic health information exchange for the purposes of transmitting, using, or disclosing clinical laboratory test results in any manner required or permitted by HIPAA; and

(4) a pharmacist in accordance with Section 43.5 of the Pharmacy Practice Act.

(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.)

(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.)

(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.)

(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 solicited the donors;

(2) the designated donor consents to the donation;

(3) the designated donor's blood may be obtained in sufficient time to meet the health care needs of the recipient;

(4) the designated donor is qualified to donate blood under the criteria for donor selection promulgated by the federal Food and Drug Administration; and

(5) the blood of the donor is acceptable for the patient's medical needs.

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(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.)

(210 ILCS 25/Art. IX heading) ARTICLE IX. OFFENSES AND PENALTIES

(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.)

(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.)

(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.)

(210 ILCS 25/Art. X heading) ARTICLE X. INJUNCTIONS

(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.)

(210 ILCS 25/Art. XA heading) ARTICLE XA. SEVERABILITY OF THE ACT

(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.)

(210 ILCS 25/Art. XI heading) ARTICLE XI. MISCELLANEOUS PROVISIONS

(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.)