93RD GENERAL ASSEMBLY
State of Illinois
2003 and 2004
HB4864

 

Introduced 02/04/04, by Angelo Saviano

 

SYNOPSIS AS INTRODUCED:
 
New Act

    Creates the Clinical Laboratory Science Practice Act. Provides for the regulation of clinical laboratory practitioners, medical technologists, and medical laboratory technicians through licensure by the Department of Professional Regulation. Preempts home rule. Effective immediately.


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CORRECTIONAL BUDGET AND IMPACT NOTE ACT MAY APPLY
FISCAL NOTE ACT MAY APPLY
HOME RULE NOTE ACT MAY APPLY

 

 

A BILL FOR

 

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1     AN ACT concerning professional regulation.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
4     Section 1. Short title. This Act may be cited as the
5 Clinical Laboratory Science Practice Act.
 
6     Section 5. Declaration of policy; purpose. It is hereby
7 declared to be a policy of this State that the practice of
8 clinical laboratory science by health care professionals
9 affects the public health, safety, and welfare and is subject
10 to control and regulation in the public interest. It is further
11 declared that clinical laboratories and clinical laboratory
12 practitioners provide essential services to practitioners of
13 the healing arts by furnishing vital information that may be
14 used in the diagnosis, prevention, and treatment of disease or
15 impairment and the assessment of the health of humans. The
16 purpose of this Act is to assure better protection of public
17 health by requiring minimum qualifications for clinical
18 laboratory practitioners and by ensuring that clinical
19 laboratory tests are performed with the highest degree of
20 professional competency by those engaged in providing such
21 services in this State.
 
22     Section 15. Definitions. The following words and terms
23 when used in the Act shall have the following meaning unless
24 otherwise indicated within the context:
25     "Accredited clinical laboratory education program" means a
26 program planned to provide a predetermined amount of
27 instruction and experience in clinical laboratory science,
28 medical technology, or cytology that has been accredited by one
29 of the accrediting agencies approved by the U.S. Department of
30 Health and Human Services.
31     "Board" means the Clinical Laboratory Science Board

 

 

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1 appointed by the Director of Professional Regulation.
2     "Categorical technologist" means an individual eligible
3 under this Act who is qualified to perform clinical laboratory
4 testing in one or more categories of laboratory testing, such
5 as microbiology, clinical chemistry, immunology, hematology,
6 immunohematology or other areas specified by the Board. The
7 categorical technologist is responsible for the establishment
8 and implementation of protocols, quality assessment, method
9 development and selection, equipment selection and
10 maintenance, and all activities related to the pre-analytical,
11 analytical, and post-analytical phases of testing. The
12 categorical technologist may also direct, supervise, consult,
13 educate, and perform research functions in their specialty
14 area. "Categorical technologist" includes a categorical
15 scientist.
16     "CLIA '88" means the Clinical Laboratory Improvement
17 Amendments of 1988.
18     "Clinical laboratory" or "laboratory" means a site or
19 location in which clinical laboratory tests or examinations are
20 performed.
21     "Clinical laboratory practitioner" means an individual who
22 has the authority to perform clinical laboratory tests.
23     "Clinical laboratory scientist" means an individual
24 eligible under this Act that performs any clinical laboratory
25 test including those that require the exercise of independent
26 judgment. In addition, this individual is responsible for the
27 establishment and implementation of protocols, quality
28 assessment, method development and selection, equipment
29 selection and maintenance, and all activities related to the
30 pre-analytical, analytical and post-analytical phases of
31 testing. The clinical laboratory scientist may also direct,
32 supervise, consult, educate, and perform research functions.
33     "Clinical laboratory technician" means an individual
34 eligible under this Act who is qualified to perform clinical
35 laboratory tests pursuant to established and approved
36 protocols that require limited exercise of independent

 

 

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1 judgment and which are performed with oversight from a clinical
2 laboratory scientist, medical technologist, technical
3 consultant, supervisor, or laboratory director as defined by
4 the Clinical Laboratory Improvement Amendments of 1988 (CLIA
5 '88) (P.L. 100-578).
6     "Clinical laboratory test" or "laboratory test" means a
7 microbiological, serological, molecular, chemical, biological,
8 hematological, immunological, immunohematological,
9 cytological, biophysical, or any other test or procedure
10 performed on material derived from or existing in a human body
11 that provides information for the diagnosis, prevention, or
12 monitoring of a disease or impairment or assessment of a
13 clinical condition. Clinical laboratory testing encompasses
14 the pre-analytical, analytical, and post-analytical phases of
15 testing.
16     "Cytotechnologist" means an individual eligible under this
17 Act who is qualified to process and interpret cellular material
18 derived from the human body delineating data regarding human
19 cytopathological disease. The cytotechnologist performs
20 testing under the supervision of a technical supervisor
21 pursuant to the CLIA '88. The cytotechnologist reviews and
22 interprets gynecological cytology preparations and screens
23 non-gynecological cytology preparations where final review and
24 interpretation is the responsibility of a qualified physician.
25     "Department" means the Department of Professional
26 Regulation.
27     "Director" means the Director of Professional Regulation.
28     "Histotechnician" means an individual who is qualified to
29 process cellular and tissue components through methods of
30 selected gross dissection and description, fixation,
31 dehydration, embedding, microtomy, frozen sectioning,
32 staining, and other related procedures and techniques employed
33 in the preparation of smears, slides, and tissues. This
34 specialty also encompasses methods for antigen detection and
35 other molecular hybridization testing methods where the
36 purpose is analysis or quantification of cellular and tissue

 

 

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1 components for interpretation by a qualified physician. The
2 histotechnician performs testing under the direct supervision
3 of a histotechnologist, technical consultant, supervisor, or
4 laboratory director as defined by CLIA '88.
5     "Histotechnologist" means an individual who is qualified
6 to process cellular and tissue components through methods of
7 selected gross dissection and description, fixation,
8 dehydration, embedding, microtomy, frozen sectioning,
9 staining, and other related procedures and techniques employed
10 in the preparation of smears, slides and tissues. This
11 specialty also encompasses methods for antigen detection and
12 other molecular hybridization testing methods where the
13 purpose is analysis or quantification of cellular and tissue
14 components for interpretation by a qualified physician. The
15 histotechnologist performs testing under the supervision of a
16 technical consultant, supervisor, or laboratory director as
17 defined by CLIA '88.
18     "Medical technologist" means an individual eligible under
19 this Act that performs any clinical laboratory test including
20 those that require the exercise of independent judgment. In
21 addition, this individual is responsible for the establishment
22 and implementation of protocols, quality assessment, method
23 development and selection, equipment selection and
24 maintenance, and all activities related to the pre-analytical,
25 analytical, or post-analytical phases of testing. The medical
26 technologist may also direct, supervise, consult, educate, and
27 perform research functions.
28     "Medical laboratory technician" means an individual
29 eligible under this Act who is qualified to perform clinical
30 laboratory tests pursuant to established and approved
31 protocols that require limited exercise of independent
32 judgment and which are performed with oversight from a clinical
33 laboratory scientist, medical technologist, technical
34 consultant, supervisor, or laboratory director as defined by
35 the Clinical Laboratory Improvement Amendments of 1988.
36     "Pathologist's assistant" means an individual who is

 

 

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1 qualified to perform surgical pathology specimen examinations
2 and post-mortem examinations. This specialty also encompasses
3 related functions which are necessary to insure the successful
4 completion or processing of the above. The pathologist's
5 assistant performs testing under the supervision of a qualified
6 pathologist. The functions of the pathologist's assistant
7 shall be to assist a pathologist in arriving at a final
8 diagnosis. Rendering the final diagnosis, however, is the
9 responsibility of a pathologist.
10     "Point of care testing" means clinical testing that is so
11 critical to patient care that it must be performed immediately
12 at or near the patient. Tests meeting this definition provide
13 clinically relevant information that direct therapy, are
14 limited to procedures that produce accurate and precise data in
15 a short period of time, meet the current standards of quality
16 in laboratory science, and comply with all standards of
17 accrediting agencies. The term does not include a clinical
18 laboratory test performed in a physician's office laboratory.
19     "Waived test" means a simple laboratory examination or
20 procedure, as defined by the CLIA '88 and approved by the
21 Board.
 
22     Section 20. Exemptions. This Act does not apply to any of
23 the following:
24         (1) A person licensed in this State under any other Act
25     who engages in the practice for which he or she is
26     licensed, providing the Act specifically authorizes him or
27     her to perform laboratory testing.
28         (2) Clinical laboratory practitioners employed by the
29     United States government or any bureau, division, or agency
30     thereof while in the discharge of the employee's official
31     duties.
32         (3) Clinical laboratory practitioners engaged in
33     teaching or research, provided that the results of any
34     examination performed are not used in health maintenance,
35     diagnosis, or treatment of disease.

 

 

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1         (4) Students or trainees enrolled in a clinical
2     laboratory education program, provided that these
3     activities constitute a part of a planned course in the
4     program, that the persons are designated by title such as
5     intern, trainee, or student, and the persons work directly
6     under (i) an individual licensed by this State to practice
7     clinical laboratory science, (ii) a person exempt from
8     licensure under this Act by item (3) of this Section, or
9     (iii) a licensed physician.
10         (5) A person solely performing waived tests under the
11     Clinical Laboratory Improvement Amendments of 1988 (P.L.
12     100-578).
13         (6) Personnel performing point of care testing
14     provided that, within the point of care testing laboratory,
15     a licensed Clinical laboratory scientist, medical
16     technologist, categorical technologist, clinical
17     laboratory technician, medical laboratory technician, or
18     licensed physician is responsible for all of the following:
19             (A) Designing and providing or supervising the
20         training programs for the point of care testing
21         personnel.
22             (B) Supervising and monitoring the quality
23         assurance and quality control activities of the
24         testing site.
25             (C) Assisting in the selection of technology.
26             (D) Reviewing the results of proficiency testing
27         and recommending corrective action, if necessary.
28             (E) Monitoring the continued competency of the
29         testing personnel. Failure to comply with the above
30         requirements subjects the point of care testing
31         personnel to the loss of the exemption.
32         (7) Histotechnicians and histotechnologists who
33     perform clinical laboratory testing under the supervision
34     of a technical consultant, supervisor, or laboratory
35     director as defined by the CLIA '88.
36         (8) Pathologist's assistants who perform clinical

 

 

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1     laboratory testing under the supervision of a qualified
2     pathologist.
 
3     Section 25. License required.
4     (a) Beginning January 1, 2005, no person shall perform or
5 consult regarding clinical laboratory tests or hold himself or
6 herself out as a clinical laboratory practitioner in the State
7 unless he or she is licensed under this Act.
8     (b) All persons performing or consulting regarding
9 clinical laboratory tests on the effective date of this Act who
10 are certified by or eligible for certification by an agency
11 acceptable to the Department and who have applied to the
12 Department on or before January 1, 2005 and have complied with
13 all necessary requirements for application may continue to
14 perform clinical laboratory tests until (1) the expiration of
15 12 months after filing the application, (2) the denial of the
16 application by the Department, or (3) the withdrawal of the
17 application, whichever occurs first.
18     (c) Before January 1, 2007, a person not meeting the
19 education, training, and experience qualifications for a
20 license under this Act may be granted licensure if they have 3
21 years of acceptable experience at the professional level for
22 which licensure is sought immediately prior to the effective
23 date of this Act and submit to the Board the job description of
24 the position that the applicant has most recently performed,
25 attested to by his or her employer.
26     (D) Beginning January 1, 2007, no initial license shall be
27 issued until an applicant meets all of the requirements under
28 this Act and successfully completes a national certification
29 examination authorized by the Department.
 
30     Section 30. Administration.
31     (a) The Department shall adopt rules consistent with the
32 provisions of this Act for the administration and enforcement
33 thereof and may prescribe the forms that shall be issued in
34 connection with this Act. The rules shall include standards and

 

 

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1 criteria for licensure and professional conduct and
2 discipline. The Department shall consult with the Board in
3 adopting rules. Notice of proposed rulemaking shall be
4 transmitted to the Board and the Department shall review the
5 Board's response and any recommendations the Board makes. The
6 Department shall notify the Board in writing with an
7 explanation of its deviations from the Board's recommendations
8 and response.
9     (b) The Department may solicit the advice and expert
10 knowledge of the Board on any matter relating to the
11 administration and enforcement of this Act.
12     (c) The Department shall issue to the Board a quarterly
13 report of the status of all complaints related to the
14 profession received by the Department.
 
15     Section 35. Clinical Laboratory Science Board.
16     (a) There is hereby created a Clinical Laboratory Science
17 Board within the Department of Professional Regulation which
18 shall consist of 8 persons who have been residents of this
19 State for at least 2 years prior to their appointment and who
20 are actively engaged in their areas of practice. The Director
21 may make appointments to the Board from lists submitted by
22 organizations of clinical laboratory science practitioners and
23 organizations of physician pathologists.
24     (b) The Board shall be composed of the following members:
25 (i) one physician certified by the American Board of Pathology
26 or the American Board of Osteopathic Pathology; (ii) 6 clinical
27 laboratory practitioners who, except for initial appointments,
28 hold active and valid licenses as clinical laboratory
29 practitioners in this State, at least one of whom is a
30 non-physician laboratory director, as defined by the CLIA '88,
31 2 of whom are clinical laboratory scientists or medical
32 technologists, one of whom is a clinical laboratory technician
33 or medical laboratory technician, and one of whom is a
34 cytotechnologist; and (iii) one public member who is not
35 associated with or financially interested in the practice of

 

 

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1 clinical laboratory science.
2     (c) Board members shall serve for a term of 3 years and
3 until their successors are appointed and qualified, except that
4 the initial appointments, which shall be made within 60 days
5 after the effective date of this Act, shall be as follows:
6         (1) A pathologist, a non-physician laboratory
7     director, as defined by the CLIA '88, and 2 clinical
8     laboratory practitioners shall be appointed to serve for 3
9     years.
10         (2) A public representative shall be appointed to serve
11     for 2 years.
12         (3) The remaining members shall be appointed to serve
13     for one year.
14     (d) Whenever a vacancy shall occur on the Board by reason
15 other than the expiration of a term of office, the Director
16 shall appoint a successor of like qualifications for the
17 remainder of the unexpired term. No person shall be appointed
18 to serve more than 2 successive 3-year terms.
19     (e) The Director shall have the authority to remove any
20 member of the Board from office for neglect of any duty
21 required by law or for incompetency or unprofessional or
22 dishonorable conduct.
23     (f) The Director shall consider the recommendations of the
24 Board on questions involving standards of professional
25 conduct, discipline, and qualifications of applicants or
26 licensees under this Act.
 
27     Section 40. Standards for licensure.
28     (a) The Department shall issue a clinical laboratory
29 scientist or medical technologist license to an individual who
30 meets the qualifications promulgated by the Department,
31 including successful performance on a national certification
32 examination at the clinical laboratory scientist or medical
33 technologist level authorized by the Department and at least
34 one of the following:
35         (1) Baccalaureate degree in clinical laboratory

 

 

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1     science or medical technology or the equivalent from an
2     accredited college or university and successful completion
3     of an accredited clinical laboratory science or medical
4     technology education program.
5         (2) Baccalaureate degree from an accredited college or
6     university and completion of 36 semester hours in the
7     biological, chemical, or medical laboratory sciences in
8     addition to or part of the baccalaureate degree and
9     successful completion of an accredited clinical laboratory
10     science or medical technology education program or
11     successful completion of a 50-week or more military medical
12     laboratory training program.
13         (3) Baccalaureate degree from an accredited college or
14     university and completion of 36 semester hours in the
15     biological, chemical, or medical laboratory sciences in
16     addition to or part of the baccalaureate degree, certified
17     as a clinical laboratory technician or medical laboratory
18     technician, and completion of the equivalent of 2 years of
19     full-time clinical laboratory work experience within the
20     last 4 years. This experience must have included a minimum
21     of 4 months in each of the 4 major clinical laboratory
22     disciplines (chemistry or urinalysis, hematology,
23     immunohematology, and microbiology).
24         (4) Baccalaureate degree from an accredited college or
25     university and completion of 36 semester hours in the
26     biological, chemical, or medical laboratory sciences in
27     addition to or part of the baccalaureate degree and
28     completion of the equivalent of 4 years of full-time
29     clinical laboratory work experience within the last 8
30     years. This experience must have included a minimum of 4
31     months in each of the 4 major clinical laboratory
32     disciplines (chemistry or urinalysis, hematology,
33     immunohematology, and microbiology).
34     (b) The Department shall issue a categorical technologist
35 license to an individual who meets such qualifications as
36 promulgated by the Department, including successful

 

 

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1 performance on a categorical examination offered by a national
2 certification organization authorized by the Department and at
3 least one of the following:
4         (1) For the categories of microbiology and chemistry,
5     (i) a baccalaureate degree from an accredited college or
6     university, (ii) successful completion of 30 semester
7     hours in the biological, chemical, or medical laboratory
8     sciences, and (iii) one year of full-time experience within
9     the last 10 years in the category for which licensure is
10     sought or successful completion of a structured training
11     program that is under the auspices of an accredited medical
12     technology or clinical laboratory science education
13     program in the category for which licensure is sought.
14         (2) For the categories of hematology, immunology, and
15     immunohematology, (i) a baccalaureate degree from an
16     accredited college or university, (ii) successful
17     completion of 30 semester hours in the biological, chemical
18     or medical laboratory sciences, and (iii) 2 years of
19     full-time experience within the last 10 years in the
20     category for which licensure is sought or successful
21     completion of a structured training program that is under
22     the auspices of an accredited medical technology or
23     clinical laboratory science education program in the
24     category for which licensure is sought.
25         (3) A masters or doctorate in a chemical, biological,
26     or medical laboratory science from an accredited college or
27     university and 6 months of full time acceptable clinical
28     laboratory experience or clinical laboratory training
29     within the last 10 years in the category for which
30     licensure is sought.
31     The Department may establish other categorical
32 technologist licenses as necessary, provided that the licenses
33 require a baccalaureate or graduate degree in an appropriate
34 field, clinical training or work experience, and national
35 certification.
36     (c) The Department shall issue a clinical laboratory

 

 

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1 technician or medical laboratory technician license to an
2 individual who meets such qualifications as promulgated by the
3 Department, which shall include successful performance on a
4 national certification examination at the clinical laboratory
5 technician or medical laboratory technician level authorized
6 by the Department and at least one of the following:
7         (1) Associate's degree or 60 semester hours from an
8     accredited post-secondary academic institution and
9     successful completion of an accredited clinical laboratory
10     technician or medical laboratory technician education
11     program.
12         (2) Associate's degree or 60 semester hours from an
13     accredited post-secondary academic institution with 24
14     semester hours of college course work in the biological,
15     chemical, or medical laboratory sciences, including 6
16     semester hours of chemistry and 6 semester hours of biology
17     and successful completion of a 50-week or more military
18     medical laboratory training program.
19         (3) Associate's degree or 60 semester hours from an
20     accredited post-secondary academic institution with 24
21     semester hours of college course work in the biological,
22     chemical, or medical laboratory sciences, including 6
23     semester hours of chemistry and 6 semester hours of biology
24     and successful completion of an approved laboratory or
25     clinical assistant education program, and completion of
26     the equivalent of one year of full-time clinical laboratory
27     work experience within the last 2 years. This experience
28     must have included a minimum of 3 months in each of the 4
29     major clinical laboratory disciplines (chemistry or
30     urinalysis, hematology, immunohematology, and
31     microbiology). Laboratory work experience must be under
32     the supervision of a certified clinical laboratory
33     scientist or medical technologist, certified clinical
34     laboratory technician or medical laboratory technician.
35         (4) Associate's degree or 60 semester hours from an
36     accredited post-secondary academic institution with 24

 

 

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1     semester hours of college course work in the biological,
2     chemical, or medical laboratory sciences, including 6
3     semester hours of chemistry and 6 semester hours of biology
4     and completion of the equivalent of 2 years of full-time
5     clinical laboratory work experience within the last 4
6     years. This experience must have included a minimum of 3
7     months in each of the 4 major clinical laboratory
8     disciplines (chemistry or urinalysis, hematology,
9     immunohematology, and microbiology). Completion of one
10     year of the laboratory work experience must be under the
11     supervision of a certified clinical laboratory scientist
12     or medical technologist, certified clinical laboratory
13     technician or medical laboratory technician.
14     (d) The Department shall issue a cytotechnologist license
15 to an individual who meets such qualifications as promulgated
16 by the Department, which shall include successful performance
17 on a national certification examination at the
18 cytotechnologist level authorized by the Department and a
19 baccalaureate degree from an accredited college or university
20 with 20 semester hours of biological science and 8 semester
21 hours of chemical science, and successful completion of an
22 accredited cytology laboratory education program.
 
23     Section 45. Temporary license.
24     (a) Licensure applicants that qualify by education,
25 experience, or training but have not taken or passed an
26 approved nationally recognized certification examination may
27 be granted a temporary license that will allow that individual
28 to engage in the practice of clinical laboratory science at the
29 appropriate level. The temporary license will be valid for 6
30 months and can be renewed twice upon failure to pass an
31 approved nationally recognized certification examination.
32     (b) Internationally trained licensure applicants must have
33 their transcripts evaluated by a transcript evaluation agency
34 acceptable to the Department and submitted directly to the
35 national certifying agency. The evaluation must indicate that

 

 

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1 the applicant's education is equivalent to that which is
2 required for licensure of U.S. graduates in the level of
3 licensure being sought. Upon submission of proof to the
4 Department of acceptance to sit for the certification
5 examination the individual may apply for a temporary license in
6 the corresponding category.
 
7     Section 50. Waiver of requirements. The Department of
8 Professional Regulation shall adopt rules providing procedures
9 for waiver of the requirements under Section 40 for all
10 applicants who hold a valid license or equivalent issued by
11 another state if the requirements under which that license or
12 equivalent was issued are equivalent to or exceed the standards
13 required by this Act.
 
14     Section 55. Licensure application procedures.
15     (a) Licensure applicants shall submit their application
16 for licensure to the Department upon the forms prescribed and
17 furnished by the Department and shall pay the designated
18 application fee.
19     (b) Upon receipt of an application and payment of a fee,
20 the Department shall issue a license for a clinical laboratory
21 scientist or medical technologist, categorical technologist,
22 clinical laboratory technician or medical laboratory
23 technician, or cytotechnologist, to any person who meets the
24 qualifications specified in this Act and the rules adopted
25 pursuant to this Act.
 
26     Section 60. Licensure renewal.
27     (a) A license issued under this Act shall expire 2 years
28 after receipt.
29     (b) Every person licensed under this Act shall be issued a
30 renewal license upon (i) submission of an application for
31 renewal on a form prescribed by the Department and payment of
32 an appropriate fee determined by the Department and (ii) proof
33 of completion, in the period since the license was first issued

 

 

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1 or last renewed, of at least 24 hours of continuing education
2 courses, clinics, lectures, training programs, seminars, or
3 other programs related to clinical laboratory practice that are
4 approved or accepted by the Board or proof of recertification
5 by a national accrediting organization that mandates an annual
6 minimum of 12 hours of continuing education.
7     (c) The Department may require other such evidence of
8 competency as it shall deem reasonably appropriate as a
9 prerequisite to the renewal of any license provided for in this
10 Act, so long as the requirements are uniform as to application,
11 are reasonably related to the measurement of qualification,
12 performance, or competence, and are desirable and necessary for
13 the protection of the public health.
 
14     Section 65. Disciplinary grounds.
15     (a) The Department may refuse to issue or renew or revoke a
16 license, may suspend, place on probation, censure, or reprimand
17 a licensee, or may take such other disciplinary action as the
18 Department may deem appropriate, including the imposition of a
19 civil penalty not to exceed $5,000 for conduct that may result
20 from but not necessarily be limited to any of the following:
21         (1) A material misstatement in furnishing information
22     to the Department.
23         (2) A violation or negligent or intentional disregard
24     of this Act or the rules adopted pursuant to this Act.
25         (3) A conviction of any crime under the laws of the
26     United States or any state or territory thereof which is a
27     felony or a misdemeanor, an essential element of which is
28     dishonesty or of any crime which is directly related to the
29     practice of the profession.
30         (4) Making any misrepresentation for the purpose of
31     obtaining registration or violating any provision of this
32     Act.
33         (5) Professional incompetence.
34         (6) Malpractice.
35         (7) Failing to provide information in response to a

 

 

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1     written request made by the Department within 60 days after
2     receipt of the request.
3         (8) Discipline by another state, territory, or country
4     if at least one of the grounds for the discipline is the
5     same or substantially equivalent to those set forth in this
6     Act.
7         (9) Directly or indirectly giving to or receiving from
8     any person, firm, corporation, partnership, or association
9     any fee, commission, rebate, or other form of compensation
10     for any professional services not actually rendered.
11         (10) A finding by the Department that the licensee,
12     after having his license placed on probationary status, has
13     violated the terms of probation.
14         (11) Wilfully making or filing false records or reports
15     in his or her practice, including but not limited to, false
16     records filed with State agencies or departments.
17         (12) Violation of any standard of professional conduct
18     adopted by the Department.
19         (13) Engaging in dishonorable, unethical, or
20     unprofessional conduct of a character likely to deceive,
21     defraud, or harm the public.
22         (14) Providing professional services while mentally
23     incompetent or under the influence of alcohol or narcotic
24     or controlled dangerous substance that is in excess of
25     therapeutic amounts or without valid medical indication.
26         (15) Directly or indirectly contracting to perform
27     clinical laboratory tests in a manner that offers or
28     implies an offer of rebate, fee-splitting inducements or
29     arrangements, or other remuneration.
30         (16) Aiding or assisting another person in violating
31     any provision of this Act or any rule adopted pursuant to
32     this Act.
33     (b) The determination by a circuit court that a licensee is
34 subject to involuntary admission or judicial admission as
35 provided in the Mental Health and Developmental Disabilities
36 Code operates as an automatic suspension. Such suspension will

 

 

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1 terminate only upon a finding by a court that the patient is no
2 longer subject to involuntary admission or judicial admission
3 and the issuance of an order so finding and discharging the
4 patient, and upon the recommendation of the Board to the
5 Director that the registrant be allowed to resume practice.
6     (c) The Department may refuse to issue or may suspend the
7 registration of any person who fails to file a return, to pay
8 the tax, penalty, or interest shown in a filed return, or any
9 final assessment of tax, penalty, or interest, as required by
10 any tax Act administered by the Illinois Department of Revenue,
11 until such time as the requirements of such tax Act are
12 satisfied.
 
13     Section 70. Injunction; cease and desist order.
14     (a) If any person violates a provision of the Act, the
15 Director may, in the name of the People of the State of
16 Illinois, through the Attorney General of the State of
17 Illinois, petition for an order enjoining such violation or for
18 an order enforcing compliance with the Act. Upon the filing of
19 a verified petition in such court, the court may issue a
20 temporary restraining order, without notice or bond, and may
21 preliminarily and permanently enjoin such violation, and if it
22 is established that such person has violated or is violating
23 this injunction, the Court may punish the offender for contempt
24 of court. Proceeding under this Section shall be in addition
25 to, and not in lieu of, all other remedies and penalties
26 provided by the Act.
27     (b) If any person shall practice as a clinical laboratory
28 practitioner or hold himself out as such without having a valid
29 license required under this Act, then any licensee, any
30 interested party, or any person injured thereby may, in
31 addition to the Director, petition for relief as provided in
32 subsection (a) of the Section.
33     (c) Whenever in the opinion of the Department any person
34 violates any provision of the Act, the Department may issue a
35 rule to show cause why an order to cease and desist should not

 

 

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1 be entered against him. The rule shall clearly set forth the
2 grounds relied upon by the Department and shall provide a
3 period of 7 days from the date of the rule to file an answer to
4 the satisfaction of the Department. Failure to answer to the
5 satisfaction of the Department shall cause an order to cease
6 and desist to be issued.
 
7     Section 75. Investigations. The Department may
8 investigate the actions of any applicant or of any person or
9 persons holding or claiming to hold a license to engage in the
10 practice of clinical laboratory science. Before refusing to
11 issue or renew a license, the Department shall notify in
12 writing the applicant or holder of the nature of the charges
13 and that a hearing will be held on the date designated. Such
14 notice shall be sent at least 10 calendar days prior to the
15 date set for the hearing. Such written notice may be served by
16 personal delivery or certified or registered mail to the
17 respondent at the address of his last notification to the
18 Department. At the time and place fixed in the notice, the
19 Board shall proceed to hear the charges and the parties or
20 their counsel shall be accorded ample opportunity to present
21 such statements, testimony, evidence and argument as may be
22 pertinent to the charges or to the defense thereto. The Board
23 may continue such hearing.
 
24     Section 80. Record of proceedings. The Department, at its
25 expense, shall preserve a record of all proceedings at the
26 formal hearing of any case involving the refusal to issue or
27 renew a license. The notice of hearing, complaint and all other
28 documents in the nature of pleadings and written motions filed
29 in the proceedings, the transcript of testimony, the report of
30 the Board and orders of the Department shall be the record of
31 such proceedings.
 
32     Section 85. Compel witnesses. Any circuit court may, upon
33 application of the Department or its designee, or of the

 

 

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1 applicant or licensee against whom proceedings under Section 70
2 of the Act are pending, enter an order requiring the attendance
3 of witnesses and their testimony, and the production of
4 documents, papers, files, books, and records in connection with
5 any hearing or investigation. The court may compel obedience to
6 its order by proceedings for contempt.
 
7     Section 90. Findings of fact, conclusions of law, and
8 recommendations. At the conclusion of the hearing, the Board
9 shall present to the Director a written report of its findings
10 and recommendations. The report shall contain a finding whether
11 or not the accused person violated this Act or failed to comply
12 with the conditions required in this Act. The Board shall
13 specify the nature of the violation or failure to comply, and
14 shall make its recommendations to the Director.
15     The report of findings of fact, conclusions of law, and
16 recommendations of the Board shall be the basis for the
17 Department's order for refusal or for the granting of a license
18 or for other disciplinary action. If the Director disagrees in
19 any regard with the report of the Board, the Director may issue
20 an order in contravention thereof. The Director shall provide a
21 written report to the Board on any deviation and shall specify
22 with particularity the reasons for such action in the final
23 order. The finding is not admissible in evidence against the
24 person in a criminal prosecution brought for the violation of
25 this Act, but the hearing and finding are not a bar to a
26 criminal prosecution brought for the violation of this Act.
 
27     Section 95. Motion for rehearing. In any case involving
28 the refusal to issue or renew a license or to discipline a
29 licensee, a copy of the Board's report shall be served upon the
30 respondent by the Department, either personally or as provided
31 in this Act for the service of the notice of hearing. Within 20
32 calendar days after such service, the respondent may present to
33 the Department a motion in writing for a rehearing, which
34 motion shall specify the particular grounds therefor. If no

 

 

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1 motion for rehearing is filed, then upon the expiration of the
2 time specified for filing such a motion, or if a motion for
3 rehearing is denied, then upon such denial the Director may
4 enter an order in accordance with recommendations of the Board,
5 except as provided for in Section 85. If the respondent shall
6 order from the reporting service, and pay for a transcript of
7 the record within the time for filing a motion for rehearing,
8 the 20 calendar day period within which such a motion may be
9 filed shall commence upon the delivery of the transcript to the
10 respondent.
 
11     Section 100. Rehearing. Whenever the Director is not
12 satisfied that substantial justice has been done in the
13 revocation, suspension or refusal to issue or renew a license,
14 the Director may order a rehearing by the same or other
15 examiners.
 
16     Section 105. Hearing officer. The Director shall have the
17 authority to appoint any attorney duly licensed to practice law
18 in the State of Illinois to serve as the hearing officer in any
19 action or refusal to issue or renew a license or discipline a
20 licensee. The Director shall notify the Board of any such
21 appointment. The hearing officer shall have full authority to
22 conduct the hearing. The hearing officer shall report his
23 finding of fact, conclusions of law, and recommendations to the
24 Board and the Director. The Board shall have 60 days from
25 receipt of the report to review the report of the hearing
26 officer and present its own findings of fact, conclusions of
27 law and recommendations to the Director. If the Board fails to
28 present its report within the 60 day period, the Director shall
29 issue an order based on the report of the hearing officer. If
30 the Director disagrees in any regard with the report of the
31 Board or hearing officer, he may issue an order in
32 contravention thereof. The Director shall provide a written
33 explanation to the Board of any such deviation and shall
34 specify with particularity the reasons for such action in the

 

 

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1 final order. At least 2 licensed clinical laboratory
2 practitioner members of the Board shall be present at all
3 formal hearings on the merits of complaints brought under the
4 provisions of this Act.
 
5     Section 110. Prima facie proof. An order or a certified
6 copy thereof, over the seal of the Department and purporting to
7 be signed by the Director, shall be prima facie proof that:
8         (1) the signature is the genuine signature of the
9     Director;
10         (2) the Director is duly appointed and qualified; and
11         (3) the Board and its members are qualified to act.
 
12     Section 115. Restoration. At any time after the suspension
13 or revocation of any license, the Department may restore the
14 license to the accused person, upon the written recommendation
15 of the Board, unless after an investigation and a hearing, the
16 Board determines that restoration is not in the public
17 interest.
 
18     Section 120. Surrender of license. Upon the revocation or
19 suspension of any license, the licensee shall forthwith
20 surrender the license to the Department, and if the licensee
21 fails to do so, the Department shall have the right to seize
22 the license.
 
23     Section 125. Temporary suspension. The Director may
24 temporarily suspend the license of a clinical laboratory
25 practitioner without a hearing, simultaneously with the
26 institution of proceedings for a hearing as provided in Section
27 70 of this Act, if the Director finds that evidence in his or
28 her possession indicates that a clinical laboratory
29 practitioner's continuation in practice would constitute an
30 imminent danger to the public. In the event that the Director
31 suspends temporarily the license of a clinical laboratory
32 practitioner without a hearing, a hearing by the Board must be

 

 

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1 held within 30 calendar days after such suspension has
2 occurred.
 
3     Section 130. Judicial review. All final administrative
4 decisions of the Department are subject to judicial review
5 pursuant to the provisions of the Administrative Review Law and
6 all rules adopted pursuant thereto. The term "administrative
7 decision" is defined as in Section 3-101 of the Administrative
8 Review Law. Proceedings for judicial review shall be commenced
9 in the circuit court of the county in which the party applying
10 for review resides. If the party is not a resident of this
11 State, the venue shall be in Sangamon County.
 
12     Section 135. Certification of record. The Department shall
13 not be required to certify any record to the court or file any
14 answer in court or otherwise appear in any court in a judicial
15 review proceeding, unless there is filed in the court, with the
16 complaint, a receipt from the Department acknowledging payment
17 of the costs of furnishing and certifying the record, which
18 costs shall be computed at the actual cost per page of such
19 record. Failure on the part of the plaintiff to file such
20 receipt in court shall be grounds for dismissal of the action.
 
21     Section 140. Criminal penalties. Any person who is found
22 to have violated any provision of the Act is guilty of a Class
23 A misdemeanor for the first offense, and a Class 4 felony for
24 second and subsequent offenses.
 
25     Section 145. Illinois Administrative Procedure Act. The
26 Illinois Administrative Procedure Act is hereby expressly
27 adopted and incorporated herein as if all of the provisions of
28 such Act were included in this Act, except that the provision
29 of paragraph (d) of Section 10-65 of The Illinois
30 Administrative Procedure Act, which provides that at hearings
31 the licensee has the right to show compliance with all lawful
32 requirements for retention, continuation, or renewal of the

 

 

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1 license is specifically excluded. For the purpose of this Act,
2 the notice required under Section 10-25 of The Illinois
3 Administrative Procedure Act is deemed sufficient when mailed
4 to the last know address of a party.
 
5     Section 150. Home rule. The regulation and licensing of
6 clinical laboratory practitioners are exclusive powers and
7 functions of the State. A unit of local government, including
8 home rule units, may not regulate or license clinical
9 laboratory practitioners. This Section is a denial and
10 limitation under subsection (h) of Section 6 of Article VII of
11 the Illinois Constitution.
 
12     Section 997. Severability. The provisions of this Act are
13 severable under Section 1.31 of the Statute on Statutes.
 
14     Section 999. Effective date. This Act takes effect upon
15 becoming law.