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1 | AN ACT concerning professional regulation.
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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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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
|
| |||||||
| |||||||
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.
|
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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
|
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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
|
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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
|
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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 |
| |||||||
| |||||||
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. |