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93RD GENERAL ASSEMBLY
State of Illinois
2003 and 2004 HB4864
Introduced 02/04/04, by Angelo Saviano SYNOPSIS AS INTRODUCED: |
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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 |
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A BILL FOR
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HB4864 |
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LRB093 17749 AMC 46506 b |
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| AN ACT concerning professional regulation.
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| Be it enacted by the People of the State of Illinois, |
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| represented in the General Assembly:
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| Section 1. Short title. This Act may be cited as the |
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| Clinical Laboratory
Science Practice Act.
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| Section 5. Declaration of policy; purpose. It is hereby |
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| declared to be a
policy of
this State that the practice of |
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| clinical laboratory science by health care
professionals
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| affects the public health, safety, and welfare and is subject |
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| to control and
regulation in the
public interest. It is further |
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| declared that clinical laboratories and clinical
laboratory
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| practitioners provide essential services to practitioners of |
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| the healing arts
by furnishing
vital information that may be |
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| used in the diagnosis, prevention, and treatment
of disease
or |
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| impairment and the assessment of the health of humans. The |
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| purpose of this
Act is to
assure better protection of public |
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| health by requiring minimum qualifications
for clinical
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| laboratory practitioners and by ensuring that clinical |
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| laboratory tests are
performed with
the highest degree of |
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| professional competency by those engaged in providing
such
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| services in this State.
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| Section 15. Definitions. The following words and terms |
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| when used in the Act
shall have the following meaning unless |
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| otherwise indicated within the context:
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| "Accredited clinical laboratory education program" means a |
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| program planned to
provide a predetermined amount of |
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| instruction and experience in clinical
laboratory
science, |
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| medical technology, or cytology that has been accredited by
one |
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| of the
accrediting agencies approved by the U.S. Department of |
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| Health and Human Services.
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| "Board" means the Clinical Laboratory Science Board |
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HB4864 |
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LRB093 17749 AMC 46506 b |
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| appointed by the Director
of Professional Regulation.
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| "Categorical technologist" means an individual eligible |
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| under this Act who is
qualified to perform clinical laboratory |
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| testing in one or more categories of
laboratory
testing, such |
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| as microbiology, clinical chemistry, immunology, hematology,
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| immunohematology or other areas specified by the Board. The |
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| categorical
technologist
is responsible for the establishment |
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| and implementation of protocols, quality
assessment,
method |
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| development and selection, equipment selection and |
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| maintenance, and all
activities related to the pre-analytical, |
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| analytical, and post-analytical
phases of testing.
The |
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| categorical technologist may also direct, supervise, consult, |
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| educate, and
perform
research functions in their specialty |
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| area. "Categorical technologist" includes
a
categorical |
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| scientist.
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| "CLIA '88" means the Clinical Laboratory Improvement |
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| Amendments of 1988.
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| "Clinical laboratory" or "laboratory" means a site or |
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| location in which
clinical
laboratory tests or examinations are |
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| performed.
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| "Clinical laboratory practitioner" means an individual who |
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| has the authority
to
perform clinical laboratory tests.
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| "Clinical laboratory scientist" means an individual |
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| eligible under this Act
that
performs any clinical laboratory |
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| test including those that require the exercise
of
independent |
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| judgment. In addition, this individual is responsible for the
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| establishment
and implementation of protocols, quality |
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| assessment, method development and selection,
equipment |
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| selection and maintenance, and all activities related to the |
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| pre-analytical,
analytical and post-analytical phases of |
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| testing. The clinical laboratory scientist may also
direct, |
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| supervise, consult, educate, and perform research functions.
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| "Clinical laboratory technician" means an individual |
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| eligible under this Act
who
is qualified to perform clinical |
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| laboratory tests pursuant to established and
approved
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| protocols that require limited exercise of independent |
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HB4864 |
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LRB093 17749 AMC 46506 b |
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| judgment and which are
performed
with oversight from a clinical |
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| laboratory scientist, medical technologist,
technical
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| consultant, supervisor, or laboratory director as defined by |
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| the Clinical
Laboratory
Improvement Amendments of 1988 (CLIA |
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| '88) (P.L. 100-578).
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| "Clinical laboratory test" or "laboratory test" means a |
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| microbiological,
serological, molecular, chemical, biological, |
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| hematological, immunological,
immunohematological, |
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| cytological, biophysical, or any other test or procedure
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| performed
on material derived from or existing in a human body |
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| that provides information
for the
diagnosis, prevention, or |
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| monitoring of a disease or impairment or assessment
of a
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| clinical condition. Clinical laboratory testing encompasses |
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| the pre-analytical,
analytical,
and post-analytical phases of |
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| testing.
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| "Cytotechnologist" means an individual eligible under this |
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| Act who is
qualified to
process and interpret cellular material |
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| derived from the human body delineating
data
regarding human |
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| cytopathological disease. The cytotechnologist performs |
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| testing
under
the supervision of a technical supervisor |
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| pursuant to the CLIA '88. The
cytotechnologist reviews
and |
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| interprets gynecological cytology preparations and screens
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| non-gynecological
cytology preparations where final review and |
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| interpretation is the
responsibility of a
qualified physician.
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| "Department" means the Department of Professional |
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| Regulation.
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| "Director" means the Director of Professional Regulation.
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| "Histotechnician" means an individual who is qualified to
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| process cellular and tissue components through methods of |
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| selected gross
dissection and
description, fixation, |
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| dehydration, embedding, microtomy, frozen sectioning,
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| staining,
and other related procedures and techniques employed |
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| in the preparation of
smears,
slides, and tissues. This |
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| specialty also encompasses methods for antigen
detection and
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| other molecular hybridization testing methods where the |
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| purpose is analysis or
quantification of cellular and tissue |
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| components for interpretation by a
qualified
physician. The |
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| histotechnician performs testing under the direct supervision |
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| of
a
histotechnologist, technical consultant, supervisor, or |
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| laboratory director as
defined by
CLIA '88.
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| "Histotechnologist" means an individual who is
qualified
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| to process cellular and tissue components through methods of |
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| selected gross
dissection
and description, fixation, |
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| dehydration, embedding, microtomy, frozen
sectioning,
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| staining, and other related procedures and techniques employed |
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| in the
preparation of
smears, slides and tissues. This |
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| specialty also encompasses methods for antigen
detection
and |
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| other molecular hybridization testing methods where the |
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| purpose is analysis
or
quantification of cellular and tissue |
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| components for interpretation by a
qualified
physician. The |
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| histotechnologist performs testing under the supervision of a
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| technical
consultant, supervisor, or laboratory director as |
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| defined by CLIA '88.
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| "Medical technologist" means an individual eligible under |
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| this Act that performs any clinical laboratory test including |
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| those that require the exercise of independent judgment. In |
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| addition, this individual is responsible for the establishment |
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| and implementation of protocols, quality assessment, method |
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| development and selection, equipment selection and |
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| maintenance, and all activities related to the pre-analytical, |
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| analytical, or post-analytical phases of testing. The medical |
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| technologist may also direct, supervise, consult, educate, and |
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| perform research functions. |
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| "Medical laboratory technician" means an individual |
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| eligible under this Act who is qualified to perform clinical |
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| laboratory tests pursuant to established and approved |
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| protocols that require limited exercise of independent |
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| judgment and which are performed with oversight from a clinical |
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| laboratory scientist, medical technologist, technical |
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| consultant, supervisor, or laboratory director as defined by |
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| the Clinical Laboratory Improvement Amendments of 1988. |
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| "Pathologist's assistant" means an individual who is
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LRB093 17749 AMC 46506 b |
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| qualified to perform surgical pathology specimen examinations |
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| and post-mortem
examinations. This specialty also encompasses |
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| related functions which are
necessary to
insure the successful |
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| completion or processing of the above. The pathologist's
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| assistant
performs testing under the supervision of a qualified |
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| pathologist. The
functions of the
pathologist's assistant |
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| shall be to assist a pathologist in arriving at a final
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| diagnosis.
Rendering the final diagnosis, however, is the |
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| responsibility of a pathologist.
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| "Point of care testing" means clinical testing that is so |
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| critical to patient
care that
it must be performed immediately |
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| at or near the patient. Tests meeting this
definition
provide |
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| clinically relevant information that direct therapy, are |
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| limited to
procedures that
produce accurate and precise data in |
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| a short period of time, meet the current
standards of
quality |
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| in laboratory science, and comply with all standards of |
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| accrediting
agencies. The
term does not include a clinical |
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| laboratory test performed in a physician's
office
laboratory.
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| "Waived test" means a simple laboratory examination or |
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| procedure, as defined
by
the CLIA '88 and approved by the |
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| Board.
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| Section 20. Exemptions. This Act does not apply to any of |
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| the following:
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| (1) A person licensed in this State under any other Act |
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| who engages in the
practice for which he or she is |
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| licensed, providing the Act specifically
authorizes
him or |
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| her to perform laboratory testing.
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| (2) Clinical laboratory practitioners employed by the |
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| United States
government or any bureau, division, or agency |
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| thereof while in the discharge of
the employee's official |
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| duties.
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| (3) Clinical laboratory practitioners engaged in |
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| teaching or research,
provided that the results of any |
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| examination performed are not used in health
maintenance, |
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| diagnosis, or treatment of disease.
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LRB093 17749 AMC 46506 b |
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| (4) Students or trainees enrolled in a clinical |
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| laboratory education
program, provided that these |
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| activities constitute a part of a planned course
in the
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| program, that the persons are designated by title such as |
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| intern, trainee, or student,
and the persons work directly |
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| under (i) an individual licensed by this State to
practice |
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| clinical laboratory science, (ii) a person exempt from |
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| licensure under
this
Act by item (3) of this Section, or |
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| (iii) a licensed physician.
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| (5) A person solely performing waived tests under the |
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| Clinical Laboratory
Improvement Amendments of 1988 (P.L. |
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| 100-578).
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| (6) Personnel performing point of care testing |
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| provided that, within the
point of care testing laboratory, |
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| a licensed Clinical laboratory scientist,
medical
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| technologist, categorical technologist, clinical |
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| laboratory technician, medical laboratory technician, or
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| licensed
physician is responsible for all of the following:
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| (A) Designing and providing or supervising the |
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| training programs
for the point of care testing |
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| personnel.
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| (B) Supervising and monitoring the quality |
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| assurance and quality
control activities of the |
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| testing site.
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| (C) Assisting in the selection of technology.
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| (D) Reviewing the results of proficiency testing |
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| and
recommending corrective action, if necessary.
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| (E) Monitoring the continued competency of the |
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| testing personnel.
Failure to comply with the above |
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| requirements subjects the point of care
testing |
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| personnel to the loss of the exemption.
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| (7) Histotechnicians and histotechnologists who |
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| perform clinical
laboratory testing under the supervision |
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| of a technical consultant, supervisor,
or
laboratory |
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| director as defined by the CLIA '88.
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| (8) Pathologist's assistants who perform clinical |
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LRB093 17749 AMC 46506 b |
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| laboratory testing under
the supervision of a qualified |
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| pathologist.
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| Section 25. License required.
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| (a) Beginning January 1, 2005, no person shall perform or |
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| consult regarding
clinical laboratory tests or hold himself or |
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| herself out as a clinical
laboratory practitioner
in the State |
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| unless he or she is licensed under this Act.
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| (b) All persons performing or consulting regarding |
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| clinical laboratory tests
on the
effective date of this Act who |
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| are certified by or eligible for certification
by an agency
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| acceptable to the Department and who have applied to the |
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| Department on or
before
January 1, 2005 and have complied with |
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| all necessary requirements for
application may
continue to |
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| perform clinical laboratory tests until (1) the expiration of |
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| 12
months after
filing the application, (2) the denial of the |
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| application by the Department, or
(3) the
withdrawal of the |
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| application, whichever occurs first.
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| (c) Before January 1, 2007, a person not meeting the |
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| education, training,
and
experience qualifications for a |
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| license under this Act may be granted licensure
if they
have 3 |
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| years of acceptable experience at the professional level for |
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| which
licensure is
sought immediately prior to the effective |
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| date of this Act and submit to the
Board the job
description of |
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| the position that the applicant has most recently performed,
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| attested to
by his or her employer.
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| (D) Beginning January 1, 2007, no initial license shall be |
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| issued until an
applicant
meets all of the requirements under |
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| this Act and successfully completes a
national
certification |
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| examination authorized by the Department.
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| Section 30. Administration.
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| (a) The Department shall adopt rules consistent with the |
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| provisions of this
Act for
the administration and enforcement |
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| thereof and may prescribe the forms that
shall be
issued in |
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| connection with this Act. The rules shall include standards and
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HB4864 |
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| criteria for
licensure and professional conduct and |
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| discipline. The Department shall consult
with the
Board in |
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| adopting rules. Notice of proposed rulemaking shall be |
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| transmitted to
the Board
and the Department shall review the |
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| Board's response and any recommendations
the
Board makes. The |
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| Department shall notify the Board in writing with an
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| explanation of
its deviations from the Board's recommendations |
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| and response.
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| (b) The Department may solicit the advice and expert |
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| knowledge of the Board on
any matter relating to the |
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| administration and enforcement of this Act.
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| (c) The Department shall issue to the Board a quarterly |
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| report of the status of all
complaints related to the |
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| profession received by the Department.
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| Section 35. Clinical Laboratory Science Board.
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| (a) There is hereby created a Clinical Laboratory Science |
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| Board within the
Department of Professional Regulation which |
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| shall consist of 8 persons who have
been
residents of this |
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| State for at least 2 years prior to their appointment and who
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| are actively
engaged in their areas of practice. The Director |
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| may make appointments to the
Board
from lists submitted by |
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| organizations of clinical laboratory science
practitioners and
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| organizations of physician pathologists.
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| (b) The Board shall be composed of the following members: |
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| (i) one physician
certified by the American Board of Pathology |
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| or the American Board of
Osteopathic
Pathology; (ii) 6 clinical |
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| laboratory practitioners who, except for initial
appointments,
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| hold active and valid licenses as clinical laboratory |
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| practitioners in this
State, at least one
of whom is a |
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| non-physician laboratory director, as defined by the CLIA '88, |
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| 2
of whom
are clinical laboratory scientists or medical |
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| technologists, one of whom is a clinical laboratory
technician |
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| or medical laboratory technician, and one of
whom is a |
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| cytotechnologist; and (iii) one public member who is not |
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| associated
with or
financially interested in the practice of |
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| clinical laboratory science.
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| (c) Board members shall serve for a term of 3 years and |
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| until their
successors are
appointed and qualified, except that |
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| the initial appointments, which shall be
made within
60 days |
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| after the effective date of this Act, shall be as follows:
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| (1) A pathologist, a non-physician laboratory |
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| director, as defined by the
CLIA '88, and 2 clinical |
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| laboratory practitioners shall be appointed to serve
for 3
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| years.
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| (2) A public representative shall be appointed to serve |
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| for 2 years.
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| (3) The remaining members shall be appointed to serve |
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| for one year.
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| (d) Whenever a vacancy shall occur on the Board by reason |
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| other than the
expiration of a term of office, the Director |
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| shall appoint a successor of like qualifications
for the |
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| remainder of the unexpired term. No person shall be appointed |
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| to serve more than
2 successive 3-year terms.
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| (e) The Director shall have the authority to remove any |
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| member of the Board
from office for neglect of any duty |
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| required by law or for incompetency or unprofessional
or |
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| dishonorable conduct.
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| (f) The Director shall consider the recommendations of the |
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| Board on questions
involving standards of professional |
25 |
| conduct, discipline, and qualifications of applicants or
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| licensees under this Act.
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| Section 40. Standards for licensure.
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| (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,
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| 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:
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| (1) Baccalaureate degree in clinical laboratory |
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| science or medical
technology or the equivalent from an |
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| accredited college or university and
successful completion |
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| of an accredited clinical laboratory science or medical
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| technology education program.
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| (2) Baccalaureate degree from an accredited college or |
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| university and
completion of 36 semester hours in the |
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| biological, chemical, or medical
laboratory sciences in |
8 |
| addition to or part of the baccalaureate degree and
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| successful completion of an accredited clinical laboratory |
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| science or medical
technology education program or |
11 |
| successful completion of a 50-week or more
military medical |
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| laboratory training program.
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| (3) Baccalaureate degree from an accredited college or |
14 |
| university and
completion of 36 semester hours in the |
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| 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 |
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| technician, and completion of the equivalent of 2 years of
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| full-time clinical laboratory work experience within the |
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| last 4 years. This
experience
must have included a minimum |
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| of 4 months in each of the 4 major clinical
laboratory |
22 |
| disciplines (chemistry or urinalysis, hematology, |
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| immunohematology,
and microbiology).
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| (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
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| completion of the equivalent of 4 years of full-time |
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| 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).
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| (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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| performance on a categorical examination offered by a national |
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| certification organization
authorized by the Department and at |
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| least one of the following:
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| (1) For the categories of microbiology and chemistry, |
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| (i) a baccalaureate
degree from an accredited college or |
6 |
| university, (ii) successful completion of 30
semester |
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| 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
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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.
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| (2) For the categories of hematology, immunology, and
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| immunohematology, (i) a baccalaureate degree from an |
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| accredited college or
university, (ii) successful |
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| 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
|
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| 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.
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| (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.
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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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| 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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| 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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| 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 |
|
|
|
HB4864 |
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| 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 |
|
|
|
HB4864 |
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|
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| 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 |
|
|
|
HB4864 |
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LRB093 17749 AMC 46506 b |
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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 |
|
|
|
HB4864 |
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LRB093 17749 AMC 46506 b |
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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 |
|
|
|
HB4864 |
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LRB093 17749 AMC 46506 b |
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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 |
|
|
|
HB4864 |
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LRB093 17749 AMC 46506 b |
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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 |
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| 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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HB4864 |
- 23 - |
LRB093 17749 AMC 46506 b |
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| 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 |
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| to the last know
address
of a party.
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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 |
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| laboratory
practitioners.
This Section is a denial and |
10 |
| limitation under subsection (h) of Section 6 of
Article VII of
|
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| the Illinois Constitution.
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| Section 997. Severability. The provisions of this Act are |
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| severable under
Section 1.31 of the Statute on Statutes.
|
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| Section 999. Effective date. This Act takes effect upon |
15 |
| becoming law. |