093_SB1068

 
                                     LRB093 07598 AMC 07777 b

 1        AN ACT concerning professional regulation.

 2        Be it enacted by the People of  the  State  of  Illinois,
 3    represented in the General Assembly:

 4        Section  1.  Short  title.  This  Act may be cited as the
 5    Clinical Laboratory Science Practice Act.

 6        Section 5.  Declaration of policy; purpose. It is  hereby
 7    declared  to  be  a policy of this State that the practice of
 8    clinical laboratory  science  by  health  care  professionals
 9    affects the public health, safety, and welfare and is subject
10    to  control  and  regulation  in  the  public interest. It is
11    further declared  that  clinical  laboratories  and  clinical
12    laboratory   practitioners   provide  essential  services  to
13    practitioners  of  the  healing  arts  by  furnishing   vital
14    information  that  may  be used in the diagnosis, prevention,
15    and treatment of disease or impairment and the assessment  of
16    the  health  of  humans. The purpose of this Act is to assure
17    better protection  of  public  health  by  requiring  minimum
18    qualifications  for  clinical laboratory practitioners and by
19    ensuring that clinical laboratory tests  are  performed  with
20    the  highest  degree  of  professional  competency  by  those
21    engaged in providing such 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
26    a program  planned  to  provide  a  predetermined  amount  of
27    instruction  and  experience  in clinical laboratory science,
28    medical technology, cytology,  or  histology  that  has  been
29    accredited  by  one of the accrediting agencies recognized by
30    the U.S. Department of Education.
 
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 1        "Board"  means  the  Clinical  Laboratory  Science  Board
 2    appointed by the Director of Professional Regulation.
 3        "Categorical technologist" means an  individual  eligible
 4    under   this   Act  who  is  qualified  to  perform  clinical
 5    laboratory testing in one or more  categories  of  laboratory
 6    testing,    such   as   microbiology,   clinical   chemistry,
 7    immunology,  hematology,  immunohematology  or  other   areas
 8    specified  by  the  Board.  The  categorical  technologist is
 9    responsible  for  the  establishment  and  implementation  of
10    protocols,  quality  assessment,   method   development   and
11    selection,  equipment  selection  and  maintenance,  and  all
12    activities  related  to  the  pre-analytical, analytical, and
13    post-analytical   phases   of   testing.   The    categorical
14    technologist  may  also  direct, supervise, consult, educate,
15    and perform  research  functions  in  their  specialty  area.
16    "Categorical technologist" includes a categorical scientist.
17        "CLIA  '88"  means  the  Clinical  Laboratory Improvement
18    Amendments of 1988.
19        "Clinical laboratory" or "laboratory"  means  a  site  or
20    location  in  which clinical laboratory tests or examinations
21    are performed.
22        "Clinical laboratory practitioner"  means  an  individual
23    who has the authority to perform clinical laboratory tests.
24        "Clinical   laboratory  scientist"  means  an  individual
25    eligible under this Act that performs any clinical laboratory
26    test including those that require the exercise of independent
27    judgment. In addition, this individual is responsible for the
28    establishment  and  implementation  of   protocols,   quality
29    assessment,   method  development  and  selection,  equipment
30    selection and maintenance, and all activities related to  the
31    pre-analytical,  analytical  and  post-analytical  phases  of
32    testing.  The  clinical laboratory scientist may also direct,
33    supervise, consult, educate, and perform research  functions.
34    "Clinical    laboratory   scientist"   includes   a   medical
 
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 1    technologist.
 2        "Clinical  laboratory  technician"  means  an  individual
 3    eligible under this Act who is qualified to perform  clinical
 4    laboratory   tests   pursuant  to  established  and  approved
 5    protocols  that  require  limited  exercise  of   independent
 6    judgment  and  which  are  performed  with  oversight  from a
 7    clinical   laboratory   scientist,   medical    technologist,
 8    technical  consultant,  supervisor, or laboratory director as
 9    defined by the Clinical Laboratory Improvement Amendments  of
10    1988   (CLIA   '88)   (P.L.  100-578).  "Clinical  laboratory
11    technician" includes a medical laboratory technician.
12        "Clinical laboratory test" or "laboratory test"  means  a
13    microbiological,     serological,     molecular,    chemical,
14    biological,           hematological,           immunological,
15    immunohematological, cytological, biophysical, or  any  other
16    test  or  procedure  performed  on  material  derived from or
17    existing in a human body that provides  information  for  the
18    diagnosis,   prevention,   or  monitoring  of  a  disease  or
19    impairment or assessment of a  clinical  condition.  Clinical
20    laboratory    testing    encompasses    the   pre-analytical,
21    analytical, and post-analytical phases of testing.
22        "Cytotechnologist" means  an  individual  eligible  under
23    this  Act  who is qualified to process and interpret cellular
24    material  derived  from  the  human  body  delineating   data
25    regarding     human     cytopathological     disease.     The
26    cytotechnologist  performs testing under the supervision of a
27    technical  supervisor  pursuant  to   the   CLIA   '88.   The
28    cytotechnologist   reviews   and   interprets   gynecological
29    cytology  preparations and screens non-gynecological cytology
30    preparations where final review  and  interpretation  is  the
31    responsibility of a qualified physician.
32        "Department"   means   the   Department  of  Professional
33    Regulation.
34        "Director" means the Director of Professional Regulation.
 
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 1        "Histotechnician" means an individual who is qualified to
 2    process cellular and tissue  components  through  methods  of
 3    selected   gross   dissection   and   description,  fixation,
 4    dehydration,   embedding,   microtomy,   frozen   sectioning,
 5    staining,  and  other  related  procedures   and   techniques
 6    employed  in  the preparation of smears, slides, and tissues.
 7    This specialty also encompasses methods for antigen detection
 8    and other molecular hybridization testing methods  where  the
 9    purpose  is analysis or quantification of cellular and tissue
10    components for interpretation by a qualified  physician.  The
11    histotechnician performs testing under the direct supervision
12    of  a histotechnologist, technical consultant, supervisor, or
13    laboratory director as defined by CLIA '88.
14        "Histotechnologist" means an individual who is  qualified
15    to  process cellular and tissue components through methods of
16    selected  gross   dissection   and   description,   fixation,
17    dehydration,   embedding,   microtomy,   frozen   sectioning,
18    staining,   and   other  related  procedures  and  techniques
19    employed in the preparation of smears,  slides  and  tissues.
20    This specialty also encompasses methods for antigen detection
21    and  other  molecular hybridization testing methods where the
22    purpose is analysis or quantification of cellular and  tissue
23    components  for  interpretation by a qualified physician. The
24    histotechnologist performs testing under the supervision of a
25    technical consultant, supervisor, or laboratory  director  as
26    defined by CLIA '88.
27        "Pathologist's  assistant"  means  an  individual  who is
28    qualified to perform surgical pathology specimen examinations
29    and post-mortem examinations. This specialty also encompasses
30    related  functions  which  are  necessary   to   insure   the
31    successful   completion  or  processing  of  the  above.  The
32    pathologist's   assistant   performs   testing   under    the
33    supervision  of a qualified pathologist. The functions of the
34    pathologist's assistant shall be to assist a  pathologist  in
 
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 1    arriving at a final diagnosis. Rendering the final diagnosis,
 2    however, is the responsibility of a pathologist.
 3        "Point of care testing" means clinical testing that is so
 4    critical   to   patient   care  that  it  must  be  performed
 5    immediately at  or  near  the  patient.  Tests  meeting  this
 6    definition   provide  clinically  relevant  information  that
 7    direct  therapy,  are  limited  to  procedures  that  produce
 8    accurate and precise data in a short period of time, meet the
 9    current standards  of  quality  in  laboratory  science,  and
10    comply  with  all standards of accrediting agencies. The term
11    does not include a clinical laboratory test  performed  in  a
12    physician's office laboratory.
13        "Waived  test"  means  a simple laboratory examination or
14    procedure, as defined by the CLIA '88  and  approved  by  the
15    Board.

16        Section  20.  Exemptions.  This Act does not apply to any
17    of the following:
18             (1)  A person licensed in this State under any other
19        Act who engages in the practice for which he  or  she  is
20        licensed,  providing  the Act specifically authorizes him
21        or her to perform laboratory testing.
22             (2)  Clinical laboratory practitioners  employed  by
23        the  United States government or any bureau, division, or
24        agency thereof while in the discharge of  the  employee's
25        official duties.
26             (3)  Clinical  laboratory  practitioners  engaged in
27        teaching or research, provided that the  results  of  any
28        examination performed are not used in health maintenance,
29        diagnosis, or treatment of disease.
30             (4)  Students  or  trainees  enrolled  in a clinical
31        laboratory  education  program,   provided   that   these
32        activities  constitute  a part of a planned course in the
33        program, that the persons are designated by title such as
 
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 1        intern,  trainee,  or  student,  and  the  persons   work
 2        directly  under  (i) an individual licensed by this State
 3        to practice clinical laboratory science,  (ii)  a  person
 4        exempt  from licensure under this Act by item (3) of this
 5        Section, or (iii) a licensed physician.
 6             (5)  A person solely performing waived  tests  under
 7        the  Clinical  Laboratory  Improvement Amendments of 1988
 8        (P.L. 100-578).
 9             (6)  Personnel  performing  point  of  care  testing
10        provided  that,  within  the  point   of   care   testing
11        laboratory,  a  licensed  Clinical  laboratory scientist,
12        medical technologist, categorical technologist,  clinical
13        laboratory   technician,   or   licensed   physician   is
14        responsible for all of the following:
15                  (A)  Designing and providing or supervising the
16             training  programs  for  the  point  of care testing
17             personnel.
18                  (B)  Supervising  and  monitoring  the  quality
19             assurance and  quality  control  activities  of  the
20             testing site.
21                  (C)  Assisting in the selection of technology.
22                  (D)  Reviewing   the   results  of  proficiency
23             testing  and  recommending  corrective  action,   if
24             necessary.
25                  (E)  Monitoring the continued competency of the
26             testing personnel.  Failure to comply with the above
27             requirements  subjects  the  point  of  care testing
28             personnel to the loss of the exemption.
29             (7)  Histotechnicians  and  histotechnologists   who
30        perform clinical laboratory testing under the supervision
31        of  a  technical  consultant,  supervisor,  or laboratory
32        director as defined by the CLIA '88.
33             (8)  Pathologist's assistants who  perform  clinical
34        laboratory  testing  under the supervision of a qualified
 
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 1        pathologist.

 2        Section 25.  License required.
 3        (a)  Beginning January 1, 2004, no person  shall  perform
 4    or  consult  regarding  clinical  laboratory  tests  or  hold
 5    himself  or herself out as a clinical laboratory practitioner
 6    in the State unless he or she is licensed under this Act.
 7        (b)  All  persons  performing  or  consulting   regarding
 8    clinical  laboratory  tests on the effective date of this Act
 9    who are certified by or  eligible  for  certification  by  an
10    agency  acceptable  to the Department and who have applied to
11    the Department on or before January 1, 2004 and have complied
12    with all necessary requirements for application may  continue
13    to perform clinical laboratory tests until (1) the expiration
14    of  12 months after filing the application, (2) the denial of
15    the application by the Department, or (3) the  withdrawal  of
16    the application, whichever occurs first.
17        (c)  Before  January  1,  2006,  a person not meeting the
18    education, training,  and  experience  qualifications  for  a
19    license  under this Act may be granted licensure if they have
20    3 years of acceptable experience at  the  professional  level
21    for  which  licensure  is  sought  immediately  prior  to the
22    effective date of this Act and submit to the  Board  the  job
23    description  of  the  position  that  the  applicant has most
24    recently performed, attested to by his or her employer.
25        (D)  Beginning January 1, 2006, no initial license  shall
26    be  issued  until  an applicant meets all of the requirements
27    under  this  Act  and  successfully  completes   a   national
28    certification examination authorized by the Department.

29        Section 30.  Administration.
30        (a)  The Department shall adopt rules consistent with the
31    provisions of this Act for the administration and enforcement
32    thereof  and  may prescribe the forms that shall be issued in
 
                            -8-      LRB093 07598 AMC 07777 b
 1    connection with this Act. The rules shall  include  standards
 2    and  criteria  for  licensure  and  professional  conduct and
 3    discipline. The Department shall consult with  the  Board  in
 4    adopting  rules.  Notice  of  proposed  rulemaking  shall  be
 5    transmitted  to the Board and the Department shall review the
 6    Board's response and any recommendations the Board makes. The
 7    Department  shall  notify  the  Board  in  writing  with   an
 8    explanation    of    its    deviations   from   the   Board's
 9    recommendations and response.
10        (b)  The Department may solicit  the  advice  and  expert
11    knowledge  of  the  Board  on  any  matter  relating  to  the
12    administration and enforcement of this Act.
13        (c)  The  Department shall issue to the Board a quarterly
14    report of  the  status  of  all  complaints  related  to  the
15    profession received by the Department.

16        Section 35.  Clinical Laboratory Science Board.
17        (a)  There   is  hereby  created  a  Clinical  Laboratory
18    Science  Board  within   the   Department   of   Professional
19    Regulation  which  shall  consist  of 8 persons who have been
20    residents of this State for at least 2 years prior  to  their
21    appointment  and  who  are actively engaged in their areas of
22    practice. The Director may make  appointments  to  the  Board
23    from  lists submitted by organizations of clinical laboratory
24    science  practitioners   and   organizations   of   physician
25    pathologists.
26        (b)  The   Board  shall  be  composed  of  the  following
27    members: (i) one physician certified by the American Board of
28    Pathology or the American  Board  of  Osteopathic  Pathology;
29    (ii)  6  clinical  laboratory  practitioners  who, except for
30    initial appointments,  hold  active  and  valid  licenses  as
31    clinical laboratory practitioners in this State, at least one
32    of whom is a non-physician laboratory director, as defined by
33    the  CLIA  '88, 2 of whom are clinical laboratory scientists,
 
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 1    one of whom is a clinical laboratory technician, and  one  of
 2    whom  is  a cytotechnologist; and (iii) one public member who
 3    is not associated  with  or  financially  interested  in  the
 4    practice of clinical laboratory science.
 5        (c)  Board  members shall serve for a term of 3 years and
 6    until their successors are appointed  and  qualified,  except
 7    that  the initial appointments, which shall be made within 60
 8    days after the effective  date  of  this  Act,  shall  be  as
 9    follows:
10             (1)  A   pathologist,   a  non-physician  laboratory
11        director, as defined by the  CLIA  '88,  and  2  clinical
12        laboratory  practitioners shall be appointed to serve for
13        3 years.
14             (2)  A public representative shall be  appointed  to
15        serve for 2 years.
16             (3)  The  remaining  members  shall  be appointed to
17        serve for one year.
18        (d)  Whenever a vacancy  shall  occur  on  the  Board  by
19    reason  other  than  the  expiration of a term of office, the
20    Director shall appoint a successor of like qualifications for
21    the remainder of the  unexpired  term.  No  person  shall  be
22    appointed to serve more than 2 successive 3-year terms.
23        (e)  The  Director shall have the authority to remove any
24    member of the Board from  office  for  neglect  of  any  duty
25    required  by  law  or  for  incompetency or unprofessional or
26    dishonorable conduct.
27        (f)  The Director shall consider the  recommendations  of
28    the  Board  on  questions involving standards of professional
29    conduct, discipline,  and  qualifications  of  applicants  or
30    licensees under this Act.

31        Section 40.  Standards for licensure.
32        (a)  The  Department  shall  issue  a clinical laboratory
33    scientist  license   to   an   individual   who   meets   the
 
                            -10-     LRB093 07598 AMC 07777 b
 1    qualifications   promulgated  by  the  Department,  including
 2    successful completion of a national certification examination
 3    at the clinical laboratory scientist level authorized by  the
 4    Department and at least one of the following:
 5             (1)  Baccalaureate  degree  in  clinical  laboratory
 6        science  or  medical technology or the equivalent from an
 7        accredited   college   or   university   and   successful
 8        completion of an accredited clinical  laboratory  science
 9        or medical technology education program.
10             (2)  Baccalaureate degree from an accredited college
11        or  university and completion of 36 semester hours in the
12        biological, chemical, or medical laboratory  sciences  in
13        addition  to  or  part  of  the  baccalaureate degree and
14        successful   completion   of   an   accredited   clinical
15        laboratory  science  or  medical   technology   education
16        program  or  successful  completion  of a 50-week or more
17        military medical laboratory training program.
18             (3)  Baccalaureate degree from an accredited college
19        or university and completion of 36 semester hours in  the
20        biological,  chemical,  or medical laboratory sciences in
21        addition  to  or  part  of  the   baccalaureate   degree,
22        certified   as  a  clinical  laboratory  technician,  and
23        completion of the equivalent  of  2  years  of  full-time
24        clinical  laboratory  work  experience  within the last 4
25        years. This experience must have included a minimum of  4
26        months  in  each  of  the  4  major  clinical  laboratory
27        disciplines   (chemistry   or   urinalysis,   hematology,
28        immunohematology, and microbiology).
29             (4)  Baccalaureate degree from an accredited college
30        or  university and completion of 36 semester hours in the
31        biological, chemical, or medical laboratory  sciences  in
32        addition  to  or  part  of  the  baccalaureate degree and
33        completion of the equivalent  of  4  years  of  full-time
34        clinical  laboratory  work  experience  within the last 8
 
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 1        years. This experience must have included a minimum of  4
 2        months  in  each  of  the  4  major  clinical  laboratory
 3        disciplines   (chemistry   or   urinalysis,   hematology,
 4        immunohematology, and microbiology).
 5        (b)  The    Department    shall   issue   a   categorical
 6    technologist  license  to  an  individual  who   meets   such
 7    qualifications  as  promulgated  by the Department, including
 8    successful completion of a categorical examination offered by
 9    a  national  certification  organization  authorized  by  the
10    Department and at least one of the following:
11             (1)  For  the   categories   of   microbiology   and
12        chemistry,  (i) a baccalaureate degree from an accredited
13        college or university, (ii) successful completion  of  30
14        semester  hours  in  the biological, chemical, or medical
15        laboratory sciences, and  (iii)  one  year  of  full-time
16        experience  within  the last 10 years in the category for
17        which licensure is sought or successful completion  of  a
18        structured training program that is under the auspices of
19        an  accredited  medical technology or clinical laboratory
20        science education  program  in  the  category  for  which
21        licensure is sought.
22             (2)  For  the  categories of hematology, immunology,
23        and immunohematology, (i) a baccalaureate degree from  an
24        accredited   college   or   university,  (ii)  successful
25        completion  of  30  semester  hours  in  the  biological,
26        chemical or medical  laboratory  sciences,  and  (iii)  2
27        years of full-time experience within the last 10 years in
28        the  category for which licensure is sought or successful
29        completion of a structured training program that is under
30        the auspices  of  an  accredited  medical  technology  or
31        clinical  laboratory  science  education  program  in the
32        category for which licensure is sought.
33             (3)  A  masters  or   doctorate   in   a   chemical,
34        biological,   or   medical  laboratory  science  from  an
 
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 1        accredited college or university and  6  months  of  full
 2        time   acceptable   clinical   laboratory  experience  or
 3        clinical laboratory training within the last 10 years  in
 4        the category for which licensure is sought.
 5        The    Department   may   establish   other   categorical
 6    technologist  licenses  as  necessary,  provided   that   the
 7    licenses  require  a  baccalaureate  or graduate degree in an
 8    appropriate field, clinical training or work experience,  and
 9    national certification.
10        (c)  The  Department  shall  issue  a clinical laboratory
11    technician  license  to  an   individual   who   meets   such
12    qualifications  as promulgated by the Department, which shall
13    include successful completion  of  a  national  certification
14    examination  at  the  clinical  laboratory  technician  level
15    authorized  by  the  Department  and  at  least  one  of  the
16    following:
17             (1)  Associate's degree or 60 semester hours from an
18        accredited   post-secondary   academic   institution  and
19        successful   completion   of   an   accredited   clinical
20        laboratory technician education program.
21             (2)  Associate's degree or 60 semester hours from an
22        accredited post-secondary academic  institution  with  24
23        semester  hours of college course work in the biological,
24        chemical, or medical  laboratory  sciences,  including  6
25        semester  hours  of  chemistry  and  6  semester hours of
26        biology and successful completion of a  50-week  or  more
27        military medical laboratory training program.
28             (3)  Associate's degree or 60 semester hours from an
29        accredited  post-secondary  academic  institution with 24
30        semester hours of college course work in the  biological,
31        chemical,  or  medical  laboratory  sciences, including 6
32        semester hours of  chemistry  and  6  semester  hours  of
33        biology   and   successful   completion  of  an  approved
34        laboratory or clinical assistant education  program,  and
 
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 1        completion  of  the  equivalent  of one year of full-time
 2        clinical laboratory work experience  within  the  last  2
 3        years.  This experience must have included a minimum of 3
 4        months  in  each  of  the  4  major  clinical  laboratory
 5        disciplines   (chemistry   or   urinalysis,   hematology,
 6        immunohematology,  and  microbiology).  Laboratory   work
 7        experience  must  be under the supervision of a certified
 8        clinical   laboratory   scientist,   certified   clinical
 9        laboratory  technician,  clinical  laboratory   scientist
10        consultant, or the equivalent.
11             (4)  Associate's degree or 60 semester hours from an
12        accredited  post-secondary  academic  institution with 24
13        semester hours of college course work in the  biological,
14        chemical,  or  medical  laboratory  sciences, including 6
15        semester hours of  chemistry  and  6  semester  hours  of
16        biology  and  completion  of the equivalent of 2 years of
17        full-time clinical laboratory work experience within  the
18        last  4  years.  This  experience  must  have  included a
19        minimum of 3 months in  each  of  the  4  major  clinical
20        laboratory    disciplines   (chemistry   or   urinalysis,
21        hematology,    immunohematology,    and    microbiology).
22        Completion of one year of the laboratory work  experience
23        must  be  under  the  supervision of a certified clinical
24        laboratory  scientist,  certified   clinical   laboratory
25        technician,  clinical laboratory scientist consultant, or
26        the equivalent.
27        (d)  The  Department  shall  issue   a   cytotechnologist
28    license  to  an  individual  who meets such qualifications as
29    promulgated by the Department, which shall include successful
30    completion of a national  certification  examination  at  the
31    cytotechnologist  level  authorized  by  the Department and a
32    baccalaureate degree from an accredited college or university
33    with 20 semester hours of biological science and  8  semester
34    hours  of  chemical  science, and successful completion of an
 
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 1    accredited cytology laboratory education program.

 2        Section 45.  Temporary license.
 3        (a)  Licensure  applicants  that  qualify  by  education,
 4    experience, or training but  have  not  taken  or  passed  an
 5    approved  nationally recognized certification examination may
 6    be  granted  a  temporary  license  that  will   allow   that
 7    individual  to  engage in the practice of clinical laboratory
 8    science at the appropriate level. The temporary license  will
 9    be  valid  for 6 months and can be renewed twice upon failure
10    to  pass  an  approved  nationally  recognized  certification
11    examination.
12        (b)  Internationally trained  licensure  applicants  must
13    have  their  transcripts evaluated by a transcript evaluation
14    agency acceptable to the Department and submitted directly to
15    the national certifying agency. The evaluation must  indicate
16    that the applicant's education is equivalent to that which is
17    required  for  licensure  of  U.S.  graduates in the level of
18    licensure being sought.  Upon  submission  of  proof  to  the
19    Department   of  acceptance  to  sit  for  the  certification
20    examination the individual may apply for a temporary  license
21    in the corresponding category.

22        Section  50.  Waiver  of  requirements. The Department of
23    Professional   Regulation   shall   adopt   rules   providing
24    procedures for waiver of the requirements  under  Section  40
25    for  all  applicants  who  hold a valid license or equivalent
26    issued by another state if the requirements under which  that
27    license  or equivalent was issued are equivalent to or exceed
28    the standards required by this Act.

29        Section 55.  Licensure application procedures.
30        (a)  Licensure applicants shall submit their  application
31    for licensure to the Department upon the forms prescribed and
 
                            -15-     LRB093 07598 AMC 07777 b
 1    furnished  by  the  Department  and  shall pay the designated
 2    application fee.
 3        (b)  Upon receipt of an application and payment of a fee,
 4    the  Department  shall  issue  a  license  for   a   clinical
 5    laboratory   scientist,  categorical  technologist,  clinical
 6    laboratory technician, or cytotechnologist, to any person who
 7    meets the qualifications specified in this Act and the  rules
 8    adopted pursuant to this Act.

 9        Section 60.  Licensure renewal.
10        (a)  A license issued under this Act shall expire 2 years
11    after receipt.
12        (b)  Every person licensed under this Act shall be issued
13    a  renewal  license upon (i) submission of an application for
14    renewal on a form prescribed by the Department and payment of
15    an appropriate fee determined  by  the  Department  and  (ii)
16    proof  of  completion,  in  the  period since the license was
17    first issued or  last  renewed,  of  at  least  24  hours  of
18    continuing  education  courses,  clinics,  lectures, training
19    programs, seminars, or other  programs  related  to  clinical
20    laboratory  practice  that  are  approved  or accepted by the
21    Board or proof of recertification by a  national  accrediting
22    organization  that  mandates an annual minimum of 12 hours of
23    continuing education.
24        (c)  The Department may require other  such  evidence  of
25    competency  as  it  shall  deem  reasonably  appropriate as a
26    prerequisite to the renewal of any license  provided  for  in
27    this  Act,  so  long  as  the  requirements are uniform as to
28    application, are reasonably related  to  the  measurement  of
29    qualification,  performance, or competence, and are desirable
30    and necessary for the protection of the public health.

31        Section 65.  Disciplinary grounds.
32        (a)  The Department may  refuse  to  issue  or  renew  or
 
                            -16-     LRB093 07598 AMC 07777 b
 1    revoke  a  license, may suspend, place on probation, censure,
 2    or reprimand a licensee, or may take such other  disciplinary
 3    action  as the Department may deem appropriate, including the
 4    imposition of a  civil  penalty  not  to  exceed  $5,000  for
 5    conduct  that  may result from but not necessarily be limited
 6    to any of the following:
 7             (1)  A   material   misstatement    in    furnishing
 8        information to the Department.
 9             (2)  A   violation   or   negligent  or  intentional
10        disregard of this Act or the rules  adopted  pursuant  to
11        this Act.
12             (3)  A conviction of any crime under the laws of the
13        United  States or any state or territory thereof which is
14        a felony or a misdemeanor, an essential element of  which
15        is  dishonesty  or of any crime which is directly related
16        to the practice of the profession.
17             (4)  Making any misrepresentation for the purpose of
18        obtaining registration or violating any provision of this
19        Act.
20             (5)  Professional incompetence.
21             (6)  Malpractice.
22             (7)  Failing to provide information in response to a
23        written request made by the  Department  within  60  days
24        after receipt of the request.
25             (8)  Discipline  by  another  state,  territory,  or
26        country if at least one of the grounds for the discipline
27        is  the  same  or  substantially  equivalent to those set
28        forth in this Act.
29             (9)  Directly or indirectly giving to  or  receiving
30        from  any  person,  firm,  corporation,  partnership,  or
31        association any fee, commission, rebate, or other form of
32        compensation  for  any professional services not actually
33        rendered.
34             (10)  A finding by the Department that the licensee,
 
                            -17-     LRB093 07598 AMC 07777 b
 1        after having his license placed on  probationary  status,
 2        has violated the terms of probation.
 3             (11)  Wilfully  making  or  filing  false records or
 4        reports in his or her practice, including but not limited
 5        to,  false  records  filed   with   State   agencies   or
 6        departments.
 7             (12)  Violation  of  any  standard  of  professional
 8        conduct adopted by the Department.
 9             (13)  Engaging   in   dishonorable,   unethical,  or
10        unprofessional conduct of a character likely to  deceive,
11        defraud, or harm the public.
12             (14)  Providing professional services while mentally
13        incompetent or under the influence of alcohol or narcotic
14        or  controlled  dangerous  substance that is in excess of
15        therapeutic amounts or without valid medical indication.
16             (15)  Directly or indirectly contracting to  perform
17        clinical  laboratory  tests  in  a  manner that offers or
18        implies an offer of rebate, fee-splitting inducements  or
19        arrangements, or other remuneration.
20             (16)  Aiding   or   assisting   another   person  in
21        violating any provision of this Act or any  rule  adopted
22        pursuant to this Act.
23        (b)  The determination by a circuit court that a licensee
24    is  subject to involuntary admission or judicial admission as
25    provided in the Mental Health and Developmental  Disabilities
26    Code  operates  as  an  automatic suspension. Such suspension
27    will terminate only upon  a  finding  by  a  court  that  the
28    patient  is  no  longer  subject  to involuntary admission or
29    judicial admission and the issuance of an  order  so  finding
30    and  discharging  the patient, and upon the recommendation of
31    the Board to the Director that the registrant be  allowed  to
32    resume practice.
33        (c)  The  Department  may  refuse to issue or may suspend
34    the registration of any person who fails to file a return, to
 
                            -18-     LRB093 07598 AMC 07777 b
 1    pay the tax, penalty, or interest shown in a filed return, or
 2    any  final  assessment  of  tax,  penalty,  or  interest,  as
 3    required  by  any  tax  Act  administered  by  the   Illinois
 4    Department of Revenue, until such time as the requirements of
 5    such tax Act are satisfied.

 6        Section 70.  Injunction; cease and desist order.
 7        (a)  If  any  person violates a provision of the Act, the
 8    Director may, in the name of  the  People  of  the  State  of
 9    Illinois,  through  the  Attorney  General  of  the  State of
10    Illinois, petition for an order enjoining such  violation  or
11    for  an  order  enforcing  compliance  with the Act. Upon the
12    filing of a verified petition in such court,  the  court  may
13    issue  a temporary restraining order, without notice or bond,
14    and may preliminarily and permanently enjoin such  violation,
15    and  if it is established that such person has violated or is
16    violating this injunction, the Court may punish the  offender
17    for contempt of court. Proceeding under this Section shall be
18    in  addition  to,  and not in lieu of, all other remedies and
19    penalties provided by the Act.
20        (b)  If  any  person  shall  practice   as   a   clinical
21    laboratory  practitioner  or hold himself out as such without
22    having a valid license required  under  this  Act,  then  any
23    licensee, any interested party, or any person injured thereby
24    may,  in  addition  to  the  Director, petition for relief as
25    provided in subsection (a) of the Section.
26        (c)  Whenever in the opinion of the Department any person
27    violates any provision of the Act, the Department may issue a
28    rule to show cause why an order to cease  and  desist  should
29    not  be entered against him. The rule shall clearly set forth
30    the grounds relied upon by the Department and shall provide a
31    period of 7 days from the date of the rule to file an  answer
32    to  the  satisfaction of the Department. Failure to answer to
33    the satisfaction of the Department shall cause  an  order  to
 
                            -19-     LRB093 07598 AMC 07777 b
 1    cease and desist to be issued.

 2        Section    75.  Investigations.    The   Department   may
 3    investigate the actions of any applicant or of any person  or
 4    persons  holding  or  claiming to hold a license to engage in
 5    the practice of clinical laboratory science. Before  refusing
 6    to  issue  or renew a license, the Department shall notify in
 7    writing the applicant or holder of the nature of the  charges
 8    and  that a hearing will be held on the date designated. Such
 9    notice shall be sent at least 10 calendar days prior  to  the
10    date  set  for the hearing. Such written notice may be served
11    by personal delivery or certified or registered mail  to  the
12    respondent  at  the  address  of his last notification to the
13    Department. At the time and place fixed in  the  notice,  the
14    Board  shall  proceed  to hear the charges and the parties or
15    their counsel shall be accorded ample opportunity to  present
16    such  statements,  testimony, evidence and argument as may be
17    pertinent to the charges or to the defense thereto. The Board
18    may continue such hearing.

19        Section 80.  Record of proceedings.  The  Department,  at
20    its  expense,  shall  preserve a record of all proceedings at
21    the formal hearing of any case involving the refusal to issue
22    or renew a license. The notice of hearing, complaint and  all
23    other  documents  in  the  nature  of  pleadings  and written
24    motions  filed  in  the  proceedings,   the   transcript   of
25    testimony,  the  report  of  the  Board  and  orders  of  the
26    Department shall be the record of such proceedings.

27        Section  85.  Compel  witnesses.  Any  circuit court may,
28    upon application of the Department or its designee, or of the
29    applicant or licensee against whom proceedings under  Section
30    70  of  the  Act  are  pending,  enter an order requiring the
31    attendance  of  witnesses  and  their  testimony,   and   the
 
                            -20-     LRB093 07598 AMC 07777 b
 1    production of documents, papers, files, books, and records in
 2    connection  with  any hearing or investigation. The court may
 3    compel obedience to its order by proceedings for contempt.

 4        Section 90.  Findings of fact, conclusions  of  law,  and
 5    recommendations.  At the conclusion of the hearing, the Board
 6    shall present  to  the  Director  a  written  report  of  its
 7    findings  and  recommendations.  The  report  shall contain a
 8    finding whether or not the accused person violated  this  Act
 9    or failed to comply with the conditions required in this Act.
10    The  Board  shall  specify  the  nature  of  the violation or
11    failure to comply, and shall make its recommendations to  the
12    Director.
13        The  report  of findings of fact, conclusions of law, and
14    recommendations of the Board  shall  be  the  basis  for  the
15    Department's  order  for  refusal  or  for  the granting of a
16    license or for other disciplinary  action.  If  the  Director
17    disagrees  in  any  regard  with the report of the Board, the
18    Director may issue an order  in  contravention  thereof.  The
19    Director  shall  provide a written report to the Board on any
20    deviation and shall specify with  particularity  the  reasons
21    for  such  action  in  the  final  order.  The finding is not
22    admissible in evidence  against  the  person  in  a  criminal
23    prosecution  brought  for  the violation of this Act, but the
24    hearing and finding are not a bar to a  criminal  prosecution
25    brought for the violation of this Act.

26        Section  95.  Motion for rehearing. In any case involving
27    the refusal to issue or renew a license or  to  discipline  a
28    licensee,  a  copy of the Board's report shall be served upon
29    the respondent by the Department,  either  personally  or  as
30    provided  in  this  Act  for  the  service  of  the notice of
31    hearing. Within 20 calendar  days  after  such  service,  the
32    respondent  may present to the Department a motion in writing
 
                            -21-     LRB093 07598 AMC 07777 b
 1    for a rehearing, which motion shall  specify  the  particular
 2    grounds  therefor.  If no motion for rehearing is filed, then
 3    upon the expiration of the time specified for filing  such  a
 4    motion,  or  if  a  motion for rehearing is denied, then upon
 5    such denial the Director may enter  an  order  in  accordance
 6    with  recommendations of the Board, except as provided for in
 7    Section 85. If the respondent shall order from the  reporting
 8    service,  and  pay  for a transcript of the record within the
 9    time for filing a motion for rehearing, the 20  calendar  day
10    period within which such a motion may be filed shall commence
11    upon the delivery of the transcript to the respondent.

12        Section  100.  Rehearing.  Whenever  the  Director is not
13    satisfied that substantial  justice  has  been  done  in  the
14    revocation,  suspension  or  refusal  to  issue  or  renew  a
15    license,  the  Director  may order a rehearing by the same or
16    other examiners.

17        Section 105.  Hearing officer. The  Director  shall  have
18    the  authority  to  appoint  any  attorney  duly  licensed to
19    practice law in the State of Illinois to serve as the hearing
20    officer in any action or refusal to issue or renew a  license
21    or discipline a licensee. The Director shall notify the Board
22    of  any such appointment. The hearing officer shall have full
23    authority to conduct the hearing. The hearing  officer  shall
24    report   his   finding  of  fact,  conclusions  of  law,  and
25    recommendations to the Board  and  the  Director.  The  Board
26    shall  have  60 days from receipt of the report to review the
27    report of the hearing officer and present its own findings of
28    fact, conclusions of law and recommendations to the Director.
29    If the Board fails to present its report within  the  60  day
30    period, the Director shall issue an order based on the report
31    of  the  hearing  officer.  If  the Director disagrees in any
32    regard with the report of the Board or  hearing  officer,  he
 
                            -22-     LRB093 07598 AMC 07777 b
 1    may  issue  an  order  in contravention thereof. The Director
 2    shall provide a written explanation to the Board of any  such
 3    deviation  and  shall  specify with particularity the reasons
 4    for such action in the  final  order.  At  least  2  licensed
 5    clinical  laboratory  practitioner members of the Board shall
 6    be present at all formal hearings on the merits of complaints
 7    brought under the provisions of this Act.

 8        Section 110.  Prima facie proof. An order or a  certified
 9    copy  thereof, over the seal of the Department and purporting
10    to be signed by the Director,  shall  be  prima  facie  proof
11    that:
12             (1)  the  signature  is the genuine signature of the
13        Director;
14             (2)  the Director is duly appointed  and  qualified;
15        and
16             (3)  the Board and its members are qualified to act.

17        Section   115.  Restoration.   At   any  time  after  the
18    suspension or revocation of any license, the  Department  may
19    restore  the  license to the accused person, upon the written
20    recommendation of the Board, unless  after  an  investigation
21    and  a  hearing, the Board determines that restoration is not
22    in the public interest.

23        Section 120.  Surrender of license. Upon  the  revocation
24    or  suspension  of  any license, the licensee shall forthwith
25    surrender the license to the Department, and if the  licensee
26    fails  to do so, the Department shall have the right to seize
27    the license.

28        Section  125.  Temporary  suspension.  The  Director  may
29    temporarily suspend the  license  of  a  clinical  laboratory
30    practitioner  without  a  hearing,  simultaneously  with  the
 
                            -23-     LRB093 07598 AMC 07777 b
 1    institution  of  proceedings  for  a  hearing  as provided in
 2    Section 70 of this Act, if the Director finds  that  evidence
 3    in his or her possession indicates that a clinical laboratory
 4    practitioner's  continuation  in practice would constitute an
 5    imminent danger to the public. In the event that the Director
 6    suspends temporarily the license  of  a  clinical  laboratory
 7    practitioner  without  a hearing, a hearing by the Board must
 8    be held within 30 calendar days  after  such  suspension  has
 9    occurred.

10        Section  130.  Judicial  review. All final administrative
11    decisions of the Department are subject  to  judicial  review
12    pursuant  to  the provisions of the Administrative Review Law
13    and  all   rules   adopted   pursuant   thereto.   The   term
14    "administrative  decision"  is defined as in Section 3-101 of
15    the Administrative Review Law.     Proceedings  for  judicial
16    review  shall be commenced in the circuit court of the county
17    in which the party applying for review resides. If the  party
18    is  not  a  resident  of  this  State,  the venue shall be in
19    Sangamon County.

20        Section 135.  Certification  of  record.  The  Department
21    shall  not  be required to certify any record to the court or
22    file any answer in court or otherwise appear in any court  in
23    a  judicial  review  proceeding, unless there is filed in the
24    court, with the complaint,  a  receipt  from  the  Department
25    acknowledging   payment   of  the  costs  of  furnishing  and
26    certifying the record, which costs shall be computed  at  the
27    actual  cost  per page of such record. Failure on the part of
28    the plaintiff to file such receipt in court shall be  grounds
29    for dismissal of the action.

30        Section 140.  Criminal penalties. Any person who is found
31    to  have  violated  any  provision  of the Act is guilty of a
 
                            -24-     LRB093 07598 AMC 07777 b
 1    Class A misdemeanor for the first  offense,  and  a  Class  4
 2    felony for second and subsequent offenses.

 3        Section  145.  Illinois Administrative Procedure Act. The
 4    Illinois Administrative Procedure  Act  is  hereby  expressly
 5    adopted  and  incorporated herein as if all of the provisions
 6    of such Act were  included  in  this  Act,  except  that  the
 7    provision  of  paragraph (d) of Section 10-65 of The Illinois
 8    Administrative Procedure Act, which provides that at hearings
 9    the licensee has the right to show compliance with all lawful
10    requirements for retention, continuation, or renewal  of  the
11    license  is  specifically  excluded.  For the purpose of this
12    Act, the notice required under Section 10-25 of The  Illinois
13    Administrative Procedure Act is deemed sufficient when mailed
14    to the last know address of a party.

15        Section  150.  Home rule. The regulation and licensing of
16    clinical laboratory practitioners are  exclusive  powers  and
17    functions of the State. A unit of local government, including
18    home  rule  units,  may  not  regulate  or  license  clinical
19    laboratory  practitioners.  This  Section  is  a  denial  and
20    limitation  under  subsection (h) of Section 6 of Article VII
21    of the Illinois Constitution.

22        Section 997.  Severability.  The provisions of  this  Act
23    are severable under Section 1.31 of the Statute on Statutes.

24        Section  999. Effective date.  This Act takes effect upon
25    becoming law.