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Minnesota Legislature

Office of the Revisor of Statutes

HF 1715

as introduced - 87th Legislature (2011 - 2012) Posted on 05/16/2011 09:04am

KEY: stricken = removed, old language.
underscored = added, new language.

Bill Text Versions

Engrossments
Introduction Posted on 05/16/2011

Current Version - as introduced

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A bill for an act
relating to health occupations; establishing licensure for medical laboratory
science professionals; creating the Board of Medical Laboratory Science;
establishing fees; proposing coding for new law as Minnesota Statutes, chapter
148F.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [148F.01] DEFINITIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Applicability. new text end

new text begin For purposes of this chapter, the following terms
have the meanings given them.
new text end

new text begin Subd. 2. new text end

new text begin Accredited medical laboratory educational program. new text end

new text begin "Accredited
medical laboratory educational program" means a program to provide instruction and
experience in medical laboratory science that has been accredited by an accrediting agency
recognized by the United States Department of Health and Human Services.
new text end

new text begin Subd. 3. new text end

new text begin Categorical medical laboratory scientist. new text end

new text begin "Categorical medical
laboratory scientist" means an individual eligible for licensure under this chapter who
performs the functions of a medical laboratory scientist in one or more of the following
areas of the laboratory depending upon the certification examinations passed: chemistry,
hematology, immunohematology, and microbiology.
new text end

new text begin Subd. 4. new text end

new text begin CLIA. new text end

new text begin "CLIA" means Clinical Laboratory Improvement Amendments of
1988 and includes Public Law 10-578 and Code of Federal Regulations, title 42, section
493. CLIA regulations provide a minimum foundation upon which personnel standards
for entry level technical personnel in this state are built. Qualifications and responsibilities
for laboratory director, technical supervisor, and technical consultant are as specified in
CLIA regulations. All medical laboratory personnel are under the supervision, control,
and responsibility of the laboratory director.
new text end

new text begin Subd. 5. new text end

new text begin Commissioner. new text end

new text begin "Commissioner" means the commissioner of health or the
commissioner's designee.
new text end

new text begin Subd. 6. new text end

new text begin Cytotechnologist. new text end

new text begin "Cytotechnologist" means an individual who
specializes in the cellular analysis of patient samples from all body sites, for the purpose
of evaluating, detecting, and providing diagnostic and prognostic information regarding
disease processes, including those that require the exercise of independent technical
judgment, and who:
new text end

new text begin (1) assists health care providers with the collection, detection, and interpretation
of normal and abnormal cells, infectious agents, and other noncellular material from
submitted specimens;
new text end

new text begin (2) performs a variety of medical laboratory tests to ascertain information to
help in classification, prognosis, or disease detection, including, but not limited to,
immunohistochemical and molecular techniques;
new text end

new text begin (3) establishes and implements protocols, quality control, method selection,
equipment selection and maintenance, and activities related to the preanalytic, analytic,
and postanalytic phases of testing; and
new text end

new text begin (4) may direct, supervise, consult, and educate and perform research functions.
new text end

new text begin Subd. 7. new text end

new text begin Histotechnician. new text end

new text begin "Histotechnician" means an individual who:
new text end

new text begin (1) prepares tissue specimens for microscopic examination;
new text end

new text begin (2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
and validity of laboratory testing and procedures including, but not limited to, techniques
in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
new text end

new text begin (3) prepares gross specimens as defined by and under the direction of a
board-certified pathologist;
new text end

new text begin (4) establishes and implements protocols, quality assurance, and quality control
related to the following procedures: histochemical, immunohistochemical, electron
microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
hydrolysis, laser capturing, molecular techniques, and research; and
new text end

new text begin (5) participates in method selection, development, equipment selection and
maintenance, and activities related to the preanalytical and analytical phases of tissue
preparation.
new text end

new text begin Subd. 8. new text end

new text begin Histotechnologist. new text end

new text begin "Histotechnologist" means an individual who:
new text end

new text begin (1) prepares tissue specimens for microscopic examination;
new text end

new text begin (2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
and validity of laboratory testing and procedures including, but not limited to, techniques
in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
new text end

new text begin (3) prepares gross specimens as defined by and under the direction of a
board-certified anatomic pathologist;
new text end

new text begin (4) establishes and implements protocols, quality assurance, and quality control
related to the following procedures: histochemical, immunohistochemical, electron
microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
hydrolysis, laser capturing, molecular techniques, and research;
new text end

new text begin (5) establishes and implements new protocols and procedures dealing directly in
quality assessment, method development, and equipment selection and maintenance and
all activities related to preanalytical and analytical phases of tissue preparation; and
new text end

new text begin (6) may direct, supervise, consult, educate, and perform research functions.
new text end

new text begin Subd. 9. new text end

new text begin Independent medical judgment. new text end

new text begin In the laboratory, "independent medical
judgment" is exercised only by a pathologist or other licensed physician in the diagnosis
and treatment decisions related to clinical laboratory tests.
new text end

new text begin Subd. 10. new text end

new text begin Independent technical judgment. new text end

new text begin "Independent technical judgment"
means the performance or conduct of clinical laboratory tests and assumption of
responsibility for determination of the validity of clinical laboratory test results without
intervention by or under the supervision of another health care provider authorized by
law to assume responsibility for the conduct and validity of clinical laboratory tests.
The authorized exercise of independent technical judgment does not include or permit
the independent medical judgment in the diagnosis, treatment, or reporting of clinical
laboratory results or their interpretation to patients, except as authorized by a laboratory
director and according to CLIA.
new text end

new text begin Subd. 11. new text end

new text begin Medical laboratory or laboratory. new text end

new text begin "Medical laboratory" or "laboratory"
means any facility or office in Minnesota in which medical laboratory tests are performed.
new text end

new text begin Subd. 12. new text end

new text begin Medical laboratory scientist or generalist. new text end

new text begin "Medical laboratory
scientist" or "generalist" means an individual eligible for licensure under this chapter who:
new text end

new text begin (1) performs medical laboratory tests, including tests that require the exercise of
independent technical judgment;
new text end

new text begin (2) establishes and implements protocols, quality assessment, method development
and selection, equipment selection and maintenance, and all activities related to the
preanalytic, analytic, and postanalytic phases of laboratory testing; and
new text end

new text begin (3) may direct, supervise, consult, educate, and perform research functions.
new text end

new text begin Subd. 13. new text end

new text begin Medical laboratory specialist. new text end

new text begin "Medical laboratory specialist" means an
individual certified and eligible for licensure in one of the categories in subdivisions 14 to
16 to perform testing including the tests that require the exercise of independent technical
judgment needed to establish and implement protocols, quality assessment, method
development and selection, equipment selection and maintenance, and all activities related
to the preanalytic, analytic, and postanalytic phases of laboratory testing, and who direct,
supervise, consult, and educate in a specific specialized section of the laboratory.
new text end

new text begin Subd. 14. new text end

new text begin Medical laboratory specialist in cytogenetics. new text end

new text begin "Medical laboratory
specialist in cytogenetics" means an individual eligible for licensure under this chapter to
perform standard cytogenetic and molecular testing procedures used to evaluate possible
genetic anomalies.
new text end

new text begin Subd. 15. new text end

new text begin Medical laboratory specialist in molecular biology/pathology.
new text end

new text begin "Medical laboratory specialist in molecular biology/pathology" means an individual
eligible for licensure under this chapter to perform all aspects of molecular analysis
including, but not limited to, recombinant DNA technology, polymerase chain reaction,
and hybridization techniques.
new text end

new text begin Subd. 16. new text end

new text begin Medical laboratory specialist in histocompatibility. new text end

new text begin "Medical
laboratory specialist in histocompatibility" means an individual eligible for licensure
under this chapter to perform histocompatibility testing procedures including, but not
limited to, molecular and serological techniques.
new text end

new text begin Subd. 17. new text end

new text begin Medical laboratory technician. new text end

new text begin "Medical laboratory technician" means
an individual eligible for licensure under this chapter who performs medical laboratory
tests at all CLIA complexity levels according to established and approved protocols and
requiring limited exercise of independent judgment.
new text end

new text begin Subd. 18. new text end

new text begin Medical laboratory test or laboratory test. new text end

new text begin "Medical laboratory
test" or "laboratory test" means a microbiological, serological, chemical, biological,
hematological, immunological, immunohematological, radiobioassay, cytological,
histological preparation, molecular, biophysical, or any other test or procedure performed
on material derived from or existing in a human body, which provides information for
the diagnosis, prevention, or monitoring of a disease or impairment or assessment of a
medical condition. A medical laboratory test includes components of the preanalytic and
postanalytic phases of testing, as well as the analytic phase, which occurs in the laboratory.
new text end

new text begin Subd. 19. new text end

new text begin Medical laboratory subspecialists. new text end

new text begin "Medical laboratory subspecialists"
means an individual eligible for licensure under this chapter to perform the functions
of a medical laboratory scientist in a subspecialty or esoteric clinical laboratory that is
not one of the general categorical areas of the laboratory. The subspecialty/esoteric
laboratories may be disease or medical specialty-oriented or utilize advanced technology
not routinely used in the clinical laboratory. These subspecialty/esoteric laboratories may
be subspecialized areas within the hematology, chemistry, immunology, transfusion,
medicine, genetics, or microbiology disciplines.
new text end

new text begin Subd. 20. new text end

new text begin Nationally recognized certification agency. new text end

new text begin "Nationally recognized
certification agency" means an agency that provides certification examinations for medical
laboratory professionals. As the agency defines new certification examinations, the
commissioner and the advisory council will recognize these examinations.
new text end

new text begin Subd. 21. new text end

new text begin Pathologist's assistant. new text end

new text begin "Pathologist's assistant" means an individual
specializing in prediagnostic surgical pathology and autopsy pathology who assists
pathologists.
new text end

new text begin Subd. 22. new text end

new text begin Phlebotomist. new text end

new text begin "Phlebotomist" means an individual who is qualified to
obtain blood samples for testing by means of venipuncture, capillary puncture, or access
of venous access devices, to perform specimen processing and preparation of samples for
testing, and to perform waived and point-of-care testing.
new text end

new text begin Subd. 23. new text end

new text begin Point-of-care testing. new text end

new text begin "Point-of-care testing" means analytical patient
testing activities provided within a facility, which do not require permanent dedicated
space including, but not limited to, analytic instruments that are temporarily brought to a
patient care location. Point-of-care testing must be under the direction of an individual
licensed under this chapter at the baccalaureate degree level or who qualifies as a
laboratory director under federal CLIA regulations.
new text end

new text begin Subd. 24. new text end

new text begin Trainee/student. new text end

new text begin "Trainee/student" means an individual who has
not fulfilled the educational requirements to take an approved nationally recognized
certification examination or who needs to obtain full-time comprehensive experience
under supervision.
new text end

new text begin Subd. 25. new text end

new text begin Waived test. new text end

new text begin "Waived test" means a laboratory examination or procedure
as determined by the United States Food and Drug Administration which has an
insignificant risk of an erroneous result, including those which:
new text end

new text begin (1) have been approved by the United States Food and Drug Administration for
home use;
new text end

new text begin (2) employ methodologies that are so simple and accurate as to render the likelihood
of erroneous results negligible; or
new text end

new text begin (3) pose no reasonable risk of harm to the patient if performed incorrectly.
new text end

Sec. 2.

new text begin [148F.02] EXCEPTIONS.
new text end

new text begin (a) This chapter does not apply to:
new text end

new text begin (1) the qualifications for laboratory directors, technical supervisors, or technical
consultants as established by federal CLIA;
new text end

new text begin (2) other licensed or registered professionals performing functions within the
professional's scope of practice;
new text end

new text begin (3) medical laboratory science professionals employed by the United States
government, or any bureau, division, or agency, while performing duties within the scope
of the professional's federal employment;
new text end

new text begin (4) medical laboratory science professionals engaged exclusively in basic science or
investigative research, provided that the results of any examination performed are not used
in health maintenance, diagnosis, or treatment of disease as described in federal CLIA
regulations under Code of Federal Regulations, title 42, section 493;
new text end

new text begin (5) professionals engaged exclusively in assay development or management-related
activities in the clinical laboratory, provided the results of any examination performed
are not used in health maintenance, diagnosis, or treatment of disease as described in
federal CLIA regulations;
new text end

new text begin (6) professionals engaged exclusively in the education of medical laboratory science
professionals, provided that results of any examination performed are not used in health
maintenance, diagnosis, or treatment of disease as described in federal CLIA regulations;
new text end

new text begin (7) professionals engaged exclusively in providing phlebotomy services;
new text end

new text begin (8) pathologist's assistants or individuals performing pathology assistant activities
under supervision by pathologists;
new text end

new text begin (9) cytotechnologists, which fall under the federally mandated CLIA personnel
certification requirements;
new text end

new text begin (10) histotechnicians and histotechnologists;
new text end

new text begin (11) students or trainees enrolled in a medical laboratory science education program
provided that:
new text end

new text begin (i) the activities performed by the student or trainee constitute a part of a planned
course in the program;
new text end

new text begin (ii) the student or trainee is clearly designated as intern, trainee, or student; and
new text end

new text begin (iii) the student or trainee is working directly under an individual licensed under
this chapter to practice medical laboratory science or by a professional who is exempt
under this section;
new text end

new text begin (12) individuals who only perform waived tests or moderately complex point-of-care
tests under the direction of a qualified CLIA laboratory director according to federal
CLIA regulations; and
new text end

new text begin (13) individuals who perform moderately complex testing as defined by federal
CLIA regulations provided that the laboratory complies with the following requirements:
new text end

new text begin (i) within the laboratory, a licensed medical laboratory scientist or individual who
qualifies as a laboratory director under federal CLIA regulations is responsible for:
new text end

new text begin (A) designing, providing, and supervising the training programs for the testing
personnel;
new text end

new text begin (B) supervising and monitoring the quality assurance and quality control activities
of the testing site;
new text end

new text begin (C) assisting in the selection of technology;
new text end

new text begin (D) reviewing the results of proficiency testing and recommending corrective
action, if necessary; and
new text end

new text begin (E) monitoring the continued laboratory testing competency of the testing personnel;
new text end

new text begin (ii) documented personnel evaluation processes are in place, which ensure and
document the continued competency of the testing personnel; and
new text end

new text begin (iii) after the effective date of this chapter, the licensed medical laboratory scientist
or individual who qualifies as a laboratory director under CLIA regulations must ensure
that new employees have initial certification as a certified or registered medical assistant
or certified office laboratory technician by the American Medical Technologists (AMT),
the American Association of Medical Assistants (AAMS), or other national certification
agency recognized by the commissioner. Individuals employed as a medical assistant or
office laboratory technician on the effective date of this chapter will be grandfathered
in. Failure to comply with the requirements in this clause subjects the individual to the
requirements of this chapter and requires the individual to be licensed as required in
this chapter.
new text end

new text begin (b) This chapter does not apply to a declared emergency as defined in section 12.03,
that reduces laboratory capacity or increases testing demands, or other loss of critical
laboratory capacity. Practitioners who are not licensed in any state, but are certified by one
of the agencies recognized in this chapter or deemed competent by the affected laboratory
director may practice as needed in the emergency situation.
new text end

new text begin new text end

Sec. 3.

new text begin [148F.03] LICENSURE REQUIRED; TITLES USED, RESTRICTED,
AND ALLOWED.
new text end

new text begin Subdivision 1. new text end

new text begin Unlicensed practice prohibited. new text end

new text begin Effective January 1, 2013, no
individual shall perform a medical laboratory test unless the individual is licensed under
this chapter as a medical laboratory scientist, categorical medical laboratory scientist,
medical laboratory technician, medical laboratory specialist in cytogenetics, medical
laboratory specialist in molecular biology/pathology, or medical laboratory specialist in
histocompatability, medical laboratory subspecialist, or is exempt from licensure under
section 148F.02.
new text end

new text begin Subd. 2. new text end

new text begin Protected titles and restrictions on use. new text end

new text begin No individual shall use the phrase
medical laboratory scientist, categorical medical laboratory scientist, medical laboratory
technician, medical laboratory specialist in cytogenetics, medical laboratory specialist in
molecular biology/pathology, or medical laboratory specialist in histocompatability, or
medical laboratory subspecialist, or the initials MLS or MLT, alone or in combination
with any other words or initials to form an occupational title, or to indicate or imply that
the person is licensed as one of the professionals listed unless the individual is licensed
under this chapter.
new text end

new text begin Subd. 3. new text end

new text begin Persons licensed or certified in other states. new text end

new text begin An individual who
is licensed under this chapter and licensed or certified in another state may use the
designation licensed or certified with a protected title only if the state of licensure or
certification is clearly indicated.
new text end

Sec. 4.

new text begin [148F.035] SCOPE OF PRACTICE.
new text end

new text begin Medical laboratory professionals licensed under this chapter shall perform laboratory
tests and provide test results to physicians and patients upon request or upon physician
referral according to CLIA. The practice of medical laboratory science includes:
new text end

new text begin (1) the production of test data;
new text end

new text begin (2) monitoring the accuracy, precision, and utility of laboratory testing;
new text end

new text begin (3) analytical correlation and interpretation of test data; and
new text end

new text begin (4) designing, evaluating, and implementing new laboratory test methods.
new text end

new text begin The services provided by medical laboratory professionals must be consistent with good
practice and sound professional ethics.
new text end

Sec. 5.

new text begin [148F.04] DUTIES OF COMMISSIONER.
new text end

new text begin The commissioner, with the advice of the advisory council, shall:
new text end

new text begin (1) administer the procedures for this chapter, including, but not limited to, verifying
the qualifications and standards for education, experience, examinations, and continuing
education, as established by the certification agencies recognized in this chapter, and
other methods for determining whether an applicant or licensee is qualified, as specified
under this chapter;
new text end

new text begin (2) enforce standards for professional conduct found in the Code of Professional
Ethics;
new text end

new text begin (3) issue licenses to qualified individuals;
new text end

new text begin (4) collect and deposit fees as established under section 148F.16;
new text end

new text begin (5) on the recommendation of the advisory council, approve future nationally
recognized, validated, competency-based written, oral, or practical examinations
developed by the American Society for Clinical Pathology Board of Certification,
American Medical Technologists, American Association of Bioanalysts, and American
Society for Histocompatibility and Immunogenetics, or successor organizations, for
purposes of licensure of medical laboratory science professionals as provided for in this
chapter; and
new text end

new text begin (6) maintain a roster of the names and addresses of individuals currently licensed
under this chapter and of all individuals whose licenses have been disciplined under
this chapter.
new text end

Sec. 6.

new text begin [148F.05] MEDICAL LABORATORY SCIENCE PROFESSIONAL
LICENSING ADVISORY COUNCIL.
new text end

new text begin Subdivision 1. new text end

new text begin Membership and qualifications of advisory council. new text end

new text begin (a) The
commissioner shall appoint a nine-member advisory council that may include applicants
recommended by laboratory professional associations. Members must be actively
employed for at least two years in their specific area of practice.
new text end

new text begin (b) Four members must be medical laboratory science professionals who are licensed
under this chapter and include:
new text end

new text begin (1) one nonphysician laboratory director;
new text end

new text begin (2) one medical laboratory scientist;
new text end

new text begin (3) one medical laboratory technician; and
new text end

new text begin (4) one specialist in cytogenetics, histocompatibility, or molecular biology.
new text end

new text begin (c) Three members must be physicians certified by the American Board of Pathology
or the American Board of Osteopathic Pathology. All three must be certified in clinical
pathology.
new text end

new text begin (d) One of the members must be a physician who is not a laboratory director and
is not a pathologist.
new text end

new text begin (e) One member must be a public member as defined in section 214.02.
new text end

new text begin Subd. 2. new text end

new text begin Duties. new text end

new text begin The advisory council shall:
new text end

new text begin (1) advise and make recommendations to the commissioner regarding the medical
laboratory science practitioner licensure standards;
new text end

new text begin (2) advise the commissioner on enforcement of this chapter;
new text end

new text begin (3) provide for distribution of information regarding medical laboratory science
practitioners licensure standards;
new text end

new text begin (4) review applications upon the request of the commissioner and make
recommendations on granting or denying licensure or licensure renewal;
new text end

new text begin (5) advise the commissioner on issues related to receiving and investigating
complaints, conducting objective hearings, and imposing disciplinary action in relation to
complaints received against medical laboratory science practitioners; and
new text end

new text begin (6) perform other duties requested by the commissioner.
new text end

new text begin Subd. 3. new text end

new text begin Organization. new text end

new text begin The advisory council shall be organized and administered
under section 15.059. The advisory council shall select a chair from its membership at
the first meeting of the advisory council.
new text end

new text begin Subd. 4. new text end

new text begin Support. new text end

new text begin The commissioner shall provide the necessary support staff
and meeting space for the advisory council.
new text end

Sec. 7.

new text begin [148F.06] TEMPORARY REQUIREMENTS FOR LICENSURE;
TRANSITION PERIOD.
new text end

new text begin Subdivision 1. new text end

new text begin Experienced medical laboratory science professionals transition.
new text end

new text begin (a) Notwithstanding section 148F.03, an individual who is certified by or eligible to be
certified by a certification agency recognized by the commissioner to perform medical
laboratory testing, or meets the subspecialty requirements in section 148F.07, subdivision
7, may perform medical laboratory tests without the appropriate license provided the
individual has applied to the commissioner for licensure and the application:
new text end

new text begin (1) has not been denied by the commissioner; or
new text end

new text begin (2) has not been withdrawn.
new text end

new text begin (b) This subdivision expires January 1, 2013.
new text end

new text begin Subd. 2. new text end

new text begin Employed medical laboratory science professional transition. new text end

new text begin (a) An
individual who does not meet the education, training, and experience qualifications for
any license described in this chapter on July 1, 2011, has until January 1, 2013, to be
licensed under this subdivision.
new text end

new text begin (b) The commissioner shall issue a license under this subdivision if the applicant:
new text end

new text begin (1) is practicing in the field on July 1, 2011, or has a minimum of 1,040 total hours
of employment experience in the three years immediately prior to July 1, 2011; and
new text end

new text begin (2) on a form provided by the commissioner submits the job, title, description of the
position, period of employment, and confirmation of competent practice as attested to by
the applicant's employer who must submit a signed statement verifying the applicant is
not subject to disciplinary action or past disciplinary action in employment, professional
association membership, or under any credentialing authority in any jurisdiction, and is
not disqualified on any basis under section 148F.14.
new text end

new text begin (c) The commissioner and advisory council shall determine which type of license the
applicant is eligible for and issue the license if the requirements of this subdivision are met.
new text end

new text begin (d) An initial license issued under this subdivision must be renewed following the
procedures required under section 148F.10, provided the license is maintained without
interruption.
new text end

new text begin (e) This subdivision expires January 1, 2012.
new text end

Sec. 8.

new text begin [148F.07] STANDARDS FOR LICENSURE.
new text end

new text begin Subdivision 1. new text end

new text begin Medical laboratory scientist (MLS). new text end

new text begin The commissioner shall issue
a medical laboratory scientist's license to an individual who meets the criteria in clauses
(1) to (3), or (4):
new text end

new text begin (1) possesses a baccalaureate degree from a regionally accredited college or
university and verified by the nationally recognized certification agencies;
new text end

new text begin (2) has met the medical laboratory experience and training required by the
recognized certification agencies; and
new text end

new text begin (3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, American Society for
Clinical Pathology Board of Registry, National Credentialing Agency, American Medical
Technologists, American Association of Bioanalysts, or successor organizations; or
new text end

new text begin (4) has completed an official military training program of at least 50 weeks approved
by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or a
national accrediting agency acceptable to the commissioner and held the military enlisted
occupational specialty of medical laboratory specialist and possesses a baccalaureate
degree from an accredited college or university.
new text end

new text begin Subd. 2. new text end

new text begin Medical laboratory scientist, categorical. new text end

new text begin The board shall issue a
categorical medical laboratory scientist's license to an individual who:
new text end

new text begin (1) possesses a baccalaureate degree from a regionally accredited college or
university and verified by the nationally recognized certification agencies;
new text end

new text begin (2) has met the medical laboratory experience and training required by the
recognized certification agencies; and
new text end

new text begin (3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, American Society for
Clinical Pathology Board of Registry, National Credentialing Agency, American Medical
Technologists, American Association of Bioanalysts, or successor organizations.
new text end

new text begin Subd. 3. new text end

new text begin Medical laboratory technician (MLT). new text end

new text begin The commissioner shall issue a
medical laboratory technician's license to an individual who meets the criteria in clauses
(1) to (3) or (4):
new text end

new text begin (1) possesses an associate degree from a regionally accredited college or university
verified by the nationally recognized certification agencies;
new text end

new text begin (2) has met the medical laboratory experience and training required by the
recognized certification agencies; and
new text end

new text begin (3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, American Society for
Clinical Pathology Board of Registry, National Credentialing Agency, American Medical
Technologists, American Association of Bioanalysts, or successor organizations; or
new text end

new text begin (4) has completed an official military training program of at least 50 weeks approved
by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) or a
national accrediting agency acceptable to the commissioner and held the military enlisted
occupational specialty of medical laboratory specialist and possesses a baccalaureate
degree from an accredited college or university.
new text end

new text begin Subd. 4. new text end

new text begin Medical laboratory specialist in molecular biology. new text end

new text begin The commissioner
shall issue a medical laboratory specialist in molecular biology license to an individual
who:
new text end

new text begin (1) possesses a baccalaureate degree from a regionally accredited college or
university verified by the recognized certification agencies;
new text end

new text begin (2) meets the medical laboratory experience and training required by the nationally
recognized certification agencies, or alternatively one year of on-the-job training; and
new text end

new text begin (3) either passes a nationally recognized certification examination administered by
the American Society for Clinical Pathology Board of Certification, American Society
for Clinical Pathology Board of Registry, National Credentialing Agency, American
Association of Bioanalysts, or successor organizations.
new text end

new text begin Subd. 5. new text end

new text begin Medical laboratory specialist in cytogenetics. new text end

new text begin The commissioner shall
issue a medical laboratory specialist in cytogenetics license to an individual who:
new text end

new text begin (1) possesses a baccalaureate degree from a regionally accredited college or
university verified by the nationally recognized certification agencies;
new text end

new text begin (2) has met the medical laboratory experience and training required by the nationally
recognized certification agencies or alternatively one year of on-the-job training; and
new text end

new text begin (3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, National Credentialing
Agency, or successor organizations.
new text end

new text begin Subd. 6. new text end

new text begin Histocompatibility technologist. new text end

new text begin The commissioner shall issue a medical
laboratory specialist in histocompatibility license to an individual who:
new text end

new text begin (1) possesses a baccalaureate degree from a regionally accredited college or
university verified by the nationally recognized certification agencies;
new text end

new text begin (2) has met the medical laboratory experience and training required by the nationally
recognized certification agencies or alternatively one year of on-the-job training; and
new text end

new text begin (3) passes a nationally recognized certification examination administered by the
American Board of Histocompatibility and Immunogenetics.
new text end

new text begin Subd. 7. new text end

new text begin Medical laboratory subspecialist. new text end

new text begin The commissioner shall issue a
medical laboratory subspecialist license to an individual who:
new text end

new text begin (1) possesses a baccalaureate from a regionally accredited college or university
verified by the recognized certification agencies;
new text end

new text begin (2) has met the required medical laboratory experience and training through one
year of on-the-job training; and
new text end

new text begin (3) either is deemed competent via written confirmation by the respective laboratory
director or passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification or successor organizations.
new text end

Sec. 9.

new text begin [148F.08] RECIPROCITY.
new text end

new text begin Subdivision 1. new text end

new text begin Licensure. new text end

new text begin The commissioner may waive the licensure requirements
for an applicant who holds a valid license or its equivalent issued by another state
provided that the requirements under which that license or its equivalent was issued are
equivalent to or exceed the standards required by this chapter. Once the license is up
for renewal, the applicant shall be issued a Minnesota license upon meeting the license
renewal requirements in section 148F.11.
new text end

new text begin Subd. 2. new text end

new text begin Current credentials required. new text end

new text begin An applicant applying for licensure by
reciprocity must provide all necessary evidence to the commissioner that the applicant
holds a current and unrestricted license for the practice of medical laboratory science
in another jurisdiction that has requirements equivalent to or higher than the standards
required to be licensed as a medical laboratory professional in one of the categories
defined in this chapter.
new text end

new text begin Subd. 3. new text end

new text begin Verification of credentials required. new text end

new text begin An applicant for licensure under
this section must have maintained the appropriate and unrestricted credentials in each
jurisdiction during the last five years as demonstrated by submitting letters of verification
to the commissioner. Each letter must state the applicant's name, date of birth, credential
number, date of issuance, a statement regarding disciplinary actions, if any, taken against
the applicant, and the terms under which the credential was issued.
new text end

Sec. 10.

new text begin [148F.09] TEMPORARY LICENSE REQUIREMENTS.
new text end

new text begin (a) The commissioner may issue a temporary license to an applicant who:
new text end

new text begin (1) is eligible to sit for and registered to take a certification examination or has taken
the examination and is awaiting results;
new text end

new text begin (2) meets the educational requirements of the nationally recognized certification
agency and is seeking to qualify for the certification examination by completing the
required supervised medical laboratory experience; or
new text end

new text begin (3) meets the educational requirements for the position and is undergoing the
required on-the-job training necessary for a specialized clinical laboratory.
new text end

new text begin (b) A temporary license shall be issued for a 12-month period and may be renewed
for two additional 12-month periods at the discretion of the commissioner, in order to
allow the applicant to complete the required supervised medical laboratory experience or
retake a certification examination, or be deemed competent by the laboratory director.
new text end

new text begin (c) A temporary license expires 12 months after it is issued or on the date the
commissioner issues or denies a permanent license to the holder.
new text end

new text begin (d) A temporary license authorizes the holder to perform medical laboratory tests
only in the area of practice for which the individual seeks to be permanently licensed.
new text end

Sec. 11.

new text begin [148F.10] LICENSURE APPLICATION PROCEDURES.
new text end

new text begin (a) Applicants must submit an application for licensure to the commissioner upon
the forms prescribed and furnished by the commissioner, and must submit with the
application the designated application fee as specified in section 148F.16.
new text end

new text begin (b) Upon receipt of the application and the application fee, the commissioner shall
issue a license for a medical laboratory scientist, a medical laboratory technician, or
an appropriate specialty license to an individual who meets the qualifications specified
in this chapter.
new text end

new text begin (c) The commissioner shall approve, approve with conditions, or deny licensure. The
commissioner shall act on an application for licensure according to paragraphs (b) to (d).
new text end

new text begin (d) The commissioner shall determine if the applicant meets the requirements for
licensure. The commissioner, or the advisory council at the commissioner's request, may
investigate information provided by an applicant to determine whether the information
is accurate and complete.
new text end

new text begin (e) The commissioner shall notify an applicant of action taken on the application
and, if licensure is denied or approved with conditions, the grounds for the commissioner's
determination.
new text end

new text begin (f) An applicant denied licensure or granted licensure with conditions may make
a written request to the commissioner, within 30 days of the date of the commissioner's
determination, for reconsideration of the commissioner's determination. Individuals
requesting reconsideration may submit information which the applicant wants considered
in the reconsideration. After reconsideration of the commissioner's determination to deny
licensure or grant licensure with conditions, the commissioner shall determine whether
the original determination should be affirmed or modified. An applicant is allowed no
more than one request in any one biennial licensure period for reconsideration of the
commissioner's determination to deny licensure or approve licensure with conditions.
new text end

Sec. 12.

new text begin [148F.11] LICENSURE RENEWAL.
new text end

new text begin Subdivision 1. new text end

new text begin Renewal term. new text end

new text begin Licenses issued under this chapter must be renewed
every two years. The renewal term is the effective date of the initial license or renewed
license to the date of expiration of the license.
new text end

new text begin Subd. 2. new text end

new text begin Renewal applications. new text end

new text begin In order to renew a license, a licensee must submit:
new text end

new text begin (1) a completed and signed application for renewal on a form prescribed by the
commissioner;
new text end

new text begin (2) the applicable renewal fee as specified in section 148F.16; and
new text end

new text begin (3) documentation that the licensee has completed continuing education requirements
as prescribed by the recognized certification agencies or 12 hours annually of documented
continuing education.
new text end

Sec. 13.

new text begin [148F.12] LICENSURE FOLLOWING LAPSE OF LICENSURE
STATUS.
new text end

new text begin For an applicant whose licensure status has lapsed, the applicant must:
new text end

new text begin (1) apply for licensure renewal according to section 148F.11 and document
compliance with the continuing education requirements as prescribed by the nationally
recognized certification agency since the applicant's license lapsed; and
new text end

new text begin (2) fulfill the requirements of section 148F.07 and provide evidence of compliance
with the continuing education requirements as prescribed by one of the nationally
recognized certification agencies.
new text end

Sec. 14.

new text begin [148F.13] CONTINUING EDUCATION REQUIREMENTS.
new text end

new text begin Continuing education requirements shall be as described by the applicable
certification agencies recognized under this chapter.
new text end

Sec. 15.

new text begin [148F.14] INVESTIGATION PROCESS; GROUNDS FOR
DISCIPLINARY ACTION.
new text end

new text begin Subdivision 1. new text end

new text begin Disciplinary action. new text end

new text begin (a) The commissioner may impose disciplinary
action as described in paragraph (b) against an applicant or licensee whom the
commissioner, by a preponderance of the evidence, determines:
new text end

new text begin (1) has violated a statute, rule, or order that the commissioner issued or is empowered
to enforce;
new text end

new text begin (2) has been convicted of or pled guilty to a felony, gross misdemeanor, or
misdemeanor, an essential element of which is dishonesty, or of any crime which is
directly related to the practice of the profession;
new text end

new text begin (3) has made a misrepresentation for the purpose of obtaining licensure, either on
an application provided by the commissioner or in response to oral or written questions
from the commissioner;
new text end

new text begin (4) violated the code of professional conduct in subdivisions 2 to 4;
new text end

new text begin (5) engaged in dishonorable, unethical, or unprofessional conduct of a character
likely to deceive, defraud, or harm the public;
new text end

new text begin (6) failed to perform services with reasonable judgment, skill, or safety due to the
use of alcohol, drugs, or other physical or mental impairment;
new text end

new text begin (7) aided or assisted another person in violating any provision of this chapter or
any applicable rules;
new text end

new text begin (8) made any misrepresentation with regard to the existence or category of license or
other certification or professional qualification held in connection with any employment
application;
new text end

new text begin (9) intentionally submitted false or misleading information in response to a written
request by the commissioner or advisory council;
new text end

new text begin (10) failed, within 30 days, to provide information in response to a written request
by the commissioner or advisory council;
new text end

new text begin (11) performed services for which the license is issued in an incompetent manner or
in a manner that falls below community standards;
new text end

new text begin (12) violated any provision of this chapter;
new text end

new text begin (13) been convicted of violating any state or federal law, rule, or regulation that
directly relates to the practice related to the discipline for which the individual is licensed;
new text end

new text begin (14) violated a federal or state court order, including a conciliation court judgment,
or a disciplinary order issued by the commissioner, related to the individual's practice for
which they are licensed under this chapter;
new text end

new text begin (15) aided or abetted another person in violating any provision of this chapter;
new text end

new text begin (16) been disciplined for conduct in the practice of an occupation by the state of
Minnesota, another jurisdiction, or a national professional association, if any of the
grounds are the same or substantially equivalent to those in this chapter;
new text end

new text begin (17) not cooperated with the commissioner or the advisory council in an investigation
conducted according to this paragraph;
new text end

new text begin (18) engaged in conduct with a patient that is sexual or may reasonably be
interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
demeaning to a patient; or
new text end

new text begin (19) any other just cause related to the practice for which they are licensed under
this chapter.
new text end

new text begin (b) If grounds for disciplinary action exist under paragraph (a), the commissioner
may take one or more of the following actions:
new text end

new text begin (1) refuse to grant or renew a license;
new text end

new text begin (2) revoke a license;
new text end

new text begin (3) suspend a license;
new text end

new text begin (4) impose limitations or conditions on a license, including, but not limited to,
practice under supervision, continued practice on the demonstration of knowledge or skill
by appropriate examination or other review of knowledge, skill, and competence;
new text end

new text begin (5) censure or reprimand the licensee;
new text end

new text begin (6) impose a civil penalty not exceeding $10,000 for each separate violation,
the amount of the civil penalty to be fixed so as to deprive the applicant or licensee
of any economic advantage gained by reason of the violation charged, to discourage
similar violations, or to reimburse the commissioner for the cost of the investigation and
proceeding including, but not limited to, fees paid for services provided by the Office of
Administrative Hearings, legal and investigative services provided by the Office of the
Attorney General, court reporters, witnesses, reproduction of records, advisory council
members per diem compensation, staff time, and travel costs and expenses incurred by
staff and advisory council members; or
new text end

new text begin (7) any reasonable lesser action including, but not limited to, censure, reprimand, or
restriction on licensure, or any action authorized by statute.
new text end

new text begin (c) Upon notice from the commissioner denying licensure renewal or upon notice
that disciplinary actions have been imposed and the person is no longer entitled to provide
the services for which the person was previously licensed under this chapter, the person
shall cease to provide the services under this chapter, to use the protected titles pursuant to
this chapter, and to represent to the public that the person is licensed by the commissioner.
new text end

new text begin (d) A person who has had licensure suspended may request and provide justification
for reinstatement following the period of suspension specified by the commissioner. The
requirement of this chapter for renewing licensure and any other conditions imposed with
the suspension must be met before licensure may be reinstated.
new text end

new text begin (e) The commissioner shall contract with the health professional services program as
authorized by sections 214.31 to 214.37 to provide these services to practitioners under
this chapter. The health professional services program does not affect the commissioner's
authority to discipline violations of this chapter.
new text end

new text begin Subd. 2. new text end

new text begin Duty to patient. new text end

new text begin Medical laboratory professionals shall:
new text end

new text begin (1) be accountable for the quality and integrity of the laboratory services they
provide;
new text end

new text begin (2) maintain high standards of practice and sound judgment in establishing,
performing, and evaluating laboratory testing; and
new text end

new text begin (3) safeguard the dignity and privacy of patients and provide accurate information to
other health care professionals about the services they provide.
new text end

new text begin Subd. 3. new text end

new text begin Duty to colleagues and profession. new text end

new text begin Medical laboratory professionals shall:
new text end

new text begin (1) uphold and maintain the dignity and respect of the profession and strive to
maintain a reputation of honesty, integrity, and reliability; and
new text end

new text begin (2) actively strive to establish cooperative and respectful working relationships with
other health care professionals with the primary objective of ensuring a high standard of
care for the patients they serve.
new text end

Sec. 16.

new text begin [148F.15] REPORTING OBLIGATIONS.
new text end

new text begin Subdivision 1. new text end

new text begin Permission to report. new text end

new text begin A person who has knowledge of any conduct
constituting grounds for disciplinary action under this chapter may report the violation to
the commissioner.
new text end

new text begin Subd. 2. new text end

new text begin Institutions. new text end

new text begin A state agency, political subdivision, agency of a local unit
of government, private agency, hospital, clinic, prepaid medical plan, or other health
care institution or organization located in this state shall report to the commissioner any
action taken by the agency, institution, or organization or any of its administrators or
medical or other committees to revoke, suspend, restrict, or condition a medical laboratory
professional's privilege to practice in the institution, or as part of the organization, any
denial of privileges, or any other disciplinary action for conduct that might constitute
grounds for disciplinary action by the commissioner under this chapter. The institution,
organization, or governmental entity shall also report the resignation of any medical
laboratory science professional before the conclusion of any disciplinary action proceeding
for conduct that might constitute grounds for disciplinary action under this chapter, or
before the commencement of formal charges but after the practitioner had knowledge that
formal charges were contemplated or were being prepared.
new text end

new text begin Subd. 3. new text end

new text begin Professional societies. new text end

new text begin A state or local professional society for medical
laboratory science professionals shall report to the commissioner any termination,
revocation, or suspension of membership or any other disciplinary action taken against a
medical laboratory science professional. If the society has received a complaint that might
be grounds for discipline under this chapter against a member on which it has not taken
any disciplinary action, the society shall report the complaint and the reason why it has not
taken action on it or shall direct the complainant to the commissioner.
new text end

new text begin Subd. 4. new text end

new text begin Licensed professionals. new text end

new text begin A licensed health professional shall report to the
commissioner personal knowledge of any conduct that the licensed health professional
reasonably believes constitutes grounds for disciplinary action under this chapter by a
medical laboratory science professional, including conduct indicating that the individual
may be medically incompetent, or may be medically or physically unable to engage safely
in the provision of services. If the information was obtained in the course of a client
relationship, the client is a medical laboratory science professional, and the treating
individual successfully counsels the medical laboratory science professional to limit or
withdraw from practice to the extent required by the impairment, the commissioner may
deem this limitation of or withdrawal from practice to be sufficient disciplinary action.
new text end

new text begin Subd. 5. new text end

new text begin Self-reporting. new text end

new text begin A medical laboratory science professional shall report
to the commissioner any personal action that would require that a report be filed with
the commissioner by any person, health care facility, business, or organization under
subdivisions 2 to 4. The medical laboratory science professional shall also report the
revocation, suspension, restriction, limitation, or other disciplinary action in this state
and report the filing of charges regarding the practitioner's license or right of practice
in another state or jurisdiction.
new text end

new text begin Subd. 6. new text end

new text begin Deadlines; forms. new text end

new text begin Reports required by subdivisions 2 to 5 must be
submitted no later than 30 days after the reporter learns of the occurrence of the reportable
event or transaction. The commissioner may provide forms for the submission of required
reports, may require that reports be submitted on the forms provided, and may adopt rules
necessary to ensure prompt and accurate reporting.
new text end

new text begin Subd. 7. new text end

new text begin Immunity for reporting. new text end

new text begin A person, health care facility, business, or
organization is immune from civil liability or criminal prosecution for reporting to
the commissioner violations or alleged violations of this chapter. All such reports are
classified under section 13.41.
new text end

new text begin Subd. 8. new text end

new text begin Immunity for investigation. new text end

new text begin The commissioner, employees of the
Minnesota Department of Health, consultants to the department, and advisory council
members are immune from civil liability and criminal prosecution for any actions,
transactions, or publications in the execution of, or relating to, their duties under this
chapter.
new text end

Sec. 17.

new text begin [148F.16] FEES.
new text end

new text begin Subdivision 1. new text end

new text begin Initial licensure fee. new text end

new text begin The initial licensure fee for medical laboratory
scientist, categorical medical laboratory scientist, medical laboratory specialist in
molecular biology, medical laboratory specialist in cytogenetics, histocompatibility
technologist, other specialists and categoricals, and medical laboratory technicians is
$....... The commissioner shall prorate fees based on the number of quarters remaining
in the biennial licensure period.
new text end

new text begin Subd. 2. new text end

new text begin Licensure renewal fee. new text end

new text begin The biennial licensure renewal fee for medical
laboratory scientist, categorical medical laboratory scientist, medical laboratory
specialist in molecular biology, pathology, medical laboratory specialist in cytogenetics,
histocompatibility technologist, other specialists and categoricals, and medical laboratory
technicians is $.......
new text end

new text begin Subd. 3. new text end

new text begin Late fee. new text end

new text begin The fee for late submission of a renewal application is $45.
new text end

new text begin Subd. 4. new text end

new text begin Temporary licensure fee. new text end

new text begin The fee for temporary licensure is $50.
new text end

new text begin Subd. 5. new text end

new text begin Verification to other states. new text end

new text begin The fee for verification of licensure to other
states is $25.
new text end

new text begin Subd. 6. new text end

new text begin Verification to institutions. new text end

new text begin The fee for verification of licensure to
institutions is $10.
new text end

new text begin Subd. 7. new text end

new text begin Nonrefundable fees. new text end

new text begin All fees are nonrefundable.
new text end

new text begin Subd. 8. new text end

new text begin Penalty fees. new text end

new text begin (a) The penalty fee for practicing medical laboratory science
without a current license after the credential has expired and before it is renewed is the
amount of the license renewal fee for any part of the first month, plus the license renewal
fee for any part of any subsequent month up to 36 months.
new text end

new text begin (b) The penalty fee for applicants who engage in the unauthorized practice of
medical laboratory science before being issued a license is the amount of the license
application fee for any part of the first month, plus the license application fee for any part
of any subsequent month up to 36 months. This paragraph does not apply to applicants not
qualifying for a license who engage in the unauthorized practice of medical laboratory
science.
new text end

new text begin (c) The penalty fee for failing to submit a continuing education report by the due
date with the correct number or type of hours in the correct time period is $50. The
licensee must obtain the missing number of continuing education hours by the next
reporting due date.
new text end

new text begin (d) Civil penalties and discipline incurred by licensees prior to January 1, 2013, for
conduct described in paragraph (a), (b), or (c), shall be recorded as nondisciplinary penalty
fees. For conduct described in paragraph (a) or (b) occurring after January 1, 2013, and
exceeding six months, payment of a penalty fee does not preclude any disciplinary action
reasonably justified by the individual case.
new text end

Sec. 18. new text beginADVISORY COUNCIL; DEADLINES.
new text end

new text begin The commissioner of health shall complete the first appointments under Minnesota
Statutes, section 148F.05, by September 1, 2011. The commissioner's designee shall
convene the first meeting of the council by October 1, 2011. The council must elect its
chair at its first meeting.
new text end

Sec. 19. new text beginEFFECTIVE DATE.
new text end

new text begin Setup of licensing functions and creation of the advisory council shall be effective
July 1, 2011. Licensure shall be effective January 1, 2013.
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