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SF 133

as introduced - 88th Legislature (2013 - 2014) Posted on 03/07/2014 02:45pm

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

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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;
providing penalties; establishing fees; appropriating money;proposing coding
for new law as Minnesota Statutes, chapter 148G.

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

Section 1.

[148G.01] DEFINITIONS.

Subdivision 1.

Applicability.

For purposes of this chapter, the following terms
have the meanings given them.

Subd. 2.

Accredited medical laboratory educational program.

"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.

Subd. 3.

Categorical medical laboratory scientist.

"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.

Subd. 4.

CLIA.

"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.

Subd. 5.

Commissioner.

"Commissioner" means the commissioner of health or the
commissioner's designee.

Subd. 6.

Cytotechnologist.

"Cytotechnologist" means an individual who
specializes in the cellular analysis of patient samples from all body sites, for the purpose
of evaluating, detecting, and identifying potential disease processes through the exercise
of independent technical judgment, under the supervision, control, and responsibility of
the laboratory director, and who:

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

(2) performs a variety of medical laboratory tests that may include the use of
molecular techniques with approval and oversight of a medical director, to ascertain
information to help in classification of a specimen consistent with the scope of work
provided under the Clinical Laboratory Improvement Amendments of 1988;

(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

(4) directs, supervises, consults, educates, and performs research functions.

Subd. 7.

Histotechnician.

"Histotechnician" means an individual who, with the
approval, supervision, and control of a board-certified anatomic pathologist, may perform
the following functions:

(1) prepares tissue specimens for microscopic examination;

(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;

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

(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

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

Subd. 8.

Histotechnologist.

"Histotechnologist" means an individual who, with
the approval, supervision, and control of a board-certified anatomic pathologist, may
perform the following functions:

(1) prepares tissue specimens for microscopic examination;

(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;

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

(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;

(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

(6) directs, supervises, consults, educates, and performs research functions.

Subd. 9.

Independent medical judgment.

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.

Subd. 10.

Independent technical judgment.

"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. The authorized
exercise of independent technical judgment shall not be deemed to include or permit the
exercise of independent medical judgment in the diagnosis or treatment of, or reporting of
clinical laboratory test results or their interpretation to patients, except as authorized by a
laboratory director and according to CLIA.

Subd. 11.

Medical laboratory or laboratory.

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

Subd. 12.

Medical laboratory scientist or generalist.

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

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

(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

(3) directs, supervises, consults, educates, and performs research functions.

Subd. 13.

Medical laboratory specialist.

"Medical laboratory specialist" means
an individual certified and eligible for licensure in one of the categories described in
subdivisions 14, 15, and 16, to perform testing, including 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.

Subd. 14.

Medical laboratory specialist in cytogenetics.

"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.

Subd. 15.

Medical laboratory specialist in molecular biology/pathology.

"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.

Subd. 16.

Medical laboratory specialist in histocompatability.

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

Subd. 17.

Medical laboratory technician.

"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.

Subd. 18.

Medical laboratory test or laboratory test.

"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, that 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, that occurs in the laboratory.

Subd. 19.

Medical laboratory subspecialists.

"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.

Subd. 20.

Nationally recognized certification agency.

"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.

Subd. 21.

Pathologist's assistant.

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

Subd. 22.

Phlebotomist.

"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.

Subd. 23.

Point-of-care testing.

"Point-of-care testing" means analytical patient
testing activities provided within a facility that 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.

Subd. 24.

Trainee/student.

"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.

Subd. 25.

Waived test.

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

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

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

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

Sec. 2.

[148G.02] EXCEPTIONS.

This chapter does not apply to:

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

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

(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;

(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;

(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;

(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;

(7) professionals engaged exclusively in providing phlebotomy services;

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

(9) students or trainees enrolled in a medical laboratory science education program
provided that:

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

(ii) the student or trainee is clearly designated as intern, trainee, or student; and

(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;

(10) 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

(11) individuals who perform moderately complex testing as defined by federal
CLIA regulations provided that the laboratory complies with the following requirements:

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

(A) designing, providing, and supervising the training programs for the testing
personnel;

(B) supervising and monitoring the quality assurance and quality control activities
of the testing site;

(C) assisting in the selection of technology;

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

(E) monitoring the continued laboratory testing competency of the testing personnel;

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

(iii) after July 1, 2013, 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) or
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 July 1, 2013, are not required to be certified. Failure
of a laboratory to comply with the requirements described in clause (11) subjects the
individual to the requirements of this chapter and requires the individual to be licensed as
required under this chapter.

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.

Sec. 3.

[148G.03] LICENSURE REQUIRED; TITLES USED, RESTRICTED,
AND ALLOWED.

Subdivision 1.

Unlicensed practice prohibited.

Effective January 1, 2015, 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, cytotechnologist, histotechnician, or
histotechnologist, or is exempt from licensure under section 148G.02.

Subd. 2.

Protected titles and restrictions on use.

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, cytotechnologist, histotechnician, or histotechnologist,
or the initials MLS, MLT, CT, HT, or HTL, 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.

Subd. 3.

Persons licensed or certified in other states.

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 (if other than Minnesota) is clearly indicated.

Sec. 4.

[148G.035] SCOPE OF PRACTICE.

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:

(1) the production of test data;

(2) monitoring the accuracy, precision, and utility of laboratory testing;

(3) analytical correlation and interpretation of test data;

(4) designing, evaluating, and implementing new laboratory test methods; and

(5) documenting and reporting test results.

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

Sec. 5.

[148G.04] DUTIES OF THE COMMISSIONER.

The commissioner, with the advice of the advisory council, shall:

(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;

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

(3) issue licenses to qualified individuals;

(4) collect and deposit fees as established under section 148G.16;

(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

(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.

Sec. 6.

[148G.05] MEDICAL LABORATORY SCIENCE PROFESSIONAL
LICENSING ADVISORY COUNCIL.

Subdivision 1.

Membership and qualifications of advisory council.

(a) The
commissioner shall appoint an 11-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.

(b) Six members must be medical laboratory science professionals who are licensed
under this chapter and include:

(1) one nonphysician laboratory director;

(2) one medical laboratory scientist;

(3) one medical laboratory technician;

(4) one specialist in cytogenetics, histocompatibility, or molecular biology;

(5) one cytotechnologist; and

(6) one histotechnician or histotechnologist.

(c) Three members must be physicians certified by the American Board of Pathology
or the American Board of Osteopathic Pathology. Two must be certified in clinical
pathology.

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

(e) One member must be a public member as defined in section 214.02.

Subd. 2.

Duties.

The advisory council shall:

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

(2) advise the commissioner on enforcement of this chapter;

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

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

(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

(6) perform other duties requested by the commissioner.

Subd. 3.

Organization.

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.

Subd. 4.

Support.

The commissioner shall provide the necessary staff support
and meeting space for the advisory council.

Sec. 7.

[148G.06] TEMPORARY REQUIREMENTS FOR LICENSURE;
TRANSITION PERIOD.

Subdivision 1.

Experienced medical laboratory science professionals transition.

(a) Notwithstanding section 148G.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 148G.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:

(1) has not been denied by the commissioner; or

(2) has not been withdrawn.

(b) This subdivision expires January 1, 2015.

Subd. 2.

Employed medical laboratory science professional transition.

(a) An
individual who does not meet the education, training, and experience qualifications for
any license described in this chapter on July 1, 2013, has until January 1, 2015, to be
licensed under this subdivision.

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

(1) is practicing in the field on July 1, 2013, or has six months of acceptable
experience of at least half time, 1,040 hours per year, in the three years immediately
prior to July 1, 2013; and

(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 by
the applicant's employer, who shall submit a signed statement stating that the applicant is
not the subject of a disciplinary action or past disciplinary action in their employment,
professional association membership, or under any credentialing authority in this or
another jurisdiction, and is not disqualified on the basis of section 148G.14.

(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.

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

(e) This subdivision expires January 1, 2014.

Sec. 8.

[148G.07] STANDARDS FOR LICENSURE.

Subdivision 1.

Medical laboratory scientist (MLS).

(a) The commissioner shall
issue a medical laboratory scientist's license to an individual who meets the following
requirements in paragraph (b):

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

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

(3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, American Medical
Technologists, American Association of Bioanalysts, or successor organizations.

(b) The commissioner shall issue a medical laboratory scientist's license to an
individual who has completed an official military training program of at least 50 weeks,
which was 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 a regionally accredited college or university.

Subd. 2.

Medical laboratory scientist, categorical.

The commissioner shall issue a
categorical medical laboratory scientist's license to an individual who:

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

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

(3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, American Medical
Technologists, American Association of Bioanalysts, or successor organizations.

Subd. 3.

Medical laboratory technician (MLT).

(a) The commissioner shall
issue a medical laboratory technician's license to an individual who meets the following
requirements in paragraph (b):

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

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

(3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, American Medical
Technologists, American Association of Bioanalysts, or successor organizations.

(b) The commissioner shall issue a medical laboratory technician's license to an
individual who has completed an official military training program of at least 50 weeks,
which was 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 an
associate degree from a regionally accredited college or university.

Subd. 4.

Medical laboratory specialist in molecular biology.

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

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

(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

(3) either passes a nationally recognized certification examination administered by
the American Society for Clinical Pathology Board of Certification, American Association
of Bioanalysts, or successor organizations.

Subd. 5.

Medical laboratory specialist in cytogenetics.

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

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

(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

(3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, or successor organizations.

Subd. 6.

Histocompatibility technologist.

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

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

(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

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

Subd. 7.

Medical laboratory subspecialist.

The commissioner shall issue a
medical laboratory subspecialist license to an individual who:

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

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

(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.

Subd. 8.

Cytotechnologist.

The commissioner shall issue a cytotechnologist license
to an individual who:

(1) possesses a baccalaureate degree from a regionally accredited college or
university required and verified by the recognized certification agencies;

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

(3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, or successor organizations.

Subd. 9.

Histotechnologist.

The commissioner shall issue a histotechnologist
license to an individual who:

(1) possesses a baccalaureate degree from a regionally accredited college or
university required and verified by the recognized certification agencies;

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

(3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, or successor organizations.

Subd. 10.

Histotechnician.

The commissioner shall issue a histotechnician license
to an individual who:

(1) possesses an associate degree from a regionally accredited college or university
required and verified by the recognized certification agencies;

(2) has medical laboratory experience and training required by the recognized
certification agencies; and

(3) passes a nationally recognized certification examination administered by the
American Society for Clinical Pathology Board of Certification, or successor organizations.

Sec. 9.

[148G.08] RECIPROCITY.

Subdivision 1.

Licensure.

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 148G.11.

Subd. 2.

Current credentials required.

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.

Subd. 3.

Verification of credentials required.

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.

Sec. 10.

[148G.09] TEMPORARY LICENSE REQUIREMENTS.

(a) The commissioner may issue a temporary license to an applicant who:

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

(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

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

(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.

(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.

(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.

Sec. 11.

[148G.10] LICENSURE APPLICATION PROCEDURES.

(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 148G.16.

(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.

(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).

(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.

(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.

(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 that 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.

Sec. 12.

[148G.11] LICENSURE RENEWAL.

Subdivision 1.

Renewal term.

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.

Subd. 2.

Renewal applications.

In order to renew a license, a licensee must submit:

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

(2) the applicable renewal fee as specified in section 148G.16; and

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

Sec. 13.

[148G.12] LICENSURE FOLLOWING LAPSE OF LICENSURE
STATUS.

For an applicant whose licensure status has lapsed, the applicant must:

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

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

Sec. 14.

[148G.13] CONTINUING EDUCATION REQUIREMENTS.

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

Sec. 15.

[148G.14] INVESTIGATION PROCESS; GROUNDS FOR
DISCIPLINARY ACTION.

Subdivision 1.

Disciplinary action.

(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 has:

(1) violated a statute, rule, or order that the commissioner issued or is empowered
to enforce;

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

(3) 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;

(4) violated the code of professional conduct in subdivisions 2 to 4;

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

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

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

(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;

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

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

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

(12) violated any provision of this chapter;

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

(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 the individual is licensed under this chapter;

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

(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;

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

(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

(19) engaged in any other behavior that gives rise to just cause for discipline related
to the practice for which they are licensed under this chapter.

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

(1) refuse to grant or renew a license;

(2) revoke a license;

(3) suspend a license;

(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;

(5) censure or reprimand the licensee;

(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

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

(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.

(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.

(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.

Subd. 2.

Duty to patient.

Medical laboratory professionals shall:

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

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

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

Subd. 3.

Duty to colleagues and profession.

Medical laboratory professionals shall:

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

(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.

Sec. 16.

[148G.15] REPORTING OBLIGATIONS.

Subdivision 1.

Permission to report.

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

Subd. 2.

Institutions.

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.

Subd. 3.

Professional societies.

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.

Subd. 4.

Licensed professionals.

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.

Subd. 5.

Self-reporting.

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.

Subd. 6.

Deadlines; forms.

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.

Subd. 7.

Immunity for reporting.

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.

Subd. 8.

Immunity for investigation.

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.

Sec. 17.

[148G.16] FEES.

Subdivision 1.

Initial licensure fee.

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
$155. The commissioner shall prorate fees based on the number of quarters remaining
in the biennial licensure period.

Subd. 2.

Licensure renewal fee.

The biennial licensure renewal 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 $115.

Subd. 3.

Late fee.

The fee for late submission of a renewal application is $45.

Subd. 4.

Temporary licensure fee.

The fee for temporary licensure is $50.

Subd. 5.

Verification to other states.

The fee for verification of licensure to other
states is $25.

Subd. 6.

Verification to institutions.

The fee for verification of licensure to
institutions is $10.

Subd. 7.

Nonrefundable fees.

All fees are nonrefundable.

Subd. 8.

Penalty fees.

(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.

(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.

(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.

(d) Civil penalties and discipline incurred by licensees prior to January 1, 2015, 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, 2015, and
exceeding six months, payment of a penalty fee does not preclude any disciplinary action
reasonably justified by the individual case.

Sec. 18. ADVISORY COUNCIL; DEADLINES.

The commissioner of health shall complete the first appointments required by
Minnesota Statutes, section 148G.05, no later than September 1, 2013. The commissioner's
designee shall convene the first meeting of the council no later than October 1, 2013.
The council must select its chair as required by Minnesota Statutes, section 148G.05, at
the first meeting of the council.

Sec. 19. APPROPRIATION.

$284,000 in fiscal year 2014 is appropriated from the state government special
revenue fund to the commissioner of health to implement this act. Base funding is
$488,000 in fiscal year 2015 and $376,000 in fiscal year 2016.

Sec. 20. EFFECTIVE DATE.

Sections 1 to 18 are effective July 1, 2013.

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700 State Office Building, 100 Rev. Dr. Martin Luther King Jr. Blvd., St. Paul, MN 55155 ♦ Phone: (651) 296-2868 ♦ TTY: 1-800-627-3529 ♦ Fax: (651) 296-0569