Bill Text: MN HF203 | 2013-2014 | 88th Legislature | Introduced
Bill Title: Medical laboratory science professional licensure established, Board of Medical Laboratory Science created, penalties and funding provided, fees established, and money appropriated.
Sponsorship: Slight Partisan Bill (Democrat 14-5)
Status: (Introduced - Dead) 2014-02-27 - Author added Gunther [HF203 Detail]
Download: Minnesota-2013-HF203-Introduced.html
1.2relating to health occupations; establishing licensure for medical laboratory
1.3science professionals; creating the Board of Medical Laboratory Science;
1.4providing penalties; establishing fees; appropriating money;proposing coding
1.5for new law as Minnesota Statutes, chapter 148G.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. [148G.01] DEFINITIONS.
1.8 Subdivision 1. Applicability. For purposes of this chapter, the following terms
1.9have the meanings given them.
1.10 Subd. 2. Accredited medical laboratory educational program. "Accredited
1.11medical laboratory educational program" means a program to provide instruction and
1.12experience in medical laboratory science that has been accredited by an accrediting agency
1.13recognized by the United States Department of Health and Human Services.
1.14 Subd. 3. Categorical medical laboratory scientist. "Categorical medical
1.15laboratory scientist" means an individual eligible for licensure under this chapter who
1.16performs the functions of a medical laboratory scientist in one or more of the following
1.17areas of the laboratory depending upon the certification examinations passed: chemistry,
1.18hematology, immunohematology, and microbiology.
1.19 Subd. 4. CLIA. "CLIA" means Clinical Laboratory Improvement Amendments of
1.201988 and includes Public Law 10-578 and Code of Federal Regulations, title 42, section
1.21493. CLIA regulations provide a minimum foundation upon which personnel standards
1.22for entry level technical personnel in this state are built. Qualifications and responsibilities
1.23for laboratory director, technical supervisor, and technical consultant are as specified in
1.24CLIA regulations. All medical laboratory personnel are under the supervision, control,
1.25and responsibility of the laboratory director.
2.1 Subd. 5. Commissioner. "Commissioner" means the commissioner of health or the
2.2commissioner's designee.
2.3 Subd. 6. Cytotechnologist. "Cytotechnologist" means an individual who
2.4specializes in the cellular analysis of patient samples from all body sites, for the purpose
2.5of evaluating, detecting, and identifying potential disease processes through the exercise
2.6of independent technical judgment, under the supervision, control, and responsibility of
2.7the laboratory director, and who:
2.8(1) assists health care providers with the collection, detection, and identification
2.9of normal and abnormal cells, infectious agents, and other noncellular material from
2.10submitted specimens;
2.11(2) performs a variety of medical laboratory tests that may include the use of
2.12molecular techniques with approval and oversight of a medical director, to ascertain
2.13information to help in classification of a specimen consistent with the scope of work
2.14provided under the Clinical Laboratory Improvement Amendments of 1988;
2.15(3) establishes and implements protocols, quality control, method selection,
2.16equipment selection and maintenance, and activities related to the preanalytic, analytic,
2.17and postanalytic phases of testing; and
2.18(4) directs, supervises, consults, educates, and performs research functions.
2.19 Subd. 7. Histotechnician. "Histotechnician" means an individual who, with the
2.20approval, supervision, and control of a board-certified anatomic pathologist, may perform
2.21the following functions:
2.22(1) prepares tissue specimens for microscopic examination;
2.23(2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
2.24and validity of laboratory testing and procedures, including, but not limited to, techniques
2.25in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
2.26(3) prepares gross specimens as defined by and under the direction of a
2.27board-certified anatomic pathologist;
2.28(4) establishes and implements protocols, quality assurance, and quality control
2.29related to the following procedures: histochemical, immunohistochemical, electron
2.30microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
2.31hydrolysis, laser capturing, molecular techniques, and research; and
2.32(5) participates in method selection, development, equipment selection and
2.33maintenance, and activities related to the preanalytical and analytical phases of tissue
2.34preparation.
3.1 Subd. 8. Histotechnologist. "Histotechnologist" means an individual who, with
3.2the approval, supervision, and control of a board-certified anatomic pathologist, may
3.3perform the following functions:
3.4(1) prepares tissue specimens for microscopic examination;
3.5(2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
3.6and validity of laboratory testing and procedures including, but not limited to, techniques
3.7in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
3.8(3) prepares gross specimens as defined by and under the direction of a
3.9board-certified anatomic pathologist;
3.10(4) establishes and implements protocols, quality assurance, and quality control
3.11related to the following procedures: histochemical, immunohistochemical, electron
3.12microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
3.13hydrolysis, laser capturing, molecular techniques, and research;
3.14(5) establishes and implements new protocols and procedures dealing directly in
3.15quality assessment, method development, and equipment selection and maintenance and
3.16all activities related to preanalytical and analytical phases of tissue preparation; and
3.17(6) directs, supervises, consults, educates, and performs research functions.
3.18 Subd. 9. Independent medical judgment. In the laboratory, "independent medical
3.19judgment" is exercised only by a pathologist or other licensed physician in the diagnosis
3.20and treatment decisions related to clinical laboratory tests.
3.21 Subd. 10. Independent technical judgment. "Independent technical judgment"
3.22means the performance or conduct of clinical laboratory tests and assumption of
3.23responsibility for determination of the validity of clinical laboratory test. The authorized
3.24exercise of independent technical judgment shall not be deemed to include or permit the
3.25exercise of independent medical judgment in the diagnosis or treatment of, or reporting of
3.26clinical laboratory test results or their interpretation to patients, except as authorized by a
3.27laboratory director and according to CLIA.
3.28 Subd. 11. Medical laboratory or laboratory. "Medical laboratory" or "laboratory"
3.29means any facility or office in Minnesota in which medical laboratory tests are performed.
3.30 Subd. 12. Medical laboratory scientist or generalist. "Medical laboratory
3.31scientist" or "generalist" means an individual eligible for licensure under this chapter who:
3.32(1) performs medical laboratory tests, including tests that require the exercise of
3.33independent technical judgment;
3.34(2) establishes and implements protocols, quality assessment, method development
3.35and selection, equipment selection and maintenance, and all activities related to the
3.36preanalytic, analytic, and postanalytic phases of laboratory testing; and
4.1(3) directs, supervises, consults, educates, and performs research functions.
4.2 Subd. 13. Medical laboratory specialist. "Medical laboratory specialist" means
4.3an individual certified and eligible for licensure in one of the categories described in
4.4subdivisions 14, 15, and 16, to perform testing, including tests that require the exercise
4.5of independent technical judgment needed to establish and implement protocols, quality
4.6assessment, method development and selection, equipment selection and maintenance,
4.7and all activities related to the preanalytic, analytic, and postanalytic phases of laboratory
4.8testing, and who direct, supervise, consult, and educate in a specific specialized section of
4.9the laboratory.
4.10 Subd. 14. Medical laboratory specialist in cytogenetics. "Medical laboratory
4.11specialist in cytogenetics" means an individual eligible for licensure under this chapter to
4.12perform standard cytogenetic and molecular testing procedures used to evaluate possible
4.13genetic anomalies.
4.14 Subd. 15. Medical laboratory specialist in molecular biology/pathology.
4.15"Medical laboratory specialist in molecular biology/pathology" means an individual
4.16eligible for licensure under this chapter to perform all aspects of molecular analysis,
4.17including, but not limited to, recombinant DNA technology, polymerase chain reaction,
4.18and hybridization techniques.
4.19 Subd. 16. Medical laboratory specialist in histocompatability. "Medical
4.20laboratory specialist in histocompatability" means an individual eligible for licensure
4.21under this chapter to perform histocompatibility testing procedures, including, but not
4.22limited to, molecular and serological techniques.
4.23 Subd. 17. Medical laboratory technician. "Medical laboratory technician" means
4.24an individual eligible for licensure under this chapter who performs medical laboratory
4.25tests at all CLIA complexity levels according to established and approved protocols and
4.26requiring limited exercise of independent judgment.
4.27 Subd. 18. Medical laboratory test or laboratory test. "Medical laboratory
4.28test" or "laboratory test" means a microbiological, serological, chemical, biological,
4.29hematological, immunological, immunohematological, radiobioassay, cytological,
4.30histological preparation, molecular, biophysical, or any other test or procedure performed
4.31on material derived from or existing in a human body, that provides information for
4.32the diagnosis, prevention, or monitoring of a disease or impairment or assessment of a
4.33medical condition. A medical laboratory test includes components of the preanalytic and
4.34postanalytic phases of testing, as well as the analytic phase, that occurs in the laboratory.
4.35 Subd. 19. Medical laboratory subspecialists. "Medical laboratory subspecialists"
4.36means an individual eligible for licensure under this chapter to perform the functions
5.1of a medical laboratory scientist in a subspecialty or esoteric clinical laboratory that is
5.2not one of the general categorical areas of the laboratory. The subspecialty/esoteric
5.3laboratories may be disease or medical specialty-oriented or utilize advanced technology
5.4not routinely used in the clinical laboratory. These subspecialty/esoteric laboratories may
5.5be subspecialized areas within the hematology, chemistry, immunology, transfusion,
5.6medicine, genetics, or microbiology disciplines.
5.7 Subd. 20. Nationally recognized certification agency. "Nationally recognized
5.8certification agency" means an agency that provides certification examinations for medical
5.9laboratory professionals. As the agency defines new certification examinations, the
5.10commissioner and the advisory council will recognize these examinations.
5.11 Subd. 21. Pathologist's assistant. "Pathologist's assistant" means an individual
5.12specializing in prediagnostic surgical pathology and autopsy pathology who assists
5.13pathologists.
5.14 Subd. 22. Phlebotomist. "Phlebotomist" means an individual who is qualified to
5.15obtain blood samples for testing by means of venipuncture, capillary puncture, or access
5.16of venous access devices, to perform specimen processing and preparation of samples for
5.17testing, and to perform waived and point-of-care testing.
5.18 Subd. 23. Point-of-care testing. "Point-of-care testing" means analytical patient
5.19testing activities provided within a facility that do not require permanent dedicated space,
5.20including, but not limited to, analytic instruments that are temporarily brought to a patient
5.21care location. Point-of-care testing must be under the direction of an individual licensed
5.22under this chapter at the baccalaureate degree level or who qualifies as a laboratory
5.23director under federal CLIA regulations.
5.24 Subd. 24. Trainee/student. "Trainee/student" means an individual who has
5.25not fulfilled the educational requirements to take an approved nationally recognized
5.26certification examination or who needs to obtain full-time comprehensive experience
5.27under supervision.
5.28 Subd. 25. Waived test. "Waived test" means a laboratory examination or procedure
5.29as determined by the United States Food and Drug Administration that has an insignificant
5.30risk of an erroneous result, including those that:
5.31(1) have been approved by the United States Food and Drug Administration for
5.32home use;
5.33(2) employ methodologies that are so simple and accurate as to render the likelihood
5.34of erroneous results negligible; or
5.35(3) pose no reasonable risk of harm to the patient if performed incorrectly.
6.1 Sec. 2. [148G.02] EXCEPTIONS.
6.2This chapter does not apply to:
6.3(1) the qualifications as established by federal CLIA for laboratory directors,
6.4technical supervisors, or technical consultants;
6.5(2) other licensed or registered professionals performing functions within the
6.6professional's scope of practice;
6.7(3) medical laboratory science professionals employed by the United States
6.8government, or any bureau, division, or agency, while performing duties within the scope
6.9of the professional's federal employment;
6.10(4) medical laboratory science professionals engaged exclusively in basic science or
6.11investigative research, provided that the results of any examination performed are not used
6.12in health maintenance, diagnosis, or treatment of disease as described in federal CLIA
6.13regulations under Code of Federal Regulations, title 42, section 493;
6.14(5) professionals engaged exclusively in assay development or management-related
6.15activities in the clinical laboratory, provided the results of any examination performed
6.16are not used in health maintenance, diagnosis, or treatment of disease as described in
6.17federal CLIA regulations;
6.18(6) professionals engaged exclusively in the education of medical laboratory science
6.19professionals, provided that results of any examination performed are not used in health
6.20maintenance, diagnosis, or treatment of disease as described in federal CLIA regulations;
6.21(7) professionals engaged exclusively in providing phlebotomy services;
6.22(8) pathologist's assistants or individuals performing pathology assistant activities
6.23under supervision by pathologists;
6.24(9) students or trainees enrolled in a medical laboratory science education program
6.25provided that:
6.26(i) the activities performed by the student or trainee constitute a part of a planned
6.27course in the program;
6.28(ii) the student or trainee is clearly designated as intern, trainee, or student; and
6.29(iii) the student or trainee is working directly under an individual licensed under
6.30this chapter to practice medical laboratory science or by a professional who is exempt
6.31under this section;
6.32(10) individuals who only perform waived tests or moderately complex point-of-care
6.33tests under the direction of a qualified CLIA laboratory director according to federal
6.34CLIA regulations; and
6.35(11) individuals who perform moderately complex testing as defined by federal
6.36CLIA regulations provided that the laboratory complies with the following requirements:
7.1(i) within the laboratory, a licensed medical laboratory scientist or individual who
7.2qualifies as a laboratory director under federal CLIA regulations is responsible for:
7.3(A) designing, providing, and supervising the training programs for the testing
7.4personnel;
7.5(B) supervising and monitoring the quality assurance and quality control activities
7.6of the testing site;
7.7(C) assisting in the selection of technology;
7.8(D) reviewing the results of proficiency testing and recommending corrective
7.9action, if necessary; and
7.10(E) monitoring the continued laboratory testing competency of the testing personnel;
7.11(ii) documented personnel evaluation processes are in place, which ensure and
7.12document the continued competency of the testing personnel; and
7.13(iii) after July 1, 2013, the licensed medical laboratory scientist or individual
7.14who qualifies as a laboratory director under CLIA regulations must ensure that new
7.15employees have initial certification as a certified or registered medical assistant or
7.16certified office laboratory technician by the American Medical Technologists (AMT) or
7.17the American Association of Medical Assistants (AAMS) or other national certification
7.18agency recognized by the commissioner. Individuals employed as a medical assistant
7.19or office laboratory technician on July 1, 2013, are not required to be certified. Failure
7.20of a laboratory to comply with the requirements described in clause (11) subjects the
7.21individual to the requirements of this chapter and requires the individual to be licensed as
7.22required under this chapter.
7.23This chapter does not apply to a declared emergency as defined in section 12.03
7.24that reduces laboratory capacity or increases testing demands, or other loss of critical
7.25laboratory capacity. Practitioners who are not licensed in any state, but are certified by one
7.26of the agencies recognized in this chapter or deemed competent by the affected laboratory
7.27director, may practice as needed in the emergency situation.
7.28 Sec. 3. [148G.03] LICENSURE REQUIRED; TITLES USED, RESTRICTED,
7.29AND ALLOWED.
7.30 Subdivision 1. Unlicensed practice prohibited. Effective January 1, 2015, no
7.31individual shall perform a medical laboratory test unless the individual is licensed under
7.32this chapter as a medical laboratory scientist, categorical medical laboratory scientist,
7.33medical laboratory technician, medical laboratory specialist in cytogenetics, medical
7.34laboratory specialist in molecular biology/pathology, or medical laboratory specialist in
8.1histocompatability, medical laboratory subspecialist, cytotechnologist, histotechnician, or
8.2histotechnologist, or is exempt from licensure under section 148G.02.
8.3 Subd. 2. Protected titles and restrictions on use. No individual shall use the phrase
8.4medical laboratory scientist, categorical medical laboratory scientist, medical laboratory
8.5technician, medical laboratory specialist in cytogenetics, medical laboratory specialist in
8.6molecular biology/pathology, or medical laboratory specialist in histocompatability, or
8.7medical laboratory subspecialist, cytotechnologist, histotechnician, or histotechnologist,
8.8or the initials MLS, MLT, CT, HT, or HTL, alone or in combination with any other words
8.9or initials to form an occupational title, or to indicate or imply that the person is licensed
8.10as one of the professionals listed, unless the individual is licensed under this chapter.
8.11 Subd. 3. Persons licensed or certified in other states. An individual who
8.12is licensed under this chapter and licensed or certified in another state may use the
8.13designation licensed or certified with a protected title only if the state of licensure or
8.14certification (if other than Minnesota) is clearly indicated.
8.15 Sec. 4. [148G.035] SCOPE OF PRACTICE.
8.16Medical laboratory professionals licensed under this chapter shall perform laboratory
8.17tests and provide test results to physicians and patients upon request or upon physician
8.18referral according to CLIA. The practice of medical laboratory science includes:
8.19(1) the production of test data;
8.20(2) monitoring the accuracy, precision, and utility of laboratory testing;
8.21(3) analytical correlation and interpretation of test data;
8.22(4) designing, evaluating, and implementing new laboratory test methods; and
8.23(5) documenting and reporting test results.
8.24The services provided by medical laboratory professionals must be consistent with good
8.25practice and sound professional ethics.
8.26 Sec. 5. [148G.04] DUTIES OF THE COMMISSIONER.
8.27The commissioner, with the advice of the advisory council, shall:
8.28(1) administer the procedures for this chapter, including, but not limited to, verifying
8.29the qualifications and standards for education, experience, examinations, and continuing
8.30education, as established by the certification agencies recognized in this chapter, and
8.31other methods for determining whether an applicant or licensee is qualified, as specified
8.32under this chapter;
8.33(2) enforce standards for professional conduct found in the Code of Professional
8.34Ethics;
9.1(3) issue licenses to qualified individuals;
9.2(4) collect and deposit fees as established under section 148G.16;
9.3(5) on the recommendation of the advisory council, approve future nationally
9.4recognized, validated, competency-based written, oral, or practical examinations developed
9.5by the American Society for Clinical Pathology Board of Certification, American
9.6Medical Technologists, American Association of Bioanalysts, and American Society for
9.7Histocompatibility and Immunogenetics, or successor organizations, for purposes of
9.8licensure of medical laboratory science professionals as provided for in this chapter; and
9.9(6) maintain a roster of the names and addresses of individuals currently licensed
9.10under this chapter and of all individuals whose licenses have been disciplined under
9.11this chapter.
9.12 Sec. 6. [148G.05] MEDICAL LABORATORY SCIENCE PROFESSIONAL
9.13LICENSING ADVISORY COUNCIL.
9.14 Subdivision 1. Membership and qualifications of advisory council. (a) The
9.15commissioner shall appoint an 11-member advisory council that may include applicants
9.16recommended by laboratory professional associations. Members must be actively
9.17employed for at least two years in their specific area of practice.
9.18(b) Six members must be medical laboratory science professionals who are licensed
9.19under this chapter and include:
9.20(1) one nonphysician laboratory director;
9.21(2) one medical laboratory scientist;
9.22(3) one medical laboratory technician;
9.23(4) one specialist in cytogenetics, histocompatibility, or molecular biology;
9.24(5) one cytotechnologist; and
9.25(6) one histotechnician or histotechnologist.
9.26(c) Three members must be physicians certified by the American Board of Pathology
9.27or the American Board of Osteopathic Pathology. Two must be certified in clinical
9.28pathology.
9.29(d) One of the members must be a physician who is not a laboratory director and
9.30is not a pathologist.
9.31(e) One member must be a public member as defined in section 214.02.
9.32 Subd. 2. Duties. The advisory council shall:
9.33(1) advise and make recommendations to the commissioner regarding the medical
9.34laboratory science practitioner licensure standards;
9.35(2) advise the commissioner on enforcement of this chapter;
10.1(3) provide for distribution of information regarding medical laboratory science
10.2practitioners licensure standards;
10.3(4) review applications upon the request of the commissioner and make
10.4recommendations on granting or denying licensure or licensure renewal;
10.5(5) advise the commissioner on issues related to receiving and investigating
10.6complaints, conducting objective hearings, and imposing disciplinary action in relation to
10.7complaints received against medical laboratory science practitioners; and
10.8(6) perform other duties requested by the commissioner.
10.9 Subd. 3. Organization. The advisory council shall be organized and administered
10.10under section 15.059. The advisory council shall select a chair from its membership at
10.11the first meeting of the advisory council.
10.12 Subd. 4. Support. The commissioner shall provide the necessary staff support
10.13and meeting space for the advisory council.
10.14 Sec. 7. [148G.06] TEMPORARY REQUIREMENTS FOR LICENSURE;
10.15TRANSITION PERIOD.
10.16 Subdivision 1. Experienced medical laboratory science professionals transition.
10.17(a) Notwithstanding section 148G.03, an individual who is certified by or eligible to be
10.18certified by a certification agency recognized by the commissioner to perform medical
10.19laboratory testing, or meets the subspecialty requirements in section 148G.07, subdivision
10.207, may perform medical laboratory tests without the appropriate license provided the
10.21individual has applied to the commissioner for licensure and the application:
10.22(1) has not been denied by the commissioner; or
10.23(2) has not been withdrawn.
10.24(b) This subdivision expires January 1, 2015.
10.25 Subd. 2. Employed medical laboratory science professional transition. (a) An
10.26individual who does not meet the education, training, and experience qualifications for
10.27any license described in this chapter on July 1, 2013, has until January 1, 2015, to be
10.28licensed under this subdivision.
10.29(b) The commissioner shall issue a license under this subdivision if the applicant:
10.30(1) is practicing in the field on July 1, 2013, or has six months of acceptable
10.31experience of at least half time, 1,040 hours per year, in the three years immediately
10.32prior to July 1, 2013; and
10.33(2) on a form provided by the commissioner, submits the job, title, description of the
10.34position, period of employment, and confirmation of competent practice, as attested by
10.35the applicant's employer, who shall submit a signed statement stating that the applicant is
11.1not the subject of a disciplinary action or past disciplinary action in their employment,
11.2professional association membership, or under any credentialing authority in this or
11.3another jurisdiction, and is not disqualified on the basis of section 148G.14.
11.4(c) The commissioner and advisory council shall determine which type of license the
11.5applicant is eligible for and issue the license if the requirements of this subdivision are met.
11.6(d) An initial license issued under this subdivision must be renewed following the
11.7procedures required under section 148G.10, provided the license is maintained without
11.8interruption.
11.9(e) This subdivision expires January 1, 2014.
11.10 Sec. 8. [148G.07] STANDARDS FOR LICENSURE.
11.11 Subdivision 1. Medical laboratory scientist (MLS). (a) The commissioner shall
11.12issue a medical laboratory scientist's license to an individual who meets the following
11.13requirements in paragraph (b):
11.14(1) possesses a baccalaureate degree from a regionally accredited college or
11.15university and verified by the nationally recognized certification agencies;
11.16(2) has met the medical laboratory experience and training required by the
11.17recognized certification agencies; and
11.18(3) passes a nationally recognized certification examination administered by the
11.19American Society for Clinical Pathology Board of Certification, American Medical
11.20Technologists, American Association of Bioanalysts, or successor organizations.
11.21(b) The commissioner shall issue a medical laboratory scientist's license to an
11.22individual who has completed an official military training program of at least 50 weeks,
11.23which was approved by the National Accrediting Agency for Clinical Laboratory Sciences
11.24(NAACLS) or a national accrediting agency acceptable to the commissioner, and held the
11.25military enlisted occupational specialty of medical laboratory specialist and possesses a
11.26baccalaureate degree from a regionally accredited college or university.
11.27 Subd. 2. Medical laboratory scientist, categorical. The commissioner shall issue a
11.28categorical medical laboratory scientist's license to an individual who:
11.29(1) possesses a baccalaureate degree from a regionally accredited college or
11.30university and verified by the nationally recognized certification agencies;
11.31(2) has met the medical laboratory experience and training required by the
11.32recognized certification agencies; and
11.33(3) passes a nationally recognized certification examination administered by the
11.34American Society for Clinical Pathology Board of Certification, American Medical
11.35Technologists, American Association of Bioanalysts, or successor organizations.
12.1 Subd. 3. Medical laboratory technician (MLT). (a) The commissioner shall
12.2issue a medical laboratory technician's license to an individual who meets the following
12.3requirements in paragraph (b):
12.4(1) possesses an associate degree from a regionally accredited college or university
12.5verified by the nationally recognized certification agencies;
12.6(2) has met the medical laboratory experience and training required by the
12.7recognized certification agencies; and
12.8(3) passes a nationally recognized certification examination administered by the
12.9American Society for Clinical Pathology Board of Certification, American Medical
12.10Technologists, American Association of Bioanalysts, or successor organizations.
12.11(b) The commissioner shall issue a medical laboratory technician's license to an
12.12individual who has completed an official military training program of at least 50 weeks,
12.13which was approved by the National Accrediting Agency for Clinical Laboratory Sciences
12.14(NAACLS) or a national accrediting agency acceptable to the commissioner, and held the
12.15military enlisted occupational specialty of medical laboratory specialist and possesses an
12.16associate degree from a regionally accredited college or university.
12.17 Subd. 4. Medical laboratory specialist in molecular biology. The commissioner
12.18shall issue a medical laboratory specialist in molecular biology license to an individual who:
12.19(1) possesses a baccalaureate degree from a regionally accredited college or
12.20university verified by the recognized certification agencies;
12.21(2) meets the medical laboratory experience and training required by the nationally
12.22recognized certification agencies, or alternatively one year of on-the-job training; and
12.23(3) either passes a nationally recognized certification examination administered by
12.24the American Society for Clinical Pathology Board of Certification, American Association
12.25of Bioanalysts, or successor organizations.
12.26 Subd. 5. Medical laboratory specialist in cytogenetics. The commissioner shall
12.27issue a medical laboratory specialist in cytogenetics license to an individual who:
12.28(1) possesses a baccalaureate degree from a regionally accredited college or
12.29university verified by the nationally recognized certification agencies;
12.30(2) has met the medical laboratory experience and training required by the nationally
12.31recognized certification agencies or alternatively one year of on-the-job training; and
12.32(3) passes a nationally recognized certification examination administered by the
12.33American Society for Clinical Pathology Board of Certification, or successor organizations.
12.34 Subd. 6. Histocompatibility technologist. The commissioner shall issue a medical
12.35laboratory specialist in histocompatibility license to an individual who:
13.1(1) possesses a baccalaureate degree from a regionally accredited college or
13.2university verified by the nationally recognized certification agencies;
13.3(2) has met the medical laboratory experience and training required by the nationally
13.4recognized certification agencies or alternatively one year of on-the-job training; and
13.5(3) passes a nationally recognized certification examination administered by the
13.6American Board of Histocompatibility and Immunogenetics.
13.7 Subd. 7. Medical laboratory subspecialist. The commissioner shall issue a
13.8medical laboratory subspecialist license to an individual who:
13.9(1) possesses a baccalaureate from a regionally accredited college or university
13.10verified by the recognized certification agencies;
13.11(2) has met the required medical laboratory experience and training through one
13.12year of on-the-job training; and
13.13(3) either is deemed competent via written confirmation by the respective laboratory
13.14director or passes a nationally recognized certification examination administered by the
13.15American Society for Clinical Pathology Board of Certification, or successor organizations.
13.16 Subd. 8. Cytotechnologist. The commissioner shall issue a cytotechnologist license
13.17to an individual who:
13.18(1) possesses a baccalaureate degree from a regionally accredited college or
13.19university required and verified by the recognized certification agencies;
13.20(2) has met the medical laboratory experience and training required by the
13.21recognized certification agencies; and
13.22(3) passes a nationally recognized certification examination administered by the
13.23American Society for Clinical Pathology Board of Certification, or successor organizations.
13.24 Subd. 9. Histotechnologist. The commissioner shall issue a histotechnologist
13.25license to an individual who:
13.26(1) possesses a baccalaureate degree from a regionally accredited college or
13.27university required and verified by the recognized certification agencies;
13.28(2) has met the medical laboratory experience and training required by the
13.29recognized certification agencies; and
13.30(3) passes a nationally recognized certification examination administered by the
13.31American Society for Clinical Pathology Board of Certification, or successor organizations.
13.32 Subd. 10. Histotechnician. The commissioner shall issue a histotechnician license
13.33to an individual who:
13.34(1) possesses an associate degree from a regionally accredited college or university
13.35required and verified by the recognized certification agencies;
14.1(2) has medical laboratory experience and training required by the recognized
14.2certification agencies; and
14.3(3) passes a nationally recognized certification examination administered by the
14.4American Society for Clinical Pathology Board of Certification, or successor organizations.
14.5 Sec. 9. [148G.08] RECIPROCITY.
14.6 Subdivision 1. Licensure. The commissioner may waive the licensure requirements
14.7for an applicant who holds a valid license or its equivalent issued by another state
14.8provided that the requirements under which that license or its equivalent was issued are
14.9equivalent to or exceed the standards required by this chapter. Once the license is up
14.10for renewal, the applicant shall be issued a Minnesota license upon meeting the license
14.11renewal requirements in section 148G.11.
14.12 Subd. 2. Current credentials required. An applicant applying for licensure by
14.13reciprocity must provide all necessary evidence to the commissioner that the applicant
14.14holds a current and unrestricted license for the practice of medical laboratory science
14.15in another jurisdiction that has requirements equivalent to or higher than the standards
14.16required to be licensed as a medical laboratory professional in one of the categories
14.17defined in this chapter.
14.18 Subd. 3. Verification of credentials required. An applicant for licensure under
14.19this section must have maintained the appropriate and unrestricted credentials in each
14.20jurisdiction during the last five years as demonstrated by submitting letters of verification
14.21to the commissioner. Each letter must state the applicant's name, date of birth, credential
14.22number, date of issuance, a statement regarding disciplinary actions, if any, taken against
14.23the applicant, and the terms under which the credential was issued.
14.24 Sec. 10. [148G.09] TEMPORARY LICENSE REQUIREMENTS.
14.25 (a) The commissioner may issue a temporary license to an applicant who:
14.26(1) is eligible to sit for and registered to take a certification examination or has taken
14.27the examination and is awaiting results;
14.28(2) meets the educational requirements of the nationally recognized certification
14.29agency and is seeking to qualify for the certification examination by completing the
14.30required supervised medical laboratory experience; or
14.31(3) meets the educational requirements for the position and is undergoing the
14.32required on-the-job training necessary for a specialized clinical laboratory.
14.33(b) A temporary license shall be issued for a 12-month period and may be renewed
14.34for two additional 12-month periods at the discretion of the commissioner, in order to
15.1allow the applicant to complete the required supervised medical laboratory experience or
15.2retake a certification examination, or be deemed competent by the laboratory director.
15.3(c) A temporary license expires 12 months after it is issued or on the date the
15.4commissioner issues or denies a permanent license to the holder.
15.5(d) A temporary license authorizes the holder to perform medical laboratory tests
15.6only in the area of practice for which the individual seeks to be permanently licensed.
15.7 Sec. 11. [148G.10] LICENSURE APPLICATION PROCEDURES.
15.8(a) Applicants must submit an application for licensure to the commissioner upon
15.9the forms prescribed and furnished by the commissioner, and must submit with the
15.10application the designated application fee as specified in section 148G.16.
15.11(b) Upon receipt of the application and the application fee, the commissioner shall
15.12issue a license for a medical laboratory scientist, a medical laboratory technician, or
15.13an appropriate specialty license to an individual who meets the qualifications specified
15.14in this chapter.
15.15(c) The commissioner shall approve, approve with conditions, or deny licensure. The
15.16commissioner shall act on an application for licensure according to paragraphs (b) to (d).
15.17(d) The commissioner shall determine if the applicant meets the requirements for
15.18licensure. The commissioner, or the advisory council at the commissioner's request, may
15.19investigate information provided by an applicant to determine whether the information
15.20is accurate and complete.
15.21(e) The commissioner shall notify an applicant of action taken on the application,
15.22and if licensure is denied or approved with conditions, the grounds for the commissioner's
15.23determination.
15.24(f) An applicant denied licensure or granted licensure with conditions may make
15.25a written request to the commissioner, within 30 days of the date of the commissioner's
15.26determination, for reconsideration of the commissioner's determination. Individuals
15.27requesting reconsideration may submit information that the applicant wants considered in
15.28the reconsideration. After reconsideration of the commissioner's determination to deny
15.29licensure or grant licensure with conditions, the commissioner shall determine whether
15.30the original determination should be affirmed or modified. An applicant is allowed no
15.31more than one request in any one biennial licensure period for reconsideration of the
15.32commissioner's determination to deny licensure or approve licensure with conditions.
15.33 Sec. 12. [148G.11] LICENSURE RENEWAL.
16.1 Subdivision 1. Renewal term. Licenses issued under this chapter must be renewed
16.2every two years. The renewal term is the effective date of the initial license or renewed
16.3license to the date of expiration of the license.
16.4 Subd. 2. Renewal applications. In order to renew a license, a licensee must submit:
16.5(1) a completed and signed application for renewal on a form prescribed by the
16.6commissioner;
16.7(2) the applicable renewal fee as specified in section 148G.16; and
16.8(3) documentation that the licensee has completed continuing education
16.9requirements as prescribed by the recognized certification agencies or 12 hours of
16.10documented continuing education.
16.11 Sec. 13. [148G.12] LICENSURE FOLLOWING LAPSE OF LICENSURE
16.12STATUS.
16.13 For an applicant whose licensure status has lapsed, the applicant must:
16.14(1) apply for licensure renewal according to section 148G.11 and document
16.15compliance with the continuing education requirements as prescribed by the nationally
16.16recognized certification agency since the applicant's license lapsed; and
16.17(2) fulfill the requirements of section 148G.07 and provide evidence of compliance
16.18with the continuing education requirements as prescribed by one of the nationally
16.19recognized certification agencies.
16.20 Sec. 14. [148G.13] CONTINUING EDUCATION REQUIREMENTS.
16.21Continuing education requirements shall be as described by the applicable
16.22certification agencies recognized under this chapter.
16.23 Sec. 15. [148G.14] INVESTIGATION PROCESS; GROUNDS FOR
16.24DISCIPLINARY ACTION.
16.25 Subdivision 1. Disciplinary action. (a) The commissioner may impose disciplinary
16.26action as described in paragraph (b) against an applicant or licensee whom the
16.27commissioner, by a preponderance of the evidence, determines has:
16.28(1) violated a statute, rule, or order that the commissioner issued or is empowered
16.29to enforce;
16.30(2) been convicted of or pled guilty to a felony, gross misdemeanor, misdemeanor,
16.31an essential element of which is dishonesty, or of any crime that is directly related to the
16.32practice of the profession;
17.1(3) made a misrepresentation for the purpose of obtaining licensure, either on an
17.2application provided by the commissioner or in response to oral or written questions
17.3from the commissioner;
17.4(4) violated the code of professional conduct in subdivisions 2 to 4;
17.5(5) engaged in dishonorable, unethical, or unprofessional conduct of a character
17.6likely to deceive, defraud, or harm the public;
17.7(6) failed to perform services with reasonable judgment, skill, or safety due to the
17.8use of alcohol, drugs, or other physical or mental impairment;
17.9(7) aided or assisted another person in violating any provision of this chapter or
17.10any applicable rules;
17.11(8) made any misrepresentation with regard to the existence or category of license or
17.12other certification or professional qualification held in connection with any employment
17.13application;
17.14(9) intentionally submitted false or misleading information in response to a written
17.15request by the commissioner or advisory council;
17.16(10) failed, within 30 days, to provide information in response to a written request
17.17by the commissioner or advisory council;
17.18(11) performed services for which the license is issued in an incompetent manner or
17.19in a manner that falls below community standards;
17.20(12) violated any provision of this chapter;
17.21(13) been convicted of violating any state or federal law, rule, or regulation which
17.22directly relates to the practice related to the discipline for which the individual is licensed;
17.23(14) violated a federal or state court order, including a conciliation court judgment,
17.24or a disciplinary order issued by the commissioner, related to the individual's practice for
17.25which the individual is licensed under this chapter;
17.26(15) aided or abetted another person in violating any provision of this chapter;
17.27(16) been disciplined for conduct in the practice of an occupation by the state of
17.28Minnesota, another jurisdiction, or a national professional association, if any of the
17.29grounds are the same or substantially equivalent to those in this chapter;
17.30(17) not cooperated with the commissioner or the advisory council in an investigation
17.31conducted according to this paragraph;
17.32(18) engaged in conduct with a patient that is sexual or may reasonably be
17.33interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
17.34demeaning to a patient; or
17.35(19) engaged in any other behavior that gives rise to just cause for discipline related
17.36to the practice for which they are licensed under this chapter.
18.1(b) If grounds for disciplinary action exist under paragraph (a), the commissioner
18.2may take one or more of the following actions:
18.3(1) refuse to grant or renew a license;
18.4(2) revoke a license;
18.5(3) suspend a license;
18.6(4) impose limitations or conditions on a license, including, but not limited to,
18.7practice under supervision, continued practice on the demonstration of knowledge or skill
18.8by appropriate examination or other review of knowledge, skill, and competence;
18.9(5) censure or reprimand the licensee;
18.10(6) impose a civil penalty not exceeding $10,000 for each separate violation,
18.11the amount of the civil penalty to be fixed so as to deprive the applicant or licensee
18.12of any economic advantage gained by reason of the violation charged, to discourage
18.13similar violations, or to reimburse the commissioner for the cost of the investigation and
18.14proceeding including, but not limited to, fees paid for services provided by the Office of
18.15Administrative Hearings, legal and investigative services provided by the Office of the
18.16Attorney General, court reporters, witnesses, reproduction of records, advisory council
18.17members' per diem compensation, staff time, and travel costs and expenses incurred
18.18by staff and advisory council members; or
18.19(7) any reasonable lesser action, including, but not limited to, censure, reprimand, or
18.20restriction on licensure, or any action authorized by statute.
18.21(c) Upon notice from the commissioner denying licensure renewal or upon notice
18.22that disciplinary actions have been imposed and the person is no longer entitled to provide
18.23the services for which the person was previously licensed under this chapter, the person
18.24shall cease to provide the services under this chapter, to use the protected titles pursuant to
18.25this chapter, and to represent to the public that the person is licensed by the commissioner.
18.26(d) A person who has had licensure suspended may request and provide justification
18.27for reinstatement following the period of suspension specified by the commissioner. The
18.28requirement of this chapter for renewing licensure and any other conditions imposed with
18.29the suspension must be met before licensure may be reinstated.
18.30(e) The commissioner shall contract with the health professional services program as
18.31authorized by sections 214.31 to 214.37 to provide these services to practitioners under
18.32this chapter. The health professional services program does not affect the commissioner's
18.33authority to discipline violations of this chapter.
18.34 Subd. 2. Duty to patient. Medical laboratory professionals shall:
18.35(1) be accountable for the quality and integrity of the laboratory services they provide;
19.1(2) maintain high standards of practice and sound judgment in establishing,
19.2performing, and evaluating laboratory testing; and
19.3(3) safeguard the dignity and privacy of patients and provide accurate information to
19.4other health care professionals about the services they provide.
19.5 Subd. 3. Duty to colleagues and profession. Medical laboratory professionals shall:
19.6(1) uphold and maintain the dignity and respect of the profession and strive to
19.7maintain a reputation of honesty, integrity, and reliability; and
19.8(2) actively strive to establish cooperative and respectful working relationships with
19.9other health care professionals with the primary objective of ensuring a high standard of
19.10care for the patients they serve.
19.11 Sec. 16. [148G.15] REPORTING OBLIGATIONS.
19.12 Subdivision 1. Permission to report. A person who has knowledge of any conduct
19.13constituting grounds for disciplinary action under this chapter may report the violation to
19.14the commissioner.
19.15 Subd. 2. Institutions. A state agency, political subdivision, agency of a local unit
19.16of government, private agency, hospital, clinic, prepaid medical plan, or other health
19.17care institution or organization located in this state shall report to the commissioner any
19.18action taken by the agency, institution, or organization or any of its administrators or
19.19medical or other committees to revoke, suspend, restrict, or condition a medical laboratory
19.20professional's privilege to practice in the institution, or as part of the organization, any
19.21denial of privileges, or any other disciplinary action for conduct that might constitute
19.22grounds for disciplinary action by the commissioner under this chapter. The institution,
19.23organization, or governmental entity shall also report the resignation of any medical
19.24laboratory science professional before the conclusion of any disciplinary action proceeding
19.25for conduct that might constitute grounds for disciplinary action under this chapter, or
19.26before the commencement of formal charges but after the practitioner had knowledge that
19.27formal charges were contemplated or were being prepared.
19.28 Subd. 3. Professional societies. A state or local professional society for medical
19.29laboratory science professionals shall report to the commissioner any termination,
19.30revocation, or suspension of membership or any other disciplinary action taken against a
19.31medical laboratory science professional. If the society has received a complaint that might
19.32be grounds for discipline under this chapter against a member on which it has not taken
19.33any disciplinary action, the society shall report the complaint and the reason why it has not
19.34taken action on it or shall direct the complainant to the commissioner.
20.1 Subd. 4. Licensed professionals. A licensed health professional shall report to the
20.2commissioner personal knowledge of any conduct that the licensed health professional
20.3reasonably believes constitutes grounds for disciplinary action under this chapter by a
20.4medical laboratory science professional, including conduct indicating that the individual
20.5may be medically incompetent, or may be medically or physically unable to engage safely
20.6in the provision of services. If the information was obtained in the course of a client
20.7relationship, the client is a medical laboratory science professional, and the treating
20.8individual successfully counsels the medical laboratory science professional to limit or
20.9withdraw from practice to the extent required by the impairment, the commissioner may
20.10deem this limitation of or withdrawal from practice to be sufficient disciplinary action.
20.11 Subd. 5. Self-reporting. A medical laboratory science professional shall report
20.12to the commissioner any personal action that would require that a report be filed with
20.13the commissioner by any person, health care facility, business, or organization under
20.14subdivisions 2 to 4. The medical laboratory science professional shall also report the
20.15revocation, suspension, restriction, limitation, or other disciplinary action in this state
20.16and report the filing of charges regarding the practitioner's license or right of practice
20.17in another state or jurisdiction.
20.18 Subd. 6. Deadlines; forms. Reports required by subdivisions 2 to 5 must be
20.19submitted no later than 30 days after the reporter learns of the occurrence of the reportable
20.20event or transaction. The commissioner may provide forms for the submission of required
20.21reports, may require that reports be submitted on the forms provided, and may adopt rules
20.22necessary to ensure prompt and accurate reporting.
20.23 Subd. 7. Immunity for reporting. A person, health care facility, business, or
20.24organization is immune from civil liability or criminal prosecution for reporting to
20.25the commissioner violations or alleged violations of this chapter. All such reports are
20.26classified under section 13.41.
20.27 Subd. 8. Immunity for investigation. The commissioner, employees of the
20.28Minnesota Department of Health, consultants to the department, and advisory council
20.29members are immune from civil liability and criminal prosecution for any actions,
20.30transactions, or publications in the execution of, or relating to, their duties under this
20.31chapter.
20.32 Sec. 17. [148G.16] FEES.
20.33 Subdivision 1. Initial licensure fee. The initial licensure fee for medical laboratory
20.34scientist, categorical medical laboratory scientist, medical laboratory specialist in
20.35molecular biology, medical laboratory specialist in cytogenetics, histocompatibility
21.1technologist, other specialists and categoricals, and medical laboratory technicians is
21.2$155. The commissioner shall prorate fees based on the number of quarters remaining
21.3in the biennial licensure period.
21.4 Subd. 2. Licensure renewal fee. The biennial licensure renewal fee for medical
21.5laboratory scientist, categorical medical laboratory scientist, medical laboratory specialist
21.6in molecular biology, medical laboratory specialist in cytogenetics, histocompatibility
21.7technologist, other specialists and categoricals, and medical laboratory technicians is $115.
21.8 Subd. 3. Late fee. The fee for late submission of a renewal application is $45.
21.9 Subd. 4. Temporary licensure fee. The fee for temporary licensure is $50.
21.10 Subd. 5. Verification to other states. The fee for verification of licensure to other
21.11states is $25.
21.12 Subd. 6. Verification to institutions. The fee for verification of licensure to
21.13institutions is $10.
21.14 Subd. 7. Nonrefundable fees. All fees are nonrefundable.
21.15 Subd. 8. Penalty fees. (a) The penalty fee for practicing medical laboratory science
21.16without a current license after the credential has expired and before it is renewed is the
21.17amount of the license renewal fee for any part of the first month, plus the license renewal
21.18fee for any part of any subsequent month up to 36 months.
21.19(b) The penalty fee for applicants who engage in the unauthorized practice of medical
21.20laboratory science before being issued a license is the amount of the license application fee
21.21for any part of the first month, plus the license application fee for any part of any subsequent
21.22month up to 36 months. This paragraph does not apply to applicants not qualifying for a
21.23license who engage in the unauthorized practice of medical laboratory science.
21.24(c) The penalty fee for failing to submit a continuing education report by the due date
21.25with the correct number or type of hours in the correct time period is $50. The licensee must
21.26obtain the missing number of continuing education hours by the next reporting due date.
21.27(d) Civil penalties and discipline incurred by licensees prior to January 1, 2015, for
21.28conduct described in paragraph (a), (b), or (c), shall be recorded as nondisciplinary penalty
21.29fees. For conduct described in paragraph (a) or (b) occurring after January 1, 2015, and
21.30exceeding six months, payment of a penalty fee does not preclude any disciplinary action
21.31reasonably justified by the individual case.
21.32 Sec. 18. ADVISORY COUNCIL; DEADLINES.
21.33The commissioner of health shall complete the first appointments required by
21.34Minnesota Statutes, section 148G.05, no later than September 1, 2013. The commissioner's
21.35designee shall convene the first meeting of the council no later than October 1, 2013.
22.1The council must select its chair as required by Minnesota Statutes, section 148G.05, at
22.2the first meeting of the council.
22.3 Sec. 19. APPROPRIATION.
22.4$284,000 in fiscal year 2014 is appropriated from the state government special
22.5revenue fund to the commissioner of health to implement this act. Base funding is
22.6$488,000 in fiscal year 2015 and $376,000 in fiscal year 2016.
22.7 Sec. 20. EFFECTIVE DATE.
22.8Sections 1 to 18 are effective July 1, 2013.
1.3science professionals; creating the Board of Medical Laboratory Science;
1.4providing penalties; establishing fees; appropriating money;proposing coding
1.5for new law as Minnesota Statutes, chapter 148G.
1.6BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:
1.7 Section 1. [148G.01] DEFINITIONS.
1.8 Subdivision 1. Applicability. For purposes of this chapter, the following terms
1.9have the meanings given them.
1.10 Subd. 2. Accredited medical laboratory educational program. "Accredited
1.11medical laboratory educational program" means a program to provide instruction and
1.12experience in medical laboratory science that has been accredited by an accrediting agency
1.13recognized by the United States Department of Health and Human Services.
1.14 Subd. 3. Categorical medical laboratory scientist. "Categorical medical
1.15laboratory scientist" means an individual eligible for licensure under this chapter who
1.16performs the functions of a medical laboratory scientist in one or more of the following
1.17areas of the laboratory depending upon the certification examinations passed: chemistry,
1.18hematology, immunohematology, and microbiology.
1.19 Subd. 4. CLIA. "CLIA" means Clinical Laboratory Improvement Amendments of
1.201988 and includes Public Law 10-578 and Code of Federal Regulations, title 42, section
1.21493. CLIA regulations provide a minimum foundation upon which personnel standards
1.22for entry level technical personnel in this state are built. Qualifications and responsibilities
1.23for laboratory director, technical supervisor, and technical consultant are as specified in
1.24CLIA regulations. All medical laboratory personnel are under the supervision, control,
1.25and responsibility of the laboratory director.
2.1 Subd. 5. Commissioner. "Commissioner" means the commissioner of health or the
2.2commissioner's designee.
2.3 Subd. 6. Cytotechnologist. "Cytotechnologist" means an individual who
2.4specializes in the cellular analysis of patient samples from all body sites, for the purpose
2.5of evaluating, detecting, and identifying potential disease processes through the exercise
2.6of independent technical judgment, under the supervision, control, and responsibility of
2.7the laboratory director, and who:
2.8(1) assists health care providers with the collection, detection, and identification
2.9of normal and abnormal cells, infectious agents, and other noncellular material from
2.10submitted specimens;
2.11(2) performs a variety of medical laboratory tests that may include the use of
2.12molecular techniques with approval and oversight of a medical director, to ascertain
2.13information to help in classification of a specimen consistent with the scope of work
2.14provided under the Clinical Laboratory Improvement Amendments of 1988;
2.15(3) establishes and implements protocols, quality control, method selection,
2.16equipment selection and maintenance, and activities related to the preanalytic, analytic,
2.17and postanalytic phases of testing; and
2.18(4) directs, supervises, consults, educates, and performs research functions.
2.19 Subd. 7. Histotechnician. "Histotechnician" means an individual who, with the
2.20approval, supervision, and control of a board-certified anatomic pathologist, may perform
2.21the following functions:
2.22(1) prepares tissue specimens for microscopic examination;
2.23(2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
2.24and validity of laboratory testing and procedures, including, but not limited to, techniques
2.25in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
2.26(3) prepares gross specimens as defined by and under the direction of a
2.27board-certified anatomic pathologist;
2.28(4) establishes and implements protocols, quality assurance, and quality control
2.29related to the following procedures: histochemical, immunohistochemical, electron
2.30microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
2.31hydrolysis, laser capturing, molecular techniques, and research; and
2.32(5) participates in method selection, development, equipment selection and
2.33maintenance, and activities related to the preanalytical and analytical phases of tissue
2.34preparation.
3.1 Subd. 8. Histotechnologist. "Histotechnologist" means an individual who, with
3.2the approval, supervision, and control of a board-certified anatomic pathologist, may
3.3perform the following functions:
3.4(1) prepares tissue specimens for microscopic examination;
3.5(2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
3.6and validity of laboratory testing and procedures including, but not limited to, techniques
3.7in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
3.8(3) prepares gross specimens as defined by and under the direction of a
3.9board-certified anatomic pathologist;
3.10(4) establishes and implements protocols, quality assurance, and quality control
3.11related to the following procedures: histochemical, immunohistochemical, electron
3.12microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
3.13hydrolysis, laser capturing, molecular techniques, and research;
3.14(5) establishes and implements new protocols and procedures dealing directly in
3.15quality assessment, method development, and equipment selection and maintenance and
3.16all activities related to preanalytical and analytical phases of tissue preparation; and
3.17(6) directs, supervises, consults, educates, and performs research functions.
3.18 Subd. 9. Independent medical judgment. In the laboratory, "independent medical
3.19judgment" is exercised only by a pathologist or other licensed physician in the diagnosis
3.20and treatment decisions related to clinical laboratory tests.
3.21 Subd. 10. Independent technical judgment. "Independent technical judgment"
3.22means the performance or conduct of clinical laboratory tests and assumption of
3.23responsibility for determination of the validity of clinical laboratory test. The authorized
3.24exercise of independent technical judgment shall not be deemed to include or permit the
3.25exercise of independent medical judgment in the diagnosis or treatment of, or reporting of
3.26clinical laboratory test results or their interpretation to patients, except as authorized by a
3.27laboratory director and according to CLIA.
3.28 Subd. 11. Medical laboratory or laboratory. "Medical laboratory" or "laboratory"
3.29means any facility or office in Minnesota in which medical laboratory tests are performed.
3.30 Subd. 12. Medical laboratory scientist or generalist. "Medical laboratory
3.31scientist" or "generalist" means an individual eligible for licensure under this chapter who:
3.32(1) performs medical laboratory tests, including tests that require the exercise of
3.33independent technical judgment;
3.34(2) establishes and implements protocols, quality assessment, method development
3.35and selection, equipment selection and maintenance, and all activities related to the
3.36preanalytic, analytic, and postanalytic phases of laboratory testing; and
4.1(3) directs, supervises, consults, educates, and performs research functions.
4.2 Subd. 13. Medical laboratory specialist. "Medical laboratory specialist" means
4.3an individual certified and eligible for licensure in one of the categories described in
4.4subdivisions 14, 15, and 16, to perform testing, including tests that require the exercise
4.5of independent technical judgment needed to establish and implement protocols, quality
4.6assessment, method development and selection, equipment selection and maintenance,
4.7and all activities related to the preanalytic, analytic, and postanalytic phases of laboratory
4.8testing, and who direct, supervise, consult, and educate in a specific specialized section of
4.9the laboratory.
4.10 Subd. 14. Medical laboratory specialist in cytogenetics. "Medical laboratory
4.11specialist in cytogenetics" means an individual eligible for licensure under this chapter to
4.12perform standard cytogenetic and molecular testing procedures used to evaluate possible
4.13genetic anomalies.
4.14 Subd. 15. Medical laboratory specialist in molecular biology/pathology.
4.15"Medical laboratory specialist in molecular biology/pathology" means an individual
4.16eligible for licensure under this chapter to perform all aspects of molecular analysis,
4.17including, but not limited to, recombinant DNA technology, polymerase chain reaction,
4.18and hybridization techniques.
4.19 Subd. 16. Medical laboratory specialist in histocompatability. "Medical
4.20laboratory specialist in histocompatability" means an individual eligible for licensure
4.21under this chapter to perform histocompatibility testing procedures, including, but not
4.22limited to, molecular and serological techniques.
4.23 Subd. 17. Medical laboratory technician. "Medical laboratory technician" means
4.24an individual eligible for licensure under this chapter who performs medical laboratory
4.25tests at all CLIA complexity levels according to established and approved protocols and
4.26requiring limited exercise of independent judgment.
4.27 Subd. 18. Medical laboratory test or laboratory test. "Medical laboratory
4.28test" or "laboratory test" means a microbiological, serological, chemical, biological,
4.29hematological, immunological, immunohematological, radiobioassay, cytological,
4.30histological preparation, molecular, biophysical, or any other test or procedure performed
4.31on material derived from or existing in a human body, that provides information for
4.32the diagnosis, prevention, or monitoring of a disease or impairment or assessment of a
4.33medical condition. A medical laboratory test includes components of the preanalytic and
4.34postanalytic phases of testing, as well as the analytic phase, that occurs in the laboratory.
4.35 Subd. 19. Medical laboratory subspecialists. "Medical laboratory subspecialists"
4.36means an individual eligible for licensure under this chapter to perform the functions
5.1of a medical laboratory scientist in a subspecialty or esoteric clinical laboratory that is
5.2not one of the general categorical areas of the laboratory. The subspecialty/esoteric
5.3laboratories may be disease or medical specialty-oriented or utilize advanced technology
5.4not routinely used in the clinical laboratory. These subspecialty/esoteric laboratories may
5.5be subspecialized areas within the hematology, chemistry, immunology, transfusion,
5.6medicine, genetics, or microbiology disciplines.
5.7 Subd. 20. Nationally recognized certification agency. "Nationally recognized
5.8certification agency" means an agency that provides certification examinations for medical
5.9laboratory professionals. As the agency defines new certification examinations, the
5.10commissioner and the advisory council will recognize these examinations.
5.11 Subd. 21. Pathologist's assistant. "Pathologist's assistant" means an individual
5.12specializing in prediagnostic surgical pathology and autopsy pathology who assists
5.13pathologists.
5.14 Subd. 22. Phlebotomist. "Phlebotomist" means an individual who is qualified to
5.15obtain blood samples for testing by means of venipuncture, capillary puncture, or access
5.16of venous access devices, to perform specimen processing and preparation of samples for
5.17testing, and to perform waived and point-of-care testing.
5.18 Subd. 23. Point-of-care testing. "Point-of-care testing" means analytical patient
5.19testing activities provided within a facility that do not require permanent dedicated space,
5.20including, but not limited to, analytic instruments that are temporarily brought to a patient
5.21care location. Point-of-care testing must be under the direction of an individual licensed
5.22under this chapter at the baccalaureate degree level or who qualifies as a laboratory
5.23director under federal CLIA regulations.
5.24 Subd. 24. Trainee/student. "Trainee/student" means an individual who has
5.25not fulfilled the educational requirements to take an approved nationally recognized
5.26certification examination or who needs to obtain full-time comprehensive experience
5.27under supervision.
5.28 Subd. 25. Waived test. "Waived test" means a laboratory examination or procedure
5.29as determined by the United States Food and Drug Administration that has an insignificant
5.30risk of an erroneous result, including those that:
5.31(1) have been approved by the United States Food and Drug Administration for
5.32home use;
5.33(2) employ methodologies that are so simple and accurate as to render the likelihood
5.34of erroneous results negligible; or
5.35(3) pose no reasonable risk of harm to the patient if performed incorrectly.
6.1 Sec. 2. [148G.02] EXCEPTIONS.
6.2This chapter does not apply to:
6.3(1) the qualifications as established by federal CLIA for laboratory directors,
6.4technical supervisors, or technical consultants;
6.5(2) other licensed or registered professionals performing functions within the
6.6professional's scope of practice;
6.7(3) medical laboratory science professionals employed by the United States
6.8government, or any bureau, division, or agency, while performing duties within the scope
6.9of the professional's federal employment;
6.10(4) medical laboratory science professionals engaged exclusively in basic science or
6.11investigative research, provided that the results of any examination performed are not used
6.12in health maintenance, diagnosis, or treatment of disease as described in federal CLIA
6.13regulations under Code of Federal Regulations, title 42, section 493;
6.14(5) professionals engaged exclusively in assay development or management-related
6.15activities in the clinical laboratory, provided the results of any examination performed
6.16are not used in health maintenance, diagnosis, or treatment of disease as described in
6.17federal CLIA regulations;
6.18(6) professionals engaged exclusively in the education of medical laboratory science
6.19professionals, provided that results of any examination performed are not used in health
6.20maintenance, diagnosis, or treatment of disease as described in federal CLIA regulations;
6.21(7) professionals engaged exclusively in providing phlebotomy services;
6.22(8) pathologist's assistants or individuals performing pathology assistant activities
6.23under supervision by pathologists;
6.24(9) students or trainees enrolled in a medical laboratory science education program
6.25provided that:
6.26(i) the activities performed by the student or trainee constitute a part of a planned
6.27course in the program;
6.28(ii) the student or trainee is clearly designated as intern, trainee, or student; and
6.29(iii) the student or trainee is working directly under an individual licensed under
6.30this chapter to practice medical laboratory science or by a professional who is exempt
6.31under this section;
6.32(10) individuals who only perform waived tests or moderately complex point-of-care
6.33tests under the direction of a qualified CLIA laboratory director according to federal
6.34CLIA regulations; and
6.35(11) individuals who perform moderately complex testing as defined by federal
6.36CLIA regulations provided that the laboratory complies with the following requirements:
7.1(i) within the laboratory, a licensed medical laboratory scientist or individual who
7.2qualifies as a laboratory director under federal CLIA regulations is responsible for:
7.3(A) designing, providing, and supervising the training programs for the testing
7.4personnel;
7.5(B) supervising and monitoring the quality assurance and quality control activities
7.6of the testing site;
7.7(C) assisting in the selection of technology;
7.8(D) reviewing the results of proficiency testing and recommending corrective
7.9action, if necessary; and
7.10(E) monitoring the continued laboratory testing competency of the testing personnel;
7.11(ii) documented personnel evaluation processes are in place, which ensure and
7.12document the continued competency of the testing personnel; and
7.13(iii) after July 1, 2013, the licensed medical laboratory scientist or individual
7.14who qualifies as a laboratory director under CLIA regulations must ensure that new
7.15employees have initial certification as a certified or registered medical assistant or
7.16certified office laboratory technician by the American Medical Technologists (AMT) or
7.17the American Association of Medical Assistants (AAMS) or other national certification
7.18agency recognized by the commissioner. Individuals employed as a medical assistant
7.19or office laboratory technician on July 1, 2013, are not required to be certified. Failure
7.20of a laboratory to comply with the requirements described in clause (11) subjects the
7.21individual to the requirements of this chapter and requires the individual to be licensed as
7.22required under this chapter.
7.23This chapter does not apply to a declared emergency as defined in section 12.03
7.24that reduces laboratory capacity or increases testing demands, or other loss of critical
7.25laboratory capacity. Practitioners who are not licensed in any state, but are certified by one
7.26of the agencies recognized in this chapter or deemed competent by the affected laboratory
7.27director, may practice as needed in the emergency situation.
7.28 Sec. 3. [148G.03] LICENSURE REQUIRED; TITLES USED, RESTRICTED,
7.29AND ALLOWED.
7.30 Subdivision 1. Unlicensed practice prohibited. Effective January 1, 2015, no
7.31individual shall perform a medical laboratory test unless the individual is licensed under
7.32this chapter as a medical laboratory scientist, categorical medical laboratory scientist,
7.33medical laboratory technician, medical laboratory specialist in cytogenetics, medical
7.34laboratory specialist in molecular biology/pathology, or medical laboratory specialist in
8.1histocompatability, medical laboratory subspecialist, cytotechnologist, histotechnician, or
8.2histotechnologist, or is exempt from licensure under section 148G.02.
8.3 Subd. 2. Protected titles and restrictions on use. No individual shall use the phrase
8.4medical laboratory scientist, categorical medical laboratory scientist, medical laboratory
8.5technician, medical laboratory specialist in cytogenetics, medical laboratory specialist in
8.6molecular biology/pathology, or medical laboratory specialist in histocompatability, or
8.7medical laboratory subspecialist, cytotechnologist, histotechnician, or histotechnologist,
8.8or the initials MLS, MLT, CT, HT, or HTL, alone or in combination with any other words
8.9or initials to form an occupational title, or to indicate or imply that the person is licensed
8.10as one of the professionals listed, unless the individual is licensed under this chapter.
8.11 Subd. 3. Persons licensed or certified in other states. An individual who
8.12is licensed under this chapter and licensed or certified in another state may use the
8.13designation licensed or certified with a protected title only if the state of licensure or
8.14certification (if other than Minnesota) is clearly indicated.
8.15 Sec. 4. [148G.035] SCOPE OF PRACTICE.
8.16Medical laboratory professionals licensed under this chapter shall perform laboratory
8.17tests and provide test results to physicians and patients upon request or upon physician
8.18referral according to CLIA. The practice of medical laboratory science includes:
8.19(1) the production of test data;
8.20(2) monitoring the accuracy, precision, and utility of laboratory testing;
8.21(3) analytical correlation and interpretation of test data;
8.22(4) designing, evaluating, and implementing new laboratory test methods; and
8.23(5) documenting and reporting test results.
8.24The services provided by medical laboratory professionals must be consistent with good
8.25practice and sound professional ethics.
8.26 Sec. 5. [148G.04] DUTIES OF THE COMMISSIONER.
8.27The commissioner, with the advice of the advisory council, shall:
8.28(1) administer the procedures for this chapter, including, but not limited to, verifying
8.29the qualifications and standards for education, experience, examinations, and continuing
8.30education, as established by the certification agencies recognized in this chapter, and
8.31other methods for determining whether an applicant or licensee is qualified, as specified
8.32under this chapter;
8.33(2) enforce standards for professional conduct found in the Code of Professional
8.34Ethics;
9.1(3) issue licenses to qualified individuals;
9.2(4) collect and deposit fees as established under section 148G.16;
9.3(5) on the recommendation of the advisory council, approve future nationally
9.4recognized, validated, competency-based written, oral, or practical examinations developed
9.5by the American Society for Clinical Pathology Board of Certification, American
9.6Medical Technologists, American Association of Bioanalysts, and American Society for
9.7Histocompatibility and Immunogenetics, or successor organizations, for purposes of
9.8licensure of medical laboratory science professionals as provided for in this chapter; and
9.9(6) maintain a roster of the names and addresses of individuals currently licensed
9.10under this chapter and of all individuals whose licenses have been disciplined under
9.11this chapter.
9.12 Sec. 6. [148G.05] MEDICAL LABORATORY SCIENCE PROFESSIONAL
9.13LICENSING ADVISORY COUNCIL.
9.14 Subdivision 1. Membership and qualifications of advisory council. (a) The
9.15commissioner shall appoint an 11-member advisory council that may include applicants
9.16recommended by laboratory professional associations. Members must be actively
9.17employed for at least two years in their specific area of practice.
9.18(b) Six members must be medical laboratory science professionals who are licensed
9.19under this chapter and include:
9.20(1) one nonphysician laboratory director;
9.21(2) one medical laboratory scientist;
9.22(3) one medical laboratory technician;
9.23(4) one specialist in cytogenetics, histocompatibility, or molecular biology;
9.24(5) one cytotechnologist; and
9.25(6) one histotechnician or histotechnologist.
9.26(c) Three members must be physicians certified by the American Board of Pathology
9.27or the American Board of Osteopathic Pathology. Two must be certified in clinical
9.28pathology.
9.29(d) One of the members must be a physician who is not a laboratory director and
9.30is not a pathologist.
9.31(e) One member must be a public member as defined in section 214.02.
9.32 Subd. 2. Duties. The advisory council shall:
9.33(1) advise and make recommendations to the commissioner regarding the medical
9.34laboratory science practitioner licensure standards;
9.35(2) advise the commissioner on enforcement of this chapter;
10.1(3) provide for distribution of information regarding medical laboratory science
10.2practitioners licensure standards;
10.3(4) review applications upon the request of the commissioner and make
10.4recommendations on granting or denying licensure or licensure renewal;
10.5(5) advise the commissioner on issues related to receiving and investigating
10.6complaints, conducting objective hearings, and imposing disciplinary action in relation to
10.7complaints received against medical laboratory science practitioners; and
10.8(6) perform other duties requested by the commissioner.
10.9 Subd. 3. Organization. The advisory council shall be organized and administered
10.10under section 15.059. The advisory council shall select a chair from its membership at
10.11the first meeting of the advisory council.
10.12 Subd. 4. Support. The commissioner shall provide the necessary staff support
10.13and meeting space for the advisory council.
10.14 Sec. 7. [148G.06] TEMPORARY REQUIREMENTS FOR LICENSURE;
10.15TRANSITION PERIOD.
10.16 Subdivision 1. Experienced medical laboratory science professionals transition.
10.17(a) Notwithstanding section 148G.03, an individual who is certified by or eligible to be
10.18certified by a certification agency recognized by the commissioner to perform medical
10.19laboratory testing, or meets the subspecialty requirements in section 148G.07, subdivision
10.207, may perform medical laboratory tests without the appropriate license provided the
10.21individual has applied to the commissioner for licensure and the application:
10.22(1) has not been denied by the commissioner; or
10.23(2) has not been withdrawn.
10.24(b) This subdivision expires January 1, 2015.
10.25 Subd. 2. Employed medical laboratory science professional transition. (a) An
10.26individual who does not meet the education, training, and experience qualifications for
10.27any license described in this chapter on July 1, 2013, has until January 1, 2015, to be
10.28licensed under this subdivision.
10.29(b) The commissioner shall issue a license under this subdivision if the applicant:
10.30(1) is practicing in the field on July 1, 2013, or has six months of acceptable
10.31experience of at least half time, 1,040 hours per year, in the three years immediately
10.32prior to July 1, 2013; and
10.33(2) on a form provided by the commissioner, submits the job, title, description of the
10.34position, period of employment, and confirmation of competent practice, as attested by
10.35the applicant's employer, who shall submit a signed statement stating that the applicant is
11.1not the subject of a disciplinary action or past disciplinary action in their employment,
11.2professional association membership, or under any credentialing authority in this or
11.3another jurisdiction, and is not disqualified on the basis of section 148G.14.
11.4(c) The commissioner and advisory council shall determine which type of license the
11.5applicant is eligible for and issue the license if the requirements of this subdivision are met.
11.6(d) An initial license issued under this subdivision must be renewed following the
11.7procedures required under section 148G.10, provided the license is maintained without
11.8interruption.
11.9(e) This subdivision expires January 1, 2014.
11.10 Sec. 8. [148G.07] STANDARDS FOR LICENSURE.
11.11 Subdivision 1. Medical laboratory scientist (MLS). (a) The commissioner shall
11.12issue a medical laboratory scientist's license to an individual who meets the following
11.13requirements in paragraph (b):
11.14(1) possesses a baccalaureate degree from a regionally accredited college or
11.15university and verified by the nationally recognized certification agencies;
11.16(2) has met the medical laboratory experience and training required by the
11.17recognized certification agencies; and
11.18(3) passes a nationally recognized certification examination administered by the
11.19American Society for Clinical Pathology Board of Certification, American Medical
11.20Technologists, American Association of Bioanalysts, or successor organizations.
11.21(b) The commissioner shall issue a medical laboratory scientist's license to an
11.22individual who has completed an official military training program of at least 50 weeks,
11.23which was approved by the National Accrediting Agency for Clinical Laboratory Sciences
11.24(NAACLS) or a national accrediting agency acceptable to the commissioner, and held the
11.25military enlisted occupational specialty of medical laboratory specialist and possesses a
11.26baccalaureate degree from a regionally accredited college or university.
11.27 Subd. 2. Medical laboratory scientist, categorical. The commissioner shall issue a
11.28categorical medical laboratory scientist's license to an individual who:
11.29(1) possesses a baccalaureate degree from a regionally accredited college or
11.30university and verified by the nationally recognized certification agencies;
11.31(2) has met the medical laboratory experience and training required by the
11.32recognized certification agencies; and
11.33(3) passes a nationally recognized certification examination administered by the
11.34American Society for Clinical Pathology Board of Certification, American Medical
11.35Technologists, American Association of Bioanalysts, or successor organizations.
12.1 Subd. 3. Medical laboratory technician (MLT). (a) The commissioner shall
12.2issue a medical laboratory technician's license to an individual who meets the following
12.3requirements in paragraph (b):
12.4(1) possesses an associate degree from a regionally accredited college or university
12.5verified by the nationally recognized certification agencies;
12.6(2) has met the medical laboratory experience and training required by the
12.7recognized certification agencies; and
12.8(3) passes a nationally recognized certification examination administered by the
12.9American Society for Clinical Pathology Board of Certification, American Medical
12.10Technologists, American Association of Bioanalysts, or successor organizations.
12.11(b) The commissioner shall issue a medical laboratory technician's license to an
12.12individual who has completed an official military training program of at least 50 weeks,
12.13which was approved by the National Accrediting Agency for Clinical Laboratory Sciences
12.14(NAACLS) or a national accrediting agency acceptable to the commissioner, and held the
12.15military enlisted occupational specialty of medical laboratory specialist and possesses an
12.16associate degree from a regionally accredited college or university.
12.17 Subd. 4. Medical laboratory specialist in molecular biology. The commissioner
12.18shall issue a medical laboratory specialist in molecular biology license to an individual who:
12.19(1) possesses a baccalaureate degree from a regionally accredited college or
12.20university verified by the recognized certification agencies;
12.21(2) meets the medical laboratory experience and training required by the nationally
12.22recognized certification agencies, or alternatively one year of on-the-job training; and
12.23(3) either passes a nationally recognized certification examination administered by
12.24the American Society for Clinical Pathology Board of Certification, American Association
12.25of Bioanalysts, or successor organizations.
12.26 Subd. 5. Medical laboratory specialist in cytogenetics. The commissioner shall
12.27issue a medical laboratory specialist in cytogenetics license to an individual who:
12.28(1) possesses a baccalaureate degree from a regionally accredited college or
12.29university verified by the nationally recognized certification agencies;
12.30(2) has met the medical laboratory experience and training required by the nationally
12.31recognized certification agencies or alternatively one year of on-the-job training; and
12.32(3) passes a nationally recognized certification examination administered by the
12.33American Society for Clinical Pathology Board of Certification, or successor organizations.
12.34 Subd. 6. Histocompatibility technologist. The commissioner shall issue a medical
12.35laboratory specialist in histocompatibility license to an individual who:
13.1(1) possesses a baccalaureate degree from a regionally accredited college or
13.2university verified by the nationally recognized certification agencies;
13.3(2) has met the medical laboratory experience and training required by the nationally
13.4recognized certification agencies or alternatively one year of on-the-job training; and
13.5(3) passes a nationally recognized certification examination administered by the
13.6American Board of Histocompatibility and Immunogenetics.
13.7 Subd. 7. Medical laboratory subspecialist. The commissioner shall issue a
13.8medical laboratory subspecialist license to an individual who:
13.9(1) possesses a baccalaureate from a regionally accredited college or university
13.10verified by the recognized certification agencies;
13.11(2) has met the required medical laboratory experience and training through one
13.12year of on-the-job training; and
13.13(3) either is deemed competent via written confirmation by the respective laboratory
13.14director or passes a nationally recognized certification examination administered by the
13.15American Society for Clinical Pathology Board of Certification, or successor organizations.
13.16 Subd. 8. Cytotechnologist. The commissioner shall issue a cytotechnologist license
13.17to an individual who:
13.18(1) possesses a baccalaureate degree from a regionally accredited college or
13.19university required and verified by the recognized certification agencies;
13.20(2) has met the medical laboratory experience and training required by the
13.21recognized certification agencies; and
13.22(3) passes a nationally recognized certification examination administered by the
13.23American Society for Clinical Pathology Board of Certification, or successor organizations.
13.24 Subd. 9. Histotechnologist. The commissioner shall issue a histotechnologist
13.25license to an individual who:
13.26(1) possesses a baccalaureate degree from a regionally accredited college or
13.27university required and verified by the recognized certification agencies;
13.28(2) has met the medical laboratory experience and training required by the
13.29recognized certification agencies; and
13.30(3) passes a nationally recognized certification examination administered by the
13.31American Society for Clinical Pathology Board of Certification, or successor organizations.
13.32 Subd. 10. Histotechnician. The commissioner shall issue a histotechnician license
13.33to an individual who:
13.34(1) possesses an associate degree from a regionally accredited college or university
13.35required and verified by the recognized certification agencies;
14.1(2) has medical laboratory experience and training required by the recognized
14.2certification agencies; and
14.3(3) passes a nationally recognized certification examination administered by the
14.4American Society for Clinical Pathology Board of Certification, or successor organizations.
14.5 Sec. 9. [148G.08] RECIPROCITY.
14.6 Subdivision 1. Licensure. The commissioner may waive the licensure requirements
14.7for an applicant who holds a valid license or its equivalent issued by another state
14.8provided that the requirements under which that license or its equivalent was issued are
14.9equivalent to or exceed the standards required by this chapter. Once the license is up
14.10for renewal, the applicant shall be issued a Minnesota license upon meeting the license
14.11renewal requirements in section 148G.11.
14.12 Subd. 2. Current credentials required. An applicant applying for licensure by
14.13reciprocity must provide all necessary evidence to the commissioner that the applicant
14.14holds a current and unrestricted license for the practice of medical laboratory science
14.15in another jurisdiction that has requirements equivalent to or higher than the standards
14.16required to be licensed as a medical laboratory professional in one of the categories
14.17defined in this chapter.
14.18 Subd. 3. Verification of credentials required. An applicant for licensure under
14.19this section must have maintained the appropriate and unrestricted credentials in each
14.20jurisdiction during the last five years as demonstrated by submitting letters of verification
14.21to the commissioner. Each letter must state the applicant's name, date of birth, credential
14.22number, date of issuance, a statement regarding disciplinary actions, if any, taken against
14.23the applicant, and the terms under which the credential was issued.
14.24 Sec. 10. [148G.09] TEMPORARY LICENSE REQUIREMENTS.
14.25 (a) The commissioner may issue a temporary license to an applicant who:
14.26(1) is eligible to sit for and registered to take a certification examination or has taken
14.27the examination and is awaiting results;
14.28(2) meets the educational requirements of the nationally recognized certification
14.29agency and is seeking to qualify for the certification examination by completing the
14.30required supervised medical laboratory experience; or
14.31(3) meets the educational requirements for the position and is undergoing the
14.32required on-the-job training necessary for a specialized clinical laboratory.
14.33(b) A temporary license shall be issued for a 12-month period and may be renewed
14.34for two additional 12-month periods at the discretion of the commissioner, in order to
15.1allow the applicant to complete the required supervised medical laboratory experience or
15.2retake a certification examination, or be deemed competent by the laboratory director.
15.3(c) A temporary license expires 12 months after it is issued or on the date the
15.4commissioner issues or denies a permanent license to the holder.
15.5(d) A temporary license authorizes the holder to perform medical laboratory tests
15.6only in the area of practice for which the individual seeks to be permanently licensed.
15.7 Sec. 11. [148G.10] LICENSURE APPLICATION PROCEDURES.
15.8(a) Applicants must submit an application for licensure to the commissioner upon
15.9the forms prescribed and furnished by the commissioner, and must submit with the
15.10application the designated application fee as specified in section 148G.16.
15.11(b) Upon receipt of the application and the application fee, the commissioner shall
15.12issue a license for a medical laboratory scientist, a medical laboratory technician, or
15.13an appropriate specialty license to an individual who meets the qualifications specified
15.14in this chapter.
15.15(c) The commissioner shall approve, approve with conditions, or deny licensure. The
15.16commissioner shall act on an application for licensure according to paragraphs (b) to (d).
15.17(d) The commissioner shall determine if the applicant meets the requirements for
15.18licensure. The commissioner, or the advisory council at the commissioner's request, may
15.19investigate information provided by an applicant to determine whether the information
15.20is accurate and complete.
15.21(e) The commissioner shall notify an applicant of action taken on the application,
15.22and if licensure is denied or approved with conditions, the grounds for the commissioner's
15.23determination.
15.24(f) An applicant denied licensure or granted licensure with conditions may make
15.25a written request to the commissioner, within 30 days of the date of the commissioner's
15.26determination, for reconsideration of the commissioner's determination. Individuals
15.27requesting reconsideration may submit information that the applicant wants considered in
15.28the reconsideration. After reconsideration of the commissioner's determination to deny
15.29licensure or grant licensure with conditions, the commissioner shall determine whether
15.30the original determination should be affirmed or modified. An applicant is allowed no
15.31more than one request in any one biennial licensure period for reconsideration of the
15.32commissioner's determination to deny licensure or approve licensure with conditions.
15.33 Sec. 12. [148G.11] LICENSURE RENEWAL.
16.1 Subdivision 1. Renewal term. Licenses issued under this chapter must be renewed
16.2every two years. The renewal term is the effective date of the initial license or renewed
16.3license to the date of expiration of the license.
16.4 Subd. 2. Renewal applications. In order to renew a license, a licensee must submit:
16.5(1) a completed and signed application for renewal on a form prescribed by the
16.6commissioner;
16.7(2) the applicable renewal fee as specified in section 148G.16; and
16.8(3) documentation that the licensee has completed continuing education
16.9requirements as prescribed by the recognized certification agencies or 12 hours of
16.10documented continuing education.
16.11 Sec. 13. [148G.12] LICENSURE FOLLOWING LAPSE OF LICENSURE
16.12STATUS.
16.13 For an applicant whose licensure status has lapsed, the applicant must:
16.14(1) apply for licensure renewal according to section 148G.11 and document
16.15compliance with the continuing education requirements as prescribed by the nationally
16.16recognized certification agency since the applicant's license lapsed; and
16.17(2) fulfill the requirements of section 148G.07 and provide evidence of compliance
16.18with the continuing education requirements as prescribed by one of the nationally
16.19recognized certification agencies.
16.20 Sec. 14. [148G.13] CONTINUING EDUCATION REQUIREMENTS.
16.21Continuing education requirements shall be as described by the applicable
16.22certification agencies recognized under this chapter.
16.23 Sec. 15. [148G.14] INVESTIGATION PROCESS; GROUNDS FOR
16.24DISCIPLINARY ACTION.
16.25 Subdivision 1. Disciplinary action. (a) The commissioner may impose disciplinary
16.26action as described in paragraph (b) against an applicant or licensee whom the
16.27commissioner, by a preponderance of the evidence, determines has:
16.28(1) violated a statute, rule, or order that the commissioner issued or is empowered
16.29to enforce;
16.30(2) been convicted of or pled guilty to a felony, gross misdemeanor, misdemeanor,
16.31an essential element of which is dishonesty, or of any crime that is directly related to the
16.32practice of the profession;
17.1(3) made a misrepresentation for the purpose of obtaining licensure, either on an
17.2application provided by the commissioner or in response to oral or written questions
17.3from the commissioner;
17.4(4) violated the code of professional conduct in subdivisions 2 to 4;
17.5(5) engaged in dishonorable, unethical, or unprofessional conduct of a character
17.6likely to deceive, defraud, or harm the public;
17.7(6) failed to perform services with reasonable judgment, skill, or safety due to the
17.8use of alcohol, drugs, or other physical or mental impairment;
17.9(7) aided or assisted another person in violating any provision of this chapter or
17.10any applicable rules;
17.11(8) made any misrepresentation with regard to the existence or category of license or
17.12other certification or professional qualification held in connection with any employment
17.13application;
17.14(9) intentionally submitted false or misleading information in response to a written
17.15request by the commissioner or advisory council;
17.16(10) failed, within 30 days, to provide information in response to a written request
17.17by the commissioner or advisory council;
17.18(11) performed services for which the license is issued in an incompetent manner or
17.19in a manner that falls below community standards;
17.20(12) violated any provision of this chapter;
17.21(13) been convicted of violating any state or federal law, rule, or regulation which
17.22directly relates to the practice related to the discipline for which the individual is licensed;
17.23(14) violated a federal or state court order, including a conciliation court judgment,
17.24or a disciplinary order issued by the commissioner, related to the individual's practice for
17.25which the individual is licensed under this chapter;
17.26(15) aided or abetted another person in violating any provision of this chapter;
17.27(16) been disciplined for conduct in the practice of an occupation by the state of
17.28Minnesota, another jurisdiction, or a national professional association, if any of the
17.29grounds are the same or substantially equivalent to those in this chapter;
17.30(17) not cooperated with the commissioner or the advisory council in an investigation
17.31conducted according to this paragraph;
17.32(18) engaged in conduct with a patient that is sexual or may reasonably be
17.33interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
17.34demeaning to a patient; or
17.35(19) engaged in any other behavior that gives rise to just cause for discipline related
17.36to the practice for which they are licensed under this chapter.
18.1(b) If grounds for disciplinary action exist under paragraph (a), the commissioner
18.2may take one or more of the following actions:
18.3(1) refuse to grant or renew a license;
18.4(2) revoke a license;
18.5(3) suspend a license;
18.6(4) impose limitations or conditions on a license, including, but not limited to,
18.7practice under supervision, continued practice on the demonstration of knowledge or skill
18.8by appropriate examination or other review of knowledge, skill, and competence;
18.9(5) censure or reprimand the licensee;
18.10(6) impose a civil penalty not exceeding $10,000 for each separate violation,
18.11the amount of the civil penalty to be fixed so as to deprive the applicant or licensee
18.12of any economic advantage gained by reason of the violation charged, to discourage
18.13similar violations, or to reimburse the commissioner for the cost of the investigation and
18.14proceeding including, but not limited to, fees paid for services provided by the Office of
18.15Administrative Hearings, legal and investigative services provided by the Office of the
18.16Attorney General, court reporters, witnesses, reproduction of records, advisory council
18.17members' per diem compensation, staff time, and travel costs and expenses incurred
18.18by staff and advisory council members; or
18.19(7) any reasonable lesser action, including, but not limited to, censure, reprimand, or
18.20restriction on licensure, or any action authorized by statute.
18.21(c) Upon notice from the commissioner denying licensure renewal or upon notice
18.22that disciplinary actions have been imposed and the person is no longer entitled to provide
18.23the services for which the person was previously licensed under this chapter, the person
18.24shall cease to provide the services under this chapter, to use the protected titles pursuant to
18.25this chapter, and to represent to the public that the person is licensed by the commissioner.
18.26(d) A person who has had licensure suspended may request and provide justification
18.27for reinstatement following the period of suspension specified by the commissioner. The
18.28requirement of this chapter for renewing licensure and any other conditions imposed with
18.29the suspension must be met before licensure may be reinstated.
18.30(e) The commissioner shall contract with the health professional services program as
18.31authorized by sections 214.31 to 214.37 to provide these services to practitioners under
18.32this chapter. The health professional services program does not affect the commissioner's
18.33authority to discipline violations of this chapter.
18.34 Subd. 2. Duty to patient. Medical laboratory professionals shall:
18.35(1) be accountable for the quality and integrity of the laboratory services they provide;
19.1(2) maintain high standards of practice and sound judgment in establishing,
19.2performing, and evaluating laboratory testing; and
19.3(3) safeguard the dignity and privacy of patients and provide accurate information to
19.4other health care professionals about the services they provide.
19.5 Subd. 3. Duty to colleagues and profession. Medical laboratory professionals shall:
19.6(1) uphold and maintain the dignity and respect of the profession and strive to
19.7maintain a reputation of honesty, integrity, and reliability; and
19.8(2) actively strive to establish cooperative and respectful working relationships with
19.9other health care professionals with the primary objective of ensuring a high standard of
19.10care for the patients they serve.
19.11 Sec. 16. [148G.15] REPORTING OBLIGATIONS.
19.12 Subdivision 1. Permission to report. A person who has knowledge of any conduct
19.13constituting grounds for disciplinary action under this chapter may report the violation to
19.14the commissioner.
19.15 Subd. 2. Institutions. A state agency, political subdivision, agency of a local unit
19.16of government, private agency, hospital, clinic, prepaid medical plan, or other health
19.17care institution or organization located in this state shall report to the commissioner any
19.18action taken by the agency, institution, or organization or any of its administrators or
19.19medical or other committees to revoke, suspend, restrict, or condition a medical laboratory
19.20professional's privilege to practice in the institution, or as part of the organization, any
19.21denial of privileges, or any other disciplinary action for conduct that might constitute
19.22grounds for disciplinary action by the commissioner under this chapter. The institution,
19.23organization, or governmental entity shall also report the resignation of any medical
19.24laboratory science professional before the conclusion of any disciplinary action proceeding
19.25for conduct that might constitute grounds for disciplinary action under this chapter, or
19.26before the commencement of formal charges but after the practitioner had knowledge that
19.27formal charges were contemplated or were being prepared.
19.28 Subd. 3. Professional societies. A state or local professional society for medical
19.29laboratory science professionals shall report to the commissioner any termination,
19.30revocation, or suspension of membership or any other disciplinary action taken against a
19.31medical laboratory science professional. If the society has received a complaint that might
19.32be grounds for discipline under this chapter against a member on which it has not taken
19.33any disciplinary action, the society shall report the complaint and the reason why it has not
19.34taken action on it or shall direct the complainant to the commissioner.
20.1 Subd. 4. Licensed professionals. A licensed health professional shall report to the
20.2commissioner personal knowledge of any conduct that the licensed health professional
20.3reasonably believes constitutes grounds for disciplinary action under this chapter by a
20.4medical laboratory science professional, including conduct indicating that the individual
20.5may be medically incompetent, or may be medically or physically unable to engage safely
20.6in the provision of services. If the information was obtained in the course of a client
20.7relationship, the client is a medical laboratory science professional, and the treating
20.8individual successfully counsels the medical laboratory science professional to limit or
20.9withdraw from practice to the extent required by the impairment, the commissioner may
20.10deem this limitation of or withdrawal from practice to be sufficient disciplinary action.
20.11 Subd. 5. Self-reporting. A medical laboratory science professional shall report
20.12to the commissioner any personal action that would require that a report be filed with
20.13the commissioner by any person, health care facility, business, or organization under
20.14subdivisions 2 to 4. The medical laboratory science professional shall also report the
20.15revocation, suspension, restriction, limitation, or other disciplinary action in this state
20.16and report the filing of charges regarding the practitioner's license or right of practice
20.17in another state or jurisdiction.
20.18 Subd. 6. Deadlines; forms. Reports required by subdivisions 2 to 5 must be
20.19submitted no later than 30 days after the reporter learns of the occurrence of the reportable
20.20event or transaction. The commissioner may provide forms for the submission of required
20.21reports, may require that reports be submitted on the forms provided, and may adopt rules
20.22necessary to ensure prompt and accurate reporting.
20.23 Subd. 7. Immunity for reporting. A person, health care facility, business, or
20.24organization is immune from civil liability or criminal prosecution for reporting to
20.25the commissioner violations or alleged violations of this chapter. All such reports are
20.26classified under section 13.41.
20.27 Subd. 8. Immunity for investigation. The commissioner, employees of the
20.28Minnesota Department of Health, consultants to the department, and advisory council
20.29members are immune from civil liability and criminal prosecution for any actions,
20.30transactions, or publications in the execution of, or relating to, their duties under this
20.31chapter.
20.32 Sec. 17. [148G.16] FEES.
20.33 Subdivision 1. Initial licensure fee. The initial licensure fee for medical laboratory
20.34scientist, categorical medical laboratory scientist, medical laboratory specialist in
20.35molecular biology, medical laboratory specialist in cytogenetics, histocompatibility
21.1technologist, other specialists and categoricals, and medical laboratory technicians is
21.2$155. The commissioner shall prorate fees based on the number of quarters remaining
21.3in the biennial licensure period.
21.4 Subd. 2. Licensure renewal fee. The biennial licensure renewal fee for medical
21.5laboratory scientist, categorical medical laboratory scientist, medical laboratory specialist
21.6in molecular biology, medical laboratory specialist in cytogenetics, histocompatibility
21.7technologist, other specialists and categoricals, and medical laboratory technicians is $115.
21.8 Subd. 3. Late fee. The fee for late submission of a renewal application is $45.
21.9 Subd. 4. Temporary licensure fee. The fee for temporary licensure is $50.
21.10 Subd. 5. Verification to other states. The fee for verification of licensure to other
21.11states is $25.
21.12 Subd. 6. Verification to institutions. The fee for verification of licensure to
21.13institutions is $10.
21.14 Subd. 7. Nonrefundable fees. All fees are nonrefundable.
21.15 Subd. 8. Penalty fees. (a) The penalty fee for practicing medical laboratory science
21.16without a current license after the credential has expired and before it is renewed is the
21.17amount of the license renewal fee for any part of the first month, plus the license renewal
21.18fee for any part of any subsequent month up to 36 months.
21.19(b) The penalty fee for applicants who engage in the unauthorized practice of medical
21.20laboratory science before being issued a license is the amount of the license application fee
21.21for any part of the first month, plus the license application fee for any part of any subsequent
21.22month up to 36 months. This paragraph does not apply to applicants not qualifying for a
21.23license who engage in the unauthorized practice of medical laboratory science.
21.24(c) The penalty fee for failing to submit a continuing education report by the due date
21.25with the correct number or type of hours in the correct time period is $50. The licensee must
21.26obtain the missing number of continuing education hours by the next reporting due date.
21.27(d) Civil penalties and discipline incurred by licensees prior to January 1, 2015, for
21.28conduct described in paragraph (a), (b), or (c), shall be recorded as nondisciplinary penalty
21.29fees. For conduct described in paragraph (a) or (b) occurring after January 1, 2015, and
21.30exceeding six months, payment of a penalty fee does not preclude any disciplinary action
21.31reasonably justified by the individual case.
21.32 Sec. 18. ADVISORY COUNCIL; DEADLINES.
21.33The commissioner of health shall complete the first appointments required by
21.34Minnesota Statutes, section 148G.05, no later than September 1, 2013. The commissioner's
21.35designee shall convene the first meeting of the council no later than October 1, 2013.
22.1The council must select its chair as required by Minnesota Statutes, section 148G.05, at
22.2the first meeting of the council.
22.3 Sec. 19. APPROPRIATION.
22.4$284,000 in fiscal year 2014 is appropriated from the state government special
22.5revenue fund to the commissioner of health to implement this act. Base funding is
22.6$488,000 in fiscal year 2015 and $376,000 in fiscal year 2016.
22.7 Sec. 20. EFFECTIVE DATE.
22.8Sections 1 to 18 are effective July 1, 2013.
