.................... moves to amend S.F. No. 999, the third engrossment, as follows:
Delete everything after the enacting clause and insert:
"Section 1. [148F.01] DEFINITIONS.
1.4 Subdivision 1. Applicability. For purposes of this chapter, the following terms
1.5have the meanings given them.
1.6 Subd. 2. Accredited medical laboratory educational program. "Accredited
1.7medical laboratory educational program" means a program to provide instruction and
1.8experience in medical laboratory science that has been accredited by an accrediting agency
1.9recognized by the United States Department of Health and Human Services.
1.10 Subd. 3. Categorical medical laboratory scientist. "Categorical medical
1.11laboratory scientist" means an individual eligible for licensure under this chapter who
1.12performs the functions of a medical laboratory scientist in one or more of the following
1.13areas of the laboratory depending upon the certification examinations passed: chemistry,
1.14hematology, immunohematology, and microbiology.
1.15 Subd. 4. CLIA. "CLIA" means Clinical Laboratory Improvement Amendments of
1.161988 and includes Public Law 100-578 and Code of Federal Regulations, title 42, section
1.17493. CLIA regulations provide a minimum foundation for which personnel standards for
1.18entry-level technical personnel in this state are built. Qualifications and responsibilities
1.19for laboratory director, technical supervisor, and technical consultant are as specified in
1.20CLIA regulations. All medical laboratory personnel are under the supervision, control,
1.21and responsibility of the laboratory director.
1.22 Subd. 5. Commissioner. "Commissioner" means the commissioner of health or the
1.24 Subd. 6. Cytotechnologist. "Cytotechnologist" means an individual who
1.25specializes in the cellular analysis of patient samples from all body sites, for the purpose
1.26of evaluating, detecting, and providing diagnostic and prognostic information regarding
2.1disease processes, including those that require the exercise of independent technical
2.2judgment, and who:
2.3(1) assists health care providers with the collection, detection, and interpretation
2.4of normal and abnormal cells, infectious agents, and other noncellular material from
2.6(2) performs a variety of medical laboratory tests to ascertain information to
2.7help in classification, prognosis, or disease detection, including, but not limited to,
2.8immunohistochemical and molecular techniques;
2.9(3) establishes and implements protocols, quality control, method selection,
2.10equipment selection and maintenance, and activities related to the preanalytic, analytic,
2.11and postanalytic phases of testing; and
2.12(4) may direct, supervise, consult, and educate and perform research functions.
2.13 Subd. 7. Histotechnician. "Histotechnician" means an individual who:
2.14(1) prepares tissue specimens for microscopic examination;
2.15(2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
2.16and validity of laboratory testing and procedures including, but not limited to, techniques
2.17in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
2.18(3) prepares gross specimens as defined by and under the direction of a
2.19board-certified anatomic pathologist;
2.20(4) establishes and implements protocols, quality assurance, and quality control
2.21related to the following procedures: histochemical, immunohistochemical, electron
2.22microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
2.23hydrolysis, laser capturing, molecular techniques, and research; and
2.24(5) participates in method selection, development, equipment selection and
2.25maintenance, and activities related to the preanalytical and analytical phases of tissue
2.27 Subd. 8. Histotechnologist. "Histotechnologist" means an individual who:
2.28(1) prepares tissue specimens for microscopic examination;
2.29(2) monitors, performs, selects, develops, evaluates, correlates, and ensures accuracy
2.30and validity of laboratory testing and procedures including, but not limited to, techniques
2.31in fixation, processing, embedding, microtomy, cryotomy, ultramicrotomy, and staining;
2.32(3) prepares gross specimens as defined by and under the direction of a
2.33board-certified anatomic pathologist;
2.34(4) establishes and implements protocols, quality assurance, and quality control
2.35related to the following procedures: histochemical, immunohistochemical, electron
3.1microscopy, cytopreparation, in situ hybridization, enzyme histochemical, DNA
3.2hydrolysis, laser capturing, molecular techniques, and research;
3.3(5) establishes and implements new protocols and procedures dealing directly in
3.4quality assessment, method development, and equipment selection and maintenance and
3.5all activities related to preanalytical and analytical phases of tissue preparation; and
3.6(6) may direct, supervise, consult, educate, and perform research functions.
3.7 Subd. 9. Independent medical judgment. In the laboratory, "independent medical
3.8judgment" is exercised only by a pathologist or other licensed physician in the diagnosis
3.9and treatment decisions related to clinical laboratory tests.
3.10 Subd. 10. Independent technical judgment. "Independent technical judgment"
3.11means the performance or conduct of clinical laboratory tests and assumption of
3.12responsibility for determination of the validity of clinical laboratory test results without
3.13intervention by or under the supervision of another health care provider authorized by law
3.14to assume responsibility for the conduct and validity of clinical laboratory tests. The
3.15authorized exercise of independent technical judgment shall not be deemed to include or
3.16permit the exercise of independent medical judgment in the diagnosis or treatment of, or
3.17reporting of clinical laboratory test results or their interpretation to patients except as
3.18authorized by a laboratory director and according to CLIA.
3.19 Subd. 11. Medical laboratory or laboratory. "Medical laboratory" or "laboratory"
3.20means any facility or office in Minnesota in which medical laboratory tests are performed.
3.21 Subd. 12. Medical laboratory scientist or generalist. "Medical laboratory
3.22scientist" or "generalist" means an individual eligible for licensure under this chapter who:
3.23(1) performs medical laboratory tests, including tests that require the exercise of
3.24independent technical judgment;
3.25(2) establishes and implements protocols, quality assessment, method development
3.26and selection, equipment selection and maintenance, and all activities related to the
3.27preanalytic, analytic, and postanalytic phases of laboratory testing; and
3.28(3) may direct, supervise, consult, educate, and perform research functions.
3.29 Subd. 13. Medical laboratory specialist. "Medical laboratory specialist" means
3.30an individual certified and eligible for licensure in one of the categories described in
3.31subdivisions 14, 15, and 16 to perform testing including the tests that require the exercise
3.32of independent technical judgment needed to establish and implement protocols, quality
3.33assessment, method development and selection, equipment selection and maintenance,
3.34and all activities related to the preanalytic, analytic, and postanalytic phases of laboratory
3.35testing, and who direct, supervise, consult, and educate in a specific specialized section of
4.1 Subd. 14. Medical laboratory specialist in cytogenetics. "Medical laboratory
4.2specialist in cytogenetics" means an individual eligible for licensure under this chapter to
4.3perform standard cytogenetic and molecular testing procedures used to evaluate possible
4.5 Subd. 15. Medical laboratory specialist in molecular biology/pathology.
4.6"Medical laboratory specialist in molecular biology/pathology" means an individual
4.7eligible for licensure under this chapter to perform all aspects of molecular analysis
4.8including, but not limited to, recombinant DNA technology, polymerase chain reaction,
4.9and hybridization techniques.
4.10 Subd. 16. Medical laboratory specialist in histocompatibility. "Medical
4.11laboratory specialist in histocompatibility" means an individual eligible for licensure
4.12under this chapter to perform histocompatibility testing procedures including, but not
4.13limited to, molecular and serological techniques.
4.14 Subd. 17. Medical laboratory technician. "Medical laboratory technician" means
4.15an individual eligible for licensure under this chapter who performs medical laboratory
4.16tests at all CLIA complexity levels according to established and approved protocols and
4.17requiring limited exercise of independent technical judgment.
4.18 Subd. 18. Medical laboratory test or laboratory test. "Medical laboratory
4.19test" or "laboratory test" means a microbiological, serological, chemical, biological,
4.20hematological, immunological, immunohematological, radiobioassay, cytological,
4.21histological preparation, molecular, biophysical, or any other test or procedure performed
4.22on material derived from or existing in a human body, which provides information for
4.23the diagnosis, prevention, or monitoring of a disease or impairment or assessment of a
4.24medical condition. A medical laboratory test includes components of the preanalytic and
4.25postanalytic phases of testing, as well as the analytic phase, which occurs in the laboratory.
4.26 Subd. 19. Medical laboratory subspecialist. "Medical laboratory subspecialist"
4.27means an individual eligible for licensure under this chapter to perform the functions
4.28of a medical laboratory scientist in a subspecialty or esoteric clinical laboratory that is
4.29not one of the general categorical areas of the laboratory. The subspecialty/esoteric
4.30laboratories may be disease or medical specialty-oriented or utilize advanced technology
4.31not routinely used in the clinical laboratory. These subspecialty/esoteric laboratories may
4.32be subspecialized areas within the hematology, chemistry, immunology, transfusion,
4.33medicine, genetics, or microbiology disciplines.
4.34 Subd. 20. Nationally recognized certification agency. "Nationally recognized
4.35certification agency" means an agency that provides certification examinations for medical
5.1laboratory professionals. As the agency defines new certification examinations, the
5.2commissioner and the advisory council may recognize these examinations.
5.3 Subd. 21. Pathologist assistant. "Pathologist assistant" means an individual
5.4specializing in prediagnostic surgical pathology and autopsy pathology who assists
5.6 Subd. 22. Phlebotomist. "Phlebotomist" means an individual who is qualified to
5.7obtain blood samples for testing by means of venipuncture, capillary puncture, or access
5.8of venous access devices, to perform specimen processing and preparation of samples for
5.9testing, and to perform waived and point-of-care testing.
5.10 Subd. 23. Point-of-care testing. "Point-of-care testing" means analytical patient
5.11testing activities provided within a facility, which do not require permanent dedicated
5.12space including, but not limited to, analytic instruments that are temporarily brought to a
5.13patient care location. Point-of-care testing must be under the direction of an individual
5.14licensed under this chapter at the baccalaureate degree level or who qualifies as a
5.15laboratory director under federal CLIA regulations.
5.16 Subd. 24. Trainee or student. "Trainee or student" means an individual who has
5.17not fulfilled the educational requirements to take an approved nationally recognized
5.18certification examination or who needs to obtain full-time comprehensive experience
5.20 Subd. 25. Waived test. "Waived test" means a laboratory examination or procedure
5.21as determined by the United States Food and Drug Administration that has an insignificant
5.22risk of an erroneous result, including those which:
5.23(1) have been approved by the United States Food and Drug Administration for
5.25(2) employ methodologies that are so simple and accurate as to render the likelihood
5.26of erroneous results negligible; or
5.27(3) pose no reasonable risk of harm to the patient if performed incorrectly.
Sec. 2. [148F.02] EXEPTIONS.
5.29(a) This chapter does not apply to:
5.30(1) the qualifications for laboratory directors, technical supervisors, or technical
5.31consultants as established by federal CLIA;
5.32(2) other licensed or registered professionals performing functions within the
5.33professional's scope of practice;
6.1(3) medical laboratory science professionals employed by the United States
6.2government, or any bureau, division, or agency, while performing duties within the scope
6.3of the professional's federal employment;
6.4(4) medical laboratory science professionals engaged exclusively in basic science or
6.5investigative research, provided that the results of any examination performed are not used
6.6in health maintenance, diagnosis, or treatment of disease as described in federal CLIA
6.7regulations under Code of Federal Regulations, title 42, section 493;
6.8(5) professionals engaged exclusively in assay development or management-related
6.9activities in the clinical laboratory, provided the results of any examination performed
6.10are not used in health maintenance, diagnosis, or treatment of disease as described in
6.11federal CLIA regulations;
6.12(6) professionals engaged exclusively in the education of medical laboratory science
6.13professionals, provided that results of any examination performed are not used in health
6.14maintenance, diagnosis, or treatment of disease as described in federal CLIA regulations;
6.15(7) professionals engaged exclusively in providing phlebotomy services;
6.16(8) pathologist assistants or individuals performing pathology assistant activities
6.17under supervision by pathologists;
6.18(9) cytotechnologists, which fall under the federally mandated CLIA personnel
6.20(10) histotechnicians and histotechnologists;
6.21(11) students or trainees enrolled in a medical laboratory science education program
6.23(i) the activities performed by the student or trainee constitute a part of a planned
6.24course in the program;
6.25(ii) the student or trainee is clearly designated as intern, trainee, or student; and
6.26(iii) the student or trainee is working directly under an individual licensed under this
6.27chapter to practice medical laboratory science;
6.28(12) individuals who only perform waived tests or moderately complex point-of-care
6.29tests under the direction of a qualified CLIA laboratory director according to federal
6.30CLIA regulations; and
6.31(13) individuals who perform moderately complex testing as defined by federal
6.32CLIA regulations provided that the laboratory complies with the following requirements:
6.33(i) within the laboratory, a licensed medical laboratory scientist or individual who
6.34qualifies as a laboratory director under federal CLIA regulations is responsible for:
6.35(A) designing, providing, and supervising the training programs for the testing
7.1(B) supervising and monitoring the quality assurance and quality control activities
7.2of the testing site;
7.3(C) assisting in the selection of technology;
7.4(D) reviewing the results of proficiency testing and recommending corrective
7.5action, if necessary; and
7.6(E) monitoring the continued laboratory testing competency of the testing personnel;
7.7(ii) documented personnel evaluation processes are in place, which ensure and
7.8document the continued competency of the testing personnel; and
7.9(iii) after the effective date of this chapter, the licensed medical laboratory scientist
7.10or individual who qualifies as a laboratory director under CLIA regulations must ensure
7.11that new employees have initial certification as a certified or registered medical assistant
7.12or certified office laboratory technician, by the American Medical Technologists (AMT)
7.13or the American Association of Medical Assistants (AAMA) or other national certification
7.14agency recognized by the commissioner. Individuals employed as a medical assistant or
7.15office laboratory technician on the effective date of this chapter will be grandfathered in.
7.16Failure to comply with the requirements described in clause (13) subjects the
7.17individual to the requirements of this chapter and requires the individual to be licensed as
7.18required under this chapter.
7.19(b) This chapter does not apply to a declared emergency as defined in section 12.03,
7.20that reduces laboratory capacity or increases testing demands, or other loss of critical
7.21laboratory capacity, practitioners who are not licensed in any state, but are certified by one
7.22of the agencies recognized in this chapter or deemed competent by the affected laboratory
7.23director may practice as needed in the emergency situation.
Sec. 3. [148F.03] LICENSURE REQUIRED; TITLES USED, RESTRICTED,
7.26 Subdivision 1. Unlicensed practice prohibited. Effective January 1, 2012, no
7.27individual shall perform a medical laboratory test unless the individual is licensed under
7.28this chapter as a medical laboratory scientist, categorical medical laboratory scientist,
7.29medical laboratory technician, medical laboratory specialist in cytogenetics, medical
7.30laboratory specialist in molecular biology/pathology, medical laboratory specialist in
7.31histocompatibility, medical laboratory subspecialist, or is exempt from licensure under
7.33 Subd. 2. Protected titles and restrictions on use. No individual shall use the phrase
7.34medical laboratory scientist, categorical medical laboratory scientist, medical laboratory
7.35technician, medical laboratory specialist in cytogenetics, medical laboratory specialist
8.1in molecular biology/pathology, medical laboratory specialist in histocompatibility, or
8.2medical laboratory subspecialist, or the initials MLS or MLT, alone or in combination
8.3with any other words or initials to form an occupational title, or to indicate or imply that
8.4the person is licensed as one of the professionals listed unless the individual is licensed
8.5under this chapter.
8.6 Subd. 3. Persons licensed or certified in other states. An individual who
8.7is licensed under this chapter and licensed or certified in another state may use the
8.8designation licensed or certified with a protected title only if the state of licensure or
8.9certification is clearly indicated.
Sec. 4. [148F.035] SCOPE OF PRACTICE.
8.11Medical laboratory professionals licensed under this chapter shall perform laboratory
8.12tests and provide test results to physicians and patients upon request or upon physician
8.13referral according to CLIA. The practice of medical laboratory science includes:
8.14(1) the production of test data;
8.15(2) monitoring the accuracy, precision, and utility of laboratory testing;
8.16(3) analytical correlation and interpretation of test data; and
8.17(4) designing, evaluating, and implementing new laboratory test methods.
8.18The services provided by medical laboratory professionals must be consistent with
8.19good practice and sound professional ethics.
Sec. 5. [148F.04] DUTIES OF COMMISSIONER.
8.21The commissioner, with the advice of the advisory council, shall:
8.22(1) administer the procedures for this chapter, including, but not limited to, verifying
8.23the qualifications and standards for education, experience, examinations, and continuing
8.24education, as established by the certification agencies recognized in this chapter, and
8.25other methods for determining whether an applicant or licensee is qualified, as specified
8.26under this chapter;
8.27(2) enforce standards for professional conduct found in the Code of Professional
8.29(3) issue licenses to qualified individuals;
8.30(4) collect and deposit fees as established under section 148F.16;
8.31(5) on the recommendation of the advisory council, approve future nationally
8.32recognized, validated, competency-based written, oral, or practical examinations
8.33developed by the National Credentialing Agency, American Society for Clinical Pathology
8.34Board of Registry, American Society for Clinical Pathology Board of Certification,
9.1American Medical Technologists, American Association of Bioanalysts, and American
9.2Society for Histocompatibility and Immunogenetics, or successor organizations, for
9.3purposes of licensure of medical laboratory science professionals as provided for in this
9.5(6) maintain a roster of the names and addresses of individuals currently licensed
9.6under this chapter and of all individuals whose licenses have been disciplined under
Sec. 6. [148F.05] MEDICAL LABORATORY SCIENCE PROFESSIONAL
9.9LICENSING ADVISORY COUNCIL.
9.10 Subdivision 1. Membership and qualifications of advisory council. (a) The
9.11commissioner shall appoint a nine-member advisory council that may include applicants
9.12recommended by laboratory professional associations. Members must be actively
9.13employed for at least two years in their specific area of practice. Members shall serve
9.14two-year terms and until their successors have been appointed.
9.15(b) Four members must be medical laboratory science professionals who are licensed
9.16under this chapter and include:
9.17(1) one nonphysician laboratory director;
9.18(2) one medical laboratory scientist;
9.19(3) one medical laboratory technician; and
9.20(4) one specialist in cytogenetics, histocompatibility, or molecular biology.
9.21(c) Three members must be physicians certified by the American Board of Pathology
9.22or the American Board of Osteopathic Pathology. All three must be certified in clinical
9.24(d) One of the members must be a physician who is not a laboratory director and
9.25is not a pathologist.
9.26(e) One member must be a public member as defined in section 214.02.
9.27 Subd. 2. Duties. The advisory council shall:
9.28(1) advise and make recommendations to the commissioner regarding the medical
9.29laboratory science practitioner licensure standards;
9.30(2) advise the commissioner on enforcement of this chapter;
9.31(3) provide for distribution of information regarding medical laboratory science
9.32practitioners licensure standards;
9.33(4) review applications upon the request of the commissioner and make
9.34recommendations on granting or denying licensure or licensure renewal;
10.1(5) advise the commissioner on issues related to receiving and investigating
10.2complaints, conducting objective hearings, and imposing disciplinary action in relation to
10.3complaints received against medical laboratory science practitioners; and
10.4(6) perform other duties requested by the commissioner.
10.5 Subd. 3. Organization. The advisory council shall be organized and administered
10.6under section 15.059. The advisory council shall select a chair from its membership.
10.7 Subd. 4. Support. The commissioner shall provide the necessary staff support
10.8and meeting space for the advisory council.
10.9 Subd. 5. Expiration. Notwithstanding section 15.059, subdivision 5, this section
10.10expires June 30, 2013.
Sec. 7. [148F.06] TEMPORARY REQUIREMENTS FOR LICENSURE;
10.13 Subdivision 1. Experienced medical laboratory science professionals transition.
10.14(a) Notwithstanding section 148F.03, an individual who is certified by or eligible to be
10.15certified by a certification agency recognized by the commissioner to perform medical
10.16laboratory testing, or meets the subspecialty requirements in section 148F.07, subdivision
10.177, may perform medical laboratory tests without the appropriate license provided the
10.18individual has applied to the commissioner for licensure and the application:
10.19(1) has not been denied by the commissioner; or
10.20(2) has not been withdrawn.
10.21(b) This subdivision expires January 1, 2012.
10.22 Subd. 2. Employed medical laboratory science professional transition. (a) An
10.23individual who does not meet the education, training, and experience qualifications for
10.24any license described in this chapter on July 1, 2010, has until January 1, 2012, to apply
10.25for a license under this subdivision.
10.26(b) The commissioner shall issue a license if the applicant under paragraph (a):
10.27(1) is practicing in the field on July 1, 2010, or has six months of acceptable
10.28experience of at least half-time, 1,040 hours per year, in the three years immediately
10.29prior to July 1, 2010; and
10.30(2) on a form provided by the commissioner submits the job, title, description of
10.31the position, period of employment, and confirmation of competent practice, as attested
10.32to by the applicant's employer.
10.33(c) The commissioner and advisory council shall determine which type of license the
10.34applicant is eligible for and issue the license if the requirements in this subdivision are met.
11.1(d) An initial license issued under this subdivision must be reviewed following the
11.2procedures required under section 148F.10, provided the license is maintained without
11.4(e) This subdivision expires January 1, 2012.
Sec. 8. [148F.07] STANDARDS FOR LICENSURE.
11.6 Subdivision 1. Medical laboratory scientist (MLS). The commissioner shall issue
11.7a medical laboratory scientist license to an individual who meets the requirements in
11.8clauses (1) to (3), or in clause (4):
11.9(1) possesses a baccalaureate degree from a regionally accredited college or
11.10university and verified by the nationally recognized certification agencies;
11.11(2) has met the medical laboratory experience and training required by the
11.12recognized certification agencies; and
11.13(3) passes a nationally recognized certification examination administered by the
11.14American Society for Clinical Pathology Board of Certification, American Society for
11.15Clinical Pathology Board of Registry, the National Credentialing Agency, American
11.16Medical Technologists, American Association of Bioanalysts, or successor organizations;
11.18(4) who has completed an official military training program of at least 50 weeks,
11.19which was approved by the National Accrediting Agency for Clinical Laboratory Science
11.20(NAACLS) or a national accrediting agency acceptable to the commissioner, and held the
11.21military enlisted occupational specialty of medical laboratory specialist and possesses a
11.22baccalaureate degree from a regionally accredited college or university.
11.23 Subd. 2. Medical laboratory scientist, categorical. The board shall issue a
11.24categorical medical laboratory scientist license to an individual who:
11.25(1) possesses a baccalaureate degree from a regionally accredited college or
11.26university and verified by the nationally recognized certification agencies;
11.27(2) has met the medical laboratory experience and training required by the
11.28recognized certification agencies; and
11.29(3) passes a nationally recognized certification examination administered by the
11.30American Society for Clinical Pathology Board of Certification, American Society for
11.31Clinical Pathology Board of Registry, the National Credentialing Agency, American
11.32Medical Technologists, American Association of Bioanalysts, or successor organizations.
11.33 Subd. 3. Medical laboratory technician (MLT). The commissioner shall issue a
11.34medical laboratory technician license to an individual who:
12.1(1) possesses an associate degree from a regionally accredited college or university
12.2verified by the nationally recognized certification agencies;
12.3(2) has met the medical laboratory experience and training required by the
12.4recognized certification agencies; and
12.5(3) passes a nationally recognized certification examination administered by the
12.6American Society for Clinical Pathology Board of Certification, American Society for
12.7Clinical Pathology Board of Registry, the National Credentialing Agency, the American
12.8Medical Technologists, American Association of Bioanalysts, or successor organizations;
12.10(4) who has completed an official military training program of at least 50 weeks,
12.11which was approved by the National Accrediting Agency for Clinical Laboratory Science
12.12(NAACLS) or a national accrediting agency acceptable to the commissioner, and held the
12.13military enlisted occupational specialty of medical laboratory specialist and possesses an
12.14associate degree from a regionally accredited college or university.
12.15 Subd. 4. Medical laboratory specialist in molecular biology. The commissioner
12.16shall issue a medical laboratory specialist in molecular biology license to an individual
12.18(1) possesses a baccalaureate degree from a regionally accredited college or
12.19university verified by the recognized certification agencies;
12.20(2) meets the medical laboratory experience and training required by the nationally
12.21recognized certification agencies, or alternatively one year of on-the-job training; and
12.22(3) either passes a nationally recognized certification examination administered by
12.23the American Society for Clinical Pathology Board of Certification, American Society
12.24for Clinical Pathology Board of Registry, the National Credentialing Agency, American
12.25Association of Bioanlysts, or successor organizations or is deemed competent via written
12.26confirmation by the respective laboratory director.
12.27 Subd. 5. Medical laboratory specialist in cytogenetics. The commissioner shall
12.28issue a medical laboratory specialist in cytogenetics license to an individual who:
12.29(1) possesses a baccalaureate degree from a regionally accredited college or
12.30university verified by the nationally recognized certification agencies;
12.31(2) has met the medical laboratory experience and training required by the nationally
12.32recognized certification agencies or alternatively one year of on-the-job training; and
12.33(3) passes a nationally recognized certification examination administered by the
12.34American Society for Clinical Pathology Board of Certification, National Credentialing
12.35Agency, or successor organizations or is deemed competent via written confirmation by
12.36the respective laboratory director.
13.1 Subd. 6. Histocompatibility technologist. The commissioner shall issue a medical
13.2laboratory specialist in histocompatibility license to an individual who:
13.3(1) possesses a baccalaureate degree from a regionally accredited college or
13.4university verified by the nationally recognized certification agencies;
13.5(2) has met the medical laboratory experience and training required by the nationally
13.6recognized certification agencies or alternatively one year of on-the-job training; and
13.7(3) passes a nationally recognized certification examination administered by the
13.8American Board of Histocompatibility and Immunogenetics or is deemed competent via
13.9written confirmation by the respective laboratory director.
13.10 Subd. 7. Medical laboratory subspecialist. The commissioner shall issue a
13.11medical laboratory subspecialist license to an individual who:
13.12(1) possesses a baccalaureate degree from a regionally accredited college or
13.13university verified by the nationally recognized certification agencies;
13.14(2) has met the required medical laboratory experience and training through one
13.15year of on-the-job training; and
13.16(3) either is deemed competent via written confirmation by the respective laboratory
13.17director or passes a nationally recognized certification examination administered by the
13.18American Society for Clinical Pathology Board of Certification, American Medical
13.19Technologists, American Association of Bioanalysts, or successor organizations.
Sec. 9. [148F.08] RECIPROCITY.
13.21 Subdivision 1. Licensure. The commissioner may waive the licensure requirements
13.22for an applicant who holds a valid license or its equivalent issued by another state
13.23provided that the requirements under which that license or its equivalent was issued are
13.24equivalent to or exceed the standards required by this chapter. Once the license is up
13.25for renewal, the applicant shall be issued a Minnesota license upon meeting the license
13.26renewal requirements in section 148F.11.
13.27 Subd. 2. Current credentials required. An applicant applying for licensure by
13.28reciprocity must provide all necessary evidence to the commissioner that the applicant
13.29holds a current and unrestricted license for the practice of medical laboratory science
13.30in another jurisdiction that has requirements equivalent to or higher than the standards
13.31required to be licensed as a medical laboratory professional in one of the categories
13.32defined in this chapter.
13.33 Subd. 3. Verification of credentials required. An applicant for licensure under
13.34this section must have maintained the appropriate and unrestricted credentials in each
13.35jurisdiction during the last five years as demonstrated by submitting letters of verification
14.1to the commissioner. Each letter must state the applicant's name, date of birth, credential
14.2number, date of issuance, a statement regarding disciplinary actions, if any, taken against
14.3the applicant, and the terms under which the credential was issued.
Sec. 10. [148F.09] TEMPORARY LICENSE REQUIREMENTS.
14.5(a) The commissioner may issue a temporary license to an applicant who:
14.6(1) is eligible to sit for and registered to take a certification examination or has taken
14.7the examination and is awaiting results;
14.8(2) meets the educational requirements of the nationally recognized certification
14.9agency and is seeking to qualify for the certification examination by completing the
14.10required supervised medical laboratory experience; or
14.11(3) meets the educational requirements for the position and is undergoing the
14.12required on-the-job training necessary for a specialized clinical laboratory.
14.13(b) A temporary license shall be issued for a 12-month period and may be renewed
14.14for two additional 12-month periods at the discretion of the commissioner, in order to
14.15allow the applicant to complete the required supervised medical laboratory experience or
14.16retake a certification examination, or be deemed competent by the laboratory director.
14.17(c) A temporary license expires 12 months after it is issued or on the date the
14.18commissioner issues or denies a permanent license to the holder.
14.19(d) A temporary license authorizes the holder to perform medical laboratory tests
14.20only in the area of practice for which the individual seeks to be permanently licensed.
Sec. 11. [148F.10] LICENSURE APPLICATION PROCEDURES.
14.22(a) Applicants must submit an application for licensure to the commissioner on
14.23forms prescribed and furnished by the commissioner, and must submit with the application
14.24the designated application fee as specified in section 148F.16.
14.25(b) Upon receipt of the application and the application fee, the commissioner shall
14.26issue a license for a medical laboratory scientist, a medical laboratory technician, or
14.27an appropriate specialty license to an individual who meets the qualifications specified
14.28in this chapter.
Sec. 12. [148F.11] LICENSURE RENEWAL.
14.30 Subdivision 1. Renewal term. Licenses issued under this chapter must be renewed
14.31every two years. The renewal term is the effective date of the initial license or renewed
14.32license to the date of expiration of the license.
14.33 Subd. 2. Renewal applications. In order to renew a license, a licensee must submit:
15.1(1) a completed and signed application for renewal on a form prescribed by the board;
15.2(2) the applicable renewal fee as specified in section 148F.16; and
15.3(3) documentation that the licensee has completed continuing education requirements
15.4as prescribed by the nationally recognized certification agencies or 12 hours annually of
15.5documented continuing education.
Sec. 13. [148F.12] LICENSURE FOLLOWING LAPSE OF LICENSURE
15.8For an applicant whose licensure status has lapsed, the applicant must:
15.9(1) apply for licensure renewal according to section 148F.11 and document
15.10compliance with the continuing education requirements as prescribed by the nationally
15.11recognized certification agency since the applicant's license lapsed; and
15.12(2) fulfill the requirements of section 148F.07 and provide evidence of compliance
15.13with the continuing education requirements as prescribed by one of the nationally
15.14recognized certification agencies.
Sec. 14. [148F.13] CONTINUING EDUCATION REQUIREMENTS.
15.16Continuing education requirements shall be as described by the applicable
15.17certification agencies recognized under section 148F.07.
Sec. 15. [148F.14] INVESTIGATION PROCESS; GROUNDS FOR
15.20 Subdivision 1. Disciplinary action. (a) The commissioner may impose disciplinary
15.21action as described in paragraph (b) against an applicant or licensee whom the
15.22commissioner, by a preponderance of the evidence, determines:
15.23(1) has violated a statute, rule, or order that the commissioner issued or is empowered
15.25(2) has been convicted of or pled guilty to a felony, gross misdemeanor, or
15.26misdemeanor, an essential element of which is dishonesty, or of any crime which is
15.27directly related to the practice of the profession;
15.28(3) has made a misrepresentation for the purpose of obtaining licensure, either on
15.29an application provided by the commissioner or in response to oral or written questions
15.30from the commissioner;
15.31(4) violated the code of professional conduct in subdivisions 2 and 3;
15.32(5) engaged in dishonorable, unethical, or unprofessional conduct of a character
15.33likely to deceive, defraud, or harm the public;
16.1(6) failed to perform services with reasonable judgment, skill, or safety due to the
16.2use of alcohol, drugs, or other physical or mental impairment;
16.3(7) aided or assisted another person in violating any provision of this chapter or
16.4any applicable rules;
16.5(8) made any misrepresentation with regard to the existence or category of license or
16.6other certification or professional qualification held in connection with any employment
16.8(9) intentionally submitted false or misleading information in response to a written
16.9request by the commissioner or advisory council;
16.10(10) failed, within 30 days, to provide information in response to a written request
16.11by the commissioner or advisory council;
16.12(11) performed services for which the license is issued in an incompetent manner or
16.13in a manner that falls below community standards;
16.14(12) violated any provision of this chapter;
16.15(13) been convicted of violating any state or federal law, rule, or regulation that
16.16directly relates to the practice related to the discipline for which the individual is licensed;
16.17(14) violated a federal or state court order, including a conciliation court judgment,
16.18or a disciplinary order issued by the commissioner, related to the individual's practice for
16.19which they are licensed under this chapter;
16.20(15) aided or abetted another person in violating any provision of this chapter;
16.21(16) been disciplined for conduct in the practice of an occupation by the state of
16.22Minnesota, another jurisdiction, or a national professional association, if any of the
16.23grounds are the same or substantially equivalent to those in this chapter;
16.24(17) not cooperated with the commissioner or the advisory council in an investigation
16.25conducted according to this paragraph;
16.26(18) engaged in conduct with a patient that is sexual or may reasonably be
16.27interpreted by the patient as sexual, or in any verbal behavior that is seductive or sexually
16.28demeaning to a patient; or
16.29(19) any other just cause related to the practice for which they are licensed under
16.31(b) If grounds for disciplinary action exist under paragraph (a), the commissioner
16.32may take one or more of the following actions:
16.33(1) refuse to grant or renew a license;
16.34(2) revoke a license;
16.35(3) suspend a license;
17.1(4) impose limitations or conditions on a license, including, but not limited to,
17.2practice under supervision and continued practice on the demonstration of knowledge or
17.3skill by appropriate examination or other review of knowledge, skill, and competence;
17.4(5) censure or reprimand the licensee;
17.5(6) impose a civil penalty not exceeding $10,000 for each separate violation,
17.6the amount of the civil penalty to be fixed so as to deprive the applicant or licensee
17.7of any economic advantage gained by reason of the violation charged, to discourage
17.8similar violations, or to reimburse the commissioner for the cost of the investigation and
17.9proceeding including, but not limited to, fees paid for services provided by the Office of
17.10Administrative Hearings, legal and investigative services provided by the Office of the
17.11Attorney General, court reporters, witnesses, reproduction of records, advisory council
17.12members per diem compensation, staff time, and travel costs and expenses incurred by
17.13staff and advisory council members; or
17.14(7) any reasonable lesser action including, but not limited to, censure, reprimand, or
17.15restriction on licensure, or any action authorized by statute.
17.16(c) Upon notice from the commissioner denying licensure renewal or upon notice
17.17that disciplinary actions have been imposed and the person is no longer entitled to provide
17.18the services for which the person was previously licensed under this chapter, the person
17.19shall cease to provide the services under this chapter, to use the protected titles pursuant to
17.20this chapter, and to represent to the public that the person is licensed by the commissioner.
17.21(d) A person who has had licensure suspended may request and provide justification
17.22for reinstatement following the period of suspension specified by the commissioner. The
17.23requirement of this chapter for renewing licensure and any other conditions imposed with
17.24the suspension must be met before licensure may be reinstated.
17.25(e) The commissioner shall contract with the health professional services program as
17.26authorized by sections 214.31 to 214.37 to provide these services to practitioners under
17.27this chapter. The health professional services program does not affect the commissioner's
17.28authority to discipline violations of this chapter.
17.29 Subd. 2. Duty to patient. Medical laboratory professionals shall:
17.30 (1) be accountable for the quality and integrity of the laboratory services they
17.32(2) maintain high standards of practice and sound judgment in establishing,
17.33performing, and evaluating laboratory testing; and
17.34(3) safeguard the dignity and privacy of patients and provide accurate information to
17.35other health care professionals about the services they provide.
17.36 Subd. 3. Duty to colleagues and profession. Medical laboratory professionals shall:
18.1 (1) uphold and maintain the dignity and respect of the profession and strive to
18.2maintain a reputation of honesty, integrity, and reliability; and
18.3(2) actively strive to establish cooperative and respectful working relationships with
18.4other health care professionals with the primary objective of ensuring a high standard of
18.5care for the patients they serve.
Sec. 16. [148F.15] REPORTING OBLIGATIONS.
18.7 Subdivision 1. Permission to report. A person who has knowledge of any conduct
18.8constituting grounds for disciplinary action under this chapter may report the violation to
18.10 Subd. 2. Institutions. A state agency, political subdivision, agency of a local unit
18.11of government, private agency, hospital, clinic, prepaid medical plan, or other health
18.12care institution or organization located in this state shall report to the commissioner any
18.13action taken by the agency, institution, or organization or any of its administrators or
18.14medical or other committees to revoke, suspend, restrict, or condition a medical laboratory
18.15professional's privilege to practice in the institution, or as part of the organization, any
18.16denial of privileges, or any other disciplinary action for conduct that might constitute
18.17grounds for disciplinary action by the commissioner under this chapter. The institution,
18.18organization, or governmental entity shall also report the resignation of any medical
18.19laboratory science professional before the conclusion of any disciplinary action proceeding
18.20for conduct that might constitute grounds for disciplinary action under this chapter, or
18.21before the commencement of formal charges but after the practitioner had knowledge that
18.22formal charges were contemplated or were being prepared.
18.23 Subd. 3. Professional societies. A state or local professional society for medical
18.24laboratory science professionals shall report to the commissioner any termination,
18.25revocation, or suspension of membership or any other disciplinary action taken against a
18.26medical laboratory science professional. If the society has received a complaint that might
18.27be grounds for discipline under this chapter against a member on which it has not taken
18.28any disciplinary action, the society shall report the complaint and the reason why it has not
18.29taken action on it or shall direct the complainant to the commissioner.
18.30 Subd. 4. Licensed professionals. A licensed health professional shall report to the
18.31commissioner personal knowledge of any conduct that the licensed health professional
18.32reasonably believes constitutes grounds for disciplinary action under this chapter by a
18.33medical laboratory science professional, including conduct indicating that the individual
18.34may be medically incompetent, or may be medically or physically unable to engage safely
18.35in the provision of services. If the information was obtained in the course of a client
19.1relationship, the client is a medical laboratory science professional, and the treating
19.2individual successfully counsels the medical laboratory science professional to limit or
19.3withdraw from practice to the extent required by the impairment, the commissioner may
19.4deem this limitation of or withdrawal from practice to be sufficient disciplinary action.
19.5 Subd. 5. Self-reporting. A medical laboratory science professional shall report
19.6to the commissioner any personal action that would require that a report be filed with
19.7the commissioner by any person, health care facility, business, or organization under
19.8subdivisions 2 to 4. The medical laboratory science professional shall also report the
19.9revocation, suspension, restriction, limitation, or other disciplinary action in this state
19.10and report the filing of charges regarding the practitioner's license or right of practice
19.11in another state or jurisdiction.
19.12 Subd. 6. Deadlines; forms. Reports required by subdivisions 2 to 5 must be
19.13submitted no later than 30 days after the reporter learns of the occurrence of the reportable
19.14event or transaction. The commissioner may provide forms for the submission of required
19.15reports, may require that reports be submitted on the forms provided, and may adopt rules
19.16necessary to ensure prompt and accurate reporting.
19.17 Subd. 7. Immunity for reporting. A person, health care facility, business, or
19.18organization is immune from civil liability or criminal prosecution for reporting to
19.19the commissioner violations or alleged violations of this chapter. All such reports are
19.20classified under section 13.41.
19.21 Subd. 8. Immunity for investigation. The commissioner, employees of the
19.22Minnesota Department of Health, consultants to the department, and advisory council
19.23members are immune from civil liability and criminal prosecution for any actions,
19.24transactions, or publications in the execution of, or relating to, their duties under this
Sec. 17. [148F.16] FEES.
19.27 Subdivision 1. Initial licensure fee. The initial licensure fee for medical
19.28laboratory scientist, categorical medical laboratory scientist, medical laboratory
19.29specialist in molecular biology/pathology, medical laboratory specialist in cytogenetics,
19.30histocompatibility technologist, other specialists and categoricals, and medical laboratory
19.31technician is $....... The commissioner shall prorate fees based on the number of quarters
19.32remaining in the triennial licensure period.
19.33 Subd. 2. Licensure renewal fee. The biennial licensure renewal fee for medical
19.34laboratory scientist, categorical medical laboratory scientist, medical laboratory
19.35specialist in molecular biology/pathology, medical laboratory specialist in cytogenetics,
20.1histocompatibility technologist, other specialists and categoricals, and medical laboratory
20.2technician is $.......
20.3 Subd. 3. Late fee. The fee for late submission of a renewal application is $45.
20.4 Subd. 4. Temporary licensure fee. The fee for temporary licensure is $50.
20.5 Subd. 5. Verification to other states. The fee for verification of licensure to other
20.6states is $25.
20.7 Subd. 6. Nonrefundable fees. All fees are nonrefundable.
20.8 Subd. 7. Penalty fees. (a) The penalty fee for practicing medical laboratory science
20.9without a current license after the credential has expired and before it is renewed is the
20.10amount of the license renewal fee for any part of the first month, plus the license renewal
20.11fee for any part of any subsequent month up to 36 months.
20.12(b) The penalty fee for applicants who engage in the unauthorized practice of
20.13medical laboratory science before being issued a license is the amount of the license
20.14application fee for any part of the first month, plus the license application fee for any part
20.15of any subsequent month up to 36 months. This paragraph does not apply to applicants not
20.16qualifying for a license who engage in the unauthorized practice of medical laboratory
20.18(c) The penalty fee for failing to submit a continuing education report by the due
20.19date with the correct number or type of hours in the correct time period is $50. The
20.20licensee must obtain the missing number of continuing education hours by the next
20.21reporting due date.
20.22(d) Civil penalties and discipline incurred by licensees prior to January 1, 2012, for
20.23conduct described in paragraph (a), (b), or (c), shall be recorded as nondisciplinary penalty
20.24fees. For conduct described in paragraph (a) or (b) occurring after January 1, 2012, and
20.25exceeding six months, payment of a penalty fee does not preclude any disciplinary action
20.26reasonably justified by the individual case.
Sec. 18. ADVISORY COUNCIL; DEADLINES.
20.28The commissioner of health shall complete the first appointments required by
20.29Minnesota Statutes, section 148F.05, no later than September 1, 2010. The commissioner's
20.30designee shall convene the first meeting of the council no later than October 1, 2010.
20.31The council must select its chair as required by Minnesota Statutes, section 148F.05, at
20.32the first meeting of the council.
Sec. 19. EFFECTIVE DATE.
21.1Setup of licensing functions and creation of the advisory council shall be effective
21.2July 1, 2010. Licensure shall be effective January 1, 2012.
Delete the title and insert:
relating to health professions; requiring licensing for medical laboratory
professionals;proposing coding for new law as Minnesota Statutes, chapter