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NORTH DAKOTA STATUTES AND CODES

43-48 Clinical Laboratory Personnel

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CHAPTER 43-48CLINICAL LABORATORY PERSONNEL43-48-01. Definitions. In this chapter, unless the context or subject matter otherwiserequires:1."Board" means the North Dakota board of clinical laboratory practice.2."Clinical laboratory" means a site where clinical laboratory testing is done.3."Clinical laboratory personnel" means all clinical laboratory scientists or medical
technologists or specialists, and clinical laboratory technicians or medical laboratory
technicians working in a clinical laboratory, but does not include persons employed
by a clinical laboratory to perform clerical duties or other duties classified as
supportive functions not related to the direct performance of patient tests, such as
phlebotomists, does not include clinical laboratory students, and does not include
cytologists performing cytology procedures and histologists or histotechnicians
performing histology procedures.4."Clinical laboratory student" means a person having qualified and enrolled in an
approved program of structured clinical education and who is seeking training and
experience required to meet minimum qualifications for a license by the board to
practice as a clinical laboratory person in this state.5."Clinical laboratory testing" means a microbiological, serological, chemical,
hematological, radiobioassay, biophysical, or immunological assay which is derived
from the human body, to provide information for diagnosis, prevention, or treatment
of a disease or assessment of a medical condition.6."Consumer" means a person who might use laboratory medicine services or the
services of its practitioners, but does not derive such person's livelihood from these
services.7."National certifying examination" means national examinations given to certify
clinical laboratory personnel and recognized by the board.8."Screening test" means a test measuring only the approximate value of the analyte
being tested and not used for diagnosis.9."Specimen" means any material derived from the human body for examination or
other procedure for the purpose of providing information for the diagnosis,
prevention, or treatment of any disease, impairment, or assessment of the health of
humans.10."Structured clinical education" means a program accredited by an appropriate
accrediting agency to provide a predetermined amount of instruction and experience
in clinical laboratory, and approved or modified by the board.43-48-02. License required. No person may practice as a clinical laboratory scientist ora clinical laboratory technician unless the person is the holder of a current license issued by the
board, or is exempt from licensure.43-48-03. Exemptions. The provisions of this chapter do not apply to the following:1.Physicians duly and currently licensed to practice medicine.2.Nurses duly and currently licensed to practice nursing and practicing within the
scope of the nursing license.Page No. 13.Persons performing clinical testing for teaching or research, provided that the results
of any examination performed in such laboratories are not used in health
maintenance, diagnosis, or treatment of disease.4.Persons employed by the United States government, or any bureau, division, or
agency thereof, and working in a licensed laboratory.5.Any person in the pursuit of a supervised course of study leading to a degree at an
accredited or educational program approved by the board.6.Phlebotomy personnel performing phlebotomy procedures.7.Persons performing testing for their own personal use and persons performing
screening tests for mass screening under appropriate supervision.8.Agents of the state or federal government performing hematological tests for anemia
upon participants of the special supplemental food program for women, infants, and
children.9.An individual supervised by an individual who is licensed by the board and who
performs tests and uses methods identified by rules adopted by the board.43-48-04. Powers and duties of the board. In order to enforce and administer thischapter, the board shall:1.Maintain an office to conduct business.2.Conduct or approve licensing or certification examinations for entry into clinical
laboratory practice as authorized under this chapter.3.Issue and renew a license to any person who currently meets the qualifications in
the category for which license is sought.4.Establish fees and receive all moneys collected under this chapter.5.Issue subpoenas, examine witnesses, administer oaths, and investigate allegations
of practices violating the provisions of this chapter.6.Discipline licensees as necessary, which may include reprimand of the licensee,
probation, denial, suspension or revocation of license.7.Adopt rules pursuant to chapter 28-32, necessary for the implementation of this
chapter, including rules relating to professional licensure and to the establishment of
standards of practice for persons holding a license to practice clinical laboratory
testing in this state. The rules must specifically address the special needs of rural
hospitals and clinics with regard to laboratory personnel.8.Employ an executive director and such other professional and secretarial staff as
may be necessary.9.Authorize all expenditures necessary for conducting the business of the board. Any
balance of fees and other moneys received by the board after payment of
expenditures is to be used in administering the provisions of this chapter.10.Establish or approve criteria for the continuing education of clinical laboratory
personnel as it may deem reasonably appropriate as a prerequisite to the renewal of
any license provided for in this chapter, so long as such requirements are uniform as
to application, and are reasonably related to the measurement of qualification,Page No. 2performance, or competence desirable and necessary for the protection of the public
health.43-48-05. Board of clinical laboratory practice - Administration.1.There is hereby created a North Dakota board of clinical laboratory practice which
shall consist of seven persons appointed by the governor, who must be residents of
the state for at least two years prior to their appointment and who, except for the
consumer members, must be currently engaged in their area of practice.2.The board must be composed of:a.One physician recommended by the North Dakota pathology organization. The
North Dakota pathology organization shall submit to the governor a list of
physicians qualified to serve, such list to contain at least three names.b.The following laboratory persons, whose names may be included on a list of
such persons qualified to serve submitted to the governor by the North Dakota
society for medical technology or other interested persons, such list to contain
at least three names for each vacancy:(1)One administrative nonphysician clinical laboratory director;(2)One clinical laboratory scientist; and(3)One clinical laboratory technician.c.Two consumer members, each of whom must be a citizen of the United States,
a resident of North Dakota for at least two years before the date of
appointment, and a current resident of North Dakota.d.The state health officer or such officer's designee, ex officio.3.The members of the board shall serve for terms of three years, except that members
of the first board must be appointed as provided in this chapter within sixty days after
July 12, 1989, for the following terms:a.A nonphysician laboratory director member and a consumer member, each for
a term of three years.b.A clinical laboratory technician member and clinical laboratory scientist
member, each for a term of two years.c.A physician laboratory director member and a consumer member, each for a
term of one year.d.The state officer member or such officer's designee must be appointed and
serve ex officio during such term of office in the state department of health.4.Each member of the board shall qualify by taking the oath required by civil officers
and shall hold office until the successor is duly appointed and qualified.5.The governor may remove any board member for good cause after giving that
member a written statement of the reason for removal and after the member has
had an opportunity for hearing.6.Whenever any board vacancy shall occur, the appointment authority shall in the
same manner as the prior appointment, appoint a successor of like qualifications for
the remainder of the unexpired term.Page No. 37.The board must be authorized to appoint subcommittees which must be
representative of the various disciplines licensed under this chapter to assist, advise,
and make recommendations to the board.8.The board shall meet at least once during the first three months of each calendar
year and at least one additional meeting must be held before the end of each
calendar year.Other meetings may be convened at the call of the boardchairperson or the written request of any three board members.9.In addition to the expenses incurred while engaged in the performance of their
duties, each board member shall receive a per diem fee set by the board, not to
exceed the fee established by law for the legislative assembly.43-48-06.Fees.The board shall set by rule the applicable licensure fee for thosepersons subject to this chapter, including the initial fee, license fee, late renewal fees, and limited
permit fees. These fees must be set in such reasonable amount as to reimburse the board for
the cost of its services.43-48-07. Duties and qualifications of clinical laboratory personnel - Requirementsfor licensure.An applicant applying for license as a clinical laboratory scientist or clinicallaboratory technician shall file a written application provided by the board, along with the
appropriate fee, showing to the satisfaction of the board that the applicant is qualified for the said
position.43-48-08. Clinical laboratory scientist or medical technologist or clinical laboratoryspecialist - Licensure qualifications.1.A clinical laboratory scientist or medical technologist has graduated with a bachelor
of science or a bachelor of arts degree in a science-related discipline and has
passed a national certifying examination approved by the board. Upon receipt of
documentation that all necessary educational and experience qualifications for a
clinical laboratory scientist or medical technologist have been met, or upon
successful completion of an examination approved by the board, the board shall
issue a clinical laboratory scientist or medical technologist license to any person
meeting the above qualifications.2.A clinical laboratory scientist or specialist is educated in chemical, physical, or
biological science and performs in a clinical laboratory only functions directly related
to such person's particular specialty. Upon successful completion of an examination
covering only those fields in which an applicant is eligible to be examined, and
documentation of competency by a nationally recognized certifying agency, the
board shall issue a clinical laboratory specialist license to any person meeting the
following minimum qualifications:a.A baccalaureate or higher degree with a major in one of the chemical, physical,
or biological sciences.b.Has passed a national certifying examination in a specialty area.A license issued must be issued as a clinical laboratory specialist followed by
designation of area of specialty.43-48-09.Clinical laboratory technician or medical laboratory technician -Licensure qualifications. A clinical laboratory technician or medical laboratory technician has
successfully completed the academic requirements of an educational program recognized by the
board and has passed a national certifying examination approved by the board.Upon receipt of documentation that all necessary educational and experiencequalifications for clinical laboratory technician have been met, or upon successful completion ofPage No. 4an examination approved by the board, the board shall issue a clinical laboratory technician
license to any person meeting the above qualifications.43-48-10. Student work authorization. A clinical laboratory student may perform testsunder the supervision of licensed clinical laboratory personnel without being licensed therefor by
the board.43-48-11. Provisional permits. The board may, under criteria established by the board,grant a limited permit to a person who has completed the education and experience
requirements of this chapter. Such permit allows the person to practice medical technology in
association with licensed clinical laboratory personnel. The permit is valid for no longer than a
period of three years or until the person holding the permit is duly issued a license or the permit
is revoked by the board.43-48-12. Grandfather provisions. Upon receipt of evidence showing that a person iscurrently employed in the practice of clinical laboratory medicine on July 12, 1989, or has been
so employed during the preceding one year for a minimum period of six months, and that person
does not meet the criteria established for licensure by the board, the board shall, upon
application, issue a qualifying license to such person to continue to practice in a laboratory under
the person's scope of practice existing on July 12, 1989. Persons licensed under this section
must meet the same continuing education requirements as any other licensees.43-48-13. Issuance of license. The board shall issue a license to any person whomeets the requirements of this chapter upon application therefor and payment of the license fee
established by the board.43-48-14. Renewal of license. A license issued under this chapter is subject to biennialrenewal and expires unless renewed in the manner prescribed by the board and upon the
payment of a renewal fee. The board may provide for the late renewal of a license upon the
payment of a late fee in accordance with its rules.43-48-15. Supervision and revocation of license - Refusal to renew.1.The board may deny, refuse to renew, suspend, or revoke a license or permit, or
may impose probationary conditions if the licensee or permittee or applicant for a
license or permit has been found to have committed unprofessional conduct which
has endangered or is likely to endanger the health, welfare, or safety of the public.
Unprofessional conduct includes:a.Obtaining or attempting to obtain a license by means of fraud, deceit,
misrepresentation, or concealment of facts.b.Being convicted of an offense, as defined by subsection 20 of section
12.1-01-04, and which the board determines has a direct bearing upon a
person's ability to serve the public as a licensed clinical laboratory personnel or,
following the conviction of any offense, if the board determines that the person
is not sufficiently rehabilitated.c.Violating any lawful order or rule rendered or adopted by the board.d.Violating any provision of this chapter.2.A denial, refusal to renew, suspension, revocation, or imposition of probationary
conditions upon a licensee or permittee may be ordered by the board after a hearing
in the manner provided by rules adopted by the board and in conformance with
chapter 28-32. An application for reinstatement may be made to the board one year
from the date of the revocation of a license. The board may accept an application
for reinstatement, and may hold a hearing to consider such reinstatement.Page No. 543-48-16.Penalty.Any person who violates section 43-48-02 is guilty of a class Bmisdemeanor.Page No. 6Document Outlinechapter 43-48 clinical laboratory personnel

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