House Study Bill 231
HOUSE FILE
BY (PROPOSED COMMITTEE ON
STATE GOVERNMENT BILL BY
CHAIRPERSON MASCHER)
Passed House, Date Passed Senate, Date
Vote: Ayes Nays Vote: Ayes Nays
Approved
A BILL FOR
1 An Act establishing a board of clinical laboratory science,
2 requiring the licensure of clinical laboratory science
3 practitioners, and providing for fees and penalties.
4 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
5 TLSB 2117HC 83
6 jr/nh/5
PAG LIN
1 1 Section 1. Section 147.1, subsections 3 and 6, Code 2009,
1 2 are amended to read as follows:
1 3 3. "Licensed" or "certified", when applied to a physician
1 4 and surgeon, podiatric physician, osteopathic physician and
1 5 surgeon, physician assistant, psychologist, chiropractor,
1 6 clinical laboratory science practitioner, nurse, dentist,
1 7 dental hygienist, dental assistant, optometrist, speech
1 8 pathologist, audiologist, pharmacist, physical therapist,
1 9 physical therapist assistant, occupational therapist,
1 10 occupational therapy assistant, respiratory care practitioner,
1 11 practitioner of cosmetology arts and sciences, practitioner of
1 12 barbering, funeral director, dietitian, marital and family
1 13 therapist, mental health counselor, social worker, massage
1 14 therapist, athletic trainer, acupuncturist, nursing home
1 15 administrator, hearing aid dispenser, or sign language
1 16 interpreter or transliterator means a person licensed under
1 17 this subtitle.
1 18 6. "Profession" means medicine and surgery, podiatry,
1 19 osteopathic medicine and surgery, practice as a physician
1 20 assistant, psychology, chiropractic, nursing, dentistry,
1 21 dental hygiene, dental assisting, optometry, speech pathology,
1 22 audiology, pharmacy, physical therapy, physical therapist
1 23 assisting, occupational therapy, occupational therapy
1 24 assisting, respiratory care, cosmetology arts and sciences,
1 25 barbering, mortuary science, marital and family therapy,
1 26 mental health counseling, social work, dietetics, massage
1 27 therapy, athletic training, acupuncture, nursing home
1 28 administration, hearing aid dispensing, or sign language
1 29 interpreting or transliterating, or clinical laboratory
1 30 science.
1 31 Sec. 2. Section 147.2, subsection 1, Code 2009, is amended
1 32 to read as follows:
1 33 1. A person shall not engage in the practice of medicine
1 34 and surgery, podiatry, osteopathic medicine and surgery,
1 35 psychology, chiropractic, physical therapy, physical therapist
2 1 assisting, nursing, dentistry, dental hygiene, dental
2 2 assisting, optometry, speech pathology, audiology,
2 3 occupational therapy, occupational therapy assisting,
2 4 respiratory care, pharmacy, cosmetology arts and sciences,
2 5 barbering, social work, dietetics, marital and family therapy
2 6 or mental health counseling, massage therapy, mortuary
2 7 science, athletic training, acupuncture, nursing home
2 8 administration, hearing aid dispensing, or sign language
2 9 interpreting or transliterating, or shall not practice as a
2 10 physician assistant or as a clinical laboratory science
2 11 practitioner, unless the person has obtained a license for
2 12 that purpose from the board for the profession.
2 13 Sec. 3. Section 147.13, Code 2009, is amended by adding
2 14 the following new subsection:
2 15 NEW SUBSECTION. 24. For clinical laboratory science
2 16 practitioners, the board of clinical laboratory science.
2 17 Sec. 4. Section 147.14, subsection 1, Code 2009, is
2 18 amended by adding the following new paragraph:
2 19 NEW PARAGRAPH. x. For clinical laboratory science, four
2 20 clinical laboratory science practitioners, at least one of
2 21 whom is a nonphysician laboratory director, one of whom is a
2 22 clinical laboratory scientist, and one of whom is a clinical
2 23 laboratory technician, and who, except for the initial
2 24 appointments, hold active and valid licenses as clinical
2 25 laboratory science practitioners in this state; one physician
2 26 certified by the American board of pathology or American board
2 27 of osteopathic pathology; one physician who is not a
2 28 pathologist or a laboratory director; one member who is not
2 29 licensed to practice as a clinical laboratory science
2 30 practitioner and who shall represent the general public. A
2 31 majority of members of the board constitutes a quorum.
2 32 Sec. 5. NEW SECTION. 148F.1 TITLE, FINDINGS, AND
2 33 PURPOSE.
2 34 1. This chapter may be cited and referred to as the
2 35 "Clinical Laboratory Science Practice Act".
3 1 2. The general assembly finds all of the following:
3 2 a. The practice of clinical laboratory science by health
3 3 care professionals affects the public health, safety, and
3 4 welfare and is subject to control and regulation in the public
3 5 interest.
3 6 b. Clinical laboratories and clinical laboratory science
3 7 practitioners provide essential services to practitioners of
3 8 the healing arts by furnishing vital information which may be
3 9 used in the diagnosis, prevention, and treatment of disease or
3 10 impairment, and the assessment of the health of humans.
3 11 3. The purpose of this chapter is to provide for the
3 12 better protection of public health by providing minimum
3 13 qualifications for clinical laboratory science practitioners,
3 14 and by ensuring that clinical laboratory tests are performed
3 15 with the highest degree of professional competency by those
3 16 engaged in providing such services in this state.
3 17 Sec. 6. NEW SECTION. 148F.2 DEFINITIONS.
3 18 As used in this chapter, the following definitions apply,
3 19 unless the context otherwise requires:
3 20 1. "Accredited clinical laboratory science program" means
3 21 a program planned to provide a predetermined amount of
3 22 instruction and experience in clinical laboratory science that
3 23 has been accredited by one of the accrediting agencies
3 24 recognized by the United States department of education.
3 25 2. "Board" means the board of clinical laboratory science.
3 26 3. "Clinical laboratory" or "laboratory" means any
3 27 facility or office in which clinical laboratory tests are
3 28 performed.
3 29 4. "Clinical laboratory science practitioner" or "one who
3 30 engages in the practice of clinical laboratory science" means
3 31 a health care professional who performs clinical laboratory
3 32 tests or who is engaged in management, education, consulting,
3 33 or research in clinical laboratory science, and includes
3 34 laboratory directors, supervisors, clinical laboratory
3 35 scientists, specialists, and technicians working in a
4 1 laboratory. "Clinical laboratory science practitioner" does
4 2 not include persons employed by a clinical laboratory to
4 3 perform supportive functions not related to direct performance
4 4 of laboratory tests or clinical laboratory trainees.
4 5 5. "Clinical laboratory scientist" means a person who
4 6 performs laboratory tests pursuant to established and approved
4 7 protocols requiring the exercise of independent judgment and
4 8 responsibility, maintains equipment and records, performs
4 9 quality assurance activities related to test performance, and
4 10 may supervise and teach within a clinical laboratory setting.
4 11 6. "Clinical laboratory technician" means a person who
4 12 performs laboratory tests pursuant to established and approved
4 13 protocols which require limited exercise of independent
4 14 judgment and which are performed under the personal and direct
4 15 supervision of a clinical laboratory scientist, laboratory
4 16 supervisor, or laboratory director.
4 17 7. "Clinical laboratory test" or "laboratory test" means a
4 18 microbiological, serological, chemical, hematological,
4 19 radiobioassay, cytological, biophysical, immunological, or
4 20 other pathological examination which is performed on material
4 21 derived from the human body, or any other test or procedure
4 22 conducted by a laboratory or facility which provides
4 23 information for the diagnosis, prevention, or treatment of a
4 24 disease, or assessment of a human medical condition.
4 25 8. "Limited function test" means a test conducted using
4 26 procedures which, as determined by the board, have an
4 27 insignificant risk of an erroneous result, including any of
4 28 the following:
4 29 a. Tests which have been approved by the United States
4 30 food and drug administration for home use.
4 31 b. Tests which employ methodologies that are so simple and
4 32 accurate as to render the likelihood of erroneous results
4 33 negligible.
4 34 c. Tests which the board has determined pose no reasonable
4 35 risk of harm to the patient if performed incorrectly.
5 1 Sec. 7. NEW SECTION. 148F.3 DUTIES OF THE BOARD.
5 2 The board shall administer this chapter. The board's
5 3 duties shall include but are not limited to the following:
5 4 1. Adoption of rules to administer this chapter and
5 5 chapters 147 and 272C with respect to the licensing of
5 6 clinical laboratory science practitioners.
5 7 2. Adoption of rules relating to professional conduct and
5 8 licensing and the establishment of ethical and professional
5 9 standards of practice.
5 10 3. Adoption of rules relating to the qualifications for
5 11 licensure of clinical laboratory science practitioners.
5 12 4. Acting on matters concerning licensure and the process
5 13 of applying for, granting, suspending, imposing supervisory or
5 14 probationary conditions upon, reinstating, revoking, or
5 15 renewing a license.
5 16 5. Establishing and collecting licensure fees as provided
5 17 in section 147.80.
5 18 6. Developing continuing education requirements as a
5 19 condition of license renewal.
5 20 7. Evaluating requirements for licensure in other states
5 21 to determine if reciprocity may be granted.
5 22 8. Establishing procedures by rule for the waiver of the
5 23 requirements under section 148F.5 for applicants who hold a
5 24 valid license or its equivalent issued by another
5 25 jurisdiction; provided that the requirements under which that
5 26 license or its equivalent was issued are equal to or exceed
5 27 the standards required by this chapter.
5 28 Sec. 8. NEW SECTION. 148F.4 PERSONS AND PRACTICES NOT
5 29 AFFECTED.
5 30 This chapter does not prevent or restrict the practice,
5 31 services, or activities of any of the following:
5 32 1. Any person licensed in this state under any other
5 33 statute from engaging in the practice for which the person is
5 34 licensed.
5 35 2. Clinical laboratory science practitioners employed by
6 1 the United States government while in the discharge of the
6 2 employee's official duties.
6 3 3. Clinical laboratory science practitioners engaged in
6 4 teaching or research, provided that the results of any
6 5 examination performed are not used in health maintenance or
6 6 diagnosis or treatment of disease.
6 7 4. Students or trainees enrolled in an accredited clinical
6 8 laboratory science program provided that the activities
6 9 constitute a part of a planned course in the program, that the
6 10 persons are designated by title such as intern, trainee, or
6 11 student, and the persons work directly under an individual
6 12 licensed by this state as a clinical laboratory science
6 13 practitioner.
6 14 5. Individuals performing only limited function tests.
6 15 6. Persons incidentally in this state to provide service
6 16 as part of an emergency response team working in conjunction
6 17 with disaster relief officials.
6 18 Sec. 9. NEW SECTION. 148F.5 REQUIREMENTS FOR LICENSURE.
6 19 1. The board shall adopt by rule requirements for
6 20 licensure for all of the following types of clinical
6 21 laboratory science practitioners:
6 22 a. Clinical laboratory scientist.
6 23 b. Clinical laboratory technician.
6 24 c. Clinical histotechnologist.
6 25 d. Clinical histologic technician.
6 26 e. Cytotechnologist.
6 27 f. Clinical laboratory scientist in cytogenetics.
6 28 2. The board may establish standards for such other
6 29 clinical laboratory science practitioners specializing in
6 30 areas such as biophysics, chemistry, cytology, hematology,
6 31 histologic technique, immunohematology, microbiology,
6 32 serology, nuclear medical technology, or similar recognized
6 33 academic and scientific disciplines.
6 34 Sec. 10. Section 272C.1, subsection 6, Code 2009, is
6 35 amended by adding the following new paragraph:
7 1 NEW PARAGRAPH. af. The board of clinical laboratory
7 2 science, created pursuant to chapter 147.
7 3 Sec. 11. INITIAL BOARD. The initial members of the board
7 4 of clinical laboratory science created pursuant to section
7 5 147.14, subsection 1, paragraph "x", as enacted in this Act,
7 6 shall be appointed to the following terms:
7 7 1. Two clinical laboratory science practitioner specialist
7 8 members eligible for licensure, one physician member, and one
7 9 public member shall be appointed for terms of two years.
7 10 2. Two clinical laboratory science practitioner members
7 11 eligible for licensure and one physician member shall be
7 12 appointed for terms of one year.
7 13 EXPLANATION
7 14 This bill creates new Code chapter 148F that requires the
7 15 licensure of clinical laboratory science practitioners. The
7 16 bill provides for the establishment of a seven=member board of
7 17 clinical laboratory science consisting of four members who are
7 18 clinical laboratory science practitioners, two members who are
7 19 physicians, and one member who represents the general public.
7 20 The bill provides for fees to fund the board and provides
7 21 penalties for violation of the practice requirement; those
7 22 penalties are set out for all health=related boards in Code
7 23 chapters 147 and 272C. Code section 148F.5 sets out several
7 24 levels of licensure along with a directive to the new board to
7 25 adopt licensure requirements by rule for each type of license.
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