H-0384

AN ACT Relating to clinical laboratory science practitioners; adding a new chapter to Title 18 RCW; and providing effective dates.

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

NEW SECTION. Sec. 1. The legislature finds that the profession of clinical laboratory science practitioners satisfies the criteria of RCW 18.120.010, and that the applicants for regulation of this profession have satisfied the factors described in RCW 18.120.030. Therefore, the legislature declares that it is necessary to protect the public health, safety, and welfare to prescribe minimum qualifications for clinical laboratory science practitioners.

NEW SECTION. Sec. 2. Unless the context clearly requires otherwise, the definitions in this section apply throughout this chapter.

(1) "Accredited clinical laboratory program" means a program that provides a predetermined amount of instruction and experience in clinical laboratory science and is accredited by one of the accrediting agencies recognized by the United States department of education or department of health and human services.

(2) "Board" means the clinical laboratory board appointed by the governor.

(3) "Clinical laboratory" or "laboratory" means any facility, office, or site where clinical laboratory tests are performed.

(4) "Clinical laboratory scientist" or "medical technologist" means a person who performs tests according to established and approved protocols that require the exercise of independent judgment and responsibility, maintains equipment and records, performs quality assurance activities related to test performance, and may supervise and teach within a clinical laboratory setting.

(5) "Clinical laboratory science practice" means the performance of clinical laboratory tests and related activities.

(6) "Clinical laboratory science practitioner" means a health care professional who performs clinical laboratory tests or is engaged in management, education, consulting, or research in clinical laboratory science, and may include laboratory directors, supervisors, clinical laboratory scientists, specialists, technicians, and assistants working in a laboratory or testing site. Persons employed by a clinical laboratory to perform supportive functions not related to direct performance of laboratory tests and clinical laboratory trainees are not included.

(7) "Clinical laboratory technician" or "medical laboratory technician" means a person who performs laboratory tests pursuant to established and approved protocols that require limited exercise of independent judgment and that are performed under the supervision of a clinical laboratory scientist, supervisor, or director.

(8) "Clinical laboratory test" or "laboratory test" means a microbiological, serological, chemical, hematological, radiobioassay, cytological, biophysical, immunological, or other pathological examination that is performed on material derived from the human body, or any other such test or procedure conducted that provides information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition, including screening.

(9) "Clinical laboratory trainee" means any person in a structured program, approved by the board, providing instruction and experience in the clinical laboratory sciences including, but not limited to, accredited programs. Trainees must be under the direct supervision of a person qualified to perform the work being performed.

(10) "Department" has the meaning given in RCW 18.122.020.

(11) "Secretary" has the meaning given in RCW 18.122.020.

(12) "Laboratory assistant" means a person who performs tests in a limited function laboratory or who performs a limited scope of testing under the direct supervision of a person qualified to perform or supervise such testing.

(13) "Limited function laboratory" means a testing site that uses test methodologies performed on instruments requiring little technical skill and no independent judgment due to the instruments' internal self-calibrated standards, and manual or automated test methodologies requiring little technical skill and no problem-solving or interpretive ability, or a testing site that only performs a limited scope of tests within one specialty or subspecialty.

(14) "Specialist" means a laboratory science practitioner or related health care professional who is qualified to practice and who is specialized in an area of the clinical laboratory sciences such as cytology, chemistry, hematology, immunology, immunohematology, or microbiology.

(15) "Specialty laboratory" means any site that only performs tests within one specialty or subspecialty.

(16) "Supervisor" means the person responsible for the supervision of the testing personnel and/or performance of tests.

NEW SECTION. Sec. 3. (1) No person may practice clinical laboratory science, or appear to be a practitioner of clinical laboratory science, unless licensed by the department under this chapter.

(2) All clinical laboratory science practitioners who applied to the department before January 1, 1993, and who complied with all necessary requirements for applying, may continue to direct, supervise, or perform clinical laboratory tests until either: (a) The end of twelve months from the filing date of their application; (b) the department denies the application; or (c) the applicant withdraws.

(3) For twenty-four months after January 1, 1993, and only during that time, the department may issue a license to a currently practicing practitioner, or a prospective practitioner, without requiring the practitioner to successfully complete an examination or obtain certification. The practitioner shall supply evidence that he or she holds the title for which the license is to be issued and has practiced at the level required by the license for sixty days before applying for the license.

NEW SECTION. Sec. 4. This chapter does not apply to:

(1) Any person licensed by this state who engages in the practice for which he or she is licensed, as long as such person is not engaged in any activity for which a license is required under this chapter;

(2) Clinical laboratory science practitioners employed by the federal government or any of its bureaus, divisions, or agencies while in the discharge of the employee's official duties;

(3) Clinical laboratory science practitioners engaged in teaching or research if the results of any examination performed are not used in health maintenance, diagnosis, treatment of disease, or screening;

(4) Students or trainees enrolled in a clinical laboratory science education program if these activities constitute a part of a planned course in the program, the persons are designated by title such as intern, trainee, or student, and the persons work directly under an individual licensed by this state to practice clinical laboratory science, or an instructor exempt under subsection (3) of this section;

(5) Physicians licensed in this state who are certified by the American board of pathology or the American board of osteopathic pathology;

(6) Business managers of laboratories if they have no direct or indirect involvement with test performance;

(7) Any person performing tests which are not regulated under chapter 70.42 RCW.

NEW SECTION. Sec. 5. (1) The clinical laboratory board is created within the department of health which shall consist of seven persons who are United States citizens and are residents of this state, and, except for the members of the public, who are actively engaged in their areas of practice. The governor shall make appointments to the board, and those appointments shall be confirmed by the senate.

(2) After the initial appointments are made, the board shall be composed of:

(a) One physician certified by the American board of pathology or the American board of osteopathic pathology;

(b) Four clinical laboratory science practitioners, at least one of whom is a nonphysician laboratory director or manager, one of whom is a clinical laboratory scientist (medical technologist), and one of whom is a clinical laboratory technician (medical laboratory technician), and who hold active and valid licenses as clinical laboratory science practitioners in this state; and

(c) Two members of the public, neither of whom is a member of any other licensing board, or holder of a health occupation license, or an employee of any health facility, or who has any fiduciary obligation to a health facility or agency, or who has a material financial interest in the rendering of health services.

(3) Board members shall serve for a term of three years and until their successors are appointed and qualified, except that the initial appointments, which shall be made within ninety days after the effective date of this act, shall be as follows:

(a) A pathologist, a nonphysician laboratory director or manager, and a clinical laboratory technician shall be appointed to serve for three years;

(b) The public representatives shall be appointed to serve for two years; and

(4) Whenever a vacancy shall occur on the board by reason other than the expiration of a term of office, the governor shall appoint a successor of like qualifications for the remainder of the unexpired term. No person shall be appointed to serve more than two successive full terms.

(5) The board shall hold a regular annual meeting at which it shall select from its members a chairman and vice-chairman. Other meetings shall be held at such times as the rules of the board may provide. Special meetings may be held at such times as may be deemed necessary or advisable by a majority of its members. Reasonable notice of all meetings shall be given in a manner prescribed by the rules of the board. A quorum of the board shall consist of a majority of its members. The secretary of the board shall be appointed by the board and shall serve at the pleasure of the board. The secretary may or may not be a member of the board. The board shall work with and through the department of health.

NEW SECTION. Sec. 6. The clinical laboratory board shall:

(1) Prescribe, publish, adopt, and amend rules for the implementation of this chapter including but not limited to rules that delineate qualifications for licensure of clinical laboratory science practitioners; specify requirements for the renewal of licensure or certification; establish standards of professional conduct; and have power to amend or repeal the same. Following their adoption, the rules shall govern and control the professional conduct of every person who holds a license or certificate to perform clinical laboratory tests or otherwise engages in the profession of clinical laboratory science (medical technology);

(2) Approve accrediting and certification bodies for purposes of licensure of clinical laboratory science practitioners as provided for in section 4 of this act;

(3) Adopt rules governing qualifications for licensure of specialists in such clinical laboratory science specialties as the board may determine in accordance with the standards of licensure set forth in this chapter;

(4) Adopt rules governing personnel performing tests in limited-function laboratories, and personnel performing limited scopes of testing;

(5) Advise the department of health in the fixing and publication of fees for application and renewals;

(6) Assist the department of health in the maintenance of a roster of the names and addresses of persons currently licensed and registered under the provisions of this chapter, and of all persons whose licenses have been suspended or revoked within the previous year;

(7) Establish criteria and approve programs for the continuing education of clinical laboratory science practitioners as required for license renewal; and

(8) Adopt other rules necessary to implement and further the purpose of this chapter.

NEW SECTION. Sec. 7. (1) The department shall establish a schedule of fees for license and certificate applications and renewals. The department shall set the fees at a sufficient level to defray the cost of administering the program. In determining the fee schedule, the department shall consider the following: (a) The level of license or certificate; (b) general costs of the program established under this chapter; and (c) the advice of the board.

(2) The department shall deposit all fees collected under this section into the clinical laboratory licensure account.

NEW SECTION. Sec. 8. (1) The board shall issue a clinical laboratory scientist's license to an individual who is certified, or who holds equivalent credentials in the clinical laboratory sciences by an agency acceptable to the board, and who meets such other qualifications as adopted by the board, including at least one of the following qualifications. Where experience requirements are not met in the four major disciplines, the board shall issue a categorical license for those disciplines in which the person is qualified:

(a) A baccalaureate degree in clinical laboratory science (medical technology) from an accredited college or university whose curriculum included appropriate clinical education;

(b) A baccalaureate degree in biological, chemical, or physical science from an accredited college or university, and at least twelve months of appropriate clinical education in an accredited clinical laboratory science program;

(c) A baccalaureate degree which includes a minimum of thirty-six semester or equivalent hours in the biological, chemical, and physical sciences from an accredited college or university plus two years of acceptable full-time work experience within the last five years including a minimum of four months in each of the four major disciplines of laboratory practice, i.e. clinical chemistry, clinical microbiology, hematology, and immunology/immunohematology;

(d) Approved certification as a clinical laboratory technician or equivalent and an associate degree or sixty semester or equivalent hours of college course work including thirty-six semester or equivalent hours in the biological and physical sciences plus three years of acceptable full-time laboratory work experience within the last ten years which has included a minimum of four months in each of the four major disciplines of laboratory practice, i.e. chemistry, hematology, immunology/immunohematology, and microbiology. At least two years of the laboratory work experience must be under the supervision of an appropriately qualified clinical laboratory scientist;

(e) An associate degree or sixty semester or equivalent hours of college course work including thirty-six semester or equivalent hours in the biological and physical sciences plus four years of acceptable full-time laboratory work experience within the last ten years which has included a minimum of six months in each of the four disciplines of laboratory practice, i.e. chemistry, hematology, immunology/immunohematology, microbiology. At least two years of the laboratory work experience must be under the supervision of an appropriately qualified clinical laboratory scientist; or

(f) A valid license, certificate, or equivalent issued in another state, city, or country, provided that the requirements under which the license, certificate, or equivalent was issued are equivalent to or exceed the standards required by this subsection.

(2) The board shall issue a clinical laboratory technician's license to an individual who is certified, or who hold equivalent credentials, in the laboratory sciences by an agency acceptable to the board, and meets such other qualifications as adopted by the board, including at least one of the following qualifications. Where experience requirements are not met in the four major disciplines, the board shall issue a categorical license for those disciplines in which the person is qualified:

(a) An associate degree or completion of sixty semester or equivalent hours from a clinical laboratory technician program or equivalent accredited by an agency recognized by the United States department of education that included a structured curriculum in clinical laboratory techniques;

(b) A high school diploma or equivalent and (i) completion of twelve months in a technician training program in an accredited school approved by the board, or (ii) successful completion of an official military medical laboratory procedure course of at least fifty weeks' duration and has held the military enlisted occupational specialty of medical laboratory specialist (laboratory technician);

(c) Four years' full-time laboratory work experience which has encompassed the four major disciplines of laboratory practice, i.e. clinical chemistry, hematology, immunohematology, and microbiology plus eight continuing education units in clinical laboratory science within the last seven years. At least two years of the laboratory work experience must be under the supervision of an appropriately qualified clinical laboratory scientist, consultant, or technician; or

(d) A valid license, certificate, or equivalent issued in another state, city, or country, provided that the requirements under which the license, certificate, or equivalent was issued are equivalent to or exceed the standards required by this subsection.

(3) The board may establish standards for such other clinical laboratory science practitioners specializing in areas such as biophysics, chemistry, cytology, hematology, histology, immunohematology, microbiology, serology, nuclear medical technology, or similar recognized academic and scientific disciplines.

(4) The board shall issue limited function certificates to laboratory assistants who meet at least one of the following qualifications:

(a) Completion of an appropriate training program which is accredited by an agency recognized by the United States department of education or the department of health and human services;

(b) Completion of a formal education program in medical assisting which is accredited by an agency recognized by the United States department of education or the department of health and human services; or

(c) Four years' full-time laboratory work experience plus twenty hours of approved education in clinical laboratory science.

NEW SECTION. Sec. 9. (1) Licensure applicants shall submit their application for licensure to the department upon the forms prescribed and furnished by the board and the department, and shall pay the designated application fee.

(2) Upon receipt of application and payment of a fee, the board shall issue a license for a clinical laboratory scientist (technologist), a clinical laboratory technician or an appropriate specialty or categorical license, or limited function certificate to any person who meets the qualifications specified in this chapter and the rules adopted in this chapter.

(3) The board may establish by rule a procedure for issuance of temporary permits to individuals otherwise qualified under this chapter who intend to engage in clinical laboratory science practice in this state for a limited period of time not to exceed eighteen months.

NEW SECTION. Sec. 10. All licensed clinical laboratory science practitioners shall be subject to the disciplinary standards and procedures established in chapter 18.130 RCW.

NEW SECTION. Sec. 11. The department shall not disclose the identity of persons from whom specimens of material were taken for testing by a clinical laboratory science practitioner without a written release from that person or an order from a court with proper jurisdiction.

NEW SECTION. Sec. 12. (1) Sections 5 through 10 of this act shall take effect July 1, 1992.

(2) Sections 1 through 4 and 11 of this act shall take effect January 1, 1993.

NEW SECTION. Sec. 13. Sections 1 through 11 of this act shall constitute a new chapter in Title 18 RCW.