6071

AN ACT Relating to clinical laboratory science practitioners; adding a new chapter to Title 18 RCW; creating a new section; prescribing penalties; providing effective dates; and declaring an emergency.

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

NEW SECTION. Sec. 1. INTENT--CONSTRUCTION. The legislature finds that it is necessary to regulate the practice of clinical laboratory science in order to protect the public health, safety, and welfare. It is the intent of the legislature that this chapter shall provide for the better protection of public health and safety by providing minimum qualifications for clinical laboratory science practitioners, thereby ensuring that clinical laboratory tests are performed with an acceptable degree of professional competency by those engaged in providing such services to the citizens of this state.

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

(1) "Accredited clinical laboratory program" means a program providing a predetermined amount of instruction and experience in clinical laboratory science that has been 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 a facility, office, or site where clinical laboratory tests are performed.

(4) "Clinical laboratory scientist" or "medical technologist" means a person who performs tests pursuant to established and approved protocols requiring the exercise of independent judgment and responsibility, maintains equipment and records, performs quality assurance activities related to test performance, may supervise and teach within a clinical laboratory setting, and may accredit and certify level I practitioners subject to the authority granted and the rules adopted by the board.

(5) "Clinical laboratory science practice" means the performance of clinical laboratory tests and related activities including all phases of test performance from procurement of specimens, such as phlebotomy, to reporting of results.

(6) "Clinical laboratory science practitioner" means a health care professional who performs clinical laboratory tests and related activities or is engaged in management, education, consulting, or research in clinical laboratory science, and may include laboratory directors, supervisors, clinical laboratory scientists, medical technologists, specialists, technicians, and assistants working in a laboratory or testing site. Such practitioners shall be considered licensed providers under chapter 18.135 RCW and may perform, and train and authorize others to perform, phlebotomy. 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 and related activities pursuant to established and approved protocols which require limited exercise of independent judgment and which are performed under the supervision of a clinical laboratory scientist, supervisor, or director. Such practitioners shall be considered licensed providers under chapter 18.135 RCW and may perform, and train and authorize others to perform, phlebotomy.

(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. These are the methods, procedures, and tests contained in the federal regulations implementing P.L. 100-578 (CLIA 88).

(9) "Clinical laboratory trainee" means a 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. Such training shall contribute to the experience requirements under this chapter.

(10) "Department" means the department of health.

(11) "Director" means the person responsible for the technical and administrative functions of laboratory testing.

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

(13) "Level I practitioner" means a person certified to perform tests utilizing test methodologies and instruments such as described for the limited function laboratory.

(14) "Limited function laboratory" means a testing site utilizing 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, or a point of care testing site operating in or near an acute care setting.

(15) "Specialist" means a masters or doctorate level 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.

(16) "Specialty laboratory" means any site which only performs tests within one specialty or subspecialty. A person performing tests at such sites may be granted a limited license or certificate to perform such testing providing the person meets appropriate qualifications set by the board.

(17) "Supervisor" means the person responsible for the supervision of the testing personnel, performance, or both, of tests and related activities.

NEW SECTION. Sec. 3. EXEMPTIONS. This chapter does not apply to:

(1) Any person licensed in this state who, under any other licensing authority, engages in the practice for which he or she is licensed;

(2) Clinical laboratory science practitioners employed by the United States government or any bureau, division, or agency of the United States while in the discharge of the employee's official duties;

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

(4) Students or trainees enrolled in a clinical laboratory science education program, provided that these activities constitute a part of a planned course in the program, that 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 provided they have no direct or indirect involvement with test performance;

(7) A person performing tests that are waivered from regulatory requirements under P.L. 100-578 (CLIA 88);

(8) Perfusionists performing within their scope of practice related to their function during surgery. Alternatively, certified perfusionists may qualify for a limited license under this chapter and may exercise their option to apply for such a license.

NEW SECTION. Sec. 4. LICENSE REQUIRED. (1) No person may practice clinical laboratory science or hold himself or herself out as a clinical laboratory science practitioner in this state unless licensed under this chapter.

(2) All persons engaged in the practice of clinical laboratory science on the effective date of this act, and who have applied to the board on or before the effective date of this act and have complied with all necessary requirements for such application may continue to direct, supervise, or perform clinical laboratory tests until (a) the expiration of twelve months after the filing of the application, (b) the denial of the application by the board, or (c) the withdrawal of the application, whichever occurs first.

(3) The board may issue an initial license to an applicant who is an existing or prospective practitioner, who applies within twenty-four months of the effective date of this act without requiring such applicant to successfully complete an examination or obtain certification upon proof that the applicant holds the title and has been practicing at the level of the license requested.

(4) Effective twenty-four months after the effective date of this act, no initial license shall be issued until an applicant meets all of the requirements under this chapter and successfully meets certification or equivalent qualifications approved by the board.

NEW SECTION. Sec. 5. ADMINISTRATION. (1) There is created a clinical laboratory board within the department of health which shall consist of seven persons who are United States citizens and are actual residents of this state, and, except for the public members, 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) The board shall be composed of:

(a) One physician certified by the American board of pathology or 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 or medical technologist and one of whom is a clinical laboratory technician or medical laboratory technician, and who, except for the initial appointments, hold active and valid licenses as clinical laboratory science practitioners in this state; and

(c) Two public members, 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 terms 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 occurs 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 may 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 chair and vice-chair. 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 the 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. DUTIES AND POWERS OF THE CLINICAL LABORATORY BOARD. The clinical laboratory board shall:

(1) Prescribe, publish, adopt, amend, and repeal rules for the implementation of this chapter including but not limited to rules that delineate qualifications for licensure of clinical laboratory science practitioners relative to the complexity and risk of harm of the tests allowed by the license; specify requirements for the renewal of licensure or certification; and establish standards of professional conduct. 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 section 8 of this act;

(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 rules necessary to implement and further the purpose of this chapter.

NEW SECTION. Sec. 7. FEES--ACCOUNT. (1) The department shall establish a schedule of fees for license and certificate applications and renewals. In fixing the fees, 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 clinical laboratory licensure account is created in the state treasury. All receipts from license and certificate fees shall be deposited into the account. Moneys in the account may be spent only after appropriation. Expenditures from the account may be used only for the purposes of this chapter.

NEW SECTION. Sec. 8. STANDARDS FOR LICENSURE. (1) Clinical laboratory scientist or medical technologists. 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 or specialist license for those disciplines in which the person is qualified:

(a) A baccalaureate degree in clinical laboratory science or 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 that 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, clinical chemistry, clinical microbiology, hematology, or immunology or immunohematology;

(d) Approved certification as a clinical laboratory technician or medical 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 that has included a minimum of four months in each of the four major disciplines of laboratory practice, chemistry, hematology, immunology or 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 five years of acceptable full-time laboratory work experience within the last ten years that has included a minimum of six months in each of the four disciplines of laboratory practice, chemistry, hematology, immunology or immunohematology, or microbiology. At least two years of the laboratory work experience must be under the supervision of an appropriately qualified clinical laboratory scientist;

(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 (1).

(2) Clinical laboratory technician. The board shall issue a clinical laboratory technician's license to an individual who is certified, or who holds equivalent credentials, in the laboratory sciences by an agency acceptable to the board, and meets such other qualifications as promulgated 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 or medical 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 or laboratory technician;

(c) Four years of full-time laboratory work experience that has encompassed the four major disciplines of laboratory practice, 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;

(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 (2).

(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 that is accredited by an agency recognized by the United States department of education or department of health and human services;

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

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

NEW SECTION. Sec. 9. LICENSURE APPLICATION PROCEDURES. (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 or 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 under 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. LICENSURE RENEWAL. (1) Licenses issued under this chapter shall expire after a time specified by the board, but not less than one year or more than four years. The renewal process shall contain a grace period of not less than thirty days or more than ninety days from expiration of the license.

(2) Every person licensed or certified under this chapter shall be issued a renewal license or certificate upon:

(a) Submission of an application for renewal on a form prescribed by the board and payment of an appropriate fee determined by the department; and

(b) Proof of completion, in the period since the license or certificate was first issued or last renewed, of at least ten hours per year of continuing education courses, clinics, lectures, training programs, seminars, or other programs pertinent to clinical laboratory practice that are approved or accepted by the board; or proof of recertification by a board-approved national accrediting organization that mandates equivalent requirements.

(3) The board may require other such evidence of competency as it shall deem reasonably appropriate as a prerequisite to the renewal of a license or certificate provided for in this chapter, so long as the requirements are uniform as to application, are reasonably related to the measurement of qualification, performance, or competence, and are desirable and necessary for the protection of the public health and safety.

(4) The board shall develop procedures and criteria for the renewal of licenses which have expired. The board shall review such applications on a case-by-case basis to determine if the applicant's circumstances and qualifications meet the intent of this chapter. In the event such an application is denied, the board shall notify the applicant of the specific reasons for such denial, and may advise the applicant how to qualify for license renewal.

NEW SECTION. Sec. 11. DISCIPLINARY REQUIREMENTS. The board may refuse to issue, renew, or revoke a license, or may suspend, place on probation, censure, or reprimand a licensee, or may take such other disciplinary action as the board may deem appropriate, including the imposition of a civil penalty not to exceed that allowed under chapter 18.130 RCW for conduct that may result from, but not necessarily be limited to:

(1) A material misstatement in furnishing information to the board;

(2) A violation or negligent or intentional disregard of this chapter, or of the rules adopted under this chapter;

(3) A conviction of a crime under the laws of the United States or a state or territory of the United States that is a felony or a misdemeanor, an essential element of which is dishonesty, or of a crime that is directly related to the practice of the profession;

(4) Making a misrepresentation for the purpose of obtaining licensure or certification or violating any provision of this chapter;

(5) Violation of a standard of professional conduct adopted by the board;

(6) Engaging in dishonorable, unethical, or unprofessional conduct of a character likely to deceive, defraud, or harm the public;

(7) Providing professional services while mentally incompetent, under the influence of alcohol or narcotic or a dangerous, controlled substance that is in excess of therapeutic amounts or without valid medical indication;

(8) Directly or indirectly contracting to perform clinical laboratory tests in a manner that offers or implies an offer of rebate, fee-splitting inducements or arrangements, or other remuneration; or

(9) Aiding or assisting another person in violating a provision of this chapter or rule adopted under this chapter.

NEW SECTION. Sec. 12. DUE PROCESS PROCEDURES. The proceedings for the revocation, suspension, or limiting of a license or certificate may be initiated by a person, corporation, association, or public officer or by the board, by the filing of written charges with the board, but no license may be revoked, suspended, or limited without a hearing before the board within sixty days after the filing of such charges in accordance with the procedures established by the board. A license may be temporarily suspended without a hearing for a period not to exceed thirty days upon notice to the licensee, following a finding by the board that there exists a significant threat to the public health.

NEW SECTION. Sec. 13. OPERATING WITHOUT A LICENSE--INJUNCTIONS OR OTHER REMEDIES--PENALTY. Notwithstanding the existence or use of any other remedy, the board may, in the manner provided by law and upon the advice of the attorney general, who shall represent the board in the proceedings, maintain an action in the name of the state for an injunction, or other process against a person to restrain or prevent the performance of laboratory testing without a license under this chapter. It is a misdemeanor to do laboratory testing without a license.

NEW SECTION. Sec. 14. PETITION OF SUPERIOR COURT FOR REVIEW OF DISCIPLINARY ACTION. A person who has had a denial, condition, suspension, or revocation of his or her license, or a civil monetary penalty upheld after administrative review under chapter 34.05 RCW, may, within sixty days of the administrative determination, petition the superior court for review of the decision.

NEW SECTION. Sec. 15. PERSONS WHO MAY NOT RECEIVE A LICENSE. No person who has had his or her license revoked may be considered for relicensure within two years of the final adjudication of a license revocation.

NEW SECTION. Sec. 16. CONFIDENTIALITY OF CERTAIN INFORMATION. All information received by the board through filed reports, audits, or on-site reviews, as authorized under this chapter, may not be disclosed publicly in any manner that would identify persons who have specimens of material from their bodies at a test site, absent a written release from the person, or a court order.

NEW SECTION. Sec. 17. SHORT TITLE. This chapter may be cited as the clinical laboratory sciences practices act.

NEW SECTION. Sec. 18. SEVERABILITY. If any provision of this act or its application to any person or circumstance is held invalid, the remainder of the act or the application of the provision to other persons or circumstances is not affected.

NEW SECTION. Sec. 19. LEGISLATIVE DIRECTIVE. Sections 1 through 18 of this act constitute a new chapter in Title 18 RCW.

NEW SECTION. Sec. 20. CAPTIONS. Captions as used in this act constitute no part of the law.

NEW SECTION. Sec. 21. EFFECTIVE DATES. (1) Sections 5 through 7 of this act are necessary for the immediate preservation of the public peace, health, or safety, or support of the state government and its existing public institutions, and shall take effect July 1, 1995.

(2) Sections 1 through 4, and 8 through 18 of this act shall take effect January 1, 1996.