HB 339: "An Act relating to the licensing of clinical laboratory science professionals; and providing for an effective date."
00 HOUSE BILL NO. 339 01 "An Act relating to the licensing of clinical laboratory science professionals; and 02 providing for an effective date." 03 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA: 04 * Section 1. AS 08 is amended by adding a new chapter to read: 05 Chapter 30. Clinical Laboratory Science Professionals. 06 Article 1. Volunteer Advisory Board of Clinical Laboratory Science Professionals. 07 Sec. 08.30.010. Board creation; membership. (a) There is created in the 08 Department of Commerce, Community, and Economic Development the Volunteer 09 Advisory Board of Clinical Laboratory Science Professionals consisting of five 10 members appointed by the governor. 11 (b) Board members must be residents of the state, and the membership of the 12 board must reflect the rural and urban demographics of the state. Not more than two 13 members may be residents of the same house district. 14 (c) The membership of the board shall consist of
01 (1) four licensed clinical laboratory science professionals, with not 02 more than one member from each licensed category of clinical laboratory science 03 professional; and 04 (2) one public member who does not have a financial or personal 05 association with clinical laboratory science. 06 (d) Members of the board do not receive compensation for service on the 07 board, and are not eligible for transportation expenses or per diem under 08 AS 39.20.180. 09 Sec. 08.30.020. Board member terms; vacancies. Notwithstanding 10 AS 08.01.035, each member of the board shall serve a term of three years and until a 11 successor is appointed and qualifies. If a vacancy occurs, the governor shall appoint a 12 successor of like qualification for the remainder of an unexpired term. A person may 13 not be appointed to serve more than two successive terms. 14 Sec. 08.30.030. Duties of the board. The board shall advise the department on 15 (1) credentialing agencies or organizations; and 16 (2) what laboratory tests should be defined as waived tests. 17 Article 2. Examination and Licensing. 18 Sec. 08.30.050. License required. Except as provided in AS 08.30.100, a 19 person may not perform clinical laboratory tests, use the title "clinical laboratory 20 scientist," "medical technologist," "clinical laboratory technician," "medical laboratory 21 technician," or a title listed under AS 08.30.060, or offer or attempt to practice, or 22 advertise or announce as being prepared or qualified to perform, clinical laboratory 23 tests without a license issued under this chapter. 24 Sec. 08.30.060. Licensing of clinical laboratory science professionals. The 25 department shall issue a license to an applicant for licensure as a clinical laboratory 26 scientist, clinical laboratory technician, clinical laboratory assistant, phlebotomy 27 technician, cytotechnologist, histotechnologist, or histotechnician if the applicant 28 submits an application on the form approved by the department, pays the required fee, 29 and provides evidence satisfactory to the department that the applicant is certified by a 30 nationally recognized credentialing agency or organization approved by the 31 department.
01 Sec. 08.30.070. Scope of practice. A person licensed under this chapter may 02 perform clinical laboratory testing as follows: 03 (1) a clinical laboratory scientist may perform any clinical laboratory 04 test or research function and direct, supervise, consult, or educate other clinical 05 laboratory professionals; 06 (2) a clinical laboratory technician shall follow established protocols 07 that require a limited exercise of independent judgment and act under the supervision 08 of a licensed clinical laboratory scientist; a clinical laboratory technician may perform 09 waived and moderately complex tests; 10 (3) a clinical laboratory assistant shall follow established protocols that 11 require a limited knowledge of general laboratory procedure and act under the 12 supervision of a licensed clinical laboratory scientist; a clinical laboratory assistant 13 may perform waived and moderately complex tests as determined by the department 14 in regulation; 15 (4) a phlebotomy technician may, under the supervision of a licensed 16 clinical laboratory scientist, licensed physician, or medical laboratory director, obtain 17 blood samples for testing by means of venipuncture, capillary sticks, or access by 18 venous devices and may perform waived and point of care testing; 19 (5) a cytotechnologist may 20 (A) process and interpret cellular material derived from the 21 human body to delineate data regarding human cytopathological disease; 22 (B) review and interpret gynecological cytology preparations; 23 and 24 (C) screen other cytology preparations if reviewed and 25 interpreted by a person licensed to practice medicine under AS 08.64; 26 (6) a histotechnologist may 27 (A) process cellular and tissue components through methods of 28 selected gross dissection and description fixation, dehydration, embedding, 29 microtomy, frozen sectioning, staining, and other related procedures and 30 techniques employed in the preparation of smears, slides, and tissues; and 31 (B) perform methods for antigen detection and other molecular
01 hybridization testing methods if the purpose of the testing is to analyze or 02 quantify cellular tissue components for interpretation by a person licensed to 03 practice medicine under AS 08.64; 04 (7) a histotechnician may, under the supervision of a medical 05 laboratory director, licensed histotechnologist, or licensed clinical laboratory scientist, 06 (A) process cellular and tissue components through methods of 07 selected gross dissection and description fixation, dehydration, embedding, 08 microtomy, frozen sectioning, staining, and other related procedures and 09 techniques employed in the preparation of smears, slides, and tissues; and 10 (B) perform methods for antigen detection and other molecular 11 hybridization testing methods if the purpose of the testing is to analyze or 12 quantify cellular tissue components for interpretation by a person licensed to 13 practice medicine under AS 08.64. 14 Sec. 08.30.080. Renewal of license. (a) A license, other than a temporary 15 license, issued by the department is valid for three years or until the license is 16 relinquished, suspended, or revoked. 17 (b) The department may renew a license under this section if the applicant 18 submits 19 (1) a completed application on a form approved by the department; 20 (2) the fee established by the department; and 21 (3) satisfactory proof of 22 (A) continuing certification by a nationally recognized 23 credentialing agency or organization approved by the department; and 24 (B) other measures of competency as required by the 25 department. 26 Article 3. General Provisions. 27 Sec. 08.30.090. Grounds for denial of license or for disciplinary sanctions. 28 The department may deny a license, refuse to renew a license, or impose a disciplinary 29 sanction under AS 08.01.075 on a person licensed under this chapter when the 30 department finds that the person 31 (1) made a material misstatement of fact in information presented to
01 the department; 02 (2) violated a provision of this chapter or a regulation implementing 03 this chapter; 04 (3) was convicted of a crime that is a felony or that is a misdemeanor 05 that involves dishonesty or the practice of clinical laboratory science in any state or 06 federal jurisdiction; 07 (4) was issued a license based on a misrepresentation of fact; 08 (5) engaged in unprofessional conduct described in regulations adopted 09 by the department; 10 (6) engaged in dishonorable or unethical conduct of a type likely to 11 deceive, defraud, or harm the public; 12 (7) provided professional services while mentally incompetent or 13 under the influence of alcohol or of a controlled substance that was used in excess of a 14 therapeutic amount or without valid medical indications; or 15 (8) performed or agreed to perform clinical tests directly or indirectly 16 in a manner that offers or implies a rebate, fee-splitting inducements or arrangements, 17 or other benefit other than the person's salary. 18 Sec. 08.30.100. Exemption from license requirement. The license 19 requirements under this chapter do not apply to a 20 (1) person licensed in the state to perform activities for which the 21 license was issued; 22 (2) clinical laboratory science professional employed or contracted by 23 the United States government while performing official duties; 24 (3) clinical laboratory science professional while engaged exclusively 25 in research that does not involve health maintenance, diagnosis, or treatment of a 26 person; 27 (4) student or trainee who is enrolled in a clinical laboratory science 28 program while performing duties under the program and under the direct supervision 29 of a licensee; 30 (5) person performing waived testing; 31 (6) person performing point of care testing in an acute care facility if
01 the facility 02 (A) employs a licensed clinical laboratory science professional 03 to manage testing by 04 (i) designing and supervising a training program for 05 point of care testing personnel; 06 (ii) supervising and monitoring quality assurance and 07 control over activities occurring at the testing site; 08 (iii) assisting in the selection of technology used for the 09 testing; 10 (iv) reviewing the results of proficiency testing and 11 recommending corrective action when necessary; 12 (v) monitoring the continued competency of testing 13 personnel; and 14 (B) adopts and employs procedures approved by the 15 department that include adequate documentation by and monitoring of testing 16 personnel. 17 Sec. 08.30.500. Definitions. In this chapter, 18 (1) "board" means the Voluntary Advisory Board of Clinical 19 Laboratory Science Professionals established under AS 08.30.010; 20 (2) "clinical laboratory testing," "clinical laboratory test," or 21 "laboratory test" means a microbiological, serological, chemical, biological, 22 hematological, immunological, immunohematological, genetic, radiobiassay, 23 cytological, biophysical, or any other procedure performed on material derived from 24 or existing in a human body that provides information for the diagnosis, prevention, or 25 monitoring of a disease, impairment, or clinical condition; clinical laboratory tests 26 encompass the pre-analytic, analytic, and post-analytic phases of testing; 27 (3) "department" means the Department of Commerce, Community, 28 and Economic Development; 29 (4) "medical laboratory director" means a licensed physician who is 30 responsible for the administrative, scientific, and technical operation of a medical 31 laboratory and who provides evidence satisfactory to the department that the person is
01 certified in clinical pathology by a nationally recognized credentialing agency, 02 organization, or school approved by the department; 03 (5) "moderately complex test" means a clinical laboratory procedure 04 that is more technologically demanding than is a waived test and requires some degree 05 of independent judgment and interpretation as further defined by the department; 06 (6) "point of care testing" means a procedure that involves analysis, is 07 performed at the site of patient care, and does not require independent laboratory or 08 technological support; 09 (7) "supervision" means the provision of direction and evaluation of 10 the tasks assigned; 11 (8) "waived testing" or "waived test" means a simple laboratory 12 procedure, as further defined by the department, that employs methodologies that are 13 so simple and accurate as to render the likelihood of an erroneous result negligible 14 and, even if performed incorrectly, that does not pose a significant risk of harm; 15 "waived tests" include those approved by the United States Food and Drug 16 Administration for home use. 17 * Sec. 2. The uncodified law of the State of Alaska is amended by adding a new section to 18 read: 19 APPLICABILITY. AS 08.30.050 - 08.30.500, added by sec. 1 of this Act, apply 20 immediately to persons who have not been employed in the state in the field of clinical 21 laboratory science, as described in this Act, before the effective date of this Act. For persons 22 who have been employed in the state within the past five years in a specified field of clinical 23 laboratory science and have been certified by any national certifying agency or organization 24 approved by the department, the provisions of sec. 1 of this Act apply two years after the 25 effective date of this Act. 26 * Sec. 3. The uncodified law of the State of Alaska is amended by adding a new section to 27 read: 28 VOLUNTEER ADVISORY BOARD OF CLINICAL LABORATORY SCIENCE 29 PROFESSIONALS; TRANSITION; STAGGERED TERMS. Notwithstanding AS 08.30.010, 30 added by sec. 1 of this Act, the members appointed to the Voluntary Advisory Board of 31 Clinical Laboratory Science Professionals
01 (1) may be unlicensed for the first year of the member's initial appointment or 02 until 30 days after the department has begun issuing licenses, whichever first occurs; and 03 (2) shall be appointed to staggered terms in the first year as follows: 04 (A) two members shall be appointed to serve three years; 05 (B) two members shall be appointed to serve two years; and 06 (C) one member shall be appointed to serve one year. 07 * Sec. 4. This Act takes effect October 1, 2008.