HB 28: "An Act relating to the licensing of clinical laboratory science professionals; and providing for an effective date."
00 HOUSE BILL NO. 28 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 08.01.010 is amended by adding a new paragraph to read: 05 (39) regulation of clinical laboratory science professionals under 06 AS 08.30. 07 * Sec. 2. AS 08 is amended by adding a new chapter to read: 08 Chapter 30. Clinical Laboratory Science Professionals. 09 Article 1. Volunteer Advisory Board of Clinical Laboratory Science Professionals. 10 Sec. 08.30.010. Board creation; membership. (a) There is created in the 11 Department of Commerce, Community, and Economic Development the Volunteer 12 Advisory Board of Clinical Laboratory Science Professionals consisting of five 13 members appointed by the governor. 14 (b) Board members must be residents of the state, and the membership of the
01 board must reflect the rural and urban demographics of the state. Not more than two 02 members may be residents of the same house district. 03 (c) The membership of the board shall consist of 04 (1) four licensed clinical laboratory science professionals, with not 05 more than one member from each licensed category of clinical laboratory science 06 professional; and 07 (2) one public member who does not have a financial or personal 08 association with clinical laboratory science. 09 (d) Members of the board do not receive compensation for service on the 10 board, and are not eligible for transportation expenses or per diem under 11 AS 39.20.180. 12 Sec. 08.30.020. Board member terms; vacancies. Each member of the board 13 shall serve a term of three years and until a successor is appointed and qualifies. If a 14 vacancy occurs, the governor shall appoint a successor of like qualification for the 15 remainder of an unexpired term. A person may not be appointed to serve more than 16 two successive terms. 17 Sec. 08.30.030. Duties of the board. The board shall advise the department on 18 credentialing agencies or organizations. 19 Article 2. Examination and Licensing. 20 Sec. 08.30.100. License required. Except as provided in AS 08.30.210, a 21 person may not perform clinical laboratory tests, use a title listed under AS 08.30.110, 22 or offer or attempt to practice, or advertise or announce as being prepared or qualified 23 to perform, clinical laboratory tests without a license issued under this chapter. 24 Sec. 08.30.110. 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 competent, 30 as evidenced by the applicant's certification by a credentialing agency or organization 31 approved by the department in consultation with the board.
01 Sec. 08.30.120. 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 licensed physician; 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 licensed physician; 03 (7) a histotechnician may, under the supervision of a medical 04 laboratory director, licensed histotechnologist, or licensed clinical laboratory scientist, 05 (A) process cellular and tissue components through methods of 06 selected gross dissection and description fixation, dehydration, embedding, 07 microtomy, frozen sectioning, staining, and other related procedures and 08 techniques employed in the preparation of smears, slides, and tissues; and 09 (B) perform methods for antigen detection and other molecular 10 hybridization testing methods if the purpose of the testing is to analyze or 11 quantify cellular tissue components for interpretation by a licensed physician. 12 Sec. 08.30.130. Duration of license; license renewal. (a) A license, other than 13 a temporary license, issued by the department is valid for three years or until the 14 license is relinquished, suspended, or revoked. 15 (b) The department may renew a license under this section if the applicant 16 submits 17 (1) a completed application on a form approved by the department; 18 (2) the fee established by the department; and 19 (3) satisfactory proof of 20 (A) continuing certification by a nationally recognized 21 credentialing agency or organization approved by the department; and 22 (B) other measures of competency as required by the 23 department. 24 Article 3. General Provisions. 25 Sec. 08.30.200. Grounds for denial of license or for disciplinary sanctions. 26 The department may deny a license, refuse to renew a license, or impose a disciplinary 27 sanction under AS 08.01.075 on a person licensed under this chapter when the 28 department finds that the person 29 (1) made a material misstatement of fact in information presented to 30 the department; 31 (2) violated a provision of this chapter or a regulation implementing
01 this chapter; 02 (3) was convicted of a crime that is a felony or that is a misdemeanor 03 that involves dishonesty or the practice of clinical laboratory science in any state or 04 federal jurisdiction; 05 (4) was issued a license based on a misrepresentation of fact; 06 (5) engaged in unprofessional conduct described in regulations adopted 07 by the department; 08 (6) engaged in dishonorable or unethical conduct of a type likely to 09 deceive, defraud, or harm the public; 10 (7) provided professional services while mentally incompetent or 11 under the influence of alcohol or of a controlled substance that was used in excess of a 12 therapeutic amount or without valid medical indications; or 13 (8) performed or agreed to perform clinical tests directly or indirectly 14 in a manner that offers or implies a rebate, fee-splitting inducements or arrangements, 15 or other benefit other than the person's salary. 16 Sec. 08.30.210. Exemption from license requirement. The license 17 requirements under this chapter do not apply to a 18 (1) person licensed in the state to perform activities for which the 19 license was issued; 20 (2) clinical laboratory science professional employed or contracted by 21 the United States government while performing official duties; 22 (3) clinical laboratory science professional while engaged exclusively 23 in research that does not involve health maintenance, diagnosis, or treatment of a 24 person; 25 (4) student or trainee who is enrolled in a clinical laboratory science 26 program while performing duties under the program and under the direct supervision 27 of a licensee; 28 (5) person performing waived testing; 29 (6) person performing point of care testing in an acute care facility if 30 the facility 31 (A) employs a licensed clinical laboratory science professional
01 to manage testing by 02 (i) designing and supervising a training program for 03 point of care testing personnel; 04 (ii) supervising and monitoring quality assurance and 05 control over activities occurring at the testing site; 06 (iii) assisting in the selection of technology used for the 07 testing; 08 (iv) reviewing the results of proficiency testing and 09 recommending corrective action when necessary; 10 (v) monitoring the continued competency of testing 11 personnel; and 12 (B) adopts and employs procedures approved by the 13 department that include adequate documentation by and monitoring of testing 14 personnel. 15 Sec. 08.30.220. Department regulations. The department shall adopt 16 regulations, subject to AS 44.62 (Administrative Procedure Act), to carry out the 17 purposes of this chapter and the duties assigned to the department under this chapter. 18 Sec. 08.30.299. Definitions. In this chapter, 19 (1) "board" means the Voluntary Advisory Board of Clinical 20 Laboratory Science Professionals established under AS 08.30.010; 21 (2) "clinical laboratory testing" or "clinical laboratory test" means a 22 microbiological, serological, chemical, biological, hematological, immunological, 23 immunohematological, genetic, radiobiassay, cytological, biophysical, or any other 24 procedure performed on material derived from or existing in a human body that 25 provides information for the diagnosis, prevention, or monitoring of a disease, 26 impairment, or clinical condition; clinical laboratory tests encompass the pre-analytic, 27 analytic, and post-analytic phases of testing; 28 (3) "department" means the Department of Commerce, Community, 29 and Economic Development; 30 (4) "medical laboratory director" means a licensed physician who is 31 responsible for the administrative, scientific, and technical operation of a medical
01 laboratory and who provides evidence satisfactory to the department that the person is 02 certified in clinical pathology by a nationally recognized credentialing agency, 03 organization, or school approved by the department; 04 (5) "moderately complex test" means a clinical laboratory procedure as 05 defined by the United States Food and Drug Administration under 42 C.F.R. 06 493.17(a), as amended, and listed in the Federal Register under 42 C.F.R. 493.17(c), 07 as amended; 08 (6) "point of care testing" means a procedure that involves analysis, is 09 performed at the site of patient care, and does not require independent laboratory or 10 technological support; 11 (7) "supervision" means the provision of direction and evaluation of 12 the tasks assigned; 13 (8) "waived testing" or "waived test" 14 (A) means a simple laboratory procedure, as defined by the 15 United States Food and Drug Administration under 42 C.F.R. 493.15(b), as 16 amended, and listed under 42 C.F.R. 493.15(c), as amended; and 17 (B) includes those tests described in (A) of this paragraph 18 approved by the United States Food and Drug Administration for home use. 19 * Sec. 3. The uncodified law of the State of Alaska is amended by adding a new section to 20 read: 21 APPLICABILITY. AS 08.30.100 - 08.30.299, added by sec. 2 of the Act, apply 22 (1) immediately to persons who have not been employed in the state in the 23 field of clinical laboratory science, as described in this Act, before the effective date of this 24 Act; and 25 (2) two years after the effective date of this Act as to persons who have been 26 employed in the state within the five years immediately preceding the effective date of this 27 Act in a specified field of clinical laboratory science and have been certified by a national 28 credentialing agency or organization approved by the Department of Commerce, Community, 29 and Economic Development under AS 08.30.110 and 08.30.220, added by sec. 2 of this Act. 30 * Sec. 4. The uncodified law of the State of Alaska is amended by adding a new section to 31 read:
01 VOLUNTEER ADVISORY BOARD OF CLINICAL LABORATORY SCIENCE 02 PROFESSIONALS; TRANSITION; STAGGERED TERMS. Notwithstanding AS 08.30.010, 03 added by sec. 2 of this Act, the members appointed to the Voluntary Advisory Board of 04 Clinical Laboratory Science Professionals 05 (1) may be unlicensed for the first year of each member's initial appointment 06 or until 30 days after the Department of Commerce, Community, and Economic Development 07 has begun issuing licenses, whichever first occurs for each member; and 08 (2) shall be appointed to staggered terms in the first year as follows: 09 (A) two members shall be appointed to serve three years; 10 (B) two members shall be appointed to serve two years; and 11 (C) one member shall be appointed to serve one year. 12 * Sec. 5. This Act takes effect October 1, 2009.