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SB 166: "An Act relating to the licensing of medical laboratory science professionals; and providing for an effective date."

00 SENATE BILL NO. 166 01 "An Act relating to the licensing of medical 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) Board of Medical Laboratory Science Professionals 06 (AS 08.30.010). 07 * Sec. 2. AS 08.03.010(c) is amended by adding a new paragraph to read: 08 (22) Board of Medical Laboratory Science Professionals 09 (AS 08.30.010) - June 30, 2017. 10 * Sec. 3. AS 08 is amended by adding a new chapter to read: 11 Chapter 30. Medical Laboratory Science Professionals. 12 Article 1. Board of Medical Laboratory Science Professionals. 13 Sec. 08.30.010. Board creation; membership. (a) The Board of Medical 14 Laboratory Science Professionals is created in the Department of Commerce,

01 Community, and Economic Development. The board consists of five members 02 appointed by the governor. 03 (b) Board members must be residents of the state, and the membership of the 04 board must reflect the rural and urban demographics of the state. Not more than two 05 members may be residents of the same house district. 06 (c) The membership of the board shall consist of 07 (1) four licensed medical laboratory science professionals, with not 08 more than one member from each licensed category of medical laboratory science 09 professional; and 10 (2) one public member. 11 Sec. 08.30.020. Board member terms; vacancies. Notwithstanding 12 AS 08.01.035, each member of the board shall serve a term of three years and until a 13 successor is appointed. Except as provided in AS 39.05.080(4), an appointment to fill 14 a vacancy on a board is for the remainder of the unexpired term. A member who has 15 served all or part of two successive terms on a board may not be reappointed to the 16 board unless four years have elapsed since the person has last served on the board. 17 Sec. 08.30.030. Duties of the board. (a) In addition to the duties specified in 18 AS 08.01, the board shall 19 (1) establish standards and procedures for the approval of credentialing 20 agencies and organizations considered acceptable to the board for the purpose of proof 21 of continuing certification under AS 08.30.130(b)(3)(A); 22 (2) establish measures of competency for the purpose of the proof that 23 may be required under AS 08.30.130(b)(3)(B); 24 (3) establish standards and procedures for the approval of medical 25 laboratory science programs to implement the licensing exemption available under 26 AS 08.30.210(4); 27 (4) establish continuing education requirements for the renewal of a 28 license under this chapter; and 29 (5) adopt regulations necessary to carry out the board's duties under 30 this chapter; the regulations must comply with federal regulations promulgated under 31 42 U.S.C. 263a (Clinical Laboratory Improvement Act of 1967).

01 (b) The board may delegate to the department, and the department may 02 perform, a duty for which the board has authority. 03 Article 2. Examination and Licensing. 04 Sec. 08.30.100. License required. Except as provided in AS 08.30.210, a 05 person may not perform medical laboratory tests, use a title listed under AS 08.30.110, 06 or offer or attempt to perform, or advertise or announce as being prepared or qualified 07 to perform, medical laboratory tests without a license issued under this chapter. 08 Sec. 08.30.110. Licensing of medical laboratory science professionals. The 09 department shall issue a license to an applicant for licensure as a medical laboratory 10 scientist, medical laboratory technician, medical laboratory assistant, or phlebotomy 11 technician if the applicant submits an application on the form approved by the 12 department, pays the required fee, and provides evidence satisfactory to the 13 department that the applicant is competent, as evidenced by the applicant's 14 certification by a credentialing agency or organization approved by the board. 15 Sec. 08.30.120. Scope of practice. A person licensed under this chapter may 16 perform medical laboratory testing as follows: 17 (1) a medical laboratory scientist may 18 (A) perform, interpret, and correlate laboratory procedures 19 requiring the broad exercise of independent judgment and responsibility with 20 minimal technical supervision; 21 (B) maintain equipment and records, establish and implement 22 protocols, select or develop test methodology, and perform quality assurance 23 activities related to test performance; 24 (C) supervise medical laboratory scientists, medical laboratory 25 technicians, medical laboratory assistants, and phlebotomy technicians; 26 (D) perform the duties of a phlebotomy technician; 27 (E) provide technical training to other health care professionals; 28 (F) perform research functions; 29 (2) a medical laboratory technician may 30 (A) perform medical laboratory tests, following established 31 protocols that require limited exercise of independent judgment, under the

01 supervision of a licensed medical laboratory scientist; 02 (B) perform the duties of a phlebotomy technician; 03 (3) a medical laboratory assistant may 04 (A) perform medical laboratory tests as determined by the 05 board in regulation, following established protocols that require limited 06 exercise of independent judgment, under the supervision of a licensed medical 07 laboratory scientist; 08 (B) perform the duties of a phlebotomy technician; 09 (4) a phlebotomy technician may 10 (A) perform specimen processing, preparation of specimens for 11 testing, and point-of-care testing; 12 (B) under the supervision of a licensed medical laboratory 13 scientist, licensed physician, licensed osteopath, or medical laboratory director, 14 obtain blood samples for testing by means of venipuncture, capillary sticks, or 15 access by venous devices. 16 Sec. 08.30.130. Duration of license; license renewal. (a) Notwithstanding 17 AS 08.01.100, a license issued by the department under this chapter is valid for three 18 years or until the license is relinquished, suspended, or revoked. 19 (b) The department may renew a license under this section if the applicant 20 submits 21 (1) a completed application on a form approved by the department; 22 (2) the fee established by the department; and 23 (3) satisfactory proof of 24 (A) certification by a nationally recognized credentialing 25 agency or organization approved by the board; and 26 (B) other measures of competency as required by the board. 27 Article 3. General Provisions. 28 Sec. 08.30.200. Grounds for denial of license or for disciplinary sanctions. 29 The department may deny a license, refuse to renew a license, or impose a disciplinary 30 sanction under AS 08.01.075 on a person licensed under this chapter when the 31 department finds that the person

01 (1) made a material misstatement of fact in information presented to 02 the department; 03 (2) violated a provision of this chapter or a regulation implementing 04 this chapter; 05 (3) was convicted of a crime that is a felony or that is a misdemeanor 06 that involves dishonesty or the practice of medical laboratory science in this or another 07 jurisdiction; 08 (4) was issued a license based on a misrepresentation of fact; 09 (5) engaged in unprofessional conduct described in regulations adopted 10 by the board; 11 (6) engaged in dishonorable or unethical conduct of a type likely to 12 deceive, defraud, or harm the public; 13 (7) provided professional services while mentally incompetent or 14 under the influence of alcohol or of a controlled substance that was used in excess of a 15 therapeutic amount or without valid medical indications; or 16 (8) performed or agreed to perform medical tests directly or indirectly 17 in a manner that offers or implies a rebate, fee-splitting inducements or arrangements, 18 or other benefit other than the person's salary. 19 Sec. 08.30.210. Exemption from license requirement. The license 20 requirements under this chapter do not apply to a 21 (1) person licensed in the state performing medical laboratory testing 22 within the scope of the practice for which the person's license was issued; 23 (2) person who performs medical laboratory testing who is employed 24 or contracted by the United States government while performing official duties; 25 (3) person who performs medical laboratory testing while engaged 26 exclusively in research that does not involve health maintenance, diagnosis, or 27 treatment of a person; 28 (4) student or trainee who is enrolled in a medical laboratory science 29 program approved by the board while performing duties under the program under the 30 direct supervision of a person licensed under this chapter who would be qualified 31 under AS 08.30.120 to supervise the type of testing the student or trainee is

01 performing; 02 (5) newly hired person who is performing medical laboratory testing 03 who has applied for a license under this chapter for up to six months after the date of 04 submission of the license application to the department while the person is acting 05 within the scope of practice authorized under AS 08.30.120 for the type of license 06 applied for; 07 (6) nonresident who enters the state on a temporary basis to perform 08 medical laboratory testing for not more than a combined 13 weeks in a consecutive 09 12-month period; the employer of a temporary nonresident medical laboratory testing 10 professional shall submit to the department the name and dates of employment for the 11 nonresident; 12 (7) person performing point-of-care testing in a clinical facility if the 13 facility 14 (A) employs a licensed medical laboratory professional to 15 manage testing by 16 (i) designing and supervising a training program for 17 point-of-care testing personnel; 18 (ii) supervising and monitoring quality assurance and 19 control over activities occurring at the testing site; 20 (iii) assisting in the selection of technology used for the 21 testing; 22 (iv) reviewing the results of proficiency testing and 23 recommending corrective action when necessary; 24 (v) monitoring the continued competency of testing 25 personnel; and 26 (B) adopts and employs procedures approved by the 27 department that include adequate documentation by and monitoring of testing 28 personnel; 29 (8) person performing medical laboratory testing under the direct 30 supervision of a pathologist. In this paragraph, "pathologist" means a physician or 31 osteopath licensed under AS 08.64 with a specialty in pathology;

01 (9) person who meets the personnel standards of a cytotechnologist 02 under federal law and who performs medical laboratory testing by 03 (A) processing and interpreting cellular material derived from 04 the human body to delineate data regarding human cytopathological disease; 05 (B) reviewing and interpreting gynecological cytology 06 preparations; 07 (C) using immunohistochemical and molecular techniques for 08 classification, prognosis, or disease detection; 09 (D) screening other cytology preparations to be reviewed and 10 interpreted by a physician or osteopath licensed under AS 08.64. 11 Sec. 08.30.299. Definitions. In this chapter, 12 (1) "board" means the Board of Medical Laboratory Science 13 Professionals established under AS 08.30.010; 14 (2) "department" means the Department of Commerce, Community, 15 and Economic Development; 16 (3) "medical laboratory director" means a licensed physician who is 17 responsible for the administrative, scientific, and technical operation of a medical 18 laboratory and who provides evidence satisfactory to the department that the person is 19 certified in clinical pathology by a nationally recognized credentialing agency, 20 organization, or school approved by the department; 21 (4) "medical laboratory testing" or "medical laboratory test" means a 22 microbiological, serological, chemical, biological, hematological, immunological, 23 immunohematological, genetic, radiobiassay, cytological, or any other procedure 24 performed on material derived from the human body that provides information for the 25 diagnosis, prevention, or monitoring of a disease, impairment, or clinical condition; 26 medical laboratory tests encompass the pre-analytic, analytic, and post-analytic phases 27 of testing; 28 (5) "point-of-care testing" means analytical patient testing activities 29 provided within an institution that do not require permanent dedicated space including 30 testing with analytic instruments that are temporarily brought to a patient care 31 location;

01 (6) "supervision" means the provision of direction and evaluation of 02 the tasks assigned. 03 * Sec. 4. AS 44.62.330(a) is amended by adding a new paragraph to read: 04 (49) Board of Medical Laboratory Science Professionals. 05 * Sec. 5. The uncodified law of the State of Alaska is amended by adding a new section to 06 read: 07 APPLICABILITY. The license requirement of AS 08.30.100, added by sec. 3 of this 08 Act, 09 (1) applies immediately to persons who have not been employed in the state to 10 perform medical laboratory testing, as defined in AS 08.30.299, enacted by sec. 3 of this Act, 11 before the effective date of this Act; and 12 (2) does not apply until two years after the effective date of this Act to a 13 person who has been employed on at least a half-time basis in the state within at least three of 14 the five years immediately preceding the effective date of this Act to perform medical 15 laboratory testing if the person, on the effective date of this Act, is certified by a national 16 credentialing agency or organization approved by the Board of Medical Laboratory Science 17 Professionals under AS 08.30.030 and 08.30.110, added by sec. 3 of this Act, and is 18 performing medical laboratory testing within the scope of that certification. 19 * Sec. 6. The uncodified law of the State of Alaska is amended by adding a new section to 20 read: 21 TRANSITION. (a) For up to one year following the effective date of this Act or the 22 date the Department of Commerce, Community, and Economic Development begins issuing 23 licenses, whichever is later, the licensing requirement of AS 08.30.100, added by sec. 3 of this 24 Act, does not apply to a person who 25 (1) has acquired at least 1,040 hours of acceptable medical laboratory testing 26 experience during two of the three calendar years immediately preceding the effective date of 27 this Act; and 28 (2) submits to the Board of Medical Laboratory Science Professionals, 29 established under this Act, the job descriptions for the positions in which the applicant 30 acquired the experience required under (1) of this subsection, attested to by the applicant's 31 employers.

01 (b) After reviewing the job descriptions submitted under (a) of this section, the Board 02 of Medical Laboratory Science Professionals shall determine the type of medical laboratory 03 testing license for which the applicant is eligible, and the department shall issue the license. 04 (c) A license issued under (b) of this section is subject to the provisions of AS 08.30, 05 including renewal under AS 08.30.130. 06 * Sec. 7. The uncodified law of the State of Alaska is amended by adding a new section to 07 read: 08 BOARD OF MEDICAL LABORATORY SCIENCE PROFESSIONALS; 09 TRANSITION; STAGGERED TERMS. (a) In making initial appointments to the Board of 10 Medical Laboratory Science Professionals, the governor shall consider a medical laboratory 11 testing professional to be licensed for the purpose of AS 08.30.010 if the medical laboratory 12 testing professional has practiced medical laboratory testing in this state on at least a half-time 13 basis for the 24-month period immediately preceding appointment. 14 (b) Notwithstanding AS 39.05.055, the governor shall appoint the initial members of 15 the board to staggered terms as follows: 16 (1) two members shall be appointed to serve three years; 17 (2) two members shall be appointed to serve two years; and 18 (3) one member shall be appointed to serve one year. 19 (c) Notwithstanding AS 08.30.010, added by sec. 3 of this Act, a member appointed 20 to the Board of Medical Laboratory Science Professionals who is not a public member may be 21 unlicensed under AS 08.30, added by sec. 3 of this Act, for the first year of each member's 22 initial appointment or until 30 days after the Department of Commerce, Community, and 23 Economic Development has begun issuing licenses, whichever first occurs for each member. 24 * Sec. 8. This Act takes effect October 1, 2012.