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.