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.