00 CS FOR SENATE BILL NO. 261(FIN)                                                                                       
01 "An Act relating to needle stick and sharps injury protections and the use of                                           
02 safe needles by health care facilities and health care professionals; relating to the                                   
03 vaccination of health care workers against diseases transmitted by bloodborne                                           
04 pathogens; and providing for an effective date."                                                                        
05 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF ALASKA:                                                               
06    * Section 1.  AS 18.60 is amended by adding new sections to read:                                                  
07 Article 13.  Health Care Protections.                                                                                 
08  Sec. 18.60.880.  Needle stick and sharps injury protections for health care                                          
09 workers.  (a)  An employer shall conduct product evaluations of needleless systems                                     
10 and sharps with engineered sharps injury protections.  The product evaluations shall                                    
11 include the categories of devices that are used in the employer's facilities.  For each                                 
12 category of device, the product evaluations shall be performed by front-line health care                                
13 workers representing all wards and medical specialties where the devices are used.                                      
14 The evaluation committee described in (g) of this section shall determine the amount                                    
01 of time necessary for the front-line health care workers to perform product evaluations                                 
02 under this subsection.  The categories of devices to be evaluated under this subsection                                 
03 include                                                                                                                 
04   (1)  IV catheters;                                                                                                   
05   (2)  IV access devices and IV connectors;                                                                            
06   (3)  vacuum-tube blood collection devices;                                                                           
07   (4)  blood-drawing devices including phlebotomy needle and tube                                                      
08 holders, butterfly-type devices, and syringes and other similar devices;                                                
09   (5)  syringes used for purposes other than blood drawing;                                                            
10   (6)  suture needles;                                                                                                 
11   (7)  scalpel devices; and                                                                                            
12   (8)  any other category of device used at the employer's facilities where                                            
13 there is a sharps injury risk.                                                                                          
14  (b)  The department shall, by regulation, adopt a standard concerning the use                                         
15 of needleless systems and sharps with engineered sharps injury protections for devices                                  
16 listed in (a) of this section.  The regulations must provide that                                                       
17   (1)  needleless systems and sharps with engineered sharps injury                                                     
18 protections must be included as engineering and work practice controls; however, the                                    
19 needleless systems and sharps with engineered sharps injury protections are not                                         
20 required if                                                                                                             
21   (A)  the devices are not available in the marketplace;                                                              
22   (B)  the evaluation committee described in (g) of this section                                                      
23 determines by means of objective product evaluation criteria that use of the                                            
24 devices may jeopardize patient safety if used for                                                                       
25   (i)  a class or type of procedure; or                                                                              
26   (ii)  a class or type of procedure when performed on a                                                             
27 certain type of patient;                                                                                                
28   (C)  a certified or licensed health care worker directly involved                                                   
29 in the patient's care determines, in the reasonable exercise of clinical judgment,                                      
30 that use of the devices will jeopardize the patient's safety or the success of the                                      
31 particular medical procedure involving the patient;  a health care worker who                                           
01 makes this determination shall file a report with the employer, in writing,                                             
02 including the date, time, patient, and procedure involved, and a statement of the                                       
03 reasons why the employee failed to use an approved needleless system or sharp                                           
04 with engineered sharps injury protections;                                                                              
05   (D)  the employer can demonstrate by means of objective                                                             
06 product evaluation criteria that use of the devices is not more effective in                                            
07 preventing exposure incidents than the alternative used by the employer; or                                             
08   (E)  the employer can demonstrate, with respect to an                                                               
09 engineering control that has not been available in the marketplace for at least                                         
10 12 months, that reasonably specific and reliable information is not available                                           
11 regarding the safety performance of the engineering control for the employer's                                          
12 procedures, and that the employer is actively determining by means of                                                   
13 objective product evaluation criteria whether the use of the engineering control                                        
14 will reduce the risk of exposure incidents occurring in the employer's                                                  
15 workplace;                                                                                                              
16   (2)  a written exposure control plan include an effective procedure for                                              
17 identifying and selecting existing needleless systems and sharps with engineered sharps                                 
18 injury protections; the procedure must provide that an evaluation committee described                                   
19 in (g) of this section has responsibility for identifying and selecting the devices;                                    
20   (3)  written exposure control plans shall be updated when necessary to                                               
21 reflect progress in implementing needleless systems and sharps with engineered sharps                                   
22 injury protections as determined by the evaluation committee described in (g) of this                                   
23 section; updating must occur at least once every year;                                                                  
24   (4)  information concerning exposure incidents shall be recorded in a                                                
25 sharps injury log as required by (c) of this section.                                                                   
26  (c)  A sharps injury log must include at least                                                                        
27   (1)  the date and time of the exposure incident;                                                                     
28   (2)  the type and brand of sharp involved in the exposure incident; and                                              
29   (3)  the description of the exposure incident that must include                                                      
30   (A)  the job classification of the exposed employee;                                                                
31   (B)  the department or work area where the exposure incident                                                        
01 occurred;                                                                                                               
02   (C)  the procedure that the exposed employee was performing                                                         
03 at the time of the incident;                                                                                            
04   (D)  how the incident occurred;                                                                                     
05   (E)  the body part involved in the exposure incident;                                                               
06   (F)  if the sharp had engineered sharps injury protections,                                                         
07 whether the protective mechanism was activated, and whether the injury                                                  
08 occurred before the protective mechanism was activated, during activation of                                            
09 the mechanism, or after activation of the mechanism;                                                                    
10   (G)  if the sharp had no engineered sharps injury protections, the                                                  
11 injured employee's opinion as to whether and how such a mechanism could                                                 
12 have prevented the injury, as well as the basis for the opinion; and                                                    
13   (H)  whether an engineering, administrative, or work practice                                                       
14 control could have prevented the injury, as well as the recorder's basis for the                                        
15 opinion.                                                                                                                
16  (d)  The department shall adopt regulations to implement AS 18.60.880 -                                               
17 18.60.890 and to revise the bloodborne pathogen standard to prevent sharps injuries                                     
18 or exposure incidents.  The regulations may include                                                                     
19   (1)  training and education requirements;                                                                            
20   (2)  measures to encourage the vaccination of health care workers                                                    
21 against diseases transmitted by bloodborne pathogens;                                                                   
22   (3)  requirements for the strategic placement of sharps containers as                                                
23 close to the work area as practical; and                                                                                
24   (4)  requirements for the increased use of personal protective equipment.                                            
25  (e)  The department shall compile and maintain a list of sources of information                                       
26 on existing needleless systems and sharps with engineered sharps injury protections.                                    
27 The department shall make the list available to assist employers in complying with the                                  
28 requirements of the bloodborne pathogen standard adopted under this section.                                            
29  (f)  Standards adopted under (b) of this section do not apply to the use of a                                         
30 drug or biologic prepackaged within an administration system or used in a prefilled                                     
31 syringe that is approved for commercial distribution or investigational use by the                                      
01 federal Food and Drug Administration.                                                                                   
02  (g)  An employer who employs 10 or more front-line health care workers shall                                          
03 establish an evaluation committee, at least half the members of which are front-line                                    
04 health care workers.  An employer who employs fewer than 10 front-line health care                                      
05 workers shall establish an evaluation committee with at least one member who is a                                       
06 front-line health care worker.  An employer who has established a committee before                                      
07 the effective date of this section that satisfies the requirements of this subsection is not                            
08 required to establish an additional committee under this subsection.                                                    
09  (h)  Standards adopted under this section do not apply to an employer or                                              
10 supervised employee who primarily uses needles and other sharps for intraoral                                           
11 procedures.                                                                                                             
12  Sec. 18.60.890.  Definitions.  In AS 18.60.880 - 18.60.890,                                                         
13   (1)  "bloodborne pathogens" means pathogenic microorganisms that are                                                 
14 present in human blood and can cause disease in humans, including hepatitis B virus,                                    
15 hepatitis C virus, and human immunodeficiency virus;                                                                    
16   (2)  "department" means the Department of Labor and Workforce                                                        
17 Development;                                                                                                            
18   (3)  "employer"                                                                                                      
19   (A)  means an employer having an employee with occupational                                                         
20 exposure to human blood or other material potentially containing bloodborne                                             
21 pathogens; but                                                                                                          
22   (B)  does not include an employer who has fewer than 25 full-                                                       
23 time-equivalent employees;                                                                                              
24   (4)  "engineered sharps injury protections" means a physical attribute                                               
25 built into                                                                                                              
26   (A)  a needle device used for withdrawing body fluids, accessing                                                    
27 a vein or artery, or administering medications or other fluids that effectively                                         
28 reduces the risk of an exposure incident by a mechanism such as barrier                                                 
29 creation, blunting, encapsulation, withdrawal, retraction, destruction, or other                                        
30 effective mechanisms; or                                                                                                
31   (B)  another type of needle device, or a nonneedle sharp, that                                                      
01 effectively reduces the risk of an exposure incident;                                                                   
02   (5)  "engineering controls" means controls, including needleless systems                                             
03 and sharps with engineered sharps injury protections, that isolate or remove the                                        
04 bloodborne pathogens hazard from the workplace;                                                                         
05   (6)  "front-line health care worker" means a nonmanagerial employee                                                  
06 responsible for direct patient care with potential occupational exposure to sharps-                                     
07 related injuries;                                                                                                       
08   (7)  "needleless system" means a device that does not use needles for                                                
09   (A)  the withdrawal of body fluids after initial venous or arterial                                                 
10 access is established;                                                                                                  
11   (B)  the administration of medication or fluids; or                                                                 
12   (C)  another procedure involving the potential for an exposure                                                      
13 incident;                                                                                                               
14   (8)  "sharp" means an object used or encountered in a health care setting                                            
15 that can be reasonably anticipated to penetrate the skin or any other part of the body                                  
16 and to result in an exposure incident, including needle devices, scalpels, lancets,                                     
17 broken glass, and broken capillary tubes;                                                                               
18   (9)  "sharps injury" means cuts, abrasions, needlesticks, or other injuries                                          
19 caused by a sharp;                                                                                                      
20   (10)  "sharps injury log" means a written or electronic record satisfying                                            
21 the requirements of AS 18.60.880(c);                                                                                    
22   (11)  "work practice controls" are controls that reduce the likelihood of                                            
23 exposure by altering the manner in which a task is performed.                                                           
24    * Sec. 2.  AS 18.60.880(f) is repealed December 31, 2003.                                                          
25    * Sec. 3.  This Act takes effect January 1, 2001.