BILL ANALYSIS                                                                                                                                                                                                    



                                                                       



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          |SENATE RULES COMMITTEE            |                  SB 1237|
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                              UNFINISHED BUSINESS


          Bill No:  SB 1237
          Author:   Padilla (D), et al
          Amended:  8/20/10
          Vote:     21

           
           SENATE HEALTH COMMITTEE  :  5-0, 4/21/10
          AYES:  Alquist, Leno, Negrete McLeod, Pavley, Romero
          NO VOTE RECORDED:  Strickland, Aanestad, Cedillo, Cox

           SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8 

           SENATE FLOOR  :  24-5, 5/28/10
          AYES:  Alquist, Calderon, Cedillo, Corbett, Correa,  
            DeSaulnier, Ducheny, Florez, Hancock, Kehoe, Leno, Liu,  
            Lowenthal, Negrete McLeod, Padilla, Pavley, Price,  
            Romero, Simitian, Steinberg, Strickland, Wolk, Wright,  
            Yee
          NOES:  Ashburn, Dutton, Hollingsworth, Huff, Runner
          NO VOTE RECORDED:  Aanestad, Cogdill, Cox, Denham, Harman,  
            Oropeza, Walters, Wiggins, Wyland, Vacancy, Vacancy

           SENATE FLOOR  :  22-10, 8/30/10 (Concurrence)
          AYES:  Alquist, Blakeslee, Calderon, Corbett, Correa,  
            DeSaulnier, Ducheny, Florez, Hancock, Kehoe, Leno, Liu,  
            Lowenthal, Negrete McLeod, Padilla, Pavley, Price,  
            Romero, Simitian, Steinberg, Strickland, Wolk
          NOES:  Aanestad, Cogdill, Denham, Dutton, Harman,  
            Hollingsworth, Huff, Runner, Walters, Wyland
          NO VOTE RECORDED:  Ashburn, Cedillo, Emmerson, Oropeza,  
            Wiggins, Wright, Yee, Vacancy

           ASSEMBLY FLOOR  :  70-4, 8/26/10 - See last page for vote
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           SUBJECT  :    Radiation control:  health facilities and  
          clinics: records

           SOURCE :     Consumer Attorneys of California


           DIGEST  :    This bill requires health facilities and clinics  
          that use imaging procedures that involve computed  
          tomography X-ray systems (CT) for human use to record the  
          dose of radiation on every CT study produced during a CT  
          examination, and requires, commencing July 1, 2013,  
          facilities that furnish CT to be accredited and to report  
          to the State Department of Public Health (DPH) an event in  
          which the administration of radiation results in an  
          overdose, as specified.

           Assembly Amendments  delete the previous content and revised  
          and recast the measure related to the same subject matter.   
          The amendments require, commencing July 1, 2012, a person  
          that uses a CT X-ray system for human use to record the  
          dose of radiation on every CT study produced during CT  
          examination.  The amendments require the facility  
          conducting the study to electronically send each CT study  
          and protocol page that lists the technical factors and dose  
          of radiation to electronic the electronic picture archiving  
          and communications system.

           ANALYSIS  :    Existing law: 

          1. Under the Radiation Control Law, Department of  Public  
             Health (DPH) administers provisions that establish  
             standards for, and regulate sources of, ionizing  
             radiation.  Requires DPH to license persons who receive,  
             possess, or transfer radioactive materials, and devices  
             or equipment utilizing these materials. 

          2. Establishes the Radiologic Health Branch within DPH,  
             which is responsible for licensing of radioactive  
             materials, registration of X-ray producing machines,  
             certification of X-ray and radioactive material users,  
             inspection of facilities using radiation, investigation  
             of radiation incidents, and surveillance of radioactive  

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             contamination in the environment. 

          3. Gives DPH, or any state or local agency with which an  
             agreement has been made, the power to enter property,  
             within the jurisdiction of the agency, in order to  
             inspect and determine whether there is compliance with  
             the state's standards and requirements. 

          This bill:

          1. Requires, commencing July 1, 2012, a person that uses a  
             CT for human use to record the dose of radiation on  
             every CT study produced during a CT examination. 

          2. Requires the facility conducting the study referenced in  
             #1 above to electronically send each CT study and  
             protocol page, that lists the technical factors and dose  
             of radiation, to the electronic picture archiving and  
             communications system. 

          3. Requires the displayed dose to be verified annually by a  
             medical physicist to ensure the displayed doses are  
             within 20 percent of the true measured dose measured in  
             accordance with #6 below unless the facility is  
             accredited. 

          4. Requires the radiology report of a CT, in accordance  
             with #5 below, to include the dose of radiation by  
             either recording the dose within the patient's radiology  
             report or attaching the protocol page that includes the  
             dose of radiation to the radiology report. 

          5. Requires the provisions in this bill to be limited to CT  
             systems capable of calculating and displaying the dose. 

          6. Requires, for the purposes of this bill, that dose  
             radiation be defined as one of the following: 

             A.   The computed tomography index volume and dose  
               length product, as defined by the International  
               Electrotechnical Commission and recognized by the  
               federal Food and Drug Administration; and,

             B.   The dose unit as recommended by the American  

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               Association of Physicists in Medicine. 

          7. Requires, commencing July 1, 2013, facilities that  
             furnish CT to be accredited by an organization that is  
             approved by the federal Centers for Medicare and  
             Medicaid Services, an accrediting agency approved by the  
             Medical Board of California, or DPH. 

          8. Requires a health facility, except for an event that  
             results from patient movement or interference, to report  
             to DPH an event in which the administration of radiation  
             results in and of the following: 

             A.   Repeating of a CT examination, unless otherwise  
               ordered by a physician or radiologist, if the  
               following dose values are exceeded:

                 (1)      0.05 Sv (5 rem) effective dose equivalent;
                 (2)      0.5 Sv (50 rem) to an organ or tissue; or 
                 (3)      0.5 Sv (50 rem) shallow dose equivalent to  
                   the skin. 

             B.   CT X-ray irradiation of a body part other than that  
               intended by the ordering physician or a radiologist if  
               one of the following dose values are exceeded:

                 (1)      0.05 Sv (5 rem) effective dose equivalent;
                 (2)      0.5 Sv (50 rem) to an organ or tissue; or
                 (3)      0.05 Sv (50 rem) shallow dose equivalent to  
                   the skin. 

             C.   CT or therapeutic exposure that results in  
               unanticipated permanent functional damage to an organ  
               or a physiological system, hair loss, or erythema, as  
               determined by a qualified physician; 

             D.   A CT or therapeutic dose to an embryo or fetus that  
               is greater than 50 mSv (5 rem) dose equivalent, that  
               is a result of radiation to a known pregnant  
               individual unless the dose to the embryo or fetus was  
               specifically approved, in advance, by a qualified  
               physician; 

             E.   Therapeutic ionizing irradiation of the wrong  

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               individual, or wrong treatment site; and, 

             F.   The total dose from therapeutic ionizing radiation  
               delivered differs from the prescribed dose by 20  
               percent or more. Require a report in any instance  
               where the dose administered exceeds 20 percent of the  
               amount prescribed in a situation where the radiation  
               was utilized for palliative care for the specific  
               patient. Require the radiation oncologist to notify  
               the referring physician that the dose was exceeded. 

          9. Requires the facility, no later than five business days  
             after discovery of an event described in 1) above, to  
             provide notification of the event to DPH and the  
             referring physician of the person subject to the event.   
             Requires the facility, no later than 15 business days  
             after discovery of an event described in #1 above, to  
             provide written notification to the person who is  
             subject to the event. 

          10.Requires the information required in the provisions of  
             this bill to include, but not be limited to, information  
             regarding each substantiated adverse event, as defined  
             in existing law, reported to DPH, and may include  
             compliance information history. 

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes    
          Local:  Yes

           SUPPORT  :   (Verified  8/25/10)

          Consumer Attorneys of California (source) 
          Breast Cancer Fund
          California Nurses Association
          Consumer Federation of California

          ARGUMENTS IN SUPPORT  :    According to supporters,  
          Californians are at increasing risk of over radiation, and  
          cites statistics that total exposure to ionizing radiation  
          has nearly doubled over the past two decades, in large part  
          because of increased use of computed tomography scans for  
          medical diagnostic and treatment purposes.  Medical  
          radiation can save lives, but can be deadly if improperly  
          administered, and can increase a person's lifetime risk of  

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          developing cancer.  Problems at Cedars-Sinai Medical Center  
          in 2009, in which 206 patients were exposed to overdoses of  
          radiation over an 18-month period, roughly eight times the  
          recommended level of radiation, when a scanner used for  
          brain scans was reconfigured.  Over radiation is difficult  
          to detect if there is no record of the dosage administered,  
          which this bill would ensure.

          The Consumer Attorneys of California (CAC), the sponsor of  
          SB 1237, states that aside from the tragic incidents that  
          occurred at Cedars-Sinai Medical Center, Californians in  
          general are at increasing risk of over radiation that can  
          subsequently increase the risk of cancer.  CAC states that  
          the surge in new technology provides many benefits for  
          diagnosing and treating disease; however, the increasing  
          dependence on it has created new avenues for errors in  
          software and operation, and those mistakes cannot only be  
          difficult to detect, but can become embedded in a treatment  
          plan and repeated over and over with patients.  CAC states  
          that oversight of medical imaging is fragmented and SB 1237  
          is intended to take steps to protect patients, including  
          recording of radiation dosage and adoption of quality  
          assurance programs to prevent errors such as the ones that  
          have been recently reported.

          The Consumer Federation of California (CFC) states that  
          this bill will increase patient safety by deterring  
          one-time over radiation errors, which can cause damage to  
          DNA and increase a person's lifetime risk for cancer,  
          especially for children and youth.  The risk for over  
          radiation is becoming more and more likely, as the National  
          Council on Radiation Protection and Measurements reports  
          that US citizens are being exposed to ionizing radiation at  
          twice the level of two decades ago.  CFC states that  
          one-time instances of over radiation may be difficult to  
          detect without proper documentation of the dosage  
          administered.


           ASSEMBLY FLOOR  :  
          AYES: Adams, Ammiano, Arambula, Bass, Beall, Bill  
            Berryhill, Tom Berryhill, Block, Blumenfield, Bradford,  
            Brownley, Buchanan, Caballero, Charles Calderon, Carter,  
            Chesbro, Conway, Cook, Coto, Davis, De La Torre, De Leon,  

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            Eng, Evans, Feuer, Fletcher, Fong, Fuentes, Furutani,  
            Galgiani, Garrick, Gatto, Hagman, Hall, Harkey, Hayashi,  
            Hernandez, Hill, Huber, Huffman, Jeffries, Jones, Lieu,  
            Logue, Bonnie Lowenthal, Ma, Mendoza, Miller, Monning,  
            Nava, Nestande, Niello, Nielsen, V. Manuel Perez,  
            Portantino, Ruskin, Salas, Saldana, Silva, Skinner,  
            Smyth, Solorio, Audra Strickland, Swanson, Torlakson,  
            Torres, Torrico, Villines, Yamada, John A. Perez
          NOES: Anderson, DeVore, Fuller, Gaines
          NO VOTE RECORDED: Gilmore, Knight, Norby, Tran, Vacancy,  
            Vacancy


          CTW:nl  8/31/10   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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