BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       SB 1237                                      
          S
          AUTHOR:        Padilla                                      
          B
          AMENDED:       As Introduced                                 
                         
          HEARING DATE:  April 21, 2010                               
          1
          CONSULTANT:                                                 
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          Hansel/                                                     
          3              7                                           
                                     SUBJECT

            Radiation control: health facilities and clinics: records

                                     SUMMARY  

          Requires health facilities and clinics that use imaging  
          procedures that involve ionizing radiation for diagnostic  
          purposes to record the dose of radiation used during the  
          administration of the radiation on the radiology film.


                             CHANGES TO EXISTING LAW  

          Existing law:
           Requires the Department of Public Health (DPH) to license  
            persons who receive, possess, or transfer radioactive  
            materials, and devices or equipment utilizing these  
            materials.

           Requires DPH to adopt registration and certification  
            regulations for mammography equipment.

           Requires DPH to develop and enforce standards for the  
            education, training, and experience of persons who use  
            radiologic technology on human beings.

           Requires DPH, on or before January 1, 2008, to adopt  
            regulations that require personnel and facilities using  
                                                         Continued---



          STAFF ANALYSIS OF SENATE BILL  SB 1237 (Padilla)Page 2


          

            radiation-producing equipment for medical and dental  
            purposes to maintain and implement medical and dental  
            quality assurance standards that reduce unnecessary  
            exposure to ionizing radiation while ensuring that images  
            are of diagnostic quality.

           Requires ionizing radiation machines to be inspected once  
            each year for mammography X-ray units, once every three  
            years for high-priority sources of ionizing radiation,  
            and once every four and one-quarter years for  
            medium-priority sources, as specified.

           Requires a facility that operates a mammogram machine to  
            post notices of serious violations in an area that is  
            visible to patients within two working days after receipt  
            of the documents from the department, as specified. 

          This bill:
           Requires health facilities and clinics that use imaging  
            procedures that involve ionizing radiation for diagnostic  
            purposes to record the dose of radiation used during the  
            administration of the radiation on the radiology film.


                                  FISCAL IMPACT  

          This bill has not been analyzed by a fiscal committee.


                            BACKGROUND AND DISCUSSION  

          According to the author and sponsor, 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 (CT) scans for medical  
          diagnostic and treatment purposes.  The author and sponsor  
          state that medical radiation can save lives, but can be  
          deadly if improperly administered, and can increase a  
          person's lifetime risk of developing cancer.  The author  
          and sponsor cite 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.  The author and sponsor argue  
          that over radiation is difficult to detect if there is no  




          STAFF ANALYSIS OF SENATE BILL  SB 1237 (Padilla)Page 3


          

          record of the dosage administered, which SB 1237 would  
          ensure.

          Medical imaging technology
          Medical imaging procedures, which are used to view  
          different areas inside the human body, can provide  
          physicians with important clinical information.  Imaging  
          exams can allow for noninvasive diagnosis of disease and  
          monitoring of therapy, and can support medical and surgical  
          treatment planning.  For many diseases, early detection,  
          more effective diagnosis, and improved monitoring of  
          therapy through the use of imaging exams may contribute to  
          reduced morbidity, additional treatment options, and  
          increased life expectancy.  Image-guided techniques are  
          also commonly used in a variety of procedures, such as  
          putting in place catheters or stents, or removing blood  
          clots or other blockages.

          According to the National Council on Radiation Protection  
          and Measurements, in 2006 Americans received 67 million CT  
          scans, 18 million nuclear medicine procedures, and 17  
          million interventional fluoroscopy procedures.  According  
          the federal Food and Drug Administration (FDA), the average  
          American's total radiation exposure has nearly doubled over  
          the past two decades, largely because of CT scans.  Medical  
          radiation now accounts for more than half of the total  
          radiation that Americans are exposed to.


          FDA White Paper
          In February 2010, the FDA issued a white paper and launched  
          a collaborative Initiative to Reduce Unnecessary Radiation  
          Exposure from Medical Imaging, with a focus on the types of  
          imaging procedures that are associated with the highest  
          radiation doses--CT, fluoroscopy, and nuclear medicine.   
          The initiative is designed to reduce factors contributing  
          to unnecessary radiation exposure by focusing on three  
          areas:  

           Requirements for manufacturers of CT and fluoroscopic  
            devices to incorporate important additional safeguards  
            into the design of these machines, develop safer  
            technologies, and provide additional training to support  
            safe use by practitioners;

           Requirements for manufacturers of CT and fluoroscopic  




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            devices to incorporate equipment features that will  
            provide clinicians with more information to guide their  
            decision making, which may include requirements that CT  
            and fluoroscopic devices be capable capturing the  
            radiation dose value from each exam and linking it with  
            the study image to facilitate the storage of dose  
            information in a patient's paper or electronic medical  
            record or requiring that devices be capable of  
            automatically recording radiation dose information in a  
            standardized Digital Imaging and Communications in  
            Medicine (DICOM) structured report, and transmitting this  
            information to a patient's electronic medical record or a  
            dose registry; and

           Increasing patient awareness by giving them information  
            and tools to help them and their physicians manage their  
            exposure to radiation from medical procedures, which may  
            include development of a patient medical imaging record  
            card.

          According to the FDA, like all medical procedures, computed  
          tomography (CT), fluoroscopy, and nuclear medicine imaging  
          exams present both benefits and risks. Managing the risks  
          of computed tomography (CT), fluoroscopy, and nuclear  
          medicine imaging procedures depends on two principles of  
          radiation protection: (1) Appropriate justification for  
          ordering and performing each procedure; and (2) Careful  
          optimization of the radiation dose used during each  
          procedure. 

          CMS Accreditation Process
          Pursuant to requirements in the Medicare Improvements for  
          Patients and Providers Act of 2008 (Act), the federal  
          Centers for Medicare and Medicaid Services (CMS) has begun  
          accrediting Medicare providers of advanced imaging  
          services, including physicians and physician organizations.  
           For purposes of the Act, advanced imaging services are  
          defined to include computerized tomography, nuclear  
          medicine, positron emission tomography, and magnetic  
          resonance imaging.  To date, CMS has recognized three  
          accrediting organizations, the American College of  
          Radiology, the Intersocietal Accreditation Commission, and  
          The Joint Commission.  The accreditation organizations will  
          require providers to meet established criteria regarding  
          the qualifications of technologists and other medical  
          staff, procedures to ensure the safety of persons who  




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          furnish advanced imaging services and patients who receive  
          these services, and procedures to ensure reliability and  
          accuracy of diagnostic images.

          Recent incidents 
          In October 2009 Cedars-Sinai Medical Center in Los Angeles  
          disclosed that it had mistakenly administered up to eight  
          times the normal radiation dose to 206 possible stroke  
          patients over an 18-month period.  At Mad River Hospital in  
          Arcata another case was reported involving a 2  year old  
          child, who was subjected to 151 CT scans on the same area,  
          well in excess of the 25 images that would normally be  
          taken.  The incident led to the revocation of the X-ray  
          technician's license.

          Based on these incidents and others nationwide, the FDA has  
          begun an investigation of more than 300 cases of radiation  
          overdoses at four hospitals, including Cedars-Sinai.  The  
          FDAs investigation will try to determine whether the  
          radiation overdoes have been the result of design problems  
          with the scanners, human error, or a combination of the  
          two.
          The FDA is urging hospitals to follow up with patients who  
          have received scans, check the dosage levels provided, make  
          sure protocols are strictly adhered to, and verify that the  
          scanners are working properly.

          In November 2009, DPH issued an advisory to all facilities  
          to immediately review Computed Tomography (CT) brain  
          perfusion study protocols in consultation with a medical  
          physicist.  Brain perfusion studies are performed using  
          multi-slice CT scanners to aid in the diagnosis and  
          treatment of stroke.  The advisory asks facilities  
          performing CT scans to be aware that the newer machines may  
          be configured to display dose estimates for a given  
          examination, which provides a valuable reference for  
          patient exposure.  The advisory states that staff  
          technologists should be trained to check dose estimates  
          before and after scanning patients, and routine recording  
          of this information should be considered.
           
          The advisory notes that use of CT scanners in brain  
          perfusion studies results in a patient dose of radiation  
          about ten times higher than that for a routine head CT  
          scan, and also notes that in the Cedars-Sinai case,  
          unauthorized or unannounced changes may have been made,  




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          resulting in the CT scanner continuing to operate at or  
          near maximum strength.

          The advisory concludes by saying that recent incidents may  
          be an indicator of deficiencies in CT quality assurance  
          programs in general, and not limited to a particular  
          facility or imaging procedure, and notes that if patient  
          doses are higher than expected levels, but not high enough  
          to produce obvious signs of radiation injury, problems may  
          go undetected, putting patients at increased risk for  
          long-term radiation effects.

          Arguments in support
          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 states that SB 1237  
          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.

          Related bills
          SB 148 (Oropeza) Chapter 169, Statutes of 2009, requires a  
          facility that operates a mammogram machine to post notices  
          of serious violations, as defined, in an area that is  




          STAFF ANALYSIS OF SENATE BILL  SB 1237 (Padilla)Page 7


          

          visible to patients.

          Prior legislation
          AB 929 (Oropeza) Chapter 427, Statutes of 2005, requires  
          the RHB to adopt regulations regarding quality assurance  
          standards for facilities using specified  
          radiation-producing equipment and to provide the  
          regulations to the Health Committees of the Assembly and  
          the Senate on or before January 1, 2008.


                                     COMMENTS
           
          1.  Scope of sources of ionizing radiation may be too  
          broad.  As drafted, SB 1237 would require health facilities  
          and clinics that use any form of ionizing radiation to  
          record the dose on the radiology film.  As noted above,  
          problems with over radiation have been associated with  
          certain types of machines and procedures, such as CTs.  A  
          suggested amendment would be to limit the requirement to  
          record dosage to sources of ionizing radiation that produce  
          the highest radiation levels, such as CTs.

          2.  Dose recording requirements may be difficult with older  
          machines.  While most newer machines have the capability to  
          measure and record the radiation dose, and some older  
          machines can be adapted to do so through the use of  
          supplemental software or features, there may be some older  
          machines that do not have this capability.  A suggested  
          amendment would be to limit the requirement to record  
          dosage to machines for which it is technologically feasible  
          to do so, either directly or through the use of added  
          software or features.

          3.  Bill should encourage use of safety protocols to reduce  
          of errors.  Arguably, most cases of over radiation in  
          medical settings are the result of medical errors or poor  
          quality assurance procedures.  While requiring radiation  
          dosage to be recorded could be helpful in alerting medical  
          staff to situations in which a higher dose of radiation is  
          administered than is necessary, and particularly to  
          systemic problems where a higher dose is consistently  
          applied over time, requiring the adoption of protocols for  
          safe administration of radiation in medical settings could  
          also be effective in reducing the incidence of over  
          radiation errors.  A number of protocols for this purpose  




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          are evolving.  A recommended amendment would be, at a  
          minimum, to require providers who furnish advanced imaging  
          services, such as magnetic resonance imaging, CT, and  
          nuclear medicine to be accredited by an organization that  
          is approved by the federal Centers for Medicare and  
          Medicaid Services, as will be required for Medicare  
          providers of these services, starting 2012.


                                    POSITIONS  


          Support:  Consumer Attorneys of California (sponsor)
                    Consumer Federation of California (CFC)

          
          Oppose:   None received


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