BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       SB 1237                                      
          S
          AUTHOR:        Padilla                                      
          B
          AMENDED:       August 20, 2010                             
          HEARING DATE:  August 30, 2010                              
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          CONSULTANT:                                                 
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          Hansel/cjt                                                  
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                                7               

                              PURSUANT TO S.R. 29.10  

                         
                                     SUBJECT
                                         
           Radiation control: health facilities and clinics: records

                                     SUMMARY  

          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.  Requires  
          facilities that furnish CTs to be accredited, and to report  
          to the Department of Public Health (DPH) an event in which  
          the administration of radiation results in an overdose, as  
          specified.


                             CHANGES TO EXISTING LAW  

          Existing law:
           Establishes the Radiologic Health Branch within the  
            Department of Public Health (DPH), which is responsible  
            for the licensing of radioactive materials, registration  
            of X-ray producing machines, certification of X-ray and  
            radioactive material users, inspection of facilities  
                                                         Continued---



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            using radiation, investigation of radiation incidents,  
            and surveillance of radioactive contamination in the  
            environment.

           Requires DPH to license persons who receive, possess, or  
            transfer radioactive materials, and devices or equipment  
            utilizing these materials.

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

           Requires general acute care hospitals, acute psychiatric  
            hospitals, and special hospitals to report adverse  
            events, as defined, to DPH no later than five days after  
            the adverse event has been detected, or, if that event is  
            an ongoing urgent or emergency threat to the welfare,  
            health or safety of patients, personnel, or visitors, not  
            later than 24 hours after the adverse event has been  
            detected.

           Requires DPH to make information regarding reports of  
            substantiated adverse
            events, and outcomes of inspections and investigations,  
            readily accessible to consumers throughout California,  
            including on the department's website by January 1, 2015.

          This bill:
           Requires, commencing July 1, 2012, a person that uses a  
            CT exam for human use to record the dose of radiation on  




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            every CT study produced during a CT examination.

           Requires the facility conducting CT exams to  
            electronically send each CT study and protocol page,  
            which lists the technical factors and dose of radiation,  
            to the electronic picture archiving and communications  
            system.

           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, as defined,  
            unless the facility is accredited.

           Requires the radiology report of a CT study to include  
            the dose of radiation, by either recording the dose  
            within the patient's radiology report or attaching the  
            protocol page, as specified.

           Limits the requirements of the bill to CT systems capable  
            of calculating and displaying the dose.

           Establishes, for the purposes of the bill, a definition  
            of dose of radiation, as specified.

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

           Requires a health facility to report to DPH, except as  
            specified, an event in which the administration of  
            radiation results in any of the following:
               --Repeating of a CT examination, unless otherwise  
               ordered by a physician or radiologist, if specified  
               dose values are exceeded;

               --CT X-ray irradiation of a body part other than that  
               intended by the ordering physician or a radiologist,  
               if specified dose values are exceeded;

               --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;




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               --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;

               --Therapeutic ionizing irradiation of the wrong  
               individual, or wrong treatment site; and,

               --The total dose from therapeutic ionizing radiation  
               delivered differs from the prescribed dose by 20  
               percent or more, except in any instance where the  
               radiation was utilized for palliative care; however,  
               the radiation oncologist would be required to notify  
               the referring physician that the dose was exceeded.

           Requires the facility, no later than five business days  
            after discovery of an event, to notify DPH and the  
            referring physician of the person who is the subject to  
            the event, and, no later than 15 business days after  
            discovery of an event, to provide written notification to  
            the person who is the subject of the event.

           Provides that the information required to be reported  
            include, but are not limited to, information hospitals  
            must currently report regarding substantiated adverse  
            events, and may include compliance information history.


                                  FISCAL IMPACT  

          According to the Assembly Appropriations Committee  
          analysis, this bill would result in no direct fiscal impact  
          to DPH to continue oversight of radiology professionals.


                            BACKGROUND AND DISCUSSION  

          The author and sponsor state that 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 CT scans for medical diagnostic and  




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          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 8 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 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  




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          requirements for manufacturers of CT and fluoroscopic  
          devices pertaining to the design and dose recording  
          capabilities of the machines, and increasing patient and  
          physician awareness of exposure risks and monitoring of  
          cumulative exposure.

          According to the FDA, like all medical procedures, CT,  
          fluoroscopy, and nuclear medicine imaging exams present  
          both benefits and risks. Managing the risks of 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. 

          UCSF study
          According to a recent study conducted at the University of  
          California-San Francisco, the use of CT scans in medicine  
          to diagnose disease, and in many cases save lives, has  
          exploded in recent decades. The down side, a new study  
          concludes, is that the radiation US patients receive from  
          these medical exams will eventually result in 29,000 new  
          cancer cases and 15,000 new cancer deaths each year at  
          current levels of CT usage and cancer cure rates.   
          Furthermore, the dose of radiation delivered during CT  
          exams is wildly variable, the researchers found, even  
          within the same type of exam. In general, the radiation  
          dosages delivered to patients were substantially higher  
          than expected. The research findings are published in the  
          current issue of the Archives of Internal Medicine.

          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  




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          the qualifications of technologists and other medical  
          staff, procedures to ensure the safety of persons who  
          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 8 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 overdoses 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 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.
           
          Arguments in support
          The Consumer Attorneys of California (CAC), the sponsor of  
          SB 1237, states that aside from the tragic incidents that  




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          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.

          Arguments in Opposition
          Taking an oppose unless amended position, the California  
          Hospital Association (CHA) states that it supports the  
          intent of SB 1237 but has significant concerns about the  
          reporting requirements in the bill.  CHA states that  
          deviations from planned doses of radiation may be required  
          due to changes in therapeutic needs, which would not be  
          captured in the reporting thresholds.  Given the complexity  
          of this issue, and the fact the reporting requirements were  
          added to the bill just recently and that national standards  
          are being discussed, CHA requests that the reporting  
          provisions be removed from the bill.  CHA also states that  
          it is working with the author on a number of technical  
          issues, such as clarification of the meaning of phrases  
          such as "irradiation of a body part other than that  
          intended".

          Related bills




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          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  
          visible to patients.

          Prior legislation
          SB 1301 (Alquist) Chapter 647, Statutes of 2006 requires  
          general acute care hospitals, acute psychiatric hospitals,  
          and special hospitals to report adverse events, as defined,  
          to the Department of Public Health.  Requires DPH to make  
          onsite inspections or investigations of reported adverse  
          event, as specified.  Requires DPH, by January 1, 2013, to  
          provide information regarding reports of substantiated  
          adverse events and the outcomes of inspections on the  
          department's website.
          
          AB 929 (Oropeza) Chapter 427, Statutes of 2005, requires  
          the Radiologic Health Branch (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.  Assembly amendments.  SB 1237 was heard by this  
          committee on April 21, 2010.  As it left the Senate, SB  
          1237 required, commencing January 1, 2012, health  
          facilities and clinics that use imaging procedures that  
          involve computed tomography for diagnostic purposes to  
          record the dose of radiation used during the administration  
          of the radiation on the radiology image.  The bill delayed  
          these requirements for small and rural hospitals and health  
          facilities and clinics in medically underserved areas,  
          until January 1, 2013.  The bill additionally required,  
          commencing January 1, 2012, physicians or other  
          practitioners, facilities, or other entities that furnish  
          diagnostic magnetic resonance imaging, computed tomography,  
          and nuclear medicine services, including positron emission  
          tomography, to be accredited by an organization that is  
          approved by the federal Centers for Medicare and Medicaid  
          Services.

          The Assembly amendments:





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           Clarify and specify in greater detail the requirements of  
            facilities and individuals who use or provide CT systems  
            regarding recording and verifying radiation dosage;

           Eliminate the delayed operative date of the bill's  
            requirements for small and rural hospitals and health  
            facilities and clinics in medically underserved areas;

           Define dose of radiation;

           Limit the accreditation requirements to health  
            facilities, but include facilities accredited by  
            organizations approved by the Medical Board of California  
            or DPH; and,

           Add requirements that health facilities report specified  
            adverse events involving radiation to DPH, referring  
            physicians, and patients.

          2.  Author's intent regarding reporting requirements and  
          definition of "dose of radiation".  As drafted, the bill  
          does not specify an operative date for the mandatory  
          reporting requirements in the bill.  However, the dose  
          recording requirements would take effect on July 1, 2012  
          and the accreditation requirements would take effect on  
          July 1, 2013.  The author has indicated that his intent is  
          for the reporting requirements to take effect on July 1,  
          2012, and is submitting a letter to the Senate Journal to  
          clarify the intent.  

          The author is additionally clarifying his intent that the  
          definition of "dose of radiation" in the bill is not  
          intended to conflict with federal regulations or  
          international standards dealing with reporting or recording  
          of radiation doses.

                                  PRIOR ACTIONS

          Senate Health:       5-0
          Senate Floor:       24-0
          Assembly Health:    19-0
          Assembly B.P. & C.P.11-0
          Assembly Appropriations17-0
          Assembly Floor      70-4





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                                    POSITIONS  

          Support:  Consumer Attorneys of California (sponsor)
                 AARP
                 Breast Cancer Fund
                 California Nurses Association
                 Children's Advocacy Institute
                 Congress of California 
                 Consumer Federation of California 
                 Medical Imaging and Technology Alliance
                 Healthcare Solutions Institute
                 Philips Healthcare
                 Siemens
          
          Oppose:  California Hospital Association (unless amended)