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 1 CONSULTANT: 2 Hansel/cjt 3 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--- STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 2 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 STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 3 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; STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 4 --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 STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 5 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 STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 6 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 STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 7 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 STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 8 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 STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 9 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: STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 10 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 STAFF ANALYSIS OF SENATE BILL 1237 (Padilla) Page 11 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)