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: 2 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 STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 4 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 STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 5 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, STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 6 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 STAFF ANALYSIS OF SENATE BILL SB 1237 (Padilla)Page 8 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 -- END --