BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 1237| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 651-1520 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ 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 CONTINUED SB 1237 Page 2 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 CONTINUED SB 1237 Page 3 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 CONTINUED SB 1237 Page 4 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 CONTINUED SB 1237 Page 5 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 CONTINUED SB 1237 Page 6 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, CONTINUED SB 1237 Page 7 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 **** END **** CONTINUED