BILL ANALYSIS SB 1237 Page 1 SENATE THIRD READING SB 1237 (Padilla) As Amended June 23, 2010 Majority vote SENATE VOTE :24-5 HEALTH 19-0 BUSINESS & PROFESSIONS 11-0 ----------------------------------------------------------------- |Ayes:|Monning, Fletcher, |Ayes:|Hayashi, Conway, Eng, | | |Ammiano, Carter, Conway, | |Hernandez, Hill, Ma, | | |De La Torre, De Leon, | |Nava, Niello, Ruskin, | | |Eng, Gaines, Hayashi, | |Smyth, Nestande | | |Hernandez, Jones, Bonnie | | | | |Lowenthal, Nava, | | | | |V. Manuel Perez, Salas, | | | | |Smyth, Audra Strickland, | | | | |Gilmore | | | | | | | | ----------------------------------------------------------------- APPROPRIATIONS 17-0 -------------------------------- |Ayes:|Fuentes, Conway, | | |Bradford, | | |Charles Calderon, Coto, | | |Davis, | | |De Leon, Gatto, Hall, | | |Harkey, Miller, Nielsen, | | |Norby, Skinner, Solorio, | | |Torlakson, Torrico | | | | -------------------------------- SUMMARY : Requires health facilities and clinics that use imaging procedures that involve computed tomography X-ray systems (CT) for diagnostic purposes to record the dose of radiation produced during the administration of a CT examination in the patient's medical record and on the image produced by the examination. Specifically, this bill : 1)Requires general acute care hospitals, acute psychiatric hospitals, and special hospitals (collectively health SB 1237 Page 2 facilities), as specified, that use CT for diagnostic purposes to record the dose of radiation produced during the administration of CT examination in the patient's medical record and on the image produced by the examination, commencing January 1, 2012. 2)Requires the dosage to be recorded using both dose length product (DLP) and volume CT index (CTDI vol), as defined by the International Electrotechnical Commission (IEC) and recognized by the federal Food and Drug Administration (FDA). 3)Requires the health facility to ensure that the CTDI vol is recorded in the patient's medical record and on any image produced from the examination. 4)Clarifies that the requirements in 1) above be limited to CT examinations performed on equipment where it is currently possible to record the CTDI vol directly or through the addition of updates that have been approved or cleared by the FDA. 5)Exempts small and rural hospitals and those facilities specified in 1) above, that are located in an area that is designated as a federal medically underserved area, from the provisions of this bill until January 1, 2013. 6)Requires health facilities that furnish CT services 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, commencing January 1, 2012. 7)Requires a health facility that uses CT to notify the California Department of Public Health (DPH), the affected patient, and the patient's treating physician immediately, in writing, of the occurrence of any of the following events: a) Repetition of CT exposure due to equipment defect or malfunction; b) Irradiation of the wrong patient or irradiation of a body part other than that intended by the ordering physician and surgeon; or, SB 1237 Page 3 c) A diagnostic dosage that exceeds by 50% or more the protocols referenced in 2) above; 8)Requires each facility that utilizes therapeutic X-ray systems operating at energies below one million electron volts (MeV) to notify and report to DPH, in accordance with DPH regulations, and to also notify the affected patient and his or her treating physician within 10 days, in writing, of the occurrence of any of the following events: a) Irradiation of the wrong individual or wrong treatment site; b) Any treatment consisting of three or fewer fractions, with the calculated total administered dose differing from the total prescribed dose by more than 10% of the total prescribed dose; or, c) Any exposure resulting in a calculated total administration dose differing from the total prescribed dose by more than 10% of the total prescribed dose. 9)Requires each facility that utilizes therapeutic X-ray systems operating with energies at or above one Mev to notify and report to DPH, in accordance with DPH regulations, and to notify the affected patient and his or her treating physician within 10 days, in writing, of the occurrence of any of the following events: a) Any event involving irradiation of the wrong individual, administration of the wrong type of radiation or the wrong energy, or irradiation of the wrong treatment site; b) Any treatment consisting of three of fewer fractions, with the calculated total administered dose differing from the total prescribed dose by more than 10% of the total prescribed dose; or, c) Any exposure resulting in a calculated total administration dose differing from the total prescribed dose by more than 20% of the total prescribed dose. EXISTING LAW : SB 1237 Page 4 1)Under the Radiation Control Law, 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 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. FISCAL EFFECT : According to the Assembly Appropriations Committee analysis, this bill would result in no direct fiscal impact to DPH to continue oversight of radiology professionals. COMMENTS : According to the author and sponsor, Californians are at increasing risk of over exposure to radiation, and they cite 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 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. According to the author, oversight for radiation scans is currently very fragmented; the FDA oversees the approval of medical devices, such as CT scanners, but does not regulate how diagnostic tests are used in clinical practice. The author maintains that one-time instances of over exposure to radiation are difficult to detect if there is no record of the dosage administered and exposure to radiation has a cumulative effect over a lifetime. 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. By requiring health facilities to record CT radiation dosages in a patient's SB 1237 Page 5 health record and requiring quality assurance accreditation of practitioners and health facilities that use diagnostic radiation, this bill addresses the serious risks associated with over exposure to radiation. Analysis Prepared by : Tanya Robinson-Taylor / HEALTH / (916) 319-2097 FN: 0005629