California Assembly Bill AB510 Amended / Bill

 BILL NUMBER: AB 510AMENDED BILL TEXT AMENDED IN SENATE MARCH 29, 2012 AMENDED IN ASSEMBLY JANUARY 13, 2012 AMENDED IN ASSEMBLY JANUARY 4, 2012 AMENDED IN ASSEMBLY MARCH 31, 2011 INTRODUCED BY Assembly Member Bonnie Lowenthal FEBRUARY 15, 2011 An act to amend Sections 115111, 115112, and 115113 of the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGEST AB 510, as amended, Bonnie Lowenthal. Radiation control: health facilities and clinics: records. Under existing law, the State Department of Public Health licenses and regulates health facilities and clinics, as defined. Under existing law, the Radiation Control Law, the department licenses and regulates persons that use devices or equipment utilizing radioactive materials. Under existing law, the department is authorized to require registration and inspection of sources of ionizing radiation, as defined. Existing law, commencing July 1, 2012, requires that a facility using a computed tomography (CT) X-ray system record the dose of radiation on every CT study produced. Existing law requires that the displayed dose of radiation be verified annually by a medical physicist to ensure the accuracy of the displayed dose unless the facility is accredited. Violations of these provisions are a crime. This bill would  require the facility to record the dose of radiation on every diagnostic CT study and would  exempt specified CT studies from being required to record the dose. This bill would delete the exemption for accredited facilities and would authorize a facility  that has an accredited machine   with an accredited CT X-ray system  to elect not to annually verify the displayed dose of radiation, as specified. Because accredited facilities could now be subject to these provisions, and because a violation of these provisions is a crime, the bill would impose a state-mandated local program by expanding the scope of a crime. The bill also would require the dose to be verified for the facility's standard adult brain, adult abdomen, and pediatric brain protocols. Existing law, commencing July 1, 2013, requires facilities that furnish CT X-ray services to be accredited by an approved organization, as specified. This bill would  not require   eliminate the requirement that  the facilities  to  be accredited  , but   and  instead would require the CT X-ray systems to be accredited by an approved organization, as specified. Existing law, commencing July 1, 2012, requires a facility to report the discovery of certain information about an event in which the administration of radiation results in prescribed occurrences, including the CT X-ray irradiation of an area of the body other than that intended, within 5 business days of the discovery of the event, to the department and the patient's referring physician. This bill would require instead a facility to report a CT X-ray irradiation  image   examination  that does not include the intended  anatomic area   area of the body if specified dose values are exceeded . This bill would provide that reporting is not required if adjacent body parts are irradiated during the same treatment, unless specified  does values are exceeded  . This bill would  instead  require that  this report   these reports  be made within  10 business days of the discovery of the event   5 business days of the discovery of a therapeutic event and within 10 business days of the discovery of a CT event  . The bill would also make technical and clarifying changes. The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement. This bill would provide that no reimbursement is required by this act for a specified reason. Vote: majority. Appropriation: no. Fiscal committee: yes. State-mandated local program: yes. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 115111 of the Health and Safety Code is amended to read: 115111. (a) Commencing July 1, 2012, subject to subdivision (e), a person that uses a computed tomography (CT) X-ray system for human use shall record the dose of radiation on every  diagnostic  CT study produced during a CT examination. CT studies used for therapeutic radiation treatment planning  or image guidance for interventional radiologic procedures   or delivery  shall not be required to record the dose. (b) The facility conducting the study shall  electronically  send  electronically  each CT study and protocol page that lists the technical factors and dose of radiation to the electronic picture archiving and communications system. (c) (1)  The   Until July 1, 2013   , the  displayed dose shall be verified annually by a medical physicist for the facility's standard adult brain, adult abdomen, and pediatric brain protocols, to ensure the displayed doses are within 20 percent of the true measured dose measured in accordance with subdivision (f). (2) A facility that has a  machine   CT X-ray system  that is 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 the State Department of Public Health  may elect not to perform the verification described in paragraph (1). (d) Subject to subdivision (e), the radiology report of a CT study shall 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. (e) The requirements of this section shall be limited to CT systems capable of calculating and displaying the dose. (f) For the purposes of this section, dose of radiation shall be defined as one of the following: (1) The computed tomography index volume (CTDI vol) and dose length product (DLP), as defined by the International Electrotechnical Commission (IEC) and recognized by the federal Food and Drug Administration (FDA). (2) The dose unit as recommended by the American Association of Physicists in Medicine.  (g) For purposes of this section, "CT X-ray system" means the same as provided in Section 892.1750 of Title 21 of the Code of Federal Regulations.  SEC. 2. Section 115112 of the Health and Safety Code is amended to read: 115112. Commencing July 1, 2013, CT X-ray systems shall 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 the State Department of Public Health. SEC. 3. Section 115113 of the Health and Safety Code  , as amended by Section 1 of Chapter 139 of the Statutes of 2011,  is amended to read: 115113. (a) Except for an event that results from patient movement or interference, a facility shall report to the department an event in which the administration of radiation results in any of the following: (1) Repeating of a CT examination, unless otherwise ordered by a physician or a radiologist, if one of the following dose values are exceeded: (A) 0.05 Sv (5 rem) effective dose. (B) 0.5 Sv (50 rem) to an organ or tissue. (C) 0.5 Sv (50 rem) shallow dose to the skin. (2) A CT X-ray irradiation  image   examination  that does not include the intended  anatomic area   area of the body  by the ordering physician or a radiologist if one of the following dose values are exceeded: (A) 0.05 Sv (5 rem) effective dose. (B) 0.5 Sv (50 rem) to an organ or tissue. (C) 0.5 Sv (50 rem) shallow dose to the skin. (3) 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. (4) A CT or therapeutic dose to an embryo or fetus that is greater than 50 mSv (5 rem) dose, 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. (5) Therapeutic ionizing irradiation of the wrong individual or the wrong treatment site. Reporting is not required if adjacent body parts are irradiated during the same treatment, unless they exceed the values in paragraph (6) of this subdivision. (6) The total dose from therapeutic ionizing radiation delivered differs from the prescribed dose by 20 percent or more. A report shall not be required pursuant to this paragraph 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. The radiation oncologist shall notify the referring physician that the dose was exceeded. (b) The facility shall, no later than  five business days after the discovery of a therapeutic event described in paragraphs (3) to (6), inclusive, of subdivision (a) and no later than  10 business days after discovery of an event described in  paragraphs (1) to (4), inclusive, of  subdivision (a), provide notification of the event to the department and the referring physician of the person subject to the event and shall, no later than 15 business days after discovery of an event described in subdivision (a) provide written notification to the person who is subject to the event. (c) This section shall become inoperative on the effective date of the act that added this subdivision, and shall remain inoperative until July 1, 2012. SEC. 4. No reimbursement is required by this act pursuant to Section 6 of Article XIII B of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIII B of the California Constitution.