California Senate Bill SB1237 Amended / Bill

 BILL NUMBER: SB 1237AMENDED BILL TEXT AMENDED IN ASSEMBLY AUGUST 20, 2010 AMENDED IN ASSEMBLY JUNE 23, 2010 AMENDED IN SENATE APRIL 28, 2010 INTRODUCED BY Senator Padilla (Coauthor: Senator Alquist) FEBRUARY 19, 2010 An act to add  Section 115111   Sections 115111, 115112, and 115113  to the Health and Safety Code, relating to public health. LEGISLATIVE COUNSEL'S DIGEST SB 1237, as amended, Padilla. 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 may also require registration and inspection of sources of ionizing radiation, as defined. Violation of these provisions is a crime. This bill would, commencing  January   July  1, 2012, require hospitals and clinics, as specified, that use computed tomography (CT) X-ray systems for  diagnostic purposes   human use  to record, where currently possible, the dose of radiation  on every CT study  produced during the administration of a CT  X-ray  examination  in the patient's medical record and on an image produced by the examination  , as specified.  This bill would not require small and rural hospitals, as defined, or hospitals and clinics that are located in an area that is designated as a medically underserved area pursuant to federal law, to comply with these requirements until January 1, 2013.   The bill would require the dose to be verified annually by a medical physicist, as specified, unless the facility is accredited.  This bill would, commencing  January 1, 2012   July 1, 2013  , require facilities that furnish CT X-ray services 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 the State Department of Public Health  . The bill would also require the facility to report  , immediately and in writing,  certain information to the department, the affected patient, and the patient's treating physician. Because this bill expands the definition of a crime, it would impose a state-mandated local program. 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 is added to the   Health and Safety Code   , 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 CT study produced during a CT examination. (b) The facility conducting the study shall 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. (c) The displayed dose shall 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 subdivision (f) unless the facility is accredited. (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.   SEC. 2.   Section 115112 is added to the   Health and Safety Code   , to read:   115112. Commencing July 1, 2013, facilities that furnish CT X-ray services 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 is added to the  Health and Safety Code   , 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 and of the following: (1) Repeating of a CT examination, unless otherwise ordered by a physician or a radiologist, if the following dose values are exceeded: (A) 0.05Sv (5 rem) effective dose equivalent. (B) 0.5 Sv (50 rem) to an organ or tissue. (C) 0.5 Sv (50 rem) shallow dose equivalent to the skin. (2) 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: (A) 0.05 Sv (5 rem) effective dose equivalent. (B) 0.5 Sv (50 rem) to an organ or tissue. (C) 0.5 Sv (50 rem) shallow dose equivalent 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 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. (5) Therapeutic ionizing irradiation of the wrong individual, or wrong treatment site. (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 discovery of an event described in 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) The information required pursuant to this section shall include, but not be limited to, information regarding each substantiated adverse event, as defined in Section 1279.1, reported to the department, and may include compliance information history.   SECTION 1.   Section 115111 is added to the Health and Safety Code, to read: 115111. (a) Except as provided in subdivisions (b) and (c), commencing January 1, 2012, general acute care hospitals, acute psychiatric hospitals, and special hospitals licensed pursuant to Article 1 (commencing with Section 1250) of Chapter 2 of Division 2, clinics licensed pursuant to Article 1 (commencing with Section 1200) of Chapter 1 of Division 2, and clinics exempt from licensure pursuant to Section 1206 that use computed tomography (CT) X-ray systems for diagnostic purposes shall record the dose of radiation produced during the administration of a CT X-ray examination. The dosage shall be recorded using both dose length product (DLP) and volume computed tomography index (CTDI vol), as defined by the International Electrotechnical Commission (IEC) and recognized by the federal Food and Drug Administration (FDA). The facility shall ensure that the CTDI vol is recorded in the patient's medical record and on any image produced from the examination. (b) The requirement specified in subdivision (a) shall 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. (c) Small and rural hospitals, as defined in Section 124840, and health facilities and clinics specified in subdivision (a) that are located in an area that is designated as a medically underserved area pursuant to federal law, shall not be required to comply with the requirements of subdivision (a) until January 1, 2013. (d) Commencing January 1, 2012, facilities that furnish CT X-ray services shall 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. (e) A facility that uses CT X-ray systems shall notify the department, the affected patient, and the patient's treating physician immediately, in writing, of the occurrence of any of the following events: (1) Repetition of a CT X-ray exposure due to equipment defect or malfunction. (2) Irradiation of the wrong patient or irradiation of a body part other than that intended by the ordering physician and surgeon. (3) A diagnostic dosage that exceeds by 50 percent or more the protocols established in subdivision (a). (f) Each facility that utilizes therapeutic X-ray systems operating at energies below one million electron volts (MeV) shall notify and report to the department, in accordance with department regulations, and shall 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: (1) Irradiation of the wrong individual or wrong treatment site. (2) Any treatment consisting of three or fewer fractions, with the calculated total administered dose differing from the total prescribed dose by more than 10 percent of the total prescribed dose. (3) Any exposure resulting in a calculated total administered dose differing from the total prescribed dose by more than 10 percent of the total prescribed dose. (g) Each facility that utilizes therapeutic X-ray systems operating with energies at or above one Mev shall notify and report to the department, in accordance with department regulations, and shall notify the affected patient and his or her treating physician within 10 days, in writing, of the occurrence of any of the following events: (1) 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. (2) Any treatment consisting of three or fewer fractions, with the calculated total administered dose differing from the total prescribed dose by more than 10 percent of the total prescribed dose. (3) Any exposure resulting in a calculated total administration dose differing from the total prescribed dose by more than 20 percent of the total prescribed dose.   SEC. 2.   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.