115105-115115
HEALTH AND SAFETY CODE
SECTION 115105-115115
115105. The department shall require each person who acquires, possesses or uses a source of ionizing radiation to maintain records relating to its receipt, storage, transfer or disposal, and other records as the department may require, subject to exemptions as may be provided by regulations. 115110. The department shall require each person who possesses or uses a source of ionizing radiation to maintain appropriate records showing the radiation exposure of all individuals for whom personnel monitoring is required by regulations of the department. Copies of these records and those required to be kept in accordance with Section 115105 shall be submitted to the department upon request. The department shall adopt reasonable regulations, compatible with those of the United States Atomic Energy Commission, pertaining to reports of exposure of personnel. The regulations shall require that reports of excessive exposure be made to the individual exposed and to the department, and shall make provision for periodic and terminal reports to individuals for whom personnel monitoring is required. Section 6411 of the Labor Code shall not be construed as exempting any person from making any report required by this section. 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. 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. 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. 115115. The person responsible for registering mammographic X-ray equipment or a certified supervisor, as defined in subdivision (i) of Section 114850, shall establish and maintain a Mammography Quality Assurance Program that includes: (a) A Mammography Quality Assurance Manual for the identification of mammography quality assurance tests performed, test frequency, test equipment used, maintenance and calibration of test equipment, and the qualifications of individuals who perform the tests in order to ensure compliance with the May 1990 version of "Rules of Good Practice for Supervision and Operation of Mammographic X-Ray Equipment" or the regulations of the department. (b) A "Mammography X-Ray Equipment and Facility Accreditation Certificate" issued by the department that shall be posted on each X-ray machine specifically dedicated for the purpose of mammography.