Today's Law As Amended

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AB-510 Radiation control: health facilities and clinics: records.(2011-2012)



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 in the patient’s record, as defined in Section 123105. CT studies used for therapeutic radiation treatment planning or delivery or for calculating attenuation coefficients for nuclear medication studies shall not be required to record the dose.
(b) The facility conducting the study may 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) 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 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 interpretive report of a diagnostic CT study shall include the dose of radiation by either recording the dose within the patient’s report or attaching the protocol page that includes the dose of radiation to the 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.
 (a) Except as provided in subdivision (b), commencing July 1, 2013, CT X-ray systems shall be accredited by an accrediting organization that is approved by the federal Centers for Medicare and Medicaid Services, an accrediting organization approved by the Medical Board of California, or the State Department of Public Health. A facility that is subject to accreditation may elect to have the CT X-ray system accredited pursuant to a single accreditation survey that includes the CT service by the accrediting organization.
(b) A CT X-ray system shall not be subject to accreditation if any of the following apply:
(1) The system is used for therapeutic radiation treatment planning or delivery.
(2) The system is used for calculating attenuation coefficients for nuclear medicine studies.
(3) The system is dedicated for image guidance for interventional radiologic procedures.

SEC. 3.

 Section 115113 of the Health and Safety Code 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 is 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 examination for any individual for whom a physician did not provide approval for the examination if one of the following dose values is 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) A CT X-ray for an examination that does not include the area of the body that was intended to be imaged by the ordering physician or radiologist if one of the following dose values is 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.
(4) 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.
(5) 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.
(6) Therapeutic ionizing irradiation of the wrong individual or the wrong treatment site, excluding the area of the body that was intended to be irradiated.
(7) 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 if the dose administered exceeds 20 percent of the amount prescribed in a situation if 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 (7), 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.
SEC. 5.
 This act is an urgency statute necessary for the immediate preservation of the public peace, health, or safety within the meaning of Article IV of the Constitution and shall go into immediate effect. The facts constituting the necessity are:
In order to protect the health and safety of Californians and ensure that certain facilities using a computed tomography (CT) X-ray system fully comply with the reporting requirements that go into effect on July 1, 2012, it is necessary for this act to take effect immediately.