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Article 6. Records of California Health And Safety Code >> Division 104. >> Part 9. >> Chapter 8. >> Article 6.
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.
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.
(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.
(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.
(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.
(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.
(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.
(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.
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.
(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.
