BILL NUMBER: SB 1237	CHAPTERED
	BILL TEXT

	CHAPTER  521
	FILED WITH SECRETARY OF STATE  SEPTEMBER 29, 2010
	APPROVED BY GOVERNOR  SEPTEMBER 29, 2010
	PASSED THE SENATE  AUGUST 30, 2010
	PASSED THE ASSEMBLY  AUGUST 26, 2010
	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 Sections 115111, 115112, and 115113 to the Health
and Safety Code, relating to public health.


	LEGISLATIVE COUNSEL'S DIGEST


   SB 1237, 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 July 1, 2012, require hospitals and
clinics, as specified, that use computed tomography (CT) X-ray
systems for human use to record, if the CT systems are capable, the
dose of radiation on every CT study produced during the
administration of a CT examination, as specified. 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 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 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.


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.
  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.