BILL NUMBER: SB 1237	AMENDED
	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.