CRS LogoCRS Header
Cal Rad Update
Update on New California Radiation Safety Law

 

There has been some confusion regarding the effective dates of provisions on SB 1237 (Padilla) on CT radiation safety requirements and radiation oncology procedures.

 

The majority of the provisions do not take effect until at least 7/1/2012 and CT accreditation is not mandated until 1/1/13. In the rush to complete the bill prior to adjournment in August, we had noticed that all the provisions of SB 1237 had specific implementation dates with the exception of the section on reporting of radiation misadministration. With the bill constructed that way, we were concerned that it could be interpreted that the reporting mandate would begin on 1/1/11 which is when most new laws would take effect. We discussed the concern with the author and he agreed that we wanted all provisions of SB 1237 to have delayed implementation until at least 2012. It was, however, too late in the session to amend the bill. He did announce his intent on the Senate Floor and memorialized that intent with a letter to the Senate Journal.

 

The CRS had been in communication with CDPH to verify their interpretation to delay the reporting requirements. Their legal counsel would not agree because the date was not contained in the statute. Senator Padilla will introduce an urgency bill in January that will insert the date of 7/1/12 as the effective date for the misadministration reporting requirement. We will move that bill very quickly and it will take effect upon signature by the Governor.

 

The CRS will also be working with the Senator and other interested parties on another bill to amend SB 1237 to address other concerns. We have reprinted below the major provisions of SB 1237.The misadministration reporting provisions are in # 8. Stay tuned for additional updates.

  1. Requires, commencing July 1, 2012, a person that uses a CT for human use to record the dose of radiation on every CT study produced during a CT examination.
  2. Requires the facility conducting the study to 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.
  3. Requires the displayed dose to be verified annually by a Medical physicist to ensure the displayed doses are within 20 percent of the true measured dose unless the facility is accredited.
  4. Requires the radiology report of a CT to 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.
  5. Requires the provisions in this bill to be limited to CT systems capable of calculating and displaying the dose.
  6. Requires, for the purposes of this bill, that dose radiation be defined as one of the following:
    • The computed tomography index volume and dose length product, as defined by the International Electro technical Commission and recognized by the Federal Food and Drug Administration; and,
    • The dose unit as recommended by the American Association of Physicists in Medicine.
  7. Requires, commencing July 1, 2013, facilities that furnish CT 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 DPH
  8. Requires a health facility, except for an event that results from patient movement or interference, to report to DPH an event in which the administration of radiation results in any of the following:

    • Repeating of a CT examination, unless otherwise ordered by a physician or radiologist, if the following dose values are exceeded:

      • 0.05 Sv (5 rem) effective dose equivalent;
      • 0.5 Sv (50 rem) to an organ or tissue; or
      • 0.5 Sv (50 rem) shallow dose equivalent to the skin.

C.   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; 

 

 D.   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;

 

E.   Therapeutic ionizing irradiation of the wrong individual, or wrong treatment site; and,

 

F.   The total dose from therapeutic ionizing radiation delivered differs from the prescribed dose by 20 % or more. In a situation where the radiation was utilized for palliative care for the specific Patient the radiation oncologist need only notify the referring physician that the dose was exceeded.

 

9. Requires the facility, no later than five business days after discovery of an event described in 1) above, to Provide notification of the event to DPH and the referring physician of the person subject to the event.   Requires the facility, no later than 15 business days after discovery of an event described in #1 above, to provide written notification to the person who is subject to the event.