CT Dose Recording and Reporting of Radiation Mis-Administration Takes Effect on July 1, 2012

SB 1237 ( Padilla) was originally signed into law in 2010 with delayed implementation until July 1, 2012 for all of its provisions. The CRS has been involved with the original bill and several follow-up bills that were intended to either clarify or modify the original provisions. Since July 1 is rapidly approaching we wanted to provide you with some resources for compliance and provide an update on the final bill AB 510 (Lowenthal) which will be on the Governor's desk for signature in mid-July and is an urgency statute, meaning it takes effect upon his signature.

The UC-DOSE Project has published Recommendations for Compliance with SB 1237 on May 21, 2012 which provides a very good analysis of the specific elements of the law including dose recording, accreditation requirements, and required reporting of mis-administration of CT or radiation therapy. Here is a link to that document.  

The Radiologic Health Branch within the Ca. Department of Public Health is the agency that has responsibility  for regulating users of ionizing radiation and the enforcement of the provisions of SB 1237 and the subsequent bills. They have made available two Frequently Asked Questions documents, the first published after SB 1237 was initially adopted and the second in May 2012 with an update on issues. It is important to note that both the UC-DOSE project and RHB will publish updated documents after AB 510 is signed into law. Here are links to the two RHB FAQ documents;

RHB January 2011     

RHB May 2012 

The CRS had been trying to clarify the requirement for dose recording to avoid any need for the radiologist to include or dictate the CDTi vol and DLP into their actual report. The original language of SB 1237 was an attempt to offer an option of either including the dose in the report or attaching a copy of the protocol page that would show those values. We suggested language that would have replaced "report" with "medical record" and thus the protocol page would be part of the "medical record". Unfortunately the politics were such that no change was made and there are some in the radiology community who are advocating for dose to be included in the interpretative report. There may be software applications that can populate dose information into the report or equipment manufacturers may develop refinements in the future, but for the time being radiologists need to have the dose accessible to the referring doctor and the patient if the latter requests their report.

As indicated above AB 510 will soon be on the Governor's desk and will include the following changes to SB 1237;

•         There is no dose recording requirement for CT used in therapeutic radiation treatment planning or PET/CT or SPECT/CT used for attenuation  correction only and not for diagnosis. That interpretation is already contained in the FAQs from BRH but it would now be placed in statute.
•         A dedicated CT unit used for image guidance of IR will not be required to be accredited. Similarly, units that only do non-diagnostic CTs described in the point above would also not need to be accredited.  There will be the need for annual physicist evaluation to verify dose for dedicated image guidance units.
•         The two sections on reporting of a CT performed on the wrong patient or repeated without order will be harmonized in terms of the dose values that have to be exceeded before reporting is triggered. One section currently says that the values for effective dose, dose to an organ or tissue, or shallow dose must all be exceeded whereas the other section requires reporting if any one of them is exceeded. Both sections will now say of "any one" of those dose values is exceeded a report must be submitted to RHB.
•         There are some language changes to the section on CT to wrong anatomic area to clearly reflect that it refers to "intended area of the body to be imaged" so if adjacent organs are radiated that is not reportable since it was the intended area of the procedure.

We hope this information will be helpful and we will provide additional detail once AB 510 is signed into law.