Gov Arnold Schwarzenegger of California has signed into law a medical radiation protection bill aimed at protecting patients from excessive radiation exposure received during CT scans and radiation therapy procedures. Greasing the wheels for the first state law of its kind in the U.S., SB 1237, as the bill is known, mandates strict new procedures and reporting requirements when it becomes effective July 1, 2012. It also provides an accreditation mandate for CT scanners slated to take effect six months later.
The bill requires that imaging providers record radiation doses on images and in patients’ health records, and that radiation overdoses be reported to patients, treating physicians, and the state Department of Public Health (DPH). An identical level of monitoring is required for therapeutic radiation used to treat cancer.
Among many reporting provisions contained in SB 1237, medical facilities must advise the DPH whenever the radiation dose for a given scan exceeds 20% of the prescribed dose, or whenever the wrong anatomic area is scanned. Additionally, facilities offering CT and X-ray services must be accredited by an organization approved by the Centers for Medicare and Medicaid Services, an accrediting agency approved by the medical board of California, or the DPH.
The seeds for SB 1237 were sown in the fall of 2009, when the DPH learned that over an 18-month period, some 260 patients had been exposed to radiation doses of eight times higher than normal while undergoing CT perfusion scans at Cedars-Sinai Medical Center in Los Angeles. A subsequent review found that similar incidents had occurred at other centers throughout the state, including, among others, Los Angeles County-USC Medical Center in Los Angeles; Mad River Community Hospital in Arcata; Glendale Adventist Medical Center in Glendale; Providence Saint Joseph Medical Center in Burbank; and Bakersfield Memorial Hospital in Bakersfield. Medical staff members at these institutions, as well as scanner manufacturers, were implicated in the errors.
“The fact that these overdoses continued for 18 months speaks to the urgent need for protocols and safeguards to prevent overdoses in the future,” Sen. Alex Padilla (D-Pacoima), who authored the bill, said in a statement issued upon its approval by the California State Assembly in late August.
Details of how the law will be implemented and who will oversee compliance have yet to be ironed out, imagingBiz learned. However, it appears, imaging providers will bear the burden of doing the necessary reporting, as well as ensuring that rules pertaining to equipment are followed. A summary of the bill appears on the ACR web site.
The burden would be even more cumbersome had language contained in the original bill not been amended due to the efforts of the California Radiological Society (CRS), which worked on the bill in conjunction with Padilla, its sponsors, and the DPH. Such modifications were made to eliminate reporting requirements deemed by the CRS to be “impractical”, ” unworkable” and/or would interfere with day-to-day medical decision-making, according to Robert Achermann, executive director.
For example, Achermann says, language mandating that the DPH be notified every time a pregnant woman is scanned for any reason was revised to stipulate the reporting of only those scans that may have resulted in direct delivery of radiation to the fetus or embryo. A provision requiring that the state be informed any time a CT scan is repeated was modified to include solely those instances in which a scan was not repeated for common reasons, such as patient movement, or was not ordered by a physician and the amount of dose exceeded a certain level, Achermann explains.
Achermann said the CRS is “neutral” on the bill, but recognizes its importance. “It’s livable, which is the key thing,” he concludes.