California Dose Legislation: National Implications
Arnold Schwarzenegger, California’s governor, signed a new radiation patient protection law in October 2010 that mandates strict procedures and reporting requirements for CT scanners and radiation-therapy procedures, as well as the reporting of radiation overdoses to the state’s Department of Public Health (DPH). Whether the law prompts similar measures in other states (or at the federal level) remains to be seen. Robert Achermann, executive director of the California Radiological Society (CRS), says, “I’ve had calls from other states where the issue is being raised. Even though the incidents that drove this issue were from California, it is an issue of nationwide interest.” Rumblings are also being heard in Washington, DC, but Dave Adler, director of government relations for the American Society for Radiation Oncology, says, “I think everything, right now, is on hold,” attributing the lack of activity earlier this year to the midterm congressional election. How soon any action might be taken, now that the election is over, is unknown. The California radiation-protection law stems from findings by the DPH that over 260 patients were exposed to eight times the normal dose of radiation during CT perfusion scans at Cedars–Sinai Medical Center in Los Angeles. A review found that similar incidents had occurred throughout California, including at Los Angeles County–USC Medical Center, at Glendale Adventist Medical Center, and at Bakersfield Memorial Hospital. First of Its Kind Parts of the California law, particularly the recording of each dose of radiation, make it the first state law of its kind in the nation. As of July 2012, those using CT systems must record the dose of radiation on every study by putting it in the radiology report or attaching the protocol page to the radiology report. The displayed dose must be verified annually by a medical physicist to ensure that it is within 20% of the true measured dose. Facilities that do CT studies must send each CT study and protocol page that lists the technical factor and radiation dose to a PACS. In addition, health facilities must report to the DPH events that meet certain requirements, including CT irradiation of a body part other than the one intended, but only if certain radiation-dose requirements are exceeded. Definitions of other events are outlined in the law, a summary of which can be found at www.acr.org/HomePageCategories/News/ACRNewsCenter/California-State-Senate-Bill-1237.aspx. Starting in July 2013, all facilities that offer CT studies must become accredited by an organization approved by CMS. Achermann notes that the law could have been a lot worse without the involvement of the CRS in the legislative process. Other Radiation-safety Efforts One pitfall of the California law is the interpretation of the data placed in the database. The lack of clear standards defining what is (and is not) a radiation overdose—since variables such as a patient’s size, the body part being scanned, and other factors can affect dose calculation—can make such a determination difficult. The radiation dose also is only tracked on a per-exam basis, and isn’t tracked across state lines or between facilities. This makes it difficult for patients to gauge their lifetime exposure to radiation, according to David Avrin, MD, PhD, vice chair of informatics and professor of clinical radiology for the Department of Radiology and Biomedical Imaging at the University of California–San Francisco. “This is one more reason why we need a national medical-record identifier,” Avrin says. Such legislation would assign patients a single number to track all their medical information over a lifetime. Although such a patient identifier was included in past federal legislation, privacy concerns have since derailed efforts to institute it. Although there is no pending federal legislation that mandates reporting of adverse radiation events related to advanced imaging, talk is underway to create a process that would allow such events to be tracked across the nation, according to Adler. Adler notes that as part of the group’s Target Safely (http://www.astro.org/targetsafely/ ) campaign, the association has called for developing a national database for reporting linear-accelerator and CT medical errors. “There is a reporting database for errors involving radioactive materials, but there’s no national system for reporting machine-based medical errors,” he adds. One federal radiation-safety bill that is pending in the House and Senate is the Consistency, Accuracy, Responsibility and Excellence in Medical Imaging and Radiation Therapy legislation, which has more than 100 sponsors in the House and was introduced in the Senate in September 2010. This legislation sets basic educational and certification standards for health workers who administer radiologic procedures. “There are a lot of states out there that don’t have these standards, and this would create a national set,” Adler says, adding that this law would be a good first step, at the federal level, toward enhancing radiation safety. Jane Cys is a contributing writer for ImagingBiz.com.