CA Governor Signs Radiation Overdose Bill into Law

In the first law of its kind, California Gov. Arnold Schwarzenegger has signed a bill that will require health facilities to notify the state Department of Public Health any time a patient receives a radiation dose in an imaging scan that exceeds 20% of what was intended.

Effective July 1, 2012, the law requires that CT scanners receive accreditation by an organization approved by the Centers for Medicare and Medicaid Services by Jan. 1, 2013.

The legislation comes in the wake of several incidents in California hospitals in which patients received dangerous overdoses of CT radiation.  A year ago, officials at Cedars-Sinai disclosed that 260 patients who underwent CT brain perfusion scans to detect a stroke between February 2008 and September 2009 had developed rashes and hair loss, and were at increased risk of developing cataracts.

The radiation dosages were estimated at as much as eight times what the patients should have received, according to hospital statements.

In 2008, at Mad River Community Hospital in Humboldt County, a two-year old boy who had fallen out of bed received 151 scans during a 65-minute imaging test, and an excessive overdose of radiation.

Under the new law, hospitals and clinics that use computed tomography X-ray systems for human use will be required to record, if the CT systems are capable, the dose of radiation on every CT study produced during the administration of a CT examination, according to the California Legislative Counsel's digest.

The dose is required to be verified annually by a medical physicist unless the facility is accredited. The law also requires the facility administering the scan to report certain information about the scan to the department, the affected patient, and the patient's treating physician. Technical factors and dose must also be sent to the electronic picture archiving and communication systems.

State health officials will be required to be informed about any event, within five days of its discovery, in which

• The administration of radiation results in a repeat CT exam, unless otherwise ordered by a physician or a radiologist, if the following dose values are exceeded: .05Sv (5 rem) effective dose equivalent, .5Sv (50 rem) to an organ or tissue or .5Sv (50 rem) shallow dose equivalent to the skin.
• ACT X-ray irradiation is done of a body part other than that which was intended by the ordering physician or radiologist if certain dosages are exceeded.
• CT or therapeutic exposure results in unanticipated permanent functional damage to an organ or a physiological system, hair loss, erythema or skin reddening or rash, as determined by a qualified physician.
• A CT or therapeutic dose to an embryo or fetus 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.
• Therapeutic ionizing irradiation is done on the wrong individual or wrong treatment site.

The new law makes an exception for instances when total dose of ionizing radiation exceeds 20% or more, but is done "for palliative care for the specific patient."

The California incidents, as well as CT overdoses elsewhere in the nation, have prompted the U.S. Food and Drug Administration to issue new rules for how manufacturers of imaging devices set dosage controls on their machines.

In a statement issued by Consumer Attorneys of California, one of the Cedars patients, Michael Heuser, said the new law "should serve as a foundation for legislation nationwide. Congress needs to step in and use its power to ensure that that these sort of tragic mishaps don?t ever happen again."

The statement says that Heuser was labeled 'Patient 1' after he became the first to report troubles to health care officials. "He was bombarded by at least 8 times the allowable radiation dose, a level equivalent to 50,000 chest X-rays. Heuser had to fight with recalcitrant hospital officials to learn that he had been overdosed during the scan."

In a statement last month after the bill passed the state Assembly, its author State Sen. Alex Padilla (D-Pacoima), said the legislation "will provide physicians the information they need to track dosage levels and prevent patients from receiving overdoses of
radiation."

See also:

Class Action Lawsuit Filed Against Cedars-Sinai Over CT Radiation Overdose

Cedars-Sinai Offers to Pay Medical Costs For Patients Overexposed to CT Radiation

Cedars-Sinai Caused Immediate Jeopardy in CT Scanner Case, Say State Officials