Radiation dose reporting regulation recently enacted in California, while well-intentioned, has the potential to subject radiologists to new and unvalidated standards, restrict necessary adjustments to imaging protocols and mislead patients, according to an article published online May 10 in the Journal of the American College of Radiology.

The law also may have the side effect of serving as the basis for lawsuits against providers, according to Jonathan L. Mezrich, MD, JD, MBA, LLM, of the University of Maryland Medical Center, and Eliot L. Siegel, MD, of VA Maryland Health Care System and University of Maryland School of Medicine, both in Baltimore.

Under the new rules, radiation doses from CT scans must be recorded and included within or attached to the imaging report. Displayed dose must be verified after 12 months by a medical physicist against standard protocols to ensure displayed doses are within 20 percent of the true measured dose, according to the authors. Radiation exposure does not have to be calculated for a patient’s specific age, sex or size, and the law doesn’t address cumulative dosage. These data provide only a rough assessment of whether a dose is appropriate.

Without mandating a method for calculating acceptable doses in a given patient or case, it’s unclear whether the California law will actually improve patient safety, but Mezrich and Siegel wrote that plaintiffs’ attorneys are “licking their collective chops” at the easily accessible radiation dose data. “Juries and lawyers will not appreciate the subtleties and challenges of adjusting dose for different organs, body sizes, ages, sexes, and so on. No easily applicable or universally agreed upon calculation is available to determine the actual dose any single patient has received, only a variety of yet-to-be-approved methodologies that, at best, will yield broad ranges rather than specific numbers.”

Low-dose imaging may not yield adequate image quality for every body part or body habitus, requiring imaging departments to modify protocols for a given study, though the California requirements threaten this flexibility for radiologists, according to the authors.

“Putting the patient's welfare first is certainly an admirable goal, to the extent that it does not interfere with treatment,” wrote Mezrich and Siegel. “But statutorily mandating the documentation of dose values eliminates flexibility and mandates rote numeric compliance."

What is “undoubtedly beneficial,” according to the authors, is for the imaging profession to voluntarily minimize dose using exposure modulation, iterative reconstruction, appropriateness guidelines and adherence to the “as low as reasonably achievable” principle.

“The California law is premature,” concluded Mezrich and Siegel. “In our rush to be more patient centered and our desire to put the patient first, we may be succeeding only in making ourselves feel more responsive and responsible. The new legislation, based on the best intentions of better communication, may do more to handcuff radiologists than benefit patients.”