Ben Lauing, Imaging Performance Partnership
Our recent webconference Advancing Radiation Dose Risk Management touched briefly on the landscape for emerging radiation dose regulations. I thought I’d take this opportunity to go into a little more detail on the states we profiled: California, Connecticut, and Texas.
California updates original 2010 law
The new 2012 law (originally A.B. 150) revises some provisions from the original 2010 legislation (originally S.B. 1237) to require accreditation, allow for certain exemptions, and specify error reporting procedures.
First, the original law mandated that facilities must include CT radiation dose in patient records. The new law states that facilities are not required to report dose if the CT scan is used for therapeutic treatment planning or nuclear medicine.
Second, the original law indicated that all facilities must verify dose annually to ensure displayed dose remains within 20% of measured actual dose; however, this provision exempted facilities that were accredited. According to the new law, until July 1, 2013, facilities who have not yet achieved accreditation are still required to perform annual verification of displayed dose for standard adult brain, abdomen, and pediatric brain protocols.
Beginning on July 1, however, all CT systems must be accredited through an approved modality-specific or facility-wide accreditation process. This change thus renders obsolete the verification mandate for unaccredited facilities. The new law further dictates that CT studies used for radiation oncology, nuclear medicine, or interventional radiology are exempt from mandated accreditation.
Third, the original law required facilities to report certain events related to ionizing radiation (e.g. repeat CT, wrong site, bodily injury, dose exceeds mandated thresholds) to the department and the referring physician within five business days. The new law details other measures (e.g. performing CT without physician approval) and sets specific dose thresholds for each; if these dose levels are exceeded, facilities must report to various parties within five, 10, or 15 business days, depending on the error.
Connecticut follows California’s example
Bill 6423 was introduced earlier this year and is currently in committee in the Connecticut General Assembly. Very similar in nature to California’s legislation, the bill would:
- Require providers to record CT radiation dose in patient radiology reports
- Require annual inspection of CT scanners to ensure displayed dose doesn’t deviate more than 20% from actual measured dose
- Mandate five days for reporting to the state and referring physician and 15 days for reporting to patients certain error events (e.g. repeat CT raising cumulative dose to an excessive level, wrong site, permanent damage to patient caused by dose) when dose thresholds, to be established by the Commissioner of Public Health, are exceeded
Texas develops comprehensive regulations
New regulations from Texas this year came through a different channel—the Texas Department of State Health Services (DSHS). Their update to Texas Administrative Code §289.227, effective May 1, 2013, extends beyond CT and includes a number of regulations for fluoroscopy. The new rules also mandate the development of radiation protocol committees; depending on modality, these committees must include certain participants and must meet at least every 14 months.
Programs must record radiation output on all CT and fluoroscopy exams (using CTDI, DLP, or air kerma). After instating dose thresholds, programs must report to the DSHS any overdose incidents.
Will these regulations affect me?
If you are in California or Texas, yes. If you are in Connecticut, probably. And for other states, it’s only a matter of time. Recent conversations with members across the nation indicate that radiation risk is still a prominent issue and that radiation safety measures are likely to spread.
In addition, the American Board of Radiology Foundation is currently developing a master action plan for safe and appropriate use of medical imaging, and the results of this research may very well inform future regulatory policies on radiation safety.
The regulations in these three states have in common that they:
- Require dose exposure levels on patient reports
- Establish or mandate the establishment of specific dose thresholds
- Require reporting to state authorities when these thresholds are surpassed
Regulations in other states, as they appear, are likely to contain these basic components as well. While there will be some variation, the message is clear: start developing procedures for dose reporting now to be sure you’re prepared.
Missed our webconference? View an archived version of Advancing Radiation Dose Risk Management.
Our work on radiation dose management is part of our larger research study, The New Radiology Quality Mandate. Be sure to register for our national meeting so you don’t miss it.
Want more from this author? See all of Ben's blog posts.
Payer and Regulatory Policy,