February 12, 2016

Maryland Radiation Board Evaluates Reporting Requirements

The Maryland Radiation Control Advisory Board (RCAB) gathered information at its Feb. 3 meeting to determine if the state’s rapid reporting requirements and financial penalties for misadministrations of medical radiation are overly stringent.

Current policy was established in an April 2015 memo from the Maryland Radiological Health Program (RHP) to the registrants of diagnostic and therapeutic radiation machines. They are required to report all misadministration of ionizing radiation to the RHP by telephone within a day after the discovery.

State regulations define a misadministration of a teletherapy radiation dose or dose from a radiation machine as the following.
  • A medical procedure involving the wrong individual, wrong mode of treatment, or wrong treatment site, or of a type other than the one intended; (this would include an X-ray of a wrong extremity); 
  • When the treatment consists of three or fewer fractions, a difference of the calculated total administered dose from the total prescribed dose by more than 10 percent of the total prescribed dose;
  • A calculated weekly administered dose that is 30 percent greater than the weekly prescribed dose; or 
  • A calculated total administered dose that differs from the total prescribed dose by more than 20 percent of the total prescribed dose. 
At the meeting, the RCAB questioned interested parties about concerns and avenues for resolution for disagreements with RHP’s reporting policy. RCAB Chair Richard S. Hudes is chief of radiation oncology at Saint Agnes Hospital, Baltimore. Invited representatives included Mahadevappa Mahesh, PhD., chief physicist of The Johns Hopkins Hospital, Frederic Yeganeh, MD, a representative from the Maryland Radiological Society and Eugenia Krimer-Brandt, the American College of Radiology’s director of state legislative affairs.

While agreeing on the need for rigorous radiation safety standards, the stakeholders raised concerns about stringent interpretation of the existing rule. They drew distinctions between information that can be appropriately analyzed and addressed internally by medical providers and information that must be reported to state authorities. They stressed that overly stringent reporting requirements and resulting financial penalties may create a negative environment where fearful medical personnel are reluctant to report radiation misadministration incidents.

One recommendation revolved around adopting reporting thresholds from the Conference of Radiation Program Directors (CRCPD) documents on radiation medical events. The CRCPD has defined reporting criteria for radiation medical event and specific thresholds that trigger reporting requirements for therapy and diagnosis. A medical event indicates that a facility experienced technical or quality assurance problems in administering the physician’s orders. Within the reporting criteria, the CRCPD recommends that “any wrong patient or wrong site imaged, regardless of dose received, should be reported, documented, and addressed internally within the facility.” The reasoning is that the facilities are much better equipped to assess infractions and respond in a meaningful manner.

Stakeholders also voiced a need for continued dialogue and review of recommendations from the radiation control advisory board. If medical events were to be stratified in a way that was clearly defined and understandable, the subsequent reporting would be more manageable and more meaningful as a result. In the near future, the advisory board will work to develop recommendations to the state on the interpretation and enforcement of existing regulations.

CRCPD documents 

Memo from Maryland Department of the Environment