There seems to be a general sense of delayed reaction within the healthcare arena when it comes to preparation for California’s Senate Bill (SB) 1237 and Assembly Bill (AB) 510 and other pending legislation that adopts regulations regarding the capture and reporting of radiation dosing. (See sidebar below for details about the bills.) The looming threat of violating California law with the potential for fine implications has begun to sink in, yet the bigger picture seems to be lost in translation.
Currently, it seems as though many organizations do not consider that dose monitoring is essential to improving healthcare or that an analysis of the dose data, not just a screen capture, allows physicists and healthcare providers to improve the safety and well-being of their patients. Some organizations have taken initial steps to implement a system to record radiation doses, but then do not consider the critical next steps. They either undervalue or misunderstand what these reported doses mean, when they should be reported and/or rectified and who is responsible for the communication of the data being captured.
Healthcare organizations need to fully understand that this new breadth of information is going to expand further to drive the development of new and modified workflows that will take into consideration a larger radiation safety initiative and patient awareness. The creation and understanding of these new workflows and procedures will help ensure full user adoption, not only of a software product, but also the larger purpose of dose monitoring — overall patient safety and radiation performance.
By incorporating a dose monitoring solution into a healthcare environment, organizations take on the responsibility of implementing a program, not a product, which necessitates review and support around workflow design, protocol review and revision, policies and procedures, training development, change management and communication with both clinicians and patients. In order to achieve user adoption and enhance patient safety, it is important to define these processes within your organization.
Current and Future State Workflows
Prior to mapping out your organization’s workflows related to dose monitoring, your organization first should assess how dose information is currently stored (assuming storage has already begun) and how it will be stored in the future. From there, the questions can be exhausting: How do you currently, or plan to, track and report dose information? Which values are captured and reported, who is responsible for this task and how often are the values captured and tracked? How will clinicians be notified? Will the alert reach the technologist, radiologist or ordering physician before the exam is performed?
These questions are critical. Your organization must know the “who, what, when, where, why and how” with regard to technologist and physician workflows.
Protocol Review and Revision
Another important issue to address is your organization’s computed tomography (CT) protocols. Are they currently over the recommended dose thresholds? If so, this needs to be addressed. If the dose thresholds are not set, there is absolutely no reason that this should not be resolved immediately.
Having a dose monitoring system that automatically collects and organizes dose exposure data makes this process much easier. With a dose monitoring system, you have the ability to quickly look up and manage radiation dose exposure delivered to patients. This facilitates better control of quality and use of existing modalities. Current protocols can be baselined and then adjusted to ensure the lowest possible dose to the patient, while maintaining the diagnostic quality of the images.
Policies and Procedures
Each organization should produce policies and procedures for incorporation into its ALARA (as low as reasonably achievable) program, with the critical identifier being a patient’s potential exposure to radiation that exceeds the organization’s dose thresholds. The thresholds should follow the American College of Radiology (ACR) CT Accreditation Requirements and American Association of Physicists in Medicine (AAPM) Dose Check Guidelines.
The policies and procedures should outline a codified set of processes that proactively assess a patient’s aggregate and proposed exposure indices from the use of medical nontherapeutic ionizing radiation. They also should outline a process for tracking and reporting of events where exposure exceeds the organization’s predetermined exposure thresholds and the necessary response path.
If you have implemented, or you plan to implement, a dose monitoring system, do you know what you will do with it? Have you identified who will be trained on the new system and the workflow they will follow?
The training plan should cover end-user training as well as the clinical workflow training. These should not be considered separate training environments, as the effectiveness of an organization’s radiation safety program is dependent upon proper results in both areas.
Change Management and Communication
Most large organizations have a change management process, but not every organization does. You must assess if your organization is equipped to handle the change in process associated with the implementation of a dose monitoring system. Having a change management plan in place will help to ensure efficient and prompt handling of the required process changes and prevent incidents that affect the quality of patient care.
Communication is a critical key to the success of dose monitoring. Ensuring patient safety in any medical activity requires effective communication between clinicians and patients. What is your organization currently communicating to patients regarding patient radiation safety? Do patients know whether or not they are receiving the lowest possible dose?
Healthcare providers are beginning to realize the powerful marketing implications that come from accreditation and an effective radiation safety program. As the new legislature in California influences other states and the federal government, patients will become more educated regarding radiation doses. Your orgnization should be initiating conversations about dose, not the patient. Printed publications regarding your organization’s radiation safety program should be readily available and distributed. Patients should feel confident that all aspects of their care have been accounted for and addressed.
Making the decision to add a dose monitor product into your organization is a huge leap forward in acknowledging the necessity and urgency of this long-standing, but newly acknowledged, matter of radiation safety. Implementing a dose monitoring program to accompany a product is where true value can be created through the enhancement of workflows, changes in protocols and sharing of knowledge.
Don’t just collect the data, use the data. The dose data collected by healthcare organizations over the next few years will provide a wealth of knowledge surrounding best practices for CT and will ultimately open the door to data collection and best practices for all radiography modalities.
If your organization is located outside of California, then it is your decision whether or not to adopt the only known legislative mandates at this time. However, indications are that other state and federal legislative authorities will utilize the California legislative language as a baseline for adoption to be applied nationwide. The standard of practice with regards to radiation dose is changing. Is your organization being proactive in protecting patients?
Neomi Mullens is a project manager and Brandon Taggart is a project manager and consultant at Ascendian Healthcare Consulting. For more information: www.ascendian.com
California Legislation Takes Effect in July
California legislation (SB 1237) was introduced in 2010 and subsequently passed, regarding reportable events from the use of computed tomography (CT). According to the California Department of Public Health, it was enacted “in response to multiple events where patients were exposed to excessive radiation of diagnostic CT scanners. The intent of the law is to prevent such events. However, if excessive exposures do occur, systems need to be alerted and corrected as expeditiously as possible so that patients can be assured that they are receiving quality medical care.”
The law, which was slightly amended in Assembly Bill 510 in mid-April, will go into effect for all hospitals and clinics in California on July 1. The new requirements, as recapped by LegiScan, [1,2] are that these facilities:
• Record the dose of radiation on every CT study produced during a CT exam, except studies used for therapeutic radiation treatment planning or delivery;
• send each CT study and protocol page listing technical factors and radiation dose to the picture archiving and communication system (PACS);
• include the radiation dose in the radiology report of a CT study, either by recording the dose within the report or attaching to the report the protocol page that includes the radiation dose; and
• until July 1, 2013, displayed doses must be verified annually by a medical physicist for the facility’s standard adult brain, adult abdomen and pediatric brain protocols, to ensure they are within 20 percent of the true measured dose (dose is defined as either the computed tomography index volume [CTDI VOL] and dose length product [DLP] or the dose unit as recommended by the American Association of Physicists in Medicine [AAPM]). A facility that has an accredited CT system can elect not to perform such verification, however. After July 1, 2013, CT systems must be accredited.
This is all providing that the CT system is capable of calculating and displaying the dose, the legislation states.
Other provisions require the reporting of events in which radiation results in the following:
• Repeating of a CT exam, if certain specified dose values are exceeded;
• a CT exam that doesn’t include the intended area of the body, if certain specified dose values are exceeded;
• CT or therapeutic exposure that results in unanticipated permanent functional damage to an organ or a physiological system, hair loss or erythema;
• CT or therapeutic dose to an embryo or fetus that is greater than 50 mSv, that is a result of radiation to a known pregnant individual unless the dose was specifically approved in advanced by a qualified physician;
• the wrong individual or treatment site receives dose; or
• the total delivered dose varies from the prescribed dose by 20 percent or more, except in situations where the radiation was for palliative care.
While this currently is the only legislation of its kind, the state’s Department of Public Health has indicated that it has had inquiries from other states or agencies, which are monitoring progress and reaction to California’s law.
For more, visit www.leginfo.ca.gov
1 “Bill Text: CA Senate Bill 1237 - 2009-2010 Session” http://legiscan.com/gaits/text/61208. Accessed 4/27/2012.
2 “Bill Text: CA Assembly Bill 510 - 2011-2012 Session” http://legiscan.com/gaits/text/628437. Accessed 4/27/2012.