California Dreaming: Avoiding CT Dose Law Nightmares
As of July 1, California facilities are required to record dose from every CT study performed. As providers in the Golden State prep for the first CT dose reporting law in the U.S., their peers are watching in anticipation, as other states may follow suit.
In 2009, the FDA launched an investigation after it was reported that more than 200 patients at Cedars-Sinai Medical Center in Los Angeles were overradiated during CT brain perfusion scans due to a computer-resetting error. Several lawsuits and investigations later, the state passed the California Dose Reporting Law to help prevent overradiation during CT scans. The legislation now places hospital staff in uncharted waters.
CT scanners capable of producing radiation dose reports fall under the law, and facilities also will be required to have CT scanners accredited by approved Centers for Medicare & Medicaid Services (CMS), Medical Board of California, state department or public organizations by July 2013. According to SB 1237, California providers are now required to report scans that are repeated (unless advised by clinicians) and scans to the wrong body part that result in:
Employees at the 368-bed Sharp Memorial Hospital in San Diego have taken a proactive approach to the law, potentially providing a model for others. They set two goals: to comply with the law and to provide clinically useful diagnostic images with as little radiation exposure as possible.
The law requires each facility to send CT dose reporting pages electronically through both the RIS and PACS. Puckett says that being up to date with health IT will be difficult for smaller facilities, but the bigger challenge will be getting CT scanners accredited, as it is a time-consuming process. Besides recording the radiation dose on every CT study produced during a scan, scanners will need to be accredited and CT radiation doses will need to be verified annually by a medical physicist.
“This will help get the physicians who are ordering the exams to look for trends and help cut down on our imaging exams,” Puckett says.
The dose reporting law has made Sharp Memorial’s medical physicist Bette W. Blankenship, MS, DABR, and colleagues question if they image efficiently and consistently using uniform protocols. As the hospital’s radiation dose overseer, Blankenship works to balance CT quality with the minimal appropriate dose. She recommends reassessing protocols. At Sharp, staff re-examined, reset and overhauled hundreds of preset protocols within the four CT scanners located around the hospital.
“Our protocols for CT were not being very well monitored as far as radiation dose goes,” says Jonathan M. Gurney, MD, medical director of radiology for Sharp Memorial. The protocols did not exceed dose or overradiate patients, but they were based on doctor preference rather than standardized protocols.
“If you have not been keeping track of your protocols in a systematic manner, it is likely that you have five to six different protocols per body part,” says Gurney. He advises facilities to start by filtering out the exam protocols that are used least often.
The staff was able to eliminate unused or unsanctioned protocols and replace them with facility-wide, approved protocols that helped to standardize CT dose emitted. Puckett says re-examining these protocols has allowed staff to cut down on radiation dose in multiple exams. For example, sinus CTs, which normally have a higher degree of contrast, have seen a nearly 70 percent reduction in dose, without the loss of diagnostic accuracy. Now, the revised volume CT dose index (CTDI vol) for a sinus series is 9 mGy, compared with the American College of Radiology’s reference level of 75 mGy.
“There are times when you need more dose,” Puckett says. “However, just being able to recognize where you can lower the dose across multiple platforms by sifting through protocols does wonders.”
Additional challenges remain within Sharp Memorial, including staff sifting due to manual, hand-written dose reports. While two scanners have the capability to electronically capture CTDI and dose-length product (DLP) data on the patient dose screen, the PET/CT unit and the other CT scanners do not. Staff must document CTDI and DLP from these scanners, which requires time and manpower.
Sharp Memorial is considering the use of an IT software patch that could update the two scanners and push data to electronic storage, along with images. “We can only hope that automated products will become available so the process can be examined as an investment, rather than a time and cost burden,” Gurney says.
After reviewing protocols for each facility, the group shares ideas on how to further decrease dose. For example, while a typical head CT has 16 to 20 variables, sharing what settings the radiologist prefers can help further reduce dose. The group discusses beam energy, beam quality, image noise index and other factors. “Comparing dose gives us the opportunity to glean ideas, bring them back to our scanners and further reduce dose to assure excellent diagnostic images,” she says.
It will be challenging for radiation safety officers to understand the magnitude of oversight required with the new law, says Puckett. “They must oversee the way radiation is used on patients and how this exposure is being recorded.”
To take this a step further, Blankenship and colleagues have begun training staff to understand appropriate doses. Questions answered during training are: How will we best refer patients? How will we deliver dose? What is the proper terminology to use?
“The big changes are cultural, not mechanical or logistical,” says Puckett. “Radiologists should be looking at dose to ensure it’s in the correct parameters.”
California is a pioneer state in this effort, but being first in an endeavor of this scope has its drawbacks. The law aims to achieve better oversight, but Blankenship says there is still some ambiguity in the bill’s language. For example, the bill requires CT users to record the dose of radiation on every CT scan and electronically send each CT study and protocol page to the RIS and PICS. However, it is still unclear whether this refers to the radiologist’s dictated report or the dose report itself.
An assembly amendment is in the works to clarify these requirements. In the meantime, providers in California and elsewhere are keeping an eye on how the law affects hospitals, their radiology departments and, importantly, patient care. While it remains to be seen how the dose reporting law will directly affect practice, hospital administrators and clinicians remain vigilant with the aim of performing CT with doses that are as low as reasonably achievable.
In 2009, the FDA launched an investigation after it was reported that more than 200 patients at Cedars-Sinai Medical Center in Los Angeles were overradiated during CT brain perfusion scans due to a computer-resetting error. Several lawsuits and investigations later, the state passed the California Dose Reporting Law to help prevent overradiation during CT scans. The legislation now places hospital staff in uncharted waters.
CT scanners capable of producing radiation dose reports fall under the law, and facilities also will be required to have CT scanners accredited by approved Centers for Medicare & Medicaid Services (CMS), Medical Board of California, state department or public organizations by July 2013. According to SB 1237, California providers are now required to report scans that are repeated (unless advised by clinicians) and scans to the wrong body part that result in:
- An effective dose that exceeds 0.05 Sv;
- A dose in excess of 0.5 Sv to any organ or tissue; or
- Shallow dose of 0.5 Sv to the skin; and
- Permanent damage.
Employees at the 368-bed Sharp Memorial Hospital in San Diego have taken a proactive approach to the law, potentially providing a model for others. They set two goals: to comply with the law and to provide clinically useful diagnostic images with as little radiation exposure as possible.
How will facilities get there?
“Currently, radiation dose is an unregulated area,” says Michael P. Puckett, MD, president of the California Radiological Society and chief medical officer of San Diego Imaging Medical Group, a provider of Sharp Memorial. According to the American Society of Radiologic Technologists, 39 states have licensure or certification laws for radiography, three with CT-specific requirements.The law requires each facility to send CT dose reporting pages electronically through both the RIS and PACS. Puckett says that being up to date with health IT will be difficult for smaller facilities, but the bigger challenge will be getting CT scanners accredited, as it is a time-consuming process. Besides recording the radiation dose on every CT study produced during a scan, scanners will need to be accredited and CT radiation doses will need to be verified annually by a medical physicist.
“This will help get the physicians who are ordering the exams to look for trends and help cut down on our imaging exams,” Puckett says.
The dose reporting law has made Sharp Memorial’s medical physicist Bette W. Blankenship, MS, DABR, and colleagues question if they image efficiently and consistently using uniform protocols. As the hospital’s radiation dose overseer, Blankenship works to balance CT quality with the minimal appropriate dose. She recommends reassessing protocols. At Sharp, staff re-examined, reset and overhauled hundreds of preset protocols within the four CT scanners located around the hospital.
“Our protocols for CT were not being very well monitored as far as radiation dose goes,” says Jonathan M. Gurney, MD, medical director of radiology for Sharp Memorial. The protocols did not exceed dose or overradiate patients, but they were based on doctor preference rather than standardized protocols.
“If you have not been keeping track of your protocols in a systematic manner, it is likely that you have five to six different protocols per body part,” says Gurney. He advises facilities to start by filtering out the exam protocols that are used least often.
The staff was able to eliminate unused or unsanctioned protocols and replace them with facility-wide, approved protocols that helped to standardize CT dose emitted. Puckett says re-examining these protocols has allowed staff to cut down on radiation dose in multiple exams. For example, sinus CTs, which normally have a higher degree of contrast, have seen a nearly 70 percent reduction in dose, without the loss of diagnostic accuracy. Now, the revised volume CT dose index (CTDI vol) for a sinus series is 9 mGy, compared with the American College of Radiology’s reference level of 75 mGy.
“There are times when you need more dose,” Puckett says. “However, just being able to recognize where you can lower the dose across multiple platforms by sifting through protocols does wonders.”
Additional challenges remain within Sharp Memorial, including staff sifting due to manual, hand-written dose reports. While two scanners have the capability to electronically capture CTDI and dose-length product (DLP) data on the patient dose screen, the PET/CT unit and the other CT scanners do not. Staff must document CTDI and DLP from these scanners, which requires time and manpower.
Sharp Memorial is considering the use of an IT software patch that could update the two scanners and push data to electronic storage, along with images. “We can only hope that automated products will become available so the process can be examined as an investment, rather than a time and cost burden,” Gurney says.
A dose of collaboration
Teamwork may help overcome some of the challenges of complying with the dose law. Along with Blankenship, Gurney, the radiation safety officer and CT lead technologists sit on Sharp’s radiation safety committee. Cath lab employees and employees from radiation oncology also are involved. During the monthly meetings, staff consults on the design of protocols and procedures that may help lower dose and improve care on the hospitalwide CT scanners. Additionally, best practices of CT use are shared.After reviewing protocols for each facility, the group shares ideas on how to further decrease dose. For example, while a typical head CT has 16 to 20 variables, sharing what settings the radiologist prefers can help further reduce dose. The group discusses beam energy, beam quality, image noise index and other factors. “Comparing dose gives us the opportunity to glean ideas, bring them back to our scanners and further reduce dose to assure excellent diagnostic images,” she says.
It will be challenging for radiation safety officers to understand the magnitude of oversight required with the new law, says Puckett. “They must oversee the way radiation is used on patients and how this exposure is being recorded.”
To take this a step further, Blankenship and colleagues have begun training staff to understand appropriate doses. Questions answered during training are: How will we best refer patients? How will we deliver dose? What is the proper terminology to use?
“The big changes are cultural, not mechanical or logistical,” says Puckett. “Radiologists should be looking at dose to ensure it’s in the correct parameters.”
California is a pioneer state in this effort, but being first in an endeavor of this scope has its drawbacks. The law aims to achieve better oversight, but Blankenship says there is still some ambiguity in the bill’s language. For example, the bill requires CT users to record the dose of radiation on every CT scan and electronically send each CT study and protocol page to the RIS and PICS. However, it is still unclear whether this refers to the radiologist’s dictated report or the dose report itself.
An assembly amendment is in the works to clarify these requirements. In the meantime, providers in California and elsewhere are keeping an eye on how the law affects hospitals, their radiology departments and, importantly, patient care. While it remains to be seen how the dose reporting law will directly affect practice, hospital administrators and clinicians remain vigilant with the aim of performing CT with doses that are as low as reasonably achievable.