Tuesday, October 6, 2015

Challenges with X-ray Dose Reporting.

In my travels when teaching healthcare imaging and IT in other countries I notice certain areas that
are definitely ahead of other regions and also some that are lagging behind. The US is finally catching up with widespread EMR implementations due to the ARRA act incentives requiring practitioners to meet Meaningful Use requirements unless they want to be penalized by future reimbursement cuts. We are still lagging behind wide-scale implementations of Health Information Exchanges, especially as incentives are running out for creating public ones, but the private ones that are set up by large provider groups are really taking off.

From a regulatory perspective, the HIPAA regulations were a game-changer and had a major impact, not only on policies and procedures, but also on the way that systems implement security and privacy, for example, tracking activity through audit trails. Here is where a lot of countries follow the US example. The same is now happening with the requirement to track X-ray Dose, few countries and/or states are actively enforcing this, unlike the US.

However, as with many regulatory requirements, technology is running behind and trying to catch up to the requirement to track dose, especially from CT scans, and also from fluoroscopy, angiographic and cardiology procedures. Several incidents that happened only a few years ago, whereby hundreds of patients were severely overdosed at several major medical centers, triggered stricter dose regulations. Prior to that, it was common to track or at least to record the dose for radiation therapy and digital mammography.

In radiation therapy, there is a thin line between over exposing and therefore hurting the patient’s recovery too much and under-exposing thereby not killing all the cancer cells and risking a recurrence, and therefore, dose registration has been a practice all along. For digital mammography, there is a similar concern that too much and frequent screening could cause, rather than prevent cancer and even though I am not aware that the dose information has actually been tracked, it has been practice to at least record it with the images in the DICOM header.

For CT, fluoroscopy, angiography and cardiology procedures, recording dose has not been common until it became a recent requirement. The good news is that new modalities now are being shipped with the capability to export detailed information in the form of DICOM Structured Reports. The bad news is that this only represents a relatively small portion of the installed base, and that the infrastructure to archive and register this information is not there yet. The result is a patchwork of different solutions to capture this information. The options to capture this information include using the DICOM header such as used for digital mammography, to capture it as part of the Modality Performed Procedure Step (MPPS), or as a screen save aka Secondary Capture.

The MPPS solution is hampered by sparse implementations for a variety of reasons. Some of the barriers for MPPS implementations are lack of knowledge and understanding by the user community, a resistance to activate it by the modality vendors, as it is more work and potentially increases support issues, and finally poor implementations. An example of the latter is provided by a major PACS vendor that closes the study upon receiving the MPPS complete, thereby causing all images sent after that to become “unverified” requiring intervention. And even if you were able to make MPPS work, the information about the dose in this transaction does not have a lot of detail and does not necessarily reflect the complete exposure, especially for fluoroscopy exams where the part of the exam that does not create images is not part of the dose recording.

The screen-save solution is somewhat better but also limited with regard to the information that is recorded, and requires some type of intelligence in the form of Optical Character Recognition (OCR) or screen scraping to collect the dose information in a format that can be electronically stored in a database.

Talking about a database, as of today there are few PACS vendors that offer a dose management solution as part of their PACS system. Users might have to rely on third parties to collect that data and, if needed, forward it to a regional or national registry. There is an open source solution called RADIANCE (see footnote), but like all open source, there could be a concern about support and sustainability.

Therefore, despite the requirement for dose registration and dose management that is only going to be extended to more modalities and specialties in the future, the technology is trying to catch up and health care imaging and IT professionals who are tasked with installing and supporting this are being challenged. Hopefully, when more structured report solutions and dose management applications become available, this will become easier.

Footnote: Journal of Digital Imaging 2013 Aug; 26(4): 663–667: An Interactive RADIANCE Toolkit for Customizable CT Dose Monitoring and Reporting

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