December 2012

Radiology Today Interview With Ascendian Healthcare Consulting President & CEO Shawn McKenzie: Reporting CT Dose
Radiology Today
Vol. 13 No. 12 P. 22

Ascendian Healthcare Consulting is an operational and IT consulting firm based in Roseville, California. Radiology Today (RT) recently interviewed Ascendian President and CEO Shawn McKenzie regarding the ramifications of California Senate Bill 1237 and Assembly Bill 510 that require radiation dose reporting. Per this legislation, since July 1, 2012, all hospitals and clinics in the state are required to capture the dose for all CT exams and report any radiation incidents. In addition, effective January 13, 2013, all CT providers must be accredited by the Centers for Medicare & Medicaid Services or a California Medical Board-approved organization.

RT: What exactly does the law in California require regarding dose reporting?

McKenzie: In addition to reporting certain events to the state Department of Public Health’s Radiologic Health Branch, the law requires that the CTDIvol (CT dose index) and the DLP (dose length product) for the device or the dose protocol for the procedure be in the radiology report or attached to the report. This is according to clarifications from the Radiologic Health Branch.

When it comes to the actual reporting, there are several events that need to be reported:

• Any reexamination without a radiologist’s request when a full dose exceeds thresholds of a 50-mSv effective dose or a 500-mSv organ, tissue, or skin dose is a reportable event. The only exception is with rotation or movement of the patient. If the patient moves and a reexamination is necessary, that is not a reportable event.

• Irradiation of any body part other than that intended by the order—when the total exceeds the thresholds—is considered a reportable event. This plays into workflow. For example, when there’s an order for a chest and abdomen CT and the radiologist then requests a pelvic scan without an order, that constitutes irradiation of a body part other than that intended by the order, which is reportable if it reaches those thresholds.

• CT or therapeutic exposure that results in unanticipated permanent functional damage to an organ or a physiological system, such as hair loss or erythema, as determined by a qualified physician, is another reportable event.

• Dose to an embryo or fetus that is greater than 50 mSv is another reportable event if the woman is known to be pregnant, unless the dose was specified by a physician.

• Diagnostic radiation to the wrong patient or site is a reportable event.

The quandary is how do technologists determine whether a threshold based on effective dose has been met. That’s a calculation that has to be done by physicists. Calculating effective dose requires patient information such as BMI factors and weight and height. To address this, the ACR has come out with some guidelines related to CTDIvol and DLP, which are available to technologists, providing CTDIvol and DLP numbers that suggest the dose probably is getting close to the thresholds.

RT: So the threshold numbers the law requires aren’t really available to the technologists? To address that problem, the ACR provides guidelines suggesting that if the CTDIvol and DLP numbers reach a certain point, that translates to an effective dose that is likely a reportable event. That’s how you determine whether an event needs to be reported? That’s a little fuzzy.

McKenzie: I agree. There is no way to really gather effective dose with the current technology. Imaging departments would go batty if the staff tried to determine effective dose on every scan we do, especially with the volume of CT being done these days.

RT: Does the law require just tracking individual events or does it require dose tracking per patient?

McKenzie: This is per patient, per procedure. There’s nothing in the legislation regarding cumulative dose or what is an accurate dose, which is what I’m most interested in when it comes to radiation. Frankly, I feel the legislation is not complete. For example, the legislation only looks at dose per procedure. A person could come in and have 30 CT scans in a day and as long as each one of those scans does not reach the threshold for that individual procedure, it’s not reportable. That seems shortsighted to me. I think that cumulative dose is ultimately going to manifest into its own threshold levels, but at this point, the legislation does not define it that way.

RT: What messaging is required with this law and how should it be handled?

McKenzie: According to California law, if you break the threshold and have a reportable event, you not only have to send that information to the state, you have to send it to the physician who ordered the CT scan. Also, within 15 days, you need to send notice of this reportable event to the patient. The question for sites that are adopting this type of legislation is what should that message say? This is about policy and procedure. This is public relations. This is about getting the message right. This is a lot of stuff that we haven’t had to deal with before.

RT: So what do you say in the communications? Is that what everyone is still trying to sort through?

McKenzie: I think that the culture of the organization is going to define the message. We recommend being honest. Let’s not create anecdotal information, like comparing the patient’s threshold break to the equivalent of about 45 minutes in the sun in Denver at 5,000 ft. The message is that this radiation exposure event happened. We need a physicist and a radiologist to create a message to the patient that says here’s what happened and here’s what risk factor looks like. And it all needs to be done with empirical data.

We’re in a fairly litigious society. If we’re going to take this on, we need to take it head-on. I think that means that the message needs to be this is what happened, here’s what we’re going to do, and here are the experts saying what the result is likely to be. Some folks don’t want to present that message, but I say be proactive about it. It puts you in a better light. It also lets people know that you’re actively tracking this, which is very positive to the community. Chances are patients won’t be litigious with people who are on their side.

RT: It looks like a law intended to do the right thing isn’t quite there yet. Do you think this legislation will put hospitals on the path toward collecting cumulative dose information?

McKenzie: What they do is going to be up to them. Some organizations we’re talking to are going to simply meet the requirement because this is a mandate they’re required to address. They have other things going on around them and will do strictly what the law requires. But that isn’t every organization.

When we discuss a dose reduction and radiation tracking program with clients, aggregate dose and cumulative dose are topics that come up all the time as something they’re very interested in tracking and utilizing dose data. This type of information can help in a number of areas, particularly decision support about using ionizing radiation or considering ultrasound or MRI instead of CT or X-ray. Most of our clients are interested in aggregate dose, but that is not part of the legislation or regulations at this point. We suggest to our clients that they consider looking ahead and preparing for this. I ultimately believe that legislation like this will pass in other states or there will be federal legislation that will either bolster or trump it. I see guidance on threshold and aggregate dose coming from ACR; I know the organization is interested in thresholds and numbers.

RT: To what extent are your clients outside California involved in dose reduction and tracking?

McKenzie: Many of our larger clients who are not in California are pursuing enterprise dose reduction programs on their own. Radiation dose reporting hits a chord within the profession that it is the right thing to do. You can’t see it, taste it, or feel it, and there is no immediate effect of radiation dose exposure, so it tends to go by the wayside. It’s time for us to start acting proactively.

RT: Does the California law risk becoming a de facto legal standard that’s ahead of the scientific information? I can envision trial lawyers pointing to California law when on the books in their state. Is that a risk? That might be a reason why an organization might want to be involved in a comprehensive plan like you mentioned.

McKenzie: You’re spot on. For example, in an attempt to explain SB-1237 and AB-510 to our clients, we went to the Radiologic Health Branch of the California Department of Public Health. Senior leadership there said they have been contacted by almost every state to receive copies of this legislation. Either they’re going to enact it, abridge it, or create their own with similar language. If not state to state, yes, I can see this happening nationally.

The Radiologic Health Branch has also been contacted by British Columbia, so folks in Canada are watching the situation closely as well.

RT: From what you’re saying, it also seems like the ACR is trying to get out in front of this in the hopes of shaping such rules in a way that makes sense.

McKenzie: End users look to the ACR and the American Association of Physicists as experts when it comes to guidelines. Frankly, not a lot of data regarding thresholds has been collected over the years, so they’re working diligently. The horses are out of the gate on this, and ACR is working hard to not only stay ahead of the legislation but in front of thresholds and reestablishing benchmarks. It’s an ever-evolving thing.

Many people are waiting for ACR for some direction, but I think waiting for them is a bad idea because it delays gathering data. Organizations should start developing dose-reduction programs, capturing the dose on PACS and then creating procedures to build the program. Once you have the system automated, it will not be difficult to adjust thresholds in the software as guidelines evolve. I’d recommend facilities get a system in place, get it into your workflow, and get your policies and procedures in place.

RT: What are some key considerations imaging providers need to work out when planning a dose program?

McKenzie: There are several things that are critical to a dose program. What is the workflow time? How do we know we’re not going to overdose somebody? When a CT order is entered into PACS, do we generate a threshold at that point and say that person is in our enterprise even though we don’t know they’ve been here?

It’s important to know a person’s history, too. We use the same PACS, so we would know if this person has received numerous CT scans at our facility in the past six months. (We wouldn’t know that otherwise because we don’t do any precheck.) With the workflow for capturing the order, we can check to see what the aggregate dose threshold is and maybe we create a decision-support tree at that point. This person has been really irradiated. Is there another modality we could use? Is it medically viable? Do the expected results from the diagnostic study outweigh the potential risks? That’s a physician’s decision. If something does come up in the new workflow, that creates the opportunity for radiologists to be consulted like they used to be rather than merely acting as report brokers. They are the experts.

RT: What else will be needed to move this effort forward?

McKenzie: When talking about aggregate doses, a health information exchange is important. It gives you the ability to look at patient information and cross-pollinate across affiliated and unaffiliated hospitals. Patients may have a collection of images taken at a number of locations. Ultimately, when we have true health information exchange, we will be able to get aggregate dose information per patient, leading to decision support and good metrics. That’s when we’re truly watching the patient from 30,000 feet to make sure that the healthcare delivery model in America is not overdosing.

Patients are becoming more educated today, taking control over their healthcare. If you have a program in place with dose measurement software in PACS, that tells the public you are actively engaged in their healthcare and in minimizing risks to them.

RT: This is all growing out of the imaging department. Ultimately, however, doesn’t it need to get pushed into the EMRs so the collation of all this information from different sources becomes available?

McKenzie: The radiology report should ultimately reside in the EMR anyway. Looking long term, it would be ideal for decision support if a physician could receive some kind of warning regarding the number of CT scans a patient has already received when placing another order for a CT scan. Using a computerized physician order system would allow the physician to see the patient’s electronic health records and calculate their accurate dose based on what’s in PACS or the exchange.

Physicians could receive a message related to where that patient stands regarding the threshold numbers for radiation. A green light means that the patient is under the threshold, a yellow light means to be cautious, or a red would mean the patient has reached or gone beyond the threshold. It would be great if the system had a halt feature that actually halted the order until there was a consultation with a radiologist. That is truly being able to make the best decision for the patient as it relates to not only protection from radiation exposure but also helps them decide if there is another modality that could do the job. It will get better when organizations move to the exchange environment where, no matter where you go for service, you aggregate all the patient data.

RT: As you say, we’re not there yet. There are several steps ahead. What should facilities be thinking about and consider doing now to make sure they’re ready (or at least closer) if this does coalesce?

McKenzie: They should start with CT, which is the California law. Automate your equipment’s dose-tracking capabilities. There’s software available that can reduce the dose on the scanner itself.

Next, institute a radiation dose program that involves automating the dose reporting and the thresholds. In addition, create policies and procedures for when a threshold bust occurs. Work on creating your report messaging. If you can do that now, you have an active and evolving dose program. Then it’s just a matter of abiding by any threshold changes that ACR or someone else might be developing or adding a modality to the program.

Another good step is to work with radiologists to establish protocols by procedure and then lock down those protocols. Establish a protocol change committee that involves a physicist who is looking at possible threshold loss against effective dose.

And everyone involved with the protocols needs to be educated. Make sure technologists understand CTDIvol and DLP. I know from my experiences as a technologist that personnel can become bogged down in the day to day of working through scans as patients stack up in the hallways. Reducing and tracking radiation dose requires workflow change for the imaging department and an increased sense of awareness among technologists.