September 27, 2017

Keeping Up With Change in Breast Imaging

In this Spotlight, we talk with Jean M. Weigert, MD, FACR, Director of Women's Imaging at Mandell and Blau MDs, PC, about what's new and changing in quality and safety.

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What is the importance of quality and safety for breast imagers in these evolving times?
Breast imaging was the first type of radiology that was kind of regulated and for which quality and safety came to the forefront. That was over 25 years ago. While we've had the most experience with it, breast imaging has continued to evolve and change, especially as technology has changed. We've gone from film screen mammography to digital mammography and now to 3D tomosynthesis. We've added breast ultrasound, breast MRI and modalities we now use to do biopsies. We've had to be flexible in figuring out how to accommodate all these technologies and make sure that we're doing a consistent job of evaluating sites around the country for accreditation. Originally, the FDA mandated mammography accreditation, and we took the next step at the ACR and said, "That's not the only tool that we use." We have to ensure quality and safety for all these other technologies. It's a big task, and there are always learning curves as you add things and change things to make sure that the radiologists in the breast imaging community can succeed at what we're asking them to do.

What is new and changing in the areas of mammography accreditation?
Most recently, we've seen the introduction of the new Digital Mammography Quality Control Manual and the new phantom, which have just gone live in ACR Accreditation. The digital manual is intended to guide the development and implementation of your quality control program for mammography digital imaging equipment — including detailed responsibilities of the radiologist, technologist and medical physicist. In July, the ACR began implementing the 2016 ACR Digital Mammography Quality Control Manual into the accreditation process. Facilities that choose to use the 2016 ACR Digital Mammography Quality Control Manual can submit phantom images obtained with the ACR Digital Mammography Phantom and QC results using the new manual for accreditation of their 2D full-field digital mammography systems. Another development that breast imagers should be aware of is the FDA EQUIP guidance, which has three new questions that inspectors will ask when they visit each accredited breast imaging facility.

In accreditation, what is the importance of peer review and of using all the tools and resources available to help you to meet these changing requirements? 
When I started as an accreditation reviewer back in the early 1990s doing film screen mammography, we saw that quality was not consistent across the board. Technologists and radiologists were given tools to be trained on requirements for accreditation, and the quality of mammography improved significantly. We asked people to do statistical analysis, for example. What is the positive predictive value at your site? Are you getting statistics of how many biopsies you are ordering, and what is the outcome? Those are now well-accepted processes, and with computer systems, it's much easier to do that. In the ACR Accreditation process, we literally give you everything you need to do it right. The only thing you have to do is be vigilant and make sure that the equipment is working well, the technologists are performing quality scans and the radiologists ensure that the studies they are interpreting are of a quality that they can actually see what they need to see. With each new technology, we go through a learning curve. With digital mammography, we saw we needed to make changes. Now with 3D tomosynthesis, there will be more changes, and we'll need to go through the accreditation learning curve again. But the ACR team will be with breast imagers every step of the way. We will go through these changes together.

What will it take to succeed in the new era of accreditation?

You have to really constantly underscore the fact that it's imperative to stay current with the skills for positioning and correct compression. You have to ensure that all your computers are set up properly, and that your phantoms are reading properly. You have to be obsessive and compulsive. And you have to stay up-to-date with the latest regulations and accreditation requirements. You can't let it slide, because things are changing so quickly, and you need to make sure that everybody on the team is up-to-date with the latest requirements and skill sets and training. For example, the FDA has added another level to its review in terms of making sure that radiology practices are doing peer review — among radiologists and technologists as well. It's a daunting task, but the bottom line in screening is that we're trying to find tiny cancers before they become serious, so we need to remain vigilant and very rigorous.

What steps should breast imagers take to ensure that they're meeting these new requirements?
As radiologists, we need to collaborate with our technologists and have a detailed checklist to review together on a monthly basis to ensure quality and safety. Currently, a top reason that mammography facilities fail ACR Accreditation is predominantly because of positioning. Whether it's because new technologists aren't being trained with the same vigilance that the older technologists were or that we aren't keeping up with changes coming in with newer technologies. If a site is dinged or fails accreditation, it's imperative to see it as a positive, where they can learn, fix the mistakes and do better work. We are seeing a new crop of breast imaging leaders emerge, who are actively involved in quality and safety, who are learning about the latest requirements and technologies, and who are bringing that knowledge back to the rest of the staff. I think we're going to see more of that going forward.

Where can current and emerging breast imaging leaders turn for help in those areas? 
The ACR staff is absolutely always available if people have questions. The ACR bends over backwards to ensure that, if a site has an accreditation problem, they are there to help you with it. It's a real opportunity. Medicine is a skill. We practice medicine, which means we're never perfect. And we're given every opportunity to make it better. There's never a perfect mammogram. There's a good mammogram, but I've never seen a perfect mammogram. It's okay to ask for help. The good news is, the ACR is there for you. They want everybody to succeed.

Why should more people get involved on ACR committees and as accreditation reviewers for their peers? 
To be honest, it is time consuming, but I've found it a really great way to learn. I think I'm a better mammographer, because of my involvement with the ACR. I work better with my staff. I can teach them. When I'm reviewing cases and find problems, I'll bring my techs in and go, "Okay, what's wrong with this case?" It's a great teaching tool. I also enjoy meeting people who are passionate about the things that we do in radiology. The ACR team and the other physicians involved inspire me. They are an amazing group of people. We all want to make sure that radiologists do our work well and are doing the best job possible for our patients.

Meet the Physician 

Jean M. Weigert, MD, FACR is Director of Women's Imaging at Mandell and Blau MDs, PC. In addition to serving as Chair for the Committee on Mammography Accreditation, Weigert has been an accreditation reviewer for the ACR Mammography Accreditation Program since 1994. She has also served on the Committee on Stereotactic Breast Biopsy Accreditation and the Committee on Breast Ultrasound Accreditation, as well as multiple reference committees. Weigert is a member of the ACR Ethics Committee and served as President of the Radiological Society of Connecticut from 2013–2015.