Hello, my name is Kathleen Frazier. I'd like to share with you a QI project we have completed in the state of Michigan, and we're titling it, Using a Collaborative Quality Improvement, Registry to Improve Radiation Dose Reporting and Reduction, the BMC2PCI Experience in Michigan. The co-authors for this project are Anne-Marie Forrest, Milne Seth, and John Slye. We've provided this graphic to give you an overview of what BMC2 is. BMC2 is a Blue Cross Blue Shield cardiovascular consortium. It is sponsored by Blue Cross Blue Shield of Michigan, and it is one of their continuous quality improvement projects. BMC2 is the original Blue Cross Blue Shield of Michigan quality improvement project. We have been collecting data for over 25 years now. You will notice that there's two other projects under the BMC2 umbrella, which include vascular surgery procedures, and the other, MISHIC, includes structural heart procedures. We have collected data on over 650,000 PCIs performed in the state of Michigan and represent every facility that performs PCI in the state of Michigan. Now that you have an overview of what BMC2 is, it's important to share the mission of BMC2. Our mission is to improve safety and quality, appropriateness of care, and enhance high-value care in the state of Michigan for all percutaneous coronary interventions. I'd like to give you a brief overview of how this works in Michigan. Every single BMC2 PCI participating facility participates in NCDR-Cath PCI. For every single case that's performed in the state of Michigan, they enter that data into NCDR-Cath PCI and also enter Michigan-specific data into bmc2.org. NCDR sends BMC2 a quarterly data feed. We combine that data with the data that was entered into bmc2.org and produce quarterly reports for BMC2 facilities. We provide hospital and physician-level reports, and the collaborative benchmark is also provided for various measures on that report. We use NCDR data to also match our state against the national benchmark, and since all of our sites do participate in NCDR-Cath PCI, they too receive their individual reports that provide them with the national benchmark for their volume group. In short, we use that data to improve quality in the state of Michigan. Now we'll get into the nitty-gritty of the project itself, now that you have a good idea of what it is we do. What prompted us to pursue reducing air karma doses in our state were the risks associated with high radiation exposure to our patients and to the staff members that are taking care of these patients when radiation is used during the procedure. Full note in the boxes below, risk to the patients, skin damage, erythema, burns, ulceration, hair loss, cataract, cancer, leukemia, hereditary effects, risk to providers and staff, brain tumors, primarily left-sided. This study did spark a lot of attention. Articles had been produced noting pretty young physicians in particular developing left-sided brain tumors, premature cataracts, thyroid disease, reproductive system issues, effects, and premature carotid atherosclerosis, and early vascular aging. As you can see, there's a lot of risks associated with radiation exposure, so our desire is to limit the radiation exposure as much as possible. This slide is to provide you with an overview of the difference between deterministic and stochastic effects of radiation. Stochastic are the skin injuries. They have a specific threshold. They would be set for different procedures that utilize radiation. We are only talking about the cath lab today, but if you are a healthcare provider, you know that there are many tests that our patients undergo that use radiation to help our physicians diagnose. These skin injuries, if you'd like to see images of them, there are plenty of images out there, anywhere from the erythema to severe tissue damage, and also things to look for when the surface doesn't look so bad. There can be more damage underneath. There are certain parameters set at every facility when a patient reaches certain doses. For instance, when you hit 15 grays, that's a sentinel event with the Joint Commission, and that's a required report by your facility. Many facilities have scheduled follow-up for patients that receive doses of 10 grays. There are various recommendations out there for when you refer your patients for further evaluation after their procedure based on these air kerma doses. For sarcostic, those are cumulative, more long-term, thin cancer, reproductive issues, that type of concern, and it's just to make you aware that there are different types of effects and what you can monitor for, and to be aware that you can dig deeper into your facility to see what the recommendations are. They're pretty universal, but you should still be familiar with them and make sure that your patients are getting the follow-up that they should be. We'll discuss the background for this project now. BMC2 was collecting radiation doses, both air kerma and dose area product. We noticed a lot of variability in both the number of times the dose was actually collected and the doses themselves. Sometimes the doses didn't even make sense. We do have the benefit of having a smaller number of sites, so we can physically contact someone. Sometimes I would be on site and we would look at their radiation equipment to compare were the doses on the report matching the radiation equipment, and if not, who can we get to correct this, and also making the data abstractors aware of the issues we were finding with the doses themselves. Sometimes the dose wasn't being reported at all. It was going somewhere to radiation safety, but was not included on the procedural report. So after those type of things were ironed out, and during the process when those things were still getting ironed out for some of our sites, we analyzed the data and noticed that there were higher than the desired number of procedures that had an air kerma at or over five grays, and decided to work with the sites to improve this. The goals for this project were to increase dose reporting to greater than 98% and to decrease the number of procedures with air kerma doses equal to or greater than five grays to less than 1%. The second goal was to increase our collaborative level performance, so BMC2 as a whole, of the NCDR radiation dose measure by 10%. This is a roadmap of the project in its entirety. We will be discussing each one of these steps in subsequent slides. Prior to the movement of radiation dose collection moving to NCDR from BMC2, we analyzed all the data related to dose area product and air kerma for each one of our sites. We looked at the mean, the median, and the doses themselves. In January of 2018, we then started to contact sites that had high levels of variability. Doses didn't make sense. They had doses missing, et cetera. So the RNs at BMC2, the two of us contacted our sites either when we were visiting the sites and we would go look at their equipment and compare to their reports and do the dose unit comparison. We noted that a lot of times the doses were available, but they weren't on the reports or the units didn't match. They used one unit for their canned report and didn't change it from lab to lab. So those type of things were ironed. We started ironing those out in January of 2018. In April of 2018, NCDR-CAF-BCI started collecting radiation doses with version 5.0. BMC2 also held a collaborative meeting. We have an annual collaborative meeting where administration, physicians, RNs, abstractors, anyone related to BMC2, BCI Matters is invited to attend and we have presentations. In April of 2018, Dr. Ryan Mader from Spectrum Health in Grand Rapids presented on radiation. He's a well-versed, well-published physician in these matters and he kicked off our focus on reducing radiation doses in the CAF lab. In November of 2019, Dr. Mader shared an article that was published in JACC based on BMC2 data collection of radiation doses. They discussed the article itself, the actual findings, the data, the variability between sites, within sites, the current state in general of radiation doses in the state of Michigan. He discussed and made recommendations related to the future steps and interventional cardiologists that were attending shared their opinions, what they felt were obstacles, and additional data that they would like to see collected by us or surveyed so that we can get a better handle of what is actually going on in the state as it relates to radiation. So in December of 2019, we did produce a survey and distribute it to our sites, which asked multiple questions related to what equipment they were using, radiation equipment in particular, the CAF lab, how old it was, what type it was, equipment that they were using to protect their patients and staff, everything from a rad pad to robotics and suspended lead suits and everything in between. We also asked about how follow-up was managed when patients received higher than threshold doses, higher than five, higher than 10 and higher than 15. Our sites responded, we analyzed that data and moved forward with identifying opportunities within the state of Michigan. In February of 2020, we shared the radiation survey results with the interventional cardiologists that oversee BMC2, both at the coordinating center and at the various sites that participate in BMC2. They were provided with information related to CAF lab equipment and protective equipment so that we could collaborate and decide on next steps moving forward. In April of 2020, another article related to radiation in the state of Michigan was published in JAC. This article addressed institutional variability. What was noted in that article was per facility, air kerma doses over five, the rates varied from 0% to almost 11%. Our statistician adjusted for various characteristics for the patients, et cetera, and still noted there was a correlation between the facility and the number of events where patients received an air kerma dose equal to or greater than five grays. The first item you'll notice refers to a performance index measure. A performance index measure is a measure of focus for BMC2 PCI for a given timeframe. It's also financially incentivized by Blue Cross Blue Shield of Michigan. So basically in January of 2021, we made this measure an area of focus. In order for a facility to receive full points, they would have to have less than 2% of their procedures, PCI procedures, with an air kerma dose of less than five grays. And it's any PCI procedure, it wasn't a certain type. I had been asked that question before, so I'll just answer it up front. April 2021, Dr. Mater, who I've referred to previously as an interventional cardiologist who has a focus and is well-published on matters related to radiation and PCI, reviewed why we collect radiation doses for PCI procedures, the clinical rationale behind it, and just a general overview of what this all means for our coordinators. BMC2 coordinator equates to NCDR CAF PCI registry site manager. Abstractors are also welcome to these calls. And we recorded this particular presentation and shared it on our YouTube site so that our facility representatives could share it with other people at their site. Anecdotally, I've been told that that particular video was shared with CAF Lab staff, portions of it at their meetings, things like that, trying to get it back to the clinical staff, what it is the registry is doing, and also a part of the clinical information related to the radiation so that everybody is on a good starting point and understands why this is an area of focus. In May of 2021, BMC2 PCI published a best practice protocol for radiation safety. This best practice protocol is meant to serve as a guide for CAF Lab staff. What it does is provide practical tips, frames per second, how to position things, your equipment, I mean, how to position the II angulation, things like that, and also safety equipment and discusses other radiation concerns that CAF Labs would usually be facing. It is published on our website and at the end, I provide information on how you could locate that if you choose to do so. Now it's time to share results. This particular graph demonstrates how collection or reporting of air kerma dose has steadily increased from second quarter of 2018 till third quarter of 2021. We started out 88.6% and this particular slide, 99.2% in the third quarter of 2021. As you may recall from prior slides, our goal was twofold, to increase the reporting of air kerma doses and also to reduce the number of cases that had air kerma doses over five grays. You will see from second quarter of 2018, where we had 2.8% of cases over five grays to quarter three of 2021, down to under 1% of cases with air kerma over five gray. That's a percent change of 67.9. You will see once we got into quarter four of 2018, we're steadily coming down, which is what everyone wants to see, slow and steady usually means lasting change. So pretty excited about the results. This is the same information provided on the two prior slides related to the results of the BMC2 air kerma over five gray dose reporting and number of cases exceeding that level of radiation combined, layered on top of each other. So you'll see a steady increase of the reporting of those doses and you see a steady decrease of the number of cases that have air kerma over five grays. Again, as I've discussed on the prior slides, quality people love to see slow and steady just because it usually indicates a change in the habits of the staff. This isn't a little blip to get excited about. This is usually indicative of lasting change. Way back in slide eight, we talked about the goals for this project. The first goal was to increase the reporting of air kerma doses and lower the number of procedures with air kerma greater than five. The second goal was to increase our performance by 10% for the NCDR measure related to radiation, which is focused on the reporting of all three of these doses, fluoro time, air kerma, and dose area product. Our goal was to increase our performance by 10%. We did achieve that from 2019 quarter one until 21 quarter three, our percent change was 21.4%. Again, the slow steady pattern and again, much hard work from our participating sites and the rest of the country. You can see the rest of the country is coming up nicely as well. This might seem simple to people, but just getting processes to change at your site, getting those doses in that report, it was quite a challenge. So kudos to everyone. The value proposition for this project is that patients benefited by decreasing their exposure to radiation, which reduced risk of radiation complications. Providers and staff benefited from receiving less scatter radiation during procedures, which reduced their health risks associated with repeated radiation exposure. They also learned from experts and other providers how to maximize views and radiation equipment settings to decrease their exposure. Payers benefited from decreased costs related to decreased radiation injuries to patients. In conclusion, radiation exposure has negative immediate and long-term health implications for patients, providers, and staff. The risks of these health implications has been decreased by increased dose reporting to assure completeness of reporting. BMC2 facilities were provided the ability to utilize statewide data and clinical experts to support these efforts through educational meetings, site visits, and providing materials to share with other staff members. Before I conclude the presentation, I wanted to share some resources with you and also my contact information. The first resource is the BMC2 Radiation Safety Best Practice Protocol that I mentioned previously. There is a link to locate that best practice protocol. You would go to bmc2.org and go to the Quality Improvement tab and then select the Best Practice Protocols. You would then see a listing of best practice protocols and just select the radiation safety. My contact information is below that and you can feel free to email me with any questions you might have. This is another slide for resources. This is the references and links. For the articles that were mentioned in this presentation, the links are below. If you have any questions, please refer to the prior slide and send me a quick email. Thank you for listening to the presentation and I wish you good luck with your future quality improvement efforts.

quality improvement project

radiation dose reporting

radiation reduction

percutaneous coronary interventions

data analysis

dose reporting