Accreditation for Cardiovascular Excellence (ACE):  Specific to the Cath Lab

What’s the purpose of the Accreditation for Cardiovascular Excellence (ACE) organization? The overall purpose is to accredit facilities performing invasive cardiovascular and endovascular procedures. By doing so, we hope to set an objective, independent professional and peer-based standard for what should be occurring at those institutions, and will continue to monitor them with the goal of improving patient care. Why create this type of organization? There really hasn’t been any type of cath lab-specific accreditation available to facilities. If you look at medical accreditation from a larger perspective, many facilities accredit their echo labs, CT labs and a whole host of other diagnostic procedures. But, at the moment, there is nothing to accredit invasive diagnostic and therapeutic interventional procedures and procedure facilities. The SCAI actually started discussions over 5 years ago with the Centers for Medicare & Medicaid Services (CMS) about accrediting carotid stenting facilities. Most of the professional societies involved with discussions with CMS at the time thought that facilities should be accredited to perform carotid stenting, but there was no organization available to perform those activities. CMS, because they agreed with the idea of accreditation, wrote it into the coverage decision, but then CMS itself became the default for actually performing accreditation. Their system is pretty lean and is not really based on outcomes. It does not use the currently available data and standards to actually hold facilities accountable for their outcomes. After talking with CMS over the last 5 years, we are cautiously optimistic that the next time CMS does open the coverage decision, that ACE will be able to be acknowledged as an accrediting body. Right now, carotid stenting is the only thing mandated for facility accreditation, but we think the same type of standards should be applied to the rest of the procedures that we all do. Also, we expect that when percutaneous valve therapies become available, then it is likely that CMS will write something similar into the coverage for those procedures. What’s the relationship of ACE to the Society of Cardiovascular Angiography and Interventions (SCAI)? The SCAI is the founding sponsor of ACE as a separate, not-for-profit organization. The SCAI has provided the start-up funds for us to be able to make things happen. We formally announced it at the May SCAI meeting in San Diego, but ACE was actually formed last July, over a year ago. We are now at a point where we actually have product to talk about. The previous year has really been development time. We are now open to accept applications for accreditation for carotid artery stenting. Is there a relationship with the American College of Cardiology Foundation (ACCF)? We are pleased that the SCAI and ACCF have just finalized a joint venture agreement concerning ACE. We are excited about the partnership and believe that this further emphasized the profession organizations commitments to quality and adherance to standards. How is ACE determining standards for carotid stenting accreditation? Several documents have been used to develop the standards. One is the original carotid stenting training and competence document, which is a multi-specialty document that was published in 2005.1 It outlined the facility requirements and many of those criteria were actually incorporated into the coverage decision by CMS. Since that time, there has been a great deal of additional data, both randomized as well as registry studies, which have been published. All of these data have been incorporated by the working group that was developed by ACE to set the standards for carotid stenting. We know that more data will continue to be published, and as that happens, if the standards appear to change, then we will update our requirements to meet those particular criteria. This is a living activity. It’s not etched in stone. It is what it is today based on the available data. But clearly, as things evolve, we will continue to evolve with it. How would ACE accreditation compare to CMS accreditation for carotid stenting? Currently, CMS accredits labs and that is the mechanism for them being reimbursed. Compared to the CMS process, what we are proposing is far more robust and far more outcomes and quality driven than the current CMS process. We are hoping to replace the CMS process with something that is more meaningful. This is an ongoing discussion with CMS that hopefully will be addressed during the next open coverage decision. CMS is open to that? The fact is that carotid stenting accreditation is not something that they do regularly. I think they recognize the value of having other options available. ACE would be one of those other options. Where does ACE stand right now in terms of its ability to accredit? We are live and are accepting applications at https://www.cvexcel.org. What can labs expect from the review process? There is an initial application process that asks for a lot of the basic information as well as data, in terms of patient mixes and outcome data. The data are reviewed in-house by a nurse review team, as well as a physician team. There will then be a site visit by nurse reviewers. Their report will determine whether a site should also have a physician site visit. After that entire process, then ACE would then grant either full accreditation or provisional accreditation, or hopefully, rarely, non-accreditation. It is important to point out that the goal is not to be punitive; it’s not to close facilities, or limit their reimbursement for any of these procedures. Our mission is to provide corrective action plans and tools for all facilities performing carotid stenting in order to improve their processes and outcomes, such that we raise everyone’s quality and outcomes. What’s the cost to have a review done? We are currently estimating the cost to be about $15,000 for the application process. Who will be applying for this accreditation? Because the coverage has been limited, there are very few hospitals doing large volumes of carotid stenting. About half of the (currently accredited by CMS) programs are doing 25 procedures or less per year. What is driving that is reimbursement, and so most of the facilities that ACE will be reviewing will not be high volume. If a lab does fail the process, what is the time until they can re-apply? Probably it’s a function of what the deficiencies are and how quickly the facility can correct the identified problems. Certainly, I think that at a minimum it would take 6 months for most hospitals to make those kinds of changes, and conceivably longer, so we have not set a minimum time for re-application. The realities are that it would be at least 6 months to a year before most hospitals who are really at that level would be able to make sufficient changes to warrant re-application. Can you talk about the involvement of your co-directors, Dr. Ken Rosenfield and Dr. Christopher White? They have really been integral. We have used the group to identify the different data that needed to come together to make this happen. They helped in setting the standards and in looking at what data we needed to identify in order to verify our standards, as well as to look at the process. The three of us have truly worked as a team with Mary Heisler, RN, BA, Executive Director of ACE. It is important to highlight that ACE relies upon a multidisciplinary working group. We had vascular surgeons, vascular medicine specialists, cardiologists, neurologists, radiologists, and so on. Although the Society for Cardiac Angiography and Interventions and the American College of Cardiology Foundation are promoting ACE, and they have underwritten the initial activities, it is ultimately a multidisciplinary group that has put it all together. When do you expect that ACE might begin accrediting additional procedures? We have already started to build the working group to look at standards for other endovascular procedures, as well as for percutaneous coronary intervention. We hope to be doing some pilot processes by late fall and early winter. What are some of the challenges you have faced? We went into facilities during our pilot phase to help them identify all the pieces they need to have in place to actually get through an accreditation process. It’s been a little challenging, but that’s part of the learning curve for us, as well as the facilities. People will be much more aware of what they need to have available when we come in to do these site visits. We have been training the site visitors and making sure the people who are coming in to evaluate these sites are knowledgeable regarding the information that we are trying to validate and review. One of the challenges of carotid stenting, in general, is that in many facilities it is multidisciplinary, and so having people come together and do this as an institution can be challenging. In some environments more than in others. The bottom line is that the accreditation process is ultimately patient-centric. We make sure patients undergoing these procedures can be confident that where they are having them done, the people who are involved, and the systems built around them provide the best quality of care available. We are hoping that accreditation will, in fact, improve patient outcomes across the board.

More information about the Accreditation for Cardiovascular Excellence organization is available at https://www.cvexcel.org. Reference 1. Rosenfield K, Babb JD, et al. Clinical competence statement on carotid stenting: training and credentialing for carotid stenting — multispecialty consensus recommendations: a report of the SCAI/SVMB/SVS Writing Committee to develop a clinical competence statement on carotid interventions. Catheter Cardiovasc Interv 2005;64(1):1–11.

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