As technology and specialties in cardiac and endovascular care continue to develop at a rapid pace, oversight becomes increasingly important to ensure the highest quality patient care. The demand for quality comes from many directions—the public, regulators, and insurers. However, oversight for delivering the best possible care at facilities where percutaneous coronary intervention (PCI) and other endovascular procedures are performed can only come from the multispecialty professionals who set and meet national outcomes-based standards in their daily practice.
The Accreditation of Cardiovascular Excellence
The challenge is finding an effective way to incorporate all of the data, standards, knowledge and experience of these professionals into one uniform process that monitors systems and outcomes and ensures that quality is continuously improved and refined in light of new evidence. The Accreditation of Cardiovascular Excellence (ACE; www.cvexcel.org) is a multidisciplinary effort to meet this challenge. ACE is a new accrediting body for invasive diagnostic and therapeutic interventional procedures and procedure facilities. It provides the structure, transparency and accountability that encourage and facilitate adherence to standards and best practices.1 The governing board of ACE includes highly respected and experienced leaders from the cardiovascular community including Drs Ralph Brindis, Charles Chambers, Gregory Dehmer, and Christopher White.
ACE involves leading physicians and other experts from the cardiac, surgical, and endovascular arenas in identifying metrics. These experts develop thorough processes for collecting and evaluating data that will ultimately assist facilities as they maintain and strive to improve their programs. The ACE process of objective peer review of outcomes, commitment to the highest standards of care and corrective guidance for facilities when necessary are designed to increase the consistency care in cardiovascular procedures throughout the US. When patients are treated at a cardiovascular center that is ACE-accredited, they can feel confident that the facility has taken the appropriate, evidence-based steps to ensure the best possible care.
An Alternative Kind of Accreditation
Many facilities accredit their non-invasive laboratories for diagnostic procedures, but ACE is the first professional organization to offer catheterization laboratory-specific accreditation. When writing about its decision on carotid artery stenting (CAS), the Centers for Medicare and Medicaid Services (CMS) agreed with professional societies in recommending accreditation requirements for facilities performing CAS. When CMS included the requirement in its coverage decision with no third-party accreditation process in place, it had to provide one of its own so that facilities could comply with the mandate. Unfortunately CMS accreditation does not offer the level of oversight envisioned by the endovascular specialists who first suggested it. For this reason they formed ACE—an independent, not-for-profit, multispecialty organization to certify facilities that meet standards based on national outcomes data. In the summer of 2010, ACE launched its first accreditation program for CAS facilities and began accepting online applications (for more information visit www.cvexcel.org).
ACE accreditation is voluntary, but when CMS opens the coverage decision for CAS, ACE will apply for official status as an accrediting body for CMS and other payors. For now, even if a facility is already registered and self-accredited with CMS, it can apply for certification from ACE. ACE has a structure for peer review and data reporting, as well as formal, objective, and independent evaluation and monitoring of facilities. These ensure and certify to patients and the healthcare community at large that by adhering to practice guidelines established by the top medical groups in cardiac and endovascular care, a facility meets the highest possible standards for safety and efficiency.
The Process at Work
Accreditation by ACE is an ongoing process that addresses the issues of cardiovascular and multispecialty performance of cardiovascular procedures within a given institution. This includes addressing issues of performance of the same procedure carried out in multiple locations (e.g. the catheterization laboratory, radiology suite, and operating room) within a given institution, where appropriate. It is a professional review of an organization’s structure, internal processes, patient safety practices, and clinical outcomes. ACE determines whether an organiation meets the required standards based on criteria derived from evidence-based best practices (i.e. practice guidelines and national outcomes data). In addition to offering accreditation for CAS, ACE work groups are developing standards for similar programs to be offered in the future for other non-carotid endovascular procedures, as well as cardiac catheterization and PCI.
The standards for ACE’s CAS accreditation are based on several documents: the original carotid stenting training and competence multispecialty document that was published in 2005,2 and published randomized and registry studies. They encompass five areas of review:
- quality assurance;
- patient indications; and
- patient outcomes.
The specifics of these will fluctuate based on continual analysis of new data.
Once the initial standards were established, a working group of vascular surgeons, vascular medicine specialists, cardiologists, neurologists, and radiologists incorporated them into the ACE accreditation process for CAS. As data continue to be published, ACE will change the standards as necessary to meet the new criteria. ACE’s accreditation process has five steps:
- ACE determines a facility’s eligibility for accreditation or re-accreditation based upon its unique situation and requirements.
- ACE collects outcome data. The frequency of this collection depends on a variety of factors, including prior accreditation and the type and nature of any significant changes at the facility.
- During the initial review step, ACE reviews the application with a focus on quality and outcomes assessment to determine whether the facility meets the standards set by the ACE standards committee.
- ACE staff contact the facility to schedule an onsite visit. During the visit, a trained review team will validate the application, review patient records and collect additional data. A tour of the facilities, collection of angiographic studies and an interview with the key members of the program completes the onsite process. Once the review team has gathered the necessary information, ACE issues a formal report giving the facility’s accreditation status within 30 days.
- Finally, to maintain accreditation ACE requires that a facility report on its outcomes at regular intervals.
Participation in a national registry is encouraged but is not mandatory as long as all data required are submitted according to ACE’s requirements. If the facility does not participate in such a registry, additional effort is required to validate the data submitted by confirming the use of comparable definitions and completeness. Facilities are also required to report any significant program changes, including changes to equipment or procedures, adding or removing operators and sentinel events. ACE also requires completion of an annual online survey.
On completion of the application process, facilities receive full or provisional accreditation, or non-accreditation. Facilities that achieve full accreditation receive a certificate of recognition and acknowledgement in the ACE newsletter and on its website. Any facility that does not receive full accreditation will have the benefit of ACE corrective action plans and tools to improve processes, systems and outcomes until the facility can achieve and maintain full accreditation. ACE accreditation is not a punitive process. It does not close facilities or limit reimbursement. The goal is to support best practices and to provide corrective action plans for facilities with performance deficiencies.
Accreditation is valid for two years and is subject to periodic review during this period to monitor changes in critical factors at the institution. Internal assurance and monitoring in a catheterization laboratory can be challenged by conflicting influences related to both hospital administration and peer relationships. The process is designed to address these issues and to assist physicians and hospitals by providing guidance and tools to improve the processes and outcomes. ACE also provides independent (outside) oversight of programs for the purposes of:
- meeting or exceeding published appropriate use criteria;
- facilitating data reporting; and
- facilitating quality assurance peer review.
Although full accreditation is the ultimate goal for all facilities, the true purpose of ACE accreditation is to maximize the quality of invasive endovascular and cardiovascular procedures and outcomes, hence it action-plans based on objective data to improve performance.
Plans to Accredit Other Endovascular Procedures
The only mandate from CMS at this time is to accredit facilities that perform carotid stenting. However, the same outcomes-based standards should be applied to all invasive cardiovascular and endovascular procedures. Given the current state of healthcare reform, mandates for other new high-risk procedures, such as percutaneous valve therapies, might be anticipated in the future. The ACE will apply the same structure and experience to accredit programs for these and other cardiovascular procedures, including cardiac catheterization, angiography, structural heart disease intervention, PCI, and the accreditation of catheterization laboratories.
ACE is already working with expert workgroups in cardiac and endovascular care to develop standards and pilot new accreditation offerings. As the volume and complexity of PCI procedures requires more extensive and ongoing oversight, ACE will make some modifications to the process established for CAS. These adjustments will include a critical review of standards for independent quality assurance and peer review as well as a more robust process for ongoing evaluation. Catheterization/PCI is now available, and it is anticipated that other endovascular procedures will be operational by early 2011.
Benefits of Accreditation of Cardiovascular Excellence Accreditation
The US’s current focus on healthcare reform provides an excellent opportunity to share the standards and processes established, constantly re-evaluated, and improved by members of the cardiovascular profession. ACE’s standardized, unbiased process assures quality patient care and is a mechanism for certifying this to patients, physicians, families, insurers, and to the state and federal agencies that regulate the delivery and reimbursement of healthcare. It is one way to establish trust in the physician, facility, systems, and processes in place to provide such care.
ACE accreditation also:
- provides a standard of care, enabling patients to make informed decisions concerning facility choice;
- verifies to insurers that their beneficiaries are getting the best care—a step toward broader coverage and more treatment options for patients;
- provides independent, unbiased, outcome-based evidence to patients and their families to prove they are receiving the highest quality care;
- establishes the evidence necessary to support the image that the facility would like to promote to the public;
- validates the facility’s position, voice, and influence in government policy-making circles;
- minimizes liability by encouraging best practices, early identification, and resolution of problems at the facility;
- offers evidence of having met best practice standards in the event of a lawsuit;
- reduces costs by supporting a more effective and efficient operation based on uniform standards; and
- minimizes complications, which in turn benefits payers, patients, and society by reducing costs.
ACE provides the most benefit to the patient. Patients should have the opportunity to understand, weigh, and compare the care available to them. The accountability and transparency afforded by ACE accreditation will help them to do this. At the same time it will help all of those involved—patients, regulators, payors, and providers—to benefit from the effective systems, processes, operators, and facilities that produce the best outcomes.