The practice of interventional cardiology has evolved and now includes intraprocedural lesion assessment, complex coronary revascularization procedures, structural heart disease procedures, congenital procedures, and peripheral interventions. Critical to interventional practice is continuous quality assessment (CQA) and continuous quality improvement (CQI) programs. Broadly defined, “quality” is a science that involves ensuring that appropriate structural and process elements are in place to achieve the best patient outcomes. Specific to the practice of medicine, “quality” at the patient level ensures providing the right procedure to the right patient at the right time in the right way. While didactic training and clinical rotations have evolved to meet this need, training requirements in CQA and CQI have not been explicitly defined 1. Fellows-in-training (FIT) and practicing interventional cardiologists should receive training to participate and lead efforts to attain the triple aim of improving the patient experience of care, the health of a population, and reducing the per capita cost of health care 2, 3. Each facet of the triple aim is dependent on successfully executing “quality” care. While professional societies have introduced clinical guidelines, expert consensus statements and appropriate use criteria, it is now essential to include recommendations regarding core curriculum for CQA/CQI training 4. A consistent framework for quality management must be developed to couple the clinical and administrative team to effectively identify, prioritize, and implement effective quality strategies. This expert consensus statement outlines the key components of CQA/CQI training for FITs to be able to implement these skills after fellowship training. These components are applicable to both adult and pediatric interventional FITs. The Institute of Medicine has defined quality as “the degree to which health services for individuals and population increase the likelihood of desired health outcomes and are consistent with current professional knowledge” 5. One approach to measure quality is based on the Donabedian framework; a model for examining health services and evaluating quality of care. According to the model, information about quality of care can be drawn from three categories of measurement: structure, process and outcome 6. Structure measures describe the context in which care is delivered, including the physical and organizational work setting. Examples pertinent to the catheterization laboratory include hospital and catheterization laboratory structure, registry participation, specialty certification and credentialing criteria. Process metrics are the set of activities which occur between practitioners and patients and are intended to assess the care provided. Examples include pre-hospital care algorithms for the management of ST segment elevation myocardial infarction (STEMI) and out of hospital cardiac arrest (OHCA), hospital based systems of care including STEMI and OHCA protocols, and inpatient systems to apply evidence-based care to patients. Simple process measures include aspirin use, statin therapy, beta blocker therapy, door-to-balloon times for STEMI, dual antiplatelet therapy post stent implantation, risk adjusted bleeding events and referral to cardiac rehabilitation. Outcome measures are changes in the patient's health status due to the care delivered. These include risk adjusted mortality, morbidity, readmission rates, and functional status. In addition, outcome measures can also include patient satisfaction as well as cost. FITs should receive CQA/CQI training in this framework and should review pertinent structure measures, process metrics, and outcomes measures (e.g., National Cardiovascular Data Registry (NCDR) feedback reports). FITs should then identify and participate in a new or ongoing process improvement project in conjunction with a faculty mentor. A primary mission of the Society for Cardiovascular Angiography and Interventions (SCAI) is to provide interventionalists and their catheterization laboratory staff the tools for continuous learning to remain up-to-date with the evidence, ongoing assessment of actual performance and targeted efforts toward improvement. Since 1978, SCAI has emphasized standards and best practices for performance, quality control and peer review 7-9. In 2011, SCAI published a series of two expert consensus statements specific to CQA/CQI standards as applied in the catheterization laboratory 10, 11. Part I 11 outlines CQA/CQI standards and the responsibilities of the catheterization CQI committee. Responsibilities include peer review coupled with processes and methods of remediation for individual operators. Best practices include benchmarking, data collection, and review of procedural appropriateness, documentation of the CQI committee's proceedings and deliberations, and methods of non-punitive reporting to individual operators. Part II 10 addresses public reporting and risk adjustment, calling attention to the limitations inherent in both. These consensus statements did not, however, specifically address the training requirements, tools, and requisite knowledge base for FITs to achieve competency in CQA/CQI. The ACC Core Cardiology Training Symposium (COCATS) expert consensus statements published in 2008 12 and updated in 2015 13 serve as the guide for training general and subspecialty FITs. The COCATS Task Force 3 addressed the training requirements in diagnostic and interventional cardiology which were consistent with the training requirements from the American Board of Internal Medicine, requiring a certifying examination in interventional cardiology and formal training accreditation by the Residency Review Committee of the Accreditation Council for Graduate Medical Education. These entities recognize six core domains, of which two include CQA/CQI (i.e., Systems Based Approach, Practice Based Learning Improvement). A specific and detailed listing of the necessary knowledge base of available CQA/CQI tools and techniques is not delineated in the current guidelines. In addition, Maintenance of Certification (MOC) programs may require demonstration of ongoing CQA and CQI initiatives. Therefore, this expert consensus statement will assist not only fellowship training program directors to establish a strong curriculum for CQA/CQI, but also professional and credentialing organizations as they develop future recommendations for education in CQA/CQI and possibly in MOC activities. FITs should be involved in the following aspects of the CQA/CQI process: peer review, morbidity and mortality (M&M) conference, and registries (local, regional, or national). In Addition, FITs Should Become Familiar with the Concepts of Benchmarking, Performance Measures, and Process Metrics and systems-Based Practice Peer review, mandated by The Joint Commission (TJC) and recommended by interventional cardiology guidelines, is an important feature of CQA/CQI 1, 7, 14. Components of peer review have been outlined previously 1, 7, 10, 11 and these reviews recognize the potential problems of conflict of interest in maintaining objectivity. This includes the potential for conflicts related to camaraderie/practice group affiliation. While peer review is essential for any case review as related to adverse outcomes, random case review is also essential to assure quality. This is especially germane in the “open” cath lab environment at institutions with competing practice groups 15, 16. Maintaining strict confidentiality and objectivity is crucial, and familiarity with statutes such as the Health Care Quality Improvement Act (HCQIA) of 1986 protecting those being scrutinized as well as peer reviewers is essential. FITs should become familiar with the requirements of the National Practitioner Data Bank (NPDB) for the reporting of certain categories of actions that may ensue from peer review actions. After completing fellowship, physicians will have increasing responsibilities in the peer review process during their careers that warrant broad-based familiarity with the topic 17, 18. FITs should become active participants in peer review conferences, acquire skills including the determination of appropriateness of PCI based on published AUC guidelines and become familiar with the national practitioner data bank requirements. Cases with unfavorable outcomes are reviewed in departmental or hospital-based morbidity and mortality conferences (M&MC). These conferences are recommended or required in a variety of national guidelines 1, 11, 12. The history of M&MC has been described previously 19. Core principles for conducting M&MC are applicable to interventional cardiology 1, 19, 20. The conference format should be non-judgmental, involve open discussion, and allow physicians and staff to identify and learn from mistakes. Case selection should include all cases with serious adverse patient outcomes. A moderator, usually a senior physician, should conduct the discussion in a supportive atmosphere. Any perceived conflicts of interest of the moderator should be identified. Attendance of all team members should be encouraged. The discussion should be summarized with a set of conclusions coupled with potential opportunities to improve care or avoid similar errors in the future. Meeting minutes should be recorded to document the discussion and to be available for future review. Efforts must be made to protect patient privacy and confidentiality. At times, M&MC may identify high-risk errors or system-based errors that require further evaluation. Such evaluation may include other CQA/CQI techniques such as a formal root cause analysis 21. FITs should participate in these quality processes and techniques as a routine part of fellowship training. In particular, FITs should provide a formal written summary of their cases selected for review at M&MC, should present the case during the conference, and provide their perspective on aspects of the case, if any, that could have been done differently to obtain a better outcome. Registry data are essential in understanding local and national variations in treatment and outcomes 22 and form the basis for ongoing performance analysis. The ACC-National Cardiovascular Data Registry (NCDR) is the most comprehensive outcomes-based quality improvement program in the US and includes a number of hospital-based registries with over 2,400 participating hospitals, and one outpatient registry 23. Registries use standardized definitions, subject to rigorous data control actions 24, to collect baseline demographics, clinical and procedural variables, and outcomes for each procedure. These data elements are then used for calculation of performance measures, risk-adjustment algorithms, procedural appropriateness, and in-hospital outcomes 11, 25 and are linked to current ACCF/AHA/SCAI clinical practice guidelines (Table 1). NCDR provides both physician-level and hospital-level performance metrics that are critical to identifying and measuring performance. These analyses are fundamental in assessing quality of care, are a part of the American Taxpayer Relief Act of 2012 26, and should be expressly taught during fellowship training. Appropriate use criteria (AUC) metrics are classified into proportion of procedures that are “appropriate,” “may be appropriate,” or “rarely appropriate” and are stratified according to patients with and without acute coronary syndromes 29. PCI process metrics provide comparisons of a hospital with other US hospitals with regards to anticoagulant use, stent use, and assessment of intermediate lesions by intravascular ultrasound or fractional flow reserve testing. The CathPCI Registry® recently introduced the “NCDR Physician Dashboard,” which allows individual physicians to confidentially evaluate certain individual metrics in detail, study longitudinal data trends, and compare metrics with other physicians using national benchmarking data. In addition to in-hospital outcomes, novel approaches with probabilistic matching of patient data have created linkages of CathPCI Registry® to claims data from payers, including the Centers for Medicare and Medicaid Services, and allowed measurement of longitudinal outcomes in the Medicare population 30. The NCDR IMPACT Registry® is a pediatric interventional cardiology registry comprised of quality and technical performance outcomes. Pediatric Interventional FITs should be familiar with the definitions of quality as defined through this registry. Pediatric interventional FITs should be familiar with the NCDR IMPACT® registry-defined quality metrics and especially the metrics surrounding the six key interventional categories 31. Pediatric interventional FITs should be trained in the data elements and reporting of data into IMPACT® Registry. Quality and performance metrics of IMPACT® Registry (e.g., technical performance and radiation reduction) should be included during fellowship training. FITs should be trained in the NCDR feedback report content including performance measures and quality metrics. FITs should understand data abstraction and the statistical tools and methods used to present the data. FITs should participate in institutional quarterly review of the data and, in conjunction with the physician and hospital administrative staff, prioritize items for CQI (Table 2) 32. While measurement of performance measures is essential for CQA/CQI, it does not provide a context for performance relative to peers or to self over time. The process of comparing performance measures across providers is called “benchmarking,” a complex process involving measuring performance measures, risk adjusting using robust statistical modeling, and reporting the aggregate result. Risk models for mortality 33, bleeding 34, and acute kidney injury 35 have been developed and are frequently used for CQA/CQI. The process of measuring and benchmarking has been simplified through the availability of large regional or national registries, which include the Northern New England Registry, the MassDAC registry, the New York State Department of Health PCI registry, the NCDR CathPCI Registry® and the NCDR IMPACT Registry 24, 36, 37. All registries collect data electronically on process measures including use of specific antithrombotic agents, and outcomes including mortality, bleeding, and acute kidney injury. Registries incorporate standardized definitions for outcomes and provide risk-adjusted benchmarking to hospital participants. Awareness of the challenges inherent to benchmarking is critical, such as insufficient or incomplete data, lack of granular information on contraindications or special situations, and the effects of procedural volume on the performance measures. Registries utilize auditing to ensure completeness and fidelity with the medical record, but unlike clinical trial data, every data field is not “source document verified” 24, 27. As such, the accuracy and completeness of some subjective data elements may be suboptimal. A related problem is the reliable capture of contraindications to specific therapies. Because process-related performance measures include the proportion of patients who receive evidence-based therapies, defining the denominator is essential to benchmarking. For example, the NCDR CathPCI Registry® data collection form includes a field for contraindications for each medication listed so that patients with contraindications are excluded from the denominator of the reported metric. Reported metrics are usually expressed as a percentage, and the low volume sites can appear to be either leading or lagging centers simply due to smaller numbers of patients (smaller denominator). The analytic process accounts for this by setting a requirement for the number of patients required per site for inclusion in the reporting of the performance measures. Benchmarking reports for sites that do not have the requisite number of patients without contraindications usually display “numbers not sufficient” for specific performance measures. To implement a quality improvement program, a multidisciplinary team including nurses, technologists, physicians, quality improvement specialists and a hospital administrator is essential. This team should be supported by the hospital leadership and continuously engage in quality improvement activities (Table 3). It is essential to develop a list of projects and develop a consensus to prioritize the efforts. For the team to be successful there must be an advocate for the vision, who works effectively within a team while assisting in developing the right priorities. First, the team should identify the problem and agree on the definition and the magnitude of the problem. Next, the team should identify the key stakeholders and generate interest amongst the participants. All team members must agree on the methodology, measured metrics, timeframe to complete and respective roles. Many quality improvement techniques developed and implemented in the non-healthcare industrial sector have distinct applicability to healthcare and contain essential tools for FITs to be successful. A brief descriptive listing is provided along with examples of applications specific to interventional cardiology and the catheterization laboratory environment. W. Edwards Deming (1900–1993) advocated using reiterative plan-do-check-act cycles in modern industrial quality control using the principles of careful focus group selection/inclusion of stakeholders, brainstorming, affinity diagrams, flowcharts, and other tools to direct focused attention to a given problem [38]. Now referred to as plan-do-study-act cycles (PDSA cycles) this technique is often used to assess process measures and determine whether best practices have been followed. The group would plan, initiate/do a new process change, check/study the results, and act upon the results. Items amenable to PDSA cycles in the catheterization laboratory include patient safety measures including dual antiplatelet therapy, antithrombotic therapy, and radiation exposure. In addition, resource utilization including inter-procedural turnover time, equipment utilization and patient readiness are also amenable to this technique. Root cause analysis (RCA), developed by NASA initiatives in the 1950s, is a retrospective quality tool required by TJC for all Sentinel Events 39. This technique is often used to determine why there was variation in standard practice (identified by PDSA) and is predicated on the belief that problems are best dealt with by removing contributing causes and that systems need designed-in redundancy to prevent future problems 40. RCA evaluates the causes of a failure in a reactive, ex post facto context after an untoward event has transpired, and makes frequent use of cause-and-effect diagrams (Ishikawa diagrams, “fishbone” diagrams) in which contributing factors in a few selected domains are listed and analyzed by the RCA focus group. Examples of the most frequently chosen domain headers for the “bones” of the “fish” would include the “4Ps” (place, procedure, people, policies), the “4Ms” (methods, machines, materials, manpower), or the “4Ss” (surroundings, suppliers, systems, skills). Subsidiary factors are then gathered through group brainstorming. Examples of RCA application for FITs might include assessing verbal communication errors 41, medications errors, and M&MC case analyses 42. Failure modes and effects analysis (FMEA) attempt to identify possible system design inadequacies which may negatively impact patient safety 43-45. In contrast to RCA however, FMEA is prospective and assesses where and how a process might fail as well as what might be the relative impact of the failure. This allows one to correct the process prior to the failure occurring as well as to assess the impact of the system redesign prior to implementation. Both RCA and FMEA may make use of cause-and-effect diagrams, brainstorming, flow-charting, and other shared techniques for implementation. FMEA has the distinctive feature of forecasting implications for events and control plans if encountered. A popularly used scoring scale addresses the probabilities for future events in the realms of occurrence, detection and severity. An example germane to FITs might be an FMEA analysis of the potential for contrast induced nephropathy or severe radiation induced skin injury in the catheterization laboratory. Tools and techniques for both RCA and FMEA are outlined in detailed guides available through TJC Resources 43, 44. Total quality management (TQM) incorporates an organizational orientation that embeds awareness of the importance of quality in a system wide meta-process. TQM emphasizes the importance of quality measurement, customer orientation, leadership, empowerment, elimination of waste and continuous improvement. A relevant example might be the creation of cross-functional teams including pharmacy, nursing, information technology, residents, FITs, and attending cardiologists to assure discharge medication adherence to current guidelines for optimal medical management for coronary artery disease after PCI, with adequate care coordination with referring physicians, resulting in improved quality and patient satisfaction. Initially utilized by Toyota in the 1970s, the lean production model is highly relevant to contemporary healthcare, with its emphasis not only on improving quality but also doing so at reduced cost 38. The cost/value equation is important in the current era of diminishing healthcare reimbursement and has recently been refined 46. Pertinent examples include the development of standards for vascular access, equipment selection, antithrombotic agents and post procedure recovery. Six sigma, developed by Motorola, is a management strategy which applies a set of practices to reduce or eliminate defects 47. Projects follow two methodologies: DMAIC (define, measure, analyze, improve, control) for existing programs and DMADV (define, measure, analyze, design, verify) for new products or processes. There are multiple vendors of the education/certification process and more recently there has been a fusion with the lean methodology of Toyota, referred to as Lean Six Sigma, which is utilized with increasing frequency in the healthcare industry. The concept of systems-based practice and the four sub-competencies outlined previously serve as an outline to achieve organizational knowledge and leadership. A good leader understands the organizational structure in the immediate practice environment and promotes a culture that is patient-focused and which seeks continuous improvement. Communication with fellow colleagues in all phases of the institutional health care delivery team adds credibility to the CQI leader. CQI organizational structure should not be merely vertical but also horizontal to encompass all members of the team. As part of the training program, FITS should serve on their institutional CQI committees. FITs should also develop organizational skills by joining organizations such as ACC and SCAI. Opportunities exist for FITs to participate in committees of the ACC, NCDR, and SCAI organizations. The education of FITs and graduates must evolve to include specific knowledge of registries as well as specific techniques and practices that promote the ability to effectively participate and lead local CQA/CQI initiatives. It is essential for all interventional cardiologists to develop the expertise required to be effective partners and leaders in efforts that promote the triple aim of improving the patient experience of care, the health of a population, and reducing the per capita cost of health care 2, 3. Each facet of the triple aim is dependent on successfully executing “quality” care. Medical societies must develop curricula focused on CQA/CQI that can be incorporated into interventional fellowship programs. These efforts, in turn, will lead to the successful partnership between clinicians, patients, and health system administrators in executing high quality and value-based care. The authors thank Dr. Eric Stecker and Troy Schmitt for their assistance in reviewing this document.