SCAI expert consensus statement: 2016 best practices in the cardiac catheterization laboratory: (Endorsed by the cardiological society of india, and sociedad Latino Americana de Cardiologia intervencionista; Affirmation of value by the Canadian Association of interventional cardiology–Association canadienne de cardiologie d'intervention)*

The SCAI Expert Consensus Statement: 2012 Best Practices in the Cardiac Catheterization Laboratory provides standards for preprocedure, intraprocedure, and postprocedure evaluation and management, and served as a patient-centered approach to safety and quality in the cardiac catheterization laboratory (CCL) 1. It was noted that the CCL is a setting in which elective, urgent, and emergent percutaneous procedures are performed, and that high throughput and increasing patient complexity demand optimal periprocedural communication, clinical management, documentation, and protocol. Regulations primarily targeted at open surgical suites have the potential to negatively impact the quality of care because they shift the focus to performance measures that are not necessarily relevant to the CCL. Accordingly, directives were tailored to the percutaneous setting in order to assure quality and optimal patient safety while maintaining efficiency. This clinical expert consensus statement pertains to diagnostic and therapeutic coronary artery procedures. Given the variety of practice settings in which peripheral vascular procedures are being performed, and the more nascent field of structural heart interventions, which have their own expert consensus statements, a discussion of noncoronary artery procedures is beyond the scope of this document. The purpose of this document is not to represent all acceptable practices, but to provide a consensus opinion on “best practices” as goals for CCL implementation. This update of the 2012 best practices incorporates new standards in the field, and a section on CCL governance has been added. It is anticipated that regulatory bodies, accreditation organizations, hospitals and health systems, and CCL directors and hospital administrators will reference this document for process improvement and standardization. This document should not be used to determine coverage or reimbursement policies in the United States. There remains a dearth of objective evidence guiding many aspects of this document. When available, evidence-based data have been cited. Further research specifically on the CCL process and quality improvement is needed. All physicians must maintain procedure-specific credentialing and privileging by their institution, typically requiring American Board of Internal Medicine (ABIM), American Osteopathic Association (AOA), or evolving certification models such as that from the National Board of Physicians and Surgeons (NBPAS) 2. Each CCL should have a procedure for recertification of privileges, required every 2 years by The Joint Commission (TJC). TJC requires the completion of ongoing professional practice evaluations (OPPE) more often than annually on all physicians. TJC also mandates completion of a focused professional practice evaluation (FPPE) for newly hired operators, established operators requesting permission to perform a new procedure, and established operators performing a procedure in case of a perceived problem 3. Case volume should be documented by the CCL director on a biannual basis. In addition, procedural outcomes, including success rates and observed in-hospital complications, should be documented. Risk adjustment models are recommended to put these observed outcomes in perspective 4, 5. Participation in national or regional quality improvement registries, such as the National Cardiovascular Data Registry (NCDR) CathPCI registry, is necessary to meet NCDR quality standards 6. In addition, physicians should participate in at least quarterly quality improvement, peer review, and/or morbidity and mortality (M&M) meetings to maintain privileges, as well as participate in procedural appropriateness evaluations. Technologists are strongly encouraged to obtain Registered Cardiovascular Invasive Specialist (RCIS) certification, and nursing staff ideally should have a minimum of one year of critical care experience. In addition, nursing, physician assistant, and technologist staff must comply with continuing education requirements for their state(s) or certifying bodies. Clinical competence guidelines state that in order to maintain proficiency while keeping complications at a low level, a minimum volume of ≥200 PCIs/year be achieved by all institutions 2. In addition, although the clinical competence guidelines acknowledge only a moderate correlation between operator percutaneous coronary interventions (PCI) volume and mortality, for each operator a minimum PCI volume of ≥50/year is recommended, averaged over 2 years. The performance of primary percutaneous coronary intervention (PPCI, PCI in the setting of acute ST elevation myocardial infarction) requires an additional cognitive and technical skill set 2; therefore, it is recommended that operators perform ≥11 PPCI/year and that institutions should perform ≥36 PPCI/year, when possible 2. For institutions without on-site cardiac surgery, oversight to ensure the quality of procedures is paramount 2, 7. For such sites, operators should perform at least 50 PCIs/year, including ≥11 primary PCIs, and the institution should ideally recruit more experienced operators. Less experienced operators should have additional oversight, such as backup support. The CPORT-E Trial serves as a model for facilities performing PCI without on-site cardiac surgery 8. Consistent with its design, such facilities should participate in national registries, routinely utilize risk-adjustment tools, have immediately available consultation with a tertiary care center, implement cross-training of personnel, and have a well-developed system for expeditious transfer for emergency coronary artery bypass graft (CABG). A multidisciplinary approach within the CCL is needed. The primary operators must be adequately trained and credentialed. They are usually assisted by a physician trainee and/or physician extenders (e.g., certified technologist, physician assistant, or nurse). Typically, 1–2 CCL staff are tableside, with an additional 2 CCL staff serving in “circulating” and “monitoring/recording” roles. Tableside assistants must be trained in the setup of manifolds, automatic/power injectors, the use and preparation of wires, catheters, balloons, and other devices, as well as in radiation safety and sterile technique. Appropriate staffing to ensure an adequate nurse-to-patient ratio should be ensured. A nurse providing moderate sedation during the procedure must have no other responsibilities that would compromise continuous patient assessment. In cases where there is concern for using more than moderate sedation, an anesthesia provider should be present, and policies should be drafted that are consistent with hospital credentialing and state guidelines. Basic Life Support and Advanced Cardiovascular Life Support certification of all staff should be up to date. ABIM or AOA certification in interventional cardiology is required for operators who completed fellowship training after 1993 and is strongly recommended for all operators. After the first certification, ongoing recertification is also strongly recommended. NBPAS certification, an alternative to the ABIM recertification process, is also available. Utilization of national benchmarking and self-assessment tools such as the NCDR registries, hospital or CCL quality data, and patient satisfaction data is highly encouraged. Continuing Medical Education (CME) ≥30 hr in invasive or interventional cardiology over 2 years, or consistent with state regulations should be completed by all physicians. Physician and CCL staff membership in professional societies such as Society for Cardiovascular Angiography & Interventions (SCAI) and the American College of Cardiology (ACC) is highly encouraged. CCL staff should obtain, at a minimum, the continuing education units (CEUs) as required by the respective state. Procedural indications should be well documented and reconciled with published appropriate use criteria (AUC); key variables (e.g., anginal class and medication use) must be documented to confirm appropriateness 9, 10. A number of on-line calculators are available to assist in this process 11. Supporting data, such as a pre-procedure electrocardiogram (ECG), prior cardiac procedures or surgeries, echocardiography, coronary computed tomography (CT) angiography, and/or stress testing results (with characterization of findings as “low-risk,” “intermediate-risk,” or “high-risk” rather than “abnormal”) should be described 9. For procedures with “rarely appropriate” ratings, additional documentation should be included to explain why the procedure is appropriate for the particular patient. All must have an prior to the procedure, by a physician or an practice professional (e.g., physician or nurse For emergent a targeted and are with more the For a and within by hospital is with a focused update by the physician within hr prior to the This update should in or For an should be within hr of or a minimum, this should the of the with Cardiovascular Society and Association heart documentation of relevant including within the relevant and a of systems, on the during cardiac catheterization peripheral and of or other should be including the to or such as a for and to should be The should prior or moderate sedation The should be focused on the and vascular system and document peripheral In addition, because the patient sedation, appropriate evaluation should be of the to sedation, and at or other that impact the performance of the procedure (e.g., an to should be and calculators for complications (e.g., mortality, and to should be documented is a process that a patient is with all the and of a be the patient must be and provide a with of as a is necessary every procedure and is consistent with the of patient The hospital must have a on that the process used to obtain including documentation and as well as that would for to such as emergent in an patient. the process should be in a to the 2012 Expert Consensus on Cardiac Catheterization be by trained operators or physician but the should be when the primary operator the procedure with the The should be in the using that a to the procedure the and to the procedure including no invasive and potential outcomes and complications that during and after the procedure that from the findings of a diagnostic procedure (e.g., and their should be as well as and the process should be by a by the or a staff of the and the The must be within by hospital and must be on the of the should be of not and that it has been for the of the procedure and a minimum of hr the procedure, with the interventional in to tools have been to the process with the use of is during procedures to patient and and is usually by the performing The for moderate sedation be by the and or for coronary artery procedures. The American Society of has a of of anesthesia and has established guidelines in this for the training and credentialing of physicians Physicians in the CCL should be by their hospital for providing moderate typically to as of the of sedation, and should be during the procedure and documented by the and as of and within hr of the procedure is required in although there is no evidence to this process in the CCL. prior to a procedure, for at least 2 hr after of or at least hr after of a although institutions no the of evidence be for emergency at of should be with to that impact the or of the The use of should be and physicians to or in of procedures where coronary intervention is possible or For who a potential with should be with (e.g., or a to or in such cases should be There is for procedures of The for and the of should be as this will impact the for with or low or performing the procedure on for are available For on in be the ratio should be hr prior to the procedure, with the of for procedures. 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Accordingly, to the transfer of in the CCL during procedures should be established physicians and CCL to of the the physician should be for all the and data for NCDR to ensure and The physician should the interventions performed, and complications with the patient and The procedure should also be with should be cognitive to sedation has A procedure or should be immediately postprocedure and included in the prior to to the of a procedure be in the immediately after the procedure, a should be with for the postprocedure including the of the and of procedure, complications, and In this a procedure should be completed within hr of the procedure and by TJC for as well as documentation of indications for PCI that provide all the to determine is critical for a quality procedure that key data and from the Data and for the Clinical and of with and be For a procedure to procedures in the including the additional in 3. 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The patient should have a with a provider or physician who is in the of care within of For with or procedural complications, should be with prior to or during the A documented evaluation of the must be The should be for and with guidelines. care should including cardiac and and the for on procedural results All PCI should be to cardiac of the CCL to the volume and complexity of the multidisciplinary (e.g., the use of and evolving and the of All should have a physician director and a in with all the other including hospital is critical to providing the for the CCL to perform its not only staffing and but also the required for and of quality The director should be a interventional ideally with a minimum of experience. the should be an a technologist or with a minimum of CCL who also has to participate in and CCL The director requires will more but a of A minimum of of (e.g., is This should be by the institution at a with the from clinical and consistent with The director is for setting the and for all other physicians and is for criteria for and privileges, physician and nursing and technical the director should with the on quality improvement, patient of and after of and education and to all CCL CCL staff meetings and as between CCL and physicians The CCL is a by and clinical the CCL by the should and at least annually update CCL policies and and provide appropriate education and training to operators and staff should the of all relevant When process and/or should be for continuous quality improvement as CCL must have a quality which appropriate quality registries, and at least and/or be regional or national and should for benchmarking of process and other operators and are available for PCI (e.g., NCDR (e.g., NCDR provide additional and data and for of up with procedural should provide trained to perform data and should be to operator and and outcomes as well as procedural appropriateness 10. It is that when outcomes (e.g., that these rates be and interventional cases should be and peer for all operators. peer should be when by physicians to the should be for their appropriateness and for should not be used to all cases there are when patient or clinical for a In such documentation is the criteria are a not all indications have been and there is to be they impact quality of care and All CCL and in-hospital complications should be at a at least quarterly requiring be using procedural such as that data are in a CCL should be from Clinical Cardiology as the technical aspects of the of more (e.g., should over (e.g., vascular and should as as after an has when a is A of care intraprocedure, in which aspects of care at each are and where consensus is over of the is recommended The of case and is process and it is critical that the physician nursing, and technical staff should be required to A statement of should on in or state and should also be and or should be Each CCL should have a that the and of other This is for complications not in and other of CCL such as completion of quality of to and as required by the state of and TJC complications in the CCL and these have not in a complications for which should be are in 5. should be at in the CCL to practice to these for from interventional surgery or interventional for emergency computed tomography when is and not to measures for emergency computed to when appropriate for invasive to or when available for and a and to emergent for emergent transfer to institutions for care when appropriate for emergency for anesthesia care and in the CCL for of or (e.g., for of of for of for emergency for emergency for emergency of including and every for anesthesia care and in the CCL for cardiac surgery as for emergency or for anesthesia care and in the CCL for emergency or percutaneous assist and satisfaction impact clinical All hospitals participate in a patient process that measures of their hospital as of and is and by the for and by the National and results are available on the these not patient satisfaction with CCL CCL physicians in the CCL patient would to and a for this CCL as well as in and postprocedure care all have the to impact the patient for patient satisfaction are in the physician and hospital these “best practices” the to assure the consistent of high quality care in the cardiac catheterization measures are critical to patient laboratory and patient and physician care should provide adequate and of physician extenders where to assure the performance of these practices and their ongoing

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