Clinical expert consensus statement on best practices in the cardiac catheterization laboratory: Society for cardiovascular angiography and interventions

The cardiac catheterization laboratory (CCL) is a setting in which elective, urgent, and emergent percutaneous procedures are performed. This poses challenges to maintaining and prioritizing high quality care and patient safety. Nonetheless, process expectations of a high-quality CCL include appropriate periprocedural communication, clinical management, documentation, and universal protocol. Regulations primarily targeted at open surgical operating rooms have the potential to negatively impact care because they may mandate focus on performance measures that are not necessarily relevant to the cardiac catheterization laboratory. For example, routine site marking for percutaneous access is irrelevant for most patients since failure to obtain access on one side (e.g., right femoral artery) simply leads to attempting access on the other side (e.g., left femoral artery). Instead, directives should be tailored to the percutaneous procedure setting to assure quality and optimal patient safety. This document will therefore provide expert consensus opinion on a number of issues pertaining to “best practices” within the CCL, focusing on quality and safety during each step of the process. The writing committee acknowledges a dearth in high-quality published studies in this area, making many of the enclosed recommendations based primarily on expert consensus. Although references are provided when available, further research specifically in catheterization laboratory processes and quality improvement is needed. The document is divided into “best practices” that should be performed during the preprocedure, intraprocedure, and postprocedure settings for diagnostic cardiac catheterization and coronary intervention, to be consistent with the typical patient flow into and out of the CCL. Despite the long history of cardiac catheterization that dates back several decades, a document describing these “best practices” has not yet been written. The purpose of this document is not to represent all acceptable practices, but to provide consensus opinion on what would currently be considered “best practices” as future goals for catheterization laboratories. All physicians should maintain appropriate credentialing and privileging by their institution 1. In addition, each cardiac catheterization laboratory should have a procedure for recertification of privileges. Case numbers need to be tracked by the CCL director and documented on an annual basis, and all physician staff should comply with the continuing medical education requirements of the state(s) in which they practice. In addition, procedural outcomes, including success rates and observed complications in hospital, should be documented and recorded. Currently, there is also a trend towards tracking 30-day outcomes as a quality measure. A variety of risk adjustment models are available to put these observed outcomes in perspective, and their use is recommended 2, 3. Participation in national or regional quality improvement registries, such as the National Cardiovascular Data Registry's CathPCI registry, is also recommended 4. In addition, physicians should participate in regularly scheduled quality improvement and/or peer review meetings to maintain privileges, and participate in procedural appropriateness evaluations. Technicians should obtain RCIS certification, and nursing staff should have a minimum of 1 year critical care experience. In addition, nursing and physician assistant staff should comply with the continuing medical education unit requirements for the state(s) in which they practice. To ensure optimal safety and efficacy of cardiac catheterization, a multidisciplinary approach is needed. Performing cardiologists must be adequately trained and credentialed, as mentioned above. They are usually assisted by a physician trainee, certified technologist, physician assistant, or nurse. Typically two individuals are tableside, with an additional two individuals serving in “circulating” and “monitoring” roles. Tableside assistants must be trained in the set-up of manifolds, automatic/power injectors, radiation safety, and sterile technique. In cases where there is a risk of developing more than moderate to deep sedation, a CRNA or staff anesthesiologist should be considered, and policies should be drafted that are consistent with hospital credentialing and state guidelines. All patients that undergo cardiac catheterization must have a history and physical (H however, there are limited data on their safety and efficacy 14. For patients with baseline renal insufficiency (creatinine clearance <60 ml min−1), providing saline or sodium bicarbonate hydration should be strongly considered unless contraindicated by congestive heart failure 15. Recent data suggest that N-acetyl cysteine may not offer significant benefit, and is therefore no longer routinely recommended for patients with baseline renal insufficiency 15, 16. A baseline EKG is essential as it serves as a basis for comparing changes that occur during or after the procedure. A chest X-ray is not required unless congestion or other pulmonary pathology is evident on physical examination. Women of childbearing age should have beta-HCG levels checked within 2 weeks of the procedure 17. For patients who have had prior catheterization or coronary/peripheral bypass surgery, every effort should be made to review procedural reports to help guide the operator during the procedure. The documentation of allergies should focus on the most common allergy-related problems encountered in the CCL, in addition to medication allergies. Specific allergies, including contrast and latex allergies and allergies to medications used during the procedure (heparin, aspirin, etc.) need to be documented along with the patient's history of multiple allergies. It is important that the history be reviewed for previous heparin-induced thrombocytopenia (HIT). Several regimens have been used to prevent contrast allergy, however none have been subject to randomized controlled trials. Each laboratory should have an established protocol for preventing contrast allergic reactions. Table II lists a sample regimen with several variations on the suggested regimen used in clinical practice. Although one study supports the administration of allergy prophylaxis 13 hr before the procedure 18, the appropriate timing of prophylactic regimens has not been established. Shellfish allergy is no longer considered a predictor of contrast reactions, and therefore does not require pretreatment. Patients should be kept NPO except medications for at least 3 hr prior to the procedure, and at least 8 hr if conscious sedation is clearly required. Diabetic patients need to have all oral hypoglycemic medications and insulin regimens reviewed and adjusted. Patients should be educated on access site management issues that may occur postprocedure. Finally, for outpatients, the patient should arrange for someone to transport them home postprocedure. Upon arrival to the procedure room, a nurse, technician, advanced practitioner, or physician should perform a thorough review of the medical record, including documentation of NPO status and duration, access site concerns, allergies, results of blood tests, recent medications (such as heparin and other anticoagulants), advance directives, informed consent and living wills. If a preprocedure checklist was used then it should be reviewed by the attending physician or designee. All of these items must be documented in the medical record prior to the procedure, as discussed in the preprocedure section and the checklist mentioned above. For the vast majority of patients undergoing diagnostic or therapeutic procedures, conscious sedation is ordered by the performing physician, physician assistant or physician trainee, and administered by a nurse. The performing physician manages the sedation process, including the level of sedation, the medications used, and the personnel involved. Physicians involved in cardiac catheterization must therefore maintain current hospital credentials for conscious sedation and be licensed to prescribe controlled substances. A nurse, or provider with equivalent credentials, should be present during the administration of such medications to monitor for side effects, hemodynamic instability, and change in respiration and/or oxygenation. Misadministration or overadministration can lead to serious respiratory complications. A thorough knowledge of indications, contraindications, and appropriate dose ranges for patients of varying body sizes and ages is therefore required, as is familiarity with dosing and indications for various reversal agents. Drugs administered during the procedure must be recorded in a procedure log or electronic record and signed by the attending physician, either electronically or physically, where they can be easily accessed by other members of the health care team, particularly when the patient leaves the CCL. Infectious complications are rare in the current environment but when they do occur, they have the potential to be significant. Clipping over the access site is routine. A variety of antimicrobial agents are available, and chlorine-based preparations are most commonly used due to their demonstrated efficacy. Patient drapes that adhere to skin around the access site without loosening during the procedure are important. Although practices vary, the consensus of the writing committee is that physicians should perform surgical hand scrubs for the first of the day and use before surgical scrubs for every are reasonable. their efficacy it is for and to be for every procedure. and should be for procedures of such as and and to and prophylaxis is not for routine catheterization procedures, but is routinely used before of the Each CCL should be as an patient care with the that radiation is being used All personnel in the should including lead and For team members to the radiation should be considered. should be to radiation in and specifically to any should and record and/or radiation dose and physicians when of potential radiation are in of are the patient should be educated radiation skin and followed in to radiation skin All team members should be as to the procedure and the of that procedure. This is most easily performed within the of a performed before vascular access is when all members of the team are Patient should be checked and and there should be on the procedure to be performed. the of most procedures in the CCL is to access the heart and associated procedures are not a to the coronary can be and femoral and therefore site marking is not Table a sample If team members out of the room, then it is their to their who should to the team and their the procedure are followed in each than on a All on the must be in This specifically used for and other agents (e.g., of common medications should be into and of and must also be available as part of the sterile Finally, appropriate documentation of physician to be out by the or nurse and these confirmed by the performing physician at the of the with a The attending physician should the results of the procedure, as well as any complications, findings and directly with the patient and In addition, the management for the patient and any further for the patient and family should be including the need for and duration of dual antiplatelet therapy in who a this should be in a setting to patient For cases in which the patient or has been with the physician should of findings the patient is In the the results may be to available family if prior has been obtained from the The patient and family should have the to and vascular are used in cases of femoral For patients who have and can occur when the an is when using bivalirudin for unless the patient has a clearance is not with For and can occur at of in patients with renal In patients with a clearance or on should be checked and may be the is can be to hr after the dose of is for hr the procedure, on If vascular are is for hr postprocedure of of site and peripheral is necessary prior to by for the access site is usually obtained with are after the procedure of the anticoagulation There are no with however it is the opinion of the writing committee that most patients should the for hr after Patients should be on in a recovery or other unit in the care of patients cardiac Patients should have checked every for the first postprocedure by nursing personnel trained in recovery from sedation, as well as access site is the patient's hospital unless by the attending of for diagnostic catheterization ranges from 2 to hr on access site used and the nursing assessment of patient and The of for PCI is on access site complications, patient and need for further procedures, therapy or At the of physicians and/or their designees (e.g., nurse, physician or physician who are care of the patient must review the procedure and the of physical may on patient physical and procedure performed are determined at this along with for the with the physician and the need for further laboratory and other (e.g., outpatient In particular, patients at risk for contrast should have checked within days of the physician's and and the number of the is for patient If a patient a a with the should be is performed on multiple medications are of home and hospital medications is of medication include medications to medications that have been that have been and medications for which a change has been may be performed by the medical assistant, nurse, attending physician, or are involved in medication must be clearly documented on the which are to the antiplatelet therapy PCI is recommended for at least 1 year after and after on whether the patient with an coronary is recommended to be for hr contrast in with baseline and who have ml of contrast medications are as as Patients on warfarin should their and arrange for PT/INR within 1 of The of as a to therapeutic warfarin and is not routinely recommended to the potential for except in cases of mechanical and other for risk of Although an the procedure, and nursing personnel can subsequently patient require appropriate documentation by the including procedure complications, and plan for the This is usually provided to the nurse care in the but the of a procedure as well to the electronic systems that the procedure to all physicians are The care physician, or an appropriate physician should the patient in at weeks hospital This is to ensure medication medication including in cardiac and to the plan for long-term based on procedural results In addition, an must be performed of the access site to and For patients with baseline renal anemia or other procedural complications, the is usually to 1 during which a CBC and/or should be For patients with significant cardiac outpatient are recommended to review appropriate appropriate changes in medication and A of appropriate peer quality and and is the of this document and can be Each cardiac catheterization laboratory should have a in for and peer review of This must be and This is one of appropriate quality which also best practice before and during the procedure. In addition, each must have a review in for all cases with or significant (e.g., and emergent Significant should be to all and open to any the patient's several “best practices” as described are required to assure consistent high patient safety, and patient and physician as it to cardiac catheterization and care systems should provide which are of physician where to assure the performance of these practices and their