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)*

Provider/Institutional Competence and Documentation

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).

Optimal Catheterization Laboratory Team

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.

Maintenance of Qualifications

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.

Documentation: Procedure Indications and History and Physical (H&P) Examination

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 patients must have an H&P examination prior to the procedure, performed by either a physician or an advanced practice professional (APP) (e.g., physician assistant or nurse practitioner). For emergent procedures, a targeted history and limited physical examination are reasonable, with more complete information added following the procedure. For outpatient procedures, a timed and dated H&P within 30 days (sooner if dictated by local hospital policy) is acceptable, with a focused update by the attending physician within 24 hr prior to the procedure. This update should reflect any changes in history, physical examination findings, test results, or medications. For inpatients, an H&P should be performed within 24 hr of admission or registration. At a minimum, this H&P should include the history of the present illness along with Canadian Cardiovascular Society angina and New York Heart Association heart failure classes, documentation of relevant medications, including those received within the last 48 hr, relevant comorbidities, and a review of systems, focusing on the systems encountered during cardiac catheterization (i.e., renal, gastrointestinal, peripheral vascular, neurological and pulmonary). Any history of contrast reaction or other allergies should be documented, including the specific reaction. Potential issues related to antiplatelet or anticoagulant therapy, such as a concomitant requirement for long-term oral anticoagulation, and barriers to long-term dual antiplatelet therapy (DAPT) adherence should be noted. The history should note any prior airway or moderate sedation issues.

The physical examination should be focused on the cardiopulmonary and vascular system and document peripheral pulses 12, 13. In addition, because the patient may undergo sedation, appropriate evaluation should be performed of the patient's ability to tolerate sedation, and at what level. Orthopedic, neurologic, or other conditions that might impact the performance of the procedure (e.g., an inability to remain supine) should be noted. Ideally, risk scores and calculators (www.ScaiPCIRiskApp.org) for predicting complications (e.g., mortality, bleeding, contrast-induced nephropathy [CIN]), and methods employed to reduce risk should be documented 11, 14, 15.

Informed Consent Process and Documentation

Informed consent (IC) is a legal process that ensures a patient is familiar with all the risks, benefits, and alternatives of a procedure. To be valid, the patient must be competent and voluntarily provide consent; otherwise, a person with power of attorney may act as a surrogate. IC is necessary before every procedure and is consistent with the ethical principles of patient autonomy 16. The hospital must have a written policy on IC that describes the process used to obtain consent, including documentation and surrogate decision-maker issues, as well as circumstances that would allow for exceptions to obtaining IC, such as emergent ST-Elevation Myocardial Infarction (STEMI) in an unconscious patient.

Ideally, the IC process should be performed in a neutral environment. According to the 2012 ACC/SCAI Expert Consensus Document on Cardiac Catheterization Standards Update, “the written informed consent may be obtained by trained secondary operators or physician extenders, but the major concerns should be reiterated when the primary operator discusses the procedure with the patient” 17. The IC should be in the patient's native language, using terms that allow a layperson to understand what the procedure entails; the risks, benefits, and alternatives to the procedure proposed, including no invasive treatment; and potential outcomes and complications that may occur during and after the procedure 18, 19. Potential treatments that may result from the findings of a diagnostic procedure (e.g., ad hoc PCIs and their attendant risks) should be reviewed, as well as issues surrounding dual antiplatelet therapy (DAPT) and restenosis. Ideally, the IC process should be witnessed by a third party, preferably by the patient's family or a staff member independent of the CCL, and subsequently entered into the medical record. The consent must be obtained within 30 days (sooner, if indicated by hospital policy), and must be reaffirmed on the day of the procedure. Specific mention should be made of do not resuscitate (DNR) status and that it has been revoked for the duration of the procedure and a minimum of 24 hr following the procedure, with the interventional cardiologist involved in any decision to reinstate DNR. Recently, tools have been developed to enhance the informed consent process with the use of electronic decision-making aids 19, 20.

Sedation, Anesthesia, and Analgesia Evaluation

Moderate sedation/analgesia is frequently provided during procedures to minimize patient discomfort and anxiety, and is usually ordered by the performing physician. The need for moderate sedation can be individualized by the treating physician, and anxiolysis or pain control alone may suffice for coronary artery procedures. The American Society of Anesthesiologists (ASA) has defined a continuum of depth of anesthesia and has established guidelines in this area for the training and credentialing of physicians 21. Physicians in the CCL should be credentialed by their hospital for providing moderate sedation/analgesia, typically referred to as “conscious sedation”. Monitoring of the level of sedation, pulmonary ventilation, and oxygenation should be performed during the procedure and documented by the staff. ASA and Mallampati classification as part of pre-sedation assessment and updated within 24 hr of the procedure is required in some hospitals, although there is no evidence to support this process in the CCL. Patients traditionally fast prior to a procedure, for at least 2 hr after ingestion of clear liquids or at least 6 hr after ingestion of a meal, although some institutions no longer require nil per os (NPO) status given the lack of supportive evidence 22. These instructions can be waived for emergency procedures, perhaps at some increased risk of aspiration.

Patient Preparation within 48 hr and Immediate Preprocedure Checklist (Table 1)

Patient Preparation in the Procedure Room

Upon arrival to the procedure room, a nurse, technologist, APP, physician extender, or physician should review the preprocedure checklist (Table 1). If a checklist review was not performed, 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, IC, and living wills must occur. NCDR-related (or equivalent) preprocedural information should be reviewed by the attending physician or designee and clarified with personnel responsible for entering that information into the electronic health record. All of these items must be documented in the medical record prior to the procedure or as part of the checklist mentioned above. Noninvasive hemodynamic and oximetric monitoring of patient vital signs should be routine. Defibrillation pads should be attached to all STEMI patients. Access related risks should be considered with the goal of choosing the optimal access site to reduce complications. CCL staff should ensure that at least one working IV is in place prior to the start of the procedure.

Sedation, Anesthesia, and Analgesia Administration and Documentation

All patients should have documentation of their suitability to receive moderate sedation according to five classes categorized by the ASA guidelines 36. Moderate sedation should be considered for all patients 37. Nasal cannula should be considered for all patients in whom conscious sedation is utilized. A nurse, or provider with equivalent credentials, should be present during sedation administration to monitor for side effects, hemodynamic instability, and changes in respiration and/or oxygenation. A combination of opioids, such as fentanyl 25–50 mcg, and benzodiazepines, such as midazolam 0.5–2 mg, are most frequently utilized, but dosage should be carefully considered based on age, body size, and comorbidities. Reversal agents should be readily accessible. Naloxone 0.01 mg/kg IV can be utilized and titrated to reverse narcotic analgesics, and re-bolus may be required, given its short duration of action. Flumazenil, a pure benzodiazepine antagonist, can be given 0.2 mg IV every 2–5 minutes to a maximum of 1 mg. All drugs must be recorded in a procedure log or electronic record and signed by the attending physician, and such records should be easily accessible, particularly when the patient leaves the CCL.

Infection Control in the Catheterization Laboratory

Infectious complications resulting from cardiac catheterization are exceedingly rare; however, best practices for sterile technique are essential. Electric clippers should be used to prepare the femoral access site. A variety of antimicrobial agents are available, and chlorhexidine-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. Physicians may use Chlorhexidine/ethyl alcohol solutions, such as 3M Avagard, an FDA-approved surgical hand antiseptic, which can be used for the first scrub of the day and all subsequent scrubs. However, a traditional surgical scrub with water and soap is an alternative. Although their efficacy remains unproven, it is reasonable but not mandatory for hats and masks to be worn for every procedure. Antibiotic prophylaxis is not indicated for routine coronary procedures, but is often used before permanent implantations other than coronary stents and, at some institutions, before vascular closure device (VCD) placement in high-risk subsets, such as diabetics or immunocompromised persons (38).

Radiation Exposure

All CCL procedures should be performed with the goal of keeping radiation doses as low as reasonably achievable (ALARA) 39, 40. All personnel in the room should wear personal protective equipment, including lead aprons and thyroid shields as well as radiation badges. For team members closest to the radiation source, leaded glasses should be used. Radiation exposure to the staff should be carefully monitored and posted in a central area. Reducing imaging frame rates (15 fps or 7.5 fps), using “fluoro store” when possible, masking, and keeping the flat panel detector close to the patient are recognized methods, among others, of reducing radiation exposure. Using multiple angles for imaging reduces the radiation exposure to any one site on the patient's body, and keeping the radiation source farther away from the operator can minimize physician exposure. A complete description of strategies to reduce radiation exposure to patients and operators is beyond the scope of this article 39.

CCLs should record total radiation doses in Grays (Gy) in real time, and inform the operator and referring physician when thresholds indicative of potential radiation damage are reached 39. For exposures greater than 5 Gy, patients should be educated regarding potential skin changes (e.g., erythema). For >10 Gy exposure, a qualified medical physicist should promptly calculate peak skin dose with skin examined at 2–4 weeks. TJC considers exposures over 15 Gy a sentinel event for which hospital risk management and regulatory agencies should be contacted within 24 hr. Suspected tissue injury should be referred to a specialist, with a biopsy performed if required.

Angiographic Contrast Administration

Nonionic, low-osmolar contrast (e.g., iohexol, iopamidol, ioversol) should be utilized for the majority of cases. While iso-osmolar contrast agents (e.g., iodixanol) could be considered for patients with chronic kidney disease, recent data suggest this approach may have no benefit. Total contrast administered to the patient must be monitored in real time and limited as clinically possible. A maximum contrast volume of 3.7 x eGFR can be used as an upper limit of acceptable contrast dose during a single procedure to help limit the risk of CIN 32. CCL staff should inform physicians when these limits have been reached.

Universal Protocol and “Time out” Procedure

All team members should understand the intended procedure and the sequence of that procedure. This should be performed during a dedicated “Time Out” protocol, performed before vascular access or moderate sedation is initiated, when all members of the team are present. Patient identification should be confirmed with unanimous agreement on the procedure to be performed. Since the goal is to access the heart and its associated vasculature, “wrong site” procedures are generally not a concern (access to the coronary arteries can be gained via radial, brachial, and femoral arteries) and therefore site marking is not indicated 41, 42. Table 2 provides a sample “Time Out” checklist. If team members rotate out, then it is their responsibility to brief their replacement, who must introduce themselves to the team and announce their role, whereupon a repeat “Time Out” should be completed.

Universal infection precaution protocols for the staff should be followed in each case rather than on a case-by-case basis. All solutions on the table must be labeled in real-time (not prelabeled), including syringes specifically used for lidocaine and other agents (e.g., iodinated contrast). Preprinted labels of common medications should be incorporated into drape kits, and sheets of blank labels and felt-tip markers must also be available as part of the sterile field. For ad-hoc coronary interventions, a “Pre-PCI Timeout” should be strongly considered, during which there is consideration of (1) appropriate use classification; (2) radiation exposure and contrast use; (3) issues regarding dual-antiplatelet therapy; (4) adequate pre-treatment with aspirin, P2Y12-receptor inhibitors, and statins; and (5) baseline hemodynamics. A pre-PCI timeout assumes more importance if another operator is performing the PCI. Finally, appropriate documentation of the physician's verbal orders needs to be carried out by the recording technologist or nurse and these orders confirmed by the performing physician at the close of the case with a signature.

Procedural Data Recording

All elements of the procedure should be recorded into an electronic record that documents the procedure and events that took place. The record should contain the patient's vital signs during the procedure, the access site, the time and dosage of medication administration, what catheters were used and when, all hemodynamic measurements, the target lesion and equipment that were delivered to the body, the names of the CCL staff, and whether a closure device was used at the end of the procedure. This record should be immediately available to the staff in the post procedure area.

For patients who receive heparin, an Activated Clotting Time (ACT) must be checked to document adequate anticoagulation. It is reasonable to target ACT >200 in the presence of intravenous anti-platelet therapy, >250 in the presence of adequate oral anti-platelet therapy, and potentially >300 in the absence of both. This should be repeated every 15–20 min for patients on heparin, but only an initial acceptable ACT is required for patients receiving bivalirudin. Results and timing of such testing should be recorded in the procedure log.

NCDR-specific information (or equivalent) is critical for maintenance of quality standards in the CCL. Accordingly, methods to facilitate the transfer of information collected in the CCL during procedures should be established among physicians and CCL staff. Prior to closure of the case, the physician should be responsible for reviewing all the pre- and intra-procedural data entered for NCDR purposes to ensure accuracy and completeness.

Physician to Patient Communication

The physician should discuss the findings, interventions performed, and complications directly with the patient and family. The post procedure management plan should also be addressed. Discussions with patients should be delayed until cognitive impairment due to sedation has resolved.

Procedure Report

A procedure report, whether electronic or handwritten, should be generated immediately postprocedure and included in the patient's chart prior to transferring to the next level of care. If a procedure report cannot be placed in the medical record immediately after the procedure, then a brief progress note should be entered with sufficient information for the immediate postprocedure care, including the name of the operator, indication and type of procedure, findings, estimated blood loss, specimens removed if appropriate, complications, post-procedure diagnosis, and recommendations. In this instance, a procedure report should be completed within 24 hr of the procedure and include essential elements mandated by TJC for operative procedures, as well as comprehensive documentation of indications for PCI that provide all the information needed to determine appropriateness. Since terminology is critical for a quality procedure report, we recommend that key data elements and definitions from the 2013 ACCF/AHA Key Data Elements and Definitions for Measuring the Clinical Management and Outcomes of Patients with Acute Coronary Syndromes and Coronary Artery Disease be adopted 43. For a comprehensive procedure report specific to commonly performed procedures in the CCL, we recommend including the additional information outlined in Table 3. The writing committee concurs with the ACC/AHA/SCAI 2014 Health Policy Statement on Structured Reporting for the CCL, which states that a structured report is the optimal format for generating procedure reports 44.

Access Site Management and Closure Devices

Manual compression, compression devices, and VCDs are all options in cases of femoral access. Femoral angiography is recommended after access to identify any immediate procedure-related complications and the sheath location, particularly prior to anticoagulation for PCI and prior to VCD placement 45, 46. For patients who have received heparin, sheath removal and manual compression can occur when the ACT is <180 sec. ACT is generally not useful with LMWH. For bivalirudin, sheath removal and manual compression can occur at 2 hr post cessation of infusion in patients with normal renal function. In patients with a creatinine clearance <30 mL/min or those on dialysis, ACT should be checked and sheaths removed once the value is <180 sec. Sheaths can be safely removed 8 to 12 hr after the last dose of acute coronary syndrome therapeutic LMWH. After manual compression, ambulation is restricted for 2–6 hr following the procedure, depending on the ease of initial access, sheath size, and any early signs of bleeding 47, 48. If VCDs are utilized, ambulation is restricted for 1–4 hr postprocedure 49, 50. Generally, studies show that while use of VCD is noninferior to manual compression with respect to access site complications, and infection rate may be higher, the time to hemostasis and earlier ambulation are potential advantages 45, 51. Resterilization of the access site, the use of new gloves, and the use of antibiotics prior to VCD insertion may reduce infection risk in high-risk subsets.

Hemostasis by manual compression for the radial access site is usually obtained with wristband compression devices. Sheaths are removed immediately after the procedure, regardless of anticoagulation status. The “patent hemostasis” technique should be used, performed by placing a pulse oximeter on the corresponding index finger and compressing the ulnar artery while lowering the hemostatic wristband compression pressure to the point where the plethysmographic waveform returns without pulsatile bleeding at the radial access site 52-54. There are no ambulation restrictions with radial access, but patients should avoid weight-bearing or other activity of the arm for 2–4 hr after sheath removal. Further information is available in a separate expert consensus statement on transradial best practices from the SCAI transradial working group 52.

Appropriate Monitoring and Length of Stay

Patients should be monitored on telemetry in a recovery or other unit specializing in the care of patients receiving cardiac procedures. Vital signs should be monitored every 15 min for the first 2 hr post procedure by personnel trained in recovery from moderate/conscious sedation and access site management. Telemetry is continued throughout the hospital stay, unless specified otherwise by the attending physician. Length of stay for diagnostic catheterization ranges from 2–6 hr, depending on the access site used and the nursing assessment of patient ambulation and well-being. The length of stay for PCI is dependent on access site complications, patient comorbidities, and need for further procedures, therapy, or testing 55. Selected patients after elective PCI can be considered for same-day discharge 56 if the appropriate monitoring time has been completed (usually 6–8 hr) and the discharge aligns with patient preference and physician approval.

Discharge Instructions and Patient Information

At the time of discharge, the duration of DAPT should be discussed and need for adherence stressed. If a patient received a stent, a card with the device information should be provided. Limitations of physical activity, driving, along with instructions for the follow-up appointment and further tests should be discussed and included with discharge instructions. Patients at increased risk for CIN should have serum creatinine checked within 3–5 days. All patients, especially those having same-day discharge post-PCI, should be contacted by a CCL team member within 24–48 hr of the procedure to ensure that no complications have occurred, medication adherence is reinforced, and to answer any questions the patient or caregiver may have.

Medication Reconciliation

Medication reconciliation is necessary before discharge to update all medications, including those deleted or added during the hospitalization, and must be clearly documented on the discharge instructions, which are sent immediately to the referring physician. The expected duration of DAPT should be based on current guidelines and documented as part of medication reconciliation. Particular attention should be given to patients requiring “triple therapy” (antiplatelets/anticoagulants), and duration of each medication should be explicitly stated. Due to increased bleeding risk, triple therapy should be maintained for the least amount of time possible. Patients previously on a TSOAC can restart the next day. Patients previously on warfarin should restart their standard regimen immediately, and arrange for follow-up PT/INR within 1 week of discharge. LMWH as a bridge to therapeutic warfarin is not routinely recommended (due to the potential for bleeding) except in cases of mechanical prosthetic valves, recent deep venous thrombosis or pulmonary embolism, and other causes for extreme risk of thrombosis 57. Metformin should be held for 48 hr 58. Proton-pump inhibitors should be prescribed for patients with prior history of gastrointestinal bleeding who are discharged on DAPT, and should be considered for all patients on triple therapy 29.

Appropriate Attending to Referring Physician Handoff

Although an invasive cardiologist performs the procedure, noninvasive cardiologists, internists/hospitalists, and nursing personnel can subsequently assume patient care. Formal handoffs (nurse-to-nurse and physician-to-physician) should be conducted and the operator should ensure that the formal procedure note is available to the team assuming care and is sent to all referring physicians.

Appropriate Follow-up Evaluation

The patient should have a follow-up visit with a provider (physician or physician extender) who is competent in the management of post-procedure care within 4 weeks of discharge. For patients with baseline renal insufficiency, anemia, or procedural complications, follow-up should be earlier, with indicated studies performed prior to or during the visit. A documented evaluation of the access site must be performed. The patient's medical therapy should be assessed for effectiveness, side effects, compliance, and conformity with guidelines. Additional outpatient care should address lifestyle modifications, including cardiac rehabilitation and smoking cessation, and reinforce the plan for long-term follow-up based on procedural results 29. All patients following PCI should be referred to cardiac rehabilitation 29.

Role of CCL Director, Manager, and Hospital Administration

Management of the CCL presents unique challenges due to the volume and complexity of patients treated, the multidisciplinary (e.g., anesthesia, surgery) coordination required, the use of advanced and continuously evolving technologies, and the resultant magnitude of resources required. All CCLs should have a physician director and a nonphysician manager, working in collaboration with all the other team members, including hospital administration. Hospital administration is critical to providing the requisite resources for the CCL to perform its duties. These include not only staffing and capital needs but also the personnel required for collection, maintenance, submission, and retrieval of accurate quality data.

The director should be a licensed, board-certified interventional cardiologist, ideally with a minimum of 5 years' experience. Likewise, the manager should be an APP, either a registered cardiovascular technologist or nurse, with a minimum of 5 years' CCL experience, who also has administrative expertise to participate in institutional and CCL decision making. The director role requires dedicated administrative time. Larger labs will require more administrative time, but even small labs require a fixed amount of administrative time. A minimum of 10% of time (e.g., ½ day per week) is necessary. This should be compensated by the institution at a level commensurate with the physician's income derived from clinical activities, and consistent with fair market value.

The director is responsible for setting the example and expectations for all other physicians and is responsible for developing policies, establishing criteria for granting and renewing privileges, reviewing physician performance, and overseeing nursing and technical supervisors. Additionally, the director should partner with the manager on quality improvement, fiscal administration, patient throughput, team training, provision of debrief and feedback after adverse events, delegation of authority, and facilitating education and mentorship to all team members (Table 4).

Management of Industry Presence

Incorporation of Guidelines, New Data, and New Procedures

The CCL is a dynamic environment shaped by ever-changing technologies, guidelines, and clinical data. As such, the entire CCL team, led by the director, should review and at least annually update CCL policies and processes, and provide appropriate education and training to operators and staff around any changes. Protocols should define the roles of all relevant personnel. When appropriate, related process and/or outcome metrics should be reviewed for continuous quality improvement as well.

Cost Considerations

Quality Assurance: Registry Participation, Case Review, and M&M Conference

Every CCL must have a quality assurance (QA) program, which includes appropriate quality registries, and at least quarterly, scheduled QA/case review and/or M&M conferences. Quality registries may be regional or national and should allow for anonymous benchmarking of process and outcome metrics against other operators and institutions. Procedure-based registries are available for PCI (e.g., NCDR CathPCI, http://cvquality.acc.org/NCDR-Home/Registries.aspx). Outpatient registries (e.g., NCDR PINNACLE) may provide additional pre- and post-procedure data and allow for linkage of follow up with procedural data. Hospitals should provide dedicated, trained personnel to perform chart abstraction, data entry, registry query, and report generation/distribution. Registries should be utilized to monitor operator and institutional volumes and outcomes as well as procedural appropriateness 10. It is important that when comparing outcomes (e.g., bleeding, CIN, mortality) across operators/institutions that these rates be risk-adjusted 72-74.

Diagnostic and interventional cases should be randomly selected and peer reviewed for all operators. Ideally, peer review should be blinded and, when possible, performed by physicians external to the hospital/program. Cases should be reviewed for their appropriateness and for any complications. However, AUC ratings should not be used to judge all cases since there are times when patient preference or clinical judgment calls for a procedure. In such circumstances, clear documentation is necessary. While the current AUC criteria are a useful framework, not all indications have been rated and there is still much to be learned about how they impact quality of care and outcomes.

All major CCL and in-hospital complications should be reviewed at a regularly scheduled M&M conference, held at least quarterly 75. Cases requiring review may be identified using procedural registries such as those cited above, assuming that data are entered in a timely fashion. CCL M&M should be distinct from Clinical Cardiology M&M as the former may emphasize technical aspects of the procedure. Presentation of more serious events (e.g., death) should take precedence over less serious (e.g., vascular complications) events, and review should occur as soon as feasible after an adverse event has occurred, especially when a preventable cause is suspected. A formal phase of care (preprocedure, intraprocedure, postprocedure) analysis in which various aspects of care at each stage are critically analyzed and where consensus is reached over preventability of the complication is recommended 76.

The aim of random case review and M&M is process and outcome improvement; thus, it is critical that the environment remain non-punitive. Ideally, physicians, physician trainees, APPs, nursing, and technical staff should be required to attend. A statement of confidentiality should appear on any material distributed in print or electronically. Applicable state and federal laws should also be cited and unauthorized disclosure or duplication should be prohibited.

Each CCL should have a Quality Committee that includes the director, manager, and representatives of other stakeholders. This committee is responsible for reviewing complications not discussed in M&M conferences and other metrics of CCL quality, such as completion of time-outs, quality assurance checks of equipment, door to balloon times, and others as required by the hospital, state department of health, and TJC 77.

CCL Emergency Preparedness Protocols

Though rare, serious complications do occur in the CCL and these can have devastating consequences if not handled in a timely manner. Select complications for which specific protocols should be developed are listed in Table 5. Drills should be performed at routine intervals in the CCL to practice response to these complications.

Patient Experience Optimization

Patient experience and satisfaction may impact clinical outcome. All hospitals participate in a patient survey process that measures patients' perspectives of their hospital care, known as Hospital Consumer Assessment of Healthcare Providers and Systems, (HCAHPS, http://www.hcahpsonline.org). HCAHPS is designed and regulated by the Centers for Medicare and Medicaid Services (CMS), endorsed by the National Quality Forum, and results are publicly available on the website, hospitalcompare.hhs.gov. However, these surveys do not directly measure patient satisfaction with CCL services. CCL physicians interested in assessing the CCL patient experience would need to develop and administer a unique survey for this purpose.

CCL team members as well as those involved in scheduling and postprocedure care all have the ability to impact the overall patient experience and, thus, overall outcome. Some techniques for enhancing patient satisfaction are listed in Table 6 78.