Implementation of a Highly-Performing Electrophysiology Device Implant Program: Is There a Role for Niche Hospitals?
- 2 Aug 10
- Posted on: 8/2/10
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Good Samaritan Hospital (GSH) and Lebanon Cardiology Associates (LCA) recently partnered to create a community hospital EP program caring for elderly, ill patients, and experienced lower overall implant complications compared to available national trials and single academic centers. Find out more information here.
After approximately two years of planning, Good Samaritan’s invasive cardiac EP lab was opened on July 1, 2008. There are two full-time technologists (David Lugg, BS, RCIS and Douglas Hollis, RCIS) and one full-time nurse (Robert Gray, BSN, RN). In addition, we have one part-time technologist, Michelle Stoner, BS, CVT, who still participates in traditional coronary and peripheral interventional cardiology procedures.
Jeffrey L. Williams, MD, MS, FACC is the Director of Cardiac Electrophysiology and is board-certified in Internal Medicine, Cardiovascular Disease and Clinical Cardiac Electrophysiology. In July 2009, he was joined by Co-Director of Electrophysiology Robert Stevenson, MD, who is board-certified in Internal Medicine, Cardiovascular Disease, and Nuclear Cardiology. Julie Miksit, RN, BSN, MBA is the Assistant VP of Cardiovascular Services at Good Samaritan. Alicia Wike, RN, is the Cardiac Catheterization and EP Lab Supervisor, and the manager of the Cardiac Catheterization and EP Labs is Jennifer Hemperly, RN.
The implementation of the GSH EP device implant program is best described using key premises outlined by the Baldrige National Quality Program: leadership, strategic planning, customer focus, workforce focus, process management, measurement/analysis/knowledge management, and results (Figure 1).1 Of note, GSH also utilizes Lean Six SigmaSM principles for certain process improvements.
We routinely perform ablations for supraventricular tachycardia, ventricular tachycardia, and atrial fibrillation in our state-of-the-art procedure room; however, our device implant program is the focus of this report.
Leadership and Planning
The implementation of the Good Samaritan EP program began 18 months prior to program inception in July 2008. Dr. Williams and Mrs. Miksit began a systematic planning strategy for lab implementation with the full support of Good Samaritan and Lebanon Cardiology Associates. The demographics of the area, especially serving Health Professional Shortage Areas, necessitated the Good Samaritan EP lab have capabilities to perform all aspects of device implantation. Electrophysiology equipment acquisition was based upon the desire of Good Samaritan Hospital and Lebanon Cardiology Associates to offer state-of-the-art cardiovascular care to the Lebanon Valley community. The Good Samaritan Hospital’s invasive cardiac electrophysiology laboratory is 800 square feet and fully-equipped to function as a cardiothoracic surgical suite. We have our own anesthesia equipment that consists of a traditional ventilation machine and full anesthesia cart (Dräger Fabius® Tiro compact anesthesia system, Draeger Medical, Inc., Telford, PA) and the Monsoon Jet Ventilator (ACUTRONIC Medical Systems AG, Switzerland). The fluoroscopy system is a GE Innova 2100 single-plane unit (GE Healthcare, United Kingdom).
Effective supply chain management processes (e.g., vendor relations/contracts) were instituted and elaborated prior to inception of program. Staff education plans were determined and pre-implementation training sessions were held with Dr. Williams prior to his arrival at GSH. Staff education and training goals were outlined prior to implementation, and these discussions hinged upon the required implant capabilities of our EP lab. Community education is just as important as staff education; Drs. Williams and Stevenson are very involved with community/provider education and regularly perform outreach talks to raise awareness of sudden death and arrhythmias. We have recently instituted a monthly staff education seminar that covers all aspects of electrophysiology commonly encountered during hospital care.
Staffing of the Good Samaritan EP laboratory was decided upon after discussing the role of anesthesia services. There is data to suggest that patients undergoing invasive electrophysiology procedures may require deep conscious sedation that often is converted to general anesthesia.2 Thus, our initial staffing was based upon anesthesia providers (MDs, CRNAs) performing procedural sedation. Indeed, the majority of device implantations were sedated by anesthesia services rather than EP lab staff.
EP workforce engagement is an important element of our EP program. First and foremost, we foster a culture of open communication that starts in the outpatient setting and culminates when the patient enters the EP lab. Preprocedure patient summaries and timeouts are performed with the EP lab staff to ensure all care providers have full understanding of the patient and the procedure to be performed. We encourage staff participation in the publication and presentation of clinical research to maintain their engagement. Educational opportunities are also identified to address Good Samaritan EP strategic plans; we have formulated an EP technologist training program that includes a stepwise training program to permit career and skill set advancement.
The EP laboratory workforce environment is constantly monitored for capabilities, capacity, and climate. Assessment of the needs, skills, competencies, and staffing levels is addressed with any new procedure. This allows us to prepare for changing needs/capabilities and prevent/minimize impact of any workforce reduction. Finally, routine fluoroscopic level monitoring and ergonomics are evaluated to improve our workforce safety.
Outpatient EP Processes
The majority of our EP laboratory patients are seen in the outpatient setting by the LCA electrophysiologist that will be performing the procedure; the benefits of this continuity of care are obvious. However, there are times when the evaluating physician is not available to perform the procedure (in particular, the inpatient setting), and in these instances, there is a physician-to-physician patient briefing to ensure continuity of care. All EP consents are procedure-specific, and we attempt to have both patient and family members sign consents. Preprocedure order sets are filled out by the implanting electrophysiologist when a patient is consented for a procedure.
EP Laboratory Work Processes
Standardization of work processes simplifies procedural setup and completion while allowing a system that permits identification of inefficiencies. All consents are procedure-specific, and standardization of procedure processes and order sets are essential. We have standardized pre- and post-implant order sets (Figure 2) that have been shown to improve care processes in other fields.3,4 In addition, we have standardized post-implant intravenous heparin protocols for patients at high risk for thromboembolism post-procedurally (e.g., mechanical valves). Finally, we have standardized EP laboratory hospital discharge instructions, which offer particular instructions on wound care and device care/follow-up.
EP Laboratory Process Management
We have performed Olympic averaging for EP device implant cases to optimize standard procedure scheduling times (e.g., dual-chamber pacemaker allotted 90 minutes and dual-chamber defibrillator allotted 120 minutes). These times are adjusted with physician discretion in certain complex circumstances (e.g., persistent superior vena cava or single-chamber devices). We monitor on-time starts for both initial anesthesia evaluation and electrophysiologist preprocedure timeouts. In particular, GSH utilized Lean Six SigmaSM DMAIC approach to successfully improve our EP procedural start times. Finally, we follow Surgical Care Improvement Project (SCIP) guidelines by monitoring antibiotic administration time prior to skin incision. We also participate in the ACC NCDR® ICD Registry™.
Patient (and Customer) Focus
We first identified service offerings to meet and exceed our patients’ expectations. This mandated that our EP device implant program offer the full gamut of procedures, including single-, dual-chamber, and biventricular pacemakers and defibrillators as well as implantable loop recorders. A culture of positive patient experiences is a focus of both Lebanon Cardiology Associates and Good Samaritan Hospital. This system-wide attitude is used as a means to keep us current with health care service needs and direction. Again, we routinely participate in patient health education outreach talks and have an active role in the American Heart Association’s Lebanon Division (Dr. Williams and Mrs. Miksit serve on the AHA Board as the Medical Director and Hospital Liaison, respectively).
Obviously, patients are the main focus; however, we are cognizant of other stakeholders in the health care continuum. These include the patients’ families, the community-at-large, payors, employers, and vendors. We have identified key patient/stakeholder communication mechanisms. The Good Samaritan Continuing Medical Education program focuses on both patient and provider education, and recently, Good Samaritan and Lebanon Cardiology Associates teamed to offer the 2010 Lebanon Valley Cardiovascular Symposium. Faculty from around the country were invited to discuss current state-of-the-art cardiovascular care issues with over 40 care providers in our region.
Voice of the Customer
Our patient focus hinges on our ability to listen, determine the level of satisfaction, and use these data to improve our services. We routinely survey EP patients using Press-Ganey satisfaction surveys. The Press-Ganey scores allow us to identify our weaknesses and strengths, improve marketing, and identify opportunities for innovation. Indeed, our patient focus is evident, as we recently had a patient travel over 150 miles from Delaware for our EP services.
The strength of the system implemented via the partnership between Lebanon Cardiology Associates and Good Samaritan is only as strong as our outcomes. We recently published data from our first 250 consecutive patients who underwent device implantation in the Good Samaritan Hospital EP laboratory starting with its inception July 2008.5 Standard procedures for implantation were used. Pacemakers, defibrillators, and generator changes were included; temporary pacemakers were excluded. Major complications were defined as in-hospital death, cardiac arrest, cardiac perforation, cardiac valve injury, coronary venous dissection, hemothorax, pneumothorax, transient ischemic attack, stroke, myocardial infarction, pericardial tamponade, and arterial-venous fistula. Minor complications were defined as drug reaction, conduction block, hematoma or lead dislodgement requiring reoperation, peripheral embolus, phlebitis, peripheral nerve injury, and device-related infection. Complications included those from implant through 6 weeks post-implant. Table 1 depicts these data.
1. 2009-2010 Health Care Criteria for Performance Excellence, The Baldrige National Quality Program at the National Institute of Standards and Technology, Gaithersburg, MD. 2. Trentman TL, Fassett SL, Mueller JT, Altemose GT. Airway interventions in the cardiac electrophysiology laboratory: A retrospective review. J Cardiothorac Vasc Anesth 2009;23:841-845. 3. Barritt AW, Clark L, Teoh V, et al. Assessing the adequacy of procedure-specific consent forms in orthopaedic surgery against current methods of operative consent. Ann R Coll Surg Engl 2010;92:246-249. 4. Santolin CJ, Boyer LS. Change of care for patients with acute myocardial infarctions through algorithm and standardized physician order sets. Crit Pathw Cardiol 2004;3:79-82. 5. Williams JL, Lugg D, Gray R, et al. Patient demographics, complications, and hospital utilization in 250 consecutive device implants of a new community hospital electrophysiology program. Am Heart Hosp J 2010;8:33-39. 6. Aggarwal RK, Connelly DT, Ray SG, et al. Early complications of permanent pacemaker implantation: No difference between dual and single chamber systems. Br Heart J 1995;73:571-575. 7. Alter P, Waldhans S, Plachta E, et al. Complications of implantable cardioverter defibrillator therapy in 440 consecutive patients. Pacing Clin Electrophysiol 2005;28:926-932. 8. Lee DS, Krahn AD, Healey JS, et al. Evaluation of early complications related to De Novo cardioverter defibrillator implantation insights from the Ontario ICD database. J Am Coll Cardiol 2010;55:774-782. 9. Lin G, Meverden RA, Hodge DO, et al. Age and gender trends in implantable cardioverter defibrillator utilization: A population based study. J Interv Card Electrophysiol 2008;22:65-70. 10. Curtis JP, Luebbert JJ, Wang Y, et al. Association of physician certification and outcomes among patients receiving an implantable cardioverter-defibrillator. JAMA 2009;301:1661-1670. 11. Greenberg JO, Dudley JC, Ferris TG. Engaging specialists in performance-incentive programs. N Engl J Med 2010;362:1558-1560. 12. Cardiac Surgery in Pennsylvania 2006-2007: Information about hospitals and cardiothoracic surgeons. Pennsylvania Health Care Cost Containment Council. August 2009. http://www.13.org/reports/cabg/07/docs/cabg2007report.pdf 13. U.S. Department of Health & Human Services and Centers for Medicare & Medicaid Services (CMS), Hospital Compare, (http://www.hospitalcompare.14.gov), Accessed 2-8-10. 14. Reynolds MR, Cohen DJ, Kugelmass AD, et al. The frequency and incremental cost of major complications among medicare beneficiaries receiving implantable cardioverter-defibrillators. J Am Coll Cardiol 2006;47:2493-2497. 15. Saba S, Ravipati, LP, Voigt A. Recent trends in utilization of implantable cardioverter-defibrillators in survivors of cardiac arrest in the United States. Pacing Clin Electrophysiol 2009;32:1444-1449.