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Spotlight Interview: William Beaumont Hospital

Debbie Kulik, RN, BSN, MSA, Nurse Manager, Heart Center: HRC, QA and Prep, Royal Oak, Michigan

May 2007

What is the size of your EP lab facility and number of staff members? What is the mix of credentials at your lab? Our hospital system has EP labs located at our Royal Oak and Troy campuses. Our responses in this Spotlight Interview represent the Royal Oak program. Our Royal Oak campus has three single-plane Siemens labs with GE Prucka EP systems. Last year we performed over 3,200 cases. The staff for the department consists of a Nurse Manager, two Nurse Clinicians, 11 Registered Nurses (RNs), 1 Registered Cardiovascular Invasive Specialist (RCIS), two assistants, and one Scheduler. We have seven primary physicians and all are certified Electrophysiologists. We have three additional physicians with privileges. There is also a new EP Fellowship program at Beaumont, with the first graduation to take place this June. When was the EP lab started at your institution? EP procedures were originally done in a special procedure room located outside the Critical Care Unit. However, the EP case volumes started to rapidly increase in the late 1990s, and it was decided to make two separate departments. We moved around the hospital as the program grew, in and out of the Cath lab, ICU and OR. The Heart Rhythm Center was located to our own area in 2000. What types of procedures are performed at your facility? EP studies (EPS) and ablations (including atrial tachycardias, atrial flutter, supraventricular tachycardias, complex ventricular tachycardias, and accessory pathways) are performed daily. Pulmonary vein isolation ablation cases are done 2 - 4 times weekly. Complex ablations are performed using guidance from our Carto (Biosense Webster Inc., a Johnson & Johnson company, Diamond Bar, California) and EnSite NavX (St. Jude Medical, St. Paul, Minnesota) 3D mapping systems. All types of device implants (BiV ICDs, ICDs, PPMs and loop recorders) as well as NIPS and cardioversion procedures are performed. Laser lead extractions are done using the Spectranetics Excimer laser. In addition, we complete approximately 500 tilt table tests yearly. The staff is also responsible for staffing a four-bed pre- and post-procedure area. Approximately how many are performed each week? What complications do you find during these procedures? We perform 12 - 16 procedures daily. The most common complications for device implants would be pocket hematomas and lead dislodgement. In fact, our nurses and physicians recently completed a prospective trial of 941 consecutive patients of which we determined that the most important predictors of post-device hematoma formation were the use of IV heparin or oral clopidogrel. Who manages your EP lab? Debbie Kulik, RN, BSN, MSA is the Nurse Manager and Dr. David Haines, MD, is the Medical Director. Is the EP lab separate from the cath lab? How long has this been? Are employees cross-trained? There is a total operational separation between the two centers within the Cardiology Department. Material Management staff, who is responsible for the maintenance of inventory, cross-cover for both departments. Staff may assist in the other department by transporting patients who require monitoring or by assisting in the prep/recovery department when the need arises; however, staff are not cross-trained to cover for cases. Do you have cross training inside the EP lab? What are the regulations in your state? All RNs and RCIS's are fully trained to staff every case within our department. This includes positions as circulator, scrub nurse, Bloom stimulator (Fischer Medical Technologies Inc.) and Prucka system (GE Healthcare) operator, and device nurse (including interrogations and threshold testing). Currently, three of the staff are also trained in the operation of the EnSite NavX (St. Jude Medical) and Carto systems (Biosense Webster Inc.). The nurses are required to have a Michigan nurses license. A Registered Cardiovascular Invasive Specialist certification is required for technicians within the lab. All staff working with patients in the lab are BLS- and ACLS-certified. What new equipment, devices and/or products have been introduced at your lab lately? How has this changed the way you perform those procedures? Within the last four years, our lab has added the Carto 3D Mapping System from Biosense Webster, the EnSite NavX Mapping System from St. Jude Medical, intracardiac echocardiography (ICE) from Boston Scientific and ACUSON, cooled-tip and large-tip ablation catheters, and cryoablation therapy. Recently, Beaumont was also the first center to perform atrial fibrillation (AF) ablation in the randomized pivotal trial of the ProRhythm HIFU (high intensity focused ultrasound) balloon ablation catheter. Other AF ablation technologies in clinical testing at Beaumont include the CardioFocus laser balloon ablation catheter and the Bard EP mesh ablation catheter. With the addition of 3D mapping technology, we have found that our case mix has shifted to include more challenging ablation cases. This has resulted in an increase in average case times. In order to optimize patient safety in these cases, we placed anesthesia machines in every lab, so we have the ability to perform general anesthesia as any time. Who handles your procedure scheduling? Do you use particular software? We use the hospital'[s Appointment Center to schedule all elective cases boarded through the physician offices. They also schedule the patient to be evaluated in Cardiology Prep, an area where the patient will receive pre-procedure education and evaluation. The Heart Rhythm Center has a permanent full-time scheduler who uses a home-grown scheduling system tailored to meet the needs of Cardiology. They are in charge of all inpatient scheduling and assume control of the pre-scheduled appointments for final time assignments. Good, clear communication is the objective in assuring that all patient needs are met prior to and during the case. A preadmission scheduling form, in which the physician not only indicates the procedure but the indication and information pertinent to the case, is also utilized. Having someone who is experienced in scheduling these cases is critical to assuring patient safety and minimization of case delay due to last-minute case requirements. The scheduling of multiple complex procedures around busy physician schedules, while still accommodating add-ons and emergencies, is a challenge. What types of quality control/quality assurance measures are practiced in your EP lab? The EP lab staff charges for inventory using a barcode/scanning system to keep track of usage. High-cost inventory charges are individually double checked by Material Management staff. Discrepancies are resolved within 24 hours. Procedural charges are reviewed daily to assure accuracy. The Department of Cardiology has a Quality Assurance division that is responsible for chart review and the reporting of quality data to physicians. Nursing QA is overseen by the EP Lab Manager and performed by the department. Recent initiates include final verification and administration of IV antibiotics within 1 hour of device implant. Has your EP lab recently expanded in size and patient volume, or will it be in the near future? Our patient volume has been relatively stable for the past two years. The EP lab has the ability to utilize Cath lab space for device implants if the volume dictates. Beaumont strives to meet the needs of our community. Marketing is underway to increase awareness of our services and the issues surrounding sudden cardiac death. Additional space or labs for our department is determined by patient need. How has managed care affected your EP lab and the care it provides patients? We now do more combined procedures that shorten the inpatient hospital length of stay. What measures has your EP lab implemented in order to cut or contain costs? In addition, in what ways have you improved efficiencies in patient throughput? Beaumont uses a bid process in which we sign contracts with vendors for a designated period of time. Our group purchasing organization, Broadlane, is used when applicable. Bulk buys are at times considered. We have implemented standardization within the Cardiology Departments at our two hospital sites. Value Analysis meetings are held to determine clinical acceptability and financial analysis prior to the induction of new items. We constantly evaluate efficiencies in patient through-put in weekly staff meetings. Standard PPM and EPS trays, standard protocols in the Prucka System, and standard order sets are all examples of ways we assure consistency and efficiency. Pyxis machines are in every lab for management of inventory and charging. Does your EP lab compete for patients? Has your institution formed an alliance with others in the area? We are located at William Beaumont Hospital in Royal Oak, Michigan. We have an affiliation with William Beaumont Hospital in Troy, Michigan. Our physicians have privileges at both sites. There is no competition between our two hospitals for patient volumes. Patients are scheduled at the location of their choice for basic EP procedures in order to promote patient satisfaction. Locally, there are many hospitals in the immediate area that are now performing EP procedures. Cardiology practices, who in the past referred their patients to Beaumont, have hired their own EP physicians and are now performing these procedures at the hospital where they have privileges. Locally, there is intense competition, through marketing, for this population. What procedures do you perform on an outpatient basis? Tilt table tests, cardioversions, NIPS, EPS and device generator changes are scheduled to be performed on an outpatient basis. The patient's co-morbidities and their response to the procedure are all considered when designating appropriate patient status for device implants. Most ablation procedures are inpatient. How are new employees oriented and trained at your facility? New employees are assigned to an experienced mentor in the EP lab for six weeks. During that period, they will complete a thorough training manual that has been developed and kept current by the staff. They also spend time receiving training in radiation safety as well as inventory control from representatives in those departments. After initial orientation, they are paired with senior staff and placed in cases to facilitate their learning curve. Usually, new staff are very competent in all basic cases within one year of hire. What types of continuing education opportunities are provided to staff members? Continuing education is encouraged and reimbursed by the hospital. Each year two to four nurses are sent to the Heart Rhythm Society's annual conference. Weekly, vendors provide short updates on product innovations. Staff are provided the opportunity to go to training and education seminars offered by industry. There are online education requirements that staff must complete on a yearly basis that are completed on the job. The department has weekly staff meetings that may include education topics regarding team development to updates on hospital initiatives. How is staff competency evaluated? Yearly evaluations are conducted with the Manager and Charge Nurse checking competency of employees. There is yearly testing on high risk, low occurrence procedures and equipment. As new procedures and/or technology become available, the staff is inserviced and then evaluated for competency prior to practicing independently. How do you handle vendor visits to your department? Vendors are scheduled for ICD and BiV ICD device implants. They may also be scheduled to assist with specific technologies during a case. All others make scheduled appointments to be present in the department. There is a corporate vendor policy that outlines all the requirements they must meet prior to being given access to the department. All vendors in all areas of the hospital are required to dress in yellow and black for rapid identification. All vendors receive a distinct vendor badge as well. Does your lab utilize any alternative therapies? No. Please describe one of the more interesting or bizarre cases that have come through your EP lab. We see a wide variety of complex atrial arrhythmias in our labs. Common atrial flutter is often not common in our patient population with the frequent observation of scar-related atrial flutters, left atrial macro-reentry, post surgical maze atrial tachycardias, and focal atrial tachycardias from all locations. We have seen several patients with focal atrial tachycardias with earliest sites of activation immediately contiguous to the AV node. Ablation approaches that have been successful have included ablation with a cryothermic catheter, ablation from the left atrial septum, and ablation from the non-coronary cusp of the aortic valve. How does your lab handle call time for staff members? We have not had an on-call team for the department. The completion of late cases and add-ons has been accomplished by the department staff and physicians working together to meet the needs of patients while still maintaining the staff morale and preventing burnout. The very rare weekend emergency case has been staffed with volunteers. However, with an increase in average case time, there is now an interest in a trial of a call schedule, and we will be pursuing this. Does your lab use a third party for reprocessing? Currently we are only reprocessing AcuNav catheters using Ascent Healthcare Solutions. Approximately what percentage of your ablation procedures is done with cryo? What percentage is done with radiofrequency? Almost all of our cases are done with radiofrequency. Less than 10% are done with cryo. Do you perform only adult EP procedures or do you also do pediatric cases? The department serves the geriatric and adult population. Adolescents over age 14 are treated as well, but younger pediatric patients are referred elsewhere. Do your nurses/techs participate in the follow up of pacemakers and ICDs? Post-operative, our Nurse Clinicians check the site and give discharge instructions and implant education. Beaumont has a separate department, the Pacemaker Clinic, which is responsible for the post-procedure interrogation after implant. Upon discharge, patients will receive instructions to continue their follow-up in the Pacemaker Clinic or the private physician office. What trends do you see emerging in the practice of electrophysiology? How is your lab preparing for these future changes? Atrial fibrillation is continuing to be an opportunity to utilize advanced EP technologies. Two of our EP Nurses have worked along with our EP Director, Dr. David Haines, in the creation of an Atrial Fibrillation Clinic. This AF clinic provides a means for the patient to be scheduled in one day to receive multiple tests and then at day's end have the results reviewed during a meeting with an electrophysiologist. This provides an easy referral service for the physician to medically manage patients who need EP evaluation, as well as increase patient satisfaction by having a one-day work-up with results. In addition, we are noting an increase in the scheduling of TEE along with EP procedures. In order to facilitate the growing number, we now perform these procedures in the lab prior to the procedure. What are your thoughts about non-EPs implanting ICDs? Do you train such individuals? The Heart Rhythm Center physicians from Beaumont Hospital, in conjunction with the Michigan EP Society, met and concluded that we should strongly endorse the training and credentialing guidelines for device implantation. Working through the Michigan Chapter of the ACC and the national ACC, a letter delineating the standard of care for ICD implantation in Michigan was sent to all Michigan hospital presidents, chiefs of staff, and chairs of credentialing and qualifications committees. Only CCEP board-certified electrophysiologists have privileges for ICD and BiV device implantation at Beaumont Hospitals. What about device recalls? How has your lab handled these? In the past four years, we've experienced 2 - 3 recalls with two major companies. The devices were explanted and the companies and staff worked together to make the transition as smooth as possible for the patient. Since that time, patients have become more aware of potential device problems due to media attention, and are fairly vocal about preferences. Is your lab doing web-based/transtelephonic device follow-up? Our Pacemaker Clinic currently does not perform transtelephonic device follow-up. Medtronic's CareLink® Network is used for Medtronic implants, and the Latitude® Patient Monitoring System is available for our Guidant implants. Is your EP lab currently involved in any clinical research studies or special projects? Which ones? Device trials in which we are currently participating include the MADIT-CRT and DETERMINE trials. Atrial fibrillation trials that are underway or will be in the near future include the ProRhythm HIFU balloon ablation trial (the focusAF trial), the CardioFocus laser balloon ablation trial (ENABLE trial), the Bard Mesh Ablation trial, and the Toray Hot Balloon ablation trial. We are one of the lead enrollers in Atritech's WATCHMAN left atrial appendage occlusion device trial (PROTECT AF study). In addition, a number of single-center trials are underway, such as Treatment of Ventricular Tachyarrhythmias Refractory To Shock With Beta Blockers: The SHOCK and BLOCK Trial, which tests the benefit of beta blockade in cardiac arrest. When was your last JCAHO inspection? Our last inspection was two years ago; we are currently awaiting JCAHO inspection this year. Are you ACGME-approved for EP training? What do you think about two-year EP programs? We are ACGME-approved for one CCEP training slot per year. Fellows entering the fourth year of training from within our general Cardiovascular Diseases training program all have at least nine months of EP training prior to the fourth year. Since we have only one fourth-year fellow and we are a very high-volume lab, each fellow is extensively trained by the end of the fourth year. Thus, we do not promote the notion of a mandatory two-year EP program. Does your lab provide any educational or support programs for patients who may have additional questions or those who may be interested in support groups? All ICD/BiV ICD patients are sent invitations to attend support meetings that are held quarterly. Give an example of a difficult problem or challenge your lab has faced. How it was addressed? In the last year, we have begun working with EP fellows on a regular basis. This has brought on new challenges for physicians and staff alike. While we used to be a volume-driven unit, our procedure time has been considerably lengthened with the learning curve of each fellow. This in turn has contributed to longer case times, with more staff being asked to stay longer hours to accommodate this need. Preserving staff morale while meeting the needs of the patients, physicians and institution has been a recurrent theme throughout the years in our EP lab. Currently the schedule is scrutinized the day prior to try and mirror the staffing level and timing along with case timing and needs. Staff are requested to come in early or late as needed, or days on and off are switched to meet the lab demands. A reduction in the amount of meetings being held has been implemented to prevent staff from having overtime on these days. Hiring of new staff has been focused on keeping more staff on the later shifts. Providing contingents for coverage in the holding area and NIPS/CV procedures has been approved. In addition, staff have voted to trial an on-call schedule. Describe your city or general regional area. How does it differ from the rest of the U.S.? Royal Oak is a large suburb of Detroit, Michigan. The local economy has been negatively impacted by the recent change in the automotive industry. This has cause a decline in the number of elective surgeries being scheduled by all hospitals. Please tell our readers what you consider unique or innovative about your EP lab and staff. Our facility is one of the only labs in the area that implants permanent pacemakers without the assistance of industry. In addition, each of our labs is staffed with a CRNA and is fully equipped to deliver general anesthesia. An anesthesiologist oversees all the procedural sedation. This has provided an extra measure of safety for all our procedures, especially for those at high risk for airway management concerns. For more information about William Beaumont Hospital, please visit: www.beaumonthospitals.com


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