Carolinas HealthCare System is the largest healthcare system in the Carolinas, and the fourth largest public system in the nation. Carolinas HealthCare System owns, leases, and manages hospitals, nursing homes, physician practices, home health agencies, and other healthcare-related operations comprising of more than 4,300 licensed beds and approximately 25,300 employees. Carolinas Medical Center (CMC) is the flagship facility of Carolinas HealthCare System. As one of the Carolinas’ largest hospitals, it serves as a quaternary referral center for a 29-county multi-state region and portions of the Southeast and beyond. CMC opened in 1940 and has 795 beds.

Figure 1.

EP lab staff (L to R): Allen Faler, RCP, Richard Cannon, RN, Bob Turner, RRT, Chasity McDaniel, Patient Scheduler, Shana Welsher, RN, Chad McMillan, RT, and Dennis Chadwick, RCIS (in back row).

What is the size of your EP lab facility and number of staff members? What is the mix of credentials at your lab?
       We have two EP suites that consist of:
• 1 bi-plane Philips system
• 1 single-plane Philips FP system
       Both suites were constructed to meet OR standards allowing utilization for implant procedures as well as electrophysiology procedures. Pre/post procedure holding areas are divided into a 10-bed outpatient unit, a 13-bed inpatient/outpatient unit, and a two-bed pediatric area. These areas prep and recover patients from cardiovascular procedures as well as EP procedures.
       The EP staff consists of 10 FTEs that work 10 hours a day for four days/week. At least eight are scheduled daily. Credentials include RCIS, RCP, RTR, and RN. Seniority runs from a few months to 10 years, with the average length of service at approximately two years.

When was the EP lab started at your institution?
       Electrophysiological procedures were first performed in 1975.

Figure 2.

Warren Holshouser, MD, and Samuel H. Zimmern, MD.

What types of procedures are performed at your facility?
       The electrophysiology services include a broad range of diagnostic and therapeutic procedures, consultation, both inpatient and outpatient, and specialized clinics following AICD and pacemaker implantation. In 2005, the Lab performed 2,312 EP procedures, of those 1,788 were therapeutics. Adult and Pediatric procedures performed include: single- and dual-chamber pacemakers, biventricular pacemakers and implantable cardioverter defibrillators (ICDs), diagnostic electrophysiology (EP) studies, catheter ablations (radiofrequency [RF] and cryo), tilt table studies, and cardioversions. Ablations are performed for supraventricular tachycardia, atrial fibrillation, atrial flutter and ventricular tachycardia.

What is the primary goal of your program (AF ablations, lead extractions, BiVs, etc.)?
       The goal of the Electrophysiology Program is to provide excellent personalized care for all patients with heart rhythm disorders (arrhythmias). An integrated team of physicians, nurses and other healthcare professionals provide a comprehensive approach to the diagnosis and treatment of a broad range of rhythm disturbances and associated underlying conditions. Our program supports the Carolinas Healthcare System vision of clinical excellence, education and research.

Figure 3.

Left to right: Mike Bouchard, NASPExAM, Normand Picard, RCIS, Nancy Lee, RN, RCIS, Abby Walden, Paul Colavita, MD, Jessica Mullens, Chris Worthy, MSN, ACNP-C.

Approximately how many are performed each week? What complications do you find during these procedures?
       We perform approximately 50 cases per week. Our complication rate is extremely low, approximately 0.01%. Although rare, the EP lab encounters the common complications of perforation and infection.

Who manages your EP lab?
       Patricia Pye, RN, MS, is the Director of Invasive and Non-Invasive Cardiovascular Services and manages the cath lab, cardiology, heart failure and EECP. Dennis Chadwick, RCIS, BS is the Technical Supervisor and oversees all inventory management, digital imaging, the computer networks, and electrophysiology. Kevin Collier, RCIS is the Clinical Supervisor and oversees all Invasive Specialists, the scheduling board, and the educational coordinator. Tricia McCombs, RN, BSN and Carmen Shaw, RN, BSN are the Interim Nursing Supervisors overseeing the holding areas. Richard Gentsch, MPA/MBA is the Senior Management Associate responsible for financial management of all Invasive and Non-Invasive Cardiovascular Services. We also have two team leaders, Nancy Lee, RCIS, RN, BSN, and Michael Bouchard, RCIS, NASPE-Testamur EP/AP to supervise the EP rooms on a daily basis. Rounding out the administrative team is Albert Doku, RN, BS, Supervisor of the Heart Station/Cardiology and Nikki Lacy, RN, BSN, the Coordinator for the Heart Failure Program.
       Samuel Zimmern, MD is the Medical Director of the Electrophysiology Labs, and Richard Smith, MD is the Director of the Pediatric Electrophysiology Program.

Figure 4.

Left to right: Dennis Chadwick, RCIS, Kevin Collier, RCIS, Patricia Pye, RN, Mike Mullowney, VP-Administration, and Mason Ellerbe.

Is the EP lab separate from the cath lab? How long has this been? Are employees cross-trained?
       In 1982, two rooms within the Cath Lab Suite were designated as the EP Lab. Along with this designation came a separate staff, a Monday through Friday schedule, and no call or weekends responsibilities. The EP Lab shares the director, technical supervisor, management associate, materials coordinator and educational/QA coordinator with the Cath Lab. The close proximity to Cath Diagnostic and Interventional rooms allows both EP Specialists and cath lab personnel to assist each other if their schedule permits. Some EP Specialists have been cross-trained to assist in the cath lab and a few Invasive Specialists have been trained to assist with implants.

Do you have cross training inside the EP lab? What are the regulations in your state?
       All EP Specialists/nurses are cross-trained to fill every role (scrub, circulate and monitor) and they rotate positions every case (i.e., scrub to monitor, monitor to circulate and circulate to scrub). All Invasive Specialists dispense medications under the direct supervision of the physicians.

Figure 5.

Pacemaker Clinic staff: Vicki Brown, RN, Robin Smith, RN, Janet Porter, RN, Amanda Sowell, RN, Eric Tomten, RN, Amy Tucker, RN, Leslie Jordan, MOA, and Cynthia Cummings, Outpatient Registrar.

What new equipment, devices and/or products have been introduced at your lab lately?
       The latest advance in technology for our lab is the CARTOMERGE™ image integration software module (Biosense Webster, Inc., a Johnson & Johnson company, Diamond Bar, California). CARTOMERGE™ allows for the importation of a CT image of the heart. We are also using CryoCath for ablation procedures that are close to or within the AV node.
       In addition, Guidant has recently introduced remote (wandless) programming for ICD/PPM implants. The THERMOCOOL catheter from Biosense Webster, Inc. for RF ablations is being used more frequently in atrial fibrillation and atrial flutter cases.

How has this changed the way you perform those procedures?
       Utilization of CARTOMERGE™ cuts the procedure time by allowing the physician to more accurately identify cardiac landmarks. This reduces procedure time and increases our ability to provide more patient care. Utilization of the CryoCath also enables us to perform more pediatric and young adult procedures.

Who handles your procedure scheduling? Do you use particular software?
       Our Procedure Coordinator is responsible for scheduling outpatient procedures. Scheduling of inpatients is managed by our EP team leaders. We utilize an in-house computer software program called “Cath Lab Scheduler;” this program was created by our IT department to facilitate the smooth progression of patient flow from the patient rooms to procedure room and back. This program allows anyone who is caring for this patient to visualize where the patient is in the procedure process.

What type of quality control/quality assurance measures are practiced in your EP lab?
       We monitor patient wait times, room turnover times, moderate sedation, patient education and currently have a groin management/hematoma process improvement project underway. All devices in the labs have QAs that are performed on a daily basis.
       The x-ray machines are checked quarterly by the Radiology Engineering department. All cases with greater than 30 minutes of fluoro usage are reported to the Radiation Safety Officer.

How is inventory managed at your EP lab? Who handles the purchasing of equipment and supplies?
       Our inventory is managed through the Witt Biomedical Series IV system (Melbourne, Florida). Par levels have been established based on the frequency of usage. As equipment is used and documented in the case report, it is removed from inventory. A Below Par Level report is generated daily. Inventory is managed by the Materials Coordinator. The responsibilities of the position include:
1. Maintaining current par levels.
2. Identifying par level shortages and overages.
3. Identifying equipment that is near or exceeded expiration date.
4. Maintaining monthly equipment usage reports.
5. Monitoring daily report and orders as appropriate.

       When a new device is FDA-approved and the physicians express an interest in using it for patient care, several steps must be completed before it can be purchased.
1. There must be a FDA approval letter on file in the cath lab.
2. A “Request for New Product Purchase, Evaluation or Contract” must be completed, approved and sent to Materials Management. This form has all pertinent information related to justification, financials, etc.
       We recently trialed the Mobil Aspects IRIS (Pittsburgh, Pennsylvania) Inventory system and were very impressed by the concept of RFID (radiofrequency identification) for inventory management. We are currently exploring ways to interface this system with the Witt system to further enhance our control over costs.

Has your EP lab recently expanded in size and patient volume, or will it be in the near future?
       In 2004, the renovation of EP Lab #1 was an upgrade from a fluoro unit used only for implant procedures to a full-fledged EP lab able to perform any EP procedure. This was done to decompress the scheduling load on the other EP Lab for ablation procedures. There are plans to add additional capacity in the near future to meet the increasing demands for these services.

How has managed care affected your EP lab and the care it provides patients?
       Our lab provides the same high level of service excellence irrespective of insurance or reimbursement. As a team, we continuously search for cost-effective tactics. Such strategies include minimizing down time, matching devices with the patients’ clinical need, inventory control, and aggressive equipment negotiations.

Have you developed a referral base?
       Referrals are generated from outlying hospitals and through the Carolinas HealthCare System, which consists of 17 hospitals. We also have developed an ICD referral program. All cath patients are surveyed, and if they meet the criteria, an EP consult is initiated.

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 through-put?
       In 2000, the Carolinas HealthCare System formed an interdisciplinary team of cardiologists, healthcare administrators, operational leadership, and materials management personnel that share information and devise strategies for contracting with interventional and rhythm management manufacturers. This committee was named P.A.V.E. — Physicians Achieving Value and Excellence. Working together, they formed a strategy of “shelf pricing,” where the price of each device is set at one price for all similar devices. If the company does not agree to these terms, their devices are removed from inventory and the physicians agree not to use that product. With this level of cooperation, the PAVE committee is able to bring all the manufactures to the table for realistic pricing for all their products. This has produced significant savings for the Carolinas Healthcare System.

Does your EP lab compete for patients? Has your institution formed an alliance with others in the area?
       The cath lab works primarily with one of the largest and most prestigious cardiology groups in this region, The Sanger Clinic. They employ approximately 30 cardiologists in multiple facilities in North Carolina and South Carolina. There are currently six Sanger physicians that specialize in electrophysiology (five adult and one Pediatric).
       Carolinas HealthCare System maintains a growing fleet of aircraft that includes two EMS helicopters, two turbo-prop airplanes and one jet. All are custom-equipped to serve as airborne critical care units. The aircraft and crews are standing by 24 hours a day, 7 days a week. MedCenter Air also provides specialized ground transport with five ground ambulances. These are designed to provide regional and national transport for neonatal and pediatrics patients as well as adults.
       We also have a variety of programs directed to local and regional populations such as the Center for Cardiovascular Health, Heart of a Woman, Physician Out-reach, educational forums, health screenings, and hospital-sponsored community activities.
       Patients in outlying areas are referred through the physician network. Our physicians provides various EP services to several rural clinics.
       A second large hospital system exists within two miles of our facility, creating competitive forces.

What procedures do you perform on an outpatient basis?
       Procedures include tilt table testing, EP studies, pacemaker and ICD generator changes, loop recorder implants and cardioversions.

How are new employees oriented and trained at your facility?
       New employees who come with experience or from accredited Allied Health Programs are oriented and trained by the Team Leaders. All employees are required to be certified in Basic Life Support and Advanced Life Support, which is offered in-house by certified personnel.
       Newly hired employees attend a two-day orientation to learn about our healthcare system. They must complete a series of mandatory training modules before being assigned to a preceptor within the EP lab. Performance evaluations are conducted at 30-, 60-, and 90-day intervals. A medication calculation test and moderate sedation test must be passed to prove competency. Didactic classes are also offered at the Area Health Education Center.
       We have implemented the B.E.S.T. Program (Building Effective and Stronger Teamwork). This orientation program is available for students and hospital staff who wish to gain a clearer perspective of the electrophysiology lab and its exciting challenges and career opportunities.

What types of continuing education opportunities are provided to staff members?
       Staff members have the opportunity for CEUs at various times in the lab through product in-services. We send staff to symposiums in the area and to major conferences such as Advanced Cardiovascular Interventions (ACI), Transcatheter Cardiovascular Therapeutics (TCT), The American College of Cardiology (ACC), South Atlantic Society of Electrophysiology for Allied Professionals (SASEAP), and the Heart Rhythm Society (HRS). We also offer a “five-day” review course for employees who are challenging the registry.
       All vendors are required to sign up to conduct in-service programs. In-services are scheduled through our educational coordinator and communicated to staff via a monthly event calendar.
       Our staff and other cardiac nurses participate in an annual in-service that provides the opportunity to dissect pig hearts to better understand the anatomy of the heart. It also gives the staff a chance to learn first-hand how difficult it can be for the physician to place pacemaker and ICD leads.

How is staff competency evaluated?
       Staff competency is evaluated monthly by our team leaders and annually by our technical supervisor. Staff, in collaboration with their supervisors, formulates Individual Education Plans, which includes goals, objectives and the resources necessary for the individual to be successful. We provide an annual competency day. All staff is tested and must pass these exams in order to demonstrate they have the knowledge to safely and effectively perform their duties.

How do you prevent staff burnout?
       Administration works tirelessly to ensure that our compensation rates are competitive with other labs. We have initiated an individual Productivity Incentive Program for Invasive Specialists and nurses. It rewards employees for high levels of productivity, high-quality service delivery, and exemplary work performance. The incentive is based on a weighted case average.
       In addition, there are various after-work activities to encourage team work and increase staff morale.

What committees, if any, are staff members asked to serve on in your lab?
       Staff members are currently participating in a JCAHO education committee, Service Excellence, Shared Governance, Code STEMI, Patient Satisfaction, Hematoma Process Improvement, and the Annual Nurse/Invasive Specialist Day “Expanding Horizons: Cardiac Cath Lab” held at Hilton Head, South Carolina.

How do you handle vendor visits to your department? Do you contract with vendors?
       A new vendor policy was recently implemented. This policy allows for more rigorous control of the vendors. This was necessary because of HIPAA guidelines and AdvaMed. The policy requires documentation of sales representative’s education, vaccinations and corporate compliance. It also allows for easy identification of the vendors because of hospital-issued ID badges and the requirement for standard color of scrubs, different from hospital staff. Each vendor is assigned a scheduled day in the lab and are only allowed in the procedure rooms if the physician invites them.

Does your lab utilize any alternative therapies?
       Alternative therapies for pain management are available through our pastoral care department. We use music and touch therapy to relax our patients during the procedure. Recently, we installed XM radio in all our procedure rooms for our patient’s enjoyment. During procedures in which moderate sedation is utilized, a "patient person" is assigned to monitor the patient's needs throughout their treatment.

Please describe one of the more interesting or bizarre cases that have come through your EP lab.
       Many of our cases are particularly challenging. One of our more complex patients exhibited continuous multi-focal PVCs, which required the use a combination of RF and cryo therapy. This extremely long case resulted in NSR. Recently, we encountered two cases of Permanent Junctional Reciprocating Tachycardia (PJRT). Both patients were quickly diagnosed and treated with RF therapy with successful outcomes.

How does your lab handle call time for staff members? How often is each staff member on call? How frequently do they have to come in, on average? Is there a particular mix of credentials needed for each call team?
       EP technologists do not take call or work weekends.

Does your lab use a third party for reprocessing?
       Some of our diagnostic catheters are reprocessed through a third party.

Approximately what percentage of your ablation procedures are done with cryo? What percentage is done with radiofrequency?
       Approximately 85% of our procedures are performed with radiofrequency. Cryo therapy is performed on the remaining 15% of procedures.

Do you perform only adult EP procedures or do you also do pediatric cases? Is there cross training for pediatric cases?
       We provide all EP services to both adult and pediatric populations. All EP Specialists are required to be proficient in pediatric cases as well.

Do your nurses/techs participate in the follow up of pacemakers and ICDs? If so, how many device visits per week do they handle? Do you use any particular software for follow up? How many of your ICD/pacemaker patients require a doctor for their visits?
       Pacemaker nurses at Sanger Clinic provide all implantable device post care and follow-up. Cardiac rehab nurses provide post-implant education. Approximately 1,650 device visits per month are seen through the clinic. The nurses use PaceArt software system for follow-up. The nurses primarily assess the patient, and only a small population requires a doctor for their visits.

What trends do you see emerging in the practice of electrophysiology? How is your lab preparing for these future changes?
       The frequency of VT and atrial fibrillation ablations performed in the lab are increasing. New guidelines have created a greater need for ICD implants. The efficiency of our staff members has decreased procedure times, which allow us to accommodate these changes.

What are your thoughts about non-EPs implanting ICDs? Do you train such individuals?
       EP cardiologists perform the majority of implants. Our thoracic surgeons collaborate with the EP cardiologists with sub-pectoral and epicardial implants and lead extractions. One of our general cardiologists developed an interest in pacemakers and ICDs during his training. He passed the NASPE exam and was mentored by his EP colleagues. This individual now has privileges to implant devices, and does so with great success.

What about device recalls? How has your lab handled these?
       The cath labs and Materials Management Administrations along with the physicians are notified by the company of the recall details. The appropriate assessment is performed and decisions are made regarding the course of action to be taken.

Is your lab doing web-based/transtelephonic device follow-up?
       Sanger Pacemaker Clinic does web-based/transtelephonic device follow-up.

Is your EP lab currently involved in any clinical research studies or special projects? Which ones?
       The research team at Carolinas Medical Center is currently involved in the MADIT-CRT study. The Sanger Clinic is participating in the OMNI study, ACT registry and IMPEDE-HF.

When was your last JCAHO inspection?
       Our last inspection was in 2003. We are expecting an unannounced visit in 2006.

Are you ACGME-approved for EP training? What do you think about two-year EP programs?
       We are not ACGME-approved for EP training. Our physicians, because of their expertise, are frequently called upon to teach, mentor, and train other physicians on advanced methodologies and technologies.

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?
       ICD support group meets every other month. Sanger Pacemaker Clinic nurses provide education to patients during wound and device checks. In addition, CMC offers other patient education programs through the center for cardiovascular health and the “Heart of a Woman” program.

Give an example of a difficult problem or challenge your lab has faced. How it was addressed?
       We have initiated an individual Productivity Incentive Program for Invasive Specialists and nurses in order to resolve staffing issues and motivate the team to complete a maximum number of procedures between 7:30am and 6:00pm. The incentive rewards employees for high levels of productivity, high-quality service delivery, and exemplary work performance. It is based on a weighted case average. Since its inception, there have been noteworthy results: 89% of the cases have been completed by 6:00pm; the Lab won the PRC 5-Star award for overall quality of care and likelihood to recommend; there has been positive impact on staff morale; the vacancy rate has decreased from 17% to 4%; and overtime has decreased by 28%.

Describe your city or general regional area. How does it differ from the rest of the U.S.?
       Charlotte, also known as the Queen City, is the largest city between Washington, D.C. and Atlanta, Georgia. Its metro area population is 2.2 million. Charlotte’s southern charm presents a blend of the old and the new, as it is one of the fastest-growing areas in the country. It is strategically located nearly midway between the wonderful beaches and resorts of the Atlantic coast, and the exhilarating Blue Ridge and Great Smoky Mountains. Charlotte is known for its great weather, options for golfing, diversified shopping, boating and fishing on its many lakes, professional sports, and NASCAR races. It is the second-largest banking center in the country, and the home of many thriving corporations, colleges and universities. Construction is underway on an official Olympic training facility, the U.S. National Whitewater Center and the NASCAR Hall of Fame. Charlotte is a vibrant city that has something for everyone, allowing us to attract the best and the brightest.

Please tell our readers what you consider unique or innovative about your EP lab and staff.
       There are several areas in which we consider ourselves unique. We have a fully integrated and cross-trained EP staff. They are proficient in all three positions; scrub, circulator, and record. They operate the intracardiac monitoring/recording systems, cardiac mapping systems, and the external stimulator.