Carolinas Medical CenterCardiac Catheterization Laboratory

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. The cardiac cath lab is the third largest in the state. What is the size of your cath lab facility and number of staff members? We have eight invasive cath suites that consist of: 1 same-day cardiac diagnostic/ vascular diagnostic 1 vascular 3 interventional/diagnostic 1 pediatric/adult 2 EP labs. Two of the eight labs have bi-plane capabilities. Pre/post procedure holding areas are divided into a 10-bed outpatient unit, a 14-bed inpatient/ outpatient unit, a 5-bed unit for peripheral vascular, and 1-bed pediatric area. The lab schedules patients 7 days a week five days between the hours of 0730 and 1800, and on the weekend between 0730 and 12:00. The remaining hours are covered by on-call personnel. We also have a diagnostic cath lab with a four-bed holding area in a satellite facility approximately 10 miles away. The lab has approximately 70 FTEs, with credentials that include RCIS, RCP, RTR, EMT, RN, and CVT, as well as office support staff. Seniority runs from a few months to 25 years, with the average length of service at approximately five years. What types of procedures are performed at your facility? We perform a wide array of procedures on adult and pediatric patients. On average, we complete 200+ procedures per week, of which approximately 35 are peripheral. Adult procedures performed include: angioplasty, stenting, Rotablator® (Boston Scientific, Maple Grove, MN), directional coronary atherectomy (DCA), laser, AngioJet (Possis, Inc., Minneapolis, MN), Frontrunner CTO catheter (LuMend, Inc., Redwood City, CA), intravascular ultrasound, FloWire (Volcano Corporation, Rancho Cordova, CA), Cutting Balloon (Boston Scientific Corporation), balloon valvuloplasty, right ventricular (RV) biopsy, carotid stenting, aortic stent grafting, peripheral coiling and stenting, bi-ventricular pacemakers and implantable cardioverter defibrillators (ICDs), electrophysiology (EP) studies, radio frequency (RF) and cryo ablations, tilt table studies, and cardioversions. Pediatric procedures include diagnostics and interventions, angioplasty/stenting, coil embolizations, and septal occlusions. Our staff also performs aortic stent graft procedures in the O.R. Does your cath lab perform primary angioplasty with surgical backup? Our lab performs interventional procedures with surgical backup. We have one OR suite that remains open for emergent cases. When an OR suite is needed emergently, the on-call cardiac surgeon is consulted and performs the procedure. What procedures do you perform on an outpatient basis? We perform adult and pediatric diagnostic procedures, EP studies, device change-outs and RV biopsies on an outpatient bases. What percentage of your patients is female? Approximately 40% is female. What percentage of your diagnostic cath patients go on to have an interventional procedure? Forty-five percent of our procedures are diagnostic and fifty-five percent are interventional procedures. A portion of our interventional procedures are referrals from outlying facilities. Who manages your cath lab? Patricia Pye, RN, MS, is the Director of Invasive and Non-invasive Cardiovascular Services and manages the cath lab, cardiology and heart failure. Kevin Collier, RCIS is the Clinical Supervisor and oversees all cath technologists, the scheduling board, and the educational coordinator. Dennis Chadwick, RCIS, BS is the Technical Supervisor and oversees all inventory management, digital imaging, the computer networks, and electrophysiology. 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 nine team leaders to supervise the 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. The Medical Director is B. Hadley Wilson, MD and the Assistant Medical Director is Robert H. Haber MD; Samuel Zimmern, MD is the Director of the Electrophysiology Labs, Jeremiah H. Holleman, Jr., MD is Director of the Vascular Lab, and Herbert Stern, MD is the Director of the Pediatric Lab. Do you have cross-training? Who scrubs, who circulates and who monitors? All technologists/nurses are cross-trained to fill every role (scrub, circulate and monitor) and they rotate positions for every case (i.e., scrub to monitor, monitor to circulate and circulate to scrub). All technologists dispense medications under the direct supervision of the physicians. Does an RT (radiologic technologist) have to be present in the room for all fluoroscopic procedures in your cath lab? All technologists/nurses run the fluoroscopic equipment under the direction of the physician. However, there are RT(R)s in the lab. Which personnel can operate the x-ray equipment (position the II, pan the table, change angles, step on the fluoro pedal) in your cath lab? The physicians primarily operate the x-ray equipment, while lab personnel inject contrast. Does your lab have a clinical ladder? Non-registered technologists are assigned as Cath Tech I, RCIS-qualified become Cath Tech II, and RCIS in charge of a room are Cath Tech III/Team Leaders. We are in the process of modifying the clinical ladder to recognize clinical excellence in addition to leadership. The Holding Area nurses have a clinical ladder that recognizes clinical excellence. What are some of the new equipment, devices and products introduced at your lab lately? We have updated our Medcon Digital Imaging and Archival system (Whippany, NJ). We are using the Proxis® Embolic Protection System (Velocimed, Inc., Maple Grove, MN) and Safe-Cross wire (Intraluminal Therapeutics, Inc., Carlsbad, CA) for our CTO cases with RF ablation. We use Boston Scientific Galaxy II IVUS Systems. Our EP labs are now using cryo for ablation and we are performing more atrial fibrillation (AF) and ventricular tachycardia (VT) ablation cases. Can you describe the system(s) you utilize and how they work in cath lab daily life? We have been filmless since April 2002. All of our labs have Philips fluoroscopy equipment (Bothell, WA). Images are transferred to the Medcon archival system. The Medcon system allows us to store echo and coronary ultrasound images. It allows images to be obtained from outlying hospitals for consults. Images are available throughout the lab and in the OR. Our hemodynamic monitoring system is Witt Biomedical Series IV system (Melbourne, FL). This system has been networked throughout all the labs and the hospital information system. Our scheduling system was created by CMC’s Information Services. It is networked to the entire nursing unit. This allows the units to determine when their patient will be called for and allow adequate time to prep the patient. How is coding and coding education handled in your lab? The Sr. Management Associate handles all billing and coding in the lab and communicates with the appropriate personnel. The Associate collaborates with Medical Records, Chargemaster, Billing and Clinical Care Management to insure that billing is accurate, optimized and in accordance with all regulatory guidelines. How does your lab handle hemostasis? We use manual pressure as the gold standard with/without hemostasis devices (Chito-Seal [Abbott Vascular Devices, Redwood City, CA] and D-Stat Dry [Vascular Solutions, Minneapolis, MN]), C-clamp, FemoStop (Radi Medical Systems, Wilmington, MA), Angio-Seal (St. Jude Medical, Minnetonka, MN), Perclose (Abbott Vascular Devices), VasoSeal (Datascope Corporation, Mahwah, NJ), and Duett (Vascular Solutions). A certified cath tech/nurse utilizes Angio-Seal under physician supervision. The scrub tech or holding area nurse pulls the sheath in the holding area. Patients are observed in the main holding area and subsequently discharged or transferred to an inpatient unit. Does your lab have a hematoma management policy? Our lab follows the American College of Cardiology (ACC) guidelines for hematoma management. Although the number of hematomas is extremely low, we do have a Groin Management and Hematoma Process Improvement Project in place. We attribute our low hematoma rate to our 3-M strategy. All sites that have any indications of a potential issue are carefully MARKED and MEASURED to remove subjectivity of the actual size. The patient is then MONITORED frequently to determine if there are any physical or psychological changes necessitating modification of the treatment plan. Lastly, the site is managed based on the outcomes of the marked and monitored area. Our goal is to prevent ever reaching the ACC threshold for a hematoma by applying moderate pressure above the puncture site while it is still contained. How is inventory managed at your cath lab? Our inventory is managed through the Witt Biomedical Series IV system (Melbourne, FL). 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-level report is generated daily. Inventory is managed by the Materials Coordinator. The responsibilities of the position include: Maintaining current par levels. Identifying par level shortages and overages. Identifying equipment that is near or exceeded expiration date. Maintaining monthly equipment usage reports. 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. There must be a FDA approval letter on file in the cath lab. 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, PA) Inventory system and were very impressed by the concept of RFID 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 cath lab recently expanded in size and patient volume, or will it be in the near future? The lab expanded in the summer of 2002 with the addition of a diagnostic lab in one of our outlying hospitals. Our patient volume in interventional procedures has increased due to a referral system. Also during 2002, the Heinemann Vascular Lab was opened, and this is where the majority of our vascular procedures are performed. Renovation and modernization of two labs (1 interventional and 1 EP lab) was completed in the fall of 2004 and an additional interventional lab was completed fall of 2005. Is your lab involved in clinical research? Exciting clinical research projects in the cath lab are constantly underway. Current interventional clinical research includes: COSTAR II (evaluation of a drug-eluting stent), Endeavor VI (evaluation of a drug-eluting stent), TIMI 38 (evaluation of a drug), EVEREST I (evaluation of eClip), EVEREST II (evaluation of eClip), Madit CRT (evaluation of an ICD), ACROSS (Evaluation of a CTO device), CAPTURE (evaluation of a carotid stent), CREST (evaluation of a carotid stent), and ENOVUS II (evaluation of a device). We also have many ongoing clinical research programs in cardiac pharmacology, electrophysiology and congestive heart failure. The EVEREST trials (I & II) are an evaluation of a percutaneous mitral valve repair clip that allows a prolapsed mitral valve to be repaired without surgery. The first procedure in North and South Carolina was performed here in September 2005. It was an unqualified success. The patient was discharged the following day rather than having an open heart procedure and being hospitalized for several days. Carolinas Medical Center researchers, under the direction of Dr. Patrick Burgess and in collaboration with the cath lab, also led a study that found sodium bicarbonate effective in preventing contrast-induced renal nephropathy. Have you had any cath lab-related complications in the past year requiring emergent cardiac surgery? Our emergency CABG rate for failed interventions is approximately 0.1-0.2%. What measures has your cath lab implemented in order to cut or contain costs? In 2000, the Carolinas HealthCare System formed an interdisciplinary team of cardiologists, healthcare administrators 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. What type of quality control/quality assurance measures are practiced in your cath 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. We have a group of nurses that review charts and work with the physicians in collecting data for all interventional procedures. We are the lead hospital in the first U.S. multi-center Stent Registry. In October 2004, the lab implemented a Code STEMI protocol. A Code STEMI is an integrated response to the diagnosis of acute ST-elevation myocardial infarction (MI) using a level one trauma approach. It involves activation of specific procedures by the emergency department, cardiologists, cardiac catheterization lab, the hospital laboratory, radiology, respiratory care, bed management and others. Pre-hospital diagnosis of acute ST-elevation MI is made by paramedics using 12-lead electrocardiography in the field. Since time is of the essence, maximizing the preparation during the period of transport to the hospital speeds timely intervention. Since Code STEMI has been implemented, average time from field to dilatation is 79 minutes. How does your cath 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, PA. They employ approximately 50 cardiologists in multiple facilities in North Carolina and South Carolina. One of the services provided by our digital archive company, Medcon, is a web-based DICOM image transfer service called eMedcon. This service allows referring facilities to upload images (cath or echo) to a secure server that facilitates consulting services with our physicians. There are presently thirteen facilities that utilize our eMedcon network and send interventional cases to Carolinas Medical Center. We maintain a growing fleet of aircraft that includes: 2 EMS helicopters, 2 turbo-prop airplanes and 1 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 En-reach, educational forums, health screenings, and hospital-sponsored community activities. 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 Cath Techs II or III for an average of 90 days to achieve minimum standards. Some of our new, inexperienced employees start their training at the diagnostic lab in our satellite hospital. This allows them to learn the system and receive a detailed orientation in a slower-paced environment. Advancement is to the main cath lab and then into the Stent Center. All employees are required to be certified in Basic Life Support and Advanced Life Support, which is offered in-house by certified personnel. What type of continuing education opportunities are provided to staff members? Staff members have the opportunity to obtain 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), American College of Cardiology (ACC), and the Heart Rhythm Soeiety (HRS; formerly NASPE). 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. We have developed a Professional Exchange Program with hospitals across the country. The purpose of the program is to enrich clinical knowledge, create networking opportunities, and enhance each cath lab’s service excellence. How do you handle vendor visits to your lab? A new vendor policy was recently implemented which allows for more rigorous control of the vendors. This was necessary because of HIPAA guidelines and AdvaMed. The policy requires documentation of a 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 a standard color of scrubs, different from hospital staff. Each vendor is assigned a scheduled day in the lab. They are only allowed in the procedure rooms if the physician invites them. How is staff competency evaluated? Staff members are evaluated in writing on a monthly basis by their team leader. Annual evaluations and merit raises are accomplished by the lab supervisors. The evaluation is comprised of the 12 monthly team leader evaluations and input from the lab supervisors and the director. All evaluations require commentary on: technical ability, interpersonal relations, patient care, self motivation, and team player attributes. Does your lab utilize any alternative therapies (such as guided imagery)? 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. How does your lab handle call time for staff members? There are six call teams. The teams rotate their call day on a weekly basis. The team that covers Friday call also covers that weekend, if the weekend team has rotated off. Since all staff members are cross-trained, no specific credentials are required. All cath teams have three to four members who stay to finish scheduled late cases; three are on beeper for call back. What trends do you see emerging in the practice of invasive cardiology? We see primary interventions, a blending of surgical and percutaneous treatments, more non-invasive diagnostic techniques, shorter bed rest, shorter hospital stay and more evidence-based protocols as emerging practices in invasive cardiology. Has your lab undergone a JCAHO inspection in the past three years? The lab was inspected in the fall of 2003. No deficiencies were noted and we were awarded a verbal commendation for practices and processes. We have an ongoing system to maintain our proficiency for unannounced JCAHO inspections. Where is your cath lab located in relation to the OR department, ER, and radiology departments? The cath and EP labs are on the sixth floor and the OR department is on the fifth floor, one level below. We have a special elevator designated for emergency usage. The ER is on the third floor, three levels below. Radiology is on the fourth floor, two floors below the cath labs and on the same level as the vascular lab. Please tell the readers what you consider unique or innovative about your cath lab and its staff. Carolinas Medical Center is one of only twelve medical centers in the U.S. and twenty-five in the world which performed live case presentations at TCT 2003 and 2004 in Washington, D.C. During the 2005 TCT, Dr. Charles Simonton presented late-breaking news from the STENT Registry clinical trials regarding a head-to-head comparison of the Cypher (Cordis Corporation, Miami Lakes, FL) and Taxus (Boston Scientific Corporation, Maple Grove, MN) drug-eluting stents. Carolinas Medical Center has the only pediatric interventional and electrophysiology programs in Western North Carolina. Each year the staff participates in The Annual Advanced Cardiovascular Intervention (ACI) Symposium at Hilton Head Island, South Carolina. The chief mission of this conference is to offer a state-of-the-art learning opportunity in interventional cardiology. This is accomplished through lectures and interactive video case presentations covering the most current topics and technologies. All techs are cross-trained to work in all positions. They administer medications under the direct supervision of the physician. They all have to rotate to all labs, with the exception of EP. They are required to be proficient in all elements of adult, cardiac, peripheral, and pediatric diagnostics and interventions. The Carolinas Heart Institute is a preceptor site for staff technologists and physicians for the Galaxy II System (intravascular ultrasound, Boston Scientific Corporation). It is also the Center for Endovascular Preceptorship for cardiologists and the only National Center for certification for carotid stenting in North and South Carolina. The Carolinas Medical Center’s cath lab is a phase II training site for both Central Piedmont Community College (Charlotte, NC) and Santa Fe Community College (Gainesville, FL) cardiovascular programs. We have initiated an individual Productivity Incentive Program for techs 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. We have implemented the B.E.S.T. Program (Building Effective and Stronger Teamwork). This orientation program is available for students and staff who wish to gain a clearer perspective of the cath lab and its exciting challenges and career opportunities. Is there a problem or challenge your lab has faced? We have an increased number of novices in our lab. We provide them with many in-services taught by selected vendors and senior staff. A referral bonus has been instituted for staff that recruits new and experienced personnel. During orientation, the senior staff is provided a vacancy incentive of $5.00/hour for working in coronary diagnostics and interventions over and above their scheduled hours. What’s special about your city or general regional area in comparison to the rest of the U.S.? How does it affect your cath lab culture? 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. Charlotte is a vibrant city that has something for everyone, allowing us to attract the best and the brightest. The Society of Invasive Cardiovascular Professionals (SICP) has added two questions to our spotlight: 1. Do you require your clinical staff members to take the registry exam for Registered Cardiovascular Invasive Specialist (RCIS)? Does staff receive an incentive bonus or raise upon passing the exam? The Cath Tech II and III/Team Leader positions require passing the registry. When a Cath Tech I pass the registry they are promoted to Cath Tech II and receive a 5% pay raise. We encourage our staff to sit for the registry and provide them with an in-house registry review class and study guides. 2. Are your clinical and/or managerial team members involved with any professional organizations that support the invasive cardiology service line, such as the SICP, ACVP, or regional organizations? Yes. The ACCA, ACC, SICP, and HRS. Patricia Pye can be contacted at Patricia.Pye@carolinas.org

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