Providence St. Vincent Medical Center Cath Lab

What is the size of your cath lab facility and number of staff members? St. Vincent’s cath lab has seven rooms, one of which is a digital operating suite, shared with the cardiovascular operating room (CVOR). Of the remaining six rooms: • one is a neuro/bi-plane room; • three are dedicated to cardiac procedures; • one is a Philips Allura Xper FD20 (Bothell, WA) used for peripheral cases, with the capability to also do cardiac procedures; • one is used for both cardiac and peripheral procedures as a dual-plane room. An outpatient cath lab affiliated with the hospital is also located nearby. The digital operating suite is located within the CVOR. It is used not only for cardiac procedures, but for any surgery that needs to be performed, ranging from open heart to craniotomy, to abdominal or any peripheral surgery. At present, it is most frequently used for abdominal aortic aneurysms (AAA) and thoracic aortic aneurysm (TAA) endografts. We have performed 314 AAA and 33 TAA procedures thus far. We have also been involved with the delivery of several babies in the digital operating suite. There is a total of over 500 years experience in the lab. Staff members vary from two years to 34 years of employment. We have 34 staff, consisting of twelve cardiovascular technologists (CVTs), ten registered nurses (RNs), eight radiologic technologists (RTs), two administrative assistants, one coding and reimbursement specialist, and one materials specialist. St. Vincent’s Medical Center does have an electrophysiology (EP) lab, consisting of two suites, with a third suite planned. What types of procedures are performed at your facility? We perform cardiac cath procedures for adults, including diagnostic and interventional procedures. In our interventional cardiac cases, we have assisted the physician in the use of rotational atherectemy, coronary thrombectemy, laser therapy, kissing balloon and crushing stent techniques, FilterWire (Boston Scientific, Natick, MA), pressure wire, intravascular ultrasound (IVUS), intra-aortic balloon pump (IABP) insertion, temporary pacer placement, patent foramen ovale (PFO) and atrial septal defect (ASD) closure devices, and of course, the placement of both drug-eluting and bare-metal stents. We also perform right and left heart caths, bi-ventricular pacemaker placement and permenant pacemaker placement. As for peripheral cases, we perform a wide range of procedures, including aortic run-off, (single or bilateral, with possible angioplasty or stenting), thrombolytic infusion to thrombus in the leg, thrombolytic infusion catheter system placement (EKOS Corporation, Bothell, WA), AngioJet (Possis Medical, Inc., Minneapolis, MN), Rinspirator (ev3, Inc., Plymouth, MN), SilverHawk atherectemy (FoxHollow Technologies, Inc., Redwood City, CA), cryoplasty, dialysis graft angioplasty, kyphoplasty, vertebroplasty, Arcuplasty (Medtronic Inc., Minneapolis, MN), Yttrium-90 (Y-90) therasphere administration, drug-eluting bead deployment, Portacath and Permacath placement, cerebral angiograms with possible coilings, Wada testing, cerebral angiogram for acute stroke and thrombosis retrieval (St. Vincent Hospital is a Stroke Center), nephrotube placement, renal angiograms with possible intervention, and AAA and TAA endograft placement. We also do uterine artery and uterine fibroid embolizations, and have participated in the delivery of four babies with post-delivery uterine artery embolization. Our volume for 2007 was approximately 400-425 cases per month. The outpatient lab, which started working with us in February 2008, is averaging 30 cases per month. Does your cath lab perform primary angioplasty with surgical backup? Yes, we have 24/7 support from our cardiothoracic surgery department, consisting of several teams whose availability depends on cardiothoracic cases in progress. What procedures do you perform on an outpatient basis? Outpatient elective procedures performed in our lab include cardiac angiogram with possible angioplasty or stenting, permanent pacemaker insertion, portacath placement or removal, dialysis graft angiogram with possible angioplasty, Y-90 therasphere administration, cerebral angiograms, Wada tests and aortic run-off with possible angioplasty. What percentage of your patients is female? About 40% of our patients are female. What percentages of your diagnostic cath patients go on to have an interventional procedure? Approximately 35% go from diagnostic to interventional cardiac procedures. Most of our cardiac interventions are scheduled to be interventional only. Many of our patients have elective diagnostic procedures done at a free-standing cath lab and then have the intervention done at our lab, which decreases the amount of patients with diagnostic caths that go on to intervention. Who manages your cath lab? The cath lab is under the Heart and Vascular Institute. Kristy Wayson, RN, is the Assistant Administrator and Executive Director of Providence Heart and Vascular Institute. Our cath lab is regionally associated with other Providence hospitals in the area. Dan Scharbach, CVT, is Regional Director of Invasive Heart and Vascular Services. At the present time, he is managing the cath lab while we search for a new cath lab manager. A charge runs the day-to-day operations of the lab, either one of the senior technologists or the charge RN. Do you have cross-training? Who scrubs, who circulates and who monitors? There are some staff who have chosen to cross-train into different roles in the cath lab. Approximately 75% of our scrubs are certified cardiovascular technologists, with several certified as a registered cardiovascular invasive specialist (RCIS). There are a few RTs and RNs who also scrub. We staff four to a room during a case. One person is scrubbed in with the physician, one monitors the case and documenting, one RT runs the x-ray equipment, and one RN monitors and accesses the patient. The scrub and monitor technologist positions are rotated every other case. Does an RT have to be present in the room for all fluoroscopic procedures in your cath lab? Yes, an RT has to be present in the room for all fluoroscopic procedures in our cath lab, based on Oregon state law. 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 RT is the only personnel that can operate the x-ray equipment (position the II, pan the table, change angles, and step on the fluoro pedal) besides the physician. If your lab performs peripheral interventions, what disciplines are involved? Depending on the procedure, the same staff that assists with cardiac procedures also assists with peripheral procedures. Interventional radiologists, neurosurgeons and vascular surgeons all perform peripheral interventions in our lab. One cardiologist performs renal angiogram with stenting and carotid stenting, and also assists with TAA endograft placement. Another cardiologist is proficient in performing aortic run-off with atherectemy, angioplasty and stenting. What are some of the new equipment, devices and products introduced at your lab lately? Some of the most recent equipment introduced to our lab in the last year includes the Rinspirator, iLab IVUS (Boston Scientific), Arcuplasty, the StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA), Diamondback 360°™ Orbital Atherectomy System (CSI, St. Paul, MN) and ultrasound-aided thrombolysis by EKOS. Can you describe the system(s) you utilize and how they work in cath lab daily life? We use the MacLab physio-hemodynamic monitoring system (GE Medical Systems, Inc., Waukesha, WI) for all of our monitoring and documentation needs. It is used in every cath lab procedure to generate an operative report, monitor hemodynamic rhythm and pressure changes, billing charges, statistical findings related to volume, caseload, length of procedure, contrast usage, fluoroscopy time, etc. We use Philips x-ray equipment (Bothell, WA), Heartlab (Agfa HealthCare, Greenville, SC) for storage of cardiac cases, and Stentor (Philips Medical Systems) for storage of peripheral cases. We currently have two ultrasound machines for use in gaining access and two IVUS machines. How is coding and coding education handled in your lab? Our coding and reimbursement (C&R) specialist is an American Academy of Professional Coders (AAPC)-certified coder with an educational background in health information management (HIM). All lab procedures are documented in the MacLab system, generated by clinical staff and then turned over the C&R specialist who audits, reconciles, and codes all cardiac and interventional radiology (IR) procedures. The procedural and supply charges are then keyed into a network system, which in turn generates a claim, overseen by our regional billing department. The coding of the IR cases is put into a separate format, forwarded to a HIM specialist who then reviews the codes and enters it into the patient electronic medical record. Staff education is handled annually through staff meetings. Ongoing education is delivered on a one-to-one basis, as well as via email and through inservices. How does your lab handle hemostasis? Hemostasis can be achieved for our patients through the use of manual pressure or closure devices. Closure devices currently used in our facility include Angio-Seal (St. Jude Medical, St. Paul, MN), Perclose (Abbott Vascular), and Starclose (Abbott Vascular). The SyvekPatch (Marine Polymer Technologies, Danvers, MA) is also used to stop oozing, and FemoStop (Radi Medical Systems, Wilmington, MA) is used for hematomas and non-controllable bleeding. If the sheath is removed in the lab, the patient leaves our area only once hemostasis is achieved and then goes to a recovery area in a different department, unless their condition warrants closer observation. For those who have the sheath left in, it is pulled in the recovery area by recovery staff. What is your lab’s hematoma management policy? When a hematoma occurs post procedure, the physician is made aware of it and will order an intervention as appropriate. Most often, a FemoStop is placed or manual pressure is held for a longer duration. How is inventory managed at your cath lab? Who handles the purchasing of equipment and supplies? Our materials specialist handles the ordering of equipment and supplies. In her absence, several of the senior technologists maintain supply ordering. A template of products is maintained for each physician and then an inventory of the product is maintained in the lab. Our specialist will notice when the inventory is low or needs replacement, and will order appropriately. Manufacturer representatives frequently stop by to help maintain inventory levels and assist with outdates. Our plan is to eventually move to a radio-frequency identification (RFID) system for inventory control. Has your cath lab recently expanded in size and patient volume, or will it be in the near future? The year 2007 was a year of change for our lab. We added an outpatient lab to the mix which had a positive impact on our volumes. As more interventions come from the outpatient lab, the overall volumes within the hospital will also increase. The outpatient lab continues to increase their volumes by doing port placements in addition to regular diagnostic cardiac caths. Is your lab involved in clinical research? St. Vincent’s Heart and Vascular Institute keeps our lab involved in several appropriate research opportunities. Staff enjoys being involved in new and exciting possibilities for treatment. A list of the research studies ongoing at Providence St. Vincent are as follows: SPIRIT IV Study: A Clinical Evaluation of the Xience™ V Everolimus Eluting Coronary Stent System in the Treatment of Subjects with de novo Native Coronary Artery Lesions. Principal Investigator: Todd Caulfield, MD Co-Investigators: Naveen Sachdev, MD, William Simkoff, MD; Richard Sohn, MD; Michael Wilson, MD Sponsor: Abbott Vascular RESPECT Trial: Randomized Evaluation of Recurrent Stroke Comparing PFO Closure to Established Current Standard of Care Treatment Principal Investigator: Todd Caulfield, MD Co-Investigator: Theodore J. Lowenkopf, MD Sponsor: AGA Medical Corporation PERSEUS Study: A Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the Taxus® ElementTM Paclitaxel-Eluting Coronary Stent System for the Treatment of De Novo Coronary Artery Lesions. Principal Investigator: Todd Caulfield, MD Co-Investigators: Naveen Sachdev, MD William Simkoff, MD; Richard Sohn, MD; Michael Wilson, MD Sponsor: Boston Scientific Corporation PATRIOT Study: Peripheral Approach To Recanalization In Occluded Totals Principal Investigator: Naveen Sachdev, MD Sponsor: FlowCardia Inc. The CHAMPION Study: A Clinical Trial Comparing Cangrelor to Clopidogrel in Subjects Who Require Percutaneous Coronary Intervention. Principal Investigator: Todd Caulfield, MD Sponsor: The Medicines Company Be-RITe! Registry: Benephit® System Renal Infusion Therapy Registry Principal Investigator: Naveen Sachdev, MD Sponsor: FlowMedica Inc. Closure of Patent Foramen Ovale with the Amplatzer® PFO Occluder: PFO Access Registry Principal Investigator: Todd Caulfield, MD Sponsor: AGA Medical Corporation Xience™ V Everolimus-Eluting Coronary Stent System USA Post-Approval Study Principal Investigator: Todd Caulfield, MD Sponsor: Abbott Vascular PROVIDE Study: Post-Market Observation Study of Intra-renal Drug Delivery Principal Investigator: Naveen Sachdev, MD Sponsor: FlowMedica, Inc. Clinical Registry of the St. Jude Medical Angio-Seal™ Evolution Device following Diagnostic and Interventional Endovascular Procedures Principal Investigator: Todd Caulfield, MD Sponsor: St. Jude Medical SPIRIT Small Vessel/Long Lesion Clinical Trial: A Clinical Evaluation of the ABT Everolimus-Eluting Coronary Stent System Principal Investigator: Todd Caulfield, MD Sponsor: Abbott Vascular The AWARE Study: A randomized, double-blind, placebo-controlled, parallel group, multicenter study to evaluate the efficacy and safety of Ad5FGF-4 in female patients with stable angina pectoris who are not candidates for revascularization Principal Investigator: Todd Caulfield, MD Co-Investigators: Naveen Sachdev, MD, Richard Sohn, MD; and Michael Wilson, MD Sponsor: Cardium Therapeutics, Inc. Have you had any cath lab-related complications in the past year requiring emergent cardiac surgery? There was a case in which the right coronary artery (RCA) became dissected and required emergent surgery. This is a very infrequent occurrence in our lab. What other modalities do you use to verify stenosis? Are you using physiology for lesion assessment? We have the Volcano pressure wire (San Diego, CA) and IVUS (systems by both Volcano Corporation and Boston Scientific) to verify stenosis in a coronary artery. What measures has your cath lab implemented in order to cut or contain costs? Our corporation has organized a multi-hospital resource counsel of cardiovascular laboratory managers and directors. They use the group purchasing organization Novation. This organization gives us buying power and we do corporate contracts for many of high-dollar items, such as implantable cardioverter defibrillators (ICDs), pacemakers, drug-eluting stents, etc. We have also taken advantage of company-offered bulk purchases in a quarterly buying option. The physicians have been instrumental in helping to work with the companies to lower their prices. What types of quality control/quality assurance measures are practiced in your cath lab? We monitor quality checks for our point-of-care testing equipment on a daily basis. We also perform various audits on our documentation. We use our MacLab system to query statistics on the amount of contrast and fluoro we are using on average during cases, and review for quality improvement. We have a monthly acute myocardial infarction (MI) meeting with our medical director (Mike Wilson, MD), an ED physician, the Heart and Vascular Institute, ED charge RN, and paramedics from the community to evaluate our times to treatment for acute MI patients and look at how we can improve. We follow the American College of Cardiology recommendations for door-to-balloon (DTB) times, and track these at the acute MI meetings. Our average DTB time for the period of January–June 2008 is 75 minutes. This includes a case that was transferred from an outlying hospital 40 miles away. From the time the patient hit the outlying hospital’s door to our balloon was under 90 minutes. We also have monthly morbidity and mortality meetings for patients who undergo serious complications in the cath lab. These meetings help to troubleshoot what was done well and what could have been done better, as we look to future cases. This meeting is led by the medical director, and all cardiologists practicing in the cath lab are invited. Another monthly meeting held for quality purposes is the “High Fluoroscopy” meeting. Our medical director screens cases for high fluoroscopy times, which are then brought to the meeting in order to discuss quality and efficiency of case times with cardiologists. How does your cath lab handle radiation protection for the physicians and staff that are in the lab day after day? All staff in the room, including physicians, are required to wear lead aprons and thyroid shields with an equivalent of 0.5 mm of lead. The aprons and thyroid shields are checked periodically to ensure there are not any aprons needing replacement. We also have the lead shields at the table for the physician and scrub to shield themselves. The nurses have a rolling lead shield to stand behind during the case. This affords them protection while still permitting monitoring of the patient. Staff is also very good at communicating with the physician when they need to take care of the patient, allowing the physician to hold off on stepping on the fluoro pedal. We also monitor the amount of radiation that each individual receives. How does your cath lab compete for patients? Has your institution formed an alliance with others in the area? We are a regional referral center and have formed alliances with several nearby facilities. Staff and physicians actually visit outlying hospitals to show them our protocols and how we can work together for the better care of the patient. How are new employees oriented and trained at your facility? What licensure is required for all professionals who work in your lab? We have a three-month orientation process in which the new employee will be paired with a senior staff preceptor. In that three months, the new staff member will follow guidelines and objectives in our orientation packet to help them gain skills specific to their discipline. They must fulfill all the competency requirements through their orientation. BLS and ACLS are required for all employees. RNs are required to maintain a current RN license in the state of Oregon. RTs are required to maintain current RT license in the state of Oregon, and CVTs are strongly urged to achieve and maintain the RCIS certification. All new CVTs must have their RCIS within one year of hire. What types of continuing education opportunities are provided to staff members? We offer annual competencies and inservices are held frequently to update staff on new technology and skills. We encourage education by posting all the relevant seminars and inservices of which we are aware. There are also many free sites on the internet to obtain continuing education. How do you handle vendor visits to your lab? Vendors are required to sign in at our front desk, wear a name tag and complete a vendor packet in which they are required to sign confidentiality agreements, receive hepatitis B vaccinations, and review policies about blood-borne pathogens. Tf the physician wants the vendor present, they are paged when the relevant case is about to start. Vendors are not allowed to give patient care. We appreciate the education our vendors can provide and the support they offer when using new products. How is staff competency evaluated? Staff competency is evaluated annually through “staff experts,” and quizzes or small exams that test the staff’s skills on several levels. The charge nurse and manager oversee the process ensure it is fair. Does your lab have a clinical ladder? The technologists do not currently have a clinical ladder. There is a four-step clinical ladder available to registered nurses in the cath lab. It reflects ongoing involvement in multiple areas of practice, including acting as a resource and preceptor, serving as a recognized expert/consultant in a specific areas of clinical practice, application of service excellence principles, exemplifying ongoing leadership/ ambassador roles, patient safety reporting, nursing quality improvement and involvement with shared governance activities. Clinical ladder step compensation is commensurate with the level attained. Does your lab utilize any alternative therapies (such as guided imagery, etc.)? At this time, there is no guided imagery program instituted in our department as a routine part of patient care. However, there are staff members who have utilized this technique under their own initiative to better improve patient care. How does your lab handle call time for staff members? Is there a particular mix of credentials needed for each call team? Call time during the week begins when all cases are complete, or 6:00 pm – 7:30 am. Call time is divided into one call night per week for each discipline. Weekend call is from 6:00 pm Friday through 7:30 am Monday. Weekend call frequency is generally once every 4-6 weeks. This schedule is maintained by two staff people dedicated to scheduling for the department. The call team consists of two CVTs, one RT and one RN. Within what time period are call team members expected to arrive to the lab after being paged? Call team members are expected to arrive within 30 minutes of the page. An attending cardiologist is not always on site when the page goes out. Often the cardiologist is already en route to the hospital when the call time is activated. The ED physician can activate the call team when they have a positive EKG from either the ED or from the field units. Cardiologists are also expected to arrive immediately or within 30 minutes after they have been paged. We also have a system in place for ST-elevation MI (STEMI) transfers. In those cases, we are notified of the case as the patient is leaving the outlying hospital en route to Providence St. Vincent Medical Center. Do you have flex time or multiple shifts? We staff with ten-hour shifts five days a week. Our hours are from 0730-1800 Monday-Friday. We staff for at the least four and up to five teams during the weekday. On the weekends, we staff with a call team for acute MIs. If the caseload is light, we allow staff the opportunity to go home and have extra time to spend with their families. Our outpatient lab is staffed from Monday-Friday during the hours of 0700-1730. If outpatient lab staff finish their cases and have discharged the patients to go home, they will then come up to the hospital lab for the remainder of the shift. Does your cath lab do electives on weekends and or holidays? We have a call team for emergencies and they do any cases that may come up. If a backup team is needed, the operators will call the rest of the staff after sending out a page. Holidays are covered with call people and elective cases are not scheduled. We function off a rotation that attempts to be as fair as possible so that one employee does not get several holidays more than another employee. Has your lab has undergone a Joint Commission inspection in the past three years? Yes, in 2006. The Joint Commission watched closely for us to label our medications on and off the table, including syringes and med cups. They were very interested in documentation of the point-of-care equipment. Where is your cath lab located in relation to the OR, ED and radiology departments? We are conveniently located two floors directly above the ED and adjacent to the CVOR. Our radiology department is located on the other side of the hospital. We are also located one level below labor and delivery, giving us quick access to patients who are delivering babies and need urgent uterine artery embolizations in the cath lab. There is also a interventional cardiovascular recovery unit (ICVR) located right across from the cath lab that receives and recovers patients post cath lab procedures. What trends do you see emerging in the practice of invasive cardiology? The use of clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi-Aventis) and bivalirudin (Angiomax, The Medicines Company, Parsippany, NJ) is a trend we see in our cath lab. Of course, the closure devices have only grown more and more popular over the last three years. Another trend we have noticed increasing in the last year and a half is the kissing balloon and/or crushing stent techniques used for bifurcation lesions. The patients have also been becoming younger and younger as the years go by. What do you consider unique or innovative about your cath lab and its staff? Most staff members are long-time employees. We have one employee who has over 30 years employment, five with over twenty years, and ten with over ten years employment. Our employees are passionate about their work and patient care. They work well with each other and will cover for one another when something comes up that a coworker wants to do. Is there a problem or challenge your lab has faced? How was it addressed? Our lab is challenged every month to meet or beat DTB times. We have improved our response times by making sleeping rooms available for staff when they are on call, having ED physicians page the call team immediately when suspicious of acute MI instead of waiting for the cardiologist to arrive, working with the hospital operators to create a blanket paging system that notifies everyone in the department carrying a pager, documenting times upon every acute MI call and meeting monthly to improve our times and outcomes. 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”? Our cath lab is located within about an hour of the ocean or mountains, wine tasting country, competitive professional sports teams, outdoor concerts and events, and a cool, steady climate. It affects our “cath lab culture” in that we have a diverse amount of interests, and this provides for a sense of fun and a great group of people. There is something for everyone in close proximity. 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)? Do staff receive an incentive bonus or raise upon passing the exam? At this time, the RCIS is not required, but it is strongly encouraged for those who have worked here long-term. New hires are required to have the RCIS. We are looking for ways to incorporate education to prepare for the test and make it easy for staff to obtain their RCIS. 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? Our regional manager, Dan Scharbach, is a member of the Alliance of Cardiovascular Professionals (ACVP) and we have several staff members looking to become part of these organizations. The authors can be contacted at Michael.Spangler@Providence.org

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