Tell us about your cath lab.
Carolinas HealthCare System Northeast has more than 4,200 employees that provide services through an extensive inpatient and outpatient network, including Jeff Gordon Children’s Hospital, Hayes Family Center, and Batte Cancer Center. Cardiology services are provided by the Sanger Heart and Vascular Institute. We are a primary percutaneous coronary intervention (PCI) center as well as a tertiary referral hospital for ST-elevation myocardial infarction (STEMI).
The cardiac catheterization/electrophysiology (EP) department consists of 3 labs: 2 cardiac cath labs, one of which is primarily a vascular lab, and 1 EP lab. We have a 13-bed pre/post procedure outpatient unit where we prep and recover all of our outpatients. We also perform outpatient and inpatient cardioversions (DCCV), and transesophogeal echocardiograms (TEE).
Our lab consists of 13 registered nurses (RNs), 4 registered cardiovascular invasive specialists (RCISs), 1 registered cardiac electrophysiology specialist (RCES), 1 registered radiologic technologist (RT[R]), and 1 care partner. Expertise in the department ranges from 2-25 years. We have a total of 12 cardiologists from Sanger Heart and Vascular Institute that perform procedures in the department. There are 3 interventional cardiologists and one vascular interventionalist.
What procedures do you perform?
We perform a variety of procedures in the department. The following procedures are performed in the cardiac cath, EP, and vascular labs:
- Left and right diagnostic catheterization;
- Percutaneous coronary intervention (PCI), which may include the use of intravascular ultrasound (IVUS), fractional flow reserve (FFR), instant wave-free ratio (iFR) (Volcano Corporation), AngioJet (Boston Scientific);
- Hemodynamic support with Impella (Abiomed);
- Device implants, intra-aortic balloon pump (IABP);
- Optical coherence tomography (OCT);
- CorPath robotic-assisted PCI (Corindus Vascular Robotics);
- Electrophysiology procedures/ablations;
- Permanent pacemaker (PPM), loop recorders;
- Implantable cardioverter defibrillators (ICDs);
- Biventricular (BiV)-ICD and BiV-PPM;
- Diagnostic peripherial angiograms;
- Vascular stents, venous studies, inferior vena cava (IVC) filter placement, atherectomy;
- Carotid stents, endovascular aneurysm repair (EVAR);
Is your lab planning a hybrid room in the future?
Yes, we are planning a hybrid room in the near future.
Does your cath lab perform primary angioplasty without surgical backup on site?
We have a surgical backup team available 24/7. Our cardiovascular operating room (CVOR) is conveniently located adjunct to our cath labs.
Do any of your physicians regularly gain access via the radial artery?
Interventional cardiologists regularly utilize radial access for diagnostic and interventional procedures. Overall for the last year, our percentage for transradial interventional procedures was 60%. However, we expect that number to continue to rise due to an increase in the number of STEMI cases performed via radial access.
Who manages your cath lab?
The manager of the cath and EP lab is Gina Young, BSN, RN-BC. She has been a nurse since 1992 and came to the cath lab in 1999, so she holds over 20 years of nursing experience, 17 of those in the cath lab. She is responsible for day-to-day operations of the lab. Dr. Kevin Kruse, interventional cardiologist, serves as the medical director and has been with the hospital for over 20 years. They work collaboratively to set quality standards and optimize patient care.
What percentage of your diagnostic caths is normal?
Approximately 20% of our diagnostic caths have non-obstructive coronary artery disease (CAD).
Do you have cross-training? Who scrubs, who circulates, and who monitors?
We provide cross training in our lab. The scrub role is performed by RCISs, RCESs, RNs and RT(R)s. RNs are assigned to the circulating role. The monitor role is shared by all staff members. We have a dedicated group of 3 staff members that work primarily in the EP lab; however, all 3 members are cross-trained to work in the cath lab, and cath lab staff is trained to work in the EP lab. Ablation procedures are always performed by the EP staff. We encourage all staff that work in the cath lab to become RCIS-certified and it is a requirement for all technologists.
Are there licensure laws in your state for fluoroscopy?
North Carolina has no state or local laws requiring licensing for operation of x-ray equipment. However, we strongly support efforts that would be instrumental in working to create laws requiring licensure for operating radiation-emitting equipment, such as the Consumer Assurance of Radiologic Excellence (CARE) Bill.
Since we have no state licensing laws, all staff members that scrub can perform positioning, panning, setting up views, and utilizing the fluoro pedal in our procedure rooms, under the direct supervision of the physician.
How does your cath lab handle radiation protection for the physicians and staff?
We use the standard ALARA (As Low As Reasonable Achievable) principle to minimize radiation. Minimizing time and maximizing distance is our aim. Lead-lined vests, skirts, thyroid collars, and eyeglasses are routinely used. We also use low-dose fluoroscopy and cineangiography for imaging, 15 frames per second and a fluoro-save for interventional procedures. No-brainer lead-lined hats, pelvic shielding to reduce scatter for radial cases, and long extension tubing for contrast injecting are utilized. Additionally, we use a Mavig swing table drape shield, a hanging Mavig facial shield and a portable chat ’em up screen for additional shielding (Figure 2). We also have recently been using the RaySafe radiation protection system to give real-time feedback on radiation exposure. The Corindus CorPath Vascular Robotic System offers the benefit of a radiation-shielded cockpit for coronary interventions. We receive monthly reports from our hospital’s radiation safety committee if we exceed radiation exposure limits set up for the purposes of monitoring safety.
Can you tell us more about some of the new equipment recently introduced at your lab? Why have you chosen to implement these new technologies?
We have instituted the use of the Corindus CorPath Vascular Robotic System, which has a radiation-shielded cockpit for coronary interventions. The RaySafe radiation protection system, which provides real-time feedback on radiation exposure, has also been recently implemented. We have also begun the regular use of our chat ’em up radiation protection screen, which is placed to the right side of the patient and to the left of the physician in order to limit the radiation exposure during LAO (left anterior oblique) shots, when the camera is closest to the staff. It was noted with the use of the RaySafe System that the highest radiation exposure was with LAO shots and with interventions working in the LAO projection. Use of a 48cm extension tube in place of the usual 24cm tubing allows for more distance between the technologist and the camera during contrast injection in interventions. All of these interventions have been undertaken with an eye towards reducing radiation and improving safety for the physicians and staff.
We have recently implemented the use of iFR software from Volcano Corporation to evaluate the severity of baseline lesions by angiography. We utilize the hybrid strategy and defer treatment with an iFR >0.93, and revascularize in those lesions with an iFR <0.86. Lesions in the gray zone (0.86-0.93) require adenosine administration. We have eliminated the use of adenosine in approximately 70% of our cases. This has allowed for improved procedure times, reduced cost with adenosine, and improved patient outcomes.
How have physicians and staff reacted to the introduction of the CorPath System?
The physicians have been very positive with the introduction of the CorPath Robotic System. It allows a significant reduction in radiation exposure for the primary operator, as documented by previous studies, with the use of the radiation-shielded cockpit (95% reduction). It allows for the ability to do coronary interventions without having to wear heavy lead vests and skirts, thus providing a more ergonomically friendly work environment. It allows for better visualization of the coronary arteries, as the screen is less than 10 inches in front of the operator. The system also allows more precise measurements and balloon/stent positioning via sub-millimeter controlled movements with the robotic device.
The staff has been very favorably influenced by our use of the CorPath Robotic System. It has enhanced their skill sets in regards to loading wires, balloon, and stents. It has had them become more actively involved in the cases and improved their confidence. Staff morale has been boosted as well as overall catheterization lab teamwork. Additionally, the CorPath Robotic System has caused them to become more acutely aware of radiation safety issues and more actively involved in factors aimed at reducing exposure for the entire catheterization lab team. The introduction of the robotic system influenced us all to be more acutely aware of radiation safety.
How does your lab communicate information to staff and physicians?
We implemented Managing for Daily Improvement (MDI) huddles to strengthen communication among our team. The entire staff attended training on Lean Basics to assure they were knowledgeable about the concepts on communication and group decision-making, really creating an environment for a change. The huddle is a time for the staff to bring forward ideas for improvement, equipment issues, any concerns, and to recognize the team for the work being done. Through the MDI huddles, departmental metrics are chosen and results are reported daily for continuous improvement. We have a monthly meeting with staff members and physicians. Any new products or medications are introduced by vendor representatives. Cath lab leadership attends several monthly meetings to discuss quality and any operational issues. The physicians and staff attended TeamSTEPPS training (via the Agency for Healthcare Research and Quality [AHRQ]) to improve communication and promote patient and staff safety. Teamwork is very important to our lab.
How is coding and coding education handled in your lab?
Procedures and supplies are entered into our cath lab documentation system (Merge), and through an interface, are sent to our billing system for daily charges. A physician and procedure report is created, and once it is electronically signed, it goes into the EMR. Coding reviews the documentation to ensure charges match. Two staff members are responsible for reconciling procedure charges each day for our cath labs, and the manager is the final check. The coding department applies the diagnosis codes according to the physician’s report, the case report, and any other supporting documentation available in the EMR.
Who pulls the sheaths post procedure, both post intervention and diagnostic?
All cath lab staff is trained to pull sheaths. Nursing staff on our cardiac units is also trained to pull sheaths. Per our policy, staff must show competency to pull 3 sheaths, and are proctored by either cath lab staff or a preceptor. All radial sheaths are removed by the physician post procedure and TR Bands (Terumo Interventional Systems) are utilized. A competency has been developed for removing TR Bands and again, employees must be proctored before signing the competency.
Where patients are prepped and recovered (post sheath removal)?
We have a 13-bay pre/post procedure area where all of our outpatients are prepped and recovered. If the patient is admitted to the hospital, they are placed on the Cardiovascular Intermittent Care Unit (CVIMC), Progressive Coronary Care Unit (PCCU), or the Acute Coronary Care Unit (ACCU). Angio-Seal (St. Jude Medical) is the closure device used most often in our lab, but we do have a variety of devices available.
How is inventory managed at your cath lab?
Inventory is managed in our cath lab by the team leader and manager. We have a new cath lab system that records all supplies used during each case, and at the end of the day, a report is generated that is used to order daily supplies. The supplies are ordered using the materials management system and the replenishment arrives to the lab within 1-3 days. The cath lab inventory system is used to maintain par levels within the lab and is used as a cost management system for fiscal inventory.
Is your cath lab expanding in size and patient volume?
Yes, we are growing at a rate of between 5 to 10% each year in cath volumes.
Is your lab involved in clinical research?
Carolinas HealthCare System Northeast and the Sanger Heart and Vascular Institute, along with our Clinical Research Department, is very active in clinical research. We are involved in device trials related to electrophysiology and coronary intervention, as well as pharmaceutical trials that are site-specific and some are multi-campus trials. The PRECISION Registry is a multicenter post-market registry for the evaluation of the safety and effectiveness of the CorPath System in PCIs. Currently, 122 participants have been enrolled at our facility. The staff exposure to X-ray during PCI: CorPath vs. Manual Observational Study is also currently enrolling patients who are randomized in the cath lab with a current enrollment of 27 participants in part “A” of the study and seven (7) participants in part “B”. The ABSORB IV study also randomizes participants in our cath lab. The ABSORB IV Study is assessing the safety and effectiveness of treatment of coronary blockages with a bioresorbable vascular scaffold system (BVS, Abbott Vascular) vs a metallic drug-eluting stent. ABSORB IV is a multi-site study that includes Carolinas Medical Center, Carolinas Healthcare System (CHS)-Pineville, and CHS-Northeast. We recently completed the EVERA MRI Study of the first FDA-approved MRI-safe ICD. An upcoming study is called BASELINE, sponsored by Google Life Sciences. This study extensively characterizes participants at baseline serially using a battery of clinical, imaging, physiometric, and molecular tools/testing. The study will enroll approximately 2000 patients with cardiovascular disease. We are also in the pre-approval process of a Phase III study of a new pharmaceutical treatment in subjects with acute coronary syndrome.
Can you share your lab’s average door-to-balloon (D2B) times and some of the ways and some of the ways employees at your facility have worked together to keep D2B times under the mandated 90 minutes?
Carolinas HealthCare System Northeast is a regional PCI center providing STEMI care for Cabarrus and surrounding counties. We are part of American Heart Association’s Mission: Lifeline, and have been working on improving STEMI care for many years. We have been awarded the Quality Achievement award as a Mission: Lifeline STEMI receiving center and have achieved gold plus recognition. We partner with our Cabarrus, Stanly, and Rowan County EMS agencies to bring best practices to the overall care for our patients. Our average D2B time is 48 minutes, which is within the top 10th percentile of the country. We have a highly engaged team of individuals who work to keep this initiative a high priority.
Who transports the STEMI patient to the cath lab during regular and off hours?
STEMI patients who present via the ED are transported to the cath lab by the ED staff. Patients who present by EMS bypass the ED during regular hours and are transported directly to the cath lab. Carolinas HealthCare System Northeast partnered with our local EMS agency to implement cellular ECG transmissions to the physicians’ handheld smart phones. This allows the physician to view the ECG in the field and make the decision whether to bring the patient to the cath lab.
What do you do when the call team is already busy doing a procedure and a STEMI comes into the ED?
If a STEMI presents in the ED and we have a patient on the cath table, we usually complete the diagnostic procedure and take the patient off of the table. If they require an intervention, we bring them back after the STEMI. If we are in the middle of an intervention, the interventional procedure is completed.
What measures has your cath lab implemented in order to cut or contain costs?
There is a Cardiac PEPS team, a collaborative team that looks at pricing, contracting, and equipment, that works directly with materials management, the cath labs across the system, and contracts to look for opportunities for cost savings. Most recently, through this work, we have seen considerable savings by limiting the number of vendors within our lab. Initiatives involving standardizing hemostasis devices, vascular products, and implantable devices contracts will be the focus in 2016.
What quality control/quality assurance measures are practiced in your cath lab?
Quality data from the National Cardiovascular Data Registries (NCDR) (PCI, ICD, and ACTION) are shared in a monthly Cardiovascular Quality Committee. This multidisciplinary team meets to review areas for improvement to help achieve goals and performance outcomes.
Who documents medication administration during the case?
The RN administers medications during the procedure and documents in the cath lab hemodynamic system. They are responsible for moderate sedation and complete a yearly competency to ensure safe medication administration.
Are your physicians dictating their cath procedure reports, or do they us a structured reporting tool?
In August 2015, a new Merge cath lab hemodynamic system was installed in our cath and EP labs. This system has a standard report, which flows directly to into our EMR once signed. The report is viewable before the patient leaves the cath lab, allowing for better communication to other healthcare providers. The Merge Healthcare system is used across our primary enterprise, making it a seamless approach to cath lab reporting.
What has been the impact of your hospital’s commitment to radiation safety in the cath lab?
Our hospital’s commitment to radiation safety has allowed for further education of staff about the significance of occupational hazards and safety procedures. It has brought an appreciation by the staff for the hospital’s commitment to human capital and the value of its employees to the greater mission. It is understood that providing for safety and prolonging the working careers of healthcare providers will lead to improvement in the care of our patients while providing for cost-effective efficient treatments. We are fortunate to work in a hospital system that acknowledges the value that an experienced healthcare team brings to the care of our patients.
How are new employees oriented and trained at your facility?
New employees go through at least a 6-week orientation program. They are assigned a preceptor and she/he takes care of all of their educational needs. Weekly meetings with the new employee, the preceptor, and leadership occur to determine any needs of the new employee.
What continuing education opportunities are provided to staff members?
Each staff member has around $1500.00 dollars of educational assistance money available for continuing education each year. There are in-services provided by the vendors for new equipment and once a year, we have a skills day. The day is devoted to training staff on all of the equipment in the lab that may be used for patient care. This keeps the staff knowledgeable about new equipment and changes in the current equipment. All staff members are required to complete a series of modules for the hospital for continuing education credit. The staff is eligible to attend national conferences and is encouraged to do so. It requires an application to the manager of the department with some requirements upon return.
How do you handle vendor visits to your lab?
We have a vendor policy in place that specifies how often vendors are allowed in the department. They must check in with Reptrax to obtain an ID badge that is dated for the specific date they are in the department. Some equipment representatives are allowed in the control room (determined by the procedure being performed) and others must remain in a designated area.
How is staff competency evaluated?
Staff competency is evaluated on an annual basis. We have an annual “education day” for the cath lab to validate those procedure skills that are identified as high risk and low volume. Staff is required to complete ACE modules as well as online “NEXT” learning modules.
Does your lab have a clinical ladder?
Yes. We currently have a clinical ladder for the nurses and the clinical invasive specialist. The nurses are able to apply for the Professional Nurse-Clinical Advanced Program through nursing services within our system. There are 3 levels they can achieve by completing an application and a portfolio of work. There is a monetary increase with each level achieved. The clinical specialists have a clinical ladder as well that requires steps to complete. There is also a monetary increase that in added to the base pay. Each clinical ladder step requires some approvals on what projects are allowed and the staff member must be in good standing.
How does your lab handle call time for staff members?
Each team member is assigned 6-10 call days a month. This includes their weekend rotation, which for the cardiovascular specialists, is every fifth, and for the nurse, it is every fourth. The call team consists of 1 cardiovascular specialist, 1 nurse, and 1 cardiovascular specialist or nurse. The team is available 24/7 for emergency calls.
Within what time period are call team members expected to arrive to the lab after being paged?
All of our staff is expected to respond to the hospital within 30 minutes. It is a requirement of employment that you are able to arrive within that specified time frame.
Do you have flextime or multiple shifts?
We do have multiple shifts in the department. Most employees work 10-hour shifts; however, we have some employees doing 12- and 8-hour shifts as well. Our pre and post procedure area is open until 7pm.
Has your lab recently undergone a national accrediting agency inspection?
We just had our triennial Joint Commission survey in June 2015. The cath lab was visited by the surveyor and the staff were questioned on post procedure education regarding moderate sedation, lead storage, and radiation safety. We highlighted the Corindus CorPath 200 Robotic System and the use of the RaySafe trial, since we are looking at both staff and physician safety. The survey went well. The only recommendation we received pertained to the way we stored our lead aprons. To bring our lab in compliance with the Joint Commission standard, we purchased lead hangers and removed the pegs.
Where is your cath lab located in relation to the operating room (OR) and emergency department (ED)?
The cath lab is located on the second floor of our hospital. There has been a lot of work to determine the best path especially for the STEMI transport. There is a back elevator adjacent to the Emergency Care Center and then a hallway directly into the cath lab suite. The cath labs are located next to the cardiovascular operating rooms.
What trends have you seen in your procedures and/or patient population?
We have seen an increase of radial access. We have had a decline in usage of glycoprotein IIb/IIIa inhibitors as well as the IABP. We have documented the appropriate use criteria (AUC) for our elective interventional procedures.
What is unique or innovative about your cath lab and staff?
We utilize the Corindus CorPath Robotic PCI System for many of our interventional procedures. At this time, we are the only hospital in North Carolina to have this innovative system. We also provide same-day discharge for outpatient PCI procedures. Our discharge rate is greater than 90%. We have also partnered with the local EMS agency on ECG transmission from the field. The ECG is sent to each physician’s phone, which allows for quicker diagnosis and an earlier deployment of the cath team. We utilized this technology to bypass the ED and go straight to the cath lab, saving time.
Is there a problem or challenge your lab has faced?
One of the challenges we have faced is maintaining our quality measures at 100% with aspirin, statin, and beta blocker given at discharge. We have implemented several measures as a reminder to the physicians and nurses. We monitor these measures and report them in our quality meetings.
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”?
Carolina HealthCare System Northeast is the only hospital within Cabarrus County, and is located approximately 20 miles east of Charlotte. We are fortunate to have great entertainment close by, such as the Charlotte Motor Speedway, home to Nascar Motor Sports. We are also just minutes away from Bank of America Stadium, home of the NFL Carolina Panthers. We are centrally located in North Carolina and it is only a short drive to the Blue Ridge Mountains or to the Outer Banks area. We are the PCI receiving center for surrounding rural counties and partner with local EMS to provide care. Most of our staff lives within Cabarrus County, which can help create a small-town feel. The staff delivers a great patient experience based on individual patient care needs.
A question from the American College of Cardiology’s National Cardiovascular Data Registry:
How do you use the NCDR Outcome Reports to drive QI initiatives at your facility?
We report data to the ACC-NCDR registries to benchmark our performance to like-size organizations and nationally. This data is reported monthly at our Cardiovascular Quality Meeting identifying opportunities for improvement.
Two questions from the Society of Invasive Cardiovascular Professionals (SICP):
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?
All cardiovascular invasive specialists are required to obtain the RCIS certification within one year of employment. There are 3 levels for the cardiovascular invasive specialist job code, entry level, level 1 and level 2. The entry-level position is a non-registered cardiovascular invasive specialist, level 1 is a registered cardiovascular specialist, and the third level allows a registered cardiovascular invasive specialist to progress through the clinical ladder track. There is a salary increase with each level of progression.
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?
The members of our team are involved in several professional organizations. All of the staff has membership in the SICP.