Cath Lab Spotlight: Bay Regional Medical Center

What is the size of your cath lab facility and number of staff members?
We have 39 full-time employees (FTEs), consisting of:
• 2 management staff;
• 7 cath lab registered nurses (RNs);
• 6.4 RNs for the cardiovascular care unit (CVCU, pre and post);
• 1 licensed practical nurse (LPN);
• 2 cardiovascular technologists;
• 4 registered cardiovascular invasive specialists (RCISs);
• 2 clerks;
• 8 radiologic technologists;
• 2.6 cardiac care associates (CCAs)
• 3 electrophysiology (EP) RNs.
• 8 radiologic technologists;
• 2.6 cardiac care associates (CCAs)
• 3 electrophysiology (EP) RNs and 1 EP RT.

Our institution currently has 4 rooms and in March 2008 will open a fifth room. Two rooms are primarily interventional cardiology and EP procedures. Interventional radiology and neuroradiologists use our rooms as well.

What types of procedures are performed at your facility?

We peform diagnostic and interventional cardiology, peripheral interventions (renal, carotid, aorto run-off, aneurysms, etc.), EP procedures (implantable cardioverter-defibrillator [ICD], pacemaker), intra-arterial tissue plasminogen activator (tPA) and stroke scales by certified practitioners.

What procedures do you perform on an outpatient basis?
Diagnostic caths, routine angiograms and pacemaker placement are routinely done on an outpatient basis.

Has your cath lab expanded in size and patient volume?
We are adding a fifth room in March of this year. Over the last 6 months, we have moved all cardiac procedures to one floor. Previously, we were scattered over 4 or 5 different floors. Bay Regional Medical Center recently opened a $54 million “south tower” where a large percentage of the second floor is dedicated to cardiology.

What ages do you serve?
Age 16 and up.

How and when did you begin performing peripheral procedures?
Cardiology began doing peripheral procedures in 2003. Our vascular surgeons began in 1999 and interventional radiology has been performing peripheral procedures ever since the hospital angiography suite first opened in 1977.

As you noted, different disciplines perform peripheral procedures in the same area?
Yes, vascular surgeons, interventional radiology and interventional cardiology all share space.

What specific equipment is instituted and/or dedicated to peripheral procedures?
We have a Philips FD 20/10 flat panel projector (Bothell, WA) and can do multi-angle/bi-plane shots with just one injection.

Does your staff perform antegrade puncture for peripheral procedures?

Trained nurses, radiology technologists and RCISs perform the vast majority of arterial punctures, but only a few have conducted an antegrade puncture for peripheral cases.

Have you had any cath lab-related complications in the past year requiring emergent cardiac surgery?
Yes, but these are very, very rare and usually come in as emergencies. These are mostly cardiac dissections or perforations that continue to deteriorate.

How does your cath lab compete for patients? Has your institution formed an alliance with others in your area?
Bay Regional Medical Center manages a large family practice in the West Branch area of Michigan (the northwest part of state), which provides a large referral base within a 45-mile radius. In addition, as we noted earlier, the department has been opened to all trained specialties. By bringing the specialties together, we increase our patient population by virtue of proximity. The goal of bringing the specialties together was to improve the overall quality of care and safety for this patient population.

What percentage of your patients are female?
Approximately 40% of our patients are female.

What percentage of your diagnostic cath patients go on to have an intervention?
Approximately 25% of all diagnostic patients go on to have some sort of immediate or staged intervention.

What is standard of care (ambulation and discharge) for those diagnostic patients who do not go on to an intervention?

Diagnostic patients generally receive a vessel closure device and are ambulated 1-2 hours post procedure. If stable, they are discharged immediately following ambulation (3 hours on average).

Who manages your cath lab?
Willa Rousseau, BSN, is the Director of Cardiology Services, Scott Fylling, RCIS, is Cath Lab Manager of Operations.

Who manages the training for your cath lab staff?
The clinical educator within the cath lab, Susan Stoffel, RN, RCIS.

Do you have cross training?
Who scrubs, circulates and monitors? All staff is cross-trained to scrub, but only RNs or RCISs will circulate. Monitors can be RN, CVT, RCIS or RT, if they have received hemodynamic assessment certification. All possess advanced cardiac life support (ACLS)-certification.

Does an RT have to be present in the room for all fluoroscopic procedures?
No. An RT presence is preferred but not mandatory. The fluoro is operated by the interventional cardiologist, so RT attendance not essential.

What are some of the new equipment, devices, and products introduced at your cath lab lately?

New devices include Xience V drug-eluting stent (Abbott Vascular, Redwood City, CA) which is currently used within the guidelines of SPIRIT IV, various cutting balloons, SilverHawk^® peripheral atherectomy catheter (Fox Hollow, Redwood City, CA), PolarCath cryoplasty balloon (Boston Scientific, Natick, MA) and the StarClose® Vessel Closure System (Abbott Vascular) for hemostasis. New equipment includes the Boston Scientific iLab with a tableside intravascular ultrasound (IVUS) and the PressureWire (Radi Medical Systems, Inc., Wilmington, MA), which measures flow across a lesion.

Can you describe the main systems you utilize?
Currently the systems are split between Philips and another manufacturer, but effective in March, Philips (flat panel detectors) will have the majority. Within the next three years, we will implement the Philips FD 10 in remaining rooms. We are replacing our current hemodynamic monitoring systems with Philips Xper Information Management systems. The system is a personalized cardiovascular workflow solution with a user-centric, role-based navigation that facilitates the collection and reporting of patient information along with scheduling and inventory. The best part is that it will allow patients’ families to be updated every 15 seconds while in the waiting room. Bay Regional will soon become a beta testing site for Philips.

What modalities do you utilize to verify stenosis?
Cardiologists eyeball (gold standard) the angiogram, and IVUS or the PressureWire are used on questionable lesions.

How do you handle vendors that visit your lab?
Vendors are rotated such that each primary company is allowed one day a week. In April 2008, the department will have a mandatory badge entry system. Basically, without an approved badge, the doors will remain closed. The vendor will need to first come to the administrative area for his/her badge. They must sign in and out, and they must wear scrubs.

Is your lab involved in clinical research?

Yes. Following are some ongoing studies:

AMEthyst: The Assessment of the Medtronic AVE Interceptor Saphenous Vein Graft Filter System (distal protection in saphenous vein grafts). Study completed.

ASCEND HF: Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects With Decompensated Heart Failure.

COGENT-1: A randomized, double-blind, double-dummy, parallel group, phase 3 efficacy and safety study of cgt-2168 compared with clopidogrel to reduce upper gastrointestinal events including bleeding and symptomatic ulcer disease.

FREEDOM: A Frequent Optimization Study Using the QuickOpt™ Method. The purpose of the FREEDOM Study is to demonstrate that frequent AV/PV and V-V delay optimization using QuickOpt in patients with CRT-F device results in improved clinical response over standard of care (i.e., empiric programming or one-time optimization using any non-IEGM optimization methods).

INNOCOLL: A Randomized, Controlled, Phase 3 Study of Gentamicin-Collagen Sponge (Collatamp G) in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection.

MEND CABG II: A randomized, double-blind, placebo-controlled, multi-center study to evaluate the cardioprotective effects of mc-1 in patients undergoing high-risk coronary artery bypass graft (CABG) surgery.

PROOF: A compendium registry of St. Jude Medical devices.

RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System. A Prospective, Multi-Center, Registry to Evaluate Safety and Efficacy of the StarClose Vascular Closure System in Patients Who Are Ambulated Early Post Diagnostic Catheterization. (Study completed.)

SAPPHIRE Worldwide: Carotid stenting and angioplasty with protection in patients at high risk for endarterectomy.

SATURN: Study of Coronary Atheroma by InTravascular Ultrasound: Effect of Rosuvastatin Versus AtorvastatiN.

SPIRIT IV: A Clinical Evaluation of the Xience™ V Everolimus Eluting Coronary Stent System (EECSS) in the Treatment of Subjects with de novo Native Coronary Artery Lesions.

TRACER: Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SCH 530348 in Addition to Standard of Care in Subjects With Acute Coronary Syndrome: Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome.

Following are some upcoming studies in which Bay Regional will be participating:

RESOLUTE: Looking at the next-generation Medtronic (Santa Rosa, CA) Endeavor^® Resolute drug-eluting stent system with the new BioLinx^™ polymer.

RACER: Looking at renal stent protocol and the Medtronic Racer stent.

How do you handle sponsored clinical trials in your lab? Who is the quarterback/coordinator?

Michigan Cardiovascular Institute (MCVI, www.mcvi.com) has a research team that operates studies across 4 local, affiliate hospitals. The Director of Research, Katie Mostek, handles most of the coordination for sponsored research.

How does your lab handle hemostasis?
The nurses, techologists, and RCISs at Bay Regional Medical Center have been independently performing femoral artery access and closure procedures for more than 10 years. Access and closure for all patients, even those at high risk for vascular complications (elderly, obese, diabetic, history of peripheral vascular disease, etc.) is generally 100% achieved by non-physician staff, and though not mandatory or even a requirement of the job, nearly 90% of the cath lab staff chose to undergo and complete the training necessary for certification and independent operation. Femoral angiograms are performed on each patient prior to close and the IFU for the StarClose^® device (Abbott Vascular, Redwood City) is strictly followed. Patients whose angiograms demonstrate anatomy or puncture locations unfavorable for vascular closure device use, receive manual compression (see Lee et al, “Cath Lab Nurse/Tech Vascular Access and Closure Using the StarClose^® Device,” Cath Lab Digest Nov. 2007, pages 27–30, for more information). What is your lab’s hematoma policy? Hematomas are marked for size and then labeled with a time and date. They are checked every 15 minutes post-procedure.

How is inventory managed in your cath lab?
One cath lab RT spends 50% of her time doing inventory (20 hours/week). We have an in-house billing and ordering program through McKesson HBOC (San Francisco, CA). We create our own bar-code stickers and use a wand to scan devices and equipment. The system automatically flags items for re-order.

How is coding handled in your lab?
All procedures are “wanded” (instantly and electronically scanned by a pen-sized hand-held device). Outpatient procedures are coded separately, then directed to the general hospital coding department with CPT (current procedural terminology) codes attached. Inpatient procedures are wanded and then confirmed by the coding department before being forwarded to DRG (diagnosis related groups) hospital coding.

What measures has your cath lab implemented in order to contain costs?

We work very closely with the purchasing department. Bay Regional is part of a 7-hospital system (McLaren HealthCare in Flint, Michigan) and we have compliance contracts for stents and cardiac devices. This facilitates a lower ASP (application service provider) due to increased volume. Bay Regional is part of Premier Corporation and as such manages to negotiate contracts as low as possible.

What type of quality control (QC)/quality analysis (QA) measures are practiced in your cath lab?
Bay Regional benchmarks its performance nationally by participating in the American College of Cardiology-National Cardiovascular Data Registry (ACC-NCDR). We also submit data to:
• STS (Society of Thoracic Surgeons)
• ICD (ACC-NCDR ICD registry)
• Michigan Blue Cross Blue Shield (The Blue Cross Blue Shield of Michigan Cardiovascular Consortium, or BMC2)
• ACTION (Acute Coronary Treatment and Intervention Outcomes Network Registry)
• CRUSADE (ACC has now taken over CRUSADE, which used to stand for Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/ AHA Guidelines).
We also participate in Joint Commission national safety goals for standard radiation and blood-borne pathogens, and the ACC GAP-D2b (Guidelines Applied in Practice, Door-to-Balloon Time Initiative). Has your lab undergone a Joint Commission inspection in the last three years? The last inspection was performed in 2005 and there were no findings. We are due for another inspection in 2008.

How are new employees oriented and trained in your facility? What licensure is required for all professionals who work in your lab?
New employees are assigned a preceptor and undergo a mandatory 90-day orientation period. Cardiologists sign off on staff member proficiencies for skills that are specific to the cath lab suite.
Though not mandatory or even a requirement of the job, nearly 90% of the nurses, technologists and RCISs chose to undergo the training and complete certification for independently performing arterial access and closure. Orientation for this type of advanced practice does not begin until the staff member has been competently functioning in their current position for at least 6 months.
Once identified as a training program candidate, the orientee is assigned a like-licensed mentor/preceptor and enters into a three-month observation period. During this time, they are completely “hands off,” and spend their days scrubbed into cases and aggressively shadowing their preceptors to learn the science of common femoral artery anatomy and the art of successful access and closure. Once this probationary period is complete, the trainee begins attempting arterial puncture on his/her own and is introduced to the StarClose device under strict supervision of the mentor (it is assumed that manual compression techniques have already been mastered). This intensive ‘hands on’ training period generally lasts about 6 weeks, and a checklist of knowledge, skills and abilities is provided as a structured guide. Once the preceptor is comfortable with the arteriotomy skills of the orientee, a physician is assigned to train on sheath insertion, and then observes 10 consecutive placements. If performance is satisfactory, the candidate will be ‘signed off’ with the understanding that their results will be monitored by a senior staff member over the next 2-3 months. A prolonged direct observation period is also afforded to orientees requiring additional support. During this same time, the Abbott Vascular representative is contacted to perform a proficiency evaluation with regard to the StarClose vessel closure system, and once proper deployment techniques have been demonstrated, the staff member receives a formal training certificate. The entire orientation phase can last up to 8 months.

What type of continuing education opportunities are provided to your staff members?

Internet access is available for everyone. We recommend the free continuing education websites listed below. We also have a monthly case study where participants bring two or three unique cases and present to the group. Each year, we send 3-4 staff to conferences such as the ACC Scientific Sessions, Vascular Interventional Advances (VIVA), and Transcatheter Cardiovascular Therapeutics (TCT).
Following are some websites used by the staff for education:
https://www.blaufuss.org/
https://www.ecglibrary.com/
https://www.cmecourses.com/gateway/index.cfm?PID=56
https://www.hrsonline.org
https://www.tctmd.com/
https://www.carotid.com/training_and_education.html

How is staff competency evaluated?
Aside from continuing education and mandatory computer-based competency training, a yearly re-evaluation of skills (such as femoral artery access and closure) is performed on all clinicians via a one-week observation period.

Does your lab have a clinical ladder?
Not in the true sense of the word. The RN staff within the department follows the hospital’s clinical ladder structure and receives premiums for clinical III and IV status. The remainder of the cardiac cath lab staff has the ability to take the RCIS Cardiovascular Credentialing International (CCI) exam. Upon successful completion, they receive an hourly premium.

How does your lab handle call time for staff members?
We start call Monday–Thursday at 5:00 pm and it runs to 7:00 am the following morning. The weekend call starts on Friday at 5:00 pm and ends Monday morning at 7:00 pm. The team consists of four members, including but not limited to 1 RN, 1 RT, and either an RCIS or CVT. We also cover the angio suite for the radiology department. When called in for an angio procedure, only three staff members are required to respond. The fourth responds only for heart procedure and/or sheath pull. All cases done over the weekend are called into the quality office to be reviewed for appropriateness.

Within what time period are call team members expected to arrive to the lab after being paged?
All members are required to arrive within thirty minutes.

Does your cath lab do electives on weekends or holidays?
Yes, for long weekends. For any holiday weekend over three days we schedule an in-patient day to help decrease length-of-stay and improve patient/physician satisfaction. The day chosen is normally a Sunday and we allow six patients to be done on a first-come, first-serve basis.

What trends do you see emerging in the practice of invasive cardiology?
We are seeing peripheral procedures increase in the lab every year.

Do you do radial or brachial punctures?
Yes, but less than 5% of the time.

Where are you located in relation to the OR, ED, and radiology department?
We have two labs within the radiology department, which is located adjacent to the emergency department. The other two labs (soon to be three, after our newest lab opens in March) are located on the second floor between surgery, the critical care unit, cardiac and neuro testing, and our new 28-bed cardiovascular care unit.

What do you consider unique or innovative about your cath lab and staff?
We offer integration of all the areas needed and used by cardiology. It cuts down the wait times for both the patients and the physicians we serve. Any invasive or non-invasive procedure can be done within a central area of the hospital. Plans for 2009 include the relocation of the electrophysiology lab to the second floor, along with the replacement of an older lab. Also, all staff is ACLS-certified and cross-trained in multiple, if not all, modalities with the department. Staff is also encouraged to partake in hospital improvement groups from safety to satisfaction, and everything in-between. We believe in shared leadership and have implemented a unit-based team for recommendation on department improvements and/or daily operational functions. These could range from schedule to ordering, to daily concerns.

Is there a recent problem or challenge your cath lab faces?
Yes, we find balancing the workflow of the new areas to be challenging, including but not limited to the addition of a transesophageal echo (TEE), TEE/cardioversion patient population, along with the occasional cardiac consult. In past years, we only recovered therapeutic procedures. Today, we admit and discharge from the same area for all outpatients. The scheduled in-patients are admitted in CVCU, recovered, then transferred to the floor for the remainder of their stay.

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 the RCIS?
Only those hired as CVT. We give them two years to take and pass the exam. We supply everything needed to successfully pass the registry. At present, we have hired five CVTs and all have passed the RCIS exam.

2. Are your team members involved in any professional organizations that support the invasive cardiology service line, such as SICP, ACVP, or regional organizations?
We have staff members involved with the American College of Cardiology and the American Heart Association.

Acknowledgments: Thank you to Michelle Frasik and Bay Regional Center Marketing for taking the photographs accompanying this article.