Cardiac Cath Lab – Cardiac Procedures Unit, The Frankel Cardiovascular Center at the University of Michigan Health System

Tell us about your facility and cath lab.

The Frankel Cardiovascular Center has 4 cardiac catheterization laboratories that are used for a variety of coronary, peripheral and structural procedures. These labs complement the 2 hybrid rooms we use in the OR suite and the 5 electrophysiology rooms. In addition, the Cardiac Procedures Unit has started construction on our hybrid OR suite, to be completed in early 2017. Our labs are staffed with 14 registered cardiovascular invasive specialist (RCIS)-certified technologists and 12 registered nurses (RNs). We also have interventional cardiology fellows, as well as interventional cardiology and heart failure attending physicians.

What procedures are performed at your lab? 

Our lab is a full-service interventional cardiology procedural area. We perform a myriad of routine and complex hemodynamic studies in addition to percutaneous coronary and peripheral interventions. We implant left and right percutaneous ventricular assist devices and also perform a full spectrum of structural heart procedures, including procedures on both native and bio-prosthetic valves and paravalvular leak closures.

Can you share more about your experience with transcatheter aortic valve replacement (TAVR)?  

We currently perform 4 to 6 TAVR procedures per week. Our cases take place in both the cardiac catheterization laboratory and in the hybrid rooms in the OR suite. As of January 2016, we have successfully performed over 700 implant cases, and are slated to do over 200 more by the end of 2016. We implant a variety of TAVR devices, including the Medtronic CoreValve Classic and the CoreValve Evolut, along with the Edwards Sapien XT and Edwards Sapien 3 devices. We also participate in the trial utilizing the Boston Scientific Lotus Valve.  

Who manages your cath lab? 

Stanley Chetcuti, MD, is our cath lab medical director. Janice Norville, MSN, MSBA, RN, is our director of clinical operations. Colleen Lucier, BS, RCIS is our technologist supervisor and Sheryl Wagner, BSN, RN, and Joshua Barsaleau, BSN, RN, are our nursing supervisors.

Do you have cross-training? Who scrubs, who circulates and who monitors? 

Our first-year and third-year cardiology fellows and our fourth-year interventional cardiology fellows scrub. Our cath lab technologists primarily monitor and circulate in our cases. The technologists will scrub assist when a fellow isn’t available and a dedicated group of technologists have received intensive training and education on the correct preparation and loading of all TAVR devices. This team will first assist scrub during all TAVR procedures. Our cath lab nurses document vitals, medications and assist in circulating.

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? 

Our attending physicians, interventional cardiology fellows and cath lab technologists are competent to operate the x-ray equipment, but it is usually our fellows and attendings that operate the fluoro pedals.

How does your cath lab handle radiation protection for the physicians and staff?

We carefully monitor and track dosimeter badge use and dosimeter readings every month. We fluoro all protective radiation apparel annually to validate integrity. After integrity is ascertained, we label each piece of apparel accordingly. We also complete a yearly competency on radiation safety and ALARA (as low as [is] reasonably achievable). As of December 2015, we have a real-time monitor for the lab that allows us to instantaneously monitor each individual’s exposure and make the appropriate changes in practice.

What percentage of your diagnostic caths are normal?

Approximately 20% of our diagnostic caths have normal coronary arteries. Many of these cases are sent to the lab for hemodynamic studies or as part of a pre-operative evaluation.

Do any of your physicians regularly gain access via the radial artery?

All our physicians perform radial artery procedures with some preferring this as their main access site. Some of the attendings perform 75% of their interventions through the radial artery.

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

New devices in our lab include the TandemHeart ProTek Duo (CardiacAssist) and the coronary CSI Diamondback orbital atherectomy device. New equipment to the lab includes drug-coated peripheral balloons, structural heart devices, and chronic total occlusion (CTO) platforms.

How does your lab communicate information to staff and physicians to stay organized and on top of change?  

For daily cases, we have a charge nurse and cath tech lead that communicate the flow of the day to the labs. New equipment education and maintaining yearly competencies are handled by Chuck Hobkirk, BSN, who is the nurse educator, and Katie Della Mora, RCIS, the technical educator.

How is coding and coding education handled in your lab? 

A dedicated coding and billing team communicate directly with physicians and staff to educate and advise on the latest changes in coding and billing practices. 

Who pulls the sheaths post procedure, both post intervention and diagnostic? 

We have a designated team of sheath pullers who pull post diagnostic and interventional procedures. The Sheath Pulling Team is also responsible for the removal of all intra-aortic balloons and sheaths up to a 14 French.  

A sheath puller must be supervised for 15 arterial and venous sheath pulls, and 5 intra-aortic balloons. During the evaluation period, the trainee must demonstrate the core competencies of sheath pulling, which includes proper technique and achieving successful hemostasis. Once competency is achieved, they can pull sheaths independently and participate in the on-call process.  

Where are patients prepped and recovered (post sheath removal)? 

We have a designated prep and recovery area on our unit. We use a variety of techniques to achieve hemostasis, including manual pressure, compression devices, and vascular closure devices. Post procedure, our patients are transported to the recovery area within our unit. The recovery area is staffed by a team of registered nurses and sheath pullers. All of our patients will receive care until they are ready to be discharged home or they will be admitted to another department for any care that requires a length of stay twenty-four hours or greater.

How is inventory managed at your cath lab? 

Marlon Bird is the supervisor of the supply chain in the Cardiac Procedures Unit and manages the unit inventory control process along with the unit inventory control analysts. All our equipment is scanned through our Internet-based program during the procedure by the monitoring technologist and reviewed for re-ordering by our inventory control analysts.

Has your cath lab recently expanded in size and patient volume?

Yes, and we continue to look for opportunities to expand. Our expansion includes construction of our hybrid OR suite. We also completed the design and implementation of a state-of-the-art cath lab in December 2015.

Is your lab involved in clinical research?

Yes. One ongoing research study we are involved in is the TIMI 60 (LATITUDE) trial. Past studies that we have participated in include the RESOLUTE Study and the PRE-DETERMINE Study: Biologic Markers and Sudden Cardiac Death. We also collected data in trials utilizing the TandemHeart and Impella devices: (THEME) and USpella. We also participated in a peripheral trial called MGVS Phase I in Peripheral Arterial Disease. As an implanting hospital for CoreValve Evolut, Boston Scientific Lotus, and the Edwards Sapien 3, all data we capture during our TAVR procedures are submitted to the TVT Registry.

Can you share your lab’s average door-to-balloon (D2B) times and some of the ways employees at your facility have worked together to keep D2B times under the mandated 90 minutes?  

Our D2B time is 90 minutes or less. We have regular acute myocardial infarction (AMI) meetings with Emergency Medical Services (EMS) and the emergency department (ED) as part of an ongoing quality assurance and improvement program. We also gather data for the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

Who transports the ST-elevation myocardial infarction (STEMI) patient to the cath lab during regular and off hours?

Our ED staff and our interventional cardiology fellow transport all our AMI patients 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 we are near the end of our first AMI, we have an emergency room nurse and a cardiology fellow transport the second AMI to a secondary cath lab. Upon patient arrival, a member of the AMI team will join the emergency room nurse and the cardiology fellow to prep the patient and to prepare the second lab. The Coronary Care Unit charge nurse helps transition the first AMI to their unit for continuation of care. 

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

We have implemented multiple LEAN projects to maximize efficiency in our labs while eliminating waste. Our most successful LEAN project to date is our TAVR project that earned us the title of Exemplar status in our institutional Quality Month. The TAVR LEAN project helped us increase our TAVR implants from 2 to 5 during one normal business day.  

Are your physicians dictating their cath procedure reports, or do they use a structured reporting tool?

Our physicians use Lumedx cardiovascular information systems (a structured reporting tool) to generate all of our interventional documents. 

What quality control measures are practiced in your cath lab?

We have quality control measures on all our devices and equipment through our clinical engineering department. All procedural data is reported into multiple state and national registries (ACC-NCDR, BMC2, PVI, TVT). Quarterly morbidity and mortality conferences occur where open discussion of cases is encouraged. These conferences have participation from members including our physicians, fellows, nurse practitioners, physician assistants, registered nurses, and technologists. Our lab’s outcomes are also reported in an institutional dashboard.

Both BMC2 PCI and ACC-NCDR CathPCI are used to drive quality improvement (QI) initiatives. Our computing technology department has mapped Lumedx. This mapping pulls all ACC-NCDR data fields from history and physicals, as well procedural reports. Lumedx then filters the information to databases where our QI teams review the information for accuracy and completeness before sending it to the ACC-NCDR.

Are you recording fluoroscopy times/dosages? 

Yes, we record fluoroscopy results after each case and the information populates into our electronic medical records. We capture the dose area product, air kerma data and fluoro times. We have standard parameters outlined by our radiation safety health physicist. Any values that fall outside these parameters get reported to the attending physicians and supervisors so that they can follow up accordingly with the patient.

Who documents medication administration during the case?

Our registered nurses document medication administration into the electronic medical record during cases.

How does your cath lab compete for patients? Has your institution formed an alliance with others in the area?

We collaborate regularly with area physicians, responding to every referral within twenty-four business hours. 

How are new employees oriented and trained at your facility? 

All new employees go through a standard orientation process with a preceptor. Before each standard orientation is complete, every new employee must demonstrate competency for their supervisor and educational specialist on a standard list of duties and devices. 

What continuing education opportunities are provided to staff members?

We have weekly educational conferences led by the attendings and fellows. We also have quarterly morbidity and mortality conferences. Vendors and our educational specialist provide regular in-servicing opportunities as well. Our unit also funds for three team members to attend a national interventional cardiology conference each year. 

How do you handle vendor visits to your lab? 

Vendor visits are by appointment only. Each vendor must be registered with Vendormate, which is a national vendor logging system. As part of the appointment, Vendormate generates a badge that must be worn by the vendor, including the time of the appointment, and who the appointment is with, preventing the vendor from wandering from one unit to another. Vendormate also helps the institution track vendor compliance with mandatory completion of HIPAA forms, immunization screening, and an assortment of other compliance concerns.  

How is staff competency evaluated? 

After the standard orientation process has been successfully completed, each team member receives annual performance evaluations. In the completion of the annual evaluation, hospital- and job-specific expectations must be met. Supervisory, physician and peer feedback are all used to verify the hospital- and job-specific performance expectations. In addition, standard competencies on all low-volume, high-risk procedures are completed annually in a mock simulation by our supervisor and our educational specialist.  

How does your lab handle call time for staff members? Is there a particular mix of credentials needed for each call team? 

Our staff has a 30-minute response time. Team members are offered call rooms to stay in-house if they choose to do so. The call team consists of two registered technologists, one registered nurse, one interventional cardiology fellow, and an interventional cardiology attending.

Do you have flextime or multiple shifts? 

We have 8-, 10- and 12-hour shifts.

Has your lab recently undergone a national accrediting agency inspection?

We have recently undergone inspection by Centers for Medicare & Medicaid Services (CMS). Make sure to have a well-documented and standard institutional process for tracking and confirming the integrity of all radiation protection apparel. 

Where is your cath lab located in relation to the operating room (OR) and emergency department (ED)? 

The operating rooms are two floors above our unit. The ED is located in the main hospital, with clear signs and a secure, low-traffic hallway that leads directly to the cath lab.

What trends have you seen in your procedures and/or patient population? 

Our patient population is getting older. We are seeing more non-STEMIs compared to STEMIs, and our rate of restenosis has been decreasing. We have also seen a surge of structural heart procedures and interventions on chronic total occlusions.

What is unique or innovative about your cath lab and staff?    

All of our technologists have received their RCIS credentialing. 

Our TAVR implanting physicians have given our registered technologists the unique opportunity to take the lead in the prepping of all our TAVR procedural implants. 

We practice Patient Family Centered Care (PFCC) where the family and the patient participate in the care process. The patients collaborate with our team of specialists to create a care plan that meets their individual needs.

We have a state-of-the-art waiting area that provides family members with updated information on the status of each patient’s location while maintaining confidentiality. Our waiting area also has a unit host that answers questions, provides information, and directs families as needed. 

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”?

We are centered in a diversified cultural area, which allows us to treat a variety of patient populations. Our cath lab consists of a team of physicians, nurses and technologists that strive to always be the leaders and the best. 

The authors can be contacted via Megan Kennison, RCIS, at mkenniso@med.umich.edu.