Setting High Safety Standards at Mount Sinai’s Cath Lab

Under the leadership of Samin K. Sharma, MD, and Annapoorna S. Kini, MD, The Mount Sinai Hospital’s Cardiac Catheterization Laboratory has achieved the highest safety rating among New York State’s 54 PCI-performing institutions, while also remaining one of the busiest—in 2013, the cath lab performed more than 5,000 interventions. As part of our new Cath Lab Profile series, CSWN: Interventions spoke with Dr. Sharma (director of clinical and interventional cardiology at The Mount Sinai Hospital) about achieving and maintaining such high safety standards and patient satisfaction at Mount Sinai Cath Lab.

Mt. Sinai Cath Lab
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How has Mount Sinai’s catheterization lab achieved such high safety ratings?

Dr. Samin Sharma: The key is to always have the safety point of view. At Mount Sinai, we have parameters for the cath lab and for interventions, as well as a book of protocols that we constantly update. This manual is sort of a bible for our cath lab. It provides a solution for almost every problem that may arise in the cath lab—a patient with an allergy, a patient on aspirin, a patient on warfarin, cases of thrombocytopenia, etc.

We have this clear, definitive protocol that we make available to every health care provider in our lab, from fellows to nurse practitioners. Many times, attendings come to Mount Sinai from other sites or other hospitals, but they can read, understand, and implement the practices from the manual, and this ensures that everybody is on the same page. Universal adoption of the standardized medical protocol, really, is the key to our success in terms of safety. Everybody is thinking the same way, and our protocol is updating and changing according to the newest data—particularly when it comes to complications.

How does your cath lab staff address complications?

We have a low rate of complications, and we take a proactive role in minimizing them. Any complications that occurred during procedures are written up and discussed in a meeting on the first Monday of the month. All cath lab staff—nurses, attendings, and fellows, as well as the cath lab manager and supervising staff—discuss each and every complication.

In these meetings, we focus on the why of each complication, and what we can do differently so that it does not occur again in the future. If we have a consensus that the complication in question was not a chance occurrence of a particular practice, we ask the group, “Should we kill this practice?” If the answer is “yes,” we generate a memo detailing how the practice should be changed. That decision then gets translated into our cath lab manual, so the protocols are always up-to-date.

For example, 4 or 5 years ago we started having vascular complications with femoral access in certain patients. After discussing the events, we made the decision that anybody who weighs more than 120 kilograms has to have, by default, a radial approach. This also happened with the change in catheter: we were having some problems with changing the catheter in the ascending aorta, so we decided that the exchange of the catheters should be done in the descending aorta. In that case, any small clot at the catheter tip would not embolize to the brain and travel to the leg instead. Those are just some of the cases where changes have entered into the protocol in response to complications.

How do you incorporate new technology, equipment, and devices into your practices? Do you have a hybrid operating suite on site?

We do have one hybrid operating suite at Mount Sinai, which is shared by the electrophysiology department, the vascular department, and the cath lab, where the more complex cases are treated. We do about 12 or 13 on average per month: probably three are done downstairs in the hybrid suite, and others are done in the regular cath lab.

At Mount Sinai, we are often part of the research for most of the newer technologies—whether it’s a newer stent design or a drug before market or some other innovation. We are proud of our reputation as a leader in clinical research and trial participation, while remaining one of the busiest cath labs in the country.

How do you integrate these new technologies into staff education? Is that included in the cath lab manual?

Once the new technology or device becomes available, then we must define how we are going to use it in our cath lab—this is one of the most important aspects of educating staff on new technologies and practices. Every new practice must go through orientation; for instance, before we use a new catheter in the lab, we discuss the patient, make pre- and post- preparations, and present it to the cath lab staff as well as the area where the patient will recover—whether the coronary care or telemetry unit.

All of our staff need to be educated in the new practice so they are on the same page, and this is something we also discuss in monthly meetings: the first Tuesday of the month, we have an open discussion with all cath lab staff about any new innovations in the field or in clinical research. Also, periodically, we check in with the cath lab, telemetry, and coronary care units conducting ongoing research trials. That way, when a research patient goes to the coronary care or telemetry unit, the patient is not coming to them as a surprise.

In my opinion, education is a very important part of the quality of care that a patient receives, and this effort really translates into the low complication rates we achieve. It’s a simple strategy: the better educated you are, the earlier you will be able to pick up on a problem, before it becomes full-blown.

How do you handle staff communication and training? Once trained, how is staff competency measured?

We take a similar approach when measuring staff competency, and it is important to have open communication once the staff is trained. First, we ensure that staff has attended training. Secondly, you need to have confidence that they are doing it correctly. For us, that involves initial supervision and then ensuring that everyone has performed an intervention independently. Now, for the fellows, this communication is even more immediate, because they are working closely with us day and night and we’re able to give them instant feedback. These processes help us to maintain the technical abilities of the cath lab staff.

In addition to the increase in radial access with a certain set of patients that you mentioned, have you noticed any recent trends or changes in the types of procedures performed or in your patient population?

I would say that the amount of ambulatory procedures will continue to grow in the near future. In the last 2 years, there has been a focus on discerning between inpatients and outpatients who can be discharged safely. This all ties into reimbursement for the hospital. At our facility, we came up with criteria to help with this, and to avoid mislabeling a case and the subsequent payment issues from Medicare.

Right now, about 50% of patients are discharged and about 50% are kept overnight. But, now, with the Centers for Medicare and Medicaid Services’ “two-midnight rule,” we are probably going to see the number of outpatients jump to almost 80%. This shift has already started occurring: around 2006-2007, outpatients used to account for 15–30% of all cases; in 2010, it became 30%; and in 2012–2013, it’s now 50%. My feeling is that in 2014–2015, unless a patient has an MI or some other complication, almost every patient will become ambulatory.

We’re also relying on FFR more than IVUS or other documentation to justify PCI in certain patients with angiographically intermediate lesions.

What type of quality-control or evaluation procedures are in place?

Quality control is very important. To achieve the highest quality of care for patients, our efforts are threefold. First is an angiographic review of patients who are set to undergo intervention. We randomly select and send 10% of our angiograms to four non-interventional cardiologists (this is equivalent to about 40 cases) for grading. If the blockage on angiogram is graded more than 80%, the patient will undergo additional hemodynamic testing, and we take a deeper look at the patient’s demographics, the measurement techniques used, and other factors. And if justified, then it’s no longer an issue. Otherwise, if it is not done correctly, that case will go for further review until the clinical cardiologist found that the lesion was less than 60% on angiogram. When we formed 40 years ago, almost eight of 10 patients per month had to undergo this extensive review process. Now, we actually haven’t done any case in 3 months, because everybody has been taught and our criteria are clear.

Second, we determine the complexity of a patient’s disease (based on SYNTAX score) to inform our choice of revascularizatin. Unless they meet criteria that prohibit surgery (i.e., prior MI or stroke), patients with complex disease are referred for CABG after a surgical heart team consultation.

The third point is determining the appropriateness of PCI. We have copies of Appropriate Use Criteria available in each room of our cath lab so that all of our staff is up-to-date. Only cases deemed “appropriate” will undergo PCI; in rare cases, “inappropriate” PCIs are performed, but we adhere closely to AUC. On the latest report for 2013, the number of inappropriate PCI cases at Mount Sinai was 2.3%, down from 3.3% on previous reports. For reference, nationwide, that number is 16.4%.

Our low rate of inappropriate PCIs can be attributed to the parameters we have put in place concerning appropriateness of PCI. We know that the number of appropriate PCIs will never be 100%, there will always be rare cases are when inappropriate gets done, but if everybody is cognizant of the criteria and careful about adhering to them, I can guarantee that education and awareness will translate into lower numbers.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Invasive Cardiovascular Angiography and Intervention, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias

Keywords: Writing, Quality Control, Coronary Care Units, Documentation, Cardiac Catheterization, Referral and Consultation, Nurse Practitioners, Medicaid, Warfarin, Patient Satisfaction, Centers for Medicare and Medicaid Services (U.S.), Lower Extremity, Patient Discharge, Hemodynamics, Awareness, Stents, Electrophysiology, Telemetry, Medicare, Thrombocytopenia


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