Hi, everyone. My name is Nicole Knight. I'm the Executive Vice President of Revenue Cycle Solutions and Care Transformation with MedAxiom. Happy to be joined by CB Remote Solutions as part of the device clinic essentials course for care teams. This module, we're going to discuss in-person device clinic operations and management. From a course objectives perspective, when we discuss in-person evaluations of cardiovascular implantable electronic devices, so you'll see this abbreviation throughout the presentation, CIED. These are our implantable devices, and we'll talk about what are some of the specific devices that this is related to. From a course objective perspective, we're going to look at the screen perspective, we're going to look at the structure, standardization, and management. What are those key operational considerations for staffing and scheduling? How do we measure the metrics for success? We want to remain compliant and also meet our quality goals. What are some of the best practice examples that we see in this space? So for our in-person structure and landscape, the key operational components, just as with many processes in our world, is around the people, the processes or workflow, and the technology. So in each of these areas, what are some components for success for our in-person management? When you look at a device clinic, we look at what are those areas that have a cause and effect. There are many moving parts such as the technology, the protocol, interruptions, you have providers that are part of this structure, you have staffing, you have an organizational structure for communication. The volume of these patients tends to be large as well. And then of course, maintaining that patient satisfaction and follow through. So when you look at our fishbone diagram, in taking in each of these areas, what are some of the causes and effects of that? So for example, when you look at interfaces or multiple systems, or if you're using paper from technology, or you have duplicate data entries and schedule inconsistencies, that's going to have an effect on the entire program and also go into other areas. So this slide is to really identify what are those common areas that we see, there are some gaps in the process that also may impact your staffing, your technology, your provider workflow, your patient workflow, and how from an organizational standpoint, you can have a strategic plan to facilitate any communication barriers and set the stage for the mission and vision of the in-person device clinic. For the current landscape of what we see across cardiovascular programs in the in-person space. So in-person is our patients come directly to the clinic, ambulatory setting, outpatient hospital clinic, and have their device either interrogated or programmed by a staff member who could be a technician, an advanced practitioner, a nurse, some physicians as well. And there's also a remote component to the device landscape. For this particular session, we're focused just on that in-person clinic. So we've seen a decrease in in-person device checks, however, they still remain crucial to a comprehensive device program. Many of the in-person teams are focused on the complex care of these patients, education, enrollment, and any programming needs. Many of our remote interrogations happen at that site of service and not within the in-person. So when we're seeing these patients in a clinic, the expertise needed to program their device, to manage that complex care, provide the education is part of a more comprehensive device program. The Heart Rhythm Society released a consensus statement, and they even mentioned that remote monitoring reduces the volume of in-person evaluations and can decrease the delay from when an arrhythmia onset to a clinical scission can be made, which helps with safety concerns. However, there is still a need for those in-person device checks. Normally we see in-person services of programming occurring at least once a year. So a patient may have three or four remote services a year and one in-person visit would be the standard, unless there were clinical reasons that that patient would need to be seen. It's important to support those initial implants, replacements, and any troubleshooting. This is often managed by the in-person team and has a lot of face-to-face contact. Also considerations for managing your in-clinic patients. Many of our device clinics have also been managing the in-hospital patients around their periprocedural device management, which we'll talk about as well. So facility and essential equipment. For our in-person, it's important to have a dedicated exam room. In many of the device clinics that we've seen and visited as we've looked at workflows, if they're having to share a space or they don't have the availability of that exam room to support all of the technology, the equipment that they need to support that patient, and also to have a place to educate the patient, it often interrupts the schedule and it's more of a, I'm doing it off the side of my desk, which could lead to some of the loss to follow. So really having a designated area, some dedicated support staff to assist with the ongoing scheduling, management of incoming calls, and also to manage no-shows, cancellations, be sure that they're getting their in-person and remote services, this team often works together as the support functions to facilitate a successful device clinic. The technology support, of course, IT is key depending on what systems you're using, training and the platform that's integrated for your in-person and remote. So you're managing that in-person component, but you're also managing remote data. So what systems are you using? How is that information integrated? And how is that communication available to provide that patient with the best possible care? It's essential to have educational resources available for staff and for your patients. Devices are very specific technology and do require based on the type of device, education and the needs for that are continuous. I wouldn't say once you learn about devices, you know everything, it requires some ongoing continued education, which we'll talk about around what your staff should be able to do and what certifications are recommended. So what are some keys to success? So from a best practice perspective, standard protocols, this would be a protocol that your provider teams align on. Generally your electrophysiology, EP physicians, do manage the device clinic program. However, in many cases, cardiologists and interventional cardiologists have patients with devices, but that standard protocol is something that's established around the clinical guidelines of device management and is available to your team to follow for both their in-person and remote device management. It would include how alerts are managed and also include timeframes, include when the physician should be notified and many other variables. This protocol should be reviewed annually and signed by your providers who are managing that clinic. From a patient tracking perspective, oftentimes we have our electronic health record. We may have a device platform that's being used to track and manage the patient. We also have some of the vendor sites that are available. So determining what is my source of truth that defines all of my device clinic patients and how is that managed, updated, refined? And also, is that interactive with my electronic health record? Is that a standalone system? What is that source of truth if there's a recall? Which system am I gonna go to to locate those patients with that particular device? So understanding your source of truth is important. Right patient, right schedule, right time. When you're looking at programming, you wanna be sure that patient is on the right schedule. They're seeing the person that they need to see. They're coming in for a clinic visit. They're scheduled with the physician or provider. If they're coming in for device clinic, you should have an independent device schedule and those timeframes around what are their particular needs for that device visit. Your staff ratios have to meet that patient demand and growth. So not only do you have to account for the management of your in-person clinic, you also have to look at how many new implants are you going to put in in a year based on your physicians? How is that going to impact your staffing ratios? Do you have the right support staff doing the right function? Meaning is my device tech doing administrative clerical duties or are they truly performing in-person device duties at the top of their certification and or licensure? There is always an ongoing relationship with a third party vendor when it's applicable. We see this often in many clinics and that third party vendor may be providing the staffing support and services for your remote population and working hand in hand with your in-person clinic. You wanna be sure that you have communication available, that you are communicating on an ongoing basis with your vendor and that there's a relationship that you're truly managing this as a clinic to support your patient's needs and the needs of the organization. And in-person staffing models, what do we see? So clinic device staff, meaning if you're a office-based clinic, the staff's employed, you have an internal staff. They are strictly dedicated to the device clinic. Their duties involve the device clinic only. They manage all of the services in both the clinic and remote. So this would be, I have an office, my staff that structured in the device clinic manage all of my device services and they may also have responsibilities for hospital device management. Hospital-based device staff, this would be if you're designated as a hospital outpatient department as part of your clinic. So the staff is designated to support in-hospital device services, both in the clinic and in the hospital setting. It may include interrogation, programming and that perioperative management as well. For the hybrid device staff model, you have internal staff to manage the in-person clinic services. You also have an external team that may be employed that's monitoring your remote devices or that could be contracted with a third party that's managing your remote devices. So you have your hired in-person staff, then you have an external team, whether employed or vendor supported that is managing your remote services. An industry supported clinic, I would tell you this is not something that we see a lot of anymore. This is probably a least preferred model and one we would say leaves you some gaps in efficiencies. And when you look at this, this would be your individual industry device rep coming in and actually staffing your device clinic and providing the service for the programming or interrogation of that in-person clinic. At times we see this related to an EP provider clinic schedule and you're only billing for the physician interpretation in this instance because the device clinic staff is not employed nor contracted with the clinic and therefore you can't get that technical revenue from that. Again, this is probably a least preferred model and one I would say that we see the most gaps in patients that are lost to follow or there's not one standard system or source of truth to manage those patients. So what are some of the key operational considerations? When you look at the operational considerations of a device clinic, it is much like our in-person staffing clinics. You have to identify and track the patients. You have intake and scheduling that drives that remote device management and in-person device management and then you have the reporting and ongoing management and patient satisfaction. So many of the same elements of the keys to the operational components are of our normal clinics or ambulatory services that we provide. So we talked about some of those operational or key considerations, but what are those workflow needs? Do I have a workflow for scheduling, registration and pre-visit preparation? Meaning is the insurance eligibility done on those patients that are being seen in person? If they have co-pays, if they have out-of-pocket expenses, if they require authorizations, are those things being managed and do I have a workflow for that? What does a device interrogation versus a programming assessment look like in my clinic? What is the time allocation for that? Your patient education, planning and follow-up. How is this managed? What is the workflow? What is the cadence of that follow-up for our clinic that supports our standard device clinic protocol? What are the documentation requirements and communication to facilitate that information to the provider to provide that care to the patient? Then coding, billing and compliance. How are you capturing your coding and billing for it and ensuring that you're maintaining compliance with the documentation, signature requirements and all of those elements of that operational workflow? This is an example of a device clinic in-person schedule for one full-time device clinic staff. So this would be, and this is not a standard, I would say that you have to use the schedule, but this is a typical schedule we would see. So that in-person device clinic team would have slots where they're managing those patients that are coming in for a wound check or post-op follow-up. Generally, when they come in post-op implant, they get their wound looked at and then they also have an interrogation of their device, potential programming. At the in-person device visit, a 30-minute visit versus a 45-minute slot is really based on your workflow and how that works within your clinic. So a 30-minute slot may be your standard follow-up programming patient. A 45-minute slot may be designated for a patient that is new to the device clinic and being enrolled. We've also seen slots that help to manage education appointments. So if you have someone coming in for education, for a new implant, getting them set up on remote device management, those types of things, you may have a designated time slot for those. But this gives you an idea of what a day would look like for your device clinic staff for that in-person management. When you look at staff credentialing, as we mentioned the HRS consensus statement that was published in 23, the recommendations are that your staff have appropriate education, both initial and ongoing, that they do maintain a certification and they have quality improvement reviews. When you think about device clinic, whether it's an in-person or remote device check, that is considered a diagnostic test. So in many of our diagnostic testing areas, there's a specific skill education that's both initial and ongoing, there's a certification and there are quality improvement reviews. Device clinic is no different and the consensus statement aligns with that practice. When you look at your multidisciplinary team for your in-person clinic management, as we discussed, you wanna be sure that everyone is working to the top of their certification, licensure or their skillset. And a device clinic does take a multidisciplinary team in order to do that. It's a lot of management of incoming data, patient management and ongoing follow-up education and complex clinical care. Normally we see a device clinic manager that may oversee overall operations of the clinic, including the staff, management, regulatory compliance. We also have some budgeting responsibilities, quality control as well. Sometimes that device clinic manager may be over much of the monitoring of a clinic, but they are designated to manage the device clinic services. Of course, our EP physicians are subspecialized and overseeing the care of the CIED patients. They are providing support for the clinical teams. They are helping with the overall care plan. And then of course our cardiologists are involved in broader care of these patients. So outside of their CIDs, they're generally managing their other cardiac conditions such as hypertension, coronary artery disease. Also we see advanced practice providers, which could be nurse practitioners or physician assistants that specialize and manage the day-to-day operations overseeing the device clinic patient management. So at times, that advanced practice provider is over the management and day-to-day function of supporting the provider role of an in-person device clinic. They, of course, are aligned with the EP physician and our cardiologist, but often do see that advanced practice provider role. Device clinic nurses. These are nurses that are specialized in the training of the cardiac devices, patient education, and management. A device specialist or technician is also a highly trained specialist who performs these device interrogations, programming, and troubleshooting. So at times, you will see in in-person clinics either device clinic nurses or device clinic specialists or technicians that are actually managing those in-person patients. If it's only device specialists or technicians, there is generally a nurse or an advanced practice provider that is available to provide the extended complex clinical needs or questions that may arise with the patient. But as far as the device interrogation, programming, or troubleshooting, you may see a device specialist, technician, or an actual nurse that does have that training to support these cardiac devices and the ongoing management. Administrative staff are key to our in-person device clinics. They support the clinic by managing the patients, all of the scheduling, the records, the billing, the communication with patients and providers. Often, these individuals are key to helping manage patients that may be lost to follow, following up on recalls, end-of-life devices, and really spend a lot of time working hand-in-hand with our device technicians, our nurses, and, of course, our providers. Medical assistants, at times, are used in getting that patient roomed. Also can help support scheduling and provide any of those administrative duties as well. Oftentimes, the medical assistant is able to assist the technicians and the nurses, depending on the volume of your clinics and how busy your daily clinics are with that throughput of the patient in your clinic. Then, of course, having that IT support. Oftentimes, there are interfaces that are required to the electronic health record. There's data management. There may be scanning, importing of data. So that is a key role in the overall function of that team and having support for your program. So HRS, we mentioned, recognized and recommended staff certifications. So the International Board of Heart Rhythm Examiners, the Certified Cardiac Device Specialists or Remote Monitoring Specialists, and the American Board of Internal Medicine are recognized certifications based on the HRS consensus statement that we would see in these clinics and support those highly trained individuals, whether it's a nurse or a technician, that are providing the management of the programming, interrogation of those patients within your device clinic. So how do you determine how much staff is needed for your in-person device clinic? So depending on how you set your staff structure up, which we talked about that there are variability to that. There's some hybrid models. There's an in-person model. There's an external remote monitoring. So depending on that, this gives you, from the HRS statement, the staffing capacity analysis and the tools to estimate your needs based on all of the roles we talked about. So what are your total number of patients followed in the clinic? And we would say that that's important to know by device type. So when we talk about CIED monitoring, we're talking about our pacemakers, our implantable cardioverter defibrillators, our cardiac resynchronization therapy, and our implantable loop recorders. And you often hear that referred to as our subcube monitors or our loop monitors. What are the number of hours in a full-time work week for the staff that you're looking for to staff this clinic? Meaning we know that a full-time employee is eight hours a day, generally five days a week for our clinics. However, is that full eight hours a day, 40 hours a week towards the device clinic management, or do they have other responsibilities? You want to be sure that you're allocating the hours of each team member role that they're spending in the in-person clinic to get to the number of staff that you would need based on the volume of patients that you have for your devices. What are the number of weeks worked in a year for the staff as well? So do they get to three weeks of vacation? Do they have standard meetings? How do you allocate for the number of hours per week? So really getting a true time as to their hours where they are truly providing that device clinic management work. So you want to get as close as you can to that. There is a calculator online that you can go to that does the estimates, and you can take out if you put in 80 hours of vacation a year, or you put in 40 hours of meeting a year, those types of things. And it does help you to calculate those staff hours, but it is important, as we see sometimes when they say one FTE, they're counting that FTE as 2,080 hours a year. However, that full-time FTE is not spending but maybe 60%, sometimes 40% of their time in a device clinic. So you want to be sure that you're allocating your FTEs correctly, and that is essential in the volume of patients that you have and that you're managing in these clinics. So data on in-person staffing. So interesting, the consensus statement states a minimum staffing capacity of three full-time employees per 1,000 patients. This does include all roles and the remote monitoring responsibilities. So depending on how you look at this and what you're including, you've got to consider. I would tell you that, you know, when we look at device clinics and we see the staffing, this is in line with what we generally see based on all roles that are used to support the device clinic. There was a study published in JMIR that we have a reference to that assumed each patient had one in-person visit per year and some unscheduled visits based on remote monitoring. And then that annual time per patient required for that in-person device check was relatively consistent across device types from one to 1.4 hours. And that was from the time the patient came in to the time that their device was interrogated. When you look at a AHA time study, the total annual per staff time in hours is 2.3 to 9.3 based on the device type. So again, both of these studies are interesting to reference and read as part of being in a device clinic to see the different variables with that. Because it really is based on your volume, your demand, and the capacity of your clinic and staff. And when you look at the differences, and if you go back to our cause and effect diagram, you can see some of those things that may be impacting that demand versus staffing model that could weigh in on how you're staffing these. But these are great references and best practice when looking at how to staff your clinics. So challenges with staffing, and these exist and have continued to exist over the last few years. And we have not seen an improvement in staffing in this area, particularly if you're hiring internal staff. Often the third party vendors have larger staffing models and are able to scale and support and also able to maintain that specialized knowledge. So I would say recruitment in this area, the training, and really that specialized knowledge is probably the biggest challenge. How do you retain these individuals? What is the increasing volume of patients and data? Are you competitive with salary and benefits? Once these staff are trained and have specialized knowledge, they are very valuable to the organization. So important to concentrate on retention, competitive salary, and benefits. And I will tell you, one of the biggest challenges we see is that they don't always have our technicians and nurses in this area, may not have those other administrative clerical roles to help support that volume of data, which can lead to burnout. And that's where you see that retention piece. How can you balance that with what duties are they performing? What other responsibilities do they have? And how do you equalize that to support their specialized knowledge, their competitive salary and benefits, and maintaining that retention? Right. Metrics for success. So when you look at that demand and capacity modeling, we talked about total number of patients as a key data input for the type of device, the growth of implants per year. So are you going to have a 10% growth, a 20% growth, et cetera? The adoption rate of remote monitoring or confirmed intervals per patient. So this would be something in your standard protocol that your providers would agree upon. Are we going to do three remote monitoring instances in a year? Are we going to do four? They can have up to four remote monitoring and one in-person a year. What is our cadence going to be for that in-person visit, for that remote monitoring? What is the estimated number of weeks that the clinic is operational? The percentages of remotes that don't require intervention? The time per in-clinic appointment and per remote that it takes for our staff. So what does that staffing time look like? And if you go back to those studies we referenced, there's key details around those staffing models and looking at the time studies. What's unscheduled versus scheduled services? We do see that at times being instrumental to the success of a clinic, because if you don't have a patient on an in-person schedule, your staff has a full schedule for the day, and they're getting two to five patients added to their schedule that are having clinic visits that weren't on their schedule. That can create a backlog. It creates some chaos. It also causes your patients to wait longer that may be scheduled. So really looking at that scheduling model. How are your patients scheduled? And if you do have unscheduled based on clinical needs, how do you manage that? And do you have time allocated and resources allocated to be able to manage those unscheduled patients? So in-clinic, the variation points that we see across that time in the clinic site, the length of scheduled appointments. Are my technicians, nurses seeing 15, 20, 30 minutes? Does it support the type of event that that patient is having on the schedule? What is the time of check-in, the time of rooming, the triage time for symptoms or care? So when the patients come in the clinic, ultimately they're going to tell a story. So they're going to talk about any symptoms they're having. They're going to talk about how they're doing. So there takes some time for that in-person. Time for interrogation versus programming. So are they interacting with the device? And what does that time take versus if they're just interrogating, downloading the data from that device? Time of checkout. So this is how does the patient flow through the clinic? How do they get their next scheduled appointment? How do I capture charges for that date? Patient document summary. So how much time does it take my staff to complete their portion of the documentation? Potentially download and scan any applicable information into the electronic health record. And then the provider interpretation and signature. And then ultimately dropping the bill for that encounter. All of these have a time element to that. So when you're looking at these time studies and you're thinking about the flow of the patient, the staffing of the patient, the dedicated resources for your in-person clinic, you want to be sure that you're taking into consideration these variation points and how that impacts your overall clinic. So what are some key metrics to measure? What are your volume by location? How has my anticipated growth met my projections? What is my timeliness of response of alerts or patients with clinical issues? Your charge lag or potential mischarges? So how are you reconciling your charges? Are you going back to that source of truth? Is there a charge lag because you're waiting for providers to sign the documentation? What is your process and policy around that? Are you receiving denials? Are those denials related to the timing of the device interrogation and our programming? If so, are we looking at our protocol, ensuring that our teams are trained and understand the time frames for our device management based on that specific device? How are you managing no-show missed transmission rates and what does that look like? Is my no-show rate high? Am I missing transmissions? How do you look? And looking at this data every month, every quarter, and comparing it year over year can help in providing the support needed for your device clinic and supporting that patient structure of the implantable device patients. So a few best practice examples. When you look at an in-person workflow, we normally see the patient's schedule and the appointments confirmed. The patient arrives. They go through the normal registration verification check-in process. They are roomed by a medical assistant, and the device visit occurs. So our technician or nurse comes in, does the interrogation or programming, and then the support staff of the device clinic provide that checkout and follow-up appointment. The tech or nurse does the documentation or data import. The tech or nurse also does our charge capture. The provider signs and interprets the study, and the encounter is billed. Obviously, this would be our perfect case scenario, that all of the timeliness is occurring through this, and that I'm able to complete the documentation, have it signed by a provider, and an encounter billed within three to five days of that patient's service. Now, that's best case scenario that we see, and a lot of times the area of variation is truly around the provider interpretation and signature. As our providers, we know this is part of their workflow and their work volume, but they have many other things going on, so sometimes there's a delay in that. So you want to look at what you can do to help with expediting that as much as possible, ensuring you have the right technology and process in place to ensure that that's a seamless workflow. So some of the solutions to support your best practice, integrating with your electronic health record. We will tell you that the majority of organizations who use platforms to support their device clinics, having that integration into the electronic health record, including scheduling, including documentation, rather than having to have staff intervene and upload or scan documentation, that integration is definitely something that supports that best practice. That customization of your protocols and alerts, being purposeful that aligns with your clinical initiatives of your providers, having financial short-term and long-term goals, being able to discreetly query data and reporting. So we talked about that source of truth. If you do have a recall of a device or you have patients that are end of life and have not followed up, are you able to query your current data and be able to have some reporting to go and contact those patients? Eliminate rework. So if you're manually entering data and you're electronically downloading than manually entering in your EMR, we would say eliminating the multiple steps and having that manual data entry is key. Being patient-centered to promote that quality and compliance for this in-person clinic. We talked about those complex clinical management needs and really having the support of a device clinic staff for your patients really supports that patient-centered approach. This is an example of staffing roles and responsibilities, and we talked on each of these. So this is a swim lane, and it reflects the in-person roles and responsibility of many of the teams. Sometimes they will have overlapping roles with the remote management, but for this session we're covering in-person only. But you can see as we talked about each of these roles, as you look at the swim lane, you can see those responsibilities of that individual and how that can assist with helping your clinic meet the needs of the organization and also support that best practice. So recommended standard protocols. We talked on this about the actual protocol for the device clinic. What we would tell you is having a job description for each of those device clinic roles is important so everyone knows their role and responsibility, a recall policy and procedure, some alert notification protocols, no-show policy, and even some of those documentation and coding workflow and guidance protocols. These all have assisted the teams with success in those in-person operations of the clinic. These are the references and resources that we provided throughout the presentation, and again, I think it's important to look at definitely the consensus statement and also the JMIR article. It does lend to when you're looking at demand and capacity and really understanding what we're looking at in device clinics and what we're seeing now. So that is the end of our course. I hope you enjoyed this module and look forward to seeing you in other modules. Thank you.

device clinic operations

healthcare setting

operational considerations

staffing models

credentialing

metrics for success

patient volume

best practices