And now, I would like to introduce our speaker to kick us off with Part 2 today. Ms. Laura Dixon most recently served as the Director of Risk Management and Patient Safety for the Colorado region of Kaiser Permanente. Prior to joining Kaiser, she served as the Director of Facility Patient Safety and Risk Management and Operations for COPEC from 2014 to 2020. In her role, Ms. Dixon provided patient safety and risk management consultation and training to facilities, practitioners, and staff in multiple states. Ms. Dixon has more than 20 years of clinical experience in acute care facilities, including critical care, coronary care, perioperative services, and pain management. Prior to joining COPEC, she served as the Director of Western Region Patient Safety and Risk Management for the Doctors' Company in Napa, California. In this capacity, she provided patient safety and risk management consultation to the physicians and staff for the Western United States. As a registered nurse and attorney, Laura holds a Bachelor of Science from Regis University, a Doctor of Jewish Prudence from Drake University College of Law, and a registered nurse diploma from St. Luke's School of Professional Nursing. She is licensed to practice law in Colorado and in California. Thank you so much for being back here with us this morning, Laura. I invite you to kick us off with Part 2. Great. Thank you, Lindsay. And I want to say again, thank you for everyone for coming back today. Yesterday's was very informative, and I'm so glad of the questions that were put out there during the program. Now, I do have the polling questions that Lindsay mentioned. We do have several of them. In time, and respect for your time, I don't want to run over, so just be aware if you do get the slide deck and we didn't address a particular question, it's just so I can, again, respect your time and make sure we're getting done as the program progresses. So I've got my contact information. I also have the email for CMS for rural health clinics directly. So you don't have to worry about going through a hospital one. This is for you. So if you have questions that you want to get it through CMS, I would send it off. Just keep the response once it does come back. Now, this segment tends to be a little bit more responsive than I find with the hospitals. So if you, again, have that question, send it off to them and keep their response. I always include in all my programs a disclaimer that my program is informational only. It is not meant to serve as legal advice or establish an attorney-client relationship. Please consult with your own in-house counsel, your legal representative, wherever that happens to be, as it relates to specific issues. Now if you do have a question as it relates to the regulation, please feel free to send those to Lindsey, and Lindsey's great about getting them to me. I'll respond back, again, without providing legal advice or anything such of that nature. So just a quick, very quick introduction. This is why we're here today, so that you don't end up with one of these. That is where they've come in, they've done their survey, and found that some of the requirements weren't met. You're out of compliance is how they phrase it. And no facility or provider wants to get notice that they have been involuntarily terminated from the Medicare and Medicaid agreement. We know that that can be a huge impact on any type of healthcare provider. In fact, I was just reading this morning that there is a hospital up in Michigan that was terminated from the Medicare agreement because of their lack or inability to meet the requirements and supply a valid or an acceptable plan of correction. So it's still going on. These are the topics I'm covering today. Yes, there's several of them, but nonetheless, we will get through them, because as you can see, for rural health clinics, it's not so much involved as it is with a hospital. So let's go ahead and start right off with staffing and responsibilities, and with a very quick question. Okay, let's get that one up here on your screen. Okay, so you should all now see this question, and this one asks, our clinic has much difficulty obtaining and or retaining adequate staff, primarily providers, yes or no? We'll give you just a couple of seconds, put in your responses here. I did touch on this briefly yesterday, but this gives us an opportunity to go a little bit more in depth on what some of the requirements are in order to have certification as a rural health clinic. Okay, we've gotten some good responses there. Here are those results. Okay, so yes, okay, we're kind of all over, but that's great, and that's okay. That's okay. So what are the staffing? You have staff that at least have to have one or more physicians. Now, what kind of physician? That's up to you, and it can be an MD, it can be a DO, it can be whatever specialty, but they have to understand what their responsibilities are, because they are, you know, they're responsible for care to all types of patients, whether it's an elderly individual, maybe it's a pediatric, they have to make sure that they are qualified to provide standard of care according to national guidelines. This person can be an owner, they can be an employee, or you can contract with that individual. physician, if they're not responsible for supervision or direction, because that's a medical director, then you can have a contract with that physician or third-party entity such as a locum tenant. That's okay to have such a provider. On staffing, you have to have at least one or more of the advanced practice providers, whether it's a physician assistant or nurse practitioner. And like the physician, they can be an owner, employee, or contractor. They also have to have at least one of them be an employee. Everybody else can be a contractor. So they do kind of narrow the focus there on the advanced practice providers. They have in those definitions what the education requirements are, not scope of practice, but education requirements. And basically, they do have to be licensed and operating within their scope of practice. So here are the three options for a nurse practitioner. We see a lot of these with our rural health clinics, because sometimes they have a little bit more independence than what a physician assistant does. So as far as your nurse practitioner, of course, they have to be currently licensed in the state where you are located and certified by either a nationally recognized certifying body that has established standards for that practitioner and they position masters or doctoral degree. Another option, they've done and satisfactorily completed that one academic year formal education that prepares an RN to do that expanded role of primary care. They also have to have four months of classroom instruction and supervise clinical practice. And then, of course, successfully completed that program, given that degree, certificate, whatever they happen to call it. Third option is they've completed a formal RN education program. They've worked in that expanded role, but they're not may not meet those requirements. But of number two, the one where it's a formal education, the supervised care, etc. But they have been working in this expanded role for at least 12 months during a year and a half before that effective date. So they do give them that much of a leeway. Some of those RNs have been practicing in their role. They just haven't had the opportunity or the ability to have that formal training, so to speak. A PA, likewise, has three options in order to utilize them. They have to be currently certified by that National Commission on Physician Assistance, or they've satisfactorily completed that accredited education in a supervised program. Usually these things are one year in length. Then they have that mentoring, that proctorship, so to speak, of supervised clinical practice for four months, at least four months. And it's through a program that's accredited through the AMA Committee on Allied Health Education. Third one, they've done the education for preparing PAs, but it might not meet that requirement in number two, accredited. But they've assisted primary care providers for 12 out of the year and a half before that ended on December of 1986. Again, a little bit more leeway for physician assistance. And I got to hand it to them. They are trying to help out with staffing situations because they can be very challenging at times trying to find qualified or at least enough of those educated, those qualified, those who have experience in those two roles. Now, there is a waiver. If you are an existing clinic, you can request a waiver to employ one of the mid-levels. If it's your initial application, though, you can't do that. That's not eligible. You had a one-year waiver. If you give that written request, you've shown that you have tried, despite your best efforts, to hire within the previous three months. And that request is six months or more after you've had a previous waiver expire. It's deemed granted unless you get that notice from the regional office within 60 calendar days. So, you can have a waiver if you've tried and it's just not happening. Optional staffing would include those that you aren't required to have on staff, but you can if you want to have them. Midwife, certified nurse midwife, clinical social worker, clinical psychologist, marriage and family therapist, or a mental health counselor. Like the others, they can be an owner, they can be an employee, or contract. Again, you're not required to have them. You're not required to have that midwife, that clinical social worker. You don't have to have them unless it is absolutely essential to the operation of your clinic. And I want you to take into account how many of these folks you see that might be OB patients and your physician is not or doesn't have enough experience or isn't comfortable taking care of those OBs. And you may want to have that clinical nurse, that nurse midwife. You may want to have that person on board to help and take care of those pregnant moms. If so, then they have to meet the requirements of education, training, other requirements, and of course, licensure. They have to be able to furnish care whenever you're open and operating. And again, they can be an employee or they can be contracted. So again, you're not required to have them. But if that's absolutely positively necessary for your clinic to be in business, then that's what the requirements are. By the way, that that was pretty new as of just late last this year, where they made that requirement that if it is essential, then that's what you have to have on board and they have to be trained. Then there's your other ancillary personnel. These are the folks who are supervised by your physicians or if your state law permits a PA or nurse practitioner to do so. That's your RNs, your techs, everyone else. Likewise, they have to hold their current licensure when it's required. They're supervised at all times. And you can share that supervision. It doesn't have to be just one nurse practitioner, one PA or one physician. They can share those supervisory responsibilities. The supervisor when I'm sorry, with a surveyor, when they're on site, said, who's your supervisor for the day? And hopefully they can answer. Of course, you have to have enough staff to give your services, whether it's one of the practitioners or maybe it's one of the RNs. Of course, they all have to practice within the scope of practice and other services. Those are diagnostic and therapeutic, physical exams, assessments, maybe doing lab services. What they're looking for is really first responder type emergency services. Also, on staffing the services and supplies, what you would find in a physician's office, you're a clinic, you're not expected to be a hospital. That's not what they expect. But enough qualified staff to do those services for the patients you see. Again, you can only be open if the practitioner is on site and available to provide those services. You can use telecommunications for doing those services. But nonetheless, you still have to have one of those practitioners on site. And again, only for providing services within their scope of practice. What they're trying to say here is you have to have at least one practitioner, PA nurse practitioner, or physician on site. Now, the practitioner, let's say you've got your NP on site. And a patient comes in, they need to be seen or have communications with the physician. You can use telecommunications to do that. But the NP still has to be on site, no matter what. If you lose that advanced practice provider, then you're going to have to ask for that waiver. And that's why you may need to adjust your operating hours, change your appointment. We know that's all so much fun to have to do that. But that's what you do have to do. And you have to notify the state agency, because that will affect your certification status. These are practitioners, these are not your RNs, your other type of staff. If there is no practitioner on site, and you have patients who are waiting outside to come in, you can let them into the waiting room, as long as they're not back in one of the clinic rooms, or receiving any clinical care. Maybe it's a billing issue, or you just want to get them out of the weather. In my state right now, it's 21 degrees here in Denver. So it's a little chilly outside. We can allow them in to sit and stay comfortable until a practitioner is on site. We just can't do anything for them. At that point, you're not considered to be in operation. Again, no practitioner, no services, can't do that until they're on site. Have those timeframes also, so that your staff can get their administrative, their paperwork done. So it's outside. Put your hours of administrative, let them know, these are my office hours. My clinic hours, where I'm actually providing care, are these. So that there's no expectation that a patient can come in and maybe have an appointment with that person, when that's not the case. Also follow your state law, if there is any prohibition on access, when you're not in operation. But according to CMS, you can let them in. This is the one where you will need to work with your counsel on what is acceptable hours, when can we let them in. The surveyor will determine, yes, you have a practitioner on site at all times when you're open. Let's talk about lunch hours real quickly. What if you decide we're not going to do clinic services over the lunch, but patients can sit out in the waiting room? That's fine. You can do it. Just have to make that clear. No, we are not seeing patients at this time. You can do it. You are not required to do that. They want to look at your schedules. They want to correlate that to your clinic hours. And then we'll ask the staff, RNs, whoever's hanging around, if you're open and giving service when you didn't have one of those practitioners available on site. And they're going to verify your hours. They want to make sure enough staffing within those hours of operation. I talked yesterday about services 50% of the time by your advanced practice providers. So at least 50% of your operating hours services are offered by those folks, even if you have a doc on site, doesn't matter. If you're not providing those care, but if they're in the clinic, that can still be counted toward that 50%. That's okay. Services provided to the patients outside the clinic, like in the home, that still counts. You can do that. You can do home visits, and that still counts toward your 50%. But the physician must be on site at that time. The guidelines give several examples in order to meet that 50%, just in the interest of time. I didn't want to include that here, but they are there. So if you have a question afterwards and want to know, does that comply, you can send the question to Lindsay, and I'll respond back to her. You can request a waiver for that mid-level. Again, these are only Medicare participating, and the initial applications don't apply. What you would do is you send in your written request to the state agency, show you've been unable, despite everything you've tried to do, to have that mid-level there, 50%, for the previous three months. And that, and that, likewise, from an additional waiver, in the six months preceding, you haven't done that waiver for that time. So let's say in January you had to have a waiver. And then in June, you still can't get anybody, and you had to request another waiver, it'll probably be turned down, because that's the six-month time frame in there. So that's staffing. Let's talk about what the physicians have to do. You have to have only one medical director, and that's their job. They have the direction over the clinic, they're responsible for what happens, what the quality of care is. They have to make sure that they also provide healthcare activities, they're there for consultation and supervision of staff. And that could be other physicians, if that's the way you set it up. It doesn't limit mid-level scope of practice, it's just they have to be there providing supervision. They give orders and, of course, care to other patients. They're not required, again, to be on-site to perform all duties, unless there is no one else on-site. And again, they can provide a way and time frames to complete those duties, whether it's direction, record review, consultation, or actually doing services. Your state and your clinic, by the way, can establish those requirements for actual on-site presence. You may want them regardless, whenever you're open, if that's what you want, fine. You can use locums as long as they agree to a six-month contract to provide service for at least six months. What does the PA nurse practitioner have to do? Well, we know the physician has to review their records periodically. These mid-levels, the advanced practice providers, they have to participate with the physician in that review. If your states require collaboration, then they have to review, co-sign, or both for the patients, but it must be done. And if the co-signatures aren't required, they still have to do that periodic review of those records regardless. Even though they don't have to sign off, they still have to go through with them. There are other requirements for record reviews. If you have more than one physician, you're lucky to have more than one. Other physicians can do that record review, but the policies, procedure, they have to spell out who can do review and sign off, again, if the sign-off is required by your state. The periodic timeframes aren't listed out in the regulation. You determine that based upon your volume and type of services that you want to do. Is it weekly? Is it every other week? And the review doesn't need to be done actually on-site. You can use telemedicine to do that. That's okay. The functions of your advanced practice, of course, they do services, operate within their scope of practice. They can arrange or actually refer patients out when needed. Maybe you can't provide a particular service. Maybe the patient has to have a treadmill and you don't do it. That's what they could do. They make sure records are maintained, sent off when needed, and especially when the patients are transferred. They have to make sure that that is done. Surveyor wants to talk about the clinic's owner, who's in charge of those policies governing your services. Which ones can be provided by the advanced practice? Which ones are outside that scope of practice? They will also talk to those advanced practice providers about what they do. Do you provide services that might step outside their scope? What do they do if that patient needs those services and the physician isn't there? And it could just be as simple as, I know how to reach my doctor. We get on the phone with them. I will go into the computer. I may actually do a Zoom call with them. As long as they know how to reach that provider or a provider, that's fine. That's all they need to know. And what about new practitioners? How do they make them aware of those patient care policies? They'll look at records of those patients who were sent from your clinic. They want to make sure somebody arranged for that transfer, whether it was a physician or an advanced practice provider. They want evidence that medical records, what that was needed, was transferred either with the patient or went electronically, if that's an option for you. They will look at records for care that was given by the advanced practice. They want to make sure they made entries of what care was given. They were records were properly maintained and again transferred when that patient was transferred. So that's staffing and the responsibilities. Now let's get into the meat of it, the provision of services. And that's our next question, Lindsay. Okay, let's get this one up here on your screen. Okay, so you should now see that this says our Rural Health Clinic provides the following patient care services. And you can check all that apply here. Routine health services, annual exams, sports exams, etc., prenatal care, basic laboratory services, radiology, plain films only, ultrasound, OB and routine, and or urgent care. If you do have questions for Laura up to this point, please go ahead and be typing those into the Q&A there at the bottom of your Zoom window. Or if you don't see that option, you can of course just type your questions there into the chat as well. More seconds here. Perfect. There are those results. Basic lab routine, urgent care, radiology. What basic requirements? Again, all services have to be provided following laws, state, local, federal. It's your primarily engaged in giving outpatient services. On direct services, they can include diagnostic and therapeutic. You can do your x-rays, you can do those lab services, you can have those supplies for maybe a splint. These are the ones you normally find in an office or at the entry point of a healthcare delivery system, say, coming into urgent care. They are provided by your staff. Doesn't matter if it's a practitioner, those counselors, and those that might be incidental to other services, again, splinting, maybe doing an x-ray and ultrasound. These are ones, again, common in a physician's office, like taking a medical history, doing that exam, assessing their status, some routine lab tests, diagnostic treatments such as those for COPD. Maybe you want to do a pulmonary function test. You can also do, and I mentioned this yesterday about the visiting nurse service, that's optional again, if you want to do that. You can provide others that not necessarily primarily engaged in special services. That's one thing that they want to make sure, that you cannot just be providing specialized services. In looking at primarily engaged, what they're going to look at is, what are your total hours of operation? If the majority are over 50 percent, and they involve those special services, that's how they will determine, yes, it's primarily engaged in specialized services. So here's an example. You give services nine to four Monday through Friday. You do radiology one to four Tuesday and Friday. What you're doing here though, is you are giving primary care to that rural health clinic 85 percent of the time. So you're okay in that circumstance. Now switch it. Let's say your hours are nine to four, but you're doing nothing but say OB and those services like for advanced moms, maternal issues, you're doing that most of the time, like say from nine to two, four days a week. That's specialized services, primarily engaged, and that will not fly. You have to be able to give those primary services the majority of the time. They're going to look also at your website. What are you offering? They want to talk to the director. They have to describe services offered. Do you include specialty? And again, it's okay to do that. It's just not over 50% of the time. If you do include them, they will look at the hours. And again, if it's a majority of the time, then that's specialized services. They'll look at records for the last two months, the majority of special services. What did you provide? Especially those specific services. Again, not that you can't, but they want you to be a primary care provider. That's what they're looking for. The responsibilities of the providers, of course, the physician has to develop and execute periodic review of all the written policy and procedures. And that's those that are provided to the Medicare program. They do this with the advanced practice providers. They have to do that with them. Those providers, they participate the same thing in development, execution, and periodic review of the policies that govern the care provided. Patient care policies have to be developed consistent with state laws. And they are developed with the advisory group of other personnel. It doesn't have to be just the nurse practitioner or PAR, just the physician, but someone who's not a member of the clinical staff. Think about your RNs, maybe your lab personnel. What about pharmacy? How do you provide pharmaceutical services? How do you do that? Those are the ones you want to consult with in developing those patient care policies. The review group, it has to be identified in writing who did that, and that they provide advice to the leadership on those appropriate policies. Here's the kicker. You have to look at those policies every two years. That's part of the hospital improvement rule, that big long transparency rule that I have mentioned a couple of times. So that's part of it. They want these things to be looked at. Later on, we're also gonna be talking about program review, but these are your patient care policies that you'll get just look at them. Maybe they don't need to be changed, but they want to see the date it was reviewed. Leadership, you don't have to accept the advice of that policy group. If so, if they're gonna either reject it or maybe make modification, those have to be, of course, clinically supported and appropriate. Now, they just can't come in and make a change that is way off base. It has to be appropriate for what you're doing. They want to see these meeting minutes, some kind of documentation to show, yes, indeed, those policies were reviewed. They want to verify who participated in developing those policies and then who recommended those policies to leadership. Then they're gonna go talk to leadership. Ever rejected the advice of your policy group? If so, how did you make sure those changes were clinically appropriate? And where's the documentation of the rationale for those changes or that rejection? So it just cannot be anecdotal. They want to see documentation of why those policies were modified or rejected. The policies have to include, of course, what services are you providing? Is there one that you're going to do by contract? Guidelines for medical management, that's what also has to be included. Those conditions that you have to get consults from outside or refer them on. Those guidelines on maintenance of the medical records, that periodic review and evaluation of services that you do provide. On your description of services, yes, they have to be in writing. Enough details so that if the surveyor picks it up, they know what are you doing in your clinic? What's the scope of services? Are they by agreement? Are they by your own staff? Who is providing those services? Here's just an example. The one that yes is acceptable and not enough description. So the one on the left, yes, that's acceptable. You're going to take those complete histories, do those routine labs. Common treatment and diagnosis for maybe chronic or acute illnesses. Your immunization program, family planning, that's all a good description of what your services are. What you don't, what isn't sufficient, complete management of common and acute chronic health problems. That's not enough to describe what are you actually doing. On medical management, you do need guidelines to describe them. Who is going to provide them also? Now, you don't have to have specific names because that could change. It's just our physician assistant will do this. Our nurse practitioner will do that. Our marriage and therapy counselor will be doing this. And of course, the extent nature of any supervision that's required. That's usually by the state law. If you have that state law included in those guidelines. So there again, there is a support for that guideline. Standard protocols. This is what you're going to do to take care of your patients for diagnosis and treatment. Guidelines can have multiple formats. General protocols by symptoms, you can medical directives by body system, standing orders to address those categories, whatever works for you really. How are you going to handle medical management? You know, if you get someone who comes in looking a little gray and ashen and holding on or rubbing their chest, you're going to know what that is. That's my goodness, they're having an MI. How are we going to handle that? That may be your rapid response team type protocols. That's what they're looking for, those standing orders on them. And your criteria have a way to describe that criteria to diagnose and treat those conditions. If this, then that. Some may incorporate that assessment that includes that branching lock-in. Again, if this and that, yes, no, yes, no. Maybe a more narrative works better for you, a description of the service. What was the etiology? When did this start? Then the clinical features, their presentation. How did they do with treatment, complications? Recommended diagnostic testing, whatever works for you for your guidelines. But they must be comprehensive. There must be enough information to cover those issues in a primary and preventive healthcare setting. What actions can your advanced practice providers take? Of course, with their state scope of practice, when do they have to have that consultation either with your physician or get an outside consult? And these guidelines have to be accessible to everyone. They have to know where these guidelines are kept. Are you going to keep them by computer? Fine, that's great. Are you going to keep them in paper copy? Okay, where are they going to be kept so they can access them? And by the way, if you're going to keep them by computer, have a backup system. So if it goes down, you have to shut it down because of a hacking or maybe a power outage. How can they access that information if it's not available electronically? Surveyor wants to see that copy. That's why sometimes it's helpful to have them in paper form. They want to make sure they're consistent with what you advertise, either by posters or on your website. They're going to talk to the medical director. Show me one or more of these guidelines. How are they developed? How are they used? Also, they want to make sure that it includes all of the required elements, that it's been reviewed at least every two years. And then one of the other practitioners, how do you access the clinical management policies? How are they familiar with those guidelines? How does it apply to their practice? Is there something in there that's so unique and maybe used once in two years? Is it really usable for your practice? Maybe it is. Maybe you do have that. Over to drugs and biologicals. Likewise, your policies, your care policies have to address how you're going to get these drugs, how you're going to store them, handle them and administer them within the clinic. Of course, following those accepted principles, professional principles of pharmacy and administration, adhering to our federal and state laws, think controlled substances, if you're going to use those, and standards and guidelines for administration from our nationally recognized organization. They list out some of them in the interpretive guidelines. They don't provide those guidelines from those organizations. They leave that responsibility up to us to go find them, but they do list them. I have the links, the web links in the appendix for you. So you don't have to go searching around for those. On storage, your policies have to spell out how you're going to store these medications, drugs and biologicals. Following the principles, appropriate storage. That could be sanitation, temperature, light, ventilation, keeping them separate. Maybe you have lookalikes, soundalikes. You definitely want to segregate those. Security, if those are controlled substances or even non-controlled, how are you still going to make sure they don't get legs and walk away? Other environmental conditions, you want to look at what does the manufacturer's FDA approved insert say for storage. Temperature, exposure to light, humidity. Have caution in administering those drugs or biologicals that aren't labeled to show proper storage conditions because there might have been some excursion from those proper conditions. Make sure they've been stored properly because if it's inadequate, you could affect its efficacy. It could become simply unusable and you have to toss it. Security policies, again, have to be consistent with federal and state law. Who has access to that storage area? Is it going to be just the practitioners or is it going to be maybe a charge nurse or a day charge person to have access to that storage area? It makes sure they're not stored so they're accessible to those who have no business being accessed. Visitors, patients. And secured, and I think I mentioned this yesterday, when it's in a private office where somebody is with that non-clinical person. Area is restricted to authorized persons only. That means secured. It could be your med room. As long as somebody is keeping an eye on it and the desk or the common area isn't left unattended where people could walk back in and gain access to it. Yes, it can be a hassle to unlock and lock that door every time. But when you look at the potentials for security risk, it's worth the few seconds that it has to take. You do have flexibility in keeping those non-controlled. As I mentioned, where staff is actively providing care or preparing for patients, maybe they're at the desk. That's fine, it's secured. If it's not staffed, controlled and non-controlled have to be locked up according to your state and federal law. If you're using carts, I don't know if you're big enough or if that's a viable option, but they do mention it. Someone who has authorized access has to be within close eyesight and directly monitoring the cart. They don't have to stand there like a guard. They just have to keep an eye on that cart. Monitor, be aware of other people's activities. Because again, you're responsible for the security of those drugs and biologicals in that cart. Which brings me to my third question. And I'm so happy that we're moving well along. Lindsay. Absolutely, okay. All right, so this one should now be on your screen that says, our clinic does not maintain any controlled substances on site, has very few controlled substances and limits such to schedule three and four, three through five and has scheduled two through five controlled substances, which are maintained in secured, locked locations with limited access, or maybe not sure what our clinic has for controlled substances. Looks like we did have one question come in, Laura. Okay. It says, if we are a provider-based rural health clinic under a critical access hospital, do we need to have separate policy review meetings for the RHC policies or will the policy review meeting for the critical access hospital be sufficient? Excellent question, CMS has not addressed that. Because somebody from that rural health clinic, for those policies that apply to you, they have to participate in that policy review. Because that, I don't wanna have you risk being cited because you didn't. But if you can show that, yes, indeed, you're participating in that clinical, those policy reviews, that may satisfy. You do have to participate in that review. But that's an excellent question. CMS has not addressed that question. Because usually what happens with these clinics, what they found initially was that a lot of the criticals had happened to close, converted to the rural health clinic. And therefore these things were already in place, they just needed to modify them. That's an excellent question. In fact, I'd probably send that off to CMS, see if I can get a response from them on it. Yeah, absolutely. Perfect. All right, I don't see any other questions. I'll go ahead and end this poll and show those results. And I hope I get the question right to CMS. We'll find out. Okay, they don't maintain. And that would be a little uncommon. Some do though, when they get a patient in who's got a busted arm and they're able to set it and they're hurting a lot, sometimes just getting them eased over until they can get that pain better managed. So scheduled drugs, these again are, and I'm only gonna say two through five because schedule one is like your cocaine. And hopefully we're not keeping that on site because that's a whole nother host. But for those who do have, we have to track from the beginning it hits you until you've either administered it or you sent it back or destroyed it. Locked or not in use, you have to have some accountability procedures so we can ensure control. In other words, who is going to have access and what do you do to keep track of those meds? Are you gonna do a double count every shift or what is it going to be? Track the movement, again, from entry to departure. And you have to make sure that documentation is easily available and readily available because you have to reconcile any discrepancies promptly. Where is the loss? Are you suspecting diversion? They want you to minimize that time between that discrepancy in order for the determination of, okay, where did it go and who had access to it? It can be something so totally innocent. Oh my gosh, I forgot to document that yes, we did waste a certain amount. Handling, that means everything from reconstituting and mixing to actually administrating. Compounding is included in handling. This is where you have sterile preparations, whether it's IV or other drugs, and it can be done onsite or offsite. You can use your own staff. You can use a contracted pharmacy. You can do a contracted facility. They are different. Compounded sterile preparations, it's not common for you to do those. You may have an additional service. Maybe you have as part of your service, one day a week you do infusion therapy. That could be it. But again, it's not common for them to use it. If you are using them, you have to make sure they are done according to professional practices. Even if you do use them, you're not likely to have your own pharmacy would do it. So you have to have someone else, whether it's a pharmacy or a facility. So let's talk about those two just briefly. One is an outsourcing facility. That's a 503B. That's from the Drug Quality and Security Act. It's a federal law. They have oversight over these compounding pharmacies. The facility is in one location, and this is all they do. They compound sterile drugs, and they have elected to register and comply with 503B of that Food and Drug Quality Act. So that's why they call them 503B pharmacies. Can be a little confusing, but that's what they are. They have registered. They have to comply with the good manufacturing practice from the FDA. They have to have minimum requirements for facilities, controls and manufacturing, processing, packaging. They are inspected by the FDA, and they also have to report adverse events, and they have to give FDA information on what products they have provided and compounded. What you can do, if you don't want to use the outsourcing, that facility, you can use a compounding pharmacy. It's a little bit different, and I'll get to that in a minute, but you can, and it is really preferred that you use the compounding facilities as opposed to a pharmacy, because they are inspected by the FDA. They're held to those requirements. They have to report these events. They have to have appropriate labeling. FDA has a list of these compounding, outsourcing pharmacies available for you that you can go look it up in your state. They also give you additional information, date of registration. When were they last inspected by the FDA? Any other actions? Did they have any issues? So that's nice that the FDA has provided it to us. And then the other option is your pharmacy. These are ones that come from a pharmacy that are not listed or not registered with the FDA. So they're called 503A pharmacies. They come under the purview of your state pharmacy board. What you have to show, how you made sure these medications that you received were compounded using acceptable professional principles. So how do you do that? You get these pharmacies to supply you with that information. So if you're going to contract with them, make sure you have access to their quality assurance data. Put that in the contract that yes, indeed, when you ask for it, they will provide it. Document and review that data when you do get it, and require them to meet those expectations of that 503A. Because again, they're surveyed by the State Pharmacy Board, not FDA. Another area you have to watch for medication is your expiration and beyond you state. Expiration is by your manufacturer. That's done by the stability testing that's part of their FDA approval. Because we know it can be unstable, it can be unworkable, and not just unstable, but it's not effective for what it's there for. And these are the ones where usually it's under those conditions that are inconsistent with what the manufacturer says we have to keep them at, like temperature and light. The beyond due state, that usually happens before the expiration date. And that takes into conditions and potentials for deterioration, and maybe, heaven forbid, microbial growth. That can occur during or even after it was open, during preparation or compounding. That beyond due state comes from that manufacturer. So that's how you have to figure that out. Now, if you're using a pharmacy that's coming from the outside, have them figure out what is your beyond due state so your staff doesn't have to go through the mental hopes in order to make that determination. The ones who know it better really need to make that determination. Otherwise, your practices and your policies have to reflect just basic standards of care. And what information are you going to confirm before you give that medication? The five rights, we're all familiar with them. Patient, med, dose, route, time. Those are the basic five rights. Now, there's also the medication process, which is different. That also has five stages, where it's ordered, okay? It's gonna be transcribed and verified. So someone has to take that order and then take it to the next step. Then the pharmacy dispense it and delivers it. Staff administer it. The fifth step is we're watching. How did the patient respond to that medication? They also note in here that we promote that culture for reporting. In other words, the staff can go to that provider, and this can be the pharmacy person too. They can follow up with that provider and say, I'm a little unclear on what this medication was and how much dose, and they don't have to worry about having their head bit off. They don't have to worry about that backlash. These are very safety conscious questions that the staff has to ask before they administer that medicine. If there is a bad outcome or it's the wrong med and they didn't ask, then that could lead to problems for everybody. A surveyor, they're gonna do a check of your drugs that you have, your inventory records. Is everything there that's supposed to be there? They're gonna make sure they're secured and locked if need be. They wanna check your system on tracking the movement of scheduled drugs in particular from entry to departure. Does that system have documentation so you can do quick reconciliation? Is there evidence of discrepancies? And if so, did you reconcile them? If so, was it prompt? And then they wanna talk to that person who is responsible for the storage of the medications. This could change on a day-to-day basis, granted, but they still have to know about the storage issues. If you are using a compounded sterile pharmacy that is not your 503B, in other words, it's not an FDA registered, they want evidence that you automatically evaluate and monitor that source. They will do a spot check for expired or unusable, otherwise beyond you state. They wanna ask who administers medication, including if you do provide IV meds. Are they practicing within their scope of practice? And they'll also just watch. Are they doing the five rights? Are those actually being completed? Other services that you can provide. Now we're out of meds, we're onto other services. Laboratory, you have to have the six minimum services, urine dip, H&H, glucose, occult blood, a pregnancy test, and then just doing the culture to be sent out to the reference lab. If you cannot provide the six because from some state law or a local law that said, no, you cannot do those, then you are not required to have this service for certification. Otherwise, yes, you have to provide those six lab services in order to get certified. And CLIA requirements. So that means you have to have a CLIA certificate according to what level you are providing. Maybe it's basic, maybe you're doing a little bit more advanced. Okay, but you do have to have your CLIA certificate. You can do other services. You can do them onsite or by contract, but they must again comply with all the requirements. Have an arrangement with another provider, maybe a reference lab, but that again cannot substitute for those six basic that you yourself have to provide by your staff. They still have to be done. Other services include emergency services. You just say as a first responder, those life-threatening injuries, illnesses. So you wanna have those drugs and biologicals ready, whether it's antibiotics convulsants, maybe it's an antidote. They've been bitten and you have to have something, a snake bite to treat the snake bite. Maybe they have come in and taken the wrong medication or they inhaled something, say old Santa flush or Clorox or something like that. How are you going to have that a medic handy? Maybe you need to have antibiotics on hand, analgesics, again, just your minor ones if that's what you want, or an anesthetic if you're stitching up a cut. You also have to have enough staff to handle those emergencies at all times you're open. Keep the type and quantity of drugs that are used by first responders. And that's what your policies address. Which ones you're going to have and in what quantities. Have enough to handle your volume and type of emergencies you typically handle. If you're in a farming community, that could be vastly different than if you're in a construction area, or if maybe you're in a more resort type area where you've got a lot of recreation services that are provided. Those could be vastly different. I grew up in a farming community. I'll tell you, we had some pretty nasty injuries that there was no way that clinic could handle it. What they ended up doing was stabilizing and calling 911 to get them in. I want to make one quick comment about as far as equipment. If you're going to have a crash cart, that's fine. That's your choice. Just look at keeping it stocked, keeping staff qualified and trained to handle it. And who's going to administer those medications? How do you monitor the patient? Is it better to have minimal equipment such as an AED and then call 911? In doing these, check the response time of your EMS service. Don't over promote yourself and put yourself at risk and the patients at risk if it doesn't go well. On the category, you're not required to have everything in the world, just what is your community need? What's your history of your medical needs? And those standards of practice. Have those written and policies to determine what you have on site and who's making that decision. Is it the physician in collaboration with the nursing staff? Is it the physician advanced practice and nursing? Who makes those decisions? Be able to have, and you must, by the way, have that complete list of what you have on site and in what quality. And they're going to compare it to make sure that you've got what you say you have to have. You can have agreements with other providers or suppliers. They just have to participate in Medicare. That's what they have to do. And these can be inpatient care, other physicians, as I mentioned, or those diagnostic labs that you don't provide in your clinic. If it's not writing, okay, just have something to show patients were reviewed, were referred, excuse me, and treated. Okay, provision of services was quite a bit that we covered there. Everything from normal routine services to emergency services, which brings me now to our fun part, the medical records. Next question, Lindsay. Okay. All right, so this question should not be on your screen. You can check all that apply to your organization here. The question says, our medical records are all electronic, interact with a larger system, are paper or hard copy frequently unavailable if the system is down, the department is managed by one person, and or sometimes not available when needed. If you have any questions for Laura, go ahead and be typing those in, please, as well. Give you just a couple of seconds here. Okay. Some good responses here. All right, and there are those results. Okay. Oh, wonderful, electronic. Oh, that's great. I mean, electronics can be great, kind of a headache at times, but they can also be great because when they're legible, you can read what's on there. Overall, you have to have a system according to what your policy and procedures are. So you've got your electronic records. You have to have a designated professional staff person who's responsible to maintain those records. It can be the physician, can be your manager, your director, excuse me, whoever it is, can be advanced practice provider, doesn't matter, but they have to make sure these records are complete and accurately done. They have to make sure they're accessible and organized. And some type of system, whether it's alphabetical, however it is, but you do have to have a clinical record for each and every patient, no family records. In other words, you have one for brother Billy, sister Sue, Martha mom, and David dad. Each one has to have their own record. They have to be complete, comprehensive, and accurate. This, you have to have also one person who is clinical or administrative who is responsible for the system because they have to develop and put together those policies and procedures. These policies and procedures are reviewed and approved by leadership and the professional staff. So again, you can have an administrative clerical person, a professional person, like a director of medical records who has these responsibilities. On your electronic record, you can be part of a larger system like that systematic exchange of records. So the person who asks the question about the critical access hospital, you can have a record system with them. And that's great. Then if you're gonna be sending patients to and from, it's easy to transfer that information with a click of a button. But only appropriate staff can have access to those records. Your policies, your procedures must be written and reflect if you are part of a system or an exchange. In other words, records for all visits have to meet those conditions and they're readily retrievable and distinguishable from other information in that shared system. So we know that if your patient is seen at your clinic, that people at the other, say the critical access hospital, they're part of this, that we know what's in the critical access hospital record for that same patient perhaps and what's in your clinic. And that only correct people have access to that record. We can't forget HIPAA, it's still there when we're sharing this information. They will not interpret nor assess your compliance with HIPAA. But if they believe there's a problem like a breach, they will refer to the Office of Civil Rights. That's who has responsibility for HIPAA. They establish the rules, they come in and do the surveys and they assess the penalties. We know there's been an increase in the frequency and amount of those penalties. And it doesn't have to be a hospital, that can be a nursing home facility, it can be a clinic, it can be a system, it can be even a healthcare insurer that they are now starting to find because they're not doing what they're supposed to do on access. Here they did one for a radiology because they didn't give them the films. And then they didn't input their security rule. Security rule is something, a security risk assessment that we have to do to make sure our records are secure. Entries are complete and legible. Read clearly, they're unambiguous. You can follow that plan of care and the care that was provided by reading that entry. They have to be available then to subsequent care providers. So they have to be done promptly. And for those of you who've done and read handwritten, you can probably decipher this, believe it or not. Of course, accurately written, is it the right information on the right patient? Do we have enough identifiers? So we know, yeah, that's that patient and a system to assign that unique identifier. A record number is the way it's traditionally done. Policy and procedures show how you generate those identifiers and how they're assigned. Entries only by those authorized to do so according to your policy and procedures that are written. I wanna make a note here, it doesn't have to be a nurse, doesn't have to be a doctor. Your policy spell out who is allowed to write in that record. It could be a lab tech. It doesn't have to be, like I said, a practitioner or a nurse. They though must be dated, time and authenticated. In other words, signed off. Who made that entry? If it's made on behalf of the practitioner, that person must be authorized. And then that practitioner, who the other person did a favor for him, they have to come back in date, time and sign off on it, co-sign it. Have a way to identify the author for each and every entry. Of course, we have to make sure it's not done by someone using that person's identity without, well, they don't do that. With or without consent, they don't do it. They enter on their behalf, but that's how they have to enter it. Password, key cards, we don't ever share them. And if you're using a paper system, you still have rubber stamps. No one else can use that stamp. Now, I just want to make a note here. If you do allow rubber stamps, be aware of the restrictions by payers. Some of them don't allow rubber stamps, especially like on prescriptions. They get a little hairy on them, but there has to be a way to authenticate it. Usually these, and I want to make a note here about signatures. This is informational. This slide and the next one. It's not part of Appendix G. I'm giving it as information. It's called the Program Integrity Manual that talks about signature requirements for when you have a Medicare patient. They are required because they need to determine coverage and resolve any authenticity concerns. Is it false or is it accurate? And in fact, there was just information today, two of the, there was a healthcare insurer where two employees ran a million dollar scheme because they were falsifying signatures on certain testing and authorizations for payment. The money was coming directly to them. So that's what we need to do is make sure we have that system that yes, indeed, that was Dr. Jones who made that entry. Stamp signatures are typically not acceptable, but they will be if that person, that provider has such a physical disability that they cannot sign due to that disability. So typically again, not okay. It's not for their convenience. It's because the person just cannot sign. And here's the second slide. Providers who do use electronic systems do have to recognize, hey, this could be misused and it's gonna fall under your license. So have a way, a software, whatever it is so that you can protect against modification. Should apply adequate procedures administratively to meet these standards because you do have that responsibility for authenticity where attestations have been provided. So again, it's in the guidance manual, the program integrity. This is strictly informational only should you get some pushback on some of those stamps. Otherwise your system does have to be accessible, has to be organized for open records. So we know who was this patient? What did we do for him? How long are you gonna keep these records open and readily accessible? Now, this is different from your retention timeframe. This is when you're going to keep those available before you completely take them off you can still have them accessible but they're not considered open records. Also have a systematic record system so we know how to store them and retrieve them that we can support that timely service. This is a very long survey procedure for medical records. So I've tried to narrow it down and make it as concise as possible. They will verify written records, have policy and procedures that go along for them. They will review only if observations, interviews, whatever indicate non-compliance, your policy and procedures. Don't be surprised if they do it anyway. They will verify professional staff, someone is designated as responsible for that system and then they're gonna talk to them. Have you had any changes in your system? Great, so did you update your policy and procedures to correspond with those changes? If you have electronic system, which it sounds like all of you do, right after the entrance conference, they wanna talk to the person who's in charge of that. Is it integrated? Is it a hybrid that you put together? What happens if it fails? How do you get access or accessibility to that information? They'll also walk around and watch staff using the system. Can they get the information when they need it? If you have a shared system, in other words, you're with a critical access hospital or you're with a common system, is their portion, your portion, clearly distinguishable? And of course, if paper, can you read the handwriting? If during the record review, they wanna make sure, are they accurate and complete? Every entry is dated, time and signed off. Practitioner authenticates if someone else makes that entry. Of course, that person authorized to do so. And then is that record organized? In other words, if I open up five records, can I get to the same information in each record by maybe opening a tab, turning a page? Is it the same information systematically organized? Because we need to have not only the information organized and readily retrievable, but also the record itself. So here's what each record must include. These aren't optional. Of course, who is the patient? Consent forms like consent to treat, pertinent history, assessment, brief summary of that episode, instructions to the patient, where did they go, disposition, test results like labs and x-rays, if done, orders, and if so, any other information so we can monitor their progress, and the signatures. This is what each record has to have. On social data, how do we identify that patient? Is it date of birth? Is it name? Those of you who have common names within your community, you have that second identifier. Social data, what's their address? Where do they work? Do they work? What insurance? Who's their family members? Designate a representative if they happen to have one. They don't have to have one, but do they? And I've noticed, I'd say all of them right now have that statement, we'd like to share, if we can't reach you and we need to reach somebody else, who can we share your information with? Please, if the patient hasn't filled it out, make some notation, no one, me only, then you're clear and you don't have to second guess. So please don't leave it blank. Put something in there. If it's no one, great, that's fine. Just don't leave it blank. And that's our next question. We're doing okay on time. So Lindsey, you want to put that up? Absolutely. Okay, so this one should now be on our screen. The question says, does the clinic utilize a standard consent to treat only for routine care, for all care, including any invasive procedure, only for invasive procedures, or only if the provider or physician thinks that a separate consent form is necessary? I'll give you just another couple of seconds here. Okay. Okay. I've gotten some good responses. I'll share those results. There you go. All care. Wonderful. Yes. Okay. Informed consent. We still have to do that. You have to have written policies that have those situations where consent is required. Also, what happens as an emergency? Informed consent requirements are waived, usually what they will do. So a patient comes in and they've got a really mangled up limb. You can go ahead and treat them. If they're coming in through urgent care, those of you who had urgent care, or maybe they're walking in. Yes, I've seen that happen where they walk in in a massive cut. By them coming in for care, that is an implied consent. Only in those emergencies can you utilize that implied consent and go ahead and treat them. Otherwise, you do have to have a record of informed consent for care, and especially where your policy spells it out. Any patient who walks in, we have to have a consent to treat. That's a basic consent. That means you're walking in, I can look at you, I can do some treatment. If you accept it, fine, but that's your consent. Is there a state law or a federal law that requires informed consent? Evidence, there has to be something in there that shows you have a piece of paper or some documentation that there is properly executed informed consent. We know that reflects the process. Yes, you've heard it ad nauseum, but that is how it is. Again, the exception is an emergency. Unless it's an emergency, you must have a properly executed consent before you do see them and touch them. Properly executed, what are your policies say? What are your federal and state laws or regulations say you have to have? There are minimum elements. In other words, these are the mandatory ones that have to be there. What procedures are you doing? Who is doing that? Who's providing this treatment? A statement that you've described the procedure, including benefits, material risk, and alternative therapies. I want to just take a minute. Material risk, that can be two types. Low severity, but high likelihood, or high severity, low likelihood. Let's go for low severity, high likelihood. You come in, that same cut in your arm, you're going to have a scar. That's one of the risks. You could get an infection. Is it low severity? Maybe. Low severity is probably the scar. High severity is that infection. High severity, low likelihood is you come in, we do treatment, and you have a seizure and die. Low likelihood. Those are the ones that could occur with that particular treatment. Also, a statement that you've offered alternative therapies. Other mandatory elements, signature that person for whom the patient or their representative, and the date and time it was signed by the patient. If you're using electronic signature, yes, you can. Document how it was verified and that alteration was prevented, and that it's clear the patient or the representative consented, and how you also prevented alteration. If you are using electronic signatures, how can you prove that was actually the person? You looked at their ID, whatever it happened to be. We also have to have pertinent medical history into the medical record. Is there anything in that patient's overall condition that would affect their diagnosis or course of treatment? Have they come in with these symptoms before? Medication allergies that could affect it. Is there any comorbidity that requires maybe more intervention to reduce certain risk? Who can enter the history? Only qualified people, according to your policy, can enter that medical history. In all cases, it still has to be reviewed and authenticated promptly by the practitioner, and have policies and procedures. When you need a new or an updated history, is it going to be yearly, every four years? Maybe they come in with a new complaint. That's when you maybe want to do another one. It also has to have an assessment by that practitioner. What is their status and what do they need? That's at the time of each visit. It could be a brief summary. There must be one, or reason for the visit, and where did the patient go? Any follow-up instructions. That's usually what you're going to see is patient was in, did this and this, believe their condition, their cold is viral, recommended nasal flushes or drink fluids, whatever it is, patient sent home to follow up in 10 days, if no better, or if condition worsens, or these symptoms continue. That's all it is. Again, only qualified people enter that summary, and again, authenticated by the practitioner. Report test results, consults. These are your labs, your x-rays, those referrals. We know the physical exam has to be done by that practitioner, documented, signed off. What about those test results that come back? Who's going to be responsible for those? The practitioner who ordered them is responsible for those results. They must be in the record and authenticated, in other words, signed off by that practitioner. Same with consultative findings. Who reports those also? Those have to go on the record, and the practitioner needs to know what's in that consult. There's required contents. Of course, our orders are dated, timed, and signed. Nurses know the same thing. Who made that entry from that nursing personnel, and did they sign off correctly? What treatments did you provide? Any meds you administered, including any adverse reactions, maybe they had an allergy to it. How they responded to treatments, you did your albuterol treatment, how are they responding? Are they now breathing easier? How's their coughing? Perhaps their stats have gone up. Any other information so we know how that person is doing? What's their vital signs? Has their pressure stabilized, or has their temperature started to come down? Surveyor, they will verify each patient has that history. They will verify the practitioners reviewed that history. They will talk and ask about what policy do you have to update the history and the documentation on it. Now, usually, they're going to talk to the practitioner in those respects. They also will determine if you have adopted policies and procedures about informed consent. When is it required, and that it does have. Those consents have all of that minimum elements. Any additional elements that you may want. For example, your policy may say one of our additional elements we're including in our consent is we want to list out those common risks that could occur. You don't have to do that. You just have to have the statement that they were explained, but you may want that. Just make sure your policy spells it out. Then they're going to look at your records. They want evidence of that assessment. They want to make sure there's a documented summary, any regulatory information that has to be in there, findings of your exams and your test results, and were they authenticated and timely by that practitioner. Then we get down to protection of our medical records and the information. We know we have to keep confidentiality, and we safeguard against loss, destruction, or unauthorized use. Written policy and procedures, they govern what happens if that record has to leave the clinic and the conditions for its release. You don't have to have a written consent for access, but that's when a patient wants to go and look at their record. You do have to have written consent to release information not authorized to be released without consent. What does that mean? In other words, if the patient wants that record sent off to, say, another doctor, get a written consent for that. That's the better one. Then you have those where, and those of you who've been with HIPAA, you know there are certain circumstances where you release the information. You do have to have their consent, like if it's an investigation of a criminal act. If it's for an administrative procedure that your physician has had a complaint with the Board of Medicine and they have to respond, you don't have to have patients' consent to release that information. There are times when you don't have to have that written consent, but you have to have safeguards to ensure limited access to authorized folks only. We have to protect from loss, unintended destruction, and unauthorized access or use. Nature of your safeguards, how do you store them? Is it paper? Okay. Protect it from fire, flood, being picked up and taken off. Electronic passwords, backup, a remote server. There was a $5 million fee because of hacking back in 2021. These issues continue. Just change healthcare. Had a huge hack earlier this year, affected millions of people. I never heard the final amount, but that's an example where they didn't secure it. That's why we have to do this security risk assessment. It's available from the Office of National Coordinator. They worked with OCR and Health and Human Services. It helps you do your risk assessment that is required. You can use that self-directed tour of those standards, and there's even a user guide. This tool asks yes or no to see, do I need to take a next step? It's a gap analysis, essentially. Here's how you would access that tool. It comes in a Word. It also comes in a workbook, an Excel format. Whatever works for you, but you must do this assessment. It has to be for every provider. Policies then have to address who can access and use the record, who can physically remove that record. Maybe delete them from the system when it's done, it's past your retention period, everything's done. What conditions can you take them out, when can you do it, and to whom you release that information. For release, again, get that patient's consent to send off the record, unless it's required by law. The use and disclosure, make sure it's in there when you don't have to have that authorization. Again, I mentioned for criminal, but also for your payment healthcare operations. CMS won't assess your compliance. They send it over to OCR, Office of Civil Rights, if there's concerns about disclosures. Surveyor will verify only authorized folks get access to the records. They will watch your security practices. Are paper records left unattended on a counter? Are they in hallways? Are they in rooms where others could see the information? How did you prevent alteration, damage, deletion? They want your policy and procedures to govern that disclosure, and when you have to have written consent. Retention, six years. You have the same as a critical access hospital, but check your state, because there may be a longer requirement. Use that longer one. Keep them in the original form, or at least legally reproducible. If I pull up that record, you scanned it, and you put it into computer disk, great. Can I open that disk and easily read that information? Probably retrieved and within your clinic. Now, this is our next question. I think we're getting close to time, so if you'd like to skip this question, that's fine with me. Lindsay, I'll leave it up to you. I think we're good, if you're okay with it. Yes, I am. We can pop that up real quick. Okay. This says, our clinic performs regular reviews of the services we provide. Your options here, yes, no, prefer not to answer. And as we are approaching towards the end of today's session, if you do have any questions for Laura, please go ahead and be typing those into the Q&A option found there at the bottom of your Zoom window, or of course, there in the chat. And if that applies to any questions that maybe you had left from yesterday, and you'd like to ask those today, happy to address those as well. Okay. Now, here, what I'm talking about, it's the review of what you do. If you ever worked in a hospital, you may have heard the term utilization review. So it's similar, almost, to what you're doing here. It's just a little bit different. Also, in hospitals, having to go back over and look at their program. When do you do that? And how often do you do it? It's a little different for hospitals. So yes, great. Majority of you are doing it. So that's wonderful. What you have to do, you have to look at your program, your rural health clinic. You have to do that at least every two years. This was part of that massive hospital improvement rule that pretty much covered everybody. That means, that includes utilization of your services. How many patients are you serving? What's your volume of services? You want to look at both open and closed records and your healthcare policies. This is an ongoing project. I'll be honest. It's looking every two years. I think it's going to take you an ongoing progress, but at least every two years. What you're trying to do, did you use your services appropriately? Did you have policies? And if so, were they followed? Do you need to make any changes in those policies? You can do it with your own staff. They may not like you for it, but you can do it because they're already busy. Or you can have an arrangement to have someone come in and do it. But you do have to have documentation of who did it and what were their qualifications to do that. Here are the minimum requirements. In other words, mandatory. How many patients were served? The volume that you provided of those services. Did you provide appropriate types and volumes based upon what your patient needs? Did you evaluate those policies? And if so, were they followed? And whether or not you made changes to your policies and procedures, were they necessary? So what does that mean you have a written plan to do that? Who's going to do it? When and how are they going to do it? And what's to be covered in that evaluation? Usually what you're doing is you've got a checklist of these items that they go. I would urge you to use that person. It's consistent in what they're looking at. Include a review again of your open and closed records, at least 5% of your current patients or 50 records, whichever is less. They're trying to give you some leeway here. Again, they're trying to determine were your services used appropriately. So you evaluate our personnel who are providing direct care. Are they following your policies? For your practitioners, if you only have one, yes, you have to do an outside review. That's what you're expected to do. As far as care policies, you decide who's going to look at it. Physician, advanced practice, an RN, someone who else meets that qualification criteria. For labs, you may want somebody from lab to come in and look at those policies. On your evaluations, document them in a summary report. Include any recommendations for corrective action. In other words, are you going to change your policy? Address those problems that you have seen in that evaluation. If you have a QAPI, Quality Assessment Performance Improvement, that either meets or exceeds the requirements for what I just described, your QA program is acceptable. If you have recently converted from a critical access to a rural health clinic, you probably have this program in place. Take a benefit, because again, quality assessment performance improvement is ongoing. It's not a stop and start. It is an ongoing process. And sometimes that alleviates some of the congestion and some of the backlog and that rush and hurry up and get it done. So it can be beneficial. Surveyor wants evidence of that evaluation at least every two years, unless you follow in your QAPI. They wanna make sure it included a review of your patients that you did take care of and the volume of services you offered. They want evidence of a review of a representative sample records and that it included the minimum number of records, either again, 5% or 50 records. They will ask who did this review? What portions of the review? How did you verify they were qualified? Maybe that's an RN who's done this in the past or an LPN who's done record reviews. They want evidence of the findings and recommendations. And if those findings addressed the required component. In other words, are we doing and checking up on vaccines for all of our patients as what our policies say we're going to do? And then of course, look at corrective actions. Were corrective actions even necessary? Leadership has to take into consideration those findings and any recommendations and take actions. That's their responsibility. Do they change the policy? Maybe more training for the staff, changes in supervision, maybe terminating privileges for a certain provider that maybe it's time you separate ways. Again, they want evidence of those corrective actions. Leadership, they have to document where and when the findings recommendations were considered and by who. Document what actions were taken, who recommended them, rationales for decision, especially if you don't take recommended corrective actions. Why didn't you act on that? And if you do take corrective actions that were different from recommended. So that's what leadership has to do. They do have to act on this. Now I'm going to go through emergency preparedness. Hopefully this little video here, I want to show you this was from the St. John's Mercy Hospital back in 2011. And it happened because there was a tornado coming through town. And those of you in those states that have them, hopefully this never happens to you because you will see the outcome. As this video does progress, it is moving. It's a little bit slow at the beginning. But this happened from, it was in their emergency waiting room. And this hospital fortunately did have notice. They had had some bad weather preceding in the day or two before this one. So they knew something was cooking out there. And in May, that's when you get a lot of the tornadoes the same here in my area in the mountain regions. We do get tornadoes and April, May, that's notorious for when we get them. So they had noticed that this was coming. They had the benefit to evacuate the ER waiting room. And in fact, they were trying to do the best. Now here, we're starting to see things. When you saw that go dark, that's when the major power source went out. And now the tornado is actually hitting the hospital. And you can see the massive amount of destruction, things being tossed around, just like toys being thrown up in the air because of the extreme speed. I don't remember what F level for that tornado, but it was significant enough that you can see it pretty well wiped out everything in that emergency waiting room. Most emergency waiting rooms and hospitals are on the ground level. This wasn't up on the top floor. And so that's just the sheer destruction that happened with that particular tornado. So on emergency preparedness, because they had to activate, of course, and evacuate. It's not a part of your appendix. Everything with the Hospital Improvement Rule on emergency preparedness was changed to Appendix Z, but I still want to mention it because you have to meet these requirements. They did some changes. It used to be you had to do everything yearly. It's now every two years, except for drills. In 21, they added updates to the testing and training and included emerging infectious diseases, COVID. They made a response. In May of 22, they updated and added some exemptions to training and exercises. They added outpatient requirements, that's you. They covered changes to testing and explanation on exemptions. Overall, for emergency preparedness, you have to comply with all federal, state, and local emergency preparedness requirements. You have to maintain a comprehensive program, utilizing that all hazards approach. In other words, if it could happen, take it into account. Your program has to include your overall plan, communication plan. How are you going to evacuate? If you're going to evacuate, how do you shelter in place? What do you do for emergency and standby power? Policy and procedures on patient care, training, testing. Your plan has to be reviewed every two years based upon your assessment. That's both facility and community using that all hazards approach. What strategies are you going to take into effect based upon that assessment? What is your patient population? Maybe you have people at risk. What services can you provide? And don't forget your succession plan. What happens if your leadership is impacted? And how do you collaborate and work with other officials? Your policy and procedures are based upon that plan and your assessment and your communications. It has to address how you shelter in place, documentation to keep confidentiality, and what are you going to do for staffing? Are you going to use volunteers? Communication, how do you communicate with your staff and others? That's staff, not only staff, but physicians, family members. What is your primary and alternate source and means of communication? And that could be with your emergency management personnel. How do you share information? If you evacuate, what information are you going to release? How do you communicate that condition and location of where those folks are? What about your ability to help others? Maybe you have occupancy that you can assist. That is, again, also a clinic. Training and testing, that's part of your policies. You have to develop and maintain training and testing program based upon your plan and your risk assessment. You have to review and update that training and testing every two years. Initial, that we know goes to all new staff. And include those volunteers under contract. Make it consistent with what their licensing is and their expected roles. Keep documentation of the training. You do it every two years. And staff have to be able to show the surveyor what they know about those procedures. Testing, you must do one test exercise every year. A full scale has to be done every two years. That means you can participate in something in your community, or you can put one together yourself. If you have an actual disaster where you activate your plan, you have an exemption. On the opposite years, you do something of your choice, whether a tabletop or a mock. What they want you to do is analyze those drills and learn from them, revise if necessary, but training still has to occur annually. So for you as an outpatient provider, if you had and you claimed an exemption based upon either an activated plan or something, say COVID, you're going back to your normal operations, then you still have to do your full scale in the following year. If you reactivated that plan because of an actual emergency, another tornado came through, maybe you had a flood and you had to close down, you get that exemption. So again, watch out when you claim your exemption, when your next full scale is due, and did you reactivate it? Regardless of what you do, if you did activate your plan, you still have to do your exercise of choice. That did not go away. So I'm gonna go through these briefly in the interest of time. So again, if you did your exercise of choice and you activated your plan and you were due for your full scale, you get an exemption, but you still have to do your exercise of choice. Same scenario, you had your full scale, you activated your plan, you still have to do your exercise of choice, but when your next full one comes around, you get an exemption. If you did your exercise of choice, activated your plan, then you're exempt from the full scale, but you still have to do exercise of choice. And if you go back to operations, you just go back to your cycle again. And then in number four, and it's easier just to show the pictures, and CMS did this, it's great for us. You still get full exemption if you're under your activated plan. So whenever you're due for your full scale, if you're still under your emergency preparedness plan, you get that exemption, but you must do your tabletop. If you're a part of a system, you have to still show you are participating in that plan and it's based upon your assessment and you can use the policies. So really quickly, here's our last little situation. You're a rural health clinic, you're part of a state where you get a lot of fast moving weather. Your patient population, everything from newborn to elderly, services consistent with what you have, and that includes prenatal. Now, normally pregnancies are referred out in their 35th week. In December, we have a 38 week gravidate three pair two. She has a history of eclampsia with her last pregnancy. Her nurse midwife says, you need to go to a perinatologist at the hospital for further care. We can't do it here. That was totally appropriate. At the 39 week visit, she says, I'm starting to get spotting and cramping and I got this really nasty headache and some edema. Everybody who's worked with moms and babies know eclampsia. The nurse midwife wants to get her over to the hospital for admission. The patient wants to drive rather than go by EMS because of the money involved. Hospital policies, these policies, your clinic policies don't address this situation. So they leave that to the provider after they've talked it over with the patient. What would you recommend they do? They send her via EMS, no matter what, allow her to go by private car or wait and see something comes up in the future. Right now, you got to get this mom over to the hospital. What are you going to do in that situation? What are you going to recommend? So with that, I'll leave it back to Lindsay. I'm a little bit over, I apologize for that. No, you're good. And so again, if you have questions, even after the fact, as Lindsay mentioned, she's great about getting them to me and I'll get them back to her. But I will send off that question on the rural health clinics who are in conjunction with a critical access hospital and their policies. As long as they coordinate. I have a feeling it's going to be what I said. As long as you participate in that development and you can show your participation, I think you're going to be okay. Perfect. Okay, if you have some final comments or questions here, you can go ahead and type those into the Q&A option or in the chat here, especially if you have any comments regarding this last discussion question. We'll give you a couple of seconds to do that. And while we are waiting to see if there are any questions come in, I'll just post this last reminder here in the chat for you all, just as in yesterday's session, you will receive that email tomorrow morning. And just remember that it does come from that educationnoreplyatzoom.us email address. And so I hope you all saw that email in your inbox this morning that was for yesterday's session. If not, I would encourage you to check those spam quarantine junk folders. But if it's still not there and you would like to just go back and access the recording of either yesterday or today's session, you can just use the same Zoom links that you use to join the live presentations to also access the recordings. And the recordings are available through those Zoom links for 60 days from the date of each live session. And then we do have an additional security measure in place. So when you click on the Zoom link, it'll ask you to type in your information. That will prompt an email to come to us for approval of that recording access request. We do typically approve those requests very quickly, but we just ask that you give us one business day to grant those approvals. And then once we do the approvals and you'll receive a final email from Zoom that will contain the link that'll take you directly into the recording. And again, you'll have 60 days from the date of each live session to access those recordings. And also included in tomorrow's email will be a link to the slides that Laura presented for us today. But I did go ahead and provide that link there for you in the chat now as well. And then if you're joining us as a member of the Georgia Hospital Association, please do pay special attention to that final link that will be in the email tomorrow morning. And that will be a link to this survey that you'll need to complete to obtain your continuing education credit information and to receive your certificate of attendance for this series. And then if you're joining us as a member of a partner state hospital association, I do encourage you to reach out to your contact within your association to obtain any information that they may have for you regarding CEs as well. And as Laura mentioned, if you do, I don't see any questions pending right now, Laura, but if you do have questions that maybe you feel are very specific to your organization. I know we had a couple of people on who are very new to rural health clinics. So if you maybe just have a more detailed question and you feel more comfortable with sending that to us separately, you're more than welcome to do so. My email address is education at gha.org. And you can send those questions to us. And as Laura mentioned, we'll get those to her and she always goes above and beyond in her familiness and her thoroughness and her response. And we were just so thankful for her for doing that. Okay, Laura, I don't see any pending questions. Do you wanna make any other final comments regarding this one? Okay. Yeah, what they did was they really sat down, had a conversation. She had a history of preeclampsia and she remembered what she went through with it. And so now she's got this headache. She's got this edema. She's got spotting. And she drove herself to the clinic. And so they said, it is simply not safe to risk you driving, especially since we don't know if there's road construction, we don't know what's happening. And let's worry about the bill later. Really? It's safer for you to go by EMS than risk getting into trouble, crashing your car or whatever, and having a problem. She did consent. She did consent to go by EMS. They didn't use sirens or anything. It just, somebody was with her and she didn't have to worry about it. She got there fine, delivered the baby a little bit early. Everything worked out. But they then had to go back and really revisit since they were providing natal services, what are we going to do in these situations? Because if you're a grownup, it's gonna happen again. It would have happened again. So just a quick thank you. I wanna show you some of these resources that I did mention in the appendix. I always try to include the link. You will have to copy paste that link into your surf engine. It doesn't work otherwise. I did wanna put up that memo for emergency preparedness. So if you're looking to update your policy, wanna revisit your policy, I would start there. Look at what that policy spells out. So otherwise, thank you everyone for your patience. Lindsay, thank you for your help and happy Thanksgiving to everybody. Wonderful, absolutely. Thank you so much, Laura. We appreciate you as always. Thank you all for joining us. And I echo Laura's sentiment. I do hope you all have a wonderful Thanksgiving and thank you for all that you do for your communities. Have a wonderful afternoon. Thank you, Laura.

Risk Management

Patient Safety

Rural Health Clinics

Staffing Requirements

Operational Policies

Emergency Preparedness

Medical Records Management

Electronic Records

HIPAA Compliance

Healthcare Compliance

Medicare

Medicaid

Laura Dixon