Clinics are slowly opening back up. Patients are returning for services. But things definitely look different than they did two months ago.

On this special live episode of Inside Reproductive Health, Griffin talked to Dr. Jovana Lekovich of RMA of New York and Lisa Rinehart of LegalCare Consulting. Together, we discussed the new normal of clinics and took a look at how clinics can update their Standard Operating Procedures to comply with federal guidelines, all while keeping their patients and employees safe.

This episode was recorded during a live webinar. As the COVID-19 Pandemic continues and new issues arise, we are putting out new information to help you and your fertility business. Follow us on social media for updates on upcoming webinars and how to join them live. Find this information helpful? We’d love it if you’d share with a friend or colleague in the fertility space.

**Please note that this episode contains some insights into the legal aspects of SOPs and COVD-19. This is not intended to provide legal counsel to you or to your clinic, it is merely a conversation about legalities with a licensed attorney.

Need help navigating marketing through this unprecedented time? Check out our COVID-19 Toolkit from Fertility Bridge.

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Welcome to the Coronavirus Business Response Series of Inside Reproductive Health. Here, you'll be updated on the latest insights on managing and owning a fertility business or IVF center during the COVID-19 pandemic. We put out free podcasts, webinars and articles as soon as new topics arise, so make sure to subscribe to stay updated. The best way to help us in return is to share this episode with someone in the fertility field that would find it useful. Now here's the founder of Fertility Bridge and the host of Inside Reproductive Health, Griffin Jones.

JONES 0:53
Dr. Jovana Lekovic is practicing at RMA of New York. She joined that group in 2017. She is a New York gal. She did her training at Cornell for both residency and fellowship. And Dr. Lekovic, you said your speciality is in the onco- you have a special interest in onco-fertility.

LEKOVICH 1:14
Yeah, exactly. I take care of a lot of the oncology patients or patients who need to freeze for fertility, in addition to just bread and butter infertility service.

JONES 1:25
Well, thank you for representing both the REI community and the New York side of things. Lisa Rinehart I've known for longer than five minutes and Lisa when I was doing the webinar with Dr. Katz and Taylor and Jeff from EngagedMD and I saw your name in the attendees. I thought, “Oh shoot! I should have probably had Lisa as a panelist for this webinar!” So we're taking care of that now. And the reason why I want to have Lisa as a panelist is because she's worn so many hats and does wear so many hats. In addition to having been a fertility nurse, she is an RN, she also has the letters JD after her name. She is an attorney. So she's involved with the NPG group, that's the nurses group--the LPG group, that's the legal group within ASRM, as well as ARM which is the Reproductive Managers Group. She has her own company called LegalCare Consulting, and a really unique perspective as an attorney and as a nurse. And Ms. Rinehart, I am happy to have you on the program as well. Thanks for joining us.

RINEHART 2:30
Thanks, Griffin. And please call me Lisa. You scare me when you call me Ms. Rinehart!

JONES 2:36
Everyone that listens to this show knows that I like to start with the honorific and then we get into first names as we let our collars down and be a little more comfortable. So maybe we can just give--we can start high level because we've had a number of questions in advance and but before we dig into those, we can give, just at a high level, of we've all been--for those of you that are experts have been experts for about two months in terms of COVID-19 and in standard operating procedures. Maybe give us a little bit of background and on how you're deciding to make the standard operating procedures that you are or have recommended up to this point. And then we'll start dissecting what they are individually.

RINEHART 3:21
You know what, I'm just going to kind of give you a little bit of an overview since I've been doing SOPs for quite a while, even when, many moons ago when I worked in the hospital. And it's, you know, why do we write SOPs to begin with? And I think that's where when you look at COVID is where you have to start, you know, you write them to give your staff, patients management, whatever, some direction. You write to make sure that you are in compliance with any laws or any professional standards that are out there. And then you write them to ensure patient safety, staff safety, and to do training. So I think all of us can see that with a brand new event, that not only came in as a novel virus, but has totally changed the way we were living, the way we were working, and now how we're going to reopen, that we absolutely need to have some direction. They're kind of scary when you call them SOPs, but when you just call them, let's give everybody direction, now we kind of know where we're going. And so what they are, are step-by-step processes that are going to help us understand how to perform a task, and how to do it consistently, and hopefully, how to do it well. Writing them, a lot of places have formats, but basically, what is the specific piece or task you're doing? How to start an IV, for example. Who's going to do it? What equipment do you need, if anything? And then what's the process? What is the exact process that you want? I always add in there, references which I think sometimes we forget. All of us can come up with stuff on the fly, especially those of us that have been doing our jobs for a while. Oh, yeah, fine, I can tell you how to do it. But if somebody wants to go back and check as to why you put that step in there, it's really very, very helpful to put references. And so I think moving forward is we start to look at what SOPs do we need, we need to look at why we're doing it, what we have to do, and then I venture to say, you need a key person in your organization--and maybe Jovana, you can talk about that--somebody who's going to be the go to for helping direct how these SOPs are written, and who's also going to be able to help monitor them because that's a big piece of this. We can write anything we want. If you put it on a shelf, and nobody does it, it really doesn't help us. It doesn't give us the direction we need.

LEKOVICH 5:50
Yeah, I agree. I mean, I second, everything you, Lisa, that you just said. I think that we are one of the organizations that really in everything that we do, whether that's you know how we handle a CMV positive donor sperm or whether it's, you know, a deadly viral pandemic, we rely a lot on SOPs and protocols. Because once you reach the clinical organization of this size and handling, literally, thousands of patients a year, you really have to rely on them to stay consistent and to provide the best quality care. And so obviously, there are SOPs in place that we all as a group have been, in an organized fashion, have been writing and have been collecting all the data as physicians and have been determining on how to go in this situation. The problem is not having the guidelines. And so, you know, in the words of our governor from the other day in one of his interviews, I really also liked the idea of going stone to stone across the morass, which also is an important thing to remember that going into an untapped situation that nobody really knows how to handle. Obviously, having a plan, Safety First for both patients and employees, following the guidelines, following the guidance from medical societies as well as, you know, politically, and from the government, and also every step of the way informed, and you might not know the whole path, but firm stone after firm stone and just having sort of all of these things in mind being inventive, when certain situations also appear, you cannot put everything in the SOP. But I absolutely agree with you. And you know, in order to ensure that the organization or the centralization of how we are organized and how we make sure that these measures have been followed by everyone really trickles down through the operations, through our medical director, through our CEO and through all the physicians really, and through different managers of different services within our organization, which is the nursing manager, the IVF coordinator manager, finance department managers, just as long as we’re on the same page before having those plans in place.

JONES 8:03
Lisa, of what's new, how much of it is brand new standard operating procedures versus addendums to existing SOPs.

RINEHART 8:13
You know, you bring up the “what you've got already” and I think that's always a good starting point. Most of us have had what we call “disaster plans.” So that gives you some place to start when you feel that your entire operation has been blown up and you have to start over again. We've also taken care of patients with infectious disease. That is not something that's new to anybody who's been trained in medicine. And so you can take some of the procedures that you already have and adapt them. What's going to be a little bit different, I think, is the extreme of it. Because COVID is turning out to be something that is much more easily spread than we realized. It's a much more fluid situation. So you're going to have to adapt some of your policies and procedures to encompass social distancing. We've taken care of infectious patients before, but we never said you had to be six feet apart from their partner, or from your staff--

JONES 9:16
Or that their partner can't come to the office.

RINEHART 9:18
Exactly. I mean--

JONES 9:21
And I'm interrupting you, Lisa, but just you made me think of how quickly this has all moved. I remember, I think it was March 13, talking with my sister and said, “Yeah, we're thinking about not letting our clients, we're talking with our clients about not letting partners come into the office.” And my sister's an RN and she said “No,” and lo and behold, and now every single one of our clients has asked partners to stay home. So please continue. Your point was that we've dealt with infectious diseases before, but some of these considerations, we hadn't even dreamt off.

RINEHART 9:57
We didn't because before, it would be you would isolate the person and whoever was going to take care of them would protect themselves, go take care of them and come back. And you could still go have coffee with, you know, your colleague, you could still go take care of other patients. That's not the same. And so I think where you can use some of your policies and procedures as a basis, we're going to have to be a little bit more creative on other areas, which is kind of fun for me. I love going through workplaces and just saying, How else can we do this? How can we sit six or eight feet apart and still let people do their jobs? Can we let our staff work from home? Can we job share? What are we going to do about team staffing, which I'm sure comes up. I think it actually makes you think outside--and I hate the term “outside the box”--but it is outside the box. The other thing I will mention though is the organizations that have really been studying this longer than maybe some of us have put together some unbelievable frameworks for us to use. The CDC has a lot of information that makes it much easier to adapt your policies and procedures or write new ones with regard to the Coronavirus. And so I say to you, go to the CDC, go to the WHO website, go to ACOG, it'll make your job a whole lot easier.

JONES 11:18
I wanted to ask you about that, Jovana, because you mentioned that a problem is either having or not having guidelines and how to use guidelines to inform the standard operating procedures. Lisa mentioned, the CDC, RMA of New York is a pretty large practice, it's in a large market. So in addition to ASRM and others, the Fertility Providers Alliance and as Lisa mentioned, CDC, you mentioned the importance of guidelines, whose guidelines should people look to draw from the most?

LEKOVICH 11:48
I mean, I can tell you how it went between, you know, different IVF centers, some of us are affiliated with hospitals and so naturally, would follow or would adopt some of these policies because they've been written already and you don't need to reinvent the wheel, you can adapt it, as Lisa said. A lot of it was really sharing information between different centers, collegial sort of discussion of what the center is doing, why they're following that guideline, and then really trying to make it work in your environment because not every waiting room is the same. Not every patient population will be the same. And you might not have to deal with certain things, as some other centers might have to deal with which would be, let's say, you know, having 150 patients in the morning during monitoring hours, not every center needs to deal with that difficulty. And so how do you overcome that? And how do you think inventively to still provide care with volume while following the guidelines? So, I know that talking to some of my colleagues who are affiliated with Cornell, obviously following local guidelines from the hospitals and applying them into their setting. We applied a lot of the things from the Sinai Hospital’s guidelines. CDC is a great resource. I would say the WHO, and then really just sharing information, being a united front, all of us are in this together. And I always said that 14 or 15 or a hundred heads are smarter than one. If we're driven by the same goal, which is to resume and to be able to safely provide care to our patients, I think it's very inventive and advanced to think altogether, as well.

JONES 13:28
Maybe I'll direct this one to you, Lisa, since it is about liability. Normally, when I give the disclaimer, I always say, I am not an attorney. You are, but I think we give the famous disclaimer that this isn't particular counsel, this is not particularly legal advice, but rather insights. And the question is, is the practice liable if a patient without symptoms infects an employee? So I'm guessing this means you know, they've screened for symptoms is what they're asking, and then an employee is infected by an asymptomatic person that passed through their symptom screening, can the practice be liable if they're employee is infected?

RINEHART 14:08
You know, this isn't the first time that I've heard this question. And I'm sure we're all thinking that what if it isn't just our employee who gets infected? What if it's one of our patients who gets infected, so have it go the other way? And, again, I can only give general advice. I'm only licensed in one state, but I can tell you first and foremost, you can be sued for just about anything. So that's the first answer, okay. You have a willing plaintiff, there will be a lawsuit. In this particular--

JONES 14:36
Where there’s a willing plaintiff, there's a willing lawyer!

RINEHART 14:39
You got it! And I don't condone it. I don't do malpractice at all. But I will say it's going to be--one of the things you have to prove is that somewhere there was negligence, because that's probably going to be the main claim is that somebody was negligent along the way, which fits in with why you need to have some SOPs that people are trained in and are following. But then they also have to prove that you are the ones that actually caused the injury. In this particular arena with this novel Coronavirus, it is going to be very, very difficult to prove that a person got the Coronavirus from Denise the Nurse. How are you possibly going to do that if they're out and about in any type of society? You would have had to have them completely isolated from anybody else but Denise the Nurse. So that's where I think a lot of these are going to fall down. And again, you know, yes, there will be creative lawsuits, but do I really think that a practice, if they're following good safety measures and following their own SOPs, are they going to be held liable? I think it's going to be a really difficult case. I can't say never because stranger lawsuits have happened. I just don't see how it would actually even get through the entire court system. It'd be very difficult to prove.

JONES 16:04
The next might be a question that falls in both of your wheelhouse--which action do you take when a staff member or a patient or any visitor encounter symptoms after they've visited your clinic? So maybe you get a phone call from the next day, a staff member or a patient, and I was there three days ago, or I was there five days ago, whatever it might be, and I've tested positive. What happens then?

RINEHART 16:32
Jovana, you want to say what would happen in your centers since I know you have SOPs?

LEKOVICH 16:36
The plan in place in that situation is to--basically, we haven't been doing any testing yet until their validity is proven. And so we've been referring patients with, let's say, you know, she's calling with symptoms, then the plan will be to refer her to either Urgent Care or her primary care physician to get tested. If she's calling and being positive, given that we're just slowly starting to go back after being closed for almost six weeks and starting to go back and treating patients, that first and foremost, we cannot treat patients. Our patients know that once they're starting any of their treatment cycles, whether that be a ovulation reduction,or IVF, or frozen embryo transfer cycle, their cycle will have to be discontinued, again, as per the guidance from ASRM, obviously, and so the patients would be again referred. We did not want to mention in our SOPs or to adopt or hijack any of the part of the care for the patient. In that scenario, a patient would have to, obviously, follow up with a doctor either infectious disease physician or primary care physician who would treat their condition. What we have been doing with primary and secondary and tertiary contact, I think it depends on when you're asking me this question. If this is, you know, March 7, and this would have happened, we would have obviously quarantined them. As for DOH recommendations for primary, secondary, tertiary contacts, but you know, nowadays, if you ask me that somebody who got into contact with a patient that has been positive, you might go into a liquor store and get the infection or might just be walking the sidewalk from your building to the to the car or something in New York City, and not really being able to--I mean, every one of us is, what I'm trying to say, has been in at least secondary or tertiary, if not the primary contact with somebody who's been affected. So nowadays, again, it's a situation that obviously requires a discussion, but that's how we would be dealing with it, either quarantine them or monitor for symptoms to test them.

JONES 18:43
Care to add anything to that, Lisa?

RINEHART 18:45
I just would add, and I totally agree with that approach, and I think most Departments of Public Health are saying that, but I think it also depends on the extent of the contact. If this was just a very superficial contact--she came in had blood drawn, the person had, you know, who drew the blood had PPE, she goes home and three days later you hear, chances are that there was not a lot of time spent. If, however, that person happened to have been in your office, wasn't wearing a face covering, sneezed onto a staff person that wasn't wearing a face covering, now you may want to treat it very differently. Which is why I think a lot of practices are adopting face coverings for their staff, which, here in Illinois, we're required to do by our Governor's mandate, just to prevent those kinds of things from happening. Because if my, you know, no face covering direct-contact happened, then you may want to send the staff person home to quarantine. Other than that, they're probably just going to self monitor as they would be doing anyway. Meaning they're checking their temperatures, they're letting their supervisors know if they don't feel well, and if one of your staff gets sick, you're sending them home and telling them to go see their doctors.

JONES 20:03
Sounds like there's a big range in there. Jovana, we have a question that asks about where, when, and how to test patients. So I have heard of clinics that are using PCR tests for every patient. I can't imagine that everyone is doing that. But which test do you use? PCR test, do you use the antibody test? Where, when and how do you decide which patients to test?

LEKOVICH 20:31
So we actually haven't been using any testing so far until we see, we'll probably going to be going for the saliva nucleic acid rapid test once the validity of the test has been proven, because again, as Lisa mentioned earlier, having references having the reasons why you do certain things have to be documented in your SOPs and your plans. So far, on one hand, we have tests that have not been validated that can be done elsewhere, we haven't been testing our patients, we've been screening them, obviously, with questionnaires the day before they're coming in, as well as a day off coming to the office, all the patients have to be wearing protection and their temperature is being checked upon entry into the floor or into our office. We will probably be going for testing and what some of the practices are starting to do is what I hear from my colleagues and my friends who are at other practices is that potentially starting to do a rapid test at the beginning of the cycle The question is, okay, you've done it at the beginning of a cycle, do you then have to do it every day? What if they got--on the way back home, they took an Uber or they went to buy a bottle of wine and got infected from a guy in a liquor store, do you have to test them daily then? If you have tested them for the viral presence, or if you did a PCR even testing patients for antibodies, you know, doesn't seem to be that helpful because they might have an immunity that might be gone in a week or a month or three months or a year. This is why we're actually not tapping into testing as of yet. We're still relying on screening and social distancing in our offices and protection, obviously, in protective equipment. But those are some of the things that we're considering and we're discussing as a group.

JONES 22:27
I venture that as much as whoever asked that question wanted to know the one where and how, often the underlying as well as everyone else doing? And so we'll have somewhat of an answer for you very shortly from our 21-person sample size or 22-person sample size. So the majority of practices are not testing for COVID-19. Although we do have a few that are testing every patient, which is interesting. Lisa, did you want to add anything to that?

RINEHART 22:57
No, I don't think so. I mean, I agree with Jovana. I think that it's still kind of all over the board as to what is the usefulness of the test itself. I know some practices in the Midwest are testing at the start of ovulation induction to at least give themselves some sense of security that they made an attempt to find out who may be actively shedding the virus or not. But as Jovana said, how does that help you 10 days from now?

LEKOVICH 23:28
It really don't think that--I'm sorry to interrupt you, Lisa--but I just wanted to wanted to--the only situation that comes into mind as to where or why would this be helpful, would be really to identify those who have the antibodies who could be donating plasma for convalescent plasma, which has been done in Sinai and being used to treat the most severely ill patients. I don't know what your thoughts are, but I really don't see--that's exactly why I don't see the usefulness of it.

JONES 23:58
Dr. Adamson brings up a point about the usefulness in one particular circumstance because there are so many unknowns about the virus and the antibody test they can't be relied upon, except in that a positive test for virus could be used to cancel medical procedures and quarantine.

RINEHART 24:16
Correct. And I think most providers that had somebody with a positive test or positive symptoms, they're going to cancel treatment, and they're going to quarantine or suggest the patient quarantine, we can't just put our patients in quarantine all by ourselves.

**COMMERCIAL**

Hi everyone, it's Griffin. This is the break in the show where normally, I do a little commercial for our small engagement. And we do have a small engagement that's relevant to the COVID-19 business response. If you're cutting marketing. if you're trying to bring back your people as quickly as possible. If you're trying to build a cache of treatment ready patients. We do have that, but I would rather use this break to just ask if you find this useful if you would share it with a colleague, either via email or on social media. We're doing everything we can to put out as many webinars, articles, free podcasts, all free resources to include as many people from the field as we possibly can to give you resources on how to manage and operate a fertility business or an IVF center during this time. And it's changing so quickly.

So if you find this useful, I would really appreciate it if you would please share it with a colleague via email or via social media and help us grow the audience, but only if you find it valuable, and hopefully you are. Now, back to your program.

JONES
We have a question about alternating teams. And I want to know if you've seen this, Lisa, when this was all first starting to happen--so this is pre-ASRM guidelines, which I think first came out on the 27th of March--this was pre-that and I was speaking to one physician who'd said that they had split their teams. They have A Teams and B Teams--clinic, lab, and office. A Team comes in at 5:30 or six in the morning, whatever it is, stayed till noon, and there's a 15 minute gap where they leave, get in their cars and go while Team B is in their parking lots, comes in 15 minutes later after the entire office has been sprayed and disinfected, and they never interact with one another. The nursing Team A is always on Team A. Team B is always on Team B. Have you seen this and how is it working?

RINEHART 26:36
I actually have talked to a couple centers that are doing it and they're doing it essentially to try and conserve resources in case they get an outbreak among their staff. So that they can also tell who had contact with whom, and they can, you know, so if a person on Team A is positive and they know what the contact was on that team, they can isolate more effectively than they would have been able to do otherwise. I've also seen teams used as one team is on for a week, and then they work at home for a week. And they're doing it that way back and forth. My understanding is this is what's happening in some of the ERs. I have--and am really proud of--my niece who just graduated nursing school working in an ER in Milwaukee, and that's what they've done is they've divided into teams, and it's a way to make sure that they can help protect their staff as much as possible. In the Midwest, we haven't really gotten up to full speed again, how that's going to work over time, you're stretching your resources and for all the small practices out there, I have no idea how they would be able to do that because you just don't have enough staff to be able to cut them in half, makes it hard.

JONES 27:49
Jovanna, what about RMA? Are you all splitting into A Team and B Team? How is workflow being divided?

LEKOVICH 27:56
It’s exactly how we've been practicing at every level really, up until really two days ago when we slowly started opening up. But pretty much anybody who, first of all, anybody who doesn't need to be there in person which would be IVF Coordinators, Finance Advisors, some of the Nursing staff, people are just working from home. And then Physicians, Nurses as well as the Embryologists--as the most important part of, the most vital part of our team--have been working in teams so that you're always within a certain team, exactly for what the reason that Lisa mentioned, which is if one of the team members would get sick or would develop symptoms and the teams will be separated into days and some of them into hours of the day, but mostly into you know, one days, one team, Team A and Team B, you will be able to easier track the contacts with that person and to monitor for symptoms or to then do the testing of the other ones and thus keeping the workflow and being able to have more hands on the deck. And again, this is one of the policies or interventions that we have implemented and that we have adopted from Mount Sinai because this is how our physicians have been, our OB/GYN physicians, working the labor and delivery floor. Pretty much all of our fellows got redeployed. So we're obviously monitoring that as well. And our fellows have been working in different teams on labor and delivery as well as in the emergency room. So this is, I think it's a good strategy, I don't know, Lisa, what you think, but I think it's a smart strategy when you're dealing with such a predictably contagious disease that spreads so easily and you still have to get the job done.

RINEHART 29:38
No, I absolutely agree. I think you know, if you can make it work, it certainly makes sense. You would hate to have your entire embryology team exposed. And how could you move for ward? You know, nurses can't do that. You can, you know, as you said, redeploy people to do a lot of different things, but there are certain positions that you just can't fill and you can't learn that quickly. So if you can do it, I think it's a great strategy.

JONES 30:08
One of our questions and, ladies, you may have seen this, I'm not sure exactly what they're asking when they say how to homogenize the input in IVF to have a stable activity without peak? What I am guessing is their backlog of cycles that didn't happen in March and April? I'm taking it to mean how do they distribute that especially if these are cycles that were already paid for? Without maybe you know, just having two weeks where everyone is burned out working every hour they can, how do they distribute that better? Do you infer the question differently? And if not, how would you answer it?

RINEHART 30:46
You know, I was a little unsure. So I appreciate the explanation that you just gave Griffin.

JONES 30:52
I might be faking the funk, Lisa!

RINEHART 30:53
Yeah, there you go. But you know, we'll make it fit what we can answer! I'm hearing from practices that they have kind of divided their patients into who they consider more urgent than others. Some are doing as who was more ready, who could, you know, where their cycle was falling, if they didn't keep them on birth control or something else. That's how they're getting them in. Everybody is pacing, though, again, because you don't want to have this huge onslaught at the same time when--I mean, we do have to take into consideration that many geographic areas have not hit their peaks from what we are being told with the infection rate. And that some, as they start to open up and go back to work, we're going to see another increase in the virus. So both of those are going to impact the availability of your staff and maybe how the patients are going to be able to move through. So those are the two ways I've seen it done. Some are more urgent than others, perhaps based on age, AMH, what other parameters. And some are more prepared to move forward. Jovana, what are you seeing in your center?

LEKOVICH 32:08
Thank you, Lisa. That's exactly what we've been trying to do as we're--obviously when the first ASRM guidance came through in mid-March, we just stopped all treatments, we still had to take care of a couple hundreds of patients who were actively in treatment, in the middle of IVF, you can’t just leave them unretrieved with you know, dilated ovaries. I mean, having an ovarian torsion gives a much higher risk of ending up in the ER at the time of COVID and diverting resources from COVID patients. So they were also pregnancies that had been conceived before the first guidance came out, so we had to sort of, obviously, wrap those up, treat those patients see them through, stop all the actions and so as we've been slowly starting to reopen, I remember that at that time, what was really important because we had, you know, shelter=-in-place in New York state and for those patients who really needed to still come for their treatments and complete their treatments that have been previously started, we have issued a letter to each patient that they are supposed to show to a police officer if they get stopped in the street, because, you know, that was the condition in New York in March and beginning of April. Now, as we're slowly starting to treat the patient, obviously, how you--and that's very good point, Griffin, it just shows a very good understanding of IVF process on your end--is that you control the number of patients you're going to have in the operating room or in the recovery room by the number of patients who are starting. Here or there you might have 22 retrievals, as opposed to 17. I mean, we're a huge center and so for us, there's not a big difference, but in this setting, where you cannot have as many patients in the recovery room because you have to have distancing. You cannot do scheduled procedures every 15 or 20 minutes because you have to ensure social distancing of partners in production rooms, of patients coming in and getting screened, of patients in the recovery room. We've been controlling--and that's really how you control it. I remember learning this from Cornell, really controlling how many starts do we have today, you need to know how many patients are starting. So even if somebody ends up being triggered and retrieved a day early on somebody a day later, those are still not huge differences that you might see on a daily basis. So you basically have to see what your capacity is, obviously, for each center might be different, because, you know, not all of us have the same number of physicians, nursing staff that can help in the recovery room, not the same number of beds in the recovery room, not the same number of examination rooms, operative rooms and a number of anesthesiologists, but that's exactly where you need to control that bottlenecking is how many patients are starting every day. And so for us, that has been a certain number that, depending on how many physicians we have, and if we are able to continue working to full capacity would have been maybe one patient from each physician every day or one patient from each physician every other day to be able to start if a slot goes unfilled, it can be filled by somebody else's patient. Or if there's a patient that needs to start more urgently, you know, speaking of those criteria, that is also very important. And so all of the physicians that have prepared their own patients that will be going into the treatments as we're opening up slowly and as Lisa mentioned, these criteria really are driven by--there's like a whole algorithm that we're using, but it's basically driven by their age, by their AMH, obviously cancer patients or patients who have a medical condition that might diminish their fertility and who have to be treated, those are definitely more urgent patients. There are patients that we're not treating as of yet and I'm sure might be a different question, but you know, patients who have a BMI that we're able to manage that knowing that high BMI is one of the significant risk factors for the most severe COVID-19 disease, those patients might have to wait. Also patients with comorbidities including asthma, hypertension, we're just becoming much more strict when it comes to those conditions. Because if a patient is to get sick, especially for patients to get pregnant and then sick with those comorbidities, that patient is at a higher risk of getting sicker and needing hospital treatment. And so there are definitely some--we put a lot of thought into this and a lot of criteria and it's another SOP for us.

JONES 36:34
Connie wants to know if the clinic tests--who is responsible for their care if positive? So most of the folks answered that they're not testing, but there were a few that are, so let's say you get a positive then who's responsible for their care? And then I asked, just because I think you could take that a few different ways or you could have a few questions that offshoot from that instead, you know, you cancel an IVF cycle, sign off to PCP, what's the responsibility of the REI if they do test positive?

RINEHART 37:03
I think that is the same care that we would give to any patient where we found some other illness or condition is you hand them off to another physician. So if somebody were to test positive for COVID-19 right now, most of the CDC, WHO guidelines, etc. say you have to have them contact their primary care physician so that you're not just saying we're canceling you and we don't treat this. Because we don't treat it. We are not primary treaters of COVID-19. But, you know, just if you were to find something else in your patient, if we find diabetes, we don't take care of it, we send them to an endocrinologist. So I think, you know, you need to just make sure that they get back to their primary care physician. Whether you want to do follow up on that or not, it depends. Do you have a policy if you send somebody back to their physician for an illness that you always follow up? And my recommendation is always follow your policies! Don't make this an exception.

JONES 38:03
Lisa, in the beginning when this was happening there were people that-- this is pre-ASRM guidance--back in the early days of mid March. When people--

LEKOVICH 38:12
That was like years ago!

RINEHART 38:15
It was years ago, I think!

JONES 38:16
You’re not kidding. It really does feel that way! I feel like it's finally gotten back to week to week. You know, whereas at that time it was hour to hour, how rapidly everything was changing. And one of the things that people were starting to offer or to consider was just to say if you have to cancel your cycle, that it will be refunded by the practice. Some of the pharmacies and the manufacturers added on to that, that if you test positive during the cycle, we'll refund your medication or at least allow you to reorder with a credit of the same value when you restart. Is that required, Lisa? Are most people doing that now? What can you advise with respect to refunds and restarts?

RINEHART 39:05
I have not seen anything that says it's required. Okay? Meaning that if a patient has paid you for services that you've provided, and they get sick with the novel Coronavirus that you have to give them their money back. Again, I go back to one, I think this is a time when people are being extremely generous. And I would never discourage that because we want to make sure that our patients and our staff are healthy and anything we can do to help them, I think, is appropriate. But, you know, we have to let our patients know ahead of time. So as we're starting back, if our patients start treatment, and we make a decision as an individual practice that if you make pre payments, and we have to stop you, you will still owe us for the work we did and it's spelled out upfront and the patient's aware of it, that shouldn't be a problem, as long as you're transparent with your patients. But as far as anything that requires reimbursing them because they get sick with this, I have not seen anything at all. It's up to the individual practice

JONES 40:08
Jovana, did RMA try this at any point?

LEKOVICH 40:11
Fortunately, we haven't been facing--we haven't faced this situation as of yet. We certainly discussed it, again as a group, and discussed with our legal team and precisely what Lisa said, I think that, you know, what the consensus was among us was that if there's a work that was done--I think it's a case by case, obviously if we’re treating a cancer patient or if you're treating somebody who absolutely has no means or has no insurance, we're lucky to be practicing in a mandated state, but you know, that's exactly what Lisa said. All the patients are sort of being given this information booklet before starting. We discuss with them, finance discusses their part, and they are fully aware and understand what the situation might be and should they test positive, obviously, their treatment has to be discontinued. At that point when it gets discontinued, RMA might not be able to reimburse them for their investments until that point if certain things have already happened in the cycle, such as embryology, that work has happened or it was a retrieval, but we couldn't do anything with the eggs or or something like that. It's a very hard decision and I just feel like it's for all of us--I mean, these are such sad conversations to have because, obviously, the unemployment rate has been raging and the whole world has been just financially going down. And economically, it's a very, very hard situation. So more like less from a legal aspect of it, but more from a humane aspect of it, this is something that I think needs to be also handled on an individual basis, you have to take into consideration where the patient's coming from, what was their situation. I mean, we've donated cycles many times before and for certain situations before COVID, before all of this, so it's an individual scenario that also counts, I think.

JONES 42:07
Dr. Martin asks, who's responsible if they test positive after they conceive? I imagine it's the same answer. You refer them to their PCP. Maybe he's asking if this is pre, seven and a half week, pre 10 week, whenever they graduate from their REI, if they test positive, and then some of their care is still scheduled--maybe he's asking to see someone when they're still positive that if they need to come in for an ultrasound, they haven't moved on to their OB, what about a situation like that?

RINEHART 42:36
I mean, I would think that you would have to look at how you can safely hand them off to somebody. Do you have to do that initial ultrasound, for example, to make sure that the fetus is where it should be, that you don't have an ectopic or anything like that? And perhaps in the past, when we've had infected patients, I've had practices that have used clean rooms in the hospitals to do those exams and not bring them into your practice. Something to consider. Have you even talked about that in your practice? That's a great question.

LEKOVICH 43:10
It's a very good question and we certainly have talked about it because I mean, we monitor weekly, 9 days after the transfer would be the first pregnancy test, then 48 hours later to ensure appropriate rise at the beta hCG. After which we follow with weekly ultrasounds. Are those weekly ultrasounds really clinically needed? Not really. And as Lisa mentioned, there are two that are really essential for any obstetrical practice, like early obstetrical practice, we as REIs provide, which is you want to make sure it's in the right place, right? Even with naturally conceived pregnancies, I always bring them in for a five week ultrasound just to ensure it's not an ectopic pregnancy. An ectopic pregnancy is a surgical emergency that doesn't have to end as badly as if you treat it with methotrexate when you know that it's not in the wrong place. And sometimes the laboratory might not show it. Some ectopics have perfect rise and then all of a sudden she is an ectopic topic. The other one is the seven week ultrasound that you know, we want to see if there's a heartbeat. So I think the crucial or the most difficult situation in this regard would be if you have a patient that is testing positive, yet you haven't identified an intrauterine pregnancy. All the other ultrasounds are actually not that essential. Right? The patient’s not in danger if you have documented an intrauterine pregnancy, you might as well discharge for five weeks, and she can wait for her obstetrician and make sure that--you know, if it was a natural conception, they wouldn't have seen her before before 10 weeks anyway, and you can monitor progesterone or you can just wean her off progesterone as you would usually do. The problem is this sort of micro scenario where you might have a patient who test positive before documentation of an intrauterine pregnancy. And, you know, I guess that also might go case by case. You know, as you're saying, I think that's a very good idea, potentially sending them to Urgent Care. Obviously, you don't want to divert any resources from providing care to COVID-infected patients. But at the end of the day, it might be something to consider to basically evaluate them in a different setting, somewhere where there isn’t COVID raging already, which is an urgent care hospital. And basically just making sure that they have, you know, or if they would have symptoms like if she starts bleeding, or she starts having abdominal pain that she would have to go.

JONES 45:26
Do we think these measures apply outside the US in countries like Canada, my guess would be almost everything would. The variance of legal liability would certainly be different depending on jurisdiction, but seems like most of what you've talked about applies in other countries. Can you offer some insight?

RINEHART 45:47
Well, what we're talking about is infection control and patient safety. I don't think that changes no matter where you're located. You’re right, the legal liability may change based upon jurisdiction, but when you get right down to it, taking care of your patients, taking care of your staff. I would love to see that be the same, no matter where you're sitting.

JONES 46:07
I want to thank you both for coming on. Is there any parting wisdom that you'd like to leave with as folks are continually revisiting their standard operating procedures of what they need to consider as they make and reformulate these?

RINEHART 46:28
I would just add that, you know, even though it seems to have slowed down, we're still very fluid. There's still a lot we don't know. And that basic patient safety and infection control is what we're looking at. So keep that in the forefront. And the back end of it, take good care of each other. I worry about acceleration of burnout, and as we're getting ready for Nurses Week. I want to say thank you to all the nurses and nurse extenders and say hang in there everybody and just keep working together and keep talking to each other as Jovana said, I mean that's the best thing we can do is share information and help each other.

LEKOVICH 47:08
Yeah, I couldn't agree more with what Lisa just said. I think these times are extremely important. It's extremely important to be kind to each other because everybody's being hit, maybe not to the same extent, but everybody's being hurt, everybody's suffering right now and we really need to be unified. Not just as reproductive doctors or you know, reproductive people within this field of medicine, but generally as humans we just have to be really unified. I really enjoy, as I said, Griffin, I really enjoy reading and I learned so much from your organization and from your podcast, but one thing that I keep reading in your interviews, especially the more recent ones, which is a hope of all of us, is that well what are we going to do when this is over, and when this is over, when this is behind us? And I just feel like--I don't want to sound pessimistic, but I'm not sure If this will be over or if we're going to reach the certain low constant and some of the elements of what and how we're practicing right now might remain for a longer time. And this might be our new normal. And so I think that you know, finding clever and you know inventive ways of handling these situations, I think it's a very positive thing. And I think that you know, as we said, stone by stone, sometimes you can’t have everything figured out and you know, in a completely new viral pandemic that we haven't had in the past 100 years, but I think that being inventive, trying to think outside the box, because we might not have all the answers and just getting used to this new normal.

JONES 48:48
That's a good closing, Jovana, if we know anything from the Great Recession or from September 11th, some things go back to normal and some things never do. Thank you both so much for coming on inside Reproductive Health, Dr. Lekovich, Jovana, Mrs. Rinehart, Lisa, thank you both so much for coming on the show.

RINEHART 49:09
Thank you, Griffin, for having me.

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