INSIDE REPRODUCTIVE HEALTH PODCAST
Ep. # 34 - How At Risk Are You as a Physician? Mitigating Liability In Your Practice: An Interview with Dr. Steven Katz
A malpractice case can be the end of an REI practice, and with IVF errors often making it into the news, the pressure to be perfect is high. Thankfully, technology aimed to reduce errors has grown. On this episode, Griffin talks to Dr. Stephen Katz, CEO and Founder of REI Protect, a company formed to provide risk management services and coverage for REI practices across the country. They discuss what can go wrong in an office or IVF lab, and, more importantly, how to protect your practice from errors.
Welcome to Inside Reproductive Health, the shoptalk of the fertility field. Here, you'll hear authentic and unscripted conversations about practice management, patient relations, and business development from the most forward-thinking experts in our field.
Wall Street and Silicon Valley both want your patients, but there is a plan if you're willing to take action. Visit fertilitybridge.com to learn about the first piece of building a Fertility Marketing System--The Goal and Competitive Diagnostic. Now, here's the founder of Fertility Bridge and the host of inside Reproductive Health, Griffin Jones.
GRIFFIN JONES: Today on Inside Reproductive Health, I'm joined by Dr. Stephen L. Katz. Dr. Katz has focused his career exclusively on Advanced Reproductive Medicine since 1995. He went to Cornell Medical College. He completed his residency in OB/GYN and his REI fellowship at the University of California San Francisco (UCSF). In 1999, Dr. Katz started the Fertility Associates of the Bay Area and he's also been a part of launching and helping other programs from an investment group that he's formed called the IVF Centers of Excellence, LLC. They helped operate the Hawaii Reproductive Center until its sale in 2011. In 2012, Dr. Katz created and operated the Arizona Reproductive Institute, which was also sold to a privately held group in April 2014. And today, Dr. Katz now dedicates his professional life to helping fertility centers and providers through REI Protect, LLC, which is the only risk management and medical professional liability program solely dedicated to REI practices and IVF labs in the United States. Dr. Katz, Steve, welcome to Inside Reproductive Health.
STEPHEN KATZ: Thank you, Griffin. Thank you for having me.
JONES: We're were going to have you on in the fall. We decided to have you on much sooner because of some recent events because your expertise is one that I think a lot of people need to hear going on with some of the current events and we'll talk more about those as we get into the show. But, in terms of helping to protect REI practices--that's come from a really personal experience. I want to allow you to give some introduction about the experience that you've gone through in your own career and how that has parlayed into serving REI practices. So, both how it has been a part of the narrative of the program, and also what that's like because this is pretty intimate for you.
KATZ: Well Griffin, very much so. I lived through an embryo lab error, many years ago, actually the year 2000. It seems like yesterday, but almost 20 years ago. And that really led me to understand that not only were protections not in place, but the risk management industry and the medical malpractice industry were not yet sophisticated enough to really handle the rapid evolution of the field of Reproductive Endocrinology. So having lived through a lab error, I have personal experience in the importance of having the right risk management program, and the right medical malpractice coverage, and the right interface between the two. And for those reasons, we set up REI Protect. And REI Protect’s sole focus is on protecting REIs, the practice of infertility medicine, and as I think we're going to talk about in detail, the risks that are now up and coming in the IVF laboratory itself.
JONES: Talk a little bit about what protection means. Does it mean legal policies? Does it mean standard operating procedures? Does it mean insurance plans?
KATZ: You can break it up into two categories, Grif. The first category, of course, is risk management. And risk management has a wide range of areas of focus from policies and procedures to what to do, what not what to do, what guidelines to follow, what really should be happening for best practice in the REI clinical practice. And then we have course expanded that into the IVF laboratory. Our focus really is on the IVF laboratory because we at REI Protect think the likelihood of a mistake or an error in the IVF lab is really six times greater than the clinical practice and we'll talk about those reasons, I'm sure, later in the show. Then secondarily, beyond the risk management in the climate we live in, are policies and paper protections that medical practices must have become very specific in our field. And so we offer very specific coverages for REI practices and the IVF lab including a very unique coverage for the storage of cryopreserved sperm, eggs, and embryos and now recently also the shipping of those gametes and embryos. So great question. There's really two focuses: one the risk management part, but also the paper policies and endorsements. Those are all intertwined in our program.
JONES: You talk about the risk being six times greater on the lab side than on the clinic side. No small part of the reason why you and I are talking now is because of the very high profile case that has happened recently with an independently-owned clinic in the Los Angeles area with two embryos that were transferred from different intended parents into the uterus of a separate intended mother who was supposed to have two of her own embryos--don't believe any donor gametes were involved. And part of the bells that went off as reported in the press were that there were supposed to be at least one female embryo transferred if not two, and at the ultrasound, there were two male fetuses inside the uterus. And then finally on the day of delivery, both the babies came out Caucasian and both of the intended parents were of East Asian descent, so this one is sort of--it's sort of obvious. It wasn't the sex that we were told that the baby was going to be and they're not our ethnicity. It makes one wonder, had they been the promised sex, or had they not done PGT and hadn't selected a an embryo for that reason, and if the babies had been the same ethnicity as the parents, when we have not even known about this? And it does beg the question of how often does this happen? Or how much that this is happening? So when you say that the risks are six times greater on the lab side, what does that mean in terms of incidents? What's happening? And what are the most common?
KATZ: I think we should start off by really realizing that hundreds of thousands of IVF cycles and embryo transfers are occurring in the United States every year. And even if the science and the procedural aspects were perfect in the human sense, we would still have a number of misapplication. So from an incident perspective, I think everyone would say we want to be as close to perfect as we can, but we will never be able to get there. So given a denominator of a couple hundred thousand cases each year, there are certainly likely that there is more than a handful of mix-ups, as you could say, in our field. Some come to light, some don't come to light. What's most important is if the clinic realizes that a mix-up has occurred, they need to address that in a very transparent way. Which means immediate disclosure, immediate acceptance of the wrongdoing, finding out how that error occurred to make sure it didn't affect other patients. Then, of course, moving forward, prevention of that error from ever happening again. So the answer to your question is: I'm sure it happens. I think if I pulled 50 other REIs, we would all agree that it does happen. But I think we all work very hard and diligently to lower the number of errors in our field.
JONES: The transfer of the incorrect embryo is one instance. What are some other things that can happen in the lab?
KATZ: Well, I think you can really start off with egg collection because an IVF cycle, really, in the lab, starts off with collection of eggs, from the egg harvest or the egg retrieval. Those eggs have to be labeled properly. When fertilized, of course, they have to be fertilized with the properly labeled and selected sperm. So mislabeling does occur and we really spend a lot of time in the lab focusing on making sure that gametes are labeled properly. There are now scientific platforms out there that help with this labeling concept. The Tomorrow Platform, radio frequency identification, and other platforms are available to help prevent mislabeling. From mislabeling, we go to chain of custody, meaning that the eggs need to be moved into the incubator, they need to be fertilized, embryos need to be cultured, sometimes the media is changed. Every time the embryologist touches the now embryos, we have to make sure that the labeling remains consistent, i.e. exact. That's where these scientific systems can play a role in enhancing the human knowledge base, looking at labels, making sure everything is clear. Nowadays, in modern times, most embryos are cryopreserved. We come back weeks later with a frozen embryo transfer and this is shown to enhance success rates over the past three to five years or so. So we've added another labeling issue to our cycle. That is the embryos now have to be frozen and properly labeled in the tank and extracted properly for thaw, and then bring our transfer. Years ago when we were just doing fresh embryo transfer, the labeling was a little bit tighter because embryos that were properly labeled were selected for transfer in a fresh manner, but now that they're being frozen relabeled, thawed, and then loaded in the catheter, and it's a whole other area of potential mislabeling mistakes. So that's one really large category and that's what I think we see because mislabeling or taking the wrong embryos or embryo transfer are similar errors. In other words, when embryos are identified and shown to the patients before embryo transfer, that sort of is--selection of those embryos is part and parcel with the labeling concept. Another area of mishaps in the laboratory is really back into what I call the core procedures of the laboratory. Collection of gametes, fertilization, creation of embryos, culture, etc. And that is just simple human error--dropping sperm, dropping eggs, turning over a plate--all these things are human error. But because the embryos and eggs are so valuable, that loss of the eggs and embryos can be catastrophic, especially in an older woman who may not be able to produce the same quality of eggs moving forward. So I break this up into two categories: one are the mistakes related to the core procedures in the IVF lab, but now we have a whole new category and that whole new category is related to the adjunct procedures being performed in the IVF lab for example, genetic testing. It's absolutely critical that the REI physicians give proper informed consent to their patients that genetic testing is far from perfect. I think patients innately think that if you test an embryo to be male or female, it's a hundred percent exact. It's not. We have a number of incidents in this country were male embryos were thought to be put back and female embryos appear on ultrasound or vice versa. So the genetic testing is not exact and patients really need to be given informed consent on this topic. There's no such thing as perfection in genetic testing. Furthermore in genetic testing, the chain of custody comes into play again, because the IVF lab has to biopsy the embryo, it has to send that properly labeled biopsy to the genetic company, the genetics company that has to test that biopsy, give results within the same labeling structure, send it back to the clinic, the clinic then has to recognize not only the test results, but also the identification, and so the chain of custody in that situation and lead to further mistakes. So we're seeing the potential for a real number of mistakes in these adjunct procedures that are being performed in the lab particularly focused around genetic testing. So when we group it all together, I think you can start to see that the risk in the IVF lab is substantially more than the risk in the physician's practice. Years ago, it was not thought that way. It was always thought that the physician and the procedures or the surgeries that the physician performed led to the greatest risk, but it's not the case anymore and we can talk a bit about that later. Physician or REI practice has really changed or evolved over the last few decades.
JONES: The chain of custody really is remarkable. And you talked about a number of different electronic solutions--technology that can help to mitigate some of that risk. One thing that you mentioned was radiofrequency labeling, electronic labeling, another might be digital witnessing. Can you talk about that at all?
KATZ: Absolutely! I think organization of data in the REI practice and the IVF lab has never been more important and on the simplest level, it's because the organization of data allows you really to specifically choose the best embryo for transfer or later come back and look at the data and try to develop a better treatment plan if the first cycle failed. So organization the data is really important. It's much harder to organize data on paper or paper charts, then it would be an electronic medical records. So electronic medical records, not only organizes the data better, but it plays a tremendous role in multiple check mechanisms that offer patient protection. For instance, if the physician or nurse orders a laboratory test, the electronic medical record has a double check mechanism to make sure that result is put in the patient's electronic chart and that the value is normal. The patient has been contacted. The test has been signed off on. It's really important. The second part of many parts of the EMR protection is also digital witnessing because there needs to be some chain of custody if I can use that term again or digital witnessing. Yes, it's important for witnessing to occur in very important areas of REI medicine. But, that witnessing also has to be documented and the EMR can play a very strong role in that documentation that the transfer between plates, or tubes, or catheters has been cracked. So, long-winded answer, I think the EMR plays a really strong role in the protection of the practice of medicine, well beyond just the electronic attainment of patient information.
JONES: Where does biometrics play into all of this? I know that something that eIVF has been talking a lot about, I wanted to have Jawid on the show as well. But I figured I could at least ask you a little bit about biometrics. It’s something that Jawid’s been talking about a lot, and being extremely integral to the safety of the lab. How is biometrics implemented for mitigating risk in the lab?
KATZ: Well, I think Jawid would be better to explain his view on biometrics, but a view from 30,000 feet is really--any correlative data that we can promote in the IVF lab to stay on top of where the gametes, where the embryos are in terms of development of the cycle, is monumentally important. And so I've always supported eIVF in their biometrics platform. I think any modern technology of data surveillance or data collection and organization is really good for the IVF lab. Years ago, there used to be a logbook and lab directors would scribble names or identifiers or birth dates in a log book and that was all we had. Maybe there was an Excel spreadsheet, but now the world has really changed. The safety of the storage of cryopreservation of gametes and embryos and the identification of those gametes and embryos is light years advanced to where it was 20 years ago.
JONES: I don't know if you have an opinion about this, but I tend to have this sort of feeling that I have no idea if it's justified by any sort of data, but we think of technology as reducing human error, because it does greatly. It seems to me--again, this could be completely unfounded--but it seems to me that perhaps the danger of larger incidents happening once could be greater because of using digital solutions. If something goes wrong, you know, we are a marketing company. We use Facebook and Instagram. It seems like Instagram goes down once a week it seems, and this is one of the largest companies in the consumer space. The chairman of the Fed, Jerome Powell, I believe, says that his biggest concern is security breach at an international level into our very banking system of the fed. And so as we move to eliminate human error using technology, is there risk for larger incidents that might go wrong?
KATZ: So I think I understand the corollary, well thought, but I actually don't think so in the IVF world. And the reason I don't think so is there's really not a mother ship that's controlling each of the individual clinics. Other than, say a large-scale blackout at a large EMR company. I don't see there being a mother ship. I see that these technologies are additive to the safety of the performance of each click or IVF lab, but I see them as supportive rather than controlling. And so I don't think there's going to be a large-scale event in our field or the foreseeable future. What I see is that there are so many cycles being performed them with so many adjunct procedures in the IVF lab, that invariably, there are going to be errors like the one you brought up in Southern California.
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JONES: I'm not sure which of these might be the case, but from a public relations spin, larger practice groups can say, “This is a problem for boutique practices because they don't have the systems in place. They don't have the investment in technology. They don't have enough personnel and therefore, the chance of human errors greater.” I could see boutique practices positioning larger practice groups saying, “They've got so many people coming in and out as opposed to having one embryologist who's responsible for everything and that's why there's more opportunity in larger groups.” Are either of those the case? Do you see risk being greater or lower depending on practice size or lab volume?
KATZ: You know, I don't. I think that bigger practices have different risks than smaller practices. I think bigger practices, as you point out, have such high volume, that they’re are forced to put absolute policies and procedures in place. That's protected. But the problem is their volume is so high, that they have so many embryologists, some that may not even know each other well. So I think big practices have that risk. Smaller practices also have a risk that they may be busy in their own world, that they haven't been able to put proper policies and procedures in place that a dedicated person could do at a larger practice. The practice I do worry about, is the single person practice that practices the same way today, as they did 25 years ago. Because I think if you're going to do PGTA, then the embryologist that does the biopsy has to be properly trained and doing enough biopsy cases to maintain that certification. Infertility practices have changed greatly over the last 40 years since Louise Brown. I mean, people think about Louise Brown in 1978, of course the first successful IVF cycle, but it was really a surgical treatment modality that was commonplace in fertility practices in those decades. In other words, most treatment plans were focused on surgical intervention, which was a really successful. Nowadays, REI is performing very little surgery. Their focus, Griffin, is really, as you know, on performing IVF, which is so successful. So changes in the REI practice are commonplace and those changes really are important because it's those changes that really limit risk. So to answer your question very specifically, I think large practices have their own set of risks, and small practices have their own set of risks, but as a patient looks at a practice, I don't think they should view a larger or smaller one as having a greater risk.
JONE: As a general stereotype, physicians across the board are labeled to be those that hate lawyers and live in fear of malpractice. In your summation, are the REIs that you're talking to, are they taking this seriously?
KATZ: So, the REI Protect Program is really by invitation only. We seek out those REIs that we feel practice above the standard of care and, most importantly, communicate really well so that if there's a mishap or if they sense something is wrong, they will reach out to us ahead of the curve. What we'd rather not have is a call after some tragic event has happened where the physicians knew or sensed that it was happening for weeks or months. In either case, we respond with tremendous expertise, but we certainly want to be ahead of the curve. I think REIs across the country are much more focused on medical malpractice issues in our field, because I think they feel like they're doing a good job in the clinic: improved informed consent, they've decreased their surgical volume. I think REIs, in general, communicate well with their patients and form excellent relationships with their patients. What they're concerned about is the unknown in the IVF lab and who's responsible for those mistakes? Because if a physician does an egg retrieval and the eggs are properly labeled in the IVF lab and then the IVF lab hands him or her back the wrong embryos, here's a very strong argument--a very strong factual argument that the physician didn't make any mistakes. And our litigious society has not caught up with that fact. They're focused on, ”Well, who was your doctor? He's responsible for what goes on in the IVF lab.” We at REI Protect are trying to separate out the two through legal modalities, meaning that it's actually not the physician’s professional responsibility for what goes on in the lab. He or she hires licensed and certified lab directors and embryologists, and then he or she counts on those professionals to do their job. So, we focus on IVF lab coverage and physician REI practice coverage and we have separation between the two. So I think REI physicians are very well aware of what's happening with these mishaps, lawsuits in the country. They're mostly coming out of the IVF lab and that's what concerns them, because their control in the IVF lab is a lot less than their control in their own practice.
JONES: So what can people do to protect themselves? If you were just having a drink with someone at ASRM and it's a practice owner who has just seen the headlines of the tank issues from 2018, of this most recent incident in Los Angeles in July of 2019, and has concerns, what are the first few steps that this person takes? How do you counsel someone when you're just having a side conversation with them telling them from experience selling them from your professional experience?
KATZ: Well, they have to get their IVF lab house in order. And many smaller groups don't have the structure in their IVF lab that they need. It's my feeling that they should have an outside or off-site Lab Director, which is separate from the Managing Partner of the REI practice. And that highly-qualified 8 CLD Lab Director should be responsible for overseeing that the policies and procedures in the laboratory are effective and meet all of the certification criteria, whether it's CAP or JCHO, the Lab Director has to make sure that the IVF lab is certified. The second thing I would say as part of getting the IVF lab house in order is you have to have enough qualified embryologists meet the caseload. Whether that number is a hundred or a hundred and twenty cases per embryologist--the ASRM has produced guidelines on such-the embryologist cannot be overworked. Sometimes when clinics batch or clump cycles together, there's too many cycles per day, the theory is the embryologist have a week or two off a month, so they can regather their energy, but we have to focus on making sure that there aren't too many cases per embryologist. In other words, getting the IVF house in order. That's really where I lead. Of course, we've been going to do you have an IV- focused specific electronic medical records system? What is your surgical caseload look like? Are you using the ASRM based consent? You feel like you have a professional and helpful administrator or Executive Director that understands the modern REI practice? Those are really all questions we focus on. And If I'm meeting someone, as you said, at the ASRM, I'm really focused first on getting their IVF house--or IVF lab house in order.
JONES: Who polices this? Is that the FDA? Is the State Medical Boards? Is it Health and Human Services?
KATZ: Well, I think it's a combination of organizations. Certainly the medical board and every state polices it at some level, as they police every physician. I think SART and CAP have done a very good job in trying to bring certification standards to our community. I don't know if anybody polices it necessarily, but there are a number of organizations really through the ASRM or the AAB that really pride themselves on the certification process and make sure that these clinics and labs are following proper procedures and protocols.
JONES: The intensity of a malpractice suit and what that can do to a clinic, I think, is all but obvious. This is pure speculation, but I just--I don't think that anyone would really disagree--I don't see this clinic in Los Angeles coming back. I don’t see this embryologist working in the field again, and or at least not for a very long time. And so that sort of fear of what can happen as unsurvivable cost is all but obvious. Are there any cost savings or any cost benefits to becoming compliant sooner without having anything go wrong? Such as if people use biometrics or if they use digital labeling--electronic labeling, if they use digital witnessing, are there any ways that their premiums on their insurance are lower because they have certain technologies or systems in place?
KATZ: Well Griffin, I would start from the back end and move forward. In other words, if one of these events in the IVF laboratory especially occurs at your clinic, your clinic is probably not going to survive. So the cost of clinic closure, both in terms of economics, let alone the social cost is monument. So any reasonable cost that you can place on prevention of any of these catastrophic errors from occurring is extremely wise. And I say that to all of our current clients and all of those that are looking at us, because it's not just the cost effectiveness of our program, it's the cost effectiveness of preventing a catastrophic loss. In reality, physicians or labs that have never had a mistake, or have never had a claim, can feel like it will never happen to them. And that's when I looked them in the eye, grab their collar, squeeze their hand, and say, “Are you kidding me?” It's not just programs that are practicing below the standard of care, it's any practice that does hundreds of cycles of IVF that can have this happen to them. So that is really our mission. Our mission is to bring the understanding or knowledge that any one of these events can happen any of the best clinics in the country. And I would suggest some of these events of the last two years, have happened to some of the best clinics in the country. So no one in life is free from a medical illness, an auto accident, a child with a learning disability, or malpractice claim like we're seeing, because the IVF lab now is growing exponentially with procedures that we just don't have a handle on yet. At REI Protect, Griffin, we do something special. We invite groups that we think, as I said, practice above the standard of care and communicate with us. We're a very tightly knit group and there's tremendous benefits within REI Protect. Interestingly, our members seek out new technologies that will help them prevent mistakes. I don't go to them and say, “Here's an additional insurance discount if you use this biometrics platform or this RFID platform.” I present it to them, if they hear about it before I do, they present it to me and we look into it. So our community looks to always be better. The premiums are being charged for the policy portion are lower than markets begin with. So this never really is about economics. This is about making the REI arena safer for patients. And when it's safe for patients, then it's, of course, safer for physicians and better for the physician-patient relationship.
JONES: Our audience is mostly practicing REIs and physicians and some practice managers. I do see more patients than normal and more folks from the infertility community than normal listening to this episode, because I think it's really fascinating and interesting for them as well. So, I'd like to conclude with saying that, referencing your point of the denominator is one of hundreds of thousands, if not millions of cycles worldwide, and we're talking about a few incidents. But, we are recognizing the inevitability of some errors due to technological and human with a denominator that great. And so I guess, how would you want to conclude about lab error, about risk management on both sides of practice--how would you like to part on this topic with our audience?
KATZ: Well, if I were talking directly to the patients now, I would say that the field of reproductive endocrinology is incredible. It's incredible for the practitioners that practice it and I think it's incredible for society to be able to assist individuals, couples to have children from which they may otherwise not have. This field is rapidly, if not exponentially, advancing. We said it in the 90s, we set it in the early 2000s, I say it with my friends every time we meet at the ASRM. And inevitably, in the world that we live in when a field or a scientific area is advancing so rapidly, there will be errors. Our job, maybe really the job of REI Protect in conjunction with the REI practices, is to help those errors from occurring. And I think we actually do a really good job with that. But I don't want patients to lose faith what we're doing. We're doing some incredible work. Whether it's a small or a medium or large size practice, all of them have their own special niches and are playing a really important role for different patients who are looking for different things. What I also want to say Griffin, I think organizations like yours, that bring information to the public, to the patient world, to other practicing physicians, and maybe even entities that are certifying and regulating our field, I think it's very valuable what you personally are bringing to our field as well. It's really all hands on deck. There's so much growth and so much success now in our field, everybody is needed.
JONES: Dr. Stephen Katz of REI Protect, thank you so much for coming on Inside Reproductive Health.
KATZ: It's been a pleasure and I thank you for the invite!
You’ve been listening to the Inside Reproductive Health Podcast with Griffin Jones. If you're ready to take action to make sure that your practice drives beyond the revolutionary changes that are happening in our field and in society, visit fertiltybridge.com to begin the first piece of the Fertility Marketing System, the Goal and Competitive Diagnostic. Thank you for listening to Inside Reproductive Health.