Part II in a series from a Harvard patient safety conference with a physician proposal and a defense attorney’s words of caution.

Guest Commentators

• Ellen Epstein Cohen, JD; Adler, Cohen, Harvey, Wakeman, Guekgazian; Boston, MA
• Caprice Greenberg, MD, MPH; Brigham and Women’s Hospital; Boston, MA

Transcript

This legal report features the second in a series of excerpts from a presentation by a physician and a medical malpractice defense attorney. They spoke at a Harvard-sponsored patient safety conference in the summer of 2009, about the benefits and risks of improving surgeries by putting cameras in operating rooms.

First, the audience of clinicians and patient safety leaders heard from Dr. Caprice Greenberg, a surgeon at Dana Farber Cancer Institute and Brigham & Women’s Hospital in Boston. Dr. Greenberg advocated for wider use of video to study performance and safety in the operating room.

Following Dr. Greenberg would be Boston defense attorney Ellen Epstein Cohen, of Adler, Cohen, Harvey, Wakeman, Guekguezian, who described the legal risks associated with video use.

Dr. Greenberg began by pointing out that more than half of all adverse events in health care are surgical in nature, and that 75 percent of those events related to surgery occur in the operating room.

• Dr. G.

  For this reason, we know that it is important to understand what happens in the OR in order to improve patient safety and performance. Traditionally in patient safety research, we’ve tried to do that by recreating what happens. We’ve tried to recreate it through the use of medical malpractice claims. We have tried to recreate it through root cause analyses, and we tried to recreate it through self-reporting systems rather than studying it in real time. If we look at what other domains have done, they’ve used video to prospectively capture performance for evaluation and improvement. Just as this technique can impact performance in competitive sports, so too can surgical technique affect surgical outcomes. Skills and team performance can be optimized by giving feedback through video images of intraoperative care. Like football teams watch game tapes on Monday, an OR team could see how they functioned as a team, and this can lead to an appreciation of how seemingly inconsequential events and activities in the OR impact performance and influence outcomes. So research is taken to the point of care. You have a complete record of what’s happening. The other way to perform research at the point of care is to have observers go on and perform field observations. And there you’re based on what the observers are actually able to record, whereas the video really is a complete record of everything that happens. You can do your analysis once outcome is realized. You’re able to go back and review older cases as new patterns arise in the data, and finally, it allows for a larger number of observers. And it also allows for the involvement of experts when something needs to be clarified, both surgical experts as well as experts in fields like human factors.

Dr. Greenberg also mention limitations, including costs, workflow interruptions, and culture.

• Dr. G.

  …So this is expensive, the hardware is expensive, the personnel is expensive, and I am going to talk in a minute about how culture is changing, but I think a lot of our institutions are actually investing this type of hardware. So having video cameras in the OR is becoming more and more common, so a lot of what you’ll need to do this actually exists and that can cut down on some of the expense. It can be viewed as intrusive, and I think you have to keep that in mind when you design your methodologies. As I was talking about, trying to find alternatives to putting a lapel mic on everybody so that really you minimize the impact on work flow. It can be limiting in the range of setting, so you can’t do this in an operating room where the video equipment isn’t available or you have to go in and install it, which can again influence the intrusiveness of the study. The analysis is very time consuming, which adds to the expense, so estimates vary from four hours to 12 hours per hour of video for transcribing and analyzing. And then there are issues relating to discoverability, confidentiality and privacy and cultural barriers. So as far as some of the medical/legal considerations, which I’m sure will be touched on, there’s really two sets of subjects when you do this type of research. So there’s the OR personnel and there’s the patient. So you have to think about the logistics of how you’re gonna consent the OR personnel. Because this is so time consuming, these studies usually have a very low number of cases that are enrolled, and does it make sense to consent hundreds of people when you’re probably only going to be involving about 10 cases? But if you try to get informed consent on the morning of the surgery, that’s gonna cause a large impediment in people’s work flow. And then the consenting of the patients. Our standard consent at Partners now includes a clause saying that your surgery may be videotaped, and this would be used for educational purposes or for presentation at national meetings. Now the question is, does that cover research or do you want to do a separate consent for patients because I think a lot of people would argue that this type of research goes beyond what is expected as part of the clinical course. We came up with this idea of retention policy as opposed to destroying the videotapes because it puts in a little bit more of a positive light, but the question is, how long do you need to retain the videos? I think ultimately, one of the goals at least in my mind should be to have a video bank, something that parallels a tissue bank for the clinicians in the room where we have videotapes that our prospectively recorded, and they are stored in parallel with a database that has patient and surgery characteristics so that you can go back and do research in quality, safety, and even education. So just to summarize my position on this, video has the potential to greatly advance surgical safety research by allowing real time analysis of system, individual and team performance in the OR. Most of the fear about this type of research is hypothetical, and I’ve talked to a lot of people around the country who are doing this in coming to that conclusion. And in my mind the benefits outweigh the risks. Thank you.

Attorney Cohen provided some words of legal caution. In her role as a medical malpractice defense attorney, Attorney Cohen has extensive experience defending some of the top physicians and hospitals in Massachusetts. Although she did not advise against videotaping surgical procedures for performance improvement and patient safety, Cohen offered several considerations for hospitals to think about.

• EC

  I’m back. So if a picture is worth a thousand words. A videotape to a plaintiff’s lawyer, priceless. So this is something that’s been going on in litigation as an issue, been coming up as an issue for as long as I’ve been a lawyer. And the increasing technology and ability to videotape, whether laparoscopically or from external cameras, either head cameras or room cameras, makes this even more enticing and exciting to the other side of the bar, to the plaintiff lawyers. And so the one thing I can say about this is if you’re using it for research and to improve patient safety, you have to remember that we’ve always had this very difficult balance between transparency, you know, everything’s up front, we own up to our mistakes, we tell the patients everything, we report facts and problems to our patients vs. peer review, which has been embedded in all of you from day one. And there is a cloak of secrecy and it’s statutorily protected about peer review, so there’s this dynamic, this tension between the way doctors have always been taught to study and improve, to talk about things behind closed doors and to make notes and minutes and reports that we know no one can see and the courts actually protect this. We’ve done a good job legally of making peer review sacrosanct for the most part versus this transparent idea of everyone can see everything I’m doing, what I’m wearing, how I’m speaking, how I’m holding my instruments, how long this is actually taking me, and so on. And so there is a tension that you can’t ignore between those two concepts. There is also another tension that I think is critically important to recognize and somehow address, and that is the tension between promoting increased communication in the operating room setting between different caregivers, anesthesia, surgery, nursing. We as defense lawyers, we want you talking. You as providers want each other talking throughout the procedure. You want open and ongoing communication, and no matter how many times you tell people this is for research and we’re not evaluating you, I think it’s very difficult to avoid the chilling effect that having multiple cameras at multiple different angles that you know people are going to be studying especially if there’s any intention of using this for credentialing that that chilling effect may have an adverse patient care impact in that you’re gonna decrease communication among providers, you’re going to have a very quiet OR and that’s exactly the opposite of what you want. So I would ask you to keep in mind that sort of opposite effect from what you’re looking for. Ownership of the videotape, ownership is huge when it comes to the legal question. You know, if someone goes and has their mammograms done and then they need their mammograms, they show up in Radiology, they say they’re my films, and I want them and technically they are. Medical record may be the hospital’s record, but the patient owns that information, and the patient owns those films. And you have to make abundantly clear in any consent form that has to be gone over with the patient, not the moment before surgery, A. this is for research only, it has to be in writing, and B. that this is the property of the hospital or the study that’s funding it or whoever is going to own it and C. you need the consent of the patient both to take it, to share it with others; it needs to be clear what that’s going to be used for. And at the very end of the day you want to be clear about how this is going to be maintained. I love that you’re calling it a retention policy and not a destruction policy, someone has been listening, but at the same time, it means it’s not gonna be here after a certain period of time and the consent form needs to make that clear as well. Because once you tell someone we are videotaping and they say ‘okay,’ And then they have a bad outcome, the first thing they want is the videotape. The first thing their lawyer wants is the videotape, and if the videotape no longer exists and it isn’t clear what it was being done for and why it no longer exists, all of a sudden you have either a huge suggestion of cover-up or you have from a legal perspective what we call a spoliation of evidence issue. A videotape is going to be the best evidence of what happened in that operating room and so if that gets…is not retained or destroyed, there is a suggestion that there was something about that videotape that was harmful to the people who were in it. So you have to be very careful to spell those things out. So I guess I would throw out there even though this is for patient safety improvement, improvement of performance, if you’re unfortunate to film a poor outcome, a complication, something significant and serious which, of course, you want to study, do you have a different obligation to maintain that or to notify before you destroy that? From a legal perspective, that might be a very important thing to consider. Thank you.