Media Availability Session (continued)

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JOHN EISENBERG: Thanks.

PEGGY EASTMAN, ONCOLOGY TIMES: I'm Peggy Eastman representing Oncology Times and Caring Magazine which covers aging and long-term care. Dr. Crane, I'd like to ask you: you've already implemented some patient safety strategies within Kaiser as I understand it, and including the fact that every doctor has a terminal, a computer terminal. At least my brother does anyway, he's an internist. And so before he writes a prescription he looks up somebody's record, and he sees if there might be any interactions or adverse drug reactions or whatever.

I guess my question is, why did you all decide to do some of those things, and did you do that on your own? I mean nobody beat you over the head and said you have to do that - there was no national thing saying that you have to do that. Why did you do that, and what did you gain from those internal safety mechanisms, and are these replicable by other healthcare providers?

CRANE: Well, Kaiser-Permanente made a commitment to implement electronic patient records several years ago, and we're in the process of implementing that. Building on Mike's point earlier, it is a very costly enterprise. We'll have spent close to a billion dollars putting this system into place but it will, as you have noted, have an impact on the coordination of care across an increasingly complicated medical care system, the prevention of errors, and giving a physician at his fingertips the information he needs to most effectively treat his or her patients. So there are a multiplicity of benefits that we see, and it was based on those benefits that we decided to move forward in this arena.

In terms of your question about, is it easier for Kaiser Permanente to do this than perhaps others? I think it is, because we are an organized and integrated system in which physicians are dedicated to taking care of our patients. I think it is more difficult, but certainly not any less important, to implement these systems in the more fragmented part of our healthcare system.

JOHN EISENBERG: Thanks. Yes.

UNIDENTIFIED PARTICIPANT: Would a systematic, in terms of research, would a systematic review of court decisions and out-of-court settlements identify any trends in potentially compensible events and what the causes are?

JOHN EISENBERG: One of the research projects that has lead to most of the data that we already know about what happens in hospitals was intended to do just that. That is a study of the experiences in New York, to look at the cases of malpractice and how that correlated with what actually happened in the hospital. There has been very little research in this area. But we do want to distinguish between those events which are considered to be malpractice and those events which are either medical errors or system issues that then lead to harm to an individual patient.

I do think that that that would be an interesting area to explore, and Tim you may want to comment.

FLAHERTY: The only comment I'd make is that there certainly is a basis for this with the Anesthesia Patient Safety Foundation. There's been a tremendous reduction in the liability and the problems with anesthesia in this country, where maybe a ten-fold or even greater decrease in mortality during the anesthetic experience. And that was based on closed claims studies that the American Association of Anesthesiologists did. And so that is an ongoing effort, where they've looked at it. This is something that's, you know, closed claims that have been looked at, they've changed their monitoring devices that they used, as far as the technology, it's really a public-private partnership. As we've done with the Patient Safety Foundation, they've tried to get some real changes put in from the public-private sector.

JOHN EISENBERG: Thank you.

SABRINA EATON, CLEVELAND PLAIN-DEALER: There's been a lot of talk about...

JOHN EISENBERG: Would you identify yourself please?

EATON: I'm Sabrina Eaton from the Cleveland Plain Dealer.There's been a lot of talk about how, for the reporting systems, there needs to be like a liability shield. How do you make that mesh with the need of people to know what's happened to them and possibly seek redress if there has been a fatal accident that caused something to happen with their family members? I'd like to hear from Ms. Sheridan on that too.

JOHN EISENBERG: Let me start by commenting that the QulC report includes in it a call to all health professionals and institutions to report to the individual and the family when an event has occurred that has caused harm. And therefore there would not be a need for people to go to that database in order to find out what happened to them. They would know that. And the experience that Ms. Sheridan had would not have occurred. That's number one.

Number two, we believe that there ought to be reporting systems which exist, and that those databases ought to have peer review protection, which means that they can be used for the purposes of research and for the purposes of feedback to those who need to learn from those mistakes, but that they not be disclosed publicly because it would not be necessary for it to be disclosed publicly in order for somebody to know that harm had been done.

And then finally there is in no way an intention to shield the original clinical data, which is of course the material from which these reports would come, and the material that would be used in any malpractice case. So we want to clearly distinguish the process of learning from errors and reporting about patient safety at the level of an institution or the level of a State, from the individual reporting that must be done in a way that's better than has been done in the past.

SHERIDAN: Well, as you know, actually in both cases, both my son and my husband, we walked out of the hospital both times with a clean bill of health. We were not told about our son's brain injury until we requested records a year later, when there was an MRI that showed brain damage in the area that happens when a baby has severe jaundice.

To be frank, I have little confidence in the mandatory reporting and I think there is such a strong culture that I think that area first needs to be addressed to ensure that if there is no reporting of medical errors that there are consequences. And that's what I have found, and frankly have been very surprised, that there are no consequences if they don't report. So I have a little different opinion on that.

Now I am a bit concerned about some of this secrecy about what we might call the standard of care because unfortunately, in the court of law, medical expert witnesses are allowed to determine the standard of care, and I think that should be up to an agency who is independent. Because, in my son's case, we did file a lawsuit, and there were clear undeniable breaches in the standard of care.

We lost. There was a resident who documented the wrong blood type. It was a blood incompatibility. The nurses were unfamiliar with the basics of jaundice management, and then it was found that the hospital, which delivers 5,000 babies a year, did not have any policies and procedures related to jaundice management or blood-typing.

We lost the case because medical expert witnesses were willing to provide unsound scientific information. They helped their colleagues attempt to cover up what happened to my son. The judge, however, stepped up and granted us a new trial, and he was brave enough to say that the defendants used medical malpractice expert witnesses to intentionally mislead the jury.

So I think that someone else at a higher level, an independent level, like some type of authority or regulatory body to come in and say what is the standard of care. And the secrecy issue concerns me a little bit.

JOHN EISENBERG: I want to be sure that we're focusing on the issue of research and patient safety. I know the issue of malpractice is one that is of great interest to you, but it's not the topic of the session today. To the degree that it relates, I think it's very important to point out that with better research on patient safety and errors, we will eliminate many of the instances which then would come to malpractice. And that's really the purpose of the session here today.

I do want to make one other comment which is that, Mrs. Sheridan pointed out in answer to your previous question, let's have some examples of some interventions that work that aren't being used, and she described at least a couple in terms of double-checking laboratory results and pathology reports to be sure that they are known, both by the patient, but also by the referring physician. And computerized systems have been demonstrated to help with that problem as well, to find those lab results so that they don't fall through the cracks.

Yes.

UNIDENTIFIED PARTICIPANT: Could I just follow-up on the issue of the so-called culture of silence. This is...

JOHN EISENBERG: If it's a research-related question I'd be happy to deal with it.

UNIDENTIFIED PARTICIPANT: It is. Sure. This is a key item that came out when the Institute of Medicine report was released, and it was acknowledged at the time that it would be very difficult to change the doctor point-of-view on this, that, different than airplane pilots who don't get sued for malpractice, doctors do.

What kinds of interventions are there that would help change doctors' minds and just to follow-up with Dr. Flaherty, again, when the IOM report came out, the AMA was critical, saying, we understand that this material isn't going to be made public, but we're still worried that some of the material might come out. Have you changed your view on that? Has the organization relented a little bit on that and is it now more in favor of the IOM point-of-view?

JOHN EISENBERG: Let me remind everybody we have four minutes remaining if we're going to fulfill our promise to get you out at 1:15.

FLAHERTY: I'll be very brief, John, thank you. No, I think the issue for us was, what kind of reporting. I don't think there's any question that there has to be reporting. And the question is how the report's going to be used, and what for.

Our concern was mandatory reporting. We don't think that mandatory reporting as it's been out there right now has worked very effectively. You know, over 20 States have some kind of mandatory reporting, voluntary or mandatory reporting. And we've not really mined that data. We've not looked at it from the geologist's standpoint, we've just collected the rocks, and not really looked at the cause and effect. We're concerned that mandatory reporting would drive reporting underground. Now, obviously we've learned a lot from the Joint Commission on Accreditation of Healthcare Organizations from the sentinel event reporting.

And it's really been just a small, minuscule number of sentinel events reported, but we've taken potassium chloride off the floor. Things like this where we've been able to gain from that experience. So you don't have to have all the data I don't think. You don't have to have every report, but you have to have enough to see trends, you can see problems and you can address those. And really the issue for us is how do you communicate that information to the profession so it's incorporated in the practice?

UNIDENTIFIED PARTICIPANT: Do you think that doctors will get that message?

FLAHERTY: We hope do. I think this is one of our obligations as an organization.

UNIDENTIFIED PARTICIPANT: You acknowledge there would be reluctance to come forward as it is now?

FLAHERTY: Yes, you know I think the issue though is how you come forward. We do a lot of peer review in institutions, and the question is that something that's constructive or not. I think it is constructive. I think it raises the quality of care.

JOHN EISENBERG: We've heard from people in both the professions and the organizations that they want more data so that they can learn from their data. The comment that I've been reminded of is that if you want to tell what time it is so that you can stay on time you have to have a clock, you have to have something which measures how well you're doing. And we're not doing so well. So I'm only going to take one more question, in the back.

ADAM BELMAR, TRIBUNE BROADCASTING: I'm Adam Belmar, with Tribune Broadcasting. Dr. Eisenberg, you spoke at the beginning about research and implementation and the disconnect there. How are we going to implement the research that you all are talking about now? When this is done and the research is complete, how do we implement it? Where does the rubber meet the road here?

JOHN EISENBERG: Well, I have some ideas about that, but I'd like to let those who are going to be responsible for putting the research into practice to comment. Would any of you like to reflect on that? Steve?

WETZELL: I'd like to comment. Representing employers that act as agents for a lot of folks that are getting their healthcare coverage. We want to change our purchasing behavior to basically say that if you provide superior quality or safety, we're going to pay you more for it or send you more patients or some combination of those two. And we're going to educate the patients about the importance of paying attention to that.

And that's the hand off. If we can find from the research that the system does improve if we educate consumers, and we pay for quality, and we disclose fair measures on patient safety and quality then that makes the business case for employers to go out there and push this very aggressively to make this a purchasing standard when they go out and buy health insurance or direct contract with physician groups or hospitals.

JOHN EISENBERG: Maybe Marie can describe what States are going to do.

DOTSETH: Well, I think it's clear that States are going to have to set up some of these mandatory reporting systems, and information such as what do you report and what don't you report, what kinds of trends you make publicly available, which do you not, all of that's going to be critical to us as we put together something that we hope is very effective at really getting at reducing medical errors. So we're going to use it.

CRANE: And I think that healthcare institutions, provider organizations are also anxious to know what best works. There's a myriad of choices, limited dollars, and to the extent that research can focus on where we can get the most significant improvement for the dollar spent, that will be a very important contribution.

JOHN EISENBERG: When we think about pharmaceuticals and technology we always ask, are they effective? And are they safe? When we think about interventions in the organization of medicine and in the reporting of healthcare events like we're talking about today, we should be asking the same questions: Is it effective? Is it safe? Does it work? We need to ask those same kinds of questions about healthcare safety interventions just as we ask them about drugs and diagnostic testing. Does it work, when does it work, how well does it work?

I think we'll take one final question, and Carol, if you'd like to ask the last question, and then we'll close.

CAROL EISENBERG, NEWSDAY: Carol Eisenberg, Newsday, no relation.

JOHN EISENBERG: No relation. But it is why I called on you.

CAROL EISENBERG: I have a real basic question about your mandate and your budget. First, you're talking about, you're getting this wish-list from all different kinds of constituencies about research. Is there a government budget, or a lot of the people sitting on your panel obviously fund research through their own organizations. What is the budget for this? And also related to many of the questions that have been asked in terms of your mandate, clearly there is a lot of research on many of these things now. We heard how a report in 1975, you know, has been percolating out there for 25 years and people are still ignoring it. What is the enforcement wedge here? Are you going to be making recommendations at some point to mandate some kind of enforcement regulation incentives to make this stuff work?

JOHN EISENBERG: Let me answer from the narrow perspective of the Agency for Healthcare Research and Quality first. And that is that we are an Agency re-authorized last year, renamed the Agency for Healthcare Research and Quality, and made the Federal Government's lead Agency in the area of healthcare quality, with the main focus on developing better research so we can know more about how to measure and how to improve quality. And that is our responsibility. The Senate and the House of Representatives met before they took their break for the conventions, and agreed that the Agency would receive a substantial budget increase, most of which will be focused on the area of patient safety, probably about 50 million dollars in the area of patient safety.

CAROL EISENBERG: 25, ... 50?

JOHN EISENBERG: That was the agreement. It hasn't come out of the Congress, and it hasn't been signed, but that's where their thinking is right now. A lot of that would be focused on demonstrations, showing what works, when it works, and how it can be translated. To answer your question, the Congress understands the need for research that's upstream from there as well, to understand the burden of patient safety problems, and the reasons that these problems occur. The Institute of Medicine recommended a 100 million dollar budget within three years and we think that this is a down payment. It's a good first start in moving in that direction.The Association for American Medical Colleges has called for "billionizing" our Agency, which would get us into a ballpark of funding where we think we could really get at this problem in a very serious way.

For translation. Translating research is a challenge for all researchers, from the NIH, to the Howard Hughes Foundation, to us. Because we want to shorten the time that it takes to get research put into practice. We call that our Translating Research Into Practice agenda, or TRIP.

And that's the reason we want to work with partners. You heard today from many of those who testified that the best way to get the research translated is to get the users involved at the beginning, first so that we answer the questions they care about, and, second, so that when the research is done it's being done in collaboration with those who are going to put it to use at the end. That's our plan.

Now, speaking more broadly, for the QulC, there are other Federal agencies who are involved in research related to patient safety, and there are other foundations, especially those who are here with us today, who are going to be interested in moving along in this area. So, just as is the case in biomedical research where the NIH funds a substantial amount but not all of the biomedical research, we anticipate that AHRQ will fund a substantial amount but not all of the research related to patient safety.

CAROL EISENBERG: So is it accurate to say you are anticipating spending 50 million in the next budget year on patient safety research?

EISENBERG: Well, if the current plan from the Congress is fulfilled, and the budget comes through the way that the conference committee decided, we will have 50 million dollars starting on October 1 to spend in the area of patient safety. But that hasn't passed yet, and it hasn't been signed yet. We're anticipating it, we're planning for it, and we're hoping for it.

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Current as of September 2000

Internet Citation:

Transcript: Media Availability Session. National Summit on Medical Errors and Patient Safety Research. September 11, 2000. Agency for Healthcare Research and Quality, Rockville, MD. http://www.quic.gov/summit/mediatrn1.htm

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