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Copyright 2000 Federal News Service, Inc.  
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February 22, 2000, Tuesday


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 (FNS regrets that this hearing begins in progress due to techincal problems beyond our control.)

MR. THOMAS LEONARD GARTHWAITE : -- in analyzing the root cause of error and of close calls and in design and implementation of approved systems of care. We'll continue to fund our four patient safety centers of inquiry.

These centers currently target their safety research on organizational issues in training, on fall prevention and the development of safer hospital rooms, on human factors engineering including interactions among health care workers and between workers and their machines and on training on safety with an emphasis on the use of simulators for research and competency testing. In addition, each of our quality enhancement research initiatives will add patient safety to their goals and objectives. These research initiatives seek to move health services research to the bedside by targeting the effects of providers and systems on patient outcome.

We'll add staff dedicated to patient safety. We estimate adding 190 full-time equivalent employees to our current composite effort of 294. In addition, we have a goal that half of all full-time staff receive 20 hours of training in patient safety this fiscal year. This represents a commitment of over $39 million and 1.6 million man hours of training.

We will continue to fund the VA scholars program. This unique fellowship in quality and safety is currently available for 10 physicians per year at five VA facilities affiliated with academic institutions. It is designed to promote the academic awareness of safety design issues in medicine.

Underlying our comprehensive program for patient safety are several key principles. We believe that the institution delivering care has a responsibility to assume that individuals will make errors. Those institutions must find the systems that allow the errors to occur and improve the design of those systems.

The new designs might either prevent error or minimize the impact of error. We also believe that those institutions must share their lessons learned. Otherwise, each system is doomed to harm a patient wherein the very lesson previously learned in another institution. All institutions have a responsibility to detect the less common cause of error related to incompetent providers and to take appropriate action.

In VA, we believe that we must first openly inform patients or family about their errors. Secondly, have a system of mandatory but not punitive reporting and analysis of adverse events within a process protected from public disclosure of individual patient practitioners.

Third, have a complimentary, voluntary system of reporting, which in other systems like aviation, has been shown to provide additional important information. Fourth, to analyze those adverse events and close calls for possible systemic fixes and new standards.

Fifth, and critically important to implement new standards rapidly and universally across our health care system. And sixth, to share our important lessons and improvements with other health care institutions in VA and outside.

VA has chosen to use its unique position as a publicly- accountable national health care system to lead in the effort to ensure the safety of patients. We also will use our strength as a major research and educational organization to conduct research on safety and to add human factors and organizational design to the curriculum of clinical administrative students in VA.

It is the opportunity to learn from a single mistake that all health care must embrace. And which underlies the need for events reporting systems. VA has established such systems. We believe that we must share our lessons learned broadly, but also hope to learn from the experience of others. Thank you.

SEN. FRIST: Thank you, Dr. Garthwaite. Dr. Garthwaite I've spent 10 years before coming to the United States Senate working in VA hospital doing heart surgery. One of the things that was interesting to me doing heart surgery in VA hospital, both in Tennessee and on the West Coast, was the protection as an individual from the tort system.

Not protection but separation and it's unique and as we talked about the VA system, then we talk about 5,500 other hospitals who are outside of that system, I think it's at least important for us to address the issue.

First of all, correct me, the VA falls, if I'm wrong, under the federal court system. And individual physicians working for the VA are not sued or cannot be sued for medical errors. Is that correct?

MR. GARTHWAITE: That's correct. As long as they're operating within their job description and their assigned duties.

SEN. FRIST: Very different than outside of the VA system. Could you comment, and again it goes back to what Dr. Eisenberg and in the report is mentioned, this blame-free environment. How important of a role is that different, more protective environment in terms of the willingness to participate in reporting medical errors or mistakes based on your experience and what you've heard?

MR. GARTHWAITE: I'm sure it must play some role. Although, if we do make a payment on the behalf of a provider, we do the responsibility when we determine that their care was substandard of reporting them to the national practitioner data banks. There are some consequences for individual providers who are deemed to have provided a less than standard care.

I think that another distinct difference is that we employ most of our physicians.

Some are on contract, but most of our physicians are employed directly by VA. So, that sets up employer/employee relationship in the sense of a supervisory/supervisee relationship that are relatively unique to the VA.

SEN. FRIST: Does the blame-free environment, do you feel, make people more willing to come forward and report errors?

MR. GARTHWAITE: I think it can and should. Although, I would say that, for instance in our report, is 3,000 errors that Senator Collins alluded to, those were in fact 3,000 adverse events. Many of those were not actual errors, but those were events that were unanticipated that we felt demanded further investigation same as three of deaths associated with those adverse events.

We received a fair amount of encouragement from the press about that. We also received some not so flattering commentary about the number of errors that were occurring in the VA health care system. I only say that because it's not just whether or not there is a tort action that really suppresses people from coming forward.

It's often the shame in the sense that you've done less than you really set out to do and that embarrassment for doing less than you believe you can do. That's very important in keeping people from bringing forward and discussing errors. We did a survey of our staff and in fact, shame significantly outranked fear of punishment as a reason for not sharing medical mistakes.

SEN. FRIST: Good. I think that you're exactly right. That sort of peer pressure is something that can't be understated in medicine. That which means more disclosure can make the system work better. It doesn't have to be just, you know, punishment and taking people into the courtroom. I think that's very important. A lot of people don't understand that.

Dr. Eisenberg, as you know, we work very hard on this committee in the reauthorization of the Agency for Health Care Research and Quality signed into law this past year. And what we attempted to do is refocus the entire agency on quality issues, quality improvement recognizing that we don't have the answers to all of these difficult challenges.

That the pace of science and health care delivery is moving quickly and therefore, you have taken that charge. It' now written into law. And part of that, which we wrote into it, was this reduction of medical error before the IOM report and we granted the agency very broad authority. Funding issues we have to continue to address.

You were very clear in your opening statement or your opening paragraph that you were speaking today, not primarily wearing your hat from the agency itself, ARQ (sp), but I'm going to ask you to put it on and tell us what affect the recommendations will have on your agency.

And specifically, do you believe that we need to create a new center within ARQ to accomplish what has emerged, the IOM recommendations, that recommendations that have been put forward or will be put forward today by the administration? Your ARQ hat.

MR. EISENBERG: You're correct in your comment about the fact that we have been thinking about the issue of errors for some time. In fact the agency funded investigators in Massachusetts looking at the issue of errors as early as the first part of the decade of the preceding decade in the '90s.

And it was much of the work that was funded by the agency that led to an understanding of what the risk is and what the numbers of deaths are. So, this is part of an ongoing project for us. It's also part of our ongoing quality agenda. I think, though, that the Institute of Medicine report has had a very positive effect for all of us who are concerned about the need for more research in health care quality.

Because it's taken an issue, which has been difficult to explain, and it's made it feel more real to people. It's taken a part of the quality challenge to this country and it has made it very clear to Americans that while we have very good health care, we could have better health care. It's also made it clear to them that there's a lot we don't know about how we could have better health care. That we need better research in this area, both to understand the causes and to understand how we can improve care.

I've often thought that if health care quality were a disease and it were listed as the fifth or eighth leading cause of death that people would not hesitate for a moment in calling for a major research agenda. Now that the quality agenda has taken more life through the issue of patient safety, I think that it's easier for us to explain the rationale for a major national agenda in health care research.

SEN. FRIST: What about the new center?

MR. EISENBERG: Secondly, on the center, we applaud the IOM's recommendation and agree with it. We believe that a new center can be created within the agency building on what we have as a center for quality improvement. So that it would expand the scope of that center to become a center for quality improvement in patient safety with a broader scope and broader set of responsibilities,

SEN. FRIST: Thank you. Senator Specter.

SEN. ARLEN SPECTER (R-PA): Thank you very much. Dr. Eisenberg, starting with the good news, there's been a request for $20 million in funding from our subcommittee and I believe Senator Harkin and I will lead the way on providing that funding for you.

I was pleased to hear you say that you agree with the thought that I expressed that there's a professional responsibility to tell the patient when there has been an error made by the hospital. My question involves whether you would agree with me that there ought to be a mandatory requirement as a matter of law?

There's no doubt that a patient has the right to get the information when an error has been made or a full disclosure if a patient seeks to exercise that right in court. Would agree that there ought to be a provision that where there is a patient who has suffered death or acute injury that should be disclosed to the patient or to the estate?

MR. EISENBERG: Well, the quickest take in a position that it is an obligation of the individual clinician and the hospital to tell the individual about that event. We really haven't taken a position on whether that requires a federal law or even state laws for that matter. But we certainly believe that at a minimum it's a professional responsibility.

SEN. SPECTER: Well, I'd ask you to take a look beyond there. It' a mandatory requirement for reporting, in Pennsylvania for example, by hospitals, but there is relatively little -- I note that you have called for the reporting by the states as opposed to the federal government and I believe that's a matter which requires some analysis.

You've also noted that the 6,000 hospitals funded by HCFA would have a mandate which goes pretty far on having a federal responsibility - there's a little more of an inclination to report when it's a federal responsibility, federal mandate perhaps backed up by loss of payments from HCFA, for example.

There's an analogy in the campus reporting where we found that the obligation of universities policies to report crimes on campus was disregarded to a substantial measure and that legislation came through our subcommittee. And we have since added some pretty tough penalties. Do you think that ultimately there will have to be some stick as well as a carrot to get compliance by those who have an obligation to report on a mandatory basis?

MR. EISENBERG: I think that the state systems as they currently exist demonstrate the fact that in their diversity, we don't know enough about how to collect the state and we don't know how to report it at this point. What we need to do is to look at the state systems. We need to work with the states to demonstrate how the process can work best.

If in three years, we find that states have not adopted a mandatory reporting system, then we will have by that time learned which of the state programs work best, how they work best. And the will report back to QUICK (sp) will report back to the administration with recommendations about how to go beyond the current proposal, if that's necessary.

But we're optimistic that with federal help, through for example the quality forum helping to standardize the kinds of measures that ought to be used, that the state systems can work.

SEN. SPECTER: Well, perhaps the demonstration projects Senator Harkin and I have recommended with five institutions on mandatory, confidential and five on mandatory with a statutory obligation to tell the patient, will give us some insights there.

Want to ask you one final question, Dr. Eisenberg before turning to Dr. Garthwaite, if I have sufficient time. The American Hospital Association President, Richard Davidson (sp) is reported in today's "New York Times" saying that they were not going to attend the White House event today because we thought that there was an agreement with the White House in a public/private partnership, but there has been little or no consultation.

Before Senator Harkin and I introduced our legislation, we consulted with many of the national agencies, including the American Hospital Association. And while they did not like the idea of mandatory reporting, they did give some ideas on technology.

When President Clinton proposed this national health plan late in 1993 and we had the very heated debate in 1994, there was considerable concern, really criticism by the private sector of lack of consultation. My question to you is, what do you plan to do, if anything, to try to bring on board groups like the American Hospital Association to try to get cooperation from the private sector, which I think is going to be necessary if there is to be what Mr. Davidson calls a change in the culture in hospitals?

MR. EISENBERG: Well, we look at this process as beginning not ending. And we stated very clearly in the report that we want consultation of the states, of the private sector, including the hospitals, medical community, nursing community as we lay out the implementation of the principles that we have established.

But a careful read of this report, and I'm sure that the hospital community will read it carefully, will demonstrate that these are principles that are established and we don't pretend to know exactly how these programs ought to be implemented. In fact that's the gist of my response to you about the state programs.

We think we have a lot to learn from the states and from the hospitals about how to implement a mandatory reporting system so that it encourages and doesn't discourage the reporting process.

SEN. SPECTER: My red light just went on Dr. Garthwaite, but I have you on the record for our last hearing. Thank you for joining us.

SEN. FRIST: Thank you. Senator Kennedy.

SEN. SPECTER: Thank you very much.

SEN. EDWARD M. KENNEDY (D-MA): Thank you. I just, at the outset, I was listening to my colleague and friend, Senator Frist talk about what's happened in the military. We have what they call the Ferris Doctrine (ph), which is another way of stating what has been reviewed earlier today about the limitations and the ability of service men or women to be able to recover.

That's a long-standing doctrine that I think is worthy of maybe review at some time. I don't know whether we want to get into it today because we've had extensive hearings on the Armed Services Committee over a period of time and I think there's some legitimate questions about that.

The protections that exist now have been basically adopted because we were going to have a war situation, didn't want to have people that are involved in conflict having to think twice about how they're going to be able to treat various service men and women. And we've had a long period of peace now and we find incidents whether consumers are adequately protected or not.

That, I think, is a legitimate issue or question. You also have in the military the kinds of protections for whistleblowers that we don't have out there at the present time, which permit the information to come forward and these service personnel are protected, which is enormously important.

That was something that we also tried to provide in the Patient Bill of Rights that doesn't exist here today. So that is of significant importance. All these things, obviously as I said, the protections for medical personnel have been included, at least it's not included, but it was an attempt to include it in our Patients Bill of Rights. That's an important kind of issue.

Basically in the limited time that we have I want ask on the prescription drug benefit program, one of the aspects of this whole issue is the various kinds of adverse drug reactions that particularly affect our elderly population. We know that the senior citizens are ones that have a heavy utilization of prescription drugs.

I'm very hopeful that we'll get action in this Congress on an extended prescription drug benefit. But we also want to make sure, if we're going to do that, that we're going to give adequate kinds of protection for our seniors so to avoid the kinds of adverse drug reactions that the various studies have revealed.

Could you tell us about how important you think making sure that we provide at least something along the lines of a pharmacy benefit, commission or protection for seniors, how important is that? How important will that be? As there's an increasing reliance upon prescription drugs.

What can you tell us as result of these studies? What are you recommending that we do in order to make sure that we're going to provide protections for seniors and how important is it that we prepare a prescription drug benefit program?

MR. EISENBERG: Well, the issue of patient safety and medications in the elderly is a very critical issue. We know that as many as 7,000 of the people who die every year from errors die because of drug errors. We think that about one out of every 10 hospitalizations occur because of a drug-related issue, a prescription drug-related issue.

And we have three ways in which we think we ought to approach this issue. The first one does relate to your point about a drug benefit which is that when drug benefits are offered they're often managed by organizations like a pharmaceutical benefits manager. And if that's the way a drug benefit is organized that would provide us with an opportunity to have a safety program embedded it the prescription and dispensing process.

We understand from pharmaceutical benefit managers that they do have programs in place to enhance patient safety, to provide utilization review to the clinicians and education to them as well. But in addition to that, we think that the FDA plays a key role in its reporting systems to enhance it's reporting systems, to develop standards so that drug packaging and labeling and the naming of drugs is safer.

And then third, we believe that it's very important to understand what the risks are of adverse events and the Centers for Education and Research and Therapeutics at ARQ will provide us a mechanism of enhancing that knowledge. So, we believe that to your question that it has to be a multifold way of addressing it and a drug benefit would give us an opportunity to address it head on.

SEN. KENNEDY: Dr. Garthwaite, any - -

MR. GARTHWAITE: I'd just add that often we think of errors as errors of commission, that errors of omission are important in terms of patients overall quality of care. The use of Beta blockers and aspirin after a heart attack has significant effect on preventing hospitalization and extending life.

Some private sector studies suggest that happens as increasingly as 21 percent of the time. We've been able through a use of systems of reminders and education of our providers to get the VA rate up into the 90 percent of administration of Beta blockers and aspirin. So, the availability of drugs can be critical.

MR. KENNEDY: You've mentioned, Dr. Eisenberg, the importance of educating patients so they make informed decisions.

Will the Office of Personnel Management rate health plans and institutions participating in the federal employees health benefit program and how well they perform on medical error reduction and patient safety standards, make that information available to participants?

We have about 10 to 11 million people that are involved in that program at the present time. I'm interested in whether you've thought about that or what suggestions you have.

MR. EISENBERG: We have thought about it. The Office of Personnel Management intends to have a requirement that plans describe the systems that they have in place and that that be made available to individuals in the book that describes the plans as federal employees choose those plans.

The OPM does not have a plan right now to rank or rate programs, but rather to abort the degree to which they exist. In addition to that OPM uses the consumer assessment of health plan survey that was developed by ARQ to educate federal employees about the satisfaction of other federal employees and people who use health plans. And we believe that patient safety and satisfaction with patient safety experiences of patient safety could be embedded in that as well.

SEN. KENNEDY: Thank you, Mr. Chairman.

SEN. FRIST: Senator Harkin.

SEN. TOM HARKIN (D-IA): Thank you, Mr. Chairman. I just wanted to pose this upon two areas, I think. Your plan, Dr. Eisenberg, your plan sets up 100 demonstration projects where reporting will be mandatory for those institutions that volunteer to participate in those demonstrations, but you don't require other hospitals to do the same.

I'm just wondering given the authority that HCFA has to determine which providers can participate in Medicare why don't you go further? I mean, why are not going and you've got a big stick there with HCFA, why don't you go further?

MR. EISENBERG: Well, HCFA has proposed several initiatives with one guiding principle, which is that it needs experience. It wants to get that experience as quickly as possible about how these systems work, when they work the best and how to design a system that might go beyond the first demonstration project.

So, the program to which you are referring is a program that would be a demonstration with a peer review organization. It would have mandatory reporting, but it would be confidential and 100 hospitals would participate in it. We believe that very soon after the institution of a program like that we would know more about how a broader system, such as you describe, should be instituted so that it has more affect.

SEN. HARKIN: Why aren't you taking the approach that Senator Specter and I have in our bill looking at different types of systems rather than just the one system that you promote out there that you're doing?

MR. EISENBERG: I think we'd be more than happy to sit down and talk with you about expanding beyond the program that the Health Care Financing Administration has proposed at this point to explore whether more would be appropriate.

SEN. HARKIN: OK. Secondly, we included in our bill a provision for demonstrations on best practices and I don't see that in your proposal. I mean, there's a lot of information out there. I mean some places are doing really good work.

I don't have all the information at my fingertips right now, but I have been informed of some unique approaches at the Latter Day Saints Hospital in Salt Lake City? Salt Lake City and they're supposed to be faxing me a bunch of information. I guess they really have moved way ahead in this area and again to include demonstrations on best practices.

MR. EISENBERG: That' s a critical issue for us. In fact in the proposal that we have before your committee, there is $11 million requested for the Agency for Health Care Research Quality to study whether the best practices really are best, how they compare to their alternatives. So that we can prove that they're best rather than just assert that they are best.

That 11 million will enable us to fund research like the research at LDS Hospital, which in fact our agency had funded earlier demonstrating that programs can work. LDS tells us that eight other hospitals are now coming to them asking them for advice and we're proud of that because we funded the initial research. And that shows that research can be translated into practice.

So, it is a large part of what we see as the research agenda in this area and we have requested 11 million for what we call the translating research into practice part of the safety agenda. In addition to that, we'll have evaluations of programs such as those that the VA and the Defense Department are instituting.

SEN. HARKIN: So, you requested $11 million. Run that by me again, what are you going to do with that money?

MR. EISENBERG: The total request for the agency's patient safety initiative is 20 million. Of that, five million would be sent in new knowledge in this area, four million would be spent in developing new tools to implement that new knowledge and 11 million would be spent in the area that you're describing, which is evaluating best practices. And getting those best practices translated and disseminated and into the field to see how we can get them disseminated as quickly as possible. We think that the 11 million is a good down payment on the suggestion that the Institute of Medicine has made.

SEN. HARKIN: Thank you very much, sir.

SEN. FRIST: Thank you. While we're looking talking about the money could you just answer one question for me. Twenty million dollars you walked through. I think that's very important. The IOM specifically said $35 million. What did they recommend that you're not doing? The IOM report that came out said $35 million for three years, isn't that correct?

MR. EISENBERG: That's right.

SEN. FRIST: And the president has recommended $20 million and you just walked through it with Senator Harkin. What's the difference? Should we be doing more? What are we leaving out?

MR. EISENBERG: Well, the Institute of Medicine's recommendation was for 35 million in the first year and a hundred million dollars within five years in this area. We currently are spending about $4 in this area. So, the total is about 24 million, not the 35 million that the Institute of Medicine had recommended.

I don't think that there's a major area that the IOM suggested that we work on, whether it's understanding root causes or developing measures or evaluating outcomes and effectiveness of these programs that we're not doing. It's an issue of the magnitude of the investment and the degree to which we can address those issues.

SEN. FRIST: I think that's something that Senator Specter and we need to come back to because if it's as big, and as Senator Harkin says, there are more things we need to be doing, we need to do it. Senator Collins.

SEN. SUSAN M. COLLINS (R-ME): Thank you, Mr. Chairman. Dr. Eisenberg, the emphasis in both the Institute of Medicine report and your recommendations is on patient safety and reducing medical errors in the hospital setting.

And yet a great deal of health care is now being delivered outside of hospitals, whether in ambulatory care clinics or physicians offices. Have you taken a look at whether there are similar problems in those settings? And it seems to me we have every reason to believe that there are and has there been any attempt to address medical errors outside of the hospital setting?

MR. EISENBERG: There hasn't been enough. We think, as you do, that there are a number of adverse events which are preventable which occur outside of hospitals. And because of that we think that we ought to take several steps. One of them is to start with hospitals because we know that we have ways in which we can institute improvement programs there.

The VA and DOD have shown us that.

Secondly, we know that many hospitals are parts of broader systems and throughout our report, we describe a way of addressing this challenge not just from hospitals but systems of care. So that we can look at the system no matter where the patient is, whether the patient's vertical or horizontal, walking or in the hospital, we can address this issue.

And third, we make a major emphasis on the importance of information systems because, whether a patient's in the hospital or out of the hospital, we need to have data on what's happening with that patient. And our information systems in the health care industry lag far behind the information systems that are available in many other industries like aviation or banking even where more data's available and more is known.

If we could have better information systems then I think that I would be able to give you a more satisfying answer to your question because we'd know more about what's happening in the outpatient setting. I think Senator Kennedy's question gets to that as well with regard to outpatient use of drugs.

SEN. COLLINS: A second question that I have for you, Dr. Eisenberg concerns the desperate burden on small hospitals versus large hospitals of some of the new requirements that we're talking about. My state is typical of many. We have the 600 bed main medical center in Bourbon Port (sp) and then our smallest hospital's a 14 bed hospital, the Charles Adeen (sp) Hospital, in Greenville, in rural Greenville.

And obviously we want to have quality patient care no matter where it is delivered, but those hospitals, that tiny hospital versus that very large, by main standards, hospital face very different challenges. As we look at this issue and how best to address it, is there a way to take into account the sizes of hospitals, the burden of certain reporting requirements so that particularly rural hospitals that are fragile financially already aren't pushed over the brink?

MR. EISENBERG: There is and we've thought about that very seriously because we agree with you that it's an important issue. And there's several ways of addressing it. One of them is for us to emphasize how we're only asking that the reporting that is mandatory and publicly disclosed reporting be on those events which are preventable, very serious events and avoidable death.

One of our concerns is that in small hospitals, like the ones you describe, the number of those events will be small and the number of events that are occurring that are not quite as serious will still be small. Any single event that should never happen, should never happen no matter how big or how small the hospital.

But if we're looking at events that might be related to more serious events like a missed prescription that might be caught. What Dr. Garthwaite was calling a close call. We're concerned that if we were to require mandatory reporting on those that the reporting burden could be substantial.

Therefore, we think that what we're proposing is doable, feasible in the short term. And second, we believe that for hospitals like that we need to put programs together, for example, with the quality forum that will help them to understand what the measures are that they ought to be measuring so that they have to reinvent the wheel in every single hospital.

SEN. COLLINS: Thank you. Dr. Garthwaite, I've been concerned for some time, and I know you're well aware of this, about the cutbacks at the VA hospitals across the country but particularly in the Northeast and particularly at Togos (sp) in Maine.

And I've been concerned that the cutbacks are going to reduce veteran's access to care. But they also threaten to jeopardize the quality of care. When you have a situation as we do in Maine where there's currently no oncologists, when the physicians complain repeatedly to us about the pressures to ever greater numbers of patients and ever shorter amounts of time. When there are large waiting times for treatment, it paints a picture that raises serious questions in mind whether we're creating the kind of environment that is conducive to medical errors.

Aren't the kinds of staff reductions and cutbacks that we're seeing at Togos and at other hospitals likely to increase rather than reduce the kinds of medical errors that you're working so valiantly to try to reduce at VA hospitals?

MR. GARTHWAITE: Well, I certainly hope not. We are attempting to reduce nondirect care providers in most of the areas where we find our expenses exceed other areas of the country in terms of how much it costs to give a certain unit of care. But I think your point is a valid one both in the VA and in the health care sector in general, and that is as there are increasingly intense pressures to decrease the cost of health care that that can lead to staffing issues.

One of our patient safety centers of inquiry will look specifically at staffing mixes and staffing ratios and others and whether or not the number of staff and how busy they are has contributed as a root cause to any of the adverse events that we uncover. So, I think it's a very valid point. I think it's not just a VA issue, it's a general issue and we think it's a very important one to examine.

SEN. COLLINS: Thank you, Mr. Chairman.

SEN. FRIST: Thank you. Senator Reed.

SEN. JACK REED (D-RI): Thank you very much, Mr. Chairman. Dr. Eisenberg, in your testimony, you've indicated that, and this -- (inaudible) -- will begin to test strategies to improve patient safety in high hazard areas. Are you aware of their already ongoing work between the Department of the Army and hospitals and med teams?

I'm aware that a lot of the research is around the hospital. That they are essentially taking the technique the Army has used to develop training for aviation crews and applying them to emergency rooms, seems to be working well. Could you comment specifically about the med teams and more in general about the adaptation of some of this crew training that the military is particularly adept at and the application to medicine?

And just one other point, it seems to me that, something Senator Harkin said, that this seems to be more of a systemic problem. But in many respects it might be more like a group crew training problem because medicine is today, despite the skill and the individual training of physicians and nurses, the breakdown might come about so that that way they can't work together as a cooperative crew or team. So, please comment on it.

MR. EISENBERG: The QUICK (ph) has provided us a wonderful opportunity for federal agencies to learn from one another and the example that you give is a terrific example of just that. We've learned from the Defense Department about how it's learning from systems that have been put into place for other purposes, how they can be applied to systems in the health care system.

And as opposed to having individual independent that a well organized, systematic approach that's goal oriented can help us to address those issues. In fact, the Defense Department has the lead in helping us to develop this what's called a breakthrough series in reducing errors in high hazard environments.

We're going to be doing that with the Institute for Health Care Improvement in Boston. And it'll be a number of federal agencies, the VA, the DOD, the public health care agencies, will all be participating in this. It's a way we can learn from the Defense Department experience in the area that you describe.

SEN. REED: And just to elaborate a bit, is it your sense that this notion of crew training might be a critical way to handle some of the problems that in fact our physicians are without doubt the best trained in the world as our technicians, our nurses, et cetera and I guess it makes the question is, are some of these errors the result of poor teamwork rather than the lack of individual skill?

MR. EISENBERG: Many of them are the result of poor teamwork and poor systems that undergird the team. In the best American hospital, both of those have been addressed. We have teams who are working together in a very well organized way. In fact team care and share decision-making are themes in the patient safety area in hospitals around this country.

But even that isn't enough if they don't have the underpinning of an information system to help them communicate with each other and to help them understand what the data is about their patients.

SEN. REED: Dr. Garthwaite, do you have a comment?

MR. GARTHWAITE: I would just say that we have a simulator for an operating at the Palo Alto VA affiliated with the university. And when they bring a team in and put them through and emergency and then they tape record it from every angle, all the communication and then play it back to get exactly what you suggested, in that people don't realize how imprecise the communication is and what they're actions are like when they're taken out of that situation.

They get to watch and critique themselves. So, it's that whole factor of analysis, that factor of human analysis is going to be critical in solving some of these issues.

SEN. REED: Dr. Eisenberg, I presume that your plans are to take this already existing knowledge and technique, the simulation and rapidly deploy it into hospitals. Is that at the core of what you're doing or should it be?

MR. EISENBERG: Well, you've heard Dr. Garthwaite describe the VA's intentions. Federal agencies do operate some hospitals. They are ones that we talked about today, the VA and DOD, also the Coast Guard, the Bureau of Prisons, Indian Health Service, all of whom are participating in this program.

In those institutions where we provide care, we intend to implement these programs as quickly as we can. But we want to do what we can to stimulate and help the private sector.

SEN. REED: Your testimony also suggests that OPM, for example, we kind of urge all 300 health plans in the federal employees health benefits to include error reduction and patient safety. I mean, urging, suggesting, persuading, at what point do you recommend that they do things like put all their surgeons through teams and surgical teams through this kind of crew training?

MR. EISENBERG: Well, the Office of Personnel Management, at this point, believes that the information available to federal employees and letting federal employees make decisions about the choice of plans or hospitals and whether or not they have patient safety programs in place, that will be a very forceful incentive for those plans and those hospitals to put those programs into place. Now, we will evaluate that and if it doesn't work, we may come back to you and say, it didn't work we need something else. But at this point we believe that that's the right first step.

SEN. REED: It just seems to me that, reflecting back on the number of hospitals in my state, there are only a few, I suspect they will put down in their brochure that they have these techniques. If they do, the question is, are they up to speed? And it's hard for a lay person, I think, to make a critical distinction along those lines but at least it's first step.

Let me just ask Dr. Garthwaite, you've already done some work in VIS (sp) aid VIS-22 (sp) about close-call reporting. I feel particularly moved to ask this question today as the pilot in my plane this morning came back with a flashlight to make sure that the landing gear was down. And as he walked back to the front of the plane I said, I wonder if they're reporting that close call. But can you comment on this close-call event reporting? (Laughter.)

MR. GARTHWAITE: We learned from our initial forays into adverse event reporting that it wasn't just sending out a policy and hoping that people read it and understood what it really meant or that our caregivers had any intrinsic knowledge about how to do a root cause analysis.

So, rolling out the new system, we have done extensive education and targeted two pilot health care networks, one in Florida and one in Southern California. I think that's what you're referring to. The one in Florida's been up for about three months and we have very good feedback.

In fact other networks have asked to move up their dates of implementation somewhat because this seems to work much better than the older system. The key, I think, is the total education, the immersion and the computer aided analysis system that walks people through what a true root cause analysis is. And we hope to learn even more as we implement this, that we believe that's going to make a major difference.

SEN. REED: My time is up. Just quick, they are in fact reporting close calls?

MR. GARTHWAITE: We think we should hear about errors and close calls both in our mandatory and in our voluntary systems. We think that we'd rather have to much information and err on that side at the present time until we begin to understand.

It really takes knowing about an error to learn from it. You don't have to learn the same lesson six times or 12 times. It's not how frequently you learn it. You got to find it, design a fix and then implement that systematically.

SEN. REED: Thank you, Doctor. Thank you, Mr. Chairman.

SEN. FRIST: Thank you, Senator Reed. Senator Hutchinson.

SEN. TIM HUTCHINSON (R-AR): Thank you, Mr. Chairman. I'd like to pursue the voluntary versus the mandatory a little bit.

Dr. Eisenberg, my understanding was that the administration had supported voluntary reporting requirements and that now the plan calls for mandatory, at least in the case of death and serious injury. Am I correct that there has been a switch in thinking in the administration?

MR. EISENBERG: No, that's not correct. We did support a voluntary program, we still do but had not taken a position prematurely nor announced this position prematurely on whether we were supporting and how we were going to support mandatory programs.

And so what you might have read is that at the time, we were not prepared to announce what our findings were going to be because we thought that we ought to come to you and announce them here. So that was not accurate.

SEN. HUTCHINSON: From your statement today and the -- approach where there would mandatory and voluntary and you indicated a willingness to negotiate that and discuss that so that seems to me to be somewhat of retreat of a blanket commitment to a mandatory system. Did I miss understand something there or could you expand on that?

MR. EISENBERG: Well, we think that a mandatory system is necessary. We think though that the whole spectrum of reporting activities should be undertaken and that we should evaluate how they work best. And even within mandatory systems, we believe that there should be confidential systems of confidential systems of mandatory reporting and mandatory systems that should be disclosed.

We haven't retreated from anything. In fact, our position on mandatory systems that are to be disclosed is that there ought to be a nationwide state-based system of mandatory and disclosed reporting on major events that are either - -

SEN. HUTCHINSON: Wouldn't that preclude Senator Harkins - where you would have. I mean it's obvious that you're doing voluntary, it's not mandatory because you're doing both.

MR. EISENBERG: As I understand that proposal, and I should say that the administration has not had a chance to review it or take a position on it. But as I understand it, they propose to go beyond the cautious approach of having mandatory reporting of major life ending events or life threatening events to look at what more we can do than that and to evaluate those in short order. We agree with that, that we need to evaluate more than just the mandatory reporting of major events.

SEN. HUTCHINSON: Okay. The "New York Times" story today that was referred to by Senator Specter earlier sets the precedence and issue at least of some important questions unanswered.

Among those what is the federal role as opposed to a reporting system and will the states get additional money to catalogue, analyze reports to those?

When you were talking about the 20million, we're putting a new mandate upon the states regarding reporting and their role in that. Will there be any incentive or any assistance for the states in this new obligation?

MR. EISENBERG: There will. The 20 million that we were describing was for the research part of this, not for the implementation part. We do think it's very important though that we assist the states in implementing these programs through, first asking the quality forums to come up with a core set of measures so that there's some standardization and the states don't have to all struggle to find out what a good set of measures ought to be.

We also want to help the states to evaluate what those programs are, bring the states together in the convening role with the federal government, help them to learn from each other. And once we know what works best then we can help the states to move forward and to implement those programs that are most effective.

SEN. HUTCHINSON: You mean move forward in the sense of assisting them with funding at some point?

MR. EISENBERG: Well, we haven't taken a position on that because we don't know what the best system would be. But I trust that when we do know that then we'll come back to work with the Congress to evaluate how much it would cost to implement a program like that and whether it should be funded federally or not.

SEN. HUTCHINSON: In that same "New York Times" article, Dr. Anthony Dickey (sp), former president of the AMA, is quoted as saying they're opposed to mandatory reporting and that it may very well drive underground the information needed to improve safety.

A number of states have mandatory reporting. There's no evidence that they have greater safety or fewer errors. Would you respond to that concern that so that it may drive that information underground and that the states that have mandatory reporting that there is no evidence that you have few errors?

MR. EISENBERG: I would. Well, first we don't think that having mandatory reporting of events that the doctors and the hospitals should disclose to the patients anyway is going to drive anything underground because they should have reported it to the patient in the first place. So, none of this should have been secret.

The kinds of events we're describing are the events of deaths that were avoidable or a major event that caused the patient a lifetime or a long-term problem. And as we've already discussed that ought to be disclosed so we're just talking about reporting those events which already have been disclosed.

Secondly, in response to your question, do we know if these programs work or not? No, we don't and we don't know well they work or when they work best. So that the comment that is quoted is on target. We need to know a lot more about these programs. And there's no way we're going to learn more about them unless we have them and we can evaluate them very carefully.

The final thing I want to say is that the American Medical Association, I think, should take great pride in the fact that it has taken a very professional approach to this issue of patient safety, raised the issue. And recognized the responsibility of the profession for doing just what the VA and DOD have been doing and translating that to the nation as a whole to learn from errors as well as to make them available to the public.

SEN. HUTCHINSON: I would have thought though that in the states that have had mandatory reporting requirements that there would be some indicators, some evidence that in fact we had a better track record there as far as the serious adverse events than in states that don't have that. You're saying that there's been no analysis, there's no evidence.

MR. EISENBERG: Not that there's been no analysis, it's been there's very little. Our agency, as you know, is a small agency and our research budget is likewise small. But we have funded a few projects, one of which looked at the New York system. And demonstrated then in New York that with mandatory reporting of cardiovascular death that there was a reduction subsequent to that in death from cardiovascular surgery.

In Pennsylvania, what we found is that the reporting system existed but that it wasn't disseminated widely to the public and the public by an large didn't know about it. So, those two research projects that we sponsored tell us that programs can work, but that they, if you extrapolate from that research, they don't work if you don't do anything with the information. It's that kind of research that we think we need to sponsor to look at other states programs to find out how they can work best.

SEN. HUTCHINSON: Thank you, Mr. Chairman.

SEN. FRIST: Thank you. Senator Dodd.

SEN. CHRISTOPHER J. DODD (D-CT): Well, thank you. Thank you very much, Mr. Chairman. This is very interesting and I appreciate again the opportunity to listen to these witnesses and our colleagues. And I think you made the point that our earlier statements and opening statements be included in the record and I ask that be done.

SEN. FRIST: Without objection.

SEN. DODD: Let me jump ahead. We have the next panel coming up and it's on the issue of whether or not someone suggesting that in fact there's not much need for a Patients Bill of Rights, that in fact if we could deal with the issue of proper reporting of medical errors that that would in effect suffice in some way. That a misguided effort in Congress.

And I disagree with that, but I'd like you, Dr. Eisenberg to comment on this. You might not have the chance when you leave that microphone and there is a distinction in my view between a physician committing an inadvertent error that causes serious injury or death. And a deliberate decision by a health care provider from providing health care coverage. That's how I see it as a fundamental distinction.

I think both issues are very important. I don't see how one necessarily supplants the other and I wonder if you might just take a minute and comment on coming witnesse's position on that issue.

DR. EISENBERG: Well, I can't comment on his position because I haven't heard it, but I will comment on your statement. I think it's so important for us to recognize that to get high-quality care delivered to Americans that they need to have health care insurance. And the administration has taken very strong position, as has the Congress, to improve the access to insurance.

We also believe that once you have insurance, you need to have access to care and that's what the Patients Bill of Rights is all about, to be sure that just because you have insurance you may not have access to necessary care and we want to be sure that that happens.

But even if we have a Patients Bill of Rights and even if people have access to care, what we're talking about today is what happens when people do have access to care and to be sure that they have access to high quality care.

So, the way we look at it is, in a sense, like three legs of a stool. In order for us to have high-quality care, we've got to have insurance so that people are covered. We've got to have access to the necessary services and once you get access to those services, they have to be safe services, error-free services and high-quality services. So, they are separate issues. They're separate parts of the same story of trying to get high-quality care to the American public.

SEN. DODD: One doesn't replace the other here?

MR. EISENBERG: No, they're all necessary.

SEN. DODD: Doctor. I see you nodding your head, but you want to add any comment to that?

MR. GARTHWAITE: No, I would agree.

We try to set the same kind of system in VA. It's very important that decisions about what is a covered service are made openly and publicly and are adequately disclosed to the patient.

SEN. DODD: Let me come back, and I just left, I think Senator Hutchinson was raising some good questions on this mandatory/voluntary. And I apologize if one of the last people to ask you a question here if it was somewhat uncertain in terms of what we mean by mandatory reporting.

First of all, let me just ask you, and I realize this is a work in progress, to describe it, but to get some clarity on this if we could, mandatory for whom? Mandatory for hospitals, for doctors, for pharmacists, who does that cover? When you use the word mandatory what's the universe you're talking about here?

MR. EISENBERG: Well, first the universe is defined by what it is that needs to be reported in a mandatory way. And it's a system responsibility to assure that those reports are being made. We believe, as was the implication of the question earlier, that this is a team issue.

That it's not the responsibility of any one group or any one clinician, but it's the responsibility of the system to be sure that mechanisms are in place to be sure that these reports occur and that people feel safe in doing that reporting.

Some of the reporting will be confidential. Some of the mandatory reporting will be confidential, but the definition of who does the reporting is really driven by what it is that they're reporting about if it's surgery or if it's a drug or some other part of health care.

SEN. DODD: But the question of confidentiality, I think there's an implication in the minds of some people, maybe more on this side of the table than the health care profession, that if you say mandatory that the question of confidentiality.

Once something is mandatorily required there's an assumption, and I don't think without any justification, that once it has to be reported, how much assurance do you have that that information's going to be held in confidence? Once there's a larger universe that has that information, to what degree is a sense that I'm not going to be subjected to unwarranted lawsuits, a concern that many have?

MR. EISENBERG: Right. That is a critical part of this proposal, that the confidentiality be serious, that there be peer review protections extended to those who are organizing and holding these databases of errors or breaches of patient safety and that we not fear discovery of those secondary databases.

They shouldn't be discoverable. We don't want those databases to be available to people who just want to go on a fishing expedition to find examples of errors. The charts are available and they will always be available, I hope, to anybody who has the right to look at them.

But we don't think these secondary databases where we're collecting the errors that have occurred should be disclosed. There should be peer review protections of those.

SEN. DODD: Any penalties that you're recommending for disclosure, unwarranted disclosure of information?

MR. EISENBERG: We haven't been so specific as to recommend what the penalties are and we recognize that that's an area in which we're going to need to work very closely with you in the Congress to develop a mechanism for implementing those peer review protections.

SEN. DODD: Because the other side of that is, and again I realize it's an unanswered question a bit, but that if there is a pattern, I mean if it's an inadvertent mistake it's one thing, if it becomes a pattern that shows up do you then decide that holding information confidential then places patients at significant risk by protecting information to otherwise be in the public domain for the patients and their families to make intelligent decisions about who provides care.

MR. EISENBERG: We believe that if the events are serious enough that they need to be disclosed, as the ones that you've described would be, that they ought to be disclosed to the public. But that mostly these events are avoidable events that sometimes will lead to an adverse event.

But that not all adverse events, of course, occur from an error. Some of them occur despite the best medical care that could have been provided. Because of that we want to emphasize the aspect of learning from errors, whether it's a mandatory or a voluntary system.

And we do think that we need to count on the medical profession, its accrediting organizations and professional societies to do just what you said, which is to act on that information. But we do think that some of that information needs to be held confidential so that the reporting is full and complete.

SEN. DODD: My time is up. Mr. Chairman, could I ask just one other question? I wanted to get Dr. Garthwaite. This bar coding that you do at the VA that's a best practice method. I just wondered how expensive is that could do? Could an individual hospital bar code? Is there enough technology available today that you could do it at a relatively low cost?

MR. GARTHWAITE: Yeah, I believe there is. It's never completely free. We have 170 medical centers, 173 and implemented in all of those the actual hardware is probably $25 million. But it will save money too in the fact that a lot of extended hospitalizations are by giving the wrong dose or the mistiming of medication or so forth where a lot of hospitalizations are the result of adverse administration.

So, we think there are some savings to be gained. There is significant expense to training, but I think overall it's such a common error and the effects in our pilot study were so dramatic in reducing the number of errors that it's worthwhile. And I assume the price will come down as it does in everything else in electronics.

SEN. DODD: Okay, I over extended my time.

SEN. FRIST: Thank you very much. I know we need to move to the second panel. Let me just say Dr. Eisenberg, I appreciate your three- legged stool approach to quality and I think it is very important because in each of the medical errors hearing that we've had, we've had Patient Bill of Rights come up.

And then we have, should you separate the two or not separate the two and the real answer is you need to look at all these issues together. I do think it's important, really for my colleagues as much as others, to understand that that approach to quality of medicine was very much a part of the Patients Bill of Rights bill that was marked up by this committee, that was taken to the Senate floor, that passed the United States Senate, that is currently being talked about as Patient Bill of Rights in our conference.

I say that because the authorization for ARQ, the emphasis on quality, the only legislation last year to pass on medical errors, which is part of ARQ, started in this committee, was debated. And when we look at the bills that were on the Senate floor last year for Patient Bill of Rights, medical errors was part of the Senate-passed bill and was not a part of the other bills debated on the floor and was not a part of the Patients Bill of Rights in the House.

I say that because a lot of people don't know it. Ultimately, we ended up pointing that out, passing it at the end of last session so that we could keep moving ahead. And I think as demonstrated today, your leadership in ARQ addresses this larger picture of quality where you actually have a Patients Bill of Rights, we have insurance, we have access.

But we got to address people who get into the system and minimize the errors that are there. Let me just ask one thing that I think will clarify things for me and then we'll move to the second panel. I'm a heart transplant surgeon, Nashville, Tennessee. I get patients coming in from all around Tennessee in a field that's pretty new, transplantation.

We're using drugs that people who go through medical school now are trained to use, but most physicians are not accustomed to using cyclosporine and they certainly don't know, it's a fairly new drug, 15, 20 years old now, they certainly don't know the interactions with other drugs.

So, I transplant a patient, send them back to a small town in Tennessee where they go back to work, live a normal life but they're on seven, eight, nine, 10 different medicines.

The family practitioner in that area sees a sore throat, starts erythromycin, doesn't realize the cyclosporine and erythromycin interact and all of the sudden the erythromycin drives cyclosporine levels up, kidneys shut down, adverse reaction, possible death, hospital.

Eleven bed hospital there so it's in the county, typical small rural hospital, 11 beds like Senator Collins said. How would the system under the recommendations that are being made today by the president and conceptually based on your discussions, how does the system work?

Is it reported through hospitals? Who does the reporting? Does the 11-bed hospital there, are they responsible for collecting that data? And then you have the emphasis on states, who do they report it to? Do they report it to the Department of Public Health in Tennessee, which doesn't have the organization or the administration or the focus now?

And then once it gets to the state with this mandatory reporting does it come to ARQ, does it come to you? Where basically we're talking about funding. Or does it go to the FDA or the NIH? Where does this data eventually go?

DR. EISENBERG: Well first, that example that you gave is certainly an avoidable error, one that should not have occurred. The first question is would that have been defined by the quality forum as one of those select examples of a reportable event that ought to be reported to the state? Every state may want to choose the events that it decides are reportable, but we're going to ask the quality forum to help the states to look at those where there's an evidence base to them.

SEN. FRIST: And that has not been defined. We don't have that definition out there right now, do we?

DR. EISENBERG: That's right and if you look through the Institute of Medicine report, they describe every state's definition and they're all different. The quality forum will be a special place for this to happen, I think, because it brings together the hospital, the physicians, the purchasers, consumers, providers all together to decide what the appropriate list out to be.

So, that would be the first question. The second would be if the report would occur through the hospital, as we see this system developing. As I mentioned earlier perhaps when we see how well that system works and how it can work best that could be expanded to systems of care. But right now we think it ought to start with hospitals. Third, to whom? The report would go to - -

SEN. FRIST: Even if the patient's no hospitalized?

DR. EISENBERG: If the patient's not hospitalized, the way that the reporting system would currently take place, I don't think that that would be picked up. Now - -

SEN. FRIST: Okay. Just keep going.

DR. EISENBERG: Okay. I don't think any of us see that as where we'd like to end, but it's at least where we're starting. Where would it go? Well, in each of the states there's a different mechanism for who collects the data in the state. And so each of the states would decide that independently.

What would happen to the data after that? Well, I should say in addition to this reporting that we're describing, you'll hear, I think later from the JCHO, about a different kind of reporting system which that hospital might want to report to that wouldn't just go through the state but would be through the accrediting organizations and Dr. O'Leary can comment on that.

And then finally what would happen to the state data, you asked. We believe that we ought to have a mechanism for pooling the data nationally so that we can help the states to compare their experience with other states, but it ought to be deidentified. It ought not to have the name of the individual patient or the name of the individual clinician.

And when it comes to the national data set, in fact the hospitals ought to be coded so that they're relatively deidentified too, but the state would be able to break that code and find out how the hospitals are doing. We believe that could be done at ARQ in our research role to help the states to analyze that information but without any regulatory responsibility for doing so.

SEN. FRIST: I know we got to go to the next panel, but that really helps me walking through it because there are so many different points at the very local level all the way up. Just the last one with ARQ and you said it in the last sentence, but I want my colleagues to be aware. Conceptually, I don't think we want ARQ to be in the regulatory business at least right now.

And I don't know, we can have that discussion, but in terms of the authorization and as the data bubbles up through the system, if ARQ is the place - and you made it very clear what you said is basically the research and the gathering, if this is the system we decide upon where is the focus repository?

And we need to be thinking, at least five years out or 10 years out where we want it to be and then is it going to be mainly a research institution or is going to be a regulatory or both. If so, we need to go back and - -

MR. EISENBERG: That's a critical issue. In the aviation area, the decision was made to split out the regulation from the research role and that information goes to the research group not to the regulatory group, who then inform the regulators about where the problems may be but it's a separated process.

SEN. FRIST: Thank you. I know we need to move to the second panel.

SEN. DODD: You raised the issue of it and I appreciate you going through this step by step as well. And we're losing 100,000 people a year and those numbers I don't know what direction they're heading in, whether or not that's static or continuing to go up each year.

But that's not an insignificant problem we're dealing with here. And I 'm not interesting in watching yet another agency of the federal government become a regulatory agency. I'd like to leave as much at the states as possible, but I'm sitting here wondering. I can see a patchwork developing here that could be so uneven in terms of what degree of confidence that people would have about whether or not they're going to be in good hands and starting to make decisions.

And people today with the mobility of medical technology where people go different places because it's noted in Tennessee there's a better heart surgeon. In Philadelphia, there may be a better brain surgeon and so you move around a lot.

And now if you got add to that, if you got to concern yourself whether or not each state is going to have a better record keeping so I can make a good decision on whether or not my brother, my sister, myself are going to be in good hands. I get uneasy about that approach. I understand the rationale for it.

SEN. SPECTER: Senator Dodd, if you're going to talk about Philadelphia, you're going to have to talk at greater length. We have an obligation - -

SEN. DODD: Just a last point.

SEN. SPECTER: Let me make one statement here. -- the White House at 12:10. We've got four more witnesses and questions.

SEN. DODD: I understand that. You're not going to answer it here today, but I think the point that Senator Frist is raising, I'd be very interested in some cost analysis on what this is going to cost states because ultimately I can see the issue coming back to us in terms of what sort of dollars we're going to provide states.

I presume you don't have the answer to that today. Senator Hutchinson raised it, Senator Frist did implicitly. I'd like to know what you're anticipating in terms of cost of this, if the states are going to do it.

SEN. FRIST: Okay. Thank you both very much, appreciate it. We will have the second panel come forward. Senator Specter, why don't you begin with the introductions? We'll go through all four introductions.

We'll move straight in. We'll ask everybody to try to keep their testimony to five minutes, summarize. It'll be made a part of the record and then we'll continue with questioning recognizing that people do need to get to the White House.

Senator Specter.

SEN. SPECTER: Our first witness will be Dr. Steven Udvarhelyi, Senior Vice President and chief medical officer for Independent Blue Cross and its affiliated companies, Keystone Health Plan East and AmeriHealth (sp) in Philadelphia. He has extensive experience in the managed health care industry.

And serves on several panels concerned about quality in health care. His MD is from John Hopkins and his BA from Harvard. In the interest of time, I'm going to go ahead and introduce one other witness and then I'll yield to Senator Frist for two introductions.

Let me just express for the record my regrets at being absent for a bit. We have a Judiciary Committee meeting on judges, which is a very important item that I had to step out for just a few minutes.

Dr. Dennis O'Leary is on this panel. Dr. O'Leary is president of the Joint Commission on Accreditation of Health Care Organizations. Prior to joining that commission, Dr. O'Leary served as dean of clinical affairs at George Washington University Medical Center and vice president of the university health care plan, MD from Cornell, BA from Harvard.

SEN. FRIST: Thank you, Senator Specter. I'm happy to introduce Dr. Tom Russell, Executive Director of the American College of Surgeons. Dr. Russell has served as chairman in the department of surgery at California Pacific Medical Center, with which he's been affiliated since 1975, also a clinical professor of surgery at the University of California, San Francisco and has been affiliated with a number of hospitals in the San Francisco area, a member of many professional medical societies, has published extensively on scientific and educational topics, and surgery and it's a pleasure to have you with us, Dr. Russell.

And Dr. Arnold Relman is with us, the fourth member of our panel, professor emeritus of medicine and of social medicine, Harvard Medical school and also editor-in-chief emeritus of the New England Journal of Medicine, which I receive weekly and keep reading, even the United States Senate. He's been professor of medicine at Boston University School of Medicine and he was -- Thomas, professor of medicine and chairman of the department of medicine at the University of Pennsylvania School of Medicine over a span of almost 30 years. He's published numerous articles in original search clinical studies, as well as textbook chapters and, in recent years, has written widely on the economic ethical legal and social aspects of health care. Dr. Relman, it's good to have you with us and we will begin with Dr. Eisenberg.

DR. STEVE EISENBERG: Good morning, Chairman Frist, Chairman Specter and members of the committee. My name is Dr. Steve Eisenberg, the chief medical officer for Independence Blue Cross in Philadelphia, Pennsylvania and I thank you for the opportunity to testify today on the very important issue of patient safety. I'm testify on behalf of the American Association of Health Plans, which represents more than 1,000 HMOs, PPOs, and similar network plans that provide health coverage to more than 150 million Americans.

Independence Blue Cross, my company, serves approximately 2.7 million individuals in Southeastern Pennsylvania and offers a full range of health insurance products, including Medicare, Medicaid and commercial health plans.

The Institute of Medicine reports, to err is human, has performed an important service by raising the public's awareness about the longstanding problems with medical errors. But it is important to note that that preventable medical errors are neither a new nor a newly discovered phenomena. For example, in 1984, the Harvard Medical Practice Study listed over 30,000 hospital patients in New York and found that about 3,000 patients suffered serious complications from preventable medical errors. Based on this, the author has estimated that over 27,000 individuals die each year in New York alone, as a result of preventable adverse medical events.

So if the evidence on the proliferation of medical errors is not new, then why have we not been able to effectively improve patient safety? The answer has to do with the atmosphere in which physicians, hospitals and other health care providers functions. When a mistake occurred, we're all eager to point the finger at someone and our current liability system promotes this culture of blame.

Both the Institute of Medicine and President Clinton's advisory commission have noted that fears of litigation negatively impacts error reporting. In fact, there is really no doubt that the current culture of blame inhibits the identification of medical errors and, in so doing, helps perpetuate them.

Mandatory reporting of medical errors by itself will not necessarily lead to reduction errors or better outcomes for patients. We must first create an environment that encourages the reporting of errors and that enables all participants in the health care systems to learn from mistakes in an effort to prevent them from occurring.

A central characteristic of this environment must be malpractice reform to reduce the punitive consequences of reporting. And I agree with Senator Specter's earlier comment that such reform should address how to compensate injured individuals.

Other elements of the new environment that must be embraced, if we are to move away from the current culture of blame and towards improved patient safety, include confidentiality and a national-based reporting system.

There must be strong confidentiality protections in place for any error reporting system, whether voluntary or mandatory, again, in part, so that reports cannot be used as a basis for initiating or pursuing liability claims. Additionally, data should be reported and analyzed in the aggregate wherever possible.

We need a national, rather than a state-based system to promote uniform reporting and to enable us to identify the underlaying systematic causes of medical errors. Only an environment with malpractice reform, strict confidentiality, and nationally based reporting, do we believe mandatory reporting for medical errors is appropriate.

Implementation of an error reporting system also raises a number of other important issues: including what type of errors should be reported; who will be able to report those errors; what type of information should be included in an error report; and who will have access to the data and how will it be used?

In conclusion, the American Association of Health Plans wholeheartedly supports the goals of the Institute of Medicine Committee to decrease errors and develop a systematic approach to prevent their recurrence.

We also believe that at the Institute of Medicine report has showed us nothing else, it has demonstrated that the current debate over patient protection legislation needs to be viewed in a new light. As noted by the ION and the President Clinton's advisory commission and the current liability system deters the reporting of errors. Expansion of such a system, as proposed by the Norwood-Dingall ill, would do nothing to promote improved patient safety.

Chairman Frist and Chairman Specter, we are committed to working with your committees and all the state -- involved in this issue to develop an effective way to identify errors and use that knowledge to improve patient safety.

Thank you for the opportunity to provide testimony today and I'd be happy to answer any questions at the end.

SEN. FRIST: Thank you.

Dr. Russell.

DR. TOM RUSSELL: Mr. Chairman, Senator Specter, it's a real pleasure to be here. My name is Tom Russell. And until very recently, two months ago, I was a busy practicing surgeon in San Francisco and I've been recently in the health care environment personally and teaching residents.

I'm now the executive director of the American College of Surgeons.

And on the behalf of the 62,000 fellows of this colleges, representing all surgical specialties, I wanted to be here to present these two distinguished Senate committees.

Patient safety is not a new topic for our organization and I'm proud to say that for the entire 87 years of the college's history, patient safety and quality of care have been of paramount importance. Our work in this area is described in some detail in my written statement. I will not bore you with our past history or what our future plans are.

While we have done much in the past, we recognize that much yet needs to be done. The recent IOM report gives us the impetus to re- look at what we are doing and the college leadership, the staff, and our committees are now reviewing this report to see what additional steps our professional organization must take to enhance patient safety in this country's hospitals.

Let me turn now, specifically for the sake of time, to some of the specific key recommendations of the IOM report. One urges that the Congress pass legislation extending peer review protections to data related to patient safety and quality improvements.

The college strongly supports this position. It would greatly enhance the current peer review system's work in evaluating errors, identify patterns of poor care, and addressing health care system problems, and I underline systems problems.

This was actually recognized even before the IOM report. Last June, the Medicare Payment Advisory Commission, MEDPAC, called upon Congress to enact legislation to protect the confidentiality of individually identifiable information relating to errors in health care delivery when that information is reported for quality improvement purposes.

In making these recommendations, MEDPAC did not attempt to distinguish between different types of adverse events. In fact, MEDPAC argued that reporting incidents of preventable errors in health care delivery is unlikely to become routine practice, as long as providers fear that the information they disclose can be used against them in a punitive manner.

Therefore, the college believes that legislation extending confidentiality protections to all data an work products, related to patient safety and quality improvements is a step that is likely to bear immediate dividends, particularly in creating the culture in the hospital and the health care setting for reporting of events.

A second recommendation calls for a nationwide mandatory reporting system. The college has some concerns about this and wished to know more of the details. We believe it is unfortunate the that the IOM Committee concluded that the information (colleged ?) through mandatory reporting should not receive the same level of confidentiality protection as that received through the voluntary reporting process. This makes it appear that the purpose of a mandatory reporting system may be punitive in nature, a perception that seems unlikely to foster the quality improvements that we are all looking for.

Second, the IOM report calls for narrowly defined mandatory systems that stops far short of providing those important details. The college believes that more work is needed to identify the data that should be collected and how such data should be used.

It will be critical to ensure that the time and effort involved in submitting information be used effectively and patient safety improvement occurs. Reporting of data alone will do nothing to improve the system. The loop must be closed. Without this assurance, the college believes it would be a waste of taxpayers' dollars to create yet another mandatory reporting system and data repository. This cautious approach, I might add, should in no way prevent progress on patient safety.

A third IOM recommendation stresses voluntary reporting efforts should be encouraged. We could not agree more. In fact, we believe that a wide variety of voluntary reporting systems should be encouraged. In this regard, the federal role could be one of providing the funding needed to develop and test the variety of voluntary reporting systems and other patient safety initiatives.

The agency for health care research and quality -- seems well positioned to play a role, provided it is given adequate resources to do so.

To conclude, I want to assure Dr. Specter that the American College of Surgeons wants to participate in this activity. The American College of Surgeons has a longstanding history in patient safety, beginning in 1918, when it initiated the hospital standardization program which you now know today is the JCAHO.

I could enumerate all of our activities as far as training the young doctors in medical school, what we do in residency training for all surgical specialties, how we relate to the American Board of Medical -- what we do for ongoing CME education, what some of our committees do with respect to trauma and cancer care in this country, and we are forming a framework to developing lifelong learning for physicians throughout their professional life, so they remain confident. And we're obviously very interested in public education and making certain that the public knows about surgery and how to select surgeons and what to expect from an operative procedure.

So we look forward to working with Congress, with these committees, the administration and other interested professional groups, to ensure that patients receive the highest quality possible. Thank you very much.

SEN. FRIST: Thank you, Dr. Russell.

Dr. O'Leary.

DR. DENNIS O'LEARY: Thank you. I am Dr. Dennis O'Leary, president of the Joint Commission on Accreditation of Health Care Organizations. I'm very pleased to address you today concerning medical errors. This is perhaps the most pressing health care issue of our time and I applaud the efforts of both your committees in this area.

The Joint Commission accredits over 18,000 organizations whose services include acute care, long-term care, ambulatory care, behavioral health care, laboratory services and home care. Since 1996, we have played a leadership role in encouraging error reporting and analysis. This centennial event program has provided us some unique lessons learned that we would like to share with you today.

Dramatically reducing the numbers of errors will take a concerted effort by all responsible parties to participate in and oversee the delivery of health care. This coordinated approach must necessarily bridge the public and private sectors.

We believe that medical error reduction is fundamentally an information problem. With this in mind, we suggest that five critical information-based tasks are essential to an effective error-reduction strategy.

The first task is the creation of a blame-free protected environment that encourages the systematic surfacing and reporting of serious adverse events. Fear of reprisals, public castigation and loss of business will continue to impede the reporting of serious errors, unless we provide incentives for making mistakes known to accountable oversight bodies.

Today the blame and punishment orientation of our society drives the errors underground. Indeed, we believe that most medical errors never reach the leadership levels of the organization in which they occur. If we are to better understand the epidemiology of medical errors, we must create a protective blame-free environment that permits access to information about its scope and nature.

Further, it is imperative that any medical error reporting program operate under a pragmatic and carefully crafted definition of what constitutes the serious adverse event.

The second task is the production and protection of credible root cause analyses of serious adverse events. When a serious error occurs, there must follow an intensive no-holds-barred betting of all of the clauses underlying the events. These root cause analyses, which we believe hold the critical answers to future error reduction, focused primarily on organization systems.

Unfortunately, most reporting systems, both voluntary and mandatory, fail to require or encourage the performance of root cause analyses.

Not surprisingly, organizations are hesitant to share these root cause analysis with the joint commission or anyone else. We must recognize that preparing a document that delays -- the weaknesses in the health care provider system -- writing a plaintiff's brief. Therefore, we cannot expect uniform preparation of these documents without federal protections against their inappropriate disclosure.

The third task is to implement concrete planned actions to reduce the likelihood of similar errors in the future. The principle derivative of a root cause analysis is an action plan that focuses on improving the organization systems related the serious adverse occurrence. It is essential that implementation of this action plan be monitored and confirmed by an independent oversight body. Review the monitoring or planned systems changes in organizations is a key element of public accountability, therefore, we believe that any public sector error-reporting program must provide for the sharing of relevant adverse information with responsible accreditors.

The fourth task is the establishment of patient safety standards which health care organizations must meet. We believe that all quality oversight bodies should have explicit requirements that make the identification and management of medical errors a high priority for organization leadership. The Joint Commission implemented such standards in January 1999 in order to bring both visibility and focus to the problem. These standards expect organization action on both medical error crashes and near misses in the delivery of patient care.

The last half is dissemination of experiential information to all organizations at risk for adverse events. To have a positive impact on patient safety, information gleaned from the analyses of errors must be widely disseminated to help all organizations reduce the likelihood of adverse events.

The Joint Commission does this through its continuing series of similar event alert. To date, we have issued alerts on medication errors, wrong-site surgery, restraint-related death, blood transfusion errors, patient suicide, infant abductions, and post-operative complications.

Such dissemination activities are highly depended upon having good information and adequate resources to reach health care decisionmakers. This is, therefore, an area where more effective public-private sector collaboration is highly desirable.

Finally, it must be understood that access to error-related data and information undergirds and drives this overall system of accountability and oversight. The Congress should, therefore, support coordination of error-reduction strategies and sharing of relevant data amongst all of the responsible public and private sector oversight bodies.

The Joint Commission -- event program has identified the critical information-based tasks that are essential to solving the medical error problem. But this program also illustrates the harsh realities of the litigious atmosphere in health care that creates major barriers to the surfacing and reporting of error-related information.

It is abundantly clear that without federal legislation, the Joint Commission's error-reporting program and others like it will continue to fall significantly short of their intended goal. Thank you.

SEN. FRIST: Thank you Dr. O'Leary. Mr. Relman.

DR. ARNOLD RELMAN: Thank you, Mr. Chairman. Thank you for the opportunity of describing how Massachusetts promotes the quality of medical care in its hospitals. I am chairman of the unit in the state board of medicine that is responsible for this program and I will briefly explain how it works.

All licensed hospitals in Massachusetts are required by state law to have approved programs for quality assurance. The most important element in which is a system for reporting all serious mishaps in their medical care.

Now, by serious mishaps, we don't mean necessarily mistakes and we don't necessarily mean mistakes that are preventable. We mean all serious unexpected outcomes in the course of medical care, whether they're errors or not and whether they're deemed preventable or not. So we kept a very broad net. These reports are filed quarterly with the board and must include a full medical account of what happened, along with the results of the hospital's investigation into the cause of the incident and the steps the hospital has taken to prevent any recurrences.

Each incident report is carefully reviewed by the physician members of our unit, with the assistance of our staff nurses. We often request additional information and sometimes when a hospital is in trouble, we meet directly with its staff and its medical leadership. Before we close our file on a case, we need to be satisfied that all appropriate remedial steps have been taken where indicated.

Now two crucial features of our program make it unique, I believe, and promote its effectiveness. First, as noted already, it is located within our state board of registration and medicine. The rationale for this arrangement is that medical errors in hospitals or anywhere else, for that matter, cannot be reduced without the full participation of physicians. External regulators who are themselves physicians, are most likely to know when hospital physicians are meeting their professional responsibility for peer review. And if the regulators also hold the power of licensure, as we do, they're likely to get the serious attention of the medical staff to the hospitals.

A second critical feature of our reporting program is that, while it is mandated by state law, its information is kept totally confidential and protected by law from subpoena, legal discovery or introduction into evidence. Moreover, our unit does not share any of its files with other parts of the board. The rationale for this policy is to encourage hospitals and their medical staff to be totally forthcoming in their reports to us and to take responsibility for dealing with their own problem without fear of adverse publicity or a disciplinary action, simply for doing so.

Of course, and it should be understood. Our program does not preempt existing state laws and regulations requiring disciplinary action, under certain circumstances, and disclosure, in cases of medical malfeasance. So it does not change our state's policy on informing the public about such matters and we have, I think, one of the leading state programs in informing the public about the performance of physicians.

We have accomplished a great deal in less than a decade, despite serious limitations in our resources and initial suspicions from the provider community that were quite profound. We are now gaining the trust and cooperation of hospitals and doctors and, just as importantly, of their lawyers. So the number and quality of reports that we receive is steadily improving. Meanwhile, our analysis of these reports has identified common causes of potential mishaps and we are feeding this information back to the hospital, generally to the state as a whole, or sometimes to a particular hospital.

Now it is too early to measure precisely the effect of our program on the quality of hospital care, been working for half a dozen or eight years.

It is too early to measure, but we have anecdotal evidence that hospitals and doctors are learning how to prevent mistakes. This evidence also supports our conviction that prevention is more effective than discipline or publicity in the reduction of medical mistakes.

Now what can the federal government do to help? This is my personal opinion and it has nothing to do with the experience of our board. In general, I support the IOM's recommendation for the establishment of a national mandatory reporting program in all states and I believe the report should be anonymous and confidential. that's absolutely crucial and I echo what's been said before. I also support the idea of creating a center for patient safety within the agency for health care research and quality to act as a repository for standardized information from the states and to study and do research and disseminate the anonymized information.

In addition, I strongly recommend a program of federal grants and aid to the state to help them develop monitoring programs like the one we have or maybe better. Few states have the resources to do this alone. Now, we're not getting the help that we need from our states, although we're slowly persuading our legislators that it really is worthwhile. I'll be just another few seconds. But without the full participation of state board, no federal reporting program could succeed.

Let me emphasize that. You can pass all the laws that you want. You can have all the federal agencies that you want, but the raw data and the information and the analysis that must be made where the data are obtained, namely, in the health care institution, that must be at the state level. You can't do that at the federal level.

And I estimate that the total cost of these state grants might be about $35 to $40 million annually. I am convinced that an investment of this kind would take huge dividends in improving hospital care throughout the country and when it's applied to ambulatory institutions, much more broadly and in reducing the financial burden of medical mishaps and substandard care. Thank you for your attention. I have already distributed a booklet to you describing the Massachusetts program in greater detail, but I'll be glad to take your questions. And with me is Elizabeth O'Brien who is the nurse-attorney who is in charge of the staff work of our program and she can make sure that I give you correct answers.

SEN. FRIST: Thanks. Senator Specter.

SEN. SPECTER: Dr. Relman, you talk about anonymous and confidential, would you agree that the hospital physician, professional has an obligation to tell the patient about the error?

DR. RELMAN: Absolutely.

SEN. SPECTER: How does that comport with the requirement of confidentiality?

DR. RELMAN: Well, the -- when the physician talks to the patient and says we have made a mistake and this is what happened, that is the -- now sometimes it comes back, Senator, to what I said about the difference between unfortunate things that happen, mishaps, and errors. There is a huge number of unfortunate things that happen in a hospital and our committee is just beginning to get a mind-boggling idea, the variety of things that that might go wrong.

SEN. SPECTER: -- that's going to happen very fast. That's an issue which the Congress has been wresting with for a long time and the states have made some legislative changes. But with your endorsement of mandatory reporting, is that unconditional?

DR. EISENBERG: Senator, I think it would be conditioned on changes in the liability because if the mandatory reporting were to lead to an increase in claims and it became a vehicle by which additional claims were brought and that became a primary use of the mandatory reporting, we think that that would have a counterproductive effect on creating the correct climate and culture to learn from these and to encourage the reporting.

SEN. SPECTER: Well -- I will conclude with just a very brief statement. I'm sorry, Dr. Leary, I didn't have a chance to pursue with you the blame-free comment, but the red lights go on very fast. We would ask your assistance in our effort to draft legislation or implement the administration of these demonstration projects.

You talked with Dr. Russell about identifying data, how you use it, closing the loop. You've been our experts. We're going to have to rely up on the experts to work with the federal agencies, the active practitioners, where those in the bureaus may not have the kind of detailed knowledge you have.

If we move ahead promptly with demonstration projects, we can find a lot of answers. The goal of having mandatory system within three years is a fine goal, but it's unlikely to happen, if you're requiring 50 states. But if we have some experience on the differences between voluntary reporting and mandatory reporting and even mandatory reporting with some disclosures, we will then be in a position to try to really understand and solve this problem. Thank you all very much for coming.

SEN. FRIST: Dr. AAA, could you comment on the administration's recommendation for mandating safety plans for all health plans in FEHBP, Federal Employee Health Benefits Program? Do you support it? Do you not support it?

DR. I. STEVEN UDVARHELYI: Senator, I have not yet seen the final proposal that OPM is going to come out with, so it's a little premature to comment on the specifics. I think health plans can play a supportive role in patient safety. We do today have credentialling requirements to make sure that the physicians in hospitals and our networks meet certain requirements and we think that's an area where we can encourage physicians in hospitals to do more in patient safety. We also share best practices with them. We think we can do more there and we promote patients going to a center.

As you well, know, one of the best ways to get a good outcome is to go to a center that has the requisite experience and track record, as opposed to one that does not and we think that these are all ways that we can assist. But at the end of the day, the care is provided in the physician's office or the drug is prescribed in the hospital and we think that it's critical to have the support of physicians and hospitals on the front lines to identify errors and to report them. And without their support, a requirement on the health plan to do something without the support of the physicians and other providers, is going to be difficult.

SEN. FRIST: Now, one of the big challenges is educating broadly. This is systemwide and what we talked about today, you can point your fingers to any one area, so let's fix it -- fix the system. The health plans are in a unique situation in that the health plans interact with doctors, nurses, providers, hospitals, rural hospitals urban hospitals and I can't help but to think that it kind of falls on your shoulders to take a leading role. It can be accreditation, it can be individual states, it can be federal law.

But I guess we're going to need to look to you to see how in a way that's consistent with all the other things you're doing and I guess it's going to be important for you to put certain pressures on there, if voluntary is to work and mandatory is going to be important, but limited in terms of the full system-wide impact and the health plans, I think, can play a very important role. They are consistent with what you're doing already, but probably are reaching out more. Would you object to, in some way, and I know new mandates is the last thing you want to see, but having every health plan out there, at least put in writing to notify patients, perspective patients, what is being done in terms of medical error reduction?

DR. UDVARHELYI: We would support the dissemination of information of that patient's safety, certainly, but, again, for us to take an active role, one thing we cannot do is change liability issues ourselves. And if the information is exchanged in ways that are not protected and are not confidential and we can't change that, it may be problematic.

SEN. FRIST: Well, the confidentiality and the liability. I mean, everybody has said it's got to be addressed and to try to fix the system and come out with a range of proposals that doesn't include that, I think, is irresponsible and we hear that again and again. How we address it is tough.

Dr. Russell, in all of the medical errors, we hear the numbers and it's appalling to people, they're surprised. It is inexcusable, given the information systems that we have today in contrast to 30 years ago, where you really can computerize. We have pockets that are doing very well, hospital systems that are doing well, medical centers that are doing very well. You've been a part of many of those, as I have, in our own practices. And therefore, we shouldn't leave the impression that nothing is being done. The question is we can do a lot more and we need to figure out how together we can do that private-public sector.

Tell, for my colleagues, morality and morbidity rounds, M&M rounds, at Vanderbilt for the 10, 11 years I was there every week, we had M&M rounds, at Stanford when I was there, at Mass General when I was there. And again, it was a standard part, but I was in academic health centers. What are M&M rounds, mortality and morbidity rounds? Are they just academic health centers, training centers where residents and fellows are taught? How many hospitals have M&M rounds that might be community hospitals that aren't engaged in training? Set that perspective of what M&M rounds are?

DR. RUSSELL: All right. You know, M&M rounds is looking at your results. Now it's ideal for surgery, because we are doing surgical procedures and not always do you have good results. I mean, but these not are not necessarily an error, you have complications. And it's very important, as Dr. Relman alluded, to differentiate complications from an error.

M&M rounds is an effort to look at, in surgery, the results of operations and a look at what problems or complications occurred.

These occur in teaching hospitals. It's a very important culture to create in young surgeons to assume responsibility, because in surgery, you know, we make patients often sicker, to start with, in order to get them well. We set them back a little bit and we have to be very critical of our results. I think the M&M, the morbidity and mortality conference is great learning tool for young surgeons to set, once again, the culture of responsibility of results from the operations that we do and this can easily be applied in private hospitals. And I think a lot of private community hospitals do morbidity and mortality conference on sort of a monthly basis, where they criticize and they critique their results with the idea that they're trying to make the product better.

SEN. FRIST: And confidentiality there is not an issue because you're within a system and it is mainly physicians and nurses talking together, looking at systems, looking at failure, errors, unexpected outcomes. But in truth, it's pretty much limited go where training is going on, is that right or is that incorrect?

DR. RUSSELL: No. I think that's true. It is where training is going on, but a lot of private hospitals where there's no training, get the staff together on a weekly or a monthly basis and go over complications that have surfaced in the last reporting period. It's a very important part of the Internal reporting and you need to create a culture of not -- critical but, rather, a learning experience.

SEN. FRIST: Thank you. Dr. O'Leary, what role to do you think states should play in this collection and dissemination of information at the state level, based on what you've seen for the --?

DR. O'LEARY: We have, you know, no problem with the state-based reporting system. I do worry about standardization of reporting, something that was addressed in the IOM report. I didn't hear quite as clearly in the -- task force report, but I think we have to carefully define what is going to be reported and speak to standardize at across-the-state systems, so we will, you know, have bad data, you know, for openers. I think it is also important that the states establish requirements for root cause analyses for, you know, for those hospitals and other organizations are going to be reporting to them why in one of the failures of the current mandatory reporting systems in states to demonstrate improvement is that simply counting cases doesn't cause improvement. You need to know underlying causes, gather that information and share the lessons learned out of that. That's been very much the joint commission's experience.

I think the other comment about the state reporting systems is that the need for confidentiality is underscored by our experience. If you look at the -- at the states that have confidentiality protections, those are the ones that have pretty good numbers of reports, although there's probably still underreporting there. The states that don't have confidentiality protections had very low numbers. You know, that message is pretty clear. We need to learn from that experience. I would finally hope that in any system that we create, that there be data sharing amongst the responsible parties. Many of the hospitals involved in my report to the states are accredited by the joint commission. We have an active follow-up program. I think the states and the responsible accrediting bodies need to share information between themselves.

SEN. FRIST: Thank you. Dr. Relman, the six, eight years that things have been going pretty well, how many hospitals are there in Massachusetts, roughly?

DR. RELMAN: About 110.

SEN. FRIST: 110. And have every -- how many reports do you get? It is broad, serious unexpected outcomes, fairly broad. How many reports do you get a year?

DR. RELMAN: It's a rising number, which doesn't mean the care is getting worse, it means that cooperation is getting better and the system is really beginning to operate. It's getting better all the time. It's a moving target. It's now between 5 and 600 a year, based on about 15,000 beds. Our estimate is that that represents only about 10 percent or 15 percent of what actually is going on.

SEN. FRIST: And it is mandatory?

DR. RELMAN: Absolutely.

SEN. FRIST: And of the 110 hospitals, how many have not reported any, just roughly?

DR. RELMAN: About two.

SEN. FRIST: About have not reported any? And are there --

DR. RELMAN: They're going to be hearing from us and they already have. We watch that and it's remarkable how if you sit down, our doctors on one side of the table and their doctors and their president of the board of trustees and then CEO on the other side of the table and we look them in the eye and we say, what's going on here? Are you saying nothing bad ever happens, no, unfortunate outcomes, nothing is unexpected and then there's a dialogue. And as long as they know that you're honestly telling them this is in confidence, and it's not punitive and we want to help you do what you know is the right thing to do, you begin to get cooperation.

SEN. FRIST: And do you work for government? You're a state employee?

DR. RELMAN: Well, I wouldn't call it that. I'm essentially a volunteer. The State of Massachusetts pays me $35 plus free parking for every day that I spend time working for them.

SEN. FRIST: And how many doctors, realistically, who are -- understand the field who are making basically looking at clinical errors, for the most part and interpreting them and looking across the table, how many do you think you're going to get to do that for $35?

DR. FRIST: You have to be old and foolish the way I am and a little idealistic. But I think that there are a lot of my contemporaries who have had full careers and the practice and the teaching and research and medicine, are available. It's not a full time. It takes about, I don't know, it takes 15 or 20 percent of my time to do, and a lot of nights and weekends, and I have a lot of contemporaries, at least in Massachusetts, who would like to do that because it's a very satisfying thing to watch your profession get the message and realize that they really could do much better if they are reassured that this going to be in a constructive confidential way and it does not interfere with any of the existing laws about reporting on convictions and malpractice litigation and so on and all --

SEN. RELMAN: But it's important that people understand when you're talking about medical errors and medical mistakes in judgment, system failure, we're talking about probably some of the most sophisticated decision making in medicine today.

DR. RELMAN: Absolutely.

SEN. FRIST: You're seeing the toughest, I think, when you go from M&M round and you sit there for hours and dissect individual cases and I guess I wonder, looking at state governments in all 50 states, whether or not you're going to be able to pull that sort of expertise for $35 or whatever and that --

DR. RELMAN: Well, if you want to recommend a raise, I would --

SEN. FRIST: Well, I will. Sitting here, I may be able to do that safely. But it is sophisticated and I commend you for the success there. But then it goes to my next question and Massachusetts it's six years, you don't get paid very much. You're probably way underfunded for what you're required to do.


SEN. FRIST: You have compulsory reporting for not only what we see in M&M rounds, but in every adverse or serious unexpected outcome, which is thousands, I would think, if every -- 10 percent -- DR. RELMAN: We think in Massachusetts there are several thousand --

SEN. FRIST: Right.

DR. RELMAN: That's episodes and so far, we're looking at about 500 or maybe this year we'll see 600.

SEN. FRIST: But we're talking about the most sophisticated of medicine that is going to require expertise. We're not going to all be able to have Dr. Relman with your long history.

DR. RELMAN: Well, we draw on consultants, too, on an ad hoc basis when we need them. We don't have all the expert --

SEN. FRIST: And all this is done through the state board of medicine?

DR. RELMAN: Through the state. And the trick is that the doctors know that there are state regulations which say licensees or the state board of medicine in Massachusetts are not allowed to practice in an institution that does not have an approved quality assurance program and we want you to convince that we should approve your quality assurance program. Furthermore, we can always report bad performances in hospitals to the state department of public health.

SEN. FRIST: Now, let me -- I've written down a question and you got to it at the end about the why do you need the federal laws coming in. You made this progress. Ultimately, you feel strongly it should be down at the state level, I assume.

DR. RELMAN: But we need help.

SEN. FRIST: You need help and you need.

DR. RELMAN: And the federal government.

SEN. FRIST: And you need some money, as you heard me ask earlier, if the administration is serious about mandatory reporting of thousands of errors with making the most sophisticated dissemination of information back, I'm sure it's not a little disingenuous for them to come forward with tiny bits of money and make this mandatory compulsory reporting, we have good in it, requiring the most sophisticated expertise in medicine today at the table if you could really interpret the data that's coming forward. If you just want to get it out there and disseminate it, it's a different issue, then we're going to have to sort of face the facts of what the resource is going to be.

Your $40 million figure of grants, based on what you've told me, that's a nice start. We haven't heard that requested by the administration. We're talking about $20 million for overall funding of all research for the 1155 which Dr. Eisenberg -- to approach that again. It's important, $40 million.

DR. RELMAN: This would go to the state.

SEN. FRIST: I understand. I understand. Right now we got, how much money, say, zero probably or a few million dollars.

DR. RELMAN: We don't get any federal support.

SEN. FRIST: I know. We're going to give some to Massachusetts, please Senator Kennedy here. Anyway, I appreciate it because the program is admirable. It demonstrates the overall complexity of it. Public dissemination of information in a transplant field very early on, by federal legislation, we are required to report every transplant that we did. This is early on, 1986. It's probably one of the first fields where you report the outcome of who you operated on, what was the outcome, what are the life-death, quality of life or life at six months, three months or six months a year and three years, infectious -- outcome, all this and we had all this data reporting and nobody knew what to do with it.

Then it was put in the newspapers and all of a sudden, transplant centers were very threatened because you might have without, it's really definition of case mix, how difficult the transplant cases you were doing. All of sudden, if somebody doing easy ones, their hospital looks real good or their transplant program and the others looked real bad. So for about three years, we really struggled. And therefore, I'm a little bit suspicious, based on that experience, of just getting raw data. Without the sort of expertise, you've been able to demonstrate and report it to any agency of the government without a real careful, thoughtful sophisticated plan. Now, it might be from the private plans, it might be from JCAA, it might be from individual hospitals, physicians. But again, the principles are good.

But before we get too far along, I think we need to think long and hard about this information coming to the top, how it's digested in a sophisticated way and then disseminate it. I think everybody says that that disclosure needs to be there and that's why I want to hear exactly how it's going to be done, as we go through. That's why I keep bringing up points like that.

Dr. O'Leary, in your written comments, you talked about error- related information. Congress should enact, again, I'm talking about federal government versus state government. You said that Congress should enact federal protections for error-related information, and I think I agree. f the information has been coming up, but what do you mean by that? How broad should these federal protections actually be?

DR. O'LEARY: Well, I think the protection should be for the report of the occurrence, the serious adverse events really coming to the definition of that. And for the root cause analysis, the in-depth investigation of what happened at a systems level within the organization. That is specifically what we are -- what we're talking about protecting.

SEN. FRIST: And in terms of the actual wording of that, you're fairly confident that we could come in with legislation that would circumscribe that and define it and take care of that?

DR. O'LEARY: Yeah.

SEN. FRIST: The other comments on that whole issue of legislating federal protections for error-related information. All of you think it can be done?


SEN. REED: Dr. O'Leary, you also stated the problem with medical errors is an information problem and, actually, both of you did, Dr. Barrick, as well, and in your testimony go through it. Some people, Dr. O'Leary, have suggested that we're not making use of all the information that's out there today. Is that accurate and is there a role for Congress to make better use of that information?

DR. O'LEARY: Well, I don't know that we have a lot of useful information in the medical arena. A lot of it is locked within organizations, even getting caregivers to report significant medical errors inside organizations is a problem in that existing information, but it's not even known to organization leaders, let alone to the joint commission or to the state agencies or to HCVA or anyone else.

And until we know what's happening inside our organizations, we have no ability to leverage the analyses that need to be performed, nor to harvest those analyses for lessons learned and to share those broadly across the country. Now, we do that one a very modest scale. Last year, we had 333 -- events made known to us. Eighty-three percent of those were self-reported. The root cause analyses that we required in each one of those cases are very rich sources of information and we publish about quarterly something called -- Event Alert on a topical error in medical errors. And those are widely read and I believe used because we can show that in some areas we have seen a reduction in the frequency of certain errors reported, potassium chloride related deaths being the case in point.

SEN. FRIST: Docotr Udvarhelyi, when you come back, again, the health plan, you're in a unique situation because you're collecting so much information. Most of it's claims information right now, but still you're the one in the groove here, who's plans are talking to a range of providers, facilities, nurses, doctors. They have to report to you, you have to report them most of its claims, dollars and cents. Is there information that either you're receiving now that would help with the medical errors or that, in some way, could be identified but attached in such a way that it could address the medical errors?

DR. UDVARHELYI: Senator, I don't think that health plans do have access to the type of information that would be useful to identify medical errors.

Again, as I said earlier, we are not there where care is being delivered and that's where these errors are identified and I think it's important, as has been said before, there are adverse events which may or may not be due to an error and then there are errors which may or may not lead to adverse events. I think in order to have error reduction, you need to understand the totality of errors, including those that don't produce an adverse event. And really, it's the physicians and hospitals that are in the best position and other health care providers to know how the decisions are being made and I agree with Dr. Relman that you need to understand the context of these events, from a clinical standpoint and again, it's health plans are not in a good position to do that. We can play a supportive role -

SEN. FRIST: Dr. Russell?

DR. RUSSELL: -- Perhaps the health plans can't. But the ideal place is the hospital, because that's where it happened and that's where it's disclosed. And in hospitals, I think a lot of hospitals in this country, when something happens, everybody knows about it. That's the environment you want to create.

For example, in our hospital, it would only happen maybe once a year; there would be a death in the operating room. I'd know that within 30 minutes of the death; the word would get around the hospital. That's the kind of environment you want to create. So when something comes up you have the right committees get involved and it's handled internally. It's not hidden, it's opened up to internal discussion and then if it needs to be reported to an external organization that's fine and dandy. But I think it has to start and hopefully can get finished locally and then by improving the process.

That's the ideal way for it to work, and I think, there are some hospitals in this country where it works very effectively. And we shouldn't always just look to where there's bad cases; we should look to where we have good use of this data and results come from the analysis. We should model our programs after that.

SEN FRIST: Thank you. I want to give -- I'm going to wrap things up here shortly, but give everybody an opportunity to close with a couple minutes or a minute a piece, if you'd like.

Dr. Relman, in terms of what other states are doing, do you interact with other states at all, probably not very much?

DR. RELMAN: Unfortunately, no we do not, but to the best of my knowledge, the particular combination of methods and procedures that we follow are unique. I looked at the material that the ILM had collected, that none of it resembles what we do. In fact, what is stated as being what Massachusetts does, is what the department of Public Health does, not what we do and it's quite different.

SEN. FRIST: And the federal role for you is, maybe the mandatory, just so everybody will have to get in the business, every state, in terms of what congress needs to do. And number two, the confidentiality end of it. And what was the third?

DR. RELMAN: And then to...

SEN FRIST: The grant and other money "-" like that.

DR. RELMAN: And then, I agree with John Eisenberg, that you need to have a center where you receive non-identifiable information, statistical information. These are the common problems that we're identifying and then you need to have some research on, can they be prevented and what works and what doesn't.

There is an enormous amount of information on the procedure of health care, in hospitals, in clinics, and in private offices, that we have to know about and we need research. And the federal government can support that research; states can't afford to do that...

SEN. FRIST: Right.

DR. RELMAN: -- and disseminate the results of research.

SEN. FRIST: Are you a regulatory agency, the group that you work with?

DR. RELMAN: Yes we are.

(Cross talk)

SEN. FRIST: Will you close down hospitals if you don't...

DR. RELMAN: We hope we don't have to but we have the statutory authority, state authority, to declare that a program, a quality assurance program, in a given hospital is not satisfactory. And we also have the authority to determine the conditions under which licensees, medical licensees can practice. Now, we have never had to exercise that authority; we hope we don't. All of our lawyers are not quite sure what would happen if we came to that point but we don't have to. The hospitals get the word; they don't want it to come to that point and staffs respond.

SEN. FRIST: Thank you. Let's just go down, Dr. Udvarhelyi, any closing comments?

DR. UDVARHELYI: Senator, just to emphasize that we think that there is a role for legislation to create the popular environment and that after that has been done, that mandatory reporting is a viable option. And within that context, we think that if we can identify "-" and learn about the root causes, then all parties will be able to make a concentrated effort to reduce their frequency.

SEN. FRIST: Thank you. Dr. Russell.

DR. RUSSELL: Well, Senator, I just would like to say that, I think this is really worth while that we're looking at this but I would want to hasten to say that we do a lot of good in hospitals today. The severity of illness of patients in hospitals in this area is amazing and what we have to do to them, with co-morbid problems and multitude of difficulties. New diseases, the ravages of aids and the way that effects patients.

It's remarkable what health care can do today and so; we can't loose track of that. We have a good system, but we're going to make it better. So let's not beat ourselves, totally, over the back on this thing. We have to recognize the good of the system and then build on that. That would be my closing comments.

SEN. FRIST: Thank you very much. Dr. O'Leary.

DR. O'LEARY: There are two points that I would want to emphasize. One is the importance of information sharing, regarding medical errors eventually amongst those with a legitimate need to know. The oversight players are; the privet sector crediting bodes, the state agencies, HCFA (Health Care Financing Administration) in its subparts, PRO's (Peer Review Organizations).

The accountability surrounding medical errors are not just for reporting, nor even doing root cost analysis, but eventually for the implementation of action plans to reduce the likely hood of future errors. We can not tolerate a situation where medical errors are being reported to one place and we, as an accrediting body, don't have access to that information, and yet are held accountable for improving patient safety to our federal dean status relationship. I emphasize this point because it is not addressed in the quick task force report and we need to assure that there is appropriate information sharing.

The second issue, more briefly is, most of the recommendations in the quick task force report have significant time lines associated with them. But the thing that can be done now is the enactment of confidentiality protection information for error related information. We have many hospitals that tell us they would report serious adverse events and the root cost analysis, to the joint commission, if they had that protection. That can happen now.

SEN. FRIST: Thank you. Dr. Relman.

DR. RELMAN: The responsibility for medical care is - that's clearly with the medical profession and allied professions, nursing professions and so on. And if you're concerned about improving the quality, you have to start by motivating doctors and nurses to do everything they can to look at what they do critically and carefully and honestly.

Identify what goes wrong or what is unexpected. Find out why it went wrong and then do something about it, if it can be. And you cannot be to draconian, you cannot be to bureaucratic, you cannot make to many rules and have to many organizations requiring doctors and nurses and health care personnel to do the right thing.

However; you can make sure that they do it by saying to them, we want you to tell us that you are and we understand what you're telling us, we know, we've been there, we've done it ourselves, we are doctors, we are nurses. You convince us that you are doing the right thing and that your correcting it and that is all we can... Now patients have a right to expect that their doctor tell them what they ought to know; that's different from public disclosure. It's got to be confidential; it can't be just, everything done in the public arena. What's between the doctor and the patient, you know, is privet. That should not transpire in the public arena.

But doctors have got to do it and hospitals have got to do it. And, I believe that the federal government and the state government each have a role to play and can be very supportive because it does take money.

Hospitals, by the way let me put in a word for the hospitals. Hospitals are being stressed terrible now, as you know very well. This ads cost, they have peer review function, cost money, cost time. Quality assurance nurses, there are reports being filed with agencies and so on. It takes more money and more effort and they need some help.

SEN. FRIST: Thank you. I want to thank all of the witnesses. Today was a joint hearing, and we don't do joint hearings that much. But, to bring together the appropriation committee with senator specter, which is the subcommittee on Labor, Health and Human Services and Education, and Senator Jeffords' committee, the committee on Health, Education, Labor and Pension, and I think that bringing together, is a reflection - the way this has to be addressed.

Both in terms of adequate financial resources, which again we have come back to again and again, and terms with the appropriate authorizations given to the appropriate agency. Which I am delighted that we've come again and again back to the agency for health care research and quality, which is very specific in legislation that originated in this room, two years ago, that became apart of the Senate Past Patient Bill of Rights. That was taken out and passed last year because of the critical importance of addressing quality and medical errors in addition to access and insurance is a critical component of that.

Now all together, I think, demonstrates really what you said at the end, Dr. Relman, that it has to be a lot of partnerships at the local doctor/patient, nurse/patient relationship, traveling all the way up to the federal government. How we collect, how we report, with everything from the health plan to the accrediting agencies, to the hospitals, to the professional societies out there today. And It's got to be addressed, I think, in that very sophisticated, very inclusive, and in a comprehensive way to achieve what we all recognize can be achieved.

Accountability, it boils down to accountability and how we can assure accountability at every level. And I think, based on the joint hearing today and the three previous hearings that we've had on medical errors in the health committee, that we've got a great foundation. And now we need to, all again, in a partnering way, put our heads together, put on paper what needs to be put, usher it through the United States Congress and set a frame work. Again, I don't think it has to be overly regulatory, but it really does have to lower those barriers where the accountability can flourish.

I think it can be done, I think it is now our responsibility to do just that. It's going to take all of us working together and listening very carefully in a bipartisan, comprehensive way, house and senate ought to go ahead and accomplish that. With that, let me thank all of you for taking time, sorry the hearing went on so long but it was because the amount of information that we wanted to listen to, collect, and discuss.

Thank you all.


LOAD-DATE: February 24, 2000

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