THE WHITE HOUSE

Office of the Press Secretary

                           PRESS BRIEFING BY
                    SENIOR ADMINISTRATION OFFICIALS
           ON PRESIDENT'S INITIATIVE TO REDUCE MEDICAL ERRORS

                 The James S. Brady Press Briefing Room

1:50 P.M. EST

MR. KENNEDY: The President unveiled some landmark initiatives to reduce preventable medical errors, and here to amplify on that and provide additional background are two senior administration officials.

SENIOR ADMINISTRATION OFFICIAL: Good afternoon. I'm an administration official that is not a doctor, and I have one over here who is. So you can refer to him as Dr. Administration Official. I'm going to quick summary, and then just enable you to do some Q's and A's, and I'll ask the doctor to come up.

Today, as you saw, the President announced his response and the administration's response to the Institute of Medicine's report that was released at the end of November, just a few months ago. Largely, his report and the recommendations that are outlined in the report that he endorsed today endorse the IOM recommendations, but in many ways go beyond them, and underscores his commitment to agree with the IOM that we move towards eliminating at least 50 percent of preventable errors over the next five years.

The President's -- the initiative that he unveiled was a multifaceted initiative. There are administrative initiatives, executive actions, legislative initiatives, and then there will be other initiatives that we'll be working with the states on as we move forward to implement a program that we believe will go a long way to eliminating preventable medical errors and enhancing patient safety.

We believe that this initiative very significantly complements the work that the President and all the departments and agencies and the Congress have been doing on patients' bill of rights legislation, but we view this issue to be a separate initiative, an initiative oriented towards patient improvements, quality improvements in patient safety enhancement -- whereas the patients' bill of rights is oriented towards processes within health plans and access to services that are covered within the health plans, or should be covered, and assessable. We'll get to that if you have any questions.

Clearly, the problem of preventable errors has been very well-documented. I won't go through that. We've given you some backup on that. Many of you have reported on it already. The President's initiative calls for the establishment of a new patient safety center within the Agency for Health Care Research and Quality at the Department of Health and Human Services. That was consistent with the IOM recommendations. It calls for the development of a new regulation that will require all hospitals participating in the Medicare program, fully over 6,000 hospitals, to implement patient safety initiatives, including medications, safety-oriented approaches. It calls for the development of new standards by FDA to deal with and help prevent medical errors caused by proprietary drug names and packaging that are easily confused with other drugs.

Health care professionals and patients have, for a long time, for a longstanding period of time, indicated that these were very real issues and led to actual implementation problems and compliance problems related to medication errors. And as we move forward, we are going to be fully implementing the VA patient safety initiatives that have been outlined in your papers, as well as moving towards mandatory initiatives at DOD, and I can outline those shortly.

This is all done in the context of a broader commitment to ensuring that we take all actions necessary, within the government and with our private sector partners, to develop an environment that enhances the desires and commitment to implement medical-error initiatives. And that includes reporting systems. Reporting systems are not the only component that is necessary to have enhanced quality, but they are an important component that we believe needs to be part of the process.

The President's proposal endorses a combination of mandatory and voluntary-approach reporting systems, mandatory being oriented to reports of deaths and serious injuries, and voluntary reporting dealing with all other errors, as well as those incidents that are categorized as near-misses and/or close calls. This is very consistent with the IOM recommendation.

We do this in the context of a state-based approach. We endorsed the approach that the mandatory reporting should be done by all 50 states within three years. It should be focused on the definitions that I've just outlined. But it should also be done in such a way that incorporates public reporting of health care systems and hospitals, but not of individual patients and not of individual health care professionals. The orientation is not to orient this towards blame, but orient it towards an environment of working collaboratively to address these concerns.

Now, as we do this, we believe it's important that we implement initiatives to make sure these reporting systems work most appropriately. And what we do -- how we do that is, we are supporting the expansion of peer review protections within hospitals, which are oriented towards systems in hospitals that, following an error, they do follow-up investigations to see what causes those and other like errors, and whether -- and to determine whether or not they're system-wide problems. If they are system-wide problems -- and I think we call these secondary effects, or secondary issues -- if a hospital finds that out and implements initiatives to address those concerns, those issues are protected from discovery and liability.

Any individual case in which there has been harm, in which someone has died, people individually would still have access to all the information they would need in a malpractice suit, for example.

We also are working towards the development of showing that we're leading the way in this area by developing information -- comparable information standards, so when people are reporting these errors, that we're comparing apples to apples, so that when a hospital does report from all parts of a state, that information is comparable and it is something that you can compare one to another in appropriate ways.

Lastly, as we move towards these mandatory-voluntary systems, we are leading the way in a number of different areas by implementing mandatory programs at the VA, the DOD, mandatory reporting at FDA, and voluntary initiatives program-wide at the VA, which we can talk about in some detail.

I'll conclude with that, other than to say this -- our announcement today, we had witnesses, including our administration representative here with me today, testifying before the Congress. The Senate had a hearing -- it was a joint committee hearing between the Senate Help Committee, formerly known as the Labor Committee; and the Labor-HHS Appropriations Committee. The recommendations were very well received. The hearing went very well. We had Senator Specter, Senator Jeffords, and Senator Harkin here today with the President indicating their strong support of working collaboratively this year to get initiatives done. We're very encouraged by the response.

We've had very broad-based support from a wide range of experts in this area. We think we start in a good place. We look forward to working with all interested parties to get this job done. And with that, we'll open it up for any questions you may have.

Q Aren't you going to have an onslaught of malpractice suits as a result, if the government is going to certify that a major error was made in medical treatment?

SENIOR ADMINISTRATION OFFICIAL: Well, actually, all we are suggesting is reporting deaths and near-misses that should be reported anyway today. In fact, under the AMA Code of Ethics and just the general practice of hospitals, if you have these incidents you are supposed to report it to your patients. Moreover, if you die or if you have the wrong leg amputated, you probably know that. Moreover, we have 18 states who already have mandatory systems in place and we have not seen an increase in incidents of liability concerns whatsoever.

Q You have 18?

SENIOR ADMINISTRATION OFFICIAL: Eighteen have mandatory hospitals. There are 21 states who have mandatory reporting systems. The other three actually focused on nursing homes, and there's two others that have voluntary reporting systems. There's a total of 23.

Q If this was such a good idea, how is it that both the American Medical Association and the American Hospital Association are so vehemently opposed to it?

SENIOR ADMINISTRATION OFFICIAL: Well, actually, I think it's not a fair characterization to say that they're vehemently opposed to the whole proposal. In fact, if you talk to them individually, you'll find that most of the recommendations they widely support and accept and want to work with us on. There is one issue that both of them have raised issues about, primarily oriented to mandatory reporting and concerns about what the implications are of mandatory reporting.

We believe that we've addressed them by laying the foundation for a much more workable system than currently exists. We think they haven't had a lot of time to review these recommendations. We look forward to working with them. We had today, for example, a number of hospital associations saying very supportive things. The American College of Physicians today said very supportive things. The New York Hospital Association we've worked with today who are out there at your stakeout. So I think this is an area where, with collaboration and a working partnership that we've had in the past, we will be able to address some of their concerns.

Q Are you disappointed that they didn't show up today at the presentation?

SENIOR ADMINISTRATION OFFICIAL: The AMA had representatives today, and I think we've worked well with the American Hospital Association in the past, I think we will in the future. They can choose not to come to any event that we have. I think they believe that their statement speaks for itself as it relates to their current review of these recommendations, but we think over time, we'll have a very good working relationship and we'll get agreement.

Q Why did you not, on the federal level, make this mandatory, the reporting? One, does that require congressional action? That's not something that can be done -- the mandatory reporting right now is a federal program; the President can do that through executive order or some other executive fiat. He couldn't make mandatory reporting in all 50 states without congressional legislation. Is that correct? And two, would you like to have done that?

SENIOR ADMINISTRATION OFFICIAL: Well, as I think we worked very carefully in the report to indicate, we believe that mandatory systems in place today are positive, but they can be done better. And before you require that all states have them implemented, we should have some of these other initiatives that we recommend in this report underway, so that they can work in the best way possible.

We also feel that, as does the Institute of Medicine, that these should be state-based rather than federally based approaches. And our conversation with the NGA and other states led us to conclude that there's a lot of interest at the state level in moving in this direction. Rather than requiring them to do that, we think that we can provide some of the support systems at HHS and other agencies throughout the federal government to do it right. And we anticipate that they will. If they do not after three years, then we will support approaches to ensure that all 50 states do have reporting systems.

Q The provisions on reporting, and shielding of information liability -- it seems to protect the hospitals but leave the doctors open to exposure. That is, if a hospital has a, you know, a poor system that leads to mistakes, that material is protected from litigation. But a doctor who's at the end of the chain who makes a mistake seems to be exposed here.

SENIOR ADMINISTRATION OFFICIAL: I'll have the doctor respond to that. But I will say this, that our reporting system explicitly exempts physicians and other health care professionals from public reporting of this data.

Q But it doesn't protect the institution. Anybody who's got a -- any smart ambulance-chasing lawyer's going to figure out what case was involved.

SENIOR ADMINISTRATION OFFICIAL: We've also proposed a peer review protection extension from what currently exists for the peer review organizations, so that it would extend beyond that to these systems as well. We believe that when the hospital industry looks at that, that they will be pleased at the peer review extension and they'll see that that will allow them to have a healthier and more constructive reporting system that won't put people at risk for having made the report.

In addition to that, we're going to limit the disclosed mandatory reporting process to very serious errors -- preventable deaths, and serious events which cause a long-lasting problem for the patient.

That's going to be a clearly delineated list, and we're going to work with the Quality Forum to describe that list. The Quality Forum, you will recall, is the organization that the Vice President kicked off, but is a private sector organization, including the hospital industry and the physicians and the purchasers, and we're going to ask them to come up with a list that ought to be reported. Therefore, the physicians and providers will have a voice in what that limited list of disclosed items ought to be on the mandatory reporting system.

Q Can you explain that expansion of the peer review protections?

SENIOR ADMINISTRATION OFFICIAL: Yes. Right now, if you have a system, if you have a reporting process within the peer review organizations, then that secondary data set, that aggregation of the events that occurs in the hospital is protected by the peer review statute from being discovered. It certainly doesn't protect the primary database, the chart, the medical record, but it does protect the secondary data set. So that prevents a system like we're describing from being used for a fishing expedition or by someone who wants to just go find out if there are individuals who might have been harmed.

Because, number one, that data should have been told to the patient in the first place, so the data will have been already disclosed, and secondly, we think that for the hospitals and for the medical community to address this in a constructive way, they have to feel comfortable that if they do this reporting, it will be protected by the peer review protections.

Q A couple of years ago, the American Medical Association had its own study in which it looked at the incidence of medical mistakes and took upon itself to try to police its own members. Is this an indication, this proposal today, that they haven't done a good enough job of it?

SENIOR ADMINISTRATION OFFICIAL: Not at all. In fact, we admire the leadership that the AMA has taken in initiating the National Patient Safety Foundation at the AMA. We believe that what they've done has been to help us to understand that there is a large professional role in the area of improving from the information that we can gather through these reporting systems, but we also recognize that there needs to be a balance between the reporting systems that are focused on learning, and the reporting systems that respond to the public's need to know that their hospitals are safe and that the hospitals not only are safe in terms of the reporting of publicly disclosed information that I mentioned earlier, but we also believe that the hospitals ought to describe to potential patients which patient safety practices they have in place.

So that if you were going to go to a hospital, you would be able to find out easily, do they have a computerized order entry system, do they have a bar coding system for their blood transfusions, and know that that hospital has or doesn't have those practices in place. We think what this does is complement what the AMA has been doing, by taking the professional responsibility for reducing errors through a learning process.

Q And to fast-forward three years, assuming that you have tons of information in place about medical error, then what? In other words, how does that immediately roll over into your goal of reducing preventable medical errors by 50 percent? In other words, you've got the data, then how do you implement?

SENIOR ADMINISTRATION OFFICIAL: Well, what you're referring to is the statement that we made that we believe that the states will be able to put successful programs into place, and we want to help them to do that in every way that we can, through better information, help in understanding best practices, understanding how the reporting systems can be done best.

But we also feel we need to evaluate those systems. If within three years we determine that the state-based systems are not working well, then there is a federal inter-agency health committee, representing all of the groups within the federal government that have an interest in, and a commitment to, health care quality, who will evaluate those results and make a recommendation at that time about whether something different from a state-based program is needed.

Q Do you have a target at three years?

SENIOR ADMINISTRATION OFFICIAL: No later than three years is the target.

Q Right. But does something have to happen in three years, specifically?

SENIOR ADMINISTRATION OFFICIAL: At the state level, yes.

Q Do individual hospitals have to cut errors 50 percent within five years? And if not, how do you realistically expect to reach that 50 percent reduction goal?

SENIOR ADMINISTRATION OFFICIAL: Well, first, hospitals have different rates of errors, we suspect, although we don't have much information on this at the present time. We're not suggesting that every hospital reduce its rate of errors by 50 percent. There are hospitals who have already instituted programs and have demonstrated substantial reductions already. But we do believe across the nation there should be a 50 percent reduction within five years, which was the Institute of Medicine's recommendation as well.

Q What are the keys to make sure that happens?

SENIOR ADMINISTRATION OFFICIAL: Well, let me explain. The approach that we're taking is, looking at all of the different levers that the federal government has in order to make that happen. Through the Health Care Financing Administration, we have conditions of participation that will require that every hospital have a patient safety program in place. Through the Food and Drug Administration, we will enhance the reporting system for adverse events of drugs. Through the VA and the Defense Department, we have exemplary programs that we think that the private sector will pick up on. Through the Agency for Health Care Research and Quality, we will institute a research program that will show best practices and demonstrate that they really are best.

So there's not a single program. We don't believe that this is such an easy problem that it can be answered with a single answer, but rather that multiple are going to be necessary.

Q A lot of attention has been paid to things like sawing off the wrong limb, leaving something in a body cavity during an operation. But the President also talked today about the difficulty of wrongful identification of drugs, sometimes having the wrong interaction between drugs, which is a little more prosaic. Do you have any percentage of the number of serious medical errors which are caused by the wrong drugs?

SENIOR ADMINISTRATION OFFICIAL: Yes, we do. We believe -- the data that's available, the best data that's available suggests that at least 7,000 deaths per year occur because of adverse events that are caused by drugs. About 10 percent of the admissions to hospitals in this country are caused by drugs that have an adverse effect, either because they were prescribed wrong, or because they may have been prescribed correctly, but they still had an adverse effect. So it is a very, very serious problem.

There are those who have calculated that between -- at least 19 percent, and as many as a quarter of the adverse events that occur in this country are due to drug errors.

Q A quarter of the adverse -- now, the study showed, what, 44,000 to 80,000-some odd deaths, so you're talking about presumably a quarter of that?

SENIOR ADMINISTRATION OFFICIAL: We're talking about different studies. One study said 19 percent to a quarter of the errors, not the deaths, but the errors are due to drug errors. Another study said that 7,000 of the deaths are due to drug-related errors. And let me emphasize also that these numbers that I'm quoting are in the context of somewhere between 2.5 and 4 percent of people who go into the hospital who have a serious event that occurs to them while they're in the hospital that was preventable.

Ironically, this is not just an American problem. The same numbers have come out of Australia and the United Kingdom. So we recognize that this is a global problem, not just an American problem.

Q Even if you achieve the worthy goal of reducing medical mistakes by 50 percent, they still count as one of the leading causes of death in this country. Are you raising the bar high enough with a 50 percent reduction?

SENIOR ADMINISTRATION OFFICIAL: We think that 50 percent is achievable. We would like to continue to make improvements beyond that, but let me give you an example of how we might be able to do better over a longer period of time.

The physicians who are anesthesiologists, the guys who basically put patients to sleep when they're getting surgery, started a program about two decades ago in which they looked for systematic ways in which they could prevent errors in the operating room. Changing the dials, for example, so that the dials in every operating room were consistent, and you wouldn't have to learn a new system every time you went to a new machine.

They have reduced the number of errors in anesthesiology seven-fold in two decades. And we're talking about a one-half fold decrease in five years. So I think what we can say is, we are confident that the 50 percent reduction is achievable. But I also think it's fair to say that we won't stop at five years, we'll continue to look for ways to improve beyond that as well.

Q What can a patient do?

SENIOR ADMINISTRATION OFFICIAL: What patients ought to do is to learn what measures -- what practices their hospitals ought to be putting into place in order to reduce errors. If I were a patient going to a hospital today, I'd want to know how the hospital dispensed drugs. I'd want to know if they had a computerized order entry system, if they had a double-check system in the pharmacy, if they had potassium chloride, for example, which is a very toxic drug, in concentrated forms on the unit. And, in fact, we have a list which has been put together by the National Patients Safety Partnership, led by the VA, of about 10 or 15 practices that every hospital ought to undertake.

But we're going to ask the Quality Forum, the group I mentioned earlier, to come up with a list that they will issue -- the hospitals, the purchasers, all these groups together will put together a list of practices that every hospital ought to have in place, and will make that available to the public very soon.

But let me just say one other issue about the individual patient, or person. I think there are certain things that people can do to be sure they're sharing decision-making with their physician, and that they're engaged in that decision-making process. Nothing could help that more than people asking questions, to be sure they understand what their drugs are, understand why their drugs are being given, and when they go back in to see the physician, bring those drugs with them to be sure that the right drugs were dispensed.

Q Are doctors being taught to educate more their patients in terms of what they're doing?

SENIOR ADMINISTRATION OFFICIAL: There are some model programs in medical schools and residency programs to educate physicians not only to share decision-making with their patients, but also to institute some of these best practices. The amount of education, though, in many medical schools is disappointing. The Senate Help Committee introduced legislation about a year and a half ago to institute special programs called Centers for Education and Research in Therapeutics across the country, which have now been established -- there are four of them around the country -- to try to do a better job of helping physicians to understand how they can reduce those errors.

Q One of the main criticisms of the New York system, which has a mandatory reporting system, is the information falls into a black hole at times, and that as a consumer, as a patient, unless you're in the know, you have no idea where to access that information. What's your goal for the states to do as far as patient -- or anyone -- public accessibility? I mean, one proposal in New York is that hospitals be made to post their reported errors. How do you envision -- how easy should it be for patients and the public to get the information?

SENIOR ADMINISTRATION OFFICIAL: Clearly, we want to make sure that it's accessible information for beneficiaries, for patients, for anyone -- family members. The issue is, though, as you present that information you need to make sure it's usable information that is comparable from institution to institution. And one thing that we have focused on in these recommendations is to develop appropriate comparable information standards to do that, and not only just to do that in a fair way for all the institutions, but in a presentable way for patients and their families.

You can have all the information you want, but if you can't understand what they're showing you, it doesn't mean anything. And one of the recommendations in the report that we've unveiled is working with the Quality Forum and others to develop that type of information. But we believe that just saying, go post the information, before you know how best to do that could be not as productive as it otherwise might be.

Q Can you describe exactly what needs to be in legislation in order to make this happen -- I mean, related to that comment?

SENIOR ADMINISTRATION OFFICIAL: Well, in our overall recommendations, in terms of our recommendations today, we have administrative actions that include the regulation for conditions of participation for all hospitals and the FDA standards. We have budget initiatives which will require congressional review and approval, ranging from funding VA and DOD and HHS for the development of the patient safety center. And then there's collaborations, I would suggest, with the state. And I'm sure, in fact, this upcoming week when the governors come, next week, we're going to have a whole health forum, and I'm sure this issue is going to come up as well with the governors.

Q -- in Congress?

SENIOR ADMINISTRATION OFFICIAL: Well, Congress -- again, the appropriation in the budget process they're going to have to be looking at those particular initiatives, yes -- as well as the center.

Q If they want to produce patient safety legislation, what can they put in it to be useful to you?

SENIOR ADMINISTRATION OFFICIAL: Well, I think clearly they've already indicated a desire to work with us to have adequate funding in these areas. The authorization for the development of this new Center within the arc. And I think also just any type -- there may be some new authority the FDA will require in doing some of the medication work that they're doing.

SENIOR ADMINISTRATION OFFICIAL: And the peer review protections will need congressional consideration as well.

SENIOR ADMINISTRATION OFFICIAL: Yes, which may be federal or state.

Q Does the government have a watchdog to ensure patient safety and making sure, you know, Medicare and Medicaid programs, you know, run well? Does it have one --

SENIOR ADMINISTRATION OFFICIAL: Well, the Health Care Financing Administration uses the peer review organizations as their method of monitoring and improving health care quality. So for the Medicare program, we count on the PROs. We also count on the accrediting organizations, like the Joint Commission for the Accreditation of Health Care Organizations and CQA, who accredit those organizations.

For physicians, as you know, physicians are licensed by the states and they get their certification from their professional societies. So it's fair to say there isn't a single place that would be the watchdog agency or the watchdog site. But there are multiple places in the health care system who have responsibility for assuring that patient safety is in place.

MR. KENNEDY: We'll take one more question.

Q Yes, given the widespread under-reporting in existing mandatory reporting programs in states that already have them, how do you intend to assure that reporting is done, that there's compliance? And also, do you contemplate any penalties for people who fail to report?

SENIOR ADMINISTRATION OFFICIAL: Well, let me answer the second part first. Because these are state programs, it's up to the states to decide what and whether they would have any penalties in place.

We believe, and consistent with one of the previous questions, that if this information is disseminated, and if it's safe -- if the peer review protections are in place, and the publicly disclosed information is limited to the lists that we both described earlier -- then we believe that there will be an incentive for people to report, because they'll learn from the reporting, and they'll be able to compare their institution with other institutions; further, that patients are going to be looking for that kind of information, not only to know that the hospital is safe, but that it has safe practices in place.

We believe that those kinds of incentives will increase the amount of reporting that occurs, and also increase the value of the disseminated information to the public.

SENIOR ADMINISTRATION OFFICIAL: Can I just add one last thing, and that is that -- and Joe's going to kill us, so -- okay -- is that if we're real successful at reducing the errors, at least the 50 percent, and our goal would be to eliminate all preventable errors, except we can't -- clearly that will also have the beneficial impact for all providers of avoiding unnecessary and expensive litigation associated with liability problems.

When people raise the issue of, I'm concerned about liability, it's sort of interesting to me, because if we do this right, if we do this well, this will remove a lot of the problems that people currently have with the liability concerns, because if you eliminate the errors in the first place, we believe that you can eliminate some of the excessive litigation that we're seeing in the health care delivery system right now.

Q Would you object to any putting together of this with patients' bill of rights out of Congress?

SENIOR ADMINISTRATION OFFICIAL: On that issue, getting a strong, enforceable patients' bill of rights done this year is a high priority. So, too, is this. We believe they're complementary initiatives. As long as one doesn't slow down the other, and does not ensure that neither gets done, we'd be open to that. But we would evaluate those in that context.

THE PRESS: Thank you.

END 2:20 P.M. EST