The James S. Brady Press Briefing Room
February 22, 2000 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: Do you have a target at three years?
Senior Administration Official: No later than three years is the
target.
Question: Right. But does something have to happen in three years,
specifically?
Senior Administration Official: At the state level, yes.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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.
Question: 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 decisionmaking 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.
Question: 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.
Question: 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.
Question: —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.
Question: 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.
Question: 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.
Question: 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.
Question: 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
Internet Citation:
Press Briefing by Senior Administration Officials on
President's Initiative to Reduce Medical Errors. The James S. Brady Press Briefing Room, February 22, 2000. From the White House Web site (http://www.whitehouse.gov).
http://www.ahrq.gov/wh22200brf.htm
540 Gaither Road Rockville, MD 20850