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National Summit on Medical Errors and Patient Safety Research

Media Availability Session

On September 11, 2000, as part of the Government's response to the Institute of Medicine's landmark November 1999 report, To Err is Human: Building a Safer Health System, the Federal Quality Interagency Coordination (QuIC) Task Force sponsored a national summit to help set a research agenda on medical errors and patient safety. During the summit, five panels of experts offered suggestions for what types of research the Government and the private sector need to conduct to help reduce and prevent future errors. Representatives from the panels were available to talk with the media during a noontime break.

DR. JOHN EISENBERG, QulC OPERATING CHAIR AND DIRECTOR, AGENCY FOR HEALTHCARE RESEARCH AND QUALITY: Greetings, and thank you for joining us. As you all know our goal in this conference is to talk about what we need in a national agenda for research in patient safety to reduce the number of medical errors and to reduce the magnitude and the impact of medical errors. And I just want to underscore that: we're here to talk about a research agenda on medical errors and patient safety.

Now as you all know, the Institute of Medicine had a report that came out in November that said that there are between 44,000 and 98,000 people who die in this country every year because of these problems in patient safety that cost about 29 billion dollars per year in additional healthcare costs. That's the challenge. It's the fifth to the eighth cause of death depending on which numbers you use. It is a big public health problem. It is a big problem in American healthcare.

Now if you think about the other problems that we have in healthcare in this country, like cancer and heart disease, and stroke and AIDS, you'll recognize that we have spent billions of dollars trying to investigate what the causes are and what the solutions are for those problems. And we've spent billions of dollars for years in these areas.

This is a long running investment, and we have to do the same in the area of medical errors. We're going to have to treat this like an epidemic. We're going to have to declare war on medical errors, and we're going to do that in the way we have with other diseases. We're going to do that through good research and then not just doing the research but being sure that that research gets translated into high quality and safe medical care.

Now, we know a lot more today than we're doing today and one of the problems is learning why we're not putting into effect what we already know. But beyond that there's a lot more that we need to know about what the reasons for these errors are and about what the solutions for these medical errors are. So we're going to need to learn to put into place what we already know, but we're going to need also to learn more. That's going to require a plan, a battle plan if you will, if this is a war on medical errors. It's going to require a plan that's going to come out of a conference like today's on what the research agenda is. We're listening to the users of the research.

There are three key words that describe this session today. One of them is that the people who are on the panel are the funders of research. And we're listening to those who are going to use the research because they know better than anybody what research is needed in order to move this field along. So far this morning we have had a number of excellent suggestions about the kind of research that ought to be sponsored and this afternoon's panel will give us more.

Now I'm sure you've been thinking about a lot of questions that you'd like to ask the witnesses about the research agenda, about how we're going to take these challenges in patient safety and learn more, to develop a research agenda for this country.

So now is your chance. We've got six people, from whom you're going to hear in a few minutes and they're going to represent each of the panels from whom you've heard in today's summit. I'm going to ask each of them to give a very brief, about two minutes, opening comment. I'll ask that you hold your questions until after we've heard them. But they promise to be brief so that there's lots of time for you to ask questions of them at the end.

We've got Susan Sheridan a consumer from Boise, Idaho, Steve Wetzell from the Leapfrog Group. We've got Robert Crane from Kaiser Permanente, Michael Cohen from the Institute for Safe Medication Practices, Marie Dotseth from the Minnesota Department of Health, and Tim Flaherty from the American Medical Association.

So why don't we start with you Sue Sheridan.

SUSAN SHERIDAN, CONSUMER FROM BOISE IDAHO: Thank you. I'll try to keep this brief. I was asked to represent consumers because two of my family members have been injured due to medical errors. My son who was born in 1995 at St. Luke's of Boise Idaho suffered brain damage from jaundice, a very very common condition, that was due to a blood incompatibility.

My son, as I mentioned earlier is starting kindergarten today, and he is unable to walk or crawl, and he is hearing and speech impaired, all because of a failure in the system that was entirely preventable. A $27 test could have prevented his condition.

Four years later, my husband was diagnosed with a tumor in his neck, and it was removed by a top institution in the nation. It was declared benign, and he was told to go home and live his life. However, six months later the tumor returned, much larger and aggressively, and this time it grew into his spinal cord. And, as we know, spinal cords can't be removed. It wasn't until the day of discharge that we requested all of my husband's medical records, and we found that the first surgery did indicate that it was a malignant sarcoma. But the pathology was dated 23 days later and was never, ever, communicated to us.

So the areas of research that I propose are, well, number one, which is probably the toughest, how do you restore ethics to the medical system? I think it's too easy for doctors and hospitals to cover up what has happened to patients, and this has a terrible effect on the reporting, and then the reaction to the reporting.

The second area is, I believe, that there should be mandatory standards, policy procedures at hospitals. My son's condition and my husband's condition could have been prevented by mandatory policies and procedures.

The third area is, I think, that the monitoring of competencies of doctors and nurses must be looked at, that there must be an ongoing system of evaluation and assessment.

And then the fourth area that they touch on, that is very unclear to me, is what is the role of the consumer? How are consumers informed of how to report medical errors? Is there a formal system? Who are all these entities that regulate or are involved in the regulation of hospitals? What are their responsibilities and how do they let us know who they are?

So those are the topics of research that I see. We need to look at how can we make the system more user friendly. How do we empower the consumer? I think from our experience, the consumer has been left out of the loop. We've got to get him back in there, and hopefully we can make a difference.

STEVE WETZELL, LEAPFROG GROUP: Good afternoon everybody, I'm Steve Wetzell. I'm representing our organization called the Leapfrog Group. We're a coalition of employers and businesses from across the country that have come together to try to use our influence as purchasers to advance the cause of patient safety and the quality of American healthcare.

Some of our founding members are General Motors, GE, GTE, the Buyers Health Care Action Group in the twin cities of Minneapolis and St. Paul, and the Pacific Business Group on Health. And we are sponsored by the Business Roundtable, with a three year initiative to see what purchasers can do to advance the cause of patient safety. We come at this from the perspective that the reason we're not getting the kind of safety and quality that American consumers deserve is because the market hasn't really had the incentives to reward providers for focusing on those important issues.

And that's where we come in as purchasers. More than 60 percent of Americans get their healthcare through their employers, probably another quarter get their healthcare through government programs. So we think that government and private purchasers have a role to play in advancing the cause of patient safety. That's what we're all about. We're writing standards into our purchasing requirements that are designed to drive patient safety into the healthcare marketplace and we're also trying to do a better job of getting our employees and our family members involved in understanding that there are differences in quality in the system, that it is worth paying attention to safety issues. And we need to give them the data and the opportunity to protect their rights and their interests in the healthcare market as much as they do when they get on an airplane.

So that creates, in our mind, a number of research opportunities. The first is, is there a case for purchasers to get involved in this? Will employers and government see a payback if, as group purchasers, we start advancing the cause of patient safety? That is an untested concept that we think is worth researching.

Also, as we start putting specifications in our contracts that are designed to reward patient safety, the question is will it make a difference? Will it actually improve safety or not? And we think that's worth spending some money on to find out. And also what kind of incentives will improve safety and make the system work better for consumers? Should we be punitive? Should we offer rewards? Is it regulations? Is it just disclosure of data? Again, it's untested ground, and that's an indictment of how poor a job we've done in the past, but the bottom line is we're not sure what incentive is really going to drive the right behavior in the market to try improve safety.

We also would like to learn more about how to engage consumers. We've heard an example from somebody who got engaged in the most horrible way imaginable today, and we need to get people engaged before that happens, so they have the data and the knowledge to protect their interests by going to the right places that are going to do the best job. And we're not sure how to do that. What information do they need? How can we best reach them? And how can we activate consumers to protect their own interests in healthcare because our belief is that today they don't have the tools or the opportunity to do that.

The other question we have is how do we make hospitals safer? We're focusing on three or four areas: intensive care unit staffing, prescription drug ordering, things of that nature that clearly will have an impact. But what is the best way to advance in-patient safety, and how do we go about doing that? Also, because more and more care is being delivered on an out-patient or in an ambulatory setting, what is the best way we can advance patient safety and quality in an ambulatory environment?

So that's our short list of things. We'd like to applaud John's group and all the other foundations and funding agencies for being here on this important topic, and we're excited to be here and look forward to your questions.

ROBERT CRANE, KAISER PERMANENTE INSTITUTE FOR HEALTH POLICY: Good afternoon. I'm Robert Crane, Senior Vice President with Kaiser Permanente. Kaiser Permanente is a non profit, pre-paid, integrated healthcare delivery system serving 8 million Americans in 11 States and the District of Columbia. And we brought to the forum five large categories of areas for research for improving patient safety.

The first is understanding best practices and better understanding outcomes, and the ways in which those practices can be put into effect, implemented.

The second area has to do with human factors and systems engineering. The healthcare system can learn a great from the airline industry that has for years used these approaches in understanding how the machine-human interface works to avoid errors.

The third area is the better understanding of the use of technology and the way in which technology may be used to reduce errors and improve patient safety. There are a range of suggestions that have been made in this area, and they all cost a lot of money, and one of the areas for research is to understand what are the most effective ways that we can move forward in this area.

The fourth area has to do with reporting medical errors. The IOM report recommended that we establish a nationwide state-based system of mandatory reporting. There are state systems in existence and they represent a laboratory for understanding what elements of those systems most effectively can move patient safety reporting forward.

And then, fifth, culture and environment. Speaker after speaker today talked about the importance of culture and the environment, and moving from an environment that is blaming to one that is blame-free and learning. There a variety of ways that research projects can focus on that issue.

One specific way is design of a measurement of how blame-free our current healthcare environment is and we believe that AHRQ can move forward on that agenda.

The final point I'd like to make has to do with the confidentiality of data that comes out of research that is going on. It will be important to fashion confidentiality, particularly if the information that is generated with institutions is going to be shared in a broader array. And we recommend that the Agency for Healthcare Research and Quality pull together the various interest groups to try to find a way to assure appropriate confidentiality of information, to stimulate as broad a base of research for patient safety as possible

Thank you.

MICHAEL COHEN, INSTITUTE FOR SAFE MEDICATION PRACTICES: I'm Michael Cohen. I'm a pharmacist, and I head up the Institute for Safe Medication Practices. ISMP is a non-profit organization and it's interdisciplinary; we have nurses, pharmacists and physicians that interact.

Many years ago we started a reporting program looking specifically at medication errors or errors that were related to devices when medications were involved. And over the years it's grown. We have 17 different monthly publications now, and various columns, journals, newsletters, etc. In 1996, in January, we began a biweekly publication called The ISMP Medication Safety Alert, which communicates this information to hospitals and other organizations around the country. As a matter of fact, pretty much every hospital gets our information through the Safety Alert.

The program itself is a national reporting program for medication error. Specifically it's operated by the United States Pharmacopeia which is located in Rockville. And we also interact with the Food and Drug Administration. They have an Office of Post-Marketing Drug Risk Assessment which looks at medication errors. We interact with FDA and USP which is a standards-setting organization, and many others as well. Our information is communicated at all levels of healthcare, including the pharmaceutical industry, and regulatory authorities, standards-setting organizations, etc.

And I guess the frustration for many of us in healthcare and those of working in medical safety has been that the information that is available, that is known, either based on the reporting programs or on research that's been done in the field, is not being incorporated in a consistent manner nationwide. And our recommendation then is to understand better why, what are the barriers?

Too often, we've seen the same types of errors repeating themselves, and we know darn well that they're going to continue. The first error that we ever reported, for example, had to do with an abbreviation for the word "unit". For example with insulin administration, the drug is measured in units and the word "unit" is abbreviated with a "U". Many times we've seen people abbreviate six units as "6 U" which can easily be misread as "60". That was our first error, recorded in 1975, and I'm sorry to say that we still see it used in hospitals today, sometimes to the detriment of the patients that we care for, because it causes an overdose and CNS impairment and sometimes death.

Why haven't our medical schools and our pharmacy schools incorporated this learning? Why haven't our oversight organizations like the Departments of Health, for example, in each State, and so on, put this information to use and provided some type of oversight? I can tell you that there's a national organization that's composed of FDA and the Joint Commission and many others that has developed, for example, a whole list of abbreviations that are dangerous and should never be used. And it might sound trivial to you, but they are still used and they still cause serious errors. And unfortunately there's no oversight to make sure that this is followed. This is just one small area.

We also think that we need some research to learn what effective communication strategies are needed. It's more than just medication errors, as someone on the panel pointed out. We need communication about other types of errors as well, and it's got to go to all levels of health care including the consumers. There are things that you as consumers can do to prevent the possibility of error.

We also need to do some research to learn what types of reporting programs would best serve our nation, and we also need to look at ways that we could benchmark and learn from organizations that have developed best practices that should be emulated by other organizations. And we truly do not know how to do that yet with medical error.

Thank you.

MARIE DOTSETH, MINNESOTA DEPARTMENT OF HEALTH: Hi. I'm Marie Dotseth from the Minnesota Department of Health. I'm here today asking this fantastic group of panelists to consider research opportunities particularly around medical errors reporting systems from the perspective of a State regulator and State public health agency.

Policy makers, particularly State legislators, are going to feel compelled to act quickly in reponse to public pressure around this issue. And it's becoming evident that the most likely response is going to be to establish a mandatory reporting system at the State level.

And in fact the Federal Government has requested States to have these reporting systems implemented within three years. State regulators and legislators have questions and actually need assistance in developing these systems. We want them to be effective and efficient, and we need to be acutely aware of the complex balance between State and Federal regulators, State medical boards, providers, and private accrediting organizations, and the legal system.

Some of the questions we have for the panel today:

What's the best definition for medical error?

How can States assure accountability of data at all levels?

What's the appropriate combination of mandatory and voluntary reporting?

What are the effects of various State and, in fact, international malpractice laws on the level and quality of medical error reporting?

What's the cost versus benefit of some of this medical error reporting? And cost meaning not only cost to us as a State agency or the Federal Government, but cost to the entire system, versus the benefit in terms of actual healthcare quality improvement.

Probably our most important question is how mandatory reporting systems, or any reporting system, will best use the information they collect to really effect a major change in healthcare quality at the provider level.

Most of these issues have been prioritized already by AHRQ, and we're just here to validate that these are in fact the questions we need answers to, and the sooner the better.

Minnesota has a strong track record of high quality healthcare, but in terms of our State Agencies' response to this issue, we're here to learn and to share our questions and concerns. We want to make sure that before we set up or add requirements to a potentially costly reporting system that we are reasonably confident these reporting systems will get us a measurable improvement in patient safety and health quality.

Contrary to popular belief, State regulators do not want to collect data for its own sake. Summits like this and the subsequent research that comes from it will help us learn how to implement an effective system.

Thank you.

TIMOTHY FLAHERTY, AMERICAN MEDICAL ASSOCIATION: Good afternoon. I'm Dr. Tim Flaherty. I'm the Chair-elect of the American Medical Association Board of Trustees and a member of the National Patient Safety Foundation Board, which was established by the AMA in 1997. I'm going to be brief, but asking me to be brief is like asking me to be thin. I'll read my prepared statement, so I'll stay on time, John, so there won't be any overrun.

AMA was founded to promote patient safety. We have been there for over 150 years doing that and patients have a right to expect that their care is going to be provided in a culture of safety throughout the healthcare system. Preventable injuries must be identified, diagnosed and eliminated through methods that maximize safety and quality while minimizing secrecy, blame, and retribution, which you've heard about today.

To accomplish this we must work together to design and implement a scientifically valid, evidence-based research program. Valid research is critical to the design, implementation and evaluation of practical programs to learn about and prevent health system errors. Research must be supported by proven ways to disseminate prevention strategies and to monitor the implementation of those strategies. Research can only be valid and reliable if it's confidential, non-punitive, and oriented to professional and organizational learning.

It is critical that every element of the healthcare system participate in providing research data, searching for solutions, and disseminating and implementing those best practices. Physicians and other healthcare professionals will always be essential to the collection of patient safety data. However, research on such data is only meaningful if it relates directly to patient care in the clinical setting.

Collecting data simply for the sake of collecting data is a waste of precious healthcare resources. The research community must work closely with the practicing community if research is to be relevant. We know that right now there are many States that are simply warehousing data, and I make the analogy to the geologist as compared to the rock collector. The geologist looks for answers and history and formations. The rock collector just collects rocks. But we have to have that research data if efforts to move that patient safety reporting system for gathering data is going to be something that we can all use and develop from.

Physicians clearly recognize the responsibilities that are inherent to professionalism and accountability. It is critical that effective patient safety research be designed and, learning from, not retribution for, improvement for, not control, and collaboration, not mutual blaming be the way we go. Research designed with patients in mind is the first step to implementing a culture of safety for the entire healthcare system.

Thank you.

MODERATOR: Our six guests will please now stand, and Dr. Eisenberg will recognize questioners. Please identify your media outlet before asking a question. Thank you.

JOHN EISENBERG: And let me make one thing clear while people are coming up that this is a session sponsored by the Quality Interagency Coordination Task Force, which is a consortium of Federal Agencies appointed by President Clinton and Vice-President Gore to help us to come together for collaboration. But the five research-oriented agencies who are co-sponsoring this are joined by seven foundations, three other countries, and two delivery organizations who sponsor research.

All the people on the panel are those who sponsor research.

Yes, sir.

IRV CHAPMAN, BLOOMBERG RADIO: You said that there are any number of things that are already known, just not being adequately applied. We heard one example, related to pharmacy, but could you tell me what you meant by that? What is already known that's not being applied? And why?

JOHN EISENBERG: Well, there has been some research in the area of patient safety that demonstrates that certain interventions, such as a computerized order entry system, will work to eliminate errors in handwriting. And what we need to do is to apply those systems so that we understand how effective they are, when they are most effective, and in fact whether there are any adverse effects of those new technologies, so that we can start to apply those things that we have already learned about in the past. Let me also see if anybody else wants to add to this.

CHAPMAN: So is it that the worst thing that happens in hospitals happens because doctors and other personnel don't communicate either orally or in writing, explicitly and clearly?

JOHN EISENBERG: What happens in a hospital is much like what happens in any other team, when hand offs are fumbled or passes are dropped. There is a problem in communication and transfer of the object of our efforts, which is the patient. It's very critical that that communication occurs, both of the information and of the material that goes around in a hospital and this is one example of it.

Mike, do you want to add to that?

COHEN: Yes, let me just respond, too. With the computerized prescribing, we know from research that about a 55 percent reduction in prescribing errors can be had with implementation of the system. There are many barriers to doing this. They're tremendously costly. Not that that isn't something we shouldn't pursue, but we have to be sure that we have the types of systems that we can easily implement and see widespread use with.

But, it goes beyond just the handwriting. It's also the merging of patient and drug information that makes for the 55 percent reduction. For example, sometimes people prescribe, and it's absolutely impossible for anyone to know everything that they need to know, as far as every drug that could interact with one another, every lab test that might be affected, all the types of adverse events. But with the computerization, and merging of the patient information, their age, their weight, their sex, their height, their pregnancy status, renal function, kidney function, etc., with the drug information, we would be able to rapidly identify for the physician that this drug should be reduced, the dose should be reduced, for this particular patient, or that it shouldn't be used, etc. etc.

There are many other areas that research has proven would reduce the possibility of errors. One that I have seen recently was a 66 percent reduction with a pharmacist present in the intensive care unit. And it's also experiential evidence that errors can be reduced.

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