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Transcript of Web-assisted Teleconference (continued)

Session 2: How Can States and Institutions Work Together to Create a Culture of Safety?

Can You Minimize Health Care Costs by Improving Patient Safety?


Before going to questions, however, I would like to say a few words about our sponsor. The mission of AHRQ is to develop and disseminate research-based information that will help clinicians and other health care stakeholders make decisions to improve health care quality and promote efficiency in the way that health care is delivered.

As you will be hearing during the course of this Web-assisted audio conference call, AHRQ has sponsored some valuable research that is directly relevant to patient safety. AHRQ's User Liaison Program serves as a bridge between researchers and State and local policymakers. ULP not only brings research information to policymakers so that you are better informed; ULP brings your questions back to AHRQ researchers so that they are aware of priorities at the State and local level. Hundreds of State and local officials participate in ULP workshops every year.

We will have audiotapes of this Web-assisted audio conference series available for purchase after all three events are completed and I will give further details about this at the end of today's show.

You may request copies of the slides presented in this series by sending an E-mail message to info@ahrq.gov and please indicate whether you would like the slides to the entire series or for specific presentations.

Finally, an archive of these events will also be available on the AHRQ/ULP Web site. The URL is http://www.ahrq.gov/news/ulpix.htm and that will be available in the next several weeks.

We would appreciate any feedback about today's program and at the end of the broadcast a brief evaluation form will appear on your screen. Easy-to-follow instructions are included on how to fill it out and alternatively you can E-mail your comments to the AHRQ User Liaison Program at info@ahrq.gov. So we do ask you to call in or write in because we would like to hear from you. I am going to go around now and ask some questions from the presenters.

Marge, let's start with you. You talked about perceived risk in your opening. What do you think those risks are?

Marge Keyes: I think one of the concerns that has been bubbling up pretty vociferously lately is the issues revolving around confidentiality, privacy and the implementation of HIPAA. People either perceive these to be real issues or in fact they may be real issues. I think the comment that came out of the business case scenario was related to the ability to work around the perceptions that they are actually barriers.

Cindy DiBiasi: And to see them as?

Marge Keyes: They are issues that they have to be worked around, but they may not necessarily be impediments that cannot be overcome. I think researchers that I have listened to over the last several weeks in a variety of different conferences and conference calls sponsored by the agency and others have also suggested the very same thing.

Cindy DiBiasi: Let's talk about this because as you said, this really is a very hot issue right now. For all of you, what do you feel is the public's right to know? Is there a line that we need to draw here?

Scott Williams: Well, it depends on whether you are talking about individual information or aggregate information. Obviously the public doesn't really have I don't think much of a right to know about individual cases. That is personal medical information. Sometimes those cases end up in the media but I don't think it is either the industry's or the State's role to be the disseminator of that information. Sometimes we have to use aggregate. The aggregate data is much more difficult because there is concern, as Marge just said about, some of the liability issues and whether a case against a hospital, whether that information is discoverable, the aggregate experiences of that institution and dealing with patient safety issues and that is discoverable and could be applied to an individual liability case in court. I think some of those questions still need some work. As Marge said, they are not barriers that cannot be overcome, but we may need some clear guidelines as to how this information could be used.

Cindy DiBiasi: Because we are talking about potentially releasing information on specific doctors that might be, are those issues that we have to, naming names on the other side, not from the patient's point of view but from the hospital point of view, the doctor's point of view practicing, people involved.

Scott Williams: Right. That has a chilling effect on both individuals with interest in participating. Although at some point the accountability has to be public and so I think we just have to move fairly methodically and slowly so that we make sure that the public's knowledge about this is balanced with the provider's, protection of the provider's reputation. This data isn't always that easy to present in a clear way.

Cindy DiBiasi: You were talking a bit about AHRQ's Patient Safety Improvement Corps. What topics would you like to see covered? What specific topics would you like to see covered?

Scott Williams: Actually that was talked about by Marge. But we have an interest in that because as we work on that area, we realized that we are sort of in new territory. One of the things I think we would really like to see is improvement in the lexicons. It is the language that we used in the standards. What is a serious, reportable event? How is that defined and how are we all going to work on that? There is work being done on that which we are very much looking forward to. Seeing the outcome of and applying, we can change our rule in Utah as that language becomes more specific or more standardized nationally. So that is one of the issues.

The "what works" stuff and especially as Julie mentioned, the Harvard Executive Sessions and how you engage leadership change, those kinds of things are very interesting to us. How to do a better job of looking at how root cause analysis is done and doing it because we find a fairly wide variation across our hospitals and the approach to that.

Then the finance thing of this whole thing is really important both to us, in terms of the capacity we need to do our job and also the industry's capacity to do it. Where is the financing going to come from to really do the job that needs to be done and then as I mentioned the involving of patients and families which is kind of a new area for a lot of us. How do you really move that forward in a way that isn't just cosmetic but helps to contribute to that culture change?

Cindy DiBiasi: Is Utah's program, is the program in your State one of the leading programs? It seems like as soon as that IOM report came out you were really I guess a combination of personal and professional reasons and the chips falling in the right places, went ahead, full steam on this. Are there other States doing similar things? If so, where are you in that range?

Scott Williams: I think there are many other States. Massachusetts has been at this far longer than we have. I think we, as I said at the beginning, responded to the set of conditions of, the cards we were dealt and so we have been able to take that particular set of cards and move it forward. I find that, and Marge may know this better than I, I think many States have put some sort of either statutory or rule-based or cooperative voluntary programs into place but we put ours into rule. I think one of the reasons we were able to do it quickly is we chose not to go with the statutes because we felt like our health department had the authority already. Going through the legislative process with this is such a complex topic. We were not sure that we would get out the other end what we really felt needed to be done.

Cindy DiBiasi: Marge, we talked about evidence-based practices. What criteria were used to evaluate the evidence-based practices?

Marge Keyes: There were a number of criteria, but I think the overriding issue when the practices were identified and there was this four-person editorial board that was related to reviewing all this evidence in addition to the numbers of individuals that were participating in this. Before that I talked about it, they had to ask themselves if I wanted to improve patient safety at my institution over the next three years and resources were not a significant factor, how would I grade this practice? So that was the generic level. Then they went on to look at the potential impact of the practice's effectiveness, the strength of the supporting evidence in terms of its relative weight, its effect size, the need for vigilance to reduce any potential negative collateral affects and I think that is one thing people need to keep in mind, because any time you institute a new procedure or practice, there are certainly consequences for everything that is done and some of them may be unanticipated and they may be negative.

Cindy DiBiasi: Now, does AHRQ have any plans for further research on the practices that were identified to be in need of more research?

Marge Keyes: Well, there were two ways that we are addressing that. We have something called Program Announcement that includes, and these are general, very generic calls for research that includes patient safety in a number of different areas. Individuals who are interested in pursuing these practices, pursuing research in those areas could certainly submit grant applications in that regard.

Also we have a contract with the National Quality Forum(NQF) to follow up on our patient safety practices and they are developing a compendium which I think is being released, was just released in its second draft on Friday, that goes through their consensus development process. Part of the work that they were supposed to do is also identify those areas where they think further research is needed. So it is through those two general veins that we are following up on this.

Cindy DiBiasi: Now, the IOM report is fairly new, but patient safety is not something that suddenly became an issue in the last few years. If you look at the continuum of where we are, from the beginning of time when records were kept, how do you see this issue?

Marge Keyes: I think the label "patient safety" is relatively new. It is certainly embedded to some degree in and around quality improvement, but there have been a few patient safety researchers who have been conducting work for quite some time, but the available funding has been very, very sparse. So it wasn't until about a year and a half ago that the funding became more readily available.

Cindy DiBiasi: That is the question that I asked Scott earlier about where Utah falls. Are States really picking up the pace here in terms of stepping up to the plate on these things?

Marge Keyes: Well, I can only mention two other States. I think there are certainly others that are pursuing patient safety reporting systems but in the evaluation grants that Scott had talked about earlier which his organization is a recipient of one, we also are including New York and Massachusetts so there is work ongoing there to evaluate those reporting systems as well. I am sure there are many others that are ongoing.

Scott Williams: Pennsylvania has put in legislation that addresses patient safety connected to their challenges with malpractice insurance premiums. I know Georgia is also considering them and Oregon is considering them so several States are on this path.

Cindy DiBiasi: Julie, when you were talking about hospital leaders, what leadership positions were you referring to?

Julie Morath: I was starting at the Board. The Board of Leadership Consumer Panels Positional Leaders such as CEO, COO, vice presidents. But also the leaders of our professional and medical staff as well as informal and attitude leaders. How these individuals respond to error making, how they respond to medical accidents and how they understand the experience with the environment really sets the tone for success or not in patient safety.

Cindy DiBiasi: It is really an issue that has got to come from the top down, not from the bottom up.

Julie Morath: It has to come from both. I think there has to be an engaged, energized front line staff knowing that when they call out a report, a hazard, a risk, a vulnerability, or error making that it will be taken into account and effective action will result.

Cindy DiBiasi: Let's talk a little bit more, Marge, about the Corps. When do you expect the Corps to be operational?

Marge Keyes: I had mentioned that we expect people to actually be trained and back out in the field in late 2003 or early 2004. I can't go into too much detail about this because it is a procurement that has not been released to the public yet so we are currently working on that. But those are the deadlines that we anticipate.

Cindy DiBiasi: Can you tell us how State officials would apply to participate in the Corps?

Marge Keyes: I think it is probably too early, premature in the process to be able to talk about that.

Cindy DiBiasi: OK. Julie, can you tell us how AHRQ's Patient Safety Improvement Corps might complement your efforts?

Julie Morath: I have a number of thoughts on that. If I might just talk about the reporting for just a moment. I think the enlightened view of Scott and his colleagues as well as the AHRQ tells us that the suppressed air will prevent any ability to learn, predict and prevent. But that is different than individual malfeasance, impairment, felony and intentional violation or failure to learn over time. Those are barriers and must be dealt with administratively and through a legislative process.

I think the Patient Safety Corps is a structure to present ideas, to generate new ideas, provide us designs and methods to evaluate the effectiveness of interventions, help others replicate those that work and their strength has always been in the deployment and dissemination of strategies within and across organizations.

Cindy DiBiasi: Scott, do you think regulation can be used to encourage some of the seven principles from the Patient's Safety Manifesto that Julie talked about?

Scott Williams: I think it can be used to incur it, but as opposed to the traditional approach to licensing where we go in and say you have to do A, B, and C and we are going to come in and inspect to make sure.

We have tried to take a different approach. In fact, our Patient Safety Program, there is a fire wall between our licensing system and our Patient Safety Program because we didn't want people to believe that any of this information was going to cross over to licensing and become part of their licensing process. So we have regulations, but it is regulation requiring hospitals to do something that won't affect their license. There are penalties if they don't do it, that we have tried to be sort of a softer approach on that. If a hospital is really recalcitrant, we could go in.

Cindy DiBiasi: What types of penalties are you talking about?

Scott Williams: Well, there are some civil monetary penalties. If the hospital just simply refuses to report to us, their sentinel events are there and they refuse to develop a patient safety program. We put those in because there is actually a requirement that administrative rules have some sort of penalty in them. So it wasn't something that we put in there ourselves. It does serve as a check and balance if you happen to have a facility that really was in trouble and was just ignoring all of this and you could go in and kind of push it a little bit.

But if we end up relying on that to have the majority of the hospitals comply, then I think we have missed the boat. Really, again, this was at two of the hospitals developed together to say we all need to do this together. No one can compete on cost at the expense of quality. So what we are trying to do, the only way that this information can get over into licensing is if the hospital reports a sentinel event to us, to our review of their root cause analysis we find that they haven't taken the event seriously, that their recommendations are way too limited compared to the event that occurred. We file a dissenting report about their root cause analysis outcome. They can appeal that to an administrative law judge. If the administrative law judge upholds our dissenting report, then it can get transferred into their licensing file.

But my expectation is that will probably never happen. It is a mechanism to assure that a recalcitrant hospital could be moved to that direction. But again, if we are pushing this that hard, then it means that hospital probably has a lot more problems to address than just this.

Cindy DiBiasi: Let's talk about some of the pitfalls State officials face in trying to encourage patient safety improvements.

Julie Morath: I think if we just reversed everything Scott said and found another State that wasn't following that pattern, you certainly would have a pitfall. The ones that jump out at me are that if the State takes on a watchdog versus a partnership relationship with the hospitals and health care organizations, real work around patient safety and alignment will not occur.

I think the policymakers and the State organizations are often distant from the real phenomenon and complexity of care being delivered today. So again the partnership is important to understand the environment in which this phenomenon is taking place. The need to balance public accountability and expectations which are often for heads to roll when things go wrong and to be able to restrain from that immediate response to create the space for real learning and improvement to take place.

Cindy DiBiasi: Julie, how has Children's worked with the State through the statewide coalition?

Julie Morath: We are working with the State in a number of ways. We have a very expansive collaborative through the Minnesota Hospital and Healthcare program in which the State as well as professional organizations and hospital leaderships have come together. We have a program called MAPS that is looking at best practices in patient safety and developing collaboratives that systematically implement those.

Cindy DiBiasi: Have you received interest from other facilities about the work that you are doing at Children's?

Julie Morath: Continually.

Cindy DiBiasi: I guess that would be a complement. What are the questions and what types of issues do they usually approach you with?

Julie Morath: One of the first questions that I always get is where do you start and what are three or four bullet points? But when you are working with broad range cultural change and the complexity of patient safety, it is a story; it is not a bullet point. So helping people first understand their own experience and then developing strategies that work within inside their own organization is most effective.

We receive about 72 requests for information a month.

Cindy DiBiasi: Do you notice that when you are giving the advice back that you can sort of put it into different buckets depending on different characteristics of the facilities? Are there some similar trends that you see across certain health care facilities?

Julie Morath: What I am most attuned to and hear most about is professional staff who are very interested in mobilizing but can't get their senior leadership there yet. So leadership support and strategies to engage that seems to be the predominance of the consultations that I am asked about.

The other is around establishing blameless yet accountable reporting systems within an organization and strategies to move the stories around and learn from them. The third is very specific tactics to mobilize frontline providers to get engaged in patient safety at a local level.

Scott Williams: That is why we are so interested in her first point about how you can engage the leadership which is why we are so interested in hearing about their Harvard Executive Session because the patient safety courses that we have held in the State of Utah, when you looked around at who was attending those, it was kind of a choir who is there. It is risk managers and the nursing unit directors and people who have actually had a lot of background and they are kind of fine tuning their knowledge, but they are not able to get that culture change alone. It is sort of a "change sandwich" as people say. Kind of bottom up and top down. The bottom up part is there, but they don't know how to create the top down part. Those senior executives in hospitals tend to not attend those kinds of meetings very much. So you really need a very different kind of experience for them to get them engaged.

Cindy DiBiasi: What is that experience?

Scott Williams: That is what Julie is going to tell us after she gets done.

Cindy DiBiasi: (Laughing) Not to put any pressure on you Julie. We have a question from Eileen Henshaw and her question is can someone address patient safety initiatives with respect to nursing homes and their liability insurance? Also the relationship between mandatory reporting statutes and patient safety initiatives, some speakers can see the circumstances under which serious events would need to be reported to regulatory authorities for media attention. For example, the abuse or neglect of nursing home residents.

Scott Williams: We are looking at moving this into where the nursing homes are for a couple of reasons. One is we believe that there is at least as many if not more of these kinds of events occurring in nursing homes because of the complexity of the patients and the resource problems with staffing.

The other reason we are looking at it is that we believe there is actually Federal funding available through the Civil Monetary Penalties that States collect for nursing home violations that can be used to staff a State-level process of doing patient safety but it has to be connected to the nursing home industry so we have actually looked at that.

In terms of connected to their liability insurance, I am not sure that I can address that specifically. It sort of makes me worry anytime we make a sort of quid pro quo promise about these things that if you do this, then your premiums will go down because I don't know that a lot of the insurance industry's problem right now has to do with the status of their investment portfolios, not so much the award. That is part of it but their investment portfolios are what is driving their premium issues a lot right now. So I don't know that we can promise a turnaround in that, at least not in the short term.

Cindy DiBiasi: Do you see any differences in trying to engage in the leadership of nursing homes versus the leadership in different types of facilities or is it the same issue?

Scott Williams: I think it is the same kind of process, just a different arena.

Julie Morath: I would agree. But I do think that insurers and payers more and more are asking organizations for evidence of their work and patient safety. What they are doing based on what evidence and what their findings are.

Scott Williams: One we haven't talked about also is payers. What are payers going to do related to this and how are they going to make sure that they are in the game and align their incentives with what the rest of us are trying.

Cindy DiBiasi: A question from Valerie Barowski. She says Pennsylvania is considering implementing some form of patient safety legislation. What suggestions do you have for such legislation, specifically what do you think is the most important thing to address? Scott?

Scott Williams: Well, I just keep going back to the IOM report. I think it was so well conceived, what was put down there and it has been a good guide for us. I think you start with sentinels and the reason you do that isn't so much, at least from my point of view because you make a huge improvement in patient safety. Those are rare events. They don't occur that often in any one facility. You can learn from them. But that is only 10% or less of the kinds of things that occur. So that 80/20 or in this case maybe the 5/95% rule is most of what you are going to get out of the facility looking at those kinds of events that aren't the big, headline grabbing events that are going to change their culture.

So in addition to the sentinel event reporting, you need to make sure the facilities, and this is the other part of the IOM, have an internal system where they are looking at patient safety issues internally but don't necessarily have to report each individual event to a mandatory reporting system.

So if you could get those two things in place some how, I think you have gone a long way. Then I think we are going to have to live with those systems for a couple, three years and fine tune them and make them better.

I think one of the things that we feel good about is that we started down this path with the industry. Even if our reporting system ends up being the wrong one and we scrap it and have to start over, we will all be there. The industry and the State will be at that point in time together and we will make that decision together. It is sort of a learning process that we are going through that we want to be part of that evolution and the development process.

Cindy DiBiasi: At least off the table.

Scott Williams: Yes.

Marge Keyes: I think one of the things that might be helpful too, and this is a little bit on the long-term side I guess is that the reporting evaluation demonstrations that I was talking about earlier, those were three-year grants, one year which has already passed. So somewhere between two and three years from now, information on those reporting projects will be in place and Congress certainly has a very strong interest in the results of those particular projects. They are looking at wanting to divide reporting systems into those required or mandatory reporting, voluntary reporting and mandatory reporting that includes telling patients and/or their families. So that information will be forthcoming. But not in the very near term.

Cindy DiBiasi: Regarding a collection of data for patient safety, we have a listener who wants to know how confidential is the information from organizations like Protection and Advocacy Services or other advocacy organizations?

Scott Williams: Well, again the data reported to us, if it is individual patient data it is protected under GRAMA, the Government Records Access and Management Act, so we don't have an obligation to release any individual data. When the data is reported to us about the sentinel event, we don't know the name of the patient that it occurred to. We decided to take that out. We just want to know about the event and what is being done about it.

Aggregate data is still a bit of a challenge because when you say how many events did hospital X report during the last three years, we don't have the same kinds of GRAMA protections for releasing that information. We are still working that through. We believe that we can put that in context and we have decided intentionally not to create official aggregate reports of that data within the health department so there isn't a document to be requested. But there still could be I suppose, someone wanting all the individual reports assimilated into an aggregate report and our attorneys are still, they are confident that we can avoid that until we feel that the industry accepts how the data is being put together and it is in the public's best interest to make that available.

Cindy DiBiasi: Julie, where do you look for best practices?

Julie Morath: All over. Conferences, the research organizations. We constantly scan the literature. Talk to providers, do pilots and studies so we are constantly surfacing new information. One of the things I wanted to emphasize as we were talking about reporting and sentinel events is that really our best sources of learning about safety is through the near misses and patient safety is as much about things going right and are sources of success and recovery as they are about things going wrong. So if we rush without a really thoughtful process into legislative action without taking into account the need to really examine this other dimension of patient safety, we will fall short of where we have the potential to move.

Cindy DiBiasi: Marge, how did you get input to develop the Patient Safety Improvement Corps Concept?

Marge Keyes: Well, there were a couple of things that we did. First we conducted a feasibility study and that included a number of individuals. I think it was about 26 individuals that were experts in patient safety and education and a variety of different areas. Once that study was completed and the results were a little bit different than we had anticipated because we had a couple of models in mind when we issued that feasibility study contract. We went to the AHA and to NASHP to try to get some feedback from what we considered to be our potential users. So with the AHA we held four conference calls that included about 60 individuals trying to get some feedback on what they would like to see in a program like this. About two-thirds of the participants in the AHA calls were CEO's or COO's.

In addition to that as I mentioned we went to NASHP and they brought together somewhere in the neighborhood I think of 15 to 20 State representatives that gave us some feedback both before and after the AHA conference calls. We had initially thought that States would be the primary audience, perhaps even the only audience for a program like this, but we have since come to believe that we need to be broader in the help that we provide and suspect that in the future hospital representatives and State representatives might be attending a program like this in tandem and working on projects together so that they are being trained using the same material and basically working from the same page as it were.

Cindy DiBiasi: I think we had better clarify NASHP.

Marge Keyes: Jill, can you help me out here? National Academy for State Health Policy?

Scott Williams: Correct.

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