„Quality is already an economic factor, and in my opinion, quality is absolutely profitable.“ With these words, Hedwig François-Kettner, chairwoman of the German Alliance for Patient Safety (Aktionsbündnis Patientensicherheit e.V.), clearly positions herself in favor of quality-oriented needs planning for hospitals. However, she immediately qualifies this statement, because in her opinion, „we are not yet at the point where we can tackle quality-oriented remuneration for the entire system on a societal level.“ As the long-time director of nursing at Berlin’s Charité hospital, responsible for 4,100 nurses, she knows very well what she is talking about in her interview in „Monitor Versorgungsforrschung“ (Monitor Healthcare Research).

Federal Health Minister Hermann Gröhe has proposed using existing quality indicators to create a joint needs assessment for hospitals and doctors, and even to regulate remuneration accordingly. Is it in the interest of the Alliance for Patient Safety if quality becomes an economic factor?
Quality is already an economic factor, and in my opinion, quality is absolutely profitable. However, quality improvements are sometimes neglected due to concerns about rising costs. This approach can provide positive impetus. Unfortunately, we are not yet at the point where we could implement a quality-oriented remuneration system across society. To do something like this, I believe a comprehensive overview and a framework are needed—an inventory of the German healthcare system, including its regional differences and corresponding needs. In this respect, I support the planning proposals of Federal Health Minister Gröhe. The "agony of quality"—how good a hospital truly is, but also how difficult it is to apply common quality criteria to an objective evaluation of outcomes—has long been discussed in the public sphere and was very vividly described by Werner Bartens in the "Süddeutsche Zeitung" in July.

Do you consider the overview of regional quality differences and the analysis of their causes almost more important than needs planning and remuneration?
Not more important – but one shouldn't put the cart before the horse. A supply and demand analysis should precede any action. Above all, regional needs analyses must not stop at state borders; hospital planning, too, must ultimately be done from a bird's-eye view, transcending national boundaries. In my opinion, it's still too early for quality-based reimbursement, and I'm not entirely convinced it's even sensible in every case.

Too early? How long should one wait?
We simply don't know enough yet. Just think about the rural areas in Germany where the population is currently shrinking. It's quite obvious that you can't, and indeed shouldn't, provide all services directly on-site there, if you manage to establish other, reliable infrastructure. But that's precisely what we haven't done yet.
This is also, and perhaps primarily, due to the fact that we do not yet have a fully functional electronic health card that could structurally map patient needs, because it would reveal the actual needs – and not those predicted overnight.

What's also missing is a meaningful pay-for-performance approach, which would also mean "no pay for no performance." Is our system even ready for such a shift in thinking about services actually provided to patients?
Discounts already exist today. Pay for Performance would essentially just be a tightening of this existing penalty system. However, it's important to warn that our current structure presents some significant problems that could outweigh any anticipated benefits.

An example?
Let's consider nursing care, where, for example, a deduction already exists if a patient develops a pressure ulcer. But if you assign one nurse to 45 patients on a night shift and expect her to reposition 30 patients correctly every two hours, it's easy to see that this simply isn't feasible, if only for time reasons. This means we're dealing with a structural problem that our healthcare system is currently either not addressing at all or not addressing adequately. Sure, small support programs are launched here and there, but these are nothing more than a band-aid and a mere token gesture. This approach is one of the major fundamental problems of our system. It is precisely for this reason that I find potentially sensible approaches like quality-based remuneration or methods like pay for performance premature, not to say harmful.

What do you think of the recent strike by nurses at the Charité hospital?
I can fully understand the reasons for this strike. After all, I was the director of nursing there myself for a long time. During that time, I repeatedly pointed out, in very different contexts, that the staffing levels were insufficient to guarantee high-quality and adequate care across all shifts.
To make matters worse, Charité is one of the hospitals in Europe that treats a large number of high-risk patients. This fact alone results in a significantly higher workload compared to all other hospitals in the area. This additional workload is in no way covered by the nursing care plans. Therefore, I can fully understand the reasons for the strike. However, I believe that employers are responsible for providing sufficient staff, if only for quality reasons. It is the responsibility of policymakers to ensure the necessary framework is in place.

What is the current state of quality in German hospitals?
Reports are coming in from many sources indicating that the situation isn't so bad at all. In fact, it feels quite good. This is reflected in the experiences of many patients who have been treated and cared for abroad, all of whom say: "If I get sick, I just want to get home to Germany as quickly as possible." Even our current Federal Minister of Health emphasizes this point repeatedly.
The figures also reflect this impression. Our healthcare system is truly good in terms of the individual activities of the various stakeholders, especially in acute care. However, we actually know far too little about the specifics, because we are also aware of errors and adverse events that repeatedly occur. In the Alliance for Patient Safety, we focus specifically on these indications and findings.

That's exactly the right place for us, a journal for health services research. What do we need to know better and in more detail?
For example, we would need to see how health and disease development actually progresses over the years. And equally importantly, which factors are decisive in whether care improves or deteriorates. Currently, many aspects and interventions are recorded and sometimes analyzed separately, but a comprehensive overview is lacking, including in international comparisons.
Certainly, there are, albeit only for a few years, clinical cancer registries, trauma registries, Berlin heart attack registries, and, for example, endoprosthesis registries. Thus, for many individual segments and indications, there are separate registries and healthcare research projects, but no central body that consolidates this data. This is because each registry operator considers the data they collect to be their own property.

This is an important point: The data would have to be brought together and, in and of itself, belongs to the patient.
But that's just one point among many. Let's consider medical malpractice. The German Medical Association reviews and evaluates reported cases of medical malpractice, as do health insurance companies and liability insurers. However, even here, the data collected is not centrally compiled; it is treated like personal property. In fact, all data collected in the healthcare system, regardless of who collects it, originates from the patient or at least is data initiated by the patient. This data should, of course, be made available to the public in anonymized form, because we urgently need it, both systemically and collectively, to improve quality and needs assessment.

To return to the original question.
It's quite simple: because the data isn't sufficiently aggregated, we often don't know exactly where we stand: how good or how bad are we doing? And: where could we improve? In other words: we feel like we're doing quite well, but we don't know for sure by measuring it.

Why can the respective data collectors consider the data their property?
This is our system, which functions federally and sectorally. Furthermore, our healthcare system is governed by a self-governing body that is moderated to varying degrees, and sometimes not at all, by the system itself.

Are you against self-governance?
But no, I support self-governance, which, however, must function in the interest of the common good. But precisely for this reason, someone is needed who acts as a kind of conductor or moderator within the overall system. This conductor—let's call the role that for now—has the task of working together with the relevant stakeholders to determine what is best for the healthcare of the nation, not just for the benefit of the self-governing bodies. Such a holistic perspective would give our healthcare system a completely new, far more patient-centered direction. That would, of course, represent a paradigm shift compared to the current status quo.

But is this feasible or even capable of gaining a majority?
No. Because no party is currently interested in that. That would mean no longer just focusing on reforms and minor adjustments, but seriously attempting a fundamental restructuring of the system.

Up to now, much has been viewed from a purely economic perspective, instead of having a vision of a future-proof healthcare system.
Unfortunately, that's the way it is. That's my personal opinion, not that of the Alliance for Patient Safety. But I stand by it; I simply feel the healthcare system lacks a skilled leader. And while we're on the subject: Why is the healthcare industry even a business that has to generate profits? I believe that a future-proof healthcare system must be a non-profit organization designed to invest every cent it earns in improving care. Be it in infrastructure, staff, or important and necessary healthcare research studies that truly help move our healthcare system forward.
I don't believe that healthcare profits should be used to benefit shareholders. That's just my personal opinion.
On the other hand, you said earlier that economics is only one side of the coin. On the other side are historically developed federal, regional political, and also class interests that stand in the way of a meaningful overall improvement of the system.
That is absolutely correct.

For the next stage, namely fee and needs planning, you believe we are currently lacking a great deal of information. On the other hand, there is already a plethora, indeed thousands, of individual quality indicators. Are we measuring the wrong things when it comes to quality?
I don't want to say that at all. During my time in office, I personally measured a great deal, such as the progression of pressure ulcers, patient satisfaction levels, fall rates, and other factors. I also had the quality of documentation reviewed in the context of actual patient observations. All of these things are important for identifying areas where action is needed and for making the appropriate decisions. In my opinion, external quality assurance laid a solid foundation upon which to build.
But I still can't easily compare all the collected data with data from other hospitals. At least not consistently. To stick with the example of pressure ulcers: A patient's risk factors for developing pressure ulcers are significant. If you have a patient who can't be repositioned due to increased intracranial pressure, it's very likely they'll develop a pressure ulcer. Does that mean the hospital has to accept a lower rating? In other words, quality measurement is good in itself. But you have to know what you're measuring and draw the right conclusions. And that's not always easy.

The hospital report makes it clear that greater experience and routine seem to influence better quality outcomes. Who could ensure that such facts are investigated more thoroughly?
The networks for healthcare research and upcoming healthcare research funding programs, such as those through the Innovation Fund, have a role to play here. As the APS (Association for Health Services Research), we expect that patient safety concerns will be examined and addressed. Beyond temporary project priorities, this is actually a task for universities and public institutions. This ensures that the data collected doesn't simply disappear into some drawer, but is available to the public.

We already have two quality institutes and soon a third. Do we perhaps need a fourth?
We don't need a large number of institutes, but rather a wide range of activities. All these institutes, whether three or four, are embedded in existing structures and thus bound to the current system. A system should be viewed independently from the outside if one wants to fundamentally reform it. Ideally, we should hold a sufficiently long workshop with intelligent, independent people and define what the system should look like in which we all want to grow old as healthily as possible.
What do you think about the emerging nursing councils? What's your opinion on them? Are they part of a future-oriented healthcare system?
As long as we live in a system of professional chambers, nursing must also have its own chamber. That is my firm conviction. If a health chamber were ever to exist in Germany, I could also envision other structures that are less entrenched in the "benches" mentality. But as a first step, a chamber will enable nurses themselves to define what constitutes quality and what does not. Currently, the nursing profession is told what constitutes quality care – and that is far from ideal.

Do you have an example of that?
Let's take, for example, the reduction of bureaucracy in nursing documentation. I'm skeptical whether this will truly work well without simultaneous professional evaluation of outcomes and rapid adjustments in case of problems. Not because this approach is inherently flawed, but because it's driven primarily by economic considerations. If, in the future, we measure fewer factors, but perhaps the wrong ones, we shouldn't be surprised if quality doesn't improve. Of course, it's true that documentation needs to be streamlined, but nursing itself must develop this. Currently, when it happens, it's done in our spare time. Because so far, all the comprehensive and advanced work in nursing is very often done on a voluntary basis.

This can't go on any longer.
But currently, there's often hardly anyone available who can even properly prepare legal commentaries. The few active members do it at midnight – often after their late shift. That's unacceptable! These are some of the reasons I'm fighting for nursing councils.

One of the central statements of the action alliance is that in cases of medical errors or generally undesirable health events, only the tip of the iceberg is actually being considered.
This observation is well-supported by scientific evidence. The German Council of Experts on Health already used this image in its 2003 annual report. I am not a scientist, but a pragmatic person who has worked in the healthcare sector for 47 years. I know all too well that not everything will ever come to light. Therefore, we can be glad to see the tip of the iceberg, even if that is the only thing that comes to light.

That's surely a very high number of unreported cases, right?
That's a reasonable assumption. Scientific estimates show that at most one in 30 cases is reported, probably only one in 100. It's difficult to get an accurate answer about the actual number. That's precisely the problem, because the number of unreported cases will always be much higher than the number of reported cases. But that's true everywhere, and it's also very human nature.

Does the action group have more precise figures?
The error estimates are based on a systematic review of all relevant studies published in the APS annual reports for 2008 and 2009. More recent studies confirm these findings; there is no evidence that the error rates have fundamentally changed.

Let's turn to the unseen 80 percent of the iceberg. Do you have any ideas about where the problems lie in these undisclosed cases of medical malpractice?
Within the Alliance for Patient Safety, we have gathered a wealth of information on adverse events, which are still all too often triggered by inadequate transfer to the hospital. Therefore, we advocate for a standardized patient record, at least for the information relevant to a hospital stay. The Institute for Patient Safety – a professorship endowed by the Alliance for Patient Safety – has just completed the High-5 study in Bonn in collaboration with the German Agency for Quality in Medicine (ÄZQ). The initial findings are as clear as they are alarming: Even in the courageous pilot hospitals that participated – and these were certainly not the worst in Germany – medication errors of up to 50 percent were observed. Although the results* were not representative, they are revealing and require our collective intervention, as they exemplify the need for action.

50 percent. That's an unbelievable scandal.
It illustrates the complexity of the task and how often things can go wrong. Unfortunately! The problem is multifaceted and requires systemic interaction. When a patient is admitted to the hospital, they have often been taking medications prescribed by their family doctor for years, but the hospital doesn't have these medications in stock. The hospital will therefore make a change. Sometimes this is done by a resident physician, and certainly sometimes it's not carefully considered whether a substitution is truly that simple, for example, regarding the efficacy of the active ingredient and bioavailability. The study results quickly prompted us to communicate with the stakeholders, and the implementing institutions are developing a manual for safe medication changes. Furthermore, the reverse process often occurs during discharge management. The treating family doctor may receive a discharge summary recommending a medication change, which is not always followed reliably.

A patient file that can be used by everyone is certainly useful in this regard.
The German Alliance for Patient Safety recently published a position paper, developed in collaboration with patients. It proposes that at least emergency data and other important medication information must be readily available on or via the patient's electronic health card.

If only it weren't for data protection laws.
In our experience, this is often just a pretext. Hopefully, the resistance from certain stakeholders will end with the e-health law, in the interest of greater patient safety.

What attitudes towards patient safety do you encounter among the various stakeholders? Are they generally positive, rather skeptical, or do you even perceive it as an obstacle?
I've just had a truly astonishing experience with our position paper on the electronic health card. Initially, we were met with outright aggression, coupled with the question of why the Alliance for Patient Safety was even concerned with the health card.

Why the aggression?
Many involved fear becoming too transparent and open to scrutiny. While this is understandable, it's important to put things into perspective. I've actually managed to do this in several discussions. The most important thing is that we've shown we've become bolder in addressing even uncomfortable issues. We need to stop shying away from unpleasant topics.

Surely everyone claims to be working for the best interests of the patient, at least outwardly.
Sure. That's how it is. That's why I'm also against the press sensationalizing things so quickly. No one who works in the healthcare system gets up in the morning intending to make a mistake. Everyone wants to do their best work.
But to achieve this, we must provide the many people who are actively involved in the healthcare system with the right structures and support them. If something is wrong, however, we must acknowledge it and learn from it. Every individual, and especially the system.

Aren't many media outlets, which are often primarily interested in scandals, rather detrimental to a healthy culture of learning from mistakes?
A brief note on terminology: not "culture of error," because errors should not be cultivated. We want to implement and establish a culture of safety. And sensationalism is detrimental to patient safety. The APS has spoken out against sensationalism in public reporting on medical errors and advocated for an objective, goal-oriented discussion. However, this should not prevent us from thoroughly analyzing the reasons that led to a particular error. Upon closer examination, errors are often not attributable to individuals, but rather are frequently systemic and enabled by systemic weaknesses that accumulate over time. Therefore, we need a new culture of safety that focuses not on assigning blame, but on problem-solving.

Do you see hospitals, nursing homes, and other facilities already on the path to that? Or are we still largely in the phase of covering things up, forgetting, and burying them?
There are many institutions that work very diligently on a positive safety culture. This has a great deal to do with leadership. Unfortunately, we still have enormous leadership weaknesses, especially in healthcare facilities. Many still think more in terms of punishment than in terms of clarification and learning from mistakes. And others completely refuse to acknowledge any wrongdoing, claiming that mistakes simply don't happen in their institutions.
But that's also due to the system itself.
Those who use mortality rates as a criterion shouldn't be surprised by this. Overall, however, we have seen significant progress in the last ten years in expanding clinical risk management specifically, and in promoting a patient safety culture more generally. The work of APS members has certainly made valuable contributions in this regard.

Nevertheless, mortality is certainly not the best criterion for comparing hospitals with often very different patients.
The fact that people die, and that this is the "normal" way in elderly care, cannot be considered a poor quality criterion, at least not there. People working on the front lines know which criteria would be better. We must use this knowledge to address our weaknesses. But if we intimidate these very people and don't listen to them, then we have a problem.

Where is a good safety culture already being implemented?
I see many people in hospitals and care facilities proactively addressing this issue. For example, at Charité Hospital, after evaluating patient satisfaction surveys over many years, we visited the five worst-performing wards and asked them what the reasons for the poor feedback might be and where we, as top management, could help. Then, together, we tried to address and resolve the problems. This was often very successful. Of course, we also visited the best-performing wards to learn from them and to acknowledge their achievements. One of my fundamental insights is that top management, in particular, needs to pay very close attention and be aware of the areas for action. Delegated tasks do not absolve us of personal responsibility.

The most difficult thing is certainly always to initiate a cultural change in such a way that it is not too strongly driven by individuals and therefore dependent on them.
That's right. But it's equally important to value what people tell you. And it's definitely wrong to undermine their resilience. There's still a lot of work to be done in that area.

That's why you also award the German Prize for Patient Safety.
We awarded the German Patient Safety Prize for the first time in 2014 and found it to be very encouraging.
Last year's winner was a nursing home that discovered its elderly residents were receiving too many medications. They then reviewed the medications together with a pharmacist and other stakeholders and were able to reduce them by 20 percent. They then recommended to the doctors that they no longer prescribe these unnecessary 20 percent.
This has led to the residents becoming much more lively and actively participating in life. Aside from the improved quality of life, unnecessary medications are, of course, a significant cost factor. Extrapolated to the entire country, considerable savings could be achieved.
This year, the Alliance for Patient Safety celebrates its tenth anniversary. What have been the biggest milestones in these ten years?
One of our greatest achievements was undoubtedly the establishment and permanent foundation of the only professorship in Germany dedicated to patient safety, located in Bonn. We have also developed numerous brochures and recommendations for action, disseminating our findings within the healthcare system and ensuring their practical implementation. In this way, we have made significant progress in improving patient safety.

For example, they also launched the "Clean Hands" campaign, or ASH for short, in 2008. It's surprising that such a campaign is even necessary after 150 years of hygiene in medicine.
In 2015, we had 1,858 participating facilities that underwent self-assessment or were certified. However, this also means that there are still many hospitals, nursing homes, and medical practices that have not opted for ASH (Audit-Safety Standards) and that could significantly improve their prevention efforts. So, there is still much to be done. The APS (Association for Patient Safety) has called for the first "International Patient Safety Day" on September 17th and encouraged its members and all stakeholders in the healthcare sector to participate. The goal is to raise awareness of hygiene and infection prevention beyond the healthcare system and into the wider public.

The APS homepage* also lists many institutions that inform their patients and staff, as well as the local and regional public, about hygiene and infection prevention programs on this day.
Patient safety concerns everyone; and – to quote Friedrich Dürrenmatt from "The Physicists": "What concerns everyone can only be solved by everyone." Patient safety is, after all, a task for society as a whole, which must be solved together.

Ms. François-Kettner, thank you very much for the interview.

The interview was conducted by MVF editor Prof. Dr. Reinhold Roski, edited by MVF editor-in-chief Peter Stegmaier.

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doi: 10.24945/MVF.05.15.1866-0533.1919