I came to Germany with the intention of finding better solutions for preventing and resolving medical malpractice claims. I started my research examining error prevention strategies in Germany, and I sort of got caught up in learning about the patient safety agenda, and my research re-focused a bit more on prevention than originally intended. One of the main things that emerged was Germany’s use of critical incident reporting systems (CIRS), and I was struck by the seeming unanimous support for these systems among stakeholders in the healthcare industry here, especially considering the level of confidentiality and protection needed to encourage reporting by healthcare providers. Of course, the flip side of error reporting within the hospital is talking to the patient about medical errors, and this requires not confidentiality, but transparency. When I started reading about error disclosure, I found that there is a much stronger movement in the U.S. for open disclosure and communication with patients. I identified a real struggle between confidentiality needed for error reporting with CIRS and the transparency associated with communicating information about medical errors to patients.
Insurance also plays a very big role in physician communication with patients. In the past, the insurance companies told doctors that if they admitted too much about an error to the patient, then the patient would have a better position at trial and that the doctor could lose their insurance cover. This was the case in Germany. So in cases of error, this changed the doctor-patient relationship, because the doctors were silent about the error.
What is the current insurance position on admitting medical errors?
I think that doctors can now admit errors without risking their insurance cover, but I’m not sure whether the situation has really changed, because it’s a matter of mentality. It depends on how the insurance company and the hospital administrators counsel the doctors. There are mixed emotions when a doctor has to admit a mistake. This is complicated for doctors anyway, because you have the administrative director maybe telling the doctor, “don’t admit too much,” and then there’s the insurance company discouraging discussion about errors. Then, of course, there is the patient who wants an explanation and information. This is a conflict for the doctor, and I can understand it, but I believe that the doctor is first and foremost a doctor, and he has to communicate with the patient.
As I understand, the Patients’ Rights Law (PRG) requires the doctors to disclose errors if either the patient asks or if it has a consequence on their medical treatment. But, if there are all these mechanisms that discourage the doctors from admitting “too much,” then it probably doesn’t work to have a law requiring disclosure, right? I mean, that’s not going to be effective, because the change has to come from inside the hospital?
Right. And the PRG did not substantially change the actual law. It was just a codification of the existing law created by the courts. It offered more transparency to the law, and that’s the benefit.
In the case of a medical error, the patient has to prove that there was a mistake and the patient has to prove that he was damaged. Then there is the question of causation. And there is an ongoing discussion in Germany about when the burden of proof should shift to the physician. One situation where the burden shifts is in cases of gross error.
In terms of the disclosure duty, I’ve compared the policies in the U.S. and Germany, and the big difference I noticed was that the PRG focuses on “errors” whereas the U.S. focuses on any “unanticipated events,” which is a broader scope and encompasses more than just treatment errors. Some of the criticism I read about the disclosure duty in the German law is that it is asking doctors to make a legal determination of what constitutes an “error.”
Yes, this shifts the communication process to a legal conversation.
An explanation of the unexpected effects of the treatment is part of the informed consent process. Theoretically, you have to directly tell the patient, for example, about all the possible consequences of surgery. There must be a conversation in Germany. It cannot just be written on a sheet of paper. And there is a duty to have the informed consent discussion 24 hours before the surgery, but whether this really happens all of the time, no one knows.
According to Heike Morris at the UPD, doctors in Germany do a pretty good job talking to patients before treatment, but it’s after treatment that providers fail to provide explanations.
Patients are satisfied with the German health system, because it is easy to have surgery quickly, but the people don’t feel very well informed. The amount of treatment in Germany is really high. Each German goes to the doctor 16-18 times per year on average. In Scandinavian countries, it is 4 times on average. I think this is typical in Germany, because people get a lot of treatment, but they aren’t satisfied and they come back, because they weren’t well informed. It’s also a matter a reimbursement – the hospital gets more money when the patient returns.
It does seem like Germany does a good job of using CIRS to prevent medical errors. I mean, there’s no uniformity in error reporting in the U.S. like there is here.
Well . . .
(laughing) of course, you are self-critical
We don’t have a national system. We have many kinds of CIRS in Germany. Also, it’s required in hospitals, but it is really hard to prove if a hospital really utilizes the system to prevent errors, because the number of cases doesn’t mean anything. A report can be in the system, but it is hard to determine whether there was an appropriate response. I think that in order to measure how the system works, we should ask how many actions or measures were implemented instead of looking at the number of reported cases.
Also, patients can’t report in CIRS in Germany. In Austria, CIRS is open for patients, and I suggested that we open CIRS for patients in Germany.
We are starting a new CIRS project for doctors’ offices.
What are your thoughts on protecting the confidentiality of the system? Is there a greater social benefit to protecting trust in the CIRS system or should the law recognize some circumstances where lawyers or the judge is allowed to look into the system?
It’s difficult. If lawyers were allowed into the system, then I think that doctors would start to report in a strategic way to limit what they report.
In the U.S., although we have a federal law that protects certain information reported to improve patient safety, the individual states can choose to mandate reporting of this information and then the reports lose protection under the federal law. Actually, Florida has done that.
You have a completely different culture in the U.S. regarding transparency of information. In Germany, we have a culture that says that the institutions own the information, and they would never give something to the public or to someone who could use the information to harm them. It ties into the right against self-incrimination. A shift of culture to more transparency is developing very slowly, but we are working on this and Weisse Liste is very interested in transparency, but we have a long way to go.
But maybe, on the other hand, too much transparency isn’t good. It seems like because of this protection of information culture, Germany has had more success with CIRS-type reporting.
You’re right that the data is more protected, but the error culture is different here. If someone makes an error, it’s not a treasure in Germany like in the U.K. or U.S. and that kind of error culture doesn’t produce a very good CIRS system, because it’s a culture of guilt and revenge.
I think that this has to do with the medical profession generally and the way it’s designed. Even in the U.S., there is traditionally a culture of silence and blame. I think one of the hard questions is how to use confidentiality to change this error culture by enabling doctors to talk openly about errors while also protecting the patient with a policy of transparency – trying to find that balance.
In Germany, there are different ways to deal with an error. A patient can go to a lawyer and file a lawsuit, but there is also the Schlichtungsstelle and the medical service of the health insurance company, both of which offer free expert opinions regarding the patient’s treatment. The problem is that, for patients, is it not very clear where to go and what the advantages of the different options are. For example, if you decide to file a lawsuit, then you cannot go to the Schlichtungsstelle, but this isn’t written anyplace for the patient to read. We want to create a website where patients can go to get support if they suspect an error and where they can get information about the different possibilities.
What are the advantages and disadvantages of the Schlichtungsstelle?
I think the advantage is that the process of faster. In Germany, it takes 8-10 years for lawsuits to resolve in court. And it’s free. The risk is that you don’t achieve, monetarily, what you could in court, because it is a compromise.
Do you think they (the Schlichtungsstellen) produce fair results?
I think they do. The number of cases in which they find error is not so bad compared to when people go to the insurance experts or to court.
Not a lot of people go to the Schlichtungsstelle, because they don’t know about it. In my opinion, many patients don’t want monetary compensation, but they want to speak face-to-face with their doctor, and even if they go to court or to the Schlichtungsstelle, they don’t get what they want. Sometimes you don’t need a lawyer, but you need a mediator who tries to reestablish communication between doctor and patient.