Interview with Reiner Heuzeroth & Doris Holding

Reiner Heuzeroth is the Risk Manager and Doris Holding is a key member of the Quality Assurance team at Asklepios, which is recognized as one of Germany’s best hospitals and regularly makes the list for best hospitals in the world.

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"The patient safety culture at Asklepios comes from the top. The owner of the institution wants patient safety and quality to come first, so he puts a lot of emphasis on quality assurance."

How many hospitals are in the Asklepios network?

We have 43 clinics in Germany.

How long did it take to implement CIRS (Critical Incident Reporting System) in Asklepios Clinics?

CIRS implementation was a step-by-step process that spanned 10 years. We began with pilot programs and now have fully implemented CIRS in all of our acute clinics.

How did you promote participation in CIRS?

Encouraging participation was a very important, but difficult task. When we began, there was a negative culture surrounding error reporting, and we had to convince the employees that the system would improve patient safety. We began with a two-month long training period for all employees during which we conducted CIRS training in every clinic.

What were the biggest challenges concerning CIRS acceptance?

Many people were afraid to report, because they feared that their bosses would consider them bad employees if they self-reported errors. In the beginning, I had to fight the preconception that employees might be punished if they reported errors. We have a written declaration directly from the CEO that guarantees CIRS reporting will be confidential and anonymous and that there will be no punishment. Even though, in theory, the declaration protected employees from negative consequences, in reality, if the leaders did not accept that reporting was a good thing, then employees would be hesitant to report.

I had to work hard to change the blame culture for everyone to accept that incident reporting is good and is not something that should be punished and that there should be no finger pointing. There was a lot of personal work involved. We went to all the medical board meetings and expert meetings. In some of those meetings, there was a big resistance from the chief officers who complained that error reporting was unnecessary, a waste of time, and not the main focus of providers.

The ultimate success of this work was that it began to replace blame culture with safety culture. In Germany, patient safety culture is a very important topic and we are constantly working to improve in this area.

Does the hospital’s internal CIRS system allow reporting by patients and family members?

Our internal CIRS system does not allow reporting for family and patients, because patients’ complaints are collected in a separate complaint management system. The hospital actively encourages patient complaints and feedback. At the entrance of every hospital, there are brochures to inform patients about the process for filing complaints and a complaint box for collection. Patients can also file complaints from a computer. At every clinic, there is a complaint manager who is trained to analyze and respond to patient complaints. This system is different from CIRS, because it is not anonymous. We must know the patient’s name and contact information so that we can respond to the complaint.

Have you noticed any demographical trends for people more or less likely to participate in CIRS?

We are not able to measure reporters based on age or gender, but nurses have more fear for reporting than doctors. Sometimes there is a disagreement between doctors and nurses about whether an error occurred that needs to be reported.

Can lower level staff, like cleaning staff, report in CIRS?

In theory, lower level staff can login to the internal CIRS system and report directly, but they are not likely to walk up to a computer and send a report. They are more likely to report an incident or problem to their supervisor or a nurse, who would then register the report in the system.

Does the CIRS system collect reports of incidents that cause damages?

No. Only near-misses are reported in CIRS. There is a separate damage reporting system that collects information about damage-causing adverse events.

Is it mandatory to report damage-causing adverse events?

Reporting damages is mandatory for our employees. We have a damage management team that analyzes and handles complaints of damages caused by treatment errors, which is separate from the CIRS management team. There are also some external reporting obligations that require us to report damages, for example, adverse drug reactions.

Is CIRS reporting of near-misses mandatory?

No. The law requires implementation of a CIRS system, but reporting is always voluntary.

Are the internal damage reports and analysis protected from litigation?

In Germany, if a patient complaints to anyone regarding an error or suspected error in their medical treatment, they have a right to view their medical records, including any documentation of an error.

The other scenario is that an error is recorded in our internal quality assurance system and the patient does not complain. In that case, the hospital has quality assurance experts analyze the event and give advice for improvements, but they are not obligated to produce the internal analysis to the patient.

How do you handle incidents that are initially reported as near-misses, but later determined to have caused damage?

When it is known that an incident caused damage, then the damage reporting system takes over the complaint, but the initial near-miss report in CIRS is still analyzed in the anonymous system by quality assurance experts.

How can you be sure that all information and documents in CIRS are protected from being used in litigation?

There is no law that explicitly protects documents and information in CIRS from being used in litigation, but there is an understanding that CIRS is anonymous, confidential, and used only for systemic analysis and prevention as opposed to blaming an individual.

Can patterns of errors in CIRS be used to show organizational failures in litigation?

If errors are reported and nothing is done to prevent similar errors, then we would consider that an organizational failure internally. We prevent this scenario with multi-level monitoring of CIRS reports by our risk management team. A case cannot be closed until proper preventive measures are implemented. If an attorney wanted to claim organizational failure by the hospital, we would be able to defeat such a claim by showing that the risk management process for responding to CIRS complaints was appropriate. With that being said, I am not aware of any cases in which the courts looked into the CIRS system to show organizational negligence.

How does CIRS impact error prevention at Asklepios?

The first step in the process is to change the culture and encourage reporting, but the real impact of CIRS is seen in the second level, which focuses on analysis and implementing preventive measures. The risk management team monitors incoming reports and cases cannot be closed in the system until preventive measures have been implemented. The system is in continuous follow-up and is constantly learning, which improves patient safety.

Can you measure whether CIRS has decreased the number of treatment errors at Asklepios?

You cannot really measure a specific result from CIRS, because it is a preventive system and it is hard to know how many errors have been prevented. In addition, the temporal connection between the adverse events, preventive measures, and the effects is too remote in many cases. Also, with the rapid change in medical science and technology, the numbers of patients treated, indications for treatment, and treatment processes are in flux, which makes it difficult rely strictly upon numbers of adverse events to measure CIRS success. You can measure changes in culture with a successful CIRS system, and we have seen a positive shift in our patient safety culture.

Do CIRS reports raise any problems with patient confidentiality? 

No, because the reports do not concern an individual patient’s treatment.

Is there any danger that an employee could recognize a CIRS report as one of their cases and breach confidentiality?

No. We redact any identifying information during the anonymisation process. In addition, the anonymisation team can change the patient’s biographical details and the specific story line, but keep the same error pattern, so that the event cannot be recognized.

Are problems with obtaining a patient’s consent captured in CIRS?

No. There is a separate quality assurance system that goes into our hospitals to check consent forms to make sure they fulfill legal requirements and give feedback to the hospital, but this system is separate from CIRS.

So, in addition to CIRS, it sounds like there are several quality assurance systems in place at Asklepios.

Yes. Just to mention a few, in addition to CIRS, we have a peer review system, a document audit system, a case analysis system, a risk analysis system, and a documentation analysis system. Also, in different departments, we have additional risk management systems specific to the department that work with external specialist organizations to improve patient outcomes.

Which specialties are considered high-risk?

Obstetrics, neonatal, anesthesia, orthopedics, and neurosurgery are some of the high-risk specialties.

On the culture of Asklepios:

The patient safety culture at Asklepios comes from the top. The owner of the institution wants patient safety and quality to come first, so he puts a lot of emphasis on quality assurance. Also, the CEOs at the various clinics send out a “Safety First” newsletter 3-4 times a year, which discusses CIRS report patterns, analysis, and recommendations. The newsletter is sent to approximately 40,000 recipients in the Asklepios network.

One prominent complaint of doctors is the U.S. is that the paperwork obligations are too onerous and they do not have time to treat patients. Is this a complaint at Asklepios?

Of course, but because doctors work in shifts, proper documentation is absolutely necessary to ensure continuity in the patient’s treatment and to prevent errors. We tell our doctors that they must document anytime a patient’s condition changes. Our legal department also provides training to teach doctors about the legal requirements of documentation and how to document efficiently, so that instead of writing pages and pages of documentation, providers are trained on how to document what is important. We also work on individualizing standard documentation forms to document more effectively and efficiently.

Also, Germany requires more and more reporting on quality assurance, the results of which are published to the public. In these cases, it is very often that the care we provide is actually better than what is documented. I tell our doctors and nurses to make sure they show how good they are by proper documentation and not to let a documentation deficiency misrepresent their skills.

With all the required documentation, how did you convince providers to participate in a voluntary reporting system?

It was not easy. First you have to convince them that reporting will have a positive impact. We also make the reporting process easy and quick, so that reporting can be done on the computer and within five minutes.

CIRS is more effort for the people who have to analyze the reports. You need sufficient resources for analysis in every department otherwise there is no feedback. It is important to have leadership for CIRS in every hospital and to have open, direct, and regular communication with all the CIRS leaders throughout the institution. I have the ability to look at the CIRS activity for all hospitals from my computer at the main office, so I can constantly follow-up and coach the CIRS quality managers. It is a lot of work, but it is worth it.

On socials protections in Germany:

Germany has a social system in place by law for more than 100 years that guarantees a certain standard of living, so if someone suffers an injury, then they are protected by the social system regardless of whether someone else caused the damage. This social net provides the patient with all physical therapy, medical treatment, and psychological treatment needed. Also, everyone in Germany has a right to have a place to live, healthcare, and a monthly income. It’s not large amount of money, but it provides a safety net that no one falls through.

Does the government provide any financial incentive for participation in CIRS?

There is going to be some monetary support for participation in a national system, but they have not set the amount yet. It is nice to have the national system, but I think the internal CIRS system is more important. The national system puts the focus on the levels above the individual institution as opposed to where things are actually happening, so information goes up into the system, but there is no individual response. At the organizational level, there is communication between the actors and the information can be analyzed, talked about, and used to prevent errors. I wish the government provided monetary support for internal CIRS systems.