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Germany Prevents Medical Errors with Near-Miss Reporting


In response to the alarming statistics regarding the rate of medical errors and German public opinion that medical errors were an important problem, Germany sought solutions. It recognized that the most common cause of medical errors resulted from deficiencies in communication and coordination, which were frequently caused by insufficient organization, and in 2005, Germany introduced its Critical Error Reporting System (CIRS) to target these organizational deficiencies.

The Institute of Medicine’s (IOM) 1999 To Err is Human report shook the healthcare industry worldwide, forcing them to confront shocking statistics regarding medical errors and respond with error prevention measures.[1]

The IOM estimated that 98,000 people died annually in the United States as a result of preventable medical errors.[2] While there has been no similar study in Germany estimating the number of deaths caused by medical errors, there have been a few estimates derived from data produced by international studies. The German Advisory Council for Concerted Action in Healthcare reported that in 2001, preventable medical errors caused an estimated 31,600 – 83,000 deaths in Germany.[3] Based on data from a 2006 study by the German Coalition for Patient Safety (APS), annual deaths caused by medical errors was estimated to be around 17,000.[4] A 2005 European Union Study reported that 72% of Germans believed that medical errors were an important problem and 29% of Germans expressed concern that they might be affected by a medical error at some point during their lives. [5] In 2001, 19% of Germans felt that they had already been a victim of a medical error. [6]

History and Structure of CIRS in Germany

In response to the alarming statistics regarding the rate of medical errors and German public opinion that medical errors were an important problem, Germany sought solutions. It recognized that the most common cause of medical errors resulted from deficiencies in communication and coordination, which were frequently caused by insufficient organization,[7] and in 2005, Germany introduced its Critical Error Reporting System (CIRS) to target these organizational deficiencies.[8] The CIRS network encompasses systems that allow institutional, regional, and nationwide analysis as well as disciplinary-specific systems.[9]
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Source: Netzwerk CIRSmedical.de [10]

The German CIRS network follows the World Health Organization’s recommendation that reporting systems have the following features:[11]

(1) Reporting is safe for individuals who report.

(2) Reporting leads to a constructive response.

(3) Expertise and adequate financial resources are available to allow for meaningful analysis of reports.

(4) The reporting system must be capable of disseminating information on hazards and recommendations for changes.

What is Reported?

A main feature of CIRS is that it is primarily a “near-miss” reporting system. As “near-miss” (Beinahe-Schaden) is a “critical event” that did not result in harm. A “critical event” (Kritisches Ereignis) is an event that could lead to or increase the possibility of an adverse event. Near-miss events are more frequent and more open to discussion, because they do not cause damage.[12]

Because CIRS is focused on prevention and not liability, reports should not include data that identifies the reporter or other persons involved.[16] All CIRS should ensure that personal data and specific details of the report (ie. lab values, data, etc.) are deleted or modified by the administrators during the anonymisation process.[17]

How is Information Reported?

The German Center for Quality in Medicine (AZQ) and APS recommend that reporting forms be available for both electronic and paper submission. The form should be in plain language, so that no technical knowledge is required to fill it out. The recommended data set includes five free-text fields: (1) What happened? (2) What was the result? (3) What were the consequences? (4) Why did it happen? and (5) How can it be prevented in the future?[13] In addition to the free-text fields, there should also be selection fields that specify where and when the event occurred and the general job description of the person involved (ie. doctor, nurse, staff, etc.).[14] Overall, the reporting time required should be no more than ten minutes.[15]

Who Can Report?

All employees of the healthcare system from clinicians and administrative staff to supporting staff in purchasing and cleaning can report in CIRS.[18] The national CIRS network, accessible at www.CIRSmedical.de allows people, including patients and their families, to report independent of an institution.[19]

In order for CIRS to be successful, reporters must know that they will not suffer any disadvantages from working with CIRS. APS strongly recommends a written agreement between CIRS users and hospital management that spells out the voluntariness, anonymity, and sanctions-free nature of the CIRS system, but excludes protection from gross incompetence, disregard for procedural rules, violation of regulations, or illegal activities.[20]

The Patients Rights Law (Patientenrechtegesetz – PRG) also provides protection for reporters. Pursuant to SGB V §135a (3), notifications and data from CIRS cannot be used in legal proceedings to the detriment of the reporter, except under rare circumstances that involve criminal charges.[21] This reporter protection is usually utilized in an employment law context.

Implementing and Maintaining CIRS

In addition to generating reports, a successful CIRS must provide analysis and feedback of reported incidents. First, in order to ensure continued reporting, reporters need to know that the time they spend on reporting is well-invested and sensible changes in the hospital and thus their own working environment will result from the report.[22] Second, the system will have no preventive effect if the data collected does not inform organizational changes. Following the receipt of a report, the hospital should analyze the report within its internal risk management system then forward the report within the CIRS network for regional, national, and discipline-specific analysis and feedback.

To maximize the preventive potential of the system, AZQ recommends the following seven phases for the introduction of CIRS:[23]

Phase 1: Decision Phase – develop legal framework, examine possibility of integrating CIRS into existing systems, and consider clinics and departments for pilot projects.

Phase 2: Planning Phase – create a project plan, decide upon confidentiality principles for both patients and employees, define reporting procedures (ie. form, contents, etc.), define workflow, and conduct training on the content plan and implementation.

Phase 3: CIRS Introduction – conduct CIRS training and introduce reporting.

Phase 4: Evaluation – conduct risk analysis and assessment, using outside expert knowledge, if required.

Phase 5: Organization of Improvement Measures in Risk Management – define and implement corrections and suggestions.

Phase 6: Handling Feedback – create evaluation reports, inform employees about CIRS reports and their evaluation

Phase 7: Evaluation of Initial Experiences with CIRS – report results, describe pitfalls, adjust CIRS procedure, and expand CIRS to other departments.

German Law Requires and Financially Supports CIRS

The Patients Rights Law (PRG) requires most healthcare providers to develop a quality management system and introduce internal error reporting systems. Although the implementation of cross-facility error reporting is optional, the law provides remuneration allowances for providers with systems that meet the minimum standards established by the Federal Joint Committee (Gemeinsamer Bundesausschus – G-BA).[24]

On July 5, 2016, the G-BA’s minimum standards for external error reporting systems became effective. While details regarding implementation and organization of the system are managed by the hospital to account for its specific circumstances, the G-BA requires that error reporting systems be easily accessible to employees and that reporting be voluntary, anonymous, and without sanction.[25]

Prior to the PRG’s mandate, many healthcare systems in Germany had already implemented CIRS. For example, in Asklepios hospitals, a CIRS has been gradually introduced since 2009. This introduction was based on a management decision, which stipulates that CIRS must be introduced into all Asklepios hospitals by 2014.[26] In March, I will meet with the risk management team at Asklepios responsible for the implementation and management of CIRS to discuss their experience. Stay-tuned for a report following my meeting.


[1] L. T. Kohn, J. Corrigan, & M. S. Donaldson, To err is human: Building a safer health system. National Academy Press (Nov. 22, 2016, 11:34 a.m.), http://www.nationalacademies.org/hmd/~/media/Files/Report%20Files/1999/To-Err-is-Human/To%20Err%20is%20Human%201999%20%20report%20brief.pdf.

[2] Id.

[3] Advisory Council for the Concerted Action in Health Care, Health Care Finance, User Orientation and Quality, Sachverständigenrat zur Begutachtung der Entwicklung im Gesundheitswesen (Feb. 6, 2017, 1:22 p.m.), http://www.svr-gesundheit.de/fileadmin/user_upload/Gutachten/2003/Kurzf-engl03.pdf

[4] B. Hoffman, et al., Patient Safety and Error Management: What Causes Adverse Events and How Can They Be Prevented? Deutsches Ärzteblatt international (Feb. 6, 2017, 1:45 p.m.), http://www.aerzteblatt.de/int/archive/article/67639 (citing Conen D, Gerlach FM, Grandt D, et al.: Aktionsbündnis Patientensicherheit. Agenda Patientensicherheit 2006 Witten, Aktionsbündnis Patientensicherheit 2006.)

[5] Id. (citing Eurobarometer Spezial 241 / Welle 64.1 & 64.3. Medizinische Fehler. Europäische Kommission 2006.)

[6] Advisory Council for the Concerted Action in Health Care, supra.

[7] Id.

[8] Das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ), CIRSmedical.de (Feb. 6, 2017, 2:06 p.m.), http://www.aezq.de/patientensicherheit/cirs .

[9] Das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ), Netzwerk CIRSmedical.de (Feb. 6, 2017, 2:06 p.m.), http://www.aezq.de/patientensicherheit/cirs/netzwerk-cirsmedical.de.

[10] Id.

[11] World Health Organization, World alliance for patient safety : WHO draft guidelines for adverse event reporting and learning systems : from information to action. Geneva: World Health Organization (Feb. 6, 2017, 2:29 p.m.), http://apps.who.int/iris/bitstream/10665/69797/1/WHO-EIP-SPO-QPS-05.3-eng.pdf

[12] Das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ), CIRSmedical.de (Feb. 6, 2017, 2:06 p.m.), http://www.aezq.de/patientensicherheit/cirs.

[13] Aktionsbündis Patientensicherheit, Empfehlungen zur Einführung von Critical Incident Reporting Systemen (CIRS): Praxistipps für Krankenhäuser, APS (Feb. 6, 2017, 2:39 p.m.) http://www.aps-ev.de/wp-content/uploads/2016/08/07-12-10_CIRS_Brosch__re_mit_Umschlag.pdf

[14] Id.

[15] Das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ), CIRSmedical.de (Feb. 6, 2017, 2:06 p.m.), http://www.aezq.de/patientensicherheit/cirs.

[16] Aktionsbündis Patientensicherheit, supra.

[17] Das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ), CIRSmedical.de (Feb. 6, 2017, 2:06 p.m.), http://www.aezq.de/patientensicherheit/cirs.

[18] Aktionsbündis Patientensicherheit, supra.

[19] Das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ), CIRSmedical.de (Feb. 6, 2017, 2:06 p.m.), http://www.aezq.de/patientensicherheit/cirs.

[20] Aktionsbündis Patientensicherheit, supra.

[21] Gesetz zur Verbesserung der Rechte von Patientinnen und patienten; Bundesgesetzblatt (Federal Gazette, BGBI) I 277 ff of 25 February 2013.

[22]Aktionsbündis Patientensicherheit, supra.

[23] Das Ärztliche Zentrum für Qualität in der Medizin (ÄZQ), CIRSmedical.de (Feb. 6, 2017, 2:06 p.m.), http://www.aezq.de/patientensicherheit/cirs.

[24] Gesetz zur Verbesserung der Rechte von Patientinnen und patienten; Bundesgesetzblatt (Federal Gazette, BGBI) I 277 ff of 25 February 2013.

[25] Gemeinsamer Bundesausschus, Anforderungen an einrichtungsübergreifende Fehlermeldesysteme von Krankenhäusern als Grundlage für Vergütungszuschläge in Kraft getreten, G-BA (Feb. 6, 2017, 4:56 p.m.), https://www.g-ba.de/downloads/34-215-628/26-2016-07-05_Erstfassung%20Fehlermeldesystem.pdf.

[26] T. Oetken, CIRS – Ein System im Qualitätsmanagement zur Analyse und Reduktion von Fehlern im Krankenhaus, Hochschule für Angewandte Wissenschaften Hamburg (Feb. 6, 2017, 5:01 p.m., http://edoc.sub.uni-hamburg.de/haw/volltexte/2014/2294/pdf/BA_Tobias_Oetken.pdf