The Medical Service prepared 13,059 specialist reports on suspected treatment errors in 2022. According to this survey, an error and damage were found in every fourth case; In every fifth case, the error was the cause of the damage suffered. This emerges from the current annual statistics on treatment error assessments, which the Medical Service (MD) presented in Berlin in mid-August this year. Not least because the same mistakes happen again and again, like the MD, the Patient Safety Action Alliance (APS) is also calling for a so-called “Never Event” register. The Patient Safety Action Alliance e. V. has also defined 22 events in its SEVer prevention list. The APS defines this as incidents with a high potential for damage that could, in principle, be prevented. Since the same mistakes happen again and again, it is important to analyze what these mistakes can be attributed to.

> In order to improve patient safety, serious but certainly preventable events such as side or medication mix-ups (“never events”) should be reported. “This is the international standard in patient safety. From the patient’s perspective, it is unacceptable that Germany does not implement this,” said Dr. Stefan Gronemeyer, Chairman of the Federal Medical Service. The APS fully shares this position, but has already called for this in a position paper in 2019 (1). This demand for complete and representative national statistics of all avoidable undesirable events is much older, as the action alliance wrote in its position paper at the time. The APS referred to the IOM report “To Err is Human”, which was published in 2000 and which, in its Recommendation 5.1, included not only voluntary but also mandatory national reporting systems for serious cases of damage as a central recommendation: “A nationwide mandatory reporting system should be established that provides for the collection of standardized information by state governments about adverse events that result in death or serious harm. Reporting should initially be required of hospitals and eventually be required of other institutional and outpatient care delivery settings.” (2)
“There is a fine line between honestly recognizing that errors in health care can never be completely eliminated and uncompromising commitment to patient safety,” writes Dr. Ruth Hecker, chairwoman of the Patient Safety Alliance. V., in their foreword to the recommendations for action in the SEVer list (3). In her foreword, she also emphasizes that this is a balancing act, but one that the APS is prepared to undertake with the present list (“Serious events that we want to be sure to prevent”). Hecker: “On the APS board, we are aware that wherever people work, mistakes can occur. On the other hand, we are firmly convinced that the institutions have a responsibility to do everything in their power to prevent the undesirable events listed here.” How many there are and how they are distributed across the various specialist areas is explained in the Current annual statistics on the MD's treatment error assessment are clear - but not which ones could be avoided.
In order to create precisely this list of avoidable medical errors, the APS board set up a group of experts called “Never Events”. The aim of this expert group was to develop a list of events that should be reliably prevented by systemic security barriers. This first step was the basis for the now published SEVer prevention list, the content of which will subsequently be developed by one or more APS working groups. The experts of the action alliance assume that the events detected by the MD must always be seen as an indication that the safety barriers to prevent harm to patients in the facility in question were not fully effective.
“This goes hand in hand with the requirement that every SEVer that occurs is always dealt with with utmost vigor in order to understand the systematic causes and derive effective preventative measures for the future,” explained Dr. Ruth Hecker on this. The APS has already published instructions for case analysis. The reaction of the facilities to these incidents is even more important than the absolute number of cases. In the APS's opinion, passages in the WHO's "Global Patient Safety Action Plan" (2021-2030) should also be read in the same way, which also includes the instrument of national lists of serious patient safety-relevant events (sentinel events) (4).
However, in her foreword to the SEVer prevention list, the APS board member also emphasizes that recognizing serious events and, in the best case scenario, preventing them in the reality of care is far from sufficient for safe patient care. Dr. Ruth Hecker: “This is just a first step towards a strong safety culture in which everyone involved works together to ensure that risks are identified and controlled as best as possible. The aim of the APS is to pave the way for this with the publication of this list.”

The 22 points of the SEVer list
The APS SEVer list was based on the established compilations used in the American and British healthcare systems. The APSSEVers were determined based on the current list of Serious Reportable Events (SRE) from the US National Quality Forum (NQF) and the Never Event List from the British National Health Service (NHS). This was done in more detail
Discussion excluded all events that did not meet all previously defined criteria of the APS SEVer list. These were in particular events that were due to the local conditions of the countries from which they came or were not sufficiently influenced by the health facility.
According to the APS, after the remaining events were translated, they were discussed in detail and checked again with regard to the previously defined criteria, in particular whether they could be influenced by a health facility and whether they were “absolutely” preventable. The recently published publication by the NHS “National learning report: Never Events analysis of HSIB's national investigations report” (5) confirmed the discussion that had already taken place in the expert group at the inaugural meeting.
The idea of preventability was confirmed and subsequently influenced the naming once again. The idea recommended there to rethink the term “Never Events” based on the results of case analyzes presented led to a different term being found, namely SEVer. Based on the procedure described, the 22 APS SEVers were then defined (see list) and worked out in detail below from page 7 of the paper (3).

MD medical malpractice assessment

How important and forward-looking the work of the APS was and is is shown clearly and harshly by the current annual statistics on treatment error assessments (6) by the Medical Service (MD), presented in mid-August of this year.
Last year, the Medical Service nationwide prepared 13,059 specialist reports on suspected treatment errors. According to the present evaluation, an error causing damage was confirmed in every fourth case (3,221 cases). In every fifth case (2,696 cases), the error was the cause of the damage suffered - only then would patients have a chance of receiving compensation. Overall, the number of reports is at the same level as previous years. “The assessment figures only show a very small part of what is actually happening,” explains Dr. Gronemeyer. “Scientific studies have often shown that the number of unreported cases is significantly higher: experts assume that around one percent of hospital cases are affected by treatment errors. Only about one percent of all adverse events are tracked.”
So-called never events are of great importance for prevention measures. These are easily preventable adverse events that can lead to serious harm to patients: These include patient and side mix-ups, serious medication errors or foreign bodies unintentionally left behind after operations. These damaging events appear every year in the medical services' assessment statistics (2022: 165 cases; 2021: 130 cases), even though the risks are known and suitable preventive measures are available. Such events show that there are risks in the supply process and that the security precautions on site are inadequate. That is why, for Gronemeyer, “Never Events” are particularly important for recognizing, implementing and evaluating security measures and are therefore already being used successfully for prevention in many other countries. “Germany should finally implement this. The planned amendment to the Patient Rights Act offers the opportunity to introduce a mandatory national never-event list and thereby strengthen patient safety in care,” said Gronemeyer. “The reporting of damage events is solely for prevention purposes. It should be sanction-free and pseudonymous for the institutions.

Accusations of errors in many specialist areas and in a wide variety of procedures
In the current annual statistics, two thirds of all allegations of malpractice related to inpatient care, mostly in hospitals (8,827 cases). A third related to doctor's offices (4,208 cases). “Most of the allegations relate to surgical procedures. Since these often take place in hospitals, they are assigned to the inpatient sector,” explained Dr. Christine Adolph, Deputy Chairwoman and Chief Physician of the Bavarian Medical Service.
According to the evaluation, 30.3% of all allegations (3,960 cases) related to orthopedics and trauma surgery, 12.2% to internal medicine and general medicine (1,599 cases), almost 9% each to gynecology and obstetrics (1,143 cases) and general and visceral surgery (1,133 cases). ). Dentistry also accounted for almost 8% (1,006 cases) and nursing care (834 cases) accounted for over 6%. 26% of the allegations were spread across 29 other specialist areas.
The annual statistics for 2022 include 13,059 suspected cases with a total of 1,019 different diagnoses. The allegations concern incorrect treatment for hip and knee joint wear, bone fractures, circulatory problems in the heart, gallstones or dental diseases.
The MD emphasizes that the annual statistics are not representative; they would simply show the medical service's assessment numbers and results. “An accumulation of allegations in a specialist area says nothing about the error rate or safety in the respective area,” explains the senior doctor at the Bavarian Medical Service. “They just show that patients react when treatment does not meet their expectations.” Errors in surgical procedures are also generally easier for patients to recognize than, for example, medication errors, which is why errors in operations are more likely to be blamed than in others Treatments.
In almost two thirds (60.5 percent) of the cases examined, the damage to the patient's health occurred temporarily, but an intervention or hospitalization was still necessary and the patient recovered completely.
However, permanent damage was caused in over a third of those affected (35%). The medical services differentiate between light, medium and severe damage. Mild permanent damage can be a slight restriction of movement or a scar. Moderate permanent damage can be chronic pain symptoms, significant restriction of movement or disruption of organ function. Severe permanent damage occurs when the injured person becomes in need of care or becomes blind or suffers permanent paralysis due to a mistake. In 3% of the cases (84), however, an error led to the death or contributed significantly to it. <<

SEVer prevention list from the Patient Safety Action Alliance e. v.

I APS SEVer in connection with surgical procedures:
1. An operation or other invasive procedure that is started on the wrong patient or in the wrong part of the body or that deviates from the originally agreed intervention. This applies regardless of whether the error is discovered during the intervention or only afterwards.
2. Accidentally leaving a foreign body in the patient during surgery, other invasive procedures, or in a body cavity.
3. Artificial insemination with false sperm and/or egg cells.
4. Undetected esophageal intubation

II APS SEVer related to drug, hemotherapy and transplantation:
5. Misapplication of a medication in any of the following ways:
5.1. Intrathecal administration of a chemotherapy drug to be administered intravenously
5.2. Parenteral administration of a medication to be administered enterally/orally
5.3. Intravenous administration of a medication to be administered epidurally
5.4. Intra-arterial administration of a medication to be administered intravenously
6. Erroneous intravenous administration of a highly concentrated potassium chloride solution instead of the prescribed medication
7. Insulin overdose resulting from incorrect application:
7.1. Administration of insulin via a syringe that does not contain an insulin-specific label
7.2. Withdrawing insulin from an insulin pen and administering it via a syringe
8. Overdose of methotrexate for non-oncology patient care (e.g. daily rather than weekly administration)
9. Use of a contaminated drug or biologic whose contamination occurred in the healthcare facility
10. Incorrect transfusion of an ABO-incompatible blood product. Transplantation using ABO-incompatible organs, tissues, tissue preparations or cells. The incompatibility must be clinically relevant.

III APS SEVer related to the treatment process:
11. Loading a naso-/orogastric tube whose misposition cannot be ruled out
12. Air embolism during treatment
13. Burns or scalds resulting from the treatment or care process
14. Improper custodial measures in the treatment or care process
15. Inadequate oxygen delivery to a patient identified as requiring oxygen

IV APS SEVer due to technical or organizational errors:
16. Improper use of a medical device in patient care due to deficiencies in instruction or maintenance
17. Dismissal of an underage, incapacitated person being treated (regardless of age or reason for limited decision-making capacity) without appropriate care. This includes both discharge on your own without a person caring for you and discharge into the care of a person who is not authorized to care for you or determine your whereabouts.
18. Permanent loss of an unrecoverable tissue sample
19. Intervention-relevant examination findings not communicated or not followed up
20. Attracting a magnetizable object into the magnet of an MRI scanner
21. Patient care by people who pretend to belong to the relevant health or healing profession
22. Inpatients forgotten in treatment and examination areas