GRI 416/3-3, 417/3-3

Organization and responsibilities

The business segment Fresenius Helios is managed by the holding company Helios Health. Due to the different national regulatory frameworks and standards as well as differences in the business models, the responsibility for patient and product safety lies with the management of the individual divisions. The structure of the management approaches of the divisions is regulated within the respective managements, for example via a business allocation plan. Further information on the divisions can be found in the chapter Fundamental information about the Group in the Group Management Report.

The Quality Management steering committee of Helios Germany, newly established in 2022, is composed of the Chief Medical Officer (CEO, who is also the Chief Medical Officer – CMO), the Medical Consultants, and the Patient Safety Officer, as well as the central function Medical Service and the specialist Nursing group management. The task of the steering committee is to coordinate the central steering processes of medical quality management and patient safety measures on a quarterly basis. Also on a quarterly basis, the medical management committees of the hospitals evaluate all reportable key figures together with the medical consultants. Reporting meetings are subsequently held with the steering committee on those facilities which report deviations such as suspicious quality indicators or reported cases relating to patient safety, in order to determine measures that still need to be implemented during the course of the year. These range from peer reviews at the hospital level, for example, to location-wide quality manage­ment measures at the corporate level, if necessary.

The leading physicians in their respective fields come together to form the total of 30 Helios specialist groups. They ensure that the knowledge of their medical specialty is anchored in all hospitals and represent this internally and externally. They also advise and decide on the introduction of standard processes, the selection of medical products, sensible innovations, and on campaigns. Furthermore, they discuss results from clinical trials and derive possible changes in treatment approaches from them.

The CMO at Helios Spain is responsible for quality management, as well as patient safety and satisfaction. The function is supported by the Corporate Operations department, whose focus is on improvements in the provision of therapies and health services and the design and marketing of new digital products in the ambulatory setting. The Corporate Risk unit has also been created in order to improve risk management within the company. The implementation and control of measures is carried out by the Corporate Pat­ient Safety Committee. It is responsible for implementing the central patient safety strategy, which is supported by the annual targets in the areas of quality, and patient safety and satisfaction. The assessment of whether and how the objectives have been achieved is part of the annual performance evaluation of the responsible managers of Helios Spain.

The medical departments of Helios Germany and Helios Spain exchange ideas and information on specific topics. For example, the German hospitals benefit from Helios Spain’s very close networking of outpatient and inpatient care, and can take advantage of these experiences.

The CMO of Helios Health also coordinates synergy projects between the divisions in this area as well as in the fields of medical quality and research.

In 2022, the Corporate Patient Safety Committee at Helios Spain continued to develop and implement clinical best practices. The committee consists of members from various hospitals, including clinics in Latin America. The committee has remained active throughout the pandemic, not only advising the hospitals on COVID-19 management, but also developing new strategic patient safety protocols and updating them. The existing Patient Safety Strategy dev­eloped by this committee was updated again in 2022. It is based on principles such as those of the World Health Organization (WHO) and the JCI.

The Medical Director of the Fertility Services division (Eugin Group) coordinates the Group Medical Board (GMB) of the division. It is composed of representatives from all countries or country groups, and promotes, among other thi­ngs, Group-wide projects in the area of quality. For example, key performance indicators (KPI) reports relating to clinical and laboratory results and patient satisfaction were introduced in the reporting year and are now produced quarterly across the Group. The GMB is also promoting the development of Group guidelines through dedicated working groups, mainly focused on laboratory safety. Accordingly, it will set targets for the achievement of specific KPIs related to clinical and laboratory outcomes.

Policies and regulations

No central guidelines for patient or product safety have been implemented at Helios Health level. Due to country-­specific regulatory requirements, it is the responsibility of the management of the divisions to issue internal guidelines to ensure compliance with all laws and external frameworks.

Guidelines within the divisions refer to the respective nationally applicable requirements, e. g., the Group Regulation on Hygiene of Helios Kliniken in Germany, or result from the quality management systems, e. g., ISO 9001 in Spain.

Helios Germany has built on the numerous measures introduced in the past, to increase patient safety. Two checklists are mandatory for all surgeries in the Helios’ clinics. The PRÄ checklist assesses the risks associated with ­the surgery before it takes place. The PERI checklist helps to avoid treatment errors immediately before, during, and immediately after the surgical procedure.

Since 2020, these measures have been supplemented by increased hygiene requirements due to the COVID-19 pandemic. For this purpose, the existing hygiene concepts have been adapted to the changed regulatory provisions during the year.

In its Management Policy, Helios Spain provides the ­hospitals with principles for quality assurance.

In order to ensure that all physicians working at a Helios Spain hospital perform clinical acts for which they have demonstrated competence, a model is used to validate these competencies and select the professional to perform the corresponding acts and procedures. This model has been included in a corporate policy that also defines the monitoring of physicians’ complication rates through the minimum basic dataset.

Initiative Qualitätsmedizin (IQM)

Helios Germany had been developing a quality management system since 1998 with the aim of creating transparency regarding the results of treatment quality in the clinics and making them comparable. In 2008, Helios Kliniken joined forces with 14 other hospital operators to form the Initiative Qualitätsmedizin (IQM – Initiative for Quality Medicine). IQM is now the largest voluntary quality initiative in the German healthcare system.

Public, private, university, and non-profit faith-based hospital operators use the IQM as an inter-organizational ­platform with the aim of exchanging ideas and learning from each other.

The initiative brings together various healthcare organizations in Germany with the aim of developing and improving standards for quality transparency in medical outcomes:

• medical societies and health insurance companies,
• the Research Institute of the largest German health insurance company AOK (WIdO) as partner for cross-sector measurement of treatment quality and expanding the foundation for healthcare research across operators and sectors, as well as
• the German Medical Association and numerous state medical associations to assist with the implementation of peer reviews to analyze and improve treatment procedures and structures.

About 500 hospitals in Germany and ­Switzerland are now part of the IQM and use its quality management system. More information can be found on the ­initiative’s website.

Treatment quality

GRI 2-25

The quality management system at Helios Germany is based on administrative data (routine data) from patient treatments: the hospitals document each treatment step for later billing with the health insurance companies. This routine data shows whether the healing process took longer than expected, and whether complications or even a death occurred. It also indicates whether a treatment took a normal course or if mistakes were made. Mistakes are then revi­ewed in specific audit procedures (peer reviews). Defined indicators are used to measure and monitor the quality of medical outcomes, which are published by all participating hospitals. This data illustrates how the hospitals perform compared to the national average, to other Helios hospitals or to IQM member hospitals. In addition, patients can see, among other things, how often certain treatments are performed. This gives them important information on the ­doctors’ experience and routine and helps inform their own decisions about their treatment. Furthermore, each clinic and each department receive a monthly report on the results of medical treatment quality. Thanks to the quality and risk management, key quality parameters can continuously be monitored and, if necessary, countermeasures can be taken at an early stage.

In Spain, Fresenius Helios introduced the methodology in all hospitals at the end of 2017. Since then, 45 indicators are systematically monitored on a monthly basis, in comparison to standardized national Spanish ratios. The treatment results are also compared with the goals of the IQM network. Each hospital publishes its results monthly, in a central IT system. This allows individual hospitals to check whether they deviate from the standards set.

Peer reviews

Helios Germany analyzes the cases – including treatments and medical routines – in hospitals that fail to meet individual quality targets, in order to identify and implement improvements. Particularly important are the specific audit procedures in the medical and nursing sectors, and the peer reviews – expert discussions of cases. In Germany, trained physicians from the hospitals of Helios Germany and from the IQM network in particular cooperate in the peer review, and question statistical abnormalities. Their insights are translated into concrete recommendations for action in the hospital with the aim of increasing patient safety.

Patient safety and reporting systems

Helios Germany uses reporting and learning systems for critical events and near-misses of patients in all hospitals (Critical Incident Reporting System – CIRS). This is anonymous, can be used in all areas of a hospital site, and primarily serves the preventive protection of both patients and employees. Based on the information collected via the reporting system, potential errors in processes and workflows can be identified. Measures for improvement can be derived accordingly. In addition, one clinic at a time is subject to a safety inspection every quarter. In this way, risks relevant for the overall division are identified and can be avoided.

Helios Germany has its own system for regularly measuring patient safety at its hospitals. This enables deficiencies in patient care to be analyzed and subsequently remedied. The system combines the internationally established Patient Safety Indicators (PSI) with Helios’ own indicators. The latter include, for example, the number of abdominal towels accidentally left in the body after an operation, but also side confusion during operations, misdiagnoses, serious medication errors, or falls in the clinic.

A company-wide policy for dealing with cases of damage obliges all clinics to systematically record and centrally report these indicators. Since 2019, the division in Germany has published the figures for selected indicators annually on its website. In this way, it ensures the greatest possible transparency in dealing with undesirable incidents and treatment errors.

In the spirit of this transparent error management, Fresenius Helios processes and settles its liability cases itself as far as possible instead of handing them over to a regulator. This allows the division to analyze them intensively and learn from them. If there are justified liability cases and claims in the course of patient treatment, these damages are compensated by Helios, e. g., in the form of compensation for pain and suffering.

As a member of the Patient Safety Action Alliance, Helios Germany thus also takes into account the initiative’s new recommendations for action published in September 2021 as part of clinical risk management. The importance of reporting such events is highlighted by the new Global Action Plan for Patient Safety 2021 – 2030 of the WHO. It aims to prevent preventable harm in healthcare settings.

Since 2021, Helios Germany has also developed a tool for automatically querying preventive measures. In the event of a confirmed treatment error, the company initiates a central review of the meaningfulness of the respective preventive measures.

Helios Spain uses an online reporting system for all types of incidents, from near misses to sentinel events. Based on the definition from JCI, a sentinel event is a patient safety event that results in death, permanent harm, or severe temporary harm. The system is accessible for all healthcare professionals and hospital employees. The reported events are analyzed at least quarterly by each hospital Patient Safety Commission. Trends and causes are identified in order to implement the necessary improvements. This analysis is also recorded in the reporting system and feedback is provided to the notifier.

Hygiene management in hospitals

Hygiene management at Fresenius Helios focuses on close monitoring of infections and pathogens, regular hygiene training for hospital staff, for example on correct hand disinfection, monitoring antibiotic consumption, and training physicians as antibiotic stewardship (ABS) specialists. The implementation of and compliance with hospital hygiene measures in the clinics is accompanied and monitored by our specially trained staff – e. g., hygiene specialist nurses, hospital hygienists, and hygiene officers. The Helios Group hygiene regulation is binding for all employees in all clinics of Helios Germany. It is based on the evidence-based recommendations of the Robert Koch Institute (RKI) and prescribes, among other things, hand disinfection – especially before and after contact with patients – for physicians, nurses, medical staff, and other personnel, in accordance with the guidelines of the WHO.

The clinics monitor their hygiene status continuously and transparently: every six months, Helios Germany publishes figures for each clinic on the occurrence of the three most important multi-resistant and infection-relevant pathogens. The reporting for 2022 is delayed to the first half of 2023 due to the impacts caused by COVID-19.

In Spain, Fresenius Helios conducts training courses on hygiene management on a regular basis. The clinical group participates in the EPINE program – a monitoring system for nosocomial infections that occur during or after hospital treatment. The program is coordinated by the Spanish society of preventive medicine, public health, and hygiene, and supported by the Spanish Ministry of Health and the European Center for Disease Prevention and Control. Local data is collected from the infection services of the participating facilities with the aim of improving the quality of care in the hospitals.

In 2020, Helios Spain started encouraging all hospitals to appoint a medical officer to manage infection control and prevention measures. In 2022, 61% of the hospitals had an epidemiologist to manage infection prevention and control within the hospital. Other hospitals had at least one professional specialized in infection control from other specialties (internal medicine, intensive care) who manages this area.

Training

Helios Germany has three simulation and emergency facilities in Erfurt, Krefeld, and Hildesheim. Among other things, surgical procedures or crisis scenarios in the operating room are trained here. In addition, such training courses take place in the clinics directly. In the fields of emergency medicine, anesthesia, intensive care medicine, and obstetrics, decisions on the content and number of participants in the mandatory training courses are based on resolutions of the respective specialist groups.

Helios Spain continuously provides training on patient safety, on its quality management systems, and on topics that are essential in hospital routine. In 2022, 18 different patient safety sessions were conducted in the hospital network of Helios Spain, 2,862 people were trained and 9,129 hours of training were received. The exchange of know­ledge among the hospital network has been promoted thr­ough inter-hospital clinical sessions. It now covers several medical fields such as gynecology and obstetrics, pediatrics, and internal medicine. In addition, clinical sessions have been held on several patient safety topics: best patient safety practices in the surgical block, preventing adverse events in the insertion and management of venous access, patient falls prevention, medical record and informed consent ­completion requirements, transforming the patient safety culture of the hospital through the JCI accreditation process, and evidence-based safety improvement practices.

Patient information

GRI 417-1

Fresenius Helios provides information to its patients within its hospitals about the patient admission process with the help of the treatment contract, as well as special information documents and privacy statements. The therapeutic objective is discussed with patients during admission and discharge discussions with the treating physicians.

Fresenius Helios communicates via an online magazine, social media, its website, and in its communication campaigns for the interested public. In addition, information events on specific medical topics are held in all hospitals (known as patient academies). Further details on transparency in healthcare can be found in the Compliance section.

Patient satisfaction measurement and grievance processes

The business segment uses the Helios Service Monitor to measure the satisfaction of inpatients in its German hospital locations once a week. Employees on site conduct short interviews on care and service. The goal behind this is to respond to patients’ feedback within 24 hours and to clarify their concerns, if possible, in direct contact. The data is then processed anonymously in the Helios Service Monitor. The results can currently be viewed individually by each clinic in a daily, weekly, or monthly cycle. The management of the hospital and other authorized persons receive the monthly survey results to obtain a general picture of satisfaction and to be able to identify areas of criticism. In addition, Helios Germany publishes the results of patient surveys, further data on medical treatment quality, and hygiene figures on its corporate website www.helios-gesundheit.de, see the menu item Qualität bei Helios (German language only).

In Spain, Fresenius Helios uses the NPS to get specific feedback from patients who have been treated as inpatients, outpatients, or in emergencies. 48 hours after a hospital stay, an e-mail is sent to patients asking if they would recommend the hospital and its services. The results are analyzed centrally for Helios Spain and at a hospital level by type of treatment and treatment area. The goal is to continuously improve the NPS results. The global NPS score had increased over recent years until the start of the pandemic. Once the impact of the pandemic had softened, the NPS results improved again and achieved previous levels. The information Helios Spain collected on the specific touchpoints in the patients’ journey has been extremely valuable in initiating improvement actions.

Our ambitions

Helios sets company goals to measure the quality of treatment in its hospitals, using the E-IQI methodology in Spain and the G-IQI methodology in Germany. Each hos­pital treat­ment (case) is evaluated by making use of comparative measurements, with the benchmark being the German national average as calculated by the Federal Statistical Office or comparable national benchmarks in Spain. The target is in each case to be better than the national average for the respective indication. Further quality targets in our hospitals in Spain relate to patient satisfaction and are measured via the NPS, among other methods.

Progress and measures in 2022

In the reporting year, the management approach and the governance structure of Fresenius Helios remained mainly as reported in 2021.

Since February 2022, two Medical Consultants have replaced the regional medical directors in Germany in a newly created function. They report directly to the CEO of Helios Germany and advise the management board and the regional management boards on all medical issues. They also support the hospital managements, for example in matters relating to staffing requirements. In addition, the Medical Consultants are part of the Quality Management Steering Committee, which was established in 2022 as well. More information on this can be found in the Organization and responsibilities section.

Helios Germany has anchored the implementation of measures derived from liability cases in a focus target on patient safety for hospital management and chief physicians in 2022. This aims to promote the processing of patient safety-related incidents and the development of preventive measures. The focus target on patient safety is part of the corporate goal on quality assurance and patient safety (Bonus Qualitätssicherung & Patientensicherheit) and consists of the implementation rate of adequate preventive measures in the event of confirmed treatment error as well as the full implementation of morbidity and mortality conferences. It was fully met in the reporting year. The other sub-goal of implementing checklists was achieved by 84%. The targets were each extended for 2023.

In the reporting year 2022, Helios Spain started to develop the new patient strategy quality and patient safety for the term 2022 to 2025. The strategy forms the basis for measures for improvement and targets for this material topic.

The IQI methodology was extended to some clinics in Latin America in the reporting year, such as Clínica Ricardo Palma in Perú. Clínica Imbanaco in Colombia will follow in 2023. In addition to the implementation of the necessary med­ical and patient data base, the medical documentation will be improved to gather the data relevant to calculate the IQI development.

The Fertility Services division implemented a standardized patient satisfaction survey across the group in the fourth quarter of 2022. The first results are expected in the first quarter of 2023 and will be transferred into respective measures at site-level.

Evaluation

GRI 416-1, 416-2

Fresenius Helios assesses the health and safety impacts ­of all significant treatment or service categories for improvement potential. If necessary, measures are derived. The revision of treatment guidelines usually takes place in the Helios specialist groups.

For Fresenius Helios, the quality of medical outcomes is key. For Germany specific targets key quality indicators were defined; the results are expected to be better than the German average. In 2022, the clinics recorded 1,083,063 cases (2021: 1,046,517), an increase of about 3% compared to the previous year. Considering the individual GIQI-results of the clinics, 87.0% of the targets were achieved (2021: 86.8%). Around 50% of the clinics achieved a rate of more than 90%, while 17% of the clinics achieved a rate of 100%. The target rate based on the individual targets will be considered for the short-term incentive of the Management Board compensation of Fresenius Management SE, as explained in the Compensation Report in the Annual Report 2022. The section also includes information on relevant treatment quality KPI at the division Helios Spain.

The competence gained through the research into COVID-19 and the improved diagnostics related to the infection also led to an improvement in the overall treatment in our Spanish hospitals. Earlier diagnosis, better knowledge of its management and the impact of vaccination, have resulted in less virulence of the illness, less use of intensive care beds and a lower mortality rate. In 2022, a total of 737 events were reported in CIRS in Germany (2021: 576), which were evaluated at the respective clinic level.

In 2022, 54 events were recorded for 8 selected patient safety indicators (2021: 85).

Part of Helios Germany's error management is the recording of allegations of treatment errors. In 2022, the number of allegations was 828 in the acute clinics (2021: 768²). An average of 0.8 per 1,000 (2021: 0.8) patients made an allegation of a treatment error (justified or unjustified) against Helios hospitals. These allegations include, to varying degrees, all specialties and all stages of treatment, from patient information, diagnostics, surgery, and therapy to aftercare. The goal is to ensure that there is no more than one allegation of treatment error per 1,000 full inpatient treatments.

In 2022, 739,660 patients nationwide were asked for their personal opinion using the Service Monitor. In this way, the division reached around 70% of its inpatients. Of those surveyed, 96% expressed satisfaction with their current hospital stay. Typical points of criticism relate, for example, to food supply and cleaning, but also to issues such as communication between individual professional groups or departments. Statistically conspicuous results are examined by local management and measures are taken if necessary.

At Helios Spain, the clinics report patient safety incidents including near misses. In 2022, a total of 11,299 incidents were reported (2021: 8,508). We actively encourage the reporting of incidents, including hazardous (or “unsafe”) conditions and near misses, as a way of promoting patient safety.

In 2021, Helios Spain had identified high demand for outpatient consultation that heavily penalized NPS results, as the demand from patients was higher than the capacity for consultations and number of doctors in our clinics. During 2022, the results have increased after taking actions to decrease the waiting time for appointments. This resulted in an improved patient evaluation, positively affecting the NPS.

At the end of 2022, the growth of the NPS compared to the previous year was 14%, influenced by increases of 26% in medical consultation area and 13% in the clinical analysis area.

In 2022, Helios Germany conducted a total of nine reviews (2021: seven), due to the impact of the COVID-19 pandemic and the resulting restrictions on hospital operations. In addition, four safety inspections were conducted by the Patient Safety Officer.

Helios Spain performed four peer reviews by the end of 2022 (2021: four). Internally, ISO 9001 audits were conducted at all Helios clinics in Spain.