Patient and product safety

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GRI 416 and GRI 417

The safety of our patients is our highest priority and it plays a central role along our entire value chain. In the interests of maximum safety, we go beyond the existing regulatory requirements. In our medical services, for example, disruptions in the process flow, such as natural disasters or technical failure, pose a significant risk to patients and the clinics. In addition, there are also operational risks, for example due to hygiene deficiencies. The various consequences that these and other non-financial risks can have for Fresenius are described in detail in our Opportunities and Risk Report. We counter these risks through structured processes, training and quality management systems, among other things, and work to continuously improve patient and product safety. Transparent information to the public is also part of our safety and quality commitment.

Our approach

At Fresenius, our aspiration is: better medicine for ever more people. Our commitment to always strive for the highest quality in our products, services, and therapies stems from this. The most important non-financial aspect by which we measure our success is the well-being of our patients. In order to provide patients with the best possible care, we offer them medical treatments and products that meet our strict requirements for quality and safety.

We have established sophisticated processes in all business segments that are fully geared toward the safety of our patients and efficient processes. In the area of quality management, we focus on monitoring, managing and improving these processes by means of performance indicators. The individual business segments adapt their quality management systems to their respective business models and set priorities accordingly. Our quality management systems meet or are based on various standards. International standards such as ISO (International Organization for Standardization) and GMP (Good Manufacturing Practice) are particularly important for our production facilities. In our hospitals and health care facilities, we measure the quality of patient care using various indicators.

Organization and responsibilities

All Fresenius employees must ensure that the applicable quality and safety regulations are always observed in their areas of responsibility. The employees in the production facilities, outpatient centers, and hospitals have a special obligation to exercise due care. The organizational structures are adapted to the requirements of the individual business segments.

Policies and regulations

All four business segments comply with the applicable laws within the framework of quality management.

Our operations are subject to extensive governmental regulation in virtually every country in which we operate. This includes, for example, the EU legislation on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the Restriction of Hazardous Substances (RoHS), the Medical Device Directive, the new Medical Device Regulation, and the Code of Federal Regulations (CFR) of the U.S. Food and Drug Administration (FDAFDA (U.S. Food & Drug Administration)Official authority for food observation and drug registration in the United States.).

In addition, the business segments have developed their own comprehensive guidelines. Furthermore, the business segments have voluntarily committed to complying with a wide range of industry obligations and international standards. For example, Fresenius Medical Care respects the industry initiative Kidney Disease: Improving Global Outcomes (KDIGO) foundation, the Kidney Disease Outcome Quality Initiative (KDOQI), the European Renal Best Practice Guidelines (ERBP) and industry-specific clinical benchmarks. Fresenius Kabi’s quality management system also takes applicable national and international regulations into account, including Good Clinical Practice (GCP), Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), Guideline on Good Pharmacovigilance Practices (GVP), Medical Device Regulation (MEDDEV; MDR), the Code of Federal Regulations (CFR) of the U.S. Food and Drug Administration (FDA), and the ISO 13485 quality management standard for medical devices. Helios Spain is committed to patient safety and has 24% of the hospitals certified under the quality standard UNE 179003. Fresenius Vamed’s facilities in Germany have joined the Qualitätskliniken.de initiative, and meet the requirements of the quality aspect of patient safety.

With these voluntary commitments, our business segments go beyond the statutory and regulatory requirements for patient safety; for example, they impose even more stringent regulations:

• Hand disinfection
• Fall prevention
• Decubitus prevention
• Drug therapy safety
• Education of patients/rehabilitation patients
• Complaints
• Handling of multiresistant germs, noroviruses, etc.
• Dealing with patients at risk of running away
• Regulations governing medical emergencies
• Handling non-medical emergencies (e.g. fire protection, evacuation exercises)
• Risk management
• Reporting
  

Fresenius Medical Care

Fresenius Medical Care is committed to delivering safe, high-­quality care for patients with chronic illnesses. To live up to this commitment, the company continuously monitors and analyzes the quality performance of its products and services. The company also measures patient satisfaction and takes its patients’ feedback into account to improve its services. Fresenius Medical Care is continuously working to expand access to high-quality health care for more patients and further improve the care the company offers. This also involves investing in innovations and new technologies and leveraging insights from scientific research and collaboration with partners.

Fresenius Medical Care produces and delivers a broad range of products for treating kidney disease. With its network of 44 manufacturing sites in more than 20 countries, the company takes care of the procurement, production, distribution, and supply of renal and multi-organ therapy products. The business segment manages the quality and safety of its product business over the entire product life cycle, from design and development, to operation and application.

Fresenius Medical Care’s consolidated quality management system is certified according to ISO 9001 and ISO 13485. In addition, the business segment's plants are subject to regular external quality audits and reviews in accordance with local requirements. Of the production sites managed by the Global Manufacturing, Quality and Supply function, 21 sites are certified with ISO 9001 / 13485. Furthermore, 17 sites have been audited according to the Good Manufacturing Practice (GMP) or the Current Good Manufacturing Practice (cGMP) guidelines. Fresenius Medical Care also successfully completed the Medical Device Single Audit Program (MDSAP) in 10 of its sites as well as for the company’s consolidated quality management system. This enabled the company to reach a higher level of efficiency and reduce the cost per audit.

Organization and responsibilities

In 2019, Fresenius Medical Care established the Global Medical Office to coordinate its efforts to advance medical science and patient care. It is part of a network that drives scientific and medical progress worldwide. The Global Medical Office is led by the company's Global Chief Medical Officer, who was appointed to the Management Board in 2020. Key findings of the Global Medical Office are published on a regular basis.

Internal rules of conduct and guidelines

Two global functions are responsible for Fresenius Medical Care’s product business: Global Research and Development and Global Manufacturing, Quality and Supply. Both functions report directly to the Management Board. They have jointly developed our Global Quality Policy, which describes our commitment to product and service quality. It also covers our obligation to comply with relevant regulations and maintain environmentally sound and efficient operations. The Global Quality Policy is the basis for regional quality manuals and further detailed policies that describe aspects such as responsibilities, training, risk assessments, and audits. The Management Board is regularly informed about our global quality performance.

Fresenius Kabi

Fresenius Kabi’s corporate philosophy “caring for life” describes the company’s commitment to improving the quality of life of its patients. The quality and safety of its products and services is therefore of paramount importance to Fresenius Kabi. An important goal of the quality management at Fresenius Kabi is to monitor the applicability, efficacy, and safety of products and services, as well as the success of therapies, and their continuous improvement. To ensure this, the company has established an integrated quality management system, a monitoring and reporting system, and product risk management.

Fresenius Kabi’s quality management system is organized in accordance with the ISO 9001 standard and is binding for all Fresenius Kabi organizations. Compliance with the standard is reviewed by TÜV Süd in annual audits at a global level and covers 115 Fresenius Kabi organizations through a matrix certification

Fresenius Kabi has a global quality management handbook including a global quality policy, as well as standard operating procedures. They are applicable globally and cover all sites. Fresenius Kabi uses a global electronic quality management system, KabiTrack, based on the Trackwise® software, for all quality management processes. The system supports the local implementation of centrally defined processes as well as global oversight.

Organization and responsibilities

At Fresenius Kabi, the globally responsible quality managers report directly to the respective member of the Management Board. The members of the Management Board are thus directly responsible for quality management. They are regularly informed about quality management in quality oversight meetings and receive quality management reports on a regular basis.

Policies and regulations

Fresenius Kabi has defined the following principles for its quality management:

• Clear assignment of responsibilities
• Qualification and continuous training of employees
• Monitoring of product and patient safety
• Transparent and documented processes and procedures
• Fulfillment of regulatory compliance
• Continuous improvement
• Checking of quality management effectiveness

Fresenius Helios

Helios Germany has developed a quality management system based on three pillars: Measure, Publish, Improve. It is used in a similar form by around 500 hospitals in Germany and Switzerland. This quality management system is based on administrative data (routine data) from patient treatments: the hospitals document each treatment step precisely for later billing with the health insurance companies. For example, this routine data shows whether the healing process takes longer than expected, and whether complications or even a death occurred. It also indicates whether a treatment took a normal course; if mistakes were made, they are reviewed in specific audit procedures (peer reviews). Defined quality indicators (German Inpatient Quality Indi­cators – G-IQI) are used to measure and monitor the quality of medical outcomes. The outcomes are published. This data allows patients to see, among other things, how often certain treatments are performed in Fresenius Helios hospitals. This gives patients important information on how much experience doctors have in this area and helps them make their own decisions about their treatment. Thanks to its quality and risk management, Helios Germany can continuously monitor key quality parameters and, if necessary, take countermeasures at an early stage.

Helios Spain gears its quality management toward the requirements of recognized international quality standards. All hospitals and centers are certified according to ISO Standard 9001. Further, the certification according to the most relevant international quality standards (Spanish Association for Standardization, UNE) was continued. In addition, hospitals are certified in accordance with of the Joint Commission International (JCI) and the European Foundation for Quality Management (EFQM) standards. In 2020, two further hospitals were awarded the international certification UNE 179003, which means that a total of 12 hospitals in Spain are certified in accordance with this standard. Regarding UNE 179006, the standard for infection control, eight hospitals are already certified. For 2021, we aim to include further three health centers in the JCI certification.

In Germany, as required by law, the rehabilitation clinics have been accredited in accordance with the requirements of the Federal Association for Rehabilitation (BAR) and certified according to the quality seal of the Hospital Association Schleswig-Holstein e.V. (German: Gütesiegel Medizinische Rehabilitation in geprüfter Qualität der Krankenhausgesellschaft Schleswig-Holstein e.V.). One exception is a geriatric clinic, which is certified according to the DIN EN ISO 9001/Geriatrics quality seal.

Organization and responsibilities

At Fresenius Helios, the medical director has direct responsibility for patient and product safety; further, the position of a Patient Safety Officer was created. Helios Germany’s central medical services and medical specialist groups help to implement the appropriate measures. The leading physicians in a particular field from all Fresenius Helios hospitals in Germany come together in these specialist groups. They ensure that the knowledge of their medical specialty is anchored in all hospitals and represent their respective medical fields internally and externally. They also advise and decide on the introduction of standard processes, sensible innovations, campaigns and the introduction of medical products.

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

Policies and regulations

In recent years, Helios Germany has introduced numerous measures to increase patient safety. Checklists are mandatory for all operations in Fresenius Helios’ clinics. The “pre” checklist assesses the risks associated with the operation before it takes place. The “peri” checklist helps to avoid treatment errors immediately before, during, and immediately after the operation: this reduces wrong-side errors or surgical material left behind in the body to a minimum.

In 2020, Helios Spain appointed new members to the Corporate Safety Committee with the aim of involving further hospitals and generating new ideas. The committee has remained active throughout the pandemic, not only advising the hospitals in the COVID-19-management but also developing new strategic patient safety protocols. The Patient Safety Strategy developed by this committee was completed in 2020. It is based on the principles of international insti­tutions such as the World Health Organization (WHO) and the JCI.

Fresenius Vamed

Fresenius Vamed aligns its internal processes to established quality standards such as ISO 9001, ISO 14001, and ISO 13485, as well as the EFQM standards. In addition, Fresenius Vamed has certified several health care facilities according to international standards such as JCI, ISO, and QMS-REHA®. These certifications form the basis for the continuous improvement of the processes at Fresenius Vamed.

In Germany, as required by law, the rehabilitation clinics have been accredited in accordance with the requirements of the Federal Association for Rehabilitation (BAR) and certified according to the quality seal of the Hospital Association Schleswig-Holstein e.V. (German: Gütesiegel Medizinische Rehabilitation in geprüfter Qualität der Krankenhausgesellschaft Schleswig-Holstein e.V.). One exception is a geriatric clinic, which is certified according to the DIN EN ISO 9001 / Geriatrics quality seal.

All processes are regularly checked for their suitability and adapted, if necessary. In accordance with the BAR guidelines, Fresenius Vamed implements all relevant measures to increase patient safety at its facilities – including patient surveys, complaint management, and regular internal audits of all segments. The company receives feedback on the quality of the structure, process and outcomes from the insurers, e.g. as part of the quality assurance of the German pension insurance or the statutory health insurance providers. In all Fresenius Vamed health care facilities, patients receive relevant information material and patient training to ensure long-term treatment success (see Labeling). Reporting systems for complaints are also available in some health care facilities (see Complaints systems). In Fresenius Vamed’s project business, the lead companies establish guidelines for all subsidiaries, which are reviewed in annual audits.

Organization and responsibilities

In order to raise awareness of quality requirements among employees, Fresenius Vamed employs staff for quality and risk management. These employees report directly to the management. Other quality assurance officers carry out training courses in the various segments, thus integrating all employees in the quality management systems of their facilities. The quality assurance officers can thus ensure that the employees comply with their obligation to exercise due care. Fresenius Vamed informs its employees about its understanding of quality early in the initial training and introductory events. Guidelines are traceably communicated to the relevant areas and departments in writing (e.g. via work instructions from the respective management).

The VAMED International Medical Board (IMB) ensures the exchange of information between Fresenius Vamed physicians from Austria, Germany, the Czech Republic, the United Kingdom, and Switzerland. Within Fresenius Vamed, medical specialist groups and executive conferences coordinate on quality and safety.

Policies and regulations

Fresenius Vamed sets ethical standards through its mission statement as well as through codes such as the Code of Conduct, the Clinical Code of Conduct, and the Code of Conduct for Business Partners. Fresenius Vamed’s internal guidelines are based on the regulatory requirements established throughout Europe, e.g. for rehabilitation. In addition to the statutory requirements and the requirements of the insurers, Fresenius Vamed also adheres to international standards such as ISO and EFQM, expert standards, and medical guidelines. All internal guidelines are regularly reviewed and updated as necessary. Employees can obtain information on the guidelines via the intranet.

Our ambitions

Quality targets are determined and reviewed in each business segment based on the defined quality parameters. Further information is provided in the chapter evaluation.

In 2020, Fresenius Medical Care developed a global policy on patient care, including a chapter dedicated to patient experience surveys and related processes that are harmonized worldwide. The main goal in doing so is to strengthen the inclusion of patients’ feedback. To achieve this, the business segment has set itself targets. In 2021, Fresenius Medical Care endeavors to further roll out its harmonized patient experience survey worldwide and also plans to implement a globally consistent process for making improvements in all countries in which the patient survey is rolled out.

Fresenius Medical Care has set itself the goal of implementing a global quality management system by 2024. As part of its initiative to harmonize our quality systems and processes worldwide, the business segment is planning to introduce a global electronic training system within the next three years.

The overarching goals of Fresenius Kabi’s quality management are to ensure the well-being of patients as well as the quality and safety of products, services, and therapies, and to fulfill regulatory requirements.

Helios sets company goals using the E-IQI methodology in Spain and the G-IQI methodology in Germany, making use of comparative measurements, with the benchmark being the German national average as calculated by the Federal Statistical Office. The aim is to be better than the national average for each target. Further quality objectives in our hospitals in Spain relate to patient satisfaction.

Fresenius Vamed defines its quality goals annually with the aid of additional key performance indicators. The findings from complaint, case, and risk management are also incorporated. The goals are reviewed regularly.

Progress and measures 2020

Clinical efficiency and hygiene management

Improved dialysis treatments

Continuous improvement is an essential prerequisite for enhancing the quality and safety of Fresenius Medical Care’s products. Product improvement is defined as a change that focuses on at least one of the following: patient safety and quality, product performance, or customer service. Product improvements are evaluated from the patient’s perspective. In 2020, the business segment implemented more than 440 product improvements to its dialysis machines and is planning to extend this KPI to further product groups in 2021.

Fresenius Medical Care also carries out innovations with the aim of continuously improving its portfolio. To enable access to the latest technologies, the business segments invests in research and development and collaborates with external partners, including academic institutions. Fresenius Medical Care also invests in startups that develop products, technologies and therapies in the health care sector.

Hygiene management in hospitals

The aim of Fresenius Helios’ hygiene management system is to avoid infections within the hospital and, as quickly as possible when they do occur, to prevent them from spreading. The main focus is on adequate personnel with hygiene specialists and doctors, infection and pathogen monitoring, control of antibiotic consumption, and training of physicians to become antibiotic stewardship (ABS) specialists. The planned antibiotic reporting for clinics in Germany was available for the first time at the end of 2020.

In Germany, the Helios Group regulation on hygiene is binding for all hospitals and employees; it is based on the recommendations of the Robert Koch Institute (RKI). Helios Germany regularly trains its employees in this area. The local hygiene specialists are responsible for hygiene management in everyday working life. Fresenius Helios is the only German hospital operator to present the number of pathogens in its hospitals twice a year online in what is known as the HygieneEinBlick (hygiene overview): a separate chart for each clinic shows – over the last three years – how often the most important pathogens have occurred. This data shows how many patients have already brought the respective pathogen into the hospital and how many patients acquired it during their stay in the hospital (nosocomial infection).

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 hospitals with the aim of improving the quality of care in the hospitals. In 2020, Helios Spain encouraged all hospitals to appoint a medical officer to manage infection control and prevention measures. As part of its quality management system, Helios Spain monitors a bundle of indicators related to hand hygiene compliance and to the prevention of nosocomial infections, such as the WHO Hand Hygiene Self-Assessment Framework or a central-line-catheter-related bacterial infection rate.

Hygiene management in rehabilitation and nursing care

One of Fresenius Vamed’s tasks with regard to hygiene in rehabilitation clinics and nursing facilities is to ensure the highest possible protection for everyone – without restricting individual rehabilitation. Protecting patients from infectious diseases during their stay is a key topic for Fresenius Vamed. Newly established health care facilities follow systematic guidelines from day one to prevent infections breaking out or spreading. Clearly defined procedures are followed and compliance with hygiene regulations is strictly controlled.

Fresenius Vamed’s hygiene standards in Germany are based on the recommendations of the RKI’s KRINKO (Commission for Hospital Hygiene and Infection Prevention). These recommendations take into account all legal requirements for hygiene. In Fresenius Vamed’s German facilities, the Head of Hygiene coordinates the hygiene specialists and establishes overarching standards. One of the most important hygiene measures is hand disinfection. Fresenius Vamed follows the guidelines of the WHO in this regard. Throughout the Group, specially trained employees – hygiene specialists, doctors and nurses with special hygiene responsibilities – implement hospital hygiene measures. At Fresenius Vamed in Austria, the Federal Hospitals Act forms the basis for the management of hygiene plans, hygiene inspections, the use of hygiene specialists, and doctors with special hygiene responsibilities.

Labeling and product and patient information

GRI 417-1

It is essential for the safety and well-being of our patients that we label our products appropriately, describe our ­services, and provide necessary further patient information. Each of the four business segments is subject to specific regulatory requirements and standards – depending on the business activity and the market.

Listening to patients is also important when it comes to their choice of therapy. Fresenius Medical Care treats its patients across the full spectrum of chronic kidney disease with the aim of giving them a more informed choice and providing treatment options that best fit their life circumstances. In 2020, for example, Fresenius Medical Care offered home therapy to more than 44,000 peritoneal and hemodialysis patients who choose to be treated in a famil­iar environment and whose medical condition allows them to do so. In the U.S. alone, the company educated more than 50,000 people living with chronic kidney disease or end-­stage kidney disease about home dialysis options with the help of more than 180 internal kidney care experts.

Fresenius Kabi’s products are classified, e.g. as pharmaceuticals, nutritional products, active pharmaceutical ingredients, or medical devices, based on global and national regulations and standards. The marketing of these products is subject to various laws and regulations to ensure a complete and fact-based product information. Fresenius Kabi has a global policy and global standard operating procedures for its product information to ensure that they are in accordance with applicable laws and regulations and that the product information on correct use is clear, accurate, and not misleading.

Helios Germany 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 flyers and privacy statements. The therapeutic objective is discussed and evaluated with patients during admission and discharge discussions with the treating physicians. Helios Germany communicates via its online magazine, its website, and in its communication campaigns. In addition, patient information events on specific medical topics are held in all hospitals.

Fresenius Vamed provides information to its patients in different ways – for example, in the patient information folder or in the treatment contract, via information brochures, privacy statements, the house rules, and the mission statement. Welcome lectures and training sessions are also offered. The website is available as a source of information before arrival. The goal of therapy is usually discussed and evaluated with patients during admission and discharge discussions.

Since Fresenius Vamed is also active as an accredited inspection body (ISO 17020) and as a manufacturer of medical gas supply systems (RL93 / 42 EEC), the business segment is subject to a labeling obligation and information obligation in accordance with RL93 / 42 EEC and MPG and/or ISO 13485. The accreditation authority uses external audits, for example, to check whether appropriate regulations exist and whether regulatory or normative requirements are complied with.

Training

Training courses for our employees, which guarantee the safety of our patients and products, are an important component of our quality management systems. For example, Helios Germany works with simulation centers to provide training for surgical crisis scenarios. By offering regular training on a global, regional, and local level, Fresenius Kabi ensures that employees are aware of those aspects of the quality management system that are relevant for their daily work. Helios Spain continuously provides training on patient safety, on its quality management systems and on topics which are essential in hospital routine. In 2020, 22 sessions were conducted in the hospital network.

Fresenius Vamed’s quality management officers also regularly conduct legally required training courses and quality management training courses. In addition, Fresenius Vamed plans and conducts in-person and online training courses on a wide range of topics.

Further information on employee training can be found in the chapter Employee developement.

Product complaints and recalls

GRI 417-2

Handling product complaints at Fresenius Medical Care

Fresenius Medical Care strives to ensure compliance with legal requirements related to monitoring the adverse effects of drugs – also called pharmacovigilance – and product complaints. To this end, the business segment collects and reviews adverse events and product complaints. In addition to compliance with applicable legal requirements, the company has included the topic of reporting adverse events and product complaints in its Code of Ethics and Business Conduct.

Fresenius Kabi’s monitoring and reporting systems

Fresenius Kabi interacts with patients, users, and customers not only in the delivery of products and services, it also monitors the applicability, effectiveness and safety of the products on the market. Fresenius Kabi therefore monitors and evaluates relevant information and feedback on the products, services, and therapies during their use. Fresenius Kabi has set up a monitoring and reporting system (vigilance system) and a product risk management system covering all regions worldwide, in order to be informed about product quality and patient safety issues in a timely manner and deal with them appropriately. These early-warning systems are designed in such a way that trained complaints and safety officers worldwide record complaints and side effects in IT systems and forward messages to experts for review.

Fresenius Kabi’s product risk management

The global safety officers react promptly and appropriately to potential quality-related issues. They initiate and coordinate necessary actions on a global level, for example product recalls. With its early-warning system, Fresenius Kabi ­evaluates any quality-related information from various risk areas to identify risks at an early stage and take corrective and preventive actions. Information is obtained from databases for complaints and side effects, internal and external audits, and from key performance indicators used for internal control and optimization of quality processes. With these systems, Fresenius Kabi can evaluate the safety profile of any of its products at a global level.

Product recalls, for example, are initiated as a risk-minimizing measure in cooperation with the responsible regulatory authority. At the same time, the cause of the recall is analyzed. Where necessary, corrective measures are taken to prevent the cause of the recall in the future.

Partnerships and dialog

GRI 102-43, -44

Helios Germany exchanges ideas and knowledge with other hospital operators in Germany in the Initiative of Quality Medicine (IQM) network. The network members commit themselves to three basic approaches: quality measurement with routine data, publication of results and peer reviews (quality assurance by independent experts). They provide inpatient care for approximately 7.8 million inpatients in more than 500 hospitals in Germany and Switzerland. In Germany, they account for about 40% of inpatient care.

Evaluation

Quality evaluation parameters

Quality analyses at Fresenius Medical Care

Fresenius Medical Care evaluates a set of medical indicators on an ongoing basis to measure the quality of care provided in its clinics. The company is currently harmonizing the quality reporting around kidney care to better understand geographic differences.

In 2020, Fresenius Medical Care aimed to maintain the clinical care environment as stable as possible during the worldwide COVID-19 pandemic. The impact of the pandemic was felt in all regions with the most vulnerable population of patients. However, the key clinical quality indicators showed a consistently high quality of care among Fresenius Medical Care’s patients.

¹ The numbers for 2020 are based on quality parameters of 90% of our dialysis clinics worldwide. This includes 80% of our clinics in EMEA and 46% of our clinics in Asia-Pacific.
² Kt / V provides information about the effectiveness and efficiency of dialysis.
³ Kidney Disease Outcomes Quality Initiative guidelines.
⁴ The hemoglobin value in patients’ blood should be kept within a defined range. Hemoglobin is the component of red blood cells that transports oxygen within the human body. An insufficient level of hemoglobin in the blood indicates anemia.
⁵ Kidney Disease: Improving Global Outcomes and European Renal Best Practice guidelines.
⁶ EMEA data includes patients with Hb > 12 g / dl without erythropoiesis-stimulating agents (ESA).
⁷ Certified reference material for human albumin based on specifications from Joint Research Centre of the European Commission (#ERM-DA470k) was obtained to ensure consistent results over time. 
⁸ Calcium, albumin, and phosphate levels in the blood are indicative of a patient’s general nutritional status and point to disorders in the mineral and bone metabolism of patients with chronic kidney disease. 
⁹ Phosphate specified as mg / dL of phosphorus. 
¹⁰ Catheters are associated with a serious risk of infection and an increase in the number of days spent in hospital. Fresenius Medical Care records the number of patients who do not need to use a catheter as a vascular access for dialysis. Where we as the care provider are directly responsible, the proportion of patients with permanent vascular access serves as an indirect quality indicator.
¹¹ The number of days patients are hospitalized over a 365-day dialysis treatment period per patient. This is relevant for determining the quality of care because more days spent in hospital significantly reduce the quality of life for dialysis patients and are particularly cost-intensive for health care systems.

Relating to the fourth quarter of the respective year.

Fresenius Kabi’s vigilance system

The monitoring of adverse reactions or events (side effects) associated with the use of medicinal products is referred to as pharmacovigilance (drug safety). The statutory pharmacovigilance commitments relate to our medicinal products for human use. Similar regulations exist for medical devices. Fresenius Kabi has established various standard operating procedures for the continuous monitoring of the benefit risk ratio of its own products and assesses their successful implementation on the basis of specific indicators.

• Fresenius Kabi collects and assesses reports about individual side effects and reports them to health authorities worldwide according to regulatory requirements. Fresenius Kabi claims to submit all safety reports in accordance with the applicable regulations and therefore strives to report 100% of the Individualized Case Safety Reports (ICSRs) to the authorities in time. For 2020, the worldwide compliance rate was 99.9% (2019: 99.9%). In Europe, in 2020 99.5% (2019: 99.6%) of all adverse reactions were reported to the European Medicines Agency (EMA) in due time.
• In addition, Fresenius Kabi regularly evaluates the benefit-risk ratio of its products based on safety-related information from various sources (e.g. adverse event reports, medical literature). The results of these analyses are submitted to authorities as periodic safety reports. Fresenius Kabi aims to submit all periodic safety reports worldwide to authorities in due time. For 2020, the compliance rate was 99.6% (2019: 99.1%). In Europe, 98.6% of all periodic safety reports were submitted in due time to the European Medicines Agency (EMA) in 2020 (2019: 97.5%).
• According to regulatory requirements, Fresenius Kabi as a pharmaceutical company is obliged to describe its vigilance system in a Pharmacovigilance System Master File (PSMF). Fresenius Kabi uses a global database to collect and evaluate vigilance data on a quarterly basis from all local marketing and sales units. These are ­compiled in the PSMF. The goal is to receive timely data from all marketing and sales units worldwide. This is documented in the company’s vigilance system. For 2020, the compliance rate was 100% (2019: 100%).

Fresenius Kabi’s products are subject to labeling requirements. The labeling of the products is checked as part of the regular pharmacovigilance activities and updated if necessary. For example, product labeling is updated if competent authorities, e.g. the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) publish relevant information. Fresenius Kabi uses an electronic management system for product labeling to manage the information necessary for labeling and to ensure correctness.

With the help of its vigilance activities, Fresenius Kabi ensures that the patients’ safety of its products is always guaranteed, and that the company is able to identify any changes in the benefit-risk ratio at an early stage and react in a timely manner.

Evaluation of the quality of outcomes at Fresenius Helios

For Fresenius Helios, the quality of medical outcomes is key. It is measured in Germany using the German Inpatient Quality Indicators (G-IQI). Data from the Federal Statistical Office for all hospitals in Germany serves to provide comparative values. Helios Germany has defined specific targets for 45 key G-IQI quality indicators, including, for example, the frequency of interventions and their results. Helios Germany’s results are expected to be better than the German average. The year 2020 was exceptional for the hospital landscape and was primarily determined by the pandemic and the treatment of COVID-19 patients.

In Germany, Helios achieved a total of 40 of its 45 Group targets. This corresponds to a quality target achievement of 89% (2019: 96%). In 2020, there were around 13% fewer patients in the clinics than in the previous year, but some of these had a significantly higher degree in illness compared with 2019. Many patients stayed at home, first, because of the nationwide lockdown and the overall stop of surgeries in hospitals in spring, and second, because people overall avoided postponable treatments under the impact of the pandemic. Against this background and despite these effects, Helios nevertheless succeeded in achieving high medical quality results.

The quality management system enables the hospitals to continuously compare themselves with each other and with the national average: the quality data collected at Helios Germany is analyzed weekly. The medical outcomes (see www.helios-gesundheit.de/qualitaet) from each department in our 86 hospital locations are published monthly online. This helps patients who wish to access this data and see, for example, how often certain operations are performed in a hospital. This makes it possible for them to assess how experienced the doctors are in a specific treatment. The data from the three hospitals acquired in the reporting year will be added in 2021. In addition, the results for the year and publicly available quality reports will be announced. Helios Germany shares the collected data with health insurance companies and the Federal Statistical Office, and then compares it within its own clinics and with competitors. In 2020, Helios Germany also published data on patient safety and antibiotic consumption for the first time, in addition to data on patient length of stay in hospitals.

Helios Spain has introduced quality indicators that correspond to Germany’s G-IQI. For this purpose, numerous indicators have been selected based on the most relevant and common diseases and a cooperation with the Fundación IDIS (Instituto para el Desarrollo e Integración para la Sanidad) was entered into. The aim is to use the Spanish routine medical data to determine the E-IQI (Inpatient Quality Indicators Spain) and to compare it with publicly available data. The results are also compared with the goals of the IQM network. Each hospital publishes its results quarterly in a central IT system. This allows individual hospitals to check whether they deviate from the standards set.

In addition to the G-IQI quality indicators, Helios Germany introduced a system for the evaluation of patient safety, which is binding for all hospitals, at the end of 2019. The system combines internationally established Patient Safety Indicators (PSI) from the U.S. Agency for Healthcare Research and Quality (AHRQ) with Helios Germany’s own indicators. The aim of this transparent reporting is to analyze and eliminate weaknesses in patient care. The indicators include, for example, the number of abdominal cloths or medical instruments left behind in the body during operations, wrong-side errors, serious medication errors, falls, but also incorrect diagnoses in the hospitals. In countries such as the United Kingdom or the United States, some of the indicators are already subject to legal reporting requirements. A Group regulation calls on all employees to report certain claims in a binding manner. For the first time, Helios Germany now reports on these cases. Helios Spain also uses the AHRQ patient safety indicators to analyze and address potential weaknesses in patient care.

In 2019, Helios Spain introduced a risk management tool in all Spanish hospitals, which is widely used. In 2020, the company was able to identify incidents that have been repeated in various hospitals. In order to avoid such incidents in the future, recommendations have been sent to all of our hospitals. In addition, training on root cause analysis was conducted to help identify adverse events.

Personalized and individually tailored rehabilitation goals at Fresenius Vamed

Fresenius Vamed uses modern, resource-oriented approaches, such as the ICF concept (International Classification of Functioning, Disability and Health) or the computer-­based evaluation system CHES (Computer Based Health Evaluation System). This enables patients to achieve the best possible, evidence-based functional improvement to increase activity and participation in all areas of life, even after severe illness.

In addition, the findings on treatment quality are published, for example, by Fresenius Vamed Germany on the website Qualitätskliniken.de. This allows patients to find out about key quality parameters of the various clinics before they are admitted there.

Patient grievance processes

Grievance mechanisms are another way to get patients’ feedback and understand their needs. Fresenius Medical Care has established patient grievance processes in all regions to address topics raised by patients in a timely manner. In 2020, the company harmonized the patient grievance process globally. The harmonization is included in a dedicated chapter of the patient care global policy. Fresenius Medical Care offers patients various channels through which they can express their suggestions and concerns, such as dedicated hotlines and email addresses, complaint and suggestion boxes as well as a web form on the company’s website. Patients and their representatives have the option to raise these suggestions and concerns anonymously. Fresenius Medical Care's policies ensure that grievances can be filed without fear of reprisal or denial of services.

Fresenius Helios uses reporting systems for critical events and near-misses in all hospitals. Fresenius Vamed also uses such reporting systems in its health care facilities. In addition, Fresenius Vamed uses systems for suggestions for improvement, material vigilance (material safety), and pharmacovigilance (drug safety).

Patient satisfaction surveys

Surveys of patients are a meaningful and important tool for Fresenius: They enable us to measure, monitor, and improve the quality of our services and patient care.

Patient surveys at Fresenius Medical Care

Fresenius Medical Care measures patients’ feedback using patient experience surveys as part of its global patient experience program. Overall responsibility for these surveys lies with specialized regional teams in cooperation with the Global Medical Office, which provides global guidance. The company conducts patient experience surveys at least every other year. The survey results are reviewed to identify strengths as well as opportunities. Fresenius Medical Care's aim is to derive measures to enable more personalized care and improve the quality of services.

Fresenius Medical Care measures patient experience and customer loyalty using the Net Promoter Score (NPS). In 2020, the NPS was 67. The NPS reflects the customer's overall satisfaction with the company's services. In the reporting year, 75 % of Fresenius Medical Care's patients answered that they would highly recommend the company's services to a friend. By learning about its patients’ willingness to recommend Fresenius Medical Care, the company can compare the services provided by its clinics and turn insights into action. In addition to the NPS, Fresenius Medical Care tracks survey coverage and response rates.

Satisfaction measurement at Fresenius Helios

Helios Germany uses the Helios Service Monitor to measure the satisfaction of inpatients in its hospital locations once a week. Employees at the hospitals conduct short interviews with patients on care and service. The information is collected anonymously. The management of the hospital and other authorized persons receive the monthly survey results. This makes it possible for necessary improvements to be introduced quickly. The Service Monitor is used to reach a total of around 50% of inpatients. The three hospitals acquired in 2020 will introduce the Service Monitor from 2021. 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 (German language only).

In Spain, Fresenius Helios uses the Net Promoter Score (NPS) to get specific feedback from patients who have been treated as inpatients, outpatients, or in emergencies. In 2020, it has been extended to radiology and laboratory. 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 has increased over recent years. Due to the COVID-19-pandemic, it was decided to stop the survey process from the end of March to June 2020. Therefore, the NPS in 2020 remained at the previous year's level.

In 2019, Helios Spain identified waiting times and lack of information as the main causes of dissatisfaction among patients. Therefore, the company has implemented a “15 / 15” target in all hospitals. A patient must get an appointment within 15 days, and the waiting time before the appointment starts must be under 15 minutes. In emergency departments, the maximum waiting time should not exceed 30 minutes.

Measurement of patient satisfaction at Fresenius Vamed

Fresenius Vamed measures patient satisfaction in its health care facilities in a continuous and structured process. The company collects data for this purpose, evaluates it internally, and implements appropriate measures.

Audits

We use different systems to check our quality management systems, depending on the business segment and business activity. All units are subject to regular external and internal audits. Peer reviews in hospitals are carried out if the internal quality targets are not met.

Audits at Fresenius Medical Care

Fresenius Medical Care has defined key performance indicators that help monitor its quality objectives and prevent adverse events before they occur. The company discloses the audit score, which measures its performance in certification audits, and indicates the ratio of major and critical findings to the number of external audits. In 2020, more than 60 certification audits were performed at manufacturing sites that are managed by the Global Manufacturing, Quality and Supply function. The audit score was 0.2 (2019: 0.2). Fresenius Medical Care has set the target not to exceed an audit score of 1.0 per audit to ensure the effectiveness of its quality management systems and certifications. All findings are documented and escalated depending on how critical they are. Fresenius Medical Care determines and implements appropriate corrective and preventive measures.

Audits and inspections at Fresenius Kabi

Fresenius Kabi regularly conducts internal quality audits to ensure the effectiveness of the quality management system and compliance with internal and external standards and requirements. Suppliers of Fresenius Kabi related to manufacturing of products are subject to a qualification process based on the relevance of the delivered material or service. The qualification of suppliers, as well as their recertification, includes regular audits. Inspections by regulatory authorities and audits by independent organizations and customers are performed along the entire value chain at Fresenius Kabi. Whenever these inspections reveal weaknesses or deficiencies, Fresenius Kabi promptly takes steps to deal with them.

In 2020, 59 audits and inspections (2019: 64) were performed at Fresenius Kabi by regulatory authorities or certifying bodies, and 42 global internal audits (2019: 60) were carried out. The external audits and inspections comprised a total of 21 inspections (2019: 24) regarding Good Manufacturing Practices (GMP) by the U.S. Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA), European regulatory authorities, and Quality System audits from TÜV Süd (notifying body for ISO 9001).

Based on the respective observations, an audit and inspection score is calculated. The score is calculated by addition of the number of critical and major observations identified during GMP inspections by the authorities mentioned above and the number of non-conformities identified during TÜV Süd ISO 9001 audits divided by the overall number of inspections and audits; critical observations, if any, are weighted with a multiplier compared to major observations. The audit and inspection score was at 1.3 in 2020 (2019: 1.5).¹ Observations have been and will be addressed by corrective and preventive actions (CAPAs) and effectiveness checks have been and will be defined. The observations did neither impact the GMP certification nor the ISO 9001 certificate.

In 2020, no events with a material adverse impact were recorded that conflict with our quality management goals.

¹ For the calculation of the audit and inspection score, Fresenius Kabi takes into account all information on findings from audits and inspections received by the company before December 31, 2020.

Peer reviews at Fresenius Helios

Helios Germany analyzes the cases – including treatments and medical routines – in hospitals that fail to meet individual targets, in order to identify and implement improvements. Particularly important are the specific audit procedures in the medical and nursing sectors, the peer reviews – expert discussions of cases. In Germany, specially trained physicians from the hospitals of Helios Germany and from the IQM network cooperate in the peer review. They question statistical abnormalities and search for ways to identify improvements. Their insights are translated into concrete recommendations for action in the hospital with the aim of increasing patient safety. In 2020, Helios Germany conducted a total of 8 peer reviews (2019: 60), due to the impact of the Covid-19 pandemic and the resulting restrictions on hospital operations.

Due to the pandemic, Helios Spain was able to perform only 2 peer reviews online by the end of 2020 (2019: eight). Internally, 23 ISO 9001 audits were conducted at all Helios clinics in Spain. In 2020, Fresenius Helios was the first hospital operator in Spain to certify that the organizational measures and protocols it had implemented were used to prevent and control COVID-19.

Audits and recertification at Fresenius Vamed

To ensure adherence to quality standards, Fresenius Vamed also performs regular internal audits as well as external recertifications. This is done in the certified health care companies as well as in the other facilities of Fresenius Vamed. Quality management audits are carried out there once a year in accordance with the ISO regulations. Internal audits are carried out systematically and cover all business segments and at a minimum those topics that are required by the certified standards – i.e., all quality management processes.

External assessments

GRI 416 and GRI 417

Thanks to the company’s ongoing efforts to improve patient care, Fresenius Medical Care North America achieved an excellent rating in the industry in the United States. government’s Five-Star Quality of Care Rating system. In the rating, one to five stars are awarded to facilities based on a series of measurements relating to their clinical performance and patient outcomes. Fresenius Medical Care was rated by the Centers for Medicare and Medicaid Services (CMS) against all other major dialysis providers in the country and earned the highest results in the industry.
(see 5 Star Quality Kidney Care | Fresenius Kidney Care)

The cross-operator quality competition organized by the Qualitätskliniken.de initiative supports Fresenius Vamed in Germany in evaluating patient and product safety. The basis for this is provided by the patient-reported outcome measures, i.e. tools for measuring quality of life in terms of health, which reflect the subjective success of the patients’ treatment. The selection of tools is based on the internationally agreed ICHOM (International Consortium for Health Outcomes Measurements) standard sets. In the future, the success of treatment will be measured and published across sectors – from admission to acute care facilities to aftercare.