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Our Dialysis Services Business

Our Dialysis Services Business

Our unrivaled experience as a provider of both dialysis services and products makes us a valued partner in the healthcare system. By interacting directly with patients, doctors and specialist dialysis staff, we are able to constantly improve our services while ensuring that we never lose sight of the needs of our stakeholders.

Comprehensive treatment with our nephrocare and ultracare brands

Comprehensive care of patients with chronic kidney disease is a key factor when it comes to achieving the best possible treatment quality. We take all aspects of treatment into account, from the vascular access in the patient’s arm to high-quality dialysis as well as individual diet programs and supplementary services. With our UltraCare brand in North America and our NephroCare brand in the Europe, Middle East, Africa and Latin America (EMEALA) and Asia-Pacific regions, we have established an integrated therapy concept as the standard in our clinics and in home dialysis. This enables us to achieve a sustained improvement in patients’ quality of life and keep costs for healthcare systems in check.

Our therapy concept is based on the following principles:

  • We use our own high-quality products, pharmaceuticals and procedures in our clinics and for home dialysis patients; these are continually refined by our research and development team.
  • We provide our patients with comprehensive treatment and medical advice from qualified, highly motivated clinical personnel and physicians.
  • We create a safe and pleasant atmosphere in our dialysis centers for both patients and employees.
  • We systematically improve our performance and efficiency levels by working according to both external and internal quality standards, and running our clinics in a professional manner. In addition we obtain important results by analyzing and evaluating treatment data of our own clinics on an ongoing basis.

In line with these principles, our dialysis clinics are subject to specific standards relating to patient care, hygiene in clinical practice, the design of our clinics, and the purity of water used in treatment, to name just a few. As we offer our patients comprehensive care, our teams of doctors and dialysis personnel in many dialysis centers are assisted by nutrition specialists and social workers. To help patients better understand the issues of living with dialysis, we also provide our own educational material such as films and patient journals.

In North America, various internal advisory boards promote the development of our standards and services: For example, a social work advisory board deals with the psychosocial concerns of patients and designs training programs for our social workers; a committee for dialysis nurses develops guidelines and procedures for clinical care; medical advisory boards assist us in our work with nephrologists to achieve the best outcome for our patients; and the patient advisory board advises us on such matters as how to make health educational material more readily understandable. In the International segment, too, we engage in direct dialog with our patients to continuously improve our services, for example through regular surveys or roundtable discussions. In addition, we set up the EMEALA Medical Board in the reporting year. This advises us on shaping our medical and scientific strategy for the EMEALA region.

Quality targets successfully achieved

To monitor how well we deliver on the brand promises of our therapy concepts NephroCare and Ultra- Care, we measure and compare our quality performance in our individual clinics as well as at a regional level using certain performance indicators. These are defined in the NephroCare Balanced Scorecard and UltraScore performance measurement systems, among others. As well as industry- specific clinical benchmarks (see table 2.7.1), they include our own quality targets. In the U.S., we present an annual UltraCare Center of Excellence Award to dialysis centers that meet our performance targets exceptionally well. In the EMEA region (Europe, Middle East and Africa), the “Nephro- Care Award” is given each year to the management of the countries that perform best in seven different categories as a recognition of outstanding clinical and operational excellence.

T. 2.7.1

Quality data

for the last respective quarter, in %
             
  Description Possible impact U.S. Europe/Middle East/Africa Asia-Pacific1
      2012 2011 2012 2011 2012 2011
1Philippines and Taiwan included 2International standard BCR CRM470.
Figures based on:
- KDOQI guidelines (Kidney Disease Outcomes Quality Initiative) from the U.S.
- EBPG standard (European Best Practice Guidelines) from Europe.
- KDIGO guidelines (Kidney Disease: Improving Global Outcomes), a recent global initiative, which is gaining in significance.
Kt/V > 1.2 Effectiveness of dialysis: measures how well the patient was detoxified More days spent in hospital; increased mortality 97 97 97 95 97 97
Hemoglobin = 10–12 g / dl
Hemoglobin = 10–13 g / dl
(international)
Hemoglobin is responsible for transporting oxygen around the body An insufficient level of hemoglobin in the blood is indicative of anemia 75
82

78
88

58
78

57
78

59
67

58
66

Calcium 8.4–10.2 mg/dl
Albumin ≥ 3.5 g/dl2
Phosphate ≤ 5.5 mg/dl
Measures the patient’s nutritional status and mineral balance Increased mortality 84
85
66
81
85
64
78
86
79
78
88
76
75
89
71
76
90
73
Patients without
catheter (> 90 days)
Measures the number of patients with vascular access More days spent in hospital 82 82 85 84 94 96
Days in hospital
per patient
The result of complications during dialysis Restriction to patients’ quality of life; cost-intensive 9.8 9.8 9.3 9.3 4.6 5.2

Clinical quality data in line with recognized standards

Our doctors and nursing staff work according to quality standards that are generally recognized in the industry. In 2012, they again provided our patients with top-quality treatment, as shown by the current medical quality parameters in table 2.7.1. We collect this information continuously by means of clinical data management systems and evaluate it in anonymized form. This enables us to measure the quality of our dialysis treatments so that we can continuously enhance it.

The Kt / V value shows whether a patient was detoxified effectively during dialysis. It provides information on urea content in the blood. Urea is mostly excreted by healthy kidneys. In dialysis patients, it has to be filtered out of the blood using renal replacement therapy. The Kt / V value of more than 1.2 recommended by general guidelines and standards was again attained in our clinics in almost 100% of cases in 2012.

In addition, we aim for a specific hemoglobin value in our patients. Hemoglobin is the component of red blood cells that transports oxygen around the body. Too little hemoglobin in the blood implies anemia, which typically occurs in patients with chronic kidney failure. Besides dialysis, anemia is treated with iron supplements and the hormone compound erythropoietin (EPO).

The level of albumin in the blood is indicative of a patient’s general nutritional status. Phosphate concentrations show whether treating the patient with dialysis and medication is sufficient to enable the body to absorb phosphate ingested with food. Healthy people excrete excess phosphate via the kidney, but a diseased kidney is unable to do this. If the phosphate concentrations in the blood are too high, this can lead to bone diseases, parathyroid gland damage, and vascular calcification, among other conditions. The number of days patients spend in hospital because of complications as part of their kidney disease is also an important indicator for us. We managed to reduce this figure again in 2012. Days spent in hospital significantly reduce the quality of life of dialysis patients and are also extremely cost-intensive.

In order to guarantee a sufficient blood flow and therefore an effective dialysis treatment a permanent vascular access is necessary. In this context, we record the number of patients who do not use a hemodialysis catheter (see Glossary) as a vascular access for dialysis treatment. This is because catheters are associated with serious infections and more days spent in hospital. We are committed to further enhance the number of patients without using catheters.

Quality management systems are regularly reviewed

As at our production sites, we have installed quality management systems at our dialysis centers, which are regularly checked by third-party certification bodies. In Europe, for example, this is performed by the technical certification organization TÜV. Its experts inspect our clinics in annual audits to control conformance to the ISO 9001 standard for quality management and the ISO 14001 standard for environmental management. In the U.S., our clinics are monitored by the Centers for Medicare and Medicaid Services (CMS), a public healthcare authority. We also check our quality management systems on a regular basis using internal audits, carried out by employees who we train specifically for this purpose.

Quality surveys deliver positive results

We regularly carry out patient surveys to find out where we can make further improvements and in which areas we should expand our services. At the end of the reporting year, we started a patient survey in 24 European and Latin American countries and questioned more than 60,000 patients. Initial evaluations have shown that over 95% of patients would recommend their Fresenius Medical Care dialysis center to friends or relatives if they needed dialysis. They rated our services as good or very good, and feel well cared for and informed by our employees.

We also regularly conduct patient surveys in North America. In 2012 CMS stipulated the content of the patient satisfaction survey for the first time. The survey was conducted by an independent company to ensure confidentiality and anonymity.

NephroCare Excellence sets standards in treatment quality

Our dialysis services business is characterized by highly diverse and complex healthcare and remuneration systems. This presents us with a particular challenge as we intend to penetrate new markets. In some regions, when we set up our dialysis clinics we are the first operator to actually invest in establishing a sustainable care infrastructure. Dialysis centers that we acquire, on the other hand, do not always meet our quality and management standards. However, these standards are crucial to the quality of life of our patients, the satisfaction of our employees and our own commercial success. The NephroCare Excellence program in the EMEALA region (Europe, Middle East, Africa and Latin America) enables us to operate successfully and continue to grow steadily even under such heterogeneous conditions. It defines medium and long-term quality and business targets for each of our countries in the EMEALA region. These targets relate to medical quality as well as to assigning and promoting employees, enhancing efficiency, standardizing processes, and using natural resources in a sustainable way.

To attain the targets defined in the NephroCare Excellence program, our national organizations have a range of management tools at their disposal. We are constantly developing these tools and can adapt them to changes in the economic conditions, for instance amendments to the reimbursement system. In this context, for example, the national organizations have access to clinical databases that we use throughout the Company and to training courses on our guidelines for medical care, patient care and the production of ultrapure water for treatment. In managing the dialysis centers, they can also draw on reporting systems such as the NephroCare Balanced Scorecard, NephroCare Cost Efficiency Benchmarking and satisfaction surveys for patients and employees. A central NephroCare Excellence program project team is responsible for coordinating and continuously monitoring target achievement.

In the reporting year, the dialysis centers taken over by Fresenius Medical Care as part of the acquisition of Euromedic’s service business were integrated into the NephroCare Excellence program. A review of the business and quality targets for each country was another focal point in 2012. In addition, our central teams of experts developed new management tools in conjunction with our clinics in the reporting year, such as the medical peer review process. Clinic staff can use this to track the quality of treatment for each individual patient quickly and easily and identify any need for action.

Ensuring the quality of dialysis with EuCliD and eCube

Over the last few years, we have gradually introduced EuCliD (European Clinical Database) into our dialysis centers and consistently enhanced it. More than 500 dialysis centers in the EMEALA (Europe, Middle East, Africa and Latin America) regions worked with the system in the reporting year. EuCliD is used to obtain specific quality indicators for patients in a dialysis center. The data from all participating centers is pooled and used for benchmarking. Thanks to the EuCliD database, we now have access to anonymized treatment data for 50,000 patients and 22 M dialysis treatments. As a result, we can compare the treatment quality of the various dialysis facilities and our centers can maintain and improve their own quality on an ongoing basis.

In the North American market, we use eCube Clinical, an internet-based clinical information system. In 2012 we could access anonymized clinical data of nearly 54,000 dialysis patients from 672 own clinics. This comprehensive database provides clinic staff and doctors with important information as well as allowing us to analyze treatment quality in detail.

Certified Patient Safety Organization further expanded

In the reporting year, Fresenius Medical Care North America further expanded its Patient Safety Organization (PSO), certified by the U.S. Agency for Healthcare Research and Quality. The aim of PSO s is generally to improve patient safety and the quality of the healthcare system and in this way reduce errors or occurrences that can endanger the lives of patients. For this purpose, the PSO creates a framework so that doctors and other healthcare practitioners can supply information to it about such events freely and in confidence. The PSO makes this data available to healthcare providers according to fixed rules to enable them to recognize and minimize the risks in patient care. After all, mistakes can occur even in our well-balanced system of continuous quality improvements, qualified and committed staff and structured clinic procedures – but they can be rectified if the relevant communication channels are available. All employees in clinics in the U.S. therefore report critical incidents to an internal PSO analysis system. We adapt any procedures that are prone to error and train our staff and patients to improve these procedures.

Service for patients and partners

For Fresenius Medical Care, a holistic quality concept means providing the best possible patient care, even beyond dialysis products and services. We therefore supplement our core offering as a dialysis company with advice for patients and healthcare partners as well as other services.

Patient advice is key to successful treatment

The better informed kidney patients are about their illness and how they themselves can influence the course of the disease, the better the treatment results are likely to be. This is why Fresenius Medical Care places great value on providing dialysis patients with intensive medical advice and education. One example is “Thrive! with UltraCare”. In this series of informational videos and audio CD s, dialysis patients discuss topics which many patients find difficult, but which can have a significant influence on the success of their treatment. Our patients in the U.S. can watch or listen to the Thrive! material either in the clinic or at home with their families. The program also comprises training modules aimed at helping our clinic employees to empathize more strongly with patients. In this way, they can respond even more effectively to patients’ needs and motivate them to adhere to their treatment plan in a more disciplined manner.

Advice programs for dialysis patients enhanced

Our Treatment Options Program (TOPs) is geared to patients in the preliminary stages of chronic kidney failure. In the U.S., we offer this free of charge in both English and Spanish to educate patients and their families about the various treatment options for chronic kidney failure, from hemodialysis at the clinic or peritoneal dialysis therapy at home to kidney transplants. From September 2006 to June 2012, we trained as many as 73,500 patients with TOPs. You can find further information on the internet at www.ultracare-dialysis.com. In the International segment, we use the Kidney Options program to give patients initial information on the course of chronic kidney failure and the therapy options. This educational series is now available in 25 languages and used in more than 40 countries worldwide.

The first phase of treatment is often especially difficult for dialysis patients as it changes their daily routine drastically: They need to schedule several hours for treatment a few times a week; in addition, the range of food they are allowed to eat is restricted; and they are required to take a number of drugs every day while greatly reducing their fluid intake. Many patients find it difficult to muster the necessary discipline for this treatment plan, especially when they know little about their illness. To support these patients during this difficult phase beyond their visits to our clinics, Fresenius Medical Care offers the RightStart program in North America. In the reporting year, we added additional information to this program to give new dialysis patients the best possible start to life with dialysis. In addition, dialysis patients receive a weekly visit or phone call from a dialysis specialist during the first months of treatment. The specialists provide patients with comprehensive information on the course of the illness and treatment, the importance of a high-quality vascular access, a healthy diet and specific treatment needs, for example if the patient also suffers from diabetes. They answer patients’ questions and work closely with the dialysis clinic team. RightStart helps the clinic teams to improve the quality of patients’ life during the critical initial phase of therapy, while boosting their confidence. After all, patients contribute greatly to the success of their treatment if they use sound information and make the right decisions for their health.

We also started offering a comprehensive introductory program at our dialysis centers in the EMEALA region in 2012: the Patient Introduction Package. The intention is to make the transition to life on dialysis easier for patients and provide them with a wide range of individual information.

It is important that patients who need to go to hospital are cared for consistently. However, patients’ biochemical and physical parameters often deteriorate significantly in hospital, even if they only stay for a short time. One in three dialysis patients have to return to the clinic within 30 days after spending several days in hospital. Therefore, Fresenius Medical Care developed the RightReturn program for patients in North America when they return to an outpatient dialysis center after a hospital stay. RightReturn is aimed at keeping the health of dialysis patients stable by improving communication between care teams as well as constantly monitoring the patients’ hemoglobin levels and dry weight.

Further patient programs for home therapies launched

In addition to holistic treatment concepts for our patients in dialysis centers, we offer various home dialysis programs.

In the North American market, we have developed “UltraCare at home”, a home dialysis program that not only supplies patients with the products they need, but also provides supplementary services to boost the success of home therapy. These include ongoing training and support for our patients and their partners from doctors, dieticians, social workers and other members of the dialysis support team, technical assistance and constant access to the dialysis center. To ensure maximum safety for our home dialysis patients, we launched an extremely effective monitoring system in 2012. It transmits vital functions and data from the dialysis machine to the dialysis support team every day and provides immediate notification of any abnormalities. This increases the patients’ sense of safety and means that their treatment can be adapted even more effectively to their individual needs.

In the EMEALA region, we have developed a holistic treatment concept specifically for peritoneal dialysis under the brand name P3. It is designed to improve patients’ quality of life and supports nursing staff, doctors and patients every step of the way during therapy. The P³ program enables us to align the medical parameters of peritoneal dialysis even more closely to patients’ needs to ensure that their dialysis treatment at home is as successful as possible.

Training programs intensified in Asia, Africa and the Middle East

In the complex and comparatively new medical discipline of dialysis, training doctors and nursing staff on an ongoing basis is just as important as providing advice to patients. The Advanced Renal Education Program (AREP) is our U.S. internet-based training program on the treatment and care of dialysis patients. It offers full and half-day seminars for nephrologists as well as e-learning courses for doctors and nursing staff. We have also stepped up training on quality issues in dialysis for doctors in Asia, Africa and the Middle East. Treatment standards are often still being developed in these regions, and demand for professional advice is correspondingly high. Fresenius Medical Care also organizes conferences, lectures, and workshops around the world in conjunction with international nephrology experts.

Further services make life easier for dialysis patients

In addition to our advice, educational and training programs, we offer a range of other services. One example is our internal pharmacy service, Fresenius Rx, in the U.S. In previous years, Fresenius Rx was geared to providing all-round pharmaceutical services for our patients. In 2012, we focused our services on kidney disease with the aim of becoming the leading pharmacy nationwide in this area. On the basis of this realigned strategy, Fresenius Rx can now use its expertise even better to support doctors and patients in the treatment of kidney disease. In the reporting year, we relaunched the “Strong Bones, Healthy Heart” program with Fresenius Rx to improve the mineral metabolism of the bones. The main objective of this initiative is to enhance the clinical results of dialysis patients with the help of the specialist pharmacy service. In addition, the program should help to prepare us for the expected changes in the reimbursement of costs for bone mineral metabolism drugs in 2016.

Most dialysis patients are extremely restricted in their mobility, as they are dependent on dialysis treatment several times a week. To allow them to go on vacation or on business trips despite these constraints, Holiday Dialysis International, a Fresenius Medical Care company, offers dialysis patients a free booking service so that they can be treated in clinics in many countries of the world. The Patient Travel Service helps patients in North America to plan and book dialysis treatment on trips in the U.S. and to Puerto Rico.

Dialysis services in emergency situations enhanced

To continue patients’ vital dialysis treatment even in extreme weather conditions such as severe storms or floods, Fresenius Medical Care’s professional emergency response teams are called into action in the affected regions. Their task is to protect patients and employees in emergency situations, for example during natural disasters or pandemics, and to give patients the best possible care as well as maintaining business operations, even in difficult situations. In the reporting year, the crisis management team in Asia-Pacific in particular further optimized its processes and infrastructure following its experience in previous years, and is therefore even better prepared for any new events.

In North America, the Fresenius Medical Care incident command center coordinates emergency task forces in critical situations, for example during the hurricane season. The incident command center is in close contact with the U.S.-wide Kidney Community Emergency Response Coalition (KCER). This is a network of different organizations and institutions, such as patient and professional nephrology associations, dialysis providers, hospitals, and authorities such as the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). By working with KCER, we can closely coordinate our crisis management as needed with the activities of government emergency organizations, such as the Federal Emergency Management Agency (FEMA), a U.S. national coordination office for disaster relief, and the United States Department of Homeland Security, which FEMA reports to.

Emergency aid provided in the U.S. and Italy

In June 2012, emergency task forces were in action during the severe storms in large parts of North America. Power failures and gas and water shortages posed a significant health risk to more than 71,000 dialysis patients in the region. Our action teams were also on duty during Hurricane Isaac in August and Hurricane Sandy, which wreaked considerable damage on the East Coast of the U.S. in October 2012 and affected 230 of our dialysis clinics in total. The teams acted extremely quickly to provide dialysis centers and home dialysis patients with water, generators, food and medication, thus ensuring that all of Fresenius Medical Care’s dialysis patients received the treatment they needed.

In Italy, a severe earthquake struck the province of Emilia Romagna in May 2012. Fresenius Medical Care also had a crisis management system in place here. More than 200 dialysis machines were sent to Italy in a very short time and installed there, thus enabling that dialysis patients were cared for.

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