With regard to treatment quality, our clinics work in conformance with the generally accepted quality standards of the industry, particularly the KDOQI (KidneyKidneyTwo kidneys are located at the rear of the abdominal cavity, one each on the right and left side of the spinal column. These vital organs are approximately 12 cm long and weigh only around 160 grams each. The kidneys ensure a regulated acid-base balance by filtering excreta and producing urine. Approximately 1,500 liters of blood normally pass through the kidneys every 24 hours. Disease Outcomes Quality Initiative) guidelines from the United States, the European EBPG standard (European Best Practice Guidelines) and increasingly the KDIGO (Kidney Disease: Improving Global Outcomes) guidelines, a worldwide initiative that is still at an early stage. Clinical data management systems are used to routinely collect certain medical parameters, which we evaluate in anonymized form in compliance with these guidelines. The goal is to measure and continuously improve the quality of our dialysis treatments. One of these parameters is the Kt/VKT / VIndicator to evaluate treatment quality. It is calculated by dividing the product of urea clearance (K) and the length of treatment (dialysis time, t) by the filtration rate of certain toxins (the urea distribution volume in the patient, v). value. It uses a “marker” to provide information on whether or not a patient was detoxified effectively during dialysis. The patient’s body size is taken into account in calculating the Kt/V value. A marker is the concentration of a specific substance in the blood, which is indicative of a particular illness. In the case of chronic kidney failure, the marker used is urea, a substance that is eliminated in large quantities by healthy kidneys, but in the case of diseased kidneys has to be filtered out of the dialysis patient’s bloodBloodFluid circulating in the body composed of plasma and cells (red blood cells, white blood cells, platelets, etc.). The main function of blood is to transport oxygen, nutrients and hormones to the cells and to remove waste products (such as carbon dioxide and urea). Blood also regulates the water and electrolyte balance and helps fight off contaminants as part of the immune system. by means of renal replacement therapy. Another quality indicator is the level of albuminAlbuminA protein that can be used to monitor a patient’s nutritional condition. in the blood. Albumin is a protein that is indicative of a patient’s general nutritional status. We also aim to achieve a defined hemoglobinHemoglobinSubstance in red blood cells that carries oxygen around the body. value for each of our patients in cooperation with their nephrologist. Hemoglobin is the component of red blood cells that transports oxygen around the body. Insufficient hemoglobin is an indication of anemia, which is typical in patients with chronic kidney failure. Parallel to dialysis, anemia is treated with iron supplements and the hormone compound erythropoietinErythropoietin (EPO)Hormone that stimulates red blood cell production. (EPO), which is necessary for the formation of red blood cells. Finally, phosphate concentrations show whether dialysis and medication therapy are sufficient to reduce phosphate present in 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, they can lead to bone diseases, parathyroid gland damage, and vascular calcification. The number of days patients spend in hospital for reasons other than dialysis is also an important indicator for us; days spent in hospital significantly reduce the quality of life for dialysis patients and are also very expensive.

In addition, we monitor the number of patients dialyzed with a catheterCatheterA flexible tube inserted by surgery through the skin into a blood vessel or cavity to draw out body fluid or infuse fluid. In peritoneal dialysis a catheter is used to infuse dialysis solution into the abdominal cavity and drain it out again. as their vascular access, and attempt to further reduce this number through several initiatives. The reason for this is that catheters are associated with serious infections and more frequent hospitalizations. In the U.S., for example, such efforts (of which an example can be found on page 87) have resulted in a 5% reduction of patients using catheters in 2010.

As at our production sites, we have set up quality management systems at our dialysis centers, which are regularly checked by third-party certification bodies. In Europe, for example, this is done by the TÜV (Technischer Überwachungsverein – Technical Inspection Association). These conformance and certification experts inspect our clinics in yearly audits to ensure that they conform with ISOISOInternational Organization for Standardization. 9001 as well as with the criteria of the TÜV standard “Good Dialysis Practice”. In the U.S., our clinics are monitored by the Centers for MedicareMedicare / MedicaidA program developed by the federal U.S. Social Security Administration that reimburses health insurance companies and providers of medical services for medical care to individuals over 65, people with chronic kidney failure (end-stage renal disease, ESRD) or the disabled. and Medicaid Services (CMS), a Federal health agency.

Nephrologists rely on extensive laboratory tests to tailor dialysis therapy to each patient. In 2010, our subsidiary for laboratory services, Spectra Laboratories, became the first medical testing laboratory in the U.S. to receive certification in accordance with ISO 15189-2007, a standard which defines quality requirements for medical laboratories. We also check our quality management systems on a regular basis using internal audits, carried out by employees that we train specifically for this task.

We also regularly carry out separate surveys to measure how satisfied our patients and clinic employees are. For example, according to a nationwide survey in the U.S. during the reporting year, 93% of clinic and home therapy patients were either satisfied or very satisfied with our services. We conduct this survey jointly with an independent partner every year as an integral part of UltraCare. Due to the growing number of Spanish-speaking immigrants in the U.S., it is carried out in Spanish as well as in English. In 2010, more than 65,000 people, approximately half of our patients in the U.S., filled out the comprehensive questionnaire on the quality of care and service. According to the respondents, Fresenius Medical Care’s strengths include not only the fact that our staff adhere to strict hygiene standards but also the conduct of our caregivers, nutrition specialists, and social workers: The vast majority of our patients find them respectful, courteous, and caring. Areas in which we could improve include, for example, the waiting times prior to treatment, which some of the patients consider to be too long. Some patients would also like to see even more information offered on home dialysis, thereby affirming our strategy of providing special educational programs on this topic and continuing to expand on them. Each dialysis clinic can access the results of the survey applicable to their own facility. We provide them with a tool that allows them to evaluate the questionnaire and use the information as a basis for improvement.

In addition, we conduct regular surveys as part of our NephroCare therapy concept to identify opportunities for improvement, also among our clinic personnel. In this case our goal is to foster our employees’ identification with the Company. Employee surveys are carried out in the individual countries every two years. In 2010, employees in Hungary, Slovenia, Poland, Romania, Portugal, Argentina and Colombia were questioned. Between 80 and 90% of clinic staff in the individual countries participated. The respondents especially appreciated the good facilities at their workplace, such as the state-of-the-art equipment and accessories for treating patients. Another conclusion drawn from the current survey was that the employees identify with the high level of Fresenius Medical Care’s quality standards: Nearly all respondents would recommend the clinic where they work to relatives or friends seeking dialysis treatment. Employees would like more opportunities to exchange their professional experience, for example by attending more specialist conferences, and more support through further training in general. We want to focus on this area in the coming years as part of the NephroCare Excellence program (see following paragraph).

In contrast to the North American market, our dialysis service business in the International segment is shaped by highly diverse and complex health care and reimbursement systems. We also enter new markets in this segment on a regular basis. In some regions, there is no care infrastructure in place at all for dialysis patients when we enter the market; in such cases, we are the first to invest in a sustainable care system in setting up our dialysis clinics. Dialysis centers that we acquire, on the other hand, do not always meet our quality and management standards at first. We launched the NephroCare Excellence program in the EMEALA region precisely because these standards are crucial to our patients’ quality of life, for our employees’ satisfaction and our economic success, and because, at the same time, we have to conduct our business under very heterogeneous conditions and are still growing. For the first time, NephroCare Excellence brings together in one comprehensive program all of our quality guidelines for planning daily clinic routines as well as successful quality and efficiency projects from different countries. The program is designed to support the individual countries in introducing NephroCare’s quality standards and tools to all clinics efficiently, systematically and within a defined timeframe. Our goal here is to harmonize the routines in our network of clinics, to make sure that clinic employees identify with the values of NephroCare, and to foster awareness of this still young brand both within and outside of the Company. In doing this, our aim is to continue improving the quality of our services as a whole.

The NephroCare Excellence program consists of several steps. Fulfilling the requirements at the individual stages places differing demands on the clinics. The first steps of the program stipulate that the clinics must introduce and implement the fundamental NephroCare quality standards within a set period. This entails, for example, accurately measuring the treatment quality on the basis of our clinical database, adhering to our guidelines regarding patient care and the production of ultrapure water for treatment, as well as introducing Fresenius Medical Care’s compliance program. The later steps are concerned with further improving quality, partially building on the preceding ones. One example is the subject of communicating with patients. One of the requirements in this area is that patients in our clinics have access to informational material, such as our patient magazine, and to certain advisory services provided by our employees. The next NephroCare Excellence level requires the clinic to introduce tools related to empowering patients, i.e. to boosting their self-confidence and enabling them to actively contribute towards improving their quality of life. Examples of this are our patient survey and special training programs which instruct the patients in preparing healthy meals, taking care of their vascular access or keeping themselves physically fit. How the individual countries and their clinics are classified within the scope of the program, which goals are to be set and the timetable planned to accomplish them is jointly determined by local clinic management and a central NephroCare Excellence project team and checked regularly.

In 2010, we implemented the first NephroCare Excellence projects in countries in the EMEALA region. We plan to continue developing the program and add more content in the coming years to make it the backbone of our quality management. In the process, we will also incorporate the experience gained over the first phase of the program in the individual countries.