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Fresenius Medical Care

As the world’s leading provider of dialysis care and products, Fresenius Medical Care has a special commitment to maintaining the best possible quality standards for its patients and customers. To meet these demands and the numerous regulatory requirements, Fresenius Medical Care has implemented comprehensive quality management systems in its regions, which reflect both the specific local conditions and the company’s global responsibility. These systems regulate and monitor compliance with quality and safety standards for all products and procedures, from development, production, and regulatory approval to use in clinics, customer training, and handling complaints.

We have established quality management systems at our production sites and dialysis centers and we commission regular external audits on their use. In Europe, this is performed by the German technical certification organization TÜV. These conformance and certification experts audit our clinical organizations annually to verify their compliance with ISO 9001 for quality management and ISO 14001 for environmental management. In the United States our clinics are monitored by the Centers for Medicare and Medicaid Services (CMS), a public health care authority. We also regularly review our quality management systems through internal audits. These are conducted by employees who we train specifically, including ongoing training, for this purpose.

Our UltraCare brand in North America and our NephroCare brand in the other regions are part of an integrated therapy concept that sets internal quality standards in our clinics as well as for home dialysis. We aim at introducing our quality standards into newly acquired clinics efficiently and systematically, seeking to improve the risk management for applying those standards. In doing this, we intend to continue improving the quality of our services in our clinic network as a whole. The NephroCare Excellence program defines medium- and long-term operating and quality goals. These goals pertain to medical quality, but also relate to the effective use of staff and staff development, enhancing efficiency, standardizing processes, and the sustainable use of natural resources. In 2012, the dialysis clinics that were taken over by Fresenius Medical Care through the acquisition of Euromedic’s services business were integrated into the NephroCare Excellence program.

We measure and compare our quality performance in our individual clinics using certain performance indicators. In addition to industry-specific clinical benchmarks, they include our own quality targets, i. e. linked to the services and advice we provide. Fresenius Medical Care uses quality parameters that are generally recognized in the dialysis industry:

  • 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, but for dialysis patients it must be filtered from the blood through renal replacement therapy.
  • Another quality indicator is the albumin level in the blood. Albumin is a protein that is indicative of a patient’s general nutritional status.
  • We also strive for a defined hemoglobin value in our patients. Hemoglobin is the component of red blood cells that transports oxygen around the body. An insufficient level of this in the blood is indicative of anemia, which typically occurs in patients with chronic kidney failure. Besides dialysis, anemia is treated with iron supplements and the hormone compound erythropoietin (EPO).
  • Phosphate concentrations show whether treating the patient with dialysis and medication is sufficient for 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 severe conditions.
  • The number of days patients are hospitalized because of complications as part of their kidney disease is also crucial for determining treatment quality, because they are particularly cost-intensive and can significantly reduce the quality of life of dialysis patients.
  • In order to guarantee sufficient blood flow through and therefore an effective dialysis treatment a permanent vascular access is necessary. We record the number of patients who do not use a hemodialysis catheter as a vascular access in dialysis treatment. Catheters are associated with serious infections and increases in the number of days spent in the hospital. We are committed to further increasing the number of patients without using catheters.

Constantly measuring these and other parameters helps us to further improve our standards in providing dialysis treatment.

At the end of 2012, we started a patient survey in 24 European and Latin American countries aimed at more than 60,000 patients in Europe and Latin America. The initial evaluations show that over 95% of patients would recommend their Fresenius Medical Care dialysis center to friends or relatives if they needed dialysis. We also conduct regular patient surveys in North America.

The Patient Safety Organization (PSO) was also expanded in 2012. All employees in our clinics in the United States report critical incidents to an internal PSO analysis system. Our PSO then carries out a cause analysis on the basis of the aggregated data. We adapt any procedures that are prone to error and train both our staff and patients to improve these procedures. In this way, we want to guarantee that dialysis treatments in our clinics are as safe as possible.

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