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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 clinical application, customer training and handling complaints.

The quality management system combines internal regulations and processes with the specification of external standards – such as ISO 9001:2000 for quality management systems and ISO 13485:2003 for medical products. We also apply the guidelines issued by the U.S. Food and Drug Administration, the EU Medical Device Directive (MDD) and Good Manufacturing Practices (GMP), and international rules for the safe and high-quality manufacture of pharmaceutical products and medical devices. Today, our sites are already certified to various regional quality standards. This enables products to be supplied flexibly to different markets, thus increasing the reliability of supply. The GMO division described in the procurement management section harmonized the quality management generally, e. g. to achieve supra-regionally comparable processes and systems for quality assurance and quality improvement.

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, systematically and to improve the risk management regarding applying to those standards. In doing this, we intend to continue improving the quality of our services in our clinic network as a whole.

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. To assess quality in dialysis care, Fresenius Medical Care uses quality parameters that are generally recognized throughout the dialysis industry:

  • One example is the so-called Kt/V value, which shows the cleansing performance of the dialysis treatment. This is calculated by analyzing the relationship between the duration of treatment and the amount of specific toxic molecules that were removed from the blood.
  • 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 in cooperation with their nephrologist. 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. Parallel to 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 is also crucial for determining treatment quality, because they are particularly cost-intensive and can significantly reduce the quality of life of dialysis patients.

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

The quality management implemented at our sites and at our dialysis clinics is regularly audited. In Europe, this is handled by the TÜV. These conformance and certification experts check our corporate headquarters, the production plants as well as sales organization and clinical organizations as part of their annual audits. In the United States our clinics are audited by the Centers for Medicare and Medicaid Services (CMS), the bodies responsible for the public health care program. For Fresenius Medical Care North America, 2011 was also marked by the foundation of a “Patient Safety Organizanization (PSO)“. All employees in our about 1,800 clinics in the U.S. 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. In March 2011, the PSO was officially certified by the U.S. Agency for Healthcare Research and Quality under the direction of the U.S. secretary of health.

In the International segment our dialysis care business is marked by the penetration of new markets and regions. The legal and health care systems differ from country to country and newly acquired dialysis centers might not conform to our quality and management standards. In the past year, we successfully introduced NephroCare quality standards and tools in further clinics; among others, the implementation objectives under NephroCare are now fully integrated into the local business development targets for all subsidiaries.

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