Operations and Business Environment - Fresenius Medical Care

02. 4
Our Fiscal Year
98
as well as by the application of internal standards as
defined by written process and work instructions.
Regular audits are carried out by authorized quality
management staff at each of the Group’s sites to
ensure adherence to guidelines. The audits include all
areas and aspects affecting quality, from the management
and administration to development, production
and customer satisfaction. In 2006, our production site
for dialyzers in St. Wendel successfully passed an FDA
(Food and Drug Administration) GMP Audit conducted
by TÜV-Süd Product Service Munich under the mutual
recognition agreement between the European Union
and the U.S.
Major Customers. DaVita, the world’s second-largest
provider in the dialysis care sector and one of our largest
customers in dialysis product business, has entered
into a product supply agreement with Gambro. This
contract could result in the expiration of current supply
contracts between Fresenius Medical Care and DaVita.
From our point of view, the risk related to this is small
since DaVita contributes only about 1% of Fresenius
Medical Care’s overall sales and Gambro currently
faces import restrictions by the U.S. FDA for certain
products for the U.S.
Services. Performing medical procedures on patients at
our dialysis clinics presents inherent risks. Operational
risks include, for example, the need for hygienic
conditions. We counteract these risks by using strict
organizational and operational procedures, continuous
personnel training and patient-oriented methods. Our
ISO 9001 certified clinic-quality management system is
linked with our Integrated Management System (IMS)
as detailed on page 85 . The ISO 9001 certificate attests
to “Good Dialysis Practice.” In the U.S., we achieve
the standards outlined in the Kidney Disease Outcome
Quality Initiative (KDOQI) and the Center for Medicare
and Medicaid Services (CMS) clinical performance measures
using our internal Quality Enhancement Program.
In addition to internal assessments of treatment data,
annual internal audits of our processes are a solid foundation
for continuous improvement. Our clinic quality
management system is also audited each year by
external certification institutes such as the German TÜV
or Medicare (CMS) and CMS Networks throughout
the U.S. As a consequence, quality flaws and risks can
be identified quickly and remedied in a timely manner.
The IMS also covers environmental management, taking
into account that the manufacture of dialysis products
requires the use of environmental resources and that
the operation of dialysis services produces clinical waste.
An environmental management system, certified under
the ISO 14001 standards, has been introduced for
production sites and dialysis clinics to help protect the
environment and resources while identifying potential
savings for raw materials. Please see page 85 for further
details.
The merger of a large number of facilities from Renal
Care Group (RCG) into our North America segment
could affect the quality of care provided in the facilities
and the number of patient referrals to all North American
facilities in the future. However, our management
in the U.S. has developed a very effective integration
plan that calls for the diligent incorporation of the
large number of new patients and facilities into our
organization. We have in place operating structures to
maintain the current high quality of care provided in
the whole organization.
Debtors. The risk of late or non-payment is reduced
by evaluating the credit standing of new customers and
reviewing the credit limits of our existing ones. Outstanding
payments are monitored while assessing the
Fresenius Medical Care 2006