Introduction

The average age of the dialytic population has increased by about 2 years in the past 3 years. This is due to the fact that, on average, new incident patients are older and the prevalent patients (those already on dialysis) are surviving to a much older age. In addition, there has been an increase in the transplantation rate which normally affects younger patients. The number of diabetic patients has also increased at the same pace, and similarly the incidence of patients with catheters has increased.

This demographic composition boosts the importance of good dialysis to ensure patient well-being and rehabilitation. These increasingly fragile patients complicate the challenge to all caregivers every single day. The importance of having a strong multidisciplinary team to face this new reality is becoming increasingly obvious.

In the vast majority of European countries taking care of all persons requiring medical assistance whilst at the same time respecting the values of human dignity is considered a primary duty of every government.

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© 2007 S. Karger AG, Basel 0253-5068/07/0251-0077$23.50/0

Andrea Stopper Fresenius Medical Care Else-Kroener Strasse 1 DE-61352 Bad Homburg (Germany) E-Mail [email protected]

Under this ethical assumption, there is absolutely no contradiction but much more reciprocal support between the strategies aiming to improve patient outcome (mortality and morbidity) and the goals of creating sustainable and continuous value for the shareholders.

This central role of the patient has driven the entire organization of Fresenius Medical Care's network of dialysis centers (fig. 1). With maximum patient outcome as the company mission whilst at the same time viewing the patients as being the company's most valuable asset, Fre-senius Medical Care prides itself on applying nothing less than the best and most adequate dialytic strategy.

Hence Fresenius Medical Care's strong move towards high-flux dialysis, online hemodiafiltration, ultrapure dialysate and treatment protocols compliant with state-of-the-art guidelines as proposed by the international scientific community. Knowing that medical treatment has to be more than clinical excellence and taking the patient's quality of life into consideration during and between treatments, Fresenius Medical Care's attention is also constantly addressed to the quality of its dialysis facilities and whenever possible also to any other needs a patient may have: good access to transplantation networks, psychological and nutritional support, as well as support in sociological issues.

This definition of the social role of a company also means the recognition of obligations with respect to two other groups of stakeholders: to employees and the community as a whole.

Fresenius Medical Care embraces the challenge to maximize the benefits for all stakeholders, aware that the pattern of their interactions is very clearly one of a positive and self-reinforcing loop.

Quality Assurance and Continuous Quality Improvement, the Power of Data Dialysis is probably one of the areas of medicine with more guidelines than any other. The first clinical guideline in the field of dialysis practice was released by the US Renal Physicians Association in 1993 [1], followed by the Dialysis Outcome Quality Initiative (DOQI) Guidelines of the National Kidney Foundation in 1998 [2-6]. Later on, several European scientific societies, such as the EDTA [7], British Renal Association [8], and the Societa Italiana di Nefrologia [9], prepared their own guidelines following the American example but adapting them to European or local conditions. The availability of guidelines is only the first step in quality assurance and implementing guidelines is just one part of the whole quality assurance management system. Quality assurance can be defined [10] as 'all those planned and systematic actions necessary to provide adequate confidence that a product or service will meet performance requirements'.

I mportant issues such as dialysis dose (equilibrated Kt/V) are dealt with in those guidelines defining minimum values to be reached, but very often the percentage of patients that should reach that standard (e.g. 80% of patients with more than 1.20 of equilibrated Kt/V) is not included. Then, a target has to be set, and since it should be feasible to reach this target, it is usually defined in a stepwise fashion, i.e. using a continuous quality improvement approach. Accordingly, at each stage of the continuous quality improvement cycle (Plan-Do-Check-Act), projects for improvement are initiated, results evaluated and, if the final product is better than the previous cycle (i.e. increased proportion of patients reaching the goal), the new options are integrated into the standard process.

Fig. 2. Healthcare expenditure in percent of the GDP of the European Union (WHO).

Germany France Greece Netherlands Portugal Sweden Belgium Malta Denmark Slovenia Italy Hungary

Healthcare expenditure, %

United Kingdom Spain Czech Republic Austria Finland Ireland Luxembourg Lithuania Poland Latvia Cyprus Slovakia Estonia

Healthcare expenditure, %

Healthcare expenditure, %

From this description, it is clear that quality assurance and continuous quality improvement are data driven. Opinions and perceptions, even if from skilled physicians, have no place in this approach. Therefore, the other important component of such a system is a clinical database containing all the information required to be able to operate the system.

The fast development of sophisticated hardware and software over the past years has eliminated the potential problem of storing large amounts of clinical information, allowing dialysis providers to collect as many parameters as they find necessary. This fact bears the risk of assuming that all data are equally important and therefore, given the technological conditions, all data must be collected and monitored. If we follow this assumption, we would lose the challenge of using data to continuously provide dialysis patients with an appropriate quality of care, due to the lack of a well-defined structure for data acquisition. Thus, behind any data management system for dialysis patients, a strategy is needed: the purpose must be clearly stated; the list of variables required must be established, and the structure of the database must be as logical as possible following the normal processes adopted in the dialysis centers.

There are many different categories of data that can be collected in dialysis (all available parameters, from the dialysis machine, comorbid conditions, outcome data) but there must be a reason for the data collection. Data collection must be programmed and structured from the beginning by the dialysis service provider. Without appropriate structure and data codification no benefit will be achieved for patients (identification of problems) or service providers (system efficiency improvement), especially in such a complex environment as Europe consisting of many countries with all their differences, starting from languages to laws and regulations.

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