Quality you can count on - nephrocare.cz · Quality you can count on NephroCare – Quality Report 2011 Dr. Nóra Pálvölgyi, Medical Director, Sopron, Hungary. 2 Thank you We would

Quality you can count onNephroCare – Quality Report 2011

Dr. Nóra Pálvölgyi, Medical Director,

Sopron, Hungary

2

Thank you

We would like to express our thanks to the NephroCare

staff and patients in our dialysis centres who contrib-

uted to the making of this report.

Many of the photographs were taken during actual

dialysis sessions in our centres around the world and

we are especially grateful to everyone who allowed us

to use their photographs.

3NephroCare Quality Report 2011

Content

Fresenius Medical Care – Corporate Alignment

1 Introduction 4

2 End-Stage Renal Disease 8

2.1 A growing problem – worldwide 8

3 Fresenius Medical Care 10

3.1 Creating a future worth living 10

3.2 Vertical integration 11

3.3 Integrated Management System 13

4 NephroCare 14

4.1 Committed partner in renal care 14

4.2 NephroCare Excellence Programme 16

4.3 Quality Management in NephroCare 18

4.4 Our personnel – the faces of NephroCare 22

4.5 Focus on patients 24

5 Proven Quality 26

5.1 Safety and high-quality dialysis: milestones of the process 26

5.2 Treatment options 27

5.3 Interactive data management system 30

5.4 Medical outcomes 31

References 33

4

From the early days of renal replacement therapy,

Fresenius Medical Care has been a frontline pioneer.

With more than 30 years of experience in dialysis

research and development we are the global leader in

innovative products and services – with a unique

breadth of expertise from development through

product technologies and manufacturing to patient care.

At Fresenius Medical Care, we work together, motiv-

ated by a shared vision: creating a future worth living.

For people. Worldwide. Every day.

Our position as a vertically integrated company means

we can go further in realising that vision, beyond merely

providing products to customers. With NephroCare,

our service in dialysis patient care, we manage our own

centres – providing comprehensive, renal patient care.

NephroCare is our integrated solution for patient care,

letting us put our knowledge and experience to best

use. Through NephroCare, we can provide advanced

dialysis therapies directly to patients. It is about much

more than just dialysis: NephroCare has a far-reaching

commitment to patients, national health care systems

and to our own teams.

Fulfilling our promise to patients, Fresenius Medical Care

strives for the best possible therapies to achieve the

best attainable outcomes. ONLINE Haemodiafiltration

(ONLINE HDF) for instance signifi cantly improves

patient survival, quality of life and general well-being

versus standard haemodialysis. In 2011, more than

50 % of haemodialysis treatments in Fresenius Medical

Care centres used ONLINE HDF; it is our intention to

maximise this proportion.

By actively listening to our patients and understanding

their needs, we can empower them and also improve

their quality of life. In our Patient Satisfaction Survey

2011, more than 85 % of almost 12,000 patients

actively praised the competence of our staff, expressed

feeling very safe during treatment, and 96 % would

recommend their centre to others.

Ultimately, care is provided by people; satisfied carers

provide better care. As a responsible employer,

Emanuele Gatti

Chief Executive Officer for Europe, Middle East, Africa and Latin

America (EMEALA) and Global Chief Strategist

1 Introduction


Fresenius Medical Care is committed to supporting

and developing our staff. We provide continuous

education in areas ranging from medical to shift

management, and we are careful to support active

exchange of experiences and ideas to offer our teams

meaningful work in a professional environment. All

these activities are supported by our e-learning plat-

form, which was launched in 2008 and today is

actively enrolled in more than 25 countries – with a

huge success.

Within the quality management system for our centres,

our NephroCare guidelines are key to define and

assess quality and safety for our patients as well as to

ensure process efficiency.

The NephroCare Excellence Programme brings to-

gether all of our quality standards and best practices

from different countries in one comprehensive pro-

gramme. It is based upon sophisticated international

data management systems such as EuCliD5 and

our management instrument NephroCare Balanced

ScoreCard.

A further aspect of our commitment to the future is

the substantial investment in state-of-the-art dialysis

centres. Designed to offer comfort to the patients

while maintaining the clinical standards of a hospital,

Fresenius Medical Care dialysis centres must adhere

to our Architectural Guideline, also reflecting our com-

mitment to environment protection and the vision of a

zero-emission dialysis centre.

Transparency is a fundamental prerequisite to trust,

allowing us to work together with health care authorities

to develop efficient long-term health care strategies.

This quality report is an important element in our

continuous drive to improve the quality of dialysis care,

reducing complications, and so maximising access to

the best possible therapies for the greatest number of

chronically ill patients with end-stage renal disease.

Yours sincerely

Emanuele Gatti

Youruuuuuuuuuururuuuruuurruuu s sincerely

Emanuele Gatti

66

7NephroCare Quality Report 2011 7

Fresenius Medical Care –

Corporate Alignment

Nenad Petkovic, Doctor and Internal Medicine Specialist, Šamac, Bosnia

8

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(potential)

kidney

donations

worldwide

dialysis

patients

worldwide

A steep climb – the demand for dialysis to 2020. The number of dialysis patients is expected to increase between 5 % and 7 % in the long term. At this rate, the burden on health care systems will nearly be doubled by 2020.1

8

End-stage renal disease (ESRD) is a life-threatening

condition in which renal function is essentially lost.

Waste products from normal body functions as well as

excess fluid (e.g. from drinking) accumulate in the

body. As a consequence, ESRD compromises differ-

ent body and organ functions. ESRD affects around

2.8 million people worldwide, and this number is

expected to almost double by 2020.

Patients suffering from ESRD need appropriate treat-

ment to survive. There are two therapeutic options for

these patients: kidney transplantation and dialysis.

Prevalence1

• The prevalence of treated ESRD in the general

population shows a strong global variation, with

figures ranging from less than 100 to over 2,000

patients per million people (p.m.p.).

• In the 27 countries of the European Union, the

average prevalence is around 1,040 p.m.p.

• The fact that, at 400 p.m.p., the global average is

much lower suggests that access to treatment is still

limited in many countries, meaning that many patients

with terminal renal failure do not receive treatment

at all. However, the steady increase of global prev-

alence over the years indicates a general rise in the

number of people requiring treatment for ESRD as

well as a gradual improvement of access to care.

The number of patients undergoing regular dialysis

is predicted to increase from over 2,000,000 in 2011 to around 3,800,000 by 2020.

2.1 A growing problem – worldwide

2 End-Stage Renal Disease


Haemodialysis (HD)

• Mainly done at hospital/

dialysis centre

• Schedule is usually

3 x per week

• Normally 4 hours

per treatment

• Covers about 90 %

of patients

Peritoneal dialysis (PD)

• PD is a continuous

therapy at home

• Storage space is

needed at home

• Regular clinic visits

are required

• Covers about

10 % of patients

9

Replacing renal filtration is achieved through dialysis –

an artificial process in which waste and excess water

are removed from the blood by diffusion, filtration and

osmosis. This may be performed by means of peritoneal

dialysis or haemodialysis.

Detoxification of the blood takes place in the patient’s

own peritoneal cavity. Fresh dialysate fluid is fed from

an upper bag and after “dialysis” is removed into the

lower drainage bag. PD is performed daily by the patients

themselves, at home or at work.

Haemodialysis involves connecting the patient’s blood

circulation to the extracorporeal blood circuit of a

dialysis machine. In this case, the patient’s blood is

pumped through a dialyser where waste products and

excess water are removed using a combination of dif-

fusion and filtration. The cleaned blood is then returned

to the patient’s body. This process normally requires

a few hours (3–4 hours) and must be repeated at least

three times per week.

... health care costs continue to rise as the number of patients with chronic conditions increases.... hhheeeaaalllttthhh ccaaarreee ccoosstttss ccoonntttiiinnuueee tttoo rriiisseee aaass ttthhheee nnuummbbbeeerr oofff ppaattiiieennttss wwiiitthh cchhrroonniiicc ccoonndddiiittiiioonnss iiinnccrreeaasseess.

10

Fresenius Medical Care is dedicated to improving

patients’ lives, creating a worthwhile future, providing

the highest quality in state-of-the-art dialysis.

For over 30 years, Fresenius Medical Care has been

setting the standards in dialysis, operating at all levels

of care. As a manufacturer of a full range of dialysis

products and as a service provider operating around

2,900 centres in more than 40 countries worldwide,

Fresenius Medical Care partners with health care

systems to provide tailor-made therapy options for

more than 230,000 dialysis patients around the world.

This level of integration provides Fresenius Medical

Care with access to a unique wealth of experience

through direct contact with patients, nephrologists,

nurses and technicians.

3.1 Creating a future worth living

Countries with Fresenius Medical Care dialysis centres

3 Fresenius Medical Care


At Fresenius Medical Care, each product idea under-

goes a structured development process with clearly

defined project phases, milestones and reporting lines.

This ensures that we only pursue ideas that create

added value for our patients and customers.

At the core of this culture is vertical integration, in other

words, the fact that we develop, manufacture and sell

dialysis products at the same time as offering dialysis

treatment. Our research and development teams

benefit directly from the opinions and experience of

3.2 Vertical integration

Research and Development

Patient Care

Evaluation of Treatment Outcome

Patient Database EuCliD5

Production

Products and Therapies

Vertical integration of Fresenius Medical Care

12

patients, nurses and physicians in Fresenius Medical

Care’s clinics. This knowledge flows into our produc-

tion. Fresenius Medical Care has more than 40 pro-

duction sites around the world where all machines,

dialysers, concentrates necessary for haemodialysis

and peritoneal dialysis are produced.

Since January 2010, production sites that were previ-

ously organized at a regional level have been fused

into a worldwide integrated production network, coor-

dinated by our Global Manufacturing Operations

(GMO). The aim is to allow the individual facilities to

coordinate their activities more closely. This approach

transfers best practices between the regions and

sites, and additionally provides an even more effective

interface with R&D.

As the industry leader with long-standing experience

in dialysis, Fresenius Medical Care has access to

extensive company resources: production capacities

in all regions, know-how on all aspects of highly com-

plex manufacturing technologies and processes, as

well as extensive expertise in quality management,

procurement and logistics for sophisticated medical

products. Our unique experience as a provider of

dialysis products and services increasingly makes us a

valued advisor for healthcare partners.

The results of this innovative culture within our vertical

integration include our 5008 Therapy System featuring

ONLINE HDF as standard, which reduces the side

effects associated with dialysis and helps to improve

patient outcomes.

5008 Therapy System


3.3 Integrated Management System

We want to offer our patients and customers the best

possible product and treatment quality. To this end,

Fresenius Medical Care applies extensive quality man-

agement systems. These regulate and monitor com-

pliance with quality and safety standards for all of our

products and technologies – from their development

and production to market approval and use in clinics,

right up to training customers and dealing with com-

plaints. The quality management system combines

internal rules and processes with the requirements of

external standards and guidelines, which are both rel-

evant for our business. This concept of the Integrated

Management System (IMS) was implemented in 1999.

By “integrated” we mean that the management system

combines various requirements, like those for quality,

risk and environmental management, and applies to all

company activities, from R&D to patient care.

The core goal behind the IMS is the improvement of

quality, thereby supporting the continuous perform-

ance enhancements in Fresenius Medical Care’s busi-

ness areas.

The IMS’s foundation is built upon established and

effective business processes, adapted and adminis-

tered according to our specific business needs and

reflecting our corporate philosophy. At the heart of the

IMS is the Quality Policy of Fresenius Medical Care.

For the Employees: For the Community:For the Patient: For the Shareholders:

To improve the quality of life and

increase the life expectancy of

patients with renal disease, liver

failure or immune defi ciency.

To provide safe working condi-

tions, to attract and bind qualifi ed

employees to the company and

to promote their professional

development.

To fulfi l our social responsibilities,

protect the environment, comply

with safety standards and legal

requirements, and follow the

company compliance codex.

Our long-term strategy aims at

the sustainable growth of the

shareholder value of Fresenius

Medical Care.

The Quality Policy of Fresenius Medical Care

14

As a service of Fresenius Medical Care, NephroCare is

dedicated to providing complete renal replacement

therapy at the point of care. The Fresenius Medical

Care dialysis centres in Europe, Middle East, Africa

and Latin America provide dialysis services in more

than 25 countries.

NephroCare is an explicit commitment to excellence

in renal patient care focusing efforts on three core

elements:

Our patients

All we do within NephroCare is focused upon provid-

ing our patients with a better quality of life. We work

to provide the appropriate renal care for each patient,

using advanced technologies to enable the best

possible therapies, while taking the time to listen to

patients and understand their needs. Only then we

can ensure high-quality care and em power patients to

assume responsibility.

NephroCare’s commitment to excellence and the

resulting comprehensive business model leads us to

work closely with the health care authorities to ensure

affordable renal care. Now and in the future, for the

maximum possible number of patients in need of

dialysis treatment.

Our employees

NephroCare employs over 20,000 staff committed to

delivering the highest possible quality of care. We are

aware of our responsibility to empower our staff

through a modern working environment. As such, we

include our employees in organisational and work-

related decision-making and enable a continuous pro-

fessional and social development.

Our dialysis centres

The first centre opened in Hungary in 1994. Today,

Fresenius Medical Care is treating almost 80,000

patients in over 800 dialysis centres, providing more

than 10,000,000 treatments per year in more than

25 countries. This enormous growth is the result of

massive and sustained investment in state-of-the-art

centres and technologies. The uniform enforcement of

strict safety and quality guidelines takes on an ever

increasing importance as we grow in size and capaci-

ty. Safety standards and quality directives must be

implemented and continuously monitored in our cen-

tres in accordance with Fresenius Medical Care’s

Quality Policy.

Fresenius Medical Care is continuously developing

innovative concepts for a sustainable future while fo-

cusing on proven quality in renal replacement therapy.

4.1 Committed partner in renal care

4 NephroCare


Rozalka Mihelič, Nurse, Črnuče, Slovenia

16

NephroCare Excellence brings together in one com-

prehensive programme all of our quality and efficiency

standards as well as proven best practices from differ-

ent countries. The programme is designed to support

the individual countries in introducing NephroCare’s

quality standards and tools to all clinics efficiently, sys-

tematically 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.

We launched the NephroCare Excellence Programme

in the EMEALA region specifically because these

standards are crucial to our patients’ quality of life, our

employees’ satisfaction and to our commitment to

enabling affordable renal replacement therapy for the

different health care authorities in more than 25 coun-

tries.

The NephroCare Excellence Programme supports the

NephroCare commitment to implementing improve-

ments centre by centre, encouraging local assump-

tion of responsibility.

This entails, for example, on a basic level, accurately

measuring treatment quality based on our clinical

database, extensive standardisation and efficiency

enhancements to the clinic infrastructure as well as

optimisation of dialysis treatment outcomes.

The implementation of individual goals is planned

for each country in close collaboration with the

NephroCare management and a central NephroCare

Excellence project team.

In 2010, we implemented the first NephroCare

Excellence projects in countries in the EMEALA region.

The programme is continuously under development

and additional content will be added in the coming

years to form the backbone of our quality management.

The extensive experience2 we have gained over the

last few years in the various countries where

NephroCare operates is incorporated into this

demanding process.

4.2 NephroCare Excellence Programme


Monitoring of excellence

To monitor how well we deliver on the NephroCare

promises and principles, we measure and compare

our quality performance in our individual clinics and at

a regional level using certain performance indicators.

These are defined in the “NephroCare Balanced

Scorecard”. This is a management instrument used to

measure the realisation of performance targets and

guide continuous improvement at all organisational

levels – from company-wide to a single dialysis centre.

Balanced ScoreCard

The NephroCare Balanced ScoreCard is structured on

four perspectives and nine strategic objectives which

are based on Fresenius Medical Care’s Quality Policy

as an overall strategic framework for NephroCare that

acknowledges our responsibilities to patients, employ-

ees, shareholders and the community. In order to

ensure compliance with our Quality Policy in all

centres, performance measures are established for each

strategic objective, with co rresponding targets.

Patients

For instance, one key objective from the patient’s

perspective is quality of life. Specific performance

mea sures include indicators of dialysis process perfor-

mance and treatment outcome.

Employees

Our commitment to being the preferential partner in

renal care depends on the performance of our employ-

ees. They are the ones who personally deliver excel-

lence – they are the faces of NephroCare. Our objec-

tives are to bind qualified employees and promote

their professional development.

Community

For the community perspective, the three key objec-

tives focus on upholding various social responsibilities,

following all legal and regulatory requirements and

safety standards, additionally contributing to environ-

mental conservation. The corresponding performance

measures include a wide variety ranging from mini-

misation of em ployee accidents, achieving ISO

certification to reducing usage of water, electricity and

waste.

Shareholders

We strive to offer affordable renal therapy for the largest

number of patients by using the resources provided by

health care authorities carefully and efficiently. It is a

comprehensive responsibility and we are committed to

satisfying all our stakeholders.

NephroCare Balanced ScoreCard

18

Our Integrated Management System in our dia ly-

sis centres is based on the following principles:

Our quality standards for dialysis services focus on

providing patients with the best available therapies.

We use our own high-quality products, pharmaceuti-

cals and procedures in our clinics; these are being

continually refined by our research and development

team. We provide our patients with comprehensive

therapy and medical advice from qualified, highly moti-

vated clinical personnel and physicians. We create a

safe and pleasant atmosphere for both patients and

employees in our dialysis centres. We systematically

improve our performance and efficiency levels by col-

lecting and comparing our clinical treatment data on

an ongoing basis, working according to both external

and internal quality standards, and running our clinics

in a professional manner.

The Certification System

As we have done at our production sites, we have set

up quality management systems at our dialysis centres,

which are regularly checked by third-party certification

bodies. In Europe, for example, this is done by the

Technical Inspection Association (Technischer Über-

wach ungs ver ein – TÜV). These conformity certification

experts inspect our clinics in yearly audits to ensure

that they conform with ISO 9001 as well as with the

criteria of the TÜV “Good Dialysis Practice” standard.

It’s not just our own standards that we adhere to. Our

compliance with these international standards, such

as ISO 9001:2008 for quality management, ISO

14001:2004 for environmental management and addi-

tional local laws, are regularly assessed by external

independent organisations to make sure that we meet

and exceed expectations. At the end of 2011, for

4.3 Quality Management in NephroCare


instance, almost 65 % of our 600 dialysis centres in

the EMEA region had been certified by the TÜV for

quality management, and almost 50 % for environ-

mental management. It is our objective to continue to

increase the proportion of externally certified centres.

Based on different legal requirements in the countries

of Latin America, our Fresenius Medical Care centres

in Argentina, Brazil, Chile and Venezuela will work on

local certifications. In Colombia, we are certified in 36

centres according to ISO 9001:2008.

ISO 14001:2004 for environmental mangement: Certifi cate status of Fresenius Medical Care dialysis centres in Europe, Middle East and Africa (EMEA)

49 %ISO 14001:2004

Environmental

management

65 %ISO 9001:2000

Clinic management

ISO 9001:2000 for clinic management: Certifi cate status of Fresenius Medical Care dialysis centres in Europe, Middle East and Africa (EMEA)

20

The four main NephroCare Guidelines

Corporate directives specifying key requirements for

the processes in our NephroCare organisation are

core elements of our quality management. Specific

NephroCare guidelines have been implemented for

dialysis-related processes, defining high stand ards

for quality and safety for all Fresenius Medical Care

centres.

1. NephroCare Guideline – Dialysis Centres

Archi tec ture Guideline

This is a fundamental element to ensure safety and

process efficiency in accordance with patient com-

fort. Our own in-house experts define the architec-

tural standards and guidelines for the following

aspects of the dialysis centres:

• Reconstruction

• New construction

• Expansion

• Refurbishment

In 2011, 23 projects were supported in 13 coun-

tries.

2. NephroCare Guideline – Water, Concentrate

and Dialysis Fluid for Haemodialysis and

Related Therapies

In renal replacement therapy, colourless, odourless

and tasteless water is indispensable. That is a chal-

lenge when considering the amounts of dialysis

fluid necessary to provide dialysis treatment to

each patient. One key element of our water guide-

line is our developed Online Purification Cascade

(OPC), a system for reliable and effective purifica-

tion of water. This standard complies with the

European Pharmacopoeia (EP), with the

Association for the Advancement of Medical

Instrumentation (AAMI) and with the Internatio nal

Organisation for Standardisation (ISO).

3. NephroCare Guideline – Hygiene and Infection

Control

This guideline establishes a common approach to

hygiene in our centres by defining requirements for

hygienically safe operations and by giving guidance

on hygiene issues. It covers every aspect of hygiene

and infection control including:

• Cleaning and disinfection

• Personal hygiene

• Management of transmissible diseases

• Precautions during patient care

• Personal protection

• Precautions in high risk areas

• Handling and storage of waste

4. NephroCare Guideline – Good Dialysis Care

This guideline sets standards for the care of dialysis

patients and defines feedback and review loops,

which help evaluate and improve procedures and

processes.

The guideline applies

• before, at the start of, during and at the end of

haemodialysis treatment

• to the evaluation of patients after haemodialysis

treatment

• to equipment cleaning

• to medication

• to possible complications arising during haemo-

dialysis treatment, both clinical and technical

The guideline is based on the scientific Kidney

Disease Outcome Quality Initiative (KDOQI) and the

European Renal Best Practice (ERBP) guidelines

and defines required staff qualifications in the differ-

ent countries and the sharing of best practices.


Green Dialysis

The burden of success

Dialysis therapy consumes a lot of resources. To treat

a patient three times a week for several hours requires

large amounts of energy, water and disposable medi-

cal products. The environmental balance of an aver-

age haemodialysis session is approximately 400–500

litres of water, ten kilowatt-hours of electricity and up

to three kilograms of medical waste.

The success of dialysis as a therapy has a growing

ecological and economical impact. The dramatic

growth in the number of patients has been accompa-

nied by numerous medical and technological advanc-

es which have further increased the environmental

burden of dialysis. Patient safety dictates that a large

part of the equipment and accessories for dialysis is

used only once, for example the hoses that connect

the patient with the cleaning filter.

Environmentally friendly products

Fresenius Medical Care has been working for years on

making its products and processes more environmen-

tally friendly. The results include the development of

products and materials such as the recyclable Biofine

film or the continuous improvement of production pro-

cesses to increase resource efficiency. Almost half of

the Fresenius Medical Care dialysis centres in Europe

are certified to the international environmental stan-

dard ISO 14001. Ecological controlling is gradually

being introduced in European clinics.

“Go Green in Dialysis”

Together with the EDTNA/ERCA (European Dialysis

and Transplant Nurses Association/European Renal

Care Association), Fresenius Medical Care has

launched the “Go Green in Dialysis” initiative. It brings

together specialists including nephrology nursing

experts, dialysis technicians, quality management and

environmental leaders. The project is led by Jitka

Pancirova (EDTNA/ERCA) and Jürgen Kastl

(NephroCare Coordination).

Environmental Guidelines in Dialysis

The “Go Green in Dialysis” initiative has now devel-

oped a set of standard environmental guidelines for

dialysis. The aim of the project is to increase the

awareness for environmental topics among dialysis

clinic staff.

To achieve this, a multidisciplinary project team was

selected to cover the areas of nursing, environmental

management and technical services. 15 experts from

10 different countries (half from EDTNA/ERCA, half

from Fresenius Medical Care) worked together to cre-

ate the content of this green standard document. In

September 2011, the completed 148-page booklet

was presented at the EDTNA/ERCA conference in

Ljubljana, Slovenia.

The guidelines explain the general challenges of envi-

ronmental management and address the topics of

waste, water and energy consumption. With these

guidelines, we hope to give practical help and answer

the increasing number of questions about how to per-

form an environmentally friendly dialysis.

The success of such initiatives depends on more than

the right standards and instruments. It requires a para-

digm shift in clinical practice – from the individual dialy-

sis technician to the doctor to the hospital manage-

ment. This change is now underway.

2222

There is much more to renal replacement therapy than

just dialysis. The training, education and continuous

qualification of Fresenius Medical Care employees

have a direct impact on the quality of care delivered to

the patients. In a clinical setting where technology is

an important component, the staff actually delivering

care represent the human and emotional link with the

patients and as such are very important for patient

compliance and well-being.

Development of expert personnel

Our centres are supported by Fresenius Medical Care

corporate through a combination of educational sup-

port and detailed training tools which are tailored to

country-specific needs. A productive mix of continu-

ous training programmes, study events and confer-

ence attendance help keep staff up to date with the

latest medical developments as well as organisational

require ments and procedures. By developing our staff,

we improve the quality of our service.

Physicians and nurses are encouraged to attend and

to contribute to national and international congresses

and symposia such as ERA-EDTA and EDTNA/ERCA.

Furthermore, twice yearly international meetings of the

Country Head Nurses and Country Medical Directors

support the exchange of valuable ideas and experiences,

identify our network’s needs and help us find the best

ways to develop and improve the dialysis working

processes. Similarly, in 2010 we initiated a consensus

conference as an international shared governance meet-

ing which is qualified for Continuous Medical Education

(CME) credits. In parallel to this, we arrange local con-

sensus conferences, also with CME accreditation.

The professional development of nursing staff is

actively supported through regular training events and

by using publications like NursingNow!, the nursing

magazine with training and patient care features.

e-learning

Building on this, we launched an e-learning platform in

2008. This has been a huge success with active roll-out

4.4 Our personnel – the faces of NephroCare

The Online Learning Centre in the Fresenius Medical Care e-platform


Teamwork Cooperation

of clinical staff

Leadership &

participation

Workload &

safety at work

Work content

Patient care

Personal

development

Support by

headquarters

Working

environment &

remuneration

23

in more than 25 countries. The platform has become a

popular training resource. In 2011, e-learning has

become widely accepted as the future oriented training

method for professional development and compliance

training.

Nearly 600 multi-lingual courses on medical or non-

medical topics are now offered to more than 20,000

learners.

The Employee Satisfaction Programme

In 2011 Fresenius Medical Care continued to carry out

the Employee Satisfaction Programme in NephroCare

clinics.

This Employee Satisfaction Programme has already

been established in almost all our Fresenius Medical

Care centres in our EMEALA countries. It reveals the

actual status of satisfaction of employees and helps to

derive measures for improvement. High satisfaction

and motivation of clinic staff are essential for excellent

care of dialysis patients.

In 2011 the respondents expressed their appreciation

of the way NephroCare patients were treated and said

they were proud to work in a NephroCare centre.

The employees also expressed the wish to extend the

opportunities for professional exchange and continu-

ous further development.

The NephroCare Excellence Programme has started

developing more opportunities for staff to interact with

their peers both nationally and internationally, in order

to exchange their ideas and experiences. Country-

specific education measures also provide customized

trainings.

The questionnaire of the Employee Satisfaction

Survey is focused on the following factors:

2424

At Fresenius Medical Care, an overall objective is to

establish a partnership with patients, built on trust,

which will bring them the best possible quality of life.

This is done by identifying the best possible renal

replacement therapy for each patient, empowering

him or her to take over responsibility and thereby

improving compliance.

Thanks to improved education and better access to

information, patients today understand their clinical

situation better and know how their own behaviour

can influence their condition. Greater motivation leads

to better compliance and better patient outcomes.

The most effective patient care is always our goal

Depending upon the applicable health care system,

we offer enhanced NephroCare services, e.g.

• blood pressure management

• vascular access management

• bone mineral management

• anaemia control

• dry-weight management

• ultrafiltration management

• in-house laboratory services

• nutritional consultation

• patient training and education

• patient transportation

• Fresenius Medical Care pharmaceuticals

The Patient Satisfaction Programme

In order to evaluate the NephroCare services and to

establish whether they meet patient expectations,

Fresenius Medical Care has implemented a Patient

Satisfaction Survey. This international survey was

launched in 2008 and is now carried out at least once

every two years, if not annually, such that all countries

have now performed at least one survey and most

have already completed their second or third survey.

The feedback from our patients is positive; over 85 %

of the patients praise the competence of our staff and

state feeling very secure during treatment. Indeed,

96 % of responding patients would recommend their

centre to others.

Patients also tell us clearly where they see room for

improvement: better emergency procedures in the event

of fire in the clinic or at home, better understanding of

clinical issues such as haemodialysis versus haemo-

diafiltration or the need for electronic data collection,

or the role of continuous quality improvement at Fresenius

Medical Care.

The Patient Satisfaction Programme works to implement

appropriate changes and improvements identified by

the survey and in this way supports ongoing quality

programmes in the specific countries.

4.5 Focus on patients

More than 12,000 patients* have participated in

educational programmes and 96 % of patients would

recommend their dialysis centre to others.

* in Europe, Middle East and Africa (EMEA), 2011


Patients’ lives revolve around the dialysis centre almost as much as their own homes. So it’s essential that they feel secure, comfortable and well-cared for.

PPattiientts’’ lliives revollve aroundd tthhe ddiiallyysiis centtre allmosttaass mmuucchhh aass tthhheeiiirr oowwnn hhhoommeess.. SSoo iiitt’ss eesssseennttiiiaalll tthhhaatt tthhheeyy fffeeeell sseeccuurree, ccoommfffoorrttaabbbllee aanndd wweellll--ccaarreedd fffoorr. rr

Europe, Middle East and Africa (EMEA): Number of patients who participated in the Satisfaction Survey

Country 2009 2010 2011

Bosnia and Herzegovina

73 – 289

Croatia – – 92

Czech Republic – 817 –

Estonia – 59 61

France – 694 –

Germany – 178 –

Hungary – 1,336 –

Ireland 13 29 89

Italy – 1,059 1,271

Poland – 2,347 –

Portugal – 2,973 –

Romania 843 216 1,910

Russian Federation 329 – –

Serbia 141 251 –

Slovak Republic – 624 –

Slovenia 197 170 –

South Africa – 163 –

Spain – 3,491 2,958

Sweden – 24 –

Turkey – 3,811 –

Ukraine – – 118

United Kingdom 1,366 1,837 1,834

Total EMEA 2,962 20,079 8,622

Latin America (LA): Number of patients who participated in the Satisfaction Survey

Country 2009 2010 2011

Argentina – 4,835 –

Brazil – – 2,510

Colombia 1,623 – 659

Venezuela – – 563

Total LA 1,623 4,835 3,732

TOTAL EMEA and LA 4,585 24,914 12,354

2626

The quality guidelines mentioned in section 4.3 are

supported by processes that make their implementa-

tion more effective. The recognition that clearly defined

processes are needed to achieve safe and high-quality

dialysis is at the roots of the NephroCare philosophy.

Training and education

A prerequisite for the best therapies is the understand-

ing and experience necessary to administer them to

their fullest advantage.

Training

Getting the most out of cutting-edge technology

requires extensive knowledge and experience about

the application.

Beyond the regulatory training requirements, we have

extensive experience in state-of-the-art training meth-

ods. Our combined experience from countless regional

training workshops ensures that events are designed

to be directly relevant to daily practice situations.

Education

Keeping up to date with the very latest developments

in dialysis care is a must for any dialysis professional.

Physicians and nursing staff of Fresenius Medical Care

participate in hundreds of events each year. Besides

the direct training in new technologies and applica-

tions, these events also serve as an invaluable forum

for the exchange of ideas and experiences with other

dialysis specialists.

A number of these events are also certified by regional

medical associations and may qualify for Continuing

Medical Education (CME) credits.

As a company, we pursue continuous staff devel-

opment through systematic training and education

programmes at all levels.

Clinical vigilance

The aim of the Clinical Vigilance Office (CVO) is to

ensure the safety of patients in Fresenius Medical Care

dialysis centres.

The Clinical Vigilance System was implemented in

2006 as part of the Fresenius Medical Care Integrated

Management System.

The main task is to monitor the implementation and

improvement of corporate processes of clinical vigi-

lance and risk control for treatment-related incidents

within NephroCare in Europe, the Middle East and

Africa (EMEA).

Other tasks include identifying deviations from safety

regulations in the NephroCare network. The CVO

coaches and supports the local clinical teams in prob-

lem solving, root cause analysis, further corrective and

preventive actions to protect patients and staff as well

as clarification of critical issues.

The activities are both prospective and retrospective in

the sense that the CVO identifies and acts upon poten-

tial risks, investigating any clinical safety incidents.

5.1 Safety and high-quality dialysis: milestones of the process

5 Proven Quality


Cardioprotective Haemodialysis

Despite tremendous improvements in the quality and

efficacy of haemodialysis (HD) therapy, cardiovascular

disease (CVD) remains the leading cause of death for

patients with end-stage renal disease (ESRD), almost

one in two patients with ESRD still dies as a result of

CVD.3

Fresenius Medical Care continues to contribute towards

improving the prognosis of ESRD patients. We make

every effort to slow down progression of athero-

sclerosis and protect cardiac function by providing

therapies aimed at reducing the complications of CVD.

Key therapies

Dialysis membranes

Performing dialysis using High-Flux dialysers enhances

the removal of uraemic toxins, particularly middle mol-

ecules such as β2-microglobulin or myoglobin. This is

achieved through advances in membrane structure.

ONLINE Haemodiafiltration (ONLINE HDF)

During HDF, the machine removes more water

together with metabolic toxins from the blood than

during “normal” haemodialysis. The additional liquid is

replaced with an ultra-pure electrolyte solution.

ONLINE HDF, with its numerous positive effects on

dialysis-related cardiovascular risk factors, is currently

acknowledged as the most effective dialysis treatment

modality, coming closest to the elimination profile of

the normal kidney.

In ONLINE HDF, the dialysis machine produces both

the ultra-pure electrolyte and dialysis solution itself,

further enhancing biocompatibility.

Fewer cardiovascular complications

Reduction of inflammation

Inflammation is an important cardiovascular risk factor

for dialysis patients. Serum levels of inflammatory mark-

ers such as cytokines and C-reactive protein (CRP)

are higher in these patients than in the general popula-

tion. CRP has been identified as a predictor of all-cause

and cardiovascular mortality in patients on haemodialy-

sis.4 ONLINE HDF significantly lowers levels of CRP

when compared with Low-Flux HD.5

5.2 Treatment options

Evaluation of infl ammation status5

7

6

5

4

3

2

1

0

CR

P (m

g/L

)

Low-Flux

HD

ONLINE

HDF

p = 0.03

(Graph adapted from original publication)

28

Optimised use of resources

Less hospitalisation with ONLINE HDF

Dialysis patients are often hospitalised due to dialysis-

related complications or existing comorbidities. A high

hospitalisation rate not only impacts the patients’

quality of life but also constitutes a huge burden for the

health care system.

The hospitalisation rate of patients on ONLINE HDF is

significantly lower than of patients on standard HD.6

Comprehensive programme for peritoneal dialysis (PD)

A comprehensive PD programme „P3“ has been specifi-

cally designed to improve safety and quality of dialysis.

P3 contains three components:

• Protect

Extra-safe and easy-to-understand PD systems

minimise the risk of peritonitis associated with sig-

nificant morbidity and mortality. Therefore, specific

risk factors for infection have been targeted with

the result of modified venous connections.

• Preserve

Ultra-low GDP fluids aim at improving patient sur-

vival by preserving the peritoneal membrane func-

tion, residual renal function and minimising the risk

of infection.

• Prolong

Individual state-of-the-art therapies for fluid balance

control and guided prescription modelling to help

prolong patients’ time on PD.

Fresenius Medical Care offers peritoneal dialysis wher-

ever possible and admissible.

The hospitalisation rate of patients on ONLINE HDF

is significantly lower than of patients on standard HD.6

70

60

50

40

30

20

10

0

ONLINE HDF reduces the number of hospitalisations6

Num

ber

of hosp

italis

ations (n)

HD HDF

p < 0.05

(Graph adapted from original publication)


ONLINE HDF is superior to HD in renal replacement therapy and reduces mortality significantly versus standard HD.8

ONNLLINNEE HHHDDFFF iis suppeerriioorr ttoo HHHDD iin rreennaalll rreepplllaacceemmeenntt tthhheerraappyy aannddd rreeddduucceess mmoorrttaalliittyyy ssiiggnniiffiiccaannttllyyy vveerrssuuss ssttaannddaarrdd HHDD.8

Kidney transplants – suitability is key

Even long-term haemodialysis does not eliminate the

option of a transplant.

For many patients with end-stage renal disease

(ESRD), a kidney transplant may be the best treatment

option. The proportion of our dialysis patients included

on the active transplant waiting list is exactly in line

with reference countries.

We are very much aware that the longer patients

remain on dialysis prior to a kidney transplant, the

greater the risk to the survival of the patient and the

transplanted kidney.7 Sadly, waiting times are growing

as the gap between organ demand and availability

continues to widen.

We therefore have a responsibility to all our stakeholders

not only to ensure the highest-quality haemodialysis

but also to achieve the best possible clinical status,

per best practice guidelines, so that we can maximise

transplant suitability.

30

EuCliD5, one of the largest dialysis databases, is at the

forefront of Fresenius Medical Care’s continuous qual-

ity improvement programme. It is a clinical information

system used to monitor medical aspects of patient care

through continuous anonymous data collection and

evaluation, thus improving dialysis outcomes.

Directly linked to the dialysis machines, the monitoring

system feeds patient data and medical parameters

from dialysis sessions into the data management sys-

tem, which also checks the data for completeness

and plausibility.

These data are compared with target values defined

by the European Renal Best Practice (ERBP) guide-

lines, Kidney Disease Outcomes Quality Initiative (KDOQI)

and the Kidney Disease Improving Global Outcomes

(KDIGO) initiative.

Dialysis quality indicators are regularly fed back to the

dialysis centres, enabling a comparison with other

centres and with the country’s benchmark.

Designed and maintained by Fresenius Medical Care,

EuCliD5 has been in operation since 2005.

The outstanding quality of EuCliD5 contributes to cut-

ting the costs of treatment by reducing the number of

hospital days and the amount of medication required.

While EuCliD5 is not yet fully implemented in all our

centres, its expansion to 100 % implementation

remains a clear priority. A national and international

comparison has shown that our strict guidelines have

improved treatment quality at all of our centres.

The EuCliD5 clinical information system is therefore a

fundamental element of NephroCare’s Excellence

Programme.

5.3 Interactive data management system

2009

2010

2011

Number of dialysis centres with EuCliD5

292

344

409

300350400450 250 200 150 100 50 0

25,443

29,619

35,317

Number of patients, anonymously monitored by EuCliD5

0 5 10 15 20 25 30 4035

Fresenius Medical Care in the regions Europe, Middle East and Africa (EMEA)

Thousand


5.4 Medical outcomes

Kt/V

This parameter takes into account the patient’s body

size and dialysis time. Urea is used as a “marker” to

provide information on whether or not a patient was

detoxified effectively during dialysis. And almost all of

our patients perform dialysis treatment at least three

times per week.

Haemoglobin

Insufficient haemoglobin is an indication of anaemia,

which is typical in patients with chronic kidney failure.

Parallel to dialysis, anaemia is treated with iron supple-

ments and the hormone compound erythropoietin

(EPO).

Autogenous arteriovenous fistulae

Vascular access makes chronic haemodialysis possi-

ble. The three main types of vascular access are:

autogenous arteriovenous fistulae, arteriovenous

grafts and central venous catheters. We monitor the

number of patients with autogenous arteriovenous

fistulae and arteriovenous grafts as it is the method

least likely to become infected or clotted, resulting in

fewer hospitalisations.

Quality indicators − monitored by the NephroCare Balanced ScoreCard

The high level of internal transparency that EuCliD5

provides is a valuable tool for continual improvement of

the treatment we provide. Measurable improvements

in distinct quality indicators – monitored by the

NephroCare Balanced ScoreCard – demonstrate the

effectiveness of these efforts as we continue to search

for ways to improve patient outcomes and quality of

medical treatment.

Key performance indicators (KPI)

Data for the last respective quarter, in %

2010

2011

% 100

90

80

70

60

50

40

30

20

10

0

(Data refer to haemodialysis patients monitored by EuCliD)

Patients

reached

KP

I

Kt/V > 1.2 Hgb ≥ 10 ≤ 13 g/dL Patients without catheter

32

Quality of life

The patients’ perception of their lives and their sense

of well-being is becoming increasingly accepted as a

key indicator of quality in patient care – beyond clinical

indicators alone.

This applies to the treatment of patients with chronic

kidney disease (CKD) or for any other chronic illness.

Assessing quality of life is a complex, multifactorial

process, but it can reveal a great deal about patients’

own needs and priorities in treatment as well as high-

lighting clinical parameters that may be important for

improving quality of life.

Additionally, it is shown that the same five quality indi-

cators which have been strongly associated with

reduction in hospitalisation time and mortality were

also important predictors of the patients’ quality of life

– both in physical and mental domains.9

Quality indicators are for example:

• albumin ≥ 4.0 g/dL

• equilibrated Kt/V ≥ 1.2

• phosphorus of 3.5 – 5.5 mg/L

• absence of HD catheter

Progressive achievement of these quality indicator

goals was associated with incremental gains in quality

of life. The strongest predictors of improved quality of

life is serum albumin and the avoidance of catheter

use.

Our own surveys, e.g. the Patient Satisfaction Survey,

also provide valuable insights into patients’ perceived

needs. Patient responses indicate the importance of

being treated as an individual, and of comprehensive

as well as understandable information regarding their

condition and treatment. In other words, empower-

ment is important for quality of life.

Vascular access

Published studies show that achievement of clinical

goals, especially avoiding the need for catheterisation

by maintaining natural vascular access, were predic-

tive of improvements in quality of life. Avoidance of

catheterisation also enables significantly lower infection

rates and risk of hospitalisation.

A very large cohort study10 in the USA in 2007, includ-

ing 79,545 patients, clearly showed that the risk of

hospitalisation was substantially and significantly

greater for patients with catheter vascular access

versus patients with fistula access (p < 0.001).

Furthermore, the risk of vascular access-related issues

and sepsis or bacteraemia were also greatest using

catheter access.

Clearly, this indicates a need for attention, especially con-

sidering the apparently increasing use of catheterisation.


1 Fresenius Medical Care internal estimate for 2011.

2 Stopper A, Amato C, Gioberge S, Giordana G,

Marcelli D, Gatti E: Managing Complexity at

Dialysis Service Centers across Europe, Blood

Purif 2007; 25: 77–89.

3 De Jager D. et al., JAMA (2009); 302:

1782–1789.

4 Panichi P. et al., Nephrol Dial Transplant (2008);

23: 2337–2343.

5 Pedrini L. et al., Nephrol Dial Transplant,

advanced access published Jan 18, 2011.

6 Bonforte G. et al., EDTA, Vienna (2001).

7 Kasiske BL et al., A Simple Tool to Predict

Outcomes After Kidney Transplant, American

Journal of Kidney Diseases; Vol 56, No 5

(November), 2010: 947–960.

8 Canaud B. et al., Kidney Int (2006); 69:

2087–2093.

9 Lacson E et al., Association Between Achieve-

ment of Hemodialysis Quality-of-Care Indicators

and Quality-of-Life Scores; Am J Kidney Dis, 54:

1098–1107.

10 Lacson E et al., Change in Vascular Access and

Hospitalization Risk in Long-Term Hemodialysis

Patients; Clin J Am Soc Nephrol, 5, 2010.

References

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Head office: Fresenius Medical Care Deutschland GmbH · 61346 Bad Homburg · Germany Phone: +49 (0) 6172-609-0 · Fax: +49 (0) 6172-609-2191

www.fmc-ag.com

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Quality you can count on - nephrocare.cz · Quality you can count on NephroCare – Quality Report 2011 Dr. Nóra Pálvölgyi, Medical Director, Sopron, Hungary. 2 Thank you We would