AbstractA large global dialysis provider’s core activities include
providing dialysis care with excellent quality, ensuring a
low variability across the clinic network and ensuring
strong focus on patient safety. In this article, we summarize
the pertinent components of the quality assurance and
safety program of the Diaverum Renal Services Group.
Concerning medical performance, the key components of
a successful quality program are setting treatment targets;
implementing evidence- based guidelines and clinical
protocols; consistently, regularly, prospectively and accu-
rately collecting data from all clinics in the network; pro-
cessing collected data to provide feedback to clinics in a
timely manner, incorporating information on interclinic
and intercountry variations; and revising targets, guide-
lines and clinical protocols based on sound scientific data.
The key activities for ensuring patient safety include a
standardized approach to education, i.e. a uniform educa-
tion program including control of theoretical knowledge
and clinical competencies; implementation of clinical pol-
icies and procedures in the organization in order to reduce
variability and potential defects in clinic practice; and
auditing of clinical practice on a regular basis. By applying
a standardized and systematic continuous quality
improvement approach throughout the entire organiza-
tion, it has been possible for Diaverum to progressively
improve medical performance and ensure patient safety.
Copyright © 2011 S. Karger AG, Basel
The Challenge – Cost and Quality
Healthcare systems in all Western countries are
confronted with multiple challenges related to
a growing elderly population and the dilemma
of economic constraints [1, 2]. The number of
patients with end- stage renal disease requiring
renal replacement therapy continues to grow
worldwide [3– 5]. The cost of providing dialysis
is immense and poses a significant burden to
countries worldwide [4, 6– 7], placing demands
on dialysis providers to reduce costs for dialysis
delivery while at the same time improving the
quality of care and ensuring patient safety.
Quality Assurance in Hemodialysis Care
Quality assurance in dialysis has been a matter
of importance for many years. The release of the
National Kidney Foundation Dialysis Outcomes
Quality Initiative (DOQI) guidelines in 1997
drew considerable attention to the topic and was
followed by the development of guidelines by
several organizations. In recent years, the work
New Perspective in Hemodialysis
Ronco C, Rosner MH (eds): Hemodialysis: New Methods and Future Technology.
Contrib Nephrol. Basel, Karger, 2011, vol 171, pp 39–49
The Quest to Standardize Hemodialysis Care
Jörgen Hegbranta � Giorgio Gentileb,c �
Giovanni F.M. Strippolia
aMedical- Scientific Office, Diaverum Renal Services Group, Lund, Sweden; bDepartment of Internal Medicine,
University of Perugia, Perugia, and cDiaverum Italy Medical Office, Bari, Italy
40 Hegbrant · Gentile · Strippoli
of promoting coordination, collaboration and
integration of initiatives to develop and imple-
ment clinical practice guidelines has been under-
taken by the Kidney Disease: Improving Global
Outcomes (KDIGO) foundation.
It is important to emphasize that the imple-
mentation of guidelines in dialysis does not nec-
essarily improve the quality of the care delivered
for multiple reasons. This includes the uncertain
data on which several guidelines statements rely,
which is primarily due to the paucity of existing
evidence in several areas of treatment in neph-
rology, dialysis and transplantation. The imple-
mentation of treatment guidelines is therefore
best performed as a part of a quality management
system which effectively monitors that the pre-
scription of the dialysis care and interventions
are truly delivered. Furthermore, it should iden-
tify barriers in delivering care and interventions,
and initiate actions to address them rapidly and
consistently – in summary, a standardized pro-
cess. The next key step in a continuous quality
improvement circle is represented by activities
which include providing feedback and imple-
menting action plans via medical initiatives and
appropriate educational programs and tools.
Finally, treatment targets, guidelines and clinical
protocols need to be revised continuously based
on sound scientific data.
In a single dialysis facility, a large volume of
medical information and technical data from
dialysis equipment can be gathered from the
treatment of a limited number of patients, and
local actions may be implemented to improve
care based upon these data. For an international
dialysis provider, such as the Diaverum Renal
Services Group, a delicate matter is how to col-
lect information from numerous patients treated
(approximately 18,000 in 2010) in the network
of dialysis units located in countries around the
globe, how to process this information and how
to provide feedback to each individual unit in the
network in an appropriate manner. This activity,
nonetheless, carries the potential for improve-
ments of patient care through epidemiological
analyses and population- based interventions on
the global population level.
There are several reasons why gathering data is
important for a global dialysis provider. First and
foremost, it ensures awareness of patients’ treat-
ment quality and safety. In addition, it is related to
fulfillment of local, national and international reg-
ulations and recommendations. In general, moni-
toring of medical information improves quality
per se, and improving dialysis care will improve
patient outcomes (quality of life, hospitaliza-
tion, mortality). In today’s world, optimal medi-
cal care is a key component of the strategy and a
prerequisite for any healthcare service. As such,
it is becoming increasingly important to demon-
strate excellence in care to the various different
stakeholders, which include patients and family
members who are becoming well informed, refer-
ring nephrologists who want to see ‘their’ patient
receive a good treatment, and healthcare payers
and authorities who want a good return on the
money spent and, thus, the best value for money
in terms of medical outcomes.
The Impact of Variability in Outcomes of
Hemodialysis Delivery
It is well- known that delivering dialysis is a
complex process comprising more than 150
activities, all of which need to be performed in a
timely manner to safely deliver one single dialy-
sis treatment [8]. The dialysis process is influ-
enced by a combination of many factors, which
include the clinic structure and physical layout,
the design of the dialysis monitor and the dis-
posables, the dialysis prescription, the clinic’s
policies and procedures, and patient characteris-
tics. This complexity has been shown to result in
variability of the dialysis delivery, such as treat-
ment quality and efficiency [8, 9]. As dialysis
has evolved as a technique individually adapted
to almost each unique patient rather than an
industrialized process, the variation in the pro-
cess is perhaps not surprising [9]. Intrapatient
variation in dialysis dose as measured by the
intrapatient Kt/V standard deviation has been
used as a measure of the consistency of deliver-
ing the same dose of dialysis to the same patient
Standardization of Dialysis 41
over a defined period of time, and as such is a
metric for dialysis process control. Variability in
the dialysis Kt/V delivery is likely to influence
the process outcomes, as will the variability in
virtually any performance indicator measured in
a dialysis facility.
Managing Quality and Patient Safety –
The Diaverum Experience
For a large global dialysis provider such as
Diaverum, the core activities include provid-
ing dialysis care with optimal quality, ensuring
a low variability across the clinic network and
ensuring strong focus on patient safety. In addi-
tion, Diaverum strives to develop and implement
up- to- date scientific evidence on the benefits
and harm of dialysis- related interventions, and
identify novel risk factors for adverse outcomes
in people with renal diseases or at risk for renal
diseases. In this article, we highlight some of the
pertinent components of our quality assurance
and safety program.
Medical Performance
A continuous improvement of clinical perfor-
mance represents the top priority for the medical
professionals at Diaverum. The aim is to ensure
that each patient is treated in accordance with
the most up- to- date evidence- based standards
of care. On one hand, this means attempts to
improve patient survival through the adoption
of appropriate treatment modalities, prescrip-
tion of adequate dialysis treatment times, usage
of high- flux dialyzers (>90% of the total in most
countries), etc. On the other hand, it involves
emphasis on the improvement of quality of life,
taking into account multiple and often neglected
variables that have a profound impact on the
quality of a patient’s life, such as depression, sex-
ual dysfunction, awareness of the patient’s socio-
economic status and well- being, as well as other
conditions which often remain unrecognized and
unaddressed [10].
In order to facilitate the difficult process of
monitoring and improving patient outcomes,
Diaverum has standardized a monitoring sys-
tem, consisting of repeated, consistent and inde-
pendent measurement of clinical performances,
through a clinical performance measures (CPM)
score. CPM scores allow monitoring the clinical
performance of each clinic and each geographic
area (regions, countries, continents) in a constant
and reproducible manner. CPM scores are calcu-
lated monthly, consolidated quarterly and used
to identify critical areas where improvement may
be needed. The CPM score takes into account
eleven quality indicators, for which Diaverum,
based upon internationally accepted standards,
selects a target. More specifically, these are: (1)
single- pool Kt/V (spKt/V; target value ≥1.4), (2)
albumin (≥35 g/l), (3) normalized protein cata-
bolic rate (nPCR; ≥1 g/kg/day), (4) hemoglobin
(≥10 and ≤12 g/dl), (5) ferritin (≥200 and ≤500
μg/l), (6) phosphorus (≥2.5 and ≤5.5 mg/dl), (7)
calcium- phosphorus product (<55 mg2/dl2), (8)
intact parathyroid hormone (iPTH; ≥150 and
≤600 pg/ml), (9) predialysis mean arterial blood
pressure (<105 mm Hg), (10) interdialytic body
weight gain (<4% of dry weight) and (11) preva-
lence of arteriovenous fistulas (AVF).
The overall CPM score is not based on the
simple achievement of mean values of each of
these parameters within an acceptable range
in each clinic (e.g. a mean Kt/V of ≥1.4 in each
clinic), but instead take into account the percent-
age of patients that fulfill the predefined target
for each of the eleven quality indicators and for
each month of the quarter (table 1). The consoli-
dated percentages of patients achieving the tar-
get for each quality indicator are then added to
obtain the CPM score for that quarter. Since the
adoption of this standardized performance mea-
surement metric at Diaverum, there has been a
gradual improvement in the performance scores
(fig. 1). Moreover, quarterly follow- up shows
an impressive increase in CPM scores after a
newly acquired clinic has been integrated into
Diaverum. It has been shown that the longer
a clinic has been with Diaverum, the better the
medical performance (fig. 2).
42 Hegbrant · Gentile · Strippoli
Some of the quality indicators of the CPM
score deserve specific comments. For example,
it is generally recognized that the delivery of
an ‘adequate’ dialysis dose is associated with
improved survival [11– 15]. In light of available
evidence, the optimal dialysis dose has not been
well defined, but minimum targets of delivered
dose measured by Kt/V have been established.
Many guidelines recommend a minimum equili-
brated Kt/V (eKt/V) of 1.2 in a thrice weekly
hemodialysis schedule. For practical reasons, we
use spKt/V as indicator of dialysis adequacy in all
Diaverum clinics. eKt/V is a highly linear func-
tion of spKt/V (for values between 1.3 and 1.7)
when time is held constant. The required spKt/V
to achieve an ‘adequate’ eKt/V (≥1.2) can range
from 1.35 (for a dialysis time of 4.5 h) to 1.38 (for
a dialysis time of 4 h), up to 1.58 (for a dialysis
time of 2 h) [16]. Because the large majority of our
patients receive at least 4 h of dialysis, we assume
that a spKt/V target of ≥1.4 is sufficient to reach
an eKt/V ≥1.2. Finally, the overall Kt/V standard
deviation is centrally monitored to ensure the
consistency of delivering the same dose of dialy-
sis over time. Figure 3 shows the percentage of
Diaverum patients meeting the Kt/V target ≥1.4,
which has almost doubled over 10 years.
Likewise, hemoglobin represents a quality
indicator of paramount importance. In Diaverum,
the upper boundary for the hemoglobin range
was lowered to 12 g/dl in 2007, in light of the
growing body of evidence, derived from ran-
domized trials and systematic reviews, indicat-
ing that higher hemoglobin values are associated
with an increase in the risk of all- cause mortality,
stroke, hypertension and vascular access throm-
bosis [17, 18].
With respect to the iPTH target range, it was
recently broadened from the ‘classic’ 150– 300 pg/
ml suggested by KDOQI [19], with Diaverum
Table 1. An example of how the CPM score is calculated for a single quarter
Quality indicator January February March Quarter 1
Kt/V ≥1.4 91.4 92.8 90.5 91.6
Albumin ≥35 g/l 93.6 91.7 93.0 92.7
nPCR ≥1 g/kg/day 72.4 71.3 70.0 71.2
Hemoglobin ≥10 and ≤12 g/dl 63.7 64.5 62.9 63.7
Ferritin ≥200 and ≤500 μg/l 65.8 72.2 67.2 66.9
Phosphorus ≥2.5 and ≤5.5 mg/dl 77.7 78.1 78.6 78.1
Ca × P <55 mg2/dl2 90.5 90.4 91.5 90.8
iPTH ≥150 and ≤600 pg/ml 70.8 71.6 71.4 71.1
Predialysis MAP <105 mm Hg 83.1 84.5 82.2 83.3
IDBWG <4% of dry weight 68.2 70.2 74.2 70.9
AV fistula prevalence 70.2 71.0 70.9 70.7
CPM score 847.4 858.3 852.4 851.0
Data may relate to a clinic, a region, a country or the entire organization. Values relating to the quality indicators
represent percentages. Ca × P = Calcium- phosphorus product; MAP = mean arterial blood pressure; IDBWG = interdia-
lytic body weight gain; AV = arteriovenous.
Standardization of Dialysis 43
6602003 2004 2005 2006 2007 2008 2009 2010
680
700
720
740
760
780
800CPM scores
Q1
Q2
Q3
Q4
Fig. 1. Progressive improvement in CPM scores at Diaverum, 2003– 2010.
660
680
700
720
740
760
780
800
820
840
860CPM scores
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16Quarter
17 18 19 20 21 22 23 24 25 26 27 28 29 30
Fig. 2. Quarterly follow- up after a new clinic has been integrated into Diaverum shows an impressive increase in CPM
scores.
30
40
50
60
70
80
90
%
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Fig. 3. Gradual improvement in percentage of patients meeting the dialysis adequacy target of
Kt/V ≥1.4 at Diaverum, 2000– 2010.
44 Hegbrant · Gentile · Strippoli
targeting 150– 600 pg/ml. The underlying ratio-
nale is the lack of sound evidence to support
that iPTH values between 300 and 600 pg/ml
are associated with an increased risk of all- cause
death. Such an association was only demon-
strated by observational studies, which often
improperly adjusted for key confounders; the evi-
dentiary basis to confirm key recommendations
by guideline bodies is at best scant. Analyses of
existing evidence have now been published by
international research groups [20], and are being
adopted in our strategy.
Another critical area is represented by the
vascular access [21]. The NKF- KDOQI [22]
and the European Best Practice Guidelines [23]
both stress the superiority of a vascular access
with native vessels and indicate the autogenous
radial- cephalic direct wrist AVF as the gold stan-
dard. A recent publication using observational
data from the Dialysis Outcomes and Practice
Patterns Study (DOPPS) highlighted that the
relative risk of death was increased with a graft
(15%) and a catheter (32%), as compared with an
AVF. Moreover, morbidity was also lower with an
AVF [21].
It is important to acknowledge that not every
hemodialysis patient is suitable for creation of an
AVF. In fact, apart from the diameter of vessels,
diabetes, obesity, vascular disease and age predict
the outcome of AVF. However, there are modifi-
able factors which can be addressed. For exam-
ple, the stated preference of the medical director
and the nurse managing a dialysis unit is strongly
associated with the likelihood of fistula use, i.e.
if the staff wants fistulas, more fistulas are gen-
erally attained. On the contrary, if the staff in a
unit accepts a broader use of vascular catheters,
less AVF are created. It is therefore considered
extremely important that dialysis clinicians insist
on fistula prioritization and try to intervene to
avoid routine placement of catheters or grafts;
for this reason we have included prevalence of
AVF as one of the key indicators of clinical per-
formance. When a direct control of the vascular
access process is not available, it is important to
develop a close relationship with hospitals and
surgeons to push for fistulas and to make sure
access placement is performed by well- trained
professionals. The training of the vascular access
surgeons is very important. The risk of primary
fistula failure was 34% lower when AVFs were
placed by surgeons who had created at least 25
fistulas during training [21].
Finally, the interdialytic body weight gain
of our patients is strictly monitored as subjects
with large interdialytic body weight gain are
often dialyzed with higher ultrafiltration rates
(UFRs) to minimize the risk of volume overload.
Unfortunately, greater UFRs are also associated
with greater mortality, as underscored by a recent
publication of data from the Hemodialysis Study
(HEMO) study, wherein a UFR of >13 ml/h/
kg (i.e. 900 ml/h in a 70 kg patient) was associ-
ated with a risk of increased all- cause mortality
(adjusted hazard ratio: 1.59) and cardiovascular
mortality (adjusted hazard ratio: 1.71), as com-
pared with an UFR of <10 ml/h/kg [24].
In summary, while individual indicators of
clinical performance may be based on more or less
solid evidence, accounting for an overall estimate
of key clinical performance measures appears to
be a more valuable indicator of the general status
of well- being of each patient, and can drive gen-
eral interventions towards improvement.
Transplantation, Blood- Borne Viruses and
Influenza Vaccination – Epidemiology and
Quality Management Factors in Hemodialysis
Practice
As part of the patient’s care plan, every Diaverum
patient is evaluated for suitability for receiving a
kidney transplant, which is always documented
in the patient’s medical records. Transplantation
rates are reported on a quarterly basis. Data on
the prevalence of hepatitis B, hepatitis C and HIV
are collected in all Diaverum clinics and reported
to the corporate medical office on December
31 of each year. The importance of vaccination
against seasonal influenza is emphasized within
the clinic network and the percentage of patients
receiving vaccination is collected on a yearly
basis.
Standardization of Dialysis 45
Quality Management Review Meeting and Audit
of Clinical Practice – Organizational Activities to
Prevent Incidents and Ensure Quality of Care
Monitoring
The quarterly quality management review (QMR)
meeting and the audit of clinical practice (both
of which are standard practice at Diaverum) are
helpful tools in reaching the goal of monitor-
ing and improving patients’ quality of care and
safety. QMR meetings are held at least quarterly
or immediately after any significant incident,
based upon Diaverum policies. The purposes of
the QMR meeting are (1) to objectively, system-
atically and comprehensively monitor and evalu-
ate the quality system in each Diaverum clinic;
(2) to identify improvement areas and develop
action plans for quality improvements; and (3) to
establish a standardized reporting process at the
country and international level. At a minimum,
each QMR meeting must include (1) a follow- up
from previous meetings to include any correc-
tive, preventive or other improvement actions;
(2) audit findings (both internal and external);
(3) audit of patients’ records (random- based,
minimum once a year); (4) analysis of patients
and customer complaints (patients, hospitals,
contractors and other stakeholders); (5) medical
performance outcomes analysis (i.e. percentage
of patients not meeting the quality indicators of
the CPM score or other clinically relevant quality
indicators, such as blood flow rate); (6) incident
reports; and (7) analysis of results of chemical
and microbiological water tests as well as review
of the water treatment monitoring log and the
water treatment disinfection log. A dedicated
form is used to conduct these meetings; noncon-
formities lead to the formulation of action plans,
the results of which are evaluated in the subse-
quent QMR meeting.
In order to reduce variability and potential
flaws of clinical practice, appropriate implemen-
tation of Diaverum clinical policies and proce-
dures in the organization is periodically verified
through the auditing of clinical practice. All
Diaverum clinics are audited a minimum of once
a year using a comprehensive electronic form
where 27 different sections of the dialysis treat-
ment are thoroughly assessed. The different sec-
tions include hand hygiene, set up and priming,
patient assessment, prescription, medication and
anticoagulation, arteriovenous access needling,
central venous catheter care, connection pro-
cess, blood flow optimization, documentation
and monitoring, rinse back, postdialysis care,
management of hepatitis B and C, emergency
equipment/preparedness, water treatment, etc.
When all sections are completed, a final audit
score is automatically generated. A feedback
report of the audit findings is provided to each
clinic following completion of the audit process.
Where deficiencies in clinical practice are high-
lighted, the head nurse/clinic manager and the
clinic medical director, together with the country
clinical specialist, who is responsible for the audit
process, agree on a plan which includes actions
to be taken to correct the deficiencies, the date
by which the actions should be completed and
the person(s) responsible. Immediate corrective
actions are initiated when a serious risk to patient
safety is identified. The results of each audit of
the clinical practice are then reviewed as part of
the QMR meeting. All audit data are consolidated
and assessed on a quarterly basis.
Hospitalization, Mortality and Incident Reporting
– Preventing and Monitoring Adverse Outcomes
of the Dialysis Treatment
Another critical part of the monitoring of medi-
cal and clinical activities at Diaverum is the
regular recording of hospitalizations, deaths
and incidents in a dedicated software program
(International Renal Information Management
System). Data are centrally collected and ana-
lyzed on a regular basis for the timely detection of
deviations from the expected rates. Death causes
are classified as cardiac, vascular, infection, liver
disease, gastro- intestinal, metabolic, endocrine,
other and unknown cause. Hospitalizations are
classified as cardio-/cerebrovascular, gastroin-
testinal, infection/sepsis, vascular access, other
known cause and unknown cause.
46 Hegbrant · Gentile · Strippoli
An incident is defined as a non- wished and
non- planned event of significance, which occurs
in a clinic. Incidents are classified into four cat-
egories: A (patient incidents), B (staff and visitor
incidents), C (product incidents) and D (facility/
equipment/external service incidents). Any inci-
dent must be reported within 24 h. The following
types of incidents must be reported immediately:
(1) deaths due to an event in the facility involving
a patient, staff or visitor; (2) deaths at a hospi-
tal subsequent to an event in the facility; (3) any
serious injury that may be linked to a medical
product or equipment; (4) any significant adverse
medication reaction or medication error; (5) any
incident involving multiple patients or employ-
ees, regardless of the outcome; and (6) other
serious incidents as appropriate. All incidents
are reviewed at the quarterly QMR meeting and
consolidated centrally in each country to allow
a regular and systematic review of the incidents
including trend analysis; the identification and
prioritization of operational, environmental and
product processes; and the development and
implementation of action plans that address the
necessary changes for process improvement. A
consolidation of incidents is performed at a cor-
porate level on a quarterly basis.
The Competence in Practice Program –
Educational Initiatives to Improve Patient Care
At Diaverum, we have developed an education
program specifically designed for the staff in
our clinics. The program, entitled Competence
in Practice, has been endorsed by the European
Dialysis and Transplant Nurses Association/
European Renal Care Association. The
Competence in Practice program is arranged in
sections, and our staff complete various com-
ponents based on their role within the clinic.
An Orientation Program is designed to foster a
safe working environment and promote patient
safety. It includes two modules: (1) promoting a
culture of safety, and (2) infection prevention and
control. This program is mandatory for all staff
in the dialysis network and must be completed
by new employees within the first 6 weeks of
starting work in each clinic. A Basic Dialysis
Program ensures delivery of education addressed
to fulfillment of standards for highly trained and
competent practitioners, and is mandatory for all
dialysis practitioners working within the network.
A head nurse/clinic manager is responsible for
ensuring that all new staff complete the required
Competence in Practice programs, which is
facilitated by a clinic mentor. All clinic mentors
complete the first two parts of the Competence in
Practice program, but also a Clinical Mentorship
Program. The latter program is intended to pro-
vide preparation for the clinic mentors to support
learning in the practice setting.
All programs are regularly reviewed and
revised, and updated educational materials
are released and disseminated to all clinics. To
ensure safety is an ongoing activity, mandatory
education and training sessions are provided,
including care in emergency situations, data
protection, fire safety, chemical handling, ergo-
nomics, and infection prevention and control.
Continuing education and training is provided
via several methods, including presentations by
country medical directors, country clinical spe-
cialists, clinic medical directors, etc., on various
topics; orientation and instructions concerning
new equipment, hands- on learning experiences,
external study days and seminars, college and
university courses, reflective learning, case stud-
ies, and projects administered via e- learning.
Water Treatment Standards – Ensuring High
Quality Water for Hemodialysis Treatments
On average, hemodialysis patients are dialyzed
three times per week for 4 h, and the dialyzer
membrane is the only barrier between the blood
and the dialysis fluid. Each patient is exposed
to at least 360 liters of water per week, i.e. more
than 25 times the amount of water a person nor-
mally ingests. Therefore, patients on hemodi-
alysis treatment are exposed to water volumes of
more than 18,000 liters per year, and even more
when on- line hemofiltration/hemodiafiltration is
Standardization of Dialysis 47
performed. If the water used in the dialysis pro-
cess contains microorganisms or physicochemi-
cal contaminants, the patient’s well- being and
safety is put at a very high risk.
In order to obtain the necessary levels of qual-
ity and purity of water for hemodialysis, water
provided by a municipal or public supply sys-
tem must be treated to meet local, national and
international standards. The Association for
the Advancement of Medical Instrumentation
(AAMI) as well as other organizations and
authorities periodically release chemical and
bacteriological standards and recommended
practices for hemodialysis, and provide data on
maximum allowable levels of contaminants [25].
Water quality is of paramount importance to
ensure patient safety in Diaverum. For this rea-
son, we have recently adopted the International
Organization for Standardization standard
13959:2009 (Water for haemodialysis and
related therapies) [26] in our strategy for ensur-
ing a high quality of water for hemodialysis. As
compared with the present AAMI standards,
microbiological requirements relating to levels
of colony- forming units and endotoxin content
are considerably lower in the new ISO standard.
Furthermore, more sensitive culture media
and cultivation conditions are recommended.
Fulfillment of the ISO 13959:2009 standard
requires a more frequent disinfection practice in
order to keep microbiology counts below limits
(at least 3 times per week) than is the current
practice in some countries. For the future, it
will be increasingly important to move to mod-
ern water treatment systems with (1) less man-
ual labor intervention; (2) better water- saving
capacities; (3) good environmental quality; and
(4) lower risk for patient accidents. At Diaverum,
all new water treatment installations consist of
a highly automated and user- friendly reverse
osmosis unit with heat disinfection capabili-
ties of the distribution loop and integrated heat
disinfection of the dialysis monitors. Frequent
heat disinfection of the distribution loop is the
preferable disinfection method to prevent for-
mation of biofilm [27]. Water samples are col-
lected on a regular basis at all Diaverum clinics
and analyzed to determine whether they meet
the criteria for acceptability. If a sample fails to
fulfill the requirements, appropriate actions are
immediately taken and reported.
Patient Satisfaction – Monitoring What Patients
Think
Patient satisfaction with their care is monitored
through direct patient input at Diaverum. All
Diaverum patients are given the opportunity to
complete an internal patient survey annually.
The survey is returned to the head nurses anony-
mously. Survey results are reviewed at the QMR
meeting at each clinic and a corrective action
plan for improvement is developed and imple-
mented as appropriate. The patients’ feedback
is of great importance to identify opportunities
for improvement in the care we provide. For this
reason, we also analyze data of the administered
validated questionnaires and develop epidemio-
logical analyses relating to correlates of patient
satisfaction/dissatisfaction at the corporate level.
When factors which correlate to patient satisfac-
tion/dissatisfaction are identified, we use this
information to develop appropriate actions. We
correlate the level of satisfaction/dissatisfaction
with demographics as well as the biochemical
and clinical covariates of the patients.
Conclusions
Patient safety and excellence in medical quality
is the highest priority for Diaverum. Concerning
medical performance, the key components of a
successful quality program are:
• Setting treatment targets.
• Implementing evidence- based guidelines and
clinical protocols.
• Consistently, regularly, prospectively and
accurately collecting data from the clinics.
• Processing the collected data to provide
feedback to the clinics and countries in a
timely manner, and incorporate information
on interclinic and intercountry variation.
48 Hegbrant · Gentile · Strippoli
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• Revising targets, guidelines and clinical
protocols based on sound scientifi c data.
Key activities to ensure patient safety include:
• A standardized approach to education, i.e.
introduction of a uniform education program
including control of theoretical knowledge
and clinical competencies.
• Implementation of clinical policies and
procedures in the organization in order to
reduce variability and potential defects in
clinic practice. Th e Diaverum clinical policies
are identical in all countries, but the adherent
procedures may be country- specifi c to comply
with local regulations and requirements.
• Auditing of clinical practice on a regular
basis.
As we have described in this chapter, it has
been possible for a global dialysis provider such as
Diaverum to improve medical performance and
ensure patient safety by applying a standardized
and systematic continuous quality improvement
approach throughout the entire organization.
Standardization of Dialysis 49
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key to improved access outcomes. Am
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K, Basci A, Fouque D, Kooman J,
Martin- Malo A, Pedrini L, Pizzarelli
F, Tattersall J, Vennegoor M, Wanner
C, ter Wee P, Vanholder R: EBPG
on vascular access. Nephrol Dial
Transplant 2007;22 Suppl 2:ii88–
ii117.
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Rapid fluid removal during dialysis is
associated with cardiovascular mor-
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79:250– 257.
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26 International Organization for
Standardization: Water for hemo-
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13959:2009. http://www.iso.org/.
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tion/disinfection/sterilization; in Horl
WH, Koch KM, Lindsay RM, Ronco
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of Renal Function by Dialysis.
Dordrecht, Kluwer Academic
Publishers, 2004, pp 380– 381.
Jörgen Hegbrant, MD, PhD
Chief Medical Officer
Diaverum Renal Services Group
PO Box 4167
SE– 227 22 Lund (Sweden)
Tel. +46 46 287 30 44, E- Mail [email protected]
