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Knowing What We Do and Doing What We Should: Quality Assurance in

Hemodialysis

Article  in  Nephron Clinical Practice · April 2014

DOI: 10.1159/000361050 · Source: PubMed

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 Original Paper

Nephron Clin Pract 2014;126:135–143 Received: August 7, 2013

Accepted: February 24, 2014
DOI: 10.1159/000361050
Published online: April 15, 2014

© Free Author
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Should: Quality Assurance in Hemodialysis
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Jörgen B.A. Hegbrant b Georges Martin e Christopher W. McIntyreAG, jBASEL J. O’Donoghue k
IS A VIOLATION
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a against payment
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d fee, which is based
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© Free Author Copy – for personal use only

Key Words
Hemodialysis · Quality assurance · Clinical performance
measures · Clinical information technology · On-line data
ANY DISTRIBUTION OF THIS ARTICLE WITHOUT WRITTEN CONSENT FROM S. KARGER AG, BASEL IS
Written permission to distribute the PDF will be granted against payment of a permission fee, whic
processes and quality measures supporting quality assur-
ance that have been agreed across the expert panel. It also
notes areas where more understanding is required.
© 2014 S. Karger AG, Basel

Abstract
An international group of around 50 nephrologists and sci-
entists, including representatives from large dialysis provid-
er organisations, formulated recommendations on how to
develop and implement quality assurance measures to im-
prove individual hemodialysis patient care, population
health and cost effectiveness. Discussed were methods
thought to be of highest priority, those clinical indicators
which might be most related to meaningful patient out-
comes, tools to control treatment delivery and the role of
facilitating computerized expert systems. Emphasis was giv-
en to the use of new technologies such as measurement of
online dialysance and ways of assessing fluid status. The cur-
rent evidence linking achievement of quality criteria with pa-
tient outcomes was reviewed. This paper summarizes useful
Introduction
‘In physical science the first essential step in the
direction of learning any subject is to find principles of
numerical reckoning and practicable methods for
measuring some quality connected with it.’
Lord Kelvin, Popular Lectures and Addresses, vol. 1:
‘Electrical Units of Measurement’, May 3, 1883
End-stage renal disease (ESRD) requiring hemodialysis,
along with its associated and growing healthcare costs, rep-
resents a major healthcare challenge [1, 2]. A significant
concern is to improve quality of care while simultaneously
containing costs, promote patient safety and better quality
of life (QoL) [3, 4]. Quality of care can be defined as ‘the
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© 2014 S. Karger AG, Basel Maria Alquist, MD

1660–2110/14/1263–0135$39.50/0 Medical and Safety Office
Gambro AB
E-Mail karger@karger.com
PO Box 10101, SE–220 10 Lund (Sweden)
www.karger.com/nec
E-Mail maria.alquist @ gambro.com
degree to which health services for individuals and popula-
tions increase the likelihood of desired health outcomes’
[5]. Poor-quality hemodialysis care, as defined by failure to
adhere to established targets for clinical indicators such as
minimum delivered dialysis dose (Kt/V urea) or dialysis
time or to implement processes for optimizing fluid man-
agement, has been associated with increased morbidity,
hospitalization, mortality and cost of care [6–10].
A quality assurance (QA) process in hemodialysis pro-
vides an opportunity to optimize dialysis-related medical
practice and services, to the benefit of patients, healthcare
professionals, dialysis providers and healthcare payers [3,
4]. QA processes are complex, as they involve assessment
of an array of clinical indicators, and the setting of targets
that cover many aspects of control of uremia. Achievement
of such targets must then be monitored on a regular basis
and the targets need to be periodically revalidated to ensure
that they relate to meaningful clinical outcomes [11].
This report provides an overview of clinical indicators
that can be used to set and achieve quality targets in he-
modialysis care. It includes a series of proposals and tools
that were compiled by an expert group of dialysis practi-
tioners and scientists assembled for this purpose.
Methods
During a two-day symposium, an international expert group of
nephrologists, including representatives from large dialysis pro-
viders, and scientist involved in dialysis care, met to debate hemo-
dialysis care QA. Considering current experience, evidence and
practices, the expert group worked to develop consensus proposals
for desired components of QA. Emphasis was placed on clinical
indicators where implementing and monitoring related quality
measures would be expected to impact patient outcomes. A variety
of tools to help control and monitor hemodialysis treatments, in-
cluding data capturing and sharing, were discussed. Also consid-
ered were present-day gaps in our knowledge, and areas where
future research was clearly needed. The consensus proposals were
peer-reviewed by the expert panel. The process was not designed
to follow a formal guideline development protocol, nor was the
goal to produce some sort of definitive scoring systems against
which to judge or compare hemodialysis services; rather, the aim
was to point to those quality measurement approaches which were
thought to be of highest priority and which would be likely to lead
to improved patient outcomes.
Quality Assurance Components in Hemodialysis
Clinical Performance Measures (CPMs)
Clinical performance measurement includes the eval-
uation of the process by which healthcare is delivered and
136 Nephron Clin Pract 2014;126:135–143
DOI: 10.1159/000361050
the outcomes that patients experience. Clinical perfor-
mance measurement might focus on how a particular
chronic disease is managed, how patients fare as a result
of interventions to treat that disease, and/or what the
costs are of the services that were provided [12, 13]. CPMs
are increasingly used to rank hospitals, dialysis clinics and
treatment provider networks and may be used to bring
centers and physicians to account for discrepancies in
clinical outcomes relative to national or international
norms [14–16]. The best CPMs are simple to measure,
not prone to misinterpretation, and are modifiable to en-
hance their utility. A CPM should be related to the treat-
ment and associated with one or more ‘hard’ outcomes
such as morbidity, hospitalization, and survival. Mean-
ingful outcomes also include patient well-being and QoL,
costs of care, and staff satisfaction. The measures should
be validated and the gaps in care following not reaching
target should demonstrate the importance of the mea-
sure.
Evidence-based guidelines such as Kidney Disease
Outcomes Quality Initiative [17], the European Best
Practice Guidelines [18, 19] and European Renal Best
Practices [20] provide a foundation for patient level clin-
ical indicators. Since some outcomes can only be assessed
after several years it is important to assess ‘surrogate’ out-
come indicators that reflect changes in biological status
which ultimately are thought to affect ‘hard’ outcomes
[21]. In terms of the latter, in addition to traditional ‘hard’
outcomes such as overall survival rates or suitability for
renal transplantation, one also needs to consider patient-
reported outcomes such as treatment tolerance and re-
covery time after treatment, as well as overall QoL [22–
24]. For elderly patients, improvements in well-being
may be of paramount importance, whereas in younger
patients the principal concerns may be minimizing ure-
mic injury prior to transplantation, ability to attend
school or continuing employment.
The Dialysis Outcomes and Practice Patterns Study
(DOPPS) has provided some insights into the potential
importance of facility level CPMs; for example, one anal-
ysis by the DOPPS group found improved facility level
survival in those centers having lower rates of catheter
and graft use [25]; better survival also was found in cen-
ters that reported higher delivered dialysis dose, im-
proved phosphate control, partial correction of anemia,
higher serum albumin and reduced intradialytic weight
gain [26]. A practice-related composite risk score derived
from DOPPS, which is based on the percentage of pa-
tients with single-pool (sp) Kt/V ≥1.2, hemoglobin (Hb)
≥11 g/dl, albumin ≥4.0 g/dl and access other than venous
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Alquist  et al.
catheter, was found to predict facility level outcomes such
as mortality [27].
For any dialysis facility, water and dialysis fluid quality
is of paramount importance to ensure patient safety. As-
suring adherence to international standards [28–30]
should be an integral part of quality work. The use of ultra-
pure dialysis fluid has been shown to improve inflamma-
tory status [31] and has been suggested to prevent and/or
delay the occurrence of dialysis-related complications [18].
Proposals from the expert group regarding domains of
clinical indicators that should be of prime importance are
listed in table 1.
When using CPM methodology to compare patients,
units or networks, patient comorbidities and case mix
need to be accounted for; for example, hospital specialist
centers may treat sicker patient populations. Also, some
factors affect outcomes but are not modifiable once dialy-
sis is initiated, such as late referral [32, 33] and the qual-
ity of nephrology care provided before dialysis start [34,
35]. This underlines the importance of an integrated ap-
proach in chronic kidney disease care, including engage-
ment by dialysis providers prior to dialysis.
Large dialysis provider organizations have accumulat-
ed considerable experience in applying CPMs across di-
alysis clinic networks. The approach involves application
of evidence-based guidelines and protocols to set clinical
targets, and assessment of achievement of such targets us-
ing network-wide, standardized data processing [4]. A
systematic collection, review and timely feedback of in-
formation to all clinics on the achievement of a list of
eleven CPMs (table 2), as implemented by one provider
organization, resulted in a consistent improvement of di-
alysis performance [4]. As one example, the percentage of
patients meeting a target spKt/V ≥1.4 increased from
40% in 2000 to 85% in 2010 (fig. 1).
Audit and Collaboration
Clinical audit and governance programs encourage
healthcare teams to be accountable for continuously im-
proving quality and safeguarding high standards of care.
One example of such a program is the United Kingdom
National Health Service Institute for Innovation and Im-
provement [36]. Such programs provide a means to im-
plement measures to improve clinical indicators, while
highlighting the importance of teamwork. They also of-
ten help with methods of capturing patient satisfaction.
Many audit programs adopt a PDSA cycle – a Plan-Do-
Study-Act cycle [37, 38] devised to document, provide
visibility and to encourage the adoption of best practices.
Collaborative approaches to auditing data can help im-
Quality Assurance in Hemodialysis
Table 1. QA components: domains suggested where monitoring
quality measures may be of most importance
Water and hemodialysis fluid purity
Adequacy (dose, frequency, duration, modality)
Extracellular volume/blood pressure control
Dry weight achievement
Intradialytic hypotension
Acid-base status/potassium
Anemia (hemoglobin, iron status)
Mineral bone disorder
Nutrition/inflammation
Vascular access type
Patient-reported outcomes
Quality of life, patient well-being and satisfaction
Staff training, education and satisfaction
Nephrology referral prior to dialysis initiation
Access to kidney transplantation and home dialysis therapies
Costs of services
Table 2. CPMs used to assess quality in a large dialysis service pro-
vider network (Diaverum Renal Services Group)
Kt/V (single pool) ≥1.4
Serum albumin ≥35 g/l (3.5 g/dl)
Normalized protein catabolic rate ≥1 g/kg/day
Blood hemoglobin ≥10.0 and ≤12.0 g/dl
Serum ferritin ≥200 and ≤500 μg/l
Serum phosphorus ≥2.5 and ≤5.5 mg/dl (≥0.8 and ≤1.8 mmol/l)
Serum calcium × phosphorus product <55 mg2/dl2
(<4.4 mmol2/l2)
Serum intact parathyroid hormone ≥150 and ≤600 pg/ml
(≥16 and ≤64 pmol/l)
Pre-dialysis mean arterial blood pressure <105 mm Hg
Interdialytic body weight gain <4% of the dry weight
Prevalence of arteriovenous fistulas
prove the numbers of patients achieving pre-identified
management goals in kidney care [39] and can play an
important part in improving practice standards and
achieving quality goals. Several collaborative initiatives,
such as COordination pour la Mesure de la Performance
et l’Amélioration de la Qualité Hospitalière (Compaqh)
in France and QUEST by the EDTA, have been launched
to improve quality and to reduce those excess costs which
are believed to be attributable to poor quality dialysis
care. Collaborative approaches, clinical audits and data
sharing are essential to encourage adoption of best prac-
tices reflecting, the importance of teamwork and provid-
ing training and education of facility staff.
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Nephron Clin Pract 2014;126:135–143 137
DOI: 10.1159/000361050

3HUFHQWDJHRISDWLHQWVZLWK.W9–
90
80
70
60
50

Fig. 1. Consistent improvement of dialysis
adequacy in a dialysis network which im- 30
2000
plemented a formal collection, analysis,
and reporting of CPMs, including Kt/V.
Reimbursement Systems
Ideally, all reimbursement systems should include a
system of verification that treatments are delivered to
high standards and should be set up in a way to encourage
cost-effective care delivery. Different reimbursement sys-
tems exist for chronic hemodialysis care in various coun-
tries, and often include components of bundled reim-
bursement and pay-for-performance schemes [40, 41]. In
countries such as the UK, Germany, Portugal, USA, Ar-
gentina and Japan, reimbursement is already, or soon will
be, linked to quality performance criteria.
The USA has introduced bundled reimbursement for
hemodialysis along with a quality incentive program that
withholds up to 2% of reimbursement unless better-than-
average performance on clinical measures is achieved.
The US bundled system includes payment for dialysis ser-
vices, dialysis-associated laboratory testing and parenter-
al medications for dialysis-associated disorders [40]. The
US bundled system will soon extend bundled payment to
cover several classes of oral medications relating to dialy-
sis. The US system is designed to stimulate innovation
and to improve the efficiency and quality of care, though
its impact remains to be fully evaluated. In several coun-
tries in Europe, pay-for-performance reimbursement
schemes have been initiated, aiming at establishing QA
while containing costs. For example, since 2007 in Ger-
many, payment has been dependent on achieving, in 85%
of patients per center each quarter, four CPMs: (1) Hb
≥10 g/dl, (2) dialysis duration ≥4 h per session, (3) dialy-
sis sessions given three times per week, and (4) per session
spKt/V ≥1.2 [42].
Reimbursement systems linked to performance could
encourage cost-effective delivery of care, assuring high
standards, and promote individualization of care if de-
138 Nephron Clin Pract 2014;126:135–143
DOI: 10.1159/000361050
Color version available online
 2002 2003  2005 2006 2007 2008 2009 
signed to promote treatment appropriate for individual
patient’s lifestyle and clinical needs. Yet, a risk for adverse
consequences from counterproductive cost cuts and fi-
nancial penalties should be recognized. For example, ap-
plying financial penalties to drive less catheter use could
lead to multiple access surgeries in patients more appro-
priately treated with a catheter. Further, since outcome
depends also on factors outside the direct control of the
dialysis provider, such as diet, social ability, demograph-
ics and comorbidities, sophisticated ways to account for
those are needed. The strong need to ensure clinician/
nephrologist involvement in the planning of an optimum
reimbursement system is emphasized.
Tools to Control Treatment Delivery and Fluid
Management Online/At-Point-of-Care
Online Real-Time Treatment Data
Modern dialysis machines routinely provide and col-
lect a number of treatment and patient parameters ‘con-
tinuously’ online. Online dialysance monitoring has
shown that variation in the delivery of dialysis dose
(Kt/V urea) is commonplace [43]. Further, in a retro-
spective database study in over 33,000 patients, a sig-
nificant association between intra-patient variability in
dose delivery and mortality was reported. Variation was
measured as the frequency per year that a given patient
receiving three times weekly HD had a spKt/V urea <1.2,
when that patient’s yearly average spKt/V was at least
≥1.2 [44].
Online dialysance (clearance estimation) is available
using standardized methodologies that includes calcula-
tion of Kt/V urea. Current online methods quantify clear-
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Alquist  et al.
ance by analysis of dialysate conductivity at the dialyzer
inlet and outlet in response to changes in dialysate elec-
trolyte concentrations (ionic dialysance), or by using ul-
traviolet absorbance of the spent dialysate (refractometric
solute dialysance) [45].
The benefits of online dialysance monitoring include
early detection of treatment deviations allowing for pro-
active staff intervention, potentially reducing dose vari-
ability between sessions. Further, the recognized bias of
‘dose-measuring day’ (when a special effort is made to
deliver maximized dialysis) and the bias and possible er-
rors associated with improper blood sampling technique
may then be avoided. Accordingly, an objective and un-
biased reporting of dialysis dose can be provided – ac-
counting for every treatment. Additionally, online dialy-
sance monitoring may assist in diagnosing problems
such as needle reversal and vascular access malfunction
[46, 47]. Trending machine-measured dialysance over
time may provide ‘continuous vascular access surveil-
lance’, alerting staff allowing them to intervene at an ear-
ly time point, potentially reducing the risk of access com-
plications. Vascular access surveillance may further ben-
efit from enhancing patient engagement, including
self-assessment of the vascular access as well as consider-
ing self-cannulation for selected patients. Online moni-
toring of treatment variables such as diffusion time, ac-
tual blood flow, alarm frequency, blood pressure, dia-
lyzer inlet and outlet pressures, blood volume changes,
ultrafiltration rate, intradialytic hypotension and sodium
balance, can also be used to better analyze hemodialysis
treatments in a given patient, allowing for individualized
therapy and more reliable delivery of the prescribed
treatment.
Extracellular Volume Optimization
Fluid overload is a major risk factor for hypertension,
increased cardiovascular morbidity and mortality, and
all-cause mortality [48–52]. Currently there is no gold
standard method for assessing dry weight, and accurate
estimation is challenging when a slight change in total
body water/body weight can markedly affect patient
blood pressure [53]. Offline methods of assessing dry
weight, in addition to physician assessment, include chest
radiography, ultrasound analysis of inspiratory collapse
of inferior vena cava [54], and measurement of natriuret-
ic peptides (BNP, NTproBNP) [55]. Multifrequency bio-
impedance devices are easy to use and are quite valuable
in assessing fluid status in dialysis patients while provid-
ing guidance to physicians for optimizing management of
extracellular fluid volume [56–58]. More recently, lung
Quality Assurance in Hemodialysis
ultrasound has been proposed for determining extracel-
lular fluid excess as percentage of lung water [59].
Online continuous blood volume monitoring during
dialysis to determine volume index (the relative blood
volume slope corrected for ultrafiltration rate and weight)
has been shown effective in detecting cases of fluid over-
load and preventing hypovolemia [60]. The use of blood
volume monitoring to determine both intradialytic de-
creases in blood volume and vascular compartment refill
capacity combined with clinical assessment of intradia-
lytic hypovolemia and post-dialysis fatigue have been
shown to be complementary methods of assessing dry
weight [61].
Repetitive intradialytic hypotensive episodes (IDH)
are associated with loss of residual renal function and in-
creased mortality risk [62, 63]. The frequency of IDH in-
creases with ultrafiltration rates >10 ml/kg/h [64]. The
easiest and most efficient ways to reduce IDH would be
to reduce interdialytic weight gain by educating patient to
reduce salt intake and/or to extend dialysis duration time.
At present these measures are not easily implemented in
clinical practice for compliance or logistical reasons [6].
Additional technical options have been proposed to
achieve this goal. Online blood volume measurement can
be combined with an online closed-loop biofeedback ex-
pert system that adjusts ultrafiltration and dialysate con-
ductivity to optimize changes in intradialytic blood vol-
ume (e.g. HemocontrolTM; Gambro, Sweden). In these
systems, measured relative blood volume is continuously
compared to an ‘ideal’ patient-individualized profile, and
the system automatically adjusts ultrafiltration and dialy-
sate conductivity to minimize the difference. Such sys-
tems have been shown to reduce significantly the rate of
hypotensive episodes experienced by dialysis patients
[65]. Additional therapeutic options may be proposed
such as dialysate cooling, thermal balance control [66],
sodium modelling [67] or use of convective therapies
[68]. See table 3 for proposals from the expert group on
quality control.
Future Perspectives
A Facilitating Role for Clinical Information
Technology (IT) Expert Systems
Dialysis units generate a wealth of clinical data from
various sources, such as dialysis treatment protocols,
equipment checklists, medical records and laboratory
tests. Further, modern dialysis machines inexpensively
and ‘continuously’ provide a number of treatment and
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Nephron Clin Pract 2014;126:135–143 139
DOI: 10.1159/000361050
Table 3. Quality control tools
Online dialysance monitoring provides an objective tool for
controlling hemodialysis dose delivery to prescription at every
treatment, with the potential to reduce inter-treatment variability
and providing unbiased reporting of dialysis dose. Further, in
conjunction with expert systems applied online, early detection of
needle reversal and vascular access malfunction may be at hand.
Extracellular volume optimization is challenging and there is
currently no gold standard for assessing, or even defining, dry
weight. The combination of clinical assessment with the use of
non-invasive bedside objective tools such as online blood volume
monitoring and bioimpedance offers the best approach to
approach ideal dry weight. The importance of consistently
achieving dialysis fluid removal without intradialytic hypotensive
episodes is emphasized. However, supplementing clinical
strategies to reduce fluid overload are essential, and a suggestion
of such clinical strategies are listed below:
– Intensive patient education program (with emphasis on salt
intake) with a dedicated dialysis care team.
– Careful review of the need for antihypertensive medications
and the potential benefits of special groups of
antihypertensive agents (i.e. angiotensin-converting enzyme
inhibitors, angiotensin receptor blockers, β-blockers).
– Management of dialysate sodium concentration by
prescribing dialysate sodium in the low normal range (136–
138 mmol/l).
– Additional dialysis sessions for fluid removal to minimize
hemodynamic instability.
patient parameters online to assist in controlling the out-
come of the hemodialysis delivery and allowing for more
individualized therapy.
Computerized expert systems with the capability to
process, organize and present this wealth of clinical data
can be used to present this information in a format that is
useful for review and decision-making by both caregivers
and administrators. By automatically extracting, analyz-
ing and presenting the key markers of dialysis care and
dialysis treatments, expert systems could provide benefits
to patients and to the renal team. Such technologies, in-
cluding online data collection and online feedback analy-
sis, may prove to be valuable tools for both clinical and
research use.
Patient Empowerment and Expectations
Healthcare policymakers are recognizing the impor-
tance of empowering patients and giving them control
over decisions regarding their own health. Patients may
then become advocates in the management of their dis-
ease, once well instructed and appropriately monitored.
140 Nephron Clin Pract 2014;126:135–143
DOI: 10.1159/000361050
Table 4. Future perspectives
Open communication of information relating to hemodialysis
quality is encouraged, but should be balanced to account for
population case mix and comorbidity.
Computerized expert systems organizing the wealth of clinical
data in dialysis units, including online machine-generated
data, will be a necessary facilitating tool in a standardized QA
process.
Patient demands and choices will in the future be empowered,
representing an increasingly important factor affecting future
care delivery and care costs. Optimizing patient rehabilitation,
physical and mental health, education, and involving patients in
decision-making through care planning and supported self-care
should be an integral part of a high-quality service.
Future research should include:
– A systematic literature review on QA in hemodialysis.
– Assessment and reporting of observational data from large
dialysis providers.
– Studies to determine impact of QA processes and data
collection systems on hospitalization rates, QoL outcomes,
and health economics of dialysis quality.
– Cost-utility analysis of quality measures, including
development and validation of metrics and sensitivity indexes
are needed.
– Measures of patient factors such as satisfaction, rehabilitation,
education and patient empowerment will be increasingly
important and need to be developed and validated.
In the future, individual patients will have more power
and more control over the healthcare they receive. They
will have higher expectations of their healthcare delivery
system; they will expect choice and demand quality.
Thus, quality hemodialysis care should seek to provide
treatment appropriate for individual patients taking into
account their lifestyle as well as clinical needs. Involving
patients in decision-making through care planning and
supported self-care should be an integral part of a high-
quality service for people with ESRD.
Research
There are no large randomized studies in hemodialysis
patients of the impact of QA initiatives on outcomes and
costs. Until such data are available, support may come
from available observational studies indicating that the
more quality indicators that can be achieved, the greater
the improvement in survival rates and the greater the re-
duction in hospital admission rates and resource use [69,
70]. There is a strong need for focused research to evalu-
ate and potentially establish the true value of QA and
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Alquist  et al.
quality measures in hemodialysis, including developing
and validating appropriate quality metrics. Large chains
of care providers (private or public) are now able to pro-
vide such analysis due to their capacities to collect, and on
a large scale analyze a core of quality indicators which
may provide evidence supporting the cost-effectiveness
of improving dialysis patient care by implementing a con-
tinuous QA system. Proposals from the expert group on
future perspectives are found in table 4.
Conclusion
and aspects of care are monitored and appraised. A stan-
dardized clinical performance measurement methodol-
ogy, online treatment delivery control, collaborative ap-
proaches and clinical audits, and facilitating clinical IT
systems to organize the collected wealth of clinical data
seem essential parts of a QA program for dialysis patients.
While novel reimbursement systems could further drive
and encourage cost-effective delivery of high-quality
care, their impact needs to be critically evaluated. A stan-
dardized and validated QA program may assist health-
care decision-making and provide guidance for future
outcomes research.

In conclusion, there is a need for a systematized, con-

tinuous quality improvement process within which clini- Disclosure Statement
cal practice guidelines and other quality indicators are The meeting was sponsored by a grant from Gambro, and some
implemented, and through which the hemodialysis pre- authors are employed by Gambro, but scientific content was pro-
scription, hemodialysis delivery and other interventions duced independently and reviewed by all co-authors.

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