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Saudi Journal of Kidney Diseases and Transplantation
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Year : 2001  |  Volume : 12  |  Issue : 3  |  Page : 413-419
Design and Quality Assurance of New Dialysis Centers

1 Department of Nephrology and Dialysis, Alessandro Manzoni Hospital, Lecco, Italy
2 Department of Clinical and Laboratory Research, Bellco S.p.A, Mirandola, Italy

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How to cite this article:
Pontoriero G, Tetta C, Wratten ML, Locatelli F. Design and Quality Assurance of New Dialysis Centers. Saudi J Kidney Dis Transpl 2001;12:413-9

How to cite this URL:
Pontoriero G, Tetta C, Wratten ML, Locatelli F. Design and Quality Assurance of New Dialysis Centers. Saudi J Kidney Dis Transpl [serial online] 2001 [cited 2021 Apr 19];12:413-9. Available from: https://www.sjkdt.org/text.asp?2001/12/3/413/33566

   Introduction Top

At the beginning of the New Millennium, more than 40 years after the pioneering experiments of extracorporeal substitutive therapy for renal failure, dialysis has already become an established form of therapy. Advances in dialysis technology, albeit slow in developing, have made it possible to offer safe treatment of an ever more elderly and critical patient population with end-stage renal disease (ESRD). Today, around one million ESRD patients are receiving renal replacement therapy (with the majority of them being on hemodialysis), with an incidence number of 100-250 patients per million population per year in the Western World and Japan. The profile of the treated patients has changed over the years. Older patients with co­morbidities are receiving treatment with the novel goal, not only for a longer survival, but also for a more acceptable rehabilitation and quality of life. There has been for some time, a focus towards an emphasis on membranes, materials, machines and modeling. This has been particularly evident in certain geographic regions where technical aspects, mixed with economic and industrial factors, have overshadowed patient treatment. Recently, there has been a strong trend towards pathophysiology, particularly in the areas of the removal of urea and other uremic toxins; the correction of sodium and water overload, and finally the clinical relevance of chronic inflammation, particularly in the context of the possible links to enhanced risk of mortality and morbidity from cardiovascular disease and malnutrition. Cardiovascular disease is the leading cause of death among ESRD patients with the death risk being 10-20 times higher than that observed in age- and sex-matched healthy population.

An emerging substantial current interest stands in the development of a variety of technologies to improve a broad range of outcomes, together with renal organizational and governmental interest in assessing the current administrative/socioeconomic app­roaches to dialysis programs. In this review, we will try to express current (or controversial) opinions on the different aspects concerning quality assurance in dialysis centers.

   Quality Assurance and Quality Improvement Top

In the last several years growing interest and attention have been dedicated to the problem of quality of treatment in the health-care sector in general, and in the dialysis area in particular. The debate has been especially lively in the United States, where mortality rates considerably higher than in Europe and Japan, [1] with substantial variations from one center to another, have been observed. This is not completely explainable on the basis of patient characteristics, [2] and has given rise to the concern that the interventions of cost containment, developed in response to the rapid increase in the dialysis population and their relative costs, may have reduced the quality of the dialysis. [3] Attention has been particularly focused on the for-profit dialysis centers, because these, under the financial pressures of the marketplace, can more easily be induced to take a direction, which could compromise the quality of the treatment care and reduce accessibility to transplantation. [4]

The approach towards treatment improvement is largely influenced by cultural, social, political and economic factors; and this is reflected in the choice of the strategy to be applied, which can be very varied. All the same, even though the quality systems in use in the healthcare sector are of various types, their basis rests on two mechanisms: Quality Assurance (QA) and Continuous Quality Improvement (CQI). QA is the more traditional methodology, and is based on a surveillance and inspection approach, which aims at guaranteeing adherence to a pre-established standard. The intent is to guarantee quality, identifying low-level performance, and taking the consequent corrective remedies. This is often a "top­-down" system in which an external organization imposes the standards, which must be respected. CQI instead is a strategy based on the planning of a surveillance activity and process and outcome measurement, aiming at their continuous improvement. The objective is to improve the quality of the processes typical of the treatment, rather than identifying and correcting individual or unusual errors (which are taken into consideration), in the conviction that generally, low levels of care are related to badly designed processes, inadequate information and training. It has been reported that the application of plans for improvement, based on the CQI methodology, are associated with positive modifications of the results of dialysis therapy, both when these Pans are developed inside a single center, [5] as well as when they concern much more extensive situations. The latter situation is seen in the case of the ESRD Core Indicators Projects [6] promoted by the Health Care Financing Administration (HFCA), which involved 18 United States Networks. Thus, the present tendency in dialysis centers concerned with obtaining advantages from the implemen­tation of a quality system, is that of associating CQI mechanisms to QA. The QA in fact, defines the set of the standard minimum to which the center must adhere and involves regular inspections on the part of an external organization (public health bodies, certification agencies, etc). The CQI is a process of self-evaluation, which measures processes and outcome, looks for opportunities for improvement, up-dates treatment protocols, and therefore measures their effectiveness. QA and CQI, as much as they differ, have many elements in common, and are interconnected. This undoubtedly presents several advantages (for example, the results of an external inspection visit can better allow for directing the efforts of the improvement plan), but can cause problems as far as certain aspects are concerned, such as privacy of data, and the responsibility of the healthcare professionals. In fact, while the data of the CQI process are internal and confidential, those of the QA are not confidential. The latter, when they constitute information useful in directing the choice of the patients, should be made available to the public with appropriate mechanisms; when they are relative to requests which are obligatory under law, they must be put at the disposition of the health authorities who have the job to control and to program. The parts, for which the team of nephrologists is responsible, vary according to whether a QA or a CQI activity is undertaken. When the nephrology team carries out a quality assurance activity, it is responsible to external parts of the operative unit, those of the organization of the public health system; when, instead it undertakes an activity of continuous improvement, it is responsible to the internal parts, which are the patients, the administrators, the owners, etc. [7]

   Guidelines Top

Guidelines have a long tradition in clinical medicine and are the instruments, which, on the basis of the available evidence, suggest the practices that seem to offer excellent results for all patients. They have two components: the strategy recommended to arrive at a determined clinical objective, and the recommended levels to be arrived at (measurements of clinical performance, target or standard), that is those which one can expect to obtain if the recommended strategy is followed. A well-constructed guideline should also provide the information necessary for cost/benefit analysis of the suggested recommendations. Additionally, the process of continuing evaluation of the effects of the implementation of a guideline on clinical practice and on the treatment of the patients should be an integral part of its application. The most immediate effect expected from the implementation of the guidelines is the reduction of the variability of the clinical practices. It is in this reduction of the variability that, if on one hand, doctors see the chance for improvement of the clinical practices and results for the patients, on the other hand, the managers and financiers of the health sector (including the governments) see a way to reduce costs without having negative results for the patients.

Given the fact that the guidelines provide a strategy and target or standard, they not only can improve the quality and the relationship of cost/effectiveness of the treatments, but they can also constitute a useful instrument in the CQI process, constituting a skeletal framework onto which one can base an improvement plan to be constructed.

Dialysis is an area of high technology and high costs, in which a wide variability of clinical practices exist; they lend themselves therefore to the development of guidelines. It is for this reason that in the last several years considerable efforts have been made to define guidelines based on the evidence, to reduce the variability of the clinical approach, to increase the quality of performance of the dialysis, and to improve the results for the patients. Among these initiatives, the most well known one is certainly that of the National Kidney Foundation of the United States, through which clinical guidelines have been created, concerning the adequacy of dialysis in hemodialysis and peritoneal dialysis, the treatment of anemia, vascular access, and the nutritional state. Notwithstanding these distinguished efforts, much still remains to be done to improve the effective implemen­tation of the guidelines. Finally, it is important to ensure that clinicians do not become the forced inmates of their own making. [8]

   External Review Systems Top

The first accreditation experiences of healthcare organizations began in the United States in the first decades of the twentieth century. However, it is only in the more recent years that, in this country, as in the rest of the Western world, following a growing request for making treatment providers responsible, there has been a rapid increase in the application of systems of external review. These reviews evaluate health services, comparing them with pre­established standards. There are four principal models of external evaluation of quality in use in the healthcare field. Of these, two have been developed in the healthcare area, Accreditation and Peer Review-"Visitatie", and two are industrial models applied to the healthcare sector, International Organization for Standardization (ISO) and European Foundation for Quality Management (EFQM). [9] These models are all applicable to dialysis centers; they are voluntary; and they have in common, the application of explicit standards and criteria and external review on the part of a qualified and independent subject.

Healthcare accreditation (considered as recognition of the organization of a service), typical of the Anglo-Saxon countries, has a long tradition, and is promoted by large independent agencies of which the most noted is the American Joint Commission on Accreditation of Healthcare Organizations. This system of review is very specific for the healthcare world and places particular attention on performance and indicators. Therefore, it is very attractive in the eyes of the supporters of evidence based medicine, and bench marking. Accreditation has experienced a great development in the United States in the last two decades. This development has been determined not by traditional beneficiaries of accreditation, namely the healthcare professionals, but mostly by the new users; the government, the buyers of healthcare services, and the public. This widening of use has pushed the accreditation agencies to up-date themselves, placing special attention on the involvement of the interested parts (government, consumers, patients), on the transparency of the process, on the diffusion of information relative to the accredited organizations and, on the technique of continuous improvement of quality and efficiency. [10] Peer Review - "Visitatie", a system which is widely used in the Netherlands, is one in which the healthcare professionals of a particular specialty review in a joint fashion, each others' activity, giving particular emphasis to the reciprocal exchange of ideas and to the deepening of knowledge, rather than to the process of control. This system in fact does not provide for prizes or certificates. The ISO system is used in more than 120 countries and is applicable in the most disparate of sectors: industry, commerce, service (including health). The ISO 9000 rules applied up until now, have the advantage of defining with clarity, the responsibilities and the control of the process; all the activities are described in specific procedures whose correct application is subjected to systematic verification. This brings with it in addition to a great amount of documentation, a static conception of quality. All the same, the rule was recently up-dated through the process of review known as "Vision 2000" which modified in a substantial way the objectives of the model. It went in fact from a rule aimed at guaranteeing product and/or service conformity to pre-established requirements, to one that places the accent on the way with which to manage the quality objective, which is widened to include client satisfaction and the logistics of continuous improvement. The principal objective of the EFQM is that of stimulating and supporting the European organizations in the imple­mentation of Total Quality Management and in the promotion of the activity of improvement, aimed at arriving at excellence. The instruments with which to obtain these results are the publication of a model for self-evaluation, and the award of a prize (European or national) to the best companies.

The aims and the perspectives of the four models overlap, so that rather than alternatives, they appear complementary. Moreover, neither model is static, but for each one, a review process proceeds, which in some way brings them together. The popularity and the application of each model depend not only on its charac­teristics, but also on the political and cultural context, and on the enthusiasm and interest of those who use or promote them. In fact, the present ongoing debate over the systems of external review is about, not their content, but about the balance of power between the various participants of the healthcare system which introduces one model rather than another. [11]

   Design of a new dialysis centre Top

The design of new dialysis centres will have to take into account some absolute needs one of which is the assurance of high microbiological quality of the dialysis fluid.

The following items are to be considered as indispensable:

a) Water treatment with reverse osmosis. A double reverse osmosis is now considered as a safer system along the line of the "double safety" philosophy.

b) Ring "distribution" installation with circulation and continuous backflow system upwards and two intakes for each dialysis site. Water tubing connecting device feeding the dialysis machine is of critical importance in this context. This zone of stagnation represents the ideal zone for proliferation and seedling media during the interdialytic period sowing regularly the dialysis machine. It is worth the effort to design an ultrashort connecting tubing device feeding directly the dialysis machine thereby preventing water stagnation.

c) Automatic disinfection of the equipment. Hemodialysis machine is clearly identified as the source of bacteria proliferation. The degree of contamination depends on the complexity of hydraulic circuit, the dialysate content, the presence of stagnation zones and dead spaces, the frequency and the efficacy of disinfection procedures.

Hygiene handling is the most crucial measure to ensure constant quality of the ultrapure dialysate. Major targets are the following: i) Maintenance of high purity grade of water feeding the dialysis machines. This is achieved with frequent disinfection of the water treatment system, destruction of the biofilm by chemical agents or combined heat/citrate disinfection, periodical changes of ultrafilters, permanent recirculation of treated water; ii) Prevention of recontamination and bacterial proliferation in the dialysis machine. This is achieved with frequent disinfection, use of sterile liquid (or powder) concentrate and periodical changes of ultrafilters (2 to 3 months). Water treatment system disinfection should be ideally performed weekly using for example a peracetic acid based solution having a dual bactericidal and cleansing activities alternating with heat or steam disinfection. Microfilters (0.1µm+) with depyrogenating capacity may be installed at the head of the recirculation loop to ensure sterility of treated water. Replacement of microfilters will be programmed regularly (6 months for example) to prevent saturation and possible release. Hemodialysis machines will be ideally disinfected after each run and daily as minimum, with a rapid and long acting bactericidal agent (peracetic acid solution) or by combining citric acid and heat disinfection. Hemodialysis machines equipped with ultrafilter will be preferably stored with a disinfecting agent at the appropriate concentration during the non­functioning periods of the machine (night, day off etc). Captive ultrafilters installed on the dialysis fluid line will be replaced periodically as programmed by the dialysis machine or on a quarterly basis in case of center dialysis facility.

Other structural items should be incor­porated. Room/s for extra-corporeal hemo­dialysis should be each equipped with at least four dialysis beds, each bed in a minimum space of six sqm. Separate room/s for Hepatitis B or anti-HIV positive patients should be available. One consulting room should be equipped with an examination table and a kit for minor operations. A waiting room for pre- and post-dialysis patients equipped with lounge chairs and at least two small beds should be available. The total number of beds must be equal to, or as close as possible to the number of the bed scales. A nurse room, a reception room, a secretary office and office filing space should be made available and completed with a kitchenette and separate bathrooms/lavatories for patients and for the staff (also for disabled people). Convenient storage spaces for clean, disposable material and biological waste material must be planned. A room close to the central unit devoted to temporary storage of sanitary products should be used for the treatment (daily and weekly stock). A warehouse for sanitary and pharma­ceutical products (hemodialysis disposable products and solutions/liquids) should cover a three-month need. An area should be devoted to the technical maintenance for the extracorporeal dialysis equipment. Finally, delivery of treated water, electrical system and drainage should be made available for at least eight bed scales.

   Conclusions Top

The finding of a wide variability of mortality rates between dialysis centers and between countries, suggests the possibility that the application of different models of dialysis practice contributes in a significant way to this difference in results. From this comes the great chance to evaluate and study dialysis practices, and the possibility of developing strategies aimed at obtaining an improvement in services and patient results, through a modification of the practice models applied in dialysis. The QA/CQI techniques and the guidelines represent valid instruments for the imple­mentation of these strategies directed towards improvement. One must not forget however, that in designing an effective strategy aimed at maintaining and improving the quality of the dialysis treatment, the first stage is represented by a coherent political direction, which encourages quality, using the financial lever as well, when necessary [12] .

The countries in which dialysis is provided by private centers, or by a mixed system of public and private centers, greater guarantee of access to the dialysis treatment is present, compared to those where dialysis is furnished only by public centers. [13] Nevertheless, when one discusses private dialysis centers, above all as in a context like the present one of low fees aimed at containing costs, the concern spontaneously arises that the necessity for these centers to generate profit induces cost cuts, and consequently low quality service. In effect, a "public system" is not necessarily synonymous with quality and effectiveness, as likewise, a "private system" does not necessarily mean efficient treatment, but at the risk of low quality. It is important that clear and definite rules exist, with respect to which, both public centers as well as private ones conform. In this sense, the review on the part of an independent external organization, which "certifies" the application of explicit standards and criteria is an important quality instrument for a dialysis center, whether it is public or private. Also, it dictates the requirement for responsibility on the part of the interested parties (public control bodies, buyers of health-care services, the public) with the resultant increase in patient trust.

   References Top

1.Held PJ, Brunner F, Odaka M, et al. Five­year survival for end-stage renal disease patients in the United States, Europe, and Japan, 1982 to 1987. Am J Kidney Dis 1990;15:451-7.  Back to cited text no. 1  [PUBMED]  
2.McClellan W, Soucie JM. Facility mortality rates for new end-stage renal disease patients: implications for quality improve­ment. Am J Kidney Dis 1994;24:280-9.  Back to cited text no. 2  [PUBMED]  
3.Levinsky NG. Quality and equity in dialysis and renal transplantation. N Engl J Med 1999;341:1691-3.  Back to cited text no. 3  [PUBMED]  [FULLTEXT]
4.Garg PP, Frick KD, Diener-West M, Powe NR. Effect of the ownership of dialysis facilities on patients' survival and referral for transplantation. N Engl J Med 1999; 341:1653-60.  Back to cited text no. 4  [PUBMED]  [FULLTEXT]
5.Wright LF, Francisco SM, Warmath A, et al. Improving outcomes for maintenance hemodialysis patients by using continuous quality improvement. Dial Transpl 1996; 25:346-52.  Back to cited text no. 5    
6.McClellan WM, Frankenfield DL, Frederick PR, et al. Can dialysis therapy be improved? A report from the ESDR Core Indicators Project. Am J Kidney Dis 1999;34:1075-82.  Back to cited text no. 6    
7.Kliger AS. Improving the quality of care in dialysis facilities: a model for accoun­tability. Dial Transpl 2000;29:276-9.  Back to cited text no. 7    
8.Locatelli F, Andrulli S, Del Vecchio L. Difficulties of implementing clinical guidelines in medical practice. Nephrol Dial Transplant 2000;15:1284-7.  Back to cited text no. 8  [PUBMED]  [FULLTEXT]
9.Shaw CD. External quality mechanisms for heath care: summary of the expert pro-ject on visitatie, accreditation, EFQM and ISO assessment in European Union coun-tries. Int J Qual Health Care 2000;12:169-75.  Back to cited text no. 9  [PUBMED]  [FULLTEXT]
10.Schyve PM. The evolution of external quality evaluation: observations from the Joint Commission on Accreditation of Healthcare Organizations. Int J Qual Health Care 2000;12:255-8.  Back to cited text no. 10  [PUBMED]  [FULLTEXT]
11.Klazinga N. Re-engineering trust: the adoption and adaption of four models for external quality assurance of health care services in western European health care systems. Int J Qual Health Care 2000; 12:183-9.  Back to cited text no. 11  [PUBMED]  [FULLTEXT]
12.Hidai H. Need for an incentive-based reimbursement policy toward quality care for dialysis patient management. Kidney Int 2000;58:363-73.  Back to cited text no. 12  [PUBMED]  [FULLTEXT]
13.Locatelli F, Pontoriero G, Del Vecchio L, Conte F. Technical-economic management models in dialytic treatment: an evolving reality. The Italian experience. J Nephrol 2000;13:S20-7.  Back to cited text no. 13    

Correspondence Address:
Ciro Tetta
Department of Clinical and Laboratory Research, Bellco S.p.A. Via Camurana 1, 41037 Mirandola
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