Assessment of Standard Criteria Implementation in Heamodialysis Water Treatment Units in Sharkia Governorate ()
1. Introduction
Water treatment represents a fundamental aspect of modern hemodialysis technology [1]. International standards based on Caring for Australasian with Renal Impairment (CARI) guidelines and others have been developed to promote the installation of fit for purpose water treatment facilities for heamodialysis and to safeguard the routine production of dialysis water suitable for use for heamodialysis and haemodiafiltration [2]. Haemodialysis process may expose the patient to more than 300 litres of water per week across the semi-permeable membrane of the haemodialyser. The near 30 times increase in water exposure to dialysis patients requires control and monitoring of water quality to avoid excesses of known or suspected harmful elements being carried in the water transmitted to the patient [3] [4]. The water used for the preparation of heamodialysis fluids needs treatment to achieve the appropriate quality based on Greater Metropolitan Committee Taskforce (GMCT) guidelines and Association for Advancement of Medical Instrumentation (AAMI) guidelines as the water pre-treatment system includes various components such as sediment filters, water softeners, carbon tanks, micro-filters, ultraviolet disinfection units, reverse osmosis units, ultrafilters and storage tanks. The components of the systems are determined by the quality of feed water and the ability of the overall system to produce and maintain appropriate water quality [5] [6]. Some of the important possible signs and symptoms due to water contamination include anemia, bone disease, hypertension, hypotension, muscle weakness, neurological deterioration & even death due to hazardous chemicals as aluminum, chloramine, copper, zinc, fluoride & nitrates pluse Bacteria, endotoxin [7] [8] [9]. Once water enters a heamodialysis center, the goal is to achieve high quality and safe heamodialysis water and dialysate. Water treatment, system design, and distribution material choices are contributing factors. Dialysis water treatment should remove chemical and microbial contaminants to below established allowable limits and is characterized by two phases: 1) Pretreatment, where constituents are removed from the feed water to protect the downstream treatment components and 2) water treatment, which is the process of physically removing and/or chemically inactivating remaining chemical and/or microbial contaminants [10] [11]. This study aimed to evaluate the implementation of standard criteria in heamodialysis water treatment units in Sharkia governorate and to determine the weak points in the application of standard criteria, and reach the optimal standards to improve pt. outcomes.
2. Methods
A cross-sectional study using a pre-designed questionnaire was carried out in heamodialysis units of Sharkia governorate, Egypt throughout the period of search in 2020. Sharkia Governorate is one of the governorates of Egypt. It is located in the eastern part of Egypt. The governorate is named after its location; Sharkia’s capital is the city of Zagazig. All heamodialysis units were included in the study. No exclusion criteria were listed as all units could be submitted for the study. A total number of heamodialysis water treatment units in Sharkia governorate is 63 units. A sample size of 30 heamodialysis water treatment units will be included in this study using simple random technique based on a poll technique [12]. A well-structured but simple questionnaire was developed based on Egyptian MOH protocol [13] and international guidelines such as CARI guidelines and AAMI guidelines and others by the researcher [2] [3] respectively.
The questionnaire was divided into 7 sections of infrastructure, component of HD water TTT unit, infection control policies, sterilization and sanitation, monitoring efficiency, technical staff evaluation and results of monthly water sampling.
Data Handling: All data were collected, tabulated and statistically analyzed using SPSS 22.0 for windows (SPSS Inc., Chicago, IL, USA). Qualitative data were represented as frequencies and relative percentages, Quantitative data were expressed as mean ± SD (Standard deviation), and median and range for non-parametric data.
3. Results
Among 30 water treatment units were visited and underwent the questionnaire, the following data were found, 100% of the units achieved the infrastructure and schematic structure of the HD water except for the location of the units that there were 63.3% of the studied units were not in on the ground floor and there was one unit did not have any methods of lowering temperature and 40% of the units were using fans. There were 20% of the units causes building affection. 100% of the units had water purification devices and components except that there were 33.3% of the studied units did not have Reversed osmotic pressure device (RO) 2 membrane, 20% of the studied units did not have Reversed osmotic pressure device (RO) 3 membrane, 6.7% of the studied units did not have an automatic nitrate filter and one unit with broken TDS device. 100% of the units had good monitoring and quality control except that there was one unit that had a wet floor and another unit had a treated tank on the ground directly which cause its outlet from the side and minimal stagnation of the water in the bottom. 30% of the units had controlled breakage waited to be fixed. 100% of the units didn’t had biomedical engineer, Internal supervision by specific medical staff assigned by the unit manager or Internal organized daily checklist with accepted forum. The majority of the units had good maintenance technician evaluation except that there were 6.7% of the studied units where their staff was absent, 10% of units with maintenance technician had no training and one of the studied units had its door open. All studied units had chemical disinfection and washing of HD water treatment units.
4. Discussion
Regarding sources of HD water treatment fed water; the study results as listed in Table 1 when was compared with a result of nationwide survey was done in Canada on 23 renal programs, The majority of programs (94.1%) have had experience with patients using well water, and a minority of programs (35.3%) having had patients using surface water such as ponds or lakes [14]. In the study, examination of the HD water purification devices as listed in Table 2 results were compared with a national survey was done in Italy on 148 centers concerned tap water treatment systems. (71%) of centers used a single system, in particular, RO in the majority of cases. A double water treatment system (double RO or single RO combined with an ion exchange deionizer) was used in (28%) of centers. A water storage tank was used by (65%) of centers. (85%) of centers reported that their deionizer water pipe distribution loops were made from sanitary PVC, while only (15%) used more inert materials [15]. Regarding the infection control policies and measures the results of the studied units as listed in Table 3 were compared to those obtained from another study for the assessment of safety measures in haemodialysis units in Ismailia Governorate, it was found that 66.7% of the units were of good cleanliness of the place while 33.3% of them were to some extent clean and none of the studied units was of bad cleanliness level Regarding chemical disinfection of HD water treatment units methods of the studied unit’s results as listed in Table 4 when were compared with another survey in Lagos, Nigeria showed that most centers did not routinely disinfect their water storage tanks and distribution system. Sixty-six percent of centers carried out disinfection at 3- to 6-month intervals; only 16.6% disinfected its system every month while 16.6% rarely disinfected its system as it did so once a year [16]. On the other hand about monitoring and quality control of the studied HD water treatment unit’s results as listed in Table 5, were compared with those obtained from another survey of six centers in Lagos, Nigeria about maintenance of UV system it stated that most centers did not change UV filament regularly. While 33% of centers had not replaced their UV filament since installation many years ago, 16.6% changed their UV filament 7 years after installation and another 16.6% changed their UV filament 9 years after installation. Of the centers, 16.6% had UV systems replaced 6 months after installation while another 16.6% had UV filament replaced 2 years after installation. None of the centers used bacterial filters [16]. It is recommended that there should be at least one maintenance technical staff per shift (Gorden et al., 2008), in the studied unit’s results as listed in Table 6 when compared these results with those obtained from another study for the assessment of safety measures in haemodialysis units in Ismailia Governorate it was found that the working maintenance technical staff with mean and SD (2.9 ± 1.6). As regard the efficiency of HD water samples of the study in Sharkia Governorate as listed in Table 7, it was found that all studied units match MOH and AAMI standard specifications in collecting samples by 100% but not all tested samples match the decree of 63 for 1996 in the 1st testing as in the last month only 90% of units were accepted by the first time but when we re-tested the samples, they passed. It was founded that the cause of failure of the samples mainly due to chemicals or bacterial contamination as increase amount of nitrates, chloramines or E.coli. When five samples from five random HD water treatment units were tested in our regional laboratories regarding chemical, minerals and bacteriology parameters the results of all collected samples found to be corresponded to decree of 63 for 1996 as listed in Tables 8-10. AAMI recommends testing the final water for chemical contaminants at commissioning and then annually, except for chloramine, which should be monitored at each treatment shift. AAMI also recommends daily monitoring of the performance of individual water treatment components as a supplement to these periodic chemical analyses. More frequent chemical analyses can be necessary in some circumstances, such as when there are marked seasonal variations in supply, water quality, or when RO rejection falls below 90%. Italian study by Pizzarelli etal. showed that 29% of centers studied tested HD water every month, 14% every 2 months, 37% of centers every 3 months, 4% every 4 months, 12% every 6 months, and only 4% tested yearly [15]. Also a study in Iraq regarding bacterial concentration in water samples over 5 months of monitoring for six dialysis centers showed that most of the centers were with high bacterial count. Sixty percent of the analyzed samples were above the 50 CFU/mL in comparison to AAMI action level. Five out of the six dialysis centers showed even higher values (>100 CFU/mL in comparison to the AAMI maximum level).A regular and effective disinfection procedure, as an integral part of the hygienic maintenance of the water treatment units, must be performed in order to keep the bacterial counts’ values below the action level [17].
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Table 1. The infrastructure and schematic structure of the HD water treatment unit.
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Table 2. HD water purification devices and components.
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Table 3. Infection control polices of HD water treatment units.
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Table 4. Chemical disinfection of HD water treatment units.
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Table 5. Monitoring and quality control of HD water treatment units.
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Table 6. HD water treatment plants staff (maintenance technician) evaluation.
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Table 7. Efficiency of water samples in water treatment plants in dialysis units.
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Table 8. Chemical parameters of the collected water samples.
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Table 9. Minerals parameters of the collected water samples.
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Table 10. Bacteriology of the collected water samples.
5. Conclusion
Most of the studied units fulfill the standard specifications of both MOH and AAMI in some points only. Regarding the infrastructure of the studied units, they achieved the standers only in some points as the area of units, away from direct sun exposure, source of fed water is municipal, under supervision of the unit manager also regarding the process of sample water collection under supervision of both inspector of the community and public health department and the regional laboratories specialist under certain specification, and the forum of the results, but other points are still show some shortage as presence of most of units upstairs cause building affection, not all units use air conditioning as a method of lowering temperature, no biomedical engineer assigned for any of the studied units, no internal organized supervision by specific medical staff or specific checklist, delay and missed daily documentation of TDS and chlorine, no enough training of maintenance staff, and not all collected water samples matches the decree of 63 for 1996 from the first analysis which need to be revised and updated by Egyptian MOH for better outcome.
Appendix
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Table A1. Characteristics of the studied units.