Clinical practice guidelines for the provision of renal service in Hong Kong: Haemodialysis

Guideline statements 1.1.1 Disinfection procedure guidelines for reverse osmosis (RO) machine and loop (as recommended by manufacturer). (R) 1.1.2 Written documentation of absence of disinfectant for RO and loop post disinfection. (R) 1.1.3 Daily recording of RO operational parameters, including pressures, incoming water temperature, rejection rate of RO water. (R) 1.1.4 Central station monitoring or alarm system for water treatment plant. (D) Guideline statements 1.2.1 Procedure guidelines on preparation of the machine for HD/HDF. (R) 1.2.2 Procedure guidelines for putting patient on HD/HDF. (R) 1.2.3 Procedure guidelines for taking patient off HD/HDF. (R) 1.2.4 Guidelines on disinfection and aftercare of HD/HDF machine. (R) 1.2.5 Documentation for absence of residual disinfectants for machines requiring manual chemical disinfection. (R) 1.2.6 Documentation of water quality according to the guideline 2. (R) Guideline statements 1.3.1 Infection control guidelines regarding handling of body fluids, handling of spills and decontamination procedures, sharps disposal and contingency plan on exposure of needle stick injury. (R) 1.3.2 Guidelines on proper handling of disinfectants and decontamination facilities for accidental spills. (R) 1.3.3 Appropriate personal protect equipment should be provided for staff handling the disinfectants. (R) Guideline statements 1.4.1 Contingency guidelines for suspension of water, electricity supply and fire hazard. (R) 1.4.2 Clinical guidelines for patient's management on exhibition of the symptoms of disinfectant toxicity. (R) 1.4.3 Resuscitation guidelines. (R) Guideline statements 1.5.1 Guidelines on repair of RO. (R) 1.5.2 Notification and written documentation on the completion of maintenance/repair work of RO. (R) 1.5.3 Service/maintenance record of all electronic/electric dialysis equipment. (R) Background and rationale Guidelines 1.1.1 to 1.5.3 The guidelines are modified from existing recommendations1 and should be in place for safe operation of the water treatment system and HD machine. Audit items Safety procedure checklist and procedure guidelines for water treatment system and dialysis equipment. Guideline statements 2.1.1 For culture, total viable counts (colony-forming units (CFU)) should be tested by the membrane filtration, spread plate or pour plate technique using Tryptone Glucose Extract Agar (TGEA), Reasoner's Agar 2A (R2A) or equivalent culture medium. (R) 2.1.2 Endotoxin should be tested using the limulus amoebocyte lysate (LAL) method. (R) Guideline statements 2.2.1 Sample should be collected from a point in the distal segment of the loop, immediately prior to where water returns to the RO, or immediately prior to where the water re-enters the storage tank, if one is present. (R) 2.2.2 Measurements of the inorganic contaminants (Table A1) should be done at least annually by accredited laboratories. (R) 2.2.3 Microbiological quality of the RO water should be <100 CFU/mL for bacteria and <0.25 endotoxin units (EU)/mL for endotoxin. (R) 2.2.4 If the bacterial count is ≥50 CFU/mL or the endotoxin level is ≥0.125 EU/mL, disinfection and retesting should be commenced immediately. (R) 2.2.5 Monitoring of the microbiological quality of the RO water should be done at least monthly. (R) Guideline statements 2.3.1 Sample should be collected at the inlet line of the dialyzer. (R) 2.3.2 For HD using low flux membranes, the microbiological quality of the dialysis fluid should be <100 CFU/mL for bacteria and <0.5 EU/mL for endotoxin. (R) 2.3.3 If the bacterial count is ≥50 CFU/mL or the endotoxin level is ≥0.25 EU/mL, disinfection and retesting should be commenced immediately. (R) 2.3.4 For HD using high flux membranes (also known as high-flux HD), the microbial standards same as that for HDF is highly desirable (guideline 2.3.5). (D) 2.3.5 For HDF, the microbiological quality of the dialysis fluid should be <0.1 CFU/mL for bacteria and <0.03 EU/mL for endotoxin (also known as ultrapure dialysis fluid). (R) 2.3.6 Monitoring of the microbiological quality of the dialysis fluid should be done at least monthly, rotated among machines so that each machine is tested at least once per year. (R) Guideline statements 2.4.1 Sample should be collected from the replacement line. (R) 2.4.2 Microbiological quality of the substitution fluid should be <0.1 CFU/mL for bacteria and <0.03 EU/mL for endotoxin. (R) 2.4.3 Monitoring of the microbiological quality of the substitution fluid should be done at least monthly on every machine. (R) Background and rationale Quality of drinking water unlikely fulfills all the ANSI/AAMI/ISO standards and should be treated before it is safe to prepare the dialysis fluid. In Hong Kong, the higher total chlorine and fluoride levels in drinking water are intended for prevention of bacterial growth and dental protection, respectively2, 3 (Table A1). On the other hand, a higher nitrate level may reflect the use of synthetic nitrogen fertilizers and livestock manure in agriculture as around 70%–80% of the drinking water is from Dongjiang.4, 5 Dialysis fluid, prepared by mixing the RO water and dialysate concentrates, is an essential component in HD and related therapies. The water for reprocessing dialyzers, the substitution fluid for online HDF and haemofiltration is also produced from the RO water. Any chemical or microbiological contaminants in the RO water, dialysis fluid and substitution fluid could cause serious and even fatal consequences. The rationale for the development of these guidelines is to set standards for known chemical and microbiological contaminants in the treated water, dialysis and substitution fluids, and to protect patients from adverse events arising from these contaminants. Some of these guideline statements are made reference to the existing guidelines.6, 7 Use of ultrapure dialysis fluid is highly desirable for high-flux HD because of the concern of back-transport phenomena. There is increasing evidence that use of ultrapure dialysis fluid decreases markers of inflammation and oxidative stress, increases serum albumin, lessens anaemia, decreases erythropoietin requirement and preserves residual renal functions.8, 9 Moreover, high flux HD using an ultrapure dialysis fluid is found to have better cardiovascular event-free survival and overall survival.10 Finally, guidelines supporting the regular use of ultrapure dialysis fluid for all HD modalities have also been published.11-14 Sterile fluid should contain bacterial count <10−6 CFU/mL and endotoxin <0.03 EU/mL. Such criteria should apply to the online-produced substitution fluid for HDF or haemofiltration. However, bacterial count of <10−6 CFU/mL cannot be demonstrated by culture method unless sample volume up to 1000 L is collected. Because of this, the recommended microbiological standards for substitution fluid are same as those for ultrapure dialysis fluid for practical reason. There is recommendation that monitoring of the microbiological quality for the online produced substitution fluid is not necessary if the source fluid is of an ultrapure quality and the production path are fitted with a bacteria- and endotoxin-retentive filter validated by the manufacturer and operated and monitored according to the manufacturer's instructions.6, 7 Given the increasing interest in high volume HDF in which large volume of substitution fluid infuses directly into patient's blood stream, the workgroup would adopt a and monitoring to quality of the substitution fluid. should be that quality of the online produced fluid on of the bacteria- and endotoxin-retentive and of the be by disinfection Moreover, it been that a of dialysis fluid and substitution fluid to the standards even the Audit items fluid quality endotoxin and Guideline statements should have facilities for dialysis fluid and for control of (R) dialysis is recommended to use of HD machines from the same 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with serum also demonstrated survival with high-flux among those with In the in the high-flux and However, a post a with high-flux dialysis on cardiovascular event-free survival among those with these the that high-flux should be and patients with serum albumin, dialysis or should be a for of high-flux Guideline HDF is an of treatment to HD in HD (R) Background and rationale the HDF to or high-flux one the and cardiovascular with HDF with high-flux The other including the the and the found of HDF on from on the of HDF HD HDF the of in patients with renal other not of dialysis on For the volume of HDF and survival in patients with a substitution volume L per The that the of in the patient treated with the In a post in the the of patients treated with a substitution volume L per better cardiovascular and overall survival with the high-flux HD the post in the a and in patients and these it that higher volume is with better survival in HDF are before HDF be recommended for HD Guideline 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