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Dialysis Fluid Purity Best Practice Guidelines (and real life). Elizabeth Lindley St James’s University Hospital and Leeds General Infirmary Leeds, UK. European and National Guidelines. ERA-EDTA

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Dialysis fluid purity best practice guidelines and real life

Dialysis Fluid PurityBest Practice Guidelines(and real life)

Elizabeth LindleySt James’s University Hospital and Leeds General InfirmaryLeeds, UK


European and national guidelines
European and National Guidelines

  • ERA-EDTA

    • European Best Practice Guidelines for Haemodialysis Part 1Section 4: Dialysis Fluid PurityNephrol Dial Transplant (2002) 17 Suppl 7: 45-62

  • EDTNA/ERCA

    • Technical Guidelines for the Control and monitoring of microbiological contamination in water for dialysisEDTNA/ERCA Journal 2002; 28(3), 107-115

  • UK Renal Association

    • Guidelines 3rd EditionChapter 3: Haemodialysis(Draft, March 2002)

  • DGN Guidelines (draft edition)


  • Era guidelines
    ‘ERA’ guidelines

    • Drafted by Prof Bernard Canaud with input from the panel of experts in haemodialysis

      • The panel also covered when to refer patients and start dialysis, adequacy, biocompatibility, anti-coagulation, infection control and vascular disease.

  • Evidence-based where possible, otherwise expert opinion

    • Fresenius helped with extensive literature search

  • Circulated to the National Associations for comment and approval


  • Edtna guidelines
    ‘EDTNA’ guidelines

    • The EDTNA guidelines were developed after a survey of renal units in 14 countries showed the majority of units aimed to meet the EP limits for bacteria and endotoxin contamination

    BUT……

    • 40% had no policy for routine disinfection of the water distribution pipework

    • Only 50% were regularly testing the dialysis water for endotoxin

    • Most units were checking bacteria levels routinely, but often with unsuitable culturing conditions

    EDTNA technical members requested guidelines


    Edtna guidelines1
    ‘EDTNA’ guidelines

    • Drafted by a Project Group with help from Rolf Nystrand (Consultant Microbiologist)

      • Input from an panel of interested people from renal units, industry and the regulatory bodies, and from contributors to the Journal Club

  • Evidence-based where possible, otherwise expert opinion or good practice

  • Approved by the European Society for Artificial Organs and ERA-EDTA


  • National guidelines
    National guidelines

    • UK Renal Association Guidelines were drafted by two doctors and a scientist and posted on the internet for feedback

    • DGN guidelines were drafted by a group of nephrologists with input from chemists, microbiologists, technicians and expertise from the water supplier

      • This sounds like a good multidisciplinary approach


    In house quality assurance policies
    In-house quality assurance policies

    EDTNAguidelines

    Nationalguidelines

    ERAguidelines

    Local knowledgeandCOMMONSENSE!


    Do the guidelinesagree with each other?

    What do theyrecommend?


    Chemical quality chlorine
    Chemical quality - chlorine

    • Maximum allowed level:

      • ERA “Meet European Pharmacopoeia”


    50

    Ammonium not included in list. EP includes test for heavy metals


    Chemical quality chlorine1
    Chemical quality - chlorine

    • Maximum allowed level:

      • ERA Meet EP (Total chlorine < 0.1 ppm)

      • EDTNA Total chlorine < 0.1 ppm*

      • DGN Total chlorine < 0.1 ppm

    • Frequency of testing:

      • ERA Daily

      • EDTNA Daily* (longer intervals if justified)

      • DGN According to local circumstances

    * Guidelines on carbon adsorption, to be published soon


    Other daily testsERA Guideline IV.3.1 recommends daily checks of Ca and Mg (Hardness) & Na (conductivity)


    Leeds local policy on daily checks
    Leeds local policy on ‘daily’ checks

    • Conductivity is monitored continuously

      • Alarms should be checked regularly

    • Chlorine and hardness would only be checked daily in exceptional circumstances

      • Weekly monitoring for hardness (when brine tanks are filled) has been perfectly adequate

      • Weekly (where carbon filters are installed) or monthly monitoring for chlorine is justified

        • We have a history of relatively low chlorine levels (0.05 to 0.30 ppm) and a close relationship with our water supplier


    Other chemical contaminants
    Other chemical contaminants

    • Contaminants that should be checked:

      • ERA As minimum, specified in EP

      • EDTNA Will probably recommend EP plus any ‘local problems’

      • DGN 12 point list



    The nitrate problem
    The Nitrate Problem

    • Limit for tap water 50 ppm

    • Typical rejection by RO = 85 to 95%

      • Will reduce high nitrate tap water to about 5 ppm

      • To achieve 0.05 ppm would require a triple RO

    • EP requires 2 ppm as NO3

    • AAMI requires 2 ppm as N ( 9 ppm as NO3)

      • US experts say this has not led to any problems

    • Is the EP evidence based……


    Highly purified water
    Highly purified water

    • (Question from Roelf Smit) Is highly purified water with conductivity below 1.1 µS/cm really required for HDF?

    • (My opinion, not EDTNA) Meeting this strict requirement on conductivity would be very expensive and it seems to be unnecessary.

      • Conductivity is mainly due to Na (especially if water has been softened

      • About 137 mmol/l of Na will be added to the water


    I would invest in keeping the distribution system free from bacteria (which are absolutely forbidden in HDF substitution fluid), rather than water that is free from sodium


    Testing for chemical contaminants
    Testing for chemical contaminants bacteria (which are absolutely forbidden in HDF substitution fluid), rather than water that is free from sodium

    • Frequency of testing (after validation):

      • ERA Six-monthly (quarterly in Appendix) Monthly tests for aluminium

      • EDTNA Will probably recommend 6 to 12 monthly More frequent for Al? Local decision


    Data from the RUDIAL Test Service provided by ALcontrol Labs for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)


    Sampling water for microbiological tests
    Sampling water for microbiological tests for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Frequency of testing:

      • ERA At least monthly (after validation)

      • EDTNA At least monthly (after validation)

    • Where to sample:

      • ERA Incoming (tap) water Entrance to dialysis machines

      • EDTNA At points in treated water loop with highest bacterial load


    Testing substitution fluid could be a problem. for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months) “Sterile” = <1 cfu/1000 litresA good, practical test procedure is required(e.g. Using an in-line filter during a normal HDF session)


    Sampling water for microbiological tests1
    Sampling water for microbiological tests for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Sample ports:

      • ERA Flame sterilised taps

      • EDTNA Specialised ports, flame sterilised or alcohol disinfected taps

    • Sample storage:

      • ERA Time not specified, 3 to 6°C

      • EDTNA Up to 6 hrs at <10°C (not frozen) Longer if in validated conditions

    All guidelines prefer immediate testing


    Bacteria levels in water
    Bacteria levels in water for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Maximum level (for conventional dialysis):

      • ERA <100 cfu/ml (but aim for ultrapure)

      • EDTNA <100 cfu/ml (but aim for ultrapure)

      • DGN also <100 cfu/ml

    • Test methods:

      • ERA TGEA or R2A, 20 to 22°C, 7 days

      • EDTNA TGEA or R2A, 20 to 22°C, 7 days

      • DGN TGEA or R2A, 17 to 23°C, 5-7 days


    Endotoxin levels in water
    Endotoxin levels in water for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Maximum level (for conventional dialysis):

      • ERA <0.25 IU/ml (but aim for ultrapure)

      • EDTNA <0.25 IU/ml (but aim for ultrapure)

      • DGN also <0.25 IU/ml <0.03 IU/ml for on-line HDF

    • Test methods:

      • ERA LAL assay

      • EDTNA LAL assay or other validated technique


    Aside why i like to check endotoxin
    Aside - why I like to check endotoxin for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Bacteria in the distribution system, will be producing waste products that that can pass through a dialyser membrane(e.g. pyocyanin - see caption).

    • We don’t test for waste products, only for actively reproducing bacteria and endotoxin.

    • Something could happen to stop the bacteria reproducing (e.g. UV irradiation) but for gram-negative bacterial endotoxin will still be there

    Pyocyanin producedby P. aeruginosa in adialysis fluid sample.This pigment makes pus in infected wounds go blue or green.


    Maintenance
    Maintenance for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Changes of resins, carbon and filter

      • ERA Periodic according to manufacturer’s recommendations and microbiology

      • EDTNA (Carbon) according to manufacturer’s recommendations and microbiology

    • Disinfection of RO(s) and distribution system:

      • ERA At least once a month

      • EDTNA At intervals based on microbiology, default = at least once a month


    But water is not the final product
    But water is not the final product…. for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • What do the guidelines say about dialysis fluid?

      • ERA:

        • Use same sampling, storage & testing procedures as water

        • Meet EP guidelines (ambiguous for standard dialysis)

        • Perform ‘micro-biological’ check-up of all machines monthly

      • EDTNA:

        • Take samples from in-line ports or the dialyser outlet

        • Use the same culturing technique (and limits) as for water

        • Modify disinfection protocols if endotoxin levels > water

        • Check a representative sample of machines each month

      • DGN:

        • Use same limits for dialysis fluid as for purified water


    Testing dialysis fluid in real life
    Testing dialysis fluid in real life for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • For my centre, to meet the ERA requirement would mean sampling and testing over 160 machines each month

      • This would cost over 30000 Euros per year

      • What would the benefit be?

    • Our current policy is to test a sample of machines in each location so that every machine is tested on a 6 monthly or annual basis


    Minimising the cost of tests 1
    Minimising the cost of tests (1) for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Bacteria

      • Accredited tests in labs are costly - negotiate a ‘low resolution’ or ‘indicative’ test with simplified counting

        • Actual count up to 50

        • Nearest 10 from 50 to 200

        • >200

        • >2000

      • Develop an in-house test procedure


    In house bacteria tests
    In-house bacteria tests for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)


    Incubate in a secure for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months) cupboard. I have an old laboratory incubator - the temperature controller doesn’t work but it’s okay for culturing at room temperature


    In house testing bacteria
    In-house testing - bacteria for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Problems

      • A good relationship with microbiology is essential

      • Health and safety assessment required

    • Advantages

      • Cheap (~60 cents per sample)

      • Quick (no booking or sample forms)

      • Plates can be checked easily

      • No chasing up of results

      • You can incubate for 14 days (for moulds)

      • You get to see the colonies


    Moulds on a plate incubated for 14 days
    Moulds on a plate incubated for 14 days for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)


    The value of dilution
    The value of dilution for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)


    Minimising the cost of tests 11
    Minimising the cost of tests (1) for about 54 Euros per location. (The labs send us the 5 sample bottles required for each location every 6 months)

    • Endotoxin

      • External labs are expensive - negotiate a special price for many samples with only one or two positive controls

      • In-house gel-clot tests are time consuming and costly when multiple dilutions are required - form a local group and lease an automated analyser


    Kinetic LAL test kit leased jointly by the renal units in West Yorkshire. I do routine tests on the first and third Tuesday of each month. This works out at about 11 Euros per sample



    Kinetic analyser
    Kinetic analyser pipette out small volumes accurately

    • Problems

      • Space required for kit

      • Training required for staff

    • Advantages

      • Compared to in-house gel-clot tests

        • Cheaper and quicker for large number of tests

        • No water bath, no careful timing

      • Compared to external lab

        • Cheaper for large number of tests

        • No chasing up of results

        • Unexpected results can be checked immediately


    Conclusions
    Conclusions pipette out small volumes accurately

    • The Best Practice Guidelines are in reasonable agreement

      • Especially for microbiological testing

    • Local practice must depend on local conditions

    • Invest in high quality equipment not a more expensive monitoring programme!

      • EDTNA guidelines include advice on system design


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