All Wales Renal Network Renal Dialysis Unit Water Treatment System Audit Andrew Long Head of Renal Technical Services ABM ULHB

Transcription

1 All Wales Renal Network Renal Dialysis Unit Water Treatment System Audit 2013 Andrew Long Head of Renal Technical Services ABM ULHB

2 Introduction What are the specifications we should be complying with? What type of water treatment systems do we use? What testing regimes are in place? What contingency plans are in place? What can we do to improve?

3 First a little background info

4 Mains Water Pre treatment Mains water preferably NOT from hospital tank system Break tank provides a physical air gap between mains water and the dialysis system Filter to remove any solids Softener to remove calcium/ magnesium etc. Carbon to adsorb chlorine R O 1 Break tank F i l t e r S o f t e n e r C a r b o n R O 2 Treated Water UV Older style of water treatment system Two ROs (duty & standby) they run alternatively feeding a large holding tank Water from this tank is pumped around the dialysis unit ring main. The ROs & ring main will need to be cleaned chemically (out of hours when the unit is closed). Dylade DS Cobe C3 Gambro ARTIS Dialysis unit ring main Fresenius 5008 Bbraun Dialog Nikiso

5 Mains Water Pre treatment Mains water preferably NOT from hospital tank system Break tank provides a physical air gap between mains water and the dialysis system Filter to remove any solids Softener to remove calcium/ magnesium etc. Carbon to adsorb chlorine Heating unit Heat disinfects the RO membranes & the ring main Heater unit Break tank F i l t e r S o f t e n e r C a r b o n R O 1 R O 2 Two RO units in series Gambro ARTIS Two ROs in series (in line) water passes through both ROs, and both are running constantly. The heater unit heat cleans the ROs & ring main overnight and on Sundays. Dylade DS Cobe C3 Dialysis unit ring main Fresenius 5008 Bbraun Dialog Nikiso

6 Mains Water Break tank Pre treatment Mains water preferably NOT from hospital tank system Break tank provides a physical air gap between mains water and the dialysis system Filter to remove any solids Softener to remove calcium/ magnesium etc. Carbon to adsorb chlorine F i l t e r S o f t e n e r C a r b o n R O 1 R O 2 Heater unit U l t r a f i l t e r Duty & standby with separate ultrafilter Gambro ARTIS Two ROs (duty & standby) they run alternatively, feeding an ultra filter which will remove all biofilm & endotoxins. The heater unit will heat disinfect the ring main overnight as required. The ROs will need to be cleaned chemically as required. Dylade DS Cobe C3 Dialysis unit ring main Nikiso Fresenius 5008 Bbraun Dialog

7 Guidance document prepared by the Renal Association & The association of Renal Technologists. Based upon the following international standards BS ISO 13959; 2009: Water for haemodialysis and related therapies, BS ISO 13958; 2009: Concentrates for haemodialysis and related therapies, BS ISO 11663; 2009: Quality of dialysis fluid for haemodialysis and related therapies (1-3). In addi BS ISO 26722; 2009: Water treatment equipment for haemodialysis and related therapies (4). BS ISO 23500; 2011: Guidance for the preparation and quality management of fluids for haemodialysis addresses the quality management of the water treatment system and distribution loop within the renal unit (5

8 The RA/ART guidelines recommend that the minimum frequency of monitoring of water for dialysis should be as follows Contaminant Total chlorine Total viable counts Endotoxin Chemical contaminants other than chlorine Frequency of testing At least weekly At least monthly At least monthly At least every 3 months

9 Chemical & mineral contaminants Table 1: Maximum allowable concentrations of chemical contaminants in dialysis water for which monitoring is mandatory (reproduced from ISO and EP) Table 2: Maximum allowable concentrations of chemical contaminants in dialysis water which may be omitted from routine monitoring (reproduced from ISO and EP) Table 3: Maximum allowable concentrations of chemical contaminants in dialysis water which only require monitoring when indicated. Chemical contaminant Maximum recommended concentration (mg/l=ppm) Chemical contaminant Maximum recommended concentration (mg/l=ppm) Chemical contaminant Maximum recommended concentration (mg/l = ppm) Aluminium 0.01 Calcium 2 (0.05mmol/l) Total chlorine* 0.1 Copper 0.1 Fluoride 0.2 Magnesium 2 (0.08 mmol/l) Nitrate (as N) 2 (equates to 9 mg/l NO 3 ) Ammonium 0.2 Arsenic Cadmium Chloride 50 Chromium Lead Mercury Barium 0.1 Beryllium Silver Thallium Zinc 0.1 Potassium Sodium 2 (0.05 mmol/l) 50 (2.2 mmol/l Sulphate 50

10 Microbiological contaminants Dialysis fluid Ultrapure dialysis fluid < 100 CFU/ml for bacteria < 0.1 CFU/mLfor bacteria < 0.25 EU/ml for endotoxin < 0.03EU/mL. for endotoxin

11 Interpretation of Colony Forming Units & Endotoxin levels

12 Now the data! Responses from 20 units, 2 did not respond (this may be my fault not theirs)

13 The Units Renal Unit Dialysis area Operating Body Renal Unit Dialysis area Operating Body Cardiff Main Dialysis Unit, Critical Care, Ward 5 C&VUHB Bangor Main Unit Bbraun Avitum UK Transplant Unit C&VUHB Satellite Bbraun Avitum UK West Wing FMC Ysbyty Glan Clwyd Main Unit FMC North RDU (PENTWYN): Satellite Bbraun Avitum UK Morriston Main Unit ABMUHB Llantrisant Satellite FMC Annexe ABMUHB Newport Satellite Bbraun Avitum UK Self Care Wrexham Main Unit BCUHB Carmarthen FMC ABMUHB Cunliffe HDU BCUHB Aberystwyth FMC ITU/HDU BCUHB Withybush FMC Welshpool BCUHB QE Birmingham Llandridnod Wells FMC

14 Number of dialysis stations served by water treatment system Ysbyty Glan Clwyd Wrexham main Wrexham Cunliffe Wrexham ITU/HDU Withybush UHW transplant UHW main unit Newport Renal Unit Morriston self care Morriston main unit Morriston annexe Llantrisant Llandrindod Wells Carmarthen Cardiff west wing Cardiff north pentwyn Bangor satelite Unit Bangor Dialysis Unit (Main) temporary Aberystwyth

15 All units have central water treatment systems apart form the self care unit at Morriston which uses independent stand alone ROs at each dialysis point

16 Ages of water treatment systems Ysbyty Glan Clwyd Wrexham main Wrexham Cunliffe Wrexham ITU/HDU Withybush UHW transplant UHW main unit Newport Renal Unit Morriston self care Morriston main unit Morriston annexe Llantrisant Llandrindod Wells Carmarthen Cardiff west wing Cardiff north pentwyn Bangor satelite Unit Bangor Dialysis Unit (Main) temporary Aberystwyth

17 Age of the Water Plant Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 Main tank: 16 years RO: 8 years Bangor Main Unit 2009?? Transplant Unit 3 years Satellite temp. Plant?? West Wing > 15 yrs Ysbyty Glan Clwyd North RDU (PENTWYN): Satellite Main Unit 2 years 5 years Morriston Main Unit 19 years Llantrisant Satellite 7 yrs Annexe 8 years Newport Satellite 14 yrs Self Care 3 years Wrexham Main Unit 16 yrs Carmarthen 5 Cunliffe HDU 6 yrs Aberystwyth 5??? ITU/HDU 6 yrs Withybush 5 Welshpool <1 year QE Birmingham Llandridnod Wells 2 yrs

18 Types of RO & those producing Ultrapure water in yellow Unit Dialysis area Single pass RO Single pass RO with Ultrafilter Double pass RO Cardiff Main Dialysis Unit, Critical Care, Ward 5 Single Pass duty standby No No Transplant Unit Single pass + ultafilter Yes No West Wing DWA No No Pentwyn North yes yes No Llantrisant Satellite Single Agua Safe 08?? Newport Satellite yes yes No Wrexham Main Unit 2 units single pass No No Cunliffe HDU yes No No ITU/HDU yes No No Welshpool No no Yes Bangor Main Unit? 2 Units (one on standby)? Satellite DWA?? Ysbyty Glan Clwyd Main Unit? yes No Morriston Main Unit Yes No No Annexe No No yes Self Care Yes No No Carmarthen DWA yes No Aberystwyth Aqua B No No Withybush Aqua B No No QE Birmingham Llandridnod Wells Yes no No

19 RO cleaning regime & frequency Unit Dialysis area Cleaning regime frequency of RO cleaning Cleaning of ring main Cardiff Main Dialysis Unit, Critical Care, Ward 5 Chemical When required When CFU reading starts to rise Transplant Unit Chemical Yearly Twice/week West Wing? Yearly Annually Pentwyn North Heat Weekly Weekly Llantrisant Satellite?? Annually Newport Satellite Chemical 3 monthly Quarterly Wrexham Main Unit chemical Yearly Annually Cunliffe HDU Chemical Yearly Annually ITU/HDU Chemical Yearly Annually Welshpool Chemical Depends upon results Dependant upon results Bangor Main Unit Chemical 6 monthly H: 3 times/wk Chemical: Twice/year Satellite Chemical 3 monthly Quarterly Ysbyty Glan Clwyd Main Unit Both Heat: 3/ week H: 3 times/wk Morriston Main Unit No Chemical : annually C: yearly Chemical when required When needed When needed Annexe Heat Daily 3 times/wk Self Care Both H&C Alternate Weeks N/A Carmarthen Heat Weekly Annually Aberystwyth Chemical Yearly Annually Withybush Chemical Yearly Annually QE Birmingham Llandridnod Wells Chemical Yearly Annually or when needed

20 Mandatory tests for trace Elements Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 Twice yearly Bangor Main Unit Twice yealy Transplant Unit Twice yearly Satellite Twice Yearly West Wing North RDU (PENTWYN): Satellite Ysbyty Glan Clwyd Main Unit Quarterly Quarterly Morriston Main Unit Quarterly Llantrisant Satellite Quarterly Annexe Quarterly Newport Satellite Quarterly Self Care Quarterly Wrexham Main Unit Quarterly Carmarthen Quarterly Cunliffe HDU Quarterly Aberystwyth Quarterly ITU/HDU Quarterly Withybush Quarterly Welshpool Quarterly QE Birmingham Llandridnod Wells Quarterly

21 Chlorine & Chloramine Testing Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 Weekly Bangor Main Unit Thrice Daily Transplant Unit Weekly Satellite Twice Daily West Wing Daily Ysbyty Glan Clwyd North RDU (PENTWYN): Satellite Main Unit Daily Daily Morriston Main Unit Daily Llantrisant Satellite Daily Annexe Daily Newport Satellite Twice Daily Self Care Weekly Wrexham Main Unit Daily Carmarthen Daily Cunliffe HDU Daily Aberystwyth Daily ITU/HDU Daily Withybush Daily Welshpool Daily QE Birmingham Llandridnod Wells Daily

22 Testing for Endotoxins Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 Monthly Bangor Main Unit Monthly Transplant Unit Monthly Satellite Monthly West Wing Monthly Ysbyty Glan Clwyd North RDU (PENTWYN): Satellite Main Unit Monthly Monthly Morriston Main Unit Weekly Llantrisant Satellite Monthly Annexe Monthly Newport Satellite Monthly Self Care Monthly Wrexham Main Unit Monthly Carmarthen Monthly Cunliffe HDU Monthly Aberystwyth Monthly ITU/HDU Monthly Withybush Monthly Welshpool Monthly, or more frequently if required QE Birmingham Llandridnod Wells Monthly

23 Testing for CFUs & TVCs Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 Monthly Bangor Main Unit Monthly Transplant Unit Monthly Satellite Monthly West Wing Monthly Ysbyty Glan Clwyd North RDU (PENTWYN): Satellite Main Unit Monthly Quarterly Morriston Main Unit Weekly Llantrisant Satellite Monthly Annexe Weekly Newport Satellite Monthly; Weekly on machines Self Care Not done Wrexham Main Unit Monthly Carmarthen Monthly Cunliffe HDU Monthly Aberystwyth Monthly ITU/HDU Monthly Withybush Monthly Welshpool Monthly QE Birmingham Llandridnod Wells Monthly

24 Are procedures/systems in place for results that are outside allowable limits? Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 Yes Bangor Main Unit Yes Transplant Unit Yes Satellite Yes West Wing Yes Ysbyty Glan Clwyd North RDU (PENTWYN): Satellite Main Unit Yes Morriston Main Unit Yes Llantrisant Satellite Yes Annexe Yes Newport Satellite Yes Self Care Yes Yes Wrexham Main Unit Yes Carmarthen Yes Cunliffe HDU Yes Aberystwyth Yes ITU/HDU Yes Withybush Yes Welshpool Yes QE Birmingham Llandridnod Wells Yes

25 Emergency plan if water system fails? Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 Yes Bangor Main Unit Yes Transplant Unit Yes Satellite Yes West Wing Yes Ysbyty Glan Clwyd North RDU (PENTWYN): Satellite Main Unit Yes Yes Morriston Main Unit Yes Llantrisant Satellite Yes Annexe Yes Newport Satellite Yes Self Care Yes Wrexham Main Unit Yes Carmarthen Yes Cunliffe HDU Yes Aberystwyth Yes ITU/HDU Yes Withybush Yes Welshpool Yes QE Birmingham Llandridnod Wells Yes

26 Written policy if water system fails? Unit Dialysis area Unit Dialysis area Cardiff Main Dialysis Unit, Critical Care, Ward 5 No Bangor Main Unit Yes Transplant Unit No Satellite Yes West Wing Yes Ysbyty Glan Clwyd North RDU (PENTWYN): Satellite Main Unit Yes Yes Morriston Main Unit Yes Llantrisant Satellite Yes Annexe Yes Newport Satellite Yes Self Care Yes Wrexham Main Unit Yes Carmarthen Yes Cunliffe HDU Yes Aberystwyth Yes ITU/HDU Yes Withybush Yes Welshpool In Process QE Birmingham Llandridnod Wells Yes

27 Conclusion The majority of units comply with the RA/ART guidelines on testing All units are producing water suitable for haemodialysis, some are producing ultrapure water Water treatment facilities are getting older and as a result will become more likely to fail (Nick Wilson is on the case ).

28 Recommendations All units should have documented procedures in place for dealing with, water results that are outside of limits. There should be contingency plans in place if There should be contingency plans in place if the water treatment plant should fail.

29 Thanks to Dr Mikhail Mahdi Jibani Jane Tyler Stuart Robertson Jim Blackie Liz Cariello Aled Lewis Semitha Utham Chris Allbet Kim Williams