all wales renal network renal dialysis unit water treatment system … quality audit... ·...

Andrew Long

All Wales Renal Network

Renal Dialysis Unit Water Treatment System

Audit 2013

Andrew Long

Head of Renal Technical Services

ABM ULHB

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 testing regimes are in place?

• What contingency plans are in place?

• What can we do to improve?

First a little background info

Break

tank

F

i

l

t

e

r

S

o

f

t

e

n

e

r

C

a

r

b

o

n

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

2

R

O

1

Treated

Water UV

• 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).

Gambro ARTIS

Fresenius 5008

BbraunDialog

Nikiso

Cobe C3

DyladeDS

Dialysis unit

ring main

Older style of water treatment system

R

O

2

R

O

1

Heater unit

Break

tank

F

i

l

t

e

r

S

o

f

t

e

n

e

r

C

a

r

b

o

n

Mains

Water

Pre treatment







Heating unitHeat disinfects the RO membranes & the ring main

Gambro ARTIS

Fresenius 5008

BbraunDialog

Nikiso

Cobe C3

DyladeDS

Dialysis unit

ring main

• 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.

Two RO units in series

Break

tank

F

i

l

t

e

r

S

o

f

t

e

n

e

r

C

a

r

b

o

n

Mains

Water

Pre treatment







R

O

2

R

O

1

U

l

t

r

a

f

i

l

t

e

r

Heater unit

Gambro ARTIS

Fresenius 5008

BbraunDialog

Nikiso

Cobe C3

DyladeDS

Dialysis unit

ring main

• 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.

Duty & standby with separate ultrafilter

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,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

Contaminant Frequency of testing

Total chlorine At least weekly

Total viable counts At least monthly

The RA/ART guidelines recommend that the minimum frequency

of monitoring of water for dialysis should be as follows

Endotoxin At least monthly

Chemical contaminants other

than chlorine

At least every 3 months

Table 1: Maximum allowable concentrations of

chemical contaminants in dialysis water for

which monitoring is mandatory (reproduced from

ISO 13959 and EP)

Table 2: Maximum allowable concentrations

of chemical contaminants in dialysis water

which may be omitted from routine monitoring

(reproduced from ISO 13959 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)

Aluminium 0.01

Calcium 2 (0.05mmol/l)

Total chlorine* 0.1

Chemical

contaminant

Maximum recommended

concentration (mg/l=ppm)

Ammonium 0.2

Arsenic 0.005

Cadmium 0.001

Chemical

contaminant

Maximum recommended

concentration (mg/l = ppm)

Barium 0.1

Beryllium 0.0004

Silver 0.005

Chemical & mineral contaminants

Copper 0.1

Fluoride 0.2

Magnesium 2 (0.08 mmol/l)

Nitrate (as N) 2 (equates to 9 mg/l NO3)

Potassium 2 (0.05 mmol/l)

Sodium 50 (2.2 mmol/l

Cadmium 0.001

Chloride 50

Chromium 0.014

Lead 0.005

Mercury 0.0002

Sulphate 50

Thallium 0.002

Zinc 0.1

Microbiological contaminants

Dialysis fluid Ultrapure dialysis fluid

< 100 CFU/ml for bacteria < 0.1 CFU/mL for bacteria < 100 CFU/ml for bacteria

< 0.25 EU/ml for endotoxin

< 0.1 CFU/mL for bacteria

< 0.03EU/mL. for endotoxin

Interpretation of Colony Forming Units & Endotoxin levels

Now the data !

Responses from 20 units, 2 did not respondResponses from 20 units, 2 did not respond

(this may be my fault not theirs)

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

The Units

Llantrisant Satellite FMC Annexe ABMUHB

Newport Satellite Bbraun Avitum

UK

Self Care ABMUHB

Wrexham Main Unit BCUHB Carmarthen FMC

Cunliffe HDU BCUHB Aberystwyth FMC

ITU/HDU BCUHB Withybush FMC

Welshpool BCUHB QE Birmingham Llandridnod Wells FMC

Morriston self care

Newport Renal Unit

UHW main unit

UHW transplant

Withybush

Wrexham ITU/HDU

Wrexham Cunliffe

Wrexham main

Ysbyty Glan Clwyd

Number of dialysis stations served by water treatment system

0 10 20 30 40 50 60 70 80

Aberystwyth

Bangor Dialysis Unit (Main) temporary

Bangor satelite Unit

Cardiff north pentwyn

Cardiff west wing

Carmarthen

Llandrindod Wells

Llantrisant

Morriston annexe

Morriston main unit

Morriston self care

All units have central water treatment systems

apart form the self care unit at Morriston which

uses independent stand alone ROs at each

dialysis pointdialysis point

Morriston self care

Newport Renal Unit

UHW main unit

UHW transplant

Withybush

Wrexham ITU/HDU

Wrexham Cunliffe

Wrexham main

Ysbyty Glan Clwyd

Ages of water treatment systems

0 2 4 6 8 10 12 14 16 18 20

Aberystwyth

Bangor Dialysis Unit (Main) temporary

Bangor satelite Unit

Cardiff north pentwyn

Cardiff west wing

Carmarthen

Llandrindod Wells

Llantrisant

Morriston annexe

Morriston main unit

Morriston self care

Unit Dialysis area Unit Dialysis area



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

Main Unit 2 years

North RDU

(PENTWYN):

5 years Morriston Main Unit 19 years

Age of the Water Plant

(PENTWYN):

Satellite

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

Unit Dialysis area Single pass RO Single pass RO with Ultrafilter Double pass RO

CardiffMain Dialysis Unit, Critical

Care, Ward 5Single Pass duty standby No No

Transplant Unit Single pass + ultafilter Yes No

West Wing DWA No No

Pentwyn Northyes 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

Types of RO & those producing Ultrapure water in yellow

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

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 AnnuallyITU/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




Twice yearly Bangor Main Unit Twice yealy

Transplant Unit Twice yearly Satellite Twice Yearly

West Wing Ysbyty Glan

Clwyd

Main Unit Quarterly

North RDU

(PENTWYN):

Quarterly Morriston Main Unit Quarterly

Mandatory tests for trace Elements

(PENTWYN):

Satellite

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




Weekly Bangor Main Unit Thrice Daily

Transplant Unit Weekly Satellite Twice Daily

West Wing Daily Ysbyty Glan

Clwyd

Main Unit Daily

North RDU

(PENTWYN):

Daily Morriston Main Unit Daily

Chlorine & Chloramine Testing

(PENTWYN):

Satellite

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




Monthly Bangor Main Unit Monthly

Transplant Unit Monthly Satellite Monthly

West Wing Monthly Ysbyty Glan

Clwyd

Main Unit Monthly

North RDU

(PENTWYN):

Satellite

Monthly Morriston Main Unit Weekly

Testing for Endotoxins

Satellite

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




Monthly Bangor Main Unit Monthly

Transplant Unit Monthly Satellite Monthly

West Wing Monthly Ysbyty Glan

Clwyd

Main Unit Monthly

North RDU

(PENTWYN):

Satellite

Quarterly Morriston Main Unit Weekly

Testing for CFUs & TVCs

Satellite

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




Yes Bangor Main Unit Yes

Transplant Unit Yes Satellite Yes

West Wing Yes Ysbyty Glan

Clwyd

Main Unit Yes

North RDU

(PENTWYN):

Yes Morriston Main Unit Yes

Are procedures/systems in place for results that are

outside allowable limits?

(PENTWYN):

Satellite

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



Critical Care, Ward

5

Yes Bangor Main Unit Yes

Transplant Unit Yes Satellite Yes


Clwyd

Main Unit Yes

North RDU

(PENTWYN):

Satellite


Emergency plan if water system fails?

Satellite






Welshpool Yes QE

Birmingham

Llandridnod Wells Yes



Critical Care, Ward

5

No Bangor Main Unit Yes

Transplant Unit No Satellite Yes


Clwyd

Main Unit Yes

North RDU

(PENTWYN):

Satellite


Written policy if water system fails?

Satellite






Welshpool In Process QE Birmingham Llandridnod Wells Yes

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 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 ).

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.

Thanks to

Dr MikhailMahdi JibaniJane TylerStuart RobertsonJim BlackieLiz CarielloLiz CarielloAled LewisSemitha UthamChris AllbetKim Williams

all wales renal network renal dialysis unit water treatment system … quality audit... ·...

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