WTS Audit (V3 September 2016)

• Document No.

• Audit Title

• Clinic Name

• Clinic Number

• Conducted on

  Date

• Prepared by

• Date & Time Audit commenced

  Date

• Clinic Name

• Clinic Number

• Address
  Address

• Phone No.

• Head Nurses Name

• Head Nurses Email

• Operation Managers Name

• Operation Managers Email and Phone No.

• Number of Dialysis Stations

• Technical Services provided by (Company)-

• Photo of the outside of the clinic

  Media

WTS SPECIFICATIONS

• Brand of WTS

• Make

• Model

• Year Installed

• Is there a Accurate Flow diagram within the Plant Room

  Yes

  No

  N/A

PRE-TREATMENT

• Heavy Metal Raw Water Analysis undertaken in last 12 months

  Yes

  No

  N/A

• Does Pre-Treatment comply with ISO Standard

  Yes

  No

  N/A

• Are there 2 Carbon Filters

  Yes

  No

  N/A

• Are Carbon filter(s) correct size (EBCT-Empty Bed Contact Time) for number of Dialysis Stations

  Yes

  No

  N/A

• Is there a sampling port Post Carbon Filter One

  Yes

  No

  N/A

• Is there a sampling port Post Carbon Filter Two

  Yes

  No

  N/A

• Is there a sampling port Post Softener Column

  Yes

  No

  N/A

• Brine tank is clean inside

  Yes

  No

  N/A

• Correct salt in use (Vacuum Salt Tablets=Best Practice)

  Yes

  No

  N/A

• Brine tank - is un-dissolved salt visible

  Yes

  No

  N/A

• Salt stored correctly (I.e. not on floor)

  Yes

  No

  N/A

• Does the media/sand filter controller work

  Yes

  No

  N/A

• Does the Water Softener controller work

  Yes

  No

  N/A

• Has the resin in the softener been replaced in the last 5 years?

  Yes

  No

  N/A

• Does the Carbon filter 1 controller work?

  Yes

  No

  N/A

• Has the Carbon Media in Carbon Filter 1 been replaced in the last 2 years?

  Yes

  No

  N/A

• Does the Carbon filter 2 controller work

  Yes

  No

  N/A

• Has the Carbon Media in Carbon Filter 2 been replaced in the last 2 years?

  Yes

  No

  N/A

• Pressure Pre/Post Sand/Media Filter

  Yes

  No

  N/A

• Pressure Pre/Post Carbon Filter 1

  Yes

  No

  N/A

• Pressure Pre/Post Carbon Filter 2

  Yes

  No

  N/A

• Pressure Pre/Post Water Softener

  Yes

  No

  N/A

• Pressure Pre/Post Cartridge Filters

  Yes

  No

  N/A

• Pretreatment equipment clean & in good repair

  Yes

  No

  N/A

• Photo of Pre-Treatment

  Media

REVERSE OSMOSIS SYSTEM

• Has RO System been Certified for use in Dialysis

  Yes

  No

  N/A

• Heavy metal dialysis water test annually

  Yes

  No

  N/A

• Audible/Visual alarm on RO - if dialysis water unsafe

  Yes

  No

  N/A

• Is there a nurse panel with Audible/Visual alarm on RO - if dialysis water unsafe

  Yes

  No

  N/A

• Electrical safety test on RO in last 12 months

  Yes

  No

  N/A

• Is there an RO Equipment Manual readily available

  Yes

  No

  N/A

• Is there a service Register/Report for RO

  Yes

  No

  N/A

• Have the RO Membranes been replaced in the last 5 years?

  Yes

  No

  N/A

• Has RO been Disinfected in last 6 Months

  Yes

  No

  N/A

• Reverse Osmosis clean & in good repair

  Yes

  No

  N/A

• Photo of Reverse Osmosis System

  Media

REVERSE OSMOSIS MONITORING EQUIPMENT

• Pressure gauge pre-membranes

  Yes

  No

  N/A

• Pressure gauge post membrane

  Yes

  No

  N/A

• Raw Water Conductivity Display

  Yes

  No

  N/A

• Dialysis Water Conductivity Display

  Yes

  No

  N/A

• Rejection Display

  Yes

  No

  N/A

• Dialysis Water Conductivity Alarm

  Yes

  No

  N/A

• Rejection Alarm

  Yes

  No

  N/A

• Flow Meters

  Yes

  No

  N/A

DISTRIBUTION SYSTEM

• What type of Distribution System is installed

  Select Direct Feed Indirect Feed Direct Feed to HD & Indirect to reuse equipment

  • Direct Feed
  • Indirect Feed
  • Direct Feed to HD & Indirect to reuse equipment

• Is there a readily available Manual for Distribution System

  Yes

  No

  N/A

• Is there a Service Report/Register for the Distribution loop

  Yes

  No

  N/A

• NO bladder tanks in Loop System

  Yes

  No

  N/A

• Is RO Storage Tank bottom conical in shape

  Yes

  No

  N/A

• 6 monthly Disinfection undertaken

  Yes

  No

  N/A

• UV light in the Reverse Osmosis Tank

  Yes

  No

  N/A

• UV lamp changed yearly

  Yes

  No

  N/A

• Is there 0.45 Micron Vent Filter

  Yes

  No

  N/A

• Cartridge Filter (1micron) in place after UV Light

  Yes

  No

  N/A

STAFF WTS TESTING OBSERVATIONS

• Staff wear full PPE for CFU/Endotoxins Testing

  Yes

  No

  N/A

• Did staff member demonstrate the correct Port for CFU/Endotoxins Sampling

  Yes

  No

  N/A

• Staff observed to clean port with alcohol wipe pre testing for CFU & Endotoxin sampling

  Yes

  No

  N/A

• Was sampling port turned on & running for Approx 2 Litres

  Yes

  No

  N/A

• Was tap turned off after sampling container sealed

  Yes

  No

  N/A

• Was Total Chlorine test performed correctly

  Yes

  No

  N/A

• Was Water Hardness performed correctly

  Yes

  No

  N/A

DIRECTIVES & DOCUMENTATION

• Documented policy on WTS Testing

  Yes

  No

  N/A

• Documented Work Instruction - Detailed instructions on how to undertake WTS tests

  Yes

  No

  N/A

• Is there a record book/ folder with all WTS Testing Results

  Yes

  No

  N/A

• Is there a record of Staff WTS Training

  Yes

  No

  N/A

GENERAL COMMENTS ON WATER TREATMENT SYSTEM AND PRACTICES

• Comments

• General Water Equipment Photos

  Media

HD MACHINES

• HD MACHINES ~ No. - MAKE - MODEL - AGE

• Is there an Operators Manual for each HD Machine in the Clinic

  Yes

  No

  N/A

• 4008NG & 5008 preventative maintenance undertaken each 2 Years

  Yes

  No

  N/A

• All prior to the above FMC HD Machine models Preventative Maintenance Annually

  Yes

  No

  N/A

• All other company HD Machines preventative Maintenance as per Manual

  Yes

  No

  N/A

• Record of Maintenance in Clinic

  Yes

  No

  N/A

• HD Machine mechanical condition is safe for use

  Yes

  No

  N/A

• Exterior casing in good condition

  Yes

  No

  N/A

• Rust not present on any part of machine

  Yes

  No

  N/A

• Power Cord Not Damaged

  Yes

  No

  N/A

• Machine is clean

  Yes

  No

  N/A

• Dialysis Water entry hose is Opaque

  Yes

  No

  N/A

• Dialysis Waste hose is Opaque

  Yes

  No

  N/A

• Annual Electrical Safety Test undertaken on every machine(EST)

  Yes

  No

  N/A

• Dust filter is clean (should be cleaned weekly)

  Yes

  No

  N/A

DIALYSIS FLUID ULTRA FILTER

• Filter installed on all machines (e.g. FMC machines Diasafe, Gambro U9000)

  Yes

  No

  N/A

• Filter changed every - 100 treatments, 11 degreasing Bleaches OR 3 months

  Yes

  No

  N/A

• Filter labelled with date of last change

  Yes

  No

  N/A

LABELS ~ HD MACHINES

• Machine has an ID Label

  Yes

  No

  N/A

• Machine has a warning label

  Yes

  No

  N/A

• Machine has an information label

  Yes

  No

  N/A

• Machine has a safety test (EST) label

  Yes

  No

  N/A

WATER CONNECTORS

• Machine WTS Connector is installed on external Media Panel not inside a cupboard

  Yes

  No

  N/A

• Does drainage have Air Gap

  Yes

  No

  N/A

PORTABLE RO

• Number - Make - Model - Age

• Maintenance undertaken as per Manufacturers recommendation

  Yes

  No

  N/A

• Records of all maintenance kept In Clinic

  Yes

  No

  N/A

• Operators manual for every Portable RO

  Yes

  No

  N/A

• Is Portable RO clean

  Yes

  No

  N/A

• Annual Electrical Safety Test (EST) undertaken

  Yes

  No

  N/A

PORTABLE WTS DISINFECTION

• Disinfection undertaken every Month (BEST PRACTICE)

  Yes

  No

  N/A

• Disinfection undertaken every 3 Months

  Yes

  No

  N/A

• Disinfection undertaken every 6 Months

  Yes

  No

  N/A

• Disinfection undertaken every 12 Months

  Yes

  No

  N/A

• Documentation of disinfection available in Clinic

  Yes

  No

  N/A

PORTABLE WTS PRE FILTRATION

• Carbon Cartridges replacement

  Select 1 month 3 month 6 months 12 months >13months

  • 1 month
  • 3 month
  • 6 months
  • 12 months
  • >13months

• Media Cartridge

  Yes

  No

  N/A

• Softener in place

  Yes

  No

  N/A

• Carbon Filter

  Yes

  No

  N/A

• Cartridge Media Filter

  Yes

  No

  N/A

• Is the amount of Carbon adequate (10 EBCT)

  Yes

  No

  N/A

• Carbon Media replacement

  Select 1 month 3 month 6 months 12 months >13months

  • 1 month
  • 3 month
  • 6 months
  • 12 months
  • >13months

PORTABLE WTS WATER TESTING

• Testing for CFU & Endotoxins undertaken every 3 months

  Yes

  No

  N/A

• Records of Results available in Clinic

  Yes

  No

  N/A

• Photo of Equipment

  Media

WEIGHING SCALES

• Number - Make - Model - Age

• Maintenance undertaken as per Manufacturers recommendation

  Yes

  No

  N/A

• Records of all maintenance kept In Clinic

  Yes

  No

  N/A

• Operators manual

  Yes

  No

  N/A

• Annual Electrical Safety Test (EST) undertaken

  Yes

  No

  N/A

Reprocessing Equipment

• Model, number, age

• Maintenance undertaken as per manufacturers instructions?

  Yes

  No

  N/A

• Records of service?

  Yes

  No

  N/A

• Records of Dialyser reprocessing?

  Yes

  No

  N/A

• Equipment operating manuals?

  Yes

  No

  N/A

• Annual Electrical Safety Test (EST) performed?

  Yes

  No

  N/A

• Is the reprocessing room well ventilated?

  Yes

  No

  N/A

• Is there Material Safety Data Sheet (MSDS) in the reprocessing room?

  Yes

  No

  N/A

• Is there Personnel Protection Equipment (PPE) available for staff?

  Yes

  No

  N/A

• Are the staff using PPE during reprocessing?

  Yes

  No

  N/A

• Photos of reprocessing room and equipment.

  Media

Concentrate Mixing

• Manufacture, Model, Age

• Is the Room Clean?

  Yes

  No

  N/A

• Is the Equipment Clean?

  Yes

  No

  N/A

• Is the Room Ventilated?

  Yes

  No

  N/A

• Are MSDS Information readily available for all chemicals?

  Yes

  No

  N/A