DAVITA INC.

INCENTER HEMODIALYSIS EQUIPMENT, WATER AND TESTING DEVICES

TABLE OF CONTENTS
Policy No. Origination/ Revision Date

1.

GENERAL BIOMED POLICIES 2-01-01 2-01-02 2-01-03 2-01-04 2-01-05 2-01-06 2-01-07 2-01-08 2-01-09 2-01-11 2-01-12 09-13 03-13 09-10 09-13 09-11 09-11 03-12 03-13 03-13 09-10 03-13

Responsibilities of the Biomed Department Biomed Teammate Qualifications and Training Communicating With Biomed to Obtain Service Dialysis Delivery System Failures Occurring During Treatment Machine Safety Conditions Required During Treatment Documentation of Repairs on Equipment Verification of Testing Equipment Accuracy Incoming Equipment and Spare Parts Preparation Preventive Maintenance Schedules for Equipment Machine Preparation prior to Repair and/or Maintenance Transport of Equipment 2. DIALYSIS DELIVERY SYSTEMS

FRESENIUS Fresenius Dialysis Delivery System Cleaning and Disinfection Policy Fresenius A2008H Start Up Post Chemical Disinfection Fresenius A2008H Preparation after Heat Disinfection Fresenius A2008H System Safety Check Fresenius A2008 H Pressure Holding/ Alarm Test Fresenius A2008 H UFR Calculator Programming Fresenius A2008 H Programming the Sodium Variation System Fresenius A2008 K, K2 Start Up Post Chemical Disinfection Fresenius A2008 K, K2 Pressure Holding/Alarm Test Fresenius A2008 K, K2 Preparation after Heat Disinfection Fresenius A2008 K, K2 UF Profile Fresenius A2008 K, K2 Sodium Variation System Fresenius A2008 K, K2 Automated Diasafe Plus Filter Integrity Test Diasafe Plus Filter Integrity Test Log Fresenius A2008 K, K2 Automated Diasafe Plus Filter Integrity Test Post Chemical Rinse Cycle GAMBRO CENTRYSYSTEM CS 3 and CS 3 + Gambro CentrySystem CS3 and CS3 + Dialysis Delivery System Cleaning and Disinfection Policy Gambro CentrySystem CS3 Start Up 2-02-01 2-02-01A 2-02-01B 2-02-01C 2-02-01G 2-02-01J 2-02-01K 2-02-01L 2-02-01M 2-02-01N 2-02-01O 2-02-01P 2-02-01Q 2-02-01R 2-02-01S 09-12 09-13 09-10 09-10 08-06 08-06 03-07 09-13 09-09 09-13 09-09 03-12 03-12 09-11 03-12

Archive Archive

09-13 09-13

Property of DaVita Inc. Confidential and Copyrighted 2006-2013 Origination Date: August 2006 Revision Date: March 2008, September 2008, December 2008, April 2009, September 2009, March 2010, September 2010, March 2011, September 2011, March 2012, September 2012, March 2013, September 2013 Page 1 of 7 P&PM-1050-0005

DAVITA INC. INCENTER HEMODIALYSIS EQUIPMENT, WATER AND TESTING DEVICES

TABLE OF CONTENTS
Policy No. Origination/ Revision Date

Gambro CentrySystem CS3 Automated Alarm Test Gambro CentrySystem CS3 After Use or System Shut Down GAMBRO PHOENIX Gambro Phoenix Dialysis Delivery System Cleaning and Disinfection Policy Gambro Phoenix Dialysis Delivery System Sodium Profiling Gambro Phoenix Dialysis Delivery System Diascan Gambro Phoenix Dialysis Delivery System End of Day Care BRAUN B Braun Dialog Dialysis Delivery System Cleaning and Disinfection B Braun Dialog Citric Thermal Procedure B Braun Dialog Chemical Disinfect 3. WATER TREATMENT SYSTEMS

Archive Archive

09-13 09-13

2-02-07 2-02-07A 2-02-07B 2-02-07C

09-12 08-06 08-06 08-06

2-02-08 2-02-08A 2-02-08B

03-13 03-13 03-13

Water Treatment Systems Minimum Component Requirements Water Treatment System Minimum Component Checklist AAMI Water Analysis for Inorganic Contaminants AAMI Water Analysis Collection Procedure for Water Treatment Product Water AAMI Water Analysis Collection Procedure for Water Treatment City Tap Water AAMI Water Analysis Collection Procedure for Water Treatment Product Water from CWP System AAMI Water Analysis Collection Procedure for Troubleshooting RO Product Water Water System Disinfection Policy 4. WATER QUALITY MONITORING

2-03-01 2-03-01A 2-03-02 2-03-02A 2-03-02B 2-03-02C 2-03-02D 2-03-03

03-12 03-13 03-12 09-13 09-13 09-13 09-13 09-13

General Water Quality Policy Daily Water Treatment System Monitoring Daily Water Treatment Log/Daily Log Explanation CWP Daily Water Log/CWP Supplemental Daily Log/Daily Log Explanation DI Monitoring Log

2-04-01 2-04-02 2-04-02A 2-04-02B 2-04-02C

09-13 09-13 09-13 09-13 09-13

Property of DaVita Inc. Confidential and Copyrighted 2006-2013 Origination Date: August 2006 Revision Date: March 2008, September 2008, December 2008, April 2009, September 2009, March 2010, September 2010, March 2011, September 2011, March 2012, September 2012, March 2013, September 2013 Page 2 of 7 P&PM-1050-0005

DAVITA INC. INCENTER HEMODIALYSIS EQUIPMENT, WATER AND TESTING DEVICES

TABLE OF CONTENTS
Policy No. Origination/ Revision Date

Monthly Water Treatment System Monitoring Monthly Water Treatment Log Monthly Water Treatment Log-CWP 5. WATER TESTING METHODS AND KITS

2-04-03 2-04-03A 2-04-03B

09-13 09-13 09-13

Total Hardness of the City Tap Water using Hach 5B Hardness Test Kit Hardness Test of the City Tap Water using RPC Water Hardness Test Strips Daily Water System Total Chlorine Monitoring Routine Total Chlorine Testing Log Total Chlorine Breakthrough Testing Log Total Chlorine Test using Hach Pocket Colorimeter of the City Tap Water Total Chlorine Test of the City Tap Water using Color Comparators (Hach CN-70 or CN-70T Test Kit) E-Z Chek Sensitive Total Chlorine Testing Total Chlorine Test using SteriChek Total Chlorine Test Kit Serim Hisense Ultra 0.1 Test for Total Chlorine in Feed or Rinse Water Total Chlorine Test using RPC Ultra Low Total Chlorine Test Strips Hach Pocket Colorimeter/Colorimeter II Daily Quality Control Test (SpecCheck) Daily SpecCheck QA Log for the Hach Colorimeter/Colorimeter II Water Conductivity and Total Dissolved Solids (TDS) Meters Calibration of Myron L DS Meter (RO-1) Operation of Myron L DS Meter (RO-1) Calibration of Myron L Digital Conductivity/TDS DS Meter (DP-4) Operation of Myron L Digital Conductivity/TDS DS Meter (DP-4) Calibration of Myron L AR1 Meter Operation of Myron L AR1 Meter Calibration of Myron L Ultrameter 4P Operation of Myron L Ultrameter 4P Operation and Calibration of Myron L EP and EP 10 Conductivity Meter Residual Bleach Testing Residual Bleach Testing using RPC E-Z Chek Residual Chlorine (Bleach) Test Strips Residual Bleach Testing using Hach SteriChek Residual Chlorine (Bleach) Reagent Test Strips

2-05-01A 2-05-01B 2-05-02 2-05-02A 2-05-02B 2-05-02C 2-05-02D 2-05-02E 2-05-02F 2-05-02G 2-05-02H 2-05-02I 2-05-02J 2-05-03 2-05-03A 2-05-03B 2-05-03C 2-05-03D 2-05-03E 2-05-03F 2-05-03G 2-05-03H 2-05-03I 2-05-04 2-05-04A 2-05-04B

09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13

Property of DaVita Inc. Confidential and Copyrighted 2006-2013 Origination Date: August 2006 Revision Date: March 2008, September 2008, December 2008, April 2009, September 2009, March 2010, September 2010, March 2011, September 2011, March 2012, September 2012, March 2013, September 2013 Page 3 of 7 P&PM-1050-0005

DAVITA INC. INCENTER HEMODIALYSIS EQUIPMENT, WATER AND TESTING DEVICES

TABLE OF CONTENTS
Policy No. Origination/ Revision Date

6.

CULTURE AND ENDOTOXIN TESTING 2-06-01 2-06-02 2-06-02A 2-06-02B 2-06-02C 2-06-02D 2-06-02E 2-06-02F 2-06-02G 2-06-02H 2-06-02I 2-06-02J 2-06-03 2-06-03A 2-06-03B 2-06-04 2-06-05 2-06-05A 2-06-06 2-06-07 2-06-08 2-06-09 2-06-10 2-06-10A 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13

Water Culture Policy Endotoxin Testing Policy Water Culture and Endotoxin Sample Procedure First Water Outlet Water Culture and Endotoxin Sample Procedure Dry Acid Water Outlet Water Culture and Endotoxin Sample Procedure Bicarb Water Outlet Water Culture and Endotoxin Sample Procedure Last Water Outlet Water Culture and Endotoxin Sample Procedure Pre-Clean Blood Inlet Water Culture and Endotoxin Sample Procedure Reuse Disinfectant Outlet Water Culture and Endotoxin Sample Procedure Renatron Water Culture and Endotoxin Sample Procedure RenaClear Water Culture and Endotoxin Sample Procedure - RO Product Outlet Water Culture and Endotoxin Sample Procedure - RO Product Outlet (CWP) Dialysate Culture Policy Dialysate Culture or Endotoxin Sample Collection Procedure Dialysate Culture or Endotoxin Sample Collection Procedure utilizing a Disposable Collection Assist Device Troubleshooting Elevated Bacteria-Endotoxin Policy Microbial Validation of Facility Water Treatment Systems after Installation System Validation Logs Manual Requisition for Culture, Endotoxin and Water Analysis Testing Microbial Validation of Facility Water Systems after Major Modification or Repair Microbial Validation of Bicarbonate Tank after Installation (NonCentral Delivery) Microbial Validation of Central Delivery Bicarbonate Tank after Installation Microbial Validation of Dialysis Delivery System after Installation Dialysate Culture and Endotoxin Sample Procedure for Newly Installed Dialysis Delivery System Dialysate Culture and Endotoxin Sample Collection Procedure for Newly Installed Dialysis Delivery System utilizing a Male/Male Interlock Connector Dialysate Culture and Endotoxin Sample Collection Procedure for Extended Repairs, Sequestered and Dialysis Delivery Systems brought back into Service utilizing a Male/Male Interlock

2-06-10B

09-13

Property of DaVita Inc. Confidential and Copyrighted 2006-2013 Origination Date: August 2006 Revision Date: March 2008, September 2008, December 2008, April 2009, September 2009, March 2010, September 2010, March 2011, September 2011, March 2012, September 2012, March 2013, September 2013 Page 4 of 7 P&PM-1050-0005

DAVITA INC. INCENTER HEMODIALYSIS EQUIPMENT, WATER AND TESTING DEVICES

TABLE OF CONTENTS
Policy No. Origination/ Revision Date

Connector Microbial Validation of Reprocessing Devices after Installation Monthly Microbial Corrective Action Monthly Microbial Corrective Action Form 7. DIALYSATE DELIVERY SYSTEMS AND MONITORING

2-06-10C 2-06-11 2-06-12 2-06-12A

09-13 09-13 09-13 09-13

Bicarbonate Concentrate System Mixing Bicarbonate System Logs Daily Bicarbonate Concentrate System Mixer Cleaning Bicarbonate Concentrate System Disinfection Granuflo Concentrate Dissolution Unit Granuflo Concentrate Dissolution Unit (132 Gallon) Mixing Procedure Disinfecting Granuflo Mixer Granuflo Disinfection Log Granuflo (132 Gallon) Batch Production Record Granuflo Concentrate Dissolution Unit II (99 Gallon) Mixing Procedure Granuflo (99 Gallon) Batch Production Record Acid Concentrate System, Incoming Acid Concentrate and Supply Log and Use of Acid Concentrate Containers Incoming Acid Concentrate Supply Procedure Acid Concentrate (Liquid) Supply Log Incoming and Transfer Dri-Sate Dry Acid Concentrate Mixing System Preparation of Dri-Sate Concentrate Procedure Checking Specific Gravity Values for Dri-Sate Checking pH Values for Dri-Sate Disinfecting the Dri-Sate Mixer Dri-Sate Disinfection Log Dri-Sate Production Record Daily Bicarbonate Concentrate System Cleaning for Nocturnal Programs BiCart Columns: Previously Primed Bicarb Concentrate Conductivity Batch Testing CitraPure Dry Acid Concentrate Mixing Preparation of CitraPure Concentrate Checking Specific Gravity Values for CitraPure CitraPure Batch Production Record

2-07-01 2-07-01A 2-07-02 2-07-03 2-07-04 2-07-04A 2-07-04B 2-07-04C 2-07-04D 2-07-04E 2-07-04F 2-07-05 2-07-05A 2-07-05B 2-07-06 2-07-06A 2-07-06B 2-07-06C 2-07-06D 2-07-06E 2-07-06F 2-07-07 2-07-08 2-07-09 2-07-10 2-07-10A 2-07-10B 2-07-10C

09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13

Property of DaVita Inc. Confidential and Copyrighted 2006-2013 Origination Date: August 2006 Revision Date: March 2008, September 2008, December 2008, April 2009, September 2009, March 2010, September 2010, March 2011, September 2011, March 2012, September 2012, March 2013, September 2013 Page 5 of 7 P&PM-1050-0005

DAVITA INC. INCENTER HEMODIALYSIS EQUIPMENT, WATER AND TESTING DEVICES

TABLE OF CONTENTS
Policy No. Origination/ Revision Date

8.

DIALYSATE TEST METHODS AND KITS 2-08-01 2-08-01A 2-08-01B 2-08-01C 2-08-01D 2-08-01E 2-08-01F 2-08-01G 2-08-01H 2-08-01I 2-08-01J 2-08-01K 2-08-01L 2-08-01M 2-08-01N 2-08-01O 2-08-02 2-08-02A 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13

Testing pH and Conductivity of Proportioned Dialysate Calibration of Portable Myron L Conductivity Meter (D-1) Operation of Portable Myron L Conductivity Meter (D-1) Calibration of Dual Range Conductivity Meter (D-2) Testing Bicarb Conductivity with Dual Range Myron L Meter (D-2) Testing Dialysate Conductivity with Dual Range Myron L Meter (D-2) Phoenix Meter Disinfection and Calibration Verification Measuring Conductivity, Temperature and-or pH using the Phoenix Meter Procedure Phoenix Meter Log NeoStat Meter Quality Control Operation of Portable NeoStat Meter Procedure Testing pH of Dialysate using RPC E-Z Chek 6.8-8.5 Test Strips Phoenix Meter Level I and II Calibration Monthly Phoenix Meter Calibration Log Level I and II Phoenix Meter Level I Calibration Phoenix Meter Level I Calibration Log Specific Gravity Testing Using Hydrometer Specific Gravity Testing Using Hydrometer 9. ANCILLARY EQUIPMENT PROCEDURES

Back-up Generator Operational Checks Centrifuge Function Check 10. HAZARDOUS CHEMICAL PROCEDURES

2-09-01 2-09-02

09-13 09-13

PERACETIC ACID Peracetic Acid Policy Disposal of Peracetic Acid Concentrate Peracetic Acid Concentrate Spill Procedure Peracetic Acid Spill Preparedness and Log Peracetic Acid Temperature Storage Log Air Testing Policy Drager Hydrogen Peroxide and Drager Acetic Acid in Air Test and Logs 2-10-01 2-10-01A 2-10-01B 2-10-01C 2-10-01D 2-10-02 2-10-02A 09-13 09-13 09-13 09-13 09-13 09-13 09-13

Property of DaVita Inc. Confidential and Copyrighted 2006-2013 Origination Date: August 2006 Revision Date: March 2008, September 2008, December 2008, April 2009, September 2009, March 2010, September 2010, March 2011, September 2011, March 2012, September 2012, March 2013, September 2013 Page 6 of 7 P&PM-1050-0005

DAVITA INC. INCENTER HEMODIALYSIS EQUIPMENT, WATER AND TESTING DEVICES

TABLE OF CONTENTS
Policy No. Origination/ Revision Date

Baseline Hydrogen Peroxide and Baseline Acetic Acid in Air Testing Logs Citric Acid Policy Preparation of 2% Citric Acid and Citric Acid Log Citric Acid Container, Uptake Wand, and Cap Disinfection Citric Acid Container, Uptake Wand, and Cap Disinfection and Log Preparation of 50% Citric Acid and Citric Acid Log On Demand Bleach Autodilutor Preparation of 1% or 10% Bleach Solution utilizing the On Demand Bleach Autodilution System 1% On Demand Bleach Autodilutor Verification Log 10% On Demand Bleach Autodilutor Verification Log 11. BIOMED TECHNICIAN POLICIES AND PROCEDURES

2-10-02B 2-10-03 2-10-03A 2-10-04 2-10-04A 2-10-04B 2-10-05 2-10-05A 2-10-05B 2-10-05C

09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13 09-13

General Statement on Biomed Technician Policies and Procedures Section External Transducer Protector Strikethrough Recovery External Transducer Protector Strikethrough Recovery Procedure for Arterial/Venous Pressure Monitoring Systems

2-11-01 2-11-02 2-11-02A

09-13 09-13 09-13

Property of DaVita Inc. Confidential and Copyrighted 2006-2013 Origination Date: August 2006 Revision Date: March 2008, September 2008, December 2008, April 2009, September 2009, March 2010, September 2010, March 2011, September 2011, March 2012, September 2012, March 2013, September 2013 Page 7 of 7 P&PM-1050-0005