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12 Product Water for Chemical and Bacteriological Testing for ......2017/12/12  · 1 Clinical...

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Disclaimer Healthcare facilities are required to have written policies approved by their governing body concerning the services that they provide. NxStage Medical, Inc. has prepared this document to assist you in your preparation of policies and procedures for use with the NxStage System One. The information presented herein is intended as a guide for reference purposes only, and all providers are encouraged to modify these draft policies and procedures based on their own unique needs. Warnings and precautions, as documented in the NxStage System One™ and/or PureFlow™ User Guides, have not been included in the attached Policies and Procedures. Operators of the equipment should refer to both Policies and Procedures and the User Guides. We encourage providers to include warnings and precautions into their approved Policies and Procedures in a manner consistent with facility protocol. Efforts have been made to ensure that these policies are based on current information. However, policies and procedures are the responsibility of the healthcare facility and therefore must be reviewed and edited carefully before incorporating into an individual facility’s program.
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Page 1: 12 Product Water for Chemical and Bacteriological Testing for ......2017/12/12  · 1 Clinical literature suggests that inadvertent sample contamination ranges between 2-9.1% even

Disclaimer

Healthcare facilities are required to have written policies approved by their

governing body concerning the services that they provide.

NxStage Medical, Inc. has prepared this document to assist you in your preparation of policies and procedures for use with the NxStage System One. The information presented herein is intended as a guide for reference purposes only, and all providers are encouraged to modify these draft policies and procedures

based on their own unique needs.

Warnings and precautions, as documented in the NxStage System One™ and/or PureFlow™ User Guides, have not been included in the attached Policies and

Procedures. Operators of the equipment should refer to both Policies and Procedures and the User Guides. We encourage providers to include warnings

and precautions into their approved Policies and Procedures in a manner consistent with facility protocol.

Efforts have been made to ensure that these policies are based on current information. However, policies and procedures are the responsibility of the

healthcare facility and therefore must be reviewed and edited carefully before incorporating into an individual facility’s program.

Page 2: 12 Product Water for Chemical and Bacteriological Testing for ......2017/12/12  · 1 Clinical literature suggests that inadvertent sample contamination ranges between 2-9.1% even

Transitional Care Policies & Procedures Page 2 of 4

NxStage® has prepared this document as suggested steps for centers in using the NxStage System One™ for Transitional Care Dialysis. This document is not intended to replace the NxStage System One™ or PureFlow™ SL User’s Guide or Cartridge Instructions for Use. Federal law restricts this device to sale by or on the order of a physician. NxStage® is a registered trademark of NxStage Medical, Inc. System One and PureFlow are trademarks of NxStage Medical, Inc. © 2017 TM1149 Rev A

Obtain Product Water for Chemical and

Bacteriological Testing for Transitional

Care Programs Using PureFlow SL

PROCEDURE

SUPPORTIVE INFORMATION

Collect, store, and transport the sample in accordance with the guidelines from your center or testing laboratory.

To obtain a water sample, please refer to the PureFlow User Guide that is consistent with your software version and follow the stated procedure.

1 Clinical literature suggests that inadvertent sample contamination ranges between 2-9.1% even in a hospital environment.

Policy Number: 5 Effective Date: Reviewed/ Revised Date:

Purpose: To provide a procedure for obtaining product water from PureFlow SL for chemical and bacteriological testing. Policy: Chemical and Bacteriological

§ Some regulatory agencies may request periodic product water testing for bacteriological and chemical analysis (AAMI panel).

§ The testing should be performed near or at the end of PAK life when possible. § All samples are required to be properly maintained for distribution to the lab in accordance with

guidelines from your clinic or testing laboratory. Bacteriological

§ Do not touch surfaces covered by the connector protective caps. Touching these surfaces may cause them to become non-sterile, which may cause patient infection or solution contamination.

§ Always use Universal Precautions and Aseptic Technique when handling connections. § Clinical literature suggests that inadvertent sample contamination can occur in the sampling

process, even under the best circumstances1.

Supplies: § NxStage PureFlow SL User Guide § Mask § Alcohol prep pad § Gloves § Clean disposable drape § Sterile 30 mL syringe § Sterile female-female adapter § Sterile testing kit from your clinic or testing laboratory for bacteriological testing

Page 3: 12 Product Water for Chemical and Bacteriological Testing for ......2017/12/12  · 1 Clinical literature suggests that inadvertent sample contamination ranges between 2-9.1% even

Transitional Care Policies & Procedures Page 3 of 4

NxStage® has prepared this document as suggested steps for centers in using the NxStage System One™ for Transitional Care Dialysis. This document is not intended to replace the NxStage System One™ or PureFlow™ SL User’s Guide or Cartridge Instructions for Use. Federal law restricts this device to sale by or on the order of a physician. NxStage® is a registered trademark of NxStage Medical, Inc. System One and PureFlow are trademarks of NxStage Medical, Inc. © 2017 TM1149 Rev A

ATTACHMENT A

Page 4: 12 Product Water for Chemical and Bacteriological Testing for ......2017/12/12  · 1 Clinical literature suggests that inadvertent sample contamination ranges between 2-9.1% even

Transitional Care Policies & Procedures Page 4 of 4

NxStage® has prepared this document as suggested steps for centers in using the NxStage System One™ for Transitional Care Dialysis. This document is not intended to replace the NxStage System One™ or PureFlow™ SL User’s Guide or Cartridge Instructions for Use. Federal law restricts this device to sale by or on the order of a physician. NxStage® is a registered trademark of NxStage Medical, Inc. System One and PureFlow are trademarks of NxStage Medical, Inc. © 2017 TM1149 Rev A

ATTACHMENT B


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