Action Owner Start Finish Note(s) Pre-Implementation ... · Establish a Plan to Gain Staff Buy-In TDC Unit Champion & Planning Team Incorporate RVP / Director of Operations, if applicable

APM2670RevA

Center Name: Main Center Contact: Project Name: Transitional Dialysis Care Unit

Current Date:

Action Owner Start Finish Note(s)

Initiate Budget Approval Process Center Leadership Once you've decided to implement a TDC Unit, initiate a budget approval process.

Identify Transitional Dialysis Care Unit Champion Center Leadership Champion drives behavior and has holistic interest in all center modalities

Select Staff Members for TDC Planning Team TDC Unit Champion Key members of the Interdisciplinary Care Team (IDT) should participate

Review TDC Framework & Best Practices with Planning Team TDC Unit Champion The entire Interdisciplinary Care Team (IDT) should be familiar with concept

Set Goals to Achieve by Implementing a TDC Unit TDC Unit Champion Solicit input from the IDT as necessary

Establish Key Clinical & Financial Performance Indicators to Track TDC Unit Champion & Planning Team

Establish a Plan to Gain Staff Buy-In TDC Unit Champion & Planning Team Incorporate RVP / Director of Operations, if applicable

Conduct an Economic Analysis (if not already done so) TDC Unit Champion & Center Financial Manager Important to compare economic differences between TDC and In Center models

Determine Location of TDC Unit TDC Unit Champion & Planning Team

Assess regulatory and certification requirements based on TDC location TDC Unit Champion & Center Legal Team

Determine Patient Treatment Schedule TDC Unit Champion & Planning Team

Evaluate Number of Stations & Shifts Required TDC Unit Champion & Planning Team

Finalize Supply Order Management Process TDC Unit Champion & Planning Team

Establish a Solution for Medical Record and Billing Integration TDC Unit Champion, Planning Team & IT

Determine equipment and supplies storage requirements TDC Unit Champion & Planning Team

Determine required frequency of supplies deliveries TDC Unit Champion & Planning Team

Establish a Service & Repair Plan TDC Unit Champion & Planning Team

Create a TDC Patient Education Curriculum & Care Plan TDC Unit Champion & Planning Team

Determine the Hemodialysis Prescription for hemodialysis patients TDC Unit Champion & Planning Team

Define the Roles of the Interdisciplinary Care Team (IDT) TDC Unit Champion & Planning Team

Define Staffing Requirements TDC Unit Champion & Planning Team

Define Staff Training Plan TDC Unit Champion & Planning Team

Finalize Marketing Plan for Promoting Your TDC Unit TDC Unit Champion & Marketing

Administration/Budget Approval Center Leadership / TDC Unit Champion Leadership approves project

Final Decision | Approval Process Center Leadership/Purchasing Center Leadership

Purchase Order | Process & Review Center Leadership/Purchasing Center Leadership

Submittal | Signed Purchase Agreement or A La Carte Addendum Added Center Leadership/Purchasing Verify signed agreement is in place. If no agreement, then a signed agreement is required. If agreement is in place then an a la carte addendum should be considered with manufacturer.

Review | PO & Signed Agreement if not completed Center Leadership/Purchasing

Delivery/Install of NSOs if needed | Provided by Manufacturer NxStage Field Service

Site Prep | In Center Config. Planning For TDC NxStage Field Service

Disposables Ordering | Cartridges & Fluids Chronic HD Unit Manager Customer orders through designated ordering process

Training| In-Center Staff NxStage Training Manager

GO-LIVE | 1st Patient Therapy HD Chronic and Home Team

Education | Continuing Support NxStage Manager/Educator Clinical Education Support collaboration with Home Team/NxStage.

Patients Start in TDC Unit

Pre-Implementation Approval Process

Strategic & Leadership Considerations

Patient Education & Care Plan Considerations

Logistical & Infrastructure Considerations

Staffing & Training Considerations

Financial Considerations

Marketing Considerations

Budget Approval & Equipment Purchase

39

APPENDIX A: DIALYSATE CATALOG

Premixed Dialysate Bag Formulations

Constituents (mEq/L) RFP-204 RFP-205 RFP-207 RFP-209 RFP-211

Lactate40 mEq/L

(40 mmol/L)35 mEq/L

(35 mmol/L)45 mEq/L

(45 mmol/L)45 mEq/L

(45 mmol/L)40 mEq/L

(40 mmol/L)

Potassium1 mEq/L

(1 mmol/L)3 mEq/L

(3 mmol/L)1 mEq/L

(1 mmol/L)2 mEq/L

(2 mmol/L)2 mEq/L

(2 mmol/L)

Sodium 140 mEq/L (140 mmol/L)

Calcium3 mEq/L

(1 .5 mmol/L)3 mEq/L



(1 .5 mmol/L)

3 .5 mEq/L(1 .75

mmol/L)

Magnesium 1 mEq/L (0 .5 mmol/L)

Chloride105 mEq/L

(105 mmol/L)

112 mEq/L(112

mmol/L)

100 mEq/L(100

mmol/L)

101 mEq/L(101

mmol/L)

106 .5 mEq/L (106 .5

mmol/L)

Glucose 1 .1 g/L

Osmolar–ity (calculated)

294 mOsmol/L

298 mOsmol/L

294 mOsmol/L

296 mOsmol/L

296 mOsmol/L

All RFP-2XX fluids are packaged in 5 .0 liter bags and will typically have up to 1 .5% overfill .

Dialysate ConcentratesThe PureFlow SL System prepares batches of dialysate in the following formulations and volumes:

Constituents (mEq/L)

SAK- 301/401

SAK- 302/402

SAK- 303/403

SAK- 304/404

SAK- 305/405

SAK- 306/406

SAK- 307/407

Lactate45 mEq/L

(45 mmol/L)

40 mEq/L

(40 mmol/L)

45 mEq/L

(45 mmol/L)

45 mEq/L

(45 mmol/L)

45 mEq/L

(45 mmol/L)

45 mEq/L

(45 mmol/L)

40 mEq/L

(40 mmol/L)

Potassium1 mEq/L

(1 mmol/L)

1 mEq/L

(1 mmol/L)

1 mEq/L

(1 mmol/L)

2 mEq/L

(2 mmol/L)

1 mEq/L

(1 mmol/L)

2 mEq/L

(2 mmol/L)

1 mEq/L

(1 mmol/L)

Sodium 140 mEq/L (140 mmol/L)

Calcium3 mEq/L

(1 .5 mmol/L)

3 mEq/L

(1 .5 mmol/L)

3 mEq/L

(1 .5 mmol/L)

3 mEq/L

(1 .5 mmol/L)

3 mEq/L

(1 .5 mmol/L)

3 mEq/L

(1 .5 mmol/L)

3 mEq/L

(1 .5 mmol/L)

Magnesium 1 mEq/L (0 .5 mmol/L)

Chloride100 mEq/L

(100 mmol/L)

105 mEq/L

(105 mmol/L)

100 mEq/L

(100 mmol/L)

101 mEq/L

(101 mmol/L)

100 mEq/L

(100 mmol/L)

101 mEq/L

(101 mmol/L)

105 mEq/L

(105 mmol/L)

Glucose 100 mg/dL

Batch Size 60 L 60 L 50 L 60 L 40 L 50 L 50 L

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.

Transitional Care Policies & Procedures Page 2 of 2

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

Patient Supplies for Transitional Care

Policy Number: 7 Effective Date: Reviewed/ Revised Date:

Purpose: To guide provision of appropriate supplies and equipment for transitional care. Policy:

1. Transitional care patients will have treatment equipment and supplies ordered through NxStage Medical.

2. Each transitional program will notify the supply company using procedures specified by that company for supplies. Supplies ordered will include, but not limited to the following: • Equipment supplies for treatment • Equipment such as NxStage System One, NxStage System One S and/or Pureflow SL.

3. Supplies for transitional care treatments are provided solely for use in patient’s in the

transitional care program. They are not to be utilized when/if the patient transitions to home hemodialysis. This includes disposable supplies and durable equipment.

4. Provision of dialysis supplies and equipment for treatment of hospitalized patients is wholly the responsibility of the acute care facility.

5. Supply shipment frequency will be determined by the dialysis provider’s contract agreement for transitional care with NxStage and may include more frequent deliveries and “ala carte” ordering.

Disclaimer












Treatment Documentation for Transitional Care

Reference: Nephrology Nursing Scope and Standards of Practice 7th edition 2011 Edition, Ongoing Monitoring p. 164


Supplies § Center treatment record or NxStage System One Hemodialysis Flowsheet (available on

http://www.nxstage.com/).

PROCEDURE SUPPORTIVE INFORMATION Using the chosen treatment format, instruct the Patient Care Technician (PCT) how to record and monitor patient treatment information and place in the patient’s medical record.

The Patient Care Technician should be instructed to notify the Registered Nurse of unusual pre, intra and post treatment signs, symptoms or conditions.

Purpose: To ensure each patient treatment is documented and sent to the center enabling patient surveillance and monitoring. Policy: The dialysis center clinician will document each treatment ensuring the center’s requirements for pre- treatment, intradialytic, and post- treatment information are met.

TM0557 Rev C

Equipment Redeployment

© 2013 NxStage Medical, Inc. This document is not intended to replace the NxStage System One or PureFlow SL User Guides or Cartridge Instructions for Use and does not include all

of the information necessary to use the system safely and effectively. Patients, partners, and providers should review and refer to the System One and PureFlow SL User Guides and

Cartridge Instructions for Use for complete information including all warnings and precautions. The NxStage trademark is registered in the U.S Patent and Trademark Office and is

owned by NxStage Medical, Inc. The NxStage trademark is also registered in Australia, Canada, New Zealand the European Union, and Japan. PureFlow and System One are

trademarks of NxStage Medical, Inc. CAUTION: Federal law restricts this device to sale by or on the order of a physician. TM0557 Rev. C

TM0557 Rev C

Objectives

At the end of this presentation, the attendee

should know:

– Contents of the Equipment Redeployment

Instructions

– Overview of equipment redeployment steps and

procedures

– Redeployment documentation forms

– How to obtain the redeployment instructions

TM0557 Rev C

Equipment Redeployment

Instructions

TM0557 Rev C

Contents

Redeployment Introduction

Redeployment General Information

Prior to Redeployment

Equipment Redeployment Steps

Redeployment Procedures

– Cycler Redeployment Overview

– PureFlowTM SL Redeployment Overview

– LINX® Water Pre-Treatment System Overview

– Express Fluid Warmer Redeployment Overview

– Cycler Base and Fluid Detection Sensor

Redeployment Overview

Redeployment Forms

Redeployment Instructions Availability

TM0557 Rev C

Redeployment Introduction

TM0557 Rev C

Redeploying NxStage Equipment is Safe

Disposable fluid

pathways minimize

fluid contact with

equipment

Similar to in-center

equipment use from

one patient shift to

the next

TM0557 Rev C

Redeploying NxStage Equipment is Safe

NxStage equipment:

– Has built-in self tests:

♦ Power ON

♦ Use of each Cartridge

♦ New PAK is installed/primed

♦ Use of each SAK

– Generates alarms in response to test failures

– Alerts the user if preventive maintenance is required

C2 or A853

71

TM0557 Rev C

Redeployment General Information

TM0557 Rev C

Always and as Soon as Possible

Always:

– Use universal precautions

– Call Technical Support, if needed

– Refer to:

♦ Product User Guides

♦ Equipment Redeployment Instruction

As soon as possible:

– Retrieve equipment from the patient’s home

– Perform redeployment procedures

– Inform Customer Service of redeployed equipment

serial numbers

TM0557 Rev C

Prior to Redeployment

TM0557 Rev C

Train Center Personnel

Review the Redeployment

Instructions

Provide a demonstration

of steps/procedures

Monitor a return

demonstration

Document competency

TM0557 Rev C

Obtain Patient Redeployment Kit and Gather Supplies

TM0557 Rev C

Equipment Redeployment Steps

TM0557 Rev C

Return Equipment to Center or NxStage

TM0557 Rev C

Inspect Equipment and Accessories

Call Technical

Support if…

Call Customer

Support if …

TM0557 Rev C

Perform Redeployment Steps

TM0557 Rev C

Perform Redeployment Procedures

TM0557 Rev C

Cycler Redeployment Overview

TM0557 Rev C

Cycler Redeployment

Jewel Box connections shown

TM0557 Rev C

Cycler Redeployment

TM0557 Rev C

PureFlow SL Redeployment Overview

TM0557 Rev C

PureFlow SL Redeployment

Control Unit rear connections

PAK electrical cable

connection

TM0557 Rev C


Your software version may differ from this display.

TM0557 Rev C


Check Control Unit Ultraviolet

Light preventive maintenance

– If time is less than 156

batches, replace Control

Unit

Check Control Unit

Conductivity Sensor preventive

maintenance

USER MAINTENANCE

Settings

USER MAINTENANCE

PM Info

UV Light PM

Due in XX batches

Condo Sensor PM

Due in XX days

TM0557 Rev C

Verify Conductivity Line check valve function


TM0557 Rev C


If the Conductivity Sensor preventive

maintenance time is less than 300 days,

perform the CPM-001 procedure

TM0557 Rev C


Disinfect the Conductivity Line

TM0557 Rev C

Verify Drain Line check valve function


TM0557 Rev C


Disinfect the Drain Line

TM0557 Rev C


TM0557 Rev C


Replace the PureFlow SL Air Filter media

– Note: Leave the Guard attached to PureFlow SL.

Air Filter Guard

Air Filter cover with media

Do not remove

Guard screws

TM0557 Rev C

LINX Water Pre-Treatment System

Overview

TM0557 Rev C

LINX Redeployment

TM0557 Rev C

Express Fluid Warmer Redeployment

Overview

TM0557 Rev C

Express Warmer Redeployment

TM0557 Rev C

Cycler Base and Fluid Detection

Sensor Redeployment Overview

TM0557 Rev C

Cycler Base and Fluid Detection Sensor

TM0557 Rev C

Redeployment Forms

TM0557 Rev C

Redeployment: Training Documentation

TM0557 Rev C

Redeployment: Equipment Documentation

TM0557 Rev C

Patient Equipment Log

TM0557 Rev C

NxRx Center Inventory Report

List of

Patient’s

Name

TM0557 Rev C

Redeployment Instructions

Availability

TM0557 Rev C

Available Electronically

NxDocuments

NxStage Web Site

350 Merrimack St. Lawrence, MA 01843

www.nxstage.com tel: 978-687-4700

Qthank you

Disclaimer












Maintenance and Preventive Maintenance of NxStage Equipment for Transitional Care

Purpose: Provide safe and effective maintenance and preventive maintenance of NxStage System One.

Policy: The System One will be maintained according to the NxStage User Guides and Instructions for Use.

Reference: NxStage User Guides and Instructions for Use (available on http://www.nxstage.com/)


INDICATION FOR USE SUPPORTIVE INFORMATION The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration in an acute or chronic care facility. The System One is also indicated for hemodialysis with or without ultrafiltration in the home. All treatments must be administered under a physician’s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

NxStage System One is an integrated system designed to provide a broad range of renal replacement therapies. The machine that controls the therapy is the cycler. The blood tubing set is the cartridge. The dialyzer is available attached to the cartridge, or one of many other available dialyzers may be used with the cartridge without a preattached dialyzer. The dialysate used is premixed dialysate, typically available in flexible five-liter bags and warmed by a warmer, or as prepared by the NxStage PureFlow SL. These components, along with other selected ancillary products may be used during therapy.

Refer to the appropriate current version of the NxStage User Guide or Instructions for Use for all equipment:

§ Maintenance § Preventive maintenance

NxStage User Guides sent to each center (will also be available on http://www.nxstage.com/):

§ System One § PureFlow SL § Express Fluid Warmer § ComfortMate Fluid Warmer § LINX Water Pre-Treatment System

NxStage Instructions for Use available from http://www.nxstage.com/:

§ Cycler Base and Fluid Detection Sensor § Conductivity Preventive Maintenance Test

Kit (CPM-001) Dialysis providers may consider having an extra NxStage System One cycler for transitional care in the event of equipment malfunction. This could eliminate a delay in patient treatment while a swap of the equipment is completed.

TransitionalCareStaffEducationPlan Page1of4


Day Topic ResourcesUsed AdditionalNotes Date

Completed PreTrainingPreparation ConfirmSiteandStaff

readiness

Ensureallequipmentandresourcesareonsiteandstaffreadyfortraining

SalesForcePortalUser-Entercontacts-donebyNxStageCE/CM/DirRNorAdminonly;NxRx-Equipmentreport

WEEK1 On-siteTraining UsingtheNSOandtheDialysisProcess Day Topic Resources AdditionalNotes Date

Completed1 NxStageOverview TM0472RevE 1 OverviewofNxStage

andNxSTEPSresourcesNxStageUserGuides-5

1. SystemOneCycler-NC4012RevD2. NxStagePureflowUserGuide-NC5342Rev

A3. NxStageExpressFluidWarmerUserGuide-

NC1760RevF4. NxStageFluidDetectionSystemNC6532Rev

AandNC2323RevC5. NxStageSystemOneJewelBoxand

ConNxBoxComputerRemovalandInstallationInstructions-NC3382RevC

NxSTEPSUser’sQuickReferencesGuides,TM0532RevF(5QRGs)1NurseGuideperfacilityTM0537RevCHowtocontactTechnicalSupport




Completed1 CartridgeLabeling

Flowpath UseofLockSiteand/or

heparinline(ifused)

NxStageIFUsforCartridges:1. CAR170C-NC45-0403RevB2. CAR172C-NC45-0501RevA3. CAR124C-NC45-0364RevD

CAR172IdentificationTool-TM0420RevBCleaninganduseofLockSitesonCAR172-TM0423RevASalineLockSiteMedicationAdministration-TM0422RevA

LocatedonNxDxDiscusstheCAR124-CbutjusttodescribethefeaturesMaywanttoaddCAR172SkillsChecklist-TM0421RevD

1 RXandSuppliesforTX PatientHemodialysisOrdersforNSO-NxRx-TM0680RevB

HandsonPractice 1 CyclerComponentsand

Installation CyclerSystemSettings Entertreatment

settingsCyclerTreatment-Demo

SystemOneUser’sGuideNxSTEPSFlipbookinNurseGuide-TM0678RevCHowDoIUsetheSystemOneQRG-TM0461RevEHowDoIEnterMyTreatmentInformation-TM0452RevE“UsingtheSystemOneCycler”videoonportalorDVD-TM0464RevB

NxSTEPSCheckpoint:PreparingfortreatmentNxSTEPSCheckpoint:Cycler

1 PureFlowSLInstallation PrimePak

HowDoIManagePureflowQRG-TM0463RevGUsingPureflowSL-TM0524RevADVDorNxSTEPSportal.

PureFlowUserGuide

1 ReviewNxStageandCenterPolicies/Procedures

NxDx-TM0666RevB SitewillneedtheirownP&PsinadditiontoNSOP&Ps.(TransitionalP&P)

2 UsingthecyclerusingBaggedDialysate;includingFluidDetectionSystem

HowDoIUsetheSystemOneQRG-TM0461RevESystemOneTreatmentChecklist-TM0673RevAExpressFluidWarmerUser’sGuide-NC1760RevFFluidDetectionSystemUser’sGuide-NC6532RevA

UsingtheCyclerDVDUseTM0477RevB–SkillsChecklist




Completed(cyclerbaseandleaksensor)

IdentifyComponents Install Set-up,Prime,Monitor

treatment CommonProcedures Endtreatment

HowDoIEnterMyTreatmentInformationQRG,TM0452RevE

2 TherapyPrescriptionandDosingGuidelines

PrescribingHHDppts:TM0712RevCorTM0472RevE;TM0722RevC(SystemOneS-ifapplicable)HowDoIDetermineMyTreatmentDoseQRG,TM0451RevDFlexibleTherapyandtheSystemOneSppt.,TM0722RevC

TherapyHandbook–APM907RevC

2 TherapyDosing NxStageDosingCalculator–IFU2.0NC5294RevCIFU2.1NC6493RevB

NxStageDosingCalculatorIFUandReferencesonportal

2 CyclerTroubleshootingusingBaggedDialysate

HowDoITroubleshootQRG,TM0455RevETroubleshootingtheSystemOneCyclerDVD-TM0687RevA

CyclerTroubleshootingDVDHandsonpracticeHowtosetupamocktreatmentforpractice

2 IdentifyPureFlowSLComponents

HowDoIManagePureFlowQRG,TM0463RevG UsingPureFlowSLDVD–TM0524RevANxSTEPSLearningCheckpoints

2 PureFlowSLMakeaBatch

HowDoIManagePureFlowQRG,TM0463RevGPureFlowUser’sGuideandvideo

NxSTEPSLearningCheckpoints

2 PureFlowSL WaterSampling CheckChloramines CommonProcedures

HowDoIManagePureFlowQRG,TM0463RevGHowDoITroubleshootQRG,TM0455RevE

PureFlowUser’sGuide–NC2327RevD




Completed Troubleshooting

3 UnusualConditions-Cycler

HowDoIDealwiththeUnusualQRG,TM0457RevD

3 CyclerSet-upwithPureFlowSL

Troubleshooting

UsingtheSystemOneChecklist,TM0673RevA

3 EquipmentMaintenanceandPreventativeMaintenance

NxStageUserGuidesHowDoIUsetheSystemOneQRG,TM0673RevAHowDoIManagePureFlowQRG,TM0463RevGPureFlowDrainLineCleaningKit(DLCK)-NC45-0577RevBEquipmentReturnPolicies-NC2526RevA

NxDx

3 ManageComplications HowDoIRecognizeaProblemQRG,TM0458RevC NxSTEPSportal 4 Reviewand

DocumentationTrainerEducationCertificateofCompletion-FORM344RevC

CompleteFORM344foreachtrainedstaffmember

4 Redeploymentprocedures

EquipmentRedeploymentInstructions–NC3927RevC

NxDx/NC3927RevC

4 Inventorymanagement

CustomerServiceSpecialist-ContactCSSrep NxStageCustomerService866-NxStage(697-8243)

4 GroupDemonstration Staffdemonstratetheset-upandtreatmentonNxStageSystemOne(BagsandPureflow)

CompleteTM0477RevBforeachtrainedstaffmember

WEEK2 ObserveandSupportstaffwithfirstgroupofpatients

Days1-3 On-sitesupport Provideon-sitesupportwithpatientsdialyzing DocumentCertificateof

Completionatendoftraining

UseTM0477RevBforSkillsChecklistFORM344RevC-CertificationofCompletion

FollowUpPlans Scheduleevery2-3monthsupdateandskillreviews

Disclaimer












Hemodialysis Dosing for Transitional Care

Purpose : To ensure that the delivered dose of hemodialysis administered provides adequate therapy to optimize the therapy and stabilize of the patient. Policy: The patient will receive an optimal dose of hemodialysis as ordered by the Nephrologist. The Nephrologist will order the treatment frequency, dialysate volume and composition, target blood flow rate, maximum ultrafiltration rate and estimated dry weight.

References: Available from your NxStage Account Manager/Clinical Educator

§ NxStage Dosing Calculator and Instructions for Use available on www.nxstage.com § Therapy Primer NxStage Hemodialysis Treatment § Supplemental Quick Reference Guide

PROCEDURE

SUPPORTIVE INFORMATION


Disclaimer












Anticoagulation Administration for

Transitional Care

Reference: Nephrology Nursing Scope and Standards of Practice 7th edition 2011 Edition,

Treatment and Equipment- related complications, p 132


Purpose: To establish a method for safe use of anticoagulation during hemodialysis. To ensure the patient will be free of complications associated with anticoagulation therapy.

Policy: Anticoagulation may be given as a bolus infusion. If no anticoagulation is to be used, saline flushes may be done periodically to assess dialyzer condition.

Supplies: § Anticoagulant as ordered § Syringe, needle § Appropriate Personal Protective Equipment (PPE) for Universal Precautions

PROCEDURE


1. Review physician prescription for anticoagulation orders.

2. Administer prescribed anticoagulant dose per physician order.

Physicians may consider a heparin protocol for transitional care patients. Recommended starting dose 10 to 20 units per kg.

3. Monitor clotting and document anticoagulant doses, lab values and changes as necessary.

4. Evaluation of dialyzer clotting may be done by performing a manual fluid bolus.

This additional saline must be considered when calculating fluid balance and ultrafiltration target. Refer to NxStage System One User Guide for manual fluid bolus instructions.

Transitional Care Dialysis – 4 Week Education Guide Page 1 of 4


Purpose: To provide guidance in creating a curriculum for Transitional Dialysis patients over the course of 4 weeks and the key stakeholders responsible for delivering the educational material.

Week 1 – Comfort & Assure Patient Total Weekly Duration – 170 Minutes

Goal Tactics Time Provide emotional support and comfort patient

• Briefly introduce patient to social worker (Social Worker) 10 Minutes

Determine if patient would like a family member involved in the educational process

• Conversation with patient regarding family/friend they may want involved (In Center RN)

• Encourage patient to include a family member or friend (In Center RN)

5 Minutes

Briefly introduce how dialysis works • As procedures are performed, such as

obtaining vital signs, explain why procedures are being done (PCT)

30 Minutes

Address patient/family member initial questions, fears & concerns

• Review Kidney School Module 5 – Coping with Kidney Disease (In Center RN) • Objectives: (1) Emotions, (2) Asking for Help,

and (3) Recognizing and dealing with depression

• Allow patient/family to ask initial questions (economic, social, etc.)

60 Minutes

Educate patient/family member on the cause of their ESRD

• Review Kidney School Module 1 – How They Work, How They Fail, and What You Can Do (In Center RN) • Objectives: (1) Normal Kidney Function, (2)

Warning Signs of Chronic Kidney Disease, and (3) Slowing the Progression of Kidney Disease

20 Minutes

Address pre-conceived ideas about dialysis & introduction to staff

• Briefly introduce patient/family member to each relevant staff member (In Center RN)

• Review Kidney School Module 3 – Working With Your Healthcare Team (In Center RN) • Objectives: (1) Care Team Members and Their

Roles & Job Descriptions, (2) Role of the Dialysis Patient, (3) How to Talk To Your Doctor and Ask Questions, and (4) Understanding Professional Credentials

30 Minutes

Assure patient their insurance will pay (Medicare, commercial, etc.)

• Social Worker provides patient/family member with assurance for how insurance will cover patient’s expenses (Social Worker)

15 Minutes



Week 2 – Education About Key Topics Total Weekly Duration – 285 Minutes

Goal Tactics Time Allow patient/family member to ask questions prior to week 2

• Address patient/family member questions based on week 1 (In Center RN) 30 Minutes

Educate on fluid, infection, and medication management

• Review Kidney School Module 4 – Following Your Treatment Plan (In Center RN) • Objectives: (1) Importance of following the

treatment plan, (2) Elements of the treatment plan (dialysis prescription), (3) Getting all prescribed treatment time, (4) Managing medications, (5) Managing diet and fluids, (6) Fighting thirst, (7) CKD 3 & 4 diet, (8) Access care tips, (9) PD catheter care tips

90 Minutes

Discuss patient short & long-term lifestyle goals

• Have patient complete “My Life, My Dialysis Choice” via: https://mydialysischoice.org/ (PCT reviews with patient & prints report)

30 Minutes

Provide basic modality and access education: PD, HHD; transplant and in-center

• Review Kidney School Module 2 – Treatment Options For Kidney Failure (In Center RN) • Objectives: (1) What does dialysis do?, (2)

When to start dialysis, (3) Peritoneal dialysis—how it works, (4) Hemodialysis—how it works, (5) Transplant—how it works, (6) Pro & con table for 5 modalities, (7) Modality preference checklists, (8) Choosing no treatment, (9) 6 principles for living well with kidney disease, (10) Vascular access (brief discussion of types)

60 Minutes

Present outcomes data, quality of life data

• Read and present study to patient/family member (Present Outcomes slide) (In Center RN)

30 Minutes

Review Patient Insurance Benefits

• Social Worker provides patient/family member with a more thorough overview of insurance benefits (Social Worker)

• Allow patient to ask questions regarding insurance coverage (Social Worker)

30 Minutes

Introduce prospect of home dialysis (PD and HHD)

• Consider introducing the patient/family member to another patient on HHD, even if patient is leaning towards a specific modality (Patient)

• Schedule additional time with HHD patient for any follow-up questions or concerns. (Patient)

15 Minutes



Week 3 – In-Depth Modality Education Total Weekly Duration – 350 Minutes


• Address patient questions based on week 2 (In Center RN) 30 Minutes

In-depth education (including access) on:

§ PD § HHD § In-Center § Transplant

• Provide and review Home Dialysis Comparison Chart (Home RN) (http://www.homedialysis.org/documents/ModalityComparison.pdf)

20 Minutes

• Show patient a PD cycler, catheter, etc… (Home RN) 15 Minutes

• Further show and explain NxStage HHD (system, bags, Pureflow, etc..) (PCT) 15 Minutes

• Discuss travel opportunities using various modality options (Home RN) 30 Minutes

• Discuss various forms of HHD (nocturnal, short-daily, in-center etc.) (Home RN) 30 Minutes

• Discuss various forms of PD (CAPD and CCPD) (Home RN) 30 Minutes

• Review results of “My Life, My Dialysis Choice” with the patient (Home RN) 15 Minutes

• Review Kidney School Module 8 – Vascular Access: A Lifeline for Dialysis (In Center RN) • Objectives: (1) Types of vascular access for

hemodialysis, (2) Catheters—access for PD, (3) Deciding about an access, (9) Self-cannulation and the buttonhole technique

30 Minutes

Patient/family member discusses modalities with a PD, HHD, In-Center, & Transplant patient

• Introduce patient/family member to other patients on all dialysis modalities (in-person), even if patient is leaning towards a specific modality (Patient)

• Patient advocates must be enthusiastic and factual about their modalities (Patient)

90 Minutes

Financial education regarding dialysis therapy (water consumption, transportation, etc.)

• Social Worker provides patient/family member with an overview (Social Worker) 45 Minutes



Week 4 – Patient Modality Choice Total Weekly Duration – 175 Minutes


• Address patient/family member questions based on week 3 (In Center RN) 30 Minutes

Determine patient’s modality preference

• Conversation with patient/family member to select modality (Physician) 10 Minutes

Reassure patient/family member that all options remain available

• Conversation explaining patient can change choice, if desired (Physician) 10 Minutes

Teach patient/family member dietary restrictions (Customized based on modality choice)

• Review Kidney School Module 9 – Nutrition and Fluids For People On Dialysis (Dietitian) • Objectives: (1) Calories and calorie

requirements, (2) Food value chart and food groups, (3) Getting the right amounts of nutrients (protein, fats, and carbohydrates), (4) Meal planning & estimating portion size, (5) Meal-planning grid, (6) Protein and vitamin supplements, (7) Eating out, (8) Tips for vegetarians, (9) Renal bone disease, (10) Binders and antacids

90 Minutes

If patient is interested in transplant, refer to appropriate transplant centers

• Provide patient with transplant center information (Physician)

30 Minutes (If Needed)

If patient chooses a home modality, refer them to helpful resources

• Share at least the 2 below references: (Home RN) • http://homedialyzorsunited.org/ • http://www.homedialysis.org/

5 Minutes (If Needed)

Disclaimers:

• IfModalityNurseEducatorisonstaff,theycanprovidein-deptheducationfortheirareaofexpertise • IfaFinancialAdvisorisonstaff,theymayassumesomeresponsibilitiesofthesocialworker • IfTransplantCoordinatorisonstaff,theycanassumephysicianresponsibilitiesfortransplantcenter

information • IfLPNsareonstafftheycanassumeeducationalresponsibilitiesofPCTs

Disclaimer












Water and Dialysate Evaluation and Testing

Guidelines for PureFlow SL in Transitional Care

Testing Overview

Policy Number: 4 Effective Date: Reviewed/Revised Date

Purpose: To provide guidelines for testing, evaluating, and monitoring the quality of water and dialysate used by the hemodialysis patient using PureFlow SL with the NxStage System One (known to CMS as preconfigured system) for compliance with the CMS Conditions for Coverage. Policy: Water and dialysate testing and documentation will meet NxStage, CMS, and AAMI standards and guidelines. Documentation of testing, results, and interventions will be maintained at the dialysis center.

TAG# Sample Frequency Test Performed

V593/

V594 Source water: Municipal

Initially to verify source water is within range for the use of PureFlow SL.

Chemical analysis of the standard AAMI test panel contaminants to ensure product manufacturer’s specifications are met. See PFSL User’s Guide 4), Section 10: Specifications for Source Water Purity Limits.

V594/

V276 Product water

Initially: Test first PAK used near the estimated end of PAK life.

Annually: Test near the estimated end of PAK life.

No other testing is required, such as at a PAK change or with a Control Unit service swap.

Chemical analysis of the standard AAMI test panel contaminates to ensure AAMI specifications are met.

V595 Product water

Each batch, prior to use of the batch. Analysis of chlorine/chloramines levels to ensure the AAMI and manufacturer’s specifications are met.

V595 Dialysate Quarterly: Test within the first month of use, near the estimated end of a batch.

Bacteriological and endotoxin analysis to ensure AAMI specifications are met.



NxStage technical clarification:

• Water quality can be confirmed for all new PureFlow SL patients by performing a standard AAMI test panel then comparing each contaminate level to the corresponding PureFlow SL User Guide Section 10: Specifications for Source Water Purity Limits.

• Source water pressure must be between 20 - 80 psi or 20 to 120 psi with a Pressure Regulator. • Source water flow must be at least 150ml/min or greater. • Results of source water may be recorded on Water and Dialysate Testing Log (TM0427)

available from NxStage Home Hemodialysis NxDocuments/Forms.

TAG# Regulation Interpretive Guidance

V593/ V594 / V276 Product water

Monitoring of the quality of

water and dialysate used by hemodialysis patients and testing of the water and dialysate system in accordance with:

(A) The recommendations

specified in the manufacturer’s instructions; and

(B) The system’s FDA – approved labeling for preconfigured systems designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramines testing) water and dialysate.

A chemical analysis of the product water must be done at the start of PureFlow SL treatment and at least once a year near the end of the usability of any disposable component, or when any modifications are made to the treatment components (other than the replacement of disposable components), to ensure that AAMI-defined maximum allowable chemical contaminant levels are not exceeded. When any repairs are made to water treatment equipment, the impact on water quality should be evaluated and a chemical analysis performed if indicated. Chlorine/chloramine levels must be tested prior to the start of each treatment (or before use of each new batch of dialysate) in accordance with AAMI guidance and manufacturer’s recommendations. For batch systems (integrated systems which prepare enough dialysate for multiple treatment), the chlorine/chloramines testing shall be performed at the worst case scenario, i.e. after the preparation of each batch of dialysate, but before use of that batch, from a testing port that meets manufacturer’s specifications to be in compliance with the requirements of AAMI.



TAG# Regulation Interpretive Guidance V595 Dialysate

The facility must meet testing and other requirements of ANSI/AAMI RD52:2004. In addition, bacteriological and endotoxin testing must be performed on a quarterly or more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits.

The result of water and dialysate testing for hemodialysis patients may be included in the patients’ medical records or in separate logs. According to AAMI, a log sheet should be provided by the dialysis facility and used to record all measures of water treatment system performance as required by the equipment manufacturer or the dialysis facility


• Draw initial product water near the estimated end of the first PAK life. • Draw annual product water near the estimated end of PAK life. • Modifications: NxStage will notify user when modifications are made to the system if additional

testing of product water for chemical analysis should be performed. • Repairs: No non-NxStage “field repairs” are supported by NxStage. Routine service swap of

Control Unit provides new or remanufactured equipment following FDA approved Good Manufacturing Practices. Complete self-tests on every PAK and batch ensures proper function of PFSL or the equipment will stop in fail safe condition. Any individual variations in control pressures or flow rate have no impact on water purity.

• New PAK: Testing is NOT required after installing and priming a new PAK. • Control Unit Swap: Testing is NOT required after changing the PFSL Control Unit hardware. • Sufficient volume of product water: PFSL dispenses product water from the Conductivity Line

of the SAK for initial and repeat chlorine/chloramines testing. The system will automatically go to drain when the operator indicates that the chlorine/chloramines testing has failed. The product water used for testing chlorine/chloramines represents the “worst case scenario” as the samples are representative of the last product water entering the batch.

Documentation:

• Documentation of product water testing and dialysate sampling may be recorded on the NxStage System One Hemodialysis Flowsheet (TM0196).

• Results of product water and dialysate testing may be recorded on Water and Dialysate Testing Log (TM0427).



References: CMS 42 CFR Parts 494 Conditions for Coverage for End-Stage Renal Disease Facilities and related CMS ESRD Program Interpretive Guidance (October 3, 2008) Dialysate Preparation Primer Chronic Hemodialysis with the NxStage PureFlow SL PureFlow SL User’s Guide AAMI/FDS-RD52:2004/A1 Dialysate for Hemodialysis, Amendment 1- Annex C; Special Considerations for Home Hemodialysis

NxStage technical clarification: • Follow appropriate retesting and retraining procedures in response to any positive test results. • Dialysate culture should be drawn near the estimated end of SAK life from a sterile connector. • Dialysate bacteriology testing does NOT need to be tested before starting treatment. • Testing may begin near the end of SAK life.

Documentation: • Clinicians may record chlorine/chloramines testing results on the (Sample) NxStage System One

Hemodialysis Flowsheet (TM196). • Clinicians may record water and dialysate sampling on the (Sample) NxStage System One

Hemodialysis Flowsheet (TM0196). • Results of water and dialysate testing may be recorded on the Water and Dialysate Testing Log

(TM0427).

Disclaimer












Obtain Product Water for Chemical and

Bacteriological Testing for Transitional

Care Programs Using PureFlow SL

PROCEDURE


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.


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



ATTACHMENT A



ATTACHMENT B

Transitional Care Policies and Procedures Page 1 of 15


Disclaimer












Maintenance and Preventive Maintenance of NxStage Equipment for Transitional Care

Purpose: Provide safe and effective maintenance and preventive maintenance of NxStage System One.

Policy: The System One will be maintained according to the NxStage User Guides and Instructions for Use.

Reference: NxStage User Guides and Instructions for Use (available on http://www.nxstage.com/)


INDICATION FOR USE SUPPORTIVE INFORMATION The NxStage System One is indicated for the treatment of acute and chronic renal failure or fluid overload using hemofiltration, hemodialysis, and/or ultrafiltration in an acute or chronic care facility. The System One is also indicated for hemodialysis with or without ultrafiltration in the home. All treatments must be administered under a physician’s prescription, and must be observed by a trained and qualified person, considered to be competent in the use of this device by the prescribing physician.

NxStage System One is an integrated system designed to provide a broad range of renal replacement therapies. The machine that controls the therapy is the cycler. The blood tubing set is the cartridge. The dialyzer is available attached to the cartridge, or one of many other available dialyzers may be used with the cartridge without a preattached dialyzer. The dialysate used is premixed dialysate, typically available in flexible five-liter bags and warmed by a warmer, or as prepared by the NxStage PureFlow SL. These components, along with other selected ancillary products may be used during therapy.

Refer to the appropriate current version of the NxStage User Guide or Instructions for Use for all equipment:

§ Maintenance § Preventive maintenance

NxStage User Guides sent to each center (will also be available on http://www.nxstage.com/):

§ System One § PureFlow SL § Express Fluid Warmer § ComfortMate Fluid Warmer § LINX Water Pre-Treatment System

NxStage Instructions for Use available from http://www.nxstage.com/:

§ Cycler Base and Fluid Detection Sensor § Conductivity Preventive Maintenance Test

Kit (CPM-001) Dialysis providers may consider having an extra NxStage System One cycler for transitional care in the event of equipment malfunction. This could eliminate a delay in patient treatment while a swap of the equipment is completed.



Treatment Documentation for Transitional Care

Reference: Nephrology Nursing Scope and Standards of Practice 7th edition 2011 Edition, Ongoing Monitoring p. 164


Supplies § Center treatment record or NxStage System One Hemodialysis Flowsheet (available on

http://www.nxstage.com/).

PROCEDURE SUPPORTIVE INFORMATION Using the chosen treatment format, instruct the Patient Care Technician (PCT) how to record and monitor patient treatment information and place in the patient’s medical record.

The Patient Care Technician should be instructed to notify the Registered Nurse of unusual pre, intra and post treatment signs, symptoms or conditions.

Purpose: To ensure each patient treatment is documented and sent to the center enabling patient surveillance and monitoring. Policy: The dialysis center clinician will document each treatment ensuring the center’s requirements for pre- treatment, intradialytic, and post- treatment information are met.



Hemodialysis Dosing for Transitional Care

Purpose : To ensure that the delivered dose of hemodialysis administered provides adequate therapy to optimize the therapy and stabilize of the patient. Policy: The patient will receive an optimal dose of hemodialysis as ordered by the Nephrologist. The Nephrologist will order the treatment frequency, dialysate volume and composition, target blood flow rate, maximum ultrafiltration rate and estimated dry weight.

References: Available from your NxStage Account Manager/Clinical Educator

§ NxStage Dosing Calculator and Instructions for Use available on www.nxstage.com § Therapy Primer NxStage Hemodialysis Treatment § Supplemental Quick Reference Guide

PROCEDURE


1. Using the Dosing Calculator enter the patient specific information.

The dosing calculator is an online convenient tool for physicians prescribing chronic hemodialysis therapy with the NxStage Cycler. Specific prescription parameters will vary by patient based on co-morbid conditions and individual response to therapy. It designed to provide chronic hemodialysis prescription options with the NxStage System One and Cartridge with pre-attached dialyzer based on patient and treatment parameters entered. With a specified set of algorithms, it automatically performs calculations that are typically done by a physician or licensed healthcare practitioner. It uses formulas from scientific, peer-reviewed medical journals, and patient and treatment information entered into the program. Refer to the Dosing Calculator IFU for specific formulas used. The prescription options provided by the Dosing Calculator can be used as a baseline/starting point for the development of a treatment plan which should include relevant aspects of patient management




(residual renal function, blood pressure, weight, fluid balance, laboratory results) and trends. All users must register and create an account to use the NxStage dosing calculator. Physicians should routinely monitor patients in accordance with established clinical practices for changes in condition that may necessitate a change in the patient’s prescription or medications. This tool is constrained to reflect standard practice with the NxStage Cycler with maximum dialysate volume of 60L and a maximum dialysate flow rate as follows: 12L/hr for NxStage System One and 18L/hr for NxStage System One S. Refer to the Dosing Calculator Instructions for Use for additional information.

a. The stdKt/V value entered in the Dosing Calculator must be between 2.0 -7.

This value sets the standard Kt/V that will be provided by all choices presented in the Dosing Calculator Options Table.

NKF KDOQI™ Clinical Practice Guidelines and Recommendations (2006 updates) recommends a minimum stdKt/V of 2.0 for minimally adequate hemodialysis. It is in the opinion of the Transitional Care Demonstration Initiative that Transitional care patients may benefit from a target stdKt/V > 2.5.

b. Blood flow rate entered into the Dosing Calculator must be between 100-500 mL/min.

A blood flow rate range should be prescribed to achieve maximum dialysis adequacy and maintain acceptable arterial and venous pressure ranges based on individual access type and center policy.

c. Hematocrit entered into the Dosing Calculator must be between 18–50%

The Hematocrit is used in the urea clearance calculation

d. Ultrafiltration volume and rate. The ultrafiltration rate entered must be between 0.01-2.4L/hr

The estimated dry weight is a prescriptive component necessary for the calculation of appropriate ultrafiltration volume. When determining rate the risk of all-cause and cardiovascular mortality begins to increase at ultrafiltration rates over 10mL/hr/kg.1

Follow center’s policies for maximum ultrafiltration volume and rate.

e. Treatment hours / week

Literature suggest patients get at least 12hr of dialysis per week however transitional care patient may benefit from >15 hours of dialysis per week to become clinically stable.2



Reference: NKF K/DOQI Guidelines 2006, II. Clinical Practice Guidelines and Clinical Practice Recommendations Hemodialysis Adequacy

2. Note the therapy options displayed and discuss with the healthcare team, patients and care partners.

Choose a time and frequency that is medically acceptable and will provide the patient with optimal therapy (generally 4-5 times per week). Emphasis should be on avoiding a two-day gap in hemodialysis treatments. Clinical literature supports clinical and quality of life benefits of more frequent dialysis.

a. Dialysate volume and rate Volume of dialysate exchanged is based on patient’s response to therapy. Adequacy of dose should include clinical observations. Premixed dialysate bags are available in 5L bags. Batch dialysate is available in 40, 50, 60 L SAK. PureFlow SL and Cycler System One S are required for dialysate flow rates > 12 L/hr.

3. Determine dialysate composition Composition is ordered by the physician and should be determined based on individual patient medical history and recent laboratory values.

4. Evaluate the patient’s response to the therapy option selected and adjust as required.



Water and Dialysate Evaluation and Testing

Guidelines for PureFlow SL in Transitional Care

Testing Overview

Policy Number: 4 Effective Date: Reviewed/Revised Date

Purpose: To provide guidelines for testing, evaluating, and monitoring the quality of water and dialysate used by the hemodialysis patient using PureFlow SL with the NxStage System One (known to CMS as preconfigured system) for compliance with the CMS Conditions for Coverage. Policy: Water and dialysate testing and documentation will meet NxStage, CMS, and AAMI standards and guidelines. Documentation of testing, results, and interventions will be maintained at the dialysis center.

TAG# Sample Frequency Test Performed

V593/

V594 Source water: Municipal

Initially to verify source water is within range for the use of PureFlow SL.

Chemical analysis of the standard AAMI test panel contaminants to ensure product manufacturer’s specifications are met. See PFSL User’s Guide 4), Section 10: Specifications for Source Water Purity Limits.

V594/

V276 Product water

Initially: Test first PAK used near the estimated end of PAK life.

Annually: Test near the estimated end of PAK life.

No other testing is required, such as at a PAK change or with a Control Unit service swap.

Chemical analysis of the standard AAMI test panel contaminates to ensure AAMI specifications are met.

V595 Product water

Each batch, prior to use of the batch. Analysis of chlorine/chloramines levels to ensure the AAMI and manufacturer’s specifications are met.

V595 Dialysate Quarterly: Test within the first month of use, near the estimated end of a batch.

Bacteriological and endotoxin analysis to ensure AAMI specifications are met.




• Water quality can be confirmed for all new PureFlow SL patients by performing a standard AAMI test panel then comparing each contaminate level to the corresponding PureFlow SL User Guide Section 10: Specifications for Source Water Purity Limits.

• Source water pressure must be between 20 - 80 psi or 20 to 120 psi with a Pressure Regulator. • Source water flow must be at least 150ml/min or greater. • Results of source water may be recorded on Water and Dialysate Testing Log (TM0427)

available from NxStage Home Hemodialysis NxDocuments/Forms.

TAG# Regulation Interpretive Guidance

V593/ V594 / V276 Product water

Monitoring of the quality of

water and dialysate used by hemodialysis patients and testing of the water and dialysate system in accordance with:

(A) The recommendations

specified in the manufacturer’s instructions; and

(B) The system’s FDA – approved labeling for preconfigured systems designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramines testing) water and dialysate.

A chemical analysis of the product water must be done at the start of PureFlow SL treatment and at least once a year near the end of the usability of any disposable component, or when any modifications are made to the treatment components (other than the replacement of disposable components), to ensure that AAMI-defined maximum allowable chemical contaminant levels are not exceeded. When any repairs are made to water treatment equipment, the impact on water quality should be evaluated and a chemical analysis performed if indicated. Chlorine/chloramine levels must be tested prior to the start of each treatment (or before use of each new batch of dialysate) in accordance with AAMI guidance and manufacturer’s recommendations. For batch systems (integrated systems which prepare enough dialysate for multiple treatment), the chlorine/chloramines testing shall be performed at the worst case scenario, i.e. after the preparation of each batch of dialysate, but before use of that batch, from a testing port that meets manufacturer’s specifications to be in compliance with the requirements of AAMI.



TAG# Regulation Interpretive Guidance V595 Dialysate

The facility must meet testing and other requirements of ANSI/AAMI RD52:2004. In addition, bacteriological and endotoxin testing must be performed on a quarterly or more frequent basis as needed, to ensure that the water and dialysate are within the AAMI limits.

The result of water and dialysate testing for hemodialysis patients may be included in the patients’ medical records or in separate logs. According to AAMI, a log sheet should be provided by the dialysis facility and used to record all measures of water treatment system performance as required by the equipment manufacturer or the dialysis facility


• Draw initial product water near the estimated end of the first PAK life. • Draw annual product water near the estimated end of PAK life. • Modifications: NxStage will notify user when modifications are made to the system if additional

testing of product water for chemical analysis should be performed. • Repairs: No non-NxStage “field repairs” are supported by NxStage. Routine service swap of

Control Unit provides new or remanufactured equipment following FDA approved Good Manufacturing Practices. Complete self-tests on every PAK and batch ensures proper function of PFSL or the equipment will stop in fail safe condition. Any individual variations in control pressures or flow rate have no impact on water purity.

• New PAK: Testing is NOT required after installing and priming a new PAK. • Control Unit Swap: Testing is NOT required after changing the PFSL Control Unit hardware. • Sufficient volume of product water: PFSL dispenses product water from the Conductivity Line

of the SAK for initial and repeat chlorine/chloramines testing. The system will automatically go to drain when the operator indicates that the chlorine/chloramines testing has failed. The product water used for testing chlorine/chloramines represents the “worst case scenario” as the samples are representative of the last product water entering the batch.

Documentation:

• Documentation of product water testing and dialysate sampling may be recorded on the NxStage System One Hemodialysis Flowsheet (TM0196).

• Results of product water and dialysate testing may be recorded on Water and Dialysate Testing Log (TM0427).



References: CMS 42 CFR Parts 494 Conditions for Coverage for End-Stage Renal Disease Facilities and related CMS ESRD Program Interpretive Guidance (October 3, 2008) Dialysate Preparation Primer Chronic Hemodialysis with the NxStage PureFlow SL PureFlow SL User’s Guide AAMI/FDS-RD52:2004/A1 Dialysate for Hemodialysis, Amendment 1- Annex C; Special Considerations for Home Hemodialysis

NxStage technical clarification: • Follow appropriate retesting and retraining procedures in response to any positive test results. • Dialysate culture should be drawn near the estimated end of SAK life from a sterile connector. • Dialysate bacteriology testing does NOT need to be tested before starting treatment. • Testing may begin near the end of SAK life.

Documentation: • Clinicians may record chlorine/chloramines testing results on the (Sample) NxStage System One

Hemodialysis Flowsheet (TM196). • Clinicians may record water and dialysate sampling on the (Sample) NxStage System One

Hemodialysis Flowsheet (TM0196). • Results of water and dialysate testing may be recorded on the Water and Dialysate Testing Log

(TM0427).



Obtain Product Water for Chemical and

Bacteriological Testing for Transitional

Care Programs Using PureFlow SL

PROCEDURE


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.


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



ATTACHMENT A



ATTACHMENT B



Anticoagulation Administration for

Transitional Care

Reference: Nephrology Nursing Scope and Standards of Practice 7th edition 2011 Edition,

Treatment and Equipment- related complications, p 132


Purpose: To establish a method for safe use of anticoagulation during hemodialysis. To ensure the patient will be free of complications associated with anticoagulation therapy.

Policy: Anticoagulation may be given as a bolus infusion. If no anticoagulation is to be used, saline flushes may be done periodically to assess dialyzer condition.

Supplies: § Anticoagulant as ordered § Syringe, needle § Appropriate Personal Protective Equipment (PPE) for Universal Precautions

PROCEDURE


1. Review physician prescription for anticoagulation orders.

2. Administer prescribed anticoagulant dose per physician order.

Physicians may consider a heparin protocol for transitional care patients. Recommended starting dose 10 to 20 units per kg.

3. Monitor clotting and document anticoagulant doses, lab values and changes as necessary.

4. Evaluation of dialyzer clotting may be done by performing a manual fluid bolus.

This additional saline must be considered when calculating fluid balance and ultrafiltration target. Refer to NxStage System One User Guide for manual fluid bolus instructions.



Patient Supplies for Transitional Care


Purpose: To guide provision of appropriate supplies and equipment for transitional care. Policy:

1. Transitional care patients will have treatment equipment and supplies ordered through NxStage Medical.

2. Each transitional program will notify the supply company using procedures specified by that company for supplies. Supplies ordered will include, but not limited to the following: • Equipment supplies for treatment • Equipment such as NxStage System One, NxStage System One S and/or Pureflow SL.

3. Supplies for transitional care treatments are provided solely for use in patient’s in the

transitional care program. They are not to be utilized when/if the patient transitions to home hemodialysis. This includes disposable supplies and durable equipment.

4. Provision of dialysis supplies and equipment for treatment of hospitalized patients is wholly the responsibility of the acute care facility.

5. Supply shipment frequency will be determined by the dialysis provider’s contract agreement for transitional care with NxStage and may include more frequent deliveries and “ala carte” ordering.