2008K at home Train-the-Trainer Manual Rev A

2008K@home

Train-the-Trainer Manual

2008K@home Hemodialysis Delivery System

Train-the-Trainer Manual © Copyright 2011, Fresenius USA, Inc.-All Rights Reserved This document contains proprietary information of Fresenius USA, Inc. d/b/a Fresenius Medical Care North America and its affiliates (“Fresenius Medical Care”). The contents of this document may not be disclosed to third parties, copied, or duplicated in any form, in whole or in part, without the prior written permission of Fresenius Medical Care. Fresenius, Fresenius Medical Care, the triangle logo, 2008, PURISTERIL, and success@home are trademarks of Fresenius Medical Care Holdings, Inc., and/or its affiliated companies. Hemastix® is a registered trademark of Miles, Inc. All other trademarks are the property of their respective owners.

TABLE OF CONTENTS Section 1 – Introducing the FMCNA 2008K@home™ Hemodialysis System ... 3 Section 2 – Home Requirements ... 5 Section 3 – Preparing for Dialysis ... 8 Section 4 – Access for Dialysis ... 9 Section 5 – 2008K@home System Overview... 10 Section 6 – 2008K@home Software Overview ... 17 Section 7 – Getting Started ... 19 Section 8 – Entering the Prescription ... 21 Section 9 – Machine Setup ... 24 Section 10 – Preparing Your Dialysate... 25 Section 11 – Testing your 2008K@home Machine (Tx Setup)... 27 Section 12 – Setting Up the Arterial Lines: Screen 1 (Tx Setup) ... 28 Section 13 – Arterial Lines: Screen 2 (Tx Setup) ... 30 Section 14 – Venous Bloodline (Tx Setup) ... 31 Section 15 – Priming Blood Side (Tx Setup) ... 32 Section 16 – Prime Dialysate Side: Screen 1 (Tx Setup) ... 33 Section 17 – Prime Dialysate Side: Screen 2 (Tx Setup) ... 34 Section 18 – Entering Tx Parameters (Tx Setup) ... 35 Section 19 – Starting your Treatment (Tx Connect) ... 36 1

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Section 20 – Flush Saline (Tx Connect) ... 38 Section 21 – Connect Bloodlines (Tx Connect) ... 39 Section 22 – Start Treatment (Tx Connect) ... 40 Section 23 – Monitoring the Treatment (Home Screen) ... 42 Section 24 – Ending the Treatment ... 43 Section 25 – Check Saline (Tx End)... 44 Section 26 – Return Blood (Tx End) ... 45 Section 27 – Disconnect (Tx End) ... 47 Section 28 – Emptying (Tx End) ... 48 Section 29 – Cleansing (Tx End) ... 49 Section 30 – Troubleshooting Alarms... 52 Section 31 – Troubleshooting Specific Blood Alarms and Dialysate Alarms ... 54 Section 32 – Potential Problems During Dialysis ... 64 Section 33 – Returning the Blood Manually – Handcranking ... 65 Section 34 – Potential Problems During Dialysis ... 67 Section 35 – Replacing the Diasafe Plus Filter ... 68 Section 36 – Overview of Warnings and Cautions ... 69 Section 37 – Servicing the Fresenius 2008K@home Machine... 73 APPENDIX A – GLOSSARY OF TERMS... 74 APPENDIX B – HEMODIALYSIS BASIC TRAINING ... 86 APPENDIX C – VITAL SIGN CHECK AND RECORDING ... 88 APPENDIX D – INTRADIALYTIC COMPLICATIONS ... 94 APPENDIX E – INFECTION CONTROL ... 95 APPENDIX F – VASCULAR ACCESS CARE ... 98 HOW YOUR ACCESS WORKS ... 98 PREPARING YOUR ACCESS ... 98 CANNULATE AND SECURE YOUR VASCULAR ACCESS ... 101 VASCULAR ACCESS CARE... 102 APPENDIX G – COMPETENCY CHECKLIST ... 104

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Section 1 – Introducing the FMCNA 2008K@home™ Hemodialysis System

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The Learning Theory Train-the-Trainer section should be used in conjunction with this training section to introduce the trainer to learning techniques and theory that are applicable to the successful training of 2008K@home hemodialysis system users. This section provides an overview of the main learning concepts that must be taught to potential users of the 2008K@home hemodialysis system and should be used in conjunction with the 2008K@home User’s Guide. This Train-the-Trainer section is intended to help the trainer teach safe and effective use of the 2008K@home hemodialysis machine in the home setting. This includes a thorough discussion of all warnings and cautions contained in the user’s guide, a thorough review of all alarms and troubleshooting procedures and recommendations for competence demonstrations to be completed by the trainee. For each topic, we will review the main concepts, key terms, recommended return demonstrations and critical warnings that are integral to the training of home operators. This is supported by the Competency Check List (Appendix G). It is recommended that each item on the competency checklist is included as a return demonstration during the training period. Please remember that the suggested trainer-led learning activities listed in this section are only a guide. You will want to develop your own activities based on your experience, the information you have learned reading the Learning Theory Train-the-Trainer, and on your trainee’s ability level and learning style. Refer to the 2008K@home User’s Guide for definitions of terms and for a more complete description of each of these topics.

Implementation Overview Of primary importance to the success of home dialysis treatments using the 2008K@home hemodialysis system, is the suitability of home dialysis for the patient’s lifestyle, environment, and achievement of prescription goals. The patient’s nephrologist must certify that the patient is a candidate for home hemodialysis training. It is recommended that each trainer assess the patient in conjunction with the patient’s nephrologist to confirm their suitability for home dialysis. In addition, trainers should complete and document (if not already in the patient’s chart), a patient learning assessment to determine primary language for verbal and written communication, level of literacy, potential visual impairment particularly color differentiation, hearing impairment and manual dexterity. The patient’s training session should be adapted to meet the learner’s educational needs. The main learning concepts, key terms and recommended return demonstrations listed in this manual are guidelines for teaching strategies which require individualization to meet specific patient requirements. After completing the above assessments, a mutually agreed upon training schedule should be established. In general it is anticipated that training for home hemodialysis will take approximately 4-8 weeks. Please refer to the appropriate sections of the 2008K@home User’s Guide to review each procedure, definitions of individual terms, and warnings prior to each training session.

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Goals and Objectives After the successful completion of a four to eight week training period, the patient and care partner should demonstrate the competency to perform safe and effective dialysis at home. The patient and care partner should: • Understand and perform hemodialysis treatments safely without supervision. • Demonstrate the appropriate action to be taken during possible emergencies. • Understand how to obtain assistance for any technical or medical problems. • Understand and explain the prescribed diet and medication therapies. • Demonstrate blood work draws and processing. • Demonstrate medication administration. • Understand that all elements of the dialysis treatment, including medication, diet, and blood work, are under the order of the physician. • Understand normal renal function, the effects of end stage renal disease, and the effects of the hemodialysis treatment. A more complete listing is contained in the Competency Checklist (Appendix G) Goals and objectives form the foundation for learning activities, and assessment measures. Review the objectives with the patient and care partner so that they may see how the material is related to their training and recognize them as being important.

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Section 2 – Home Requirements

Safe operation of the Fresenius 2008K@home hemodialysis machine in the home setting requires that the home have sufficient electricity, water, water quality, water pressure and drainage capacity (sewers) for proper machine operations. The power, water and other environmental factors must be evaluated and certified by a qualified technician prior to the installation of the Fresenius 2008K@home machine (see sample checklist from the user’s guide below). Table 1. Home Evaluation Checklist Note: A qualified person from your clinic must fill out this or a similar form. He or she should come to your home in person to check it over. TYPE OF HOME: □ House □ Apartment □ Mobile Home □ Nursing Home □ Retirement Home Other: _______________ COMMUNITY ENVIRONMENT: □ # of occupants: ________ □ Room shared w/ another occupant □ Urban □ Rural □ Local Hospital: ______________________ □ Approximate miles From home to hospital: __________ □ Approximate miles from Home to unit: ___________ WATER SYSTEM: □ City □ Well □ Spring

SEWAGE SYSTEM: □ City □ Septic □ Leach Bed □ Trash Service □ Other: _________________ □ # of bathrooms: _________ □ Bathroom ______ft. to bed. □ Condition of shower head ELECTRICAL: □ 3-Prong outlets (single phase, threeconductor type receptacle and a ground fault interrupter at 120 Volts, 15 Amps, 60 Hz) □ Outlet near bed COOLING: □ A/C: Central/Window Units □ Fans: Type _____________ □ Duct System: Ceiling/Floor □ Other: ______________ HEATING: □ Electrical □ Gas □ Solar □ Wood stove □ Other: _________________

Failure to properly assess and ensure the reliable availability of electricity and water can result in patient injury. For this reason the user’s guide includes the following contraindication:

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Contraindications (When this machine should not be used) The 2008K@home machine is contraindicated for use in a home setting where there is inadequate water supply or inadequate water pressure. In other words, you cannot use the 2008K@home machine in your home if you do not have a constant water supply with good pressure. Your water pressure must be at least 20 psi and no more than 105 psi. Your water temperature must be at least 10°C (50°F) and no higher than 25°C (77°F).

Home Hemodialysis Training In order to provide home dialysis training for home hemodialysis, the facility must be approved and certified by the Centers for Medicare and Medicaid Services (CMS) meeting all State and Federal program requirements as applicable. Training for home dialysis must be provided by a qualified registered nurse who meets the following minimum requirements: 1. Current licensure in the State in which he or she is employed. 2. Current licensure in the State where home visits or contact with patients via telephone occurs. 3. A minimum of 12 months experience providing nursing care. 4. Additionally the Home Training Nurse is required to have a minimum of 3 months of experience working as a nurse in the specific modality (hemodialysis or peritoneal dialysis) for which the nurse will provide patient/caregiver training.1 The qualified registered nurse is responsible for providing major portion of the home dialysis training, and for oversight and coordination of the Home Training Program.

Home Operator Training Requirements At the completion of the training program the patient and/or caregiver must successfully demonstrate competency in clinical and technical procedures and self care management, and also successfully complete a written final exam. The qualified home training Registered Nurse must validate the patient’s and/or caregiver competency including evaluating the patient’s comprehension and skills, utilizing a skills checklist (see Competency Checklist, Appendix G). These requirements must be met prior to the patient/caregiver being certified to perform home dialysis independently. Home dialysis training for the patient and/or caregiver must be individualized to the needs of the home dialysis patient/training candidate, and tailored to their level of understanding. Special attention must be provided to ensure patients’ comprehension and ability to perform and master each of the required tasks. The patient and/or caregiver may be trained in a small group or individually over a sufficient time and in a setting that facilitates learning and understanding. At a minimum, suggested content areas that must be mastered as part of home dialysis training include:

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Refer to V Tag 685 of the CMS Interpretive Guidelines.

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1. The nature and management of ESRD 2. Specific (step-by-step) instructions on using the prescribed patient equipment. Specific emphasis should be placed upon proper set-up, input of treatment parameters, initiation of a treatment, performance of a hemodialysis treatment, understanding and proper management of alerts and alarms, termination of the hemodialysis treatment and proper machine cleansing and maintenance. 3. Specific (step-by-step) instructions in home dialysis procedures for home hemodialysis to facilitate adequate dialysis as prescribed by the patient’s physician 4. Training in proper storage and administration of erythrocyte stimulating agents (ESA’s), if applicable 5. Training in proper storage, preparation and administration of other physician ordered medications in the home environment 6. Detecting, managing and reporting potential dialysis complications, including water treatment problems as applicable. 7. When and how to contact support personnel. It must be emphasized that patients are not authorized to repair the machine and must contact an authorized person. Failure to follow these instructions can result in patient injury. 8. Availability of support services and how to access and use these resources 9. Self-monitoring of health status including recording and reporting of health status information 10. Completing and presenting home dialysis documentation including treatment sheets, and technical logs to the facility for monthly review by their physician and home hemodialysis care team 11. Handling medical and non-medical emergencies 12. Infection control precautions including disposal of biohazard waste The facility is responsible to ensure that training must be documented in the patient medical record and must include evidence of patient/caregiver demonstrated competence in performing the home dialysis procedures.

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Section 3 – Preparing for Dialysis

Main learning concepts: Performing home hemodialysis is not only about being able to operate the hemodialysis machine. There are a number of medical concepts that must be reviewed and taught to home operators. These include teaching a basic understanding of simple infection control techniques, documenting treatment data, monitoring vital signs, and calculating fluid goal. Review common blood work that may be prescribed. Stress the significance of time, friction and quantity of cleanser. Discuss use of hand sanitizers (alcohol based cleansers) as needed. Key Terms: Hand washing, Sterile and clean techniques, monitoring and documenting vital signs and weight, Checking blood work, Approved hand cleanser, Paper towels Recommended return demonstrations: At the end of this section the patient will be able to: 1. Contrast sterile from clean technique 2. Monitor and document vital signs and weight 3. Explain the importance of thorough hand washing and demonstrate the skill 4. Discuss preferred use of paper towels as an infection control measure 5. Restate facility established blood work protocols for blood draws, maintaining specimen integrity and review of specimen results Critical warnings, cautions and notes: • Warning: Failure to use sterile and clean techniques can result in severe injury or death.

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Section 4 – Access for Dialysis Vascular access cannulation and care are central to performing hemodialysis. Comfort and success with cannulation is key to successful home hemodialysis. It is anticipated that this subject will be stressed throughout the 4-8 week training period.

Main learning concepts: Please also refer to Appendix F, Vascular Access Care. Discuss central venous catheters, arterio-venous (AV) fistulas, and grafts. Review the signs or symptoms of access complications, access clotting, and access infection. Train on stepladder and buttonhole techniques as per the policy of the facility and physician order. Review rules for good access care and cannulation. Verbalize how to assess the dialysis access. Describe visual assessment of access. Note possible access abnormalities such as signs of infection, bruising, or aneurysms. Stress importance of visual inspection and palpation of the thrill for the entire length of the access. If the patient will utilize a catheter for dialysis, educate the patient throughout these pathways according to the specific facility policy and procedure for catheter care. Discuss needle removal and hemostasis including that insufficient pressure may lead to prolonged bleeding while excessive pressure can lead to access clotting. Key Terms: Types of access used for hemodialysis, access care and complications, cannulation, Redness/edema/bruising, Infection/abscess Infiltration, Gauze and band aids Sharps container, AV fistula, AV graft, dialysis catheter, Povidone iodine solution, isopropyl alcohol, or other approved cleanser Recommended return demonstrations: At the end of this section the patient will be able to demonstrate appropriate care of their access and access cannulation techniques including: 1. Evaluating access thrill and bruit 2. Identifying supplies needed to clean the access 3. Identifying the parts of the fistula needle including wings, protective needle guard, needle bevel, needle back eye, anti-stick needle protector, and tubing cap 4. Restating the steps of cannulation 5. Preparing the access for cannulation 6. Explaining the process of access monitoring during the treatment 7. Listing post treatment access steps including needle disposal and securing of access site 8. Showing a positive commitment to self care Critical warnings, cautions and notes: • Warning: Problems with your vascular access must be reported immediately to your physician. • Warning: Failure to properly care for your access may result in injury or death.

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Section 5 – 2008K@home System Overview

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1. Indication for Use & General Warnings Main learning concepts: The learner must be familiarized with the 2008K@home User’s Guide and the key indications for use, contraindications and general warnings relating to the 2008K@home hemodialysis machine Key Terms: User’s Guide, indications, contraindications, warnings Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to: 1. Explain the structure and components of the user’s guide including the glossary 2. Identify symbols for alerts and warning and explain their meaning 3. Restate indications for use, contraindications to use and general warnings Critical warnings, cautions and notes: • Please refer to the section on warnings, cautions and notes of this document. 2. Introduction to the 2008K@home hemodialysis machine and overview of its functionality Main learning concepts: It is important to familiarize the home operator with the layout of the 2008K@home hemodialysis machine. This includes a complete review of the basic machine components, control screens and safety features. This is discussed in detail in the 2008K@home User’s Guide section, “Meet Your 2008K@home Machine” Key terms: Explain the key features and parts of the 2008K@home machine including each of the components listed in the diagrams on page 12. These include the key components of the control panel, module compartment, and dialysate circuit section. Other key terms include the function keys on control panel, color coding of screen buttons, the main screen Status Box and Dialogue Box, arterial drip chamber holder and tubing guides, the blood pump, the heparin pump, the level detector module, the venous clamp, the concentrate connectors for bicarbonate and acid concentrate and the dialyzer quick-connectors and the shunt interlock. Discuss the blood circuit, the dialysate circuit, modules and control panel features. Please refer to the user’s guide and the glossary at the end of this manual as necessary for help in your explanations. Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to: 1. Confirm that the user’s guide section “Meet Your 2008K@home Machine” has been reviewed 2. Identify and demonstrate each portion of the machine including those named in the illustrations below

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3. Restate the function of the control panel and each screen, each of the keys and the color coding of screen buttons 4. Explain the functional sections of the main screen including the Status Box and the Dialogue Box 5. Discuss each component in the module section including the Arterial Drip Chamber, Blood Pump, Heparin Pump, and Level Detector 6. Recognize the importance of the venous clamp and how to properly seat the venous blood line in the clamp 7. Discuss the dialysate circuit 8. Differentiate between the red acid connector and the blue bicarbonate connector 9. Demonstrate the use of the concentrate connectors for bicarbonate and acid concentrate and the handling of the dialyzer quick-connectors and the shunt interlock. Critical warnings, cautions and notes:

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Warning: The machine’s modules and internal hydraulics involve fluids. Fluid leaks may cause excess fluid removal from the patient. Correct the problem immediately or take the machine out of service. Spills can cause damage to carpeting and other surfaces. To contain such spills, the machine should be on a spill-tolerant surface. Spills can cause slips and falls; clean up spills immediately.

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Caution: Do not raise the level of the drip chamber so high that the transducer protector becomes wet. Wet transducer protectors must be replaced, as they will cause inaccurate readings and possibly serious injury or death. See “Clearing the Pressure Monitor Line” in the 2008K@home User’s Guide

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Note: The Power key does not interrupt electrical power to your machine. To disconnect completely, use the main power switch on the back or pull the power cord plug.

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2008K@home Machine Front View

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2008K@home Machine Rear View

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Machine Section

Treatment Section

Patient Section

Control Panel

Standard Module Setup

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Red Acid Connector

Concentrate Jug Connector Cap

Blue Bicarbonate Connector

Fluid Sample Line Shunt Door Shunt Interlock

Dialysate Supply Line Flow Indicator

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Dialyzer QuickConnecters 2008K@home hemodialysis system Train-the-Trainer Manual

The 2008K@home User’s Guide features a foldout map of your machine called “Your K Map”: When a procedure references a location not shown, the operator can find the matching letter and location on “Your K Map” (inside front page of the user’s guide).

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Section 6 – 2008K@home Software Overview

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Main learning concepts: The different types of touch screen buttons and their functions, nonclickable status of grayed-out buttons, flowchart at the top of dialysis procedure screens Insert diagram explaining flowchart at top of screens

Key terms: In addition to reinforcing machine terminology add: grayed-out, touch (for buttons), press (for keys), progress bar graph, flowchart Recommended return demonstrations: Demonstrate the listed steps in the corresponding section of the 2008K@home Competency Checklist (Appendix G). At the end of this section the patient will be able to: 1. Explain the various types of buttons and which are selectable 2. Explain how to read the progress bar graph on various screens 17

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3. Explain how to read the flowchart along the top of the screen 4. Explain the alert sections of the display: Status Box and Dialogue Box

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