Background
Methods
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Step 1: Selection of team members.
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Step 2: Process scope identification and listing of all key processes (using process flowchart).
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Step 3: Identification of failure mode.
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Step 4: Scoring based on risk priority numbers.
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Step 5: Designing solutions to eliminate and mitigate risk.
Step 1: team selection
Step 2: process identification and process flowchart preparation
Step 3: failure mode identification
Step 4: scoring based on risk priority numbers
Risk priority number | Definition | Rating scales |
---|---|---|
Likelihood | The perceived chance of the failure happening within a defined period | Rating of 1–10: ‘failure is unlikely’ to ‘very likely or inevitable’ |
Severity | How severe the outcome is to the patient should failure occur | Rating of 1–10: ‘no severity at all’ (would not affect individual or system) to ‘moderate’ (significant effect with no injury) to ‘major injury’ to ‘death’ |
Detectability | Is the area of failure readily known, or is it discovered only when an adverse outcome occurs? | Rating of 1–10: ‘almost certain the process or steps will detect potential cause(s)’ to ‘absolute uncertainty that the control will not detect potential cause(s) and subsequent failure mode (s) |
Steps | Failure mode |
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1. Setting up HHD system at home | |
Setting up HD Machine | Machine cannot be placed in the space at home |
Setting up water treatment system | Portable RO cannot be placed in the space at home |
Connection of portable RO and machine cannot be achieved | |
Setting up drainage | Violating municipal standards for discharge of dialysis effluent |
Incorrect technical requirement for height of drainage hole | |
Setting up and establishing power and water supply | Power socket not suitable for machine / portable RO |
Power socket not sited correctly | |
Connector to water point incompatible | |
Water points not sited correctly | |
Inadequate water pressure to operate the portable RO | |
Water temperature too high or too low | |
Creating storage and getting consumables ready | Lack of storage for consumables |
Consumables passed shelf-life (beyond expiration date) | |
2. Completing test prior to starting HHD | |
Checking water treatment system | Failure to achieve meet minimum safety and quality levels of dialysis water and fluid requirement |
Initiating HD machine self-test | Repeatedly fails self-test |
3. Performing HHD | |
3a. Preparing HHD | |
Starting HD Machine | Machine cannot be switched on |
Machine breakdown | |
Starting water treatment system | Portable reverse osmosis (RO) cannot be switched on |
Portable RO breakdown | |
Incorrect portable RO connection | |
Ensuring drainage | Inadequate water or dialysate flow |
Inadequate water pressure | |
Blocked drainage | |
Flooding from cracked lines or choked drainage | |
Starting power and water supply | Interruption in water supply |
Interruption in power supply | |
Gathering dialysis consumables | No or insufficient supply of consumables needed for treatment |
Incorrect supply of consumables | |
Failure to supply heparin | |
Failure to supply disinfectant | |
3b. Evaluation before starting dialysis | |
General evaluation | Starting dialysis when feeling unwell or have temperature > 38o C, heart rate > 110 or < 50 beats per minute, systolic blood pressure > 180 mmHg or < 100 mmHg |
Priming and connectivity of dialysis blood lines | Poor connection |
Incorrect connection | |
Kinked blood lines | |
Measuring weight | Error in weight taken |
Incorrect dry weight | |
Deciding and calculation of ultrafiltration | Excessive ultrafiltration |
Inadequate ultrafiltration | |
Taking medications before dialysis | Taking excessive antihypertensive medications |
Forgot to take antihypertensive or taking lower dose | |
3c. Managing vascular access during dialysis treatment | |
Cleaning of access site | Non-compliance to cleaning of access site |
Scab removal for those of buttonhole cannulation | Incomplete scab removal for buttonhole cannulation |
Establishing access cannulation | Unsuccessful access cannulation after three attempts |
Cannulation technique | Defective technique in cannulation access |
Securing vascular access | Poor fixation of needles to skin, traction of circuit line or movement especially during nocturnal dialysis |
Troubleshooting alarm related to vascular access | Failure to respond to arterial and venous pressure alarm |
Monitoring vascular access during dialysis | Failure to monitor vascular access during dialysis |
Vascular access needles removal | Excessive and prolonged bleeding after removal of dialysis needles |
Monitoring vascular access (general) | Failure to identify access related infection |
3d. Interruption and management of machine alarms | |
Reprogramming after temporary interruption | Failure to reprogram after disconnection |
Troubleshooting dialysis machine alarms | Dialysate (conductivity and temperature) alarm trigger |
Air detection alarm trigger | |
Blood leak alarm trigger | |
Calling for help | Unable to reach nursing or technical assistant for advice |
Emergency during dialysis treatment | Need for emergency evacuation |
3e. Administering medications on dialysis | |
Administering anticoagulation | Excessive heparin administered |
Administering new medications or using new consumables | Allergic reaction |
3f. Other | |
Caregiver assisting HHD | Needle-stick injury to family member or caregiver |
3g. Ending dialysis | |
Disposal of HD items | Improper of disposal biohazard waste |
Sharps box missing |
Step 5: designing solutions to eliminate, mitigate risk and risk review
Results
Flowchart of key processes in HHD
Failure modes and risk priority numbers
Number | Steps | Failure mode | Effect/ Consequences | Likelihood | Severity | Detectability | RPN |
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1 | Cleaning of access site | Non-compliance to cleaning of access site | Vascular access infection and septicaemia Unable to proceed with haemodialysis using vascular access | 2 | 6 | 6 | 72 |
Potential solutions for risk mitigation 2. Performing hand hygiene before setting up table to start HHD 3. Emphasize hand washing and use of chlorohexidine swab sticks or consumables that motivate compliance 4. Regular assessment of patient performing treatment observed during home visit and during physician/home haemodialysis nursing team review at HHD unit (at least once every two months) | |||||||
2 | Scab removal for those of buttonhole cannulation | Incomplete scab removal | Vascular access infection and septicaemia Unable to proceed with haemodialysis using vascular access | 2 | 9 | 8 | 144 |
Potential solutions for risk mitigation 1. Preferential selection for rope ladder cannulation [25] 2. Careful consideration on suitability of buttonhole cannulation only in selected cases and strictly avoiding individuals that are recurrent methicillin-sensitive staphylococcus aureus (MSSA) methicillin-resistant staphylococcus aureus (MRSA) colonised 3. Conversion to rope ladder cannulation method for those using button-hole cannulation if MSSA or MRSA colonised 4. Specific training for buttonhole cannulation with emphasis on infection prevention measures [26] 6. Topical mupirocin ointment to buttonhole cannulation sites [31] 7. Regular assessment of patient performing treatment observed during home visit and during physician/ home haemodialysis nursing team review at HHD unit (at least once every two months) | |||||||
3 | Establishing access cannulation | Unsuccessful cannulation after 3 attempts | Unable to proceed with haemodialysis | 3 | 3 | 1 | 9 |
Potential solutions for risk mitigation 1. Education and training with individualised cannulation plan 2.Contact HHD hotline and when necessary, report to training center 3. Re-training for cannulation technique if needed | |||||||
4 | Cannulation technique | Defective technique in cannulating access | Acute blood loss from venous extravasation and hematoma Vascular access infection and septicaemia Unable to proceed with haemodialysis using vascular access | 4 | 9 | 7 | 252 |
Potential solutions for risk mitigation 1. Dedicated staff for training 2. Individualised cannulation technique and type 3. Competency check during training and maintenance phase using audit tool | |||||||
5 | Securing vascular access | Poor fixation of needles to skin, traction of circuit line or movement especially with nocturnal dialysis | Anaemia symptoms Acute blood loss | 2 | 10 | 5 | 100 |
Potential solutions for risk mitigation 1. Discussion with patient regarding dialysis treatment plan (day time or nocturnal) and customized securing vascular access technique 2. Adequate cleaning and drying of area before cannulation [32] 4. Blood lines looped loosely to allow movement of patient and prevent blood lines pulling on needles especially in nocturnal dialysis [32] 5. Setting the lower limit of the venous pressure alarm as close as possible to current venous pressure alarm 6. Wetness detector, especially for nocturnal haemodialysis 7. Regular assessment of patient performing treatment observed during home visit and during physician review at HHD unit (at least once every two months) | |||||||
6 | Troubleshooting alarm related to vascular access | Failure to respond to arterial and venous pressure alarm | Acute blood loss Hypotensive shock and death if excessive blood loss | 3 | 10 | 6 | 180 |
Potential solutions for risk mitigation 1. Training to emphasise importance, consequences in addition to troubleshooting 2. Competency check during training and maintenance phase 3. Short concise patient education card 4. Additional devices to detect blood loss 5. A bell to notify caregiver to provide help and have a (mobile) telephone within reach to call for help | |||||||
7 | Monitoring vascular access during dialysis | Failure to monitor vascular access during dialysis | Vascular access thrombosis Bleeding from needling sites Vascular access rupture Acute blood loss causing hypotensive shock and death if excessive blood loss Unable to proceed with haemodialysis using vascular access | 4 | 8 | 8 | 256 |
Potential solutions for risk mitigation 1. Training to patient to do basic monitoring and report on signs of infection with a clinical tool, such as Mr Victor (for dialysis catheters exit site), and pseudo-aneurysm development, with photographic evidence as appropriate 2. Emergency education to use an inverted bottle top and bandaging to limit hemorrhage from a ruptured fistula 3. Training nursing staff to perform physical examination during patient encounter (at least once every two months) 4. Appropriate pump speeds [26] 5. Vascular access monitoring during clinic review 6. Cannulation sites are determined by home HD staff along with vascular surgeon including identifying unsafe sites not for cannulation 7. Close collaboration with vascular access team 8. Call emergencies services and report to hospital emergency department if bleeding or access rupture occurs | |||||||
8 | Vascular access needles removal | Anaemia symptoms Acute blood loss | 2 | 5 | 5 | 50 | |
Potential solutions for risk mitigation 1. Education and training to patient 2. Avoid excessive anticoagulation dosages [37] 3. Removal of the needles in sequences, one needle at a time once there is no bleeding 4. Training nursing staff to perform physical examination during patient encounter (initially at least once every two months) 5. Vascular access monitoring during clinic review to exclude proximal stenosis | |||||||
9 | Monitoring dialysis access (general) | Failure to identify access related infection | Unable to proceed with haemodialysis using vascular access | 2 | 8 | 5 | 80 |
Potential solutions for risk mitigation 1. Education and training to patient 2. Training nursing staff to perform physical examination during patient encounter (initially at least once every two months) 3. Patient to check for access viability before attempting cannulation 4. Vascular access monitoring during clinic review |
Risk mitigation strategies
Discussion
Emphasis on vascular access in education and training |
Specific focus on importance, consequences and how to troubleshoot for vascular access related incidents |
Dedicated staff for self-cannulation training |
Individualise cannulation therapy plan |
Concise patient reminder cards |
24 h access to dialysis nursing and vascular access hotline |
Regular vascular access checks with audit tool [47] |
Close collaboration with vascular access team |
Retraining when necessary |
New HHD programme | Established HHD programme | |
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Frequency of review | Monthly for the first 3 months then, 2 monthly clinic review and physical examination of vascular access by HHD nurse and physician 3 monthly review of vascular access by vascular surgeon with vascular access scans if necessary | 6 monthly clinic review and physical examination of vascular access by HHD nurse |
Competency assessment | 2 monthly review alternating home visit and HHD centre review by both HHD nurse and physician | 6 monthly review alternating home visit and HHD centre review by HHD nurse |