Standard 21: Dialysis and Renal Replacement (Version 11)

Why it matters. The water used to make dialysis fluid goes into the patient’s blood. Impure water can cause serious harm within a single session, so it must be treated and tested to a written standard.

Sample. Review the water test records for the last 6 months, and the water standard in force.

1. Water is tested to the documented chemical and microbiological requirements on the schedule.

Method. Check the test record against the schedule.

Evidence to show. Water test record (WAT-FRM-001).

Pass when. Every scheduled test is recorded.

2. Each result is within requirement, or the action is recorded.

Method. Check each result against the requirement.

Evidence to show. Water test record (WAT-FRM-001).

Pass when. Every out-of-range result has an action recorded.

3. No patient is dialysed on water that has not been tested in date.

Method. Check the treatments in the period against the last valid test.

Evidence to show. Dialysis water standard and testing (DIA-POL-001).

Pass when. Every treatment was on water tested in date.

Immediate fail (any one means the criterion is not met). Patients are dialysed on water that was never tested.

Why it matters. The water treatment plant, its online monitor and the pipes that carry the water can fail quietly. Maintaining them and watching them online catches a failure before a patient is harmed.

Sample. Review the online conductivity monitoring log for 10 sessions, and the maintenance record of the water treatment equipment.

1. Online conductivity is monitored during every session.

Method. Check each sampled session for the readings recorded.

Evidence to show. Online conductivity monitoring log (DIA-FRM-001).

Pass when. Every sampled session has readings recorded.

2. Each alarm is responded to.

Method. Check each alarm for the response recorded.

Evidence to show. Online conductivity monitoring log (DIA-FRM-001).

Pass when. Every alarm has a response recorded.

3. The equipment is maintained on schedule.

Method. Check the maintenance record against the schedule.

Evidence to show. Equipment inventory and service log (EQP-REG-001).

Pass when. Every scheduled maintenance is recorded.

Immediate fail (any one means the criterion is not met). An alarm on the water monitor is ignored for a shift.

Why it matters. Dialysis fluid made with the wrong concentration or in the wrong order can cause a serious event in the patient. Following a written procedure for every batch prevents the error.

Sample. Review the batch preparation records for the last 3 months.

1. Each batch is prepared to the written procedure.

Method. Check each batch record for the procedure followed.

Evidence to show. Batch preparation record (DIA-FRM-002).

Pass when. Every batch records the procedure followed.

2. Each batch is identified and traceable to its preparation.

Method. Check each batch for its identity and preparer.

Evidence to show. Batch preparation record (DIA-FRM-002).

Pass when. Every batch is identified and traceable.

3. The concentration is checked before use.

Method. Check each batch for the concentration recorded.

Evidence to show. Batch preparation record (DIA-FRM-002).

Pass when. Every batch has its concentration checked.

Immediate fail (any one means the criterion is not met). A batch of fluid is mixed from memory, with the wrong concentration.

Why it matters. Dialysers are reused only in some services and only when they are marked for reuse. A reused dialyser that is not properly cleaned or traced can transmit infection or fail.

Sample. Review the dialyser traceability and reprocessing register for the last 3 months.

1. Dialysers are reused only where marked for reuse.

Method. Check each reused dialyser for the reuse mark.

Evidence to show. Dialyser traceability and reprocessing register (DIA-REG-001).

Pass when. Every reused dialyser is marked for reuse.

2. Reprocessing follows the validated procedure, and each cycle is recorded.

Method. Check each dialyser for the cycles recorded.

Evidence to show. Dialyser traceability and reprocessing register (DIA-REG-001).

Pass when. Every cycle is recorded.

3. Each dialyser is used only on the patient it came from.

Method. Trace each dialyser to the patient recorded.

Evidence to show. Dialyser traceability and reprocessing register (DIA-REG-001).

Pass when. Every dialyser is traced to one patient.

Immediate fail (any one means the criterion is not met). A dialyser is reused on a patient other than the one it came from.

Why it matters. A patient who gets too little dialysis is harmed slowly, and no one notices unless the dose is measured. Adequacy measured for every treatment shows whether the dose is right.

Sample. Review 10 patients’ prescriptions and their adequacy records.

1. Each patient has a written dialysis prescription.

Method. Check each sampled patient for the written prescription.

Evidence to show. Dialysis prescription and adequacy record (DIA-FRM-003).

Pass when. Every sampled patient has a written prescription.

2. Adequacy is measured against the target for each treatment.

Method. Check each treatment record for the adequacy measured.

Evidence to show. Dialysis prescription and adequacy record (DIA-FRM-003).

Pass when. At least 90% of treatments have adequacy measured.

3. Changes to the prescription are recorded.

Method. Check each change for the reason recorded.

Evidence to show. Dialysis prescription and adequacy record (DIA-FRM-003).

Pass when. Every change is recorded with its reason.

Immediate fail (any one means the criterion is not met). A patient is under-dialysed for months with no measure.

Why it matters. The access in a dialysis patient’s arm or neck is the lifeline of treatment and the most common source of serious infection. Assessing it every session and tracking infections keeps it working.

Sample. Review the vascular access check records for 10 patients, and the access infection register.

1. Each patient’s vascular access is assessed at each session.

Method. Check each sampled patient for the assessment at each session.

Evidence to show. Vascular access check record (DIA-FRM-004).

Pass when. At least 95% of sessions show the access assessed.

2. Care follows the written protocol.

Method. Check each record for the protocol followed.

Evidence to show. Vascular access check record (DIA-FRM-004).

Pass when. At least 95% of records show the protocol followed.

3. Each access-related infection is recorded and reviewed.

Method. Check the register against the infections reported.

Evidence to show. Access-related infection register (DIA-REG-002).

Pass when. Every infection is recorded and reviewed.

Immediate fail (any one means the criterion is not met). A catheter infection is not reported for three weeks.

Why it matters. A dialysis machine with a fault that is not found before use can harm the patient during treatment. A checklist before each session finds faults before they reach the patient.

Sample. Review the pre-session machine check records for the last 30 days, and walk through the unit.

1. Each machine is checked before use against the checklist.

Method. Check each session for the checklist completed.

Evidence to show. Pre-session machine check (DIA-FRM-005).

Pass when. At least 98% of sessions have the checklist completed.

2. Each fault is recorded.

Method. Check each fault for the record.

Evidence to show. Pre-session machine check (DIA-FRM-005).

Pass when. Every fault found is recorded.

3. A faulty machine is withdrawn until repaired.

Method. Check each fault for the withdrawal and the repair date.

Evidence to show. Pre-session machine check (DIA-FRM-005).

Pass when. Every faulty machine is withdrawn until repaired.

Immediate fail (any one means the criterion is not met). A machine is used with a known alarm fault.

Why it matters. Dialysis patients can have a sudden drop in blood pressure, a cardiac arrest or other emergencies during treatment. Staff must be trained and the equipment ready for them.

Sample. Review the emergency plan and the rehearsal records for the last 12 months.

1. The response to emergencies during dialysis is planned.

Method. Check the plan for each emergency named.

Evidence to show. Emergency response during dialysis (DIA-PLN-001).

Pass when. The plan covers all four emergencies.

2. Staff are trained and equipment is ready on each shift.

Method. Check each shift rota against trained staff and equipment.

Evidence to show. Equipment inventory and service log (EQP-REG-001).

Pass when. Every shift has trained staff and equipment ready.

3. The response is rehearsed twice a year.

Method. Check the rehearsal record for two rehearsals a year.

Evidence to show. Emergency rehearsal record (DIA-FRM-006).

Pass when. Two rehearsals are recorded each year.

Immediate fail (any one means the criterion is not met). A patient collapses during dialysis with no one trained to respond.

Why it matters. Dialysis patients are often in and out of the unit several times a week, and infections spread easily between them. Strict hand hygiene, isolation and cleaning stop that spread.

Sample. Review the isolation and cleaning check records for the last 30 days, and walk through the unit.

1. Infectious patients are isolated.

Method. Check each infectious patient at the walk-through and in the record.

Evidence to show. Isolation and cleaning check record (DIA-FRM-007).

Pass when. Every infectious patient is isolated.

2. Shared equipment is cleaned between patients.

Method. Check each cleaning record for the clean between patients.

Evidence to show. Isolation and cleaning check record (DIA-FRM-007).

Pass when. At least 98% of changes between patients have a clean recorded.

3. Hand hygiene is audited against the procedure.

Method. Check the hand hygiene audit record for the period.

Evidence to show. Isolation and cleaning check record (DIA-FRM-007).

Pass when. Hand hygiene compliance is audited each month.

Immediate fail (any one means the criterion is not met). A shared dialysis machine is not cleaned between patients.

Why it matters. Patients with kidney failure have more than one option, such as home dialysis or transplant. Telling them the choices lets them decide what suits their life.

Sample. Review 10 patient records for the discussion of treatment options and their decisions.

1. Each patient is told about the treatment options.

Method. Check each sampled record for the options explained.

Evidence to show. Dialysis modality choice record (DIA-FRM-008).

Pass when. Every sampled patient has the options explained.

2. Home dialysis is included where it exists.

Method. Check each record for home dialysis explained where available.

Evidence to show. Dialysis modality choice record (DIA-FRM-008).

Pass when. Every record includes home dialysis where it exists.

3. The patient’s decision is recorded.

Method. Check each record for the decision.

Evidence to show. Dialysis modality choice record (DIA-FRM-008).

Pass when. Every record has the decision recorded.

Immediate fail (any one means the criterion is not met). A patient is never told that home dialysis exists.

Why it matters. A dialysis unit needs enough trained staff, and each person needs the right skills for their role. Defining staffing and competence keeps the unit safe on every shift.

Sample. Review the staffing and competence requirements and the training records for 5 staff.

1. Staffing levels, roles and competence requirements are defined.

Method. Check the policy for each element.

Evidence to show. Dialysis staffing and competence (DIA-POL-003).

Pass when. Every element is defined.

2. Each member of staff is competent for their role before working unsupervised.

Method. Check each sampled staff member for competence before unsupervised work.

Evidence to show. Training matrix register (WRK-REG-001).

Pass when. Every sampled staff member is competent before unsupervised work.

3. The shift staffing meets the defined levels.

Method. Check the rota against the defined levels.

Evidence to show. Training matrix register (WRK-REG-001).

Pass when. Every shift meets the defined level.

Immediate fail (any one means the criterion is not met). A shift is run by one nurse who has not been trained on the machines.

Why it matters. A dialysis unit that records incidents and outcomes but never reviews them keeps making the same mistakes. A defined review of incidents and outcomes, with action, makes the unit learn.

Sample. Review the incident and outcome review register for the last 12 months.

1. Incidents and outcome measures are recorded.

Method. Check the register against the incidents reported.

Evidence to show. Dialysis incident and outcome review register (DIA-REG-003).

Pass when. Every incident and measure is recorded.

2. The register is reviewed on schedule for patterns.

Method. Check each review date against the schedule.

Evidence to show. Dialysis incident and outcome review register (DIA-REG-003).

Pass when. Every scheduled review is recorded.

3. Serious incidents are investigated under the incident process.

Method. Check each serious incident for the investigation record.

Evidence to show. Root cause analysis of serious incidents (INC-SOP-001).

Pass when. Every serious incident is investigated.

Immediate fail (any one means the criterion is not met). A series of machine faults is never discussed as a pattern.