ASF Standards · Ambulatory Clinic · Standard 12
Standard 12 — Dialysis & Renal Replacement Therapy
Criteria in this standard
12.1 — Dialysis Water Treatment Meets a Verified Quality Standard
12.2 — Vascular Access Site Care Follows Recognised Core Interventions
12.3 — Patients Are Monitored for Intradialytic Complications Throughout
12.4 — Reuse or Single-Use Policy for Dialyzers Is Explicit and Followed
12.2 — Vascular Access Site Care Follows Recognised Core Interventions
12.3 — Patients Are Monitored for Intradialytic Complications Throughout
12.4 — Reuse or Single-Use Policy for Dialyzers Is Explicit and Followed
12.1
Dialysis Water Treatment Meets a Verified Quality Standard
Non-Negotiable
Water used to prepare dialysis fluid meets defined chemical and microbiological quality requirements, verified through regular testing against a recognised international standard — not assumed safe because it passes through a treatment system.
In plain terms: The water used to make dialysis fluid is tested regularly against a recognised standard for chemicals and bacteria — not assumed safe because it comes from a reverse-osmosis unit.
| Facility category | Crisis | Transition | Small | Standard |
|---|---|---|---|---|
| Applicability | N/A | Full | Full | Full |
Why this matters
A dialysis patient's blood is exposed to 120 litres of water per session. Chloramine in the water haemolyses red cells. Aluminium causes dementia and bone disease. Endotoxin from bacterial contamination causes fever, hypotension, and chronic inflammation. The reverse-osmosis system removes these — when it is working. When a membrane degrades, a carbon filter exhausts, or biofilm forms in the distribution loop, contaminated water reaches the patient invisibly. ISO 23500 and AAMI standards define the limits; monthly chemical and microbiological testing against them, with action levels, is the only way to know.
What good looks like
- Water is tested against the specific dialysis water quality standard consistently.
- Testing happens on a defined, regular schedule with genuine review.
- A specific, followed response exists for any out-of-limit result.
Common failure modes
- Testing, if it happens, isn't matched against dialysis-specific limits.
- Testing is occasional or reactive rather than scheduled.
- No defined response exists for an out-of-limit result.
Worked example
In practice
A 12-station dialysis unit with an RO plant installed five years earlier.
BeforeWater was tested 'when the engineer came' — roughly annually. The carbon filters had not been changed in 18 months. No endotoxin testing had ever been done. Patients had experienced unexplained febrile episodes for several months.
ActionThe unit adopted ISO 23500 limits. Monthly testing was contracted: chemical analysis (chloramine, aluminium, fluoride, heavy metals) and microbiology (total viable count and endotoxin) at defined sample points. Action and alert levels were set. Carbon filter change was scheduled per manufacturer with chloramine testing weekly at the point of use. The distribution loop was disinfected monthly. Results are reviewed by the unit lead and filed.
AfterThe Monitor reviewed six months of test results (all within limits after month two), the filter change log, and the loop disinfection log. Febrile episodes had ceased. Verified.
If you are starting from zero — do this first
- Find your last water test result. If it is more than a month old, that is the gap.
- Check when your carbon filters were last changed.
- Contract monthly chemical and microbiological testing against ISO 23500.
- Set action levels and a response plan.
The most common mistake: Trusting the RO unit because it was expensive — RO membranes and filters degrade silently.
Self-assessment questions
1. Is dialysis water tested against the specific chemical and microbiological limits set by the recognised standard, not general water safety limits? — Dialysis-specific limits, which are meaningfully stricter than general drinking water standards.
Evidence: Water quality testing record against ISO 23500-3 limits
Evidence: Water quality testing record against ISO 23500-3 limits
2. Is testing conducted on a defined, regular schedule, with results reviewed and acted on? — Regular, scheduled testing with genuine review, not occasional or reactive testing.
Evidence: Testing schedule and review record
Evidence: Testing schedule and review record
3. Is there a defined response if a test result exceeds the allowable limit? — A specific action, not uncertainty about what happens when a limit is exceeded.
Evidence: Out-of-limit response protocol
Evidence: Out-of-limit response protocol
Common reasons for a PARTIAL answer
- Chemical testing happens consistently but microbiological testing lapses periodically. — Both chemical and microbiological contamination carry genuine, distinct risk.
- Testing happens on schedule but results aren't reviewed by anyone with authority to act on them. — Testing without genuine review provides limited real protection.
- A response protocol exists but hasn't actually been used or tested.
Implementation plan
| When | What |
|---|---|
| Week 1 | Review current water testing practice against the specific dialysis water quality standard. |
| Week 2 | Establish or correct a defined, regular testing schedule. |
| Week 3 | Define a specific response protocol for out-of-limit results. |
| Ongoing | Review testing consistency and result trends periodically. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| DOCUMENT | Water quality testing review | Reviews testing records against the specific ISO 23500-3 chemical and microbiological limits. |
| DOCUMENT | Testing schedule review | Reviews the testing schedule for consistency and genuine review of results. |
| ASK | Out-of-limit response interview | Asks staff what happens when a water quality result exceeds the allowable limit. |
Supervisor tips
- Ask for actual test results against the specific numeric limits, not a general assurance of water safety. — Dated, specific records are the only real evidence of genuine compliance.
- Ask what happened the last time a result was concerning. — A real example reveals more than a policy description.
Evidence base
[61] International Organization for Standardization. ISO 23500-3:2024 — Preparation and quality management of fluids for haemodialysis and related therapies — Part 3: Water for haemodialysis and related therapies. Geneva: ISO; 2024 — specifies minimum chemical and microbiological quality requirements for dialysis water, with mandatory ongoing monitoring.
Train your team: AMB-12 · Dialysis & Renal on GMJ Academy →
This course teaches practical implementation of this standard. Free to enroll. ASF certificate on completion.
12.2
Vascular Access Site Care Follows Recognised Core Interventions
Non-Negotiable
Vascular access care and catheter accessing follow a defined set of core infection prevention interventions — aseptic technique, hub disinfection, and structured surveillance — verified through periodic direct observation, not assumed from staff training alone.
In plain terms: Fistula, graft, and catheter care follow a defined set of infection prevention steps — clean technique, hub disinfection, surveillance — checked by audit, not assumed.
| Facility category | Crisis | Transition | Small | Standard |
|---|---|---|---|---|
| Applicability | N/A | Full | Full | Full |
Why this matters
Vascular access is the dialysis patient's lifeline and their greatest infection risk. Catheter-related bloodstream infections kill. Fistula infections cost the access. The CDC Core Interventions — hand hygiene, catheter hub scrub with antiseptic before every connection, antiseptic skin prep before cannulation, dressing changes with sterile technique, monthly surveillance of infections — reduce infections by half when consistently applied. 'Consistently' is the word: audit shows that without observation, hub scrubs are skipped when the unit is busy.
What good looks like
- All core interventions are actively implemented together.
- Direct observation of vascular access care happens on the recommended schedule.
- Surveillance data is genuinely shared with and visible to front-line staff.
Common failure modes
- Only some core interventions are followed, with others informally skipped.
- No direct observation happens beyond initial staff training.
- Surveillance data, if collected, isn't shared with clinical staff.
Worked example
In practice
A 10-station dialysis unit with a catheter-related bloodstream infection rate it did not calculate.
BeforeCatheter care varied by nurse. Hub disinfection was 'quick.' Skin prep before fistula cannulation was a single alcohol wipe. No infection surveillance existed. When the Coordinator reviewed records, seven bloodstream infections had occurred in six months among 20 catheter patients.
ActionThe CDC Core Interventions were adopted as unit policy. Hub scrub for 15 seconds with chlorhexidine-alcohol before every connection. Chlorhexidine skin prep with 30-second dry time before cannulation. Sterile dressing changes per protocol. Monthly infection surveillance with rates per 100 patient-months. Quarterly observational audit of ten access procedures with feedback.
AfterThe Monitor observed three catheter connections with correct hub scrubs, reviewed audit results (compliance 92%), and the surveillance data (bloodstream infections down to 1 in the following six months). Verified.
If you are starting from zero — do this first
- Watch three catheter connections. Time the hub scrub. Under 15 seconds fails.
- Adopt the CDC Core Interventions as written policy.
- Start counting access infections monthly.
- Audit ten procedures a quarter and feed back.
The most common mistake: Not measuring access infections — the unit with no data believes it has no problem.
Self-assessment questions
1. Are the specific core interventions — surveillance, hand hygiene observation, vascular access care observation — all actively followed, not only some of them? — All core interventions together, not a partial selection.
Evidence: Core intervention implementation record
Evidence: Core intervention implementation record
2. Is vascular access care and catheter accessing technique directly observed on a defined schedule, not assumed from training? — Direct observation, at least quarterly, not reliance on initial training alone.
Evidence: Direct observation record
Evidence: Direct observation record
3. Is infection surveillance data calculated and actively shared with front-line clinical staff, not filed without review? — Genuine sharing that could influence practice, not passive record-keeping.
Evidence: Surveillance data sharing record
Evidence: Surveillance data sharing record
Common reasons for a PARTIAL answer
- Hand hygiene observation happens consistently but vascular access observation is less regular. — Each core intervention addresses a distinct part of the same real infection risk.
- Observation happens but findings aren't fed back to the specific staff observed. — Observation without feedback provides less real improvement than genuine feedback.
- Surveillance data is calculated but shared only with management, not front-line staff.
Implementation plan
| When | What |
|---|---|
| Week 1 | Review current practice against the full set of core interventions. |
| Week 2 | Establish or correct a quarterly direct observation schedule for vascular access care. |
| Week 3 | Establish a process for actively sharing surveillance data with front-line staff. |
| Ongoing | Track infection rates and adjust practice based on trends. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| DOCUMENT | Core intervention implementation review | Reviews evidence that all core interventions are actively implemented, not a partial selection. |
| DOCUMENT | Direct observation record review | Reviews records of direct vascular access care observation against the recommended schedule. |
| ASK | Data sharing interview | Asks front-line staff whether they've seen recent infection surveillance data for this facility. |
Supervisor tips
- Ask for actual observation records, not a description of the training staff received. — Dated observation records are the real evidence of ongoing verification, not one-time training.
- Ask a front-line staff member whether they've seen recent infection rate data for this facility. — This reveals whether data sharing is genuine practice, not just collected and filed.
Evidence base
[62] Established infection prevention guidance for dialysis settings, recognized in various forms internationally, recommends monthly infection surveillance, regular hand hygiene observation, and quarterly direct observation of vascular access care and catheter accessing technique.
Train your team: AMB-12 · Dialysis & Renal on GMJ Academy →
This course teaches practical implementation of this standard. Free to enroll. ASF certificate on completion.
12.3
Patients Are Monitored for Intradialytic Complications Throughout
Non-Negotiable
Patients are actively monitored throughout the dialysis session for signs of intradialytic complications — hypotension, cramping, access-related bleeding — on a defined schedule, not checked only at the start and end of the session.
In plain terms: During dialysis, patients are monitored on a schedule for low blood pressure, cramps, and bleeding — not just checked at the start and the end.
| Facility category | Crisis | Transition | Small | Standard |
|---|---|---|---|---|
| Applicability | N/A | Full | Full | Full |
Why this matters
Intradialytic hypotension causes cardiac ischaemia, stroke, and access thrombosis. It develops over minutes, mid-session, when the patient is quietly reading. Cramps signal excess fluid removal. Bleeding at the needle site can be silent under a blanket. A defined monitoring schedule — blood pressure and pulse every 30 minutes at minimum, more often for unstable patients, with a visual check of the access — catches these before harm. A unit where monitoring is 'when the alarm goes off' is relying on the machine to notice what a nurse should have seen.
What good looks like
- Monitoring happens at defined intervals throughout the entire session.
- Monitoring covers blood pressure, access site, and symptoms together.
- A specific, immediate response protocol exists and is known to staff.
Common failure modes
- Monitoring is concentrated at session start and end, with gaps during the session.
- Monitoring covers only one element, such as blood pressure, without the others.
- Staff are uncertain what to do if a complication is identified mid-session.
Worked example
In practice
An 8-station dialysis unit with two nurses per shift.
BeforeVital signs were taken at the start, mid-session if the nurse was passing, and at the end. A patient became hypotensive to 70/40 for an unknown period before it was noticed; she suffered a TIA. Monitoring was not scheduled or documented at intervals.
ActionA monitoring protocol was written: blood pressure and pulse every 30 minutes, every 15 minutes for patients with a history of intradialytic hypotension, recorded on a session chart; visual access check with each set of observations; defined thresholds for intervention (e.g. systolic <90 → reduce ultrafiltration, position, fluid bolus per protocol). Staffing was reviewed to make this achievable.
AfterThe Monitor reviewed 20 session charts showing 30-minute observations, observed a session with monitoring performed on schedule, and reviewed two hypotension interventions documented and managed per protocol. Verified.
If you are starting from zero — do this first
- Pull ten session charts: how often were observations recorded?
- Write a monitoring schedule — every 30 minutes minimum.
- Add intervention thresholds to the chart.
- Check that staffing allows it.
The most common mistake: Relying on the machine's alarms to detect patient deterioration — the machine monitors the circuit, not the patient.
Self-assessment questions
1. Are patients monitored at defined intervals throughout the entire session, not only at start and end? — Monitoring spread across the full session duration, not concentrated at the edges.
Evidence: Intradialytic monitoring schedule and record
Evidence: Intradialytic monitoring schedule and record
2. Does monitoring specifically include blood pressure, access site, and patient-reported symptoms together? — All three together, since each can reveal a different type of developing complication.
Evidence: Monitoring content documentation
Evidence: Monitoring content documentation
3. Is there a defined, immediate response if monitoring identifies a possible complication? — A specific, known response, not improvisation in the moment.
Evidence: Complication response protocol
Evidence: Complication response protocol
Common reasons for a PARTIAL answer
- Monitoring is thorough during quiet periods but abbreviated when the unit is busy. — Complications don't occur only when staff have time available to notice them.
- Blood pressure is checked regularly but access site and symptom checks are less consistent. — Each element of monitoring reveals a genuinely different type of developing complication.
- A response protocol exists for hypotension specifically but not other complication types.
Implementation plan
| When | What |
|---|---|
| Week 1 | Observe current monitoring practice for consistency throughout actual sessions. |
| Week 2 | Establish a defined monitoring interval covering the full session duration. |
| Week 3 | Ensure monitoring content covers blood pressure, access site, and symptoms together. |
| Ongoing | Observe monitoring practice periodically, particularly during busy periods. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| OBSERVE | Intradialytic monitoring observation | Observes actual monitoring practice during a dialysis session for consistency throughout. |
| DOCUMENT | Monitoring content review | Reviews whether monitoring covers blood pressure, access site, and symptoms together. |
| ASK | Complication response interview | Asks staff what happens when monitoring identifies a possible complication. |
Supervisor tips
- Observe during a genuinely busy period, not a quiet one. — Monitoring discipline is most likely to erode exactly when the unit is under real pressure.
- Ask about a specific complication type beyond hypotension, such as access-related bleeding. — This reveals whether response readiness extends beyond the most commonly discussed complication.
Evidence base
[63] Structured intradialytic monitoring at defined intervals throughout the dialysis session, rather than only at session start and end, is established practice in dialysis safety literature for early detection of hypotension and other acute complications.
Train your team: AMB-12 · Dialysis & Renal on GMJ Academy →
This course teaches practical implementation of this standard. Free to enroll. ASF certificate on completion.
12.4
Reuse or Single-Use Policy for Dialyzers Is Explicit and Followed
Non-Negotiable
The facility has an explicit, written policy on whether dialyzers are single-use or reprocessed for reuse, with the actual practice matching the written policy, and any reprocessing following a defined, verified protocol — not an informal practice that varies without a stated policy.
In plain terms: The unit has a written policy stating whether dialysers are single-use or reprocessed, practice matches the policy, and any reprocessing follows a defined, monitored procedure.
| Facility category | Crisis | Transition | Small | Standard |
|---|---|---|---|---|
| Applicability | N/A | Full | Full | Full |
Why this matters
Dialyser reuse can be safe when done to a rigorous standard: automated reprocessing, integrity testing, performance measurement, germicide residual testing, and patient-specific labelling. It is dangerous when done casually: manual rinsing, no integrity test, dialysers mixed between patients. The first requirement is honesty — a written policy that says what the unit actually does. The second is that practice matches it. The third, for units that reuse, is a validated reprocessing protocol with records for every dialyser, every reuse. A unit that claims single-use but reuses under pressure is lying to its patients.
What good looks like
- An explicit, written policy exists and is clear.
- Actual practice consistently matches the written policy.
- Any reprocessing follows a defined, verified protocol.
Common failure modes
- No written policy exists, only informal, undocumented practice.
- Practice diverges from what's actually written in the policy.
- Reprocessing, if it occurs, has no defined or verified protocol.
Worked example
In practice
A 14-station dialysis unit that officially used single-use dialysers.
BeforeThe written policy said single-use. In practice, when supplies ran low, dialysers were manually rinsed and reused — sometimes for a different patient. No reprocessing procedure existed. Two patients had cross-infection events that were never explained.
ActionThe unit lead and management decided: genuinely single-use, with a supply chain review to prevent shortages. Stock levels and reorder points were set. The policy was rewritten and posted. Staff were briefed that reuse under any circumstances is prohibited and must be reported if pressured. A monthly stock audit checks dialyser consumption against sessions.
AfterThe Monitor reviewed the policy, the stock records showing dialysers consumed matching sessions performed, and interviewed two nurses who confirmed no reuse. Verified.
If you are starting from zero — do this first
- Read your dialyser policy. Now ask a nurse what actually happens when stock is low.
- Decide: single-use or reuse. Write it down honestly.
- If single-use: fix the supply chain so shortage never forces reuse.
- If reuse: adopt a validated protocol with records per dialyser.
The most common mistake: Having a single-use policy on paper and reusing when supplies are short — the policy exists to be broken.
Self-assessment questions
1. Does the facility have an explicit, written policy stating whether dialyzers are single-use or reprocessed? — A specific, written policy, not an informal, undocumented practice.
Evidence: Written reuse policy document
Evidence: Written reuse policy document
2. Does actual practice match the written policy, verified directly, not assumed? — Genuine consistency between stated policy and real practice.
Evidence: N/A — tested directly
Evidence: N/A — tested directly
3. Where reprocessing occurs, does it follow a defined, verified protocol, including water quality specific to reprocessing? — A specific, verified protocol, not informal reprocessing practice.
Evidence: Reprocessing protocol and verification record
Evidence: Reprocessing protocol and verification record
Common reasons for a PARTIAL answer
- A policy exists but hasn't been updated to reflect a practice change made some time ago. — A stale policy no longer reflects genuine current practice, creating exactly the mismatch this criterion checks for.
- Practice matches policy for most patients but exceptions are made informally without documentation. — Undocumented exceptions undermine the reliability of the stated policy.
- Reprocessing follows a protocol but water quality verification specific to reprocessing wasn't recently checked.
Implementation plan
| When | What |
|---|---|
| Week 1 | Confirm current actual practice and compare against any existing written policy. |
| Week 2 | Write or update the policy to genuinely reflect current practice. |
| Week 3 | If reprocessing occurs, verify the protocol and water quality requirements specific to it. |
| Ongoing | Periodically confirm practice continues to match the written policy. |
How the Monitor verifies this
| Method | What | Detail |
|---|---|---|
| DOCUMENT | Written policy review | Reviews the facility's explicit, written reuse or single-use policy. |
| OBSERVE | Practice-policy consistency check | Checks whether actual practice matches the written policy. |
| DOCUMENT | Reprocessing protocol review | Where reprocessing occurs, reviews the defined protocol and water quality verification specific to reprocessing. |
Supervisor tips
- Ask to see the actual written policy, not a verbal description of practice. — A specific, written document is the real evidence of an explicit policy.
- Ask a front-line staff member to describe current practice, and compare it against the written policy. — This reveals whether policy and practice genuinely align, or have quietly diverged.
Evidence base
[64] International Organization for Standardization. ISO 23500-1:2024 — Preparation and quality management of fluids for haemodialysis and related therapies — Part 1: General requirements. Geneva: ISO; 2024 — addresses water used in dialyser reprocessing as a distinct, covered aspect of dialysis fluid quality management.
Train your team: AMB-12 · Dialysis & Renal on GMJ Academy →
This course teaches practical implementation of this standard. Free to enroll. ASF certificate on completion.