Dialysis & Renal Replacement Therapy
Dialysis & Renal Replacement Therapy
Requires Standards 1–7 verified first
4 criteria
| Standard 12.1 NON-NEGOTIABLE · Standard 12: Dialysis & Renal Replacement Therapy Dialysis Water Treatment Meets a Verified Quality Standard |
ASSESSMENT ASF-AMB-STD12-v3.0 |
| CR N/A | TR FULL | SM FULL | ST FULL |
| 12.1 NON-NEGOTIABLE L1 |
THE STANDARD Dialysis Water Treatment Meets a Verified Quality Standard 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. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 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. Doc: Water quality testing record against ISO 23500-3 limits |
YES | PARTIAL | NO |
| 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. Doc: Testing schedule and review record |
YES | PARTIAL | NO |
| 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. Doc: Out-of-limit response protocol |
YES | PARTIAL | NO |
ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.
| WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks |
| 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. |
REFERENCES
- [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.
| Standard 12.1 · Standard 12: Dialysis & Renal Replacement Therapy Guidance & Learning |
GUIDANCE ASF-AMB-STD12-v3.0 |
| WHY THIS STANDARD EXISTS |
Dialysis water enters the patient's bloodstream indirectly through the dialysis fluid, at volumes far exceeding typical water exposure — contamination that would be harmless in drinking water can be genuinely dangerous here, which is why this has its own dedicated international standard distinct from general water safety.
| 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. |
WHAT FAILURE LOOKS LIKE ✗ 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. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 Chemical testing happens consistently but microbiological testing lapses periodically.
Both chemical and microbiological contamination carry genuine, distinct risk.
2 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.
3 A response protocol exists but hasn't actually been used or tested.
An untested protocol may not translate smoothly into real action when actually needed.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
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.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
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.
| E-LEARNING academy.gmj.ge/amb-std12-1-water-quality — 30 min · complete before self-assessment |
| Standard 12.2 NON-NEGOTIABLE · Standard 12: Dialysis & Renal Replacement Therapy Vascular Access Site Care Follows Recognised Core Interventions |
ASSESSMENT ASF-AMB-STD12-v3.0 |
| CR N/A | TR FULL | SM FULL | ST FULL |
| 12.2 NON-NEGOTIABLE L1 |
THE STANDARD Vascular Access Site Care Follows Recognised Core Interventions 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. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 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. Doc: Core intervention implementation record |
YES | PARTIAL | NO |
| 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. Doc: Direct observation record |
YES | PARTIAL | NO |
| 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. Doc: Surveillance data sharing record |
YES | PARTIAL | NO |
ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.
| WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks |
| 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. |
REFERENCES
- [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.
| Standard 12.2 · Standard 12: Dialysis & Renal Replacement Therapy Guidance & Learning |
GUIDANCE ASF-AMB-STD12-v3.0 |
| WHY THIS STANDARD EXISTS |
Bloodstream infection is a serious, well-documented risk specific to dialysis vascular access, and international surveillance data shows real, measurable reduction in infection rates where these specific interventions are consistently followed and actively observed, not just trained once.
| 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. |
WHAT FAILURE LOOKS LIKE ✗ 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. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 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.
2 Observation happens but findings aren't fed back to the specific staff observed.
Observation without feedback provides less real improvement than genuine feedback.
3 Surveillance data is calculated but shared only with management, not front-line staff.
Front-line staff acting on the data day to day benefit most directly from seeing it.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
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.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
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.
| E-LEARNING academy.gmj.ge/amb-std12-2-vascular-access-care — 30 min · complete before self-assessment |
| Standard 12.3 NON-NEGOTIABLE · Standard 12: Dialysis & Renal Replacement Therapy Patients Are Monitored for Intradialytic Complications Throughout |
ASSESSMENT ASF-AMB-STD12-v3.0 |
| CR N/A | TR FULL | SM FULL | ST FULL |
| 12.3 NON-NEGOTIABLE L1 |
THE STANDARD Patients Are Monitored for Intradialytic Complications Throughout 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. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 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. Doc: Intradialytic monitoring schedule and record |
YES | PARTIAL | NO |
| 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. Doc: Monitoring content documentation |
YES | PARTIAL | NO |
| 3 | Is there a defined, immediate response if monitoring identifies a possible complication? A specific, known response, not improvisation in the moment. Doc: Complication response protocol |
YES | PARTIAL | NO |
ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.
| WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks |
| 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. |
REFERENCES
- [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.
| Standard 12.3 · Standard 12: Dialysis & Renal Replacement Therapy Guidance & Learning |
GUIDANCE ASF-AMB-STD12-v3.0 |
| WHY THIS STANDARD EXISTS |
A multi-hour dialysis session carries real risk of complications developing partway through, and monitoring concentrated only at the beginning and end of the session can miss a problem during exactly the hours it's most likely to actually occur.
| 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. |
WHAT FAILURE LOOKS LIKE ✗ 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. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 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.
2 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.
3 A response protocol exists for hypotension specifically but not other complication types.
Multiple distinct complication types can develop during a session, each warranting a defined response.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
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.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
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.
| E-LEARNING academy.gmj.ge/amb-std12-3-intradialytic-monitoring — 30 min · complete before self-assessment |
| Standard 12.4 NON-NEGOTIABLE · Standard 12: Dialysis & Renal Replacement Therapy Reuse or Single-Use Policy for Dialyzers Is Explicit and Followed |
ASSESSMENT ASF-AMB-STD12-v3.0 |
| CR N/A | TR FULL | SM FULL | ST FULL |
| 12.4 NON-NEGOTIABLE L1 |
THE STANDARD Reuse or Single-Use Policy for Dialyzers Is Explicit and Followed 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. |
| CLINIC SELF-ASSESSMENT Tick YES, PARTIAL, or NO for each question. |
| 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. Doc: Written reuse policy document |
YES | PARTIAL | NO |
| 2 | Does actual practice match the written policy, verified directly, not assumed? Genuine consistency between stated policy and real practice. Doc: N/A — tested directly |
YES | PARTIAL | NO |
| 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. Doc: Reprocessing protocol and verification record |
YES | PARTIAL | NO |
ALL YES Standard likely met. ANY PARTIAL Improvement plan required. ANY NO Blocks accreditation until resolved.
| WHAT THE ASSESSOR DOES ON SITE no surprises, no hidden checks |
| 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. |
REFERENCES
- [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.
| Standard 12.4 · Standard 12: Dialysis & Renal Replacement Therapy Guidance & Learning |
GUIDANCE ASF-AMB-STD12-v3.0 |
| WHY THIS STANDARD EXISTS |
Whether a facility reuses dialyzers is a real, significant infection-control decision with international variation in practice, and the risk isn't in which approach a facility chooses, but in practice quietly diverging from what's actually documented, tracked, and verified.
| 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. |
WHAT FAILURE LOOKS LIKE ✗ 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. |
| MOST COMMON REASONS CLINICS SCORE PARTIAL |
1 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.
2 Practice matches policy for most patients but exceptions are made informally without documentation.
Undocumented exceptions undermine the reliability of the stated policy.
3 Reprocessing follows a protocol but water quality verification specific to reprocessing wasn't recently checked.
Reprocessing water carries the same real quality requirements as water used for treatment itself.
| HOW TO IMPLEMENT IF YOU ARE STARTING FROM ZERO |
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.
| FOR SURVEYORS — WHAT IS NOT OBVIOUS |
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.
| E-LEARNING academy.gmj.ge/amb-std12-4-dialyzer-reuse-policy — 30 min · complete before self-assessment |
Ambulatory Clinic Standards — overviewFacility Classification — Which Type of Facility Are You?Standard 1 — Access & ArrivalStandard 2 — Reception & InformationStandard 3 — Environment & Shared SpacesStandard 4 — Care & TreatmentStandard 5 — Safety & Emergency PreparednessStandard 6 — Aftercare & Follow-upStandard 7 — Governance & ManagementStandard 8 — Dental PracticeStandard 9 — Aesthetic & Injectable MedicineStandard 10 — Longevity & IV TherapyStandard 11 — Oncology & Infusion TherapyStandard 12 — Dialysis & Renal Replacement TherapyStandard 13 — Fertility & IVFStandard 14 — Cardiology & Cardiac CatheterizationStandard 15 — Ophthalmology & Day SurgeryStandard 16 — Diagnostic ImagingStandard 17 — DermatologyStandard 18 — Allergy & ImmunotherapyStandard 19 — Plastic & Cosmetic SurgeryStandard 20 — Psychiatry & Mental HealthStandard 21 — Narcology & Addiction TreatmentStandard 22 — Gastroenterology & EndoscopyStandard 23 — Pediatric Ambulatory CareStandard 24 — Medical TourismStandard 25 — Refugee & Migrant HealthReferences & Index
STANDARD 12Dialysis & Renal Replacement Therapy12.1 Dialysis Water Treatment Meets a Verified Quality Standard12.2 Vascular Access Site Care Follows Recognised Core Interventions12.3 Patients Are Monitored for Intradialytic Complications Throughout12.4 Reuse or Single-Use Policy for Dialyzers Is Explicit and Followed
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