HD-TE-001 · Water Treatment System Monitoring & Maintenance (UPDATED)

Water Treatment System Monitoring & Maintenance

Policy HD-TE-001 · Hemodialysis Unit

Effective June 25, 2026 Review June 25, 2027 Replaces all previous

1 Purpose

To ensure water used for hemodialysis and dialysate preparation meets chemical and microbiological purity standards to prevent patient injury from contaminants, endotoxins, and bacteria as defined by AAMI/ISO 23500:2024 and MOH-Jordan regulations.

2 Scope

This policy applies to all dialysis nurses, technicians, biomedical engineers, and designated staff responsible for daily testing, monthly cultures, and maintenance of the water treatment system. The unit in-charge and nephrology director are responsible for review of results and action plans.

3 Definitions

Product Water after final treatment RO Reverse Osmosis TVC total viable count (CFU/mL) EU/mL endotoxin units Action Level investigation required Max Allowable immediate shutdown

4 Policy Statement UPDATED

Update 1.1 Enhanced microbiological surveillance

Monthly TVC/endotoxin testing at product water & loop.

Risk‑based testing: increase to weekly after any action‑level exceedance, or after loop disinfection. Same‑day notification to unit leadership for any result above action level.

Rationale: AAMI/ISO 23500:2024 emphasises risk‑based surveillance; rapid escalation prevents sustained patient exposure.

Update 1.2 Preventive maintenance & validation

PM per manufacturer, documented.

All PM must be validated with post‑maintenance testing (chlorine, hardness, conductivity) before patient use. Loop disinfection quarterly with heat/ozone/chemical; verification via TVC/endotoxin within 48h.

Rationale: Validated maintenance prevents unplanned downtime and ensures water quality is restored after any intervention.

5 Procedure UPDATED

A. Daily Monitoring – Before First Patient

Test	Frequency	Method	Action Level	Max Allowable	Action if Exceeded
Total Chlorine	Each shift, pre & post carbon	DPD kit	≥0.1 mg/L	≥0.5 mg/L	Stop dialysis. Change carbon tanks. Retest. Notify MD
Hardness	Daily	Test strips/tablets	≥1 GPG	≥2 GPG	Check softener. Regenerate. Retest
Conductivity/TDS	Daily	RO meter	25% baseline	Per manufacturer	Inspect RO. Call biomedical
RO % Rejection	Daily	(Feed‑Product)/Feed	<90%	<85%	Membrane issue. Stop use. Call biomedical

Document on Daily Water Treatment Log HD‑TE‑001‑F1 · Charge nurse reviews daily

B. Weekly Monitoring

Carbon Tank EBCT: verify ≥10 minutes total for 2 tanks; document flow rate.
Water Softener Brine Level: check and refill if <1/3 full.

C. Monthly Microbiological Testing UPDATED

Update 2.1 Sample sites & escalation

Sampling: product water port, first/last machine, reuse water. TVC ≤50 CFU/mL (action), ≤100 max. Endotoxin ≤0.125 EU/mL (action), ≤0.25 max.

Additional sample: after the final RO membrane and before the loop. Action-level response: repeat sample immediately; disinfect RO + loop within 24h; increase testing to weekly until two consecutive passes. Max-level: STOP all treatments, notify nephrologist & MOH, disinfect and retest.

Rationale: Enhanced sampling points and rapid escalation align with AAMI/ISO 23500:2024 and CDC 2016 recommendations for waterborne pathogen prevention.

TVC: TSA, 17‑23°C, read at 168h · Endotoxin: LAL test.

D. Quarterly / Semi‑Annual Testing UPDATED

Update 2.2 Chemical analysis & loop disinfection

Full chemical panel (Al, F, Cu, Zn, sulfate) sent to lab. Loop disinfection quarterly.

Chemical panel includes all AAMI/ISO required elements; results trended. Loop disinfection verified with post‑disinfection TVC/endotoxin samples within 48h. If disinfection fails, repeat until pass.

Rationale: Post‑disinfection verification ensures the efficacy of the disinfection process, a key requirement in ISO 23500‑5:2024.

E. System Maintenance UPDATED

Update 2.3 PM validation & documentation

Carbon filters replace when Cl breakthrough ≥0.1 mg/L or 12 months. RO membranes replace when rejection <90%. UV lamps annual. Loop disinfection logged.

Post‑PM validation: after any maintenance (filter change, membrane replacement, UV change), run daily tests (chlorine, hardness, conductivity) before first patient use. All PM and repairs documented in Biomedical Maintenance Log with verification signatures.

Rationale: Validation prevents patient exposure to contaminants after maintenance activities.

7 Staff Competency UPDATED

Update 3.1 Aseptic technique & alarm response

Initial: return demonstration of chlorine testing, sample collection, alarm response. Annual: written + observed.

Annual aseptic technique re‑certification for sample collection (to reduce contamination). Water system alarm drill (unplanned downtime) included in annual competency.

Rationale: Proper sampling technique is critical for accurate microbiological results; alarm drills improve response time during failures.

8 Quality Monitoring – QAPI Indicators UPDATED

Update 4.1 New KPIs & trending

% daily chlorine tests completed & within limits (target 100%); TVC >50 CFU/mL (0); endotoxin >0.125 EU/mL (0); unplanned downtime hours.

Add: • Time to corrective action (hours from action‑level result to disinfection started) • % of quarterly chemical panels completed on time • Post‑disinfection verification pass rate (first‑time pass). Monthly trending graphs reviewed at QAPI.

Rationale: Expanded KPIs drive accountability and early detection of system drift before action levels are breached.

9 References UPDATED

Update 5.1 Updated reference list

AAMI/ISO 23500‑5:2024. Preparation and quality management of fluids for haemodialysis and related therapies.
CDC. Recommendations for Preventing Transmission of Infections Among Chronic Hemodialysis Patients. 2016.
KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 Update.
Ministry of Health – Hashemite Kingdom of Jordan. Standards for Hemodialysis Units, 2023 Edition.
Additional: AAMI/ISO 23500‑4:2024 (Water treatment equipment), & ECRI Institute Water Quality Guidelines (2025).

⏺ Summary of key updates

Section	Update	Clinical / operational rationale
4. Policy	Risk‑based microbiological surveillance; post‑PM validation	Aligns with AAMI/ISO 23500:2024; prevents patient exposure after maintenance
5. Procedure (C)	Additional sample site; weekly testing after action‑level; rapid escalation	Earlier detection of contamination; clear pathway for max‑level response
5. Procedure (D)	Post‑disinfection verification (TVC/endotoxin within 48h)	Ensures loop disinfection is effective before patient use
5. Procedure (E)	Post‑maintenance validation (daily tests before first patient)	Prevents contaminants from maintenance activities reaching patients
7. Competency	Aseptic technique re‑certification; alarm drill annually	Reduces sample contamination; improves response to system failures
8. QAPI	New KPIs: time‑to‑action, chemical panel completion, disinfection pass rate	Drives accountability and early detection of system drift

Policy HD‑TE‑001 · Proposed updates June 26, 2026 All changes reviewed against AAMI/ISO 23500:2024, CDC 2016, and MOH‑Jordan 2023.

Water Treatment System Monitoring And Maintenance · Version 2026-06-27 · Hemodialysis Unit

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Aligned with KDOQI, AAMI/ISO, CDC, MOH-Jordan 2023, JCI 8th Ed.