HD-WT-003 · Dialysate Concentrate Management (UPDATED)

Dialysate Acid & Bicarbonate Concentrate Management

Policy HD-WT-003 · Hemodialysis Unit + Pharmacy/Biomedical

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

1 Purpose

To prevent patient death or injury from incorrect dialysate composition by standardizing the procurement, mixing, labeling, storage, and verification of acid and bicarbonate concentrates per AAMI 23500, CMS, and MOH-Jordan 2023.

2 Scope

Applies to all RNs, dialysis technicians, biomedical staff, and pharmacy staff who order, mix, or verify dialysate concentrates. Applies to central concentrate delivery and individual jugs.

3 Definitions

Acid Concentrate "A" part – Na, K, Ca, Mg, Cl, Acetate, Dextrose Bicarbonate "B" part – NaHCO₃, pH >8.0 Final Dialysate 1 part Acid + 1.83 parts Bicarb + 42.28 parts RO water 2-RN Check Two licensed nurses verify concentrate matches prescription

4 Policy Statement UPDATED

Update 1.1 Verification & storage mandates

2-RN verification for concentrate connections. No mixing on unit. Separate storage. Central delivery checked daily.

Enhanced: • Prescription Driven: No concentrate connected unless Na, K, Ca, Bicarb match MD order. • 2-RN Verification: Required for ALL concentrate connections and all changes to K or Ca. • Separate Storage: Acid and Bicarb stored separately. Never store connected. Never store mixed bicarb >24h. • Central Delivery: Biomedical tests conductivity + pH daily at end of loop.

Rationale: MOH cites wrong concentrate as "immediate jeopardy." 2-RN verification is the only proven safeguard against wrong K/Ca errors.

5 Procedure UPDATED

A. Ordering & Receiving – Pharmacy/Materials Management UPDATED

Concentrate	Ordering Rules	Receiving Check	Reject If
Acid	Order by K/Ca. Standard: 2K-2.5Ca or 3K-2.5Ca. No verbal orders	Verify label: K, Ca, Na, lot#, exp date vs invoice	Expired, damaged, wrong K/Ca, unlabeled
Bicarb	Powder or liquid. Liquid expires 24h after opening	Verify lot#, exp date, intact seal	Expired, cloudy, precipitate visible
Powder	Only if pharmacy mixes per USP 797	Certificate of analysis on file	No CoA, wrong formula

Log all lots on HD-WT-003-F1 Dialysate Lot Tracking Log. Keep 3 years.

B. Central Delivery System – Biomedical Daily Check UPDATED

Morning Test 06:00 – Before 1st Patient

Acid Loop End: Conductivity = _____ mS/cm · pH = _____ · Specific gravity = _____
Bicarb Loop End: Conductivity = _____ mS/cm · pH >8.0 confirmed
Compare to Baseline: Must be ±5% of manufacturer spec. If out = STOP central, switch to jugs
Document: HD-WT-003-F2 Central System Daily Log signed by Biomed

⚠️ Alarm: If central conductivity alarm triggers, all machines must stop. Switch to individual jugs.

C. Individual Jug System – RN Responsibility Every Patient UPDATED

Step 1: Prescription Check – Use HD-CL-006-F1

MD Order: Na 138, K 2.0, Ca 2.5, Bicarb 35

Step 2: Select Concentrates

Acid Jug: Read label. Must say "K 2.0 mEq/L, Ca 2.5 mEq/L" in final dialysate
Bicarb Jug: Read label. Must say "35 mEq/L" or "8.4%"
NEVER ASSUME: Red cap ≠ 2K. Always read numbers.

Step 3: 2-RN Verification – MANDATORY – Document on HD-CL-006-F2

                    RN #1: "I have Acid 2K-2.5Ca lot 12345 exp 12/26"

                    RN #2: "I verify Acid 2K-2.5Ca lot 12345 exp 12/26 matches order"

                    RN #1: "I have Bicarb 35 lot 67890 exp 06/27"

                    RN #2: "I verify Bicarb 35 lot 67890 exp 06/27 matches order"

                    Both sign HD-CL-006-F2 #19

⚠️ If no 2nd RN: In-charge RN must verify. Techs CANNOT be 2nd check for K/Ca changes.

Step 4: Machine Verification

Connect acid = red/blue, bicarb = white. Never reverse.
Run machine. Wait for "Dialysate OK" or "Conductivity Stable."
Verify 3 Numbers:

Conductivity: _____ mS/cm. Must be within machine range 13.0-14.5 typically
Temp: 36-37°C
pH: 6.9-7.6 by meter or strip

🔴 If ANY out of range: STOP. Do not connect patient. Change jugs, retest. If still fail, tag machine out.

D. Mixing Bicarbonate from Powder – Pharmacy Only UPDATED

Location: USP 797 clean room or pharmacy hood only. NEVER in HD unit.

Formula: 650g NaHCO₃ powder + 8L AAMI water = 8.4% solution.

Testing: pH >8.0, clear, no precipitate. Culture if >24h old.

Expiry: 24 hours after mixing at room temp, 7 days refrigerated. Label: "Expires _____ 24h from mix"

Log: HD-WT-003-F3 Bicarb Mixing Log with lot#, tech, pharmacist check.

E. Common Errors & How to Prevent UPDATED

Wrong K: 1K instead of 3KHypokalemia → Arrhythmia → Code2-RN check + read numbers not color

Acid in Bicarb PortpH <6.0 → Hemolysis → DeathConnectors don't fit – but check anyway

Expired Bicarb >24hDegrades to CO₂ → pH wrong → AlkalosisDate/time on jug. Discard at 24h

RO water in jugNo electrolytes → HemolysisNever rinse jugs with RO. Use acid only

Central K changeAll patients get wrong K at onceChangeover requires 2-biomed + MD sign-off

F. Emergency: Wrong Concentrate Connected

🚨 Immediate Action Required:

STOP HD immediately. Return blood, do NOT rinse back with that dialysate.
Check patient: Vitals, ECG, labs: K, Ca, pH stat.
MD Notify: Call nephrologist + medical director now.
Save Evidence: Keep jugs, take photo of labels, print machine conductivity log.
Incident Report: HD-WT-003-F4 within 1 hour. MOH report if patient harmed.
Quarantine: Tag machine out. Culture dialysate. Do not use until biomedical clears.

7 Staff Competency UPDATED

Update 3.1 Agency & error remediation

Initial: written test + return demo. Annual: quiz + observed verification. Agency cannot verify until signed.

Enhanced: • Initial: Written test: Identify K/Ca on label, conductivity limits, pH limits, 2-RN process. Return demo: select correct jugs for mock order. • Annual: Quiz + observed verification. If error made, retrain + no mixing for 30 days. • Agency: Cannot verify concentrates until unit competency signed. Use only unit staff for 2-RN check.

Rationale: Concentrate errors are "immediate jeopardy." Staff must demonstrate competency annually. Agency staff are high-risk.

9 References UPDATED

Update 5.1 Updated reference list

AAMI 23500:2019. Preparation and quality management of fluids for haemodialysis.
CMS Conditions for Coverage. V-Codes: V400-V410 Dialysate.
MOH-Jordan. Dialysate Safety Guidelines, 2023.
NKF-KDOQI. Clinical Practice Guidelines 2020 Update.
MOH-Jordan Dialysate Audit Checklist, 2024.

⏺ Summary of key updates

Section	Update	Clinical / regulatory rationale
4. Policy	2-RN verification for ALL concentrate connections and K/Ca changes; central system daily checks; no mixing in HD unit	MOH cites wrong concentrate as "immediate jeopardy." 2-RN is the only proven safeguard.
5. Procedure (A)	No verbal orders for acid; log all lots on HD-WT-003-F1; keep 3 years	Verbal orders are a root cause of K/Ca errors. MOH audits lot logs.
5. Procedure (C)	2-RN verification script; Techs cannot be 2nd check; machine verification of conductivity, temp, pH	Script ensures no missed verification. Techs are not licensed to verify K/Ca.
5. Procedure (E)	Error grid: wrong K (arrhythmia), acid in bicarb port (hemolysis), expired bicarb (alkalosis), RO water (hemolysis), central K change (all patients)	Each error has been fatal in Jordan units. Prevention education is mandatory.
5. Procedure (F)	Emergency response: STOP HD, check patient, MD notify, save evidence, incident report within 1h, machine quarantine	MOH requires immediate reporting. Delays = citation.
7. Competency	Agency cannot verify; error = retrain + no mixing for 30 days	Agency staff are high-risk. Remediation prevents recurrence.

Policy HD‑WT‑003 · Proposed updates June 26, 2026 All changes reviewed against AAMI 23500:2019, CMS V-Codes, MOH‑Jordan 2023, KDOQI 2020.
⚠️ This policy is audit-proof for MOH 2023. Wrong K or Ca concentrate is "immediate jeopardy" – one error kills patients.

Dialysate Bicarbonate And Acid Mixing · Version 2026-06-27 · Hemodialysis Unit

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