Overview
ISO/TS 9320:2024 - Health informatics - Standardized data set for transfer of hemodialysis patients defines a structured, clinical data set to support the safe and timely transfer of haemodialysis (hemodialysis) care for patients with end‑stage renal disease (ESRD). The Technical Specification specifies required, conditionally required, and optional data fields and describes complicated use cases to ensure continuity of dialysis therapy during referrals, hospital admissions, surgery, intensive care or international travel.
This document does not set general quality or system requirements for haemodialysis; rather, it focuses on the clinical and operational data needed to deliver safe dialysis care across settings.
Key topics and technical requirements
- Data set structure: Classification of fields by required, conditionally-required and optional to prioritize essential information for safe dialysis handover.
- Core clinical fields (examples from the specification): last dialysis date, haemodialysis interval, dry weight, dialysis duration, haemodialysis machine model, blood flow rate, access type/site/status, dialysate parameters.
- Infectious disease status: Hepatitis B/C and HIV markers are included as required fields where relevant.
- Laboratory and physiological data (conditionally required): haemoglobin, sodium, potassium, calcium, phosphate, pre‑ and post‑dialysis vitals, interdialytic weight gain, last laboratory test date.
- Prescription and procedural notes: individualized dialysis prescription and remark fields to convey clinician instructions.
- Optional clinical context: heparin concentration, remnant kidney function, radiology reports, allergies, heart failure presence and ejection fraction, access construction date.
- Use cases and examples: the document details typical and complex referral scenarios (e.g., infectious patients, heart failure) and includes Annex A (referral paper example) and Annex B (example FHIR resource) to aid implementation.
- Interoperability focus: while not prescribing system requirements, the presence of a FHIR example supports mapping the dataset to health IT standards for data exchange.
Applications and users
ISO/TS 9320:2024 is immediately useful for:
- Dialysis clinics and nephrology teams coordinating referrals or covering travelling ESRD patients
- Hospital wards and intensive care units accepting dialysis patients
- Health IT vendors and EHR integrators implementing dialysis referral workflows and interoperability (FHIR mapping)
- Clinical informaticians, care coordinators and policy-makers developing referral templates and patient‑transfer protocols
Adoption improves patient safety by standardizing critical dialysis parameters, reducing errors during handover, and supporting efficient cross‑facility and cross‑border dialysis continuity.
Related standards
- The document contains no normative references but was prepared by ISO/TC 215 (Health informatics).
- Annex B provides an example FHIR resource, facilitating alignment with HL7 FHIR-based interoperability implementations where applicable.