ISO/TS 9320:2024

Health informatics — Standardized data set for transfer of hemodialysis patients

The document defines a data set for the safe and timely transfer of haemodialysis procedure for end-stage renal disease (ESRD) patients. The necessary information for dialysis is provided through required, conditionally-required and optional data fields of the data set. Complicated use cases are also described in this document. This document does not cover general quality requirements or system requirements for haemodialysis.

Informatique de santé — Ensemble de données normalisées pour le transfert des patients en hémodialyse

General Information

• Status: Published
• Publication Date: 08-Aug-2024
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ISO/TC 215 - Health informatics
• Drafting Committee: ISO/TC 215 - Health informatics
• Current Stage: 6060 - International Standard published
• Start Date: 09-Aug-2024
• Due Date: 18-Apr-2025
• Completion Date: 09-Aug-2024

Standards Content (Sample)

Technical
Specification
ISO/TS 9320
First edition
Health informatics — Standardized
2024-08
data set for transfer of hemodialysis
patients
Informatique de santé — Ensemble de données normalisées pour
le transfert des patients en hémodialyse
Reference number
© ISO 2024
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ii
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms, definitions and abbreviations . 1
3.1 Terms and definitions .1
3.2 Abbreviated terms .5
4 Significance of haemodialysis data set . 5
4.1 General .5
4.2 Unique elements in the haemodialysis data set .6
4.3 Purpose of a standardized data set.6
5 Use case . 7
5.1 General .7
5.2 Haemodialytic patient with no special problems .7
5.3 HIV positive haemodialytic patient .7
5.4 Haemodialytic patient with refractory heart failure .7
6 Data sets for transfer of haemodialysis . 8
6.1 General .8
6.2 Fields of required data.10
6.2.1 General .10
6.2.2 Last dialysis date . . .10
6.2.3 Haemodialysis interval .11
6.2.4 Dry weight .11
6.2.5 Haemodialysis machine model . 12
6.2.6 Haemodialysis blood flow rate . 12
6.2.7 Haemodialysis access type . 12
6.2.8 Haemodialysis access site . 13
6.2.9 Haemodialysis access status . 13
6.2.10 Hepatitis type B antigen / antibody.14
6.2.11 Hepatitis C virus infection .14
6.2.12 Human immunodeficiency virus infection . 15
6.2.13 Dialysis duration . 15
6.2.14 Dialysate .16
6.3 Fields of conditionally-required data .16
6.3.1 General .16
6.3.2 Initial dialysis date .16
6.3.3 Last laboratory test date .17
6.3.4 Blood type .17
6.3.5 Diagnosis .18
6.3.6 Blood haemoglobin concentration .18
6.3.7 Blood sodium concentration .19
6.3.8 Blood potassium concentration .19
6.3.9 Blood calcium concentration . 20
6.3.10 Blood phosphate concentration . 20
6.3.11 Venereal disease research laboratory .21
6.3.12 Pre-dialysis vital sign . 22
6.3.13 Post-dialysis vital sign . 22
6.3.14 Interdialytic weight gain . 23
6.3.15 Prescription . 23
6.3.16 Remark note .24
6.4 Fields of optional data .24
6.4.1 General .24
6.4.2 Heparin concentration .24

iii
6.4.3 Remnant kidney function . 25
6.4.4 Other laboratory results . . 25
6.4.5 Radiology report. 26
6.4.6 Allergy . 26
6.4.7 Presence of heart failure .27
6.4.8 Heart ejection fraction .27
6.4.9 Haemodialysis access construction date . 28
Annex A (informative) Example of a haemodialysis referral paper .29
Annex B (informative) Example of an FHIR resource .30
Bibliography .53

iv
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
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with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publicat
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