Foreword

Introduction

1Scope

2Normative references

3Terms and definitions

4Principles, data concepts and process model

4.1General

4.2Principles

4.2.1General

4.2.2Proactivity

4.2.3Objectivity

4.2.4Accountability

4.2.5Transparency

4.2.6Preparedness

4.2.7Comprehensiveness

4.3Data concepts

4.3.1General

4.3.2Accuracy

4.3.3Timeliness

4.3.4Comparability

4.3.5Usability

4.3.6Relevance

4.4Process model

4.4.1General

4.4.2Recording

4.4.3Analysing

4.4.4Reporting

5Patient safety data elements

5.1General

5.2Event information

5.2.1General

5.2.2Event identification

5.2.3Event date and time

5.2.4Report date

5.2.5Event reporter information

5.2.6Event supplementary information

5.3Event categorization

5.4Event classification

5.4.1General

5.4.2Information input/output errors

5.4.2.1General

5.4.2.2Use errors

5.4.2.2.1Wrong entry/retrieval

5.4.2.2.2Partial entry/retrieval

5.4.2.2.3No entry/retrieval

5.4.2.3Machine errors

5.4.2.3.1Wrong output

5.4.2.3.2Partial output

5.4.2.3.3No output

5.4.2.3.4Delayed output

5.4.2.4Software problems

5.4.2.4.1General

5.4.2.4.2Device down or slow

5.4.2.4.3Network/server down or slow

5.4.2.4.4Software not available or not licensed

5.4.2.4.5Software not accessible

5.4.2.4.6Software issues

5.4.2.4.7Data storage and backup

5.4.2.4.8Record migration

5.4.2.4.9Power failure

5.4.2.4.10Malware

5.4.2.5Human factors

5.4.2.5.1Staffing and training

5.4.2.5.2Cognitive load

5.4.2.5.3Failure to carry out duty

5.4.2.5.4Information management

5.4.2.5.5Integration with clinical workflow

Annex AInformation on various health software surveillance systems (informative)

A.1AHRQ Common Formats

A.2NHS England's National Reporting and Learning System (NRLS)

A.3Japan's Medical Near-Miss/Adverse Event Reporting Project

Bibliography