Project on aggregation of adverse events

In 2012 a limited use case was carried out in which five hospitals participated on a voluntary basis.
These hospitals have all incident reports from 3 random months to the deepest level
coded according to the International Classification for Patient Safety of the WHO (ICPS).

After the experience with the limited usecase with 5 hospitals, the next step is a broad aggregation of
adverse events in Belgium under the motto: 'aggregation of adverse events to learn'.

Data and Resources

Project on aggregation of adverse eventsjson Download

Field	Value
Modified	2020-07-21
Release Date	2018-03-29
Identifier	8cde698d-ea65-4bdb-a8e2-a947ccd5fd7f
License	Creative Commons Attribution
Public Access Level	Public

Protocol

Protocol
Full title of the project	Project on aggregation of adverse events
Title of the project for lay people, in easily understood, i.e. non-technical, language	Learning from patient safety incidents
Name or abbreviated title of the project where available	Adverse Events
Source type	Administrative sources Patient registries

Sponsor(s)

Primary organization that oversees implementation of study and is responsible for data analysis.
Name of organisation	Federal Public Service Health, Food Chain Safety and Environment (cell quality and patient safety)

Commissioner(s)

Organisation (1) that commissioned this project
Name of organisation (1)	GZA hospitals

Organisation (2) that commissioned this project
Name of organisation (2)	Calidos

Organisation (3) that commissioned this project
Name of organisation (3)	Federal Service Public Health - cell quality and patient safety

Governance

Governance
Is there a Steering / Accompanying committee?	Yes
Name of Steering/Accompanying Committee (1)	Working group taxonomy
Composition of Steering/Accompanying Committee (1)	Dr. Luc Van Looy (GZA) Dr. Anja Braet (AZ Blasius) Tim Van Laethem (AZ Blasius) Carine De Leeuw (Titeca) Hilde Peleman (FOD)

General information

General information
Project description	In 2012 a limited use case was carried out in which five hospitals participated on a voluntary basis. These hospitals have all incident reports from 3 random months to the deepest level coded according to the International Classification for Patient Safety of the WHO (ICPS). After the experience with the limited usecase with 5 hospitals, the next step is a broad aggregation of adverse events in Belgium under the motto: 'aggregation of adverse events to learn'.
Links	www.patient-safety.be

Therapeutic area
Disease	Bacterial Infections and Mycoses Blood and lymphatic diseases Cancer Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Ear, nose and throat diseases Eye Diseases Female diseases of the urinary and reproductive systems and pregancy complications Hormonal diseases Immune System Diseases Infectious Diseases Injuries, poisonings, and occupational diseases Male diseases of the urinary and reproductive systems Mouth and tooth diseases Musculoskeletal Diseases Nervous System Diseases Nutritional and Metabolic Diseases Parasitic Diseases Respiratory Tract Diseases Skin and Connective Tissue Diseases Symptoms and general pathology Virus Diseases

Objective of the project
Additional information	No additional information available

Scope
Scope	Quality of care research Safety

Legal basis

Type of legal basis
Type of legal basis	Unknown

Design of the project

Principal inclusion and exclusion criteria
Principal inclusion criteria	All incident notifications coded by using the ICPS of the WHO

Data transfer frequency
Data transfer frequency	Unknown
Other frequency: specification	Not known yet, can be defined after discussion with healthdata.be

Method of data transfer
Data transfer method(s)	Web application (eg. online registration form, upload) Web service (system to system transfer)
Other method of data transfer: specification	A control program (parser) was developed by Calidos. This allows hospitals to validate their ICPS XML file. For this purpose, the hospital offers its XML file to the control program that verifies its conformity and bundles the results in a report. This report is fed back to the hospital and states the conformity percentage and the detail of the non-conformities.

Sites involved in the project

Type of site(s)
Care Provider	General hospitals Psychiatric hospitals

Health professionals involved (encoding) in the project

Health professionals involved (encoding) in the project
Care Giver	Nurses Other Paramedical professionals Pharmacists Physicians
Type of paramedical professionals involved (encoding) in the project	Unknown

Informed consent

Informed consent
Are subjects informed?	No information available
How are subjects informed?	No information available
Do subjects have to give their consent?	No information available
How do subjects give their consent?	No information available
Is there a procedure to provide subjects the ability to consult their registered information?	No information available
Is there a procedure to provide subjects the ability to correct their registered information?	No information available
Additional information	No additional information available

Review

Ethics Committee
Authorization by an Ethics Committee?	No information available

Sectoral Committee National Registry (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No information available

Sectoral Committee Health / Social affairs (Privacy Commission)
Authorization by the sectorial committee Health / Social affairs of the Privacy Commission	No information available

Sectoral Committee Crossroads Bank of Enterprises (Privacy Commission)
Authorization by the sectorial committee Crossroads Bank of Enterprises of the Privacy Commission (Y/N)	No information available

Data dictionary

Classifications and Terminology
Name	Unknown

Data quality

Data quality
First year for which data is available	No information available
Procedures for checking and validating the source data	No information available
Data compilation process	No information available
Punctuality for the most recent completed data collection: the data collection was completed	No information available
Participation rate of the health institutions	No information available
Participation rate of the health professionals	No information available
Extent of unit non-response	No information available
Extent of the item non-response	The rate of item non-response is not known or unacceptably high (>50%)
Extend to which the collected data are comparable across the Belgian regions	Comparability across the Belgian areas is unknown
Comparable or reconcilable over time	Comparability over time is unknown
Additional information	No additional information available
Extent of problems with the misclassification of statistical units for their key variables	No information available
Can records belonging to same entity be matched?	No information available
Additional information	No additional information available

Data storage

Data storage
The organisation in charge of storage of the collected data, is certified as being compliant with the international standards on information security management system (eg. ISO27001)?	No information available
Additional information	No additional information available

Data access

Data access
Written Data sharing policy?	No information available

Request data

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