1. The BACTS is the Belgian Association for Cardio-Thoracic Surgery, founded in November 1995.
2. The Database Committee, is a committee of the BACTS.
3. The Data-manager is a non-physician, responsible for data collection, data optimization and data mapping in preparation of the data-analysis. The data-manager optimizes the layout of the reports, as proposed by the Committee.
4. The Data-analyst is a non-physician expert in biomedical statistics, responsible for data analysis. The data-analyst interfaces with the data-manager concerning the data and with the Committee concerning the data-analysis.
5. The purpose of the Database Committee is mainly
- To create, maintain and analyse a registry of the cardio-thoracic surgical activity in
- To create therapeutic or epidemiological studies involving the cardio-thoracic therapy, with the intention to improve the quality of care. The outcome analysis will avoid all ranking. It is the mission to identify mathematically significant outliers in performance. The identified unit will be invited to re-evaluate its data and the negative outcomes. In a further step each negative outcome will be critically reviewed by the database committee or its representatives and the concerned centre. The analysis should identify if an unusual variability can be identified in some patients with negative outcomes. The record(s) with unusual variability will be removed and the analysis will be repeated. If an outlying performance remains valid, the unit will be informed. This whole process, as well the involved members of the database committee as the name of the unit, will remain confidential for all parties outside the database committee, under the responsibility of the chairman of the database.
- To participate directly (centre) or indirectly (database) in international projects.
- The database will never serve to rank centres or surgeons, will never participate in malpractice investigation or conformity checking with legal requirements of centres and surgeons.
6. The Privacy Law (Dec 8th 1992) dictates that: (1) The database should be registered at the Commission for Protection of Privacy; (2) All centres have to be informed about the identity and the address of the holder of the database, the purpose of the database, the fact that one can get more information at the "Commission Protection of Privacy", the right to access and when necessary to correct their data; (3) The person responsible for analyzing the data, has to indicate the persons who have access to the data. The contents as well as the limits of this access have to be described in a registry. The registry of the Database Committee is registered at the Commission for Protection of Privacy, Ministry of Justice, Waterloolaan 115, 1000 Brussel. The holder's identification number is 003002666, the unique identification number is 005008830.
7. The access to the data has three levels. The first two levels concern the Database Committee members.
- The first level is unrestricted. This access is given to the chairman of the database committee, the data-analyst and the data manager.
- The second level is restricted to a “need to know level”, defined by the committee and this access is given to all the members of the committee.
- The third level is restricted to the centre's own data. This access is given to the Chairman of the center. This access is unrestricted in time but limited to the data of the center.
All members of the committee, including the data manager and the data analyst are under the medical secret. The database is protected by secret entry-codes. In addition the names of the centres and the RIZIV/INAMI numbers are recoded into secret codes. The password and codes are kept in a sealed envelope with the chairman of the database committee. No database committee chairman or member has access to the actual identification of the centre or the surgeon. The Law on the Medical Secret: data cannot and should not be transferred to any third party, e.g. council of BACTS, Health authorities, industry. There are two exceptions: (1) there is a database-specific law ordering the transfer of these data; (2) all parties or centres give their written permission for each specific output.
No centre- or surgeon-specific information can be given to any third part outside the database committee without the written permission of the chairman of the centre or the individual surgeon. No centre-, nor surgeon- identified information can be looked into by the members of the database committee.
The database committee guarantees that the data (conditional to the approval of each head of the department) that are transferred, after approval of the Board of Directors of the BACTS to a supra-national organisation (e.g. EACTS), will be transferred with secret coding of the identification of the department and additional secret coding of the surgeon.
8. There is a possible conflict of interest leading to the incompatibility of simultaneous membership of the Database Committee and membership of the Board of Directors of the BACTS or membership of the College. Any other position with possible conflict of interest needs to be presented to the database committee.
The acting members of the database committee will not be member of any other national audit or malpractice committee during their membership of the Committee.
9. The chairman of the database committee is chosen by the Board of Directors of the BACTS. The Board of directors of the BACTS nominates and dismisses the members of the Committee. The number of members can be changed on the suggestion of the Chairman of the Committee. A chairman and the Committee members remain custodians of the database till the nomination of their successors, in the event that their term has ended or that they are dismissed by the Board of Directors. Violation of the confidentiality (identified by the Committee) leads to automatic dismissal of the member or chairman by the Board of Directors of the BACTS.
The chairman of the database committee reports to the Board of Directors of the BACTS on a regular basis, as requested by the Board or the Committee. In addition an annual report is given at the business meeting of the annual convention. He will answers to the questions of the members concerning all matters of the Committee. The website will be updated on a regular basis.
10. The Committee will propose an annual budget to the Board of Directors.
11. The BACTS will take charge of the legal protection of the Committee members and the Database.