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906 / Using Qualibus - A new information tool for managing nonconformities and incident reporting

ITALY
Classification of the PSP
Type of Patient Safety Practice Safe
 
Clinical Practice (CP)
Related practices from PaSQ database
"Best fit" category of the reported practice
Health IT
Documentation There is no specified text here
Topic of the reported practice
Incident reporting and learning system
Aim and the benefit of the Patient Safety Practice
 
The IRCCS CRO (National Cancer Institute) in Aviano is involved in the program of certification of quality management systems of some of its operative structures. This program includes the reporting and correction of non-compliance with the system by operators. Starting in 2010, is also active in the Institute an Incident Reporting program (a voluntary reporting of adverse events). We needed to link these two information sources considering that more or less often a system nonconformity can lead up to adverse events for patients. Moreover, both programs were managed in paper form and this led to the extension of time for closing procedures and to the difficulty in obtaining and maintaining documentation on the phenomena. The reporting of incidents as a result of non-compliance that involved or could involve the patient was totally entrusted to the sensitivity of the reporting operator. Through the informatics tool Qualibus, non-compliance and adverse events are reported and managed very easily, allowing the creation of a database and automatic reports.
Description of the Patient Safety Practice
 
The two operative structures involved managed the nonconformities, corrective and preventive actions through a specific setting of a third party commercial BPM tool based on event management. The first phase consisted in adapting this tool to the new objective. The process for managing IR is as follows:
Step 1: A user starts a specific ‘event’ titled ‘IR Alert’, by filling in a specific form with few mandatory key information.
Step 2: Department Risk Manager, automatically alerted by the system, manages the’ IR event’ recording actions and analyses results.
Step 3: Hospital Risk Manager, also alerted by automatic message system, can supervise the whole process. Risk management board periodically analyses the ‘IR events’ to evaluate any possible systemic corrective action which will be assigned to the Departmental Quality System Manager. If necessary, the Quality System Manager can start a ‘Corrective Action’.
All steps, form data, user data, timing data, action data are stored in a database for reporting and analysis purpose. Processes are connected to the document management system to dynamically extract needed documentation from documental database, if available.
In parallel, the Quality System Manager who collects and analyses nonconformities of the certificated quality system can start a new Incident Reporting emerging from a nonconformity involving a patient. The process than is as above.
The first step was the involvement of the institute leadership for the strategy definition. In 2012 the pilot phase took place in two operative structures. Then we spread the information through training moments involving all the quality managers of operative structures with ISO 9001-2008 certificate. We planned that the systemic intervention will be developed throughout 2013 and 2014.
Attachment of relevant written information and/or photos, as appropriate
There is no specified text here
There is no specified text here
There is no specified text here
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Effectiveness of the Patient Safety Practice
 
Degree of implementation of reported practice
Yes, partly
Level of implementation of reported practice
Institution level
Specific and measurable outcome for the reported practice were defined
Yes
A baseline measurement before implementation of the reported practice was obtained
Yes
A measurement after full implementation of the reported practice was obtained
Yes
Evaluation of a "positive" effect of the reported practice on Patient Safety
The evaluation showed improvements in Patient Safety outcomes
Type of before-and after evaluation
Quantitative
Enclosure of a reference or attachment in case of published evaluation's results
There is no specified text here
There is no specified text here
Health care context where the Patient Safety Practices was implemented
 
Hospital
Transferability
 
Successful implementation of this Patient Safety Practice in other health care settings than above stated
No
Specification of implementation in another health care setting(s)
There is no specified text here
Successful implementation's level  of this Patient Safety Practice across settings
There is no specified text here
Involved health care staff
 
Physicians
Nurses
Health care assistants
Pharmacists
Scientific staff / researchers
Technical support / technician
Administrative support (secretary, clerk, receptionist etc.)
Clinical manager
Quality manager
Risk manager
Patient Involvement
 
Direct service user's involvement as integral part of this Patient Safety Practice
No
Specification of the service users or their representatives' involvement in the implementation of this Patient Safety Practice
There is no specified text here
Point of time in which service user or their reprasentatives' involvement takes place
There is no specified text here
Active seeking of service users' opinion, feedback, experience, etc. as integral part of this Patient Safety Practice
There is no specified text here
Short description of the service users' level of involvement
There is no specified text here
Public accessibility of information regarding this Patient Safety Practice to patients and citizens/service users
Yes
List of sources where public information is accessible
http://buonepratiche.agenas.it/practicesdetail.aspx?id=4194
Implementation of the Patient Safety Practice
 
Existing collaboration with other countries or international organisations related to implementation of this Patient Safety Practice
No
Problems encountering in the implememntation course of this Patient Safety Practice like lack of motivation, no management support, etc.
Yes
List of the most prevelent difficulties encuntered during implementation of this Patient Safety Practice
Not sufficient human resources available
List of the most prevalent drivers for a successful implemetation of this Patient Safety Practice
There is no specified text here
Use of any specific incentives to enhance motivation while implementing this Patient Safety Practice
No
Description of used incentives, if any.
There is no specified text here
Existence of support or approval by the clinical or hospital management or any other hihg level authority in the implementation process of this Patient Safety Practice
Yes
Costs of the Patient Safety Practices
 
Completion of cost calculation related to this Patient Safety Practice
No
Total number of person days required to implement this Patient Safety Practice
Clinical staff: There is no specified text here
External consultants: There is no specified text here
Support staff: There is no specified text here
Managerial staff: There is no specified text here
Others: There is no specified text here
Not relevant: There is no specified text here
Total number of person days required for training as preparation for implementation of this Patient Safety Practice
Clinical staff: There is no specified text here
External consultants: There is no specified text here
Support staff: There is no specified text here
Managerial staff: There is no specified text here
Others: There is no specified text here
Not relevant: There is no specified text here
Total cost in Euro of specific equipment (machines, software, communications supplies, etc.) needed to support implementation of this Patient Safety Practice
There is no specified text here
Associated cost with a work reduction or foregoing in order to deliver this Patient Safety Practice
There is no specified text here
Contact information
 
Name: Moreno Calderan
Country: ITALY
Organisation: CENTRO RIFERIMENTO ONCOLOGICO
E-mail: mcalderan@cro.it
Phone: 0434 659171
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