485 / Applying the Failure Mode Effect and Criticality Analysis to develop a Intra-Operative Radio Therapy procedure

ITALY
Classification of the PSP
Type of Patient Safety Practice Safe
 
Clinical Risk Management Practice (CRMP)
Related practices from PaSQ database
"Best fit" category of the reported practice
Analysis of risk and harm
Assessment of risk and harm There is no specified text here
Topic of the reported practice
Clinical risk management
Aim and the benefit of the Patient Safety Practice
 
The FMECA technique has provided a prospective systematic method for discovering potential failures in IORT procedure; evaluating not only the frequency of failure modes but also their severity and detectability, it has given a more complete assessment of the risks. It contributes, therefore, to the optimisation of patient safety right from the start of our clinical activity, and to the improvement of the risk management culture among all the professionals involved in the Working Group. The PSP herein described aims to: - identify potentially risky activities - identify appropriate measures (checklists, double-checks, etc) - verify the procedure through simulations on mannequins; correct/complete the procedure on the basis the experience gained thanks to the simulations; - publish and disseminate the procedure; - validate the procedure
Description of the Patient Safety Practice
 
A multidisciplinary Working Group was established at the beginning of 2012 with the aim of writing the Operational Procedure by applying the FMECA to the IORT process.
The multidisciplinary Working Group includes different professional profiles: a Radiation Oncologist, a Medical Physicist, a Surgeon, an Anaesthetist , the Chief of the Radiotherapy Technicians and the Head Nurse for the Operating Theatres. The Group was coordinated by a facilitator; a Medical Doctor from the Hospital Management team, qualified in clinical risk management; skilled in risk analysis, but not an expert in radiation therapy. Each member of the Working Group was asked to identify the criticalities he/she could meet in the process steps related to his/her specific activity, with particular attention to those phases perceived as potential sources of risk for the patient. In this way a list of all potential failure modes (FM) occurring in each process step was drafted. The risk analysis was completed by asking the members of the team to evaluate the Risk priority number (RPN) of each FM, obtained by multiplying the estimated frequency of occurrence (O) by the detectability (D) of the FM and the expected severity of the damage to the patient (S), using a 5-point scale (from 1 to 5) for each parameter; thus the lowest score is 1 and the highest score is 125. The smaller the RPN, the lower is the risk; the larger the RPN, the higher is the risk. The risk reduction (preliminary RPN – final RPN) was also calculated, in order to assess the weight of the corrective measures. This analysis allowed the definition of actions aimed at reducing the risk for the patient; suggested interventions were discussed by the Working Group and implemented in the procedure.
Attachment of relevant written information and/or photos, as appropriate
102_WP4_Description.pdf
There is no specified text here
There is no specified text here
There is no specified text here
Effectiveness of the Patient Safety Practice
 
Degree of implementation of reported practice
Yes, fully
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
Both/mixed (qualitative and quantitative)
Enclosure of a reference or attachment in case of published evaluation's results
AGENAS GOOD PRACTICE WEBSITE
XXII AIRO Meeting Rome 2012
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
Yes
Specification of implementation in another health care setting(s)
Hospital
Successful implementation's level  of this Patient Safety Practice across settings
Yes, across multiple specialities within the same setting
Involved health care staff
 
Physicians
Nurses
Technical support / technician
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/practices.aspx
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
Other
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
Not relevant
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
Not relevant
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: Alfredo Perulli - Daniela Monteverdi
Country: ITALY
Organisation: Azienda Ospedaliero-Universitaria Ospedali Riuniti Trieste
E-mail: alfredo.perulli@aots.sanita.fvg.it; daniela.monteverdi@aots.sanita.fvg.it
Phone: 0039-040-3994809
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