71-441 / Implantation of Standard UNE 179003 on Risk Management for Patient Safety. Health Services.

GOP Information
Organisation sharing the GOP
Related practices from PaSQ database
Galician Health Service


Clinical risk management
Reporting and learning systems
Analysis of risk and harm
GOP Description
Implementation level
Clinical settings
Hospitals belonging to the Galician Health Service
•    Identify and evaluate risks and decrease/eliminate dangers which patients could face in the health system.
•    Reduce incidents and Adverse Events due to health care.
•    Manage risks in a proactive manner.
•    Generate greater confidence in the health system.
•    Obtain better clinical and financial results.
All patients covered by the Galician Health Service and their relatives.
All health professionals in the Galician Health Service who work in hospitals.
All hospital management teams in the Galician Health Service
Training health professionals in order to improve the patient safety culture and train health professionals in the use of tools for managing risks.
High management leadership on Risk Management for Patient Safety.
Create a multidisciplinary work group.
Establish a Risk Management policy approved by hospital management.
Define the scope of the Risk Management System.
Define criteria for risk evaluation which are to be approved by hospital management.
Lay down the goals which will be approved by hospital Management.
Lay down the resources and internal communication systems. (Notification system, bulletins) and external systems which are necessary for the correct functioning of the Risk Management System.
Lay down and document the procedures for identifying, analyzing, and processing risks in order to eliminate them or, if this was not possible, control and minimize its impact on patients.
Draw up a risk map.
Develop, approve and maintain those Documents and Records which are necessary for the correct functioning and verification of the Risk Management System. Risk Management System Guidebook.
Introduce the Risk Management System in the hospital/service/department.
Audit the correct functioning of the Risk Management System. (Internal audits and external audit for certification).
Continuous Improvement of the Risk Management System.
Timeframe implementation
1 year in a health care service.
Implementation tools available
Standard UNE 179003:2010 Health Services. Risk Management for Patient Safety. AENOR.
Root Cause Analysis
Risk prioritization
Incident Notification Systems (SiNASP)
Guidebook for Severe Adverse Events Management and Sentinel Events in the Galician Health Service. (IHI based)
Document control procedure, record control and audits in different services.
Risk Management System Manual of different services.
Risk map of different services.
Implementation cost
Cost of the external audit for certification.
Travel costs and expenses of internal auditors.
Work group meetings are time consuming.
In some cases, treatment actions need to be implemented which also lead to additional resources which lead to additional costs which must be approved by hospital management
Method used to measure the results
Internal and external Audit of the Risk Management System.
Certified services: Dialysis in Hospital Barbanza; Oncology-Hematology in the Santiago Integrated Management Area; Hospitalization, Intensive Care Unit and Blood Bank in Povisa Hospital.

The following Units have passed Stage 1 of external certification: Laboratory in Hospital Barbanza; Hospitalization Oncology-Hematology in the Lugo Hospital.
All services now have a risk map, Incident Notification System, records and indicators which translates into greater information on Adverse Events which have decreased considerably since Risk Management System implementation. Health professionals and patients are more aware of patient safety

Analysis of the results
Health professionals’ evaluation of the Risk Management System was very positive: not does it only improve patient safety, based on facts and data, but also health professionals’ safety as well.
Health professionals revise all operational procedures in their service and identify critical points and potential risks, during the health care procedure. They discover risks of which they were not aware of up until that moment and practices which allow patient safety improvement and thus improvement in quality of care.
Multidisciplinary participation is fundamental, including patient participation.
Implementation barriers
Did you find implementation barriers?
Please describe implementation barriers
–    Health professionals’ resistance to change.
–    Health professionals’ lack of time in order to set up a work schedule for developing a Risk Management System. Many hours of dedication are necessary.
–    Health professionals’ lack of knowledge and training in risk management for patient safety.
Describe the strategies used to overcome the barriers (If needed)
–    Training health professionals.
–    Training patients and general public by means of the Galician School in Public Health for Citizens.
–    The Management and Galician Health Service’s acknowledgement of the work health professionals have put forth.
–    Multidisciplinary teams provide feedback of results of work done which acts as motivation by means of bulletins, indicator monitoring, etc.
–    Certified services act as educators in risk management courses, forums and scientific meetings, offering their experiences. Participation as external auditors in audits which take place in other services
Other information
Other information about the GOP that you would like to add (Link or attached document)
As opposed to other quality management systems which health professionals do not perceive as proximate or clearly related with their work, the Risk Management System is valued in a positive way as they feel that this represents changes in the way of doing things, based on data as a result of their work, which they identify and must put forth in their healthcare duties. This does not only improve patient safety but also their own safety when carrying out their responsibilities. They note and verify the outcomes of their duties, what works well and what is not “safe”. The have feedback information on their efforts in this field. The implementation of a Risk Management System takes up a lot of health professionals’ time and effort, but they perceive the outcomes.
The implementation of Standard UNE 179003 Risk Management System implies having implemented the requirements of Standard ISO 9001.
Reference: Standard UNE 179003:2010. AENOR