Report from the Commission to the Council on the basis of Member States' reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated infections

PURPOSE: to present a report on the implementation of Council Recommendation on patient safety.

BACKGROUND: in June 2009, the Council adopted a Recommendation on patient safety, including the prevention and control of healthcare-associated infections. The Recommendation consists of two chapters.

1) The first chapter concerns general patient safety, where Member States are asked to put in place a series of measures with a view to minimising harm to patients receiving healthcare. These measures include:

·        developing national policies on patient safety ;

·        empowering and informing patients;

·        establishing reporting and learning systems on adverse events;

·        promoting the education and training of healthcare workers;

·        developing research on the issue.

The Recommendation invites Member States to share knowledge, experience and best practice and to classify and codify patient safety at EU level by working with each other and with the Commission.

2) The second chapter concerns the prevention and control of healthcare-associated infections (HAIs), where Member States are asked to adopt and implement a strategy at the appropriate level for the prevention and control of HAIs and to consider setting up an inter-sectoral mechanism or equivalent system for the coordinated implementation of such a strategy. This strategy should comprise:

·        infection prevention and control measures at national/regional level and at the level of healthcare institutions, and

·        providing surveillance systems, the education and training of healthcare workers, information to patients, and research.

The report summarises the main actions taken at Member State and EU level with regard to the Council Recommendation. 

CONTENT : in accordance with the above-mentioned Recommendation, the Commission presents, on the basis of Member States' reports, a summary of the main actions taken as regards the implementation of the Recommendation by June 2011 (July 2012 for the general patient safety part). The report highlights those areas of the Recommendation needing further attention. It is accompanied by a Commission Staff Working Document providing a more detailed technical analysis of the replies received by EU Member States and Norway.

Actions taken at Member State level: most Member States have taken a certain number of the measures recommended:

·        on general patient safety, most Member States have embedded patient safety as a priority in public health policies and designated a competent authority responsible for patient safety;

·        on encouraging training on patient safety, most countries have taken measures in healthcare settings, though only a few have formally embedded patient safety in education and training programmes for health professionals;

·        regarding systems on adverse events (systems providing information about the causes of adverse events and recording their numbers by type), the existing reporting and learning systems have been considerably improved in two main aspects: their blame-free character and offering patients the possibility of reporting events. However, there is still room for improvement in this crucial area;

·        on empowering patients, efforts focus on hospital healthcare through the involvement of patient organisations on patient safety, with only a few examples of actions addressing primary care;

·        on research, the report notes the establishment of national research programme on patient safety in 10 Member States. Existing research covers patient safety culture, reducing the risk of medication errors, improving patients’ competence in medication safety, healthcare-associated infections, and prevention of falls in the elderly population;

·        on the prevention and control of HAIs, 26 out of 28 responding countries have implemented a combination of actions to prevent and control HAI, in most cases (77%) as part of a national/regional strategy and/or action plan. Thirteen Member States report that the Recommendation has triggered initiatives on HAI, in particular the implementation of an inter-sectoral mechanism or equivalent system, preparation/revision of strategies, and information campaigns addressing healthcare workers. Most of the strategies for the prevention and control of HAI are linked to strategies for the prudent use of antimicrobial agents in human medicine and/or patient safety strategies.

Actions taken at EU level: Directive on cross-border healthcare:  the Recommendation complements other EU initiatives. Directive 2011/24/EU of the European Parliament and of the Council on the application of patients’ rights seeks to clarify the rights of patients when accessing care in another EU Member State. It also seeks to ensure that such care is safe and of good quality. It therefore includes several provisions relating to the safety and quality of healthcare. The implementation of the actions envisaged by the Recommendation will be considered as a reference for assessing safety standards under the Directive.

Apart from the Directive, the report discusses the funding of several actions, particularly in terms of the EU Health Programme or the 7th Framework Research Programme (for a total amount of EUR 16 million.)

With regard to HAIs, the Commission has adopted an ‘Action plan against the rising threats from antimicrobial resistance' which contains 12 actions to be implemented with EU Member States.

Focus of future work: the report notes that there are still various areas of the Recommendation with considerable room for improvement. Based on the findings of the report, the priority areas on which future work should focus include:

General patient safety

-At Member State level:

·        actively involve patients in patient safety, in particular provide information to patients on safety measures, complaint procedures and patients’ rights to redress;

·        collect information on adverse events through further developing reporting and learning systems, ensure a non-punitive context for reporting on adverse events and evaluate reporting progress;

·        extend patient safety strategies and programmes from hospital care to non-hospital care as well;

-At EU level:

·        collaborate with a view to proposing guidelines on how to construct and introduce patient safety standards beyond the Recommendation ;

·        make progress on common terminology on patient safety;

·        pursue exchange of best practice;

·        develop research in the area of patient safety, including studies on the cost-effectiveness of patient safety strategies.

Prevention and control of healthcare associated infections

-At Member State level:

·        ensure adequate numbers of specialised infection control staff with time set aside for this task in hospitals;

·        improve the training of specialised infection control staff and better align qualifications between Member States;

·        reinforce tailored basic infection prevention and control structures and practices in nursing homes; 

·        repeat national point prevalence surveys of HAI;

·        ensure that surveillance of infections in intensive care units and surgical site infections is in place;

·        implement surveillance systems for the timely detection and reporting of alert healthcare associated organisms and strengthen the ability to respond to the spread (including across borders) of such organisms;

·        improve the information on HAI for patients; 

·        develop an evaluation system with a set of indicators in Member States to assess the implementation of the strategy/action plan.

-At EU level:

·        continue the development of guidance on the prevention and control of HCA, including tailored guidance for nursing homes and other long-term care facilities;

·        develop research in the area of the prevention and control of HCA.

The Recommendation invites the Commission to consider the extent to which the proposed measures are working effectively. The Commission proposes extending the monitoring of the implementation of the general patient safety provisions of the Recommendation for another two years. In June 2014, the Commission will prepare a second progress report taking into account the mid-term results of the joint action on patient safety and quality of care.