Annexes to COM(2014)371 - Report to the Council on the implementation of Council Recommendation 2009/C 151/01 on patient safety, including the prevention and control of healthcare associated infections - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2014)371 - Report to the Council on the implementation of Council Recommendation 2009/C 151/01 on patient safety, including the ... |
|---|---|
| document | COM(2014)371  |
| date | June 19, 2014 |
HAI are covered by the new Decision No 1082/2013/EU on serious cross‑border health threats.[21] The Decision strengthens the Health Security framework in the EU as regards preparedness planning, risk assessment, risk management and coordinating measures, including risk communication aspects.[22] Its provisions will apply to HAI.[23]
Activities in the area of surveillance
The ECDC network for the surveillance of healthcare-associated infections (HAI-Net) coordinates different modules to support Member States in establishing or strengthening the active surveillance systems referred to in Article II.8.c of the Recommendation.
Since the Recommendation was published, one EU-wide point prevalence survey was organised in acute care hospitals in 2011-12 (ECDC PPS)[24] and two in long-term care facilities (LTCFs).[25] Targeted surveillance of HAI was implemented continuously through the surveillance of surgical site infections (SSIs) and the surveillance of HAI in intensive care units (ICUs).
Overall, the level of participation in the European HAI surveillance modules was considered high in nine countries or regions (AT, DE, ES, FR, IT, LT, MT, PT and UK‑Scotland), medium in 13 (BE, CZ, EE, FI, HU, LU, NL, NO, RO, SK, UK-England, UK-Northern Ireland and UK-Wales) and low in 11 countries (BG, CY, DK, EL, HR, Iceland, IE, LV, PL, SE and SI).
Guidance documents and reports
The ECDC produced several guidance documents and reports to support Member States:
In the area of appropriate use of antibiotics a systematic review and evidence-based guidance to improve the compliance of healthcare professionals with appropriate administration, timing, dosage and duration of perioperative antibiotic prophylaxis for the prevention of surgical site infections was published.[26]
In the area hospital infection control programmes, a systematic review on hospital organisation, management, and structures in place relating to healthcare-associated infection prevention identified a manageable set of 10 key components of hospital infection control programmes.[27]
For nursing homes and other long-term care facilities, national performance indicators for infection prevention and control and antimicrobial stewardship were developed and assessed, which will be used as a basis for monitoring improvements of Member States in this area.
Finally, core competencies for infection control and hospital hygiene professionals have been developed and are already being used by Member States.[28]
8. Conclusions Healthcare‑associated infections
By leading to the adoption of a general and specific case definition for HAI and providing a standardised methodology and framework for the national surveillance of HAI, EU‑level action contributed to strengthening HAI surveillance systems in the EU.
In particular, the ECDC’s Europe-wide point prevalence survey of HAI and antimicrobial use in 2011-12 contributed to the improved collection of data on HAI, even in Member States that had not previously started with this activity.
The point prevalence report[29] and the Commission’s first implementation report[30] indicate that Member States should focus their efforts on ensuring the targeted surveillance of HAI in surgical site infections, intensive care units and nursing homes and other long-term care facilities.
Further measures by Member States are needed to improve the routine case ascertainment of HAI, through the development of national diagnostic guidelines, continued training of healthcare workers in applying case definitions of HAI and the reinforcement of laboratory and other diagnostic capacity in healthcare institutions.
More specifically, the Europe-wide point prevalence survey – highlighted the need to ensure
adequate numbers of specialised infection control staff in hospitals and other healthcare institutions sufficient isolation capacity for patients infected with clinically relevant microorganisms in acute care hospitals standardised surveillance of alcohol hand rub consumption.
To further support Member States preventing and control healthcare-associated infections and in supporting the implementation of the Recommendation, both the Commission and ECDC have prioritised addressing HAI.[31]
General patient safety
The Recommendation has successfully raised awareness about patient safety at political level and triggered changes such as the development of national patient safety strategies and programmes and the development of reporting and learning systems in many EU Member States. It has created a climate that is conducive to improving patient safety in the EU.
However, it has had less of an impact in increasing patient safety culture at healthcare setting level, i.e. encouraging health professionals to learn from errors in a blame-free environment. The impact on empowering patients is only partial. The education and training of health professionals remains an area in which Member States and stakeholders have pointed to a need for further effort. Also, implementation of the Recommendation has not strengthened EU citizens’ confidence in the safety and quality of healthcare in their country.
Meanwhile, patient safety remains an issue in the EU, as confirmed by over 90 % of responses to the public consultation and by EU citizens’ perceptions. This is supported by research[32] highlighting significant gaps between knowledge and practice in patient safety strategies and arguing that a substantial proportion of European citizens are at risk of receiving suboptimal care as a consequence.
In this context, the Commission considers there is a need for continued effort at EU level to support Member States in improving patient safety and quality of care. The following measures could be of particular relevance for further EU work, in close collaboration with Member State s and stakeholders:
A common definition of quality of care and further support for the development of common terminology, common indicators and research on patient safety; EU collaboration on patient safety and quality of care to exchange good practices and effective solutions. This could build on the current joint action and be extended to other topics identified by Member States and stakeholders; Developing guidelines on how to provide information to patients on quality of care; Development with Member States of an EU template on patient safety and quality of care standards to achieve common understanding of this concept in the EU; Reflection with Member States on the issue of redress as provided for in Directive 2011/24/EU); Encouraging the development of training for patients, families and informal carers using also ICT tools; regular updating and dissemination of the guide on patient safety education and training for health professionals; and Encouraging reporting as a tool to spread a patient safety culture; regular updating and dissemination of the guide on the setting‑up and functioning of reporting and learning systems.
These measures could also support an optimal implementation of Directive 2011/24/EU.
[1] Council Recommendation (2009 C 151/01) of 9 June 2009 on patient safety, including the prevention and control of healthcare‑associated infections (OJ C 151, 3.7.2009, p. 6).
[2] 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 (COM(2012) 658 final).
[3] Report of the public consultation on patient safety and quality of care, June 2014; http://ec.europa.eu/health/patient_safety/policy/index_en.htm
[4] Eurobarometer B80.2 Patient safety and quality of care published in June 2014; http://ec.europa.eu/health/patient_safety/policy/index_en.htm
[5] DE sent an off-line partial reply, included in the analysis.
[6] When Danish replies from regional and national level are the same, they are reported as those of Denmark.
[7] No information from DE.
[8] Only full replies to the questions, i.e. including supporting documents or providing examples, were acknowledged.
[9] See http://ec.europa.eu/health/patient_safety/events/index_en.htm
[10] See http://www.pasq.eu/
[11] Key findings and recommendations on education and training in patient safety across Europe. Report of the Commission’s working group on patient safety and quality of care. April 2014 http://ec.europa.eu/health/patient_safety/policy/index_en.htm
[12] Key findings and recommendations on reporting and learning systems for patient safety incidents across Europe. Report of the Commission’s working group on patient safety and quality of care. April 2014 http://ec.europa.eu/health/patient_safety/policy/index_en.htm
[13] http://www.who.int/patientsafety/implementation/taxonomy/conceptual_framework/en/
[14] http://www.oecd.org/health/health-systems/healthcarequalityindicators.htm
[15] Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 on Community procedures for authorisation and supervision of medicinal products and establishing a European Medicines Agency, as amended by Regulation (EU) No 1235/2010 of 15 December 2010; Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code on medicinal products for human use, as amended by Directive 2010/84/EU of 15 December 2010.
[16] Green Paper on mobile Health ("mHealth") COM(2014) 219 final.
[17] Regulation (EU) No 282/2014 of the European Parliament and of the Council of 11 March 2014 on the establishment of a third Programme for the Union’s action in the field of health (2014-2020) and repealing Decision No 1350/2007/EC (OJ L 86, 21.3.2014, p. 1).
[18] Regulation (EU) No 1291/2013 of the European Parliament and of the Council of 11 December 2013 establishing Horizon 2020 - the Framework Programme for Research and Innovation (2014-2020) and repealing Decision No 1982/2006/EC.
[19] Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patient rights in cross-border care (OJ L 88, 4.4.2011, p. 45).
[20] Commission Implementing Decision 2012/506/EU amending Decision 2002/253/EC laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (OJ L 262, 27.9.2012, p. 40).
[21] Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).
[22] Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1)
[23] HAI was covered by Decision No 2119/98/EC.
[24] Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals, 2011-2012. Stockholm: ECDC; 2013
[25] Point prevalence survey of healthcare-associated infections and antimicrobial use in European long-term care facilities. April–May 2013. Stockholm: ECDC, 2014; Point prevalence survey of healthcare-associated infections and antimicrobial use in European long-term care facilities. May–September 2010. Stockholm: ECDC; 2014 (both in press)
[26] Systematic review and evidence-based guidance on perioperative antibiotic prophylaxis. Stockholm: ECDC; 2013
[27] These key components include: 1) organisation of infection control on a hospital level; 2) bed occupancy, staffing, workload, and pool/agency nurses; 3) ergonomic aspects; 4) appropriate use of guidelines; 5) education and training; 6) auditing; 7) surveillance and feedback; 8) multimodal and multidisciplinary prevention programmes taking into account principles of behavioural change; 9) engaging champions in prevention programmes; and 10) the role of a positive organisational culture. Zingg W, Holmes A, Dettenkofer M, et al. Hospital organisation, management, and structure in the context of healthcare- associated infection prevention: a systematic review. Lancet Infect Dis 2014: in press.
[28] European Centre for Disease Prevention and Control; Core competencies for infection control and hospital hygiene professionals in the European Union. Stockholm: ECDC; 2013.
[29] European Centre for Disease Prevention and Control (ECDC); Point prevalence survey of healthcare-associated infections and antimicrobial use in European acute care hospitals: 2011-12. Stockholm: ECDC: 2013.
[30] 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 (COM(2012) 658 final).
[31] For example, ECDC will develop a repository of existing guidance and other documents, to foster the exchange of best practices and the development of such documents in settings where they do not yet exist. Furthermore, ECDC will develop a monitoring and evaluation system with a set of indicators to assess the implementation of national strategies/action plan and their success in improving prevention and control of HAI.
[32] Sunol, R. et al. 2014, Evidence-based organisation and patient safety strategies in European hospitals.
International Journal for Quality in Health Care 2014; pp. 1–9.