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
Date: 2012-11-13
Institutions: European Commission
Subjects: health care system, health control, health risk, health service, infectious disease, nursing staff, patient's rights

EUROPEAN 
COMMISSION 

Brussels, 13.11.2012  
COM(2012) 658 final 

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 

(Text with EEA relevance) 

{SWD(2012) 366 final} 

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CONTENTS 

1. 

2. 

Introduction .................................................................................................................. 3 

Summary of main actions at Member State level ........................................................ 4 

2.1. 

General patient safety................................................................................................... 4 

2.1.1.  Development of national policies and programmes on patient safety ......................... 4 

2.1.2. 

Information about adverse events ................................................................................ 5 

2.1.3.  Empowering patients.................................................................................................... 5 

2.1.4.  Education and training of healthcare workers on patient safety .................................. 5 

2.1.5.  Cross-border activities on patient safety ...................................................................... 6 

2.1.6.  Research ....................................................................................................................... 6 

2.1.7.  Areas the most and least covered by the implementation ............................................ 6 

2.2. 

Healthcare associated infections .................................................................................. 7 

2.2.1.  Adopt and implement a strategy for the prevention and control of healthcare 

associated infections..................................................................................................... 7 

2.2.2.  Consider the establishment of an inter-sectoral mechanism or equivalent system...... 9 

3. 

3.1. 

3.2. 

4. 

Summary of main actions at European Union level................................................... 10 

General patient safety................................................................................................. 10 

Healthcare associated infections ................................................................................ 11 

Conclusions ................................................................................................................ 13 

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1. 

INTRODUCTION 

In  June  2009,  the  Council  adopted  a  Recommendation  on  patient  safety,  including  the 
prevention and control of healthcare-associated infections (2009/C 151/01), referred to here as 
the Recommendation. 

The Recommendation consists of two chapters. In the first chapter on general patient safety, 
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, and 
developing  research.  The  Recommendation  invites  the  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. 

In  the  second  chapter  on  the  prevention  and  control  of  healthcare-associated  infections 
(HAIs), 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,  surveillance  systems,  the  education  and  training  of 
healthcare workers, information to patients, and research. 

The  Recommendation  complements  other  EU  initiatives.  Directive  2011/24/EU  of  the 
European Parliament and of the Council of 9 March 2011 on the application of patients’ rights 
in cross-border healthcare1, due to be transposed by October 2013, seeks not only 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:  collaboration  of  Member  States  on  standards  and 
guidelines, information to patients on healthcare providers and on the safety/quality standards 
applied, and the possibility to refuse prior authorisation if there are doubts about the quality 
and safety of a healthcare provider in the Member State of treatment. 

The  implementation  of  the  actions  envisaged  by  the  Recommendation  (e.g.:  sharing 
knowledge,  experience  and  best  practice;  regularly  reviewing  and  updating  patient  safety 
standards  applicable  to  healthcare  provided  within  the  Member  States;  informing  patients 
about safety measures to reduce or prevent harm and about patient safety standards; adopting 
and  implementing  a  strategy  for  the  prevention  and  control  of  healthcare-associated 
infections,  including  establishing  an  inter-sectoral  mechanism  or  equivalent  system  for  the 
coordinated  implementation  of  the  strategy)  will  be  considered  as  a  reference  for  assessing 
safety standards under the Directive. 

Furthermore, Article 12 of Directive 2011/24/EU aims to foster the development of Centres of 
Excellence and European Reference Networks. As a first step, it authorises the Commission to 
define, through delegated and implementing acts, the criteria and conditions that such centres 
and networks must fulfil. Patient safety requirements and criteria are likely to be defined in 
this context. In addition, the healthcare centres of the future European Reference Networks, 

1 

OJ L 88, 4.4.2011, p. 45. 

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by  implementing  common  initiatives  or  practices  in  the  field  of  patient  safety,  will  help  in 
defining best practices in complex procedures. 

Finally,  the  five-year  ‘Action  plan  against  the  rising  threats  from  antimicrobial  resistance’, 
adopted by the Commission in November 2011, aims to put in place effective ways to prevent 
microbial  infections  and  the  spread  of  micro-organisms.  Strengthening  infection  prevention 
and  control  in  healthcare  settings  (action  4  under  the  plan)  will  contribute  to  achieving  this 
aim. 

The  Recommendation  invites  the  Commission  to  present  an  implementation  report  to  the 
Council, on the basis of information provided by the Member States. In April 2011, Member 
States  were  asked  to  report  to  the  Commission  on  their  progress  in  implementing  the 
Recommendation  based  on  a  standardised  questionnaire.  The  Commission  received  replies 
from  all  Member  States,  one  EEA  country  (Norway2)  on  a  voluntary  basis  and  five  regions 
(on general patient safety) / 15 regions (on HAIs). Additionally, 14 Member States updated 
information on the general patient safety part in July 2012. 

This Report summarises the main actions taken at Member State and EU level by June 2011 
(July  2012  for  the  general  patient  safety  part)  and  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.  In 
this Report, only the replies at national level are presented3; the Commission Staff Working 
Document includes analyses of the replies both from national and regional levels. Where this 
Report refers to countries, it means the EU Member States and Norway. 

2. 

SUMMARY OF MAIN ACTIONS AT MEMBER STATE LEVEL 

2.1. 

General patient safety 

2.1.1.  Development of national policies and programmes on patient safety 

All  countries  have  developed  specific  policies  on  patient  safety  and/or  embedded  them  as 
priorities  in  their  health  policies.  A  competent  authority  responsible  for  patient  safety  at 
national or regional level has been officially established by a legal act in 19 Member States, 
and  in  six  others  has  been  designated  without  a  legal  act.  Competent  authorities  mainly 
identify  and  promote  best  practices,  collect  information  about  patient  safety  programmes  in 
place  and  develop  guidelines  on  patient  safety.  There  are  regularly  updated  patient  safety 
standards in 15 Member States and in 11 of them they are mandatory. Eight other countries 
have  in  place  patient  safety  measures  other  than  standards  (e.g.  evidence-based  clinical 
guidelines,  accreditation  procedures  and  measurement  of  patient  safety  culture).  However, 
five Member States do not report any existing patient safety standards or other measures in 
place.  A  large  majority  of  countries  (24)  agree  that  guidelines  on  how  to  construct  and 
introduce patient safety standards would be useful for them. 

2 

3 

Norway  has  been  actively  participating  in  patient  safety  activities  at  EU  level  and  is  included  in  the 
analysis of this Report. 
Similar  responses  from  the  regions  of  a  Member  State  that  responded  only  at  regional  level  were 
counted as a country response. 

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2.1.2. 

Information about adverse events 

The  Recommendation  asks  Member  States  to  establish  reporting  and  learning  systems  on 
adverse events. In July 2012, such systems were  fully operational in 15 Member States and 
partly  implemented  in  11  others.  They  mainly  provide  information  about  the  causes  of 
adverse  events  and  record  their  numbers  by  type.  In  18  countries,  they  are  separate  from 
disciplinary  procedures  in  order  to  ensure  a  non-punitive  context  for  reporting.  Health 
professionals and other health workers are encouraged to report about adverse events in nearly 
all countries where reporting and learning systems exist. In two thirds of countries, reporting 
by health professionals has increased over the last two years. 

In 13 out of the 26 Member States in question, reporting and learning systems also provide an 
opportunity  for  patients  and  their  families  to  report.  However,  information  about  reporting 
rates is routinely collected only in nine Member States, of which five inform that reporting by 
patients has increased between 2009 and 2012. 

2.1.3.  Empowering patients 

The  Recommendation  encourages  Member  States  to  empower  patients  by  involving  patient 
organisations and individual patients. 

Patient organisations are formally invited to participate in the development of patient safety 
policies in 14 countries, while in six others their involvement is not formally required but is 
the practice. 

Member  States  are  recommended  to  disseminate  information  to  patients  on  patient  safety 
standards,  safety  measures  to  reduce  or  prevent  errors,  the  right  to  informed  consent  to 
treatment,  complaint  procedures,  and  available  remedies  and  redress.  In  all  reporting 
countries, at least one of these items of information is communicated to patients (the right to 
informed  consent  being  communicated  in  all  countries).  However,  only  five  Member  States 
provide patients with all of these details. Information about patient safety standards is the least 
available. On the other hand, more than half of Member States report that a list of accredited 
healthcare institutions is available to citizens. Information is provided to patients mostly via 
public websites or by health professionals. Twenty-three countries have in place mechanisms 
to  capture  patients’  feedback  on  the  availability  and  accuracy  of  the  information  provided. 
Examples include written or on-line questionnaires upon discharge, annual patient experience 
surveys and the possibility to post comments on a dedicated website. 

Core competencies for patients in patient safety have been developed and disseminated only 
in 12 Member States, and the reports show that the concept is interpreted differently from one 
country to another. Two Member States have developed a specific set of core competencies 
for patients, while 10 others include related elements in other health policies. 

2.1.4.  Education and training of healthcare workers on patient safety 

All  but  one  of  the  countries  report  that  they  have  promoted  the  education  and  training  of 
healthcare  professionals  on  patient  safety  over  the  last  two  years.  However,  only  15  have 
formal  requirements  in  place  to  include  patient  safety  modules  in  one  or  more  types  of 
education.  They  are  mostly  offered  to  nurses  and  medical  doctors  as  part  of  continuing 
professional  education,  postgraduate  education  or  on-the-job  training.  There  is  less  on  offer 
for  healthcare  managers  and  healthcare  workers  other  than  medical  doctors,  nurses,  and 

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pharmacists.  No  country  embeds  patient  safety  in  all  levels  of  education  for  all  groups  of 
professionals, but three countries do this for doctors, nurses and pharmacists. 

2.1.5.  Cross-border activities on patient safety 

In addition to actions at national level, some Member States report examples of cross-border 
activities. 

Three  Member  States  developed  a  cross-border  patient  safety  strategy,  in  addition  to  the 
national  strategy.  In  two  Member  States,  reporting  and  learning  systems  operate  in  a  cross-
border  context.  Fifteen  countries  have  in  place  specific  procedures  to  inform  non-resident 
patients  about  patient  safety  standards  and  other  measures.  However,  no  further  details  are 
given on these procedures. 

2.1.6.  Research 

Ten  Member  States  report  they  have  a  national  research  programme  on  patient  safety. 
Existing  research  covers  patient  safety  culture,  reducing  the  risk  of  medication  errors, 
improving  patients’  competence  in  medication  safety,  healthcare-associated  infections, 
prevention of falls in the elderly population, impact of the absenteeism of healthcare workers 
on patient satisfaction, impact of teleradiology on vital emergencies, instruments to measure 
adverse events, and the frequency of adverse events in hospitalised patients. 

2.1.7.  Areas most and least covered by implementation 

Among  the  13  actions  envisaged  by  the  Recommendation  and  analysed  in  this  Report4,  the 
following three have been implemented by the largest number of countries: embedding patient 
safety as a priority in public health policies (all countries); designating a competent authority 
responsible  for  patient  safety  (25  countries);  and  encouraging  training  on  patient  safety  in 
healthcare settings (24 countries). 

The actions implemented by the lowest number of countries are: embedding patient safety in 
the education and training of health professionals (three countries); providing full information 
to patients about patient safety (five countries); dissemination of core knowledge on patient 
safety to health workers (11 countries); and developing core competencies in patient safety for 
patients (12 countries). 

Regarding the number of actions implemented by countries, the breakdown is as follows: 

4 

Designating  the  competent  authority  responsible  for  patient  safety;  embedding  patient  safety  as  a 
priority  issue  in  health  policies;  development  of  safer  and  user-friendly  systems,  processes  and  tools; 
regularly reviewing and updating safety standards and/or best practice; encouraging health professional 
organisations  to  have  an  active  role  in  patient  safety;  promoting  safe  practices  to  prevent  the  most 
commonly  occurring  adverse  events;  involving  patient  organisations  in  the  development  of  patient 
safety policies; disseminating information to patients on patient safety standards, risk, safety measures, 
complaint  procedures  and  available  redress;  establishment  of  reporting  and  learning  systems; 
encouraging patient safety education and training for all staff in healthcare settings; embedding patient 
safety  in  the  education or  training  of health  professionals;  developing  core  competencies, knowledge, 
attitudes and skills for all healthcare staff. 

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Countries having implemented all 13 actions 

0 countries 

Countries having implemented between 10 and 12 
actions 

9 countries: 

CZ, DE, DK, ES, FR, IE, IT, NL, UK 

Countries  having  implemented  between  6  and  9 
actions 

14 countries: 

AT, BE, BG, EE, FI, LT, LU, MT, NO, 
PL, PT, SE, SI, SK 

Countries  having  implemented  between  4  and  6 
actions 

Countries  having  implemented  between  1  and  3 
actions 

3 countries: 

CY, HU, LV 

2 countries: 

EL, RO 

In  the  2008  Impact  Assessment5  the  Commission  provided  information  on  existing  patient 
safety  activities  in  Member  States  (including  the  existence  and  maturity  of  reporting  and 
learning  systems,  the  establishment  of  a  competent  authority  responsible  for  patient  safety, 
and the active participation of Member States in initiatives to develop and use knowledge and 
evidence on patient safety at either EU or international level). Comparing the situation now in 
2012  with  the  situation  in  2008,  progress  is  mostly  observed  in  the  area  of  reporting  and 
learning systems: 16 systems are blame-free as compared to only four in 2008; 11 offer the 
possibility  for  patients  to  report  adverse  events  —  in  2008  this  was  possible  only  in  three 
systems. However, other areas have seen modest progress (e.g. evaluation of existing patient 
safety  systems)  or  no  progress  at  all.  It  should  be  noted  that  this  comparison  is  subject  to 
methodological limitations and can only be considered indicative. 

2.2. 

Healthcare associated infections 

2.2.1.  Adoption  and  implementation  of  a  strategy  for  the  prevention  and  control  of 

healthcare associated infections (HAI) 

The  Recommendation  asks  Member  States  to  adopt  and  implement  a  strategy  at  the 
appropriate level for the prevention and control of HAI. Eighteen Member States consider that 
the national or federal level is the appropriate one for such a strategy. By June 2011, nine of 
these Member States had a national strategy in place, six were in the process of preparing a 
strategy  and  three  had  no  strategy  to  report  nor  were  they  in  the  process  of  preparing  one. 
Nine  countries  state  that  both  the  national  and  regional  levels  are  appropriate.  All  of  these 
have a national strategy and regional strategies in place. One Member State reports that the 
regional level is the appropriate level. 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. 

5 

http://ec.europa.eu/health/archive/ph_systems/docs/patient_ia_en.pdf. 

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The  Recommendation  states  that  a  strategy  for  the  prevention  and  control  of  HAI  should 
pursue the following main objectives: 

(a) 

implement prevention and control measures at national or regional level to support 
the containment of healthcare associated infections 

Guidelines  for  hand  hygiene  are  available  in  22  countries,  of  which  19  refer  to  WHO 
guidelines.  In  addition,  three  Member  States  have  guidelines  under  preparation  and  one  has 
regulatory  requirements  for  hand  hygiene.  Two  Member  States  have  no  guidelines  for  hand 
hygiene.  Hand  hygiene  campaigns  have  been  carried  out  in  18  countries  and  are  under 
preparation in four Member States. 

On  topics  other  than  hand  hygiene,  guidelines  for  the  prevention  and  control  of  HAI  in 
hospitals  are  available  in  23  countries  and  under  preparation  in  three  Member  States.  Two 
Member States have no agreed guidelines. 

(b) 

– 

enhance infection prevention and control at the level of the healthcare institutions 

hospitals 

infection  control  committees 

(or  equivalent  organisational  governance 
Regarding 
arrangements) in hospitals, there are legal requirements and/or professional guidelines in 22 
countries. 
requirements/guidelines.  Where 
have 
requirements/guidelines  are  in  place,  they  include  the  involvement  of  management  in  the 
infection control committee. 

Six  Member 

States 

no 

Regarding  infection  control  teams  (or  equivalent  organisational  arrangements)  in  hospitals, 
there are legal requirements and/or professional guidelines in 24 countries. Only four Member 
States  have  no  requirements/guidelines  (but  one  has  a 
legal  requirement  for  an 
epidemiologist). 

There are legal requirements for a dedicated budget at hospital level in five Member States. 

Overall,  only  two  Member  States  report  that  they  have  no  requirements  for  governance 
arrangements in hospitals. 

– 

nursing homes 

Twelve  countries  report  that  they  encourage  nursing  homes  to  have  in  place  appropriate 
organisational  governance  arrangements  for  the  preparation  and  monitoring  of  an  infection 
prevention  and  control  programme.  Among  those,  legal  requirements  or  professional 
guidelines  for  infection  control  structures  in  nursing  homes  were  in  place  in  10  Member 
States. 

(c) 

establish or strengthen active surveillance systems 

All but two countries have in place at least one type of surveillance network for HAI; in the 
two that do not (smaller Member States), surveillance is performed at hospital level and not 
through  a  national  or  regional  network.  Surveillance  networks  target  multidrug-resistant 
bacteria  (18  countries),  surgical  site  infections  (15),  infections  in  adult  intensive  care  units 
(16), and bloodstream infections (15). 19 countries have carried out prevalence surveys in the 
previous 20 years. 

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With regard to surveillance systems for the timely detection and reporting of alert healthcare 
associated organisms or clusters of HAI, such systems mostly cover clusters of some HAI. 

A system for the external quality assessment of antimicrobial susceptibility testing is in place 
in  19  countries  and  under  preparation  in  three  Member  States.  Six  Member  States  have  no 
such system in place. 

(d) 

foster education and training of healthcare workers 

A  nationally  agreed  common  core  of  competencies  (curriculum)  for  specialised  training 
and/or education programmes for infection control staff is in place in 13 countries and under 
development  in  three  Member  States.  Eleven  countries  do  not  have  such  an  agreed 
curriculum.  Non-sponsored  continuing  specialised  training  is  mandatory  in  nine  Member 
States for infection control doctors and in 11 countries for infection control nurses. 

Regarding the education of healthcare workers other than infection control staff, 13 countries 
have a nationally agreed common core of competencies in the basic principles of hygiene and 
infection prevention and control and one country is in the process of developing a curriculum 
of  this  kind.  12  countries  have  mandatory  induction  training  for  all  healthcare  workers  in 
healthcare institutions. Regular training for all healthcare workers in healthcare institutions is 
mandatory  in  14  countries.  Three  Member  States  also  have  training  for  managers  of 
healthcare institutions. 

(e) 

improve the information provided to patients by healthcare institutions 

Only three Member States have a national/regional template for information to be provided to 
patients during their stay in a healthcare institution, including information on HAI. In two of 
them, the templates include information on the measures taken by the healthcare institution to 
prevent HAI. In addition, the templates provide information on the risk of HAI (two Member 
States),  on  how  patients  can  help  to  prevent  infections  (one),  and  specific  information  for 
patients colonised or infected with healthcare associated microorganisms (two). 

Eleven Member States report that they have mechanisms to encourage healthcare institutions 
to  provide  information  to  patients.  These  mechanisms  consist  of  a  binding  regulation  in  six 
Member  States,  professional  guidelines  in  six  Member  States,  and  accreditation  or 
certification systems in four Member States. 

(f) 

support research 

In six Member States calls for tender on HAI (epidemiology, new preventive and therapeutic 
technologies and interventions, cost-effectiveness of infection prevention and control) can be 
launched under the auspices of the ministry in charge of health or research. 10 countries use 
their  inter-sectoral  mechanism  to  define  priorities  for  research  in  the  field  of  infection 
prevention and control, while three additional Member States plan to have their inter-sectoral 
mechanism involved. 

2.2.2.  Establishment of an inter-sectoral mechanism or equivalent system 

For the coordinated implementation of the strategy for the prevention and control of HAI, 17 
countries have an inter-sectoral mechanism or equivalent system, while seven Member States 
are in the process of setting up one. In most cases (13 out of 17 countries), the inter-sectoral 
mechanisms  or  equivalent  systems  also  coordinate  the  strategy  for  the  prudent  use  of 

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antimicrobial agents in human medicine. Four Member States report that they have no inter-
sectoral mechanism or equivalent system. 

3. 

MAIN ACTIONS AT EUROPEAN UNION LEVEL 

3.1. 

General patient safety 

The  European  Commission  has  pursued  the  following  activities  to  promote  mutual  learning 
among Member States and propose common definitions and terminology for patient safety. 

Under  the  Working  Group  on  Patient  Safety  and  Quality  of  Care,  the  Commission  has 
fostered the exchange of information on initiatives concerned with patient safety and quality 
of care. This Group is composed of all EU Member States, representatives of EFTA countries, 
international  organisations  (WHO,  OECD  and  the  Council  of  Europe)  and  EU  umbrella 
organisations representing patients, health professionals, healthcare managers and quality-of-
care  experts.  The  Group  has  discussed  the  work  of  the  WHO  on  the  International 
Classification  for  Patient  Safety  (15  countries  are  involved  in  this  work  and  two  have 
translated it into their national languages) as well as several examples of national activities on 
patient safety. However, to date no classification on patient safety has been proposed at EU 
level. 

The  European  Commission  co-finances,  within  the  Health  Programme,  the  project  on 
healthcare  quality  indicators,  led  by  the  OECD.  In  2011,  the  project  published  for  the  first 
time  six  indicators  on  patient  safety:  two  concerning  obstetric  trauma  and  four  concerning 
procedural and postoperative complications. Twenty of the reporting countries are involved in 
data  collection  within  this  project,  including  11  collecting  comparable  indicators  on  patient 
safety. 

The  Commission  has  also  allocated  EUR  3 600 000  for  a  three-year  collaboration  on  patient 
safety,  in  the  form  of  a  joint  action  for  the  years  2012-2015.  One  part  of  the  joint  action 
consists  in  selecting  best  practices  on  patient  safety  at  healthcare  provider  level  and  testing 
their  implementation  in  other  Member  States.  The  joint  action  will  also  map  and  analyse 
existing strategies on quality assurance and quality improvement, as well as propose a model 
for sustainable collaboration at EU level on patient safety and quality of care. All 27 Member 
States  and  Norway  are  involved  in  the  joint  action,  which  is  coordinated  by  the  Haute 
Autorité de Santé, France. Twenty one countries contribute financially to the project. 

Twenty-two of the reporting countries have developed collaboration with other EU Member 
States on different provisions  of the Council  Recommendation,  often as part of projects co-
funded  by  the  EU  or  by  international  organisations.  The  main  areas  of  collaboration  are: 
development  of  patient  safety  strategies  and  programmes  (20  countries),  developing  blame-
free  reporting  and  learning  systems  (15  Member  States),  and  development  and  review  of 
patient safety standards (15 Member States). The areas least covered (by only nine Member 
States)  are:  disseminating  information  to  patients  about  patient  safety  and  developing  core 
competencies on patient safety for patients. 

Within  the  Seventh  Research  Framework  Programme,  the  EU  has  co-financed  six  research 
projects on general patient safety, to a total amount of EUR 16 million. 

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3.2. 

Healthcare associated infections 

The prevention and control of HAI is closely linked to antimicrobial resistance, another key 
priority for the Commission. The Commission’s ‘Action plan against the rising threats from 
antimicrobial  resistance’6  contains  12  actions  to  be  implemented  with  EU  Member  States, 
including action to ‘strengthen infection prevention and control in healthcare settings’. As a 
follow-up to the action plan, priorities for funding European-wide projects will be identified 
on the basis of the findings of this Report. 

In  response  to  the  recommendation  that  Member  States  use  case  definitions  agreed  at  EU 
level7, a general case definition for a type of HAI (nosocomial infection or hospital-acquired 
infection)  is  included  in  a  draft  Commission  Implementing  Decision  amending  Decision 
2002/253/EC8  laying  down  case  definitions  for  reporting  communicable  diseases  to  the 
Community network under Decision No 2119/98/EC. This case definition has been developed 
in accordance with the opinion of a committee set up to implement Decision No 2119/98/EC. 

The Commission has already been addressing HAI by funding several European-wide projects 
under the Health Programmes 2003-2007 and 2008-2013: IPSE9 (Improving Patient Safety in 
Europe),  BURDEN10  (Burden  of  Resistance  and  Disease  in  European  Nations),  and 
IMPLEMENT11 (Implementing Strategic Bundles for Infection Prevention & Management). 

Within  the  Sixth  and  Seventh  Framework  Programmes  for  Research  and  Technological 
Development (2002-2006 and 2007-2013), the Commission funds numerous research projects 
in the area of HAI and antimicrobial resistance12. For example, the MOSAR project sought to 
better understand the transmission dynamics of resistant pathogens and study the effectiveness 
of interventions to reduce HAI. Another example is the on-going R-GNOSIS project, which 
includes  five  clinical  studies  to  identify  evidence-based  preventive  measures  and  clinical 
guidance to combat the spread and impact of infections caused by multidrug-resistant Gram-
negative bacteria. Finally, the on-going PROHIBIT13 project analyses existing guidelines and 
practices  for  preventing  HAI  in  European  hospitals,  identifies  factors  that  enable  or  reduce 
compliance with best practices, and tests the effectiveness of interventions of known efficacy. 

The European Centre for Disease Prevention and Control (ECDC) coordinates the European 
surveillance  of  surgical-site  infections,  HAI  in  intensive  care  units14,  and  antimicrobial 
resistance15. In addition, a protocol and toolkit for national point prevalence surveys of HAI 
and  antimicrobial  use  in  acute  care  hospitals  was  developed  by  experts  from  the  Member 
States and the ECDC in 2009-2010 and was implemented in the Member States in 2011-2012. 
Furthermore,  the  ECDC  is  supporting  a  European  network  for  the  surveillance  of  HAI  and 

6 

7 

8 
9 
10 
11 
12 
13 
14 
15 

Communication from the Commission to the European Parliament and the Council. Action plan against 
the  rising  threats  from  antimicrobial  resistance  (COM(2011)  748  final).  Available  from:  http://eur-
lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2011:0748:FIN:EN:PDF  
OJ  L  268,  3.10.1998,  p.  1–7  in  accordance  with  the  provisions  of  Decision  No  2119/98/EC  of  the 
European  Parliament  and  of  the  Council  of  24  September  1998  setting  up  a  network  for  the 
epidemiological surveillance and control of communicable diseases in the Community 
OJ L 86, 3.4.2002, p. 44–62. 
http://ipse.univ-lyon1.fr/. 
http://www.eu-burden.info. 
http://www.eu-implement.info/. 
http://ec.europa.eu/research/health/infectious-diseases/antimicrobial-drug-resistance/projects_en.html. 
https://plone2.unige.ch/prohibit. 
http://www.ecdc.europa.eu/en/activities/surveillance/hai/Pages/default.aspx. 
http://www.ecdc.europa.eu/en/activities/surveillance/EARS-Net/Pages/index.aspx. 

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antimicrobial  use  in  long-term  care  facilities  (HALT-2)  and  a  project  to  support  building 
capacity  for  the  surveillance  of  Clostridium  difficile  infections  (ECDIS-Net).  In  2010,  the 
ECDC  carried  out  a  needs  assessment  for  infection  control  training  in  Member  States  and 
updated the IPSE9 core competencies for infection control training in the EU (TRICE). The 
ECDC has developed evidence-based guidance for the prevention and control of Clostridium 
difficile  infections  and  issued  recommendations  to  prevent  the  spread  of  carbapenemase-
producing  Enterobacteriaceae16.  Finally,  ECDC  is  also  sponsoring  the  development  of 
guidance and indicators for HAI prevention. 

4. 

SOCIO-ECONOMIC CONTEXT 

The  economic  and  financial  crisis  has  led  to  financial  constraints  in  most  European  Union 
Member States. As part of the response to these fiscal constraints, some countries have been 
implementing extensive reforms of their healthcare systems since the beginning of the crisis. 

Member  States  have  introduced  measures  to  cut  costs  and  improve  efficiency  and 
productivity, such as: reducing healthcare spending; introducing ceilings to healthcare budget 
increase; reducing the operational costs of health services; reducing the fees paid to providers 
for 
their  services;  cutting  pharmaceutical  expenses;  and  restrictions  on  healthcare 
professionals in employment policies and retirement reforms (such as dismissing staff or not 
replacing  retiring  staff,  implementing  restrictive  policies  on  recruitment  and  replacement  of 
staff, and cutting wages in the public sector)17. 

In such a context, most Member States report that implementation of the general patient safety 
provisions of the Recommendation has slowed down due to the financial constraints resulting 
from the crisis. Some Member States with the poorest implementation record are among those 
which have been most severely hit by the financial and economic downturn. Nevertheless, it 
would be premature to conclude that there is a positive direct causal relationship between the 
financial  situation  of  Member  States  and  the  implementation  of  patient  safety  measures,  as 
there are examples of Member States that have been severely hit by the economic crisis but 
have nonetheless invested considerably in patient safety. 

Reduced  resources  should  not  jeopardise  patient  safety  and  quality  of  care,  not  only  for  the 
sake  of  the  patient  but  also  because  evidence  shows  that  healthcare-associated  harm  has 
additional  costs18.  An  international  literature  review  estimates  that  between  13  and  16 %  of 
hospital costs alone (one euro in seven) are due to healthcare-related injuries and ill health. In 
addition to this amount, the costs of treating the aftermaths of these events — not directly part 
of hospital costs — have to be taken into account to have a full picture. What is more, recent 
cost-effectiveness studies on patient safety interventions show that specific actions on patient 

16 
17 

18 

http://ecdc.europa.eu/en/publications/Publications/110913_Risk_assessment_resistant_CPE.pdf. 
European Semester Country Specific Recommendations: http://ec.europa.eu/europe2020/making-it-
happen/country-specific-recommendations/index_en.htm; 
HOPE: http://www.hope.be/05eventsandpublications/docpublications/86_crisis/86_HOPE-
The_Crisis_Hospitals_Healthcare_April_2011.pdf. 
Canadian Patient Safety Institute, 
http://www.patientsafetyinstitute.ca/English/research/commissionedResearch/EconomicsofPatientSafet
y/Documents/Economics%20of%20Patient%20Safety%20Literature%20Review.pdf). Other studies 
suggest that international rates of avoidable harm are in the region of 10 % (NES; 
http://www.nes.scot.nhs.uk/media/6470/Overview%20of%20patient%20safety_KHowe2009.pdf). 

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safety are cost-effective19. In order to design effective policy measures, to reduce the costs of 
unsafe care and to develop cost-effective patient safety programmes, further research as well 
as  evidence  specific  to  the  situation  of  EU  Member  States  is  needed.  Furthermore,  further 
work  is  needed  to  better  identify  and  design  solutions  that  fit  into  existing  institutional  and 
organisational frameworks. 

In  addition,  Member  States  highlight  the  insufficient  time  between  adoption  of  the 
Recommendation  and  reporting.  Some  point  to  internal  coordination  issues  between  health 
and education ministries and to a possible lack of political priority at national level. 

5. 

CONCLUSIONS 

Most  Member  States  have  taken  a  variety  of  actions  as  envisaged  by  the  Recommendation. 
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. 
Moreover,  most  countries  have  encouraged  training  on  patient  safety  in  healthcare  settings, 
though  only  a  few  have  formally  embedded  patient  safety  in  education  and  training 
programmes for health professionals. The existing reporting and learning systems have been 
considerably improved in two main aspects: their blame-free character and offering patients 
the possibility to report. However, there is still room for improvement in this crucial area. The 
same  applies  to  provisions  for  patient  empowerment.  Also,  efforts  focus  on  hospital 
healthcare, with only a few examples of actions addressing primary care. On the prevention 
and  control  of  HAI,  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. 

However,  there  are  still  various  areas  of  the  Recommendation  with  considerable  room  for 
improvement. Based on the findings of this Report, the priority areas on which future work 
should focus include: 

(a) 

In the area of 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,  work  on  a 
common  understanding  and  development  of  core  competencies  for  patients,  and 
encourage patients and their families to report adverse events. 

•  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,  i.e.  the  rate  of  reporting  by  health  professionals,  other  healthcare 
workers and patients. The reporting systems should complement the provisions of the new 

19 

Møller  A.H.  (2010).  A  cost-effectiveness  analysis  of  reducing  ventilator-associated  pneumonia  at  a 
Danish ICU with ventilator bundle. Journal of Medical Economics Vol. 15, No 2, 2012, 1–8. 

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legislation  on  pharmacovigilance  (Directive  2010/84/EU)  for  adverse  drug  reaction 
reporting. 

•  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,  mainly  in  the  areas  identified  by  Member  States  as 
suffering from insufficient domestic expertise or difficulties in accessing international or 
EU expertise, e.g. systematic integration of patient safety in the education and training 
of health professionals at all levels. 

•  Develop research in the area of patient safety, including studies on the cost-effectiveness 

of patient safety strategies. 

(b) 

In the area of the 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 and other healthcare institutions. 

• 

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 and other long-term care facilities. 

•  Repeat national point prevalence surveys of HAI as a means to monitor the burden of 
HAI  in  all  types  of  healthcare  institutions,  to  identify  priorities  and  targets  for 
intervention, to evaluate the impact of interventions and to raise awareness. 

•  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 and prevent their introduction into healthcare 
settings. 

• 

Improve  the  information  on  HAI  for  patients  and  strengthen  their  involvement  in  the 
compliance with infection prevention and control measures. 

•  Develop  an  evaluation  system  with  a  set  of  indicators  in  Member  States  to  assess  the 
implementation of the strategy/action plan and its success in improving the prevention 
and control of HAI. 

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•  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, including studies on 

cost-effectiveness of prevention and control measures. 

The Recommendation invites the Commission to ‘consider the extent to which the proposed 
measures are working effectively’. However, as in many Member States and at EU level the 
actions have been implemented only recently or in some cases are still under implementation, 
it  might  be  advisable  to  carry  out  such  an  assessment  again  in  two  years’  time,  taking  the 
current  report  as  a  comparative  reference.  This  is  why  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.  

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