Proposal for a Council recommendation on patient safety, including the prevention and control of healthcare associated infections {COM(2008) 836 final} {SEC(2008) 3004} {SEC(2008) 3005}
Date: 2008-12-15
Institutions: European Commission
Subjects: disease prevention, health care, health policy, organisation of health care

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COMMISSION OF THE EUROPEAN COMMUNITIES 

Brussels, 20.1.2009 
COM(2008) 837 final/2 

2009/003 (CNS) 

Corrigendum 
Annule et remplace le COM(2008)837 du 15.12.2008 
Concerne toutes les versions linguistiques (pp. 1 et 2). 

Proposal for a 

COUNCIL RECOMMENDATION 

on patient safety, including the prevention and control of healthcare associated 
infections 

{COM(2008) 836 final} 
{SEC(2008) 3004} 
{SEC(2008) 3005} 

(presented by the Commission) 

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2009/003 (CNS) 

Proposal for a 

COUNCIL RECOMMENDATION 

on patient safety, including the prevention and control of healthcare associated 
infections 

THE COUNCIL OF THE EUROPEAN UNION, 

Having  regard  to  the  Treaty  establishing  the  European  Community,  and  in  particular  the 
second subparagraph of Article 152(4) thereof, 

Having regard to the proposal from the Commission1, 

Having regard to the opinion of the European Parliament2, 

Having regard to the opinion of the European Economic and Social Committee3, 

Having regard to the opinion of the Committee of the Regions4, 

Whereas: 

(1) 

(2) 

(3) 

(4) 

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Article  152  of  the  Treaty  provides  that  Community  action,  which  shall  complement 
national policies, shall be directed towards improving public health, preventing human 
illness and diseases, and obviating sources of danger to human health. 

It is estimated that in EU Member States between 8% and 12% of patients admitted to 
hospitals suffer from adverse events whilst receiving healthcare5. 

Poor  patient  safety  represents  both  a  severe  public  health  problem  and  a  high 
economic burden on limited health resources. A large proportion of adverse events are 
preventable,  both  in  the  hospital  sector  and  in  primary  care,  with  systemic  factors 
appearing to account for a majority of them. 

The  Commission's  proposal  builds  upon,  and  complements,  work  on  patient  safety 
carried out by the World Health Organisation (WHO) through its World Alliance for 
Patient Safety, the Council of Europe and the Organisation for Economic Cooperation 
and Development. 

OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
OJ C , , p. . 
Technical report 'Improving Patient Safety in the EU' prepared for the European Commission, published 
2008 by the RAND Cooperation. 

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(5) 

(6) 

(7) 

(8) 

The  Commission,  through  the  7th  Framework  Programme  for  Research  and 
Development,  supports  research  in  health  systems,  in  particular  in  the  quality  of 
healthcare provision under the Health Theme, including a focus on patient safety. The 
latter  is  also  given  particular  attention  under  the  Information  and  Communication 
Technology Theme. 

The White Paper "Together for Health: A Strategic Approach for the EU 2008-2013" 
of 23 October 20076 identifies patient safety as an area for action. 

Evidence  suggests  that  EU  Member  States  are  at  different  levels  in  the  development 
and  implementation  of  effective  and  comprehensive  patient  safety  strategies7. 
Therefore,  this  initiative  intends  to  create  a  framework  to  stimulate  policy 
development  and  future  action  in  and  between  Member  States  to  address  the  key 
patient safety issues confronting the EU. 

Patients  should  be  informed  and  empowered  by  involving  them  in  the  patient  safety 
process;  they  should  be  informed  of  levels  of  safety  and  on  how  they  can  find 
accessible and comprehensible information on complaints and redress systems. 

(9)  Member  States  should  set  up  or  improve  comprehensive  reporting  and  learning 
systems  so  that  the  extent  and  causes  of  adverse  events  can  be  captured  in  order  to 
develop efficient solutions and interventions. Patient safety should be embedded in the 
education and training of healthcare workers, as the providers of care. 

(10)  Comparable  and  aggregate  data  should  be  collected  at  Community  level  to  establish 
efficient  and  transparent  patient  safety  programmes,  structures  and  policies,  and  best 
practices  should  be  disseminated  among  the  Member  States.  To  facilitate  mutual 
learning, a common terminology for patient safety and common indicators need to be 
developed 
the  European 
through  cooperation  between  Member  States  and 
Commission, taking into account the work of relevant international organisations. 

(11) 

Information and communication technology tools, such as electronic health records or 
e-prescriptions, can contribute to improve patient safety, for instance by systematically 
screening for potential medicinal product interactions or allergies. 

(12)  The European Centre for Disease Prevention and Control (ECDC) has estimated that 

healthcare associated infections affect about one in twenty hospital patients. 

(13)  A  national  strategy,  complementary  to  strategies  targeted  towards  the  prudent  use  of 
antimicrobial  agents,  should  be  developed  incorporating  prevention  and  control  of 
healthcare  associated  infections  into  national  public  health  objectives  and  aiming  to 
reduce the risk of healthcare associated infections within healthcare institutions. It is 
essential that the necessary resources for implementing the components of the national 
strategy are allocated as part of the core funding for healthcare delivery. 

(14)  The prevention and control of healthcare associated infections should be a long-term 
strategic  priority  for  healthcare  institutions.  All  hierarchical  levels  and  functions 

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COM(2007) 630 final. 
Safety improvement for Patients in Europe (SIMPATIE) project funded under the Community's Public 
Health Programme 2003 – 2008, www.simpatie.org 

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should  cooperate  to  achieve  result-oriented  behaviour  and  organisational  change,  by 
defining responsibilities at all levels, organising support  facilities  and  local technical 
resources and setting up evaluation procedures. 

(15) 

institutions  by  surveillance  networks, 

Insufficient data on healthcare associated infections are available to allow meaningful 
comparisons  between 
the 
epidemiology of healthcare associated pathogens and to evaluate and guide policies on 
the prevention and control of healthcare associated infections. Therefore, surveillance 
systems  should  be  established  or  strengthened  at  the  level  of  healthcare  institutions 
and at regional and national level. 

to  monitor 

(16)  To  achieve  the  patient  safety  objectives  mentioned  above,  including  the  prevention 
and  control  of  healthcare  associated  infections,  Member  States  should  ensure  a  fully 
comprehensive  approach  while  considering  the  most  appropriate  elements  having  a 
real impact on the prevalence and burden of adverse events. 

HAS ADOPTED THE FOLLOWING RECOMMENDATION: 

PART I: ACTIONS BY MEMBER STATES 

I. 

Definitions 

For the purpose of this Recommendation, the definitions set out in Annex 1 apply. 

II.  General patient safety issues 

(1)  Member  States  should  support  the  establishment  and  development  of  national 

policies and programmes by: 

(a) 

(b) 

(c) 

Designating  the  competent  authority  or  authorities  responsible  for  patient 
safety on their territory; 

Embedding patient safety as a priority issue in health policies and programmes 
at national as well as at regional and local levels; 

Supporting  the  development  of  safer  systems,  processes  and  tools,  including 
the use of information and communication technology. 

(2)  Member States should empower and inform citizens and patients by: 

(a) 

(b) 

Involving  patient  organisations  and  representatives  in  the  development  of 
policies and programmes on patient safety at all levels; 

Disseminating information to patients on risk, levels of safety and measures in 
place to reduce or prevent errors, and ensure informed consent to treatment, to 
facilitate patient choice and decision-making; 

(3)  Member States should establish or strengthen reporting and learning systems on 

adverse events that: 

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(a) 

(b) 

Provide adequate information on the extent, types and causes of errors, adverse 
events and near misses; 

Encourage healthcare workers to actively report through the establishment of a 
reporting  environment  which  is  open  and  fair.  This  reporting  should  be 
differentiated  from  Member  States'  disciplinary  systems  and  procedures  for 
healthcare  workers,  and  the  legal  issues  surrounding  the  healthcare  workers' 
liability should be clarified. 

(4)  Member States should promote education and training of healthcare workers on 

patient safety by: 

(a) 

(b) 

Encouraging  multi-disciplinary  patient  safety  education  and  training  of  all 
health  professionals,  other  healthcare  workers  and  relevant  management  and 
administrative staff in healthcare settings; 

Collaborating  with  organisations  involved  in  professional  education  in 
healthcare to ensure that patient safety receives proper attention in the higher 
education  curricula  and  in  the  ongoing  education  and  training  of  health 
professionals. 

(5)  Member States should adequately classify, codify and measure patient safety, by 

working with the European Commission: 

(a) 

(b) 

(c) 

To  develop  common  definitions  and  terminology,  taking  into  account 
international standardisation activities; 

To  develop  a  set  of  common  core  reliable  and  comparable  indicators  at  EU 
level to identify safety problems, to evaluate the effectiveness of interventions 
aimed at improving safety, and to facilitate mutual learning between Member 
States; 

To  gather  and  share  comparable  data  and  information  on  patient  safety 
outcomes in terms of type and number at EU level to facilitate mutual learning 
and inform priority setting. 

(6)  Member  States  should  share  knowledge,  experience  and  best  practice  at 

European level by: 

(a) 

(b) 

Sharing  best  practice  and  experience  of their  efforts  to  establish  efficient  and 
transparent  patient  safety  programmes,  structures  and  policies,  including 
reporting and learning systems, to address adverse events in healthcare; 

Sharing  experiences  on  the  effectiveness  of  patient  safety  interventions  and 
solutions at the healthcare setting level and evaluate the transferability of these. 

III.  Prevention and control of healthcare associated infections 

(1)  Member  States  should  adopt  and  implement  a  national  strategy  for  the 
prevention and control of healthcare associated infections, pursuing the following 
objectives: 

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(a) 

(b) 

(c) 

(d) 

(e) 

(f) 

Implement prevention and control measures at Member State level to support 
the containment of healthcare associated infections; 

Enhance  infection  prevention  and  control  at  the  level  of  the  healthcare 
institutions; 

Establish  or  strengthen  active  surveillance  systems  at  the  Member  State  level 
and at the level of the healthcare institutions; 

Foster education and training of healthcare workers at Member State level and 
at the level of healthcare institutions; 

Improve the information given to patients; 

Support research. 

(2)  Member  States  should  consider  the  establishment,  if  possible  within  one  year 
after  the  adoption  of  this  Recommendation,  of  an  inter-sectoral  mechanism  for 
the  coordinated  implementation  of  the  national  strategy  as  well  as  for  the 
purposes  of  information  exchange  and  coordination  with  the  Commission,  the 
ECDC and the other Member States8. 

IV.  Additional recommendations 

(1)  Member States should disseminate the content of this Recommendation to healthcare 
organisations, professional bodies and educational institutions and encourage them to 
follow  the  approaches  suggested  so  that  the  key  elements  can  be  put  into  everyday 
practice. 

(2)  Member States should complement the key elements set out in parts II and III of this 

Recommendation by the supporting actions set out in Annex 2. 

(3)  Member  States  should  report  to  the  Commission  on  the  implementation  of  this 
Recommendation within two years of its adoption and subsequently on request by the 
Commission with a view to contributing to the follow-up of this Recommendation at 
Community level. 

PART II: REPORT BY THE COMMISSION 

(1) 

The Commission is invited to produce, not later than three years after the adoption of 
this Recommendation, an Implementation Report to the Council assessing its impact, 
on the basis of the information provided by Member States, to consider the extent to 
which  the  proposed  measures  are  working  effectively,  and  to  consider  the  need  for 
further action. 

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The work of  this  inter-sectoral  mechanism  should  complement  the work  of, or  be  integrated  into,  the 
inter-sectoral mechanism referred to in Council Recommendation no 2002/77/EC on the prudent use of 
antimicrobial agents in human medicine. 

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Done at Brussels,  

For the Council 
The President 

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ANNEX 1 

DEFINITIONS 

Adverse event 

Incident  which  results  in  harm  to  a  patient.  Harm  implies  impairment  of 
structure or function of the body and/or any deleterious effect which arises 
from that. 

Antimicrobial agents 

Substances produced either synthetically or naturally by bacteria, fungi or 
plants,  used  to  kill  or  inhibit  the  growth  of  micro-organisms  including 
bacteria, viruses and fungi, and of parasites, in particular protozoa. 

Healthcare 
infection 

associated 

infections  (in  hospitals  also  referred 

to  as 
Healthcare  associated 
nosocomial  or  hospital-acquired  infections)  are  diseases  or  pathologies 
(illness, inflammation) related to the presence of an infectious agent or its 
products  as  a  result  of  exposure  to  healthcare  facilities  or  healthcare 
procedures. 

Healthcare institution 

An  institution  where  healthcare  workers  provide  secondary  or  tertiary 
care. 

Health professional 

A professional whose job involves providing healthcare services and who 
is registered with the appropriate Member State competent authority. 

Healthcare worker 

All staff involved in the direct delivery of healthcare. 

Infection  control 
staff 

link 

Health  professionals  working  in  clinical  wards/departments  who  act  as  a 
liaison between their wards/departments and the Infection Prevention and 
Control  Team.  Infection  control  link  staff  helps  promote  infection 
prevention  and  control  in  their  wards/departments  and  give  feedback  to 
the Infection Prevention and Control Team. 

Patient care plan 

A  document  written  to  provide  direction  for  the  delivery  of  nursing  or 
multidisciplinary care. 

Patient safety 

Primary care 

Freedom for a patient from unnecessary harm or potential harm associated 
with healthcare. 

Healthcare provided by community based health professionals who act as 
a first point of consultation for patients. 

Process indicator 

An  indicator  referring  to  the  compliance  with  agreed  activities  such  as 
hand hygiene, surveillance, standard operating procedures. 

Programme 

Secondary care 

A  broad  framework  of  goals  to  be  achieved,  serving  as  a  basis  to  define 
and plan specific projects. 

Specialised  healthcare  provided  by  specialist  health  professionals  who 
generally do not have first contact with patients. 

Structure indicator 

An  indicator  referring  to  any  resource,  such  as  staff,  infrastructure, 

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committee. 

Tertiary care 

Specialised  healthcare  -  usually  on  referral  from  primary  or  secondary 
medical  health  professionals  -  by  specialist  health  professionals  working 
in  a  healthcare  institution  that  has  personnel  and  facilities  for  special 
investigation and treatment. 

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ANNEX 2 

SUPPORTING ACTIONS 

1.  General patient safety issues 

(1)  Member  States  should  support  the  establishment  and  development  of  national 

policies and programmes by: 

(a) 

(b) 

Ensuring  that  clear  safety  standards  which  are  applicable  to  healthcare 
provided on their territory are regularly reviewed and updated; 

Ensuring  that  health  professional  organisations  have  an  active  role  in  patient 
safety. 

(2)  Member States should empower and inform citizens and patients by: 

(a) 

(b) 

Disseminating information to patients on complaints procedures and available 
remedies and redress, if they are harmed by  healthcare, and on the  terms and 
conditions applicable; 

Considering  the  development  of  core  competencies  in  patient  safety  (i.e.  the 
core knowledge, attitudes and skills required to achieve safer care) for patients. 

(3)  Member States should establish or strengthen reporting and learning systems on 

adverse events that: 

(a) 

(b) 

Provide opportunities for patients, their relatives and other informal caregivers 
to report their experiences; 

those  on 
Complement  other 
pharmacovigilance  and  medical  devices,  whilst  avoiding  multiple  reporting 
where possible. 

reporting 

systems, 

safety 

such 

as 

(4)  Member States should promote education and training of healthcare workers on 

patient safety by: 

(a) 

(b) 

(c) 

Embedding patient safety in undergraduate and postgraduate education, and the 
continuing professional development of health professionals; 

Considering  the  development  of  core  competencies  in  patient  safety  (i.e.  the 
core  knowledge,  attitudes  and  skills  required  to  achieve  safer  care)  for 
dissemination  to  all  healthcare  workers  and  relevant  management  and 
administrative staff; 

Providing  and  disseminating  information  to  all  healthcare  workers  on  risk, 
levels of safety and measures in place to reduce or prevent errors and promote 
their involvement. 

(5)  Member States should adequately classify, codify and measure patient safety by: 

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(a) 

Paying attention to definitions, terminology and international activities such as 
the  International  Classification  for  Patient  Safety  being  developed  by  WHO 
and the Council of Europe's work in this area; 

(b)  Making available indicators for safety problems both for national level and for 

the level of the healthcare settings. 

(6)  Member  States  should  share  knowledge,  experience  and  best  practice  at 

European level by: 

(a) 

(b) 

Sharing major patient safety alerts with each other in a timely manner; 

Collaborating  together,  and  with  ECDC,  the  European  Commission  and 
relevant international organisations. 

(7)  Member States should develop and promote research on patient safety: 

(a) 

Including  research  on  issues  and  interventions  in  all  sectors  of  the  healthcare 
system and the economic costs of adverse events and interventions. 

2.  Prevention and control of healthcare associated infections 

(1)  Member States should develop national strategies for the prevention and control 

of healthcare associated infections by: 

(a) 

Implementing  prevention  and  control  measures  at  Member  State  level  and  in 
particular: 

– 

– 

– 

– 

Implementing standard and risk-based infection prevention and control 
measures in all healthcare settings; 

Integrating infection prevention and control measures into patient care 
plans; 

Ensuring that guidelines and recommendations are available at Member 
State level; 

Encouraging the adherence to prevention and control measures by using 
structure and process indicators, as well as the results of accreditation or 
certification processes in place. 

(b) 

Enhancing  infection  prevention  and  control  at  the  level  of  the  healthcare 
institutions. 

The following structures are recommended to be put in place: 

– 

A Healthcare Associated Infection Prevention and Control Programme 
addressing  aspects  such  as  organisational  and  structural  arrangements, 
diagnostic  and therapeutic procedures (e.g. antimicrobial stewardship), 
resource requirements, surveillance objectives, training and information 
to patients; 

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– 

– 

An  interdisciplinary  Infection  Prevention  and  Control  Committee  for 
the  elaboration  and  the  monitoring  of  the  Healthcare  Associated 
Infection Prevention and Control Programme; 

An  Infection  Prevention  and  Control  Team,  with 
task  of 
implementing  the  Healthcare  Associated  Infection  Prevention  and 
Control Programme. 

the 

(c) 

Establishing or strengthening active surveillance systems by: 

– 

At Member State level: 

• 

• 

• 

• 

Organising prevalence surveys at regular intervals; 

Establishing  and  strengthening  coordinated  networks  for  the 
surveillance  of  the  incidence  of  targeted  infection  types  to 
establish  national  reference  data,  accompanied  by  process  and 
structure indicators to evaluate the national strategy; 

Ensuring  real  time  surveillance  and  prompt  reporting  to  the 
relevant body of clusters of healthcare associated infections; 

Reporting of clusters and infection types of relevance for the EU 
or international level in accordance with the legislation in place. 

– 

At the level of healthcare institutions: 

• 

• 

• 

Ensuring  the  quality  of  microbiological  documentation  and 
patient records; 

Surveillance  of  the  incidence  of  targeted  infection  types, 
accompanied by process and structure indicators to evaluate the 
implementation of infection control measures; 

Real  time  surveillance  of  clusters  of  particular  infection  types 
and/or particular strains of healthcare associated pathogens. 

– 

Using,  wherever  possible,  surveillance  methods  and  indicators  as 
recommended  by  ECDC  and  case  definitions  as  agreed  upon  at  EU 
level. 

(d) 

Fostering education and training of healthcare workers by: 

– 

At Member State level: 

• 

Defining and implementing specialised infection control training 
and/or  education  programmes  for  infection  control  staff  and 
strengthening  education  on  the  prevention  and  control  of 
healthcare associated infections for other healthcare workers. 

– 

At the level of healthcare institutions: 

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• 

• 

Providing  regular  training  for  all  healthcare  staff,  including 
infection 
managers,  on  basic  principles  of  hygiene  and 
prevention and control; 

Providing  regular  advanced  training  for  personnel  having 
particular  tasks  related  to  the  prevention  and  control  of 
healthcare associated infections. 

(e) 

Improving the information given to patients by healthcare institutions: 

– 

– 

accurate  and  understandable  information  about  the  risk  of  healthcare 
associated 
the 
healthcare institution to prevent them and on how patients can help to 
prevent them; 

infections,  about 

implemented  by 

the  measures 

specific  information  (e.g.  on  prevention  and  control  measures)  to 
patients colonised or infected with healthcare associated pathogens. 

(f) 

Supporting research: 

– 

epidemiology,  new  preventive  and 
interventions and on cost-effectiveness of prevention and control. 

therapeutic 

technologies  and 

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