Proposal for a COUNCIL RECOMMENDATION on patient safety, including the prevention and control of healthcare associated infections - Hoofdinhoud

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Delegations will find in the Annex the revised Presidency's suggestions regarding the text of the

above-mentioned proposal.

The additions with respect to the previous document are marked in bold, whilst deletions are

marked with strikethrough.

The additions with respect to the Commission's proposal are marked in bold, whilst deletions are

marked with strikethrough.

_________________

ANNEX

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,

1

Having regard to the proposal from the Commission , 2

Having regard to the opinion of the European Parliament , 3

Having regard to the opinion of the European Economic and Social Committee , 4

Having regard to the opinion of the Committee of the Regions , Whereas:

(1) 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.

(2) It is estimated that in EU Member States between 8% and 12% of patients admitted to 5

hospitals suffer from adverse events whilst receiving healthcare . (2a) It is estimated that, on average, healthcare associated infections occur in one

hospitalised patient in twenty, that is to say 4.1 million patients a year in the EU,

6

and that 37 000 deaths are caused every year as a result of such infections.

1 OJ C , , p. . 2 OJ C , , p. . 3 OJ C , , p. . 4 OJ C , , p. .

5 Technical report 'Improving Patient Safety in the EU' prepared for the European Commission, published 2008 by the RAND Cooperation. 6 Amendment 2

(3) 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.

(4) 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

(OECD).

(5) 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.

(6) The White Paper "Together for Health: A Strategic Approach for the EU 2008-2013" 7

of 23 October 2007 identifies patient safety as an area for action.

(7) Evidence suggests that EU Member States are at different levels in the development and 8

implementation of effective and comprehensive patient safety strategies . 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.

(8) Patients should be informed and empowered by involving them in the patient safety process; they should be informed of levels of patient safety standards, best practices and safety

measures in place and on how they can find accessible and comprehensible information on

complaints and redress systems.

(9) Member States should set up, maintain 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.

7 COM(2007) 630 final.

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

(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 through

cooperation between Member States and the European 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. Information and

communication technology tools should also aim to improve the understanding of users

9

of the medical products.

(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 10 , 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 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.

9 Amendment 43

10 E.g. Council conclusions on Antimicrobial Resistance adopted on 10 June 2008 (doc. 9637/09).

(15) Insufficient Sufficient data on healthcare associated infections are not always available to

allow meaningful comparisons between institutions by surveillance networks, to monitor 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.

(15a) Member States should aim to reduce the number of people affected by healthcare

associated infections. In order to achieve a reduction in healthcare associated infections

resulting from healthcare, recruitment of health professionals specialising in infection

control should be encouraged. Furthermore, Member States and their healthcare

institutions should consider the use of link staff to support specialist infection control

11

staff at clinical level.

(15b) Member States should work closely with the health technology industry to encourage

better design for patient safety in order to reduce the occurrence of adverse events in

healthcare.

(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.

(17) Community action in the field of public health shall fully respect the responsibilities of

the Member States for the organisation and delivery of health services and medical care.

11 Amendments 11 and 12

HEREBY RECOMMENDS:

That for the purpose of this Recommendation, the following definitions set out in Annex 1 apply:

"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 arising therefrom.

"Healthcare associated infections": healthcare associated infections are diseases or

pathologies related to the presence of an infectious agent or its products in association with

exposure to healthcare facilities or healthcare procedures or treatments.

"Patient safety": freedom, for a patient, from unnecessary harm or potential harm associated

with healthcare.

"Process indicator": an indicator referring to the compliance with agreed activities such as

hand hygiene, surveillance, standard operating procedures.

"Structure indicator": an indicator referring to any resource, such as staff, infrastructure,

committee .

HAS ADOPTED THE FOLLOWING RECOMMENDATION HEREBY RECOMMENDS

12

THAT MEMBER STATES :

PART I: ACTIONS BY MEMBER STATES

12 The following recommendations are intended to improve patient safety, including the prevention and control of healthcare associated infections. Part I includes recommendations on general principles of patient safety aimed at addressing all possible adverse events in healthcare and Part II includes additional recommendations specific to strengthening the prevention and control of healthcare associated infections.

I. General patient safety issues

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

and programmes by:

(a) Designating the competent authority or authorities or any other competent body or

13

bodies responsible for patient safety on their territory; (b) Embedding patient safety as a priority issue in health policies and programmes at

national as well as at regional and local levels;

14 systems, processes and tools, (c) Supporting the development of safer, user-friendly

including the use of information and communication technology;

(d) Regularly reviewing and updating safety standards and best practices applicable

to healthcare provided on their territory;

(e) Encouraging health professional organisations to have an active role in patient safety;

(f) Including a specific approach to promote safe practices to prevent the most commonly occurring adverse events such as medication-related events, healthcare

associated infections and complications during or after surgical interventions.

13 Amendment 17 14 Amendment 18

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

(a) Involving patient organisations and representatives in the development of policies and

programmes on patient safety at all appropriate levels;

(b) Disseminating information to patients on:

• - 

  patient safety standards which are in place;
• - 

  risk, levels of safety and measures which are in place to reduce or prevent errors, including best practices, and the right to ensure informed consent to treatment, to

facilitate patient choice and decision-making;

• - 

  complaints procedures and available remedies and redress, if they are harmed

by healthcare, and on the terms and conditions applicable;

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

patients.

Member States should Support the establishment or strengthen blame-free reporting

and learning systems on adverse events that:

(a) Provide adequate information on the extent, types and causes of errors, adverse events

and near misses;

(b) Encourage healthcare workers to actively report through the establishment of a

reporting environment which is open, and fair and non punitive. This reporting should

be differentiated from Member States' disciplinary systems and procedures for

healthcare workers, and, where necessary, the legal issues surrounding the healthcare

workers' liability should be clarified;

(c) Provide, as appropriate, opportunities for patients, their relatives and other informal caregivers to report their experiences;

(d) Complement other safety reporting systems, such as those on pharmacovigilance

and medical devices, whilst avoiding multiple reporting where possible.

(4) Member States should Promote, at the appropriate level, education and training of

healthcare workers on patient safety by:

(a) Encouraging multi-disciplinary patient safety education and training of all health

professionals, other healthcare workers and relevant management and administrative

staff in healthcare settings;

(b) Embedding patient safety in undergraduate and postgraduate education, on-the-

job training and the continuing professional development of health professionals;

(c) 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;

(d) Providing and disseminating information to all healthcare workers on patient

safety standards, risk and safety measures in place to reduce or prevent errors and

harm, including best practices, and promote their involvement;

(e) 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, including the

development of the skills in the needed to management manage and delivery

deliver the of system behavioural changes necessary to improve patient safety

through in the management and delivery of system change.

(5) Member States should adequately Classify, codify and measure patient safety at

Community level, by working with each other and with the European Commission:

(a) To develop common definitions and terminology, taking into account international

standardisation activities such as the International Classification for Patient Safety

being developed by WHO and the Council of Europe's work in this area;

(b) 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;

account should be taken of the work done at national level and of international

activities such as the OECD healthcare quality indicators project and the

European Community Health Indicators project;

(c) 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, with a view to helping Member States to sharing share relevant indicators

with the public in the future.

(6) Member States should Share knowledge, experience and best practice at European level

by working with each other and with the ECDC, the European Medicines Agency, the

European Commission and relevant European and international organisations bodies

on:

(a) Sharing best practice and experience of their efforts to The establishment of efficient and transparent patient safety programmes, structures and policies, including reporting

and learning systems, with a view to addressing adverse events in healthcare;

(b) Sharing experiences on The effectiveness of patient safety interventions and solutions at the healthcare setting level and the evaluate evaluation of the transferability of these;

(c) Major patient safety alerts in a timely manner. (7) Member States should Develop and promote research on patient safety.

II. Prevention and control of healthcare associated infections

(1) Member States should Adopt and implement a national strategy at the appropriate level

for the prevention and control of healthcare associated infections, pursuing the following

objectives:

(a) Implement prevention and control measures at Member State or regional level to

support the containment of healthcare associated infections and in particular:

• - 

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

  Ensuring Promoting consistency in, and communication of, infection prevention and control measures between healthcare providers treating or

caring for a particular patient;

• - 

  Ensuring Making 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) Enhance infection prevention and control at the level of the healthcare institutions through in particular by encouraging healthcare institutions to have in place:

• - 

  An 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;

• - 

  Appropriate organisational governance arrangements for the elaboration and the monitoring of the infection prevention and control programme;
• - 

  Appropriate organisational arrangements and qualified personnel with the task of implementing the infection prevention and control programme.

(c) Establish or strengthen active surveillance systems by at the Member State level and at

the level of the healthcare institutions:

• - 

  At Member State or regional level:

· Organising prevalence surveys at regular intervals, as appropriate;

· Taking into account the importance of surveillance of targeted infection types to establish national reference data, accompanied by process and

structure indicators to evaluate the strategy;

· Ensuring real time surveillance and Organizing the prompt timely detection and reporting of alert healthcare associated organisms or the

clusters of healthcare associated infections to the relevant body as per

requirements at Member State level;

· Reporting of clusters and infection types of relevance for the Community or international level in accordance with the legislation or

15

regulations in place.

• - 

  At the level of healthcare institutions:

· Encouraging high quality of microbiological documentation and patient records;

· Monitoring Performing the surveillance of the incidence of targeted infection types, accompanied by process and structure indicators to

evaluate the implementation of infection control measures;

15 E.g. 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 and the International Health Regulations (OJ L 268, 3.10.1998, p. 1) and Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.4.2004, p.1).

· Considering the use of real time surveillance of clusters of particular infection types and/or particular strains of healthcare associated

pathogens for the timely detection of alert healthcare associated

organisms or clusters of healthcare associated infections.

• - 

  Using, where appropriate, surveillance methods and indicators as recommended by ECDC and case definitions as agreed upon at Community

level in accordance with the provisions of Decision No 2119/98/EC.

(d) Foster education and training of healthcare workers at Member State level and at the level of healthcare institutions by:

• - 

  At Member State or regional 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:

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

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

infections.

(e) Improve the information given to the patients by healthcare institutions: - Making available objective and understandable information about the risk of healthcare associated infections, the measures implemented by the healthcare

institution to prevent them and on how patients can help to prevent them;

• - 

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

(f) Support research in the fields of, for example, such as epidemiology, the applications 16

of nanotechnologies and nanomaterials, new preventive and therapeutic technologies and interventions and on cost-effectiveness of infection prevention

and control.

(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

17

States . Consider, for the coordinated implementation of the strategy as well as for the purposes of information exchange and coordination with the Commission, the ECDC,

the European Medicines Agency and the other Member States, the establishment, if

possible within two years after the adoption of this Recommendation, of an inter-

sectoral mechanism or equivalent systems, collaborating with, or integrated into, the

existing inter-sectoral mechanism as set up in accordance with Council

Recommendation No 2002/77/EC of 15 November 2001 on the prudent use of 18

antimicrobial agents in human medicine .

16 Amendment 33

17 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 n o 2002/77/EC on the prudent use of antimicrobial agents in human medicine.

III. 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. Produce guidance on best

practice on the prevention and control of healthcare associated infections control within

two years of the adoption of this recommendation. This guidance should provide the

Member States and healthcare providers with an updated scientific background for

improving, where necessary, their systems at appropriate levels.

(3) Member States should Report to the Commission on the progress of 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.

19

PART II: REPORT BY THE COMMISSION HEREBY INVITES THE COMMISSION TO: 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.

Done at Brussels,

For the Council The President

18 OJ L 34, 5.2.2002, p.13. 19 Amendment 15

ANNEX I

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 associated infection Healthcare associated infections (in hospitals also referred to as 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 link staff 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 Freedom for a patient from unnecessary harm or potential harm associated with healthcare.

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

Secondary care 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, 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.

ANNEX II

SUPPORTING ACTIONS

• 1. 

  General patient safety issues

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

and programmes by:

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

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

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

(a) 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;

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

(b) Complement other safety reporting systems, such as those on pharmacovigilance and medical devices, whilst avoiding multiple reporting where possible.

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

safety by:

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

(b) 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;

(c) 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:

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

(b) 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;

­ 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 the task of implementing the Healthcare Associated Infection Prevention and Control Programme.

(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:

· Providing regular training for all healthcare staff, including managers, on basic principles of hygiene and infection 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 infections, about the measures implemented by the healthcare institution to

prevent them and on how patients can help to prevent them;

­ 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 therapeutic technologies and interventions and on cost-effectiveness of prevention and control.

• 15 dec '08
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• 15 dec '08
  COM(2008)837 - Patiëntveiligheid, met inbegrip van de preventie en bestrijding van zorginfecties
  
  
  
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