# EUR-Lex - 52012DC0658 - EN

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# 52012DC0658

**REPORT FROM THE COMMISSION TO THE COUNCIL on the basis of Member States' reports on the implementation of the Council Recommendation (2009/C 151/01) on patient safety, including the prevention and control of healthcare associated infections /* COM/2012/0658 final */**

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CONTENTS

1........... Introduction.................................................................................................................... 3

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

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

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

4........... Conclusions.................................................................................................................. 13

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
healthcare[1],
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, 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 (Norway[2])
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 presented[3]; 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.

2.1.2.     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 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 Report[4],
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:

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 || 3 countries: CY, HU, LV

Countries having implemented between 1 and 3 actions || 2 countries: EL, RO

In the 2008 Impact Assessment[5] 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.

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

Regarding infection control committees (or
equivalent organisational governance arrangements) in hospitals, there are legal
requirements and/or professional guidelines in 22 countries. Six Member States
have no requirements/guidelines. Where requirements/guidelines are in place,
they include the involvement of management in the infection control committee.

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.

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 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.

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 level[7], 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/EC[8] 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: IPSE[9] (Improving Patient Safety in
Europe), BURDEN[10]
(Burden of Resistance and Disease in European Nations), and IMPLEMENT[11] (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 resistance[12].
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 PROHIBIT[13] 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 units[14],
and antimicrobial resistance[15].
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 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 Enterobacteriaceae[16].
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
costs[18].
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 safety are cost-effective[19]. 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
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.

·
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.

[1]               OJ L 88, 4.4.2011, p. 45.

[2]               Norway has been actively participating in patient
safety activities at EU level and is included in the analysis of this Report.

[3]               Similar responses from the regions of a Member State
that responded only at regional level were counted as a country response.

[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.

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

[6]               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

[7]               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

[8]               OJ L 86, 3.4.2002, p. 44–62.

[9]               http://ipse.univ-lyon1.fr/.

[10]             http://www.eu-burden.info.

[11]             http://www.eu-implement.info/.

[12]             http://ec.europa.eu/research/health/infectious-diseases/antimicrobial-drug-resistance/projects_en.html.

[13]             https://plone2.unige.ch/prohibit.

[14]             http://www.ecdc.europa.eu/en/activities/surveillance/hai/Pages/default.aspx.

[15]             http://www.ecdc.europa.eu/en/activities/surveillance/EARS-Net/Pages/index.aspx.

[16]             http://ecdc.europa.eu/en/publications/Publications/110913_Risk_assessment_resistant_CPE.pdf.

[17]             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.

[18]             Canadian
Patient Safety Institute, http://www.patientsafetyinstitute.ca/English/research/commissionedResearch/EconomicsofPatientSafety/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).

[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.