Section I. 1Annex 1b

Section I.1ANNEX 1b

Acronym: PaSQ

Title: European Union Network for Patient Safety and Quality of Care

Budget: €6 000 000

Duration: 36 Months

Problem analysis including evidence base

Recent OECD studies suggest that the prevalence of adverse event mortality in the European Union is close to 1 death per 100 000 inhabitants. This would mean that almost 5000 persons die every year because of adverse medical events. These figures, even if quite alarming, are largely underestimated because they rely on reporting by health care professionals.
National studies targeting hospital settings in the UK, Spain and France have estimated that the real figures could approach 100 000 deaths annually. In primary care settings a Spanish study (APEAS) has suggested that patient safety (PS) incidents could occur in nearly 2% of all patient visits. According to the use of primary care services in Spain, this would mean that 1 in every 7 citizens would eventually experience an adverse event.
The Council Recommendation on Patient Safety (the Recommendation) declared that “it is estimated that in Member States [MS] between 8% and 12% of patients admitted to hospital suffer from adverse events whilst receiving healthcare.” Half of these are judged to be preventable by ordinary standards of care. The Recommendation further stated that “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, both in the hospital sector and in primary care, are preventable with systemic factors appearing to account for a majority of them.”
The Commission Reflection paper on healthcare quality presented to the Council Working Party on Public Health at Senior Level stated: “The EU is already playing a role in bringing together Member State experiences and best practice in this area. It could further develop this work so that all EU citizens can potentially benefit even more from high quality healthcare. High quality healthcare in this paper is understood as healthcare that is effective, safe and responds to the needs and preferences of patients".
The network approach has proven, in the EUNetPaS project, its efficiency in improving exchange of information and experience sharing between MS as requested in the Council recommendation. During the 30 months of this project, the number of national PS platforms in the EU doubled. These platforms have contributed to the development of PS strategies and to the implementation of tools addressing the main dimensions of PS (culture, education, reporting) at both national and clinical levels.
PaSQ will build on EUNetPaS’ experience and network to promote the organisation of PS and Quality of care (QC) platforms in all EU MS to improve PS and QC through the sharing of information, experience(s) and the implementation of good practices.

Target groups

The primary targets of this project are EU MS representatives National Contact Points (NCPs) and relevant stakeholders: health administrations, health care professionals, patient associations, healthcare organisations (hospitals, primary healthcare centres, pharmacies…).

Specifically, the following groups are targeted by the JA:

• 
  Decision makers at the national and EU level: The communication strategy will aim at raising awareness among this group to facilitate the implementation of the PS recommendation in MS. Their involvement will contribute to improve the organisation of PS and QC management in the MS. PaSQ will also contribute to assisting MS in implementing article 4 of the “Cross Border” Directive, enhancing the level of information available to MS regarding the QC improvement strategies and PS guidelines existing in other MS.
  
• 
  Institutions in charge of PS and QC management in EU MS. WP6 will look for Quality Management Systems (QMS) and Good Organisational Practices (GOP) at the national or regional level aiming at improving PS and QC. These GOPs will be proposed to other MS according to their needs. This exchange mechanism will be developed through expert visits in other MS (in collaboration with WP1 and WP4) and through the IT platform which will be proposed by WP2.
  
• 
  Health Care professionals: The core work packages will aim to commit them to the JA tasks and to promote PS culture in this group.
  
• 
  Patients: Their involvement will be promoted through the activities of the core work packages. WP4, WP5 and WP6 will have a specific focus on patient involvement.
  

Indirectly, however, the entire EU population is a potential target; in particular those individuals who are in greatest need of medical care (women, children, the elderly and disabled).

Methods and means

PaSQ builds upon the methods and tools developed by the EUNetPaS project (2008-2010), relevant international collaborations, and previous EU-supported PS projects.

PaSQ will provide a platform for collaboration and networking between MS, international organisations and stakeholders so that they can identify and exchange good practices.

Different levels of involvement will be proposed:

• 
  Supervisory involvement to facilitate the active participation of MS in the JA and to promote its achievements at both the EU and national levels:
  
  • 
    National coordination of subnetwork (platforms involving national stakeholders) and participation in Steering Committee meetings (WP)
    
  • 
    Exchange of information through on site visits and via interviews of national stakeholders (WP4, WP6)
    
  • 
    Involvement in the PS initiatives implementation (coordination in the field at MS level) (WP5)
    
  • 
    Dissemination via conferences or integration of PaSQ materials into national PS and QC campaigns (WP2)
    
  • 
    Impact assessment using PaSQ indicators (WP3)
    
• 
  Proactive involvement: experts share their practical and theoretical experience to address barriers to disseminate concepts, and to address implementation issues, patient involvement and transferability. Specific methods and tools include organising meetings between project partners, within and between WPs, in different locations and through the organisation of face-to-face exchanges of experts between participating MS.
  

A final public conference will present the project’s results to stakeholders and MS representatives.

Each WP will develop objective-related working methods: e.g. meta-analysis, questionnaires, interviews (WP4, WP5 and WP6), exchange of best practices, guideline development, pilot testing, reporting and learning methods, impact assessment and audit (evaluation).

To ensure the transparency and continuity of PaSQ’s work, a web-based wiki information platform will be developed with several levels of communication interoperability. This will provide easy access to information for project members and outside parties (PSQC awareness).

A specific work package will focus on the construction of a detailed business model for collaboration addressing the sustainability of the PaSQ network in Europe to fulfil MS needs with the best structure chosen among possible structures.

Expected outcomes

Based on a collaborative business model for organisational, functional and financial sustainability - that can be implemented as an extension of PaSQ, the JA will support effective collaboration in the EU that brings added value at the European, national and regional levels.

The main outcome of the JA will be the consolidation of the permanent network for PS in the EU (established under EUNetPaS) resulting from recognition of its added value.

The commitment expressed by the 27 MS to build a permanent collaborative network on PS will be enlarged to address quality issues and reinforced by assuring long-term MS engagement in the PaSQ network, together with the Commission.

Additionally, countries not yet involved in the network will recognise its advantages and join the consortium while expressing their long-term commitment.

At the end of the JA, sustainability of the Network is thus achieved provided that a collaborative business model and financial sustainability are implemented.

By sharing experiences and solutions in PS and related aspects of QC, MS, regions and health care facilities can benefit from the knowledge and experience of others. Sharing solutions to ensure patient involvement is a special topic to be addressed. PaSQ aims to implement and monitor a handfull of good practices in accordance with the Council Recommendation on PS.

A selection of good practices will be made for testing, with a preference for those that are relevant to the needs of most MS and their respective health care systems.

Knowledge about QMS in the EU may aid in understanding the principles on which they are built and assist the discussion of common principles for the long-term future.

This work should also contribute to the establishment and maintenance of national PS and quality networks or platforms involving all relevant national stakeholders. Mapping the characteristics of the systems in place in each MS will provide a structured EU overview.
This voluntary exchange of experiences could be the basis of a peer review system for quality management systems in health care if the added value of such system is acknowledged by MS.

External and internal risk analysis and contingency planning

Internal Risks:

• 
  Change in key personnel in the Coordinator, Work Package (WP) Leaders and/or Associated Partners (APs).
  

These risks will be reduced through:

• 
  Continuous monitoring of changes over the three year period in order to ensure the rapid integration of new staff, when needed;
  
• 
  Constant communication through WP1 on the progress of the individual WPs will keep the coordinator and all project partners updated.
  

• 
  Delay in reporting by APs:
  

• 
  Early development of a strategy to require preliminary reporting 30 days prior to final reporting date.
  
• 
  A separate consortium agreement (standard operating procedures, SOP) will be developed for signature by all the APs of the JA to detail the responsibilities and repercussions of not performing according to the agreed upon division of responsibilities.
  

• 
  Procedures in case of the withdrawal of a partner will be as follows: A partner who wants to withdraw its participation shall contact the Coordinator before announcing its decision. A special audience will be set up between the Coordinator and the partner in order to make sure that all other options have been exhausted and to explore any solution to maintain this partner’s contribution including discussions with the European representative for public health programs of the country concerned. Information will be sent to the EAHC
  

External Risk:

• 
  Financial or management crises in one of the AP organisations:
  

• 
  Strong central coordination with assistance of the WP leaders, together with good internal communication and distribution of tasks among partner organisations should contain the risk of disturbance.
  
• 
  Most partners have participated in previous EU funded projects and many may substitute each other where appropriate.
  
• 
  Most APs are public bodies that can handle rapid crisis management and can access extra human resources, if needed.
  

Horizontal Work packages - Description of the work

Work Package 1: Coordination of the JA

Leader: Haute Autorité de Santé (HAS), France

Main Partner of the JA

Associated partners

In addition to HAS as WP Leader, 9 APs are involved in WP1.

Table 1: WP1 APs

Country	Acronym	Organisation
Croatia	AQAH	Agency for Quality and Accreditation in Health Care and Social Welfare
Denmark	DSPS	Danish Society for Patient Safety
Germany	AQuMed	German Agency for Quality in Medicine
Greece	NKUA	National and Kapodistrian University of Athens
Slovakia	SKMoH	Ministry of Health
Spain	MSSSI	Spanish Ministry of Health, Social Services, and Equality
EU	EFN	European Federation of Nurses Associations
EU	EPF	European Patients’ Forum
EU	HOPE	European Hospital and Healthcare Federation

Budget

Total WP budget is € 800.000

WP1 will be in charge of the coordination of the work of all WPs (content, financial and administrative aspects), the coordination of internal and external communication and the monitoring of the European network of national networks on PS (e.g. as established in EUNetPaS) and related aspects of quality of care. The main partner (Coordinator) will answer to the Steering Committee (SC) and to the Executive Board (EB). It will act as the contact for the Commission and for APs in procedural, administrative, and financial matters and for monitoring. The Coordinator will ensure the secretariat for a sustainable network of National Contact Points (NCPs) and EU stakeholders.

HAS will coordinate and develop the following:

• 
  SOP project manual will be developed by WP1 and made available to all APs after validation by the SC. This document will establish the functioning and governance structure of the JA as well as the responsibilities of each partner. The final document will be signed by all APs in the JA
  
• 
  The project work plan will be developed by the Coordinator in collaboration with the rest of the EB and validated by the SC
  
• 
  An annual progress report will be prepared by in coordination with WP3. This report will be reviewed and validated by the EB to ensure rigorous quality assurance of the project and to prepare the interim and final reports for the EAHC (to be delivered at M20 and M38 respectively)
  
• 
  Coordination meetings will be organized every 9 months as well as EB conference calls.
  
• 
  Each Work Package Leader (WPL) will be responsible for coordinating activities within their WP and will assist the Coordinator with timely collection of reports from APs.
  

WP1 will organize country visits for the exchange mechanism in coordination with the NCPs. These visits will provide opportunities for experts from WP4 and WP6 to meet relevant national stakeholders, to collect information and exchange experiences regarding their respective field(s) of interest (Safe Clinical Practices for WP4 and Good Organisational Practices for WP6). They will also contribute to strengthening the EUNetPaS network, enlarging it to QC and further developing the national platforms.

The government structure of the JA PaSQ will comprise two bodies with each its specific tasks and responsibilities: the Steering Committee (SC) and the Executive Board (EB).
The Steering Committee is the decision making body of PaSQ. It will more specifically:

validate work plans, annual reports, budget

adopt strategic plans and future developments plans
The SC is comprised of all partners in the Joint Action and representatives of the European Commission (COM) and the Executive Agency for Health and Consumers (EAHC) as non-voting members. The SC will, as much as possible, make decision by consensus. If it is not possible, a voting process will occur, each associated partner having one vote, decision taken at the relative majority of expressed votes. The MP casts the deciding vote in the case of a tie.

The Executive Board has the following tasks:

to supervise the Secretariat

to prepare work plans and monitor outcomes

to follow-up implementation, reviewing of performance and resources allocation.

The EB is comprised of the work package (WP) leaders (lead partners: LP) and co-leaders. Representatives of the COM and the EAHC are invited as non-voting members.

The role of the EAHC and the Commission is to support the work of these bodies with relevant input and feedback on content, process and financing of the JA during the implementation of the action.
To support the dissemination and sustainability:
Guidance from the Council Working Party on Public Health at Senior Level will be sought to enhance steering at political level.
The Main Partner will be invited to inform the 'working group on patient safety and quality of healthcare' on progress made with the JA.
WP1 will follow-up the JA development process in 4 phases:

1. 
   Review/data collection:
   

• 
  Review of existing data: previous mapping exercises (national and international experiences), literature (M1-M6);
  
• 
  Needs assessment: collection of the expectations of MS, from the proposed collaboration and networking through the JA, exchange mechanisms M6-M9
  

2. 
   Action plan development based on the review and on a feasibility analysis, in the framework of the available resources; (M6-12) Milestone
   
3. 
   Implementing tools development (M12-M15)
   
4. 
   Implementation (Mid-term of project: M15/M18 -M36).
   

This practical approach, which cuts across the core WPs 4-5-6, will feed very well into WP7. Finally, it will enable the project not only to collate and share practices, but also draw conclusions from the implementation of the different exchange mechanisms put in place though the JA before the end of the action.

Work Package 2: Dissemination of the JA

Leader: Agency for Quality and Accreditation in Health Care and Social Welfare (AQAH), Croatia

Associated partners

In addition to AQAH as WP Leader, 13 APs are involved in WP2.

Table 2: WP2 APs

Country	Acronym	Organisation
Denmark	DSPS	Danish Society for Patient Safety
France	HAS	Haute Autorité de Santé
Germany	AQuMed	German Agency for Quality in Medicine
Greece	NKUA	National and Kapodistrian University of Athens
Italy	Agenas	National Agency for Regional Healthcare Services
Slovakia	SKMoH	Ministry of Health
Spain	MSSSI	Spanish Ministry of Health, Social Services, and Equality
Sweden	NBHW	National Board of Health and Welfare
EU	EFN	European Federation of Nurses Associations
EU	EPF	European Patients’ Forum
EU	HOPE	European Hospital and Healthcare Federation
EU	PGEU	Pharmaceutical Group of the EU
EU	UEHP	European Union of Private Hospitals

Budget

Total WP budget is € 500.000

Objectives

• 
  To ensure that the results and deliverables of the PaSQ JA are known to all partners, and available to all key audiences and target groups in accordance to Communication and Visibility Manual
  
• 
  To bring together the knowledge, experience and best practices about PS and QC
  
• 
  To raise and maintain awareness about PS and QC
  

• 
  Making the project known to relevant target groups and stakeholders (website)
  
• 
  Pilot input for the Wiki platform
  

What will be disseminated?

The content of the dissemination materials will be developed in close collaboration with all Work package leaders and associated partners. The dissemination plan will be built and presented at the first month of the PaSQ JA. Dissemination plan will include:

1. 
   Communication strategy regarding the deliverables of PaSQ:
   
   1. 
      Logo and graphical profile, graphical chart, design of the website, leaflet and templates for PaSQ presentations
      
   2. 
      Identification of target groups, key stakeholders and audiences at EU level and national levels
      
   3. 
      Development of supporting strategy for communication at national, regional and local level through the NCPs
      
   4. 
      Publications to relevant journals
      
   5. 
      Presentations at international and national conferences
      
   6. 
      Incorporation of experiences from EUNetPaS and other related projects
      

2. 
   Communication tools
   
   1. 
      External communication tools to raise awareness around PS and QC
      
      1. 
         Public Website of the project
         
         1. 
            Newsletter at least every 6 months
            
         2. 
            “Who's Who“ in PS and QC
            
         3. 
            National strategies and programs of PS and QC
            
      2. 
         Define and develop web platform for sharing good practices
         
      3. 
         Two public conferences on PS and QC with a special focus on Patient involvement
         
      4. 
         Wiki platform.
         
   2. 
      Internal communication
      
      1. 
         Forum
         
      2. 
         Extranet with restricted access
         

To whom?

The target audience of dissemination activities and results/products of the PaSQ JA will be MS representatives and relevant stakeholders:

• 
  Health administrations
  
• 
  Ministries of Health
  
• 
  Health policy bodies at national/regional level
  
• 
  NCPs
  
• 
  Relevant EU bodies
  
• 
  International organisations in healthcare policy fields
  
• 
  Health Care professionals’ organisations
  
• 
  Patient organisations
  
• 
  The public.
  

A list of target groups will be defined and close collaboration will be ensured with all WPs.

How (Method)

Tasks: WP2 associated partners will have a defined role in promoting results at European and national/regional level.

• 
  Support communication about PaSQ in their own institutions and at the national level
  
• 
  Contribution to the preparation of technical reports
  
• 
  Translation into WP2 languages, updating and monitoring the content of the Wiki
  
• 
  Timely and active dissemination of the progress and results made in the JA among their membership and through their communication channels.
  

The external and internal communication during the PaSQ JA and dissemination of the results will be facilitated by the web-based information platform.

The target audience in each individual case will dictate the choice of the particular communication channel(s).
A dedicated communication channel will be designed and set up with the purpose of allowing immediate exchange of data video – conferencing, in order to facilitate sharing of results, e-meetings, etc.
In order to inform the wider public of the project itself, WP2 will produce an information video for distribution through the JA PaSQ website.
The event proceedings will be widely disseminated through the PaSQ partners’ network by electronic means. Communication within the partners will be by e-mail, TC and meetings.
AQAH will subcontract the creation of the web site, which will include:

• 
  Newsletter at least every 6 months
  
• 
  ”Who’s Who“ in PS and QC
  
• 
  National strategies and programs of PS and QC
  
• 
  Web platform for sharing good practices
  
• 
  Tools for internal communication (e.g. forum, extranet with restricted access)
  

Dissemination will be built around the usual media:

• 
  Participation to conferences with posters and lectures in order to disseminate results/findings/outcomes of the project to the health care professionals
  
• 
  Distribution of leaflets at conferences
  
• 
  Communication via media channels
  
• 
  Meetings with patient associations, government bodies, other relevant international bodies.
  

Target groups will be notified about the website where they will be able to find good practices and other valuable resources to be used during and after the project.

A list of relevant conferences and events where the results would be disseminated should be foreseen.
Two public conferences on PS and QC with a special focus on Patient involvement will be organized in collaboration with WP1.

Milestones

M1 3-month work plan for dissemination of the PaSQ JA

M2 Making the project known to relevant target groups and stakeholders (website)

M2 Pilot input for Wiki platform

M3 3-year work plan for dissemination of the PaSQ JA

M4 Design of template for PowerPoint slides and e-newsletters

M6 Public website launch including some new functionality

M6 Promotional leaflet for PaSQ

M6 1^st WP Coordination meeting

M12 WP2 Technical Report M12

M24 WP2 Technical Report M24

M32 2^nd WP Coordination meeting

M36 WP2 Final Technical Report M36

Deliverables

Dissemination plan, Website, Wiki platform

Work Package 3: Evaluation of the JA

Leader: NKUA National and Kapodistrian University of Athens, Greece

Associated partners

In addition to NKUA as WP Leader, 13 APs are involved in WP3.

Table 3: WP3 APs

Country	Acronym	Organisation
Croatia	AQAH	Agency for Quality and Accreditation in Health Care and Social Welfare
Denmark	DSPS	Danish Society for Patient Safety
France	HAS	Haute Autorité de Santé
Germany	AQuMed	German Agency for Quality in Medicine
Hungary	GYEMSZI	National Institute for Quality and Organisational Development in Health Care and Medicines
Italy	ULSS10	Local Health Authority n° 10, Veneto Region
Latvia	REUH	Riga East University Hospital
Slovakia	SKMoH	Ministry of Health
Spain	MSSSI	Spanish Ministry of Health, Social Services, and Equality
EU	EFN	European Federation of Nurses Associations
EU	EPF	European Patients’ Forum
EU	HOPE	European Hospital and Healthcare Federation
EU	UEHP	European Union of Private Hospitals

Budget

Total WP budget is € 500.000

The evaluation focus is twofold:

1. 
   Process, focusing on whether the activities are implemented according to the project work plan, if obstacles are timely identified and dealt with and how quality management actions are taken,
   
2. 
   Effect, where the tasks will be linked to the specific project’s objectives and guarantee their efficient implementation.
   

The initial part of the evaluation process will be to capture the conceptual model and identify the most relevant, key evaluation points. Special attention will be paid to stakeholders’ views on what type of evaluation is needed and what they want to know, thus, their active participation in this process will be sought.

Secondly, key evaluation questions will be formulated covering “process” and “effect” aspects of the project’s tasks. Based on those evaluation questions, indicators and their metrics will be developed.
Thirdly, methodologies to collect the relevant data for the evaluation will be specified separately for each evaluation question. Quantitative as well as qualitative methods are envisaged to be used.
Finally, analysis of results will be undertaken having first checked the raw data, especially related to response rates or those that are considered out of range. Preparation for analysis will include codification and quality control and then an initial analysis is planned, using simple, descriptive statistical tools but if needed, more complex analyses will be recruited (e.g. analyses of variance, regression analysis) and additional analyses based on initial results may be required to address the questions that have been raised in the first analysis. The final objective of the analysis will be to synthesize and integrate results into conclusive remarks that will be communicated and discussed in ad-hoc PaSQ meetings and open fora.
All steps of the evaluation related both to process and outcome (evaluation points and questions, indicators, metrics and target values, data collection methodologies) will be tailored to the specific project objectives, especially those of core WPs.

The evaluation activities fall within three main categories:

1. 
   Measurement: baseline metrics, success criteria, indicators and metrics to assess outcome,
   
2. 
   Monitoring of processes: to ensure that ongoing activities and collection of information are on time and done efficiently,
   
3. 
   Feedback process: to ensure that preventive measures are in place to tackle emerging issues and act correctively.
   

It should be highlighted that PaSQ’s evaluation will pay special attention not use oversimplified or simplistic quantitative or qualitative metrics to get information that may be proved meaningless or even misleading. A potential flaw of our approach would be not to include baseline metrics of the current status at starting point, in a MS or in an HCO. Analysing first, baseline situations, to the extent possible, will enable us to assess the observed “change” in a more comprehensive and robust way. For example, if in a healthcare organisation many safe clinical practices (SCP) or quality management systems (QMS) are already in place and used, it is anticipated to record a rather limited “increase/improvement”, which should certainly not be interpreted as failure of PaSQ intervention. On the other end of the pendulum, if a healthcare organisation does not have any SCPs or QMS in place, the “change/improvement” will be greater, compared to the case of the previous example, although it does not reflect the reality.

Of course, if there is no adoption of new systems, we have also to take into account other parameters that may be the reason for not uptaking SCPs or QMS, such as financial, organisational, cultural etc. Thus, these types of evaluation indicators will be developed as a “percentage difference” (with the starting point appearing in the metric) and not as an absolute number demonstrating a mere difference of uptaking new SCP or QMS.
Considerations regarding the evaluation of PaSQ’s processes

Activities related to PaSQ’s processes will be studied both qualitatively (e.g. semi-structured personal interviews) and quantitatively (e.g. standardised questionnaires).

In addition, intermediate project deliverables will be evaluated against agreed standards and midterm reports for each WP will be analysed and compared with initial objectives and predefined deliverables. Possible discrepancies will be discussed and resolved, in collaboration with the PaSQ Coordinator, relevant WP and/or task leaders. The key objective of process evaluation is to monitor project activities and look for possible barriers (but also, opportunities) during the course of project lifecycle, in order to intervene proactively, or to effectively rectify identified problems, or deviations from the project work plan.
Considerations regarding evaluation of PaSQ’s outcomes

An important aspect of PaSQ is considered the satisfaction of the project’s identified target groups, stakeholders and certainly the relevant Health Authorities of EU MS. Their understanding of PaSQ’s scope, methods, expected results and benefits are of the utmost importance for the success of PaSQ. However, the main expected results of PaSQ will be the SCP and QMS that will be selected and their effective sharing among MS. The evaluation of this effort that will include the analysis of the characteristics of selected practices and systems, as well as the feasibility and efficiency of sharing among MS, along with the aspects of sustainability, will be realised by developing tailor-made indicators and metrics. Target values will also be set, to the extent possible right from the start of the project but the target values will obviously vary among MS, so they will be set after further analysis and especially after baseline analysis within each type and area under scrutiny.

Specific indicators will be developed, based on the planned activities within each WP. Quantification of the evaluation of questions will enable measurement and monitoring of PaSQ’s ongoing activities. Process and outcome indicators will be formulated, so that they will be specific, measurable, achievable realistic and timed. In addition, target values, as mentioned above, will also be set (to the extent possible from the start of the Project lifecycle) to serve as a standard for comparisons.
PaSQ’s processes will effectively be reflected to specific process indicators such as:

• 
  Report on PaSQ’s Evaluation Plan in month 4.
  
• 
  Number of MS, relevant health institutions, stakeholders, approached by PaSQ team (separate indicators for each category of target group. Target: 100% for MS, 70% for relevant health insitutions and stakeholders).
  
• 
  Four Evaluation Reports to record assessment of PaSQ’s progress of tasks, milestones and deliverables.
  
• 
  Five Co-ordination meetings.
  
• 
  Final Evaluation Report.
  

The regular evaluation reports that have been mentioned above are planned to assist partners and the EB to successfully monitor and manage PaSQ’s task implementation. The methodology that is envisioned includes quantitative methods (e.g. questionnaires, surveys, web server logs), as well as qualitative methods (e.g. interviews, focus groups, expert or stakeholder opinions). Evaluation methods will be tailored to the specific tasks in each WP as they will be described in the project work plan that is planned to be delivered in month 3.

PaSQ’s indicators will be established in coordination with core WPs and following the classification proposed in Annex1a p 14-15.
The following indicators will be discussed to establish the final list to be approved by the EB and validated by the SC:

• 
  Overview of Safe Clinical Practices and QMS that are currently used in HCO at different levels of care, used as a proxy of baseline information
  
• 
  Number and type of SCP and QMS that have been identified, assessed and considered transferable
  
• 
  Number and type of those SCP and QMS that have been available
  
• 
  Overview of type of HCO that actually accessed QMS
  
• 
  Overview of type of Clinical Units that accessed SCP
  
• 
  Number of entities (HCO, Clinical Units) that stated willingness to adopt new systems
  
• 
  Degree of participation of target groups (MS, HCO, stakeholders, relevant organisations, partners) in the formulation of strategy, methods and selection of new systems
  
• 
  Degree of participation in the web-questionnaire for collecting SCP information
  
• 
  Degree of PaSQ website use for getting SCP and QMS information, based on quantitative measures over time
  
• 
  Degree of PaSQ interactive IT platform use to share Good Clinical Practices over time
  
• 
  Number of entities that actually started using new systems
  
• 
  Number of entities that stated satisfaction from using new systems
  
• 
  Number and type of problems regarding transferability
  
• 
  Number and type of other shortcomings, limitations and risks that have been encountered during application of new systems
  
• 
  Number of “exchange mechanism” events like, national meetings, workshops, study tours, twinning, site visits, etc, as well as statistics of participation
  
• 
  Level of satisfaction after PaSQ implementation based on survey among all involved (partners and target groups)
  
• 
  Number and type of HCO/sites that plan to sustain the new system after the end of the Project
  
• 
  Number and type of health professionals who were trained and used the new systems
  
• 
  Number and type of HCO and relevant bodies that have been informed about PaSQ role and results
  
• 
  Number of relevant networks developed during PaSQ implementation and sustained after its formal end
  
• 
  Number of themes for safe clinical practices accessible via web tool
  
• 
  Number of safe clinical practices accessible via web tool
  
• 
  Total number of MS participating in the exchange mechanism, (including exchange visits hosted and attended)
  
• 
  Total number of health care professionals participating in the exchange mechanism
  
• 
  Average number of health care professionals participating in the exchange mechanism per WP4 AP with a budget for exchange mechanisms
  
• 
  Proportion of health care professionals who participate in the exchange mechanism, and find they gain new knowledge on safe clinical practices through the web tool
  
• 
  Proportion of health care professionals who participate in the exchange mechanism, and find the exchange mechanisms helpful for uptake of expertise in SCP
  
• 
  Proportion of health care professionals who participate in the exchange mechanism and find that the content of the exchange mechanisms can lead to operating SCP in a the local clinical setting
  
• 
  Proportion of health care professionals who participate in the exchange mechanism, and intend to implement SCP at local clinical setting
  
• 
  Proportion of health care professionals who participate in the exchange mechanism, and find their network in PS enriched through the WP4 work
  
• 
  Two to four stakeholders descriptive evaluation of the potential of the WP4 work, and possible future ways of developing and sustaining it
  
• 
  Number of organizations (global, by MS and regions) fulfilling all the aspects defined in the QMS framework
  
• 
  Number of organizations having expressed perceived needs
  
• 
  Number of organizations provided with suitable response to their perceived needs
  
• 
  Number of MS actively participating in the exchange mechanism. Participation means having provided or/and requested GOP to the project
  
• 
  Number of GOP accessible via web tool
  
• 
  Number of organizations participating in the visits (visiting or hosting)
  
• 
  Number of MS having initiated at least one strategy of GOP implementation.
  

Different types of data collection methods will be used, tailored to each project objective. However, questionnaires will be used to a great extent, along with interviews of key MS stakeholders (healthcare organisations, healthcare workers, patients’ representatives and policy makers) to assess PaSQ’s impact in MS. Due to the fact that questionnaires will address, among others, HCOs and high level Health Authorities, the appropriate methodology will be chosen, required permissions will be sought and cooperation will be assured beforehand. In addition, the needs and sensitivities of participants must also be considered, as they should be clearly informed how the results will be used and what are the expected benefits. To reduce sample biases, efforts must be made to increase the number of respondents. Non-respondents will be contacted and encouraged to participate (re-sending questionnaires, re-scheduling interviews, etc). Reasons for non-response will be investigated to assess potential impact on the generalisability on findings. Finally, effort will be made, so that PaSQ data collection should cause as little disruption as possible to the already busy HCOs or Health Authorities of MS. Evaluation of the results will be presented at the closing Conference, where MS representatives, international and national organisations, experts and other interested stakeholders will be asked to reach a consensus on their engagement to sustain PaSQ’s network.

Evaluation criteria for PaSQ’s deliverables will include:

1. 
   Content (completeness, clarity and unambiguity, level of detail, consistency and verifiability)
   
2. 
   Appearance (readability, terminology, definition of concepts, structure).
   

Evaluation criteria for PaSQ’s website and databases will include reliability, maintainability, portability, security, integrity, flexibility, reusability and interoperability.

 

The limitations of the evaluation are related to a number of issues, most of which have to do with the multifactorial character of clinical care and the complexity of the provision of health services in MS. It is also probable that difficulties will be encountered in accessing information within MS and in HCOs. Issues that are related to the accuracy and integrity of the information that will be collected, may also be another limitation, along with the potential lack of information regarding existing Safe Clinical Practices (SCP) and Quality Management Systems (QMS) that will inevitably be missed.

 

The work will be undertaken by the WP3 team and the project’s core team, in collaboration with the project’s key partners and an external evaluator, in the case that a very specific scientific expertise is needed for evaluation and cannot be covered by Project’s team members.

Core Work Package - Description of the work

Work Package 4: Patient Safety Good Clinical Practices

Leader: DSPS Danish Society for Patient Safety, Denmark

Associated partners

In addition to DSPS as WP Leader, 24 APs are involved in WP4.

Table 4: WP4 APs

Country	Acronym	Organisation
Austria	PMU	Paracelsus University Salzburg
Bulgaria	NCPHA	National Center for Public Health and Analyses
Croatia	AQAH	Agency for Quality and Accreditation in Health Care and Social Welfare
Finland	THL	National Institute for Health and Welfare
France	HAS	Haute Autorité de Santé
Germany	IfPS	Universitätsklinikum Bonn - Insitute for Patient Safety
Greece	NKUA	National and Kapodistrian University of Athens
Hungary	GYEMSZI	National Institute for Quality and Organisational Development in Health Care and Medicines
Italy	Agenas	National Agency for Regional Healthcare Services
Latvia	REUH	Riga East University Hospital
Lithuania	VASPVT	State Health Care Accreditation Agency
Malta	MHEC	Ministry for Health, the Elderly, and Community Care
Netherlands	RUNMC	Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre
Romania	NSPHM	The National School of Public Health and Health Management
Slovakia	HCSA	Health Care Surveillance Authority
Spain	UMH	Universidad Miguel Hernandez de Elche
UK	DH	Department of Health
UK	NHSIII	NHS Institute for Innovation and Improvement
EU	CED	Council of European Dentists
EU	CPME	Standing Committee of European Doctors
EU	EFN	European Federation of Nurses Associations
EU	EPF	European Patients’ Forum
EU	HOPE	European Hospital and Healthcare Federation
EU	PGEU	Pharmaceutical Group of the EU

Budget

Total WP budget is € 1.100.000

Focus and objective

In all clinical situations, health care staff is expected to demonstrate professionalism, responsibility and accountability, with the ultimate goals being health promotion, and avoiding harm to patients from the care that is intended to help them.

The WP4 work is based on the assumption that continuous safety improvement could be effectively pursued by promoting actions aiming at identifying innovative safe practices and at enabling/ accelerating their diffusion to the community of healthcare professionals. Thus this WP is concerned with identifying, assessing, making visible good SCP, and setting up exchange mechanisms around SCP. The exchange mechanisms will give health care professionals the opportunity to increase their knowledge and develop their skills in SCP to enhance PS.

The preliminary working definition of a SCP is: a PS method or a clinical procedure which have readily proven directly or indirectly to prevent or reduce risk or harm to patients.

The focus of WP4 is on the local clinical level, where patients and health professionals interact. The work package is concerned with SCP within the health care institution e.g. within the hospital, general or dental practice.

The objective of WP4 is to:

• 
  establish transferable SCP in PS, and
  
• 
  share SCP through an interactive web tool, and
  
• 
  build a mechanism to share these SCP involving MS and relevant stakeholders.
  

Target group

The primary group targeted by WP4 is health care professionals with a key position or decision making role which enables them to spread the knowledge gained from WP4 work, or take steps to implement the SCP at a local clinical level within their own country.

Their involvement will contribute to improving the clinical work within PS at an institutional level. The targeted health care professionals may be engaged in clinical work, or work at institutions/organisations/associations involved in PS in the MS. The WP will generally be aimed at engaging key health care workers in SCP aiming for better safety in the services provided to the EU population.

Expected outcome

Through the work of this WP it is expected that health care professionals at the clinical level will experience a increased awareness, gain new knowledge on SCP, exchange experience and learning from another with regard to handling the SCP in the local clinical setting. This WP will be innovating in the way it makes existing knowledge and expertise visible and available, and carries it into the clinical setting. This will happen through the interactive web tool and the exchange mechanism. In this way each partner or health care professional in the wider EU community should be able to find the relevant information that best suits his or her needs for enhancing PS, and through the exchange mechanism, the tools that can help the uptake of the expertise in a practical and effective way. The content of the exchange mechanisms will be geared towards capacity and network building. It is important to note that the building of the mechanism for sharing the SCP should be regarded as a test of the concept. It is not within the purpose and scope of WP4 to recommend MS to implement certain SCP. However the work of WP4 should lead to assessment and a proposal on sustainability of the general aspect of WP4 work.

Milestones

Coordination meetings are scheduled for month 7 and month 15. Further, an action plan is scheduled for M16.

Deliverable

WP4 is to deliver project deliverable no. 1 at month 34: A report of good clinical practice (=SCP) solutions in PS. The report will include the description of the SCP and, when possible, guidance for local clinical implementation and suggestions for spread strategies.