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					                 Building
     Quality Development Programme
        in Health Care in Slovakia


                      FINAL REPORT
                        2004 - 2005


              EVD INTERNATIONAL
                 MAT03/SK/9/1



Consortium

Interaction in Health - Public Health Consultants
AGIS – Health Insurance Company
Department of Social Medicine AMC/University of Amsterdam
Department Health Management Trnava University
Health Management School Bratislava
Amsterdam, January 31st, 2006




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                                                 Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




Table of contents
Table of contents................................................................................................................. 2
List of Acronyms ................................................................................................................. 3
1    Introduction.................................................................................................................. 4
    1.1        Terms of Reference .............................................................................................................. 4
    1.2        The Consortium .................................................................................................................... 4
    1.3        The counterpart and beneficiary ........................................................................................ 5
    1.4        Inception Report ................................................................................................................... 5
2      Project Outcomes ........................................................................................................ 7
    2.1        Introduction .......................................................................................................................... 7
    2.2        Activities in the project ........................................................................................................ 9
    2.3        Outputs of the project ........................................................................................................ 15
    2.4        Impact of the project .......................................................................................................... 15
    2.5        Sustainability ...................................................................................................................... 17
3      Lessons Learned ........................................................................................................18
    3.1        Terms of Reference ............................................................................................................ 18
    3.2        Coordination with other projects ..................................................................................... 18
    3.3        NIKI ...................................................................................................................................... 18
    3.4        Corporate culture of quality .............................................................................................. 18
4      Recommendations......................................................................................................20
    4.1        Introduction to the final advice ......................................................................................... 20
       4.1.1       Background.................................................................................................................................... 20
    4.2        Principles ............................................................................................................................ 20
    4.3        Systems at the National Level .......................................................................................... 22
       4.3.1       External Quality Assessment ......................................................................................................... 22
       4.3.2       Sanctions for non compliance ........................................................................................................ 24
       4.3.3       Standards for provision of “lege artis” health care ......................................................................... 24
       4.3.4       Dissemination of Clinical Guidelines .............................................................................................. 25
       4.3.5       Advice Summary National Level .................................................................................................... 25
    4.4        Quality Systems at Institutional Level ............................................................................. 27
       4.4.1       Evidence of systems ...................................................................................................................... 27
       4.4.2       Quality reporting ............................................................................................................................ 27
       4.4.3       Advice Summary Institutional Level ............................................................................................... 28
    4.5        Individual professionals .................................................................................................... 28
       4.5.1       Registration and licensing .............................................................................................................. 28
       4.5.2       Continuing Professional Development ........................................................................................... 28
       4.5.3       Summary Advice Professionals ..................................................................................................... 29
ANNEX 1 Logical Framework Building Quality Development Programme in Slovakia .30
Annex 2 Gantt Chart ...........................................................................................................34




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                    Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




List of Acronyms
AGIS       Agis Health Insurance Company
AMC/ UvA   Academic Medical Centre - University of Amsterdam
AWBZ       Medical Expenses Act
CBO        Dutch Institute of Healthcare Improvement
CME        Continuous Medical Education
EU         European Union
EVD        Economic Information Agency (Dutch government agency)
IAH        Interaction in Health Ltd.
HCSA       Health Care Surveillance Authority
HIC        Health Insurance Company
HMS        Health Management School Bratislava
MoH        Ministry of Health
MPAP       Matra Pre-accession Projects Programme
NIKI       National Institute of Quality and Innovation
OECD       Organisation Economic Co-operation Development
PPA        PSO Pre-accession Programme
ToR        Terms of Reference
UvA        University of Amsterdam
VWS        Dutch Ministry of Public Health, Welfare and Sports
WHO        World Health Organisation




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                       Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




1 Introduction
       This is the final report for the programme “Building quality development in Slovakia”
       for the health care sector (Mat 03/SK/91), covering the period January 2004 -
       December 2005. The progress of the project implementation has been reported in the
       inception report and in seven quarterly reports.


1.1   Terms of Reference

       In August 2003 the EVD, Netherlands Agency for International Cooperation,
       published the Terms of Reference for this project in the context of the pre-accession
       programme for the Slovak Republic joining the European Union. During the project
       implementation in April 2004 Slovakia joined the EU.

       Overall objective of the project
       The project aims to contribute to the accession of the Slovak Republic to the European
       Union. In particular the project aims to assist the Slovak Republic in creating good
       conditions to monitor the quality of health care provided.

       Project purpose

       The purpose of the project is to “… strengthen the capacity of the Section Health Care
       of the Slovak Ministry of Health to guarantee that care providers can be monitored in a
       proper way”.

       Project results
       According to the Terms of Reference and the subsequent consortiums‟ proposal the
       following four project results are to be achieved in three subsequent project phases:
        Analysis of current system of monitoring and evaluation of quality of health
           services;
        Set of processes and institutional indicators developed (related to the requirements
           for health care institutions) for the monitoring and evaluation of the quality of
           health services provided;
        Set of guidelines and clinical indicators developed (describing step by step
           professional practices) for the monitoring and evaluation of the quality of health
           services provided;
        Advice developed for the Ministry of Health on the introduction of a system for
           internal and external quality monitoring and evaluation in the Slovak health care
           system.


1.2   The Consortium

       After a tender procedure the project was granted to a consortium of three Dutch and
       two Slovak partners. Interaction in Health, the project organisation of Public Health
       Consultants, was the lead agency in the project. Mr. Erik Heijdelberg and Dr. Jaap
       Koot were the coordinators, liaising with the EVD agency. The Department of Social
       Medicine of the University of Amsterdam provided technical inputs for indicator
       development and quality assurance methodology. Prof. Niek Klazinga, Dr. Johannes
       Dalhuyzen, Dr. Johan de Koning, and Dr. Kiki Lombarts provided support. The Agis
       Insurance group provided technical inputs for the role of health insurance companies



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                        Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



       in quality assurance in health. Ms. Aldien Poll and Mr. Maarten Boon collaborated in
       the project, supported in the Netherlands by Chandra Verstappen. In Slovakia the
       Department of Health Management of the Trnava University collaborated in the
       project. Dr. Martin Rusnak represented the university. Dr. Viera Rusnakova of the
       Health Management School worked in the project, until she was nominated as
       coordinator of the World Bank project in quality assurance. Dr. Lucia Lenartova was
       the local project coordinator, working in the Ministry of Health.
       The consortium organised quarterly meetings for internal coordination and was in
       frequent contact with the MOH through Dr. Lenartova.


1.3   The counterpart and beneficiary

       As formulated in the Terms of Reference, he Ministry of Health was both the
       counterpart and the beneficiary of the project. The MOH nominated Dr. Tomas Szalay
       as the quality coordinator on for the project behalf of the MOH. However, he
       remained shortly in that position. In a later stage of the project the main counterpart in
       the ministry was Dr. Nagy, who coordinated the quality programmes.
       In the inception phase a taskforce for the project was installed, made up of all
       stakeholder in quality development in health. The taskforce played a role in appraising
       methodologies, selecting and reviewing pilots and in producing an advice on a
       sustainable system for quality monitoring and evaluation.
       The project worked closely with 15 hospitals in the country in the development and
       piloting of indicators and in the developing of quality reports. A group of committed
       general practitioners from the Banska Bystrica area contributed to the development of
       standards and quality indicators in primary health care.
       When the World Bank project on quality assurance started the consortium worked
       closely together with Dr. Rusnakova, the local consultant and with Dr. Andrew
       Parkes, the international consultant.


1.4   Inception Report

       During the inception phase the consultants developed together with the Ministry of
       Health of the Slovak Republic a work plan for the project starting up adequate quality
       programme as part of the ongoing reforms of the Slovak Health Care System. The
       project wanted to provide the ministry with relevant and state of the art knowledge and
       tools to decide on the further introduction of quality policies towards professionals,
       institutions and financiers. Concrete products of this two-year programme were
       agreed:

       1. Inventory and analysis
          An assessment of the existing quality of care policies in the Slovak Republic with
          respect to professionals (mainly physicians) and institutions (mainly hospitals and
          primary care facilities) as compared with the existing policies in The Netherlands
          and other EU countries. Findings will be described and specific reports will be
          produced on:
          a) Continuous Medical Education (situation in Slovakia compared with
              international situation)
          b) Technological Standards in Primary Care (situation in Slovakia compared
              with existing standards in several other countries)
          c) Quality systems for hospitals and primary care facilities (situation in Slovakia
              compared to existing international accreditation/certification models such as




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                 Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



       EFQM, ISO, JCAHO and functioning models in The Netherlands
       (NIAZ/HKZ) and the UK)
    d) Quality requirements in the contracting between financiers and providers
       (situation in Slovakia compared with the international literature on strategic
       purchasing and the existing model of AGIS in The Netherlands)

2. Indicators
   a) On the quality of health system performance (a set of indicators will be
      proposed based on the quality indicator set of the OECD and filled with
      available data from the Central Institute of Health Information and Statistics
      and the General Health Insurance Company: 10-15 indicators)
   b) On the quality of hospital performance (a set of indicators will be proposed
      based on the quality indicator sets of WHO/EURO and the Dutch inspectorate
      of health and tested in a selected group of hospitals during a pilot: 10-15
      indicators)
   c) On the quality of primary care (a set of indicators will be proposed based on
      quality indicators for primary care from the NHS and tested in a pilot in
      primary care: 10-15 indicators)

3. Guidelines
   a) Assessment of the quality of existing sets of clinical guidelines in the Slovak
      Republic with the help of the AGREE instrument (a validated instrument to
      assess the quality of guidelines developed as part of a EU research
      programme)
   b) Provision of a manual on evidence-based guideline development
   c) Support with the development of a limited set of guidelines with the help of
      the manual on relevant clinical topics (i.e. hypertension, diabetes, breast
      cancer)

4. Implementation
   Advice on the further development and implementation of quality policies
   including a training course for policy makers and a quality book (systematic
   documentation of the knowledge acquired as part of the programme and made
   accessible for future policy makers)

During the inception phase the consultants agreed on a co-ordination with the ministry
and local WHO representative and a plan for joint activities with the WHO project on
hospital indicators (Performance Assessment Tool for quality improvement in
Hospitals      (PATH)).        Furthermore,      co-operation      with    the     present
activities/projects/initiatives in the field of quality policy financed by e.g. the World
Bank was agreed among stakeholders.




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                    Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




2 Project Outcomes
2.1 Introduction

    Organisation
    This section describes the project activities, the project outputs (products), and the
    impact of the project on quality programmes in health in the Slovak Republic.
    Furthermore, the necessary conditions for sustainability of the project are described.
    In the paragraphs below the expected results of the Terms of Reference (see paragraph
    1.1) are followed. The project took place between January 2004 and December 2005.
    The first three months were spent on inception of the project, making a detailed
    problem analysis, a SWOT analysis and a work plan for the project period.
    Twice per year a Project Advisory Committee meeting (PAC) was held, where
    representatives of the MOH, the Office of the Slovak Government, the Royal
    Netherlands Embassy, and the consultants met under chairmanship of the EVD
    programme officer for Slovakia. The PAC discussed the progress reports and gave
    guidance for further steps in the project

    Context
    The purpose of the project was to “… strengthen the capacity of the Section Health
    Care of the Slovak Ministry of Health to guarantee that care providers can be
    monitored in a proper way”.
    The project was a part of the Health Sector Reforms programme.
    Supporting legislation for the Health Sector Reform programme has been passed in the
    Parliament in 2004. The legislation places emphasis on reforming the health insurance
    system and reducing the benefit package covered by mandatory social health
    insurance. The legislation with respect to these measures has taken the form of the
    following six Acts:
         Act on Health Insurance, which regulates social and private health insurance;
         Act on Health Insurance Companies and the Health Care Surveillance
            Authority, which introduces budget constraints, transparent financial
            relationships, accounting and auditing;
         Act on Providers, which introduces increased independence in decision-
            making and autonomy of individual healthcare providers and their
            responsibility for consequences of their decisions;
         Act on the Ambulance Service, which organizes and integrates emergency
            service;
         Act on Healthcare, which defines healthcare and forms of its provision, rights
            and duties, handling of health documentation, and regulation of provision of
            health-related services; and
         Treatment Act, which defines and develops the scope of services covered
            under health insurance.

    The project was confronted with major changes in legislation, while the actors were
    not sure what impact those changes would have on their work. The systems and
    procedures, which should make effective enforcement of the legislation possible, were
    not yet in place.
    New institutions like the Health Care Surveillance Authority were created and Health
    Insurance Companies were given a new framework for operation: competition and
    strategic purchasing. Hospitals were privatised or brought under regional or local
    government, with new budgets and contracts.




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The political context was characterised by a very volatile situation, with various
changes in the top of the Ministry during the project, including the staff responsible
for quality programmes in the Ministry.
The dynamic situation offered the project the opportunity to generate new ideas.
Stakeholders (in the Ministry, in national institutions and in health care facilities) in
health sector were also very motivated to contribute to the project and to generate new
ideas for quality assurance in health sector.
The project worked with four groups of stakeholders, having all their specific relations
and demands towards quality. Where previously the government provided a state
insurance and where hospitals were state facilities, now the Health Sector Reforms
gave each a specific place in the system. The project tried as much as possible to look
at quality assurance from the different perspectives.

Fig. 1 Interrelations between stakeholders in the health sector in Slovakia




Conceptual framework
The project concentrated on the professional (medical) perspective of quality. In
Slovakia the managerial perspective (financial, human resources, production figures)
was already covered and a monitoring system to that extent was developed. Hospitals
were already reporting key data to the MOH and to the insurance companies. The
OECD indicators for the health sector were already approved by the government.
The MOH asked the project to come up with a monitoring system for quality. But,
before a monitoring system can be developed, concepts of quality have to be clear to
all stakeholders. Clinical performance indicators have to be measured within the
framework of quality, accepted by the stakeholders. Nowadays, evidence-based
medicine provides the framework for quality. On the basis of body of knowledge of
evidence-based medicine, guidelines are developed, which in turn are used as
reference for performance indicators of quality. International experience shows that
the development of guidelines requires a sound methodology, which aims at
acceptance by all professionals in the health sector. Simply copying clinical practice
guidelines from other countries (or textbooks) appears to be inadequate approach. The
local context and culture has to be taken into account for proper “transposition” of
internationally accepted clinical procedures as well.



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       Individual providers of health care also have to be assessed in the context of quality
       assurance of health services. Continuing Professional Development (Continuing
       Medical Education) is all over Europe accepted as the basis for re-registration of
       professionals (next to actual work in the profession). This Continuing Professional
       Development again is rooted in evidence-based medicine.
       The figure below shows the relation between monitoring quality (of institutions and
       individuals) and evidence-based medicine.

       Fig. 2 from Evidence Based Medicine to quality assurance




       In other words: a quality monitoring system has to be anchored on sound scientific
       basis, with nationally accepted standards as a reference. Within the monitoring system
       the perspectives of various stakeholders (as for example patients and direct care
       providers) must be taken into account.


2.2   Activities in the project

 Result 1 Analysis of the current system of monitoring and evaluation

       The analysis of the currents situation, compared with international developments, was
       done in the beginning of the project. The official report of this analysis was delayed
       compared to the planning made during the inception phase, but in the meantime the
       consultants could work with the draft report. The overview document was updated
       with recent results from the project during the last quarter of it and published as a
       brochure, which was then distributed as a supplement to the Medical Weekly Journal
       to more than 10,000 health workers and other interested parties in Slovakia. It gives
       an overview of quality programmes in health in Europe and Slovakia, an overview of
       Continuing Professional Development, an overview of guideline development,
       standards and guidelines for primary health care clinics, hospital indicators and annual
       reports, and the advice for regulating quality programmes in the health sector (copy
       attached).




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                                 Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



Result 1: Analysis of current system of monitoring and evaluation of quality of
health services
Activity               Products and           Expected     Started    Completed      Remarks          Expected
                       deliverables           starting     on                                         completion
                                              date                                                    date
An assessment of       An overview            01-05-04     01-05-     15-03-2005     Reference        15-01-2005
the existing quality   document                            2004                      centre
of care policies in    describing the                                 Note: update   established,
the Slovak             current state of the                           made in the    draft
Republic compared      art in quality of                              advisory       documents
with the existing      care in the Slovak                             phase of the   distributed
policies in The        Republic.                                      project
Netherlands and
other EU countries.
Inventory state of     Report describing      01-06-04     05-06-     15-03-2005     Included in      01-01-2005
the art quality        the quality systems                 2004                      overview
systems                for hospitals and                                             document
                       primary care
                       facilities.
Assessment on          Report on              01-06-04     05-6-      30-06-2005     Workshop         01-02-2005
technological          technological                       2004                      of 18 June
Standards in           Standards in                                                  completed
Primary Care           Primary Care.
Assessment on          Report on              01-06-04     05-6-      15-03-2005     Part of          15-02-2005
continuing medical     continuing medical                  2004                      overview
education policies,    education policies,                                           document
structures and         structures and
activities.            activities.
Overview on            Report on quality      01-06-04     04-06-     15-03-2005     Presentation     15-01-2005
quality                requirements in the                 2004                      done.
requirements in the    contracting                                                   Document
contracting            between financiers                                            included in
between financiers     and providers.                                                overview
and providers                                                                        doc.
Update and             Brochure sent to                    01-11-     15-12- 2005    This was an
countrywide            10,000 subscribers                  2005                      extra
distribution of the    of Medical weekly                                             activity to
overview document      Journal                                                       share the
                       The document was                                              results of the
                       made available on                                             project with
                       the project‟s web                                             stakeholders
                       site, too.



     Result 2 Set of process and institutional indicators

              In the Health Reforms Programme of the Slovak government monitoring of
              performance through a set of key indicators was seen as a priority and incorporated in
              the legislation of 2004.
              Internationally the developments around monitoring of performance of the health
              sector are going very fast. In 2003 the OECD had formulated a set of indicators which
              measure performance of health sector, and Slovakia has committed itself to use these
              indicators for monitoring. The Matra project therefore incorporated these in the
              project.
              WHO Europe was in the process of testing specific hospital performance indicators
              when the project started (the PATH project). Thanks to the Matra project, it was
              possible to incorporate hospitals in Slovakia in this pilot.



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                                 Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



              In the programme supported by the World Bank, which actually started in 2005, the
              development of indicators was one of the activities. The Matra project collaborated
              closely with this World Bank project in the development of the indicators.
              The Matra project produced and pre-tested hospital indicators and primary health care
              indicators and standards. The MOH has given the task to the World Bank project to
              pool suggestions from the Matra project and other projects and to develop a new set of
              government indicators, which covers comprehensively the health sector. This new set
              will be used by health care facilities for reporting over the year 2005 and innovated in
              early 2006. Two members of the project were delegated to serve at a committee
              established by the State Secretary of Health with a mission to help implement the
              indicators into the practice.
              In addition to the activities planned in the inception phase, there was a workshop for
              the hospitals involved in the Matra/PATH programme on hospital indicators, to share
              the results of an international conference on hospital indicators in Barcelona.


Result 2: Set of process and institutional indicators
Activity               Products and            Expected    Started    Completed      Remarks         Expected
                       deliverables            starting    on                                        completion
                                               date                                                  date
A joint workshop       Familiarisation         01-05-04    01-05-     04-06-2004                     30-06-04
on strategic           with indicators in                  2004
purchasing with the    hospital setting.
WHO Observatory
PATH initiative.
A workshop on the      Preparation of key      01-09-04    01-10-     01-10- 2004                    01-10-04
application of         stakeholders for                    2004
external quality       pilots on indicators.
assurance
mechanisms.
Education and          Education/              01-10-04    01-10-     19-12-2005     Changed to      01-01-05
training at Trnava     Training at Trnava                  2004                      development
University/HMS in      University/HMS in                                             of guideline
quality process        quality process.                                              handbook
management. Local      Local module on                                               for all
module on quality      quality of care in                                            professional
of care in the         the public health                                             s
public                 curriculum.
health/management
curriculum
Teams of Slovak        Insight in the role     10-10-04    10–10-     15-10-2004                     01-11-04
experts on study       of different                        2004
visit to the           stakeholders in
Netherlands.           designing and
Inventory of state     implementing
of the art and a       indicator sets and
preparation for the    monitoring its use.
pilots.
Study visits to        Exchange of             01-10-04    23-05-     27-05-2005     Alternative     27-05- 2005
Austria and            experiences.                        2005                      visit
Hungary for                                                                          organised to
similar, small-scale                                                                 the NL for
projects.                                                                            Health
                                                                                     Insurance
                                                                                     staff




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Result 2: Set of process and institutional indicators
Activity               Products and           Expected     Started    Completed      Remarks         Expected
                       deliverables           starting     on                                        completion
                                              date                                                   date
Set up of health       - indicator set on     01-02-05     15-01-     15-07-2005                     01-08-05
system indicators,     health system                       05
hospitals /            performance
institutional          - indicator set on
indicators and         the quality of
primary care           hospital/institution
indicators.            al performance
                       - indicators set on
                       the quality of
                       primary care
Performance            Determination of       01-02-05                15-07-2005                     01-08-05
indicators and role    roles and
of health insurance    responsibilities
and regional           through
government             workshops.
Preparation of         Start of pilots        01-02-05     15-01-     30-03-2005                     01-07-05
pilots and                                                 05
questionnaires.
Pilots in 4-5          Implementing /         01-02-05     01-02-     15-11-2005     annual          01-08-05
hospitals.             calculating                         05                        quality
                       indicator set in                                              report
                       hospitals / Annual                                            presented by
                       quality report                                                hospitals in
                                                                                     fourth
                                                                                     quarter 2005
Pilots in 2 primary    Implementing /         01-02-05     01-02-     30-06-2005                     01-08-05
care settings.         calculating                         05
                       indicator set in
                       primary care
                       setting
Summary of             Presentation in a      01-09-05     01-09-     26-11-2005     Presentation    01-10-05
results.               forum                               2005                      in final
                                                                                     conference
Policy document.       Wrap up with a         01-09-05     01-07-     26-11-2005     Adoption of     01-10-05
                       focus on roles of                   2005                      advice in
                       stakeholders                                                  final
                                                                                     conference
Workshop on            Follow up on                                   19-12-2005     Extra
international          PATH conference                                               activity to
comparison quality     in Barcelona                                                  keep
indicators hospital    Next steps in SR                                              hospitals in
and use in QA                                                                        the loop of
programme                                                                            international
                                                                                     development
                                                                                     s and follow
                                                                                     up
Committee on           Set of indicators                   01_09_     20_12_05       Not planned,
indicators set up by   developed by the                    05                        reaction to
the MoH                project and                                                   the request
                       consulting the                                                from MoH
                       MoH




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                                   Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



       Result 3 Guidelines and clinical indicators

                During the situation analysis it was concluded that existing clinical practice guidelines
                in Slovakia did not meet the AGREE standards of quality and that developed
                guidelines were not broadly accepted by the professionals. Therefore it was decided
                that the Matra project should take a step back. Instead of producing guidelines, the
                project was to design a methodology and create a structure for formulation of quality
                clinical practice guidelines. The consultants made an extensive study of practices of
                guideline development in the Netherlands, the UK, Scotland and Australia and
                produced a guideline handbook, which contained a proposed methodology for
                Slovakia. This handbook was published and distributed widely among policy makers,
                health officials and other stakeholders. In a workshop with a broad group of
                stakeholders, the methodology was discussed and amended. The consultants –
                together with other interested parties in Slovakia – initiated the National Institute for
                Quality and Innovation (the NIKI institute) which should spearhead and coordinate the
                guideline development in Slovakia.
                A website for the NIKI institute was developed (www.niki.healthnet.sk ) and an office
                was established. By the end of the year 2005, the Institute was contracted by health
                care insurance companies to develop clinical guidelines in the area of diabetes. Early
                2006 the Institute got additional assignments for developing clinical practice
                guidelines. The Institute is working hard to become a viable undertaking.


Result 3: Set of guidelines and clinical indicators
Activity            Products and        Expected        Started      Completed       Remarks         Expected
                    deliverables        starting        on                                           completion
                                        date                                                         date
An inventory on     Report on           01-06-04        01-06-04     15-03-2005      Done; see       01-11-04
existing clinical   existence and                                                    report in
practice            quality of local                                                 overview
guidelines in SR.   guidelines                                                       document
Assessment of       See above           01-06-04        01-06-04     30-03-2005      Through the     01-12-04
quality of                                                                           Taskforce
existing sets of
clinical
guidelines
Training of local   Training module     01-08-04        01-09-       30-03-2005      Training of     01-08-05
expert with the     for local experts                   2004                         NIKI Board
AGREE               on the AGREE                                                     members
instrument and      instrument and
development of      development of
user manual         user manual
Development of      Training module     01-08-04        01-10-       15-07-2005      Guideline       01-08-05
a model for         of evidence-                        2004                         handbook
ongoing design      based guideline                                                  produced
of guidelines       development
Support with the    A set of tested     01-08-04        15-12-       31-12-2005      Developing      01-08-05
development of a    guidelines and an                   2005                         NIKI
limited set of      endorsed format                                                  Institute,
guidelines.         for guideline                                                    starting with
                    development                                                      diabetes 2
                                                                                     guidelines




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Workshop on          Consensus on                                    08-12-2005      Extra
guidelines and       further                                                         activity to
NIKI                 development of                                                  discuss
                     quality                                                         future of the
                     programmes in                                                   Institute and
                     Slovak Republic                                                 quality
                                                                                     procedures



       Result 4 Advice to the MOH

                  The consultants‟ team prepared a final advice for a quality system at the national level,
                  hospital level and individual levels. The quality system provides regulatory
                  framework which is necessary to improve overall quality of health system. In addition
                  the consultants produced a draft regulation regarding the role of guidelines in the
                  quality system. This will enable the functioning of the NIKI in health sector. The draft
                  advice was discussed with the taskforce (composed of experts from different
                  backgrounds) and with the Health Care Surveillance Authority. The draft was also
                  discussed with quality experts in the MOH. After comments a final draft was
                  produced, which was discussed during the closing conference of the project on 25 th
                  November, 2005. This advice was adopted and finally presented to the MOH.
                  During the final conference the other products of the project were presented as well,
                  i.e. the hospital indicators and annual quality reports, the primary health care
                  indicators and standards, the guideline production methodology, and finally NIKI.
                  After final conference two workshops were organised, which concentrated on the
                  continuation of quality programmes after the project. One workshop addressed quality
                  programmes, the role of NIKI and further collaboration in developing quality system.
                  The other workshop concentrated on hospital indicators international comparison and
                  internal quality procedures in hospitals.

Result 4 Advice developed on the introduction of a system for internal and
external quality monitoring and evaluation
Activity             Products and        Expected     Started    Completed       Remarks             Expected
                     deliverables        starting     on                                             completion
                                         date                                                        date
Refine               Quality book        01-08-05     01-07-     08-12-2005      The quality         01-10-05
guidelines           consisting of                    2005                       handbook was
Identification       tailor-made         01-08-05     01-07-     08-12-2005      distributed,        01-10-05
quality              approaches                       2005                       discussed in
monitoring           adapting                                                    the taskforce,
Revisiting           internationally     01-08-05                08-12-2005      discussed in        01-10-05
experiences          proven best                                                 workshop with
                     practices.                                                  stakeholders
Four workshops       Integrated advice   01-10-05     26-10-     27-11-2005      Advice              31-12-05
                     on the                           2005                       produced and
Overall              implementation      01-12-05     26-10-     27-11-2005      discussed in        31-12-05
implementation       of quality                       2005                       taskforce,
advice               assurance and                                               distributed and
                     monitoring,         01-12-05     27-11-     27-11-2005      adopted in          31-12-05
National             endorsed by                      2005                       final               31-12-05
conference           stakeholders.                                               conference
Training course      Training course     01-10-05     08-12-     19-12-2005      Extra               31-12-05
for policy           for policy                       2005                       workshops on
makers               makers                                                      quality
                                                                                 programmes
                                                                                 and indicators




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        2.3     Outputs of the project

                 The Matra project managed to produce important documents, which will help the
                 MOH in Slovakia in further development of quality programmes in the health sector.1

                     Overview document, which provides insight into developments in quality
                      assurance in health care in Europe, and makes a comparison with the actual
                      situation in Slovakia. This document was distributed in 10,000 copies to health
                      professionals and relevant stakeholders.
                     Standards for primary health care practices: this document proposes minimum
                      standards, with which primary health care practices should comply. These
                      standards can be used in quality control programmes.
                     Indicators for quality of primary health care practices: a comprehensive list, which
                      has been pre-tested and refined. These indicators merely serve for internal quality
                      assurance and peer review. Some indicators are suitable for using by the
                      government in external quality control programmes.
                     Indicators for quality of hospital services: comprehensive list, which was pre-
                      tested and revised. Because of the linkage to the WHO – PATH project, these
                      indicators could be compared internationally. The prime aim of the indicators is
                      internal quality assurance by hospitals, but some indicators can be used for
                      monitoring by government agencies and health insurance companies as well.
                     Format for Annual Quality Reports of hospitals: proposed methodology for annual
                      review of quality, assessment of activities performed and plans for quality
                      assurance for the next year.
                     Guideline Development Handbook: with a reader on methodology for production
                      of clinical practice guidelines based on international experiences and adapted to
                      Slovak conditions.
                     Statute and organogramme for the National Institute for Quality and Innovation
                      (NIKI) and actual start up of the Institute.
                     Advice on quality systems in health on national, institutional and individual
                      levels: a proposal for comprehensive system of quality assurance, which is
                      interconnected at various levels.
                     Draft Regulation on Practice Guidelines postulating the role of clinical practice
                      guidelines in the medical practice in terms of liability, implementation and
                      development processes. This Regulation provides the framework for guideline
                      development and use of guidelines in medical practice.

                 All products were produced in close collaboration with health care providers. They
                 were discussed in the Taskforce for the project and drafts were discussed with MOH
                 officials. The final products have been submitted to the MOH for adoption.


        2.4     Impact of the project

                 The project worked with three groups of stakeholders: two governmental agencies:
                 MOH and Health Care Surveillance Authority, the health care insurance companies
                 and health care providers. As mentioned in the introduction to this chapter, each of the
                 groups has its own perspective on quality and has its own demands with regard to a
                 monitoring system.

                 Health Care Providers

1
 Because of the size of the documents, the final products are not attached to the final report. They have been put
on a CD-rom, which is part of this final report.


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In the project a distinction was made between internal quality assurance and external
accountability.
 Internal quality assurance uses specific – tailor-made – indicators, has short
    feedback loops and allows for quick action for improvement of services. In health
    facilities a quality coordinator supported by quality committee concentrates on
    such work.
 External accountability is providing the necessary performance information to the
    general public, financiers, or government officials. This takes place quarterly or
    annually and has a more formal character.
The project cooperated with 15 hospitals (out of the 80) in the country to enhance the
internal quality assurance processes. Hospitals, which participated in PATH indicator
project, shared their experiences on several occasions and received a feedback from
international benchmarking (conference in Barcelona). The project also worked with
hospitals on Annual Quality Reports and several hospitals shared their reports during
the Final Conference. The project managed to establish a network of hospitals in the
country with special interest in quality assurance. By developing the methodology for
internal quality assurance, the project has managed to introduce a „corporate culture‟
of quality. This is important, as a unique focus on external quality control is not the
right start of quality enhancement in health facilities.
The project worked with general practitioners in Banska Bystrica. Although most
general practitioners work on their own, the project managed to introduce some
internal quality assurance methodology with peer review and exchange between
professionals. The same group of professionals continued to work with the World
Bank project in the development of protocols for primary health care. Through the
professional organisations and the Association of Private Physicians, the methodology
of internal quality assurance for general practitioners can be spread all over the
country.

Health Insurance Companies
Limited attention for the role of health insurance companies in quality assurance was
envisaged in the original set-up of the project. However, because of the new
legislation, their role became more important. The Project succeeded in incorporating
them into activities and organised a special study tour to Netherlands, where they were
exchanging experiences with regard to contracting health care providers, strategic
purchasing, incentives for quality services, and other methods for improvement of
quality of service provision.
Health Insurance Companies contributed to development of indicators and standards
through participation in workshops and seminars.
Health Insurance Companies are now contracting NIKI for development of clinical
practice guidelines, as part of the quality programmes.

National level
At national level the project worked closely with the MOH, the Health Care
Surveillance Authority and with several professional organisations. Many of the
products of the project, like standards and indicators were presented to the MOH for
further action. Because the World Bank project was active in the same area, MOH
combined the inputs from both projects in the development of monitoring
mechanisms.
The final advice to the MOH for development of a quality system (bringing together
elements at national, institutional and individual level) will be used by the Ministry in
further structuring of quality assurance systems.
Perhaps the most important contribution of the project was the initiative of the
National Institute for Quality and Innovation (NIKI). The Institute has already proved
to be viable and capable of coordinating guideline development in the country. As
mentioned in the introduction to this chapter, the “transposition” from evidence based


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       medicine to locally accepted guidelines, standards and protocols is an essential step in
       strengthening a sound national quality assurance system.


2.5   Sustainability

       The project has produced a number of tangible products, like the guideline handbook,
       the standards for primary health care practices, hospital indicators, hospital quality
       reporting format, etc. These products are now used by health care providers, health
       insurance companies and MOH in the further development of quality assurance
       programmes.
       More and more hospitals are developing internal quality assurance programmes. Some
       are working on accreditation or ISO certification. The hospitals which participated in
       the PATH project are networking on quality assurance issues. The project managed to
       introduce quality assurance as important issue for health care facilities. This process
       will now continue autonomously.
       Health insurance companies have appointed quality managers and are working further
       on refining their role in quality assurance. The insurance companies are now collecting
       the necessary information from hospitals and are starting benchmarking exercises.
       The NIKI has become a viable institution, which is contracted now by the health
       insurance companies to coordinate the development of clinical practice guidelines.
       Gradually, this Institute will be seen by more and more stakeholders as a valuable
       instrument in the quality system in health care in Slovakia.
       Among minor, but equally important conditions for sustainability of activities the
       project‟s web site comprises all electronic documents developed throughout the
       overall span of the project. That comprises all presentations given by consultants and
       participants at seminars and conferences, all reports and documents as well as
       extensive list of links to sites related to the project activity. The website will be
       continued by NIKI. MoH has received all the documents collected over those years to
       be able to start building up a library with quality related documents.




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3 Lessons Learned

3.1   Terms of Reference

       The Terms of Reference for this project were produced in a time when the MOH was
       starting up the health sector reforms. The project results were selected from an 8
       points programme, which that time new Minister of Health Dr. Rudolf Zajac had
       formulated. The assumption was that much of the programme would be in place by the
       start of the project. Inevitably, the process of reforms was slower than hoped by
       politicians. Creation of a Health Care Surveillance Authority was delayed by about 10
       months. Therefore the Agency could not play the role as it has been foreseen in the
       TOR. Later the roles and functions of the Institution were amended. Equally, the
       legislation for health sector reforms was delayed for some months. It was not in place
       when the Project started.
       Initially, it looked like the Project would be hampered by these delays, but by
       concentrating on the institutional level (bottom-up approach); the project could
       achieve a lot while at the political level issues were still sorted out.


3.2   Coordination with other projects

       The Matra project was able to facilitate that Slovak hospitals were incorporated in the
       WHO PATH project. This was a great boost for the development of indicators and
       internal quality assurance programmes in Slovak hospitals.
       The quality project funded by the World Bank had Terms of Reference with
       considerable overlap with the Matra project. Due to good relations with the local
       consultant, Dr. Rusnakova and the international consultant Dr. Andrew Parkes, it was
       possible to feed the Matra project results into the World Bank project.
       The coordination with other projects was possible through strong personal networks of
       the consultants. The role of the MOH in coordination was not very outspoken, partly
       due to high turn-over of MOH officials responsible for the quality programmes.


3.3   NIKI

       In the original plan for this project there was nothing like initiating an institute for the
       coordination of development of clinical practice guidelines. The idea was to start
       within the project with development of some guidelines. However, the study visit to
       the Netherlands (visit to CBO) and study of approaches in other countries made it
       clear that the project needed to take a step back and take a more fundamental
       approach. Initiating the NIKI in collaboration with professional medical associations
       in Slovakia demanded a lot of energy in the project, but has proven to be a wise
       decision. It has enhanced the sustainability of the project results.


3.4   Corporate culture of quality

       The original set-up of the project put much emphasis on the external quality control
       and monitoring of health providers‟ performance by national institutions. Partly due to
       the delay in creation of the national institutions, the project started working with



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hospitals and general practitioners on internal quality assurance indicators and
procedures. This worked out very well, as it increased the sense of ownership of
quality assurance programmes. Hospitals and general practitioners were proud to
present their work on quality assurance and were able to stimulate each other. Quality
assurance as part of the corporate culture appeared to be a much stronger drive than
external pressure from government institutions.




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     4 Recommendations
              This chapter contains the final advice to the Ministry of Health, as approved during
              the final conference of the project.

     4.1    Introduction to the final advice

     4.1.1 Background

              The project “Building Quality Development Programme in Slovakia” (financed by the
              Netherlands Ministry of Foreign Affairs through EVD International MAT03/SK/9/1)
              aims to provide an advice to the Ministry of Health of Slovak Republic in the quality
              of health services area.
              This document is meant as a basis for subsequent regulations to be developed and
              issued by the Ministry. It delineates basic principles of building quality systems on
              national, institutional and professional levels. The advice is based on experiences with
              similar systems in The Netherlands, the UK and other countries of EU. It also builds
              upon current legislation in Slovak Republic, primarily on the Act No. 578 defining in
              § 9 the System of quality in four steps:
              1. A provider is obliged to ensure a continual system of quality on maintaining and
                 increasing the standard of quality as such.
              2. It applies to all activities that in the medical facility may influence the health of
                 persons or the course of their treatment.
              3. The staffing and equipping of the medical facility corresponds at least to the
                 requirements set out in § 8.
              4. Assessment of the system of quality shall be carried out by authorised persons as
                 per a separate regulation.2)

              The details on the arrangement and assessment of the system of quality of providers
              are determined by generally binding legal regulation, which is issued by the Ministry
              of Health.


     4.2    Principles

              Actors in the quality system

              Governance at all levels of the health care system is one of the most important
              influences on quality of care. Good governance is reflected in strong systems of
              leadership and accountability. With good governance, the capacity for innovation and
              responsiveness to new technologies, challenges, and opportunities are retained within
              a system in which quality is valued and protected. Throughout the Slovak health care
              system, governance action should be directed towards ensuring that each organisation
              and individual is engaged actively in comprehensive processes of systems review, risk
              management, and systems improvement. Concerted and coordinated action involving
              each element of the health care system is required - from individual clinicians,
              through to health care organisations, and jurisdictions. All elements of quality


2
)   Act No. 264/1999 Coll. on technical requirements of products and on assessment of compliance and on
    the amendment and supplementing of certain laws, as amended.


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assurance should fit in one system, which leaves no gaps, and which cuts out
contradictions.

In the system, we distinguish three levels:
 The national level, consisting of Ministry of Health (MOH) and other
     stakeholders, like Health Care Surveillance Authority (HCSA), Health Insurance
     Companies, Slovak Medical Chamber (SMC) and other professional chambers,
     Slovak Hospital Association, Slovak Association of Private Physicians and other
     organisations.
 The institutional level, where formal organisations provide health services. These
     are mostly hospitals and clinics. Private primary health care providers are not
     institutions.
 The professional level, of the individual health care professionals, medical,
     nursing and paramedical cadres.




Regulatory strategies

Where self-regulation of the health care system is effective in achieving high quality
care, it should be supported. Where active regulatory strategies are necessary, they
should be designed to establish conditions that are conducive to, and foster, good
governance at the appropriate level in the system, so that responsibility and
accountability can be maintained. In other words, the first of objective of a quality
system is to stimulate professionals and health care organisations to improve quality
and to provide an environment conducive therefore. But, secondly, a quality system
should regulate the health sector, focusing on quality.
Regulatory strategies are not just about enforcing law, but cover a range of options
that can be categorised in ascending order of intervention under five types of policy
instruments. Voluntarism is based on an individual or organisational undertaking to do
the right thing without any coercion. Self-regulation is where an organised group
regulates the behaviour of its members (e.g. by establishing an industry-level code of
practice). Economic instruments involve supply-side funding sanctions or incentives
for health care providers, and also demand-side measures that give more power to
consumers. Meta-regulation involves an external regulatory body ensuring that health



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      care providers implement quality programmes and practices. Command and control
      involves enforcement by government (e.g. ensuring compliance with rules for
      licensing facilities).
      The regulatory approach should escalate upwards from “soft” to “hard” instruments.
      This means that health care organisations and professionals should have a system in
      place to enhance quality, as a first “soft” obligation. Achieving the highest quality
      may not always be possible, but at least the best possible within given circumstances
      should be tried. This is monitored by an external party.
      Gradually, more and more minimum standards can be introduced, which create “hard”
      obligations. There are already some “hard” obligations in place with regard to safety
      of blood products, radiation equipment or medicines.




4.3   Systems at the National Level


4.3.1 External Quality Assessment

      As explained above there are different levels of regulations. Licensure is a command
      and control type of regulation, which means it is mandatory. Accreditation and
      certification can either be considered as voluntary self-regulation or as meta-
      regulation. Meta-regulation has a stronger state involvement at the level of overseeing
      the activities (not implementing). It is recommended that accreditation and
      certification are considered are initiated as self-regulation and after some years be
      transformed into meta-regulation, and made mandatory for institutions.


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                Licensure. Licensure is a process by which a governmental authority grants
                 permission to an individual professional or health care organisation to operate or to
                 engage in an occupation or profession. Licensure generally focuses on minimum
                 standards to protect public health and safety.

                 Licences for professionals
                 In Slovakia there is a licensing system in place for medical and dental professionals,
                 who work as private practitioners, under the Health Care Providers‟ Act. Medical
                 professionals get a licence from the Slovak Medical Chamber. Dentists, working in
                 private practice, get a licence from the Slovak Dental Chamber. Similarly, nurses and
                 midwives working in private practice, get a licence from the Slovak Chamber of
                 Nurses and Midwives. Paramedics know a similar system of licences for private
                 providers. At this moment, physicians, dentists, nurses and other professionals
                 working in hospitals, do not require a licence. The system of licensing should
                 gradually expand from professionals in private practice to all professionals.
                 Primary health care providers receive a licence from the Regional Governments,
                 which is more of an administrative procedure.

                 Licences for health care organisations
                 Presently, health care organisations are registering at the Ministry of Health (MOH),
                 when starting a new facility. This registration is indefinite.
                 It is proposed that the present registration system be developed into a licensing
                 system, with licences for a limited period of time. Licences are renewable. The
                 licensing regulation should contain minimum standards for the buildings, the
                 organisational structure, financing and accountability. The licensing system could
                 apply both for the hospital sector and the bigger clinics (e.g. more than 10 employees)
                 in the primary health care sector. The Health Care Surveillance Authority (HCSA)
                 could be the right institution to issue and renew licences to health care institutions.
                 Alternatively the MOH could implement this task.

                Accreditation. Accreditation is a formal process by which a recognised body, usually
                 a Non-Governmental Organisation or company, assesses and recognises that a health
                 care organisation meets applicable pre-determined and published standards.3
                 Accreditation addresses organisational rather than individual practitioner quality. The
                 system of accreditation is less suitable for primary health care practices. In Slovakia,
                 there can be a number of accrediting bodies in health, even competing among each
                 other. The HCSA could be the appropriate government institution to oversee the
                 accrediting NGOs and companies, to ensure that equal standards are used and to rule
                 out corruption.

                Certification. Certification is a process by which an authorised body, either NGO or
                 governmental, evaluates and recognises an individual or an organisation as meeting
                 pre-determined requirements or criteria. Accreditation and certification are often used
                 interchangeably. However, one of the most distinctive differences is that, unlike
                 accreditation, certification can also apply to individuals. ISO certification concerns
                 more administrative and organisational issues, than medical technical issues. In the
                 Slovak Republic hospitals are engaged in ISO certification. For a transition period
                 both accreditation and ISO certification could be allowed, until evaluation shows
                 which method works best in quality assurance.



3
  The Slovak National Accreditation Service is an example of an accrediting organisation which could be one of
the organisations allowed to do this work.


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4.3.2 Sanctions for non compliance

      Together with a system for licensing professionals or health organisations (permission
      to operate), there should be a system of sanctions for non-compliance. A licence
      should be issued for a limited period of time (e.g. 5 years), and be renewed thereafter.
      The periodic assessment for this licence provides a moment to decide whether the
      institution/practitioner could continue working. Between the moments of assessment
      there should be a system for quality control, especially when complaints are launched
      or when other information indicates poor performance. There should be a range of
      sanctions: from advice, warning, through temporary withdrawal of the licence to
      operate, to permanent withdrawal of the licence to operate.
      It goes without saying that in addition to these sanctions, there are the legal sanctions
      imposed by criminal courts.
      The Slovak Medical Chamber should impose the necessary sanctions on individual
      medical providers. In the same vein, the Slovak Dental Chamber, Slovak Chamber of
      Nurses and Midwives, as well as other chambers, should be empowered to impose
      sanctions on non-performing professionals.
      The HCSA is the indicated government body to impose sanctions on health care
      organisations. According to the law the HCSA has the task to see to it that health care
      is provided “lege artis”. This may require additional legislation.

      Health insurance companies make contracts with health care providers and through
      their system of inspector physicians they perform quality control. However, these
      inspector physicians can advise whether the insurance company should contract the
      health institutions. In case of poor performance the insurance companies can
      (temporarily) suspend contracts. The health insurance companies provide information
      to the HCSA, which can take further actions, if necessary.
      The health care system knows certain health care organisations, which are not
      contracted by the health insurance companies (e.g. for plastic surgery). Therefore,
      relying on insurance companies for external quality control is not sufficient. They
      cannot withdraw licenses, and poor performers can continue to work for other
      insurance companies or private patients. The independent objective position of the
      HCSA is therefore a guarantee that appropriate measures are taken in the interest of
      public health.

      Accreditation and/or certification for a transition period should be a voluntary self-
      regulating instrument. This implies that there are no sanctions for health care
      organisations which are not accredited. After 3 or 4 years the system should be
      evaluated and transformed into a meta-regulation, which will then require sanctions
      for non-compliance.


4.3.3 Standards for provision of “lege artis” health care

      Standards can be distinguished in two types of standards:
       Managerial and procedural standards, which cover general quality issues. These
          standards are more or less covered in ISO standards. The model developed by the
          European Foundation for Quality Management is another approach for improving
          general management according to international standards. Normally, in
          accreditation or licensing, having standard managerial procedures in place is part
          of the conditions.
       Clinical practice guidelines or standards for diagnostic and therapeutic
          interventions. Most European countries have a system in place to develop such



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            standards, like the United Kingdom (NICE), Scotland (SIGN), New Zealand
            (NZGG) and the Netherlands (CBO).
        Clinic practice guidelines cannot by imposed like managerial procedures, as this
        would turn health care into a static process. Each patient needs a personalised
        approach, and clinical practice guidelines need to be adapted to medical-technical
        developments.
        In the Slovak Republic clinical practice guidelines should be developed through
        collaboration between professionals, health institutions and clients. The guidelines
        have to be scientifically sound, bringing together international experiences and local
        practices.
        The National Institute for Quality in Health Care (NIKI) should be delegated to
        develop the clinical practice guidelines. The organisational set-up of the institute
        should guarantee that all parties are represented and that the organisation can be
        independent and reliable. The guideline handbook, as developed by NIKI in
        September 2005, gives the proper structure of the organisation and procedures for
        development of guidelines.


4.3.4     Dissemination of Clinical Guidelines

        Health institutions and practitioners have to be informed on clinical guidelines,
        international developments and other relevant information for developing appropriate
        quality systems.
        The NIKI therefore has the task to create and maintain a resources centre, which
        provides the necessary information for stakeholders. In addition, NIKI should make
        available technical expertise to support institutions in the development of quality
        systems.


4.3.5     Advice Summary National Level

        The project formulates the following advice to the Ministry of Health in Slovak
        Republic:
        (1) Continue the present practice of licensing individual professionals, working in
            private practice, by the Slovak Medical Chamber, Slovak Dental Chamber, Slovak
            Chamber of Nurses and Midwives and other chambers. Gradually expand the
            system of licensing to all professionals, whether working in private practice of
            working in health care organisations.
        (2) Delegate the authority to issue licences for health care organisations to the HCSA
            via a separate regulation. Minimum standards for institutions should be defined,
            or drawn from other relevant legislation.
        (3) Prepare a legislative document defining the composition, roles and responsibilities
            of an Accreditation Committee at the Ministry of Health Slovak Republic. The
            terms of reference for this committee are defining the accreditation system, setting
            up the standards for the accreditation process as well as the necessary
            competences of accrediting organisations which will accredit providers of care.
            Criteria/standards for accreditation could be derived from existing accreditation
            systems in Europe or US.
        (4) The Accreditation Committee should define the tasks of the HCSA which will
            continue to monitor the accrediting organisations.
        (5) The Accreditation Committee will evaluate the self-regulating system of
            accreditation/certification after 3 – 4 years, and define the conditions for turning it
            into a meta-regulating system.




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        (6) Give the Slovak Medical Chamber and other chambers the task to clearly define
            criteria of non-compliance with licences of individual professionals and sanctions
            to be taken.
        (7) Give the chambers the task to design a system of gradual introducing of a
            licensing system for all health professionals.
        (8) Use the draft of the legislative document on Diagnostic and Therapeutic Standards
            prepared by the project to issue relevant regulation and prepare a budget to initiate
            participative guidelines development process via NIKI.

Figure 3 Overview National System of Quality Control

Licences for health care organisations

  Ministry of Health                Health Care                               Health Care
                                    Surveillance                              Organisations
                                    Authority
  Defines minimum                   Issues licences for                       Apply for licence
  standards for health              health care                               when starting to
  care organisations                organisations, after                      operate.
          (based on                 assessment.                               Re-apply every five
          legislation)              Revokes licence if                        years for
                                    non-compliance                            continuation of
                                    during periodic check                     licence
                                    or justified complaints
                                    from the public.

Licences for individual practitioners

  Ministry of Health                Slovak Medical                            Health Care
                                    Chamber (SMC) and                         Professionals
                                    other chambers of
                                    health professionals
 Delegates task of                Issues licences for                       Apply for licence
 licensing to SMC,                individual providers,                     when starting to
 SDC and other                    after assessment.                         operate.
 chambers                         Revokes licence if non-                   Re-apply every five
                                  compliance during                         years for continuation
                                  periodical check or                       of licence.
                                  justified complaints from                 Presently for
                                  the public                                professionals in
                                                                            private practice,
                                                                            gradually to be
                                                                            expanded to all
                                                                            professionals

Accreditation for health care organisations

 Ministry of               Health Care                 Accrediting /           Health Care
 Health                    Surveillance                Certificating           Organisations
                           Authority                   Bodies
 Defines                   Oversees                    Perform                 Initially engage in
 accreditation             accrediting                 accrediting or          voluntary
 standards for             bodies using                certification of        accreditation or
 health care               MOH standards               health care             certification, later in
 organisations                                         organisations           mandatory
                                                                               accreditation




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4.4   Quality Systems at Institutional Level

       Quality systems in hospitals should, be mandatory, but not prescriptive. Enforced self-
       regulation is a specific form of meta-risk management where some issue requires both
       the management problem-solving creativity of self-regulation, and the assurance that a
       minimum standard of performance is being met. The government places a statutory
       duty on health care organisations to seek quality improvements. This requires a
       hospital, for example, to integrate the elements of financial control, service
       performance, and clinical quality.
       An example of enforced self-regulation is a requirement that each hospital must have
       an infection control plan. Innovative hospital administrators are permitted to design
       their own standards, so long as they can make a good case to government that their
       standards are better than the default standards. Dynamism can be built in to enforced
       self-regulation to prod lazy managers by requiring continuous improvement.
       This means that each year, managers are required to do something to make infection
       control better than last year. The tough part about enforced self-regulation is that,
       unlike voluntary self-regulation, it is legally enforceable. Hence, if a hospital fails to
       meet one of the privately written but publicly ratified rules in its infection
       management plan, the corporation and its managers can be held accountable for that
       failure. This enforced self-regulation strategy attempts to simultaneously secure the
       creativity, flexibility, and cost-effectiveness of moving away from command and
       control, while retaining the public assurance of full enforcement credibility.


4.4.1 Evidence of systems

       All health institutions have to provide evidence to the HCSA of the existence of
       quality systems concentrating on clinical aspects, as part of the licensing procedure.
        Each institution should have a quality committee in place, which is mandated by
           the management of the institution to give guidance to practitioners in the
           institution.
        Each institution should have a quality coordinator, who on day-to-day basis makes
           a follow up on implementation of guidance given by the quality committee.
        There should be proof of quality systems in hospitals, e.g. through the availability
           of protocols or instructions for diagnosis and treatment, for nursing, examinations,
           etc. The protocols or instructions should be based on clinical practice guidelines,
           issued by NIKI.
        Users of health services should be involved in quality procedures in hospitals, e.g.
           through patient satisfaction questionnaires, suggestion boxes, complaint
           procedures, patient panels, representation in the quality committee, etc.

4.4.2 Quality reporting

       All health institution have to report on an annual basis the achievements and
       constraints regarding quality management. The collection and submission of data on
       defined national indicators is not sufficient to provide evidence on quality activities.
       The annual quality report should contain:
        Description of plans and activities undertaken during the year of reporting.
           Narrative report on major issues of quality in the hospital
        Reporting on indicators, national indicators and additional indicators, which the
           institution has formulated.
        Lessons learned and priorities for quality programmes for the next year


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                            Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



            The Heath Care Surveillance Authority publishes all reports on its website, available
            for the general public.


4.4.3 Advice Summary Institutional Level

            The project makes following advice to the Ministry of Health further specifying the §
            9 of the Act No 578:
             Issue legislative regulation (norm) on Quality Systems at the Institutional level
                (hospitals, specialised treatment and diagnostic institutions, Public Health
                Authorities, individual care providers) defining the Quality System based on the
                evidence of Quality structures (committee, manager), quality processes
                (guidelines, protocols, CME, others) and evaluation of quality outcomes
                (performance indicators, dedicated studies) summarised annually in Quality
                Report.
             The existence of quality systems in health care institutions is subject to
                assessment in the regular licensing process by the HCSA.


     4.5   Individual professionals

      4.5.1 Registration and licensing

            Individual professionals have to register and obtain a licence for practicing in private
            practices. This licensing has been introduced recently for all professions in health
            care. The licence is valid for a limited period (five years). Licensing is conditional on
            two factors:
             Having practiced the profession in the relevant area for more than a minimum
                amount of time during the previous five years.
             Have collected sufficient marks for Continuing Professional Development (250
                points during five years).

            The licensing is done by the Slovak Medical Chamber, Slovak Dental Chamber,
            Slovak Chamber of Nurses and Midwives and other chambers. Licences can be
            revoked if after five years the practitioner is not fulfilling the requirements above, or
            when after a complaint procedure, the practitioner is found guilty of serious
            professional misconduct.
            This system should be gradually expanded to all professionals, also the professionals
            working in health care organisations.

      4.5.2 Continuing Professional Development

            Individual professionals have to spend sufficient time on continuing professional
            development (CPD) (which is broader than continuing medical education).
            Three types of activities are allowed:
             Self-study, reading medical journals, documents, internet study, etc.
             Internal peer-to-peer types of learning between professionals, like clinical
                meeting, intervision, etc.
             External, accredited courses, which are offered by institutions. The external
                accreditation of courses for medical professionals is done by the SACCME, using
                UEMS criteria. For other professional CME there is no system in place yet for
                accreditation of courses.




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                    Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



     The professionals should register their credit points at Slovak Medical Chamber or
     other relevant Chamber and should be able to provide evidence of continuing
     professional development. They should be able to proof that they are aware of the
     clinical practice guidelines, as issued by NIKI.


4.5.3 Summary Advice Professionals

     The project makes following advice to the Ministry of Health
      Gradually expand the licensing system to all professionals in health care
      Link the periodical licence of practitioners at the Slovak Medical Chamber to the
        implementation of Continuing Professional Development activities
      Initiate a system of registration of collected CPD credit points, which the
        professionals need when applying for re-registration for all professionals




                                       29
ANNEX 1 Logical Framework Building Quality Development Programme in Slovakia
Project duration:                                 Project: MAT 03/SK/9/1
01-01-2004 – 31-12-2005

Overall Objective                                 Objectively Verifiable                 Means of Verification          Verification
                                                  Indicators
The project aims to contribute to the accession The quality programme matches the        WHO and EU reports             Slovakia produces OECD indicators
of the Slovak Republic to the European Union. EU/WHO policies.                                                          for monitoring health sector
In particular, the project aims to assist the                                                                           performance. Slovak hospitals
Slovak Republic in creating good conditions to                                                                          participate in the PATH network for
monitor the quality of health care provided.                                                                            monitoring performance.


Project Purpose                                   Objectively Verifiable                 Means of Verification          Verification
                                                  Indicators
Strengthening the capacity of the Section         The MoH has capacity to monitor        The HCSA has developed and     The role and functions of the HCSA
Health Care of the Slovak Ministry of Health to   care providers through a Health Care   field tested quality control   have been modified since the
guarantee that care providers can be monitored    Surveillance Authority that has the    instruments and a plan for     inception phase.
in a proper way.                                  disposition of standardised            implementation is accepted.    Health insurance companies produce
                                                  processes, guidelines and clinical                                    now monitoring reports.
                                                  indicators and output and outcome
                                                  measurement means which are well
                                                  accepted by the field.




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                                                                                            Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



Results                                            Objectively Verifiable                  Means of Verification                   Verification
                                                   Indicators
Analysis of current system of monitoring and       MoH and stakeholders are aware of Documentation available which                 Overview document produced as
evaluation of quality of health services           the state of the art in quality policies, describes ultimately the outcome      brochure and distributed in 10,000
                                                   quality standards and quality             of the analysis.                      copies.
                                                   monitoring in the European Union,
                                                   and its member countries.
                                                   An analysis done of the existing
                                                   monitoring and evaluation system in
                                                   the Slovak Republic.


Set of processes and institutional indicators      A practical list of standards and       The list is documented and              Outputs of the project:
developed (related to the requirements for         indicators is developed and field-      included in the national reference       - standards for primary health care
health care institutions) for the monitoring and   tested for hospital and primary care.   centre on quality assurance in the         clinics produced
evaluation of the quality of health services                                               MoH.                                     - indicators for general practitioners
provided                                                                                   Endorsement by beneficiary and           - indicators for hospitals
                                                                                           stakeholders.                            - guideline development handbook
Set of guidelines and clinical indicators          A list of guidelines and clinical       In line with EU and WHO                  - statute and organogramme for
developed (describing step by step professional    indicators is produced, prioritised     standards to be verified by                NIKI institute
practices) for the monitoring and evaluation of    and field tested in hospital and        matching with EU 2003-2008              World Bank programme integrating
the quality of health services provided            primary care.                           public health programme.                indicators into monitoring system for
                                                                                                                                   assessment of 2005 performance.


Advice developed for the Ministry of Health on     Consensus between all parties           Document available which            Advice produced (see chapter 4),
   the introduction of a system for internal and   involved on the contents on the         contains the advice for the MoH     approved by taskforce and closing
   external quality monitoring and evaluation      developed advice for the MoH, both      on the introduction of a system for conference of the project.
   in the Slovak health care system                on technical level and acceptance of    internal and external quality
                                                   implementation                          monitoring and evaluation.




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                                                                                          Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



Activities                                                                                                                       Comments

RESULT 1
 An inventory of the current state of the art in quality of care in the Slovak Republic resulting in an overview document       Overview document produced, with
   and technical sub-documents. Mapping out of general quality policies nationally and internationally, practical activities     the elements as agreed.
   and procedures in the Slovak Republic.                                                                                        Standards for primary health care
 An exercise (review, survey) on continuous medical education.                                                                  clinics reviewed and updated.
 An exercise (review, survey) on technical equipment standards in ambulatory care.
 A National Reference Centre will be set up in the person of Lucia Lenartova, located at the Ministry of Health.
 Analysis of existing quality processes: ISO, EFQM and JCAHO
 Network partners
 Review of existing standards on technology and equipment in outpatient care.
 Review of existing standards on continuing education.
RESULT 2
 A joint workshop on strategic purchasing with the WHO Observatory PATH initiative.                                             Workshops and pilots implemented as
 A workshop on the application of external quality assurance mechanisms on institutional level such as accreditation            planned. Indicators, annual reports
   and certification.                                                                                                            and standards formulated as planned.
 Education and training at Trnava University in quality process management with the aim to help to develop a local              Training done, but not through
   module on quality of care in the public health/management curriculum.                                                         Trnava University.
 Teams of Slovak experts on study visit to the Netherlands as a contribution to the inventory of state of the art and a         Study visit to Hungary and Austria
   preparation for the pilots.                                                                                                   replaced by study visit to the
 Study visits to Austria and Hungary for similar, small-scale projects.                                                         Netherlands for health insurance
 Review of existing standards on continuing education.                                                                          companies.
 Workshops for regional government on guidelines and indicators and quality monitoring during pilots.
 Workshops for health institutions on guidelines and indicators and quality monitoring/purchasing during pilots.
 Set up of institutional indicators (quality indicators from OECD, hospital performance indicators, joint Matra/WHO
   meeting on indicators)
 GHI performance indicators.
 Preparation of pilots and questionnaires.
 Pilots in 4-5 hospitals.
 Pilots in 2 general practices.
 Summary of results.
 Policy document.




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                                                                                          Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report



RESULT 3
 Education and training at Trnava University in quality process management with the aim to help to develop a local              Handbook for guideline development
   module on quality of care in the public health/management curriculum.                                                         produced and NIKI institute set up.
 Teams of Slovak experts on study visit to the Netherlands as a contribution to the inventory of state of the art and a         Training in AGREE instrument
   preparation for the pilots.                                                                                                   performed.
 Study visits to Austria and Hungary for similar, small-scale projects.                                                         Workshops and training sessions for
 Review of existing standards on technology and equipment in outpatient care.                                                   various groups of stakeholders, i.e.
 Familiarising with AGREE instrument and development of user manual.                                                            government officials, HCSA and HIC
 Evaluation of guidelines.                                                                                                      managers, hospital and PHC
 Taskforce discussions and suggestions                                                                                          professionals, representatives of
 Workshops for regional government on guidelines and indicators and quality monitoring during pilots.                           professional associations.
 Workshops for health institutions on guidelines and indicators and quality monitoring/purchasing during pilots.
 Pilots in 4-5 hospitals.
 Pilots in 2 general practices.
 Summary of results. Policy document CME
RESULT 4
 To refine guidelines and indicators on the basis of experiences gained                                                         Workshops and meetings organised.
 Identification of feasible mechanisms of quality monitoring and feedback systems, suitable for the Slovak situation            Advice for quality system produced,
 Revisiting of experiences that were encountered during the study visits through an e-mail forum and a counter visit            including draft ordinance for place of
   whereby expert reflection from similar processes, for example from the MoH in The Netherlands, can be invoked.                clinical guidelines in the quality
 Prepare and organise four design workshops, through subcommittees.                                                             system.
 Write overall implementation advice together with the HSCA.
 Organise National Conference.




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                                                                                             Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




                                                                        Quality Developing Programme Slovakia Matra Project MAT03/SK/9/1
       Annex 2 Gantt Chart
                                                                                      2004                                                  2005
                                                                       J F M A M J J A S O N D J F M A M J J A S O N D
       Inception phase

1. Analysis of current system of monitoring and evaluation of quality of health services
1.1    An inventory of the current state of the art in quality of
       care in the SR resulting in an overview document and
       technical sub-documents. Mapping out of general quality
       policies nationally and internationally, practical activities
       and procedures in the SR.
1.2    An exercise (review, survey) on continuous medical
       education.
1.3    An exercise (review, survey) on technical equipment
       standards in ambulatory care.
1.4    A National Reference Centre will be set up in the person
       of Lucia Lenartova, located at the Ministry of Health.
1.5    Analysis of existing quality processes: ISO, EFQM and
       JCAHO
1.6    Network partners

1.7    Review of existing standards on technology and
       equipment in outpatient care.
1.8    Review of existing standards on continuing education

1.9    Production of overview document




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                                                                                           Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




        Quality Developing Programme Slovakia                                                Matra Project MAT03/SK/9/1
        Gantt Chart                                                                 2004                                                  2005
                                                                       J F M A M J    J A S O N D J F M A M J J A S O N D
        Inception phase

2. Set of processes and institutional indicators developed (related to the requirements for health care institutions) for the monitoring and
evaluation of the quality of health services provided
2.1     A joint workshop on strategic purchasing with the WHO
        Observatory PATH initiative.
2.2     A workshop on the application of external quality
        assurance mechanisms on institutional level such as
        accreditation and certification.
2.3     Education in quality process management

2.4     Teams of Slovak experts on study visit to the Netherlands
        as a contribution to the inventory of state of the art and a
        preparation for the pilots.
2.5     Study visits to the Netherlands for HIC officers

2.6     Review of existing standards on continuing education.

2.7     Workshops for various stakeholders on guidelines and
        indicators and quality monitoring during pilots.
2.8     Workshops for health institutions on guidelines and
        indicators and quality monitoring
2.9     Set up of institutional indicators

2.10    GHI performance indicators.

2.11    Preparation of pilots and questionnaires.

2.12    Pilots in 4-5 hospitals.
        Pilots in 2 general practices.
2.13    Summary of results.
        Policy document.



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                                                                                                  Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




                  Quality Developing Programme Slovakia                                              Matra Project MAT03/SK/9/1
                  Gantt Chart                                                              2004                                                  2005
                                                                              J F M A M J J A S O N D J F M A M J J A S O N D
                  Inception phase
provided
           3.1    Education and training in quality process management

           3.2    Teams of Slovak experts on study visit to the Netherlands

           3.3    Study visits to the Netherlands for HIC officials

           3.4    Review of existing standards on technology and
                  equipment in outpatient care.
           3.5    Familiarising with AGREE instrument and development
                  of user manual.
           3.6    Evaluation of guidelines.

           3.7    Taskforce discussions and suggestions

           3.8    Workshops for various stakeholders on guidelines and
                  indicators and quality monitoring during pilots.
           3.9    Workshops for health institutions on guidelines and
                  indicators and quality monitoring/purchasing during
                  pilots.
           3.10   Pilots in 4-5 hospitals.
                  Pilots in 2 general practices.
           3.11   Documents on guidelines




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                                                                                            Matra project MAT 03/SK/9/1 Building quality systems in health – Final Report




       Quality Developing Programme Slovakia                                                  Matra Project MAT03/SK/9/1
       Gantt                                                                         2004                                                  2005
                                                                   J F M A M J J A S O N D J F M A M J J A S O N D
       Inception phase

4. Advice developed for the Ministry of Health on the introduction of a system for internal and external quality monitoring and evaluation in
the Slovak health care system
4.1    To refine guidelines and indicators on the basis of
       experiences gained
4.2    Identification of feasible mechanisms of quality
       monitoring and feedback systems, for the Slovak situation
4.3    Revisiting of experiences that were encountered during
       the study visits in phase I
4.4    Workshops on guideline development, monitoring of
       hospital indicators.
4.5    Write overall implementation advice with the HSCA.

4.6    Organise National Conference.

       Programme activity of several weeks/months                     Single event during project




                                                                                37

				
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