PATIENT SAFETY

PATIENT SAFETY IN EASTERN EUROPE AND ASIA:

BASELINES AND ADVANCES

Compiled and edited by Neda Milevska-Kostova Mina Popova Viktor Serdiuk Ksenia Kosheleva

International Initiative “Eastern European and Asian Organizations for Patient Safety”

PATIENT SAFETY IN EASTERN EUROPE AND ASIA: BASELINES AND ADVANCES Compiled and edited by Neda Milevska-Kostova, MSc, MCPPM Mina Popova, MSc Dr. Viktor Serdiuk Ksenia Kosheleva

August 2008

PATIENT SAFETY IN EASTERN EUROPE AND ASIA: BASELINES AND ADVANCES Edited by Neda Milevska-Kostova, MSc, MCPPM Mina Popova, MSc Dr. Viktor Serdiuk Ksenia Kosheleva Publishers: All Ukrainian Council for Patients Rights and Safety Prof. Dr. Yuriy Gubskiy, President Centre for Regional Policy Research and Cooperation “Studiorum” Prof. Dr. Tome Gruevski, President Technical editing and cover design: Aleksandar Manchevski Translation of Parts Three, Four and Five from Russian to English: Anastasiya Mikhaylova, Natalie Gryvnyak Printing: Media Connect, Skopje, Macedonia

The English version of this publication is prepared and published by funding provided by Centre for Regional Policy Research and Cooperation “Studiorum”, Skopje, Macedonia

This publication is part of “Eastern European and Asian Organizations for Patient Safety” Initiative, coordinated by All Ukrainian Council of Patients Rights and Safety and partially funded

by OSI East-East: Partnership Beyond Borders Program

International Initiative “Eastern European and Asian Organizations for Patient Safety”

PATIENT SAFETY IN EASTERN EUROPE AND ASIA: BASELINES AND ADVANCES Compiled and edited by Neda Milevska-Kostova, MSc, MCPPM Mina Popova, MSc Dr. Viktor Serdiuk Ksenia Kosheleva

Acknowledgements In the preparation of this publication, the following people have shared unselfishly their expertise, experience and knowledge: Prof. Yuriy Gubskiy (Ukraine) Prof. Dr. Jovan Tofoski (Macedonia) Dr. Viktor Serdiuk (Ukraine) Ksenia Kosheleva (Ukraine) Dr. Anatoliy Tsarenko (Ukraine) Dr. Madina Baimagambetova (Kazakhstan) Mirbek Nuraliev (Kyrgyzstan) Badamragchaa Purevdorj (Mongolia) Khun Tsegmed (Mongolia) Oyunbileg Naidan (Mongolia) Alisher Makhkamov (Uzbekistan) Zaruhi Mkrtchyan (Armenia) Dr. George Gegelashvili (Georgia) Rasa Terbetiene (Lithuania) Danute Kasubiene (Lithuania) Erika Matuizaite (Lithuania) Tomasz SzelÄ…gowski (Poland) Prof. Jolanta Ewa Bilinska (Poland) Dmitriy Kotovich (Republic Belarus) Andrei Fomenko (Republic Belarus) Nikolai Zhurilov (Russian Federation) Iurie Guzgan (Moldova) Valeriu Sava (Moldova) Dr. Emina Osmanagic (Bosnia and Herzegovina) Snezana Cicevalieva (Macedonia) Dr. Todorka Ignatova Kostadinova (Bulgaria) Dr. Vladimira Leskovec (Slovenia) Prof. Bojana Beovic (Slovenia)

Table of Contents Foreword: About this publication

Neda Milevska-Kostova, Mina Popova

Part One: Introduction What is Patient Safety and Why now?

Neda Milevska-Kostova, Mina Popova, Jovan Tofoski

Part Two: Initiative “Eastern European and Asian Organizations for Patient Safety�

Viktor Serdiuk, Ksenia Kosheleva

Part Three: General Meeting and Country Overview: situation and priorities Neda Milevska-Kostova (ed.)

Part Four: Work Groups results - priorities and activities

Viktor Serdiuk, Anatoliy Tsarenko

Part Five: Results of the Survey on Patient Safety

Mina Popova (ed.)

Appendix One: Questionnaire on Patient Safety: country context Mina Popova

Appendix Two: List of Participants and Experts

International Initiative Eastern European and Asian Organizations for Patient Safety

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Foreword About the publication by editors

This publication is a result of enthusiastic gathering, discussion and motivation to contribute to changes in the healthcare sector in the 16 national contexts by experts and activists, national officials and civil sector representatives that gathered in Kiev in the General Meeting of the Project on “Eastern European and Asian Organizations for Patients Rights and Safety” in May 2008. This project, initiated by a group of visionaries that envisaged networking in the Eastern Europe and Asia in this very hot issue of patient safety, is aimed exactly at – exchanging experiences and best practices, but more importantly – joining strengths and overcoming weaknesses in improvement of the legislation and implementation systems in our countries with ultimate goal of – increased health status and declining medical errors and adverse events.

“Thousand candles can be lit from single one without its life being shortened; knowledge never decreases by being shared” [Buddha Quote]

Parts One and Two present the general idea and concept of patient safety in the world today and of the basic aims and structure of the Project underlying this initiative.

Parts Three, Four and Five were created as a result of generous contribution of each of the country representatives at the General Meeting and some experts from countries that could not participate; with their unselfish sharing of expertise in their national legislation, systems and practices we could make a broader picture of what the baselines in the region and in each country are, and what are the priorities and advances that could be taken forward in the immediate and mid-term future. Part Three was created from the presentations delivered at the General Meeting, and sent for authorization of the statements to each participant; until the actual publication, the accuracy of the text were confirmed by Armenia, Belarus, Bulgaria, Georgia, Kazakhstan, Kyrgyzstan, Lithuania, Macedonia, Russian Federation, Ukraine. Part Five was prepared based on the questionnaires elaborately filled by representatives from every country that were also being generous in providing information on national specifics of this otherwise very universal issue.

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In this publication, we would like to express our gratitude to the Open Society Network and its East-East: Partnership Beyond Borders Program in most of the participating countries, for enabling the networking meeting in Kiev, which was essential for start-up of this long-term cooperation and commitment.

All of the above, and below as well – we consider to be a beginning of strong and well-established network of experts that in long run will be a relevant partner in the national and international initiatives for improvement of patient safety in the participating regions and worldwide.

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Part One Introduction What is patient safety and why now?

by Neda Milevska-Kostova, Mina Popova, Jovan Tofoski

Patient safety is a serious concern in most developed and developing countries alike. Recent studies consistently show, in an increasing number of countries, that health care errors occur in around 10% of hospitalizations.1 The concept of the patient safety is described with many operational definitions - each defined by the research context. In general, the term patient safety describes the tendency to provide conditions and interventions for patients in the healthcare settings that would enable and ensure the desirable outcome. The broadness of this concept embraces both medical and non-medical errors that can incur during the patient stay at the healthcare setting.

Although in many cases, the hospital visit and the patient safety are usually associated with the patient-physician relationship, to a large extent, besides the expertise, professionalism and ethical principles of the medical personnel, the preparedness and level of equipment of the healthcare setting plays crucial role in the outcome of certain intervention; this is another angle of the complex health systems’ relations: patient-institution relationship.

Nevertheless, the scientific literature shows that the healthcare sector is a decade or more behind other high-risk industries in its attention to ensuring basic safety for its key players (both patients and health professionals).2 Aviation for example, has focused extensively on building safe systems since World War II; between 1990 and 1994, the U.S. airline fatality rate was less than one-third the rate experienced in mid century.3 In 1998, there were no deaths in the United States in commercial aviation; in health care, preventable injuries from care have been estimated to affect between three to four percent of hospital patients.4 Since the start of medical practice in its first forms, it is known that unforeseen adverse outcomes of medical treatment can cause harm to patients; intentionally or not, the harm incurred in the already unequal relationship of doctor-patient plants a seed of distrust and disturbed confidence. In order to step in the way of

The concept of patient safety 11

International Initiative Eastern European and Asian Organizations for Patient Safety

intentional misuse of their position, in 4th century BC, Greek healers modulated a preventive phrase in the well-known Hippocratic Oath obliging them to “prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.�5 Still, despite the scientific boom in research and use of scientific evidence in medical practice during the late 19th and 20th century, the data on adverse effects of medical treatment and undesired outcomes were neither collected nor systematically stored and processed, to offer solid base for development of a more profound approach for their prevention; instead, only an anecdotal approach was taken by some commissioned studies.6 The concept of patient safety happens to be a relatively recent initiative, as a response to the generally low level of awareness and knowledge about the frequency and magnitude of avoidable adverse outcomes in healthcare industry; the first serious approach to this issue was given in 1990s, when reports in several countries revealed a staggering number of patient injuries and deaths each year.7 Since the conception of the idea, the patient safety got its many definitions, most of which however, emphasize the reporting, analysis and prevention of medical errors and adverse healthcare events, but also the near-miss events, administrative and non-medical errors that incur during the patient visit to healthcare setting. Patient safety initiatives include application of lessons learned from business and industry, advancing technologies, education of providers and the public, and economic incentives.8 According to some sources, the term is often applied to falls, medication errors, and sometimes even more far-reaching concepts such as patient education, etc.9 However, there is a recognized growing unwillingness of governments to leave patient safety to their health care systems or to the institutions and providers who make up the health care system; instead they turn to the option of regulating it with a legislative document.10 Besides the concerns raised by the national health systems, a number of civil society initiatives commenced as an expression of their anxiety over the issue; in almost every country - the developed ones without exception and most of the developing ones - organizations or movements exist and actively work on monitoring, prevention or even prosecution of medical errors. Yet, the battle is not to be fought single-handed, or even worse - one-sided. The concept of patient safety is not intended to broaden the divide between the patients and medical practitioners - on contrary, it is intended to encourage and even enforce collection and analysis of data on medical errors and adverse outcomes that will enable avoidance of the same malpractice in similar cases in the future. If the concept advocates for decreasing the adverse effects, it 12

should place honours to both patients and medical professionals if it wants an honest and profound change of knowledge, attitudes, beliefs and practices (KABPs).

The classic understanding of risk management and theories that embed this concept are to a large extent focused on single-sided approach, teaching the healthcare workers in this instance to relieve patients but if possible to avoid admitting responsibility or discussing medical errors or malpractice; not only that physicians around the world do not discuss these issues with patients, but they are in many cases refraining from debating and sharing own mistakes and mishaps with colleagues and peers. This is understandable, given the complexity of most situations that cause injury and the unreliability of determining whether an error occurred.11 But it also has created a wall of silence surrounding poor outcomes.12 This allows for widening of the gap between already unequally positioned physician and patient in their relationship, bringing the physicianpatient relationship closer to the paternalistic side of the spectrum.

The Patient Safety vs. the Willingness for Disclosure

Given the short span of the existence of patient safety paradigm and its still not well-established place on the policy agenda, there are only a small number of countries that have given it a full attention, through development and application of related policies. The leaders are again the international community and the developed countries; the initiatives of international organizations will be looked at, and also examples will be drawn from Denmark, UK and the United States, pointing out some of their very innovative measures and approaches to overcoming the reporting stigma that exists in the health professional community when it comes to reporting medical errors.

Patient safety in Action: International initiatives and national policies

In October 2004, World Health Organization (WHO) launched the World Alliance for Patient Safety in response to a World Health Assembly Resolution urging WHO and Member States “(1) to pay the closest possible attention to the problem of patient safety; (2) to establish and strengthen science-based systems, necessary for improving patients’ safety and the quality of health care, including the monitoring of drugs, medical equipment and technology�.13 The Alliance raises awareness and political commitment to improve the safety of care and facilitates the development of patient safety policy and practice in all WHO Member States. Each year, the Alliance delivers a number of programmes covering systemic and technical aspects to improve patient safety around the world; one such programme is the Patients for Patient Safety (PFPS) Programme that ensures the perspective of patients, consumers and family members around the world are ingrained within the work of the Alliance.14

WHO World Alliance on Patient Safety

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International Initiative Eastern European and Asian Organizations for Patient Safety

Other initiatives of the World Alliance for Patient Safety include15:

o Clean Care is Safer Care - the objectives of this programme are to: (1) raise awareness of the impact of health care-associated infections on the patient safety, to mobilize global commitments from all countries to reduce these infections and to produce strategy documents to help policymakers focus on solutions to the problem.

o Safer

Surgery Saves Lives – aims at improving the safety of surgical care through developing a set of practice standards for surgical interventions.

o Taxonomy for Patient Safety - a group has been formed within the WHO World Alliance for Patient Safety to develop the International Classification for Patient Safety (ICPS)16. The aim is to clarify the concepts and to come up with the brief and clear definitions in the field that would be appropriate for use by all health care stakeholders in all Member States.

o Research to improve patient safety – encourages the development of research projects in all WHO Member States under the theme of “Knowledge is the enemy of unsafe care.”

o Reporting

and Learning – the Alliance has developed Draft Guidelines for Adverse Event Reporting and Learning Systems17 to help all Member States develop their national reporting systems.

The Joint Commission International Center for Patient Safety

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Launched in 2005 as “the operational arm” for the World Alliance for Patient Safety, the mission of the Center is “to continuously improve patient safety in all health care settings”18 by bringing together all relevant stakeholders to share experience and ideas.

The Center has identified nine areas of patient care with the most common errors and has launched nine solutions to improve patient safety19: (1) look-a-like, sound-a-like medication names; (2) patient identification; (3) communication during patient handovers; (4) performance of correct procedures at correct body site; (5) control of concentrated electrolyte solutions; (6) assuring medication accuracy at transitions in care; (7) avoiding catheter and tubing misconnections; (8) single use of injection devices; (9) improved hand hygiene to prevent healthcare associated infections.

As patient safety was becoming more and more a healthcare priority, not only for the national healthcare systems, but also for the patients seeking healthcare in other member states under the patient mobility mechanism, in 2005, the EU Member States established a mechanism to discuss and take forward the patient safety; special working group was set up under the High Level Group on Health Services and Medical Care to identify priority areas for action, as the Union has committed to facilitate and support its Member States in their work and activities related to reporting and dealing with the medical injuries and adverse events. The recommendations of the High Level Group point out that reporting and learning systems in this field would permit information on problems and solutions to be shared throughout Europe; at the same time, EU patient safety network or forum, working with other international organisations, could provide focus for efforts to improve the safety of care for patients in all EU Member States, through sharing information and expertise.20

European Union

Under the Luxembourgian presidency of EU, in April 2005, the European Commission DG for Health and Consumer Protection issued the Declaration “Patient Safety - Making it Happen!” widely known as the Luxemburg Declaration. The Declaration calls for active involvement of EU institutions, in establishment of EU forum to discuss issues regarding patient safety, in cooperation with other patient safety initiatives, like the WHO Alliance on Patient Safety, and it recommends to the national authorities to establish national forums, to ensure full and free access to personal health information to patients, to optimise the use of new technologies, and above all to work towards creating a culture that focuses on learning from near misses and adverse events as opposed to concentrating on “blame and shame” and subsequent punishment.21 In 2006 the Council of Ministers made a number of recommendations in order to motivate all Member States22: (1) develop a comprehensive patient safety policy framework; (2) promote the development of a reporting system for patient safety adverse events and medical errors; (3) promote the development of educational programmes for all relevant health-care personnel, including managers, to improve the understanding of clinical decision making, safety, risk management and appropriate approaches in the case of a patient-safety incident; (4) develop reliable and valid indicators of patient safety for various health-care settings that can be used to identify safety problems, evaluate the effectiveness of interventions aimed at improving safety, and facilitate international comparisons; (5) co-operate internationally to build a platform for the mutual exchange of experience and knowledge of all aspects of healthcare safety; (6) promote patient safety research; (7) produce regular reports on actions taken nationally to improve patient safety.

European Union Health Ministers Council

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International Initiative Eastern European and Asian Organizations for Patient Safety

Denmark It is the National survey on patient’s experiences performed in Denmark that

has opened a policy debate on the issue of patient safety - the survey showed that 18% of all interviewees had experienced medical error, of which medication and surgery made almost half; compared to other developed countries Australia and New Zealand 13%, Britain 11%, France 8.9%, Canada 7.5%, this result seemed like a call to action for the Danish authorities; adding to it the study by Andersen et al in which almost one third of medical professionals are considering the change of profession because of fear of being involved in adverse events23, the patient safety issue was put high on the political agenda with priority on finding a suitable way to address it through effective policy.

As a result, Denmark became the first example of a country that introduced nation-wide mandatory reporting of medical errors and adverse outcomes.

The Danish Act on Patient Safety24 enacted by the Danish Parliament in 2003, sets the ground for obligatory reporting of adverse events by the frontline personnel to a national reporting system; the famous Article 6 of this Act25, which reads “A health care professional reporting an adverse event shall not as a result of such reporting be subjected to disciplinary investigations or measures by the employing authority, supervisory reactions by the National Board of Health or criminal sanctions by the courts�, is opening a space for professional yet sincere debate grounds for gathering, analyzing and communicating the knowledge of adverse events, in order to reduce the number of such events in the healthcare system. In January 2004 the national reporting system was set in place, obliging not only the frontline personnel to report, but also the hospital owners to act on the reports and the National Board of Health to communicate learning from the reports, after making data anonymous, and in that way lifting it to the meta analytical level. More details of this reporting system are available from the National Board of Health and Danish Society for Patient Safety (DSFP).26

Figure 1. Danish Adverse Event Reporting System 16

Unlike the unique mandatory reporting system in Denmark, the United Kingdom introduced voluntary reporting of healthcare errors. The reporting system is under the NHS National Patient Safety Agency, established in 2001, with a mandate to identify issues related to patient safety; in 2005, the Agency expanded to incorporate the National Clinical Assessment Service and the National research Ethics Service.

United Kingdom

The specificity of the UK reporting system is that it has several specific instances, referred to as “confidential enquiries”, with routine investigation initiatives; those include among other, the maternal and child health (mother or infant deaths, deaths of persons under 16), and patient outcome and death, including death of mentally ill persons, perioperative and other unexpected medical deaths. In the British case, as well, the individual data is confidential, enabling increased participation from both the patient and involved health professional.27 To this end, the National Confidential Enquiries Strategy determines the purpose of the enquiries in general (“...to investigate the contribution of deficiencies in care to serious adverse patient outcomes; to identify areas where clinical practice needs to be improved and to make appropriate recommendations for changes that will improve outcomes for patients...”) and sets up the priority for three enquiries of outmost importance for the UK health system: on Maternal and Child Health (CEMACH), Patient Outcome and Death (NCEPOD), and Suicide and Homicide by People with Mental Illness (NCISH).28 Still, the 2007 report of the NCEPOD on patient outcome and death “Trauma: Who cares?” reported that less than half of the studied patients received good care, and that 13.4% of cases received inappropriate initial hospital response, with a high likelihood of the overall care for those patients being compromised.29 In its 1999 report, the Institute of Medicine (IOM) recommended a nationwide mandatory reporting system for collection of standardized information by state governments about adverse events that result in death or serious harm.

The report suggests that the reporting should initially be required of hospitals and eventually of other institutional and ambulatory care delivery settings.30

United States

Almost immediate response came from the concerned professional organizations, like the Anesthesia Patient Safety Foundation (APSF) which responded to the report by expressing serious concerns about the practicality and utility of the IOM’s recommended reporting system: “Mandatory reporting systems in general create incentives for individuals and institutions 17

International Initiative Eastern European and Asian Organizations for Patient Safety

to play a numbers game. If such reporting becomes linked to punitive action or inappropriate public disclosure, there is a high risk of driving reporting “underground” and of reinforcing the cultures of silence and blame that many believe are at the heart of the problems of medical error and patient safety.

This would be particularly true to the extent that “innocent” providers could be unfairly accused.”31 After long debates and controversies over it, in 2005 the US Congress passed the Patient Safety and Quality Improvement Act.32 Under the new plan, hospitals would be encouraged to report their mistakes confidentially to groups that will be known as patient safety organizations. The groups could then contract with the hospitals to analyze their mistakes and develop ways to prevent errors.

The federal government would play the role of coordinator, developing the computer network used by the safety groups to collect and analyze the data.

Reports remain confidential, and cannot be used in liability cases. Consumer groups have objected to the lack of transparency, claiming it denies the public information on the safety of specific hospitals.33 Another alternative for improvement of the patient safety in the US, argued by the Harvard School of Public Health scholars is the establishment of health courts for medical injury compensation, as part of the administrative compensation system. Mello et al explain that a health court has five core features; (i) injury compensation decisions are made outside the regular court system by specially trained judges; (ii) compensation decisions are based on a standard of care that is broader than the negligence standard; (iii) compensation criteria are based on evidence from the scientific literature; (iv) this knowledge, coupled with precedent, is converted to decision aids that allow fast-track compensation decisions for certain types of injury; and (v) ex ante guidelines also inform decisions about how much for economic and noneconomic damages should be paid.34 The Joint Commission of Accreditation of Healthcare Organizations (JCAHO) is a non-governmental organization that provides lots of activities to improve patient safety in health care establishments in the U.S. These activities are part of the JCAHO’s accreditation program. Based on the analysis of adverse events, the first National Patient Safety Goals have been developed in 2002 and applied from January 2003. These Goals are intended to create conditions at the health care establishments for protecting patients. At the beginning, their number is six: (1) Improve the accuracy of patient identification; (2) Improve the effectiveness of communication among caregivers; (3) Improve the safety of using high-alert medications; (4) Eliminate wrong-site, wrongpatient, wrong-procedure surgery; (5) Improve the safety of using infusion pumps; (6) Improve the effectiveness of clinical alarm systems. A year later 18

a Goal N 7 related to reducing the risk of health care-acquired infections has been added. The Goals are revised each year as priorities are chosen on the basis of the data collected and analyzed from the surveys. Applied only for hospitals at the beginning, with years the Goals are spread to the out-patient settings, as well. Thus, JCAHO’s activities in that field are directed at patient safety improvement in all kind of health care settings.

The transfer of the medical injury compensation from tort system to administrative compensation system, is under discussion, with questions still remaining to be answered, such as how much this or the mandatory reporting system alike would create a burden on the bureaucracy and if this used financial and human capacity could be utilized in a more effective way to decrease patient injuries and trauma.

Epidemiological data from medical-legal claims can be used, for both identifying rare but unacceptable events of malpractice or medical injuries35, and to look at possibilities to prevent more often incurring cases of compromising health of the patient; yet the balance should be set in the way not to make an oversized system from which the benefit would be hard to measure or difficult to implement. Some initial research on this topic has been done recently.36 There are many ways to measure patient safety; a vast body of literature explores the number of medical injuries, ambulatory, surgical and medication adverse events. However, the absolute numbers of these events do not show the degree of injury or severity of the adverse outcome. The Agency for Healthcare Research and Quality (AHRQ) of the US Department of Health and Human Services has made one of the elaborate attempts to measure the patient safety. The AHRQ system defines the patient safety indicators (PSIs) as a set of measures that screen for adverse events that patients experience as a result of exposure to the health care system, and which are preventable by changes at the system or provider level.37 The AHRQ system defines two levels of PSI: provider level (adverse events incurred in patients that received their initial care and experienced the complication of care within the same hospitalization), and area level (where the initial care and the complication happened in different healthcare settings). The proposed PSI indicators, reported on a voluntary basis measure the accidents from decubitus and transfusion reaction, to birth and obstetric trauma and postoperative complications, such as hip fracture, sepsis, hemorrhage and pulmonary embolism, as well as unwanted events of death in low-mortality diagnostic related groups (DRGs).

Measuring patient safety - Indicators

Other patient safety indicators have been developed under the SImPatIE Project38, Organization for Economic Co-operation and Development (OECD), 19

International Initiative Eastern European and Asian Organizations for Patient Safety

European Community Health Indicator Monitoring (ECHIM), The Nordic Indicator Group, etc. Yet, the existing research in this field of mapping and quantifying the medical adverse events in the direction of reducing preventable accidents and malpractice should be furthered by its conversion into policy and implementation into practice. The political agendas of governments should be pressed and influenced to embed and act upon the research and records supplied by their healthcare systems.

Patient safety Despite being still only a concern with many debates surrounding the necessity practices of establishment of reporting system and reaching consensus over its proper form (mandatory vs. voluntary), the patient safety issues are looked at and acted upon by a large number of organizations that internationally promote patient safety issues. Such initiatives are everyday work for the patient advocates, patient organizations and self-help groups alike.

The flagship among them is the Patient-Centred Healthcare Declaration of the International Alliance of Patient Organizations (IAPO), according to which “the essence of patient-centred healthcare is that the healthcare system is designed and delivered to address the healthcare needs and preferences of patients so that healthcare is appropriate and cost-effective.� The Declaration, based on its five principles (respect, choice and empowerment, patient involvement in health policy, access and support, and information) calls for greater patient responsibility and optimal usage, that leads to improved health outcomes, quality of life and optimal value for healthcare investment.39 Another among the pioneers in this area is the WHO Patients for Patient Safety Programme, dedicated to reduction of medical errors and injuries harmful to the patients. In their London Declaration, brought in March 2006, the patients from all over the world have committed to: devising and promoting programs for patient safety and patient empowerment, driving constructive dialogue with all stakeholders concerned with the patient safety, advocating for and establishing reporting systems worldwide on healthcare harm and defining the best practices for dealing with the healthcare injuries and unwanted events.40 Partnership for Patient Safety (p4ps) is a patient-centred initiative to advance the reliability of healthcare systems worldwide, through initiating focused partnerships and joint ventures with organizations and individuals that share p4ps core values and objectives of achieving a healthcare system that is authentically patient-centred and systems based. The p4ps, which is an Illinois corporation established in 2000 by some of the leading figures in patient safety in the US, has established the Consumers Advancing Patient Safety (CAPS) in 2003, as a non-profit initiative.

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Consumers Advancing Patient Safety (CAPS) has a mission for working towards achieving healthcare that is safe, compassionate and just. In their 10 Principles, Values & Beliefs, besides promoting system-oriented and patient-centred healthcare, they encourage open and honest communication, partnership and collaboration, but also accountability and forgiveness, and appreciation and positivemindedness, strongly relying on the human nature of the health professionals and self-correcting mechanisms naturally embedded into our existence.41 To this end, and in line with the above said, the patient safety seems to be a much more urgent issue than envisaged; the relativeness of its severity in different national contexts – from hand hygiene to proper application of sophisticated protocols to measurement of detailed quality and safety indicators – urges for a more country-based approach, while at all times considering both possibilities of the national health systems and the health needs of their citizens which in the base are equal when it comes to exercising their constitutional and universal rights to health and life.

Beyond this introduction

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Part Two Initiative “Eastern European and Asian Organizations for Patient Safety”

by Viktor Serdiuk and Ksenia Kosheleva

Protection of the Patients’ Rights and setting it as a priority for medical services and public healthcare is a new global challenge for many countries in the world. Issues of patient safety are especially relevant to the countries of former Soviet influence which are going through the period of social and economical transformations. In these countries healthcare systems before 1990 used to be very similar. With the collapse of Soviet Union transformations began to take place, including the ones improving safety in healthcare. This experience is priceless for each of the countries. This initiative is based on the necessity for patients to obtain quality, safe and accessible medical services. Patientcentered healthcare has to become the core of new policies and reforms in healthcare structures of the countries of Eastern Europe and Asia. At the moment the problem of patients’ rights protection cannot be resolved without concrete ways of cooperation between state authorities, non-governmental organizations and Patient Leaders.

Preamble

18 countries from Eastern European and Asian which have declared the decision to take part in the Initiative have been included in the project.

According to the applications participating countries were divided into four main regions:

What countries participate?

1. Caucasian region (Georgia, Armenia, Azerbaijan); 2. Central-Asian region (Kazakhstan, Kyrgyzstan, Uzbekistan, Mongolia); 3. North-Eastern European region (Poland, Lithuania, Republic Belarus, Russia); 4. Central-Eastern European region (Bosnia and Herzegovina, Bulgaria, Croatia, Macedonia, Slovenia, Moldova and Ukraine).

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Figure 1. Chart of participating countries

Project Activities According to the Initiative’s concept, 18 countries from Eastern Europe and Asia were united. The aim of the Initiative is to consolidate efforts of governmental and patients’ organizations for decision-making on safety, quality and accessibility of medical services as well as provision of human rights in the sphere of public health.

Key challenges for organizations participating in the Initiative:  Carrying out research regarding the spread of adverse medical events in healthcare;  Raising awareness and education about PS of the broad publicity, medical staff, students;  Involvement of patients and members of their families in the work on PS;  Assistance with implementation of reporting and learning systems;  Implementation of patient safety principles of WHO;  Following principles of the Declaration on Patient-Centered Healthcare System 24

The project includes three main phases:

 Carrying

out General Meeting (Ukraine), which will focus on development of Cooperation Strategy in the sphere of patientcentered healthcare in the regions and creation of International Expert Group. Every country gathers representatives of patients’ organizations, governmental agencies and independent experts who work in the sphere of public health. Implementation period: 3rd month of project’s implementation. Approximately – May, 2008.

 Carrying

out 3-day Working Visits in partner countries by the International Expert Group in accordance with Schedule drafted at the General Meeting. Working visit in each region will be devoted to getting acquainted with the activity of patients, advocacy and governmental organizations which are related to public health, discussion of the issues relevant to specific region and possible ways of their resolving, discussion of the target documents of the project and carrying out Press-Conference in order to raise awareness of the general audience regarding the issues of patient-centered healthcare. Implementation period: since 4th till 9th months of project’s implementation. Approximately – June- October, 2008.

 Carrying

out Final Meeting: Final Meeting will have the following structure: development of mechanisms of involvement of state authorities representatives related to public health on local and national level in the development of patient-centered healthcare in partner countries; signing of the Resolution on patient-centered healthcare of Eastern-European and Asian countries and Cooperation Strategy of the countries of Eastern Europe and Asia in the sphere of patient-centered healthcare for the following two years by partner countries representatives; Press-Conference with participation of Final Meeting participants with aim of raising awareness of the general public about project’s results. Implementation period: 10th month of project’s implementation. Approximately – November, 2008.

What are the anticipated long-term results of the Initiative?  Establishing cooperation between leading research and patient organizations, healthcare institutions and Governments of partnering countries of the Initiative on the issues of patient safety ;  Approval and signing of Collaboration Strategy of partner organization regarding implementation of principles of patient-centered healthcare system in the countries of Eastern Europe and Asia; 25

International Initiative Eastern European and Asian Organizations for Patient Safety

 Developed

recommendations for the governments of partnering countries of the Initiative on the issues of patient-centered healthcare system in the form of Resolution;  Raising level of education of the society with respect to the issues of patient safety, support of patients’ rights advocacy groups in partner countries of the Initiative;  Implemented model of effective cooperation between Ministries of Health of participating countries and society on the issues of patient safety.

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Part Three General Meeting and Country Overview - situation and priorities

by Neda Milevska-Kostova (ed.)

As described in the project activities, the General Meeting for coordination of project activities and setting country and general priorities of the participating countries was held in Kiev between May 12 and 14, 2008.

Countries and Participants

Of the 18 countries invited from Eastern European and Asian countries, 17 have joined with a total number of 21 participants that actively participated in the Meeting. The only country that could not participate was Croatia, due to technical reasons and impossibility of the representatives to join the Meeting.

The meeting was divided into two parts: (1) country situation presentations and (2) work in groups for setting the priorities and realistic actions by regions that could be taken towards addressing those priorities.

As the list of the participating countries suggests, this represents a vastly diverse group, not in geographic terms, but more important - in terms of the economic and political systems and development, which goes hand in hand with the structure and level of development of the services and civil sector (as the two most relevant segments for this project), as well as in terms of sector representation (public/government and civil/non-government).

General observations

Yet, as the group’s enthusiasm to deconstruct the issue of patients safety both within their national contexts and on the scale of the region/whole initiative, was obvious and expressive, this apparent weakness was transformed into the strength of the group - every country offered the list of problems and priorities, as well as skills and potentials that they see as possible input into the debate and action.

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International Initiative Eastern European and Asian Organizations for Patient Safety

As the differences are related to the national context and specificities as well as on the level of expertise of each of the participants, we have taken the approach of giving a short overview of each country’s situation.

I. Caucasian countries Georgia Situation with patient rights and patient safety

In Georgia there is a legislation dealing with the patient rights (Law on patients rights), enacted in 2004. However, it was stressed that the concepts of patient safety and patient empowerment are new and relatively difficult to introduce as a result of lack of funding in the system, political and economic changes in the country, including the rapid privatization and very aggressive marketing by pharmaceutical companies.

As a result, among others the following problems have been identified: - The majority health care organizations are private; - System is decentralized with insufficient communication among health care institutions; - There is evident lack of regulations, guidelines, standards; - Existence of separate patient organizations concentrated on specific issues; - Activities are not well coordinated.

Present activities on patient safety The Georgian Alliance for Patient Safety (GAPS) was established in 2005 and aims at the improvement of health care quality and promotion of safe, patient centered, effective health care for every individual. GAPS is currently proceeding with development of final tool for hospitals’ accreditation process and pushing forward a number of legislative initiatives for regulation of the patient safety issues in the frame of the legal system of the country.

On the research side, there are ongoing initiatives for: - Promoting the safety culture in Georgian hospitals, - Medication safety - Claims sensitivity to reflect trends in patient safety - Adequacy and ethics in TV stories related to health care

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Issues and priorities At present, the following fields related to patient safety were identified as priorities: - Patient advocacy (consideration of patients letters, alternative examination of patients complaints, campaign to enhance and legalize health ombudsman, etc); - Infection control (infection control manual, hand hygiene guidelines, etc.); - Adoption of international solutions for patient safety (“look alike sound alike medications”, High Concentration Electrolytes, etc.).

On the national level, several National Patient Safety solutions have been proposed as priorities: - Peri-operative Antibiotic Therapy - PAP; - Introduction of spinal/epidural analgesia in obstetrics; - Pathological examination of postoperative tissue; - Safe drug list for pregnancy/lactation, etc.

Situation with patient rights and patient safety In Armenia, there are several legally binding documents that regulate the rights of patients: - Constitution of Republic of Armenia; - Law on medical care of 1996; - Law on psychiatric care; - Law on reproductive health and rights; - Law on medications; - Law on transplantation of organs and parts of human body, etc.

Armenia

The mechanisms for protection of patients’ rights include administrative and procedures, international court procedures, etc.

Current activities in patients’ rights Current initiatives in the field of protection of patients’ rights in Armenia are related to joint work (increased cooperation) between the Ministry of Health and civil society organizations; special projects on protection of the rights of patients, Program “Medical Law” of the OSI Foundation, formation of Workgroup (Team) on patients’ rights (under funding of OSI), development of legislation for protection of rights of particular groups of patients (mental health, people living with HIV/AIDS, etc.).

As a result, in Armenia there is an increased level of activities of the civil society organizations (CSOs), participation of patients in the process of formulation of legislation related to patients’ rights, cooperation of international organizations, 29

International Initiative Eastern European and Asian Organizations for Patient Safety

programs for cooperation between MoH and CSOs, and further developments in the formulation of legislation, together with awareness raising activities of the general public.

Problems and challenges - Lack/incompletion of the current legislation; - Lack of information targeting the general population; - Psychology of the patients and medical professionals; - Insufficient capacity of the CSOs; - Lack of coordination and cooperation activities of the international community and between governmental institutions.

Priorities and further activities - Development of legislation and medical standards; - Development of effective mechanisms for protection of patients rights; - Wide information and awareness raising of the general public; - Establishment of programs on patients’ rights for medical professionals; - Advocacy activities in all levels of government.

II. Central-Asian Countries Kazakhstan Situation with patient rights and patient safety The Institute for Healthcare Development (IHD) is a governmental organization working in the field of public health care, making researches in improvement of a system of influence on the quality of medical help. Also, it presents suggestions of improvement of regulatory–legal base, converting it to international standards, works on international collaboration and other activities aimed to improve the quality of medical service in the country.

Their activities in the past and present are in the following fields - Standardization and evaluation of the medical technologies; - Economic analyses in the field of healthcare; - Development of information technologies in healthcare; - Research in of the healthcare system; - Marketing analysis in the field of healthcare services.

Present activities in patient safety - President’s Address to people of Kazakhstan “Strategy 2030” - Implementation of the National Program for reform and 30

- - - - -

development of Healthcare System of Republic Kazakhstan for 2005-2010; Regulatory-legal base on patient safety in Kazakhstan, adding changes and proposals for Patients’ Safety maintenance; Animation of the civil sector; Non-governmental organizations; Education/School for patients; Committee on infection control and education on a base of Republic’s sanitarian-epidemiological station of Kazakhstaneducational center on the national level.

Priorities and challenges - Improvement of the normative-legal base in the field of patient safety in Kazakhstan, adding proposals and changes according to international standards; - Creation of monitoring system for adverse events in medical treatment in every health institution; - Proper registration/recording of errors in medical practice; - Development of scientifically based standards in diagnosis and treatment in the whole field of patient safety; - Clarification and dissemination of the patient safety culture among patients and health professionals; - Creation of patient-oriented healthcare system in Kazakhstan, through increased interaction between patients and doctors with help of NGOs, publishing of regulatory-legal acts, development of a glossary on Patients’ Safety; - Inclusion of Kazakhstan into the International alliance of patient safety.

Situation with patient rights and patient safety As in all sectors of Kyrgyzstan, there is a need of cardinal changes in the healthcare system. With the help of World Health Organization during 19941996, the National Healthcare reform program of Republic of Kyrgyzstan “Manas” was developed (1996-2006).

Kyrgyzstan

Main features of the newly created healthcare model are: multiplicity; forming of infrastructure that is correspondent to the needs of population in the financial resources and medical help; decentralization of management, increase of financial and management autonomy of the healthcare organization.

Healthcare sector was divided on suppliers and buyers of medical services.

Among the priorities were declared: development of primary healthcare, 31

International Initiative Eastern European and Asian Organizations for Patient Safety

family medicine, free choice of family doctor, making medical services accessible to the population in the frames of the Program of notational guarantees. New methods of financing, that was oriented on end result, and methods of paying medical workers in relation to the quality of their work done, were implemented. The results of ten-year period of the healthcare reform show that although the economic situation is quite difficult, due to the help of the country and partners from WHO, World Bank, German Bank of Reconstruction and Development, Asian Bank of Development, USAID, UN, DFID, US, Switzerland, Japan’s international organizations, The Global fund to Fight AIDS, Tuberculosis and Malaria (GFATM), international Kirgizstan’s NGO, etc. we managed to overcome systematic crisis in healthcare.

In order to improve the quality of healthcare services there is whole complex of events, that are directed to increase professional competence of the healthcare workers, to implement stimulation mechanisms, to improve material-technical base of the healthcare organizations, to make medical drugs accessible, to make monitoring and to implement modern methods of management. There were developed and implemented accreditation and licensing standards for the healthcare organizations.

Nongovernmental professional associations were created in order to support medical organizations and to lobby their interests.

There was also developed the concept of managing the quality of medical services that is based on the expertise of the medical documentation, monitoring and analysis of the quality indicators, implementation of the methods of constant quality management.

New methods of financing and providing salary to medical workers create economical stimulus that increase quality of medical services, increase of the salary and equalization in the stationeries on the premiere level.

In order to increase the quality of the medical help and patient’s safety, there was created the committee on the quality of the medical help and patient’s safety by the main doctor of the National hospital on the 6th of September 2006, #34.

Uzbekistan Situation with patient rights and patient safety In Uzbekistan, there is not much developed regulation on the issues of patients’ rights and patient safety. There is a National Bioethics Committee, which is an independent governmental body, with authority of ensuring the protection of patients’ rights and health and guarantees patient safety during biomedical investigations.

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The National Committee of Bioethics work and authorities are regulated by following legislation: - Constitution of the Republic of Uzbekistan; - Law on protection of the health of citizens (1996); - Law on medications and pharmaceutical activities (1997); - Principles of the Helsinki declaration (1996); - Belmont’s report “Ethical principles and management on the protection of people, which participate in clinical studies”; - GCP (Good Clinical Practice), recommendations of the Committee of Ethics; - Other legislation of the Republic of Uzbekistan, that refers to the Committee.

Future plans

- - -

Discovering and contacting the NGOs dealing in the field of patients’ rights; Strengthening the legal assistance for the people living with HIV/ AIDS; Coordination and creating of umbrella organization of the NGOs working in the field of patients’ rights.

Situation with patient rights and patient safety In Mongolia, the concept of patient safety has not yet been introduced; the society is still struggling with achieving the level of comprehensive definition of the patients’ rights and patients’ rights are scarcely included in essential laws.

Also, as identified by the participants of the Meeting, there is no willingness from the government to bring out the issue in the light and tend to ignore the need of having comprehensive understanding of Patients Rights concept.

Mongolia

Priorities - Immediate challenges and expectations The participating institution, the Open Society Forum (OSF) has expressed their priority as the drafting and adoption of the single comprehensive Law on patients’ rights, as integral part of the country’s legal system.

The immediate challenges identified are: - Persisting competition of patient and health care providers are closing the traffic; - Lack of legal backups for patients right activists; - Fear at the policy level that publicizing the patients’ rights will cause abuse of rights by the patients.

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International Initiative Eastern European and Asian Organizations for Patient Safety

The expectations and priorities are: - Forms of patients’ participation in health care policy dialogue; - When is the right time?

- Effective system for remedy for the violation of patients rights; - Effective monitoring system of the adverse event in the medical practices as well as reporting mechanism.

Areas of concern The Mongolian team has identified the following concerns related to patient rights and patient safety: - The complex understanding and comprehensive definition of patients rights in appropriate documents; - Medical insurance and Health care financing as one of the key tool for better protection of patients rights; - Corruption in health care sector (bribes, grafts and etc.); - Quality and safety of pharmaceuticals – as a key threat in violation of patients rights; - Palliative Care – as an important entitlement; - HIV / AIDS affected groups – Stigma and Discrimination; - Reproductive Health Care – Access and quality of the services.

III. North-Eastern European Countries Poland Situation with patient rights and patient safety Being EU member since 2004, Poland has a fairly well structured and developed legislation with respect to healthcare, health rights and the health insurance system.

In 2008, upon initiative of 3 NGOs, a White Summit was held, which included different discussion pathways in plenary sessions, steering committee meetings and work group.

The White Summit produced the following recommendations: - Reforms of the healthcare system in the direction of embedding the principles of the Patient Centered Healthcare (PCH); - Ensuring Patient Safety compliance; - Empowering the Ombudsman – power of the voice; - Preparation of Strategy for Healthcare System reforms.

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Goals and challenges The goals identified by the initiating NGOs of the process of patient safety improvement are: - Integration of patients’ organizations; - Patient empowerment and advocacy; - Development of patient’s knowledge and their social awareness.

Besides this, as a prerequisite for starting the process of patient safety improvement, the following priorities and challenges of patients involvement in the health policy process were identified: - Continuation of patients voice representation in Polish Health Council; - Establishing the two ways communications; - Focusing on educational projects – health prevention; - Organizing media workshops for preparing the media on the issue of raising public awareness; - Empowerment of co-operation among NGOs, CSR and the local government.

Situation with patient rights and patient safety In the Lithuanian legislation, the patient safety is defined as a type of process or structure whose application reduces the probability of adverse events resulting from exposure to the health care system. The most important legal act regulating patients’rights is the Law on the Rights of Patients and Compensation of the Damage to Their Health (adopted in 1996). Patient safety activities are regulated in a number of legal documents, covering specific areas of the health care. These are various laws and orders of the MoH for establishing medical norms, specific procedures and mechanisms, such as: - Drug monitoring and safety, adverse events reporting; - Radiation safety, adverse events reporting; - Use of medical devices, adverse events reporting; - Safe laboratory practice; - Requirements for quality and safety of blood and blood components, adverse events reporting; - Healthcare associated (nozocomial) infections; - Licensing of healthcare institutions; - Licensing of healthcare professionals.

Lithuania

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International Initiative Eastern European and Asian Organizations for Patient Safety

According to the Law on the Rights of Patients and Compensation of the Damage to Their Health, among other, the patient has the right to (related to patient safety): - Qualified and accessible health care; - Select physician, medical services, diagnostic and treatment methods and a health care institution; - Information on health state, medical examination results, treatment methods and a health care institution; - Refuse treatment; - Be informed on the name, surname, position and qualifications of the physician treating him/her and the nursing staff member, nursing him/her; - Complain against the health care institution or the physician treating him/her; - Compensation of the damage to health made due to the fault of a health care institution.

The Programme for the Quality of Healthcare Assurance for 2005-2010, approved by the Ministry of Health covers tools in tackling with the following tasks: - Developing patient-centered health care; - Improving quality, safety and access of health care services; - Improving internal and external health care quality management systems.

Future plans, challenges and priorities - Raising awareness on the patients rights and safety items in general and medical community; - Encourage patients’ activity in health care process; - Promoting of safety culture in health care settings; - Implementing PS education and training of health care professionals and patients; - Cooperation, sharing information on good PS practices on national and international level; - Implement PS education and training of healthcare professionals and patients.

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Republic Belarus Situation with patient rights and patient safety In Belarus, the patients’ rights and safety are regulated with a number of legal documents: - Constitution of the Republic of Belarus (adopted in 1994); - Law “On Health Care” (adopted in 1996, amended in 2002); - Law “On Psychiatric Assistance and Guarantee of Citizens Rights on its Rendering” (1999); - Law “On Sanitary-Epidemiological Well-being of Population” (adopted in 1993) - Law “On Drugs” (adopted in 2002); - Law “On Donation of Blood and its Components” (1995); etc.

Other norms, related to patients’ rights and safety, are ethical regulations, embodied in “Ethics Code of Belarusian Health Practitioners” and National Bioethics Committee set of principles. However, these norms are formal and less influential than legislative regulations.

In terms of stewardship of the healthcare sector, MoH builds up all related to health system development proposals with following mandatory approval by Council of Ministers and/or President. Belarusian health leaders are committed to improving quality of health care delivery, but initiatives to making health care safer are limited, mainly due to lack of understanding of the nature and distribution of errors and adverse events that occur in these settings. However, standardization of medical procedures, accreditation of healthcare institutions and licensing of private health professionals have been established to ensure sufficient level of patient safety in Belarusian healthcare. In addition, strong systems of pharmacy vigilance and blood safety have been working since Soviet era.

From the side of patients, the situation with regard to rights and safety is still in its developmental stage, with only a few patients’ organizations existing and being active in this field; these organizations generally focus on specific disease groups and often work in conjunction with health professionals; however, they are reluctant to criticize the health authorities and struggle for their rights.

Key points and challenges - There is a case of fragmented approach on ensuring patient’ rights by incorporating them into different legislative texts; - The Law “On Health Care” tends to emphasize the responsibility of health professionals to provide care, and less concentrates on patients’ rights; - Easy and reliable mechanism for handling patients’ complaints doesn’t exist; 37

International Initiative Eastern European and Asian Organizations for Patient Safety

- - - - - -

Problems with right to information, choice of health provider; Participation of patients in decision-making is neglected; Patients’ organizations movement in general is weak and not influential; Strong paternalistic approach in doctor-patient relationships; Patients’ rights and safety are not on the agenda for Belarusian health authorities No reliable data on the scope and characteristics of medical errors and adverse events and the factors that lead to their occurrence are available.

Way to improvement: Priorities and recommendations At individual level: - Promote active involvement in health matters, dialogue between professional corporate organizations and patients’ organizations, balancing rights and responsibilities.

At institutional level (health care delivery): Actively involve the patient in the health care process by providing appropriate information and by presenting alternative treatment methods; - Secure respect of rights of the patient; accountability and transparency; effective complaint procedures; - Promote safety culture and system approach in reducing medical errors; - Establish a medical error reporting system for gathering information needed to elaborate adequate safety interventions.

-

At governmental level: Promote the democratic participation of the patient in developing health policy through legislation, funding and other appropriate instruments; - Promote training and education programs of health care professionals, which encompass the perspective and the role of the patient.

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Russian Federation Situation with patient rights and patient safety In Russian Federation, the term patient safety is widely used. The basics of legislation of the Russian Federation about health protection of citizens from July 22, 1993, # 5487-1 (with changes and additions) as a basic law defines human rights in the healthcare sphere.

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The maintenance of huge legatorial massive is focused on regulation of legal relations in the sphere on healthcare. Normative-legatorial base serves to satisfy demands of both: consumers of medical services, and institutions providing those.

On the other hand, the legislature has established quite big opportunities in applying various kinds of legal responsibility, that are defined in accordance with existing editions of the Federal law from March 30, 1999 “About sanitary-andepidemiologic well-being of the population” (with changes and additions), the Law of the Russian Federation from February 7, 1992 “About protection of the rights of consumers” (with changes and additions), the Criminal Code of the Russian Federation from June 13, 1996 (the Criminal Code of the Russian Federation) with changes and additions, the Civil Code of the Russian Federation (with changes and editions), and other normative- legatorial acts. Separate kinds of legal relations are regulated by special legislation: law on transplantation of human organs and tissues, blood transfusion, on aid for mental health people, on medicinal facilities, and sanitarian-epidemiological wellbeing etc.

Current activities in patient safety Multisectoral strategy concerning determinants of term of healthcare of citizens includes system of political, economic, social, cultural, scientific, medical, sanitarian-hygienic, and anti-epidemiological activities, that are projected on conservation and strengthening of physical and mental health of every person, support of his/her long active lifetime, provision of medical help in case of health loss.

Main principles of citizens’ healthcare - Following human and citizens’ rights in the sphere of healthcare, maintenance of governmental guaranties related to these issues.

- Prioritizing of prophylactics in the sphere of public healthcare.

- Accessibility of medical-social aid.

- Social safety of citizens in case of health loss.

- Responsibility of state, local self-governed authorities, businesses, institutions in human rights’ maintenance in the sphere of healthcare.

Main goals of Russian Federation’s legislation in the sphere of healthcare - Defining the level of responsibility and competence of Russian Federation, subjects of Russian Federation in questions of citizens’ healthcare in accordance with the Constitution of Russian Federation and Federal laws, as well as defining the level of responsibility and competence of local self-governed bodies in questions of public healthcare.

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International Initiative Eastern European and Asian Organizations for Patient Safety

-

- -

In the sphere of public healthcare, legal regulations of activities of businesses, institutions, and organizations (regardless of patterns of ownership) together with state, municipal, and private systems of healthcare.

Defining rights of citizens, separate groups of population in the sphere of healthcare; establishing guaranties of their maintenance.

Defining professional rights and responsibilities of medical and pharmaceutical workers, setting guaranties of social support of theirs.

Future development in the field of patient safety - In framework of working national projects “Education” and “Public health services”, it is possible in the nearest future to solve the major questions of the integrated medical education within the limits of European educational space.

- Creation of information databanks (on territories, regional/ inter-regional).

- Development of formal standards on PS, a glossary, techniques, approaches in standardization, medical statistics, etc.

- Introduction of a national priority “The Healthy nation” as a way of life, support and development of improving initiatives (sports, refusal of bad habits, preventive maintenance, etc.).

- Openness of the information in sphere of public health services and its availability.

IV. Central-Eastern European Countries Bosnia and Situation with patient safety and quality healthcare Herzegovina In Bosnia and Herzegovina (BiH), there are two entities and the county of Brcko, for which reason, the whole governance system has two sets of institutions.

For both the same legal framework applies; in the field of healthcare, there are two major laws: Law on Healthcare (FBiH and RS) and Law on quality improvement system, safety and accreditation in healthcare system of FBiH (adopted in 2005). The later regulates the establishment of the agency responsible for quality and safety improvement and accreditation, and the accreditation procedures for healthcare institutions.

Patient safety - current issues Despite there are stipulations in the BiH legislation that regulate the quality and safety improvement, the legal setting is not yet established; governmental 40

institutions responsible for establishing procedures are lacking resources, thus have no specific activities in this field. Besides this, the following issues related to the institutional capacity have been identified as challenge for future action: - There are no NGOs in BiH dealing with patient safety and promotion of patient rights; - There are only patient organizations focused on specific rights (e.g. medications free of charge); - Medical (professional) organizations are mainly oriented to health professionals needs; - Advocacy institutions - the health rights are not recognized as priority for the Human rights organizations; - Governmental institutions - lack of resources for action of the Agencies for Healthcare Improvement and Accreditation.

Priorities Thus, the following priorities and topics on improvement of patient safety understanding and promotion have been identified:

- - - - - - - - - -

Establishment of roof/umbrella (state) patient organization in BiH; Adoption of EU Charter of Patient Rights and its implementation; Involvement of all stakeholders in health system related to patient rights and safety; Adopt laws and regulations to enable patients to have influence on decision-making process; Develop adverse event reporting system (mandatory and ammoniums); Make performance indicators for hospitals and health works publicly available; Training for health workers and patients related to patient safety; Labelling of pharmaceuticals; Enabling safe patient journey through the health system; Strengthening role of Agency for Quality Improvement and Accreditation in Healthcare system.

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Bulgaria Situation with patient rights and patient safety The situation of the healthcare system in Bulgaria has been characterized as relatively well structured in terms of health services financing; the main issue with health insurance system at the moment is the existence of uninsured persons which have no access to publicly funded healthcare due to unpaid contributions.

Although the legislation is well covering the issues of healthcare, health insurance, patients rights (informed consent), accreditation procedures and ethics of the medical profession, with respect to the patient safety, the MoH recognizes the lack of specific institution on the national level dealing with the issues of health care quality and patient safety.

The accreditation of healthcare facilities is established since 2000, and it is obligatory for all healthcare settings in Bulgaria. The accreditation process involves indicators to ensure safely conditions for treatment.

In this field, currently the government is involved in the following aspects: - Preparation of legislation; - Preparation and implementation of clinical guidelines and clinical pathways; - Funding bodies for accreditation; - Protection of patients’ rights; - Participation in surveys on medical errors conducted by EU Commission at the end of 2005, and WHO survey on PS in 2007; - Program for prevention of nozocomial infections.

Future plans with patient safety The National Center of Public Health Protection (NCPHP) has developed a survey methodology for patient safety and the level of medical errors, and this methodology is about to be implemented in several volunteer hospitals with the concurrence of the MoH. There is an Adverse Event Reporting System (AERS) only for the blood transfusion, and this is obligatory for all health care establishments according to the ordinance. The introduction of AERS for other medical errors is also in plan for establishment.

Challenges and priorities - To make the top leaders aware of existence of the problem; - To set up an institution to deal with the issue; - To participate more actively in international initiatives in that field; - Development of PS research; - To conduct a survey in the hospitals; 42

- - - - - -

To organize a conference to present the issue in the society; To overcome blame culture in the health care establishments; To develop and implement Adverse Events Reporting Systems for the whole treatment process; To implement RCA and dissemination of good practices; Training of hospital personnel; Development of PS strategy.

Macedonia Situation with patient rights and patient safety The Macedonian healthcare system is legally well regulated in the aspects of healthcare services, health care insurance, patients’ rights, and mechanisms for protection of patients’ rights. As it was recognized by the civil sector and the MoH that the regulation on patients’ rights was very much dispersed in different laws, it was decided that a comprehensive single law should be prepared to regulate the protection of the rights of the patients; in 2007 the law was drafted and adopted by the government, and in July 2008 it was endorsed by the Parliament.

In the field of patient safety, there is no specific law regulating this issue, however, some stipulations exist in the various health-related legislation (laws and by-laws) as well as in the ratified legally-binding international documents.

The MoH through a World Bank loan has initiated the preparation of clinical guidelines, which are now in the process of introduction and implementation into the public healthcare sector.

Other relevant laws which directly or indirectly regulate the patients rights and safety include: - Law on health protection; - Law on health insurance; - Law on pharmaceuticals and medical aides; - Law on mental health; - Law on transplantation of human organs and parts of human body; - Law on safety of blood distribution; - Law on bio-medically assisted reproduction; - Law on safety of products (consumer protection); - Law on safety of cosmetic products, etc.

Also, the government has prepared the clinical guidelines and clinical pathways, but those are not yet fully implemented/used in the healthcare facilities in the country.

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Future plans in patient safety CRPRC Studiorum, which is working in the field of health related research and policy, and cooperates with the government on the issue of patients’ rights and patient safety, has identified the following steps and activities for the coming period: - Undertaking a survey on patient safety in Macedonia (patients’ view and physicians view); - Comprehensive analysis/research of the patient safety culture and practices; - Preparation of Handbook on Patient Safety - introducing the concept (in its series “Health in all policies”); - Advocacy for introduction of the concept of patient safety among professional community and general public; - Preparation of policy papers and draft legislation in the field of PS. Priorities in patient safety - Establishment of accreditation system (and possibly reaccreditation) of healthcare facilities using indicators as merit/ evaluation system; - Complete introduction of the clinical guidelines and clinical pathways in all healthcare facilities; - Preparation of action plan for monitoring and evaluation of the implementation; - Introduction of Adverse Event Reporting System (AERS).

Slovenia Situation with patient safety and priorities Currently, Slovenia (an EU member) is holding the presidency of the EU (January-June 2008). During the Presidency of the EU, Slovenia will promote the idea of Health in all policies and human rights as precondition of successful improvement of quality and safety in health care.

Other priorities for Slovenia are: reducing the burden of cancer, anti-microbial resistance, reducing the harm from alcohol use and e-health.

In the field of patient safety of this country, the Ministry of Health (MoH) has so far prepared clinical guidelines and clinical pathways, has set and implemented the Quality and performance indicators (since 2004), and worked on public and professional awareness raising, by conducting workshops for students and professionals on quality and safety in healthcare and organizing Conference on Patient Safety in 2006, and has a plan to organize a Conference on Quality in 2008.

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In March 2002 the MoH introduced a voluntary reporting system on sentinel events in Slovenian hospitals; sentinel events were analyzed according to the place the event, its content, and root causes. The results of the first year were presented in

a conference for hospital directors and medical directors, in which a survey was conducted among the participants with the purpose of gathering information about their view on sentinel events. One hundred questionnaires were distributed. This voluntary system was running in the period 2002- 2007; in 2008 MoH is preparing a new reporting system and we will try to include also all community health centres and other health care services in Slovenia.

Present activities in Patient Safety In the sphere of patient safety, Slovenia seems to be the country that has advanced much further than the other countries participating in this initiative. So far, the Slovenian government has worked on a number of papers and documents in this field, of which the most important are the National Policy for the Development of Quality and Safety in Healthcare (2006), The Resolution on the National Health Care Plan for 2008-2013 entitled “Satisfied Users and Providers of Health Care Services� (public debate in 2008) and the National goals on patient safety for hospitals in 2009 (activity in 2008).

Future Plans on Patient Safety - Dissemination and promotion of Patient Safety and Rights; - Establishing the National Body for Quality and Patient Safety in Healthcare; - Create working group to prepare guidelines - multi-professional team, cross-sector commitment; - Education and training of health professionals, students, patients and their families; - Implementation and recommendations into all levels of healthcare (primary, secondary tertiary); - Permanent evaluation, accompaniment and update of guidelines; - Change Patient Safety Culture; - Networking at the national and international level - inclusion of all stakeholders; - Further research in patient safety.

Current situation with patient rights and patient safety As health sector is one of the priorities of the government, the current activities are related to adjusting the regulatory framework to EU standards, public health reformation/improvement and conducting the Threshold Country Program (through the Millennium Challenge Fund) with the aim of setting up Quality Improvement System in Health Care. In the framework of Action Plan Republic of Moldova-EU (Government Regulation nr.889/2006) accreditation of medical institutions applying EU requirements is foreseeing as important mechanism for quality improvement of medical services.

Moldova

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International Initiative Eastern European and Asian Organizations for Patient Safety

According to the Government Regulation 526-2002 National Council for Accreditation and Evaluation was funded. Within adopted standards 40 quality indicators are applied for healthcare institutions’ assessment. The licensing procedures are applied only for pharmacies and private medical institutions.

Although there is no specific legislation on patient safety, there are a number of laws and bylaw documents in which certain aspects of patient safety are regulated: - Law on customer rights; - Law nr 1585/1998 on Mandatory Health Insurance; - Law nr 263/2005 on Patients Rights; - Order of Ministry of Health on Pharmacovigilance (2006); - Blood safety program 2005-2010(Order MoH); - Frame Code of Deontology (Ap. MoH 2008).

Patient rights and safety theme became actual for range of state institutions and NGOs - Parliament Commission on Human Rights, National Center for Health Management „Acasă” Association, Moldovan Institute for Human Rights, Human Rights Resource Center „CREDO” Patients’ Rights Bureau etc.

But patients’ movement and advocacy actions are underdeveloped.

Future development - Proposed priorities and identified challenges The Management and Assurance in Medicine - MAM (an NGO established in 1994) has identified the following activities for their organization in the field of patient safety: - Patients organizations involvement in addressing this issue; - Governmental-nongovernmental partnership and common plan of actions; - Training of health care professionals in PS; - Applying WHO’s or EU requirements in the field of PS; - Implementation of standards in health care; - Media activities.

The results of survey performed by National Center for Health Management with participation of experts from MAM in the end of 2006 suggested certain proposals for activities to address Patient Safety issues in Moldova: - Elaboration of the concept of Quality Management in Health Care (MoH); - Establishment of state institution for quality management in health care (Gov); - Establishment and coordination of Work groups for guides, protocols elaboration (MoH with Health Insurance Company participation); 46

- - -

Dissemination of protocols, guides, training (Medical University); Monitoring of implementation of protocols and guides (Cons. of Accreditation); Monitoring of efficiency: applying quality indicators.

Short overview of the situation with patient rights and patient safety The overview is provided by the All-Ukrainian council of patients’ rights and safety.

Ukraine

The All-Ukrainian council of patient rights and patient safety is an NGO working in the field of health policy and assistance that has established three goals: - Improvement of level of patient safety; - Legal assistance to patients and lobbying of healthcare reforms - Palliative care and human rights in the end of life In Ukraine, the term “Patient Safety” is not widely used in medical practice.

There is a general lack of patients’ safety culture. Among the components of safety culture, the following ones can be highlighted: - No dialogue between the doctor and the patients yet, - Evident culture of blaming and accusation (not only in Ukraine, but in other countries as well), - Lack of political will to solve the problem of patient safety.

This may lead to the situation when progressive normative acts, that have influence on maintenance of qualities, safe and accessible medical services (for instance, the Order of Ukrainian Ministry of Health #92 from 24.02.07 “About of Criteria of governmental accreditation of medical-prophylactic institutions”), are being followed only on paper.

Present activities in patient safety In April 2007, the All-Ukrainian Council has initiated the creation of Expert Group on patient safety; the goal of the Expert Group is support in development of national network of patients-leaders. The network provides support in implementation of effective mechanisms and culture of patients’ safety in medical practice The Expert Group consists of representatives from: - Ministry of Health; - Parliamentarian Committee on healthcare; - Research institutions; - Medical professionals; - Leading NGOs; - Pharmaceutical companies and hospitals.

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The All-Ukrainian Council actively cooperates with the Ministry of Health of Ukraine in the sphere of patients’ safety as well as with lately created Department on inspection and control of quality of medical services within the Ministry of Health. It also works on the creation of the First Centre of Medical Law in the Institute of Government in the National Academy of Sciences.

The Council cooperates with the Parliament on the issue of patient safety, preparation of legislation and other health-related documents, etc.

Future plans in patient safety All-Ukrainian Council in planning the following activities: - Creation and lobbying of the public program on healthcare reforms.

- Support in implementation of the patient centered healthcare system.

- Support to existing and increasing the number of patient leaders/ advocates; - Support in the process of inclusion of Ukraine in the International Patient Safety Alliance; - Participation in the project “Eastern European and Asian Organizations for patient Safety”; - Organization of International Patient Safety Congress in December 2008; - Public awareness raising and education on the issues of patient safety; - Undertaking research and introduction of the phenomenon of adverse event reporting.

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Part Four Work Groups results - priorities and activities Viktor Serdiuk, Anatoliy Tsarenko

After the country situation presentations, the participants were divided into two groups (two country regions per group) in order to discuss the priorities and realistic activities that could be undertaken to achieve the objectives of improvement of patient safety in each of the countries. One group was formed of the countries in the Caucasus and Western Balkans, Moldova and Ukraine, and the other group was formed from the countries belonging to the regions of North-Eastern Europe and Central Asia and Mongolia.

The specific instructions were distributed to the groups, with following contents:

The Process

1. General view of the goal and tasks of work in groups; 2. Three priorities of the activity in each group; 3. Which realistic steps could be undertaken in this direction; 4. General view of the plan of work; 5. Drawing conclusion and choosing a speaker in each region.

As mentioned previously in this text, the diversity of the group imposed the possibility of differences not only in the view of the problem, but also in the understanding of the concept of patient safety and finally, the defining of the priorities and actions.

At the end, the two groups came up with the different aspects of the given issue, in which the one group focused more on the priorities and the other one - on the realistic activities that could be taken to proceed to the listed priorities and objectives.

The Results

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International Initiative Eastern European and Asian Organizations for Patient Safety

Priorities and The whole list of priorities was summarized into three major ones, under each activities to be of which the most realistic activities are given: taken 1) Awareness raising and education of the patients and professionals on the concepts and idea of patient safety (and in some countries patients’ rights): - To organize educational workshops for medical students and health providers according of WHO patient safety principles and Declaration on Patient-Centered Healthcare System principles; - To train patients’ NGOs leaders and patients’ champions, - To involve patients and members of their families into patient safety activities; - To organize educational events and develop/print educative brochures/posters for wide distribution (to patients); - To improve the best practices and experience distribution by Internet websites, round tables, conferences etc; - To improve fundraising for institutional support of patients’ NGOs; - To improve cooperation and dialogue between authority institutions, health providers and patients’ NGOs leaders to decrease adverse medical events.

2) Research on the patient safety, in terms of setting up standards and indicators, but terminology as well: - To conduct patient safety surveys (view of the patients) in particular fields in pilot healthcare settings; - To conduct research regarding the spread of adverse medical events and develop an effective monitoring and reporting system of adverse medical events; - To develop terminology guide (Patient Safety Glossary) and organize Consultative Workshop with health and legal professionals and linguists; - To conduct research on patient safety standards and develop standards drafts for the national context; - To develop draft-plan for implementation of the standards in the country; - To discuss the patient safety surveys results by Internet websites, round tables, conferences etc.

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3)

Preparation and endorsement of patient safety legislation, including specific laws, by-laws, clinical guidelines, handbooks etc: - To organize Task Force on patient safety legislation in collaboration patients’ NGOs leaders, patients’ champions, legislation and health care experts, Health Authorities and specialists; - To conduct research on acting patient safety legislation and clear the gaps to improve it; - To develop necessary patient safety legislation documents draft and discuss it by websites, Round-Tables, conferences etc; - To present patient safety legislation documents draft to the Health Authorities to approve it; - To improve the best practices and experience distribution by websites, Round-Tables, conferences etc.

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Part Five Results of the Survey on Patient Safety

by Mina Popova (ed.)

Patient Safety in 16 countries: Review of Policies, Current Initiatives and Gaps - Comparative analysis of the countries represented in the project “Eastern European and Asian Patients Organizations for Patients’ Rights and Safety” Prior to the General Meeting, a questionnaire on patient safety situation in all countries was distributed to the participants. Below is the analysis of the answered questionnaires from 16 countries.

This analysis is a part of the activities of the project “Eastern European and Asian Patients Organizations for Patients’ Rights and Safety” in which the representatives of the following 18 countries participate:  Caucasian countries (Georgia, Armenia, Azerbaijan);  Central-Asian countries (Kazakhstan, Kyrgyzstan, Uzbekistan, Mongolia);  North-Eastern European countries (Poland, Lithuania, Republic Belarus, Russia);  Central-Eastern European countries (Bosnia and Herzegovina, Bulgaria, Croatia, Macedonia, Slovenia, Moldova and Ukraine).

The aim of the analysis is to compare the policies, initiatives, and funding in the field of patient safety in order to evaluate the current situation and to try to define the main strategies for future development for all represented countries.

The analysis is based on the answers of the questionnaire distributed among the countries. The questions have been grouped into following categories: - Health care system; - Patient Safety legislation; - Surveys and Reports; - Economic price/impact of adverse events and medical errors; 53

International Initiative Eastern European and Asian Organizations for Patient Safety

- - - - - - - - - - -

Involvement of the government; System approach; Change of culture; Adverse Events Reporting System; Root Cause analysis; Accreditation and PS; Use of clinical guidelines; Feedback to hospitals and the other institutions; Patient involvement; Funding of PS activities and programs; Gaps in the sphere of PS.

Health care All counties inherit health care systems based mainly upon the Semashko systems model of tax-based financing and public health provision that guaranteed

the entire population access to free and comprehensive range of primary, secondary and tertiary health care services.

In addition, in all countries the MoH develops and implements national health policy, defines goals and priorities of the health system, works out national health programs for improvement of the health status of the population, and develops draft legislation concerning the health sector.

For some of the countries (Armenia, Uzbekistan, Russia, Belarus, Mongolia, Kyrgyzstan, Georgia, Kazakhstan, and Ukraine) MoH retains responsibility for overall supervision and financing of the health care system. For them, taxes are the main source of financing of the health care. In Georgia, Kazakhstan and Ukraine the voluntary medical insurance is under development. Mongolia also has a system of health insurance.

The rest of the countries (Poland, Bosnia and Herzegovina, Macedonia, Slovenia, Bulgaria, Lithuania, and Moldova) have systems of social health insurance. The main function of the HIFs is the management of the financial resources for medical care of the population. In addition, some of these countries (Slovenia, Bulgaria, and Lithuania) have also voluntary health insurance which is supplementary.

Therefore, for these countries HC is financed through: - Mandatory health insurance contributions; - Taxes; - Other sources: voluntary health insurance contributions (Slovenia, Bulgaria, Mongolia and Lithuania), subscriptions by employers for specified health services, cash payments by citizens, donor support, the regulated patient’s co–payment.

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The percentage for health care of GDP varies from 1.6% (Armenia) to 8.3% (Slovenia, Bosnia and Herzegovina). Except the last two countries and Macedonia (6.8%), the total health care expenditures in the other countries are low in comparison with the EU countries where this figure is around 6-8%.

Therefore, the financial resources are insufficient for the management of the health system in our countries which to a certain extent define the existence of the main problems (see Figure 1).

Figure 1. Health care expenditures as % of GDP

Source: The Questionnaire; WHO, HiT for Ukraine, Uzbekistan, Russia There is coexistence of public and private health care providers as the number of the public ones is larger than the private. General practitioners control access to specialized out-patient and hospital care. Hospitals are also public and private. The contracting model based on the contract between the 55

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HIFs and the health care providers exists in the countries with social health insurance (Poland, Bosnia and Herzegovina, Macedonia, Slovenia, Bulgaria, Lithuania, Mongolia, and Moldova).

For the other countries (Armenia, Uzbekistan, Russia, Belarus, Mongolia, Kyrgyzstan, Georgia, Kazakhstan, and Ukraine), the public health care providers are paid for from the state budget.

Patient Safety Still, the countries represented in the project do not have a Law on Patient Legislation Safety but in some of them the definition of that concept has been developed

and used in current health care legislation like Law on Health (Bulgaria, Russia, Ukraine, Republic Belarus), documents related to the prevention of the nozocomial infections (Mongolia, Lithuania, Bulgaria), accreditation and quality programs (Poland, Bosnia and Herzegovina, Bulgaria), patients’ rights (Slovenia, Kyrgyzstan, Georgia, Kazakhstan, Macedonia), ethics (Uzbekistan).

According to the representatives of Macedonia, Belarus, and Armenia, there is no exact definition of patient safety in their countries.

In general, though the existence of some terminologies related to patient safety, still it is not widely used and needs to be promoted not only among the health care professionals but also among the population. Here, the government together with the NGOs should have a significant role.

In all countries mentioned above the following legislation exists that governs the activities related to patient safety: 1. Law on Health.

2. Law on Quality Improvement System, Safety and Accreditation in Health Care.

3. Law on Health Care Establishments.

4. Law on Protection of Patients’ Rights.

5. Law on Ombudsman.

6. Codes on Ethics (for physicians and nurses).

7. Ordinance for Nozocomial Infections.

8. Medical standards, etc.

Therefore, the lack of Patient Safety Act itself does not mean that the countries represented in the project do not work in that direction. However, the activities are still mainly piece-work, e.g. they are in certain fields in order to cope with some problems (nozocomial infections, blood transfusion). Also, they do not include health care system as a whole, patients are not aware of the existence of that terminology and of the protection of their safety and rights.

Most of the countries (Poland, Slovenia, Lithuania, Moldova, Uzbekistan,

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Russia, Georgia, Kazakhstan, Ukraine), have been involved in some EU and WHO’s initiatives like EUNetPaS, PATH Project, MARQuIS, SImPATiE, CoE’s Recommendations for patient safety, etc. Mongolia have applied WHO’s guidelines of nozocomial infections, Bosnia and Herzegovina – the adoption of EU Charter of Patients’ Rights. The other like Bulgaria intends to apply the CoE’s Recommendations, to participate in PATH Project and to be more actively involved in EUNetPaS whose member is. For Macedonia, Armenia, Belarus, Kyrgyzstan there is no available information about the application of or intention to apply some of the EU and WHO’s initiatives mentioned above.

In most of the countries different surveys on patient safety or on the level of medical errors / nozocomial infections have been conducted with or without international support.

Surveys and Reports

Poland – NCQA and MoH have participated in WHO survey on PS, published last year by WHO Europe; TPJ has conducted the first Polish survey on PS in 2003, based on the Danish National Project on PS. The study concerned attitudes towards reporting medical errors in healthcare professionals. More than 78% of respondents claimed to have participated in medical errors.

Also, Patients Safety Foundation has published a survey about patients’ satisfaction about medical treatment in the country that has been published in 2006.

Kazakhstan – survey on nozocomial infections that concludes that they increase with 5% during the first 10 months in 2007 in comparison with the same period in 2006.

Georgia – two surveys on medical errors (2006 and 2007), survey on patients’ rights – implementation of ombudsman, control of infections, development of indicators for hospital assessment.

Ukraine – a survey on adverse medical events (clinicians and patients) in 2007 has been conducted but practically there is still no data about the spread, nature and causation of the adverse events.

Armenia – assessment of quality of pediatric hospital care (with WHO, in progress), survey on antimicrobial treatment evaluation at Nork Marash Medical Center (2005), comparison of three models to predict operative mortality risk for coronary artery surgery in Nork Marash Medical Center (2004).

Moldova – survey on quality of medical services related to the risk provided by National Center for Health Management (2006).

Lithuania – surveys on measures of patients’ doses in X-Ray diagnostics (since 2004), project “Bridging the gap between the patient and the doctor: research, promotion and training”, project “Patients’ rights”, etc.

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Slovenia – In 2006 the Ministry of Health for the first time conducted a National Patient Experiences Survey in all acute and psychiatric hospitals.

Second reports on survey findings from 2007 will be prepared and issued in 2008. At the same time The Ministry of health had required these hospitals to appoint Quality Coordinators to facilitate the introduction of patient safety indicators and quality improvement tools. Survey -100 questionnaires were distributed to hospital directors on sentinel events (2003).

Bulgaria – participation in a survey on medical errors conducted by EU Commission at the end of 2005 and published in 2006. Also, the NCPHP has participated in WHO survey on PS, published last year by WHO Europe. The survey methodology for patient safety and the level of medical errors is already developed and is about to be implemented in several volunteer hospitals.

Macedonia – is now preparing the survey on patients’ safety for patients, healthcare providers, legislators, and lawyers. The survey will take place in 2008/2009.

Kyrgyzstan, Bosnia and Herzegovina have implemented patient satisfaction surveys so far.

Still, surveys on patient safety have not been conducted in Belarus, Russia, Uzbekistan, and Mongolia.

Economic price/ impact of adverse events and medical errors

Most initiatives in all represented countries are still in very early stages, having been initiated within the last two years. There has as yet been no comprehensive evaluation of the economic price of medical errors or adverse events on health care system as a whole. Such evaluation might be considered as one of the future activities.

Involvement of The involvement of the governments in patient’s safety initiatives may take the government different forms: preparation of legislation (all countries), cooperation in

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organizing the conferences on patient safety and quality (Poland, Slovenia), participation in the work of the WHO and / or in EUNetPaS (Poland, Armenia, Belarus), other national or international projects (Bosnia and Herzegovina, Moldova, Georgia), funding bodies for quality and / or accreditation (Bosnia and Herzegovina, Slovenia, Lithuania, Bulgaria, Moldova, Armenia), preparation and implementation of clinical guidelines and clinical pathways (Slovenia, Bulgaria, Armenia), funding of Ethical Committee (Mongolia), protection of patients’ rights (all countries). Therefore, in all countries governments respond to the issue by taking either a leading or supporting role in the development of different initiatives. In the future, the involvement of the governments might be considered in the development of countries’ patient safety strategy.

In all countries, the health care establishments still do not consider themselves as a system or as “a collection of interrelated microsystems”42. Usually, if a medical error or adverse event occurs, the attitude of the personnel is “Blame the person, not the system”. However, everybody can make mistakes, even “the best people in the best organization” according to some UK experts.

Therefore, the problem is not in the person him/herself but the system must be changed in order to become more secure for the patients. The application of the system approach will help us not to look for “who is guilty” but to answer to questions “why it has happened” and “how to prevent patterns of errors in the future”.

System approach

The organizational culture must encourage reporting. Currently, the existence of “blame culture” does not motivate the personnel to talk about and report medical errors. The reasons for this include: fear of litigation, fear of colleagues’ disfavor and penalty, etc. The policies of all countries are premised on the need for significant change in the thinking and behavior of health care providers and health care institutions about the causes of medical errors and how to prevent them. Culture change must become one of the key concepts in all countries in order to develop and implement a successful reporting system.

Change of culture

In order to improve safety of the patients, professionals should learn from their mistakes. Lessons can be drawn when an adverse event occurred is reported by the doctor, nurse or other provider within the hospital through a regional or national reporting system. Otherwise, the same mistakes will occur repeatedly and patients will continue to be harmed by preventable errors.

Adverse Events Reporting System

In the filled questionnaires, two counties indicate the existence of Adverse Events Reporting Systems – Bosnia and Herzegovina and Armenia. In Slovenia, the voluntary reporting system on sentinel events exists in the hospitals since 2002 which is intended to be expanded in order to include all community health centers and other health care services.

In other countries, there are requirements on the national level and systems for reporting of adverse events related to: - Blood and blood transfusion (Lithuania, Bulgaria); - Radiation safety (Lithuania); - Pharmaceutical safety (Lithuania, Kazakhstan); - Nozocomial infections (Lithuania, Poland, Bulgaria); - Use of medical devices (Lithuania); - Infant and pregnant deaths (Lithuania).

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There is a system for reporting and dealing with the patients’ complaints in almost all countries represented in the project, which are attempts to discuss and talk about the issue not only among the health care professionals but also in the society. These open discussions may lead to further developments of the problem in direction of the implementation of reporting system. However, the latter requires the involvement of the top managers of the health care systems.

Root Cause By definition, root cause analysis (RCA) is “a process designed for use in Analysis investigating and categorizing the root causes of events with safety, health,

environmental, quality, reliability and production impacts”43. It means that the RCA is a means to identify not only what and how an event occurred but also why it happened. Thus, through that tool the recurrence of the event is prevented.

Among the countries represented in the project, four indicate the use of RCA in their practices – Slovenia, Georgia, Armenia, and Lithuania. Though the role of that tool for the prevention of medical errors and patient safety has been recognized, still the attitude even in these countries is fear of consequences for the health care provider and public disclosure.

For the rest of the countries, RCA has not been used yet as a tool. Therefore, more discussions and training are needed in order to understand the importance of the tool for the system of patient safety. Also, a key challenge will be to find ways to share results of RCA between organizations.

Accreditation and By definition, the accreditation is a “system of knowledge and approaches patient safety for monitoring, analysis, and assessment of quality of health care services against definite criteria, standards, and indicators”. Therefore, this is a process aimed at guaranteeing the health care quality and motivating the health care establishments to better results. Patient safety is considered as one of quality dimensions. That’s why, in most countries around the world the accreditation system is the instrument for patient safety control, as well.

Among the countries represented in the project, Bulgaria seems to have the most developed system of accreditation. Its implementation in 2000 has put the quality of health care on practical grounds for the first time. It is obligatory for all health care establishments according to the Law on Health Care Establishments.

All of them are accredited. The accreditation programs include some indicators for patient safety assessment. The development in that direction is under discussion because the accreditation does not currently equal an assurance that health care is being provided safely in accredited settings.

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Other countries with relatively well developed accreditation system are Poland, Belarus, Mongolia, Macedonia, Kyrgyzstan, Moldova, and Armenia.

Except in Poland, still the accreditation in these countries does not consider in their programs the issue of patient safety.

The accreditation is under development in the rest of the countries – Russia, Uzbekistan, Kazakhstan, Bosnia and Herzegovina, Ukraine, Lithuania, and Georgia.

Except for Poland, Belarus, and Armenia where the process is under development, clinical guidelines are developed and used either for quality assessment or as a financial tool in all other countries. In most cases these guidelines are based on the European ones but adapted for the definite country. The main participants in the process of their implementation are the MoH and the scientific societies of the medical specialists. Therefore, countries’ governments recognize that clinical guidelines contribute substantially to patient safety and quality. That’s why, the initiatives in their developments are mainly governmentally funded.

Clinical guidelines

The communication between the health care providers at the different level of health care (primary and secondary) is relatively good in order to ensure the continuity of care, which is supposed to be one of the important issues in patient safety field. As the patient safety activities in all countries are at very early stage of their developments, still the communication in that direction is weak. In the future, providers and institutions need to see the benefits in participating in adverse events reporting and root cause analysis systems.

They get to share the experience of others, giving them the potential to avoid accidents that happened. Also, web sites could be a good way to disseminate root cause analysis findings and good practices.

Feedback to hospitals and the other institutions

In almost all of the countries different forms of patient’s involvement in health care process exist. In some countries (Lithuania, Ukraine, Bulgaria) it is ensured by protection of their rights to select the health care establishments, diagnostic and treatment methods; rights to information about his or her health status as a result of treatment, etc. In Lithuania, these rights are defined with the Law on the Rights of Patients and Compensation of the Damage to their health. Such a Law is under endorsement of the Parliament in Macedonia. In Bulgaria, the protection of the patients’ rights is part of the National Framework Contract signed between the NHIF and the professional organizations of the physicians and dentists and resigned by the minister of health.

Patient involvement

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Another form of patients’ involvement is through their participation in patients’ organizations (Lithuania, Bulgaria, Ukraine, and Kazakhstan). In Kyrgyzstan, closest to the patients are the so called “health committees in the villages” whose number is 760. Their task is to provide the necessary information to and education of the patients in terms of all issues related to health. In Poland, a Federation of Polish Patients do organize conferences, seminars, workshops, etc.; also, through that Federation patients participate in many governmental activities, e.g. legislation process in Poland, cooperate with international organizations to implement the good practices and models.

In Georgia, a strategy for patients’ involvement is under development.

In Armenia, local and international NGOs with support and supervision of the MoH organize health education of the patients that also includes development of patient education materials.

Ukraine has implemented first steps towards involving patients and members of their families to the process of healthcare reforming and empowering them in order to pursue the goals of raising awareness, culture change, shifting the blame culture, focusing on patient, etc. The work is based on the WHO World Alliance for Patient Safety Project “Patients for Patient Safety”.

In Slovenia, patients participate in different working groups within the MoH and in Quality Committees, as well, that exist in the largest hospitals.

Another form of patients’ involvement in the medical process is signing “Information consent” (Moldova, Bulgaria). In such a way, the patient is informed in advance about the treatment procedures, the expected results and the adverse reaction that might occur. Thus, he/she also participate in the decision making process to accept or refuse the treatment.

In addition, patients’ satisfaction surveys are done on a regular base in almost all countries. This is also a form for the health care establishments and authorities to hear the patients’ voice. Such surveys are a good source of information for improvement of the process of the organization and management of health care activities.

Still, some countries need to make more efforts in making the patients more involved in the health care process (Uzbekistan, Belarus, Mongolia, Russia, and Bosnia and Herzegovina). That’s important because patients’ feedback is a source of information to improve care and safety.

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Still, it is difficult to make exact estimation of the financial resources devoted to patient safety and quality activities in all countries. The reason for this is that these initiatives are at very early stages of their existence. However, the development and implementation of a definite legislation, clinical guidelines, accreditation process, conducting of surveys and participation in different national and international projects mean that the government, some state institutions and NGOs provide financing in that direction, which is addressed to a certain extent to patient safety.

Funding of PS activities and programs

The analysis allows the following similarities and differences in patient safety policies and initiatives in the countries to be found:

Conclusions

Similarities:

•

The patient safety is a problem for all countries represented in the project. All of them share essentially the same policy assumptions about that issue. This includes the understanding that adverse events and medical errors in health care settings are common and are results from the weakness in the system and not personal fault.

•

Still, the initiatives related to patient safety are at very early stage, having been initiating within the last two years. Thus, there is yet no comprehensive evaluation of these countries’ activities.

•

All countries should invest efforts in creating relevant environment for involving patients in the work on patient safety. This is the only true way to achieve authenticity and patient-centeredness in any healthcare in the world.

•

Also, in all countries patient safety needs more promotion among the policy makers, patients and health care professionals.

•

Though the existence of a definite health care legislation in all countries that gives a definition about patient safety, none of the countries have a Law on Patient Safety. Therefore, it is difficult to specify the role and main responsibilities among all health care partners and also to devote financial resources directly to the activities related to that issue.

•

In all countries, the governments play a definite role in that field through supervising the accreditation process, the development of clinical guidelines, organizing conferences, workshops, etc.

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•

In all countries, research activities in patient safety are not very well developed due to the lack of financial resources set aside for this purpose.

•

Most of the countries need to recognise the importance of the adverse events reporting system and to work on its development and implementation.

•

All countries need to put more efforts in understanding and use of RCA and also in dissemination of the positive experience among health care settings.

•

More efforts are also needed in improving the communication between the healthcare establishments themselves, between them and patients’ organizations and the MoH, the health insurance funds, as well. The involvement of as much as possible partners in patient safety initiatives is a prerequisite for the success of these activities.

•

In all countries, the necessity to overcome blame culture in the health care establishments is recognized. That culture should be replaced by the culture of trust that is a necessary condition for the success of any reporting system.

•

In all countries, some efforts should be made in setting patient safety standards, development of policy papers, and training of health care personnel in the field of patient safety.

Differences:

•

The countries are at different stages of development of their patient safety initiatives. Some of them are a little bit more advanced than the others but still lots of efforts are needed to be taken in that direction.

•

In most of the countries there are NGOs at the national level that are involved in patient safety and quality initiatives and have good collaboration with the MoH and governmental institutions (Georgia, Poland, Slovenia, etc.).

•

Three of the countries (Slovenia, Bosnia and Herzegovina, and Armenia) have developed adverse / sentinel events reporting system. The early stage of its development is a reason for not having yet the evaluation and dissemination of the results.

It is a long and challenging way that the health care system in all countries should undergo. This way requires some changes to occur in terms of: • Culture – the hospitals have to overcome the culture of blame and to develop a culture of trust and learning; • Patient involvement – to use their knowledge, activeness and ensure patient-centeredness of any initiatives; • Use of system approach – patient safety has to be based on systems, which are implemented in management structures (medical, administration); • Development of reporting system, which has to become a basis for “learning from failures of the health care system”44 and for dissemination of lessons learned in order to make constructive decisions; These changes take time and do not concern only hospitals but also the other health care stakeholders: policymakers, patients, agencies, etc. However, the processes related to quality assessment and patient safety are on the agenda in other countries all-over-the world and our countries cannot stay aside from them. It is a time to take actions and we must do this now in order to meet the EU requirements. Moreover, our citizens deserve to have a health care system that is safe and secure for them.

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Appendix One Questionnaire on Patient Safety: country context

by Mina Popova

1. Health care system (please, describe healthcare system in your country): 1.1. Structure of healthcare services (specify also the name Ministry of Health and the name of Parliament’s Committee on healthcare services); 1.2. Providers of medical services: a form of property (state/private); 1.3. Financing (health care contributions, budgetary financing, private financing); 1.4. Percentage of GDP for health care.

2. Patient Safety legislation: 2.1. The concept “Patient’s Safety” is used in official terminology?

2.2. Please, mention major legislative documents that govern PS sphere in your country, if any; 2.3. Please, mention if you have applied or intend to apply any WHO’s or EU requirements in the field of PS in your countries.

3. Surveys and Reports: 3.1. Please, indicate and briefly describe any surveys or reports that were implemented in related to PS sphere in your country.

4. Economic price/impact of adverse events and medical errors: 4.1. Please, indicate any known data regarding the economical impact on national healthcare of medical harm, if any.

5. Involvement of the government: 5.1. Please, indicate the ways your country’s government is involved in managing PS. 6. System approach: 6.1. Please, state if actions on PS were implemented based systematic and comprehensive approach.

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7. Change of culture: 7.1. Please, state main challenges of the HQ system in PS sphere.

8. Adverse Events Reporting System: 8.1. Please, comment on implementation of adverse events reporting systems in your country.

9. Root Cause analysis: 9.1. Please, comment how this concept relates to PS in your country.

10. Accreditation and PS: 10.1. Please, comment on the situation with accreditation and licensing of medical institutions in your country.

11. Use of Clinical guidelines: 11.1. Please, comment on the nature and implementation of clinical guidelines in your country.

12. Feedback to hospitals and the other institutions: 12.1. Please, describe communication system between hospitals, executive bodies and other related institutions in your country.

13. Patient involvement: 13.1. Please, describe any actions/initiatives taken in your country to involve patients’ in healthcare process.

14. Funding of PS activities and programs: 14.1. Please, indicate funding mechanisms of PS activities and initiatives in your country, if any.

15. Gaps in the sphere of PS: 15.1. Please, indicate three main priority challenges to be addressed.

16. Future development: 16.1. Please, describe first real steps that could be taken in your country in the sphere of PS. 17. Please, comment on the perspectives of patient’s activism development in your country (maximum 300 words).

18. If you have any further remarks you would like to share, please, feel free to use space provided (maximum 300 words).

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Appendix Two List of Participants and Experts International Initiative “Eastern European and Asian Organizations for Patient Safety�

Dr. Madina Baimagambetova Institute for Healthcare Development E-mail: m.baimagambetova@dsdi.kz

Kazakhstan

Dr. Madina Baimagambetova has worked since 1977 as a pediatrician, as doctor at the Institute of Food and as infectologist at the National AIDS Centre. She had been Head of the department at the National AIDS Centre, and Deputy chief doctor in the Regional AIDS Centre of Alma-Ata. Since 2006, she is working as the Head of the Standardization Department in the Institute for Healthcare Development. She graduated from Pediatrician Faculty at the National Medical University of Alma-Ata, and to date has participated in various international health educational projects, like Health Education (Soros Fund), Health Education in London (Fund Know How), UN/AIDS. Institute for Healthcare Development was established for conducting applied research related to healthcare economy, management and its organization in order of the scientific approaches application both in the healthcare system reformation and its development within the territory of the Republic of Kazakhstan being involved in the market economy activities. It made the following researches: Development and introduction of the underlying principles related to healthcare reformation within the market economy transition period, Development of the advanced monitoring and population health forecasting system, Monitoring development of medical and economic standards and norms related to the public health and healthcare and many more.

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Kyrgyzstan Dr. Mirbek Nuraliev Committee for quality of medical help and patients care E-mail: nuraliev_mirbek@mail.ru

Mongolia Ms. Badamragchaa Purevdorj Open Society Forum E-mail: badmaa@forum.mn www.soros.org/about/foundations/mongolia Ms. Badamragchaa Purevdorj has worked as an executive assistant/board liaison and public event manager since 2002. Since then, she is also working as a program manager in the Open Society Forum, where she works on judicial independence, justice and human rights projects. She has finished School of Law at the National University of Mongolia, and received her LLM in Intercultural Human Rights at the St. Thomas University, School of Law (Miami, Florida).

The Open Society Forum (OSF) promotes active participation in Mongolian civic life. The successor of the Mongolian Foundation for Open Society (MFOS), OSF builds on the legacy of the foundation’s eight years of work in the country. OSF aims to provide physical and virtual space for high-quality policy research and analysis; broad public access to information resources about policies, laws, and regulations; and a venue for public engagement in policy formulation and implementation Dr. Khun Tsegmed Ministry of Health International Cooperation Department Dr. Khun Tsegmed has been working as a researcher and inspector at Public Health Institute. Than, she has worked as a Heads of Public Health Inspection department at the Governmental Agency on Public Health and of Border Contingency Inspection Unit of Public Health Department at the Government Agency on Public Health. Afterwards, she has been a License Officer at the National Center for Health Development. And since than, up to nowadays, is working as the NGO cooperation office at the International Cooperation Department at the Ministry of Health. Dr. Khun Tsegmed has contributed to formulation and development of policy documents, regulations and had several trainings and study tours in Russian Federation, the USA, Malaysia and Philippines. Has finished School of Medical Science in Irkutsk, Russia, and has an MA in Medication Science.

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Dr. Oyunbileg Naidan Head, Division of Public Health Health Department of Ulaanbaatar city E-mail address: oyu-nai@yahoo.com , ubhd@mongol.net Dr. Oyunbileg Naidan started her professional career in 1993 up to 1995, as the Head of Soum Hospital, after that for three years she was a Deputy Director at the Emergency Medical Services Center in Ulaanbaatar. Starting from 1999 up to 2002, she worked there already as a Quality Control Manager. After that, she became a Head of District hospital, and since 2003, up to the present time, is the Head of Division of Public Health in Ulaanbaatar city. Dr. Oyunbileg Naidan has received her BA in Medicine and Management in Mongolian National Medical University Ulaanbaatar and in Institute of Administration and Management. Her MA in medicine comes from Mongolian National Medical University. Dr. Oyunbileg Naidan is also a fellow in Public health from the Taipei Hospital, Taiwan. Among her volunteer works, there should be listed Volunteering for Peace Corps, US, Ulaanbaatar; First aid trainer Red Cross of Mongolia; Member of First and critical care Association of Mongolia and Master trainer “Facilitative Supervision� in Health Sector Dr. Alisher Makhkamov MD.Ph.D NGO World Vision E-mail: mahkamov@yahoo.com www.wvi.org

Uzbekistan

From 1999 to 2003, Dr. Alisher Makhkamov has worked as a Consultant physician in the Department of family medicine. Until 2005, he was a Harm reduction advisor in the World Vision NGO, where he had been supervising, coordinating and monitoring harm reduction program and the work of the drug treatment services developing contacts with national and international organizations, NGOs, and government officials. For 2 years he has been Regional Project Coordinator at the United Nations Office On Drugs and Crime (Regional office for Central Asia), where he had managed a major regional project on Diversification of HIV prevention services among Injecting Drug Users in Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan and Turkmenistan.

Since 2007, Dr. Alisher Makhamov is a Project Manager at World Vision, where he works with people infected and affected by HIV and AIDS. He holds a PhD in Public Health from The Second Tashkent State Medical Institute, and Physician Diploma and Postgraduate clinical specialization from the Tashkent State Medical Institute.

World Vision is the international humanitarian organization, partnership of several national offices that try to serve socially- vulnerable people in 71

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the society, especially children. They often participate in helping programs during major crisis and in programs of social development. Some 31,000 staff members implement programs of community development, emergency relief and promotion of justice in nearly 100 countries. World Vision works within communities and across geographical areas to help individuals and groups improve the well-being of children and overcome poverty. When disasters strike, World Vision is globally positioned to help with immediate needs like food, water and shelter. World Vision also works with communities to recover from disasters and prevent future catastrophes. Plus World Vision engages institutions, donors and the general public to address the global problems that perpetuate poverty. Advocacy staff empowers communities to speak up for their rights, both locally and globally.

Armenia Mr. Suren Krmoyan Legal Adviser to the Minister of Health Republic of Armenia E-mail: krmoyan@yahoo.com In 1999, Mr. Suren Krmoyan graduated from Yerevan State University, Faculty of Law. In 2002 Suren Krmoyan received postgraduate education from National Academy of Sciences, Institute of Philosophy and Law. Since November 2006, Suren Krmoyan has been working in National Institute of Health-Chamber of Health Policy and Legislation as a scientist. He works on development of Health legislation, improvement of Human rights protection in health sphere, legal regulation of activities of health care establishments, implementation of actions towards protection of patient’s rights. Since 2001, he is also working as Legal Adviser to the Minister of Health on Policy and Health Legislation issues, preparing draft laws on human rights, health care.

Dr. Zaruhi Mkrtchyan Health Education Association Armenia E-mail: zara_mkrtchyan@yahoo.com Among her professional experience, there are positions as the Research Assistant, Information Processing Coordinator, Program manager, all at the American University of Armenia, Center for Health Services Research, Center for Policy Analysis. Dr. Zaruhi Mkrtchyan has also worked as Monitoring and Evaluation Officer at the IntraHealth International, Project NOVA (New Approaches in Strengthening Reproductive and Maternal and Child Healthcare), Yerevan. She is currently working as a Senior Research, Monitoring and Evaluation Officer in the IntraHealth International, Project NOVA, at the 72

Health Education Association. She has received her MA in Public Health at the American University of Armenia, and graduated from the Public Health Informatics Graduate Program at the University of Illinois at Chicago, School of Public Health, Health Policy and Administration.

The Health Education Association (HEA) was founded in August 2002 by a group of graduates and employees of the American University of Armenia’s Public Health Department who believe that educating public on healthy lifestyle will lead to the better population health in Armenia. The mission of HEA is to improve health of Armenian population by promoting healthy lifestyle. During the five years of its work HEA led several health projects, including advocacy for implementing health education in Armenian schools and preschool institutions; implementation of HIV-risk-reduction interventions with high-risk groups of population; collaborating with other professional public health organizations in Armenia to advocate and reinforce he Tobacco Control policies, etc.

Dr. George Gegelashvili Georgian Alliance for Patient Safety Parliament of Georgia Committee on Healthcare and Social Issues E-mail: giorgi@parliament.ge www.gesafety.org

Georgia

Dr. George Gegelashvili has worked at the beginning of his career as the scientific fellow and resident at the Institute of Neurology. He was appointed as the Head of Pharmaceutical Section of the Institute of Neurology, where he worked 8 years. Since 1988 he worked at the British-Soviet Joint Venture “Unipharm”, as medical consultant. After that, Dr. Gegelashvili has worked as a Project Director at WHO European Regional Bureau, and as Medical Director at Sarajishvili Institute of Neurology and Neurosurgery. Starting from 2004, he is the Member of Parliament of Georgia, Head of Georgian Alliance for Patient Safety and member of the Steering Committee of the Joint Commission International. He received his MD from the Tbilisi State Medical Institute. Has received postgraduate education in Informational Systems, Pharmacology of Nervous Diseases, Care Administration and Hospital Management, Management of Rational Drug Procurement, Primary Healthcare System, Task Force Meeting in Ethical Issues in Public Health Policy in Post-Soviet Countries and finished international Summer Krakow Practicum on Patient Safety.

Georgian Alliance for Patient Safety (GAPS) aims at the promotion of specific improvements in patient safety to reduce the risk of sentinel adverse events 73

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occurring in the Georgian health care system. We focus on providing safe, patient-centered, effective care to every individual. We want to improve patient safety by providing the knowledge and skills, systematic approach, reporting, implementing solutions to prevent harm, etc. GAPS activities, oriented towards our system and the community, intend to make the healthcare system safer.

Azerbaijan Dr. Siyavush Azakov National Information Point on FP7 in Azerbaijan E-mail: azakov_s@hotmail.com www.nip-fp6.ab.az Dr. Siyavush Azakov has been a Senior scientific researcher, Professor of Physics at the Institute of Physics, National Academy of Sciences of Azerbaijan. Up to 1989, he has been the senior scientific researcher for the Steklov Mathematical Institute, Academy of Sciences of USSR, Moscow, USSR. Since 1991 he is doing scientific research in the field of theoretical and mathematical physics at the Institute of Physics, National Academy of Sciences of Azerbaijan. And since 2003, he is the Head of the Management of the NIP of FP6 in Azerbaijan, Presidium of National Academy of Sciences of Azerbaijan. He received his MS in Physics at the Peoples Friendship University, Moscow, USSR. He is the Candidate of sciences (Physics and Mathematics) in Theoretical and Mathematical Physics and Doctor of sciences (Physics and Mathematics) from Steklov Mathematical Institute, Academy of Sciences of USSR. The mission statement of the NIP organization, includes: promotion of the involvement of the scientific community of Azerbaijan in the European Research Area (ERA), and in particular their participation in activities funded

by FP7; building up appropriate information and communication channels which will stimulate the activities of research organizations domestically and through which European partner organizations can make information available to the scientific community of Azerbaijan; and providing assistance with the partner search, preparing & submitting proposals, explanation of the rules of participation funding for NIS countries, legal aspects of EC contracts. In Azerbaijan there is an organization neither in governmental nor in nongovernmental sector which is involved in Patient Safety problems. NIP is in close contact with the Ministry of Health of Azerbaijan and has an experience in participation in different international projects.

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Dr. Rasa Terbetiene State Health Care Accreditation Agency under The Ministry of Health of the Republic of Lithuania (StaHeCCa) E-mail: rasa.terbetiene@vaspvt.gov.lt

Lithuania

Dr. Rasa Terbetiene is a medical doctor, with background as GP. Currently she works in the State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania in the unit of care, provides accreditation and licensing and is engaged in quality management in health care organizations as well as in patient safety activities.

State Health Care Accreditation Agency under the Ministry of Health of the Republic of Lithuania (StaHeCCA) is responsible for providing health care specialists and organizations with licenses to deliver health care services according to requirements of legislation of the Republic of Lithuania. StaHeCCA is the Lithuanian Competent Authority in the field of medical devices and is responsible for correct application of provision of European Community’s directives regarding medical devices and performs the market surveillance.

Since December 2007 StaHeCCA is Competent Authority for organization of health technologies assessment.

Dr. Danute Kasubiene Chairperson of Lithuanian Welfare Society for People with Mental Illnesses E-mail: danutekas@takas.lt www.lspzgb.lt From 1972 to 1992, Dr. Danute Kasubiene was engineer-programmer at the Mathematics Institute of Lithuanian Academy of Sciences. Afterwards, from 1992-2002 Dr. Kasubiene has been working as social worker and as senior social worker at Vilnius Day Center „Sviesa“. Since 1997 Dr. Danute Kasubiene is the chairperson of The Lithuanian Welfare Society for People with Mental Illnesses. Starting from 2002 to 2004, she was the head of Social and Psychological Assistance Service of Vilnius Social Support Center.

In 2004 was given the qualification category of an expert social worker.

She received her Masters Degree in Social Work from Vilnius University.

Dr. Danute Kasubiene is a member of EUFAMI (European Federation of Associations of Families of People with Mental Illness), of Lithuanian Patient Organizations’ Representative Board, and of Lithuanian Social Welfare Association. She was a chairperson of Vilnius non-governmental organization „Let’s be Together“ (1995-1996).

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Lithuanian Welfare Society for People with Mental Illnesses is the organization, that defines it’s goals, as the representation of people with illnesses and striving for their life of full value in the society; protection their rights and human dignity, fighting against their discrimination; improving and expanding the system of institutions of medical service, rehabilitation and care of people with mental illnesses; to establishing activity institutions for the people with mental illnesses in the community; and establishing job places for the people with mental illnesses.

Lithuania Ms. Erika Matuizaite Centre of Civic Initiatives E-mail: erika@pic.lt Ms. Erika Matuizaite is project coordinator and also has experience in public relations work. As coordinator she manages both national and international social projects and has special interest to projects related to human rights development. Erika works actively in the field of patients’ rights and has implemented series of projects concerning education and effective implementation of patients’ rights. Erika represents Centre for Civic Initiatives (CCI) that is an independent public organization, uniting people interested in establishment of civic society in Lithuania. CCI participates in national and international projects, organizes lectures, seminars, conferences, creates teaching programs, promotes scientific research, etc.

Poland Dr. Tomasz Szelągowski The Federation of Polish Patients E-mail: t.szelagowski@federacjapp.pl Dr. Tomasz Szelagowski is a General Director pf the Federation of Polish Patients (FPP). Consultant and trainer in the range of Human Relations and Leadership skills. Gained pedagogical education. Worked as CEO for logistics companies and then settled down his own training company. His primary interest is to rise awareness of health education and engineering large-scale organizational change among patient’s environment.

The Federation of Polish Patients was set up as a non-profit and a nongovernmental organisation in 2006. Committed by our guiding statement and mission, to promote patient-centred healthcare and patient safety, our work concentrate on improving the quality of health care and medical services in Poland through a patient-driven umbrella group of member organisations. FPP presents the patient’s voice directly to the Ministry of Health and Parliament 76

Health Commissions. The basic goal of Federation is to integrate patients’ organisations, protect the rights and representation of patients and their interests, and increase patients’ knowledge and social awareness.

Dr. Jolanta Ewa Bilinska International Cooperation Health Fund E-mail: j.bilinska@nfz-lodz.pl Dr. Jolanta Ewa Bilinska has MA in Clinical Psychology. She used to diagnose hospitalised children and teenagers with personal disorders. She published almost 2000 articles concerning medical issues and politics. She was mostly interested in matters relating to patients’ rights and the way they are observed in health care system. She also raised patients’ awareness of the health care system. Since 2004 Dr. Jolanta Ewa Bilinska has performed the function of coordinator concerning European Union in National Health Fund in Łódź. Since 2005 she has been promoted a champion leader in World Alliance for Patient Safety. In 2006 she established Patient Safety Foundation.

The main aim of the Patient Safety Foundation is to promote safety measures in health service as well as to involve patients in the process of treatment, The foundation cooperates with the Ministry of Health, WHO officer and another non-governmental organization which are regarding patients’ matters.

Mr. Dmitriy Kotovich Belarusian Association of Hemophilia Patients E-mail: kds86@mail.ru

Republic Belarus

Mr. Dmitriy Kotovich is a student of Belarusian State Medical University. He works with the “Belarus Association of Hemophilia Patients” Their members collaborate with hematologists in a problem of the treatment of hemophilia.

“Belarus Association of Hemophilia Patients”- has been working for improvement of living conditions and treatment of those who suffer from haemophilia, illness of Villebrand, and other innate koagulopatias. The Association develops a non governmental register of sick people, raises the number of new technology for treatment, and strengthens the international connections with other organizations in sake of effective cooperation.

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Mr. Andrei Fomenko Government Service of medical legal expertise in Republic of Belarus E-mail: fomenko_expert@mail.ru Mr. Andrei Fomenko is the head of the quality management department of the Legal Medicine State Service. In the Ministry of Health of Belarus and WHO, working group on the elaboration of the draft of “The Law on the patients’ rights in Belarus” – in 2005, he was a member of the working group, responsible for providing reviews on international experience in the field of patients’ rights and citizens’ involvement in health care policy decisions. Andrei Fomenko is also a national expert on health policy issues and AIDS preventing measures and a collaborator in drafting National Poverty Reduction Strategy official paper for government in 2006. Author of several articles covering actual issues of health care system improvement and patients rights promotion policy.

Russian Dr. Nikolai Zhurilov Federation Moscow’s Regional Public Organization of Disabled Persons - Mercy - XXI century E-mail: nikolayzhurilov@bk.ru

Dr. Zhurilov Nilkolay has been working in the spheres of Health Service (emergency medical service, haemotransfusion, narcology); in social organizations – elective governing office (the Komsomol, trade union); and in the sphere of juridical practice, that included managing of juridical private and governmental services (the governing of mechanization of MosMetroStroy, juridical departments and services of the weekly magazine of the newspaper “IZVESTIYA”, insurance and other organizations). Until recent time he was a chief of the social organization of invalids “The Response”. For more than 10 years he worked in the GOU VPO Moscow Medical Academy of I.M. Sechenov on the faculty of medical law. Right now he is an assistant professor on that faculty. He is the co-organizer of the social organization of invalids “Mercy – XXI century” Moscow Regional social organization of disabled “Mercy – XXI century” continued the traditions of the social organization of disabled “The Response” and is working with the problem of the employment, the professional and social adaptation of disabled. Students that knew the work of Dr. Nikolai Zhurilov have suggested the organization of the movement “For Patient’s Safety” and created a web-site www.forpacientsafety.narod.ru. The main aim of the organization is to find ways of interaction between patients and doctors to prevent conflicts during medical service. The leadership in the international alliance “Patients for patient’s safety” allows them to modulate their work according the international practice.

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Dr. Iurie Guzgan NGO “Management and Assurance in Medicine” Association Republic of Moldova E-mail: iguzgan@mednet.md www.mam.md

Moldova

Dr. Iurie Guzgan, from 1984 to 1993, has worked as Lecturer at pathology department in Medical State University of Chisinau. From 1993 to 2004, he worked as a Senior researcher at the Center of Pathology and Pathobiology, Academy of Sciences of Moldova. Among other professional experience: Chief-manager at the Preventive Medical Center of Academy of Sciences, Vice-director at the “Medifarm” LTD company, Expert doctor at the National Medical Insurance Company, Assistant-coordinator at the Soros-Moldova Foundation, Project coordinator at the Management and Assurance in Medicine Association, and at first senior researcher, and now vice direcotr of the National Center for Health Management. He has received his diploma of General practitioner and PhD at Medical State University. He also received Health Management degree at ENSP (Rhenee School of Public Health, France), AESCULAPUS and EUROPHAMILI. The “Management and Assurance in Medicine” Society is an independent, non-governmental, non-political and non-for-profit organization, founded in 1996 and registered officially in 1998. The organization members are physicians, specialists in public health and management, economists, lawyers, and university students interested in health policy, health management and insurance. It’s mission is to improve the performances of the National Health System by encouraging public participation in promotion and implementation of the Health Care reforms based on the principles of Equity, medical Ethics, and respect of Human Dignity in Health Care.

Mr. Valeriu Sava Centre of Public Health and Management, Health Policy Department E-mail: vsava@mam.md Mr. Valeriu Sava has been working as the assistant professor at Testemitanu Medicine and Pharmacy State University until 1994. Starting from 1994, he has worked as an executive director at “Asimed-Moldova” Health Insurance Company. From 1997, he became a Deputy Director on science and reform issues Centre for Public Health and Management. After 2002, Valeriu Sava has been involved with the “Health Investment Fund”, where he was a Health Policy and Training Coordinator (The MoH/WB Project Coordination, 79

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Implementation and Monitoring Unit). From 2003 to 2005, he was working at the Soros Foundation as a Moldova Project Coordinator. Right now, he is working as a Senior Researcher Centre of Public Health and Management, Health Policy Department.

Bosnia and Dr. Emina Osmanagic Herzegovina Executive Director

Association for Sexual and Reproductive Health XY E-mail: k_emina@xy.com.ba, bhfpa.xy@bih.net.ba Association for Sexual and Reproductive Health XY works with young people, providing medical and counseling services and promote clients’ rights and safety (especially in unsafe abortion). We are aware of importance of improving patients’ rights and safety in Bosnia and Herzegovina.

Bulgaria Ms. Mina Popova National Canter of Public Health Protection Ministry of Health E-mail: m_popova@yahoo.com; m.popova@ncphp.government.bg www.ncphp.government.bg Ms. Mina Popova, Msc has graduated from Economic University in Sofia. Since then, she has more than 10 years of experience in the field of health care and hospital’s financing; has specialization in health economics from the University of York, UK; in financing and health care management from the “George Washington” University, Washington, DC, USA. She is a licensed expert on accreditation in health care; Quality Assurance Auditor / Lead Auditor – a license to work as an Auditor and a Lead Auditor for Certification against the requirements of ISO 9001:2000. Ms. Mina Popova provides consultations to health care establishments in the field of hospital management (development of Balanced Scorecards for hospitals); explores the issue related to quality assessment and particularly patient safety; Elaboration of analysis in the field of health care – financing of health care establishments, economic analysis of hospital performance, etc. She is also participating in working groups for development of strategic health care documents (Health of the Nation’s Report, Balanced Scorecards, etc.). Right now, she is a Chief Expert at the NCPHP. The NCPHP is an expert and consultative governmental body to the Ministry of Health and it assists other governmental bodies, municipal authorities and nongovernmental organizations in their activities in analysis of systems and models for health care. NCPHP provides consultations to the health administration and the whole health network. NCPHP is also involved in international cooperation with EU, WHO, NATO, UNDP, FAO, UNICEF etc.

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Dr. Todorka Ignatova Kostadinova Association of Bulgarian Hospitals – ABH E-mail: dora_kostadinova@yahoo.com; kostadinovadora@hotmail.com www.abh.bg Dr. Todorka Ignatova Kostadinova has received MA in International Economic Relations and International Tourism and in Pedagogy from University of Economics, Varna, Bulgaria. Her Doctoral degree in Economy and Management of Social and Cultural Activities in 2000 comes from the University of National and World Economy, Sofia, Bulgaria. In 2003, she has participated in the ASPCEE: “Leadership for Health” at The George Washington University and Georgetown university in Washington D.C. Since 2006, she is an expert at the National Civil Council to the EU Commissioner for consumer protection. From March 2005 she was visiting professor at The University of Bern, Switzerland; previous posts include consultant to Bearing Point in the Project for Strategy for Restructuring, Short term consultant to the World Bank, ECA Division in Washington D.C. She also has lecturing experience at The George Washington University, School of Public Health and Health Services and at the University of Medicine - Varna, Bulgaria, Faculty of Public Health. In 2004 she has become Elected President of The Association of Bulgarian Hospitals – national level NGO. The Association of Bulgarian Hospitals is a non-governmental organization of state, municipal and private hospitals which are independent legal entities.

Nowadays the active members are more then 97 hospitals. The mission of the ABH is to unify and support the efforts and activities of legally independent hospitals in solving of the most urgent issues in the process of changing of the healthcare system and achieving of better quality of the health care services.

Ms. Katja Jajas Member of association “Patient today” E-mail: katja.jajas@ri.t-com.hr www.pacijenti.hr

Croatia

Ms. Katja Jajas is an Attorney of law at “ Katja Jajaš & Jasminka Hodžić“.

Professional career started after graduation from Faculty of Law; University od Rijeka, 1997, and from Economic School (1987-1991). Starting from 1997, Ms. Jajas has worked as attorney of law office Danijela Kovačić, and at the law firm “Vukić, Jelušić, Šulina, Stanković i dr.” as a law clerk. Ms. Katja Jajas is an active member of “Patient today”.

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A non-profit organization (NGO society) “Patient today” was established in order to help all patients from the region in searching for their constitutional, basic and legal rights to fair medical treatment and equal opportunity in getting proper medical care. “Patient today” offers free counseling and legal assistance in the field of health care.

Macedonia Prof. Jovan Tofoski President of Macedonian Medical Assocation E-mail: mld@unet.com.mk www.mld.org.mk Prof. Jovan Tofoski, MD, PhD, President of the Macedonian Medical Association is specialist gynecologist and emeritus professor of the Faculty of Medicine at the University Sts. Cyril and Methodius in Skopje, Macedonia. During his carreer, he was appointed on many public official positions, among which member of the Ministerial Council for Health and Social Care, member of Parlamentary Commision on Health and Social Care, president of the Yugoslav Red Cross, director of the Clinic of Gynecology and Obstetrics at the University Hospital in Skopje, Minister of Health of the Republic of Macedonia, member of the International Red Cross Committee, etc. His engagement in the field of patient safety relates to the policy creation, implementation and evaluation, health sector reforms in Macedonia in line with international and European trends and continuous medical education of health professionals in this field.

Macedonian Medical Association (MMA) is a professional umbrella association of medical doctors of Macedonia, which has a mission of scientific research, research dissemination and continuing medical education for the health professionals that work on the terrotiry of Macedonia. Its mission is acomplished through organizing thematic seminars, scientific congresses, round tables and other events, as well as through publication of scientific Journal “Medicinski pregled”.

Ms. Neda Milevska-Kostova Program Director CRPRC «Studiorum» E-mail: nmilevska@studiorum.org.mk www.studiorum.org.mk Ms. Neda Milevska-Kostova, MSc, MCPPM, Program director at the Centre for Regional Policy Research and Cooperation “Studiorum” is working predominantly in the field of public health policy and healthcare sector reforms in Macedonia.

Recent policy analysis engagements are related to patients’ rights, patient safety, 82

public-private partnerships in healthcare, health insurance and decentralization of the healthcare services. She is actively involved in the preparation of the Macedonian legislation on patients’ rights and other healthcare-related regulations, and has published a number of articles in this area. Previous and current consultancy includes contracts for various domestic and international institutions and donors, such as Ministry of Health, GFATM, OSI-Europe, EAR, JBIC, JICA, etc. She is enrolled in a PhD program at the University of Sheffield, UK, at School of Health and Related Research (ScHARR).

Centre for Regional Policy Research and Cooperation “Studiorum” (CRPRC Studiorum) is a non-governmental think-tank working on different aspects of the European integration and globalization processes that are of essential importance for the region of Southeast Europe. These goals are accomplished through different policy-oriented programs and research projects, which should support central and local governments, business and non-governmental sectors in their communication and cooperation. One of the most vital departments of CRPRC Studiorum is the Department of Public Health, with programs and projects in the area of public health policy, patients’ rights and safety, publicprivate partnerships in health, etc.

Ms. Snezana Cicevalieva Head of the Department for European Integration Ministry of Health Republic of Macedonia E-mail: snezanacicevalieva@zdravstvo.gov.mk www.moh.gov.mk Ms. Snezana Cicevalieva, LLB, Head of the Sector for European Integration and International Cooperation at the Ministry of Health of the Republic of Macedonia.

She is representative of several international initiatives and institutions that are of strategic importance for the country, such as permanent national representative in Committee for Health in the Council of Europe, Executive committee member of the Health Committee, national political coordinator in the Stability Pact/ Health Area and Chair of the Executive Committee of the South-East Europe Health Network, as well as country representative for TRIPS Agreement issues and their impact to the health, FCTC negotiations and for the Conference of Parties, High Level Committee on Public Health of EC. Other positions include representation of MoH in the national WTO negotiation body, national committee for EU accession, and national committees for implementation of the UN Conventions. She is also a member of the Policy and Analysis Unit of the Ministry of Health of Macedonia. Main areas of expertise are National and International Law, Health Legislation, Health Policy, Human rights, Patient Rights, Health Management, etc.

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Slovenia Dr. Vladimira Leskovec

Ministry of Health of Republic of Slovenia E-mail: vladimira.leskovec@gov.si Dr. Vladimira Leskovec, PhD, works as senior adviser in the Ministry of Health of the Republic of Slovenia at the Department for Quality in Healthcare. Of late years The Department for Quality has been very active in introducing quality and patient safety at all levels of health care in Slovenia.

From 1st January to 30th June 2008 Slovenia is governing to the Council of the European Union. Slovenia’s major priority in the field of health during the presidency is reducing the burden of cancer disease, which remains one of the more severe public health problems in all EU Member states.

Prof. Bojana Beovic Assistant Medical Director for Quality University Medical Centre Ljubljana E-mail: infek002@kclj.si Prof. Bojana Beović is associate professor of infectious diseases. Her primary point of interest is rational antimicrobial treatment and surgical infections. She graduated at Medical School, University of Ljubljana, Slovenia. She was further educated in Ljubljana, Zagreb (Croatia) and Madison (Wisconsin, USA). Since 2005 she is assistant medical director for quality at the University Medical Centre in Ljubljana, Slovenia. Together with a group of co-workers she is establishing a comprehensive safety management programme in the hospital.

She is a founding member of the Slovenian Society for Quality in Healthcare, and Slovenian representative in Working Group for Patient Safety at the High Level Group on Health Services and Medical Care at the European Commission.

Since 2006 she is the President of the Health Council at the Ministry of Health of Slovenia.

University Medical Centre in Ljubljana is the largest hospital in Slovenia with approximately 100 000 admissions a year. The hospital provides secondary care for Ljubljana region with more than 600 000 inhabitants and is a tertiary center for a population above one million. It is a teaching centre for University of Ljubljana Medical School and some other faculties as well as nursing schools at all levels. The research activities cover one third of all national research output in the field of biomedicine.

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Prof. Yuriy Gubskiy President of All-Ukrainian Council for Patients’ Rights and Safety Member of MSA of Ukraine E-mail: jurganik@ipnet.kiev.ua www.medpravo.org

Ukraine

Professor Yuriy Gubskiy, MD, PhD is Doctor of Medical Sciences, professor, and a member of Academy of Medical Sciences of Ukraine. Has received his diploma from Kharkiv Medical University, Faculty of Treatment, and from Bohomolets Kyiv Medical University (KMU), Faculty of Treatment. Has obtained PhD at Kyiv Medical University. Starting from 1972, he started scientific and teaching career at KMU (assistant, associate professor, professor). Afterwards, Professor Yuriy Gubskiy has become a Deputy Director of Scientific Research of Kyiv National Research Institute of Pharmacology and Toxicology at the Ministry of Health of Ukraine. He is also a member of National Commission on Toxicology of the Ministry of Health of Ukraine. From 1992 to 2000, he has been the Head of Medical, Biological and Agricultural Sciences Department of the Supreme Attestation Commission (SAC) supported by the Cabinet of Ministers of Ukraine; and starting from 1994 the Head Scientific Secretary of Academy of Medical Sciences of Ukraine. Since 1997 to date, he is the Head of the Department of Bioorganic, Biological and Pharmaceutical Chemistry of Bohomolets National Medical University.

Dr. Viktor Serdiuk Vice-President of All-Ukrainian Council for Patients’ Rights and Safety E-mail: safety@medpravo.org.ua www.medpravo.org Dr. Viktor Serdiuk is an expert in issues of public health and patients’ safety. He has an experience of being a consultant in various international conferences and projects. Dr. Viktor Serdiuk has worked with governmental, non governmental, and commercial organizations and associations, like the Ministry of Health Care of Ukraine, USAID, United Nations, etc.

All-Ukrainian Council for Patients’ Rights and Safety was founded in 2002 and is a non-governmental not-for-profit organization striving to help people who experienced medical harm and to use their wisdom with the aim of patient-centered healthcare development. The aim of Council’s activity is assistance with creation of patient-centered healthcare and implementation of patient safety principles through the development of democratic society and establishment of cooperation between the publicity and medical society, legislative institutions and executive bodies taking into consideration international tendencies of Ukrainian integration into world movements.

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Ms. Kseniya Koshelyeva Project Coordinator All-Ukrainian Council for Patients’ Rights and Safety E-mail: congress@medpravo.org.ua www.medpravo.org Ms. Kseniya Koshelyeva has graduated from the Institute of Philosophy of National Science Academy of Ukraine. Since 1997 she has been lecturing at Donetsk State University at Philosophy Department and developing methodical materials on social philosophy and religious studies. She has more than 10 years of experience in the field of project management and public relations.

From 1991 till 2003 she worked as a project coordinator in International Charitable and Non-Govermental organizations such as All-Ukrainian Coalition for people with mental disabilities, Jewish Children Foundation “Our Home”, International Interdisciplinary Educational Schools in the CIS (Moscow State University), Israel (Hebrew University in Jerusalem) and the USA (American World Service), etc. From 2007 she has been working as project manager in All-Ukrainian Council for Patients’ Rights and Safety where she coordinates activities of the Initiative.

Dr. Anatoliy Tsarenko Director of Training Centre All-Ukrainian Association for Palliative Care E-mail: atsarenko@gmail.com Dr. Anatoliy Tsarenko is a medical doctor trained in Ukraine. He has experience working in All-Ukrainian Association for Palliative Care Training Centre as a Director; Ministry of Health of Ukraine Working Group member for developing legislation on Hospice and Palliative Care; Tuberculosis Control Projects implemented by Program for Appropriate Technology in Health (PATH), USAID, World Bank and International Federation of Red Cross Societies as a Project manager, Project coordinator, TB Advocacy, Legislation and Public Health Consultant; Ministry of Health of Ukraine Working Group member for developing Tuberculosis Control legislation; TB and Health Program Evaluation and Monitoring Expert; Visiting Nurses Service support, TB/HIV/AIDS, and STDs Control Program of Ukrainian Red Cross Society; European Union Project “Preventive and Primary Health Care in Ukraine in Kyiv and Selected Regions” Public Health Consultant; Health Promotion/Education for Students National Coordinator.

The goal of the All-Ukrainian Association for Palliative Care is to provide activities directed to the organization and development of palliative care to patients and their families facing the problem the incurable illness. Mission 86

statement: encouraging of palliative care development in Ukraine by support of initiatives, consolidation of efforts of public society, experts, administration and business for implementation of the palliative care in Ukraine. Priorities of the activities: Coordination of work of medical, social workers and public society directed to the solving of people with incurable illnesses; Providing of assistance to those people who could not realize their rights and interests while receiving health / social / psychological / spiritual care; Raising of the professional skills of palliative care providers; Studying of the leading foreign experience in palliative care; Encouraging of the access to pain control; Development of new principles and approaches in medical care in frames of palliative care; Technical, informational and recourse support of health care facilities providing palliative care.

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{ Endnotes } Health-EU, The public health portal of the European Union, http://ec.europa.eu/health-eu/care_for_me/patient_safety/index_en.htm (last accessed Nov 2007) 2 “To Err is Human: Building a Safer Health System” 2000. Kohn L.T, Corrigan J.M., Donaldson M.S., (Eds), Committee on Quality of Health Care in America, Institute of Medicine, National Academy Press, PRESS Washington, D.C. 3 Berwick, Donald M. and Leape, Lucian L. Reducing Errors in Medicine. BMJ. 319:136–137, 1999.

4 Brennan, Troyen A.; Leape, Lucian L.; Laird, Nan M, et al. Incidence of Adverse Events and Negligence in Hospitalized Patients. N Eng J Med. 324(6):370–376, 1991. See also: Thomas, Eric J.; Studden, David M.; Newhouse, Joseph P., et al. Costs of Medical Injuries in Utah and Colorado.

Inquiry. 36:255–264, 1999.

5 The Hippocratic Oath, NIH, http://www.nlm.nih.gov/hmd/greek/greek_ oath.html (accessed Sept 2007) 6 The Anesthesia Patient Safety Foundation, http://www.apsf.org/about/ brief_history.mspx 7 Wilson RMcL, Runciman WB, Gibberd RW, et al (1995). “The Quality in Australian Health Care Study”. Medical Journal of Australia 163 (9): 458-71.

Retrieved on 2006-07-01 Adverse Events in New Zealand Public Hospitals: Principal Findings from a National Survey. New Zealand Ministry of Health. Retrieved on 2006-07-15.

(2001) “Incidence of adverse events in hospitals. A retrospective study of medical records”. Ugeskr Laeger 163 (39): 4377-9. Retrieved on 2006-07-15.

8 Patient safety, Wikipedia the free encyclopedia, available at: http:// en.wikipedia.org/wiki/Patient_safety#_note-14 (last accessed Nov. 2007) 9 Iowa Department of Public Health, Definition of patient safety, 2006 10 Downie J., Patient Safety Law: From Silos to Systems, Dalhousie University, March 2006 11 Mello M., et al. “Health Courts” and Accountability for Patient Safety, The Milbank Quarterly, Vol. 84 (3) 2006 12 Gibson, R., and J.P. Singh. 2003. Wall of Silence: The Untold Story of the Medical Mistakes That Kill and Injure Millions of Americans. Washington, D.C.: Lifeline Press 13 Quality of care: patient safety, World Health Assembly Resolution WHA55.18, 18 May 2002, available at: http://www.who.int/gb/ebwha/pdf_ files/WHA55/ewha5518.pdf 1

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WHO Patient Safety webpage, http://www.who.int/patientsafety/en/ http://www.who.int/patientsafety/en/ 16 WHO International Classification for Patient Safety. Version 1.0 for Field Testing. 2007-2008, available at: http://www.who.int/patientsafety/ taxonomy/icps_form/en/index.html 17 WHO Alliance for Patient Safety, (2005). WHO Draft Guidelines for Adverse Event Reporting and Learning Systems 18 http://www.jcipatientsafety.org/ 19 http://www.jcipatientsafety.org/24725/ 20 High Level Group on Health Services and Medical Care http://ec.europa.eu/ health/ph_overview/co_operation/mobility/high_level_hsmc_en.htm 21 EC DG Sanco, Patient Safety – Making it Happen! Luxembourg Declaration on Patient Safety, Luxembourg, 5 April 2005 22 Council of Europe, (2006). Recommendations of the Committee of Ministers to member states on management of patient safety and prevention of ad verse events in health care 23 Andersen, H.B.; Madsen, M.D.; Hermann, N.; Schiøler, T.; Østergaard, D., Reporting adverse events in hospitals: A survey of the views of doctors and nurses on reporting practices and models of reporting. In: Investigation and reporting of incidents and accidents. Workshop (IRIA 2002), Glasgow (GB), 1720 Jun 2002. Johnson, C. (ed.), (GIST Technical Report, G2002-2) p. 127-136 24 The Danish Act on Patient Safety 2003, accessible at: http://www. patientsikkerhed.dk/admin/media/pdf/133907d0940e4d5f751852ec8f6b1795.pdf 25 Article 6 of the Danish Patient Safety Act became Section 201 of the Danish Health Act as of January 1, 2007 26 National Board of Health: http://www.sst.dk/?lang=en; Danish Society for Patient Safety (DSFP): http://www.patientsikkerhed.dk/ 27 National Confidential Enquiries Strategy 2004, National Institute for Clinical Excellence, NHS 28 ibid 29 Trauma: Who cares? A report of the National Confidential Enquiry into Patient Outcome and Death 2007 30 To Err is Human: Building a safer healthcare system, IOM 1999, available at: http://books.nap.edu/openbook.php?isbn=0309068371 (last accessed Oct 2007) 31 APSF Response to the IOM Report, APSF Comments on Specific Recommendations in the IOM Report, by Robert K. Stoelting, M.D., President, APSF, Feb 2000 32 http://www.theorator.com/bills109/s544.html 33 The Washington Post: Plan Would Compile, Analyze Medical Errors by Gilbert M. Gaul (July 29, 2005): http://www.washingtonpost.com/wp-dyn/ content/article/2005/07/28/AR2005072801907.html 34 Mello M., et al. “Health Courts” and Accountability for Patient Safety, The Milbank Quarterly, Vol. 84 (3) 2006 14 15

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Gawande, A.A., D.M. Studdert, E.J. Orav, T.A. Brennan, and M.J. Zinner.

2003. Risk Factors for Retained Instruments and Sponges after Surgery. New England Journal of Medicine 348(3):229–35.

36 Studdert, D.M., M.M. Mello, A.A. Gawande, T.K. Gandhi, A. Kachalia, C. Yoon, A.L. Puopolo, and T.A. Brennan. 2006. Claims, Errors, and Compensation Payments in Medical Malpractice Litigation. New England Journal of Medicine 354(19):2024–33.

37 AHRQ, Quality of care http://www.qualityindicators.ahrq.gov/ (last accessed Nov 2007).

38 Kristensen, S., J. Mainz, and P. Bartels. 2007. Establishing a Set of Patient Safety Indicators. ESQH. 4-15.

39 IAPO Declaration on Patient-centred Healthcare, available at: http://www. patientsorganizations.org/showarticle.pl?id=712&n=312 (last accessed Sept 2007) 40 WHO Patients for Patient Safety, London Declaration, March 26, 2006, available at: http://www.who.int/patientsafety/patients_for_patient/ London_Declaration_EN.pdf 41 Consumers Advancing Patient Safety, Statement of Principles, Values & Beliefs, available at: http://patientsafety.org/page/97014/ (accessed: Feb 2007) 42 LEVITAN, S., D. SHALLER, et al., (October 2003). The CAHPS Improvement Guide. Department of Healthcare Policy. Harvard Medical School 43 Rooney, James & Lee Heuvel, “Root Cause Analysis for the Beginners”, p. 1 44 WHO ALLIANCE FOR PATIENT SAFETY, (2005). WHO Draft Guidelines for Adverse Event Reporting and Learning Systems 35

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Contacts of the International Initiative Eastern European and Asian Organizations for Patient Rights and Safety 01133 Ukraine, Kyiv, L.Pervomayskogo str. 9-A Tel./Fax: +38 044-234-84-02 E-mail: congress@medpravo.org.ua www.ps.medpravo.org