Scientific and Practical Justification of the Process of Continuous Improvement of the Quality of Medical Care in Healthcare Institutions

The dissertation is devoted to the scientific and practical justification of the process of continuous improvement of the quality of medical care in healthcare institutions of the Russian Federation. The research is conducted in the context of the formation of the system of mandatory medical insurance and the resolution of contradictions between the declared goals of optimizing costs and improving the quality of medical care, on the one hand, and the progressive growth of complaints and lawsuits related to the quality of care provided, on the other. The author conducts a systemic analysis of the problem, identifying four problem situations: conceptual and criterion provision of quality, methods for collecting information about its state, organization of informational support for quality management, and the quality management system of medical care as a whole.

The research develops a conceptual and criterion apparatus of the quality of medical care, including a system of definitions, classifications, and quantitative indicators, as well as a method for assessing the quality of medical care with the possibility of formalized description of medical errors and application of statistical control methods. Models of an information-analytical center as an element of the quality management system, a life cycle model of specialized subdivisions, and a structural-functional model of the process of continuous improvement of the quality of medical care with feedback across five stages are proposed. The practical significance of the work consists in the implementation of the developed technologies in normative and instructional documents and in the practice of healthcare and insurance subdivisions in a number of regions of the Russian Federation.

Relevance of the Problem

The problem of improving the quality of medical care (QMC) has been at the center of specialists' attention for decades (N.V. Elyntein, 1980, 1991; A.L. Lindenbraten, 1986, 2002; V.F. Chavpetsov, 1987, 2003; A. Donabedian, 1956, 1966; H.V. Vuory, 1982; W. Jessee, 1983). This is related to the fact that when justifying each new healthcare reform, the same main goals are declared — to optimize the costs of medical care and improve its quality (O.P. Shchepin, 1993, 2000; Yu.P. Lisitsyn, 2002; D. Blumenthal, 1999).

In our country, attention to the problem of improving QMC significantly intensified after 1993, when the system of mandatory medical insurance (MMI) began to take shape. As a result, healthcare subdivisions engaged in departmental control of QMC were joined by hundreds of MMI system subdivisions evaluating QMC (V.Z. Kucherenko, 1996; Yu.V. Semenov, 2000, Yu.L. Shevchenko 2002). However, a number of recent publications present data on the progressive growth of complaints and lawsuits related to QMC (A.M. Rabets, 1998; V.Yu. Semenov et al., 1998; Yu.D. Sergeev, 2001; A.M. Taranov, 2000, 2003, etc.). The identified contradiction testifies to the continuing existence of the problem of improving QMC, whereas the literature lacks a characterization and forecasts of the problem's development. In the opinion of a number of authors, this problem remains unresolved because a systemic approach is not employed for its resolution (V.V. Grishin, 1996; T.B. Dmitrieva, 1997; V.I. Starodubov, 1998; A.I. Vyalkov, 2002; A.B. Shabrov, 2003, etc.).

The solution of this complex problem should begin with the development of a conceptual apparatus (N.Ya. Kopyt, 1983; V.I. Tsaregorets, 1986; G.I. Ruzavin, 1999, and others). However, work on improving QMC was begun without identification of the object of evaluation and impact. Publications presenting the concept of QMC are few in number (V.A. Belavin et al., 1998; A.B. Lind, 1999; D.V. Evdokimov et al., 1999; R. Massud et al., 2001), but even in them there is no justification for the definition of QMC, co-ordinate concepts, and proposed characteristics.

Improving QMC is impossible without methods for collecting and analyzing information about its state. Discussions continue in the literature regarding the integration and advantages of approaches to assessing QMC by the structure, results, and process of medical care (N.I. Vishnyakov et al., 1998; V.Z. Kucherenko, 2003; A. Donabedian, 1980; R.H. Brook et al., 1996). Analysis of publications of recent years shows that the majority of them are devoted to demonstrating the results of assessing the process of medical care using modifications of the methodology of integrated assessment of QMC (V.A. Almazov et al., 1987). This may indicate that in our country the opinion of foreign researchers is shared that the quality of the process determines the structure, results, and ultimately the price of medical care (G.E. Steffen, 1988; D.M. Berwick, 1998; D.M. Eddy, 1998). At the same time, in numerous publications there are no materials on the relevance of the methods and objects of assessment, on the correspondence of the applied methods of collecting information on QMC to the requirements of information technologies, as well as to the requirements of physicians regarding the method of assessing the quality of their primary activity. Taking into account the importance of applying statistical quality control methods for managing its state (Pareto diagrams, Ishikawa diagrams, etc.) in various areas of activity (K. Ishikawa, 1988; X. Kume, 1990, and others), separate attention deserves the filling of this gap for the purpose of improving QMC.

The identification in healthcare institutions and MMI subdivisions of units engaged in assessing QMC implies the possibility of representing them as groups of specialists united by a common goal, that is, organizations. This position could have led to a growth in the number of publications on the application of organizational design theory and the concept of the life cycle for increasing the effectiveness of collective activity for the purpose of improving QMC (V.G. Afanasyev, 1968; M. Mescon et al., 1992; A.A. Belyaev and E.M. Korotkov, 2000; B.Z. Milner, 1998; R. Daft, 2001, and others). At the same time, in the medical literature there are isolated works in which attention is drawn to the importance of clarifying the composition and interrelationships of internal variables (goal, tasks, technologies, personnel, structure) and factors of the external environment of organizations specializing in informational support for the management of QMC (S.E. Shevchenko, 1998; A.V. Resnyansky, 1998), while questions of development, conditions and criteria of effectiveness, composition of consumers of activity of the indicated subdivisions remain insufficiently studied. That the organizational aspect of the problem of improving QMC requires investigation is indicated also by those publications in which the activity of experts regarding improving QMC is characterized as ineffective or costly (M.P. Roytman et al., 1996; I.N. Denisov, 1998; G.L. Skvirskaya, 1999; I.V. Polyakov, 2001, 2003).

Recently, the emphasis has shifted from controlling QMC to managing QMC. At the same time, the prospects for resolving the problem of improving QMC are associated with the beginning of implementation in Russian healthcare of the progressive concept of Total Quality Management (TQM) and various models of its implementation (industrial, self-assessment, etc.), as well as the application of achievements of standardization (Yu.M. Komarov, 1998; G.I. Nazarenko et al., 2000; S.L. Vardosidze, 2000, 2003; P.A. Vorobiev, 2002, etc.). Specialists warn of the negative consequences of neglecting the experience of classical management theory and practice, including the necessity of creating management contours when implementing TQM (V.A. Lapidus, 2000; A.L. Shestakov, 2002; Yu.P. Adler, 2003; A.V. Glazunov, 2003). Studying the literature in which systems for managing QMC are mentioned (R.A. Khalfin, 1997; G. Gusarova, 2002; E.V. Klimova et al., 2003, etc.) showed that they contain no information on the necessary elements of the management contour, including data on feedback. All of the above determines the relevance of conducting the present research.

Goal of the Research:

To scientifically justify and develop a complex of informational and organizational technologies ensuring the implementation of the process of continuous improvement of the quality of medical care in healthcare institutions.

Tasks of the Research:

1. To conduct a systemic analysis of the state of the problem of improving the quality of medical care, to establish factors hindering its resolution at the current stage of development of healthcare systems and mandatory medical insurance.

2. To develop a conceptual and criterion apparatus of the quality management system of medical care, to assess the possibility of its implementation in the practical activity of healthcare institutions and mandatory medical insurance.

3. To develop a technology for collecting and summarizing information about the state of the quality of medical care, to assess the effectiveness of its application by healthcare institutions and medical insurance organizations for the purpose of continuous improvement of the quality of medical care.

4. To develop a model of an information-analytical center as an element of the quality management system of medical care, and to assess the effectiveness of the activity of prototypes of this organization under practical conditions.

5. To develop a structural-functional model of the process of continuous improvement of the quality of medical care and to substantiate the possibility of its application in the healthcare system.

Scientific Novelty and Theoretical Significance of the Research

The scientific novelty and theoretical significance of the research consist in the fact that for the first time:

- a systemic analysis of the problem of improving the quality of medical care was carried out, a forecast of its development was compiled, and variants of its resolution were evaluated; the problem was decomposed into four problem situations: with a conceptual and criterion apparatus of the quality of medical care; a method for collecting information about the state of the quality of medical care; an organization specializing in the collection and analysis of information about the state of the quality of medical care; and a system for managing the quality of medical care;

- a scientifically grounded conceptual and criterion apparatus of the quality of medical care was developed, including a system of definitions (quality of medical care, medical error, guarantees of proper quality of medical care, expert, organizer of expertise, etc.); classifications (medical errors, improper quality of medical care); quantitative indicators (state of individual components of the quality of medical care, structure of the quality of medical care, etc.). The possibility of their application for ensuring communications in quality management systems of medical care was demonstrated;

- a method for assessing the quality of medical care was developed, providing opportunities for formalized description of any medical error and reproduction of the process of forming an expert opinion to reduce subjectivity, whose informational capabilities allow the application of statistical quality control methods;

- in a number of medical institutions of 7 regions of the Russian Federation, an initial characterization of the state of the quality of medical care was obtained, necessary for beginning work and assessing the effectiveness of subsequent actions to improve the state of the quality of medical care;

- a model was developed and the content of internal variables and a number of factors of the external environment of direct action of healthcare and MMI subdivisions specializing in informational support of quality management systems of medical care of various basic institutions (healthcare administration bodies, medical institutions, territorial funds of mandatory medical insurance, insurance medical organizations, etc.) was substantiated;

- a life cycle model of subdivisions specializing in informational support for the management of the quality of medical care was developed; a complex of works and criteria for their fulfillment at the stages of creation, formation, and development of specialized subdivisions was scientifically grounded;

- a structural-functional model of the quality management system of medical care was scientifically substantiated, including the composition and content of the necessary elements of management contours and conditions for implementing feedback in them across 5 stages of the process of continuous improvement of the quality of medical care in medical institutions;

- in the system of medical care, a modern direction — the process approach to managing the quality of medical care — was implemented, and an algorithm for designing and controlling the technological process of continuous improvement of the quality of medical care was synthesized.

Practical Significance and Implementation in Practice

The developed open conceptual and criterion apparatus of the quality of medical care was implemented in normative and instructional documents of a number of territories of the Russian Federation.

The developed and tested technology for collecting and analyzing data on the state of the quality of medical care was implemented in the practice of work of 47 healthcare and mandatory medical insurance subdivisions of Belgorod, Pskov, Samara, and Tula oblasts, Stavropol Krai, and the city of St. Petersburg.

The proposed program of work for creating an organization (subdivision) specializing in the collection and analysis of information about the state of the quality of medical care for the purpose of improving it, including criteria for their fulfillment, was realized in the creation of the information-analytical center of the quality management system of medical care of the Stavropol Territorial Fund of Mandatory Medical Insurance.

The developed methodology for analyzing the state of organizations (subdivisions) specializing in informational support for the management of the quality of medical care is used to determine the position of organizations on the life cycle line, forecast their development, and develop measures to change the situation in institutions using the Automated Technology for Expertise of the Quality of Medical Care.

A methodology for selecting "temporary quality indicators" based on the results of initial diagnosis of the state of the quality of medical care was proposed for the continuous monitoring of the effectiveness of the implementation of managerial decisions on improving the state of the quality of medical care in healthcare institutions.

The developed methodology for assessing the state of the territorial system for managing the quality of medical care is used for analyzing the causes of insufficiently effective functioning of the management system and developing decisions for their elimination in the regions of the Russian Federation applying the Automated Technology for Expertise of the Quality of Medical Care.

The materials of the dissertation work were used in the preparation of 19 methodological, normative documents, and educational aids of federal and regional levels, including:

1. Methodological Recommendations and Aids:

- "Selection of Method and Preliminary Selection of Specialists for Expertise of the Quality of Medical Care" (approved by the Ministry of Health of the Russian Federation, 1996, No. 95/255);

- "Guarantees of the Quality of Medical Care in the System of Mandatory Medical Insurance" (approved by the Federal Fund of OMI, 1996);

- "Automated Technology for Expertise of the Quality of Medical Care and Rules for Its Application in Healthcare Institutions" (approved by the chairman of the cardiology section of the Academic Council of the Ministry of Health of the Russian Federation, Academician of RAMN, Prof. V.A. Almazov, 1998);

- "Procedure for Organizing Expertise of the Quality of Medical Care Using the Automated Technology for Expertise and the Use of Its Results for Ranking Therapeutic and Preventive Institutions Depending on the State of the Quality of Medical Care" (approved by the Federal Fund of OMI, 2000);

- "Accounting and Assessment of the Effectiveness of Measures for the Development and Interaction of Departmental and Extramural Expertise of the Quality of Medical Care in the System of Mandatory Medical Insurance" (approved by the Federal Fund of OMI, 2000);

- "Selection of Method of Extramural Expertise of the Quality of Medical Care in the System of Mandatory Medical Insurance at the Territorial Level" (approved by the Federal Fund of OMI, 2001).

1.1. Educational Programs and Aids for Physicians:

- Educational thematic plan of postgraduate professional training of specialists with higher medical education on the problem "Management of the Quality of Medical Care" (approved by the Ministry of Health of the Russian Federation, 28.05.01, Protocol No. 5/01);

- "Expertise of the Quality of Medical Care. Theory and Practice" (approved by the Deputy Head of the Accreditation Commission for Medical and Pharmaceutical Education of Russian Universities, 2001);

- "Guarantees of the Quality of Medical Care and Their Organizational and Legal Support by the System of Mandatory Medical Insurance" (approved by the Federal Fund of OMI, 1998; Deputy Head of the Accreditation Commission for Medical and Pharmaceutical Education of Russian Universities, 2001).

2. Normative Documents and Instructions:

- Regulation on Departmental and Extramural Expertise of QMC in the City of Togliatti (approved by order of the Healthcare Administration of the Mayor of Togliatti No. 107 dated 11.04.97);

- Regulation on Extramural Expertise of QMC in Tula Oblast (approved by the Acting Director of the Territorial Fund of OMI and Director of the Department of Healthcare of the Administration of Tula Oblast, 2.10.2000);

- "Regulation on Quality Control of Medical Care in the System of Mandatory Medical Insurance of Belgorod Oblast" (approved by the Head of the Administration of Belgorod Oblast, 20.01.2003);

- "Regulation on the System of Quality Control of Medical Care in the Territory of Pskov Oblast" (approved by the Chairman of the Committee on Healthcare and Executive Director of the Pskov Territorial Fund of OMI, 06.07.1997);

- "Regulation on Extramural Expertise of QMC in Vladimir Oblast" (approved by the Director of the Department of Healthcare and Executive Director of the Territorial Fund of OMI, 1996);

- "Regulation on Extramural Control of QMC in Stavropol Krai" (approved by the Acting Director of the Stavropol Territorial Fund of OMI, 1998);

- "Use of the Automated Technology for Expertise of the Quality of Medical Care in Healthcare Institutions and the OMI System of Belgorod Oblast" (approved by the Acting Director of the Belgorod Territorial Fund of OMI; Head of the Healthcare Administration of the Administration of Belgorod Oblast, 1998);

- "Regulation on the Procedure for Conducting Departmental and Extramural Control of Volumes of Medical Care and Expertise of Its Quality in St. Petersburg" (approved by Order of the Committee on Healthcare of the Government of St. Petersburg, 26.05.04, No. 163/r; coordinated by Order of the Executive Director of the Territorial Fund of OMI of St. Petersburg, 27.05.04, No. 85/A).

3. Educational Aids:

- "Use of the Results of Expertise of QMC for Managing the Therapeutic Process" (approved by the Healthcare Administration of the Administration of Belgorod Oblast, the Belgorod Territorial Fund of OMI, Belgorod State University, 2002);

- "Logic and Methodology of Expertise of the Quality of the Therapeutic-Diagnostic Process in a Separate Case of Providing Assistance" (approved by the Academic Council of St. Petersburg State Medical Academy named after I.I. Mechnikov, 2003);

- "Methods of Investigating the Quality of the Process of Medical Care and Their Informational Capabilities" (approved by the Academic Council of St. Petersburg State Medical Academy named after I.I. Mechnikov, 2003).

In accordance with the approved by the Ministry of Health of the Russian Federation educational thematic plan of postgraduate professional training, the Department of Quality Management of Medical Care of the Professional Development Faculty (FPK) of St. Petersburg State Medical Academy named after I.I. Mechnikov conducts three cycles of thematic advanced training for physicians and QMC experts; heads of expert subdivisions of healthcare institutions and OMI; heads of institutions of the healthcare system and OMI: "Fundamentals of Expertise of the Quality of Medical Care and the Automated Technology for Its Assessment" (108 hours); "Organization of Expertise of the Quality of Medical Care and the Use of Its Results for the Preparation and Formalization of Managerial Decisions" (108 hours); "Fundamentals of Management of the Quality of Medical Care" (72 hours). The materials of the dissertation are used in the educational process when delivering lectures and conducting practical classes at the departments of: New Educational Technologies, Cardiology of the FPK of St. Petersburg State Medical Academy named after I.I. Mechnikov.

Publications

Based on the materials of the dissertation, 53 printed works were published, including 3 monographs, 11 educational-methodological aids, 13 works in the central press; 7 articles in the proceedings of international conferences.

Validation of the Results of the Work

The main provisions of the dissertation were reported and discussed at 7 international conferences: the Russian-Austrian conference "Control of the Quality of Medical Care in the System of Mandatory Medical Insurance" (St. Petersburg, 1998); "Assessment of Healthcare Technology in Russia — Present and Future" (St. Petersburg, 1999); "Total Quality Management — a Tool for Overcoming the Crisis" (Togliatti, 1998; 1999, 2000; 2001; 2002). 7 all-Russian scientific-practical conferences: on cardiology and cardiac surgery (Samara, 1996); "Questions of Interaction of Departmental and Extramural Expertise of the Quality of Medical Care. Protection of the Rights of Insured Persons" (Irkutsk, 1996); "Prevention and Treatment of Cardiovascular Diseases" (St. Petersburg, 2000); "Development of the System of Ensuring the Quality of Medical Care in Modern Conditions and Problems of Optimizing the Structure of Healthcare" (Moscow, NII named after N.A. Semashko, 1999, 2000, 2001). 4 inter-regional scientific-practical conferences: "Experience of Work of Therapeutic-Preventive Institutions of the City of Togliatti, Samara Oblast, on Ensuring QMC and Possibilities of Its Application by Some Territories of the Russian Federation" (Togliatti, 1997); "Experience of Application of the Automated Technology for Expertise of QMC in Separate Regions of the Russian Federation" (Belgorod, 1998); "Ensuring the Quality of Medical Care. Problems and Prospects of Their Resolution" (Belgorod, 1999); "Extramural Expertise of QMC in the System of OMI" (Tula, 2003). At regional conferences, meetings, and consultations: a meeting of the Coordinating Council on Healthcare in the Northwestern Federal District (St. Petersburg, 2001); "Management of the Quality of Medical Care — the Most Important Problem of Modern Healthcare" (Stavropol, 2002); conferences for physicians and heads of individual therapeutic-preventive institutions of St. Petersburg, Moscow, and others (2000, 2001, 2002, 2003).

Personal Contribution of the Author

The author completely and independently conducted a systemic analysis of the situation with the problem of improving the quality of medical care; carried out a logical analysis of concepts and terms of the quality of medical care presented in the literature and used in practice, as well as conducted conceptual modeling of the definition of the quality of medical care and other co-ordinate concepts; determined the requirements for methods of collecting information about the state of the quality of medical care and carried out their logical analysis, organized surveys of physicians on the correspondence of the used methods to established requirements; in co-authorship developed the Automated Technology for Expertise of the Quality of Medical Care (Registration Certificate of Russian APO for a Computer Program "Automated Technology for Expertise of the Quality of Medical Care" No. 960494 dated November 21, 1996); proposed a methodology for assessing the position of an organization specializing in informational support for the management of the quality of medical care on the life cycle line; determined the requirements and proposed the content of elements of the internal environment of a subdivision specializing in assessing the quality of medical care; proposed a methodology for assessing the effectiveness of the activity of the indicated subdivisions; developed a matrix model of the territorial system for managing the quality of medical care and a model of the process of continuous improvement of the quality of medical care; proposed a methodology for assessing the effectiveness of quality management systems; substantiated the content of information on the state of the quality of medical care by levels of the hierarchy of the territorial system for managing the quality of medical care. With the direct participation of the author, the formation of databases of expert protocols using the Automated Technology for Expertise of the Quality of Medical Care was carried out; in the part of research studies, the author acted as an expert and organizer of expertise, and in all cases — as an analyst. The share of the author's personal participation in accumulating the empirical data used for demonstrating and justifying the proposed theoretical positions exceeds 80%; in the theoretical part of the work, generalization and analysis of materials — 100%.

Main Provisions of the Dissertation to be Defended

1. The creation of conceptual and criterion apparatuses of the quality of medical care provides conditions for the development and implementation in the practical activity of healthcare institutions and mandatory medical insurance of coordinated informational and organizational technologies: collection and summarizing of information about the state of the quality of medical care; organization of activity of groups of specialists for informational support of quality management systems of medical care; activity for the continuous improvement of the state of the quality of medical care in healthcare institutions.

2. The development and implementation in practice of a method for collecting and summarizing information about the state of the quality of medical care, corresponding to the requirements of social and information technologies, ensures the possibility of forming management contours, as necessary elements of quality management systems of medical care, including planning and control over the implementation of stages of the process of continuous improvement of the quality of medical care.

3. For the effective activity of Information-Analytical Centers of quality management systems of medical care, the following must be present: formulated and documented goals and tasks; a complex of modern expert and organizational technologies for regularly providing the decision-maker with information about the quality of medical care for the purposeful improvement of its state; trained groups of specialists for organizing, conducting expertise of the quality of medical care, summarizing and statistical analysis of its results, preparing expert conclusions and draft decisions on improving the quality of medical care; a structure of the Information-Analytical Center ensuring effective interaction of its personnel in achieving the goals of the organization, including active impact on its immediate business environment.

4. A necessary condition for the purposeful activity of an organization (subdivision) specializing in informational support for the management of the quality of medical care using a program-target approach and modern provisions of standardization is the presence of a complex of normative-legal and instructional-methodological documents constituting a "Guide for Managing the Quality of Medical Care" in the basic institution.

5. The application of the developed structural-functional and matrix models of the territorial system for managing the quality of medical care, defining the hierarchy of management contours and the dynamics of their state across 5 stages of the process of continuous improvement of the quality of medical care, ensures the presence of feedback when designing, implementing, and controlling the execution of target programs for improving the quality of medical care in the healthcare system.

6. The implementation in practice of a complex of proposed informational and organizational technologies in accordance with the developed program of work for creating quality management systems of medical care makes it possible to obtain documented facts of improvement in the state of the quality of medical care in therapeutic-preventive institutions.