Standardization in the Field of Medical Services in the Management of Quality of Medical Care

The dissertation is devoted to the problem of standardization of medical services in the context of the management of quality of medical care. The role of standardization as a system-forming element of the industry quality management program in healthcare is investigated, and the state and trends in the development of the system of standardization, classification, and coding of medical services in the Russian Federation are analyzed. The work is aimed at the scientific substantiation of the place and role of standardization of medical services in forming a systematic approach to the management of quality of medical care, as well as at the development of the regulatory-legal and organizational-methodological foundation for the implementation of this program.

In the course of the research, a comprehensive assessment of existing regulatory documents and classifiers in the field of medical services was carried out, and problems of their practical application were identified. The structure of a complex of regulatory documents and an organizational-functional model for conducting standardization work have been developed and tested in practice. The results of the work have found application in the preparation of industry standards and classifiers used in the activities of the Ministry of Health of Russia and medical organizations.

Relevance of the Problem. The Industry Program for Quality Management in Healthcare, approved by the decision of the Collegium of the Ministry of Health of the Russian Federation dated March 18, 2003, provides for a systematic approach to the management of quality of medical care and assigns a pivotal role to standardization [84].

By this time, our country has accumulated significant experience in studying the quality of medical care. Works were conducted on assessing the quality of medical care using special indicators—the integrated efficiency coefficient, the medical effectiveness coefficient, the social satisfaction coefficient, the cost-to-result ratio; expert assessment; and methods of ensuring the quality of medical care were investigated (Chavpetsov V.F. et al., 1995; 1996, Lindenbraten A.L., 1994; Komarov Yu.M. et al., 1997; Tsarik G.N., 1997; Galanova G.I., 2000; Shchepin O.P. et al., 2002, etc.). Nevertheless, disagreements are noted in the interpretation of the very concept of quality of medical care, in determining optimal approaches to its ensuring (management). The level of knowledge about the quality of medical care, its components, the methodology of its guarantee, assessment methods, and the organization of control and quality management cannot be considered sufficient.

Developing the modern direction of universal quality assurance, V.Z. Kuchenko (1999, 2001), P.A. Vorob'ev (1999, 2002), A.I. Vyalkov (2002, 2003) substantiate in their works the systemic role of standardization in forming approaches to the management of quality of medical care. A comprehensive assessment of the quality of medical care from the standpoint of resources, technologies, and outcomes (consequences) is conducted by comparing actual situations with the requirements of standards as the normative basis for quality assessment. Based on the results of the analysis, managerial decisions are made for the improvement of quality.

In recent years, a system of standardization in healthcare of the Russian Federation has been created, fundamental regulatory documents have been developed and implemented, and the main objects of standardization have been identified [82].

According to the system-forming documents on standardization, the most important and complex object of standardization are medical services, as they lie at the foundation of the organization of the diagnostic and treatment process [58, 69]. However, the role of medical services in ensuring a systematic approach to the management of quality of medical care has not yet been determined.

Thus, the goal of the present research can be formulated as follows: to scientifically substantiate the role and place of standardization of medical services in forming a systematic approach to the management of quality of medical care. The tasks of the research:

1. To analyze the regulatory legal base in the field of quality management, standardization, unification, and systematization of medical services.

2. To investigate the use of regulatory documents on standardization of medical services in healthcare of the Russian Federation.

3. To develop the structure of a complex of regulatory documents in the field of standardization of medical services aimed at the implementation of the quality management program in healthcare.

4. To form and test an organizational-functional model for the development of regulatory documents on standardization in the field of medical services.

5. To develop a complex of recommendations for the development of standardization of work and services in healthcare.

Scientific Novelty. An analysis of the state of development of the system of standardization, classification, and coding of medical services in the Russian Federation has been conducted.

The significance of the development of classifiers of medical services for the creation of a unified information space in healthcare of the Russian Federation has been determined. Problems in the practical use of classifiers of medical services in the healthcare system of the Russian Federation have been identified.

The structure of a complex of regulatory documents in the field of standardization of medical services, aimed at the implementation of the quality management program in healthcare, has been designed.

An organizational-functional model for conducting standardization work in the field of medical services has been developed and tested.

Scientifically grounded recommendations on the development of standardization of work and services in healthcare have been formulated.

Practical Significance. As a result of the present research, the following industry standards and industry classifiers have been developed, coordinated, and approved:

• Industry Classifier "Simple Medical Services" OK PMU 91500.09.0001-2001 (Order of the Ministry of Health of the Russian Federation dated April 10, 2001, No. 113);

• Industry Classifier "Complex and Comprehensive Medical Services" OK 91500.09.0002-2001 (Order of the Ministry of Health of the Russian Federation dated July 16, 2001, No. 268);

• Industry Standard "Complex and Comprehensive Medical Services. Composition" OST 91500.09.0003-2001 (Order of the Ministry of Health of the Russian Federation dated July 16, 2001, No. 269);

• Industry Standard "Technologies for Performing Simple Medical Services. General Requirements" (Order of the Ministry of Health of the Russian Federation dated July 31, 2000, No. 299).

The materials of the work were used in the preparation of regulatory documents of the federal level:

• Industry Classifier "Donated Human Blood and Its Components" (Order of the Ministry of Health of the Russian Federation dated January 31, 2002, No. 25);

• Industry Standard "Protocol of Patient Management. Decubitus Ulcers;" (Order of the Ministry of Health of the Russian Federation dated April 17, 2002, No. 123);

• Industry Standard "Protocol of Patient Management. Heart Failure" (Order of the Ministry of Health of the Russian Federation dated May 27, 2002, No. 164);

• Order of the Ministry of Health of the Russian Federation dated July 26, 2002, No. 238 "On the Organization of Licensing of Medical Activity."

The results of the present research were used in the preparation of draft regulatory documents:

• Draft Industry Standard "Quality Control of the Performance of Medical Services. General Requirements";

• Draft Industry Standard "Assessment of the Quality of Medical Services Provision. General Requirements";

• Draft Industry Standard "Technology for Performing a Simple Medical Procedure. Intravenous Administration of a Pharmaceutical Preparation."

With the author's participation, the following were prepared: a program of the thematic improvement cycle "Fundamentals of Standardization in Healthcare" for healthcare administrators and clinicians, a collection of regulatory documents on standardization in healthcare, a textbook "Fundamentals of Standardization in Healthcare," and draft methodological recommendations on the creation of protocols of patient management.

Testing

The main provisions of the dissertation research were discussed at a joint meeting of the Department of Standardization in Healthcare of the Research Institute of Public Health and Healthcare Management, the Department of Healthcare Management of the Faculty of Healthcare Management, and the Department of Hematology and Geriatrics of the Faculty of Postgraduate Professional Education of the Sechenov Moscow Medical Academy on June 26, 2003.

The results of the present research are used in the activities of the Expert Council of the Ministry of Health of Russia on standardization in healthcare and its profile commissions.

The materials of the research were tested in the course of the creation by working groups of protocols of patient management and technologies for performing simple medical services, and are used in the conduct of pre-licensing preparation of medical organizations for compliance with licensing requirements and conditions and subsequent control over their observance.

The results of the present research were repeatedly reported and discussed at all-Russian and international conferences: All-Russian Conference "Problems of Standardization in Healthcare" (Moscow, 2000, 2001, 2002, 2003); Congress "Pharmacoeconomics at the Turn of the Third Millennium" (Moscow, 2001); Scientific and Practical Conference "Questions of Standardization of Ultrasonic Investigations" (Moscow, 2000); Russian Conference of Young Scientists of Russia with International Participation "Fundamental Sciences and Progress in Clinical Medicine" (Moscow, 2001); 7th Scientific and Practical Conference "Development of the System for Ensuring the Quality of Medical Care in Modern Conditions and Problems of Optimizing the Structure of Healthcare" (Moscow, 2002); International Scientific and Practical Conference "The Sick Elderly Person. Quality of Life" (Moscow, 2002).

36 works have been published on the topic of the dissertation, including one textbook (co-authored).

Main Provisions to Be Defended:

1. Standardization in the field of medical services implies, first and foremost, the development of constantly updated classifiers of work and services as the basis for the creation of a unified information space in healthcare of the Russian Federation.

2. A complex of regulatory documents in the field of standardization of medical services, aimed at the implementation of the program of work on quality management in healthcare, includes classifiers of simple, complex, and comprehensive medical services, functional standards regulating the requirements for their performance and the assessment of the quality of provision.

3. The organizational-functional model for the development of regulatory documents in the field of medical services allows the combination of the formal requirements of the system of standardization in healthcare with the specific tasks of informational content of each regulatory document.