Use of Industry Standards in Licensing and Accreditation of Healthcare Institutions as a Means of Controlling and Managing the Quality of Medical Care (on the Example of the Oryol

The dissertation is devoted to the study of the role of industry standards in the system of licensing and accreditation of healthcare institutions as an instrument for controlling and managing the quality of medical care. The research is based on an analysis of domestic and foreign experience in the application of industry standards in the accreditation of medical institutions, as well as on the generalization of the conclusions of external experts based on expert work in the Oryol region.

The work evaluates the impact of the implementation of regional structural standards on the quality of medical care, and includes an analysis of the opinions of physicians and patients regarding the dynamics of the quality of medical care for the period from 1993 to 2002. The developed technology and methodology for conducting expert examination during accreditation have been introduced into the practice of licensing and accreditation of medical institutions in the territory of the Oryol region and are used in sector management.

Relevance of the research. At the current stage of the healthcare system's operation, accreditation of medical activities has assumed a leading position in the regulation and management of the delivery of medical care (Lindenbraten A.Yu., Shevchenko S.E., 1995; Starodubov V.I., 1997; Preobrazhenskaya V.S., 1998).

At the stage of economic reforms taking place in medicine, the role of accreditation in the development and organization of the work of medical institutions of all forms of ownership has significantly increased.

In accordance with the Federal Law "On Medical Insurance," licensing and accreditation are mandatory for all medical institutions, enterprises, and organizations, regardless of their form of ownership and organizational-legal status. Today, following the adoption of the new Federal Law "On Licensing of Certain Types of Activities," which extends the validity periods of the licenses issued, including those for the conduct of medical activities, and of Government Decree No. 499 "On Approval of the Regulations on Licensing of Medical Activities," accreditation of healthcare institutions as a mechanism for verifying compliance of a medical institution with regulatory norms and requirements and its capacity to provide the stated types of medical care has acquired even greater significance.

The problem arises of developing and implementing industry standards that meet the requirements imposed on accreditation subjects depending on their structural and organizational characteristics (healthcare institutions, private healthcare objects, individually practicing physicians).

Thus, the necessity of conducting accreditation of medical institutions using industry standards as an essential component of the system for ensuring the quality of medical care and managing healthcare is widely discussed. However, the approaches to the technology of conducting accreditation using industry standards are not fully described. The impact of accreditation procedures on the structural-functional aspects of medical institutions' activities is insufficiently covered.

At the same time, the analysis of the experience of applying structural standards taking into account regional characteristics is highly necessary for a broad familiarization with and use of this organizational form within the structure of extra-institutional control of the quality of medical activities.

The aim of the research is to analyze the impact of the use of regional industry standards on improving the quality of medical care (on the example of the Oryol region). The research tasks are as follows:

- analysis of domestic and foreign experience in the use of industry standards in the accreditation of medical institutions based on the study of regulatory and methodological documents and literary sources;

- study of the results of licensing and accreditation activities of medical institutions in the Oryol region based on the generalization of conclusions of external experts during expert work on determining the compliance of medical institutions with the norms and requirements (standards) imposed for the conduct of medical activities;

- analysis of the impact of the implementation of regional industry standards on the quality of medical care;

- study of the opinions of physicians of healthcare institutions in the Oryol region regarding the impact of licensing and accreditation on improving the quality of medical care; study of the opinions of patients of healthcare institutions in the Oryol region on the dynamics of the quality of medical care for the period from 1993 to 2002; scientific substantiation of the use of regional structural standards as a mechanism for extra-institutional control of the quality of medical care.

The scientific novelty of the research lies in the fact that, on the basis of a comprehensive study of the accreditation process of medical institutions (on the example of the Oryol region), the technology for conducting expert work during accreditation under conditions of healthcare reform and changes in the licensing technology of medical institutions of all forms of ownership is substantiated and introduced into the practice of sector management.

The practical significance of the work consists in that the developed technology and methodology for conducting expert examination during accreditation of medical institutions has been introduced into the practice of licensing and accreditation of medical institutions, as well as into sector management (the territorial fund of compulsory medical insurance, the department of healthcare) in the territory of the Oryol region.

The results of the research are used in the educational process at the Department of Public Health and Healthcare of the Saint Petersburg State Medical University named after Academician I.P. Pavlov.

The calculations of tariffs for licensing and accreditation of medical institutions are used in the practical activities of the licensing department of the Oryol region.