Assessment of risk of health from violations of mandatory sanitary and epidemiological requirements in the provision of medical services based on the results of the control and supervision activities of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing (Rospotrebnadzor)

Introduction. One of the main provisions of the reform of the state supervision system is the concept of a risk-oriented approach. The process of making changes to sanitary legislation goes on. However, not all changes take into account the risk criteria for health. In this regard, there are advisable amendments to the sanitary and epidemiological requirements using criteria based on risk assessment, including at objects with a high risk of harm to health.

The purpose of the study is to evaluate the risk of the health for the sanitary and epidemiological requirements when providing services to the population based on the results of the control and supervision activities of the Federal Service for Supervision in Protection of the Rights of Consumer and Man Wellbeing (Rospotrebnadzor).

Materials and methods. A systemic analysis of the domestic and foreign experience of the substantiation of sanitary and epidemiological requirements was carried out. More than six hundred fifty units of departmental documentation of the Rospotrebnadzor, carried out during control and supervision events in medical institutions of the Perm Territory, were studied. To establish causal relationships between the frequency of disorders of sanitary and epidemiological requirements and the adverse responses from the health side, the logistics regression method has been applied.

Results. In case of violation of the sanitary and epidemiological requirements for the provision of medical services, the level of acceptable risk was shown to be formed from 2.1 ∙ 10^–6 to 8.3 ∙ 10^–5. Thus, with the proper execution of requirements for the provision of services in medical institutions, health safety is ensured by risk criteria.

Research limitations. The application of risk criteria for health in the sanitary and epidemiological requirements is based on Art. 1 of the Federal Law of 31.07.2020 No. 248-ФЗ «On State Control (Supervision) and Municipal Control in the Russian Federation».

Conclusion. The resulting risk levels show the exercise of the powers of Rospotrebnadzor, in the context of a risk-oriented model of supervision to provide a stable sanitary and epidemiological situation in institutions providing medical services in a specific territory.

Compliance with ethical standards. This study does not require the conclusion of a biomedical ethics committee or other documents.

Contribution of the authors:
Shur P.Z. — research concept and design, editing;
Redko S.V., Lir D.N., Fokin V.A., Tsinker M.Yu. — collection and processing of material, writing the text, compilation of the list of literature.
All authors are responsible for the integrity of all parts of the manuscript and approval of the manuscript final version.

Acknowledgment. The study had no sponsorship.

Conflict of interest. The authors declare no conflict of interest.

Received: August 12, 2024 / Accepted: October 3, 2024 / Published: December 28, 2024