Organization of work with undesired events within the system of medical activities quality and safety internal control with the use of digital technology

In accordance with the current legislation a healthcare organization shall be obliged to provide conditions for safe delivery of healthcare to patients and medical personnel performance.

Implementation of effective model of medical activities quality and safety internal control producing meaningful result is a current license requirement to a healthcare organization.

Implementation of risk-oriented approach to medical activities quality and safety management is an important constituent of modern stage of the Russian Federation healthcare functioning.

It is necessary to understand sources of potential hazard within an organization, consider and analyze all undesired events and incidents arising in the process of a healthcare organization functioning and their reasons, take preventive measures to avoid them.

The tasks of digital transformation in the Russian Federation healthcare are development of integrated digital contour, transition to electronic document flow, reduction of medical personnel’s time expenditure not involving delivery of healthcare.

Implementation of customer centricity and digitalization principles is an absolute trend of modern stage of development of the Russian Federation healthcare. It determines necessity of development of present-day accounting and analyzing data system on undesired events in a healthcare organization.

The article presents the experiment of Federal Center for Traumatology, Orthopedics and Endoprosthetics (Barnaul, Russian Federation) in establishing system of work with undesired events and managerial decision-making on their avoidance and prevention with the use of present-day digital technology resulting in credible frequency reduction of undesired events in the space of 2.5 years. 

1. Murashko MA, Ivanov IV, Knyazyuk NF. Basics of quality and safety provision of medical activities. Мoscow; 2020. (In Russ.).

2. Order of the Ministry of Health of Russia No. 785n dd. 31.07.2020 “Concerning approval of Requirements to organization and assurance of medical activities quality and safety internal control”. URL: http://publication.pravo.gov.ru/Document/View/0001202010020017. [date of access: 25.07.2022]. (In Russ.).

3. Russian Federation Government Decree N 852 dd. 01.06.2021 “Concerning licensing of medical activities (except for within named activities implemented by healthcare organizations and other organizations included in private healthcare system within the territory of Skolkovo Innovation Center)”. URL: https://base.garant.ru/400846456/. [date of access: 03.08.2022]. (In Russ.).

4. Ivanov IV, Shvabsky OR, Minulin IB, Shchesyul AG. Monitoring of quality indicators of medical activities quality and safety: Audit data of 30 healthcare organizations (in-patient facilities). Menedzhment kachestva v meditsine. 2018; 2: 28-32. (In Russ.).

5. GOST R ISO 31000-2019. National standard of the Russian Federation. Risk management. Principles and guidance. (Approved and came into force by order N 1379-st dd. 10.12.2019 of Rosstandart (Federal Agency for Technical Regulation and Metrology)). URL: https://docs.cntd.ru/document/1200170125. [date of access: 25.07.2022]. (In Russ.).

6. Knyazyuk NF, Bidagaeva TG, Khaynueva GM, Kim NA. Healthcare organization risk management. Zdravookhranenie. 2016; 5: 42-50. (In Russ.).

7. Maslov MG. Errors and undesired events in medical activities. Health Care of the Russian Federation. 2019; 63(6): 339-342. (In Russ.). doi: 10.18821/0044-197X-2019-63-6-339-342

8. Fomenko A.G. Medical errors and undesired events reporting systems in healthcare is a key element of promotion of patients’ security. Voprosy organizatsii i informatizatsii zdravookhraneniya. 2008; 2: 17-26. (In Russ.).

9. Russian Federation Government Resolution N 2765-r dd. 01.10.2021 “Concerning approval of the Common plan for reaching national objectives of the Russian Federation development for the period up to the year 2024 and for the planning period up to the year 2030”. URL: http://publication.pravo.gov.ru/Document/View/0001202110110015. [date of access: 04.08.2022]. (In Russ.).

10. Perepelova OV, Petrova IA. Patient-centricity during rendering healthcare service to population as a value and principle of activity. Manager zdravoochranenia. 2019; 10: 12-17. (In Russ.).

11. Shakhabov IV, Melnikov YuYu, Smyshlyayev AV. Key aspects of patient-oriented model of healthcare organization management. Scientific Review. Medical sciences. 2020; 3: 34-38. (In Russ.).

12. RF Government Resolution N 3980-r dd. 29.12.2021 “Concerning approval of strategic direction in the area of healthcare digital transformation”. URL: http://publication.pravo.gov.ru/Document/View/0001202112310112. [date of access: 25.07.2022]. (In Russ.).

13. Russian Federation Presidential Decree N 254 dd. 06.06.2019 “Concerning development strategy of healthcare in the Russian Federation for the period up to the year 2025”. URL: http://publication. pravo.gov.ru/Document/View/0001201906070052. [date of access: 25.07.2022]. (In Russ.).

14. Report of Accounting Chamber of the Russian Federation on results of expert and analytic action “Analysis of current state of healthcare informational support in the context of development of integrated digital contour in healthcare”, approved on 31.05.2022. URL: https://ach.gov.ru/checks/zdravookhraneniya-informatizatcia. [date of access: 22.07.2022]. (In Russ.).

15. Kleymenova YeB, Yashina LP. Protocols concerning assurance of medical care safety in a multi-speciality hospital. Мoscow: Russian Medical Academy of Continuous Professional Training; 2019. (In Russ.).

16. Minulin IB, Shvabsky OR, Ivanov IV, Matytsin NO, Shcheblykina AA, Taut DF. Review of the approaches to accounting and analysis of undesired events in the course of medical activities. Manager zdravoochranenia. 2021; 3: 9-17. (In Russ.). doi: 10.21045/1811-0185-2021-3-9-17

17. Order of Roszdravnadzor (Federal Service for Supervision in Healthcare) N 4513 dd. 20.05.2021 “Concerning approval of classification of undesired events connected with medical devices circulation”. URL: http://publication.pravo.gov.ru/Document/View/0001202106100019. [date of access: 25.07.2022]. (In Russ.).

18. Order of the Ministry of Health of Russia N 1108n dd. 29.11.2021 “Concerning approval of procedure for preventive activities, revealing and recording at a healthcare organization of cases of infectious diseases connected with delivery of healthcare, nomenclature of infectious diseases connected with delivery of healthcare subject to revealing and recording at a healthcare organization”. URL: http://publication.pravo.gov.ru/Document/View/0001202112310011. [date of access: 27.07.2022]. (In Russ.).

19. Order of Roszdravnadzor (Federal Service for Supervision in Healthcare) N 1071 dd. 15.02.2017 “Concerning approval of Procedure for pharmacovigilance”. URL: https://docs.cntd.ru/document/420394411. [date of access: 28.07.2022]. (In Russ.).

20. Order of the Ministry of Health of Russia N 1113n dd. 19.10.2020 “Concerning approval of Procedure for reporting by subjects of medical devices circulation of all cases of revealing side effects not indicated in product instructions or operation manual of a medical device, of adverse reactions during its use, of special aspects of medical devices interaction, of facts and circumstances creating danger to life and health of general public and medical personnel during use and operation of medical devices”. URL: http://publication.pravo.gov.ru/Document/View/0001202012070057. [date of access: 28.07.2022]. (In Russ.).

21. Pugachev PS, Gusev AV, Kobyakova OS, Kadyrov FN, Gavrilov DV, Novitsky RE, Vladzimirskiy AV. Global trends of digital transformation of healthcare. National Health Care (Russia). 2021; 2(2): 5-12. (In Russ.). doi: 10.47093/2713-069X.2021.2.2.5-12

22. Kleymenova YeB, Yashina LP. Role of medical information technology in providing patients’ safety. Vrach i informacionnye tehnologii. 2020; 3: 13-24. (In Russ.). doi: 10.37690/1811-0193-2020-3-13-24

23. Russian Federation Government Decree N 198 dd. 17.02.2022 “Concerning approval of Regulation on information system for providing intradepartmental and interdepartmental document flow and control of assignments which includes using cloud services”. URL: http://publication.pravo.gov.ru/Document/View/0001202202180008. [date of access: 25.07.2022]. (In Russ.).

24. Peleganchuk VA, Kolyado YeV, Povalikhin AN, Suslina NA, Shults TE. Sentinel event recording in medical care: Computer program registration certificate No. 2022614739. 24.03.2022. (In Russ.).