I.M. Sechenov First Moscow State Medical University (Sechenov University) of Ministry of Health of Russian Federation (professor)
BMT-5 department «Medical equipment research, testing and exploitation» at Bauman Moscow State Technical University (head)
RUDN University («Innovative technologies in healthcare management» department at CME Faculty, head)
Irkutsk regional clinical hospital, winner of the “Mark of the Honor” (deputy CMO on quality – head of competence center)
National Quality Institute of Federal Service for Supervision in the Sphere of Healthcare (chief specialist)
BBK 51 Социальная гигиена и организация здравоохранения. Гигиена. Эпидемиология
SUMMARY Current monograph represents and reviews key approaches to creating an effective internal quality and safety control system for an organization, based on patient-oriented approach, process approach, risk management, continuous process improvement and other methods including definition of all applied terms, a number of examples and step by step manuals on executing key measures and events to create and develop a quality control system and local documentation samples. Target audience for this monograph: hospital leadership, including CMO, deputy CMO on quality, head of quality control committee or designated quality control specialist, other medical workers. ABOUT «THE BASICS OF MEDICAL CARE QUALITY AND SAFETY PROVISION» All changes and reforms in healthcare should provide for medical care quality improvement, preservation of life and health of all citizens. Once an abstract word “quality” has its’ own specific meaning today, acquired by means of legislative validation of the term “medical care quality and safety”. Providing healthcare quality and safety is one of the key priorities within the confines of Russian Federation national policy for citizens’ health protection. Current issue represents actual knowledge and practical experience in terms of medical care quality and safety control, continuous medical organization efficiency improvement. Current issue addresses the matters of theoretical and practical aspects of introducing management and internal quality and safety control system in medical care. It also contains the methodological description of Proposals (practical recommendations) of Federal Service for Supervision in the Sphere of Healthcare, developed based on global experience generalization, adapted to Russian specificity, aimed at quality and safety provision. Current issue represents a large number of samples, examples, templates and check-list tables. Data, accumulated in the monograph, allows the reader create a proper system of measures in a medical organization to comply with the order № 381-н of Ministry of Health of Russian Federation «On approving Requirements towards organizing and executing medical care internal quality and safety control». TARGET AUDIENCE Current issue is intended for a wide range of readers, interested in management: for healthcare organization leaders, CMOs and deputy CMOs, deputy CMOs on quality, quality control committee leaders or designated quality control specialists, physicians, nurses, medical academicians and students, and all specialists, interested in medical organizations’ stable development and improvement.
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18. Ivanov I.V. 8 grupp pokazatelei, chtoby provesti audit bezopasnosti obrashcheniya medizdelii [8 groups of indicators to conduct a safety inspection of the circulation of medical devices]. Zdravookhranenie, 2016, no. 11, pp. 80-87.
19. Ivanov I.V. Analiz informatsii, razmeshchennoi na ofitsial’nykh saitakh organov upravleniya zdravookhraneniem sub”ektov Rossiiskoi Federatsii po voprosam organizatsii kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti [Analysis of information posted on the official websites of the regional health authorities on issues related to quality control and safety of medical activity]. Vestnik Roszdravnadzora, 2015, no. 3, pp. 29-33.
20. Ivanov I.V. Audit bezopasnosti obrashcheniya meditsinskikh izdelii v meditsinskoi organizatsii [Safety audit of medical devices circulation in a medical organization]. Upravlenie kachestvom v zdravookhranenii, 2016, no. 4, pp. 8-14.
21. Ivanov I.V., Shvabskii O.R., Minulin I.B., et al. Audit kak instrument otsenki kachestva meditsinskoi pomoshchi [Audit as a health care quality assessment tool]. Standarty i kachestvo, 2017, no. 6, pp. 70-73.
22. Ivanov I.V., Murashko M.A., Panin A.I. Bezopasnost’ patsienta: mirovye tendentsii i otechestvennyi opyt [Patient safety: global trends and domestic experience]. Upravlenie kachestvom v zdravookhranenii, 2018, no. 2, pp. 35-41.
23. Ivanov I.V. Vnutrennii audit kachestva i bezopasnosti: kak organizovat’ i kakie dokumenty trebovat’ ot podchinennykh [Internal Quality and Safety Audit: How to organize and which documents to require from staff members]. Zdravookhranenie, 2017, no. 3, pp. 10-16.
24. Ivanov I.V., Shvabskii O.R. Vnutrennii kontrol’ bezopasnosti meddeyatel’nosti. Prakticheskie rekomendatsii [Internal security control of medical activity. Practical recommendations]. Zdravookhranenie, 2016, no. 8, pp. 62-67.
25. Ivanov I.V. Vnutrennii kontrol’ v meditsinskoi organizatsii: bezopasnost’ obrashcheniya meditsinskikh izdelii [Internal control in a medical organization: safety of medical devices circulation]. Remedium, 2016, no. 11, pp. 62-65.
26. Ivanov I.V., Shvabskii O.R. Vnutrennii kontrol’ kachestva i bezopasnosti meditsinskoi deyatel’nosti v statsionare [Internal quality and safety control of medical activities in hospitals]. Standarty i kachestvo, 2016, no. 10, pp. 84-86.
27. Ivanov I.V., Sharikadze D.T., Shvabskii O.R. Vnutrennii kontrol’ kachestva i bezopasnosti meditsinskoi deyatel’nosti v poliklinike: prakticheskie rekomendatsii [Internal quality and safety control of medical activity in the polyclinic: practical recommendations]. Upravlenie kachestvom v zdravookhranenii, 2017, no. 1, pp. 6-12.
28. Ivanov I.V., Seregina I.F., Sharonov A.N., et al. Vnutrennii kontrol’ kachestva i bezopasnosti meditsinskoi deyatel’nosti: novye trebovaniya [Internal quality and safety control of medical activity: new requirements]. Upravlenie kachestvom v zdravookhranenii, 2019, no. 4, pp. 12-21.
29. Ivanov I.V., Knyazev E.G. Vnutrennii kontrol’ kachestva i bezopasnosti: pervye prakticheskie shagi [Internal quality and safety control: first practical steps]. Zamestitel’ glavnogo vracha, 2017, no. 5, pp. 8-16.
30. Ivanov I.V. Vnutrennii kontrol’ lekarstvennoi bezopasnosti v meditsinskoi organizatsii [Internal drug safety control in a medical organization]. Remedium, 2018, no. 5, pp. 10-13.
31. Ivanov I.V., Shvabskii O.R., Minulin I.B. Edinaya strategiya po obespecheniyu kachestva i bezopasnosti meditsinskoi deyatel’nosti na baze natsional’nykh otraslevykh standartov: mezhdunarodnyi i rossiiskii opyt [A unified strategy to ensure the quality and safety of medical activity based on national sectoral standards: international and Russian practice]. Sb. nauchnykh trudov po itogam Mezhdunarodnoi nauchno-prakticheskoi konferentsii “Praktika razrabotki i vnedreniya sistemy menedzhmenta kachestva v meditsinskoi organizatsii”. Moscow, 2017, p. 79.
32. Ivanov I.V., Kalinichenko V.I. Instrument vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti po modeli obsluzhivaniya SAAS [The tool for internal control of quality and safety of medical activities under the SAAS service model]. Menedzhment kachestva v meditsine, 2019, no. 4, pp. 46-51.
33. Ivanov I.V., Shvabskii O.R., Minulin I.B., et al. Infrastruktura upravleniya kachestvom v zdravookhranenii. Mezhdunarodnyi opyt [Quality management infrastructure in health care. International experience]. Menedzhment kachestva v meditsine, 2019, no. 3, pp. 4-5.
34. Ivanov I.V., Rodoman G.V., Morozova Yu.A., et al. Kak povysit’ ekonomicheskuyu effektivnost’ kliniki na osnove rekomendatsii Roszdravnadzora [How to improve the economic efficiency of the clinic based on the recommendations of the Federal Healthcare Supervision Service]. Zdravookhranenie, 2018, no. 4, pp. 94-101.
35. Ivanov I.V. Kak provodit’ samootsenku po napravleniyu “Lekarstvennaya bezopasnost’. Farmakonadzor” [How to conduct a self-assessment in the direction of “Drug Safety. Pharmacovigilance”]. Upravlenie kachestvom v zdravookhranenii, 2019, no. 2, pp. 36-42.
36. Ivanov I.V., Shvabskii O.R., Minulin I.B., et al. Kachestvo i bezopasnost’ okazaniya ekstrennoi i neotlozhnoi meditsinskoi pomoshchi v statsionarakh [Quality and safety of providing emergency and urgent medical care in hospitals]. Problemy sotsial’noi gigieny, zdravookhraneniya i istorii meditsiny, 2019, no. 3, p. 316-319.
37. Ivanov I.V., Minulin I.B., Shcheblykina A.A. Kompleksnyi podkhod k obespecheniyu kachestva i bezopasnosti obrashcheniya meditsinskikh izdelii v meditsinskoi organizatsii: rezul’taty otsenki v ramkakh vnutrennego kontrolya [Integrated approach to quality and safety assurance of medical devices circulation in a medical organization: results of internal control assessment]. Vestnik Roszdravnadzora, 2018, no. 4, pp. 22-26.
38. Ivanov I.V. Kontrol’ kachestva v meditsinskoi organizatsii [Quality Control in a Medical Organization]. Kontrol’ kachestva produktsii, 2017, no. 7, pp. 38-43.
39. Ivanov I.V., Minulin I.B. Kontrol’ kachestva i bezopasnosti meditsinskoi deyatel’nosti: znachenie proverochnykh listov [Quality and safety control of medical activity: the value of checklists]. Upravlenie kachestvom v zdravookhranenii, 2018, no. 2, pp. 10-15.
40. Ivanov I.V., Shvabskii O.R., Minulin I.B., et al. Kontrol’ kachestva i bezopasnosti obrashcheniya meditsinskikh izdelii i lekarstvennykh preparatov v meditsinskikh organizatsiyakh [Control of quality and safety for the treatment of medical devices and pharmaceuticals in medical institutions]. Menedzhment kachestva v meditsine, 2019, no. 2, pp. 30-35.
41. Ivanov I.V., Shvabskii O.R., Minulin I.B., et al. Meditsinskaya deyatel’nost’: kachestvo i bezopasnost’ [Medical activity: quality and safety]. Standarty i kachestvo, 2017, no. 3, pp. 72-74.
42. Ivanov I.V., Sharikadze D.T., Berseneva E.A., et al. Metodicheskie podkhody k formirovaniyu risk-orientirovannoi modeli kontrol’no-nadzornoi deyatel’nosti v sfere zdravookhraneniya [Methodological approaches to the creation of a risk-oriented model of control and supervision activities in the health care sector]. Vestnik Roszdravnadzora, 2017, no. 1, pp. 34-36.
43. Ivanov I.V., Mikhailova Yu.V., Shikina I.B., et al. Metodologicheskie aspekty provedeniya nezavisimoi otsenki meditsinskikh organizatsii sub”ektov RF, okazyvayushchikh meditsinskuyu pomoshch’ prikreplennomu naseleniyu v ambulatornykh usloviyakh [Methodological aspects of an independent assessment of medical organizations of the Russian Federation constituent regions that provide outpatient medical care to the attached population]. Sotsial’nye aspekty zdorov’ya naseleniya, 2016, no. 3.
44. Ivanov I.V., Chikina O.G., Kushnareva G. Minzdrav menyaet poryadok vnutrennego kontrolya. Kak oformit’ dokumenty, sozdat’ sluzhbu po kachestvu i preodolet’ soprotivlenie personala [The Ministry of Health is changing the internal control procedure. How to arrange documents, create a quality service and overcome staff resistance]. Zdravookhranenie, 2019, no. 3, pp. 13-25.
45. Ivanov I.V., Piven’ D.V., Kitsul I.S. Novye zadachi i napravleniya raboty vrachebnoi komissii v sisteme obespecheniya i kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti [New challenges and trends of work of the medical commission in the system of assurance and control of quality and safety of medical activity]. Menedzher zdravookhraneniya, 2017, no. 2, pp. 6-13.
46. Ivanov I.V., Murashko M.A., Seregina I.F., et al. Novye trebovaniya k meditsinskim organizatsiyam po provedeniyu vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti: soderzhanie, tseli, perspektivy [New requirements for medical organizations to conduct internal quality and safety control of medical activity: content, goals, perspectives]. Vestnik Roszdravnadzora, 2019, no. 6, p. 714.
47. Ivanov I.V., Shvabskii O.R., Matytsin N.O., et al. Novye trebovaniya k meditsinskim organizatsiyam. O prikaze Minzdrava Rossii ot 07.06.2019 No. 381n “Ob utverzhdenii Trebovanii k organizatsii i provedeniyu vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti” [New requirements for medical organizations. About the Order of June 7, 2019 No. 381n “On approval of Requirements for organization and conduction internal control of the quality and safety of medical care in hospitals]. Menedzhment kachestva v meditsine, 2019, no. 4, pp. 26-31.
48. Ivanov I.V. Novyi prikaz Minzdrava o vnutrennem kontrole obsudili v Roszdravnadzore. Otvety na glavnye voprosy rukovoditelei klinik [The new order of the Ministry of Health on internal control was discussed in the Federal Service for Surveillance in Healthcare. Answers to key questions from clinic managers]. Zdravookhranenie, 2018, no. 11, pp. 15-25.
49. Ivanov I.V., Murashko M.A., Seregina I.F., et al. O proekte prikaza Minzdrava Rossii “Ob utverzhdenii trebovanii k organizatsii i provedeniyu vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti” [On the draft order of the Russian Ministry of Health “On approval of requirements for the organization and implementation of internal quality control and safety of medical activity”]. Vestnik Roszdravnadzora, 2018, no. 6, pp. 13-17.
50. Ivanov I.V., Piven’ D.V., Kitsul I.S. O trebovaniyakh prikaza MZ RF ot 10.05.2017 No. 203n k ustanovleniyu i oformleniyu predvaritel’nogo i klinicheskogo diagnozov: na chto neobkhodimo obratit’ vnimanie v meditsinskoi organizatsii [About the requirements of the order of the Ministry of Health of the Russian Federation from 10.05.2017 № 203n for the establishment and execution of preliminary and clinical diagnoses: what should be paid attention to in the medical organization]. Menedzher zdravookhraneniya, 2018, no. 1, pp. 20-26.
51. Ivanov I.V., Shvabskii O.R., Saifutdinov R.G. Obespechenie bezopasnosti meditsinskoi deyatel’nosti v meditsinskoi organizatsii na osnove predlozhenii Roszdravnadzora [Ensuring the safety of medical activity in a medical organization on the base of proposals of the Federal Service for Surveillance in Health Care]. Dnevnik kazanskoi meditsinskoi shkoly, 2016, no. 3, pp. 49-53.
52. Ivanov I.V., Astapenko E.M. Obespechenie bezopasnosti obrashcheniya meditsinskikh izdelii v meditsinskoi organizatsii [Ensuring safe circulation of medical devices in a medical organization]. Vestnik Roszdravnadzora, 2016, no. 5, pp. 28-30.
53. Ivanov I.V., Astapenko E.M. Obespechenie bezopasnosti obrashcheniya meditsinskikh izdelii v meditsinskoi organizatsii [Ensuring safe circulation of medical devices in a medical organization]. Menedzhment kachestva v meditsine, 2018, no. 1, pp. 105-109.
54. Ivanov I.V., Kovalishena O.V., Shvabskii O.R. Opyt audita obespecheniya kachestva i bezopasnosti meditsinskoi deyatel’nosti v meditsinskoi organizatsii po razdelu “Epidemiologicheskaya bezopasnost’” [Audit experience of ensuring quality and safety of medical activity in a medical organization under the section “Epidemiological safety”]. Vestnik Roszdravnadzora, 2017, no. 4, pp. 9-14.
55. Ivanov I.V., Matytsin N.O., Kulikov O.V. Otvety na voprosy glavvrachei po novomu prikazu Minzdrava o vnutrennem kontrole kachestva [Answers to the questions of chief physicians on the new order of the Ministry of Health on internal quality control]. Zdravookhranenie, 2019, no. 12, pp. 24-35.
56. Ivanov I.V., Shvabskii O.R., Minulin I.B., et al. Otsenka kachestva i bezopasnosti meditsinskoi deyatel’nosti po novomu prikazu [Quality and safety assessment of medical activity according to the new order]. Upravlenie kachestvom v zdravookhranenii, 2019, no. 4, pp. 3-11.
57. Ivanov I.V., Piven’ D.V., Kitsul I.S. Poryadok ekspertizy kachestva meditsinskoi pomoshchi [Procedure of examination of medical care quality]. Menedzher zdravookhraneniya, 2016, no. 6, pp. 6-15.
58. Ivanov I.V., Knyazev E.G. Praktika provedeniya samootsenki v meditsinskoi organizatsii pri osushchestvlenii vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti [Practice of self-assessment in a medical organization in the implementation of internal quality and safety control of medical activity]. Zamestitel’ glavnogo vracha, 2017, no. 5, pp. 8-16.
59. Ivanov I.V., Sharikadze D.T., Bobrova S.V. Predlozheniya (prakticheskie rekomendatsii) po organizatsii vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti v poliklinike [Proposals (practical recommendations) on organization of internal quality and safety control of medical activity in the polyclinic]. Vestnik Roszdravnadzora, 2017, no. 4, pp. 79-82.
60. Ivanov I.V., Emanuel’ V.L., Emanuel’ A.V., et al. Predlozheniya po vnutrennemu kontrolyu kachestva i bezopasnosti meditsinskoi deyatel’nosti v KDL [Proposals for internal quality and safety control of medical activity in a clinical diagnostic laboratory]. Upravlenie kachestvom v zdravookhranenii, 2019, no. 2, pp. 8-15.
61. Ivanov I.V., Shvabskii O.R., Minulin I.B. Rezul’taty samootsenki meditsinskimi organizatsiyami ikh sootvetstviya Predlozheniyam (prakticheskim rekomendatsiyam) Roszdravnadzora po organizatsii vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi organizatsii [The results of self-assessment by medical organizations of their correspondence to the proposals (Practical recommendations) of the Federal Service for Surveillance in Health Care for the internal quality and safety control of a medical organization]. Problemy sotsial’noi gigieny, zdravookhraneniya i istorii meditsiny, 2017, no. 6, pp. 340-343.
62. Ivanov I.V., Murashko M.A., Krupnova I.V. Risk-orientirovannyi podkhod pri planirovanii kontrol’nykh meropriyatii [Risk-oriented approach in control activity planning]. Vestnik Roszdravnadzora, 2017, no. 3, pp. 14-17.
63. Ivanov I.V., Sharonov A.N., Kovalev S.V., et al. Risk-orientirovannyi podkhod: kak snizit’ chislo planovykh proverok Roszdravnadzora [Risk-oriented approach: how to reduce the number of planned inspections by the Federal Service for Surveillance in Healthcare]. Zdravookhranenie, 2017, no. 9, pp. 32-37.
64. Ivanov I.V., Murashko M.A. Roszdravnadzor nazval novye zadachi organizatorov zdravookhraneniya [The Federal Service for Surveillance in Healthcare named the new tasks of the health care providers]. Zdravookhranenie, 2019, no. 1, pp. 46-56.
65. Ivanov I.V., Shvabskii O.R., Emanuel’ A.V., et al. Sistema upravleniya kachestvom v zdravookhranenii RF: nastoyashchee i budushchee [Russian Healthcare Quality Management System: present and future]. Standarty i kachestvo, 2016, no. 11, pp. 27-29.
66. Ivanov I.V. Sistema upravleniya kachestvom i bezopasnost’yu v meditsinskoi organizatsii. Sovremennoe sostoyanie [Quality and safety management system in a medical organization. Current situation]. Vestnik Roszdravnadzora, 2019, no. 6, pp. 15-23.
67. Ivanov I.V., Murashko M.A. Sovremennye printsipy organizatsii vnutrennego kontrolya kachestva i bezopasnosti meditsinskoi deyatel’nosti [Modern principles of organization of internal quality control and safety of medical activity]. Upravlenie kachestvom v zdravookhranenii, 2019, no. 2, pp. 3-7.
68. Ivanov I.V. Upravlenie kachestvom v meditsinskoi organizatsii: Prakticheskie rekomendatsii [Quality Management in a Medical Organization: Practical Recommendations]. Menedzhment kachestva v meditsine: Spetsvypusk, 2017, no. 16-20.
69. Ivanov I.V., Minulin I.B., Shcheblykina A.A. Assessment of Quality and Safety of Medical Care in Inpatient Facilities in Russia [Assessment of Quality and Safety of Medical Care in Inpatient Facilities in Russia]. CPQ Medicine, available at: https://www.cientperiodique.com/article/CPQME/1/6/32.
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