Nội dung được dịch bởi AI, chỉ mang tính chất tham khảo
Các phương pháp thanh tra bên ngoài và sự tham gia của quan điểm của các bên liên quan trong việc thanh tra sau các sự cố nghiêm trọng - một nghiên cứu phương pháp hỗn hợp định tính từ quan điểm của các thanh tra điều hành
BMC Health Services Research - 2024
Tóm tắt
Mục tiêu của nghiên cứu là thu thập thông tin về cách thức diễn ra các cuộc thanh tra bên ngoài sau các sự cố nghiêm trọng trong bối cảnh bệnh viện Na Uy từ góc độ của các thanh tra, và liệu rằng quan điểm của các bên liên quan có được đưa vào thanh tra hay không. Dựa trên thiết kế phương pháp hỗn hợp định tính, 10 quan chức chính phủ và thanh tra đang làm việc tại Cục Giám sát Y tế Quốc gia và ba Tỉnh trưởng ở Na Uy đã được tuyển chọn chiến lược, và các cuộc phỏng vấn bán cấu trúc cá nhân đã được thực hiện. Các tài liệu chính thức quan trọng của chính phủ đã được lựa chọn, thu thập, và phân tích theo chủ đề cùng với dữ liệu phỏng vấn. Những phát hiện của chúng tôi cho thấy hai chủ đề chính: Chủ đề (1) Quan điểm về các phương pháp thanh tra bên ngoài khác nhau trong việc phản hồi và tham gia các bên liên quan vào thanh tra sau các sự cố nghiêm trọng, Chủ đề (2) Thực tiễn làm việc nội bộ của các thanh tra so với kỳ vọng bên ngoài. Các tài liệu và tất cả các tham gia viên báo cáo một sự phát triển hướng tới các phương pháp mới trong thanh tra bên ngoài, với nhiều chính sách và sự chú ý hơn đối với việc tham gia hợp lý của các bên liên quan. Sự tham gia và tương tác với người bệnh và người chăm sóc không chính thức có thể cung cấp thông tin cho độ phức tạp của trường hợp và quá trình ra quyết định của thanh tra. Tuy nhiên, sự tham gia của các bên liên quan đôi khi phức tạp và thách thức do ví dụ, việc giao tiếp và tương tác khó khăn với bệnh nhân và/hoặc người chăm sóc không chính thức, do yêu cầu tài nguyên và/hoặc thiếu kinh nghiệm và/hoặc năng lực liên quan của thanh tra, cùng với các nhận thức khác nhau về nguyên tắc thực hành chuyên môn hợp lý, chất lượng và an toàn. Các thanh tra coi việc cân bằng giữa các mục tiêu chính thức và kỳ vọng, với kỳ vọng của công chúng và các bên liên quan khác nhau (tức là bệnh viện, bệnh nhân và/hoặc người chăm sóc không chính thức) là một phần thách thức trong công việc của họ. Sự cân bằng này được coi là một phần quan trọng trong sự phát triển liên tục nhằm đảm bảo uy tín và tính hợp pháp trong các quy trình thanh tra bên ngoài. Nghiên cứu của chúng tôi gợi ý rằng hệ thống quy định của thanh tra bên ngoài và các phương pháp sẵn có trong việc phản hồi sự cố nghiêm trọng trong bối cảnh Na Uy hiện tại không được thiết kế để đáp ứng được sự phức tạp của các nhu cầu từ các bên liên quan ở các mức độ tổ chức bệnh viện, bệnh nhân và người chăm sóc không chính thức. Các nghiên cứu tiếp theo nên chú ý đến cách thức mà hệ thống trách nhiệm rộng lớn hơn có thể hỗ trợ các thực tiễn làm việc nội bộ trong hệ thống quy định, để tốt hơn trong việc điều chỉnh các mục tiêu chính thức với kỳ vọng của công chúng.
Từ khóa
Tài liệu tham khảo
Tikkanen R, et al. In: Osborn R, editor. International profiles of health care systems. New York: The Commonwealth Fund; 2020. https://www.commonwealthfund.org/sites/default/files/2020-12/International_Profiles_of_Health_Care_Systems_Dec2020.pdf
Van Wilder A, Brouwers J, Cox B, et al. A decade of commitment to hospital quality of care: overview of and perceptions on multicomponent quality improvement policies involving accreditation, public reporting, inspection and pay-for-performance. BMC Health Serv Res. 2021;21(1):990. https://doi.org/10.1186/s12913-021-07007-w. Published 2021 Sep 20.
World Health Organization (WHO). Health care accreditation and quality of care: exploring the role of accreditation and external evaluation of health care facilities and organizations. Geneva: World Health Organization; 2022. Licence: CC BY-NC-SA 3.0 IGO. (Accessed 11 May 2023).
Øyri SF, Bates DW, et al. Comparison of external evaluation policies and regulations for quality improvement and safety of health services in Norway and the United States. Int J Health Gov ISSN. 2023:2059–4631. https://doi.org/10.1108/IJHG-06-2023-0065
Flodgren G, Pomey MP, Taber SA, et al. Effectiveness of external inspection of compliance with standards in improving healthcare organisation behaviour, healthcare professional behaviour or patient outcomes. Cochrane Database Syst Rev. 2011;CD008992. https://doi.org/10.1002/14651858.CD008992.pub2
Flodgren G, Gonçalves-Bradley DC, Pomey MP. External inspection of compliance with standards for improved healthcare outcomes. Cochrane Database Syst Rev. 2016;12(12):CD008992. https://doi.org/10.1002/14651858.CD008992.pub3. Published 2016 Dec 2.
Schaefer C, Wiig S. Strategy and practise of external inspection in healthcare services—a Norwegian comparative case study. Saf Health. 2017;3:3.
Hovlid E, Frich JC, Walshe K, et al. Effects of external inspection on sepsis detection and treatment: a study protocol for a quasiexperimental study with a stepped-wedge design. BMJ Open. 2017;7:e016213.
Hovlid E, Braut GS, Hannisdal E, et al. Mediators of change in healthcare organisations subject to external assessment: a systematic review with narrative synthesis. BMJ Open. 2020;10(8):e038850. https://doi.org/10.1136/bmjopen-2020-038850. Published 2020 Aug 30.
Hovlid E, Teig IL, Halvorsen K, Frich JC. Inspecting teams’ and organisations’ expectations regarding external inspections in health care: a qualitative study. BMC Health Serv Res. 2020;20(1):627. https://doi.org/10.1186/s12913-020-05475-0. Published 2020 Jul 8.
Hovlid E, Husabø G, Teig IL, Halvorsen K, Frich JC. Contextual factors of external inspections and mechanisms for improvement in healthcare organizations: a realist evaluation. Soc Sci Med. 2022;298:114872. https://doi.org/10.1016/j.socscimed.2022.114872
Johannesen DTS, Lindøe PH, Wiig S. Certification as support for resilience? Behind the curtains of a certification body - a qualitative study. BMC Health Serv Res. 2020;20(1):730. https://doi.org/10.1186/s12913-020-05608-5. Published 2020 Aug 8.
Øyri S. Healthcare Regulation and Resilience - a Norwegian Multilevel Case Study Thesis; University of Stavanger. Stavanger; 2021. https://uis.brage.unit.no/uis-xmlui/handle/11250/2766250 (Accessed 13 May 2023).
Brennan TA. The role of regulation in quality improvement. Milbank Q. 1998;76(4):709–512. https://doi.org/10.1111/1468-0009.00111
Sparrow M. The Regulatory Craft. Controlling risks: solving problems, and managing compliance. Brookings Institution; 2000.
Walshe K, Regulating Healthcare. A prescription for improvement? McGraw-Hill Education; 2003.
Chuang S. Adaptation versus standardisation in patient safety. In: Hollnagel E, Braithwaite J, & Wears RL, editors. Resilient health care. Ashgate Publishing Limited; 2013.
Weenink JW, Wallenburg I, Hartman L, et al. Role of the regulator in enabling a just culture: a qualitative study in mental health and hospital care. BMJ Open. 2022;12(7):e061321. https://doi.org/10.1136/bmjopen-2022-061321. Published 2022 Jul 27.
Bergerød IJ, Braut GS, Wiig S. Resilience from a stakeholder perspective: the role of next of kin in cancer care. J Patient Saf. 2020;16(3):e205–10. https://doi.org/10.1097/PTS.0000000000000532
Van Vliet EJ, Stewart J, Engel C, editors. Clarifying the concept of external evaluation. White Paper, International Society for Quality in Health Care (ISQua). Dublin, 2021. https://isqua.org/images/blog/ISQuaWhitepaperExtEvaluationJuly2021_RS.pdf. (Accessed 11 May 2023).
Bergerød I. Quality and safety in hospital cancer care: a mixed methods study of next of kin involvement. Thesis. University of Stavanger, Stavanger; 2021. https://uis.brage.unit.no/uis-xmlui/handle/11250/2753635
Rasmussen J. Risk management in a dynamic society: a modelling problem. Saf Sci. 1997;27:183–213.
Batalden PB, Davidoff F. What is quality improvement and how can it transform healthcare? Qual Saf Health Care. 2007;16:2–3.
Wiig S, Haraldseid-Driftland C, Tvete Zachrisen R, Hannisdal E, Schibevaag L. Next of kin involvement in regulatory investigations of adverse events that caused patient death: a process evaluation (part I - the next of kin’s perspective). J Patient Saf. 2021;17(8):e1713–8. https://doi.org/10.1097/PTS.0000000000000630
Wiig S, Schibevaag L, Tvete Zachrisen R, Hannisdal E, Anderson JE, Haraldseid-Driftland C. Next-of-kin involvement in regulatory investigations of adverse events that caused patient death: a process evaluation (part II: the inspectors’ perspective). J Patient Saf. 2021;17(8):e1707–12. https://doi.org/10.1097/PTS.0000000000000634
Allen T, Walshe K, Proudlove N, Sutton M. Measurement and improvement of emergency department performance through inspection and rating: an observational study of emergency departments in acute hospitals in England. Emerg Med J. 2019;36(6):326–32. https://doi.org/10.1136/emermed-2018-207941
Wears RL, Sutcliffe KM. Still not safe: patient safety and the middle managing of American medicine. 1st ed. Oxford University Press; 2020.
yri Ø SF, Braut GS, Macrae C, Wiig S. Exploring links between resilience and the macro-level development of healthcare regulation- a Norwegian case study. BMC Health Serv Res. 2020;20(1):762. https://doi.org/10.1186/s12913-020-05513-x. Published 2020 Aug 18.
Øyri S, Braut G, Macrae C, et al. Investigating hospital supervision: a case study of regulatory inspectors’ roles as potential co-creators of resilience. J Pat Saf. 2021;17(2):122–30. https://doi.org/10.1097/PTS.0000000000000814
Øyri SF, Wiig S. Linking resilience and regulation across system levels in healthcare - a multilevel study. BMC Health Serv Res. 2022;22(1):510. https://doi.org/10.1186/s12913-022-07848-z. Published 2022 Apr 15.
Ocloo JE. Harmed patients gaining voice: challenging dominant perspectives in the construction of medical harm and patient safety reforms [published correction appears in Soc Sci Med. 2010;71(6):1218]. Soc Sci Med. 2010;71(3):510–516. https://doi.org/10.1016/j.socscimed.2010.03.050
Wiig S, Rutz S, Boyd A, Churruca K, et al. What methods are used to promote patient and family involvement in healthcare regulation? A multiple case study across four countries. BMC Health Serv Res. 2020;20(1):616. https://doi.org/10.1186/s12913-020-05471-4. PMID: 32631343; PMCID: PMC7336629.
Wiig S, Hibbert PD, Braithwaite J. The patient died: what about involvement in the investigation process? Int J Qual Health Care. 2020;32(5):342–6. https://doi.org/10.1093/intqhc/mzaa034
Kok J, Leistikow I, Bal R. Patient and family engagement in incident investigations: exploring hospital manager and incident investigators’ experiences and challenges. J Health Serv Res Policy. 2018;23(4):252–61. https://doi.org/10.1177/1355819618788586
Norwegian Board of Health Supervision (NBHS). In Norwegian: Pasient- og pårørendeperspektiv ved alvorlige hendelser. Rapport fra Helsetilsynet 4/2019. In English: Patient- and informal caregivers’ perspectives following serious incidents. Oslo: Norwegian Board of Health Supervision; 2018. Report 4/2019. https://www.helsetilsynet.no/en/publications/report-of-the-Norwegian-board-of-health-supervision/2019/the-perspective-of-patients-and-relatives-when-a-serious-adverse-event-has-occurred.-examples-and-experience-gained-from-assessing-serious-adverse-events-in-2018/
Lippestad JW, Melby L, Kilskar SS, Øren A. Evaluering av meldeordning om uønskede hendelser i spesialisthelsetjenesten. SINTEF. https://www.sintef.no/globalassets/sintef-teknologi-og-samfunn/rapporter-sintef-ts/sintef-a26547_sluttrapport_meldeordning.pdf
Petkovic J, Riddle A, Akl EA et al. Protocol for the development of guidance for stakeholder engagement in health and healthcare guideline development and implementation. Syst Rev. 2020;9(1):21. Published 2020 Feb 1. https://doi.org/10.1186/s13643-020-1272-5
Norwegian Board of Health Supervision (NBHS). In Norwegian: Årsrapport 2018 fra Statens Helsetilsyn. In English: Annual Report 2018 from the Norwegian Board of Health Supervision. Oslo: Norwegian Board of Health Supervision; 2018. https://www.helsetilsynet.no/globalassets/opplastinger/publikasjoner/aarsrapporter/aarsrapport2018.pdf
Norwegian Board of Health Supervision (NBHS). In Norwegian: Årsrapport 2021 fra Statens Helsetilsyn In English: Annual Report 2021 from the Norwegian Board of Health Supervision Oslo: Norwegian Board of Health Supervision; 2021.
Ministry of Health and Care Services (MHCS). In Norwegian: Lov om statlig tilsyn med helse- og omsorgstjenesten mv. (helsetilsynsloven). In English: The Act of 15 December 2017 No. 107 relating to governmental supervision with the healthcare services (The Health Supervision Act) LOV-2017-12-15-107. Oslo: Ministry of Health and Care Services; 2017. (Accessed 11 May 2023). https://lovdata.no/dokument/NL/lov/2017-12-15-107.
Ministry of Health and Care Services (MHCS). In Norwegian: Lov om spesialisthelsetjenesten. (LOV-1999-07-02-61). In English: The Act of 2 July 1999 No. 61 relating to the specialized healthcare services (the Specialized Healthcare Services Act). Oslo: Ministry of Health and Care Services; 1999. (Accessed 11 May 2023).
Ministry of Health and Care Services (MHCS). In Norwegian: Lov Om Helsepersonell m.v.(helsepersonelloven). LOV-1999-07-02-64. English: Act of 2 July 1999 No. 64 relating to Health personnel etc. Oslo: Ministry of Health and Care Services; 1999. https://www.regjeringen.no/no/dokumenter/act-of-2-july-1999-no-64-relating-to-hea/id107079/
Ministry of Health and Care Services (MHCS). In Norwegian: Pasient- Og brukerrettighetsloven. English: the patient and user rights Act (patient and user rights Act). Ministry of Health and Care Services; 1999. https://lovdata.no/dokument/NL/lov/1999. (accessed 11 May 2023). -07-02-63/KAPITTEL_2#x2-5a Oslo.
Norwegian Directorate of Health (NDH). In Norwegian: Rapport. Pasientskader i Norge 2022– Målt med Global Trigger Tool. In English: Report. Patient injuries in Norway 2022– measured by the Global Trigger Tool. Oslo: Norwegian Directorate of Health; 2022. https://www.helsedirektoratet.no/rapporter/pasientskader-i-norge-2022--malt-med-global-trigger-tool
Norwegian Board of Health Supervision (NBHS). In Norwegian: Statens helsetilsyn. Årsrapport 2022. In English: Annual Report 2022 from the Norwegian Board of Health Supervision Oslo: Norwegian Board of Health Supervision; 2022. https://www.helsetilsynet.no/globalassets/opplastinger/publikasjoner/aarsrapporter/aarsrapport_2022.pdf
Ministry of Health and Care Services. Regulation on management and quality improvement in the healthcare services. Norwegian: Forskrift Om ledelse og kvalitetsforbedring i helse- og omsorgstjenesten. FOR-2016-10-28–1250. Oslo: Ministry of Health and Care Services; 2016. https://lovdata.no/dokument/SF/forskrift/2016-10-28-1250
Norwegian Directorate of Health (NDH). In Norwegian: Veileder for utvikling av kunnskapsbaserte retningslinjer. In English: Guidelines for the development of evidence-based guidelines. Oslo: Norwegian Directorate of Health; 10/2012. https://www.helsedirektoratet.no/veiledere/utvikling-av-kunnskapsbaserte-retningslinjer/Veileder for utvikling av kunnskapsbaserte retningslinjer (fullversjon).pdf/_/attachment/inline/efa406d5-9fe5-4ff5-9a8c-3f0e143c55c8:2cc6aceb8963dcfec76bc036a10402f12729b8ad/Veileder for utvikling av kunnskapsbaserte retningslinjer (fullversjon).pdf
Norwegian Directorate of Health (NDH). In Norwegian: Kvalitet Og Kvalitetsindikatorer. English: quality and quality indicators. Oslo: Norwegian Directorate of Health; 2021. https://www.helsedirektoratet.no/statistikk/kvalitetsindikatorer/kvalitet-og-kvalitetsindikatorer
Morse JM, Niehaus L. Mixed Method Design. Principles and procedures. Walnut Creek: Left Coast; 2009.
Patton M. Qualitative evaluation and research methods. Beverly Hills, CA: Sage; 1990.
Braun V, Clarke V. Successful qualitative research - a practical guide for beginners. Thousand Oaks, CA: Sage; 2013.
Norwegian Board of Health Supervision (NBHS). In Norwegian: Varsler som oversendes fra Statens Helsetilsyn. English: guidelines for inspection conducted by the County Governor level- appendix 2. Oslo, 14.02.2022. Oslo: Norwegian Board of Health Supervision; 2022.
Norwegian Board of Health Supervision (NBHS). In Norwegian: Saman Om Betre tilsyn. Tilrådingar Om brukarinvolvering i tilsyn. Rapport Fra Helsetilsynet 2/2019. English: recommendations related to stakeholder involvement in external inspection. Report 2/2019. Oslo: Norwegian Board of Health Supervision; 2019. https://www.helsetilsynet.no/globalassets/opplastinger/publikasjoner/rapporter2019/helsetilsynetrapport2_2019.pdf
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Informasjon til Ledere Og Helsepersonell Om stedlig tilsyn fra Statens Helsetilsyn. English: information to managers and health professionals regarding onsite inspection. 21.06.2021. Oslo: Norwegian Board of Health Supervision; 2021. https://www.helsetilsynet.no/tilsyn/varsel-om-alvorlige-hendelser/informasjon-til-ledere-og-helsepersonell--om-stedlig-tilsyn-fra-statens-helsetilsyn/
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Stedlig Tilsyn etter varsel om alvorlig hendelse som tilsynsmetode. English: Onsite inspection as method following reports of serious incidents. 01.08.2022. Oslo: Norwegian Board of Health Supervision; 2022. https://www.helsetilsynet.no/tilsyn/varsel-om-alvorlige-hendelser/mer-om-stedlig-tilsyn-etter-varsel-om-alvorlig-hendelse-som-tilsynsmetode/
Norwegian Board of Health Supervision (NBHS). In Norwegian: veiledning for statsforvalterens behandling av tilsynssaker (helse- og omsorgstjenesten). English: Guidelines - reports delegated to the County governors from the NBHS. 03.07.2022. Oslo: Norwegian Board of Health Supervision; 2022. https://www.helsetilsynet.no/tilsyn/veiledning-for-statsforvalterens-behandling-av-tilsynssaker-helse-og-omsorgstjenesten/
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Tilbakemelding til Utvalget Som Skal evaluere varselordningen for helse- og omsorgstjenesten. English: response letter from the NBHS to the Consultative Committee responsible for assessing the incident reporting regime in Norway. 13.06.2022. Oslo: Norwegian Board of Health Supervision; 2022.
Norwegian Board of Health Supervision (NBHS). In Norwegian: Påminnelse til helse- og omsorgstjenesten om oppfølging av alvorlige hendelser, etterlevelse av varslingsplikten og betydningen av dialog med involverte parter ved alvorlige hendelser. In English: Reminder: letter from the NBHS to the health care trusts and municipalities. 26.01.2022. Oslo: Norwegian Board of Health Supervision; 2022. https://www.helsetilsynet.no/publikasjoner/brev-og-horingsuttalelser-fra-statens-helsetilsyn/2022/paaminnelse-til-helse-og-omsorgstjenesten-om-oppfoelging-av-alvorlige-hendelser-etterlevelse-av-varslingsplikten-og-betydningen-av-dialog-med-involverte-parter-ved-alvorlige-hendelser/
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Annen tilsynsmessig oppfølging etter varsel om alvorlig hendelse - innhenting av redegjørelse, egenvurdering, egenrapport. English: additional external inspection follow-up following reports of serious incidents. 23.05. 2023. Oslo: Norwegian Board of Health Supervision; 2023. https://www.helsetilsynet.no/tilsyn/varsel-om-alvorlige-hendelser/mer-om-annen-tilsynsmessig-oppfolging-etter-varsel-om-alvorlig-hendelse---innhenting-av-redegjorelse-egenvurdering-egenrapport/
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Tilsynsmessig oppfølging av lovbrudd. English: external inspection follow-up of violations. 12.06.2023. Oslo: Norwegian Board of Health Supervision; 2023. https://www.helsetilsynet.no/globalassets/opplastinger/tilsyn/veileder_tilsynssaker_statsforvalteren/tilsynsmessig_oppfoelging.pdf
Norwegian Board of Health Supervision (NBHS). Virksomheten følger opp og gir tilbakemelding til statsforvalteren. English: follow up by the organization and feedback to the County Governor. 12.06.2023. Oslo: Norwegian Board of Health Supervision; 2023. https://www.helsetilsynet.no/globalassets/opplastinger/tilsyn/veileder_tilsynssaker_statsforvalteren/virksomheten_foelger_opp_og_rapporterer_til_statsforvalteren.pdf
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Tilsynsfaglige prioriteringer og vurdering. English: priorities and assessment regarding external inspection 12.12.2022. Oslo: Norwegian Board of Health Supervision; 2022. https://www.helsetilsynet.no/globalassets/opplastinger/tilsyn/veileder_tilsynssaker_statsforvalteren/tilsynsfaglige_prioriteringer_vurderinger.pdf
Norwegian Board of Health Supervision (NBHS). In Norwegian: Mottak og avklaringer. Veiledning for statsforvalterens behandling av tilsynssaker (helse- og omsorgstjenesten). In English: Reception and clarification - Guidelines for the County Governor proceedings of incidents 29.06.2022. Oslo: Norwegian Board of Health Supervision; 2022. https://www.helsetilsynet.no/globalassets/opplastinger/tilsyn/veileder_tilsynssaker_statsforvalteren/mottak_og_avklaringer.pdf
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Oversendelse til statsforvalteren som tilsynsmessig oppfølging etter varsel om alvorlig hendelse. English: delegation to the County Governor of notifications related to serious incidents. 23.05.2023. Oslo: Norwegian Board of Health Supervision; 2023. https://www.helsetilsynet.no/tilsyn/varsel-om-alvorlige-hendelser/mer-om-oversendelse-til-statsforvalteren-som-tilsynsmessig-oppfolging-etter-varsel-om-alvorlig-hendelse/
Norwegian Board of Health Supervision (NBHS). In. Norwegian: Oversendelse til virksomheten/ helsepersonellet. English: transfer to organizations/health professionals. 23.06.2023. Oslo: Norwegian Board of Health Supervision; 2023. https://www.helsetilsynet.no/globalassets/opplastinger/tilsyn/veileder_tilsynssaker_statsforvalteren/oversendelse_til_virksomheten_helsepersonellet.pdf
Bowen GA. Document analysis as a qualitative research method. Qualitative Res J. 2009;9(2):27–40. https://doi.org/10.3316/QRJ0902027
Malterud K, Siersma VD, Guassora AD. Sample size in qualitative interview studies: guided by information power. Qual Health Res. 2016;26(13):1753–60. https://doi.org/10.1177/1049732315617444. Epub 2016 Jul 10. PMID: 26613970.
Shaw C, Groene O, Berger E. External institutional strategies: accreditation, certification, supervision. In Busse R, Klazinga, N., Panteli, D. & Quentin, W. Improving healthcare quality in Europe: Characteristics, effectiveness, and implementation of different strategies Health Policy Series, No. 53. Copenhagen (Denmark): European Observatory on Health Systems and Policies; 2019. https://apps.who.int/iris/bitstream/handle/10665/327356/9789289051750-eng.pdf?sequence=1&isAllowed=y
Fulop L, Day GE. From leader to leadership: clinician managers and where to next? Aust Health Rev. 2010;34(3):344–51. https://doi.org/10.1071/AH09763
Fulop L. Leadership, clinician managers and a thing called hybridity. J Health Organ Manag. 2012;26(4–5):578–604. https://doi.org/10.1108/14777261211256927
Øyri SF, Braut GS, Macrae C, et al. Hospital managers’ perspectives with implementing quality improvement measures and a new regulatory framework: a qualitative case study. BMJ Open. 2020;10:e042847.
Husabø G, Teig IL, Frich JC, Bondevik GT, Hovlid E. Promoting leadership and quality improvement through external inspections of management of sepsis in Norwegian hospitals: a focus group study. BMJ Open. 2020;10(11):e041997. https://doi.org/10.1136/bmjopen-2020-041997. Published 2020 Nov 12.
Øyri S, Wiig S. Regulation and resilience at the macro-level healthcare system– a literature review. In: Beer and Enrico Zio Michael, editor. Proceedings of the 29th European Safety and Reliability Conference. 2019. https://doi.org/10.3850/978-981-11-2724-3_0075-cd
de Kam D. Through the Regulator’s Eyes. Thesis. Erasmus University Rotterdam, Rotterdam; 2019. file:///C:/Users/2919684/Transkribering%20Dropbox/Sina%20%C3%98yri/PC/Downloads/david-de-kam-through-the-regulators-eyes.pdf.
Kok J, Wallenburg I, Leistikow I, Bal R. The doctor was rude, the toilets are dirty. Utilizing ‘soft signals’ in the regulation of patient safety. Saf Sci. 2020;131:104914. https://doi.org/10.1016/j.ssci.2020.104914
Ayres I, Braithwaite J. Responsive regulation: transcending the deregulation debate. New York: Oxford University Press; 1992.
Hood C, Rothstein H, Baldwin R. The government of risk: understanding risk regulation regimes. Oxford University Press; 2001.
Braithwaite J. The essence of responsive regulation. UBC Law Rev. 2011;44(3):475–520.
Braithwaite J. Types of responsiveness. In: Drahos P, editor. Regulatory Theory, foundations and applications. ANU; 2017.
Backer IL. The Norwegian reform of civil procedure. Scandinavian Studies In Law, 1999–2012. https://www.scandinavianlaw.se/pdf/51-2.pdf
Husabø G, Hovlid E. What might be required for inspections to be considered fair? Comment on What lies behind successful regulation? A qualitative evaluation of pilot implementation of Kenya’s health facility inspection reforms. Int J Health Policy Manag. 2022;x(x):x–x. https://doi.org/10.34172/ijhpm.2022.7296
Kok J, de Kam D, Leistikow I, Grit K, Bal R. Epistemic injustice in incident investigations: a qualitative study. Health Care Anal. 2022;30(3–4):254–74. https://doi.org/10.1007/s10728-022-00447-3
Ramsey L, McHugh S, Simms-Ellis R, Perfetto K, O’Hara J. Patient and family involvement in serious incident investigations from the perspectives of key stakeholders: a review of the qualitative evidence. J Patient Saf. 2022;18(8):e1203–10. https://doi.org/10.1097/PTS.0000000000001054
Wailling J, Kooijman A, Hughes J, O’Hara JK. Humanizing harm: using a restorative approach to heal and learn from adverse events. Health Expect. 2022;25(4):1192–9. https://doi.org/10.1111/hex.13478
Leistikow IP, Pot AM, Bal R. Value driven regulation and the role of inspections. Commentary to: Hovlid E, Husabø G, Teig IL, Halvorsen K, Frich JC. Contextual factors of external inspections and mechanisms for improvement in healthcare organizations: A realist evaluation. Soc Sci Med. 2022;298:114872. Soc Sci Med. 2022;308:115170. https://doi.org/10.1016/j.socscimed.2022.115170
Hollnagel E. Safety-II in practice. developing the resilience potentials. Routledge; 2018.
Anderson JE, Ross AJ, Back J, et al. Implementing resilience engineering for healthcare quality improvement using the CARE model: a feasibility study protocol. Pilot Feasibility Stud. 2016;2:61. https://doi.org/10.1186/s40814-016-0103-x. Published 2016 Oct 12.
Ytterdahl SA et al. In Norwegian: Fra varsel til læring og forbedring. Rapport fra utvalg oppnevnt for å vurdere varselordningene til Statens helsetilsyn og Statens undersøkelseskommisjon for helse- og omsorgstjenesten. In English: Report regarding an external evaluation of incident reporting regimes in Norway. Oslo; 12.04.2023. Accessed 23 Aug 2023.
van de Bovenkamp HM, Stoopendaal A, Bal R. Working with layers: the governance and regulation of healthcare quality in an institutionally layered system. Public Policy Adm. 2017;32(1):45–65. https://doi.org/10.1177/0952076716652934