Healthcare Regulation and Resilience: a Norwegian Multilevel Case Study


Keywords: rescilience, hospital management, quality reform


Introduction: A new regulatory framework (the Quality Improvement Regulation) to support local, management-based quality and safety efforts in hospitals was introduced to the Norwegian healthcare system in 2017. This thesis explores healthcare regulation and resilience through the Quality Improvement Regulation, by investigating its possible links to adaptive capacity in hospital management of quality and safety enhancing activities. The literature lacks studies exploring how regulation and resilience intertwine, two concepts often considered as counterparts. Hence, there is a gap in knowledge about regulatory and supervisory impact on quality and safety, and attention to hospital managers’ competences and responsibilities as key elements to resilience in healthcare. This thesis therefore casts a new light on how regulators and inspectors may design, inspect, and enforce a regulation regime, and thereby contribute to adaptive capacity, anticipatory capacity, and learning as key elements in different hospital contexts. Overall outputs from this thesis are important to the development and implementation of future regulatory amendments.

Aim: The overall aim of this thesis was to explore the rationale, expectations, implementation, and management of the Quality Improvement Regulation. The overall and leading research question was: How does a new healthcare regulation implemented across three system levels contribute to adaptive capacity in hospital management of quality and safety?

Methods: The study was designed as a multilevel, single embedded case study. Data was collected by approximately 500 pages of documentary evidence, 29 individual interviews and 3 focus group interviews (10 participants): in total 39 participants. Data was analyzed by legal dogmatic and qualitative content analysis. Three levels of stakeholders were included from the Norwegian healthcare system: macro-level (three governmental regulatory bodies), meso- level (three County Governors), micro-level (three hospitals retrieved from two regional health authorities). Macro-level participants were seven strategic participants positioned at the Norwegian Ministry of Health and Care Services, the Norwegian Directorate of Health, and the Norwegian Board of Health Supervision. Meso-level participants were two chief county medical officers, three assistant chief county medical officers, and seven inspectors, recruited from three County Governors. Micro-level participants were 20 hospital managers or quality advisors selected from different levels at three hospitals.

Findings: Paper I (macro-level) explored the governmental rationale for developing the Quality Improvement Regulation, expectations towards hospital management and its expected influence on resilience. Data retrieved from documentary evidence and individual interviews indicated that the rationale for the Quality Improvement Regulation’s design was to make it flexible to various hospital contexts. In turn, the macro-level expected hospital managers to anticipate local risks. However, the study found that the Government expected the generic regulatory design to come across as challenging for hospital managers and clinicians. Paper II (meso-level) investigated into changes in the supervisory approach and inspectors’ work to promote or hamper adaptive capacity and learning in hospitals. Evidence emerged from documents and focus group interviews and indicated that despite supervision being adapted to specific hospital contexts and the inspectors’ trade-offs, there was a general concern about the lack of impact of supervision on hospital performance. Paper III (micro-level) explored hospital managers’ perspectives on implementation efforts and the following work practices, to understand if, and how, the new Quality Improvement Regulation influenced quality and safety improvement activities. Across interview data, participants experienced the Quality Improvement Regulation as more suitable to variation and different contexts compared to the previous regulatory framework. However, findings revealed no change in practice related to quality and safety activities, solely due to the new regulatory framework, despite recent structural and cultural changes to quality improvement systems in hospitals. Data reported that lack of time, competence and/or motivation affected hospital implementation.

Conclusions: This thesis represents a rare glimpse into regulatory implementation efforts across three system levels, set out in a resilience in healthcare perspective. This thesis revealed that regulators considered the perspective of variation, complexity, and uncertainty in hospital settings to be important when designing the Quality Improvement Regulation. The latter resonates with resilience in healthcare concepts and contradicts previous research. The Quality Improvement Regulation contributed to context adaptation, by supporting nondetailed risk based organizing and management of quality and safety. However, hospital managers’ autonomy and adaptive capacity to tailor quality improvement efforts were imperative for the regulatory requirements to have any relevant impact on hospital practice. Limited involvement of clinicians in the regulatory development process could hamper quality improvement efforts. Inspectors could nurture learning by improving their follow up, use expert inspectors, and add more hospital self- assessment activities. This thesis highlights the importance of ensuring that any macro-level quality improvement initiatives and regulatory requirements are accompanied by appropriate resourcing, support, and advanced preparation to ensure the best possible chance of getting implemented effectively.

Author Biography

Sina Furnes Øyri

University of Stavanger
Faculty of Health Sciences, Department of Quality and Health Technology


Aadland, E. (1997). Og eg ser på deg...Vitenskapsteori og metode i helse- og sosialfag, Tano Aschehoug.

Aase, K. (editor). (2018). Patient safety: theory and practice [in Norwegian]. Oslo: Universitetsforlaget.

Adil, M. (2008). Risk-based regulatory system and its effective use in health and social care. Journal of the Royal Society for the Promotion of Health. 128(4):196-201.

Aguinis, H. & Molina-Azorin, J. F. (2015). Using multilevel modeling and mixed methods to make theoretical progress in microfoundations for strategy research. Strategic Organization, 13(4):353-364.

Alvesson, M. & Kärreman, D. (2011). The use of empirical material for theory development. In Qualitative research and theory development: Mystery as method, 1-22. SAGE Publications Ltd

Amalberti R. & Vincent C. (2020). Managing risk in hazardous conditions: improvisation is not enough. BMJ Quality & Safety,29:60-63.

Anderson, R. A., Crabtree, B. F., Steele, D. J., & McDaniel, R. R. (2005): Case Study Research: The View From Complexity Science. Qualitative Health Research, 15(5), 669-685.

Anderson, J.E., Ross, A.J., Back, J., Duncan, M., Snell, P., Walsh, K. & Jaye, P. (2016). Implementing resilience engineering for healthcare quality improvement using the CARE model: a feasibility study protocol. Pilot and Feasibility Studies, 2, 61

Anderson, J.E, Ross, A.J., Back, J., Duncan, M., & Jaye, P. (2019). Resilience Engineering as a Quality Improvement Method in Healthcare, In Wiig, S. & Fahlbruch, B. (editors). Exploring Resilience. A scientific Journey from Practice to Theory. Springer Open.

Anderson, J.E, Ross, A.J., Macrae, C. & Wiig, S. (2020). Defining adaptive capacity in healthcare: A new framework for researching resilient performance. Applied Ergonomics, 87;103111.

Aranda, K., Zeeman, L., Scholes, J. & Morales, A. S.M. (2012). The resilient subject: exploring subjectivity, identity, and the body in narratives of resilience. Health, 16(5):548-563.

Argyris, C. (1977). Double Loop Learning in Organizations. Harvard Business Review. in-organizations.

Aven, T., Boyesen, M., Njå, O., Olsen, K., H. & Sandve, K. (2004). Samfunnssikkerhet. Universitetsforlaget.

Aven, T. & Renn, O. (2010). Risk Management and Governance. Concepts, Guidelines and Applications. Springer.

Aven, T. (2016). Risk assessment and risk management: Review of recent advances on their foundation. European Journal of Operational Research, 253(1), 1-13.

Ayres, I. & Braithwaite, J. (1992). Responsive Regulation: Transcending the Deregulation Debate. New York; Oxford University Press.

Bakhtin, M., M. (1984). Problems of Dostoevsky's Poetics translated and edited by Caryl Emerson, (Minneapolis: University of Minnesota Press, 1, 226-314.

Baldwin, R. & Cave, M. (1999). Understanding Regulation. Theory, Strategy, and Practice. Oxford University Press.

Bal, R., Stoopendaal, A.M.V. & van de Bovenkamp, H. (2015). Resilience and patient safety: how can health care regulations contribute? Ned Tijdschr Geneeskd, 159:A9614. 24.

Ball, D.R. & Frerk, C. (2015). A new view of safety: Safety 2, British Journal of Anaesthesia, 115, 5, 645-647,

Barber, N. (2002). Should we consider non-compliance a medical error? Quality & Safety in Health Care, 11:81-84.

Bartlett, L. & Vavrus, F. (2017). Comparative Case Studies: An Innovative Approach. Nordic Journal of Comparative and International Education (NJCIE), 1(1).

Basheer, H., Allwood, B., Lindsell, C-M., Freeth, D. & Vaux, E. (2018). Never too busy to learn - How the modern team can learn together in the busy workplace. Royal College of Physicians.

Batalden, P.B. & Davidoff, F. (2007). What is "quality improvement" and how can it transform healthcare? BMJ Quality & Safety, 16:2-3.

Berg, S. H, Akerjordet K., Ekstedt, M. & Aase, K. (2018). Methodological strategies in resilient health care studies: An integrative review. Safety Science 110:300-312.

Berg, S. H. & Aase, K. (2019). Resilient characteristics as described in empirical studies on health care. In Wiig, S. & Fahlbruch, B. (editors). Exploring Resilience. A scientific Journey from Practice to Theory. Springer Open.

Bergström, J. & Dekker, S. W. A. (2019). The 2010s and Onward Resilience Engineering. In Dekker, S. Foundations of Safety Science, Routledge.

Blandhol, S., Tøssebro, H. N. & Skotheim, Ø. (2015). Innføring i juridisk metode. Jussens Venner, 06, 50.

Blaikie, N. (2010). Designing Social Research. Cambridge: Polity Press. Boe, E. (1996). Innføring i juss - juridisk tenkning og rettskildelære. Oslo: Tano Aschehoug.

Botwinick, L., Bisognano, M. & Haraden, C. (2006). Leadership Guide to Patient Safety. IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement. oss/innsatsomrader/ledelse-av- pasientsikkerhet/_/attachment/inline/b314ed6c-3767-46c5- a8a8- fc445aa94f68:1ded2e5d159678cf61b9ebb357af4936a3d37c81/i hi-leadership-guide-to-patient-safety.pdf.

Bouwman, R., Bomhoff, M., Robben, P. & Friele, R. (2017). Is there a mismatch between the perspectives of patients and regulators on healthcare quality? A Survey Study, Journal of Patient Safety, 30, Publish Ahead of Print Issue.

Bowen, G. A. (2009). Document Analysis as a Qualitative Research Method. Qualitative Research Journal, 9, 2, 27-40; :29.

Braithwaite, J. (2011). The Essence of Responsive Regulation. UBC Law Review, 44:3 475-520.

Braithwaite, J. (2017). Types of responsiveness. In Drahos, P. Regulatory Theory, Foundations and Applications, ANU press. Braithwaite, J., Wears, R. L. & Hollnagel, E. (2016). Resilient Health Care, Volume 3: Reconciling Work-As-Imagined and Work-as- Done. CRC Press, Taylor & Francis Group. D=4710164#.

Braithwaite, J., Ellis, L., A., Churruca, K., Long, J., C., Hibbert, P. & Clay-Williams, R. (2020). Complexity Science as a Frame for Understanding the Management and Delivery of High Quality and Safer Care. In Donaldson L., Ricciardi W., Sheridan S., Tartaglia R. (editors). Textbook of Patient Safety and Clinical Risk Management. Springer, Cham.

Braun, V. & Clarke, V. (2013). Successful Qualitative Research - a practical guide for beginners, SAGE Publications, Thousand Oaks, CA.

Braut, G. S. (2001). Ei ny helseteneste? - Er det rom for variasjon, avvik og feil? Omsorg, 1.

Brennan, T. (1998). The role of regulation in Quality Improvement. The Milbank Quarterly, 76,4.

Brook R., H. (2010). The end of the quality improvement movement: long live improving value. JAMA, 27;304(16):1831-2. PMID: 20978261.

Burgess, N., Currie, G., Crump, B., Richmond, J. & Johnson. M. (2019). Improving together: collaboration needs to start with regulators BMJ, 367:l6392

Busse, R., Klazinga, N., Panteli, D. & Quentin, W. (2019). Improving healthcare quality in Europe: Characteristics, effectiveness, and implementation of different strategies. Health Policy Series, 53. Copenhagen (Denmark): European Observatory on Health Systems and Policies. 89051750-eng.pdf?sequence=1&isAllowed=y.

Cagliano, A., C., Grimaldi, S. & Rafele, C. (2011). A systemic methodology for risk management in healthcare sector. Safety Science, 49,5:695-708.

Carthey, J., Walker, S., Deelchand, V. & Griffiths, W. H. (2011). Breaking the rules: understanding non-compliance with policies and guidelines. BMJ,343:d5283.

Chuang, S. (2013). Adaptation versus Standardisation in Patient Safety. In Hollnagel, E., Braithwaite, J., Wears, R.L. (editors). Resilient Health Care. Ashgate.

Cilliers, P. (1998): Complexity and postmodernism: Understanding complex systems. New York: Routledge.

Coglianese, C. & Lazer, D. (2003). Management-Based Regulation: Prescribing Private Management to Achieve Public Goals. Law & Society Review, 37, 4, 691-730. Blackwell Publishing on behalf of the Law and Society Association Stable.

Costa, P. L., Graça, A. M., Marques-Quinteiro, P., Santos, C. M., Caetano, A., & Passos, A. M. (2013). Multilevel Research in the Field of Organizational Behavior: An Empirical Look at 10 Years of Theory and Research. SAGE Open.

Creswell, J. W. & Miller, D. L. (2000). Determining Validity in Qualitative Inquiry. Theory Into Practice, 39:3, 124-130.

Crotty, M. (1998). The Foundations of Social Research. SAGE Publications.

Curnock, E., Ferguson, J., Mckay, J., & Bowie, P. (2012). Healthcare Improvement and Rapid PDSA Cycles of Change: A Realist Synthesis of the Literature. Improvement-and-Rapid-PDSA-Cycles-of-%3A-A-Curnock- Ferguson/262851e08b5c9449f278fff6ecc47eec638bb03c.

Darzi, L. & Johnson, A. (2008). High quality care for all: NHS next stage review final report, 7432. London: The Stationery Office.

de Bree, M. & Stoopendaal, A. (2020). De- and Recoupling and Public Regulation. Organization Studies, 41(5):599-620.

Deloitte (2019). Sluttrapport 2019. Program for Patient Safety. Deming, W. E. (1986). Out of the crisis. Massachusetts Institute of Technology Center for Advanced Engineering Study.

Dewa, C.S., Loong, D., Bonato, S. & Trojanowski, L. (2017). The relationship between physician burnout and quality of healthcare in terms of safety and acceptability: a systematic review. BMJ Open;7:e015141.

Dieckmann, P., Patterson, M., Lahlou, S., Mesman, J., Nyström, P. & Krage, R. (2017). Variation and adaptation: learning from success in patient safety-oriented simulation training. Advances in Simulation, 2, 21.

Diez-Roux, A. V. (2002). A glossary for multilevel analysis. Journal of Epidemiology & Community Health, 56:588-594.

Dixon-Woods, M., McNicol, S. & Martin, G. (2012). Overcoming challenges to improving quality. Lessons from the Health Foundation's improvement programme evaluations and relevant literature. challenges-to-improving-quality.

Drew, J. R. & Pandit, M. (2020). Why healthcare leadership should embrace quality improvement BMJ, 368:m872.

Doyle, C., Lennox, L. & Bell, D. (2013). A systematic review of evidence on the links between patient experience and clinical safety and effectiveness. BMJ Open,3(1) e001570.

Eckhoff, T. (2001). Rettskildelære. Oslo: Universitetsforlaget.

Ellis, L., Churruca, K., Clay-Williams, R., Pomare, C., Austin, E., Long, J. C., Grødahl, A. & Braithwaite, J. (2019). Patterns of resilience: a scoping review and bibliometric analysis of resilient health care. Safety Science, 118:241-57.

Elo, S., Kääriäinen, M., Kanste, O., Pölkki, T., Utriainen, K. & Kyngäs, H. (2014). Qualitative Content Analysis: A Focus on Trustworthiness. SAGE Open.

Engen, O. A. H, Kruke, B. I., Lindøe, P. H., Olsen, K. H., Olsen, O. E. & Pettersen, K. A. (2016). Perspektiver på samfunnssikkerhet. Oslo: Cappelen Damm.

Engen, O., A. & Lindøe, P. H. (2019). Coping with Globalization. Robust Regulation and Safety in High-Risk industries. In Le Coze (editor), Safety Science Research Evolution, Challenges and New Directions. CRC Press, ISBN 9781351190237. 55-74.

Eurocontrol (2013). From Safety-I to Safety-II: a white paper. Network Manager, 1-32. ontrol-2013-from-safety-i-to-safety-ii_-a-white-paper.pdf.

Flodgren, G., Pomey, M. P., Taber, S. A. & Eccles, M.P. (2011). Effectiveness of external inspection of compliance with standards in improving healthcare organisation behaviour, healthcare professional behaviour or patient outcomes). Cochrane Database of Systematic Reviews, 9;(11).

Francis R. (2013). Report of the Mid Staffordshire. NHS Foundation Trust Public Inquiry: executive summary: Stationery Office.

Freeman, R. E., Harrison, J. S., Wicks, A. C., Parmar, B. L. & de Colle, S. (2010). Stakeholder Theory. The State of the Art. Cambridge University Press.

Fulop, L. & Day, G.E. (2010). From leader to leadership: clinician managers and where to next? Australian Health Review, 34(3):344-351.

Fulop L. (2012). Leadership, clinician managers and a thing called "hybridity". Journal of Health Organization and Management, 26(4-5):578-604.

Furniss, D., Barber, N., Lyons, I., Eliasson, L. & Blandford, A. (2014). Unintentional non-adherence: can a spoon full of resilience help the medicine go down? BMJ Quality & Safety, 23:95-98.

Gadamer, H. G. (1987). "Språk og forståelse" In Gadamer, H. G. Hermeneutics, Tradition and Reason, Warncke, G. Cambridge: Polity Press.

Gadamer, H. G. (1996). The Enigma of Health. Stanford University Press.

Gadamer, H. G. (2004). Sandhed og metode. Århus: Systime Academic. Gandhi, T.K., Kaplan, G.S., Leape, L., Berwick, D., M., Edgman- Levitan, S., Edmondson, A., Meyer, G., S., Michaels, D., Morath, J., M., Vincent, C. & Wachter, R. (2018). Transforming concepts in patient safety: a progress report. BMJ Quality & Safety, 27:1019-1026.

Gao J., & Dekker S. (2017). Concepts and Models of Safety, Resilience, and Reliability. In Sanchez J., Barach P., Johnson J., Jacobs J. (editors). Surgical Patient Care. Springer, Cham.

Gilad, S. (2011). Institutionalizing fairness in financial markets: Mission impossible? Regulation & Governance, 5: 309-332.

Gilje, N. & Grimen, H. (1993; 1995). Samfunnsvitenskapenes forutsetninger. Innføring i samfunnsvitenskapenes vitenskapsfilosofi. Oslo: Universitetsforlaget.

Graver, H. P. (2006). I prinsippet prinsipiell - om rettsprinsipper. Tidsskrift for Rettsvitenskap, 119, 2/3, 189-221. ISSN 0040-714 i_prinsippet_prinsipiell_-_om_rettsprinsipper.pdf (

Graver, H. P. (2008). Vanlig juridisk metode? Om rettsdogmatikken som juridisk sjanger. Tidsskrift for Rettsvitenskap, 121, 2, 149 -178. ISSN 0040-7143.

Graneheim, U. H & Lundman, B. (2004). Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Education Today, 24(2):105-12

Graneheim, U. H., Lindgren, B-M. & Lundman, B. (2017): Methodological challenges in qualitative content analysis: A discussion paper. Nurse Education Today, 56:29-34. PMID: 28651100.

Grote, G. (2019). Leadership in Resilient Organizations. In Wiig, S. & Fahlbruch, B. (editors). Exploring Resilience. A scientific Journey from Practice to Theory. Springer Open; 2019.

Gunningham, N. & Sinclair, D. (2009). Organizational trust and the limits of management-based regulation. Law and Society Review, 43(4): 865-90.

Haavik, T. K. (2020). Societal resilience - Clarifying the concept and upscaling the scope. Safety Science, 132,104964.

Hale, A., Borys, D. & Adams, M. (2015). Safety regulation: The lessons of workplace safety rule management for managing the regulatory burden, Safety Science, 71, Part B, 112-122.

Ham, C. (2003). Improving the performance of health services: the role of clinical leadership, Lancet, 361:1978-80.

Haugen, A.S., Høyland, S., Thomassen, Ø., Aase, K. (2015). 'It's a State of Mind': a qualitative study after two years' experience with the World Health Organization's surgical safety checklist. Cognition, Technology & Work, 17, 55-62.

Healy, J. (2011). Improving health care safety and quality: Reluctant Regulators. Ashgate Publishing Limited.

Healy, J. (2016). Improving Health Care Safety and Quality: Reluctant Regulators. Routledge.

Hedsköld, M., Sachs, M.A., Rosander, T., von Knorring, M. & Härenstam, K., P. (2021). Acting between guidelines and reality- an interview study exploring the strategies of first line managers in patient safety work. BMC Health Services Research, 21, 48.

Hegde, S., Zettinger, A. Z, Fairbanks, R. J., Wreathall, J., Krevat, S. A., Jackson, C.D & Bisantz, A.M. (2020). Qualitative findings from a pilot stage implementation of a novel organizational learning tool toward operationalizing the Safety-II paradigm in health care. Applied Ergonomics;82;102913.

Heimer, C. A. (2013). Resilience in the Middle. Contributions of Regulated Organizations to Regulatory Success. The ANNALS of the American Academy of Political and Social Science, 649, 1, 139-156.

Hitt, M. A., Beamish, P. W., Jackson, S. E. & Mathieu, J. E. (2007). Building theoretical and empirical bridges across level. The Academy of Management Journal, 50, 6, 1385-1399.

Hollnagel, E. (2004). Barriers and Accident Prevention. Ashgate Publishing Limited, Aldershot, UK.

Hollnagel, E., Woods, D.D. & Leveson, N. (2006). Resilience Engineering. Concepts and Precepts. Ashgate.

Hollnagel, E., (2009). The ETTO Principle: Efficiency-thoroughness Trade-off: why Things that Go Right Sometimes Go Wrong. Ashgate Publishing.

Hollnagel, E., Braithwaite, J. & Wears, R. L. (2013). Resilient Health Care. Ashgate Publishing Limited;xxv.

Hollnagel, E. (2014). Safety-I and Safety-II. The Past and Future of Safety Management. CRC Press, Taylor & Francis Group.

Hollnagel, E., Wears, R.L. & Braithwaite, J. (2015). From Safety-I to Safety-II: A White Paper. The Resilient Health Care Net. Published simultaneously by the University of Southern Denmark, University of Florida, USA, and Macquarie University, Australia.

Hollnagel, E. (2018 a). Safety-II in Practice. Developing the Resilience Potentials. Routledge.

Hollnagel, E. (2018 b). The Functional Resonance Analysis Method. The "FRAM". 201.docx.pdf.

Hood, C., Rothstein, H. & Baldwin, R. (2001). The Government of Risk: Understanding Risk Regulation Regimes. Oxford University Press.

Hopkins, A. & Hale, A. (2002): Issues in the Regulation of Safety; setting the scene. In Kirwan, B., Hale, A. & Hopkins, A. (editors). Changing regulation. Controlling risks in society. Oxford: Pergamon.

Hovlid, E., Frich, J. C., Walshe, K., Nilsen, R. M., Flaaten, H. K., Braut, G. S., Helgeland, J., Teig, I. L. & Harthug, S. (2017). Effects of external inspection on sepsis detection and treatment: a study protocol for a quasiexperimental study with a stepped-wedge design. BMJ Open;7:e016213.

Hovlid, E., Braut, G.S., Hannisdal, E., Walshe, K., Bukve, O., Flottorp, S., Stensland, P. & Frich, J.C. (2020 a). Mediators of change in healthcare organisations subject to external assessment: a systematic review with narrative synthesis. BMJ Open;10:e038850.

Hovlid, E., Teig, I.L., Halvorsen, K. & Frich, J.C. (2020 b). Inspecting teams' and organisations' expectations regarding external inspections in health care: a qualitative study. BMC Health Services Research, 20, 627.

HSE (2020). The Robens Report.

Hsieh, H-f. & Shannon, S. E. (2005). Three Approaches to Qualitative Content Analysis. Qualitative Health Research, 15(9):1277- 1288.

Hughes, R.G. (ed.). (2008). Patient Safety and Quality: An Evidence- Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality (US).

Husabø, G., Teig, I. L., Frich, J.C., Bondevik, G. T. & Hovlid, E. (2020). Promoting leadership and quality improvement through external inspections of management of sepsis in Norwegian hospitals: a focus group study. BMJ Open, 10:e041997.

Hutter, B. M. (2001). Regulation and Risk: Occupational Health and Safety on the Railways. Oxford: Oxford University Press.

Hutter, B. M. (2011). Understanding the New Regulatory Governance: Business Perspectives. Law & Policy, 33,4.

Hybinette, K., Härenstam, K. P. & Ekstedt, M. (2021). A First-line management team's strategies for sustaining resilience in a specialised intensive care unit-a qualitative observational study. BMJ Open,11:e040358.

Iflaifel, M., Lim, R.H., Ryan, K. & Crowley, C. (2020). Resilient Health Care: a systematic review of conceptualisations, study methods and factors that develop resilience. BMC Health Services Research, 20, 324.

Institute for Healthcare Improvement (IHI) (2021). Tools. Plan-Do- Study-Act (PDSA) Worksheet. ksheet.aspx.

Institute of Medicine (IOM) (2000). To Err is human: building a safer health system. Edited by Kohn L, Corrigan J, Donaldson M. Washington, DC: Institute of Medicine.

Johannesen, D. T. S. & Wiig, S. (2017). Why adopt ISO 9001 certification in hospitals? A case study of external triggers and sensemaking in an emergency department in Norway. Safety in Health, 3:7

Johannesen, D.T.S., Lindøe, P.H. & Wiig, S. (2020). Certification as support for resilience? Behind the curtains of a certification body - a qualitative study. BMC Health Services Research 20, 730.

Johannesen, D.T.S. (2020): Certification for Quality in Hospitals. Exploring adoption, approaches and processes of ISO 9001 quality management system certification. [Doctoral thesis]. University of Stavanger.

Johnson, A. & Lane, P. (2017). Resilience Work-as-Done in Everyday Clinical Work. In Braithwaite, J., Wears, R. L., Hollnagel, E. Resilient Health Care, Volume 3: Reconciling Work-As- Imagined and Work-as-Done. Taylor & Francis Group.

Johnson, M., O'Hara, R., Hirst, E., Weyman, A., Turner, J., Mason, S., Quinn, T., Shewan, J. & Siriwardena, A. N. (2017). Multiple triangulation and collaborative research using qualitative methods to explore decision making in pre-hospital emergency care. BMC Medical Research Methodology 17:11.

Kirkup, B. (2015). The Report of the Morecambe Bay Investigation. stem/uploads/attachment_data/file/408480/47487_MBI_Access ible_v0.1.pdf.

Knudsen, S.V., Laursen, H.V.B., Johnsen, S.P., Bartels, P.D., Ehlers, L.H. & Mainz, J. (2019). Can quality improvement improve the quality of care? A systematic review of reported effects and methodological rigor in plan-do-study-act projects. BMC Health Services Research 19, 683.

Koch, T. (1994), Establishing rigour in qualitative research: the decision trail. Journal of Advanced Nursing, 19: 976-986.

Kok, J., Wallenburg, I., Leistikow, I. & Bal, R. (2020). "The doctor was rude, the toilets are dirty. Utilizing 'soft signals' in the regulation of patient safety", Safety Science, 131, 104914.

Kuhn, T. S. (1962). The Structure of Scientific Revolutions. University of Chicago Press.

Kvale, S. & Brinkmann, S. (2009). Interviews: Learning the Craft of Qualitative Research Interviewing. Sage Publications (CA).

Kyriakidis, M. & Dang, V. N. (2019). Human performance, levels of service and system resilience. In Wiig, S. & Fahlbruch, B. (editors). Exploring Resilience. A scientific Journey from Practice to Theory. Springer Open.

Labaree, R. (2009). Organizing Your Social Sciences Research Paper: Limitations of the Study.

Lambert, S.D. & Loiselle, C.G. (2008). Combining individual interviews and focus groups to enhance data richness. Journal of Advanced Nursing Apr;62(2):228-37. PMID: 18394035.

Lawton, R., Taylor, N., Clay-Williams, R., & Brithwaite, J. (2014). Positive deviance: a different approach to achieving patient safety. BMJ Quality & Safety, 23(11):880-3. PMID: 25049424; PMCID: PMC4215344.

Le Coze, J.C. (2008). Disasters and organisations: From lessons learnt to theorising, Safety Science, 46, 1, 132-149.

Le Coze, J.C. (2019). Resilience, Reliability, Safety: Multilevel Research Challenges. In Wiig, S. & Fahlbruch, B. (editors). Exploring Resilience. A scientific Journey from Practice to Theory. Springer Open.

Leistikow, I. & Bal, R.A. (2020). Resilience and regulation, an odd couple? Consequences of Safety-II on governmental regulation of healthcare quality. BMJ Quality & Safety, 29:1-2.

Leveson, N., Cutcher-Gershenfeld, J., Carroll, J.S., Barrett, B., Brown, A., Dulac, N. & Marais, K. (2005). System approaches to safety: NASA and the space shuttle disasters. In Starbuck, W. H. and Farjoun, M. (editors). Organization at the limit. Lessons from the Columbia Disaster. Oxford, Blackwell Publishing.

Leveson, N., Dulac, N., Zipkin, D., Cutcher-Gershenfeld, J., Carroll, J. & Barrett, B. (2006). Engineering Resilience into Safety-Critical Systems. In Hollnagel, E., Woods, D.D. and Leveson, N. (eds.). Resilience Engineering. Concepts and Precepts. Ashgate.

Leveson, N. (2020). Safety III: A Systems Approach to Safety and Resilience. MIT ENGINEERING SYSTEMS LAB.

Lilleholt, K. (2003). Knophs oversikt over Norges Rett. Universitetsforlaget.

Lindøe, P. H, Kriingen, J. & Braut, G. S. (2015). Risiko og tilsyn. Risikostyring og rettslig regulering. 2. Utgave. Oslo: Universitetsforlaget.

Lindøe, P. H, Kriingen, J. & Braut, G. S. (2018). Regulering og standardisering. Perspektiver og praksis. Oslo: Universitetsforlaget.

Lindøe, P. H. & Baram, M. S. (2019). The role of standards in hard and soft approaches to safety regulation. In Olsen, O.E., Juhl, K., Lindøe, P. & Engen, O.A. (editors). Standardization and risk governance: a multi-disciplinary approach. London: Routledge. Lincoln, S. Y. & Guba, E. G. (1985). Naturalistic inquiry. Thousand Oaks, CA: Sage.

Lyons, O., George, R., Galante, J.R., Mafi, A., Fordwoh, T., Frich, J. & Geerts, J.M. (2020). Evidence-based medical leadership development: a systematic review. BMJ Leader, Published Online First: 16 November.

Macrae, C. (2008). Learning from patient safety incidents: Creating participative risk regulation in healthcare'. Health, Risk & Society, 10:1, 53-67.

Macrae, C. (2010). Regulating resilience? Regulatory work in high-risk arenas. In Hutter, B. M. (editor). Anticipating Risks and Organising Risk Regulation. Cambridge University Press.

Macrae, C. (2013). Reconciling regulation and resilience in health care. In Hollnagel, E., Braithwaite, J., Wears, R.L. (editors). Resilient Health Care. Ashgate.

Macrae, C. & Wiig, S. (2019). Resilience: From Practice to Theory and Back Again. In Wiig, S. & Fahlbruch, B. (editors). Exploring Resilience. A scientific Journey from Practice to Theory. Springer Open;121.

Macrae C. & Stewart, K. (2019). Can we import improvements from industry to healthcare? BMJ; 364:1039.

McDonald, N. (2006). Organizational Resilience and Industrial Risk. In Hollnagel, E., Woods, D.D. & Leveson, N. (eds.). Resilience Engineering. Concepts and Precepts. Ashgate.

McNicholas, C., Lennox, L., Woodcock, T., Bell, D. & Reed, J.E. (2019). Evolving quality improvement support strategies to improve Plan-Do-Study-Act cycle fidelity: a retrospective mixed-methods study. BMJ Quality & Safety, 28(5):356-365.

Malterud, K., Siersma, V. D., & Guassora, A. D. (2016). Sample Size in Qualitative Interview Studies: Guided by Information Power. Qualitative Health Research, 26(13), 1753-1760

Mannion, R., & Braithwaite, J. (2017). False Dawns and New Horizons in Patient Safety Research and Practice. International Journal of Health Policy and Management; 6(12): 685-689.

Mantzavinos, C. (2016). "Hermeneutics", The Stanford Encyclopedia of Philosophy (Winter 2016 Edition), Edward N. Zalta (ed.), ics/.

Mathiesen, T. (2005). Retten i Samfunnet. Pax.

May, P. J. (2007), Regulatory regimes and accountability. Regulation & Governance, 1: 8-26.

McKinley, N., McCain, R. S., Convie, L., Clarke, M., Dempster, M., Campell, W.J. & Kirk, S.J. (2020). Resilience, burnout and coping mechanisms in UK doctors: a cross-sectional study. BMJ Open, 10:e031765.

Merleau-Ponty, M. (1994). Kroppen som uttrykk og tale. Kroppens fenomenologi. Fredriksberg: Det lille forlag.

Merriam-Webster (2020). Definition of resilient. https://www.merriam-

Meyer, J. W., & Rowan, B. (1977). Institutional organizations: Formal structure as a myth and ceremony. American Journal of Sociology, 83, 340-363.

Miles, M. B., Huberman, A. M. & Saldana, J. (2014). Qualitative Data Analysis: A Methods Sourcebook. SAGE Publications.

Ministry of Health and Care Services (1983). In Norwegian: Lov 3. juni 1983 nr. 54 om tannhelsetjenesten (tannhelsetjenesteloven) § 1- 3a. In English: Dental Health Services Act.

Ministry of Health and Care (1999 a) In Norwegian: Lov 2. Juli 1999 nr. 54 om helsepersonell m.v. (helsepersonelloven). In English: Act of 2 July 1999 No. 64 relating to Health Personnel etc. (The Health Personnel Act). English version: july-1999-no-64-relating-to-hea/id107079/.

Ministry of Health and Care (1999 b). In Norwegian: Lov 2. juli 1999 nr. 61 om spesialisthelsetjenesten m.m. (spesialisthelsetjenesteloven). In English: Act of 2 July 1999 No. 61 relating to Specialist Health Care Services (the Specialized Health Services Act).

Ministry of Health and Care (2001). In Norwegian: Lov 15. juni 2001 nr. 93 om helseforetak m.m. (helseforetaksloven). In English: Act of 15 June 2001 nr. 93 relating to Health Trusts. 93?q=helseforetaksloven.

Ministry of Health and Care Services (2002). In Norwegian: Forskrift 20. desember 2002 nr. 1731 om internkontroll i sosial- og helsetjenesten (internkontrollforskriften). In English: Internal Control Regulations in the Healthcare Services (ICR). FOR- 2002-12-20-1731.

Ministry of Health and Care Services (2011). In Norwegian: Lov 24. juni 2011 nr. 30 om kommunale helse- og omsorgstjenester m.m. (helse- og omsorgstjenesteloven). In English: Municipal Health and Care Services Act.

Ministry of Health and Care Service (2012). In Norwegian: Meld. St. 10 (2012-2013). God kvalitet - trygge tjenester. In English: White paper Meld. St. 10 (2012-2013). High quality - safe services. 20122013/id709025/.

Ministry of Health and Care Services (2013 a). In Norwegian: Lederansvar i sykehus Rundskriv I-2/2013. In English: Circular on management in hospitals.

Ministry of Health and Care Services (2013 b). In Norwegian: Oppdrag til Helsedirektoratet om å utarbeide utkast til felles forskrift for internkontroll og systematisk arbeid med kvalitetsforbedring og pasient- og brukersikkerhet i helse- og omsorgstjenesten. In English: Assignment letter of drafting a new regulation.

Ministry of Health and Care Services (2014 a). In Norwegian: Pasientsikkerhetsprogrammet I trygge hender 24-7. In English: Program for Patient Safety. ogrammet-I-trygge-hender-24-7/id2005291/.

Ministry of Health and Care Service (2014 b). In Norwegian: Meld. St. 11 (2014-2015). Kvalitet og pasientsikkerhet 2013. In English: White paper Meld. St. 11 (2014-2015). Quality and Patient Safety 2013. St-11- 20142015/id2345641/?docId=STM201420150011000DDDEPIS&ch=1&q=&regj_oss=10&ref=search&term=.

Ministry of Health and Care Services (2015 a). In Norwegian: NOU 2015:11. Med åpne kort. Forebygging og oppfølging av alvorlige hendelser i helse- og omsorgstjenestene. In English: White Paper 2015:11. 790e87d8bb4576/no/pdfs/nou201520150011000dddpdfs.pdf.

Ministry of Health and Care Services (2015 b). In Norwegian: Endelig høringsutkast. In English: Final Hearing Memorandum.

Ministry of Health and Care Services (2016 a). In Norwegian: Forskrift 28. oktober 2016 nr. 1250 om ledelse og kvalitetsforbedring i helse- og omsorgstjenesten. In English: Regulation on management and quality improvement in the healthcare services (the Quality Improvement Regulation). FOR-2016-10-28-1250.

Ministry of Health and Care Services (2016 b). In Norwegian: Forskrift 28. oktober 2016 nr. 1250 om ledelse og kvalitetsforbedring i helse- og omsorgstjenesten. Kongelig resolusjon. In English: The Prerogative. PRE-2016-10-28-1250.

Ministry of Health and Care (2017). In Norwegian: Lov 15. desember 2017 nr. 107 om statlig tilsyn med helse- og omsorgstjenesten mv. (helsetilsynsloven). In English: Act of 15 December 2017 No. 107 relating to governmental supervision with the healthcare services (The Health Supervision Act). LOV-2017-12-15-107.

Ministry of Health and Care Services (2018). In Norwegian: Instruks for Helsedirektoratet. Fastsatt av Helse- og omsorgsdepartementet. In English: Instructions for the Norwegian Directorate of Health. Set by the Norwegian Ministry of Health and Care Services.

Ministry of Health and Care Services (2019). In Norwegian: Meld. St. 9 (2019-2020) Kvalitet og pasientsikkerhet 2018. In English: White paper Meld. St. 9 (2019-2020) Quality and Patient Safety 2018. 20192020/id2681185/?q=tillit&ch=3#kap8.

Ministry of Local Government and Modernization (2017). In Norwegian: Kongelig resolusjon. Sammenslåing av ni fylkesmannsembeter i fire sammenslåinger fra 1. januar 2019. In English: Royal Assent. fbbe41f1331c3e/fylkesmannsstruktur_kglres.pdf.

Ministry of Local Government (1991). In Norwegian: Forskrift 22. mars 1991 nr. 159 om internkontroll for miljø og sikkerhet. In English: Regulations relating to environment and safety. FOR-1991-03- 22-159.

Ministry of Labor and Social Affairs (1996). In Norwegian: Forskrift 06. desember 1996 nr. 11278 om systematisk helse-, miljø- og sikkerhetsarbeid i virksomheter (Internkontrollforskriften). In English: Regulations relating to systematic health, environmental and safety activities in enterprises (Internal control regulations). FOR-1996-12-06-1127.

Ministry of Justice (1967). In Norwegian: Lov av 10. februar 1967 om behandlingsmåten i forvaltningssaker (forvaltningsloven). In English: Act relating to procedure in cases concerning the public administration (Public Administration Act). LOV-1967-02-10. 10?q=forvaltningsloven.

Ministry of Criminal Justice (2005). In Norwegian: Lov av 20. Mai 2005 nr. 28 om straff (straffeloven). In English: The Penal Code. LOV-2005-05-20-28. 28?q=(straffeloven.

Ministry of Labor and Social Affairs (1977). In Norwegian: Lov av 4. februar 1977 nr. 4 om arbeidervern og arbeidsmiljø. In English: Work Environment Act (revoked and replaced by the Act of 17 June No. 62 2005 relating to working environment, working hours and employment protection, etc. LOV-2005-06-17-62. LOV-1977-02-04-4.

Mintzberg, H. (1984). Power and Organization Life Cycles. The Academy of Management Review,9,2,207-224. zberg_1984_Power%20and%20the%20life%20cycles%20of%2 0organizations.pdf.

Mintzberg, H. (1997). Towards healthier hospitals. Health Care Management Review; 22,4:9-18.

Moen, R. D., & Norman, C. L. (2010). Circling Back. Clearing up myths about the Deming cycle and seeing how it keeps evolving. Quality Progress.

Molina-Azorin, J.F., Pereira-Moliner, J. Lopez-Gamero, M. D., Pertusa- Ortega, E. M. & Tari, J. J. (2019). Multilevel research: Foundations and opportunities in management. Business Research Quarterly.

Molven, O., Holboe, J., & Cordt-Hansen, K. (2006). Bruk av advarsel ved brudd på forsvarlighetskravet. Tidsskrift for den Norske Lægeforening, 7; 126: 943-6.

Monahan, T., & Fisher, J. A. (2015). Strategies for Obtaining Access to Secretive or Guarded Organizations. Journal of Contemporary Ethnography, 44(6), 709-736.

Morgan, D., Gmeinder, M. & Wilkens, J. (2017). "An OECD analysis of health spending in Norway", OECD Health Working Paper, 91, OECD Publishing, Paris,

Nemeth, C., Wears, R., Woods, D., Hollnagel, E., Cook, R., Henriksen, K., Battles, J.B., Keyes, M.A. & Grady, M.L. (eds.) (2008). Minding the Gaps: Creating Resilience in Health Care. In Henriksen, K., Battle,s J.B., Keyes, M.A. & Grady, M.L. (editors). Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 3: Performance and Tools). Rockville (MD): Agency for Healthcare Research and Quality (US); August.

National Health Service (U.K.) (NHS) (2018). Plan, Do, Study, Act (PDSA) cycles and the model for improvement.

Norwegian Board of Health Supervision (2008). In Norwegian: «Mens vi venter …». - forsvarlig pasientbehandling i akuttmottakene? Rapport fra Helsetilsynet (2). In English: "While we are waiting - prudent patient treatment in the emergency wards"? Report.

Norwegian Board of Health Supervision (2011). In Norwegian: Retningslinjer for oppfølging og avslutning av tilsyn ved lovbrudd i virksomheter. In English: Policies for the follow-up and concluding of supervision in cases of breach of legal requirements. joner/internserien/retningslinjer_avslutning_tilsyn8_2011.pdf.

Norwegian Board of Health Supervision (2013). In Norwegian: Spesialisthelsetjenestens håndtering av henvisninger og utredning av pasienter med tykk- og endetarmskreft. Rapport fra Helsetilsynet (4). In English: The specialized healthcare service's handling of referrals and clearance of patients with cancer colon. Report. joner/rapporter2013/helsetilsynetrapport4_2013.pdf.

Norwegian Board of Health Supervision (2014). Helsetjenesten og helseforvaltningen i Norge, Undervisning - medisinstudiet UiO joner/artikler/2014/rudi_hm_helsetjenesten_helseforvaltningen_undervisning_med_stud.pdf/.

Norwegian Board of Health Supervision (2016). In Norwegian: Høringsuttalelse. In English: Hearing Comment.

Norwegian Board of Health Supervision (2017). Reaksjonsformer overfor helsepersonell og virksomheter i helse- og omsorgstjenesten. In English: Sanction options towards health personnel and entities in the health and care services. tilsynssaker/reaksjonsformer-personell-virksomheter-i-helse- omsorgstjenesten.

Norwegian Board of Health Supervision (2018). In Norwegian: Veileder for tilsyn utført som systemrevisjon. In English: Guidelines document for planned/system audits. joner/internserien/veileder_systemrevisjon_internserien4_2018. pdf.

Norwegian Board of Health Supervision (2019 a). In Norwegian: Introduksjon til tilsynsmyndighetene og tilsynet med barnevern-, sosial- og helse- og omsorgstjenester i Norge. In English: Introduction to the Supervisory Authorities and the Supervision of Child Welfare Services, Social Services and Health And Care Services in Norway. tilsynsmyndigheten-tilsyn-barnevern-sosial-helse- omsorgstjenester-norge/.

Norwegian Board of Health Supervision (2019 b). In Norwegian: Årsrapport 2018 fra Statens Helsetilsyn. In English: Annual Report 2018 from the Norwegian Board of Health Supervision. joner/aarsrapporter/aarsrapport2018.pdf.

Norwegian Board of Health Supervision (2020 a). In Norwegian: Tilsynsrapport, Fylkesmannen i Vestland. In English: Supervisory report. 19/helse-bergen-hf-haukeland-universitetssjukehus-tilsyn-med- helsehjelp-til-pasientar-som-vert-flytta-grunna-mangel-pa- plass-2019/#2Aktueltlovgrunnlagfortilsynet.

Norwegian Board of Health Supervision (2020 b). In Norwegian: Tilsynsrapport, Fylkesmannen i Oslo og Viken. In English: Supervisory report. viken/2019/drammen-sykehus-tilsyn-med-helsetjenester-til- somatiske-pasienter-som-blir-flyttet-grunnet-mangel-paa-plass- 2019/.

Norwegian Board of Health Supervision (2020 c). Reaksjoner mot helsepersonell og påpekte lovbrudd mot virksomheter i helse- og omsorgstjenesten i 2019. r-mot-helsepersonell-og-papekte-lovbrudd-mot-virksomheter-i- helse-og-omsorgstjenesten-i-2019/.

Norwegian Directorate of Health (n.d.). Standardpresentasjon til forskrift Ledelse og kvalitetsforbedring i helse- og omsorgstjenesten. oss/innsatsomrader/ledelse-av-pasientsikkerhet.

Norwegian Directorate of Health (2005): In Norwegian: Nasjonal strategi for kvalitetsforbedring i sosial- og helsetjenesten ...Og bedre skal det bli! (2005-2015). In English: National Strategy for Quality Improvement in Health and Social Services (2005 - 2015). personer-med-store-og-sammensatte-behov/metoder-og- verktoy-for-systematisk-kvalitetsforbedring-for-helhetlige-og- koordinerte-tjenester/de-seks-dimensjonene-for-kvalitet-i- tjenestene-er-sentrale-sjekkpunkter-i-forbedringsarbeidet/Og- bedre-skal-det-bli-nasjonal-strategi-for-kvalitetsforbedring-i- sosial-og-helsetjenesten-2005-2015-IS-1162- bokmal.pdf/_/attachment/inline/985d47ad-c5cc-47e4-8e4d- 2d3ae1a05bbe:cdbc34628eed68ec59098b3a2f41e0f8a28a44ee/ Og-bedre-skal-det-bli-nasjonal-strategi-for-kvalitetsforbedring- i-sosial-og-helsetjenesten-2005-2015-IS-1162-bokmal.pdf.

Norwegian Directorate of Health (2013). In Norwegian: Prosjektbeskrivelse for utkast til felles forskrift. In English: Project plan (regarding the development of the new regulatory framework; the QIR).

Norwegian Directorate of Health (2014 a). In Norwegian: Invitasjon til innspill til Helsedirektoratets arbeid med ny felles forskrift for internkontroll og systematisk arbeid med kvalitetsforbedring og pasient- og brukersikkerhet i helse- og omsorgstjenesten. In English: Invitation to give input to NDH's draft.

Norwegian Directorate of Health (2014 b). In Norwegian: Utkast til høringsnotat. In English: Draft of the Hearing Memorandum.

Norwegian Directorate of Health (2016). In Norwegian: Høringsuttalelse. In English: Hearing Comment.

Norwegian Directorate of Health (2017). In Norwegian: Veileder til forskrift om ledelse og kvalitetsforbedring i helse- og omsorgstjenesten. In English: Guidelines to Regulation on management and quality improvement in the healthcare services.

Norwegian Directorate of Health (2019 a). About the Norwegian Directorate of Health. directorate-of-health.

Norwegian Directorate of Health (2019 b). In Norwegian: Nasjonal handlingsplan for pasientsikkerhet og kvalitetsforbedring 2019- 2023. In English: National Action Plan for patient safety and quality improvement (2019-2023). kvalitetsforbedring-i-helse-og-omsorgstjenesten/Nasjonal%20handlingsplan%20for%20pasien tsikkerhet%20og%20kvalitetsforbedring%202019- 2023.pdf/_/attachment/inline/79c83e08-c6ef-4adc-a29a- 4de1fc1fc0ef:94a7c49bf505dd36d59d9bf3de16769bad6c32d5/ Nasjonal%20handlingsplan%20for%20pasientsikkerhet%20og%20kvalitetsforbedring%202019-2023.pdf.

Norwegian Directorate of Health (2020 a). In Norwegian: Rapport. Pasientskader i Norge 2019 - Målt med Global Trigger Tool. In English: Report. Patient injuries in Norway 2019 - measured by the Global Trigger Tool. norge-2019-malt-med-global-trigger-tool.

Norwegian Directorate of Health (2020 b). Corona. Information and recommendations about coronavirus for health professionals and other public sectors.

Nyssen, A-S & Blavier, A. (2013). Investigating Expertise, Flexibility and Resilience in Socio-technical Environments: A Case Study in Robotic Surgery. In Hollnagel, E., Braithwaite, J. and Wears, R. L. Resilient Health Care. Ashgate Publishing Limited. Ogrinc, G., Headrick, L., Barton, A.J., Dolanskym M.A., Madigosky, W.S. & Miltner, R.S. (2012). Fundamentals of healthcare improvement. 2nd edition. Oakbrook Terrace, IL: Joint Commission Resources.

Ogrinc, G. & Shojania, K.G. (2014). Building knowledge, asking questions. BMJ Quality & Safety,23:265-267.

Oikonomou, E., Carthey, J., Macrae, C. & Vincent, C. (2019). Patient safety regulation in the NHS: mapping the regulatory landscape of healthcare. BMJ Open, 9:e028663.

Olmos-Ochoa, T.T., Ganz, D.A., Barnard, J.M., Penney, L.S & Chawla, N. (2019). Sustaining effective quality improvement: building capacity for resilience in the practice facilitator workforce. BMJ Quality & Safety, 28:1016-1020. Oxford University Press (2019). Hermeneutics.

Parand, A., Dopson, S., Renz, A. & Vincent, C. (2014). The role of hospital managers in quality and patient safety: a systematic review BMJ Open, 4:e005055.

Pattaro, E. A. (2005). Treatise of Legal Philosophy and General Jurisprudence. Springer Netherlands.

Pimentel, M.P.T., Austin, J.M. & Kachalia, A. (2020). To improve quality, keep your eyes on the road BMJ Quality & Safety, Nov;29(11):943-946. PMID: 32393598.

Plsek, P. E. & Greenhalgh, T. (2001). The challenge of complexity in health care. BMJ, 323:625. doi:

Popper, K. (1963). Conjectures and refutations. New York: Routledge & Kegan Paul.

Provan, D. J., Dekker, S. W. A. & Rae, A. J. (2017). Bureaucracy, influence and beliefs: A literature review of the factors shaping the role of a safety professional, Safety Science,98,98-112

Ptil (PSA) (2019). About the regulations.

Quentin, W., Partanen, V.M., Brownwood, I. & Klazinga. N. (2019). Measuring healthcare quality. In Busse, R., Klazinga, N., Panteli, D. & Quentin, W. Improving healthcare quality in Europe: Characteristics, effectiveness, and implementation of different strategies. Health Policy Series, 53. Copenhagen (Denmark): European Observatory on Health Systems and Policies.

Quick, O. (2017). Regulating Patient Safety, The End of Professional Dominance? Cambridge University Press.

Reason, J. (1997). Managing the Risk of Organizational Accidents. Taylor & Francis Ltd.

Reason, J., (2001). Understanding adverse events: the human factor. In Vincent, C. & William, J. (editors), Clinical risk management: enhancing patient safety, Second Edition. BMJ Books, London, UK.

Reason, J., (2002). Combating omission errors through task analysis and good reminders. Quality & Safety in Health Care, 11 (1), 40-44. 89051750-eng.pdf?sequence=1&isAllowed=y.

Rasmussen, J. (1997). Risk management in a dynamic society: a modelling problem. Safety Science,27:183-213.

Rae, A. & Alexander, R. (2017). Forecasts or fortune-telling: When are expert judgements of safety risk valid? Safety Science, 99 156- 165157.

Rae, A., Provan, D., Aboelssaad, H. & Alexander, R. (2020). A manifesto for Reality-based Safety Science. Safety Science, 126, 1046543

Reed, J. E. & Card, A. J. (2016). The problem with Plan-Do-Study-Act cycles. BMJ Quality & Safety, 25:147-152.

Reiman, T., Rollenhagen, C., Pietikäinen, E., & Heikkilä, J. (2015). Principles of adaptive management in complex safety-critical organizations, Safety Science, 71, Part B, 80-92.

Renn, O. (2008 a). Risk governance: Coping with uncertainty in a complex world. London: Earthscan.

Renn, O. (2008 b). Concepts of Risk: An Interdisciplinary Review Part 1: Disciplinary Risk Concepts. GAIA - Ecological Perspectives for Science and Society. 17. 50-66.

Renn, O. (2008 c). Concepts of Risk: An Interdisciplinary Review - Part 2: Integrative Approaches. GAIA - Ecological Perspectives for Science and Society. 17. 196-204.

Ritzer, G. (editor). (2005). Encyclopedia of Social Theory. SAGE Publications.

Rognstad, O-A. & Hagland, B. (2020). Juridisk metodelære Del I - Rettskildelære. Vår 2020. Hovedtema III. sningsmateriale-juridisk%20metodel%C3%A6re%20/v-20- bolk-i-hovedtema-3.pdf.

Robert, G.B., Anderson, J.E., Burnett, S.J., Aase, K., Andersson-Gare, B., Bal, R., Calltorp, J., Nunes, F., Weggelaar, A.M., Vincent, C.A., Fulop, N.J. & QUASER team. (2011). A longitudinal, multi-level comparative study of quality and safety in European hospitals: the QUASER study protocol. BMC Health Service Research 11, 285.

Sandgren, C. (2007). «Framtidens doktorsavhandlingar i rättsvetenskap», Tidsskrift for Rettsvitenskap, 120,3, 388-407.

Schwappach, D. L. B., & Pfeiffer, Y. (2020). Registration and Management of "Never Events" in Swiss Hospitals-The Perspective of Clinical Risk Managers. Journal of Patient Safety

Schaefer, C. & Wiig, S. (2017). Strategy and practice of external inspection in healthcare services - a Norwegian comparative case study. Safety in Health, 3, 3.

Shaw, C., Groene, O. & Berger, E. (2019). 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. 89051750-eng.pdf?sequence=1&isAllowed=y.

Schulman, P.R. (1993). The Negotiated Order of Organizational Reliability. Administration & Society, 25(3):353-372.

Sheps, S. & Cardiff, K. (2013). Looking at Success versus Looking at Failure: Is Quality Safety? Is Safety Quality? In Hollnagel, E., Braithwaite, J. & Wears, R. L. Resilient Health Care. Ashgate Publishing Limited:xxv:49-56.

Simon, M.D. (2018). Compliance and High Reliability in a Complex Healthcare Organization. Frontiers of Health Services Management; 34(4):12-25. PMID: 29782373.

Skjervheim, H. (1976; 2001). Deltakar og tilskodar og andre essays. Oslo: Aschehoug.

Sollid, S. (2015). Risikostyring i klinisk medisin. In Aase, K. (editor). Pasientsikkerhet. Teori og praksis. Universitetsforlaget.

Sparrow, M. (2000). The Regulatory Craft. Controlling Risks, Solving Problems, and Managing Compliance. Brookings Institution Press.

Spehar, I., Frich, J.C. & Kjekshus, L.E. (2012). Clinicians' experiences of becoming a clinical manager: a qualitative study. BMC Health Services Research, 12, 421.

Spehar, I., Frich, J.C. & Kjekshus, L.E. (2014). Clinicians in management: a qualitative study of managers' use of influence strategies in hospitals. BMC Health Services Research, 14, 251.

Spehar, I., Frich, J.C. & Kjekshus, L.E. (2015). Professional identity and role transitions in clinical managers. Journal of Health Organization and Management, 29, 3:353-366.

SSB (2020a). In Norwegian: Statistikkområde. Helse: Pasienter på sykehus. In English: Statistics. Health: Patients in hospitals, 2020.

SSB (2020b). In Norwegian: Statistikkområde. Spesialisthelsetjenesten. In English: Statistics. Health: the Specialized Healthcare Services.

Stoopendaal, A. & van de Bovenkamp, H. (2015). The mutual shaping of governance and regulation of quality and safety in Dutch healthcare. Health Services Management Research;28(1-2):9- 15.

Stoopendaal, A., de Bree, M. & Robben, P. (2016). Reconceptualizing regulation: Formative evaluation of an experiment with System- Based Regulation in Dutch healthcare. Evaluation; 22(4), 394- 409.

Størkersen, K., Thorvaldsen, T., Kongsvik, T. & Dekker, S. (2020). How deregulation can become overregulation: An empirical study into the growth of internal bureaucracy when governments take a step back. Safety Science, 128.

Sujan, M. (2018). A Safety-II Perspective on Organisational Learning in Healthcare Organisations; Comment on "False Dawns and New Horizons in Patient Safety Research and Practice". International Journal of Health Policy and Management; 7(7): 662-666.

Sujan, M. A., Furniss, D., Anderson, J., Braithwaite, J. & Hollnagel E. (2019). Resilient Health Care as the basis for teaching patient safety - A Safety-II critique of the World Health Organisation patient safety curriculum, Safety Science, 118, 15-21.

Taylor, C. (2001). Fortolkning i humanvitenskapene. In. Lægreid, S. & Skorgan, T. (editors). Hermeneutisk lesebok. Oslo: Spartacus. 239-285.

Taylor, M. J, McNicholas, C., Nicolay, C., Darzi, A., Bell, D. & Reed, J.E. (2014). Systematic review of the application of the plan-do- study-act method to improve quality in healthcare BMJ Quality & Safety, 23:290-298.

Tong, A., Sainsbury, P. & Craig, J. (2007). Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. International Journal for Quality in Health Care, 19:6, 349- 357.

Van de Bovenkamp, H. M, Stoopendaal, A. van Bochove, M. & Bal, R. (2020). Tackling the problem of regulatory pressure in Dutch elderly care: The need for recoupling to establish functional rules, Health Policy, 124, 3, 275-281.

Van de Bovenkamp, H. M, Stoopendaal, A. & Bal, R. (2017). Working with layers: The governance and regulation of healthcare quality in an institutionally layered system. Public Policy and Administration, 32(1), 45-65.

van Erp, J., Wallenburg, I. & Bal, R. (2018). Performance regulation in a networked healthcare system: From cosmetic to institutionalized compliance. Public Administration, 98: 46- 61.

Vennik, F.D., van de Bovenkamp, H.M., Putters, K. & Grit, K.J. (2016). Co-production in healthcare: rhetoric and practice. International Review of Administrative Sciences, 82(1):150-168.

Vincent, C., & Amalberti, R. (2015). Safety in healthcare is a moving target. BMJ Quality & Safety, 24:539-540.

Vincent C. (2006). Patient safety. Edinburgh: Elsevier Churchill Livingstone.

Vincent C. (2010). Patient safety. Wiley-Blackwell.

Vincent C., & Amalberti R. (2016). Safer Healthcare. Strategies for the Real World. Springer.

Walshe, K. (2003). Regulating Healthcare: A Prescription for Improvement? McGraw-Hill Education.

Wears, R. L. & Sutcliffe, K. M. (2020). Still Not Safe. Patient Safety and the Middle-Managing of American Medicine. Oxford University Press.

Wears, R. L., & Hettinger, A. Z. (2014). The tragedy of adaptability. Annals of Emergency Medicine, 63,3:338-9.

Weber, M. (1949). Methodology of Social Sciences. Free Press.

Weber, M. (1962). Basic Concepts in Sociology. Philosophical Library. Weick, K.E. & Sutcliffe, K. M. (2007). Managing the Unexpected: Resilient Performance in an Age of Uncertainty. 2nd Edition San Francisco: Jossey-Bass.

Whittemore, R., Chase, S. K. & Mandle, C. L. (2001). Validity in Qualitative Research. Qualitative Health Research, 11,4:522- 537.

Wiig, S. & Lindøe, P. H. (2009). Patient safety in the interface between hospital and risk regulator. Journal of Risk Research,12:3- 4, 411-426

Wiig, S., Aase, K., von Plessen, C., Burnett, S., Nunes, F., Weggellar, A.M., Anderson-Gare, B., Calltorp, J. & Fulop, N. (2014). Talking about quality: exploring how 'quality' is conceptualized in European hospitals and healthcare systems. BMC Health Services Research, 14, 478.

Wiig. S., Aase, K. & Bal, R. (2020 a). Reflexive Spaces: Leveraging Resilience Into Healthcare Regulation and Management. Journal of Patient Safety, Jan 31. PMID: 32011428.

Wiig, S., Aase, K., Billett, S., Canfield, C., Røise, O., Njå, O., Guise, V., Haraldseid-Driftland, C., Ree, E., Anderson, J. E., & Macrae, C. (2020 b). Defining the boundaries and operational concepts of resilience in the resilience in healthcare research program. BMC Health Services Research, 20, 330.

Wiig, S., Haraldseid-Driftland, C., Tvete Zachrisen, R., Hannisdal, E. & Schibevaag, L. (2019 a). 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). Journal of Patient Safety, PMID: 31651540.

Wiig, S., Schibevaag, L., Tvete Zachrisen, R., Hannisdal, E., Anderson, J.E. & Haraldseid-Driftland C. (2019 b). Next-of-Kin Involvement in Regulatory Investigations of Adverse Events That Caused Patient Death: A Process Evaluation (Part II: The Inspectors' Perspective). Journal of Patient Safety, PMID: 31651541.

Wiig, S., Ree, E., Johannessen, T., Strømme, T., Storm, M., Aase, I., Ullebust, B., Holen-Rabbersvik, E., Thomsen, L.H., Pedersen, A.T.S., van de Bovenkamp, H., Bal, R. & Ase, K. (2018). Improving quality and safety in nursing homes and home care: the study protocol of a mixed-methods research design to implement a leadership intervention. BMJ Open, 8:e020933.

Wiig, S. & Fahlbruch, B. (editors). (2019). Exploring Resilience. A scientific Journey from Practice to Theory. Springer Open.

Wilkinson, J., Powell, A. & Davies, H. (2011). Are clinicians engaged in quality improvement? A review of the literature on healthcare professionals' views on quality improvement initiatives. The Health Foundation. clinicians-engaged-in-quality-improvement.

Woodward S. (2019). Moving towards a safety II approach. Journal of Patient Safety and Risk Management, 24(3), 96- 99.

World Health Organization (WHO) (2005). WHO Draft Guidelines for adverse event reporting and learning systems. From information to action. WHO Document Production Services, Geneva, Switzerland. EIP-SPO-QPS-05.3-eng.pdf.

World Health Organization (WHO) (2018). Handbook for National Quality Policy and Strategy. A practical approach for developing policy and strategy to improve quality of care. Co- developed by the World Health Organization and countries pursuing national quality initiatives. 41565561-eng.pdf?ua=1.

Wæhle, H.V., Haugen, A.S., Wiig, S., Søfteland, E., Sevdalis, N. & Harthug, S. (2020). How does the WHO Surgical Safety Checklist fit with existing perioperative risk management strategies? An ethnographic study across surgical specialties. BMC Health Services Research, 12;20(1):111. PMID: 32050960; PMCID: PMC7017532.

Yin, R. K., (2014). Case Study Research. Design and Methods. SAGE Publications.

Ylikoski, P. (2012). Micro, Macro, and Mechanisms. In Kincaid, H. (editor). The Oxford Handbook of Philosophy of Social Science, Oxford: Oxford University Press, 21-45.

Øyri, S., & Wiig, S. (2019). Regulation and resilience at the macro-level healthcare system - a literature review. Proceedings of the 29th European Safety and Reliability Conference 2019. Beer, M. & Zio, E. (editors).

Øyri, S.F., Braut, G.S., Macrae, C. & Wiig, S. (2020). Exploring links between resilience and the macro-level development of healthcare regulation- a Norwegian case study. BMC Health Services Research, 20, 762.

Øyri, S.F., Braut, G.S., Macrae, C. & Wiig S. (2021). Investigating Hospital Supervision: A Case Study of Regulatory Inspectors' Roles as Potential Co-creators of Resilience. Journal of Patient Safety, 1;17(2):122-130. PMID: 33480644; PMCID: PMC7908864.

Øyri, S.F., Braut, G.S., Macrae, C. & Wiig S. (2020). Hospital managers' perspectives with implementing quality improvement measures and a new regulatory framework: a qualitative case study BMJ Open, 10:e042847.

Cover for Healthcare Regulation and Resilience: a Norwegian Multilevel Case Study
August 6, 2021