Migliorare la sicurezza in cardiologia interventistica: mappatura multicentrica regionale e progettazione di una checklist specifica per il miglioramento della qualità

Alessandro Faraci; Giovanni Coppola; Selenia Principato; Alessandro Scarantino; Antonino Scardamaglia; Giuseppina Ruggieri

doi:10.54103/dn/29713

Authors

Alessandro Faraci Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" di Palermo - Università Degli Studi di Palermo, Palermo, Italy https://orcid.org/0009-0009-7779-6354
Giovanni Coppola ASP di Siracusa, Presidio Ospedaliero “Umberto I” Siracusa, Siracusa, Italy
Selenia Principato ASP Agrigento, Ospedale San Giovanni di Dio Agrigento, Agrigento Italy
Alessandro Scarantino - ASP Caltanissetta, Presidio Ospedaliero “S. Elia” di Caltanissetta, Caltanissetta, Italy
Antonino Scardamaglia Azienda Ospedaliera Ospedali Riuniti Villa Sofia – Cervello, Palermo, Italy - Università Degli Studi di Palermo, Palermo, Italy https://orcid.org/0009-0009-9508-6866
Giuseppina Ruggieri Azienda Ospedaliera Ospedali Riuniti Villa Sofia – Cervello, Palermo, Italy - Università Degli Studi di Palermo, Palermo, Italy

DOI:

https://doi.org/10.54103/dn/29713

Keywords:

Checklist, Cath Lab, Safety of Care, Patient Safety, Nurses, Nursing

Abstract

INTRODUCTION: Safety in interventional cardiology laboratories (Cath Labs) is challenged by high procedural complexity. In Italy, standardized and validated tools for the national context are lacking, making the adoption of foreign models difficult due to organizational and regulatory differences. A methodological intervention is therefore needed to address this operational gap.

OBJECTIVE: To analyze the adoption of safety practices in the 22 Cath Labs of the Sicily region and to design a regional standardized checklist to promote uniformity of care and improve care processes.

MATERIALS AND METHODS: The regional mapping was conducted via survey as part of a quality improvement project. Identification of critical issues and checklist design were guided by the PDSA cycle and a SWOT analysis. Data were analyzed descriptively, focusing on the Plan and Do phases.

RESULTS: 91% of centers (20/22) use a checklist, with marked heterogeneity: 68% use customized, non-standardized tools, and 27% operate without internal institutional validation. There was unanimous agreement (100%) on the need to adopt a single standardized tool. Based on these results and the WHO and Italian Ministry of Health guidelines, a 17-item checklist was designed, structured in the Sign-in, Time-out, and Sign-out phases, and adapted to the organizational characteristics of the Cath Labs.

CONCLUSIONS: The regional mapping confirms the need to overcome procedural fragmentation. The developed checklist could be proposed to the DASOE for regional institutionalization and will support safety, clinical appropriateness, audits, DRG classification, and the Annual Analytical Control Plan (PACA).

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References

1. Saglietto A, Manfredi R, Elia E, D’Ascenzo F, DE Ferrari GM, Biondi-Zoccai G, Munzel T. Cardiovascular disease burden: Italian and global perspectives. Minerva Cardiol Angiol. 2021;69(3):231– 240. doi:10.23736/S2724-5683.21.05538-9.

2. Berti S (Chairman), Piccaluga E, Marchese A, Varbella F, Sardella G, Danzi GB, Salvi A, Cremonesi A, Merelli A, Ciarma L, Magro B, Bedogni F. Documento di posizione SICI-GISE sugli standard e linee guida per i laboratori di diagnostica e interventistica cardiovascolare. G Ital Cardiol. 2015;16(10):590–600. doi:10.1714/2028.22050.

3. Faraci A. Safety list for a low risk nel laboratorio di emodinamica. G Ital Cardiol. 2023;24(Suppl 1–10):e23–e24. [Internet]. Available from: https://www.giornaledicardiologia.it/archivio/4102

4. Magro B, et al. Documento di posizione SICI-GISE sugli standard dei laboratori di diagnostica e interventistica cardiovascolare: le professioni sanitarie del comparto standard qualitativi e quantitativi. G Ital Cardiol. 2019;20(9 Suppl 1):8S–13S. doi:10.1714/3219.31964.

5. Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Witkowski A; Authors/Task Force Members. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014;35(37):2541–2619. doi:10.1093/eurheartj/ehu278.

6. Steg PG, James SK, Atar D, Badano LP, Blömstrom-Lundqvist C, Borger MA, Di Mario C, Dickstein K, Ducrocq G, Fernandez-Aviles F, Gershlick AH, Giannuzzi P, Halvorsen S, Huber K, Juni P, Kastrati A, Knuuti J, Lenzen MJ, Mahaffey KW, Zahger D; Task Force on the Management of ST-Segment Elevation Acute Myocardial Infarction of the European Society of Cardiology (ESC). ESC guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation. Eur Heart J. 2012;33(20):2569–2619. doi:10.1093/eurheartj/ehs215.

7. Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting Without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016;37(3):267-315. doi:10.1093/eurheartj/ehv320.

8. Byrne RA, Rossello X, Coughlan J, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan G, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Juni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RF, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. Linee guida ESC 2023 per il trattamento delle sindromi coronariche acute. G Ital Cardiol. 2024;25(2 Suppl 2):e1-e112. doi:10.1714/4191.41785.

9. World Health Organization. Implementation manual WHO surgical safety checklist 2009. Geneva: World Health Organization; 2009. [Internet]. Available from: https://www.who.int/publications/i/item/9789241598590

10. Treadwell JR, Lucas S, Tsou AY. Surgical checklists: a systematic review of impacts and implementation. BMJ Qual Saf. 2014;23(4):299-318. doi:10.1136/bmjqs-2012-001797.

11. Braaf S, Manias E, Riley R. The 'time-out' procedure: an institutional ethnography of how it is conducted in actual clinical practice. BMJ Qual Saf. 2013;22(8):647-655. doi:10.1136/bmjqs-2012-001702.

12. Braham DL, Richardson AL, Malik IS. Application of the WHO surgical safety checklist outside the operating theatre: medicine can learn from surgery. Clin Med (Lond). 2014;14(5):468-474. doi:10.7861/clinmedicine.14-5-468.

13. Pugel AE, Simianu VV, Flum DR, Patchen Dellinger E. Use of the surgical safety checklist to improve communication and reduce complications. J Infect Public Health. 2015;8(3):219-225. doi:10.1016/j.jiph.2015.01.001.

14. Ramsay G, Haynes AB, Lipsitz SR, Solsky I, Leitch J, Gawande AA, Kumar M. Reducing surgical mortality in Scotland by use of the WHO Surgical Safety Checklist. Br J Surg. 2019;106(8):1005-1011. doi:10.1002/bjs.11151.

15. Ministero della Salute. Governo clinico e sicurezza delle cure. Rome: Ministero della Salute. [Internet]. Available from: https://www.salute.gov.it/new/it/tema/governo-clinico-e-sicurezza-delle-cure/generale/?paragraph=1

16. Rafiei P, Walser EM, Duncan JR, Rana H, Ross JR, Kerlan RK Jr, Gross KA, Balter S, Bartal G, Abi-Jaoudeh N, Stecker MS, Cohen AM, Dixon RG, Thornton RH, Nikolic B; Society of Interventional Radiology Health and Safety Committee. Society of Interventional Radiology IR pre-procedure patient safety checklist by the Safety and Health Committee. J Vasc Interv Radiol. 2016;27(5):695-699. doi:10.1016/j.jvir.2016.03.002.

17. Walker IA, Reshamwalla S, Wilson IH. Surgical safety checklists: do they improve outcomes? Br J Anaesth. 2012;109(1):47-54. doi:10.1093/bja/aes175.

18. Corso R, Vacirca F, Patelli C, et al. Use of “Time-Out” checklist in interventional radiology procedures as a tool to enhance patient safety. Radiol Med. 2014;119:828-834. doi:10.1007/s11547-014-0397-9.

19. Federazione Nazionale Ordini delle Professioni Infermieristiche. Codice deontologico delle professioni infermieristiche. Roma: FNOPI; 2025.

20. Faraci A, Grimaudo R, Messana D, Corrado E, Adorno A, Evola S, Novo G. Production of an intraoperative safety list in interventional cardiology: from pilot project to clinical practice guidelines hospital. Eur J Cardiovasc Nurs. 2024 Jul;23(Suppl 1):zvae098.103. doi:10.1093/eurjcn/zvae098.103.

21. Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016 Dec;25(12):986-92. doi:10.1136/bmjqs-2015-004411.

22. Taylor MJ, McNicholas C, Nicolay C, Darzi A, Bell D, Reed JE. Systematic review of the application of the plan-do-study-act method to improve quality in healthcare. BMJ Qual Saf. 2014;23(4):290–298. doi:10.1136/bmjqs-2013-001862.

23. Langley GJ, Moen RD, Nolan KM, Nolan TW, Norman CL, Provost LP. The improvement guide: a practical approach to enhancing organizational performance. 2nd ed. San Francisco (CA): Jossey-Bass; 2009.

24. Leis JA, Shojania KG. A primer on PDSA: executing plan-do-study-act cycles in practice, not just in name. BMJ Qual Saf. 2017;26(7):572–577. doi:10.1136/bmjqs-2016-006245.

25. Vincent C. Patient Safety. 2nd ed. Chichester (UK): Wiley-Blackwell; 2010. doi:10.1002/9781444323856

26. World Health Organization. Patient safety: making health care safer. Geneva: World Health Organization; 2017

27. Lindsay AC, Bishop J, Harron K, Davies S, Haxby E. Use of a safe procedure checklist in the cardiac catheterisation laboratory. BMJ Open Qual. 2018;7(3):e000074. doi:10.1136/bmjoq-2017-000074.

28. Cardiologia negli Ospedali – Pillole di Qualità. Analisi SWOT nell’ambito delle Unità Operative Complesse per la qualità e sicurezza delle cure. Roma: Cardiologia negli Ospedali; 2024.

29. Associazione Nazionale Medici Cardiologi Ospedalieri (ANMCO). Responsabilità professionale e sicurezza delle cure: profilo SWOT. Roma: ANMCO; 2024. [Internet]. Available from: https://cardiologianegliospedali.it/wp-content/uploads/2024/10/15_GRUPPO-DI-STUDIO-RESPONSABILITA-PROFESSIONALE-E-SICUREZZA-DELLE-CURE.pdf

30. Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, Claeys MJ, Dan GA, Dweck MR, Galbraith M, Gilard M, Hinterbuchner L, Jankowska EA, Jüni P, Kimura T, Kunadian V, Leosdottir M, Lorusso R, Pedretti RFE, Rigopoulos AG, Rubini Gimenez M, Thiele H, Vranckx P, Wassmann S, Wenger NK, Ibanez B; ESC Scientific Document Group. 2023 ESC Guidelines for the management of acute coronary syndromes. Eur Heart J. 2023;44(38):3720-26. doi:10.1093/eurheartj/ehad191.

31. Reason J. Human error: models and management. BMJ. 2000 Mar 18;320(7237):768-70. doi: 10.1136/bmj.320.7237.768.

32. Hughes RG, editor. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville (MD): Agency for Healthcare Research and Quality; 2008.

33. World Health Organization. WHO Guidelines for Safe Surgery 2009: Safe Surgery Saves Lives. Geneva: WHO; 2009

34. Haynes AB, Weiser TG, Berry WR, et al. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009;360(5):491–499. doi:10.1056/NEJMsa0810119

35. World Health Organization. Patient Safety Incident Reporting and Learning Systems. Geneva: WHO; 2020.

36. Gawande A. The Checklist Manifesto: How to Get Things Right. New York, NY: Metropolitan Books; 2010.

37. Issenberg SB, McGaghie WC, Petrusa ER, et al. Features and uses of high-fidelity medical simulations that lead to effective learning. Med Teach. 2005;27(1):10–28.

38. Okuda Y, Bryson EO, DeMaria S Jr, et al. The utility of simulation in medical education: what is the evidence? Mt Sinai J Med. 2009;76(4):330–343.

39. Rosen MA, Hunt EA, Pronovost PJ, et al. In situ simulation in continuing education for patient safety. BMJ Qual Saf. 2012;21(5):119–128.

40. Bates DW, Singh H. Two decades since “To Err Is Human”: an assessment of progress and emerging priorities in patient safety. Health Aff. 2018;37(11):1736–1743.

41. Shortliffe EH, Sepúlveda MJ. Clinical decision support in the era of artificial intelligence. JAMA. 2018;320(21):2199–2200.

42. Rajpurkar P, Chen E, Banerjee O, Topol EJ. AI in health and medicine. Nat Med. 2022;28(1):31–38. doi:10.1038/s41591-021-01614-0

43. Jiang F, Jiang Y, Zhi H, et al. Artificial intelligence in healthcare: past, present and future. Stroke Vasc Neurol. 2017;2(4):230–243. doi:10.1136/svn-2017-000101

44. Wright A, McCoy AB, Hickman TT, et al. Problem list completeness in electronic health records: A multi-site study and assessment of success factors. Int J Med Inform. 2015;84(10):784–790. doi:10.1016/j.ijmedinf.2015.06.011

45. Sendak M, Gao M, Brajer N, Balu S. Presenting machine learning model information to clinical users. BMJ Health Care Inform. 2020;27(3):e100131.

46. Bates DW, Landman A, Levine DM. Health apps and health data: new opportunities. JAMA. 2018;320(19):1975–1976.

47. Johnson NP, Kirkeeide RL, Gould KL. Coronary anatomy to physiology. Circ Cardiovasc Imaging. 2013;6:719–731.

48. De Maria GL, Scarsini R, Banning AP. Diagnostic approaches to coronary microvascular dysfunction. Interv Cardiol Rev. 2018;13(2):150–155.

49. Al’Aref SJ, Anchouche K, Singh G, et al. Clinical applications of machine learning in cardiovascular disease. JACC Cardiovasc Interv. 2019;12(14):1304–1315.

50. Doorey AJ, Turi ZG, Lazzara EH, Casey M, Kolm P, Garratt KN, Weintraub WS. Safety gaps in medical team communication: Closing the loop on quality improvement efforts in the cardiac catheterization lab. Catheter Cardiovasc Interv. 2022 Jun;99(7):1953-1962. doi: 10.1002/ccd.30189. Epub 2022 Apr 14.

51. Regueiro A, Price S, Haxby EJ. Minimizing risk in the cardiac catheterization laboratory. Rev Esp Cardiol (Engl Ed). 2013;66(5):342-5. doi:10.1016/j.rec.2012.09.018.

52. Rydenfält C, Johansson G, Odenrick P, Åkerman K, Larsson PA. Compliance with the WHO Surgical Safety Checklist: deviations and possible improvements. Int J Qual Health Care. 2013;25(2):182–187. doi:10.1093/intqhc/mzt004.

53. Nicholson P, Kuhn L, Manias E, Sloman M. The design and evaluation of a pre-procedure checklist specific to the cardiac catheterisation laboratory. Aust Crit Care. 2021;34(4):350–7. doi: 10.1016/j.aucc.2020.10.005.

54. Fourcade A, Blache JL, Grenier C, Bourgain JL, Minvielle E. Barriers to staff adoption of a surgical safety checklist. BMJ Qual Saf. 2012;21(3):191-7.

55. Russ S, Rout S, Sevdalis N, Moorthy K, Darzi A, Vincent C. A qualitative evaluation of the barriers and facilitators toward implementation of the WHO Surgical Safety Checklist across hospitals in England. Ann Surg. 2015;261(1):81-91.

56. Al’Aref SJ, Anchouche K, Singh G, Slomka PJ, Kolli KK, Kumar A, et al. Clinical applications of machine learning in cardiovascular disease. JACC Cardiovasc Interv. 2019;12(14):1304-15.

57. Shortliffe EH, Sepúlveda MJ. Clinical decision support in the era of artificial intelligence. JAMA. 2018;320(21):2199-200.

58. Faraci A, Coppola G, Scarantino A, Principato S, Scardamaglia A. State of the art on safety of care in cath lab. Multicentre observational study. Cardiac catheterisation laboratory, checklist, patient safety. Eur Heart J Suppl. 2025 May;27(Suppl 5):suaf076.429. doi:10.1093/eurheartjsupp/suaf076.429.