Journal List > Prog Med Phys > v.27(3) > 1098545

Lee, Shin, Ji, Kim, An, Park, Cho, Kim, Koo, Oh, and Choi: A Study of Institutional Status of Risk Management for Radiotherapy in Foreign Country

Abstract

With the development in field of industry and medicine, new machines and techniques are being launched. Moreover, the complexity of the techniques is associated to an increasing risk of incident. Especially, a small error in radiotherapy can lead to a serious patient-related incident, risk management is necessary in radiotherapy in order to reduce the risk of incident. However, in field of radiotherapy, there are no legally binding clauses for risk management and there is an absence of risk management systems at an institutional level. Therefore, we analyzed institutional status of risk management, reporting & classification systems, and risk assessment & analysis in 31 countries. For risk management and reporting systems, 65% of countries investigated had legislation or regulations; however, only 35% of countries used classification systems. It was found that 43% more countries had legislation for risk management in healthcare than those for radiotherapy; 19% more countries had reporting systems for healthcare than those for radiotherapy. For classification systems, 60% more countries had legislation, recommendation, and guidelines in the field of radiotherapy than those for healthcare. Recently, international institutes have published several reports for risk management and patient safety in radiotherapy, owing to which, countries adopting risk management for radiotherapy will gradually increase. Before adopting risk management in Korea, we should precisely understand the procedures and functions of risk management, in order to increase efficiency of risk management because classification & reporting system and risk assessment & analysis are connected organically, and institutional management is needed for high quality of risk management in Korea.

REFERENCES

1. ISO 31000. Risk management-Principles and guidelines on implementation. International Organization for Standardization; 2009.
2. Osborn S, Williams S. In: Seven steps to patient safety-The full reference guide. National Patient Safety Agency; 2004.
3. David LC, Dubetz M, Heshmati R, et al. In: A Reference Guide for Learning from Incidents in Radiation Treatment. HTA Initiative #22; 2006.
4. Battles JB, Stevens DP. Adverse event reporting systems and safer healthcare. Qual Saf Health Care. 2009; 18:2.
crossref
5. Ekaette EU, Lee RC, Cooke DL, et al. Risk analysis in radiation treatment -application of a new taxonomic structure. Radiother Oncol. 2006; 80:282–287.
crossref
6. ISO/IEC 31010:2009: Risk management - Risk assessment techniques. International Organization for Standardization (2009).
7. WHO. Radiotherapy Risk Profile. World Health Organization; 2008.
8. Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy. Luxembourg: European Commission; 2013.
9. AAPM Task Group 100 report. Application of risk management methods to radiation therapy quality management. American Association of Physicist in Medicine; 2016.
10. ICRP Publication 86. Prevention of Accidental Exposures to Patients Undergoing Radiation Therapy. Annals of the ICRP; 2000.
11. ICRP Publication 112. Preventing Accidental Exposures from New External Beam Radiation Therapy Technologies. Annals of the ICRP; 2009.
12. HTA Initiative #15. Quantitative Approaches to Patient Safety - Research in Risk Analysis and Risk Management as Applied to Radiotherapy. Canada: AHFMR; 2004.
13. Radiation Oncology Practice Standards New Zealand. A tripartite initiative RANZCR, AIR and ACPSEM. 2013.
14. PHE-CRCE-016. Data Report on Radiotherapy Errors and Near Misses (December 2011 to November 2013). Public Health England; 2014.
16. AHRQ WebM&M. 2013 http://www.webmm.ahrq.gov/.
17. AIMS. 2000 http://www.apsf.net.au/.
19. Vigie radiothérapie. 2013 https://vigie-radiotherapie.asn.fr/.
20. DPSD. 2007 http://www.dpsd.dk/.
21. AHFMR HTA ILS. 2007 http://www.ahfmr.ab.ca/.
23. NRC. 2013 http://nrc.gov/.
24. ICHT/NRLS. 2003 http://www.nrls.npsa.nhs.uk/.
25. PRISMA-RT. 2008 http://www.prisma-rt.nl/.
26. ROSIS. 2008 http://www.rosis.info.
27. Swiss-ROSIS. 2004 http://www.rosis.ch/.
28. SAFRON. 2012 http://rpop.iaea.org/safron/.
29. SiNASP. 2013 http://www.sinasp.es/.
30. Cantone MC, Ciocca M, Dionisi F, et al. Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy. Radiat Oncol. 2013; 8:127.
crossref
31. Scorsetti M, Siqnori C, Lattuada P, et al. Applying failure mode effects and criticality analysis in radiotherapy: lessons learned and perspectives of enhancement. Radiother Oncol. 2010; 94(3):367–374.
crossref
32. Ciocca M, Cantone MC, Veronese I, et al. Application of failure mode and effects analysis to intraoperative radiation therapy using mobile electron linear accelerators. Int J Radiat Oncol Biol Phys. 2012; 82(2):e305–e311.
crossref
33. Vilaragut JJ, Duménigo C, Delgado JM, et al. Prevention of accidental exposure in radiotherapy: the risk matrix approach. Health Phys. 2013; 104(2):139–150.
34. Portaluri M, Fucilli FI, Bambace S, et al. Incidents analysis in radiation therapy: application of the human factors analysis and classification system. Ann Ist Super Sanita. 2009; 45(2):128–133.

Fig. 1.
Status of regulatory for (a) risk management, (b) classification, and (c) reporting systems in healthcare and radiotherapy for 31 countries (Austria, Belgium, Bulgaria, Czech, Denmark, Estonia, Finland, France, Greece, Hungary, Italy, Ireland, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden, United Kingdom, Norway, Switzerland, Croatia, Iceland, Moldova, Serbia, Macedonia, and Israel).
pmp-27-139f1.tif
Fig. 2.
Existence of reporting & learning systems by each country.
pmp-27-139f2.tif
Fig. 3.
Distribution of reporting & learning systems according to local and external systems.
pmp-27-139f3.tif
Fig. 4.
Distribution of 27 reporting & learning systems for voluntary, mandatory, and both in voluntary and mandatory in radiotherapy and healthcare.
pmp-27-139f4.tif
Table 1.
Reporting and learning systems used across 13 countries and 3 international organizations.
Country Reporting & Learning Systems
Australia ARIR
Canada AHFMR HTA ILS
Denmark DPSD
Finland STUK
France Vigie radiothérapie
Ireland IIMS
Starweb
Italy Incident Reporting System of Radiotherapy Activity in medical physics department
Hospital Incident Reporting System
Luxembourg CFB
Netherlands PRISMA-RT
Spain Radiotherapy reporting system at Hospital Clinico San Carlos
Local system for event notification and registration in radiotherapy
ISO 9001:2008
Notification of Deficiencies, CSN
Registre d’incidences ANTARES
ROSIS
SiNASP
Switzerland Swiss-ROSIS
United Kingdom ICHT/NRLS
Datix Web
USA JCAHO
AHRQ WebM&M
NRC
International organizations SAFRON
ROSIS
AIMS
Table 2.
Characteristics of 14 reporting and learning systems based on country, range of function (local/external), specificity, mandatory or not, confidentiality, and reportable range.
Name Country Local/External Specificity Voluntary/Mandatory Reportable range
AHRQ WebM&M [16] USA External Healthcare Voluntary All§
AIMS [17] International External Healthcare Voluntary All
ARIR [18] Australia Both Healthcare Mandatory All
Vigie radiothérapie [19] France External Radiotherapy Mandatory All
DPSD [20] Denmark Both Healthcare Voluntary* Adverse event
AHFMR HTA ILS [21] Canada, Alberta Local Radiotherapy Voluntary All
JCAHO [22] USA External Healthcare Mandatory Sentinel event
NRC [23] USA External Healthcare Mandatory Medical events (Radioactive source)
ICHT/NRLS [24] UK External Healthcare Voluntary All
PRISMA-RT [25] Netherlands External Radiotherapy Voluntary Near incidents
ROSIS [26] International External Radiotherapy Voluntary Incidents/Near miss
Swiss-ROSIS [27] Switzerland Both Radiotherapy Voluntary Incidents/Near miss
SAFRON [28] International Both Radiotherapy Voluntary All
SiNASP [29] Spain Both Healthcare Voluntary Adverse event Incidents Near-miss

* Mandatory only for adverse events.

Voluntary only for sentinel events.

Mandatory only for serious events.

§ Incidents and near miss for all refer to patient safety in each field (Healthcare/Radiotherapy).

TOOLS
Similar articles