Sequential risk and impact analyses in securing chemotherapy circuit through traceability digitalization and RFID technology implementation

Abstract

Background: Cytotoxic preparations are high-risk medications that require complete medication management process to minimize human error and improving patient safety. To achieve this, information technology solutions have been implemented in the healthcare service, and identification of chemotherapy bags through barcode readers and radiofrequency identification (RFID) has been established. The objective of this study was to analyse the a priori impact of these technologies on the chemotherapy process.

Methods: A sequential risk analysis was conducted on three key stages of organizational transformation (initial, computerized, and RFID-secured) by multidisciplinary healthcare groups. A SWOT (strengths, weaknesses, opportunities, threats) analysis identified process vulnerabilities. Two failure mode and effects analyses (FMEA) defined corrective actions necessary for deploying these technologies. An impact analysis prioritized remaining bottlenecks and assessed control measure effectiveness.

Results: SWOT analysis revealed five weaknesses in the initial process, and five threats each during the computerized and RFID-secured phases. Fifty-six failure modes were analysed using the FMEA method. During barcode implementation, unacceptable and tolerable risks under control dropped from 31 to 26 (-9%), with unacceptable risks halved from 14 to 7 (-50%). With RFID, unacceptable and tolerable risks under control decreased from 26 to 16 (-18%), with unacceptable risks from 7 to 2 (-71%). Impact analysis identified nine bottlenecks across the deployment like prescription support, reliability of stay numbers, configuration, and backup.

Conclusion: Implementing sequential risk analysis coupled with impact analysis enabled the complex transformation phase of chemotherapy circuits while securing key deployment stages. This approach allowed stepwise risk prioritization, adjustment of strategies, and early identification of emerging vulnerabilities. Among the newly identified threats exacerbated by the dematerialization of work supports, risks related to activity discontinuity will be a major focus area (e.g. failure, cyber-attacks).

Keywords: innovation; patient safety; quality improvement; risk management.