Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions

Abstract

Background: Until recently, the preparation of paediatric parenteral nutrition formulations in our institution included re-transcription and manual compounding of the mixture. Although no significant clinical problems have occurred, re-engineering of this high risk activity was undertaken to improve its safety. Several changes have been implemented including new prescription software, direct recording on a server, automatic printing of the labels, and creation of a file used to pilot a BAXA MM 12 automatic compounder. The objectives of this study were to compare the risks associated with the old and new processes, to quantify the improved safety with the new process, and to identify the major residual risks. Methods: A failure modes, effects, and criticality analysis (FMECA) was performed by a multidisciplinary team. A cause-effect diagram was built, the failure modes were defined, and the criticality index (CI) was determined for each of them on the basis of the likelihood of occurrence, the severity of the potential effect, and the detection probability. The CIs for each failure mode were compared for the old and new processes and the risk reduction was quantified. Results: The sum of the CIs of all 18 identified failure modes was 3415 for the old process and 1397 for the new (reduction of 59%). The new process reduced the CIs of the different failure modes by a mean factor of 7. The CI was smaller with the new process for 15 failure modes, unchanged for two, and slightly increased for one. The greatest reduction (by a factor of 36) concerned re-transcription errors, followed by readability problems (by a factor of 30) and chemical cross contamination (by a factor of 10). The most critical steps in the new process were labelling mistakes (CI 315, maximum 810), failure to detect a dosage or product mistake (CI 288), failure to detect a typing error during the prescription (CI 175), and microbial contamination (CI 126). Conclusions: Modification of the process resulted in a significant risk reduction as shown by risk analysis. Residual failure opportunities were also quantified, allowing additional actions to be taken to reduce the risk of labelling mistakes. This study illustrates the usefulness of prospective risk analysis methods in healthcare processes. More systematic use of risk analysis is needed to guide continuous safety improvement of high risk activities.

Prescripción y estandarización de la nutrición parenteral pediátrica

“…Un impreso de prescripción bien diseñado así como la informatización de la prescripción pueden disminuir la incidencia de errores y aumentar la eficiencia del procedimiento (2)(3)(4).…”

“…La utilización de una aplicación para el cálculo, escritura y envío de la prescripción ahorraría tiempo y eliminaría tareas repetitivas y cálculos tediosos por parte del médico, así como la trascripción por parte del farmacéutico. Todas ellas son tareas que son fuente de error (2,8). Por otro lado, sería recomendable que permita el acceso a ayudas y a alertas, como la verificación de la idoneidad de la prescripción en función de estándares definidos por peso y edad o en función de parámetros fisicoquímicos (estabilidad de la emulsión y riesgo de precipitación de calcio y fosfato) (9).…”

Extended FMEA for Sustainable Manufacturing: An Empirical Study in the Non-Woven Fabrics Industry

“…It has been well regarded as a beneficial and prominent tool in assessing potential failures and preventing their occurrence [6], rendering both qualitative and quantitative measures to prioritize the prohibition order of failures and their effects towards the quality of products/service [7]. Consequently, the execution of FMEA has been long deployed in diverse industries, such as automotive [8][9][10][11], nuclear, electronics [12,13], chemistry [14,15], lead-free solder control plan [16], sugar mill boiler [17], fuel cells [18], paper [19], metal forming [4], tanker equipment [20], waste [21,22], Hazard Analysis and Critical Control Points audition [23], households [24], engineering systems [25], energy plants [26][27][28], medical devices [29], pharmacy [30][31][32], health care services [33][34][35][36][37][38], e-commerce [39], management [40][41][42][43], software [44], electronic paper display [45], and product design [46,47].…”

Automated Compounding of Parenteral Nutrition for Pediatric Patients: Characterization of Workload and Costs

“…3 Compounding these solutions requires experienced personnel (pharmacists and pharmacy technicians) and an adequate environment where microorganisms and air particles are minimized, because of a high risk of error and contamination during compounding, which can lead to serious adverse events and even patient deaths. 3 Automated compounding devices have been purported to reduce the risk of human error and improve the efficiency of compounding compared with manual preparation. 4,5 Guidelines have been published for the use of automated compounders in the preparation of PN.…”