Controlling Risks in the Compounding Process of Individually Formulated Parenteral Nutrition: Use of the FMECA Method (Failure modes, effects, and Criticality Analysis)

Abstract

<jats:title>Abstract</jats:title><jats:p>Parenteral nutrition (PN) in the neonatal intensive care unit (NICU) involves a succession of risky processes. The objective was to identify and prioritize the risks associated with PN in order to improve the quality of the pathway. A failure modes, effects, and criticality analysis (FMECA) was used to identify potential PN pathway failure modes. A multidisciplinary working group conducted a functional analysis of the processes, then listed the failure modes (FM). The FM criticality was assessed on a scale from 1 to 5 for occurrence (O), severity (S), and detection (D). The risk priority number (RPN), ranging from 1 to 125, was calculated. The FMECA identified 99 FM (prescription (n=28), preparation (n=48), and administration (n=23)). The median RPN was 12, with scores ranging from 3 to 48. 25 % of the scores had an RPN&gt;21.75.</jats:p><jats:p>Among them, 12 were associated with prescription FM, 5 were associated with FM related to preparation and 8 were associated with a FM linked to administration. It allowed us to prioritize areas of potential quality improvement for parenteral nutrition of the preterm infant. The results demonstrated the need for the presence of a clinical pharmacist in the NICU to ensure the quality of PN process.</jats:p>

Parenteral Nutrition Process Management for Newborn and Preterm Infants – A Preliminary Risk Analysis

“…Even though several risk assessments have been performed on the parenteral nutrition (PN) processes, 15,16,[21][22][23][24] the novelty of our work is the comparison in risks of two sites within the same hospital that are involved in the process of PN for neonatal patients.…”

Compounding in Ukraine: Assessment of the Risks for the Ointment’s Quality by the FMECA Method

“…Risk assessment, according to its recommendations, should help to evaluate the critical impact of various parameters on the CM quality and the risk of impact on a particular group of patients. The most common is the description of risks assessment processes for compounded parenteral solutions with the different approaches by using FMECA method [25][26][27][28][29][30], due to the seriousness of consequences of possible deviations in their quality parameters.…”

“…The most popular among them is the failure modes, effects, and criticality analysis method (FMECA) [23,26,31]. As it is commonly used for the risks for the quality of CM [25][26][27][28][29][30]32] evaluation, it was also used in our work. Common research design is listed below (Figure 1).…”

Comparative Study of K-Means Clustering and a Novel Ranking Algorithm for Risk Priority Number Analysis in FMECA

“…append triplet [i (priority rank), p (failure mode), q (criterion index)] to priority ranking list L. 24: end while 25: return the priority ranking list L. Singh et al, 2019;Khorshidi et al, 2016;Catelani et al, 2021;Zhai et al, 2021;Catelani et al, 2011;Yssaad et al, 2012;Khalil et al, 2014;Saraswati et al, 2014;El-Dogdog et al, 2016;Silva et al, 2020;Bezerra et al, 2020;Scriboni, 2020;Royer et al, 2020;Pancholi & Bhatt, 2017;Dumnić et al, 2020;Nursanti et al, 2018;Ciani et al, 2019;Tanjung et al, 2019;Mohanty et al, 2021). Each instance is identified by a specific failure mode.…”