Use a FMECA (failure modes, effects, and criticality analysis) multidisciplinary on the paediatric parenteral nutrition process

M. Royer1, M. Dufosse1, J. Lefebvre1, M. Libessart1, J-M. Dubaele1, E. Vincent2, F. Moreau2, P. Tourneux2, F. Marçon1 1 : Hospital Pharmacy, CHU Amiens, France
2 : Neonatal and Paediatric Intensive Care Unit, CHU Amiens, France

Aims and objectives
Parenteral nutrition (PN) in neonatal intensive care units (NICU) involves a succession of risky processes (e.g. prescribing, manufacturing, administration) involving different actors (physicians, pharmacists, nurses, preparers) with different levels of training. The objective of this study was to identify and prioritise the risks associated with PN in order to improve the quality of the circuit.

A failure modes, effects, and criticality analysis (FMECA) was used to determine the potential failure modes (FM) of the PN process, whether for prescriptions, manufacturing or administration. A multidisciplinary team conducted a functional analysis of the processes and then listed the FM. Their criticality was assessed with a score scale of 1 to 5 for occurrence (O), severity (S) and detection (D). The Risk Priority Number (RPN), ranging from 1 to 125, was calculated using the formula RPN=SxOxD and using the median scores obtained.

The FMECA was completed between March and August 2018 and identified 99 FM into prescription (n=28), manufacturing (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>21.75.
Among the RPN in the last quartile: 12 were associated with a prescription FM (e.g. prescription of NP requiring manufacture in the NICU (RPN=48); no senior supervising the prescription (RPN=36); inadequacy of the prescription in relation to ESPGHAN recommendations (RPN=36) and masked sodium intakes not taken into account during the prescription (RPN=32); 5 were associated with FM in relation to manufacturing (e.g. inability to assess nutritional needs by pharmacist (RPN=48), lack of training in pharmaceutical validation (RPN=36), lack of pharmaceutical validation prior to production (RPN=36) and receipt of multiple prescriptions for the same patient (RPN=27); 8 were associated with an FM related to administration (risk of septic contamination during manufacturing in the NICU (RPN=42), during Y supplementation (RPN=36) or during handling (RPN=31.5), delayed PN hospital preparation administration due to low flow (RPN=30) and high osmolarity for peripheral access (RPN=27)).

The FMECA identified 99 FM. Of these, 25 were prioritised to propose corrective measures. This multidisciplinary approach has facilitated the development of processes that allow a more accurate assessment of preventability with all the actors involved in the nutritional care of the patient. As raised by this study a critical role may be played by the clinical pharmacist in a care unit to secure the prescription and the administration of PN admixture.

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