Assessment and Optimization of the Pediatric Parenteral Nutrition Preparation Process in a Hospital Pharmacy.

ABSTRACT

BACKGROUND: Parenteral nutrition (PN) is associated with risks that could threaten the clinical condition of premature neonates hospitalized in the neonatal intensive care unit. In this work, risk-analysis methodology was implemented to contain the risks associated with the PN production process and improve PN safety. METHODS: The Failure Modes, Effects, and Criticality Analysis was performed by a multidisciplinary team. All potential failure modes of the PN preparation process were recorded, and associated risks were scored based on their severity, occurrence, and detectability, with a risk priority number (RPN). All identified failure scenarios and the respective work stages were ranked in descending order of criticality. Corrective actions were proposed to address critical points, and the safety of the process was reassessed by the same method in a prospective manner. RESULTS: The highest RPN scores were obtained with the PN composition calculation performed manually (RPN 530) or electronically (RPN 478), completion of the PN medical order form (RPN 354), manual compounding of PN admixtures (RPN 258), and the structure/organization/maintenance of the PN preparation unit (RPN 133). The quality and safety of PN admixtures could be compromised by many critical factors, such as the increased particle-microbial load in the unit and the inadequate training/experience of the involved health professionals and their incompliance with the given instructions. The implementation of the proposed corrective measures is expected to reduce the risks of the overall PN production process by 67.5%. CONCLUSIONS: Improvement of the PN production process through risk-analysis methodologies enhances safety for premature neonates.