Laboratory of Molecular Pharmacology, Department of Pharmacy, School of Health Sciences, University of Patras, Patras, Greece.
Department of Pediatrics, School of Medicine, University of Patras, University Hospital of Patras, Patras, Greece.
JPEN J Parenter Enteral Nutr. 2020 Jul;44(5):928-939. doi: 10.1002/jpen.1787. Epub 2020 Feb 6.
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.
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.
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%.
Improvement of the PN production process through risk-analysis methodologies enhances safety for premature neonates.
肠外营养（PN）与可能威胁住院于新生儿重症监护病房的早产儿临床状况的风险相关。在这项工作中，实施了风险分析方法学，以控制与 PN 生产过程相关的风险，提高 PN 的安全性。
由多学科团队进行失效模式、影响和临界性分析。记录了 PN 准备过程中所有潜在的失效模式，并根据其严重程度、发生频率和可检测性对相关风险进行评分，得到风险优先数（RPN）。对所有识别出的失效场景和相应的工作阶段按严重程度降序排列。针对关键问题提出了纠正措施，并以相同的方法前瞻性地重新评估过程的安全性。
PN 成分计算（手动：RPN=530；电子：RPN=478）、PN 医嘱表完成（RPN=354）、PN 添加剂的手动混合（RPN=258）和 PN 准备单元的结构/组织/维护（RPN=133）的 RPN 评分最高。PN 添加剂的质量和安全性可能受到许多关键因素的影响，例如单位内颗粒微生物负荷增加以及参与的卫生专业人员培训/经验不足，且他们未遵守给定的说明。预计实施建议的纠正措施将使整个 PN 生产过程的风险降低 67.5%。
通过风险分析方法学改进 PN 生产过程可提高早产儿的安全性。
