Parenteral Nutrition Preparation Procedure: A Hazard Analysis and Critical Control Points Approach at a Pediatric Hospital in Vietnam

Abstract

Background: Hazard analysis and critical control points (HACCP) is a tool for food safety assurance, but the application of HACCP in healthcare facilities in Vietnam has been understudied and underregulated given a lack of governmental guidelines. This study aimed to explore the hazards and determine the critical control points related to the parenteral nutrition (PN) preparation procedures in a pediatric hospital in Vietnam. Methods: A cross-sectional study was conducted at Children Hospital No. 2 in Ho Chi Minh City, Vietnam, from July to September 2019. The study subjects were eleven standard operating procedures for preparation of a PN product called Vaminolact 6.5%. The hazards were explored based on the probability of occurrence, the severity of consequence, and the quantity of influenced individuals. Each step in the PN procedure was determined by multiplying the points of three standards. A step with a point equal to or higher than 18 was considered a hazard. The critical control point (CCP) was determined by following the five-question decision tree. Results: Eight hazards were explored via hazard analysis, including sanitation prior to compounding, measurement of basal solution, compounding, labeling, sanitation of preparation room, in-out control, air flow control, and primary filter system. Nine critical control points were determined as follows: sterilization by alcohol, glove change per every 10 vials, basal solution measurement, compounding, mini-spike change per every 10 vials, syringe change per every 10 vials, air flow control, primary filter system, and sterilization check-up. Conclusion: The hospital manager should consider this study as support for an evidence-based adjustment to improve PN preparation procedure.