Assessing operational readiness for plasma fractionation within Indonesia’s National Transfusion Medicine System: a cross-sectional mixed-methods study

Abstract

Background - Plasma-derived medicinal products (PDMPs) such as albumin, immunoglobulins, and clotting factors are essential in treating life-threatening conditions. Indonesia lacks local plasma fractionation capacity and relies heavily on imports, leading to high costs and financial strain on the National Health Insurance. Developing national plasma production capacity is vital for pharmaceutical independence and health system resilience.

This study assessed the readiness of regional blood centers and hospital blood center in Indonesia as potential suppliers of plasma raw material for domestic PDMP production and identified logistical and governance challenges in the existing system.

Materials and methods - A cross-sectional mixed-methods study was conducted in five institutions ‒four regional blood centers and one hospital blood center‒ across Java. Readiness was evaluated across three domains: preparation, inventory, and transportation. Instruments were adapted from WHO, LIAT, and LSAT guidelines, with expert-validated content. Content validity was ensured through expert panel review involving WHO and national regulatory representatives, and reliability was measured using the Kuder-Richardson Formula 20 (KR-20). Quantitative data were analyzed descriptively using Kruskal-Wallis and Dunn’s tests, while qualitative data were thematically analyzed.

Results - The overall KR-20 was 0.821, indicating strong reliability (Preparation=0.801; Inventory=1.00; Transportation=0.856). No significant inter-institutional differences were observed (p=0.406), suggesting uniformly high readiness. Bias testing confirmed consistent scoring patterns.

Discussion - This study provides a structured baseline assessment of Indonesia’s readiness to support domestic PDMP production, revealing strong preparedness across key operational domains. While readiness does not yet translate to full production capacity, these findings establish an evidence-based foundation for future implementation, investment planning, and governance reforms toward a sustainable and transparent plasma supply chain.