Sistem pelaporan insiden keselamatan pasien merupakan elemen penting dalam upaya mitigasi risiko yang dapat dicegah dalam layanan kesehatan. RSUPN dr. Cipto Mangunkusumo (RSCM) telah menerapkan pelaporan insiden melalui metode manual dan elektronik (e-Report), namun implementasinya belum optimal. Penelitian ini bertujuan mengevaluasi implementasi sistem pelaporan insiden di RSCM dengan pendekatan kualitatif, menggunakan kerangka Donabedian (struktur–proses–hasil) dan strategi perbaikan berbasis Plan–Do–Study–Act (PDSA). Hasil menunjukkan bahwa sistem e-Report belum memenuhi kebutuhan pengguna karena antarmuka tidak intuitif dan tidak tersedianya fitur pelacakan, notifikasi, serta umpan balik. Fragmentasi kanal pelaporan, dominasi laporan manual, serta persepsi bahwa pelaporan adalah beban administratif turut memperlemah budaya pelaporan. Di samping itu, proses tindak lanjut insiden dinilai tidak transparan dan jarang dikomunikasikan kepada pelapor, sehingga menurunkan kepercayaan terhadap efektivitas sistem. Temuan ini menjadi dasar penyusunan rekomendasi pengembangan sistem pelaporan yang terpusat, mudah digunakan, dan didukung pelatihan berbasis unit serta kebijakan pelaporan satu pintu. Pendekatan PDSA digunakan untuk merancang strategi perbaikan sistem yang lebih responsif dan berkelanjutan dalam rangka mendukung peningkatan mutu layanan dan keselamatan pasien.

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The patient safety incident reporting system is a critical component in mitigating preventable risks within healthcare services. Dr. Cipto Mangunkusumo National General Hospital (RSCM) has implemented both manual and electronic (e-Report) methods for reporting incidents. However, its implementation remains suboptimal. This study aims to evaluate the implementation of the incident reporting system at RSCM using a qualitative approach, guided by the Donabedian framework (structure–process–outcome) and the Plan–Do–Study–Act (PDSA) improvement cycle. The findings reveal that the current e-Report system does not sufficiently meet user needs due to an unintuitive interface and the absence of key functionalities such as report tracking, automated notifications, and feedback mechanisms. Additionally, fragmented reporting channels, a predominance of manual submissions, and the perception of reporting as a bureaucratic burden have contributed to a weakened safety culture. The follow-up process is also perceived as lacking transparency and is rarely communicated back to reporters, further reducing trust in the system. These challenges form the basis for recommendations to develop a centralized, user-friendly, and integrated reporting system, supported by unit-based training and a single-channel reporting policy. The PDSA cycle is applied as a strategic framework to design a more responsive and sustainable system that enhances both service quality and patient safety at RSCM.