ABSTRAK
Kementerian kesehatan bertugas dalam penyelenggaraan urusan pemerintahan di bidang kesehatan. Upaya kesehatan didukung oleh sumber daya di bidang kesehatan meliputi perbekalan sediaan farmasi, alat kesehatan, dan perbekalan kesehatan lainnya termasuk perbekalan kesehatan rumah tangga PKRT . Pengawasan dan penetapan regulasi terkait penjaminan mutu sumber daya di bidang kesehatan dilakukan oleh personil yang memiliki kompetensi di bidangnya yaitu tenaga kesehatan, termasuk Apoteker. Praktik kerja profesi dilaksanakan di Direktorat Jenderal Kefarmasian dan Alat Kesehatan selama dua pekan, bertujuan untuk mengetahui struktur organisasi dan memahami tugas pokok, fungsi, tanggung jawab apoteker, serta mendapat gambaran nyata tentang permasalahan kefarmasian di di Direktorat Jenderal Kefarmasian dan Alat Kesehatan Kementerian Kesehatan RI, khususnya di Direktorat Pengawasan Alat Kesehatan dan PKRT. Salah satu permasalahan yang ditemukan yaitu kasus hasil negatif palsu pada penggunaan alat kesehatan diagnostik in vitro Rapid Test HIV. Oleh karena itu, dilakukan analisis akar penyebab masalah terkait kasus tersebut sebagai tugas khusus selama praktik kerja profesi di instansi pemerintah. Analisis dilakukan dengan melakukan tinjauan pustaka dan diskusi dengan personil dari Direktorat Pengawasan Alat Kesehatan dan PKRT. Hasil analisis disimpulkan bahwa akar penyebab masalah yang paling dominan yaitu kondisi saat pendistribusian alat kesehatan yang tidak terkontrol dan kurangnya kemampuan penelusuran penanganan produk dalam rantai distribusi alat kesehatan.

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ABSTRACT
The Ministry of Health is in charge of administering governmental affairs in the health sector. Health promotions are supported by health resources including pharmaceutical supplies, medical devices and other health supplies including household health supplies perbekalan kesehatan rumah tangga/PKRT . Supervision and stipulation of regulation related to quality assurance of health resources is performed by competent health personnel, including pharmacist. This internship held in Directorate General of Pharmaceutical and Medical Devices for two weeks was aimed to get a knowledge about the organizational structure and to understand the main tasks, functions, pharmacist responsibilities, and get a real picture about the pharmaceutical issues in the Directorate General of Pharmaceutical and Medical Devices of the Ministry of Health, especially in the Directorate of Medical Devices and Household Health Supplies Monitoring. One of the problems found was the case of false-negative results on the use of in vitro diagnostic medical device Rapid Test HIV. Therefore, the root causes analysis related to the case was conducted as a specific assignment during phamacists internship in government institute. The analysis was conducted by doing literature reviews and discussions with personnel from the Directorate of Medical Device Monitoring and PKRT. The result of the analysis concluded that the dominant root cause of the case is the uncontrolled distribution condition of medical devices and lack of traceability in medical devices product handling during distribution chain.