Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia
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EID Laboratory, biorisk management, laboratory assessment, CWA15793
Abstract
Latar belakang: Laboratorium Badan Penelitian dan Pengembangan Kesehatan (Balitbangkes) ditunjuk sebagai laboratorium rujukan nasional dalam mendeteksi penyakit infeksi Emerging (EID) dan bertugas dalam mendeteksi pathogen infeksius serta berperan penting dalam sistem penanggulangan wabah. Laboratorium Balitbangkes harus menerapkan sistem manajemen biorisiko untuk mencegah terjadinya penyebaran penyakit yang bersumber dari laboratorium. Penerapan manajemen biorisk laboratorium yang terdiri dari biosafety dan biosecurity bertujuan untuk melindungi pekerja, lingkungan dan produk atau agen biologi. Penelitian ini bertujuan untuk menemukan kesenjangan terkait penerapan manajemen biorisk di Laboratorium Balitbangkes dengan standar.
Metode: Studi dilakukan oleh Asesor professional pada tahun 2015 dengan mewawancara penanggung jawab
Laboratorium BSL-3 (PJ BSL-3) dan Biosafety Officer (BSO) serta pemeriksaan dokumen. Pemilihan responden
berdasarkan jabatannya di laboratorium. Responden dipilih karena sebagai pelaksana teknis dan memiliki
informasi pelaksanaan biosafety dan biosecurity yang mendalam di laboratorium Balitbangkes. Pertanyaan
diadopsi berdasarkan CWA 15793: 2011, berisi 160 pertanyaan dari 16 elemen. Analisis skor diinterpretasikan
antara 0-2. Skor 0 memenuhi kesesuaian dengan standar dan skor 2 berarti tidak memenuhi standar.
Hasil: Studi ini menunjukan 3 dari 16 elemen, memiliki kesesuaian penuh dengan standar yaitu teknik mikrobiologi yang baik, alat pelindung diri serta peralatan dan pemeliharaan alat laboratorium. Elemen yang memiliki kesenjangan paling tinggi adalah keamanan dengan skor 1.16. Tidak ada elemen yang dinilai tidak memenuhi kesesuaian standar atau skor2.
Kesimpulan: Secara keseluruhan, Laboratorium Balitbangkes memiliki sistem manajemen biorisiko yang kuat
dan sudah mapan disetiap elemen. Namun, tindakan perbaikan harus segera dilakukan di beberapa elemen untuk memenuhi standard CWA 15793:2011. (Health Science Journal of Indonesia 2018;9(2):70-5)
Kata kunci: EID Laboratory, biorisk management, laboratory assessment, CWA15793
Abstract
Background: NIHRD laboratory was appointed as a national referral laboratory to perform laboratory detection
for emerging infectious disease (EID). Because of its important role, NIHRD laboratory must implement biorisk
management system. A reliable high containment laboratory is crucial to perform laboratory diagnosis for
EIDs and to avoid further spread of EIDs. The protection of laboratory workers, environment, and biological
agents is achieved by addressing laboratory biorisk management consist of laboratory biosafety and biosecurity measures. This study aims to find gaps related the implementation of biorisk management with standard.
Methods: This study was carried out by Professional Assessor in 2015 by conducting document checking and
interviewing BSL-3 Technical Managers and BSO who were considered to have in-depth information regarding
biosafety and biosecurity activities in NIHRD laboratory. Questionnaire developed based on CWA 15793:2011,
which contain 160 questions provided from 16 elements of the standard. Analysis of the scores was interpreted
between ranges of 0-2. Score 0 means full conformity and score 2 means doesn’t meet the required standard.
Results: The study showed that only 3 out of 16 elements have full conformity with the standard. They
were good microbiological technique, clothing and personal protective equipment, laboratory equipment
and maintenance. The highest gap was in security elements with the score: 1.16. No elements has a noncompliance with the standard or score 2.
Conclusion: Overall the NIHRD laboratory has a strong biorisk management system already established
which is working well in many areas. However, important action is needed in several elements in order to
comply with the standard. (Health Science Journal of Indonesia 2018;9(2):70-5)
Keywords: EID Laboratory, biorisk management, laboratory assessment, CWA15793.
Full text article
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