Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia

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. Laborator...

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Main Authors: Ida Susanti, Ni Ketut Susilarini, Vivi Setiawaty
Format: Article
Language:English
Published: Badan Penelitian dan Pengembangan Kesehatan 2018-12-01
Series:Health Science Journal of Indonesia
Subjects:
Online Access:https://ejournal2.litbang.kemkes.go.id/index.php/hsji/article/view/811
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author Ida Susanti
Ni Ketut Susilarini
Vivi Setiawaty
author_facet Ida Susanti
Ni Ketut Susilarini
Vivi Setiawaty
author_sort Ida Susanti
collection DOAJ
description 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.
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spelling doaj.art-ebfcdc24cc5c4f5cb0733b81c05fef252022-12-21T22:00:30ZengBadan Penelitian dan Pengembangan KesehatanHealth Science Journal of Indonesia2087-70212338-34372018-12-0192707510.22435/hsji.v9i2.811811Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in IndonesiaIda SusantiNi Ketut SusilariniVivi SetiawatyLatar 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.https://ejournal2.litbang.kemkes.go.id/index.php/hsji/article/view/811eid laboratorybiorisk managementlaboratory assessmentcwa15793
spellingShingle Ida Susanti
Ni Ketut Susilarini
Vivi Setiawaty
Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia
Health Science Journal of Indonesia
eid laboratory
biorisk management
laboratory assessment
cwa15793
title Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia
title_full Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia
title_fullStr Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia
title_full_unstemmed Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia
title_short Assessment of biorisk management implementation in NIHRD laboratory as national referral laboratory of emerging infectious diseases in Indonesia
title_sort assessment of biorisk management implementation in nihrd laboratory as national referral laboratory of emerging infectious diseases in indonesia
topic eid laboratory
biorisk management
laboratory assessment
cwa15793
url https://ejournal2.litbang.kemkes.go.id/index.php/hsji/article/view/811
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AT niketutsusilarini assessmentofbioriskmanagementimplementationinnihrdlaboratoryasnationalreferrallaboratoryofemerginginfectiousdiseasesinindonesia
AT vivisetiawaty assessmentofbioriskmanagementimplementationinnihrdlaboratoryasnationalreferrallaboratoryofemerginginfectiousdiseasesinindonesia