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Uncertified Facility (BSL 2 plus): Its Journey through Life for Preparations and Setting up, Compliance with Biosafety Regulations, Implementation, and Registration of the Facility with the Ministry of Health, Singapore
Korean J Clin Lab Sci 2021;53:199-200  
Published on June 30, 2021
Copyright © 2021 Korean Society for Clinical Laboratory Science.

Tin Tun, Xander Sim

Department of Research & Development, Cell ID Private Company Limited, Singapore, Singapore
Correspondence to: Tin Tun
Department of Research & Development, Cell ID Private Company Limited, 3 Gambas Crescent, Nordcom One, #09-02/03/04/05/07/08/09, Singapore 757088, Singapore
E-mail: tintun64@gmail.com
ORCID: https://orcid.org/0000-0002-7841-7645
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Body

https://doi.org/10.15324/kjcls.2021.53.1.68

The following Erratum are to address inaccurate statements in the paper which could mislead readers and to clarify the BATA’s requirements.

The corrections have been made in PDF manuscript.

Position in the paper Original wording To replace with
Page: 69; Section: Introduction; Part 1: The BATA; Table 1; Schedule 1 (Part II); Column 3 “(Uncertified facility and protected place can appeal)” “(Appeal for an approval to possess Schedule 1 Part II biological agents in a facility not designated as a Protected Place is not allowed. However, in light of the COVID-19 pandemic situation, a general exemption was granted for SARS-CoV-2 through a government gazetted Subsidiary Legislation.)”
Page: 69; Section: Introduction; Part 1: The BATA; Table 1; Schedule 2; Column 3 “Certified BSL3 and protected place with special approval granted by the director (medical services)” “Certified BSL4 and protected place with special approval granted by the Director (Medical services)”
Page: 69; Section: Introduction; Part 1: The BATA; Table 1; Schedule 3; Column 2 “Can cause serious human or animal disease but unlikely to be a serious hazard” “Can cause human or animal disease but unlikely to be a serious hazard to laboratory workers, the community or the environment”
Page: 69; Section: Introduction; Part 1: The BATA; Table 1; Schedule 4; Column 2 “Low or no individual and community risk” “Low individual and community risk”
Page: 69; Section: Introduction;
Part 1: The BATA; Table 1;
Schedule 4; Column 3
“Conditions of the permit granted
by the director (medical services)”
(Not applicable, to be deleted)
Page: 69; Section: Introduction;
Part 1: The BATA; Table 1;
Schedule 5; Column 3
“Protected palace” “Protected place”
Page: 70; Section: Introduction; Part 2: Legislation requirements, guidelines and circulars; Paragraph 1 “However the MOH issues the interim biosafety guidelines for research laboratories and diagnostic laboratories and personnel handling samples or materials associated with the inactivated schedule 1 biological agents.” “MOH may issue Interim guidelines for research laboratories and diagnostic laboratories, especially in the event of an emerging infectious disease with uncertain risk profile. An interim guideline was issued for SARS-CoV-2, and in the past, for MERS-CoV and H1N1 virus when they were first emerged.
Page: 70; Section: Introduction; Part 2: Legislation requirements, guidelines and circulars; Paragraph 3 “Ensuring that appropriate biosafety procedures and practices are in place and that research activities are carried out in a safe manner, research facilities can make an appeal for exemption from BATA control for their non-diagnostic activities involving inactivated schedule 1 biological agents.” “Ensuring that appropriate biosafety procedures and practices are in place and that research activities are carried out in a safe manner, research facilities can use truly inactivated Schedule biological agents.”
Page: 70; Section: Introduction; Part 2: Legislation requirements, guidelines and circulars; Paragraph 3 “Having thorough reviews of the application the MOH will approve to handle inactivated First Schedule biological agents in a BSL2” To delete.
Page: 72; Section: Introduction; Part 2: Legislation requirements, guidelines and circulars; Table 2: Title “Precautions and requirements regarding safe use of COVID-19 samples associated with SARS-CoV-2 virus extracted from the MOH Interim Guidelines (MOH Circular 17/2020)” “Precautions and requirements regarding safe use of COVID-19 samples associated with SARS-CoV-2 virus for diagnostic purposes as extracted from the MOH Interim Guidelines (MOH Circular 17/2020)”
Page: 76; Section: Materials and Methods; Part 10: Emergency responses; Paragraph 2 “In case of laboratory acquired infection (LAI) and that the scheduled biological agents were involved the MOH is reported within one week.” “Cases of laboratory acquired infection (LAI) involving scheduled biological agents shall be reported to MOH as soon as possible.”
Page: 76; Section: Results; Part 1: Appeal for exemption from the BATA; Paragraph 1 “Having organized all preparations, an appeal application for the possession and use of First Schedule biological agents to be exempted from the BATA is submitted to the MOH Biosafety” “Having organized all preparations, an appeal application for approval to possess a First Schedule biological agent (HIV) in an uncertified facility was submitted to the MOH Biosafety Branch.”
Page: 78; Section: Results; Part 4: Registration and approvals; Paragraph 2 “Thus, to handle and possess a First or Fifth Schedule biological agents or toxins is valid in our research laboratory,” “Thus, research work involving HIV in our laboratory is limited to activities proposed in the application and the approval to possess granted.”
Page: 79; Section: Results; Part 5: Documentation; Paragraph 2 “All documents, records, the IBC meeting minutes, accident/incident reports, permits, approvals and inventory records which are related to the BATA First and Fifth schedule biological agents and toxins such as HIV1/2 or COVID-19 virus need to be retained for at least 3 years or as per required duration.” “All documents, records, the IBC meeting minutes, accident/incident reports, permits, approvals and inventory records which are related to the BATA First Scheduled Part I biological agent applicable in the approval granted to the laboratory must be retained for at least 5 years or 3 years after the facility is deregistered.”
Page: 79; Section: Discussion; Paragraph 1 “On the other hand, the guilty offender shall be liable on conviction to a fine of up to one million Singapore dollars or to imprisonment for a term which may extend to life imprisonment or to both [2].“ “On the other hand, offenders convicted under the BATA shall be liable to a fine of up to one million Singapore dollars or to imprisonment for a term which may extend to life imprisonment or both, depending on the type of offence committed [2].”

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