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Title: MANAGEMENT PRE-START REVIEW FINAL REPORT FOR THE BIOSAFETY LEVEL 3 (BSL-3) FACILITY (B368) LAWRENCE LIVERMORE NATIONAL LABORATORY

Abstract

A Lawrence Livermore National Laboratory (LLNL) Management Pre-Start Review (MPR) Team was formed to independently verify the operational readiness of Building 368 (B368) Biosafety Level III (BSL-3) Facility to conduct research with biological pathogens and toxins including those considered Select Agents. Review objectives and criteria were developed from the DOE/NNSA and LLNL requirements. These were provided in the Implementation Plan for the Biosafety Level III (BSL-3) Facility Management Pre-Start Review (BSL-3 MPR) at Lawrence Livermore National Laboratory that was reviewed and approved by DOE/NNSA-LSO. The formal part of the LLNL MPR for the BSL-3 Facility was begun in August of 2005 but work on the MPR was stopped in October of 2005 due to the need for LLNL to reassess organizational and operational controls and respond to Centers for Disease Control and Prevention inquiries related to a shipping incident involving select agents. The MPR was restarted in mid-June of 2006. Preliminary facility tours and familiarization with project documents took place in June of 2005. The Independent Management Review Team consists of seven members led by a Team Leader with expertise in management, operations, and safety basis experience with biosafety laboratories. Other team members have expertise in electrical engineering, security, environmental/wastemore » management/regulatory compliance, biosafety/industrial hygiene/medical, structural engineering, and mechanical engineering. The MPR Team reviewed various documents, including authorization basis, safety, emergency preparedness, and various operations, configuration, and management plans. They also reviewed building plans, equipment repair/maintenance documents, training records, and many standard operating procedures. The MPR resulted in three Pre-Start Findings, one Post-Start/Critical Finding, and four observations which are shown on Tables 1, 2, and 3, respectively. Based upon this review the Team feels that the B368 Facility can be operated safely provided the Pre-Start Findings are satisfactorily closed. The Team therefore seen no reason not to expeditiously proceed towards the startup of this facility in accordance with the processes defined in DOE Order 425.1C, and the LLNL ES&H Manual. Details of the MPR Team evaluations of the various Subject (functional) Areas of the review are contained in the completed MPR Assessment Forms in Appendix A. Findings are described in completed MPR Deficiency Forms in Appendix B. The format of these forms is consistent with DOE-STD-3006.« less

Authors:
; ; ; ; ; ;
Publication Date:
Research Org.:
Lawrence Livermore National Lab. (LLNL), Livermore, CA (United States)
Sponsoring Org.:
USDOE
OSTI Identifier:
898446
Report Number(s):
UCRL-TR-223233
TRN: US200708%%99
DOE Contract Number:  
W-7405-ENG-48
Resource Type:
Technical Report
Country of Publication:
United States
Language:
English
Subject:
59 BASIC BIOLOGICAL SCIENCES; COMPLIANCE; CONFIGURATION; DISEASES; ELECTRICAL ENGINEERING; IMPLEMENTATION; LAWRENCE LIVERMORE NATIONAL LABORATORY; MANAGEMENT; MECHANICAL ENGINEERING; PATHOGENS; SAFETY; SECURITY; TOXINS; TRAINING

Citation Formats

Hull, R, O'brien, J, Owens, T, Salvo, V, Sassone, D, Tuholski, S J, and Tsan, S. MANAGEMENT PRE-START REVIEW FINAL REPORT FOR THE BIOSAFETY LEVEL 3 (BSL-3) FACILITY (B368) LAWRENCE LIVERMORE NATIONAL LABORATORY. United States: N. p., 2006. Web. doi:10.2172/898446.
Hull, R, O'brien, J, Owens, T, Salvo, V, Sassone, D, Tuholski, S J, & Tsan, S. MANAGEMENT PRE-START REVIEW FINAL REPORT FOR THE BIOSAFETY LEVEL 3 (BSL-3) FACILITY (B368) LAWRENCE LIVERMORE NATIONAL LABORATORY. United States. https://doi.org/10.2172/898446
Hull, R, O'brien, J, Owens, T, Salvo, V, Sassone, D, Tuholski, S J, and Tsan, S. 2006. "MANAGEMENT PRE-START REVIEW FINAL REPORT FOR THE BIOSAFETY LEVEL 3 (BSL-3) FACILITY (B368) LAWRENCE LIVERMORE NATIONAL LABORATORY". United States. https://doi.org/10.2172/898446. https://www.osti.gov/servlets/purl/898446.
@article{osti_898446,
title = {MANAGEMENT PRE-START REVIEW FINAL REPORT FOR THE BIOSAFETY LEVEL 3 (BSL-3) FACILITY (B368) LAWRENCE LIVERMORE NATIONAL LABORATORY},
author = {Hull, R and O'brien, J and Owens, T and Salvo, V and Sassone, D and Tuholski, S J and Tsan, S},
abstractNote = {A Lawrence Livermore National Laboratory (LLNL) Management Pre-Start Review (MPR) Team was formed to independently verify the operational readiness of Building 368 (B368) Biosafety Level III (BSL-3) Facility to conduct research with biological pathogens and toxins including those considered Select Agents. Review objectives and criteria were developed from the DOE/NNSA and LLNL requirements. These were provided in the Implementation Plan for the Biosafety Level III (BSL-3) Facility Management Pre-Start Review (BSL-3 MPR) at Lawrence Livermore National Laboratory that was reviewed and approved by DOE/NNSA-LSO. The formal part of the LLNL MPR for the BSL-3 Facility was begun in August of 2005 but work on the MPR was stopped in October of 2005 due to the need for LLNL to reassess organizational and operational controls and respond to Centers for Disease Control and Prevention inquiries related to a shipping incident involving select agents. The MPR was restarted in mid-June of 2006. Preliminary facility tours and familiarization with project documents took place in June of 2005. The Independent Management Review Team consists of seven members led by a Team Leader with expertise in management, operations, and safety basis experience with biosafety laboratories. Other team members have expertise in electrical engineering, security, environmental/waste management/regulatory compliance, biosafety/industrial hygiene/medical, structural engineering, and mechanical engineering. The MPR Team reviewed various documents, including authorization basis, safety, emergency preparedness, and various operations, configuration, and management plans. They also reviewed building plans, equipment repair/maintenance documents, training records, and many standard operating procedures. The MPR resulted in three Pre-Start Findings, one Post-Start/Critical Finding, and four observations which are shown on Tables 1, 2, and 3, respectively. Based upon this review the Team feels that the B368 Facility can be operated safely provided the Pre-Start Findings are satisfactorily closed. The Team therefore seen no reason not to expeditiously proceed towards the startup of this facility in accordance with the processes defined in DOE Order 425.1C, and the LLNL ES&H Manual. Details of the MPR Team evaluations of the various Subject (functional) Areas of the review are contained in the completed MPR Assessment Forms in Appendix A. Findings are described in completed MPR Deficiency Forms in Appendix B. The format of these forms is consistent with DOE-STD-3006.},
doi = {10.2172/898446},
url = {https://www.osti.gov/biblio/898446}, journal = {},
number = ,
volume = ,
place = {United States},
year = {Tue Jul 25 00:00:00 EDT 2006},
month = {Tue Jul 25 00:00:00 EDT 2006}
}