Chapter 26

BIOSAFETY

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Work Process E. Assessment and Improvement

The fifth core function of Integrated Safety Management (ISM) requires that feedback and continuous improvement are incorporated into the work cycle for activities that involve work with biological materials or exposure to biological materials. This function is accomplished when supervisors, work leads, PIs, line management, EHS, and others assess and continuously improve the biosafety of work conducted at Berkeley Lab.

Established assessment and continuous improvement systems are used at Berkeley Lab and incorporated into the Biosafety Program to assess ISM implementation and effectiveness, identify improvement opportunities, and implement appropriate improvement strategies. The Berkeley Lab assessment and improvement requirements and systems are defined in institutional and ES&H assurance systems documents.

This section provides an overview of how assessment and improvement are incorporated into work with biological materials and the Biosafety Program. These are based primarily on the Berkeley Lab’s Environment/Health/Safety/Security Assurance Systems Manual. Berkeley Lab uses the self-assessment process to ensure that ISM is fully implemented and effective at all levels of Laboratory activities and operations. Two self-assessment programs are described in this section: Division Self-Assessments and Program Self-Assessments (PSAs). Two other self-assessments, Division ES&H Peer Reviews and DOE/UC annual contract performance measures, are mentioned briefly below.

1.     Division Self-Assessments

The Division Self-Assessment Program requires each Berkeley Lab division to evaluate how well the division is maintaining an Integrated Safety Management System (ISMS) in its operations and work activities. Each division manages a Division Self-Assessment Program as part of the Berkeley Lab Self-Assessment Program. The Division Self-Assessment Program includes performance criteria related to the ISM plan, goals and opportunities identified by the division, and annual institutional division ES&H self-assessment performance measures. Requirements for the Division Self-Assessment Program are described in the Division ES&H Self-Assessment Manual (PUB-3105).

Division self-assessments include biosafety as one aspect of ES&H that needs to be managed and assessed. These assessments include, for example, regular safety walkarounds, annual formal inspections of all operations and workspaces, tracking and analysis of deficiencies, lessons learned, and conformance with formal authorizations such as BUAs.

2.    Program Self-Assessments

The EHS Division manages Program Self-Assessments as one component of Berkeley Lab assurance systems. Program Self-Assessments evaluate ES&H programs and processes Laboratory-wide to ensure they comply with guiding regulations, are effective, and are properly implemented by Laboratory divisions. Requirements for Program Self-Assessments are described in the Environment/Health/Safety/Security Assurance Systems Manual.

The EHS Division conducts periodic assessments of biosafety program elements as defined in the program self-assessment plans. Plans that are applicable to the Biosafety Program are listed in Table 11.

Table 11 Biosafety-related Program Self-Assessments

Program Self-Assessment

EHS Group

Examples of Assessed Biosafety Program Elements

Biosafety

Health & Safety

Field assessments of operations that have Biosafety Work Authorizations. Data review including biosafety training, biosafety authorization renewals, and biosafety cabinet certifications

Ventilation

Health & Safety

Random sampling of hood and biosafety cabinet condition, performance, installation, and compliance with internal survey or certification requirements

Medical/ Biohazardous Waste

Waste Management

Periodic compliance inspections of medical and biohazardous waste generation areas using inspection forms. Documentation and data review including waste-generator registration, biosafety authorizations, and medical/biohazardous waste training to monitor issues related to medical or biohazardous waste.

In general, Program Self-Assessments determine whether the ES&H program (e.g., the Berkeley Lab Biosafety Program) under evaluation is compliant and effective, operations (e.g., work authorizations) and divisions are compliant, corrective actions and lessons learned are implemented and effective, and opportunities for improvement in the Berkeley Lab ES&H program or process are available. Inspections, data reviews, and document reviews are performed as part of the Program Self-Assessment. Data reviews include issues documented in the Corrective Action Tracking System (CATS), injuries or illnesses in the Comprehensive Environment, Health, and Safety System (CHESS) system, items in the Lessons Learned and Best Practices Database, and occurrence reports in the Occurrence Reporting and Processing System (ORPS). This assessment also reports any needed corrective action to the responsible management chain responsible for entering actions into CATS.

3.    Other Environment, Safety, and Health Self-Assessment Programs

Berkeley Lab uses two other types of ES&H self-assessments: Division ES&H Peer Reviews and annual DOE/UC Contract ES&H performance measures. Peer reviews are management-level peer reviews focused on how well division managers implement the division’s ISM plan. Contract performance assessments evaluate performance against annual goals, objectives, measures, and targets for ES&H. These two types of assessments provide broad ISM support to the Berkeley Lab Biosafety Program.

Supervisors, work leads, and PIs must:

Supervisors, work leads, and PIs may use the following key resources to assess the biosafety and compliance of their operations:

 

 

 

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