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Integrated Safety Management (ISM) Plan

The Life Sciences Division will conduct its operations in a manner that protects the health and safety of its employees and affiliates, that does not endanger the environment, and that is consistent with applicable LBNL, University and government agency policies and regulations. LBNL's EH&S policies and requirements are contained in the LBNL Regulations and Procedures Manual (RPM), LBNL Publication 3000: The Health and Safety Manual, and in the LBNL Operating and Assurance Plan (OAP).

1.0 Scope of Plan

The Life Sciences Division has an annual budget of approximately $58.5M and has about 500 employees and affiliates. Most of the Division's research is performed by small research groups under the direction of a principal investigator. These groups are organized into departments and centers by the nature of their research interest. The Division's research is conducted in approximately 8 different buildings, including one on the UC Berkeley campus (Donner Laboratory) and one near the foot of Ashby Avenue in the city of Berkeley (a.k.a. Potter Street).  As of 2011, most of the Division’s operations are being consolidated at the Potter Street Facility. The Life Sciences Division website, including an organizational chart, can be found at http://www.lbl.gov/lsd/.

The size and geographic distribution of the Division means that effective safety management, with the full involvement of Division management, Safety Coordinators, Division Safety Committee, and the currently implemented program of safety leads are even more critical to safe work than they would be in a smaller and/or more compact division.

This Life Sciences Division Integrated Safety Management (ISM) Plan covers all Life Sciences Division workers, including employees, students, affiliates and visiting scholars, regardless of compensation or work location. LBNL work performed on the UC Berkeley campus must conform to the "Partnership Agreement Between UCB and LBNL Concerning Environment, Health and Safety Policy and Procedures." The Division currently has three research groups located in campus space (Kunxin Luo, Eva Nogales, and Abby Dernburg).

2.0 Scope of Work Authorized

The Life Sciences Division conducts research not limited to but primarily including cancer biology, molecular and nuclear medicine, radiation biology and DNA repair, subcellular structures, and genomics. Areas of expertise include genetics, biology and medicine, chemistry and pharmacology, radiation biophysics, as well as a number of other disciplines. The Division uses a broad range of generally low risk scientific devices and instruments including gel electrophoresis systems, scintillation counters, centrifuges, light and electron microscopes, and cell culture incubators. Relatively higher risk devices such as Class 3B and 4 lasers, X-ray sources, and the Biomedical Isotope Facility (BIF) are individually covered by Activity Hazard Documents (AHD's) or, as is the case with BIF, by the Final Safety Analysis Document (FSAD) and the Accelerator Safety Envelope document.

Research activities proposed in Field Task Proposals, Work for Others, and other funding venues are reviewed by the principal investigators for any increase in hazard, which would require additional safety controls and/or documentation (Chapter 6, Pub. 3000). Principal investigators have responsibility for the identification and mitigation of research activities which have potential hazards as described below.

Everyone who does work in the Life Sciences Division is a part of the Division's safety management chain. This chain links every staff member and participating affiliate, from the individual worker through each supervisor and mentor to senior management, including the Division Director.  Safety awareness and practice is a required work expectation of all Life Sciences Division staff. In this we must strive for research efficiency within the bounds of sound safety practice and common sense.

3.0 Roles, Responsibility and Accountability

Roles, responsibilities and accountability for personnel associated with LBNL are documented in PUB-3000, Chapter 1, General Policy and Responsibilities.  The Life Sciences Division adheres to all institutional requirements, including Chapter 1.  The following section defines key roles and responsibilities for implementing EH&S within the Division.

Division Director and Department Heads:
Responsibility and accountability for safety within the Division begins with the Division Director.  The Division Director, reporting directly to the LBNL Director, is ultimately responsible for the safety and compliance of all activities within the Life Sciences Division.  The Division Director, either directly or through her/his Deputy for Operations, performs the following tasks:

  1. Walks all Division lab space at least one time a year to perform a safety inspection (this responsibility cannot be delegated).
  2. Ensures safety performance is included in annual performance review.s
  3. Reviews and approves the annual Division Self Assessment Plan.
  4. Reviews and approves safety documentation for the most hazardous activities performed within the Division (i.e., Activity Hazard Documents, etc.).
  5. Reviews and approves any Occurrence Reports within the Division.
  6. Reviews and approves updates to the Division ISM Plan.

The Division Director also supports on-going safety efforts through a variety of channels such as safety incentive programs like the SPOT award program, through inclusion of safety as a permanent topic on Division leadership (LSDAC) meetings, through periodic “level-1” emails promoting safety, and through open communication with the Division’s safety personnel.

As part of each Department Head’s responsibilities and to reinforce safety leadership within the Division, Department Heads walk lab spaces under their purview at least one time per year to perform a safety inspection.

Principal Investigators:
Principal investigators are responsible and accountable directly to the Division Director for assuring that all activities under their direction are carried out in a safe manner, in accord with all LBNL EH&S policies and requirements. This responsibility and accountability cannot be delegated however supervisors and work leads play a critical role in the implementation of the safety program within the principal investigator’s laboratory.

Principal investigators are accountable for assuring the safety of their staff and operations, the protection of the environment, and compliance with EH&S requirements.  They must consult with qualified specialists (e.g. the Life Sciences Division Safety Coordinator, and/or EH&S Division) where needed, to acquire technically correct information about safety and environmental protection consistent with LBNL EH&S policy and regulatory requirements.

Some specific responsibilities of principal investigators include:

  1. Ensuring employees and affiliates have completed a Job Hazard Analysis and all institutional training classes.
  2. Ensuring employees and affiliates have completed any Division-specific training and any on-the-job training that is necessary to perform their work safely.
  3. Ensuring working conditions within the lab meet institutional and Division requirements through mechanisms such as periodic workspace inspections, discussion of safety topics at staff meetings, and cooperation with the Division’s safety staff to implement the institution’s safety programs.
  4. Ensuring subcontractors/vendors are properly managed through the subcontractor Job Hazard Analysis program before initiating work.
  5. Supporting implementation of the institutional safety programs within their lab.

Finally, principal investigators and laboratory managers are to advise the Division Safety Coordinator of plans to vacate space or relocate operations no less than two months in advance of such action. The purpose of this notification is to allow time for the disposal, cleanup and/or packaging of any radioactive or hazardous chemical materials. Such materials include unused items, items prepared for use, as well as items destined for disposal as waste.

Supervisors and Work Leads:
Supervisors are assigned through Human Resources, and work leads are assigned by supervisors.  The work lead is the individual who has sufficient experience to understand the hazards of the work and safe work methods and has visibility and oversight of the day to day operations of the lab.  In most cases, the work lead and the supervisor is the same person.

Supervisors and work leads are a critical part of the safety management continuum and are responsible to a principal investigator, a Department Head or to the Division Director.  Supervisors and work leads must be familiar with the hazards of activities under their management and the necessary safety controls and must ensure that all work performed within their areas of management are conducted in accordance with LBNL and Division safety policies and procedures.

The supervision of students is of particular concern. Students often arrive without prior laboratory experience, stay for short periods of time, and may have rapidly evolving job assignments. Supervisors of students must assure that each student receives appropriate training and close, daily supervision from staff who are present in the laboratory on a regular basis.

Responsibilities of the supervisor and work leads include:

  1. Review and approve employee’s scope of work, hazards, controls and training requirements (delegated to the work lead).
  2. Ensure work remains within the authorized scopes of work under their management.
  3. Provide necessary on–the-job training to ensure employees can work safely.
  4. Ensure employees are sufficiently qualified to work safely within their labs before allowing work without supervision.
  5. Respond to employee’s concerns (even if this is limited to directing the concerns to the Division safety staff or to the EH&S Division).
  6. Ensure implementation of the institutional safety programs within the lab.
  7. Participate in investigation, to the extent appropriate, of workplace injuries.
  8. Implement corrective actions for safety deficiencies raised through safety inspections, injuries, employee concerns, etc.
  9. Include safety performance as a consideration in performance reviews.

Employees and Affiliates:
While principal investigators and supervisors are responsible for assuring that EH&S requirements are followed by their subordinates and visitors, Life Sciences Division employees and affiliates are also individually responsible for following the EH&S requirements that pertain to the hazards of their work. Employees and affiliates are expected to work safely, follow institutional and Division safety requirements, watch out for the safety of others, and to cooperate with Life Sciences Division and LBNL EH&S efforts. 

Employees and affiliates are not to initiate work until authorized to do so, such as through the Job Hazard Analysis process and are not to work outside the boundaries of their authorized work.  If work will exceed the established boundary, employees must stop work and meet with their supervisor/work lead to expand their scope of authorized work before proceeding.

If employees or affiliates have any questions or concerns about the safety or environmental impact of an activity, they have the obligation to report unsafe operations to their supervisor or work lead, and, if necessary, to exercise LBNL's Stop Work policy for any “imminent danger” (http://www.lbl.gov/ehs/refs/stopwork.shtml), and to resolve the concern before proceeding with associated work.

Matrixed Employees:
The home division and host division of matrixed employees have complementary responsibilities for the employee’s safety.  The Life Sciences Division as the host division has the responsibility to provide a work environment free from recognized hazards, to ensure the employee’s work is authorized, and to ensure that the employee is adequately trained.  The home division must also ensure that the employee’s work is authorized appropriately and that the employee is adequately trained.  In the event of an injury, it is ultimately the home division that is responsible for the investigation however the Life Sciences Division will participate to the extent appropriate.

Subcontractors and Vendors:
All “hands-on” work performed by subcontractors or vendors as defined by LBNL must be reviewed through the Subcontractor Job Hazard Analysis (SJHA) program before work may begin.  Workers performing the hands-on work must complete all additional institution requirements including the pre-job meeting, General Employee Radiation Training (GERT) unless escorted by LBNL personnel, and any additional permits or safety documents required for the work.

The Division Safety Coordinator and Division Safety Officer, reporting directly to the Division Director, are mutually responsible for assisting with implementation of the LBNL safety programs within the Division.  The responsibilities of these individuals include:

  1. Conducting safety inspections of all Division spaces at least every 6 months.
  2. Entering safety deficiencies into the corrective action database (CATS).
  3. Leading the Division Safety Committee.
  4. Attending the Safety Advisory Committee and Safety Coordinators meetings.

They are also responsible for maintaining the Life Sciences Division Safety Plan on behalf of the Division Director, and assuring that the Division's ongoing program of self assessment is conducted in all Division spaces.

Wareham (Building Management for Potter Street):
Wareham is the building owner of the Potter Street facility.  Wareham has responsibility for maintenance of the building infrastructure and custodial services at Potter Street.  Wareham personnel are typically exempt from LBNL requirements.  One notable exception is radiation safety, under 10 CFR 835.  Wareham personnel may not enter RMAs without prior approval and escort from authorized LBNL employees.

Safety Leads:
To support the Life Sciences Division safety program and self assessment activities each Life Sciences Division principal investigator assigns a primary safety contact ("safety lead") for each of their Division laboratory spaces. These safety leads frequent these laboratories on a daily basis, are familiar with their processes and hazards, and serve as the point of contact for question regarding integrated safety management (ISM) and compliance.

Appointing a safety lead serves to spread a culture of safety more broadly throughout the workplace, however as the designated supervisor, the principal investigator retains direct line management responsibility for the safety of all employees, users and affiliates.

Division Safety Committee:
The Life Sciences Division Safety Committee consists of members of every major Division research group (approximately 20 representatives from the Life Sciences Division plus the Division Safety Coordinator, and Division Safety Officer, who is also the Division representative to the LBNL Safety Advisory Committee). These representatives include principal investigators and research staff, and serve the Division in promoting general EH&S awareness and practice.

The committee meets monthly, as necessary, except for December.  The agenda is determined prior to the meeting, and the meetings are an opportunity to discuss recent incidents or lessons learned, share developing or new safety requirements, discuss safety implementation within the Division, solicit feedback on safety, and discuss near misses or near hits. 

In addition, EH&S Division staff are included in the distribution of meeting announcements and minutes, and attend as their interest or expertise may suggest. The EH&S Division liaison for the Life Sciences Division regularly participates in these meeting.

Members of the Life Sciences Division Safety Committee serve as primary points-of-contact during self assessment activities and inspections. During such assessments, contact may also be made with the principal investigator, the Department Head, or the Life Sciences Division Directorate, on an as-needed and graded basis.

Division Safety Coordinator:
The Division Safety Coordinator is responsible for assisting with implementation of LBNL's EH&S policies and procedures within the Division.

4.0 Scope of Work, Hazard Assessment and Hazard Controls:

Defining the scope of work, assessing the hazards and identifying controls are the first three Core Functions of ISM.  The primary process to address each of these Core Functions is managed through the Job Hazard Analysis (JHAs) program and through other formal authorizations (e.g. SJHAs, BUAs, RWAs, XAs, AHDs, etc.) as applicable.   To complete these, the principal investigator, supervisor, or work lead reviews and documents the work to be performed, the hazards and preliminary controls.  At that point the information is reviewed and ultimately approved.  The review and approval of work may be limited to line management in the case of JHAs and low hazard SJHAs or it may involve an EH&S subject matter expert (i.e., BUAs, RWAs, high hazard SJHA work, etc.).  The Division Safety Coordinator or Division Safety Officer is available to assist with this process as requested by the Principal Investigator, supervisor or work lead.

In addition, the National Environmental Policy Act/California Environmental Quality Act (NEPA/CEQA) process requires that the principal investigator must sign off that no further documentation (copies with the Division Safety Coordinator) is required (or specify what is required) before a proposal may be submitted for funding.  Such documents may include Human and Animal Use, Radiation Work Authorizations, and Activity Hazard Documents.

In some situations, such as for ergonomic evaluations or chemical exposure assessments, a more detailed assessment will occur after work has been initiated.  Triggers for additional assessments vary, but include:

  1. Employee requests for ergonomic evaluations
  2. High hazard chemical usage (as defined by the EH&S Exposure Assessment procedures)
  3. Noisy operations

Additional controls may be implemented following these types of assessments, and as appropriate, the underlying safety documentation will be revised.  

5.0 Work Authorization, Qualification and Training

It is ultimately the responsibility of the principal investigator to determine the scope of work, training needs, and qualifications of her/his staff and the controls necessary to protect workers however this responsibility is typically delegated to a supervisor or work lead.  The principal investigator (or designee) will establish a work group within the JHA system that documents a preliminary work scope, potential hazards and required controls.  Each applicable employee or affiliate is then assigned to that work group.  The individual will modify their JHA accordingly to address any work activities or hazards not addressed by the work group and possibly remove tasks and hazards that are not applicable to their work (if supported by the work lead).

Individuals then need to complete all required training courses.  Any training courses required under a formal authorization (excluding the JHA) must be completed before the employee performs work potentially exposing that employee to the hazards identified in the formal authorization.  For example, prior to working under a BUA covering Risk Group 2 biological materials and bloodborne pathogens, the worker must complete General Biosafety, Bloodborne Pathogen, Hepatitis B Medical Surveillance and Bio/Medical Waste training.

For other training courses an employee may begin work provided they are working under direct supervision and complete the training courses as time permits within the first 30 days of task assignment.  On-the-job training will also be provided as needed by the supervisor, work lead or designee.  Training must be documented in the LBNL Training Database or in laboratory logs or notebooks.

In select cases, training courses may not be available to employees within the first 30 days, such as for fire extinguisher training.  In those cases, the employee is not allowed to perform a task related to the hazard that she/he will be trained on.  In the case of fire extinguishers for example, an employee is not authorized to use a fire extinguisher until they have completed their training and must evacuate in the event of a fire.

All employees and affiliates that work in the Division for more than 30 days in a calendar year are required to discuss the hazards of their work and workplace with their supervisor, in accord with the Job Hazard Assessment process, typically in one-on-one meetings although this may occur in group meetings. These group meetings, if held, are moderated by the supervisor with assistance from the Division Safety Coordinator. The results of this review process are a discussion and review of workplace hazard and safety communication, plus a safety training curriculum, specific to each individual, agreed and reviewed by both the worker and their supervisor/work lead.

Supervisors and work leads must be especially attentive to student training; assuring that each student completes the JHA and training appropriate for their work and is provided appropriate on-the-job training, including introduction to other supervisory staff that can provide continuity of support and oversight.

In addition to the review of safety hazards through the JHA and training courses, supervisors and work leads must also determine when an individual worker is qualified to perform work without supervision.  This is a judgment decision for each supervisor and work lead and does not need to be documented.  Only after a supervisor or work lead determines a worker is qualified to work safely and effectively may that worker work without supervision.

The Division Safety Coordinator tracks the completion and yearly renewal of the JHAs and training, advises division management, and contacts the responsible supervisor to remind them about specific missing, incomplete or out-of-date JHAs or training obligations.

Formal EH&S class work is mandatory as specified in PUB-3000, most critically in the areas of radiation protection and hazardous waste management, but also for a broad range of other hazard concerns, as provided in the LBNL Training web-page http://www.lbl.gov/ehs/training/index.shtml. Additionally, a number of formal classes offered by EH&S are recommended for supervisors and research staff.

Life Sciences Division staff and associated affiliates are not allowed to work alone when the mitigated hazards associated with their work could incapacitate them to such a degree that they cannot “self-rescue” themselves or activate emergency services. Compliance with the LBNL Work Alone Policy is insured through two separate mechanisms: evaluation of the severity of the hazards during the work planning process; and evaluation of the qualifications and competency of the individual staff members and affiliates.

The Division has determined that all tasks undertaken in the Division with hazards severe enough to potentially require restrictions on working alone would be covered by formal authorizations (e.g. RWA, AHD, LOTO, etc.). As part of the preparation of these formal authorizations, supervisors and work leads, with assistance from the Division Safety Coordinator and appropriate Subject Matter Experts, are to assess and identify any tasks that warrant restrictions regarding working alone. These restrictions are to be included within the scope of work of the formal authorization, and are to be communicated to staff and affiliates when the on-the-job training is provided for the authorized project. If the need for a partner or observer is determined, then the supervisor or work lead is responsible for insuring that support is provided when the designated tasks are performed.

It is possible that even though a task is not considered sufficiently hazardous to require restrictions on working alone, a supervisor or work lead may want to restrict an individual from performing a task alone without further training or establishing competency. If such a case arises, it is the responsibility of the supervisor or work lead to communicate these restrictions to the individual, and inform them of what further training or experience is necessary before they will be permitted to work alone. In these cases, it is the responsibility of the supervisor to determine if the employee or affiliate has the knowledge, skills, and technical understanding to perform the required task alone.

6.0 Working within Controls

The fourth Core Function of ISM is performing work within controls.  Controls are typically identified and documented through the Job Hazard Analysis process or through completion of an activity-specific safety document, such as a Biological Use Authorization, Radiological Work Authorization, or Activity Hazard Document.  In some cases, controls are not specifically documented and only communicated through training (either institutional or on-the-job training). 

It is the responsibility of the individual employee to work within the controls outlined in these documents or communicated through training.  Principal investigators, supervisors and work leads are responsible for ensuring controls are effectively communicated to and followed by employees.

To ensure compliance with established institutional requirements and to ensure that Life Sciences Division employees are working within the boundaries of their authorized work, the Division engages in a variety of self assessments.  Safety inspections of workspaces occur on a periodic basis.  During these inspections, Division personnel walk through workspaces verifying compliance with safety requirements and speaking with Division personnel to determine if safety requirements are being adequately communicated and that Division personnel understand their safety responsibilities.  These safety inspections are primarily performed by the Division Safety Coordinator and Division Safety Officer.  The Division Director and Department Heads participate in these inspections on an annual basis.  As part of the principal investigators, supervisors and work leads responsibilities, they are continually observing safety performance in their labs.  Deficiencies noted during the safety inspections are either corrected on the spot or are entered into CATS and tracked to completion.

In addition, at the beginning of each fiscal year, the Division identifies focus areas for detailed self assessment.  A Division Self Assessment Plan is completed annually.  This plan is reviewed and approved by Division leadership and provided to the LBNL Office of Contract Assurance for review.  As each focus area self assessment is completed, a report is generated which is also reviewed and approved by Division leadership.  Corrective actions are identified to address root causes, to the extent feasible and entered into CATS and tracked to completion.

Self assessment in the Life Sciences Division is further supported by the active participation of the four primary Division building managers in the Potter Street, Donner, buildings 64/55, and buildings 84/83 facilities. This participation includes periodic walkthroughs of their facility with the Division Safety Coordinator, and may include participation of research staff and principal investigators.  The purpose of including building managers is to provide a second perspective for self assessment walk-around inspections of Division work and spaces, and to provide the Division with significantly greater depth and distribution of experience in the area of safety management.

The EH&S Division also conducts periodic assessments of specific subject areas.  These assessments may result in findings reported back to the Division.  Corrective actions are identified for each finding, entered into CATS and tracked to completion.

In most cases, the Division Safety Coordinator or Division Safety Officer enters corrective actions into CATS and works with the applicable persons to ensure each item is completed.  Occasionally entry into CATS is performed by a representative from the EH&S Division or a staff employee within the Division.

Incident Investigations:
Any incident requiring an Occurrence Report or a Supervisor Accident and Analysis Report (SAAR) will be investigated by the Division.  The purpose of the investigation is to identify the cause of the incident and identify corrective actions that will prevent similar future occurrences.  The Division Safety Coordinator or Division Safety Officer will work with the EH&S Division to ensure that these incidents are investigated in a timely manner.  Communication between the two will occur within 24 hours of notification of the event and a plan of action will be established.  In the event the Division Safety Coordinator or Safety Officer is not available, the incident investigation process will default to the incident investigation procedure established by EH&S.

Recommendations from incident investigations will be entered into CATS for tracking.

7.0 Feedback and Continuous Improvement

Feedback and continuous improvement is the fifth and last Core Function of Integrated Safety Managment.  There are a variety of feedback and continuous improvement mechanisms in place within the Life Sciences Division.

Feedback:
The most formal methods for feedback within the Division are the Division Safety Committee and Division leadership (LSDAC) meetings. Safety Committee members and senior staff are able to provide feedback on all aspects of the Division safety program during these meetings. 

Employees have other mechanisms to provide feedback within the Division, including:

  1. Feedback to principal investigators and supervisors at their periodic staff meetings.
  2. Direct communication (email or phone) with the Division Safety Coordinator or Division Safety Officer. 
  3. Email sent to lsd.ergo@lbl.gov requesting ergonomic assistance or a request to a Division Ergo Advocate.
  4. Safety performance is a consideration for employees (including principal investigators and supervisors) on their annual performance review as well.

Feedback is also provided to the Division from external sources, primarily the EH&S Division.  This typically occurs via the EH&S Technical Assurance Program (TAP) or through notification of safety violations and non-conformances.

Continuous Improvement:
Continuous improvement is an on-going process.  The entire process of hazard identification, determination of controls, approval of work, self assessments and feedback are designed to drive continuous improvement.  As noted within this Plan, findings from various assessments and observed safety deficiencies are entered into CATS for tracking purposes.

The most formal method of continuous improvement is through the Division self assessment, which assess areas of greatest concern for the Division and strive to implement improved solutions designed to raise awareness and to better control hazards. 

Continuous improvement efforts however happen regularly through multiple channels such as:

  1. Incident investigations and subsequent corrective actions.
  2. The SPOT award incentive program.
  3. Feedback/safety discussions at staff meetings.
  4. Inclusion of safety on annual performance reviews.
  5. Periodic safety inspections and subsequent corrective actions.
  6. Reporting and investigation of near misses and near hits.
  7. Development and/or communication of Lessons Learned.
  8. Interaction between Division safety staff and Ergo Advocates with Division employees.
  9. “Level-1” email distribution to all Division members addressing relevant safety topics.

Last revised: March 2012