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Laboratory Compliance Policy

Last updated on November 3, 2023 8 min read Laboratory Compliance Policy

Prepared by: Environmental Health & Safety

Policy Statement

Boston University (BU) and Boston Medical Center (BMC) are committed to a safe and healthy laboratory workplace for its faculty, staff, students, visitors, and the environment.  All Research and Teaching laboratories at BU and BMC must adhere to federal, state, local regulations, and BU policies and procedures.   This document outlines minimum practices and standards that apply to all these laboratories and must be followed.

Background

All work in BU and BMC research and teaching laboratories must be performed in accordance with set policies.  These include the Biological Safety Manual, Chemical Hygiene Plan Manual, OSHA Bloodborne Pathogen Manual, and others.  These policies outline minimum practices to be followed, roles and responsibilities of labs, support, and other stake holders and are based on applicable federal, state, and local regulations.  All research and teaching laboratories at BU and BMC are routinely inspected by Environmental Health and Safety (EHS) to ensure for continued adherence to applicable regulations and policies.

Applicable Regulations, Standards, and Policies

Definitions

  • Laboratory: A space or room equipped for experimental study in a science or for testing and analysis a research laboratory; a place providing opportunity for experimentation, observation, or practice in a field of study.
  • Compliant: Successfully follows applicable regulations, policies, and procedures.  Furthermore, for the purpose of this document, laboratories are expected to adhere to appropriate laboratory safety guidelines and best practices.
  • Non-Compliance: Failure to act in accordance with applicable regulatory requirements, policies, procedures, and guidelines related to laboratory safety.
  • Principal Investigator: The Principal Investigator (PI) is the head of the laboratory and responsible for ensuring compliance and promote a safety culture that individuals and the University share to enhance a safe laboratory environment.
  • Laboratory Safety Coordinator: The Laboratory Safety Coordinator (LSC) is designated by the PI and perform functions designated by the PI and also listed by EHS for the LSC program.  The LSC works closely with EHS to ensure adherence to regulations, policies, procedures, as well as laboratory guidelines, and best practices that corrective actions have been completed, laboratory staff are reminded of their trainings and clearances with ROHP, and others.
  • Laboratory Staff: Laboratory Staff are lab workers including researchers and technicians performing lab work.

    Roles and Responsibilities

    • Principal Investigator (PI):
      • Ensure that all applicable regulations, policies, procedures, and laboratory safety guidelines, and best practices are followed as it applies to laboratory areas they may occupy or oversee;
      • ensure that laboratory personnel are knowledgeable of these regulations, policies, procedures, and laboratory safety guidelines and best practices;
      • ensure that all laboratory staff have completed and are current with their required safety trainings;
      • maintain and update the SciShield ® information including assigned spaces, equipment, chemical inventories, laboratory staff.
      • conduct inspections with EHS or assign LSC or other appropriate designee;
      • address and correct all findings identified during inspections in a timely manner;
      • work with EHS and other appropriate stake holders to address findings as necessary;
      • stop and suspend any work identified by EHS as “immediately dangerous to life and health”;
      • continually review safety procedures;
      • ensure appropriate PPE is always available and used properly;
      • continually review and modify as necessary lab procedures involving hazardous materials or processes to ensure potential risks are considered in advance;
      • ensure all incidents and accidents are reported appropriately. Work related injury or illness should be reported to Conduent at 833-951-2415. More information is available at https://www.bu.edu/buohc/occupational-injury-or-illness/for-employees/;
      • regularly promote a culture of safety.
    • Laboratory Safety Coordinators
      • Supports the PI to ensures safety practices are implemented;
      • represents the PI in the implementation of laboratory and worker safety;
      • serves as the primary laboratory contact with EHS for issues related to safety (i.e., biological, chemical, fire, general safety, controlled substances, etc;
      • takes positive actions to help reduce the potential for accidents and incidents associated with laboratory operations;
      • informs laboratory personnel and students of the safety hazards associated with their work;
      • instructs all laboratory personnel and students in safe work practices;
      • reports all incidents and accidents or safety concerns to the PI and EHS;. Work related injury or illness should be reported to Conduent at 833-951-2415. More information is available at https://www.bu.edu/buohc/occupational-injury-or-illness/for-employees/
      • ensures appropriate SOPs are established and lab personnel and students are appropriately trained;
      • works with EHS to determine best practices and procedures;
      • works with EHS to ensure lab personnel and students complete all required safety trainings;
      • ensures all deficiencies identified by EHS or regulatory inspectors are addressed and corrected appropriately;
      • participates in incident and accident investigations;
      • stops operations that are in clear violation of the safety requirements, approved SOPs, or may potentially result in injuries or potential exposures.
    • Laboratory Staff
      • Follows all regulations, policies, procedures, policies, procedures, and laboratory safety guidelines and best practices:
      • uses best laboratory practices to minimize incidents, injuries and exposures;
      • completes all required safety trainings;
      • complete annual clearances with Research Occupational Health program (ROHP);
      • immediately reports incidents and accidents, including any unsafe laboratory conditions to the PI, EHS, and other responsible parties;
      • utilizes control measures, such as biological safety cabinets and PPE, to prevent exposure to biological agents and contamination of personnel and facilities;
      • immediately contacts ROHP at (617) 414-7647 for any exposure or injury to ensure appropriate medical triage, evaluation, documentation and notification.
    • Department Chairs and Deans
      • support compliance with all applicable institutional laboratory safety policies;
      • support faculty in maintaining laboratory safety compliance;
      • work with the BU safety committees and EHS when addressing compliance in laboratories under their purview.
    • Environmental Health & Safety
      • develop and implement institutional laboratory safety programs to promote worker safety and compliance;
      • conduct routine inspections of laboratories to assess safe work practices and compliance;
      • develop corrective actions for observed safety findings;
      • conduct risk assessments involving hazardous materials and processes;
      • identify any process that may be “immediately dangerous to life and health” and stop the work immediately;
      • report laboratories with recurring or unresolved safety issues to the appropriate safety committee. The safety committee will review and develop corrective action plan;
      • provide training to laboratory staff as necessary;
      • investigate incidents and accidents, identify root cause and provide corrective actions to prevent or minimize recurrence;
      • provide laboratory compliance status reports to appropriate safety committee;
      • coordinate response to regulatory agency inquiries;
      • as applicable, secure, renew, and maintain permits for the institution as required by regulatory agencies.
    • BU Research Compliance
      • Promote safety policies and regulatory compliance to all laboratory members;
      • collaborate with EHS, safety committee, and the laboratory on issues of non-compliance;
      • support the mediation of non-compliance to all stakeholders.
    • BU and BMC Safety Committees:  There are several safety committees at BU and BMC that assist with the oversight of laboratory safety in research and teaching laboratories including but not limited to; the Institutional Biosafety Committee (IBC), Laboratory Safety Committee (LSC), and the Radiation Safety Committee (RSC).  These safety committees role include:
      • IBC: A standing committee comprised of faculties, EHS, ROHP, community members that reviews and approve research protocols involving infectious, potentially infectious, rDNA, and synthetic DNA materials.
      • Review reports of laboratory non-compliance, facilitate discussions, and provide recommendations.
      • LSC: A standing committee comprised of students, faculty, staff. EHS, and ROHP. Facilitate discussions and review of policies, procedures, and SOPs;

    Monitoring and Verification of Laboratory Compliance

    • Inspections: EHS conducts routine inspections of research and teaching laboratories to safety and compliance. Inspections are performed with a lab member preferably the PI, Lab Safety Coordinator, or designee.  Findings are identified and discussed during inspections including recommended corrective actions.
    • Walkthroughs: EHS performs unannounced walkthrough inspections of laboratories as needed.  These walkthroughs are intended to promote a culture of safety and to remind laboratory personnel of frequently recurring issues that require permanent resolution.
    • Biological Use Assessments (BUA): The Biosafety Officers (BSO) conducts site specific inspections and re-inspections when laboratories submit a new research protocol or a renewal to the IBC. This inspection is focused on the protocols submitted to IBC. The BSO shall verify the proposed work including all necessary safety equipment, PPE, decontamination, and procedures are in place.
    Learn more about BU's Laboratory Inspection Program

    Procedure for Laboratory Findings, Non-Compliance

    • EHS staff will notify the PI of any findings following the scheduled lab inspection;
      • PI will be provided an expected completion date for observed findings;
      • in the event that the correction has not been completed by the expected completion date, EHS will work with the PI to resolve the finding(s);
      • if findings still go unresolved, the matter will be reported to the safety committee for review and further corrective action. Generally, the safety committee will communicate directly to the PI expecting findings to be resolved. The Department Chair or Dean will be informed of the matter to assist in resolving the findings;
      • If issue continues to be unresolved following committee intervention, the matter will be brought before the Associate Vice President, Research Compliance serving as the Institutional Officer.
    • Findings that are Immediately Dangerous to Life and Health (IDLH). EHS is authorized to shut down any activity that may be considered IDLH.  If activities are stopped, EHS will immediately inform the PI, LSC or supervisor. A further risk assessment may be initiated.  Work may not resume until all hazardous conditions have been corrected.
    • Corrections involving infrastructure will be considered on a case-by-case basis and interim measures to reduce risk will be considered.

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