COVID-19 Laboratory Reopening Compliance Monitoring & Reporting

As per the Harvard University Research Laboratory Re-Entry Plan, the Office of Regulatory Affairs and Research Compliance is responsible for coordinating the functions of the COVID-19 Oversight Team (COT).  To follow, please find information about the COT’s charge, membership, general procedures expected of labs, and reporting process. For questions, please contact Stanley Estime at sestime@hsph.harvard.edu.

CHARGE

The COVID-19 Oversight Team is responsible for the following:

  • reviewing changes to individual laboratory plans and institutional guidance;
  • monitoring compliance with individual laboratory plans/institutional guidance;
  • reviewing deviation and/or non-compliance reports, and
  • collecting and providing information relevant to any changes in policies and/or procedures to COVID-19 Safety Officers and PIs.
COVID-19 OVERSIGHT TEAM MEMBERSHIP

Delia Wolf Christiani – Team Leader
Associate Dean, Regulatory Affairs & Research Compliance

Noman Siddiqi – Co-Team Leader
Chair, Lab and Biosafety Focused Forum (LBFF), HSPH

Leslie Howes
Director, Office of Regulatory Affairs & Research Compliance (ORARC)

Stanley Estime
Assistant Director, Bio & Lab Safety, ORARC

Jackie Kerr
Manager of Lab Safety Services, Environmental Health & Services (EH&S), Harvard

Michelle MacLeod
Laboratory Safety Advisor, EH&S, Harvard

Eric Rouse
Biosafety Officer, EH&S, Harvard

Alex Machaiek
Senior Director of Operations, HSPH

Danny Beaudoin
Director of Planning and Facilities, HSPH

Glenn Stern
Director of Administration
Department of Environmental Health

Marie Richard
Director of Administration
Department of Immunology and Infectious Diseases

Brian Frederick
Senior Research and Operations Manager
Department of Molecular Metabolism

Nicole Patterson
Lab, Operations, and Equipment Coordinator
Department of Environmental Health

Katrina Soriano
Executive Director
Department of Nutrition and Department of Molecular Metabolism

EXPECTATIONS OF LABORATORIES
  • Each PI is responsible for identifying a Lab COVID-19 Safety Officer. This may be an existing lab manager or safety officer.
  • Designated Lab COVID-19 Safety Officers will serve as a liaison between lab members and the COT.  Specifically, they will meet regularly with the COT to share best practices, discuss challenges and potential solutions and communicate this information back to their lab members.
  • Report all deviations, non-compliance issues and incidents to ORARC within 24 hours of occurrence, using the Harvard Chan School COVID-19 Lab Reopening Compliance Monitoring & Reporting System. These reports may include, but are not limited to, the following:
    • Modification to current approved research lab reopening plan
    • Physical/Social distancing
    • Face coverings
    • Disinfection/Lab hygiene
    • Shifts/Schedule
    • Building/Facility
    • Commute
    • Safety Culture
REVIEW PROCESS
  • The COT is expected to meet regularly.
  • Within 24 hours of receipt, new reports will receive preliminary review by the LBFF chair who will assign to relevant reviewers (e.g., EH&S and/or Operations members) based on the nature of the deviation/non-compliance.
  • COT correspondence will be provided to PI, Department Chair and Department Administrators.
  • ORARC staff will work with the COT to ensure implementation of corrective actions, as appropriate.  Corrective actions may include, but not limited to education, retraining, or reconsideration and/or modification of the lab reentry plan.
  • All serious and continuing non-compliance determined by the COT will be reported to Harvard Chan Research Planning Committee and the Committee’s decisions may include, but not limited to revocation of an individual’s or an entire lab’s ability to work on campus.
REPORTING

To report, submit through the Harvard Chan School COVID-19 Lab Reopening Compliance Monitoring & Reporting System. Of note, a reporter does not need to be identified nor be a member of the lab for which the report applies; reports may be submitted anonymously by any Harvard Chan School faculty, staff, or student.

RESOURCES