• Purpose: This policy outlines the incident reporting requirements for Principal Investigators, Biosafety Officers, and institutions whose COMS Regulated Materials (“CRM”), as defined in the Policy Introduction (II) Scope, is covered by the Committee on Microbiological Safety.
  • Applicability: Any COMS application that is approved by the committee must follow the guidance of this policy and the recommendations in the NIH Guidelines.
  • Definitions
    • CRM incident: Any incident involving a CRM. These incidents must be reported to COMS.  Local health departments (Boston Public Health Commission and/or Cambridge Biosafety Committee) may also require the reporting of a CRM.  Please refer to Appendix A: Regulatory Agency Reporting Procedure for further procedures on reporting to health departments including lists of reportable CRM.
    • Recombinant DNA Incident: Section IV-B-2-b-(7) of the NIH Guidelines states that IBCs must report "...any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses" to NIH OSP within 30 days. Appendix G of the NIH Guidelines specifies certain types of accidents that must be reported on a more expedited basis. According to NIH Guidelines Appendix G-II-B-2-k, spills or accidents in BL2 laboratories resulting in an overt exposure must be immediately reported to NIH OBA (as well as the IBC). According to NIH Guidelines Appendix G-II-C-2-q and Appendix G-II-D-2-k, spills or accidents occurring in high containment (BL3 or BL4) laboratories resulting in an overt or potential exposure must be immediately reported to NIH OSP (as well as the IBC, and BSO).  COMS expects that even incidents that do not fall into one of these expedited reporting categories will be reported to NIH OSP as soon as possible. Local health departments under COMS (City of Boston and Cambridge) also require reporting recombinant DNA incidents (See Tables 1 and 2 below).
    • Potential Exposure: A possible personal contact with a Biosafety Level Three (BL3) recombinant or synthetic CRM.  According to the NIH guidelines, this contact would be reportable to NIH Office of Science Policy (NIH OSP). Examples of potential exposures to a BL3 agent are any accidents, equipment failure, or splash to intact skin.
    • Overt Exposure: A definitive contact with a Biosafety Level Two or Biosafety Level Three recombinant or synthetic CRM.  According to the NIH guidelines, this contact would be reportable to NIH Office of Science Policy (NIH OSP).  Examples of overt exposures are needle sticks and splashes of recombinant or synthetic nucleic acid molecules agent on personnel.
  • Implementation procedures
    • Responsibilities
      • Principal Investigator: As stated in the Memorandum of Understanding and Agreement, signed by the Principal Investigator (PI) of COMS-approved research, PIs are required to report potential or overt exposures to CRM to their Institutional Biological Safety Officer (BSO).  Additionally, the NIH Guidelines state that reporting of accidents or illnesses to the NIH is the responsibility of the PI, the BSO and the Institutional Biosafety Committee (IBC).   This policy mandates the reporting through the BSO.  The following excerpts from the COMS application memorandum highlight the PI requirements under this policy: “By signing this document I agree to immediately notify COMS if a member of the laboratory staff develops symptoms of illness related to an agent involved in this study and if there is accidental release of a biohazardous agent into the environment. And in a separate paragraph, “By signing this document I accept full responsibility for laboratory biosafety training, for the maintenance of a safe workplace and for immediate reporting of accidental exposures to biohazardous agents.”
      • Biosafety Officer: As stated above, the biosafety officer is responsible for reporting any incident involving rCRM to COMS and to the appropriate government agencies, as listed under Appendix B.  In some cases, an entity may designate an institutional responsible official to complete said reporting.  The BSO is also responsible for presenting any incident and corrective action plans that have preceded each COMS meeting.
      • COMS: The committee is responsible for reviewing and discussing incidents at each committee meeting and ensuring that each institution has complied with all applicable regulations for incident reporting.  The committee also requires that each Principal Investigator comply with all applicable regulations for incident reporting.  
      • Reporting Considerations
        • Procedure
          • Personnel involved in any personal potential or overt exposure must be provided all appropriate medical evaluation and surveillance.
          • The BSO or duly designated representative will notify the Director of COMS and/or the COMS Chair the initial details of the incident. The BSO, or duly designated institutional official, will then notify all appropriate regulatory agencies as specified in Appendices D and E. Notification of the agencies should take place in accordance with reporting requirements as specified in Appendix A.
          • BSO should investigate the incident to identify route cause, training needs, and corrective action measures.
          • A verbal summary of the incident shall be provided by the BSO at the next scheduled COMS meeting and will be recorded in the meeting minutes.
          • For incidents involving laboratory acquired infections, breach of containment or overt exposures, and/or violations of the COMS approval, (or lack thereof), PIs must prepare a written response detailing the laboratory event and corrective actions taken to mitigate the event.  The letter should be submitted to COMS one week prior to the next scheduled COMS meeting so that it can be discussed during the meeting. COMS will document its review in the meeting minutes.
        • Reporting of Significant reporting events:(See Appendix A)
          • Spills and accidents which result in overt exposures to any organisms containing rCRM must be immediately reported.
          • Illnesses and/or symptoms potentially related to rCRM in use in the BL3 laboratory must be immediately reported.
          • Breach of BL3 containment which results in potential or overt exposures to organisms containing rCRM released into the environment must be immediately reported.
          • Breach of containment resulting from failure of mechanical systems (e.g. HVAC, loss of power) and laboratory equipment (Biosafety cabinet, centrifuge, ventilated animal cages) must be immediately reported.
        • Reporting of Incidents at the COMS meeting:: BSO should provide verbal report, which shall include, but not limited to, the following:
          • The nature of the incident (e.g. personnel exposure, spill, loss of containment, loss of transgenic animal, failure to obtain IBC approval, failure to follow approved containment conditions, other)
          • The COMS approval number
          • Federal, state or local agencies to which incident is being reported
          • A description of the incident, including the following information:
            • The recombinant agent or material involved. (if applicable)
            • The incident/violation location (e.g. laboratory biosafety level, vivarium, non-laboratory space).
            • The person(s) involved in the incident/violation, including others present at the incident location. [position title only] (e.g., graduate student, post doc, animal care worker, and facility maintenance worker).
            • Actions taken immediately following the incident/violation to limit any health or environmental consequences of the event, as well as the [position titles] of the individual(s) who took those actions.
            • The training received by the individual(s) involved and the date(s) the training was conducted.
            • The institutional or laboratory standard operating procedures (SOPs) for the research and a determination of whether there was any deviation from these SOPS at the time of the incident/violation.
            • Any deviation from the COMS-approved containment level or other COMS approval conditions at the time of the incident/violation.
            • The personal protective equipment in use at the time of the incident/violation.
            • The occupational health requirements for laboratory personnel involved in the research.
            • Any medical treatment/surveillance provided after the incident.
            • Any injury or illness associated with the incident.
            • Any equipment failures that occurred.
            • Any other relevant information identified during the review/investigation of the event
            • Measures taken by the Institution to mitigate identified problems (e.g., review by COMS, root cause analysis)
        • Multi-institutional research: There may be circumstances where Principal Investigators are collaborating with other institutions that are not covered by COMS.  The Principal Investigator must report to their BSO any incident that occurs under a COMS protocol.  PIs should be aware that they may have additional reporting obligations to other institutions should their work be registered at other Institutional Biosafety Committees (IBCs).
  • Policy Authority: The Committee on Microbiological Safety shall enforce this policy.
  • References

Appendix A: Regulatory Agency Reporting Procedure

Regulatory Agency

Jurisdiction

Reporting Requirements / Procedure

Timing to Report

NIH OSP

All institutions receiving NIH funding for recombinant or synthetic nucleic acid molecule research

Telephone or Email Correspondence to OSP

 

*In some cases, it may be appropriate to contact the NIH/OSP by telephone or email to determine if NIH/OSP considers the incident to be reportable.

Within 30 days.

Note: certain types of incidents require immediate reporting. Consult regulation

Boston Public Health Commission

City of Boston only

rDNA

BL3 and BL4 Labs

Reportable Infectious Agents and Toxins (see regulation for specific list of materials)

 

Clinical labs

 

Animal Bites

Telephone or Email Correspondence

 

For laboratories with BPHC BL3 Permits:

  1. Employees exhibiting symptoms or may have been exposed to agents in use in the BPHC permitted BL3 laboratory
  2. Employees absent for two or more consecutive working days, where Institutional Occupational Health personnel have reasonable suspicion that the illness may be related to an exposure to agent in use in the BPHC permitted BL3 laboratory
  3. Failures, malfunctions, or renovations of major mechanical or security systems of the BPHC permitted BL3 laboratory

 

Clinical Laboratory Reporting Form
To report: Complete form and fax

 

Animal Bite Reporting Form
To report: Complete reporting form and fax

Within thirty (30) days an institution shall report any significant problems with or violations of the Guidelines and any significant rDNA related accidents or illnesses to the Executive Director and the Boston RDNA Advisory Committee. Any such problems, accidents, or illnesses which have a potential impact on the public health and safety shall be reported immediately.

 

Immediate reporting

 

Report immediately by phone suspect or confirmed cases

 

Fax Completed Form to BPHC-CDC

Cambridge Public Health Department

 

All institutions receiving NIH funding for rDNA

 

BL3 Labs

Telephone or Email Correspondence to Director of Environmental Health

Telephone or Email Correspondence to Director of Environmental Health

 

MA DPH

State of MA Biological Waste (see regulation)

 

 

CDC/APHIS Select Agent Program

Select Agents (see regulation for complete list)

Select Agent Responsible Official must report

RO must contact APHIS or CDC immediately upon discovery of a theft, loss, or a release (occupational exposure or release of an agent or toxin outside of the primary barriers of the biocontainment area) of a Select Agent and Toxin not authorized under a federal act.

 

Appendix B: Regulatory Agency Contact List for Reporting of Incidents

 

Agency Contact

Regulation

Website/Forms

Completed reports may be sent to OSP via email at NIHGuidelines@od.nih.gov

Human Gene Transfer (HGT) Adverse Events (AEs) should still be reported to the NIH Office of Science Policy (OSP).

HGT AEs should be emailed to HGTprotocols@mail.nih.gov

 

 

Boston Public Health Commission, Communicable Disease Control Division

1010 Massachusetts Avenue, Boston, MA 02118

Phone: 617-534-5611

Fax 617-534-5905

 

Sam Lipson

Director of Environmental Health, Cambridge Public Health Department

119 Windsor Street, Ground Level
Cambridge, MA 02139

Phone 617-665-3838

Fax 617-665-3888

Email: slipson@challiance.org

 

 

APHIS Select Agent Program

4700 River Road Unit 2, Mailstop 22, Cubicle 1A07  Riverdale, MD 20737

Fax: 301-734-3652

Email: Agricultural.Select.Agent.Program@aphis.usda.gov

CDC Select Agent Program

1600 Clifton Road NE, Mailstop A-46,

Atlanta, GA 30333

Fax 404-718-2096

Email: lrsat@cdc.gov

 

Massachusetts Department of Public Health

Office of General Counsel

250 Washington Street, 2nd Floor

Boston MA 02108

Phone: 617-624-5213

  • 105 CMR 480.00 Department of Public Health Minimum Requirements for the Management of Medical or Biological Waste (State Sanitary Code Chapter VIII)