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Appendix T: Boston University Research Compliance Policy on Disease Surveillance and Reporting for High-Risk Agents

Last updated on July 1, 2016 10 min read Biosafety Manual - Appendix T: Boston University Research Compliance Policy on Disease Surveillance and Reporting for High-Risk Agents

Purpose and Applicability

This policy implements BPHC’s Guidelines for Implementation and Enforcement of Boston Public Health Commission’s Disease Surveillance and Reporting Regulation. The BPHC’s guidelines require laboratory registration and a medical surveillance program for research laboratories working with high-risk agents. The guidelines are designed to ensure that BPHC receives timely access to information regarding incidence of disease syndromes, any outbreak or cluster of a disease, and potential exposures to reportable diseases deemed harmful to the public health.

This policy sets forth the roles and responsibilities of researchers and compliance staff, as mandated by the BPHC guidelines.

This policy supplements, but does not replace or supersede, any other existing BU policies or procedures. For example, additional procedures relating to laboratory safety are set forth by EHS in the EHS Manual, and other subsidiary EHS documents.

Definitions

The Associate Vice President, Research Compliance (AVPRC) is the individual responsible for overall research compliance oversight at BU.

The Biological Safety Officer is the individual responsible for overall leadership of the biosafety program.

Expose or Exposure is any situation arising from, or related to, the work operation where an employee or community resident may ingest, inhale, absorb through the skin or eyes, or otherwise come into contact with any high-risk agent.

EHS Director is the Director of Research Safety in the EHS of Boston University.
Occupational Health Officer (OHO) is the physician(s) who is the Occupational Health Officer of ROHP at Boston University. The Occupational Health Officer may also name a designee to perform occupational health assessments or evaluations, provided that the designee is also a licensed physician experienced in occupational medicine or a registered nurse experienced in occupational health nursing.

High–Risk Agent is a select agent, defined as:

Select Agent means microbial and toxic agents listed at 42 CFR 73.4, 42 CFR 73.5, and 9 CFR 121.2 and the rulings made by the CDC and U.S. Department of Agriculture relative thereto as amended from time to time.

Research Laboratory is a workplace or a work area of a workplace that is used primarily for research, development, non–routine testing, or experimentation activity in which any high-risk agent is used by or under the direct supervision of a technically qualified individual.

Work Area is a defined space, or a room or rooms, or other area where infectious agents or substances are produced, stored, or used, and where employees are present in the course of their employment. A work area may include an entire workplace.

Workplace is an establishment or business of an employer at one geographic location at which work is performed and containing one or more work areas.

Registration of Research Laboratories

The office of the AVPRC will be responsible for registering with BPHC all research laboratories possessing, producing, storing, or otherwise working with any high–risk agent.

Such registration shall be on a form, or electronic format, provided by the BPHC’s Office of Environmental Health, and shall include the following:

  • Name of the high-risk agent
  • The location of each high-risk agent (but only if such disclosure is consistent with federal, state and institutional security restrictions and policies concerning select agents or high-risk agents).
  • Principal Investigator responsible for the high–risk agent(s).
  • Title and a brief description of the nature of the project.
  • Grant identification number or other unique institutional identifier number for the project.
  • Contact information for the IBC.
  • Name and contact information for the Occupational Health Officer.

The information in the registration form shall be updated, on a form provided by the BPHC’s Office of Environmental Health, twice a year, every July 31st and January 31st (or on the next business day if it falls on a holiday or weekend) following registration.

The AVPRC shall inform the OHO of all high-risk agents as they are identified and shall provide the OHO with a copy of each registration and update, simultaneously with filing.

Responsibilities of Principal Investigators, Supervisors, Laboratory Directors

Ensure Registration Prior to Project Commencement
The Principal Investigator, Supervisor, or Laboratory Director of any research project that proposes to possess, produce, store, or otherwise work with any high–risk agent must first contact the AVPRC, or designee, and ensure that a registration for the research laboratory is properly filed with the BPHC.

Develop Approved Plan Prior to Project Commencement

The Principal Investigator, Supervisor, or Laboratory Director of any research project who proposes to possess, produce, store, or otherwise work with any high–risk agent must:

  • Develop a plan jointly with the OHO that will enable the Principal Investigator, Supervisor, or Laboratory Director to determine whether a significant exposure of personnel has occurred in the Research Laboratory and that will set forth a protocol for monitoring significantly exposed employees (for more information, see “Medical Surveillance of Employees Working With High-Risk Agents” under “Responsibilities of the Occupational Health Officer”).
  • Indicate in writing that the Principal Investigator, Supervisor or Laboratory Director, and OHO have each approved the plan
  • The plan must also be approved by the AVPRC and the IBC before researchers on the project will be allowed access to a high-risk agent.

Mandated Reporting to OHO and EHS Director

The IBC, Principal Investigator, Supervisor, and/or Laboratory Director shall promptly report to the OHO:

  • Any diagnosis of any disease caused by a high-risk agent; and
  • Any laboratory employee or other individual having access to a research laboratory that possesses, produces, stores, or otherwise works with any high-risk agent who is absent from the workplace due to illness for a period of two or more consecutive work days.

The IBC, Principal Investigator, Supervisor, and/or Laboratory Director shall report to the AVP-RC and the OHO any violation or breach of any laboratory procedures or any other incident that the IBC, Principal Investigator, Supervisor, or Laboratory Director should reasonably believe resulted in exposure of laboratory personnel to a high-risk agent in the workplace or released any high-risk agent beyond the work area.

The manner of reporting to ROHP is outlined in the section, “Manner of Reporting to ROHP.”

Follow-up on Reporting Requirements of Laboratory Workers

Principal Investigators, Supervisors, and Laboratory Directors who learn of laboratory workers with reporting responsibilities as outlined in “Responsibilities of Laboratory Employees, Trainees, Students, and Others Who Have Access to High-Risk Agents” must confirm that such employees have reported to the ROHP before returning to work and that the employees have a written release to return to work provided by the ROHP.

Principal Investigators, Supervisors, and Laboratory Directors should refer any ill employee who has had access to a high-risk Agent to the ROHP for evaluation.

Responsibilities of Laboratory Employees, Trainees, Students, and Others Who Have Access to High-Risk Agents

Mandatory Reporting to OHO, AVPRC, and EHS

Laboratory workers or other individual having access to a research laboratory that possesses, produces, stores, or otherwise works with any high–risk agent and who are exposed to a high-risk agent from a spill or a breach in laboratory practices must immediately contact the OHO, AVPRC, and EHS Director of Research Safety to receive instructions as to appropriate immediate steps to be taken.

Mandatory Medical Evaluations

Any laboratory employee or other individual having access to a research laboratory that

  • possesses, produces, stores, or otherwise works with any high–risk agent
  • and who has been diagnosed with, is exhibiting symptoms of, or may have been exposed to, any high–risk agent
  • or who has been absent from the work place due to illness for a period of two or more consecutive work days

must report to the OHO prior to returning to work, for medical evaluation before, and as a condition for, returning to work.

Laboratory workers are encouraged to report any illness to the OHO if working with high–risk agents, even if the illness does not result in a two-day workplace absence.

The manner of reporting to ROHP is outlined in the section, “Manner of Reporting to ROHP.”

Responsibilities of the Occupational Health Officer

Medical Surveillance of Employees Working With High-Risk Agents

The OHO is responsible for having in place a general plan to determine whether employees working with various high-risk agents have had a significant exposure to a high-risk agent and a plan to monitor significantly exposed employees.

The OHO will work with the Principal Investigator, Supervisor, or Laboratory Director on any research project that proposes to possess, produce, store, or otherwise work with any high–risk agent to:

  • Develop a project-specific plan described in “Develop Approved Plan Prior to Project Commencement” as outlined in “Responsibilities of Principal Investigators, Supervisors, Laboratory Directors” which will enable the Principal Investigator, Supervisor, or Laboratory Director to determine whether a significant exposure of personnel has occurred in the research laboratory and which will set forth a protocol for monitoring significantly exposed employees; and
  • Ensure that the project-specific plan is approved by EHS and the IBC before researchers have access to a high-risk agent.

The Occupational Health Officer will immediately notify the BPHC of all presumptive Lab Acquired Infections (LAI) followed by a confirmatory report once additional information is available. In the event of any incident the Occupational Health Officer will act as a single point of contact and coordinate all Occupational Health activities and notify other agencies as appropriate.

The OHO is responsible for generating the following reports and reporting to the BPHC as indicated:

    Report of Diagnosis, Symptoms, or Exposure

    The OHO shall perform an occupational health assessment for any laboratory employee or other individual having access to the laboratory who:

    • Has been diagnosed with,
    • Is exhibiting symptoms of, or
    • May have been exposed to any high-risk agent.

    The findings of the assessment shall be immediately reported to the BPHC, via their Reporting Form, but in any event not later than one business day after completion of the assessment.

    The OHO will conduct a follow-up assessment and provide information requested by BPHC regarding isolation and/or quarantine issues. If the determination is made that the illness is caused by a high-risk agent, BPHC will be consulted before an ill worker is allowed to return to work.

    The OHO will send BPHC documentation that an exposed person has been cleared to return to work within three business days of clearance.

    Report of Workplace Absence Due to Illness

    The OHO shall perform an evaluation of any laboratory employee or other individual having access to a research laboratory that possesses, produces, stores, or otherwise works with any high–risk agent and who has been absent from the work place due to illness for a period of two or more consecutive work days.

    The evaluation shall be completed prior to the employee’s return to work.

    If the OHO has a reasonable suspicion that the employee’s illness may be related to an exposure to any high-risk agent, the OHO shall immediately notify the BPHC.

    If Occupational Health determines that the illness was caused by a high-risk agent and may be work related, the BPHC must be consulted at least three business days prior to the employee’s expected return to work.

    Report of Diagnosis of Disease

    The OHO shall report to the BPHC any diagnosis of any disease caused by a high-risk agent.

    This report shall be made within one business day of the diagnosis.

    Report of Violation of Laboratory Procedures Resulting in Release of High-Risk Agent

    The OHO shall report to the BPHC any violation or breach of any laboratory procedures or any other incident which the OHO should reasonably believe released a high-risk agent beyond the work area.

    This incident shall be reported to BPHC within one business day of the breach or incident.

    EHS Notification

    The OHO shall provide the AVPRC and EHS Director of Research Safety with written notification of all reports made to the BPHC.

    Manner of Reporting to ROHP

    Contact the ROHP 24/7 at (617) 358-7647 (ROHP).

    Appendix U: Criteria for Development of Standard Operating Procedures

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