Personnel Suitability and Reliability Policy National Emerging Infectious Diseases Laboratories

Last updated on May 8, 2023 30 min read Personnel Suitability and Reliability Policy National Emerging Infectious Diseases Laboratories

Personnel Suitability and Reliability Policy – NEIDLNational Emerging Infectious Diseases Laboratories The NE...

Current Version: 4.0
Implementation Date: November 9, 2010
Last Reviewed/Update Date: July 14, 2021

Personnel Suitability and Reliability Policy National Emerging Infectious Diseases Laboratories

Boston University recognizes the importance of research and scholarly activity and the open environment that fosters collaborative efforts amongst researchers. There is also recognition of the need to comply with myriad regulatory requirements established to enhance the safety and security of certain research facilities, individuals working in them and the materials (e.g., biological agents) that might be used in those facilities.

 A comprehensive bio-security program is built on three elements: security systems; personnel suitability; and ongoing education and training. These ensure continued personnel reliability and continued emphasis on an integrated culture of safety and responsibility based on an ongoing program of assessing and improving the operations.

The diagram below describes the framework within which such a comprehensive plan should be developed and implemented.

Within this framework the approval for entry to the NEIDL and the management and deterrence of external threats are defined as a major component of the security plan, while the ongoing assessment of personnel reliability and safety are critical components of the overall internal operations program. The National Science Advisory Board for Bio-security (NSABB) defines its vision of an optimal Personnel Reliability Program (PRP) as one that is designed to ensure that “personnel approved for access to select agents and toxins are behaving in a responsible and trustworthy manner that upholds public health and safety, national security, and the integrity of the scientific enterprise”.  This policy reflects elements of the May 2009 NSABB report “Enhancing Personnel Reliability Among Individuals with Access to Select Agents”, the September 2011 NSABB report “Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility”, the October 2012 CDC and APHIS “Guidance for Suitability Assessments”, as well as those of the Trans Federal Task Force on Optimizing Biosafety and Biocontainment Oversight and the following updates: CDC and APHIS Security Guidance for Select Agent or Toxin Facilities, 5 July 2013, and CDC and APHIS Suitability Assessment Program Guidance March 2017.

1 Purpose and Scope

The purpose of this document is to establish policies and procedures to ensure the suitability of personnel granted entry to the National Emerging Infectious Disease Laboratories (NEIDL), the description of processes to ensure those personnel are determined to be reliable on an ongoing basis, and the management of a safe environment to compliment the work being done. Requirements are summarized in Appendix 1, 2 and 3)

1.1 The Department of Public Safety will confirm that appropriate background clearances, credential checks, training, and compliance requirements are completed and approved prior to anyone being given access to the NEIDL. Entry will be granted in accordance with Appendix 4 and then, for specific laboratory areas and times, in accordance with approved protocols.

1.2 Criteria for granting entry to the NEIDL site and areas within the facility are determined by regulation (e.g., Select Agent Rule) and/or by policy and may consider job responsibilities, the need to access specific areas within the site, the type of work being done, and the need to respond to incidents. These entry permissions may be restricted by hours of day, by day of week, by availability of appropriate facilities to work in, by the type of research being conducted, by area of building and by the requirements for the Two Person Guideline (see Section 3.22).

1.3 Public Safety Personnel Suitability Specialist(s) (see Section 11.9) or designee will be responsible for granting entry to the NEIDL site and approved areas within the NEIDL facility at approved times. Entry will be granted only upon successful completion of all clearance requirements contained within this policy. All personnel granted entry will be subject to on-going entry review in accordance with this policy.

1.4 Human Resources at Boston University has established procedures for the completion of the background checks for current BU employees seeking assignment to the NEIDL and new hires for positions at the NEIDL. (see Section 4.2)

1.5 NEIDL Leadership, along with senior representatives of Human Resources, Research Occupational Health Program, Public Safety, and Environmental Health & Safety will manage an ongoing Personnel Reliability Program (Section 7) to mitigate any potential risks of theft, loss, and intentional or accidental release of select agents and toxins by individuals who have been approved for access to select agents, in a manner that does not impede the progress of science.

1.6 The ongoing management of safe and compliant programs within a secure and productive facility includes recognition of the importance of research on select agents within a culture of trust. In order to achieve the balance necessary, the following are required for an effective, ongoing biosecurity program:

          • Personal responsibility
          • Communication and transparency
          • Periodic evaluation
          • Engaged leadership
          • Ongoing monitoring
          • Fairness and flexibility
          • Privacy and confidentiality
          • Appropriate training

1.7 The ongoing suitability and reliability program will combine elements of initial assessment with an ongoing evaluation and monitoring program that recognizes changes that might have occurred since the initial assessment. Corrective actions and procedural modifications must be made to accommodate such changes.

1.8 The management of a safe environment, as well as the practice of research and all supporting operations that follow institutional safety policies, in accordance with local, state and federal regulations, will further ensure a workplace free from incidents, accidents and behaviors that may increase risk.

2 References

2.1 Regulations: this policy will include regulations associated with federal, state and local regulations pertaining to entry to the NEIDL building.

2.1.1 Mandates will include regulatory compliance pertaining to the U.S.A. Patriot Act Public Law 107-56,

2.1.2 Select Agents defined by The Federal Select Agent Program (HHS; CDC 42 CFR Part 73), and a United States Department of Justice/FBI security clearance,

2.1.3 Boston Public Health Commission, Biological Laboratory Regulations,

2.1.4 Nuclear Regulatory Commission requirements, 10 CFR, Part 20.

2.2 Other Standard Operating Procedures (SOP): Entry to the facility will also be subject to additional requirements such as initial and periodic training, medical surveillance, and respiratory protection.

3 Definitions

3.1 “Access”: for the purposes of this policy is as defined under Public Health regulations related to Select Agents 42 CFR-73 Part 73.10. ‘‘An individual will be deemed to have access at any point in time if the individual has possession of a Select Agent or toxin (e.g., ability to carry, use, or manipulate) or the ability to gain possession of a Select Agent or toxin.’’

3.2 “ASC”: Animal Science Center.

3.3 “BPHC”: Boston Public Health Commission, acting as the permitting agency for Biosafety Level-3 and Biosafety Level-4 laboratories in Boston under the provisions of the Biological Laboratory Regulations.

3.4 “CDC”: Centers for Disease Control, and regulator of the Select Agent Rule.

3.5 “Certifying Official”: Refers to the Certifying Official (CO) as required in the Select Agent Rule.

3.6 “Core”: Research or operating units within the NEIDL.

3.7 “Criminal Background Check”: A background check of an individual to detect the presence of criminal offenses which may restrict entry to the NEIDL or areas within the NEIDL. This background check will include a Massachusetts Criminal Offender Record Information (CORI) check, and information from nation-wide and potentially international sources.

3.8 “EHS”: Environmental Health and Safety.

3.9 “Entry”: defined as the ability to physically enter the NEIDL perimeter, building or spaces therein. See Appendix 4 for those authorized to grant entry permissions.

3.10 “FSAP”: Federal Select Agent Program:  (HHS; CDC and USDA)

3.11 “IBC”: BU’s Institutional Biosafety Committee, the oversight committee charged with review and approval of all uses of biohazardous materials and toxins.

3.12 “Laboratory”: a single room or suite of interconnected rooms where research is conducted.

3.13 “Ongoing Personnel Reliability Program”: A program of continuous monitoring of, and by, employees in the NEIDL to ensure the maintenance of a safe environment.

3.14 “Patriot Act”: The USA Patriot Act of 2001 – Public Law 107-56. (Uniting and Strengthening America by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism).

3.15 “Perimeter Area”: Defined as the outer perimeter fence point of entry to the NEIDL.  All persons entering the NEIDL perimeter will be subjected to a screening process conducted by NEIDL public safety personnel. Persons, possessions, and vehicles may be subjected to screening as required.

3.16 “PI”: Refers to the Principal Investigator, responsible for the activities in a given laboratory area.

3.17 “PST”: the Personnel Suitability Team described in Section 7.5.

3.18 “Reviewer”: Refers to the Reviewer (REV) as required in the Select Agent Rule.

3.19 “RO”: Refers to the Responsible Official as required in the Select Agent Rule.

3.20 “ROHP”: Research Occupational Health Program.

3.21 “Select Agent”: Select Agents are biological agents or toxins that have been determined to have the potential to pose a severe threat to public health and safety, to animal and plant health, or to animal and plant products as defined by FSAP (HHS; CDC and USDA), or specifically regulated pathogenic material under other restrictions as defined under 42 CFR Part 73

3.22 “Two Person Guideline”: Intended to mitigate safety and security risks associated with individuals working with select agents in A/BSL-3 and A/BSL-4 restricted access areas not easily accessible to co-workers or first responders in the event of an accident, injury and/or exposures.  Risk assessments will be conducted to ensure that implementation of this guideline in specific situations will not add additional risk to personnel.

The two person guideline will be managed through a combination of secure access and safe operation protocols. Security systems will be employed to ensure two authorized individuals are present in maximum containment areas. The same will be true in high containment areas unless a risk assessment has determined that doing so adds risk to either person. Under these circumstances live closed circuit television (CCTV) may be used to monitor personnel safety. Security systems including strict access control, CCTV and safe operation protocols may be used to audit compliance.

3.23 “USDA”: United States Department of Agriculture – regulators for operational aspects of the Animal Science Center

4 Suitability Requirements for Employee Access to the NEIDL and with access to Select Agent(s)

The requirements as listed below are specific to:

      • Employees who will require entry to the NEIDL with no access to Select Agents;
      • Employees and staff who are not assigned to the NEIDL but may require entry to space therein and will not have access to Select Agents.

These requirements apply to the initial hiring for all employees. Periodic recertification of the requirements will be performed at least annually or as determined necessary. The requirements, as listed below, and the specifics of such requirements, will be in accordance with the developed policies and procedures of BU Human Resources (see Section 1.4). Employees who enter for the purpose of attending seminars may be treated as Visitors (see Section 6.2)

4.1 Criminal Background Check: To be completed in accordance with this policy and all federal, state and local laws and regulations.

4.2 Basic Background Check: Includes, but not limited to, verification of:

          • Social Security Number;
          • Academic credentials;
          • Past employment;
          • Licenses and credentials;
          • Sexual Offender Registry Information (SORI) check;
          • Credit history check;
          • RMV/DMV driving record, if required.

4.3 Medical Clearance Process: includes ROHP evaluation, drug screening, psychological screening, and immunization/titer level review (as determined necessary given job function) for all employees working at the NEIDL.

4.4 Training and Education: To be completed in accordance with Section 7, Ongoing Personnel Reliability Program, for all employees working at the NEIDL.

4.5 Employees are granted routine entry to spaces within the NEIDL based on their job requirements, responsibilities and training. Entry is reviewed, adjusted, and occurs during recertification of compliance with requirements identified above.

4.6 Entry Approval from NEIDL Leadership (NEIDL Director, Director of Operations, Chief Safety Officer): Required for unescorted entry to the NEIDL.

5 Suitability Requirements for Employee Entry to the NEIDL with access to Select Agents

The requirements as listed below are in addition to all requirements for entry as specified in section 4. These requirements apply to the initial hiring for all employees who require select agent access. Periodic recertification of the requirements will be done at least annually or as determined necessary.

5.1 Department of Justice Criminal Background Check and Fingerprinting: To be completed in accordance with CDC requirements as part of application to have access to Select Agents.

5.2 Select Agent Use Approval: to be completed in accordance with all regulations including the requirements of the BPHC, IBC, and CDC.

6 Suitability Requirements for Visitor Entry to the NEIDL

Applies to individuals who may require access to the NEIDL but who are not employees of BU.  If access requirement is infrequent, these individuals will be classified as visitors and supervised at all times by the sponsoring authorized NEIDL employee or his/her designee. If subsequent access becomes more regular, the visitor will undergo appropriate background and clearance checks as defined in Sections 4 and 5, as applicable. Authorization for all non-employee access will be granted by Public Safety upon completion of written request and approval by those authorized to grant entry (Appendix 4)..

Public Safety will coordinate, when necessary, with EHS upon receipt of a request for access related to non-employees. EHS will address all issues related to risk assessment, decontamination, equipment availability as well as appropriate training related to these individuals.

6.1 Visitors: As a complex research facility, many individuals may need or desire the ability to visit with colleagues in the building. These may include, visiting scientists or other professionals, students, reporters, etc. Other visitors may also  include emergency responders, officials with regulatory agencies and vendors,

      • External visitors may have an invitation from a NEIDL staff member.  Names and other identifying information shall be provided to Public Safety in advance by filling out a Visitor Request form. Twenty-four (24) hour notice for processing will expedite visitor access to the NEIDL. Up to two weeks may be required for visitors for foreign nationals.
      • All visitors are required to present government issued photo identification for the verification of identity.
      • Visitors will be provided with a “Visitor Badge” that identifies the individual as a visitor. The badge will have an expiration date. The information required for issuance of a badge is determined by Public Safety and collected via an access-request form.
      • All visitors shall review a basic safety and security guidance form provided by Public Safety.
      • Visitors shall be accompanied at all times by an authorized staff member of the NEIDL, unless the visitor has been granted unescorted access.

6.2 Other Visitors: The NEIDL is intended to be a center of national prominence in infectious diseases research; therefore it is likely that the NEIDL will hold scientific seminars, conferences and other educational programs (e.g., the Simulator Training). Attendees of meetings will be permitted to gain entry to the lobby area which includes the seminar room, restrooms and if needed the training simulator.

    7 Ongoing Personnel Reliability Program

    On an ongoing basis, BU will manage a safe and secure environment utilizing a number of programs designed to support employees and ensure the reliability of those granted access. It is essential that the programs support the employees, provide training and guidelines related to monitoring activities and expectations, and provide plans for those that are temporarily or permanently denied access to NEIDL facilities addressed in this policy.

    The ongoing personnel reliability program provides risk assessment tools and a risk assessment process that will:

          • promote reporting of safety and security concerns based on a culture in the NEIDL of trust, respect, cohesiveness, and responsibility;
          • enable NEIDL leadership to make timely operational decisions consistent with the highest standards of personnel reliability; and
          • strike the appropriate balance between personal privacy and NEIDL safety and security.

    The emphasis of the program is to provide tools for employees to be able to recognize behaviors and conditions that may be detrimental to a safe and secure working environment (see Appendix 5) as well as an environment for reporting such situations in a manner that is supportive and free from fear of reprisal.

    The process focuses on:

          • providing training and guidelines related to monitoring activities and expectations;
          • assessing NEIDL employees’ behavioral suitability, reliability and willingness to comply with the heightened security and safety procedures required within the NEIDL;
          • assessing employees’ acceptance of responsibility with respect to safety and security requirements as well as adherence to all other  Boston University policies and procedures; and
          • providing plans for those that are temporarily or permanently denied access to NEIDL facilities.

    It is expected that all NEIDL staff will participate actively in helping to create and support a culture of safety.

    7.1 Training: All employees with access to the NEIDL will receive annual training designed to enhance their awareness of NEIDL processes and procedures related to security and safety, thereby enabling employees to effectively recognize and report behavioral changes that may affect an individual’s ability to perform his or her job in a safe and secure manner. The training will focus on:

    7.1.1 Insider threat awareness (to include both physical and informational security);

    7.1.2 NEIDL policy on ongoing suitability assessment and monitoring procedures;

    7.1.3 Behaviors of concern as they relate to the personnel suitability assessment;

    7.1.4 Self and peer reporting procedures;

    7.1.5 Corrective actions, procedures and policies; and

    7.1.6 The voluntary opt-out process afforded to specific employees at the NEIDL.

    7.1 Training:

    There are three essential components of the NEIDL personnel reliability screening:

    7.2.1 Annual evaluation through a structured interview to identify potential signs and symptoms of behavioral risks resulting from medical, psychological, or social changes which may have occurred since the initial pre-access assessment, and which may otherwise threaten an employee’s ability to safely carry out assigned duties. (See Section 7.3 below for more detail)

    7.2.2 Self and peer recognition and reporting of behavioral changes or issues of concern. (See Section 7.4 below for more detail)

    7.2.3 Utilization of a Personnel Suitability Team (PST) to receive and evaluate concerns of safety and security brought forth by the various mechanisms including outcomes of the annual evaluation, self-reporting by employees, or peer-reporting, as described below, and to render a decision as appropriate. (See Section 8.5 below for more detail)

    7.3 Employee Annual Evaluation through Structured Interview

    On an annual basis Research Occupational Health Program (ROHP) will conduct a medical and behavioral assessment designed to address behavioral issues that may impact working in the NEIDL. During the assessment the employee will be given the opportunity to discuss his or her views regarding safety and security as well as share any concerns about working in the NEIDL. ROHP will notify the Personnel Suitability Team if there are behaviors of concern or if there has been a change in behavior based on previous annual assessments.

    7.4 Self or Peer Reporting

    7.4.1 Self-Reporting

    All staff will be trained annually on the self-reporting process and the ways in which the process is designed to minimize adverse effects on the employee who self-reports. Employees will be encouraged to self-report to the PST, their supervisor, or ROHP any issues or concerns which they feel may impact their ability to safely perform their assignments, thereby posing risk(s) to the safety and security of the NEIDL. Depending on the type and nature of self-reported instances, referrals to the Office of Staff Assistance or other third party resources may be appropriate. Opt-Out Process

    The Opt-Out Process is applicable to work with tier 1 agents and is available only to those employees whose work involves or impacts the security of high-risk agents, either through access to space or systems and applies to their work directly in that environment.

    The Opt-Out Process is intended to be remedial rather than punitive in nature.  It is aimed at promoting responsible conduct by allowing employees to opt-out of certain assignments due to a) medical condition, b) current emotional or personal crisis, c) highly stressful situations currently impairing the employees’ ability to perform in adherence with biosafety standards, or d) life changing events. The employee may self-report and request the opt-out process to their Supervisor, ROHP, or any member of the Personnel Suitability Team. The PST will solicit input from the Supervisor before recommending appropriate next steps.

    Opt-Out Process is available to the following positions:

          1. All staff with physical access to BSL-3 space
          2. All staff with physical access to BSL-4 space
          3. All staff supporting those operations with physical or technological access to BSL-3 and BSL-4 space or systems, including
            • Environmental Health & Safety staff with access to the NEIDL
            • Public Safety staff with access to the NEIDL
            • Facilities Management & Planning staff with access to the NEIDL
            • Control Center and Systems staff with access to NEIDL automation systems (security and building)
            • Access and Audit staff with access to NEIDL card and biometric systems
            • IT staff with access to NEIDL systems including inventory
          4. All others with access to systems, high & maximum containment space or mechanical spaces supporting the NEIDL.

    In enhancing a culture of safety through self-reporting, employees’ reasons for the opt-out are kept confidential to the extent permitted by the law and the University’s policies. Employees must sign an acknowledgment of the opt-out decision, whereby they agree to the length and conditions to be met for them to return to normal duties. During the opt-out period, the employee’s access to or within the NEIDL will be restricted based upon the nature and extent of the opt-out period. Employees may be temporarily assigned other job duties and responsibilities during the opt-out period without loss of wages or benefits.

    Upon expiration of the time period, employees will be required to complete and sign a “Return to Work Request”, whereby they attest their ability to resume normal work duties.  Employees may also be required to undergo a formal fitness for duty assessment. The Return to Work Request and assessment, if applicable, will be reviewed by the PST with input from the employee’s supervisor.

    A key goal of the annual training on the opt-out process is to prevent stigmatization of this process by emphasizing that there is no punitive impact, and educating employees that this process does not bear any negative connotations. However, it is assumed that the need to use the opt-out process will be infrequent; if an employee uses it frequently (e.g., more than once per year or consecutively over several years), it may trigger a review by the PST and possibly result in permanent reassignment of duties if that option exists.

    7.4.2 Peer and Supervisor Reporting

    During initial and annual training, employees will learn that peer reporting of “behaviors of concern” is a responsibility of each employee, as it is a key component of maintaining individual and laboratory team safety.  Peer reporting is inclusive of supervisors, and also colleagues within and outside of the employee’s department.  Reporting should be based on specific, contemporaneous observations concerning changes in behavior, speech, appearance, and/or personal or professional interactions of the employee in a workplace setting.

    During training, a sample of job-related behavioral change indicators (Appendix 5) will be provided to all employees with access to the NEIDL. A NEIDL employee who observes any of these indicators must communicate the concerns to a member of the NEIDL Personnel Suitability Team, their Supervisor, or ROHP. All concerns that are directed to ROHP or Supervisors are brought to the PST. Upon receiving a report of concerns, the PST representative will assess the severity of the situation and consult other members of the team, as deemed necessary, to help formulate an appropriate and fair response. For immediate and imminent threat/risk, the representative will notify the Responsible Official to discuss access removal. Regardless of perceived or real severity of the report, all reports will be shared with the PST on a regular basis.  The details of cases should remain confidential within the PST to the extent permitted by the law and the University’s policies.

    7.5 Personnel Suitability Review Team and Decision-Making Process

    The PST is appointed by the AVP, Research Compliance, is chaired by the Chief Safety Officer and includes the NEIDL Director, Responsible Official, NEIDL Director of Operations, NEIDL Public Safety Core Director, Human Resources Director and the Research Occupational Health Officer/Medical Director or their designees.  The Office of General Counsel and the Office of the Ombuds may be consulted for advice when needed.

    Upon receipt of each case necessitating further review/investigation (from the ROHP’s annual behavioral interview or from either the peer or self-reporting process), the PST shall review the facts and perform a risk assessment of the extent to which the behavior impacts the overall suitability and safety of the NEIDL. The PST will issue a recommendation which may include:

          • A requirement of additional training:
          • Temporary access restriction from NEIDL and/or temporary reassignment to a non-lab environment within the NEIDL.
          • Permanent revocation of NEIDL access.

    The Associate Vice President for Research Compliance will serve as the Reviewer (REV), as defined by the Federal Select Agent Program (HHS; CDC).  The duties of the Reviewer include monitoring the personnel suitability assessment program and reviewing warranted suitability actions. The PST will forward their recommended decisions to the REV for final approval. On a routine basis, not less than semi-annually, the PST will meet to monitor the overall ongoing personnel suitability and reliability program.

    Except in cases of immediate concern for safety and security, whenever the decision is made to temporarily reassign the employee, the employee shall be notified of the decision in writing, as soon as practicable, outlining the reasons for the restriction of entry. Upon completion of the temporary reassignment, the employee will be required to undergo additional training with regards to safety and security. If appropriate, employees will be encouraged to use the services of the Faculty and Staff Assistance Office as a support vehicle to manage life stressors in a confidential, supportive, and respectful environment.

    Whenever the suitability concerns are serious enough to warrant permanent removal of entry due to the gravity of the safety or security violation committed, or due to an employee’s inability to safely perform his/her duties, the Associate Vice President for Research Compliance will include the Medical Campus Provost, Office of the University Provost and/or the Office of Human Resources as appropriate to review and concur with the decision of the PST before it is final and will also consider the implications of the decision for the future continued employment of the employee at issue. The Responsible Official will remove the employee from the NEIDL Federal Select Agent Registration if applicable.

    See Appendix 6 for responsibilities of PST

    8 Appeals Process

    Appeals to determinations of suitability and reliability requirements are available at all levels of approval processes.

    8.1 Appeals related to suitability requirements performed by Public Safety will be reviewed by the Executive Director and/or Deputy Director of Public Safety and a final determination related to personnel suitability will be made.

    8.2 Appeals related to suitability requirements performed by Human Resources will be reviewed by the Director of Human Resources and a final determination related to personnel suitability will be made.

    8.3 Appeals related to suitability requirements performed following the completion of the Public Safety/Human Resources Review will be reviewed by the Executive Director and/or Deputy Director of Public Safety and the Director of Human Resources and a final determination related to personnel suitability will be made.

    8.4 Candidates for entry who have satisfactorily completed all required Public Safety and Human Resources requirements will proceed to Research Occupational Health. Appeals related to suitability requirements performed by ROHP will be reviewed by the BU Occupational Health Officer and a final determination related to personnel suitability will be made.

    8.5 Upon completion of all suitability requirements a final review of candidates will be performed by the PST.

    8.6 Appeals related to denial at the final stage described in section 9.5 above will be reviewed by the Associate Vice President for Research Compliance (REV) in consultation with the Director of the NEIDL, Medical Campus and/or University Provost, Associate Provost for Research , and Human Resources.

    9 Final Authority

    Final authority for decisions related to personnel suitability and reliability will reside with the Associate Vice President for Research Compliance.

    10 Safety

    The NEIDL has designated individuals to be responsible for Environmental Health & Safety and Public Safety programs and to serve as Responsible Officials as required by a variety of regulatory agencies and / or internal policies. These individuals are responsible for programs defined to ensure a culture of safety throughout the NEIDL.

    10.1 Environmental Health & Safety: will be responsible for the ongoing management of policies and procedures, regulations, requirements, standards and guidelines related to a safe and compliant environment as defined by local, state and federal agencies or as determined best practice by professional groups expert in the oversight of research. EHS will also provide for the safe management of all waste streams and the oversight of compliance with regulations related to discharge and will do so in collaboration with the Office of Facilities Management and Operations.

    10.2 Training: It is expected that employees will undergo mandatory training on an annual basis or as determined necessary by the requirements in this policy. Training programs will be scheduled to ensure that employees have adequate notice and opportunity to successfully complete those programs in a timely fashion. Failure to complete programs will result in notification to the Personnel Suitability Specialist so that building access system can be restricted until training is completed.

    10.3 Lessons Learned: This policy will be reviewed and updated as necessary in order to reflect standards that reflect best practices. It is expected that ongoing collaboration with similar laboratories will provide opportunities for improvement on an ongoing basis.

    10.4 Personal Absences: It is expected that employees will request personal absences that impact the operations of the NEIDL for short or long periods of time. Such absences will be accommodated with the safety of the facility and those within it as the primary concern.

    10.5 Inspections: Environmental Health and Safety, Facilities Management and Operations, and Public Safety will inspect the environment including equipment and systems, employee practices and work spaces, policies and procedures, and for general safety concerns on an ongoing basis and will do so with the research teams in each space to ensure an atmosphere of safety and collaborative improvement of the operations.

    10.6 Public Education and Relations: Corporate Communications and Community Relations will be integrally involved in all ongoing safety initiatives, improvements, and issues to ensure transparency in communications with the community and general public.

    10.7 Public Safety: will be responsible for verifying with EHS, HR, ROHP and within PS that requirements related to initial suitability checks and  ongoing reliability checks have been met as a condition of providing approved levels of access (Appendix 4).

    11 Roles & Responsibilities

    Note: The roles and responsibilities defined below are intended to identify the operational responsibilities of each unit. The Director of each unit bears ultimately responsibility for the activities for that unit. The Director may delegate the responsibility to an individual in writing. The Director must notify and receive approval from the Director of Human Resources/Medical Campus and the RO prior to the delegation of authority/responsibility.

    11.1 NEIDL Leadership (NEIDL Director, Director of Operations, Chief Safety Officer): Responsible for the overall management of all operations in the NEIDL. In addition NEIDL Leadership will have the ultimate responsibility for approving requests for entry permissions to the NEIDL and the use of space within the NEIDL.

    11.2 The NEIDL Director: Responsible for the overall management of all research operations and initiatives and the determination of who should be allowed access to the facility and the allocation of laboratory space in order to meet that strategy.

    11.3 Director of Operations: Responsible for the physical environment as well as the  infrastructure and protective measures that support that environment.

    11.4 Chief Safety Officer:Responsible for all aspects of the health and safety of employees and visitors. This includes training, permits, hazardous materials transportation requirements, inspections and registrations (e.g. Select Agent). ). The Chief Safety Officer will have the ultimate responsibility for approving requests for entry permissions to BSL-3 and BSL-4 lab space based on approvals by the Responsible Official and Alternate Responsible Officials / BioSafety Officers and recommendations from NEIDL Training Advisory Committee (NTAC).

    11.5 Executive Director of Public Safety or designee: Responsible for complete review of the entry and permission application process to determine appropriate levels of entry to the NEIDL site and laboratories within the NEIDL

    11.6 Director of ASC or designee: In conjunction with the Institutional Animal Care and Use Committee (IACUC), has the authority to approve requests for entry to any facility where animals are housed or where research on animals is conducted (e.g. procedures room, laboratories).

    11.7 Director of Facilities: Responsible for approving requests for entry to any areas where building infrastructure (e.g. HVAC, electrical) is located or could be accessed.

    11.8 Principal Investigator: Responsible for requesting permission for granting entry to the NEIDL or accessing Select Agents.

    11.9 Public Safety Personnel Suitability Specialists:  Responsible for the confirmation of all approvals and the issuance of access permissions (Access Card and biometric access), the management of temporary visitor pass systems, the audit of access systems, and the management of access and entry permissions on an ongoing basis.

    11.10 Associate Vice President of Research Compliance: Responsible for ensuring that all research in the NEIDL is conducted in accordance with the requirements of all applicable regulations, including the Boston Public Health Commission’s Laboratory Registration Regulation. The Associate Vice President for Research Compliance is also the Reviewer under the provisions of the Select Agent Rule as described.

    11.11. Executive Director of Talent Management, Human Resources: Responsible for overseeing the development and grading of job descriptions, posting of positions, recruitment of qualified candidates, communication with job applicants, ensuring proper conduct of background checks for each position, arranging for pre-employment and post-employment occupational health screening and surveillance, extending offers of conditional and unconditional employment, and ensuring proper compensation. Human Resources, in conjunction with the Public Safety Personnel Suitability Specialist, will coordinate procedures to ensure background checks for each position are properly conducted, identify and address employees who do not meet ongoing employment standards, and manage and secure background check related documents. The Medical Campus Director of Human Resources serves as the Certifying Official (CO) under the provisions of the Select Agent Rule.

    11.12 Individual with access:  All individuals who have been granted access are responsible for following all the terms and conditions of such access at all times.

    12 Special Requirements

    In general, working with hazardous materials (biological, chemical or radiological) is subject to specific safety and security requirements. Working in the NEIDL and/or with Select Agents is subject to additional special requirements that may not be requirements for work in other laboratory facilities. All individuals who are granted entry to enter the NEIDL must meet relevant additional “Special Requirements” described in this Section before being granted such entry.

    12.1 Safety and Training Requirements

    Entry into the NEIDL and areas within the NEIDL are subject to strict health, safety, security and training requirements. The specifics of these requirements (e.g. training, personnel protective equipment, clearances, monitoring, medical surveillance) will vary depending on a number of factors such as:

          • The locations for which the individual has been granted permission to enter;
          • The hazardous materials with which the individual works with or has access to;
          • Laboratories for which the individual has been approved to enter.

    12.2 Training: Conducted in accordance with NEIDL training SOP requirements.

    12.3 Personal Protective Equipment (PPE): The type and extent of PPE required will be in accordance with EH&S policies and procedures.

    13 Applicable Locations

    This policy applies to all areas and operations of the NEIDL as well as other Boston University laboratories that are governed by the Select Agent Rule.

    14 Procedures and Instructions

    14.1 Request for Entry to the NEIDL: All persons requesting entry to the NEIDL shall submit a NEIDL Access Card Request Form to the NEIDL Personnel Suitability Specialist.

    14.2 Issuance of Access Card: Once approved by the Public Safety Personnel Suitability Specialist an Identification/Access Card will be issued and biometric registration will be conducted as applicable.

    14.3 Ongoing Entry Authorization: Access Cards are the property of Boston University and continued possession of such cards and continued entry to areas is contingent on continued compliance with the requirements in this policy. Similarly, continued access / entry through biometric security access systems requires the same continued compliance.

    14.4 Removal of Access/Entry Authorization: The Public Safety Personnel Suitability Specialist will conduct random checks of compliance with the requirements in this policy as summarized on Appendix 1 and will revoke or limit access / entry for those who fail to maintain the requirements as described in this policy.

    15 Forms: Public Safety Access Request Forms for Vendors and Visitors

    16 Records Management

    16.1 All Access Card Request forms will be kept in a safe and secure manner and will be retained by Public Safety for a minimum of three years.

    16.2 EH&S will be responsible for maintaining records of all training provided.

    16.3 ROHP is responsible for maintaining records of all medical surveillance.

    18 SOP Revision History

    VersionSection / Paragraph ChangedChanges MadeEffective Date
    V.1N/ANone, Original Version11/9/10
    V.28Included ongoing monitoring program3/7/14
    V.3AppendixAddition of two appendices9/17/14
    V.4ThroughoutUpdated roles and clarification of language, removal of two appendices07/06/21


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