Personnel Suitability and Reliability Policy – National Emerging Infectious Diseases Laboratories The NE...
Current Version: 3.0
Implementation Date: November 9, 2010
Last Reviewed/Update Date: September 17, 2014
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 access 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.
1 Purpose and Scope
The purpose of this document is to establish policies and procedures to ensure the suitability of personnel granted access 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. Access 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 access 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 access 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 3.20).
1.3 Public Safety Personnel Suitability Specialists (see Section 12.7) will be responsible for granting access to the NEIDL site and approved areas within the NEIDL facility at approved times. Access will be granted only upon successful completion of all clearance requirements contained within this policy. All personnel granted access will be subject to on-going access 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. The document, Background Check Procedures for the National Emerging Infectious Diseases Laboratories, details how all initial background checks will be conducted.
1.5 The NEIDL Director and Associate Directors, 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 8) 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 biosecurity 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.
2.1 Regulations: this policy will include regulations associated with federal, state and local regulations pertaining to access 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 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): Access to the facility will also be subject to additional requirements such as initial and periodic training, medical surveillance, and respiratory protection.
3.1 “Access”: Unless otherwise specifically defined in a section of this policy, shall refer to entering a perimeter, building or room of the NEIDL.
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 access 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 “IBC”: Institutional Biosafety Committee, the oversight committee charged with review and approval of all uses of biohazardous materials and toxins.
3.9 “EHS”: Environmental Health and Safety.
3.10 “Entry”: defined as the ability to physically enter the NEIDL perimeter or building.
3.11 “Laboratory”: Defined as a single room or suite of interconnected rooms where research is conducted.
3.12 “Ongoing Personnel Reliability Program”: A program of continuous monitoring of, and by, employees in the NEIDL to ensure the maintenance of a safe environment.
3.13 “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).
3.14 “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.
3.15 “PI”: Refers to the Principal Investigator, responsible for the activities in a given laboratory area.
3.16 “Reviewer”: Refers to the Reviewer (REV) as required in the Select Agent Rule.
3.17 “RO”: Refers to the Responsible Official as required in the Select Agent Rule.
3.18 “ROHP”: Research Occupational Health Program.
3.19 “Select Agent”: Select Agents, or specifically regulated pathogenic material under other restrictions as defined under 42 CFR 73.0, that have the potential use in the production of biological weapons.
3.20 “Two Person Guideline”: Intended to mitigate safety and security risks associated with individuals working in BSL-3 and BSL-4 restricted access areas not easily accessible to coworkers 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 high containment areas. Security systems including strict access control, CCTV (closed-circuit television), and safe operation protocols will be used to audit compliance.
The two person guideline is applied as follows:
3.20.1 BSL-4 Select Agent laboratories: access to these areas at all times will require two authorized individuals in the same high containment area at all times. Such an area may be a single room, lab, suite or buffer zone (changing areas).
3.20.2 BSL-3 Select Agent laboratories: access to these areas at all times will require two authorized individuals in the same laboratory space. Such an area may be a single room, lab or suite. Access will be allowed for individuals when all agents are properly secured for the purposes of laboratory support such as the care for animals. In such cases Public safety will conduct live CCTV monitoring for the entire time the individual is in the designated area.
3.20.3 BSL-3 non-select agent and BSL-2 laboratories will not be subject to the two person guideline.
3.21 “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 of the NEIDL who require direct access to Select Agents;
- Internal faculty and staff who work outside the NEIDL but require direct access to Select Agents at the NEIDL;
- Employees who have, or may be required to have, indirect access to Select Agents, including but not limited to those employed in Animal Sciences, Environmental Health & Safety, Facilities Management, and Public Safety.
NOTE: “Access” is defined under Public Health regulations related to Select Agents 42CFR-73 Part 73.10 as ‘‘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.’’
These requirements apply to the initial hiring for all employees. Periodic recertification of the requirements will be done 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).
4.1 Criminal Background Check: To be completed in accordance with BU Public Safety guidelines and all federal, state and local laws and regulations.
4.2 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.
4.3 Basic Background Check: Includes, but is 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.
4.4 Medical Clearance Process: includes Research Occupational Health Program ROHP is part of the ... evaluation, drug screening, initial psychological screening, and immunization/titer level review completed in accordance with NEIDL Medical Surveillance Policy for all employees working at the NEIDL.
4.5 Select Agent Use Approval: to be completed in accordance with all regulations including the requirements of the BPHC, Institutional Biosafety Committee The IBC is an instituti... and CDC.
4.6 Training and Education: to be completed in accordance with Section 8, Ongoing Personnel Reliability Program, for all employees working at the NEIDL.
4.7 Access Approval from Office of the NEIDL Director: Required for access to any research space within the NEIDL.
5 Suitability Requirements for Employee Access to the NEIDL with no access to Select Agents
The requirements as listed below are specific to:
- Employees who will require access to the NEIDL with no access to Select Agents;
- Employees and staff who are not assigned to the NEIDL but may require access to space therein.
NOTE: “Access” is defined under Public Health regulations related to Select Agents 42CFR-73 Part 73.10 as ‘‘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.’’
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).
5.1 Criminal Background Check: To be completed in accordance with BU Public Safety guidelines and all federal, state and local laws and regulations.
5.2 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.
5.3 Medical Clearance Process: includes ROHP evaluation, drug screening, initial psychological screening, and immunization/titer level review (as determined necessary given job function) for all employees working at the NEIDL.
5.4 Training and Education: To be completed in accordance with Section 8, Ongoing Personnel Reliability Program, for all employees working at the NEIDL.
5.5 Access Approval from Office of the NEIDL Director: Required for access to any research space within the NEIDL.
6 Authorization for all Employees Requiring Access to the NEIDL
6.1 Routine Employee Entry: Granted based on the individual’s need to routinely enter areas within the NEIDL site. Is reviewed, adjusted, and occurs as determined necessary during recertification of compliance with requirements in Section 4 and 5.
All access permissions will be granted based on the approved hours of operation for the individual, laboratory, or activity.
Access authorization will be granted to distinct groups including:
6.1.1 Approved Investigators and Research Staff working with Select Agents: Access granted for administrative and research space specific to an individual’s work and/or responsibilities must be in accordance with both the Two Person Guideline in areas where required and with the agent and/or laboratory specific protocols.
6.1.2 Approved Investigators and Research Staff working without Select Agents: Access granted for administrative and research space specific to an individual’s work and/or responsibilities.
6.1.3 Environmental Health and Safety Staff: Access granted for all administrative, general, research, and specific mechanical spaces (e.g. HEPA filter areas, liquid waste disposal tanks, etc.) where the individual’s presence is required for inspection or monitoring purposes.
6.1.4 Emergency Response Team (may include staff members of units defined elsewhere in this section): Access granted for areas within the NEIDL perimeter and specific locations of the building for which the team has been trained, where appropriate medical clearances have been given, and upon emergency response access activation.
6.1.5 Animal Care Staff: Access granted for animal housing areas, procedures rooms and research labs where approved animal related work is conducted.
6.1.6 Public Safety Staff: Access granted for administrative and other general space (including mechanical/electrical rooms), for all perimeter access to the site and building including laboratories, to conduct investigations with appropriate training.
6.1.7 Facilities Staff: Access granted for mechanical, administrative and other general space as required by job task/function.
6.1.8 Administrative Staff: Access granted only during authorized hours of operation for administrative space to which an individual is assigned.
6.1.9 Other Staff: Access granted to other BU employees (e.g., public affairs, Deans, Department Chairs, collaborating faculty, etc.) who may periodically need entry to the NEIDL. Access is granted on a case by case basis and as the individual is considered a visitor in compliance with the requirements set forth in Section 7.5 below.
7 Suitability Requirements for Non-Employee Access 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. Authorization for all non-employee access will be granted by Public Safety upon completion of written request and approval by the Director of the NEIDL.
Public Safety will coordinate with Environmental Health & Safety 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.
The following is the basic criteria for granting permission for such access:
7.1 Emergency Responders (external): Access permitted while accompanied at all times by an authorized staff member of the BU Emergency Response Team. Access is limited to areas for which the individual has appropriate training and will not include BSL-4 areas.
7.2 Regulatory Agencies: Access permitted while accompanied by appropriate members of NEIDL Cores, depending on the nature of the visits (e.g. EHS for BPHC, The Animal Science Center manages and oversees animal-relate... for United States Department of Agriculture, etc.). Access is limited to areas for which the individual has appropriate training and will not include BSL-4 areas.
7.3 Vendors (on contract): Unescorted access permitted to areas designated within the scope of work in the contract/service agreement in accordance with Sections 5.0. 5.1, 5.2, 5.4 and 5.5 of this document. A contract vendor’s access will be restricted to administrative areas, mechanical areas and to BSL-1 and BSL-2 facilities. BSL- 3 and BSL -4 contract work will be supervised by appropriate NEIDL personnel and will require a written request (a form available from Public Safety) from the Principal Investigator View Boston University's policy on... for access to the laboratory. Contract vendors will be subject to the established training requirements.
7.4 Vendors (non-routine): Access permitted while accompanied at all times by an authorized staff member from Facilities and/or Public Safety. Non-routine vendor access will be restricted to BSL-1, BSL-2 and BSL-3 facilities and will require a written request (a form available from Public Safety) from the PI for access to the laboratory. The non-routine vendor will be subject to the established training requirements.
7.5 Visitors: Visitors to the facility will generally fall under four broad categories Dignitaries, Collaborating Scientists (External) with access to Select Agents, Collaborating Scientists (External) with no access to Select Agents, and Other Visitors.
- External visitors must have an official invitation from the NEIDL Director, NEIDL Associate Director, or Principal Investigator. Names and other identifying information must 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.
- All visitors are required to present government issued photo identification for the verification of identity and a comparison against available public safety databases.
- 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 must attend a basic safety and security orientation session.
The specific requirements for the four categories as described below:
7.5.1 Dignitaries: A broad category of visitors who might visit the facility for general interest and may include elected officials, media representatives, foreign government officials, industry leaders, etc. Access permission for these individuals must be requested by the Director of the NEIDL, the Associate Directors, and/or other appropriate NEIDL members (e.g. Community Relations, etc.). Visitors will be supervised at all times by the sponsoring authorized NEIDL employee or his/her designee. Prior to a tour of the facility, dignitaries will be provided instructions for specific safety and security requirements.
7.5.2 Collaborating Scientists (External) with access to Select Agents: Scientists who are not employees of BU but are collaborating on scientific programs with colleagues working in the NEIDL. Collaborating scientists will be supervised at all times by the sponsoring authorized NEIDL employee or his/her designee. Permission for individuals to access the NEIDL facility will be subject to:
126.96.36.199 Written request from the NEIDL collaborating PI and the NEIDL Director. A request form is available from Public Safety.
188.8.131.52 Meeting all requirements established for employees being granted access to the NEIDL facility as established in Section 4 above.
184.108.40.206 Access to any laboratory must be approved in accordance with the requirements of the specific laboratory (e.g. BSL level, animal, Select Agents, etc.).
7.5.3 Collaborating Scientists (External) with no access to Select Agents: Scientists who are not employees of BU but are collaborating on scientific programs with colleagues working in the NEIDL. Collaborating scientists will be supervised at all times by the sponsoring authorized NEIDL employee or his/her designee. Permission for individuals to access the NEIDL facility will be subject to:
220.127.116.11 Written request from the NEIDL collaborating PI and the NEIDL Director through a form available from Public Safety.
18.104.22.168 Meeting all requirements established for employees being granted access to the NEIDL facility as established in Section 5 above.
22.214.171.124 Access to any laboratory must be approved in accordance with the requirements of the specific laboratory.
7.5.4 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 enter the facility based on pre-registration and pre-approval for such events. Attendees of meetings and programs will have restricted access and will be allowed to enter approved areas only. Visitors will be supervised at all times by the sponsoring authorized NEIDL employee or his/her designee. This category also includes research subjects.
7.5.5 Collaborating Scientists (Internal): The NEIDL is an integral part of the Boston University research enterprise. Since many of the NEIDL Investigators have collaborative programs with various scientists at both the Medical Campus and the Charles River Campus, it is essential that these individual collaborators are able to visit their colleagues at the NEIDL with minimal notice while maintaining the principals of safety and security. These individuals will be screened and presented and allowed access to ground level seminar space using their Boston University issued Identification “Terrier” Card.
8 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 Boston University’s Professional Standards of Conduct and 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.
8.1 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:
8.1.1 Insider threat awareness (to include both physical and informational security);
8.1.2 NEIDL policy on ongoing suitability assessment and monitoring procedures;
8.1.3 Behaviors of concern as they relate to the personnel suitability assessment;
8.1.4 Self and peer reporting procedures;
8.1.5 Corrective actions, procedures and policies; and
8.1.6 The voluntary opt-out process afforded to specific employees at the NEIDL.
8.2 Components of the NEIDL personnel reliability screening
There are three essential components of the NEIDL personnel reliability screening:
8.2.1 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 8.3 below for more detail)
8.2.2 Self and peer recognition and reporting of behavioral changes or issues of concern. (See Section 8.4 below for more detail)
8.2.3 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)
8.3 Employee Annual Evaluation through Structured Interview
On the annual anniversary date of the employee’s initial access to the NEIDL, the Research Occupational Health Program (ROHP) will conduct a medical and behavioral assessment designed to address behavioral issues that may impact safety and security of 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.
8.4 Self or Peer 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.
126.96.36.199 Opt-Out Process
The Opt-Out Process is available only to those employees whose work involves or impacts the security of high-risk agents, either through access to space or systems. These positions include:
- All staff with physical access to BSL-3 space
- All staff with physical access to BSL-4 space
- All staff supporting those operations with physical or technological access to BSL-3 and BSL-4 space or systems, including:
All others with access to systems, high & maximum containment space or mechanical spaces supporting the NEIDL.
- 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
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.
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 will 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.
8.4.2 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.
8.5 Personnel Suitability Review Team and Decision-Making Process
The PSRT includes the NEIDL Director, NEIDL Associate Directors, NEIDL EHS Core Director/Chief Safety Officer/Responsible Official, NEIDL Public Safety Core Director, BUMC Human Resources Director, Research Occupational Health Officer/Medical Director, NEIDL Infection Control Director, and the Executive Director of Research Compliance, 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 PSRT 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 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, outlining the reasons for the removal of access. 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 access 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 Provost of the Medical Campus and the Office of Human Resources must 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.
See Appendix 6 for responsibilities of PSRT
9 Appeals Process
Appeals to determinations of suitability and reliability requirements are available at all levels of approval processes.
9.1 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.
9.2 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.
9.3 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.
9.4 Candidates for access 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.
9.5 Upon completion of all suitability requirements a final review of candidates will be performed by the PST.
9.6 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 and Associate Directors of the NEIDL, the Medical Campus Provost, and Human Resources.
10 Final Authority
Final authority for decisions related to personnel suitability and reliability will reside with the Associate Vice President for Research Compliance.
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.
11.1 Research 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.
11.2 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.
11.3 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.
11.4 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.
11.5 Inspections: Environmental Health and Safety, Facilities Management and Planning, 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.
11.6 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.
11.7 Public Safety: will be responsible for the verification of the successful completion of requirements related to initial suitability checks, ongoing reliability checks, and compliance with safety standards through the management of all key, card and biometric access systems and will have the responsibility to ensure that the physical security environment is maintained to designed standards.
11.8 Environmental Management: will 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 Planning.
12 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.
12.1 The NEIDL Director: Responsible for the overall management of all administrative and financial operations in the NEIDL. In addition the Director will have the ultimate responsibility for approving requests for access permissions to the NEIDL and the use of space within the NEIDL.
12.2 Executive Director of Public Safety: Responsible for complete review of the access and permission application process to determine appropriate levels of access to the NEIDL site and laboratories within the NEIDL
12.3 Director of Research Safety (Environmental Health and Safety): 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 Director is also the RO under the provisions of the Select Agent Rule as described.
12.4 Director of ASC: In conjunction with the Institutional Animal Care and Use Committee (Institutional Animal Care and Use Committee IACUC oversee...), has the authority to approve requests for access to any facility where animals are housed or where research on animals is conducted (e.g. procedures room, laboratories).
12.5 Director of Facilities: Responsible for approving requests for access to any areas where building infrastructure (e.g. HVAC, electrical) is located or could be accessed.
12.6 Principal Investigator: Responsible for requesting permission for granting access to the NEIDL or accessing Select Agents.
12.7 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 permissions on an ongoing basis.
12.8 Associate Vice President for 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.
12.9 Director of Human Resources/Medical Campus: 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.
12.10 Individuals with Access: All individuals who have been granted access are responsible for following all the terms and conditions of such access at all times.
13 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 access to enter the NEIDL must meet relevant additional “Special Requirements” described in this Section before being granted such access.
13.1 Security Requirements
13.1.1 Access Card: Cards will be issued by the Public Safety Personnel Suitability Specialist upon satisfactory completion of requirements as reflected in this policy, on Appendix 7 and 8, and in the Human Resources document Background Check Procedures for the National Emerging Infectious Disease Laboratory. Access cards will include a digital photograph and must be displayed at all times in the NEIDL.
13.1.2 Biometric Iris Scanners: Each authorized and approved individual will be enrolled in the biometric access program by the Public Safety Personnel Suitability Specialist upon satisfactory completion of NEIDL access requirements as described in this policy.
13.1.3 Other: Additional equipment and materials may be issued during training sessions as required and reflected in this policy and on Appendix 7 and 8.
13.2 Safety and Training Requirements
Access to the NEIDL is subject to strict health, safety, and training requirements. The specifics of these requirements (e.g. training, personnel protective equipment, 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.
13.3 Training: Conducted in accordance with NEIDL training SOP requirements.
13.4 Personal Protective Equipment (PPE): The type and extent of PPE required will be in accordance with EH&S policies and procedures.
14 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.
15 Procedures and Instructions
15.1 Request for Access to the NEIDL: All persons requesting access to the NEIDL shall submit a NEIDL Access Card Request Form to the NEIDL Public Safety office located at 610 Albany Street. Requests shall be submitted in a timely manner to allow for processing requirements contained in Section 4 herein.
15.2 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.
15.3 Ongoing Access Authorization: Access Cards are the property of Boston University and continued possession of such cards and continued access to areas is contingent on continued compliance with the requirements in this policy. Similarly, continued access through biometric security access systems requires the same continued compliance.
15.4 Removal of Access 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 for those who fail to maintain the requirements as described in this policy.
15.5 Return of Access Cards: Access Cards will be returned to the Public Safety Office at 610 Albany Street upon completion of work that requires NEIDL access or other Select Agent access, upon termination from the University, or upon request from the Public Safety Personnel Suitability Specialist or Director of Public Safety.
16 Forms: Public Safety Access Request Forms for Vendors and Visitors
17 Records Management
17.1 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.
17.2 EH&S will be responsible for maintaining records of all training provided.
17.3 ROHP is responsible for maintaining records of all medical surveillance.
17.4 Human Resources will maintain all required background check related forms and reports in accordance with the procedures identified in the HR document, Background Check Procedures for the National Emerging Infectious Diseases Laboratories
18 SOP Revision History
|Version||Section / Paragraph Changed||Changes Made||Effective Date|
|V.1||N/A||None, Original Version||11/9/10|
|V.2||8||Included ongoing monitoring program||3/7/14|
|V.3||Appendix||Addition of two appendices||9/17/14|
Appendix 1: Quick Reference for Requirements
The National Emerging Infectious Diseases Laboratories (NEIDL) is part of a national network of secure facilities that study infectious diseases – whether they occur naturally or are introduced deliberately through bioterrorism. The NEIDL is dedicated to the development of diagnostics, vaccines and therapeutics to combat emerging and re-emerging infectious diseases. In addition to Bio Safety Level (BSL)-2 and BSL-3 laboratories, the NEIDL houses BSL-4 laboratories that will operate at the highest level of containment. The NEIDL will add to the growing life sciences industry in the region, throughout the Commonwealth of Massachusetts, and across the country.
Individuals seeking affiliation with or employment within the NEIDL may be subject to the following suitability requirements. Failure to meet any of these requirements may result in ineligibility for employment or affiliation:
- Criminal Background Check: To be completed in accordance with BU Public Safety guidelines and all federal, state and local laws and regulations.
- Basic Background Check: Includes, but is 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.
- Medical Clearance Process: includes Research Occupational Health Program (ROHP) evaluation, drug screening, initial psychological screening, and immunization/titer level review completed in accordance with NEIDL Medical Surveillance Policy for all employees working at the NEIDL.
- Training and Education: to be completed in accordance with Section 8, Ongoing Personnel Reliability Program, for all employees working at the NEIDL.
Individuals seeking or required to have approval to work with Select Agents will be subject to the following additional requirements:
- 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.
- Select Agent Use Approval: to be completed in accordance with all regulations including the requirements of the Boston Public Health Commission (BPHC), Institutional Biosafety Committee (IBC) and the Center for Disease Control (CDC).
Please note, any individual working in the NEIDL facility and granted unescorted access, is subject to
- periodic background reviews, including but not limited to: criminal background, credit history, drug screening, and behavioral evaluations;
- periodic checks and regular renewals of security credentials, any applicable licenses, and verification of the successful completion of any required training at the facility
- Search of person, clothing and effects prior to entry into or egress from NEIDL
When applicable, individuals will be required to maintain all applicable clearances and licenses and to disclose any changes in circumstances that could compromise access to the facility.
Continued employment/ affiliation is contingent upon strict adherence, at all times, to all applicable safety and security rules, procedures, and protocols, as well as required training regimens.
For additional information, please contact the Personnel Suitability Specialist at 617-414-4439.
Appendix 5 – Behavioral Change Indicators
Behavior’s that may impact an employee’s ability to perform his or her job in a safe and secure manner:
- Performance of duties declines markedly; significant increase in distraction or mistakes; increase in risk-taking behaviors; refusal to follow directions; careless or unsafe operation of equipment
- Significant changes in mood, behavior, attitudes, demeanor, or actions – e.g. increasingly withdrawn; significant and prolonged deterioration in appearance; unjustified anger or aggression; unexplained absences; signs of alcohol/drug abuse; criminal activity; and unexplained absences, sudden and/or unpredictable change in energy level
- Stated or implied threats to colleagues, institutions, the security of the NEIDL, the well-being of laboratory animals, or the general public;
- Willful non-compliance with the select agent regulations or other regulations governing sponsored research;
- Any circumstances that appear suspicious such as laboratory work that does not correspond to official project work or goals, requests for security or laboratory information without justification, acts of vandalism or property damage, attempts to gain unauthorized access for friends or colleagues;
- Providing false information on formal institutional documents • Unauthorized work performed by an individual(s) in a facility during off-hours.
- Physical and verbal abusiveness
- Inappropriate verbal response to questioning or instructions
- Extreme aggressiveness or agitation
- A pattern of untruthful or misleading statements that raise issues about the trustworthiness of the individual
- Anything that causes an individual to have concerns about his or her own ability to perform a job safely and securely