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Biosecurity Assessment Questionnaire

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Biosecurity Assessment Questionnaire

Client Name:   Assessment Provider:   Assessment Date:

RECITALS

WHEREAS, the Client operates facilities, processes, or activities that involve biological agents, materials, or organisms that may present a biosecurity risk; and

WHEREAS, the Provider possesses expertise in evaluating biosecurity practices, identifying vulnerabilities, and recommending corrective measures to reduce the likelihood of intentional or unintentional release or misuse; and

WHEREAS, the parties desire to document the scope, procedures, findings, and recommendations of a biosecurity assessment in accordance with the terms set forth below.

SCOPE OF WORK

The Provider will perform a biosecurity assessment at the Client facility described below. The assessment will include a site inspection, interviews with key personnel, review of documentation, and preparation of a written report with prioritized recommendations.

FACILITY INFORMATION

CURRENT BIOSECURITY MEASURES

Indicate whether the following measures are implemented at the facility.

Perimeter fencing
Controlled entry with badging
Vehicle checkpoints and screening

Secure storage for biological agents
Segregated workflow areas
Environmental controls and monitoring

Access authorization policies
Personnel background screening
Documented incident response plan

RISK ASSESSMENT

Describe the primary biosecurity risks identified during the assessment and the likelihood and consequence ratings:

INCIDENT HISTORY

Provide information on any security breaches, losses, unauthorized access, or near misses involving biological materials in the past five years.

TRAINING AND PERSONNEL

Describe current training programs, frequency, and recordkeeping for personnel with access to biological materials.

MATERIAL HANDLING, STORAGE, AND TRANSPORT

Describe controls for inventory, labeling, chain-of-custody, storage, and transport of regulated or sensitive biological materials.

WASTE MANAGEMENT

Describe procedures for segregation, decontamination, and disposal of biological waste.

VISITOR AND CONTRACTOR CONTROLS

Describe visitor screening, escort requirements, contractor controls, and recordkeeping.

RECOMMENDATIONS AND ACTION PLAN

PAYMENT TERMS

The Client shall pay the Provider the fees for the assessment, as described below. Fees are due in accordance with the agreed schedule. Late payments shall accrue interest as set forth below.

TERM AND TERMINATION

This Agreement commences on the Start Date and continues until completion of the services or termination by either party in accordance with this section.

Either party may terminate this Agreement for material breach if the breaching party fails to cure within the notice period above. Termination does not relieve the Client of payment obligations for work performed prior to termination.

CONFIDENTIALITY

Each party agrees that all non-public information, findings, reports, technical data, and recommendations disclosed pursuant to this Agreement are Confidential Information. The receiving party shall use Confidential Information solely for performance under this Agreement and shall protect it with at least the same degree of care it uses to protect its own confidential information, but no less than reasonable care.

Notwithstanding the foregoing, the Provider may disclose information to the extent required by law, regulation, or bona fide governmental request, provided the Provider gives the Client prompt written notice where permitted and cooperates to limit the scope of disclosure.

GOVERNING LAW

This Agreement and any dispute arising out of or relating to it shall be governed by and construed in accordance with the laws of the state indicated below, without regard to conflict of law principles.

ENTIRE AGREEMENT

This document, together with any attachments or schedules expressly incorporated herein, constitutes the entire agreement between the parties with respect to the subject matter and supersedes all prior and contemporaneous agreements, understandings, and representations, whether oral or written. Any amendment must be in writing and signed by authorized representatives of both parties.

CERTIFICATION AND ATTESTATION

The undersigned certify that the information provided in this questionnaire is true and complete to the best of their knowledge, and that any known material inaccuracies will be reported promptly to the Provider.

By checking this box, I attest to the accuracy and completeness of the information provided above.

Client:

By:

Date:

Assessment Provider:

By:

Date:

Enter text✕

What the Biosecurity Assessment Questionnaire Is

The Biosecurity Assessment Questionnaire is a standardized checklist used to collect consistent, verifiable information about laboratory and facility practices that affect biological safety and security. It documents agent inventories, access controls, training records, waste handling, incident response, and information-security safeguards. Responses support risk scoring, corrective-action planning, internal audits, grant reviews, and external assessments by regulators or funders. The form creates a written baseline that institutions use to measure improvements, demonstrate due diligence, and preserve an evidentiary trail for compliance or incident investigation purposes.

Why Use a Biosecurity Assessment Questionnaire

Use the Biosecurity Assessment Questionnaire to document biosafety controls, prioritize corrective actions, and meet institutional or federal expectations. Electronic execution is generally enforceable under ESIGN (15 U.S.C. ch. 96) and UETA; exceptions include wills, certain court orders, and other statutory exclusions.

Why Use a Biosecurity Assessment Questionnaire

Typical Users and Stakeholders

Primary users include biosafety officers, laboratory managers, institutional compliance teams, and external reviewers conducting risk evaluations.

  • Biosafety officers and compliance staff responsible for performing institutional risk assessments and remediation planning.
  • Laboratory managers documenting agent inventories, access logs, equipment maintenance, and staff training records.
  • Funders, grant reviewers, and third-party assessors verifying biosafety controls and conformity with award conditions.

Stakeholders include operations, facilities, IT, human resources, and funding or contracting officers who rely on questionnaire data for decisions.

Essential Sections Every Questionnaire Should Include

A professional Biosecurity Assessment Questionnaire groups related items so reviewers can validate controls quickly and consistently across facilities and programs.

Agent Inventory

Detailed listing of biological agents, quantities, storage location, and authorized personnel to support accountability and risk assessments.

Access Controls

Physical and logical access measures, badge systems, visitor policies, and role-based permissions that limit exposure to agents and data.

Training Records

Documentation of required biosafety, security, and incident response training for personnel, including dates and course identifiers.

Incident Reporting

Procedures for reporting exposures, spills, theft, or other security events, plus contact points and escalation timelines.

Waste & Decontamination

Protocols for biological waste segregation, sterilization, disposal, and equipment decontamination to reduce cross-contamination risk.

Records & Documentation

Location and retention of SOPs, inspection logs, maintenance records, and audit trails that support regulatory review.

Step-by-Step: Complete and Submit the Questionnaire

Follow these steps to complete and submit the Biosecurity Assessment Questionnaire accurately within your compliance cycle.

  • 01
    Gather records: Collect agent logs, SOPs, training certificates, and maintenance records before starting.
  • 02
    Complete fields: Answer each question truthfully; attach supporting documents where requested for verification.
  • 03
    Internal review: Route to biosafety officer or compliance lead for verification and required corrections.
  • 04
    Finalize and sign: Execute signatures, record dates, and save a copy for institutional records.

Typical Review and Routing Workflow

A clear routing flow reduces turnaround time and ensures accountable review by named individuals or offices.

  • Preparer: Drafts responses and attaches evidence prior to routing for review.
  • Reviewer: Biosafety officer verifies technical accuracy and flags missing items.
  • Approver: Institutional official signs and records certification for the record.
  • Records: Finalized form stored in retention system with audit metadata.

Configuring an Electronic Workflow

Configure a digital workflow to automate assignment, reminders, and audit capture for the questionnaire.

Field Configuration
Template Create reusable form template with required and conditional fields.
Approval order Set sequential or parallel routing to biosafety, facilities, then final approver.
Authentication Require email and optional SMS code or advanced signer methods for high-risk items.
Retention policy Automatically archive completed forms to secure records storage with retention tags.

Technical Considerations for eSubmission

Choose a platform that supports PDF/DOCX uploads, secure storage, and an audit trail for all signer actions.

  • File types: PDF, DOCX, XLSX supported for uploads and exports
  • Authentication: Email, SMS code, KBA, or advanced signer verification
  • Integrations: Connectors for Google Workspace, Microsoft 365, or institutional records systems

Essential Data Items to Capture

Agent list: Names and quantities
Storage locations: Freezers, shelves, rooms
Authorized personnel: Names and roles
Training logs: Course IDs and dates
Incident history: Dates and brief descriptions
Access controls: Systems and permissions

Common Preparation Errors to Avoid

  • Incomplete attachments: missing SOPs, inventory logs, or maintenance records often delay review and approval.
  • Vague entries: non-specific answers like 'adequate controls' without supporting evidence lead to follow-up requests.
  • Name mismatches: inconsistent legal or facility names create administrative obstacles for grant and regulatory processes.
  • Unauthorized signatures: lacking proper authority or missing signatory titles may render a submission invalid for compliance purposes.

Risks and Potential Consequences of Inaccurate Responses

Regulatory action: Investigations or enforcement for noncompliance
Funding loss: Grant suspension or contract termination
Operational shutdown: Facility closure pending corrective actions
Legal liability: Civil or criminal exposure in severe incidents
Data breach risk: Compromised sensitive information
Reputational harm: Loss of stakeholder trust

Typical Timing and Review Cadence

Establish deadlines for initial completion, periodic review, and incident-driven updates to keep records current.

Initial submission:

Submit with program startup or funding application deadlines

Annual review:

Conduct a full reassessment at least once per year

Post-incident update:

Update questionnaire within days after reportable incidents

Grant milestone:

Align questionnaire updates with grant reporting cycles

Ad-hoc audits:

Respond within specified timeframe in audit notices

Key Milestones and Processing Stages

Track major milestones from preparation through archival to ensure accountability and measurable progress.

01

Preparation

Collect supporting documents and complete draft responses for internal review.

02

Technical review

Biosafety officer verifies technical accuracy and flags gaps.

03

Approval

Authorized official certifies and signs the final questionnaire.

04

Archival

Store completed form and attachments in secure records with retention tags.

eSignature Vendor Pricing Snapshot for Questionnaire Workflows

Compare common vendor pricing and capabilities relevant to executing and storing Biosecurity Assessment Questionnaires electronically.

signNow DocuSign Adobe Sign PandaDoc HelloSign
Starting Price $8/user/mo $15/user/mo $14/user/mo $19/user/mo $15/user/mo
Free Trial 7-day free trial No No Yes, limited Yes, limited
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No

Real-World Examples of Questionnaire Use

Examples show how different organizations used a standardized questionnaire to improve compliance, speed, and recordkeeping.

Optica Ventures LLC

Optica standardized assessments across multiple sites to reduce variability and improve audit readiness.

  • Implementation reduced administrative follow-ups and increased data consistency.
  • Brian Fitzgibbons, COO, noted the interface was simple and easy-to-use for teams and customers, helping the organization maintain consistent records across locations while minimizing training overhead.

Fertility Centers

A clinical center used the questionnaire to document lab controls for patient-safety reporting.

  • The process clarified responsibility for sample handling and incident reporting.
  • The center reported improved compliance documentation and smoother external review cycles after adopting a standardized electronic form and retaining signed records.

Practical Tips for Accurate and Efficient Completion

Adopt consistent practices to reduce errors and speed review of questionnaire responses.

Use consistent naming
Match legal entity and facility names exactly to institutional records to avoid administrative rework and ensure traceability.
Attach evidence
Include SOPs, inventory logs, and training certificates with the questionnaire to minimize follow-up questions.
Automate routing
Configure sequential approvals and reminders so responsible reviewers receive the form promptly and approvals are recorded with timestamps.
Maintain version control
Record the effective date and revision history for each completed questionnaire to support audits and change tracking.

FAQs and Troubleshooting for Common Submission Issues

Answers to frequent questions about validity, signature methods, attachments, and authentication when using the questionnaire.


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