Attachment 1 - Draft Statement of Objectives.pdf

Statement of Objectives

1.0 Basic Services: The Contractor shall provide comprehensive technical services, independent systems verification, and biological safety regulatory compliance support to guide the staggered transition of Building 8100 from construction completion to full functional occupancy and Federal Select Agent Program (FSAP) registration. The Contractor shall serve as the "Owner's Advocate" under the direction of Defense Health Agency Research and Development (DHA R&D) Headquarters, bridging the technical gap between the construction execution (USACE/construction contractors) and the operational/compliance requirements of the end-user (DHA R&D).

Specifically, the Contractor shall provide services for regulatory compliance support and subject matter expertise from building facility project upgrades, commissioning, and FSAP registration and Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) accreditation of a Biological Safety Level/Animal Biological Safety Level (BSL/ABSL) -2, -3, and -4 biocontainment research facility ensuring compliance with the Federal, Department of War, Army, and Defense Health Agency standards as well as Environmental Protection requirements, State and Local regulations to include applicable consensus standards (i.e., BMBL current edition, NIH design review manual, Fort Detrick design criteria, Maryland Building Performance Standards (MBPS), International Building Codes (IBC), International Energy Conservation Code (IECC), National Fire Protection Association (NFPA), American National Standards Institute (ANSI) & the Guide for Care and Use of Laboratory Animals). The intent of this contract is to execute staggered/phased implementation of commissioning requirements from BSL/ABSL-2 through to BSL/ABSL-4.

2.0 Tasks: Tasks consist of the following:

2.1 Task 1: RMO/BSO Biosafety Validation & Technical Support

2.1.1 Advisory Review of Technical Design and Facility Project Plan: The Contractor shall conduct an independent advisory review of construction designs, HVAC Test and Balance (TAB) reports, and equipment submittals for the continuous flow Effluent Decontamination System (EDS), the Building Automation System (BAS) upgrades, and the Electronic Security System (ESS). The purpose of this review is to provide the Government with advisory reports identifying potential non-conformance with biocontainment engineering requirements, biosafety regulations, and facility accreditation standards prior to physical modification. The contractor shall not perform any architectural design, systems redesign or provide formal engineering approval/disapproval of construction documents.

(a) STD: Technical review memos identifying design flaws, compliance conflicts, or systems integration gaps; accompanied by actionable potential solutions and technical recommendations to support the Government’s development and evaluation of prospective Courses of Action.

AQL: Deliver technical review memos within ten (10) business days of receiving construction submittals/logs (D-001). 100% accuracy in identifying system interdependency issues.

2.1.2 Sterilization and Decontamination Validation: The Contractor shall draft validation protocols, witness functional challenge testing, evaluate results, and revise protocols as necessary for autoclave cycles and room decontamination. Each autoclave model and designated containment room space shall be independently verified for sterilization and decontamination efficacy using standardized biological indicators and load simulations.

(a) STD: Validated protocol guidelines written and executed in alignment with established peer-reviewed methodology.

AQL: Deliver draft validation plans (D-002) 30 days prior to scheduled autoclave testing.

100% on-site witnessing of validation cycles and complete log reviews. Final validation summary reports delivered within ten (10) business days of test completion. Zero un-reported biological indicator failures.

2.1.3 Specialized SOP and Validation Protocol Development: The Contractor shall draft, review, and validate suite- and laboratory-specific Standard Operating Procedures (SOPs) and safety manual. This includes documentation required for FSAP registration including but not limited to, critical protocols for: BSL/ABSL-2/3/4 facilities critical systems operation and laboratory facility verification testing requirements (HVAC, BAS, ESS, emergency power, etc.), general and laboratory specific procedural manuals; autoclave load sterilization parameters and validation; EDS operation and biological monitoring; arthropod containment requirements (ACL-3); space decontamination (such as gaseous or vapor systems) for laboratory spaces (esp., drywall environments incompatible with traditional paraformaldehyde).

(a) STD: Technically validate suite- and laboratory-specific SOPs and safety manuals in accordance with BMBL 6th Edition, NIH guidelines, and local biosafety requirements.

AQL: Submitted IAW agreed-upon milestone schedules (D-003). No more than two (2) technical revisions required per document prior to BSO approval.

2.2 Task 2: RO/ARO Regulatory Compliance Support

2.2.1 Federal Select Agent Program (FSAP) Gap Analysis and Path to Registration: The Contractor shall perform a comprehensive gap analysis of the path to registration for Building 8100's storage, BSL-2, BSL-3, and BSL-4 laboratory spaces. This analysis must be based on current FSAP inspection checklists, historical commissioning reports, preceding testing logs, and detailed physical inspections.

(a) STD: Completed Gap Analysis Report identifying physical, system, and procedural registration bottlenecks.

AQL: Draft submitted within forty-five (45) calendar days of Notice to Proceed (NTP) (D- 004). Final submitted within fourteen (14) calendar days of receiving Government comments.

Zero deviation from CDC/USDA FSAP regulations (42 CFR Part 73, 7 CFR Part 331, and 9 CFR Part 121).

2.2.2 FSAP Registration Package Compilation: The Contractor shall provide technical assembly, drafting, and review support to the Government RO/ARO for the facility's FSAP registration application. This includes updating DHA R&D) Incident Response Plan, Security Plan, Biosafety Plan, and BSAT Movement Plan. The draft plans must specifically address spill response, emergency egress in low-pressure states, and the physical security layout (three layers of security for Tier 1 agents).

(a) STD: Registration package documents compiled in complete, review-ready drafts according to FSAP submission requirements.

AQL: Completed drafts of Biosafety, Security, and Incident Response Plans (D-005) delivered to the RO/ARO and COR within ninety (90) days of NTP. Zero errors or omissions on finalized documents to the Government. 100% technical conformance with FSAP submission guidelines with no more than two (2) technical revision cycles required per document.

2.2.3 Centralized RFI & Compliance Tracking: The Contractor shall develop and maintain a centralized project tracking register to capture, organize, monitor, and resolve all identified regulatory compliance concerns, action items, Requests for Information (RFIs), and commissioning milestones through to complete technical mitigation and resolution. The tracking tool shall serve as an operational management dashboard to provide real-time visibility to Government stakeholders.

(a) STD: Implement a secure, web-accessible register for tracking design modifications, technical clarifications, and compliance resolutions.

AQL: Initial structure online within thirty (30) days of NTP (D-006). Maintained live and updated weekly. System accessible 24/7 to Government representatives. No more than three

(3) data entry or reporting delays per contract year.

2.3 Task 3: Commissioning and Operational Systems Verification (SME Advisory)

2.3.1 Critical Airflow and Containment Verification: The Contractor shall review and witness the testing of HVAC directional airflow controls in BSL-3 and BSL-4 zones. Testing must verify that secondary containment boundaries are maintained, and that no airflow reversals occur across the containment boundary under the following failure conditions: 1) Mechanical failure of an exhaust fan (verifying transition to redundant fans without airflow reversal); 2) simultaneous power failure of supply and exhaust fan components; 3) transition from normal power to emergency generator power, and the subsequent return to normal power (confirming that transient positive pressure excursions do not breach containment doors or anterooms).

(a) STD: Complete direct observation and technical log reviews of HVAC failure testing.

The contractor shall verify and report whether observed pressure excursions or pressure decay rates exceed the Government-approved design specifications and test limits.

AQL: 100% on-site witnessing and complete log analysis report (D-007) for all designated failure runs, with 100% accurate advisory compliance reporting (conformance/non-conformance). Zero un-reported airflow reversals.

2.3.2 Pressure Switch and Interlock System Witnessing: The Contractor shall witness and evaluate the functional performance testing of hard-wired pressure switches, Bubble Tight Dampers (BTDs), Air Pressure Resistant (APR) doors, and chemical suit shower skids.

(a) STD: Complete direct observation and technical log reviews of Pressure Switch and

Interlock System testing. The contractor shall verify and report that BTDs close automatically at design setpoints, APR doors maintain seal integrity, and that chemical suit shower mix skids trigger appropriate alarms and door-interlock safety states during emergency utility states.

AQL: 100% on-site witnessing and comprehensive testing log analysis report (D-008) of all designated interlock runs. Zero unrecorded or un-reported failures of safety-critical interlocks during the executed testing events.

2.3.3 Commissioning Report Critical Review: The Contractor shall conduct an independent review of the final Commissioning Report and functional test summaries compiled by the prime construction contractor and associated engineering subconsultants.. The Contractor shall verify that all noted "Commissioning Issues" (e.g., HVAC low-pressure switch settings, emergency power transfer delays, and BMS communication dropouts) are tracked to complete technical resolution.

(a) STD: Deliver formal written review comments, deficiency evaluations, and a technical risk tracking matrix to the Contracting Officer’s Representative (COR) and designated Technical Point of Contact (TPOC)

AQL: Written commissioning report critical reviews (D-009) delivered within ten (10) business days of receiving construction documentation. 100% tracking accuracy for unresolved deficiencies until final resolution.

2.4 Task 4: Project Management

2.4.1 Routine Progress Reporting: The Contractor shall submit comprehensive Monthly Progress Reports identifying the status of all deliverables, active gap analyses, document reviews, and a log of completed on-site commissioning and testing witness events.

(a) STD: Detail-rich report containing project milestone progress, work-hour tracking, active RFIs, and quality control findings.

AQL: Delivered on or before the 5th business day of each month (D-010). Zero deviation from standard.

2.4.2 Meeting Attendance & Stakeholder Integration: The Contractor's key personnel shall participate in weekly project update meetings for critical building systems (BAS, ESS, EDS, and Building 8100 phased transition progress) to ensure proposed engineering solutions and facility modifications support function occupancy, biosafety requirements, and FSAP registration.

(a) STD: Active participation by the Contractor's Lead Commissioning Engineer, Regulatory Lead, or designated subject matter expert at all scheduled weekly transition meetings. The contractor shall provide advisory evaluations of proposed changes and deliver rapid turnaround of transition notes and risk items.

AQL: Attendance at >95% of scheduled transition meetings. Impact notes and action-item updates (D-011) delivered to COR and designated TPOC within 48 hours of meeting adjournment.

3.0 Deliverables:

Ref Title of

Deliverable Submitted to Timeline/Frequency

D-001 Technical Review Memos

COR/TPOC Reoccurring; 10 business days of receiving construction submittals/logs

D-002 Sterilization and Decontamination Validation Plans

COR/TPOC Draft within 30 days of scheduled autoclave testing; final within 10 days of test completion

D-003 Specialized SOP and Validation Protocol Development:

COR/TPOC IAW Milestone Payment Schedule

D-004 Federal Select Agent Program (FSAP) Gap Analysis

COR/TPOC Draft within 45 days of NTP; final within 14 days of receiving Government comments.

D-005 Biosafety, Security, and Incident Response Plans

COR &

RO/ARO

Draft within 90 days of NTP

D-006 Centralized RFI & Compliance Tracking System

COR/TPOC Initial 30 days of NTP; Maintained live and updated weekly

D-007 Commissioning and Operational Systems Verification Report

COR/TPOC Reoccurring; 10 days from witnessing HVAC testing

D-008 Pressure Switch and Interlock System Testing Report

COR/TPOC Reoccurring; 10 days from witnessing Pressure Switch and Interlock System testing

D-009 Commissioning Report Critical Reviews

COR/TPOC Reoccurring; 10 days of receiving construction documentation.

D-010 Monthly Progress Reports

COR Monthly; 5th business day of each month

D-011 Weekly Project Meeting

COR/TPOC Reoccurring; 48 hours after meeting adjournment

4.0 Acronyms

Acronym Definition AAALAC Association for Assessment and Accreditation of Laboratory Animal Care

International ACL Arthropod Containment Level AQL Acceptable Quality Level APR Air Pressure Resistant BAS Building Automation System BMBL Biosafety in Microbiological and Biomedical Laboratories BSAT Biological Select Agents and Toxins BSL/ABSL Biological Safety Level/Animal Biological Safety Level BSO Biosafety Officer BTD Bubble Tight Dampers CDC/USDA Centers for Disease Control and Prevention/U.S. Department of Agriculture CFR Code of Federal Regulations COR Contracting Officer's Representative EDS Effluent Decontamination System ESS Electronic Security System FSAP Federal Select Agent Program IBC International Building Codes IECC International Energy Conservation Code MBPS Maryland Building Performance Standards NFPA National Fire Protection Association NIH National Institutes of Health NTP Notice to Proceed RFI Requests for Information RMO Risk Management Officer RO/ARO Responsible Official/Alternate Responsible Official SOP Standard Operating Procedures STD Standard TAB Test and Balance TPOC Technical Point of Contact USACE U.S. Army Corps of Engineers USAMRDC U.S. Army Medical Research and Development Command DHA R&D Defense Health Agency Research and Development