FFBS Inc2 PWS_25Nov25.pdf

APPENDIX A: Performance Work Statement (PWS)

C.1 SCOPE.

The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Special Operations Forces (JPM CBRN SOF), under the Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense, within the Department of Defense (DoD), is responsible for the development, production, and fielding of equipment to support Special Operations Forces. JPM CBRN SOF is conducting the Far Forward Biological Sequencing (FFBS) program to fill known operational gaps in Biological Warfare Agent (BWA) identification. The FFBS program will finalize development and complete testing, integration, and production of a biological identification system with automated sample preparation. The system will not be limited to a list of known BWAs.

C.1.1 Background.

Currently fielded biological identifiers are limited to identifying a few select BWAs with no ability to identify unknown, emerging, or engineered biological threats. As a result, far-forward warfighters must risk being unknowingly exposed to BWAs or remain in their chemical biological personal protective equipment, resulting in increased physiological burden and impacts on mission effectiveness. To address this gap, United States Special Operations Command validated a Capabilities Development Document (CDD) on 02 May 2022, with a clarification and addendum on 09 January 2024. Under multiple Defense Threat Reduction Agency-sponsored projects, work has been done to develop current industry technologies to address this known gap. The FFBS program will leverage a technology transition agreement for the automated deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) sample and library preparation protocols that have been developed. Additionally, the transition agreement will leverage advanced bioinformatics software for agnostic threat detection to increase the capability from FFBS Increment 1. Although FFBS remains closely aligned with our transition agreement partners, any delays in their transitions will not impede program progress.

FFBS will continue to pursue parallel development and integration activities to ensure timely capability delivery.

C.1.2 Objective.

C.1.2.1 FFBS received a favorable Materiel Development Decision in March 2024 and anticipates a favorable Increment 2 Milestone A Decision in March 2026. The objective of this Other Transaction Agreement (OTA) is for successful development of a prototype FFBS Increment 2 system during the Technology Maturation and Risk Reduction (TMRR) followed by an option for the Engineering and Manufacturing Development (EMD) phase. Requirements include TMRR and optional EMD development, testing, program and logistics support, and delivery of technical data (end-item products, software, and logistics).

C.1.2.2 The FFBS Increment 2 system development shall result in a biological identification system capable of identifying innumerable BWAs, limited only by the bioinformatics database loaded onto the system which can be tailored to meet mission requirements. The program schedule requires a short development period to meet a technology readiness level (TRL) of seven (7) or better within 24 months or less.

C.1.2.3 Prototype definition: The FFBS Increment 2 prototype will be a system comprised of the following elements: an automated sample and library preparation device compatible with the nanopore sequencing device and a custom computing element, which may be provided as Government Furnished Equipment (GFE), and bioinformatics software. The system shall be operable in far-forward field environments by non-laboratory trained users, in as few steps as possible, while wearing mission-oriented protective posture level 4 gear. Detailed metrics for success are further defined in the performance specification (PSpec). The USG provided equipment (if applicable) and PSpec represent the minimum viable product or the standard starting point. Vendors may propose solutions that integrate with the existing increment 1 console or provide unique designs, provided there is no degradation to the system’s ability to meet the requirements. Vendor developed hardware or software accompanied by a robust data package demonstrating system performance in a field representative environment will be prioritized.

C.2 APPLICABLE DOCUMENTS

For purposes of this PWS, “Required” means that the requirements contained in the directly cited document are contractually applicable to the extent specified. The term “For guidance only” means the document is not contractually applicable and is provided for guidance and information only. The documents cited below are “required” unless specifically identified as “For guidance only”. In the event of a conflict between the documents referenced herein and the contents of this PWS, the PWS shall take precedence.

C.2.1 Military Standards (MIL-STD) and Military Performance Specifications (MIL-

PRF).

C.2.1.1 MIL-STD-882E, System Safety, 27 Sep 23.

C.2.1.2 MIL-STD-1472H, Human Engineering, 15 Sep 20.

C.2.1.3 MIL STD-2073-1E (4) Standard Practice for Military Packaging, 27 Jun 24.

C.2.1.4 MIL-STD-129R, Military Marking for Shipment and Storage, 25 Feb 23.

C.2.1.5 MIL-STD-130N, Identification Marking of U.S. Military Property, 17 Dec 2007.

C.2.1.6 MIL-PRF-29612B, Training Data Products, 31 Dec 20.

C.2.1.7 MIL-STD-31000, Technical Data Packages 03 Feb 25.

C.2.1.8 MIL-STD-810H (1) Environmental Engineering Considerations and Laboratory

Tests, 18 May 22.

C.2.1.9 MIL-DTL-28999D Preparation of Publications, Technical, Instruction-Type, 10 Feb 20.

C.2.1.10 MIL-STD-40051.2D, Change 1, Preparation of Digital Technical Information for Page Based Technical Manuals, 20 November 2021.

C.2.1.11 MIL-STD-461G Requirements for the Control of Electromagnetic Interference Characteristics of Subsystems and Equipment, 11 December 2015.

C.2.1.12 MIL-STD-464 Electromagnetic Environmental Effects Requirements for Systems, 18 March 1997.

(The above Instructions are available at: http://quicksearch.dla.mil/)

C.2.2 Military Handbooks (MIL-HDBK).

C.2.2.1 MIL-HDBK-470A (For guidance only), Designing and Developing Maintainable Products and Systems, Volume 1, 21 Aug 24.

C.2.2.2 MIL-HDBK-61B (For guidance only), Configuration Management Guidance, 07 Apr 20.

C.2.2.3 MIL-HDBK-502B (For guidance only), Product Support Analysis, 18 Apr 25.

C.2.2.4 MIL-HDBK-2155 (For guidance only), Failure Reporting, Analysis and Corrective Action Taken, 19 Jul 19.

(The above Instructions are available at: http://quicksearch.dla.mil/)

C.2.3 Department of Defense Instructions (DoDI)

C.2.3.1 DoD Instruction 8510.01, Risk Management Framework for DoD Information Technology, 12 Mar 14 through changes dated 19 Jul 22.

C.2.3.2 DoD Instruction 5200.39 Critical Program Information (CPI) Identification and Protection within Research, Development, Test, and Evaluation, 28 May 15.

C.2.3.3 DODM 4140.27 DoD Shelf-Life Management Program, 11 Dec 19.

C.2.3.4 DoDI 4245.15 Diminished Manufacturing Sources and Material Shortages Management (DMSMS) 2 Sep 25.

(The above Instructions are available from: https://www.esd.whs.mil/DD/DoD- Issuances/ )

C.2.4 Department of Defense Documents

C.2.4.1 Department of Defense Manufacturing Readiness Level Deskbook, 2020 http://quicksearch.dla.mil/) http://quicksearch.dla.mil/) https://www.esd.whs.mil/DD/DoD-Issuances/ https://www.esd.whs.mil/DD/DoD-Issuances/ http://www.dtic.mil/whs/directives/corres/ins1.html)

Version.

(This document is available at:

https://www.dodmrl.com/MRL%20Deskbook%20V2020.pdf)

C.2.4.2 Technology Readiness Assessment Guidebook.

(This document is available at: https://www.cto.mil/wp-content/uploads/2025/03/TRA-Guide-Feb2025.v2-Cleared.pdf).

C.2.4.3 Department of Defense Security Classification Guide for Non-Traditional Agent Defense Incorporating Change 2, 16 Aug 16.

(This document is available by request to the Agreements Officer)

C.2.4.4 Risk Management Guide for DoD Acquisition, Sixth Edition, Aug 06. (This document is available at: https://apps.dtic.mil/sti/pdfs/ADA470492.pdf).

C.2.5 Army Regulations (all available at https://armypubs.army.mil/)

C.2.5.1 AR 530-1, Operations Security, 26 Sep 14.

C.2.5.2 AR 70-77 Program Protection, 08 Jun 18

C.2.5.3 AR 381-12 Threat Awareness & Reporting Program

C.2.6 FFBS Program Documents.

Program documents will be made available upon agreement award. Current documentation includes the Simplified Acquisition Management Plan; Test & Evaluation Master Plan; Life Cycle Sustainment Plan; Program Protection Plan; and Programmatic Environmental, Safety, and Health Evaluation.

C.2.7 Other Government Documents.

C.2.7.1 Modular Open Systems Architecture in DoD Acquisition, (For guidance only), 29 Oct 14. (This document is available at: http://www.acq.osd.mil/se/briefs/16943- 2014_10_29_NDIASEC-Welby-MOSA-vF.pdf)

C.2.7.2 National Aerospace Standard 411: Hazardous Materials Management Program, 3rd Edition, (For guidance only), 30 Sept 13. (This document is available at:

https://global.ihs.com/doc_detail.cfm?&rid=AIA&item_s_key=00156371&item_key_date =860301&input_doc_number=411&input_doc_title=&org_code=AIA%2FNAS)

C.2.7.3 AF 24-204/TM 38-250/NAVSUP PUB 505/MCO P4030.19J/DLAI 4145.3:

Preparing Hazardous Materials for Military Air Shipments, 12 Oct 04 (This document is available at:

https://dap.dau.mil/policy/Documents/Policy/AFMAN24_204_I%5B1%5D.pdf) https://www.dodmrl.com/MRL%20Deskbook%20V2020.pdf https://www.cto.mil/wp-content/uploads/2025/03/TRA-Guide-Feb2025.v2-Cleared.pdf https://www.cto.mil/wp-content/uploads/2025/03/TRA-Guide-Feb2025.v2-Cleared.pdf https://armypubs.army.mil/ http://www.acq.osd.mil/se/briefs/16943-2014_10_29_NDIASEC-Welby-MOSA-vF.pdf http://www.acq.osd.mil/se/briefs/16943-2014_10_29_NDIASEC-Welby-MOSA-vF.pdf https://global.ihs.com/doc_detail.cfm?&rid=AIA&item_s_key=00156371&item_key_date=860301&input_doc_number=411&input_doc_title&org_code=AIA%2FNAS https://global.ihs.com/doc_detail.cfm?&rid=AIA&item_s_key=00156371&item_key_date=860301&input_doc_number=411&input_doc_title&org_code=AIA%2FNAS https://dap.dau.mil/policy/Documents/Policy/AFMAN24_204_I%5B1%5D.pdf

C.2.7.4 Title 49 Code of Federal Regulations - Transportation (This document is available at:

https://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2015&go=G o)

C.2.7.5 DoD 5220.22-M, National Industrial Security Program (NISP) Operating Manual, 28 Feb 06 through changes dated 18 May 16.

C.2.8 Commercial Documents.

C.2.8.1 SAE EIA 649B (For guidance only), Configuration Management Standard, 2011.

(This document is available at: http://www.ansi.org)

C.2.8.2 National Defense Industrial Association (2008) guidebook, Engineering for System Assurance, (For guidance only), (This document is available at:

http://www.acq.osd.mil/se/docs/SA-Guidebook-v1-Oct2008.pdf)

C.2.8.3 ISO 9001, Quality Management Systems, 5th edition:15 Sept 15, (This document is available at:

http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=6 2085)

C.2.8.4 ASTM D3951, Standard Practice for Commercial Packaging, (This document is available at: http://www.astm.org/Standards/D3951.htm) C.2.8.5 TA-STD-0017, Product Support Analysis (This document is available at:

http://www.sae.org)

C.2.8.6 GEIA-STD-0007B, Logistics Product Data, 21 Oct 15, (This document is available at: http://standards.sae.org/wip/geiastd0007c/)

C.2.8.7 GEIA-HB-0007B (For guidance only), Logistics Product Data Handbook,10 Feb 14, (This document is available at: http://standards.sae.org/geiahb0007/) https://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2015&go=Go https://www.gpo.gov/fdsys/browse/collectionCfr.action?selectedYearFrom=2015&go=Go http://www.ansi.org/ http://www.acq.osd.mil/se/docs/SA-Guidebook-v1-Oct2008.pdf http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=62085 http://www.iso.org/iso/home/store/catalogue_ics/catalogue_detail_ics.htm?csnumber=62085 http://www.astm.org/Standards/D3951.htm http://www.sae.org/ http://standards.sae.org/wip/geiastd0007c/ http://standards.sae.org/geiahb0007/

C.3 REQUIREMENTS.

The Contractor, as an independent Contractor and not as an agent of the Government, shall provide the necessary services, personnel, labor, facilities, materials, supplies, and equipment (except those specifically designated as Government-Furnished) to perform the following work.

C.3.1 Program Management.

The Contractor shall establish a program management organization responsible for the execution of this Performance Work Statement (PWS) with the appropriate management controls and processes to ensure that the OTA requirements are met.

The Contractor shall manage the OTA activities by providing integrated program management, program control, OTA and subcontracts management, data management, and operations management. The Contractor shall use a well-defined and efficient organizational, management, and development methodology consistent with an Integrated Process and Product Development approach as the primary method of organizing and managing this PWS and ensure that all teams have the expertise and disciplines integrated throughout the process.

C.3.1.1 Meetings/Reviews/Teleconferences (Virtual meetings via Microsoft Teams)

The Contractor shall participate in the required meetings, reviews, and telecons as listed in this OTA. Whenever possible and appropriate, meetings and reviews shall be conducted virtually using the most appropriate technology (Army currently utilizes Microsoft Teams). Physical meetings and reviews shall be scheduled in tandem, or groups, to minimize personnel resources and travel expenses, when appropriate. All meetings, reviews, and telecons shall be hosted by the Contractor. The Government may request that an individual meeting or review be held at a Government facility on a case-by-case basis, and such a request must be made thirty (30) days prior to the meeting or review. The following table shows meetings, locations and deliverable timelines.

PWS Ref Deliverable Description Frequency Date Forum/Format

C.3.1.2

Kickoff Meeting

One time NLT 30 calendar days after award

Contractor Facility

C.3.1.4

Work Breakdown Schedule, Integrated Master Schedule, Integrated Master Plan

Kickoff & when updates are required

As required

Format as approved by the AOR

C.3.1.5

Monthly Report

Monthly

NLT 15th day of the month following the reporting month

MS Word or other format approved by the AOR

C.3.1.6

Bi-weekly Telecons

Twice monthly unless cancelled by the AOR

As established by the

AOR

Set up by the Contractor via

Microsoft Teams

C.3.1.7

Program Review

Twice annually As agreed to between the Contractor and AOR

C.3.1.8.1

Preliminary Design Review

One time 75 calendar days after award of OTA

C.3.1.8.2

Critical Design Review

One time 30 calendar days after DT/OT Data Delivery

C.3.1.8.3

Production Readiness Review

One time

30 calendar days after DT/OT Data Delivery

C.3.1.10

Technical Interchange Meetings

Quarterly

First TIM to take place 3 months after delivery of prototypes

C.3.1.11.2 Program Protection Working Group

Monthly unless cancelled by the AOR

As established by the

AOR

C.3.2.11.1.2

Safety Assessment Report

As Required

30 Calendar Days Prior to Each Govt. Test Event

MS Word or other format approved by the AOR

C.3.1.2 Kickoff Meeting.

The Contractor shall hold a kickoff meeting at the Contractor’s facility, or via Microsoft Teams if travel funds are limited, not later than thirty (30) calendar days after award.

Briefing agenda shall include, as a minimum, introduction of key personnel, schedule, review of key design features, and information distribution. Breakout sessions shall be conducted for functional areas as appropriate, with at least one dedicated to Integrated Product Support (IPS) to address logistics, training, and the Contractor’s planned approach to technical publications (planning, standards, methodology and draft publications rather than full publication delivery during TMRR). The Contractor shall provide an agenda and read ahead package to the Government five (5) business days prior to the kickoff and submit meeting minutes within five (5) business days after the event.

C.3.1.3 Action Items.

The Contractor shall create and implement a system for tracking, following up on, and resolving open items (“Action Items”), including the review of the status of open items during subsequent meetings. The Contractor shall immediately inform the Agreements Officer (AO) and Agreements Officer Representative (AOR) if there are open actions preventing or delaying the completion of program or OTA data delivery schedules.

C.3.1.4 Work Breakdown Structure (WBS), Integrated Master Schedule (IMS) and Integrated Master Plan (IMP).

The Contractor shall maintain, update, and execute to a WBS, IMS, and ensure that they align. The Contractor shall manage their program in accordance with (IAW) the WBS, IMS and IMP. The Contractor shall update the WBS and IMS provided in their proposal for use during the kickoff meeting, and the WBS and IMS presented by the contractor at this meeting shall reflect detailed planning for the TMRR and EMD (if option is exercised) OTA performance. The Contractor shall establish and maintain the working IMS and provide it to the Government upon any change, or at the request of the Government. The Contractor, in conjunction with the Government, shall update the IMS on an as needed basis. The Contractor shall ensure that the IMS aligns with the Government schedule throughout the life of this OTA.

C.3.1.5 Monthly Reports.

C.3.1.5.1 The Contractor shall deliver a monthly status report to the Agreements Officer’s Representative (AOR), Agreements Specialist, and Agreements Officer.

C.3.1.5.2 The Contractor shall report the status and progress on the development and delivery of technical publications to include schedule in the Monthly Report.

C.3.1.6 Bi-Weekly Telecons.

The Contractor shall hold bi-weekly telecons with the Government for ongoing activities.

The purpose of these meetings is for the Contractor and Government representatives to openly discuss technical progress, issues, and risks. The first bi-weekly telecon shall be held the first month following the kickoff meeting. Agenda topics, meeting minutes, read ahead items, if any, and action items shall be provided. The Contractor and Government may mutually agree to cancel a bi-weekly telecon during a particular month due to lack of discussion topics or a review or meeting being held the same month.

C.3.1.7 Program Reviews.

The Contractor shall conduct semi-annual Program Reviews (PRs) that include program management participation, technical management, and subject matter expert participation, as appropriate. The Contractor shall present cost, schedule, performance, and risk status at each PR and be prepared for detailed discussion with the Government. PRs may be held in conjunction with Design Reviews (DRs) and Technical Interchange Meetings (TIMs) to limit meeting proliferation. The Contractor shall prepare an agenda and read-ahead package/briefing charts for Government approval, as well as record and deliver meeting minutes.

C.3.1.8 Design Reviews.

C.3.1.8.1 Preliminary Design Review (PDR)

The Contractor shall host a Preliminary Design Review (PDR) at the Contractor’s facility or virtually no later than one-hundred and twenty (120) calendar days after OTA award. The Contractor shall submit a PDR Data Package that includes briefing materials and supporting documentation to establish the allocated baseline. The Contractor shall, as a minimum, address requirements; key system features; future material availability; long lead items; estimated life cycle costs for final design and design alternatives; projected cost of the FFBS system in production; technical and manufacturing risks; estimated failure modes and rates; Logistics Product Data (LPD) considerations; and the draft Technical Data Package (TDP) in this review. The review shall include recommended trade-offs based upon an assessment of cost, schedule, and performance risk. The Contractor shall prepare an agenda and read-ahead package/briefing charts for Government approval, as well as record and deliver meeting minutes.

C.3.1.8.2 Critical Design Review (CDR) - OPTION

The Contractor shall host a Critical Design Review (CDR) at the Contractor’s facility or virtually. The Contractor shall submit a CDR package that includes briefing materials and supporting documentation to establish the initial product baseline. The Contractor shall address requirements specified in the PSpec and include updated performance;

size, weight, and power; key system features; future Material Availability (Am); long lead items; estimated life cycle costs for final design and design alternatives; projected cost of the components and systems in production; technical and manufacturing risks;

estimated failure modes and rates; logistics management considerations; and the draft TDP in this review. The review shall include recommended trade-offs based upon an assessment of cost, schedule, and performance risk. The CDR shall be no later than 120 calendar days after OPTION AWARD. The Contractor shall prepare an agenda and read-ahead package/briefing charts for Government approval, as well as record and deliver meeting minutes.

C.3.1.8.3 Production Readiness Review (PRR) - OPTION

The Contractor shall host a Production Readiness Review (PRR) at the Contractor’s facility or virtually. The Contractor shall submit a PRR package that includes briefing materials and supporting documentation to establish the final product baseline. The Contractor shall address requirements specified in the PSpec and include updated performance; size, weight, and power; key system features; future Material Availability (Am); long lead items; estimated life cycle costs for final design and design alternatives;

projected cost of the components and systems in production; technical and manufacturing risks; estimated failure modes and rates; logistics management considerations; and the draft TDP in this review. The PRR shall be 30 days after the Developmental Testing (DT) / Operational Testing (OT) data delivery is provided to the contractor. The Contractor shall prepare an agenda and read-ahead package/briefing charts for Government approval, as well as record and deliver meeting minutes.

C.3.1.9 FFBS Spares, Consumables & Technical Data

C.3.1.9.1 Technical Data.

Technical data includes the Production baseline. The term does not include computer software. Examples include, but are not limited to, form, fit, function data; drawings;

specifications; associated lists; software data; processes; manufacturing instructions;

operating procedures; maintenance, overhaul, and repair procedures; training materials;

and media.

C.3.1.9.1.1. Technical Data Package (OPTION). The Contractor shall prepare and deliver a complete/accurate production-level (MIL-STD-31000C) TDP for each item at

PRR.

C.3.1.9.1.2. Form, Fit, and Function Data. Form, fit, and function data is technical data that describes the required overall physical, functional, and performance characteristics (along with the qualification requirements, if applicable) of an item, component, or process to the extent necessary to identify physically and functionally interchangeable items.

C.3.1.9.1.3. Software Data. Software data means computer programs, source code, source code listings, object code listings, design details, algorithms, processes, flow charts, formulae and related material that would enable the software to be reproduced, recreated, or recompiled. Software data does not include computer databases or computer software documentation.

C.3.1.9.2 Unforeseen Spare and Consumable Parts.

If the Contractor proposes to introduce any additional spare and consumable parts into the system design after OTA award, the contractor shall request Government permission to do so and shall provide the production-level TDP cost for those new spare/consumable parts to the Government prior to requesting Government approval.

During design reviews, the Government may reject designs that the Government determines will unnecessarily require the Government to obtain spare and consumable parts from the Contractor on a non-competitive basis.

C.3.1.10 Technical Interchange Meetings (TIMs).

The Contractor shall conduct quarterly TIMs to facilitate technical discussions at a working level. The TIMs may cover test results, logistic planning, design challenges, etc.

The first TIM will be three (3) months after delivery of the systems. The Contractor shall prepare an agenda and read-ahead package/briefing charts for Government approval, as well as record and deliver meeting minutes.

C.3.1.11 Security.

The contractor shall follow security requirements outlined in the FFBS Program Protection Plan (PPP) (C.2.6., Section J), and the Department of Defense Security Classification Guide for Non-Traditional Agent Defense (C.2.4.3).

C.3.1.11.1 Program Protection Implementation Plan (PPIP)

The Contractor and all subcontractors shall develop, provide, implement, and maintain a PPIP. The Contractor shall align their PPIP with the FFBS PPP and revise their PPIP accordingly if updates to the FFBS PPP occur. If Critical Program Information (CPI) or Critical Components (CC) exists per updates to the PPP IAW DoDI 5200.39, the PPIP shall cover the protection of CPI/CC, compliant with the security requirements imparted by the NISP (C.2.3.1). The PPIP should provide sufficient safeguards to ensure that all sensitive information, technical controlled unclassified information (CUI), and/or (CPI) in the possession of the Contractor is protected from unauthorized access and release.

C.3.1.11.2 Program Protection Working Group (PPWG)/Critical Program Information Assessment (CPIA).

The AOR shall host a bi-weekly PPWG starting within 30 days after the PDR and will continue the meetings as needed. Each PPWG will be chaired by the Government security manager and co-chaired by the Contractor security manager. The co-chair shall develop the agenda. The agenda shall include a CPIA that will identify potential Critical Program Information or Critical Technology (defined by Army Regulation 70-77 Program Protection, 08 June 2018, C.2.5.2). After each event, the Government will provide the minutes from the meeting via the AOR to include, but not limited to, validating any CPI/Critical Technology for the program, and/or Critical Functional Analysis.

C.3.1.11.3 Contractor Employees who require access to Government Information Systems.

All Contractor and subcontract employees with access to a government information system must be registered in the Army Training Certification Tracking System at the commencement of the OTA and must successfully complete the DoD Informational Assurance Awareness Training prior to receiving access to the information system(s) and then annually thereafter.

C.3.1.11.4 Operations Security (OPSEC) Standing Operating Procedure

If a determination is made that the program contains CPI, the Contractor shall develop an OPSEC Standard Operating Procedure (SOP) within 90 calendar days of the determination of CPI, to be reviewed and approved by the responsible Government OPSEC officer per AR 530-1 and section C.2.5.1 of this PWS. This SOP shall include the Government's critical information, why it needs to be protected, where it is located, who is responsible for it, and how to protect it. In addition, the Contractor shall identify an individual who shall be an OPSEC Coordinator and ensure this individual becomes OPSEC Level II certified per AR 530-1.

C.3.1.11.5 Threat Awareness Reporting Program (TARP)

For all contractors with security clearances. Per AR 381-12, contractor employees must receive annual TARP training by a counterintelligence agent or other trainer.

C.3.1.11.6 Handling or Access to Classified Information

The Contractor and subcontractor personnel shall comply with Federal Acquisition Regulation (FAR) 52.204-2, Security Requirements. This clause involves access to information classified “Confidential” or “Secret,” and requires Contractors to comply with the Security Agreement (DD Form 441) and the most recent version of the National Industrial Security Program Operating Manual (DoD 5220.22-M).

C.3.2 Systems Engineering.

C.3.2.1 Systems Engineering Management Plan (SEMP).

The Contractor shall provide a SEMP that describes the Contractor's system engineering process to guide all technical aspects of the development through the FFBS EMD phase IAW the Contractor’s IMS. The Contractor’s SEMP shall align with the system engineering section of the FFBS Simplified Acquisition Management Plan.

C.3.2.2 Program Risk Management

The Contractor shall develop, implement, and deliver, as part of the SEMP a Risk Management Plan (RMP) following the concepts in the Risk Management Guide for DoD Acquisition. The Contractor’s RMP shall include all program and system level plans to identify and mitigate program risks in the areas of cost, schedule, and performance.

C.3.2.2.1 The Contractor’s RMP shall address:

• Risk Management Strategy and Process

• Responsible/Executing Organization

• Risk Management Process and Procedures

• Risk Identification

• Risk Analysis

• Risk Mitigation Planning

• Risk Mitigation Plan Implementation

• Risk Tracking and Reporting

C.3.2.2.2 Risk management shall be an integral part of all PRs, DRs, TIMs, and bi-weekly telecons. The Contractor shall systematically identify, analyze, and report risk mitigation activities for all risk areas.

C.3.2.2.3 Uncertainty evaluations shall consider overall program objectives, IMS, and operational requirements baseline. The Contractor shall develop mitigation plans to identify the recommended critical path for OTA completion and the appropriate risk handling approach to lower the level of uncertainty identified. The Contractor shall recommend decision points in terms of performance, cost, and schedule objectives to facilitate management and technical control. The Contractor shall maintain a database of all risks and their status. Risk reporting shall present standard probability and consequence-screening criteria.

C.3.2.2.4 The Contractor shall establish mechanisms to effectively monitor the introduction of supply chain risk associated with critical components, and implement countermeasures to mitigate such risks, including the application of supply chain risk management best practices, applied as appropriate to the development of the system, and the enumeration of potential suppliers of critical components, as they are identified, including cost, schedule, and performance information and proposed selection decisions for the purposes of obtaining approval from the Government and engaging in the development of mutually agreeable risk management plans for the selected suppliers of critical components. Supply chain risk management key practices may be found in the National Defense Industrial Association (2008) guidebook, Engineering for System Assurance.

C.3.2.3 Requirements Analysis

The Contractor shall develop, deliver, and update the Requirements Traceability Matrix (RTM) that tracks achievement of all FFBS requirements as the development and tests progress. The RTM shall be logically organized and clearly depict the level of fidelity for each requirement assessment and trace or link to the supporting basis for the assessment. The RTM shall trace directly to the FFBS PSpec. The Contractor shall brief the overall progress in terms of the RTM at PRs, DRs, and TIMs.

C.3.2.4 Reliability, Availability, and Maintainability (RAM) Program.

The Contractor shall establish, maintain, and operate a RAM program. The Contractor shall provide the Government an overview of their reliability program at the kickoff meeting. The RAM program shall be updated and addressed by the Contractor at each PR, DR, and TIM. The Contractor shall include RAM Rationale in the SEMP as a comprehensive compendium of the Contractor’s reliability activities, functions, processes, test strategies, measurements, data collections, resources, and timelines required to ensure that the specified reliability of the system in the FFBS PSpec will be achieved before fielding.

C.3.2.4.1 Failure Reporting, Analysis, and Corrective Action System (FRACAS)

C.3.2.3.1.1 The Contractor shall use data from conformance and lot acceptance inspections and tests, Contractor conducted testing, Data Collection Events, Developmental Testing (DT), Production & Deployment Testing, Operational Testing (OT), any additional Government conducted testing, and from any field reports supplied by the Government. The Contractor shall track these occurrences in a standard format that provides adequate information to conduct failure analysis.

C.3.2.3.1.2 The Contractor shall establish a system that provides a process for reporting, classifying, and analyzing Failure Mode, Effects and Criticality Analysis and planning corrective actions in response to those failures. The Contractor shall analyze failure and nonconformance data to identify the frequency and severity of these problems and to assess the need for corrective actions and to prioritize the implementation of corrective actions to prevent recurrence. (MIL-HDBK-2155, C.2.2.4, may be used for guidance).

C.3.2.4.2 The Contractor shall include a summary of the open FRACAS items in the Monthly Reports and provide a summary at PRs, DRs, and TIMs.

C.3.2.5 Interfaces.

The Contractor shall prepare, deliver, and update interface control documentation that identify the interface requirements between: Hardware Configuration Items (HWCI) and hardware devices (HWCI to HWCI); Software Configuration Items (SCI) and hardware devices (SCI to HWCI); and HWCI and SCI to systems external to FFBS. The Contractor shall define and brief the configuration items at PRs, DRs, and TIMs.

C.3.2.6 Computer Resources/Software.

The contractor shall maintain a software development program throughout the systems engineering life cycle. The contractor shall ensure that the software development program processes and procedures are allocated to all levels of organizations internal to the contractor and its sub-contractors to ensure that the basic elements of software development and control are consistent across all members involved and that established baselines are maintained, communicated, and understood across all organizations involved. The Government reserves the right to review the contractor most current processes and procedures throughout the life of the agreement.

C.3.2.7 Modular Open System Approach (MOSA)

C.3.2.7.1 The Contractor shall use a MOSA to implement a modular design strategy for building the FFBS. The Contractor shall apply MOSA considerations in the selection of components and subsystems to meet the FFBS design functionality. A MOSA and analysis of long-term supportability (including obsolescence management), interoperability, and growth for future modifications shall be major factors in the Contractor’s final design decisions and integration approach and presented at DRs. All the FFBS system components and subsystems shall facilitate future upgrades and permit incremental technology insertion to allow for incorporation of additional or substitution of higher performance elements with minimal impact on the existing systems. The “Modular Open Systems Architecture in DoD Acquisition, October 29, 2014” (C.2.7.1) may be used as a reference.

C.3.2.7.2 The Contractor shall ensure that FFBS modular design and integration preclude dependence on closed or proprietary interface standards, technologies, products, or architectures. The Contractor shall design the FFBS system to provide sufficient growth and open interfaces to allow future reconfiguration and addition of new capabilities without large-scale redesign of the system.

C.3.2.8 Manufacturing

The contractor shall assess manufacturing readiness to determine Manufacturing Readiness Levels throughout the life of the agreement using the Manufacturing Readiness Level Deskbook as a guide (C.2.4.2). The contractor shall use the process explained in Sections 4.0 and 5.0 of that document to support the identification of high manufacturing risk technologies or components and present appropriate risk analysis and associated maturation plans at the PDR, CDR, and Program Reviews. The contractor shall specify within the IMS the locations and frequencies of any assessments of manufacturing readiness, along with all the resources to perform or support these assessments.

C.3.2.9 Quality Assurance Program Requirements (All Delivered Systems and/or Software).

C.3.2.9.1 The Contractor’s Quality Assurance Program (QAP) shall be certified to the current revision of ISO 9001 or equivalent quality standard. The Contractor’s QAP shall be designed to promptly detect, correct, and prevent conditions that adversely affect the quality of OTA deliverables including documents, services, products, and software. The Government may perform audits and assessments to assure Contractor ISO 9001 compliance or equivalent quality standard.

C.3.2.9.2 The Contractor shall ensure that the QA processes and procedures are allocated to all levels of organizations internal to the prime and its sub-contractors to ensure that the basic elements of QA are consistent across all members involved and that established baselines are maintained, communicated, and understood across all organizations involved. The Contractor shall notify the Government of any changes that affect the Contractor's established QA program.

C.3.2.10 Configuration Management

The Contractor shall implement and maintain a Configuration Management (CM) process, which governs all aspects (systems and software) of FFBS development (to include Government Furnished Equipment, Information, and Material) throughout the EMD phase of the systems engineering life cycle. SAE EIA 649B and MIL-HDBK-61B provide guidance. The Contractor shall ensure that the requirements of this CM process are allocated to all levels of organizations internal to the Contractor and its subcontractors to ensure that the basic elements of CM and control are consistent across all members involved and that established baselines are maintained, communicated, and understood across all organizations involved. Configuration control of the FFBS PSpec will be retained by the Government. The Contractor shall manage all prototype design drawings/models, TDP, specification and engineering documentation. The Contractor may request a change to the PSpec through the AOR.

C.3.2.10.1 Configuration Management Plan (CMP)

The Contractor shall implement and maintain the CM processes and procedures. The Contractor shall designate a CM representative to serve as a primary point of contact to the Government for all CM matters. Prototype CM status shall be reported at all DRs.

The Contractor shall notify the Government of any changes which affect the Contractor's established CM process. The Contractor shall submit a CMP for Government approval; once approved, the CMP shall serve as the baseline for all CM activities.

C.3.2.10.2 Engineering Change Proposals (ECP)

The Contractor shall provide ECPs for Government review and approval. Government approval of an ECP in no way invalidates performance specification unless specifically stated in an OTA modification.

C.3.2.10.3 Diminishing Manufacturing Sources and Material Shortages (DMSMS) The contractor shall flow down DMSMS contractual requirements to subcontractors in accordance with SAE-STD-0016A, Section 3.2 and using the guidance in SAE-STD-0016A, Appendix C, Section C.2. The flow down requirements shall include proactive DMSMS management, development (or maintenance, if preexisting) of a DMSMS management plan, establishment of DMSMS cases, DMSMS case management, and reporting of DMSMS metrics. Subcontractors shall be required to provide notification of DMSMS issues within 1 week of discovery. Subcontractors shall report the resolutions of cases, including details of any changes that affect the fit, form, or function of the item, equipment, or software at a frequency agreed upon with the contractor. Subcontractors may report directly to the government if that is agreeable to all parties. When reporting case resolutions, the subcontractors shall provide the following information: the item and equipment affected by the DMSMS issue, type of solution implemented, alternate item number if appropriate, cost of the solution, and cost avoided by implementing the solution.

Cost avoidance shall be determined on the basis of guidance from the program office or, if none is provided, the method described in the SD-22. All case reporting data from subcontractors delivered directly to the government will be reported using the data formats and descriptions described in Table 1 of DID DI-MGMT-82274, DMSMS Life-Cycle.

Management Data, using data elements 1-19 and 22-46.

C.3.2.10.4 Notice of Revision

The Contractor shall prepare and submit notices of revision, in conjunction with the ECP submission process.

C.3.2.10.5 Request for Deviation (RFD)

The Contractor shall prepare and submit RFDs for all system changes for Government review and approval. Government approval of RFDs in no way invalidates any contractually required warranty or performance specification unless specifically stated in an OTA modification.

C.3.2.10.6 Configuration Status Accounting Information

The Contractor shall perform configuration management and status accounting of the configuration of all aspects of the FFBS deliverable system IAW the Government approved CMP and the terms of this OTA. The Contractor shall ensure that all engineering changes, deviations, and use of non-conforming components are reflected in the CM documentation. The Contractor's CM Program shall guarantee continuous form, fit, function, and interchangeability of the FFBS system and auxiliary equipment with consumable supplies.

C.3.2.10.7 Configuration Control Board (CCB).

The Contractor shall establish a Configuration Control Board (CCB) to review changes and recommend appropriate action prior to approval and implementation. The Contractor shall provide the Government with at least a ten (10) working day notice prior to convening the CCB so if the Government chooses a representative may attend in person or via telephone or video conference.

C.3.2.10.8 Material Review Board.

The Contractor shall establish and maintain a Material Review Board (MRB) to determine the acceptance status of nonconforming parts and material used in fabrication of the FFBS deliverable system throughout the life of the OTA. The Government may attend all MRBs either in person or via teleconference or video conference.

C.3.2.11 Environmental, Safety, and Occupational Health

C.3.2.11.1 Safety and Occupational Health.

C.3.2.11.1.1 System Safety Engineering Principles.

The Contractor shall follow system safety engineering best-practices and established design standards during the development of the prototypes.

C.3.2.11.1.2 Safety Assessment Reports (SAR)

The Contractor shall provide SARs, to summarize safety and health hazard data, provide a comprehensive evaluation of the safety and health risks, and identify procedures/precautions required for safe use of the system/subsystem and prototypes.

The Contractor shall use the Hazard Severity and Probability categories and definitions along with the Hazard Risk Index Matrix in the MIL-STD-882E to assign Risk Assessment codes and categorize risk levels. The Contractor shall deliver a SAR 30 calendar days prior to each Government test event.

C.3.2.11.2 Hazardous Materials Management.

The Contractor shall evaluate, plan, and implement a program to eliminate and reduce the use of toxic and hazardous materials in processes and products IAW Executive Order No. 13693. The Contractor shall conduct efforts to minimize, eliminate, and control hazardous/toxic waste materials in FFBS production. Guidance is available in National Aerospace Standard (NAS) 411, sections 4.2, 4.4, and 5.3.

C.3.2.11.3 Ozone Depleting Substances (ODS).

The Contractor shall avoid or minimize the use of Class II ODS. (Reference FAR subparts 23.8 through 23.10, US Environmental Protection Agency (EPA) Class II Ozone Depleting Substances, and US EPA Toxic Release Inventory Listed Chemicals).

C.3.2.11.4 Hazardous Materials Use.

The Contractor shall develop and implement plans and procedures for the tracking, storing, handling, packaging, transporting, and disposing of such materials and documents when the use of hazardous materials cannot be avoided. In addition, the Contractor shall ensure that the shipping configuration or container, as applicable, be packed to meet all modes of shipment as specified in the most current version of the following required documents: Title 49 Code of Federal Regulations Part 100 thru 180;

the International Air Transportation Association (IATA) Dangerous Goods Regulation;

the International Maritime Dangerous Good (IMDG) Code; and the AF 24-204/TM 38- 250/NAVSUP PUB 505/MCO P4030.19J/DLAI 4145.3 “Preparing Hazardous Materials for Military Air Shipments.” In the event the requirements of this PWS conflict with the respective Regulation stated above for the respective mode of transportation, the Regulation listed above shall take precedence. When an item is forbidden for shipment IAW the required document for that mode of transportation, the requirements of this PWS for that mode of transportation are not applicable.

C.3.2.11.5 Material Safety Data Sheets.

The Contractor shall provide material safety data sheets (Occupational Safety & Health Administration Form 20) for known hazardous materials, to include ozone-depleting substances. (Reference: FAR subpart 23.3.)

C.3.2.11.6 Use of Recoverable Materials and Environmentally Preferable and Energy Efficient Products and Services.

The Contractor shall use environmentally preferable, recycled, or recovered materials that exceed or meet the operational and maintenance requirements as well as reduce life-cycle cost to the maximum extent possible. (Reference Executive Order 13101 and FAR subparts 23.4 and 23.7.)

C.4 TMRR Prototype Testing

The Contractor shall provide prototypes, consumables, and technical support as required to enable Government-led independent testing and evaluation of vendor prototypes developed during the Technology Maturation and Risk Reduction (TMRR) Phase. The contractor shall conduct internal testing sufficient to ensure system readiness prior to formal Government test events. Government-led testing shall generate objective performance data to validate threshold requirements and inform the decision for entry into Engineering and Manufacturing Development (EMD). The Contractor shall provide test data, reports, and analysis in a format suitable for Government review.

C.4.1 The Government will initially evaluate the FFBS prototype components and systems. The results of testing will inform a decision of which automated sample/library preparation approach will be incorporated into the design and delivered at EMD option award. The Government will also evaluate vendor provided nanopore sequencing device with a custom computing element and bioinformatics – if applicable.

C.4.2 The Contractor shall provide all necessary material, supplies, and manufacturing services to produce and deliver up to four (4) FFBS prototype components and systems. The FFBS prototype systems should include at a minimum - an automated sample and library preparation device.

C.4.3 The prototype systems delivered will undergo the following testing events:

• Developmental Testing to inform design decisions and demonstrate ability to meet CDD requirements.

• Early User Touchpoints to gain user feedback and influence system design.

The contractor shall provide no more than two onsite personnel during testing.

Contractors may not have the ability to view or remotely operate the system during testing. The Government may elect to require rework to resolve system hardware or software issues prior to additional testing.

C.5 EMD FFBS Developmental / Operational Testing (OPTION)

C.5.1 The Contractor shall provide all necessary material, supplies, and manufacturing services to produce and deliver up to sixteen (16) FFBS prototypes. The FFBS systems should include, at a minimum, an automated sample and library preparation device and – if applicable - a nanopore sequencing device with a custom computing element and bioinformatics software.

C.5.2 The systems delivered will undergo the following testing events:

• Developmental Testing to inform design decisions and demonstrate ability to meet CDD requirements.

• Early User Touchpoints to gain user feedback and influence system design.

• MIL-STD testing to demonstrate functionality in various environmental conditions.

• Operational Testing to assess effectiveness, suitability, and survivability.

The contractor shall provide no more than two onsite personnel during testing.

Contractors may not have the ability to view or remotely operate the system during testing. The Government may elect to require rework to resolve system hardware or software issues prior to additional testing.

C.5.3 System Support Package

The Contractor shall provide a System Support Package List (SSPL), as part of the proposal which details all consumables recommended for supporting up to sixteen (16) FFBS systems for testing (see C.4 and C.5). The Contractor shall supply the consumables listed in the SSPL as a System Support Package (SSP) and will be delivered together.

C.6 INTEGRATED PRODUCT SUPPORT (IPS)

C.6.1 IPS Management

C.6.1.1 The Contractor shall conduct Integrated Product Support (IPS) management and associated technical efforts to influence the design with respect to IPS (formerly referred to as integrated logistics support) and to identify and acquire the elements of IPS. The IPS elements for this program include product support management; design interface; sustaining engineering; supply support; packaging, handling, storage, and transportation; technical data; support equipment; training and training support; and computer resources.