B08 - Attachment 6 PWS Task Order.docx

Performance Work Statement For the “Chemical, Biological Defense and Biomanufacturing Research” Effort Task Order One

C.1.0 Scope. The U.S. Army Combat Capabilities Development Command, Chemical Biological Center, Biosciences Division (DEVCOM CBC BSD) has been tasked to support National Chemical, biological, radiological and nuclear (CBRN) defense programs aimed at defeating chemical and biological threats by providing laboratory technical experience and expertise, technical laboratory work, programmatic support for applied and basic research and administrative support. This effort will encompass the detection, identification, growth, purification, analysis and detoxification of known and new biological pathogens, naturally occurring and synthetic toxins, biologically active compounds, biomanufacturing of biological and chemical products and organophosphorus chemical warfare nerve agents that have high potential for use as warfare and terror.

C.1.1 Background. DEVCOM CBC BSD at Aberdeen Proving Ground Edgewood Area (APG EA) is responsible for basic research, advanced development, testing, and evaluation of technology in microbiological, biochemical, chemical and analytical fields of science, which support a broad range of research studies that include chemical and biological detection technology and sensors, immunosensor assay development, validation, production of biological reference material and biological reagents, production of tri-service biomaterials and commodity chemicals with downstream processing and data management. Furthermore, the DEVCOM CBC BSD maintains a formal Quality Management System to support its International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC) certification for quality analytical and operational processes.

The DEVCOM CBC BSD will support the current capability primarily through the conduct of chemical and biological surety and non-surety laboratory expertise. The majority of the effort shall be performed in the laboratories at DEVCOM CBC BSD. In accordance with these assignments, the DEV COM CBC BSD provides the following:

a. Research and Development programs in the areas of biomanufacturing, microbiological, biochemical, chemical and computational fields, which support a diverse base of research topics, to include pathogen studies, decontamination, toxic small molecules, threat characterization, sensor and assay development/evaluation and the production of biologically derived materials to include both biological material and chemical commodities.

C.1.2 Objective. The objective of this task order is to obtain qualified non-surety technical support, one FTE, for the DEVCOM CBC BSD mission relating to the biomanufacturing effort.

C.2.0 Applicable Documents in accordance with the BASE PWS paragraph C.2.0

C.2.1 QMS-QA-01 R2 DB Laboratory Quality Assurance Plan, current version (Available upon award)

C.2.2 Biosciences SOPS, IOPS, test plans, CBC Biosafety manual, current version etc. (Available upon award)

C.2.3 SOP Guidebook, Preparation of Standing Operating Procedures, current version

C.2.4 AR 50-6, Chemical Surety, current version.

https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN3125_AR50-6_WEB_FINAL.pdf

C.2.5 AR 190-59, Chemical Agent Security Program, current version https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/r190_59.pdf

C.2.6 AR 385-10, The Army Safety Program, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN16777_ARN16343_AR385_10_FINAL.pdf

C.2.7 AR 25-2 Army Regulation (AR 25-2 “Army Cybersecurity”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN17503_AR25_2_Admin_FINAL.pdf

C.2.8 AR 2014-5 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=104095

C.2.9 AR 381-12 C.2.17 Army Regulation (AR 381-12 “Threat Awareness and Reporting Program”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/AR%20381-12%20FINAL%20WEB.pdf

C.2.10 AR 190-17 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=1002302

C.2.11 AR 50-1 https://armypubs.army.mil/ProductMaps/PubForm/Details.aspx?PUB_ID=82123

C.2.12 AR 190-59 https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/r190_59.pdf

C.2.13 AR 11-34 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r11_34.pdf

C.2.14 530-1 C.2.18 Army Regulation (AR 530-1 “Operations Security”) https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/r530_1.pdf

C.2.15 AR 190-13 https://armypubs.army.mil/epubs/DR_pubs/DR_b/pdf/web/ARN21433_R190_13_FINAL.pdf

C.2.16 DA Pam 40-8, Occupational Health Guidelines for the Evaluation and Control of Occupational Exposure to Nerve Agents GA, GB, GD, and VX, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN6941_PAM_40_Final.pdf

C.2.17 DA Pam 40-173, Occupational Health Guidelines for the Evaluation and Control of Occupational Exposure to Mustard Agents H, HD, and HT, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/p40_173.pdf

C.2.18 DA Pam 385-61, Toxic Chemical Agent Safety Standards, current version https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/ARN12692_PAM385-61_WEB_FINALL.pdf

C.2.19 DODI 5220.22M (National Industry Security Program) https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/522022M.pdf

C.2.20 DA PAM 385-10 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/p385_10.pdf

C.2.21 DA PAM 385-69 https://armypubs.army.mil/epubs/DR_pubs/DR_a/pdf/web/p385_69.pdf

C.2.22 CFR 1910.134 https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134

C.2.23 Radiation Safety Program for DEVCOM CBC

C.2.24 DOD 8570.01 (Certification Requirements) https://public.cyber.mil/cw/cwmp/dod-approved-8570-baseline-certifications/

C.2.25 DOD 8570.01M (Information Assurance Workforce Improvement Program) https://www.esd.whs.mil/Portals/54/Documents/DD/issuances/dodm/857001m.pdf

C.3.0 Requirements. The Contractor, as an independent entity and not as an agent of the Government, shall provide the necessary resources (except those specifically designated as Government-furnished) to accomplish tasks of the type set forth below. The anticipated work requires specialized facilities, equipment and procedures, and Contractor personnel will be required to perform work on site at DEVCOM CBC, Aberdeen Proving Ground, contractor facilities, or other anticipated Government approved cites.

C.3.1 Key Personnel - The Contractor shall provide key personnel in the Technical support Level II and shall meet or exceed the resumes submitted as part of the proposal. If Contractor proposes above the minimum qualifications for Key Personnel and/or if the person proposed is different from the person provided, the person provided must meet the Contractors proposed qualifications. The Contractor shall include the substance of this requirement in any subcontract which is awarded under this contract. No substitutions in key personnel shall be made except in accordance with (IAW) this paragraph. All proposed substitutions must be submitted in writing to the Contracting Officer (KO) 30 days or180 days if security clearance is to be obtained, in advance of the proposed substitutions. All requests for substitutions must include a resume for the proposed substitute. The COR will review the proposed substitute resume to ensure Contract requirements are met. Should the Contractor fail to provide an acceptable substitute as determined by the KO, this contract may be terminated for default. Key personnel with minimum qualifications for this contract are detailed in the Table below:

TABLE 1 – Qualifications for Key Personnel

Total Overall Experience Required (Min): 5 Years

C.3.1.1 The contractor shall conduct a Start of Work Meeting within 14 calendar days after contract award.

C.3.1.1.1 The start of work meeting shall include a verbal “walk-through” of this Performance Work Statement (PWS) to summarize its understanding of the specific tasks to be completed, ask and answer questions, and serve as a venue for all parties to make introductions.

C.3.1.1.2 The contractor shall provide start of work meeting minutes to the Government No later than (NLT) forty eight (48) hours after the scheduled start of work meeting in accordance with (IAW) Exhibit Line Item Number (ELIN) A001.

C.3.2 In accordance with base PWS paragraph number C.3.2 The contractor shall provide support to the biomanufacturing effort.

C.3.2.3. The contractor shall operate the fermentation, downstream processing equipment, and/or analytical equipment in accordance with established IOP’s, SOP’s, and with project-specific production and test plans.

C.3.2.3.1 The contractor shall maintain accurate records of laboratory operations, production processes, in physical and electronic form in accordance with all relevant IOP’s, SOP’s, production and test plans, and data management procedures.

C.3.2.3.2 The contractor shall communicate project progress, results, and issues in accordance with ELIN A002.

C.3.2.3.3 The contractor shall participate as a member of the project team in the development of IOP’s, SOP’s, and other project-specific production and test plans.

C.3.2.2.5 The contractor shall provide administrative support to the COR to assist with the management, coordination and acquisition of all service contracts for the preventative maintenance and repair of government on site laboratory instruments required to support the contractor effort. Contractors shall calibrate in-house equipment if necessary and only when supporting by the instrument manufacturer protocols.

C.3.2.2.6 The contractor shall participate in the presentation of technical data to explain test results in a concise manner. The Contractor shall assist the Government in presenting work at scientific conferences and serve as an interface at scientific/Collaborator meetings.

C.4.0 Environmental

C.4.1 Compliance with Environmental Laws and Regulations. Contractor shall comply with all applicable federal, state, and local environmental laws, statutes, regulations, executive orders, permits, Army regulations (with supplements), as well as Major Subordinate Command (MSC) and installation regulations and policies. Contractor shall immediately report any conflicts between applicable federal, state, local environmental laws, statutes, executive orders, and provisions of Army Regulation 200-1, and any specifications within this contract to the Contracting Officer Representative (COR).

C.4.2 Reporting Noncompliance. Contractor shall immediately report any nonconformance and/or noncompliance with applicable Federal, State or Local environmental laws, Army and installation environmental regulations or policies to the COR who will notify the DEVCOM CBC Environmental Quality Office, 410-436-4912.

C.4.3 Compliance with Green Procurement Requirements: Contractor shall follow Federal EPA Comprehensive Procurement guidelines (www.epa.gov/cpg) and Army Contracting Command Quick Guide (https://acc.aep.army.mil/accapps/ACCMAP/Documents/Quick-Guide-for-Sustainable-Procurement.docx) for acquisition of building materials and products and select materials that have a long life cycle; the least toxic materials; recyclable materials; materials that are resource-efficient; materials with the maximum recycled content; materials harvested on a sustained yield basis; and products causing the least pollution during their manufacture, use, and reuse.

C.4.4 Notification of Federal and State Regulators: Contractor shall immediately notify the DEVCOM CBC Environmental Quality Office, 410-436-4912 and COR of the arrival on site of any Federal, State, and/or DoD environmental regulator or enforcement agent and/or the receipt of any correspondence from a Federal or State environmental agency

C.4.5 Competency Training for Contractor Personnel: Contractor shall not allow personnel to perform any activities and/or tasks on AMC installations without proper and adequate qualifications or job competency training. In the event of any identified noncompliance, the Contractor shall, if requested, provide proof of contract personnel training or qualification (individual name, training/qualification type, training/qualification certificate, and date of training/qualification) to perform those contract activities associated with the identified noncompliance.

C.5.0 Administration.

C.5.1 DoD Computer Network Access. All Contractor employees, subcontractors, and suppliers at the applicable installation or facility shall comply with governing policies for gaining network access and for securing and using email accounts. All Contractor employees, subcontractors, and suppliers shall comply with DOD and agency- specific regulations and policies pertaining to Government-owned websites and databases. The contractor shall coordinate with the Government to obtain approval from the agencies’ security and public affairs officials.

C.5.2 Deliverables. The following items shall be delivered by the contractor. All data shall be delivered in accordance with the attached DD Form(s) 1423. The contractor may obtain a copy of Data Item Descriptions listed in block 4 from: http://assist1.daps.dla.mil/quicksearch/.

C.5.2.1 ELINA001; Start of Work Meeting Minutes. The contractor shall deliver minutes from the start of work meeting.

C.5.2.2 ELINA002; Contractor Status Report. The contractor shall prepare monthly progress reports

C.5.2.3 ELIN A003; Scientific and Technical Reports. The contractor shall prepare and provide an annual report at the end of each period of performance (base year, option year 1, option year 2).

C.5.2.4 ELIN A004; Scientific and Technical Reports. The contract shall prepare and provide a final comprehensive report at the end of the total effort.

C.6.0 Security. This contract requires access to classified materials. The highest clearance required shall be SECRET. The DD Form 254 for this contract governs access and use of classified materials. The contractor and subcontractor personnel shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified "Confidential," "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). The DD Form 254 for this task governs access and use of classified information.

C.6.1 AT Level I training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. All contractor employees, to include subcontractor employees, requiring access to Army installations, facilities and controlled access areas shall complete AT Level I awareness training within 30 calendar days after contract start date or effective date of incorporation of this requirement into the contract, whichever is applicable. The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee to the COR or to the contracting officer, if a COR is not assigned, within 30 calendar days after completion of training by all employees and subcontractor personnel. AT level I awareness training is available at the following website: http://jko.jten.mil.

C.6.2 iWATCH Training. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility or area. The contractor and all associated subcontractors shall brief all employees on the local iWATCH program (training standards provided by the requiring activity ATO). This local developed training will be used to inform employees of the types of behavior to watch for and instruct employees to report suspicious activity to the CO. This training shall be completed within 30 calendar days of contract award and within 30 calendar days of new employees commencing performance with the results reported to the COR NLT 30 calendar days after contract award.

C.6.3 Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to government information systems. All contractor employees with access to a government information system must be registered in the ATCTS (Army Training Certification Tracking System) at commencement of services, and must successfully complete the DoD Information Assurance Awareness prior to access to the IS and then annually thereafter.

C.6.4 For contracts that require OPSEC training. Per AR 530-1, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained with 30 calendar days of their reporting for duty and annually thereafter.

C.6.5 For information assurance (IA)/information technology (IT) training. All contractor employees and associated subcontractor employees must complete the DoD IA awareness training before issuance of network access and annually thereafter. All contractor employees working IA/IT functions must comply with DoD and Army training requirements in DoD 8570.01, DoD 8570.01-M and AR 25-2 which must be completed upon contract awards.

C.6.6 For contracts that require handling or access to classified information. Contractor shall comply with FAR 52.204-2, Security Requirements. This clause involves access to information classified "Confidential," "Secret," or "Top Secret" and requires contractors to comply with: (1) The Security Agreement (DD Form 441), including the National Industrial Security Program Operating Manual (DoD 5220.22-M) and, (2) any revisions to DoD 5220.22- M, notice of which has been furnished to the contractor.

C.6.7 Access and general protection/security policy and procedures. This standard language is for contractor employees with an area of performance within an Army controlled installation, facility, or area. Contractor and all associated subcontractors employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in contractor security matters or processes must be completed upon contract award.

C.6.8 For contractors requiring a Common Access Card (CAC). Before CAC issuance, the contractor employee requires, at a minimum, a favorably adjudicated national Agency Check with Inquiries (NACI) or an equipment or higher investigation in accordance with Army Directive 2014-05. The contractor employee will be issued a CAC only if duties involve one of the following: (1) both physical access to a DoD facility and access, via logon, to DoD networks on-site or remotely; (2) remote access, via logon, do a DoD network using DoD-approved remote access procedures; or, (3) physical access to multiple DoD facilities or multiple non-DoD federally controlled facilities on behalf of the DoD on a recurring basis for a period of 6 months or more. At the discretion of the sponsoring activity, an initial CAC may be issued based on a favorable review of the FBI fingerprint check and a successfully scheduled NACI at the Office of Personnel Management.

C.6.9 For contractors that do not require a CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and processes using the National Crime Information Center Interstate Identification Inex (NCICIII) and Terrorist Screening Database (TSDB) (Army Directive 2014-05/AR 190-13), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

C.6.10 Threat Awareness Reporting Program. For all contractors with security clearances. Per AR 381-12, Threat Awareness and Reporting Program (TARP), contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.

C.6.11 The contractor shall return all items provided at Government on-site facilities, to include notes, reports, computer software, and files to the Government upon request or at the end of this contract.

C.7.0 Security/Surety Clearance.

C.7.1 Security/Surety Clearance. Efforts performed under this contract shall require access to documentation up to the SECRET level. Failure to obtain or maintain these clearances shall be considered grounds for termination. Access to some of the data and field test sites will require a SECRET level security clearance.

The contractor must provide personnel with SECRET level clearances on day one of task order award. New personnel must be capable of obtaining an interim SECRET level clearance within two months of contract award.

C.8.0 Place of Performance. This effort will take place at U.S. Army laboratory facilities located at the Aberdeen Proving Ground, Edgewood Area (APGEA). The Government will provide basic utilities (electric, water, gas, vacuum, communication) to support work on the contract. The contractor shall have a Government desk area and computer access, be required to facilitate and attend meetings in government conference rooms, and conduct laboratory evaluations in government lab rooms. The contractor will use Government facilities for surety evaluations.

C.9.0 Safety/Hazards Information. This contract requires the contractor to work with various solvents in accordance with Biosciences Standing Operating Procedures (SOPs), written procedures, DEV COM CBC requirements, local guidelines and material safety data sheets. The contractor shall follow the requirements of the SOP and local guidelines to minimize hazards and shall comply with the applicable SOPs. The contractor shall follow the SOP that pertains to the agent and operation per evaluation.

C.9.2.1 The contractor shall comply with the current versions of: AR 385-10 (The Army Safety Program; DA PAM 385-10 (Army Safety Program); and DA PAM 385-69 (Safety Standards for Microbiological and Biomedical Laboratories) when working with infectious agents and toxins. Revisions to these regulations and standards enacted subsequent to award of this contract become applicable to this contract. In addition, the contractor shall comply with all local policies and procedures concerning infectious agents and toxins (available upon request). The contractor shall ensure that all its subcontractors comply with these requirements.

C.9.3 RAD/ LASER: The contractor shall comply with the current versions of the CBC Radiation Safety Program for all operations involving lasers or non-ionizing radiation.

C.9.4 GENERAL: When working on-site at the Edgewood Area of Aberdeen Proving Ground, the contractor will operate under an approved Standard Operating Procedure (SOP) for all hazardous operations to include, but not limited to: toxic chemicals, microbiologicals (pathogenic and non-pathogenic), toxins, radioactive materials, explosives/pyrotechnics, lasers, x-rays devices or any other substance or equipment which is hazardous. It the contractor must prepare an SOP, it shall do so IAW the latest version of Preparation of Standing Operating Procedure (SOP). The contractor shall ensure that all its subcontractors comply with these requirements.

C.10.0 Travel Requirements. There is limited travel requirements associated with this effort, to include possible attendance at off-site meetings, conferences, or required trainings and in accordance with the Joint Travel Regulations (JTR). Travel locations for this effort are listed in the table below and are estimated based on program history; however, exact locations and trips are dependent upon anticipated requirements.

C.11.0 Period of Performance. All work, including acceptance of all deliverables by the Government, shall be completed over one 12 month base period and two 12 month option periods.

C.12.0 Government Contracting Officer’s Representative (COR). To Be Determined