Attachment 11 - Statement of Work.pdf

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Controlled by: US Army Controlled by: DBPAO CUI Category: General Procurement and Acquisition Distribution/Limited Dissemination Control: FEDONLY POC: Bryan Necciai, bryan.d.necciai.civ@army.mil

CUI

Statement of Work (SOW) Assembly/Manufacture, Storage, and Distribution Support Services

For the Defense Biological Product Assurance Office Products (DBPAO)

1.0 Scope: This Statement of Work (SOW) addresses the program objectives for the assembly/manufacture, storage, and distribution of DBPAO products contract effort. Specifically, the support embodies the assembly/manufacture of end items that incorporate the government-provided lateral flow immunoassay (LFI) strips, and the storage and distribution of DBPAO products. These DBPAO products include electrochemiluminescence (ECL) assays and reagents, polymerase chain reaction (PCR) assays, and other end items containing LFI, LFI assay strips, special configuration LFI strips, and other DBPAO products. DBPAO products is defined as any government property associated with the execution of this contract to include components of end items, or the end items themselves. Other program objectives include inventory management, disposal, and shipping to CONUS and OCONUS locations.

1.1 Background: The Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND), with its headquarters in Aberdeen, MD, has cognizance over the DBPAO, the Joint Biological Point Detection System (JBPDS), and the Joint Portal Shield (JPS) system.

These programs (and others) provide the Department of Defense with equipment and materials to detect and identify biological warfare agents (BWA).

1.2 Mission Statement: The DBPAO's mission is to serve as the principal resource of high quality, validated, and standardized biological detection assays and reagents that meet the requirements of the warfighter and Joint Biological Defense Systems, and support the biological defense community by facilitating the transition of new technologies and coordinating their advanced development, efficient production, and timely distribution.

1.3 Applicable Documents: Any documents listed in this section form a part of this contract to the extent invoked by specific reference in other paragraphs of this contract. If a document reference does not indicate the specific paragraph as being applicable, then the document is applicable in its entirety. Unless otherwise indicated, copies of the Department of Defense specifications, standards and handbooks listed below are available from the Defense Automation and Production Service, Building 4/D, 700 Robbins Avenue, Philadelphia, PA 19111-5094, or in the Acquisition Streamlining and Standardization Information System (ASSIST) database at http://assist.daps.dla.mil/quicksearch/. In the event of a conflict between the documents referenced herein and the contents of this SOW, the text of the SOW shall take precedence.

1.3.1 Government Regulations Documents and Other Publications:

1. International Traffic in Arms Regulations (ITAR), 22 CFR Parts 120-130 (2023).

2. Chemical, Biological, and Radiological (CBR) Defense Research, Development, and

Acquisition (RD&A) Information Security Classification Guide (SCG), September 7, 2018, and any other applicable security documents (2005 CRP Security Classification Guide).

3. Shippers – General Requirements for Shipments and Packaging, 49 CFR Part 173 (2023).

4. Hazardous Waste Operations and Emergency Response, 29 CFR Part 1910.120 (2023).

5. Guidelines for the Thermal Processing of Solid Wastes, Solid Wastes Accepted, 40 CFR Part

240.200 (2023).

6. Government Property, FAR Part 45 (2023).

7. MIL-STD-130 Identification Markings of U.S. Military Property.

8. MIL-STD-129 Standard Practice for Military Marking.

9. MIL-STD-1916 DOD Preferred Methods for Acceptance of Product.

10. MIL-STD-3010 Test Method 5009, Leakage Integrity.

11. ISO 9001:2015 Quality Management Systems Requirements.

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CUI

12. ANSI/ASQ Z1.4-2008 Sampling Procedures and Tables for Inspection by Attributes.

1.3.2 Government Provided Documents provided as attachments to the Request for Proposal (RFP):

1. Attachment 1: Special Packaging Instructions (SPIs)

2. Attachment 2: Joint Biological Point Detection System (JBPDS) Carrier Box Technical Data

Package

3. Attachment 3: Joint Portal Shield (JPS) Carrier Box Technical Data Package

4. Attachment 4: Hand Held Assay (HHA) Technical Data Package

5. Attachment 5: Hand Held Assay (HHA) Operational and Training Panel Technical Data

Package

6. Attachment 6: Biological Sampling Kit (BSK) Technical Data Package

7. Attachment 7: CDRLs

8. Attachment 8: DD Form 254, DoD Contract Security Classification Specification

9. Attachment 9: Government Furnished Equipment

10. Attachment 10: Non-Disclosure Agreement

11. Attachment 11: Statement of Work

1.4 Place and Period of Performance

1.4.1 The work under this contract shall be performed at the contractor’s facility.

1.4.2 The contractor shall schedule the assembly/manufacture, storage, and distribution of DBPAO products within the period of performance of 9/16/2024-9/15/2029.

2.0 Requirements

2.0.1 The contractor shall provide the services and facilities within the scope of the contract and in the context of a quality management system as described in section 2.2.1 of this SOW.

2.0.2 The contractor shall be registered under the International Traffic in Arms Regulations (ITAR) in accordance with ITAR 22 CFR Parts 120-130.

2.0.3 The contractor shall have a program manager to monitor and manage contract activities and to serve as the overall expert for successful completion of this contract.

2.0.4 The contractor facility shall have systems capable of monitoring temperature, humidity, and security.

2.1 Technical

2.1.1 Assembly/Manufacture:

2.1.1.1 The contractor shall manufacture/assemble end items that incorporate the Government-provided lateral flow immunoassay (LFI) strips. These end items include Hand Held Assays (HHAs), Operational and Training HHA Panels, Biological Sampling Kits (BSKs), individual LFI strip package (CDRL A016), special configuration LFI strips, the Joint Biological Point Detection System (JBPDS) carrier box, and the Joint Portal Shield (JPS) system carrier box. The contractor shall perform the assembly of these end items in accordance with Government requirements specified in the Government-provided documents in Section J, Attachments 2– 6 (SOW section 1.3.2).

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• JBPDS carrier box assemblies (Section J, Attachment 2)

• JPS carrier box assemblies (Section J, Attachment 3)

• Hand Held Assays (HHA) (Section J, Attachment 4)

• Operational and Training HHA Panels (Section J, Attachment 5)

• Biological Sampling Kits (BSK) (Section J, Attachment 6)

2.1.1.2 The contractor shall label all components in accordance with quality practices.

2.1.1.3 The contractor shall use heat sealers to seal outer containers of end items (foil pouches) to meet the packaging requirements.

2.1.1.4 Manufacturing of the strip carrier assembly requires ultrasonic welding. The contractor shall be familiar with and have knowledge of ultrasonic welding process.

2.1.1.5 The contractor shall maintain replicates of each piece of equipment used for assembly of end items to minimize the effects of downtime in the event of an equipment failure.

2.1.1.6 The contractor shall be responsible for the maintenance of the molds for the extruded plastic parts utilized in the assembly process.

2.1.1.7 Process Controls. The contractor shall allow the Government to come in and assess the process controls outlined in this SOW. The assessment shall be scheduled at a mutually agreed-upon date/time, four months after the receipt of Government Furnished Equipment required to operate the manufacturing and assembly of DBPAO products.

2.1.2 Manufacturing Area

2.1.2.1 The contractor facility shall have dedicated manufacturing areas sufficient for the potential maximum operations of the assembly/manufacture of the DBPAO product line.

2.1.2.2 The dedicated manufacturing areas shall be physically controlled with access limited to contractor personnel identified as manufacturing and quality assurance teams who will perform work under this contract.

2.1.2.3 The contractor shall use a standalone, 800 square feet minimum, temperature range for 20°C– 25°C (66°F–77°C), and humidity controlled/clean room (HCR) with HEPA filtration (Class 100,000) to minimize particulate exposure during the assembly of end items. The contractor shall use a wireless monitoring system to ensure the required temperature and humidity of the HCR are maintained. Assay strips and assembled carriers containing assay strips shall not be out of this temperature and humidity range for more than eight consecutive hours.

2.1.2.4 The contractor shall provide segregated areas for incoming assembly supplies to hold materials through the quality inspection process.

2.1.2.5 The floor space for the conduct of incoming acceptance shall be sufficient for potential maximum operations.

2.1.2.6 The contractor shall provide assembly tables and chairs to complete the assembly of end items.

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2.1.2.7 The contractor shall use cameras in the assembly area to ensure the product is handled in accordance with Government specifications supplied in Section J of the contract.

2.1.3 Storage and Distribution Operations

The contractor shall ensure that storage and distribution operations are covered under the quality management system (SOW section 2.2.1).

2.1.3.1 Storage

2.1.3.1.1 The contractor shall provide storage for the following DBPAO products: Hand Held Assays (HHAs), Operational and Training HHA Panels, Biological Sampling Kits (BSKs), individual LFI strips, special configuration LFI strips, the Joint Biological Point Detection System (JBPDS) carrier box, the Joint Portal Shield (JPS) system carrier box, electrochemiluminescence (ECL) assays and reagents, and polymerase chain reaction (PCR) assays, and other DBPAO products. DBPAO products is defined as any government property associated with the execution of this contract to include components of end items, or the end items themselves.

2.1.3.1.2 The contractor shall coordinate with the DBPAO/designees for the receipt of products for storage.

2.1.3.1.3 The contractor shall use a minimum of two dedicated coolers, with capability to maintain 2°-8° C temperature range, for storage of assay strips to maintain separation between agents.

2.1.3.1.4 The contractor shall provide a minimum total storage capacity of 18,000 cubic feet that will accommodate a minimum single cooler size of 350 cubic feet for bulk box product storage.

2.1.3.1.5 The contractor shall provide 24-hour emergency power back-up system(s) with temperature and humidity monitoring to maintain storage at 2°-8°C and at less than 40% relative humidity. This storage conditions are required on pre-processing, in-processing, and post-processing of the assay strips onto the end products. Backup power system(s) shall have the capability to provide uninterrupted power generation to maintain required manufacturing and storage conditions. An automated monitoring system shall be used with recorder and alarm features, and with capability to notify personnel of possible power failure and loss of environmental control. Records from the monitoring system shall be made available to the Government upon request.

2.1.3.2 Distribution

2.1.3.2.1 The contractor shall distribute the following DBPAO products: Hand Held Assays (HHAs), Operational and Training HHA Panels, Biological Sampling Kits (BSKs), individual LFI strips, special configuration LFI strips, the Joint Biological Point Detection System (JBPDS) carrier box, the Joint Portal Shield (JPS) system carrier box, electrochemiluminescence (ECL) assays and reagents, and polymerase chain reaction (PCR) assays, and other DBPAO products. DBPAO products is defined as any government property associated with the execution of this contract to include components of end items, or the end items themselves.

2.1.3.2.2 The contractor shall package DBPAO items, including Special Packaging Instructions (SPI) or commercial, and end items IAW Government requirements (see Section J, Attachment 1). In the event

SOW: AS&D for DBPAO CUI Page 5 of 18 there is no SPI for DPBAO products, packaging shall be in accordance with best manufacturing practice to ensure protection from damage, environmental conditions, and reasonable transportation delays; these packaging efforts will be charged to the Distribution CLIN (CLIN 0009).

2.1.3.2.3 The contractor shall ship DBPAO products to customers within CONUS and OCONUS locations IAW import/export regulations while ensuring the quality, performance and shelf life are maintained with the use of validated thermal (cold chain) management protocols.

2.1.3.2.4 The contractor shall be registered with the Department of State for shipment of military products to OCONUS locations.

2.1.3.2.5 The contractor shall be registered under the International Traffic in Arms Regulations (ITAR) in accordance with ITAR 22 CFR Parts 120-130.

2.1.3.2.6 The contractor shall use commercial tracking software to ensure products arrive at each particular destination intact, and on time.

2.1.3.2.7 The contractor shall use documented quality control procedures to assure products are packaged and shipped to prevent damage or deterioration.

2.1.3.2.8 The contractor shall deliver products to customers within 10 business days from DBPAO order placement, assuming products are available, and permits (if necessary) are in place.

2.1.3.2.9 The contractor shall provide customer notification with shipping information, including tracking number, within 24 hours of shipment.

2.1.3.2.10 The DBPAO is the responsible official for validating customer requirements and distribution of DBPAO products and components against the DoD Chemical, Biological, and Radiological (CBR) Defense Research, Development and Acquisition (RD&A) Security Classification Guide (SCG), dated September 7, 2018 (see SOW section 1.3.1). The contractor shall assist with DBPAO’s validation and notify DBPAO if any security concerns arise.

2.1.4 Inventory Management

2.1.4.1 The contractor shall use proven commercial or military best inventory management practices to store the following DBPAO products under the appropriate storage conditions as required by the label or other Government provided storage conditions (e.g., 2°-8° Celsius) to maximize performance integrity and shelf life:

• End items listed under section 2.1.1 of this SOW

• LFI strips used in the manufacture of the end items

• LFI strips with special configurations

• Antigens

• Electrochemiluminescence (ECL) immunoassays and reagents

• Polymerase chain reaction (PCR) assays

2.1.4.2 The contractor shall provide and maintain an inventory management system to manage the movement of goods to, from, and through the warehouse(s).

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2.1.4.3 The contractor shall include raw material inventory status in the monthly status report (CDRL A001) (SOW section 2.4.6).

2.1.4.4 The contractor shall maintain sufficient inventory of raw materials and Government Furnished Materials necessary to meet Government requirements (SOW section 5.0).

2.1.4.4 The contractor shall implement a first-in, first-out stock rotation plan, unless otherwise directed by the Government.

2.1.5 Disposal

2.1.5.1 The contractor shall dispose of end items and other DBPAO products as directed by the Government and in accordance with local, state, and federal statutes and regulations.

2.1.5.2 The contractor shall monitor products with shelf lives in their inventory management system.

When a product reaches one-year shelf life, the contractor shall notify Government and request permission from customers if they will accept short shelf life products prior to shipping products to customers.

2.1.5.3 Once the product line has expired, the contractor shall remove the product from active inventory, palletize, shrink wrap, and label for destruction. Prior to placement into the segregated destruction storage area, the product shall be audited, inventory reports shall be updated to move product from active to destruction inventory, footprint and inventory of pallet shall be completed, and pallet shall be marked for destruction.

2.1.5.4 The contractor shall conduct destruction efforts of expired products on a semiannual basis. The contractor shall coordinate this effort with the Contracting Officer Representative (COR) and request the COR’s direction and approval 30 days prior to destruction of the products.

2.1.5.5 Non-hazardous wastes (i.e., cardboard boxes, aluminum foil, aluminum pouches) shall be destroyed by incineration at a solid waste incinerator in accordance with Guidelines for the Thermal Processing of Solid Wastes, Solid Wastes Accepted, 40 CFR Part 240.200.

2.1.5.6 Expired products shall be exposed to a suitable solution (to ensure the denaturing of biologics) then transferred to licensed medical waste disposal or incinerated in accordance with federal, state and local guidelines/restrictions.

2.1.6 Shelf Life Evaluation Program

2.1.6.1 The contractor shall develop shelf life evaluation protocol to inspect and test the shelf life of DBPAO products for a period of three years from receipt of the GFM within the contract period of performance. The testing program will test the assemblies and measure the packaging integrity. The plan shall, at a minimum, inspect the packaging for leaks or moisture breach, the labels for fading or conditions affecting the legibility, and desiccant discoloration.

2.1.6.2 Shelf Life and Product Stability Plan (CDRL A012). The contractor shall submit a Shelf Life and Product Stability Plan within 60 days of the award of the contract and follow the ANSI ASQ Z1.4 -2008 standard. The plan shall include, but not be limited to, the contractor performing the following:

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2.1.6.2.1 Exterior hermetically sealed packaging leak test (MIL STD 3010 Test Method 5009).

2.1.6.4.2 Ensure labeling is legible and intact so barcode is readable by automated reader.

2.1.6.5.3 Identification when pulling products for destructive testing by inspecting the desiccant upon opening for proper color indication of sealed conditions.

2.2 Quality Control / Quality Assurance

2.2.1 Quality Management System. The contractor shall have and maintain a Quality Management System (QMS) that is equivalent to ISO 9001:2015 and aligned with MIL-STD-1916 where appropriate, to ensure that DBPAO products are manufactured/assembled, stored, and distributed in accordance with Government requirements (SOW section 1.3.2).

2.2.2 Quality Assurance Plan (QAP) (CDRL A010). The contractor shall have and maintain a Quality Assurance Plan (QAP) that defines the quality standards that will be employed in the assembly/manufacture, storage, and distribution of DBPAO products. The contractor shall submit a QAP with the first delivery order.

2.2.2.1 The contractor shall include in the QAP a sampling plan for production article testing and a quality surveillance plan. The sampling plan shall be based on the ANSI/ASQ Z1.4-2008 standard (SOW section 1.3.1). The plan shall describe the actual sampling technique to be used as well as the batch/lot size and calculations. The plan shall describe how to capture the quality signature and continue to improve on reducing defects accepted under the plan and be included in the QMS.

2.2.2.2 Standard Operating Procedures. The QAP shall include Standard Operating Procedures that will be employed in assembly/manufacturing, storage, and distribution of DBPAO products to assure compliance with contractual requirements and all local, state, and federal regulations and standards. These contractor shall make these SOPs available for Government review. These procedures shall include the following:

a. Procedures for temperature/humidity monitoring, equipment calibrations, and security of manufacturing/storage areas.

b. Quality Records Maintenance

c. Warehousing and Material Handling Procedures

d. Dangerous Goods Shipping Procedures

e. International Shipping Procedures

f. Shipping and Receiving Procedures

g. Special Packaging Procedures

h. Chemical Safety Plan

i. Biological Security Plan

j. Biological Safety Plan

2.2.3 Inspection and Test Plan (CDRL A002). The contractor shall, after submission for Government review and approval, have and maintain for the entire contract period an Inspection and Test Plan to include First Article Testing (FAT) and Production Lot Testing to ensure products meet Government acceptance criteria. The contractor shall submit the Inspection and Test Plan with the first delivery order after contract award.

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2.2.4 First Article Test (FAT) Plan (CDRL A003). The contractor shall submit a FAT Plan that describes test procedures that will be used for First Article Testing (FAT) on Special Packaging Instructions (SPI) (in accordance with SPI for each end item) and on manufactured end items (i.e., packaging, labels, ink, and outer container). The FAT shall ensure that products meet Government acceptance criteria. FAT testing timelines shall be in accordance with those outlined in the Master Schedule. The contractor shall submit for Government comments a draft FAT plan 60 days after contract start, and a final FAT Plan 15 days after receipt of Government comments. The FAT Plan shall be submitted with the first delivery order.

2.2.5 First Article Testing (FAT) and Inspection Test Report (CDRL A004). The contractor shall perform First Article Testing on Special Packaging Instructions (in accordance with SPI for each end item) and on manufactured end items (i.e., packaging, labels, ink, and outer container). The First Article Testing shall ensure that products meet Government acceptance criteria. First Article timelines shall be in accordance with those outlined in the Master Schedule. The contractor shall submit the FAT and Inspection Test Report to the Government via email within 10 business days after completion of testing. The FAT report shall include test data and conclusions drawn from inspections and test results. Government approval or comments will be provided 15 days after receipt of the report. The contractor shall submit the FAT and Inspection Report with every delivery order.

2.2.6 The contractor shall perform visual inspections of assembled end items, paying particular attention to JBPDS and JPS carriers for debris, flashing, smudges, fingerprints, and any blemish that may cause the identifiers or strip readers to register a false positive. The contractor shall monitor JBPDS and JPS carrier thickness and compare against Government specifications.

2.2.7 The contractor shall conduct process analysis for assembly of JBPDS and JPS end items to ensure they meet the receiving machinery required tolerances for physical movement in the sensors as specified in the technical data packages (Section J, Attachments 2 & 3).

2.2.8 The contractor shall perform inspections of labeling, cushioning, and temperature indicator of assembled end items.

2.2.9 The contractor shall perform vendor assessment/inspection on raw materials to ensure ordered products comply with Government specifications included in the technical data packages (Section J, Attachments 2-6).

2.2.10 The contractor shall have quality acceptance documentation and maintain material travelers for the products as they move through the assembly process.

2.2.11 The contractor shall conduct internal audits on a quarterly basis, annual reviews and system assessments, and prepare reports on deviations, root cause analysis, and corrective actions.

2.2.12 The contractor shall make quality records available to the Government upon request.

2.3 Configuration Management

2.3.1 Configuration Management Plan (CMP) (CDRL A009). The contractor shall prepare and submit a CMP that ensures the baselines are defined, changes proposed are necessary, appropriate, and acceptable to the Government and the integrity of the deliverables is maintained. The contractor shall submit the CMP with the first delivery order. The contractor CM plan shall include the following items:

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• Requirements Management

• Data Management

• Change Management

• Release Management

• Records Management

• Document Control

• Library Management

2.3.2 The CMP shall describe the control of the strips, carrier, and packaging from receipt of the commercial or Government Furnished Material, through the assembly to ensure the accurate shelf life is calculated for multiple strip configuration end items.

2.3.3 The contractor shall set configuration baselines once they are supplied the data, drawings, procedures and/or other documents. Upon baseline confirmation, the designs, drawings, etc. will be frozen and revisions or deletions must be done via procedures defined in the CMP.

2.3.4 The Government and contractor will establish a configuration control board at the Start of Work meeting.

2.4 Program Management

2.4.1 The contractor shall provide technical and administrative support to the DBPAO in the assembly/manufacture, storage, and distribution efforts under this contract.

2.4.2 Master Schedule. The contractor shall conduct a Start of Work meeting within 30 days after contract start to establish an Integrated Master Schedule (IMS) for the assembled DBPAO end items.

2.4.2.1 After receiving an assembly or manufacturing order, the contractor shall submit within 30 days a revised master schedule.

2.4.3 Program Management Plan (PMP) (CDRL A011). The contractor shall have and maintain a PMP that includes the procedures that will be used to manage technical performance, cost, schedule, and deliverables.

2.4.3.1 The contractor shall address project management efforts within the PMP by including how the contractor will interface with the Government and vendors to ensure effort is meeting cost, performance, and schedule.

2.4.3.2 The contractor shall submit a draft PMP to the Government 30 days after receiving product deliverable projections and concurrence of production requirements from the Government.

2.4.3.3 The contractor shall submit a final PMP included with Government comments, 30 days after receipt of Government comments. The contractor shall submit the PMP with the first delivery order.

2.4.3.4 The contractor shall implement and maintain the Government-approved PMP throughout the life of the contract.

2.4.4 Start of Work Meeting. The contractor shall participate in one Start of Work Meeting with the Government 30 business days after contract start. The meeting can be virtual or in-person, depending on the status of Government travel restrictions on the day the meeting is scheduled. The contractor shall

SOW: AS&D for DBPAO CUI Page 10 of 18 capture the Start of Work Meeting minutes and include them in the first status report (SOW section 2.4.6).

2.4.5 Monthly Technical Meetings. The contractor shall participate in monthly technical meetings with the Government to discuss contract status, work progress, and any existing or potential issues/problems.

Monthly meetings can be virtual or in-person, depending on the status of Government travel restrictions on the day the meeting is scheduled. The contractor shall capture meeting minutes and include them with the monthly status reports. Monthly meetings will be at the Delivery Order level.

2.4.5.1 If there are substantive changes to the IMS, these will be addressed in the Monthly Technical Meetings.

2.4.5.2 In-Process Reviews will be discussed during the Monthly Technical Meetings.

2.4.6 Monthly Status Reports (CDRL A001). The contractor shall submit monthly status reports seven business days after the end of each month. Monthly status reports shall include at a minimum, cost data updates, current status of GFM inventory (condition, expiration dates, lot numbers, quantities), notable events that occurred during the reporting period, notable events that will be occurring in the next month, and information on existing or potential problem areas and recommendations to resolve the problems.

Monthly status reports will be at the Delivery Order level.

2.4.7 Annual Program Review. The contractor shall participate and provide input at a yearly program review. The program review can be virtual or in-person, depending on the status of Government travel restrictions on the day the meeting is scheduled. The contractor shall capture the yearly program review meeting minutes and these minutes shall be included in the Monthly Status Report (SOW section 2.4.6) submitted for the last month of each year of performance.

2.4.8 Risk Management. The contractor shall identify risk areas and then provide monitoring and mitigation options for those areas. The contractor shall identify risks as they arise. Contractor shall present risk issues at the Monthly Technical Meetings with the Government.

• Identify Root Cause

• Verify and Implement Corrective Action

2.4.9 Supply Chain Management. The contractor is expected to follow supply chain management best practices during the execution of the contract to ensure minimum disruption to the supply chain.

2.4.11 General Incident Reports (CDRL A005). The contractor shall prepare and submit General Incident Reports at the delivery order level for incidents that could result in program delay, transportation delays, equipment failures resulting in product exposure to temperature outside of required temperature, and shortage of materials. The contractor shall report the incident to the Government by phone within one day of incident occurrence. The contractor shall submit to the Government, via email, a written report describing the incident within three business days of incident occurrence.

2.4.12 Change Requests

2.4.12.1 Request for Deviation (RFD) (CDRL A006). The contractor shall submit a RFD, at the delivery order level, for deviations from Contractor-owned and Government-owned technical documents such as technical drawings, packaging specifications, and other specifications included in the technical data packages. Examples of deviations would be if a component or part of the products to be assembled are no

SOW: AS&D for DBPAO CUI Page 11 of 18 longer available (or different version/model), the contractor shall submit an RFD for replacement of this component part. Government approval or comments will be provided 15 days after receipt of RFD.

2.4.12.2 Specification Change Notice (SCN) (CDRL A007). The contractor shall submit a SCN if permanent changes are needed to existing Government-owned technical documents such as technical drawings, packaging specifications, and other specifications included in the technical data packages.

Examples of permanent changes that need SCNs would be changes to assembly specifications or if other sensor programs (JBPDS, JPS) change their performance criteria. Government approval or comments will be provided 15 days after receipt of SCN.

2.4.12.3 Engineering Change Proposal (ECP) (CDRL A008). The contractor shall submit an ECP for any substantive and permanent changes to existing Government-owned technical documents such as technical drawings, packaging specifications, and other specifications included in the technical data packages. Examples of these substantive and permanent changes would be changes to major labeling, material changes, or packaging changes. Government approval or comments will be provided 15 days after receipt of ECP.

3.0 Travel

3.1 The contractor shall travel as requested to support DBPAO requirements or unforeseen technical issues requiring travel to DBPAO headquarters. The contractor shall be able to participate in teleconferences if travel is not feasible. The Government will provide funding for travel. The Government will include Travel at the Delivery Order level.

3.2 The contractor shall submit and receive approval by US Government Contracting Officer before any reimbursable travel requirements are executed. Travel shall be cost reimbursable for approved reimbursable travel.

4.0 Government Furnished Property

4.1 Equipment. The Government will provide equipment for the storage of DBPAO product lines.

4.1.1 Upon award of the contract, the Government will arrange for the delivery of GFE to the contractor facility within 45 days.

Table 1. GFE

GFE QTY Serial No. Model Compressor, Refrigerator, Copeland 1 02F28217 Compressor, Refrigerator, Copeland 1 02F28230 Compressor, Refrigerator, Copeland 1 03E00589 Compressor, Refrigerator, Copeland 1 15B04525E Compressor, Refrigerator, Duracool 1 T05D01105 PTN072H2B

Compressor, Refrigerator, Duracool 1 T05D01820 PTN072H2B

Compressor, Refrigerator, Duracool 1 T05D01821 PTN072H2B Compressor, Refrigerator, Duracool 1 T05D01823 PTN072H2B Compressor, Refrigerator, Duracool 1 T05D01824 PTN072H2B Compressor, Refrigerator, Duracool 1 T05D01827 PTN072H2B Compressor, Refrigerator, Duracool 1 T05D01828 PTN072H2B Compressor, Refrigerator, Duracool 1 T05E00850 PTN072H2B

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Compressor, Refrigerator, Duracool 1 T05E01878 PTN072H2B Compressor, Refrigerator, Duracool 1 T05E03735 PTN072H2B Compressor, Refrigerator, Duracool 1 T05F01159 PTN072H2B File, Legal, Class 6, 5-Drawer, Multi-Lock, Diebold / Part # M4- 162810-0A10

1 2561652

Generator, Backup Commercial, Katolight / Part # 431CSL6202-1I 1 135604-1206 SEN130FPG4 30799 Generator, Backup, Automatic Transfer Switch, Katolight / Part #

ZG4SA04031-02

1 1450755

JBPDS, Identifier ATP Assembly, Battelle / Part # 2001210-10 1 IDATP005 JBPDS, Identifier Assembly, General Dynamics / Part # 10080557 1 ID1256 JBPDS, Identifier Assembly, General Dynamics 1 ID1611 JBPDS, Nomen Test Assembly, Identifier ATP, General Dynamics / Part # 10080200

1 2002

JPS, Computer, Laptop, Cyber Research, GFA-1515 / Part # GFA-

1 17157

JPS, Identifier Assembly, Cyber Research 1 240 JPS, Power Supply, DC, Agilent / Part # 0-35V 15A DC 1 MY40000601 6553A Probe, Temperature, Analog, Harford 1 CS-11 Probe, Temperature, Analog, Harford 1 CS-13 Probe, Temperature, Analog, Harford 1 CS-15 Probe, Temperature, Analog, Harford 1 CS-17 Probe, Temperature, Analog, Harford 1 CS-21 Probe, Temperature, Analog, Harford 1 CS-23 Probe, Temperature, Analog, Harford 1 CS-25 Probe, Temperature, Analog, Harford 1 CS-A Probe, Temperature, Analog, Harford 1 CS-B Probe, Temperature, Analog, Harford 1 CS-C Probe, Temperature, Analog, Harford 1 CS-D Probe, Temperature, Analog, Harford 1 CS-F Probe, Temperature, Analog, Harford 1 CS-G Probe, Temperature, Analog, Harford 1 CS-H Probe, Temperature, Analog, Weiss 1 CS-19 Probe, Temperature, Analog, Weiss 1 CS-E Reader, CAC / Part # 905331 1 21121142209560 SCR3310 Reader, CAC / Part # 905331 1 53311451200083 SCR3310 Reader, CAC / Part # 905331 1 53311451200111 SCR3310 Reader, CAC / Part # 905331 1 53311451200196 SCR3310 Reader, CAC / Part # 905331 1 53311451201175 SCR3310 Recorder, Norlake, Scientific 1 03-05054 Recorder, Norlake, Scientific 1 03-05058 Recorder, Norlake, Scientific 1 03-05676 Recorder, Norlake, Scientific 1 03-05682 Refrigeration Unit, 72 Square Feet, Nor-Lake, CS-05 / Part #

MRC77612-CL/30239

03120559

Refrigeration Unit, 72 Square Feet, Nor-Lake, CS-06 / Part #

MRC77612-CL/30239

03120555

Refrigeration Unit, 72 Square Feet, Nor-Lake, CS-07 / Part #

MRC77612-CL/30239

03120558

Refrigeration Unit, 72 Square Feet, Nor-Lake, CS-09 / Part #

MRC77612-CL/30239

03120557

SOW: AS&D for DBPAO CUI Page 13 of 18

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-11 / Part #

DR3676W4H7-V

XW118A-JI

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-13 / Part #

DR3676W4H7-V

XW118A-I1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-15 / Part #

DR3676W4H7-V

XW118A

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-17 / Part #

DR3676W4H7-V

XW118-E1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-19 / Part #

DR3676W4H7-V

XW118A-B1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-21 / Part #

DR3676W4H7-V

XW118A-F1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-23 / Part #

DR3676W4H7-V

XW118A-G1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-25 / Part #

DR36767GG1M4-V

XW118A-H1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-A / Part #

DR3676W4H7-V

XW118A A

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-B / Part #

DR3676W4H7-V

XW118A-C1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-C / Part #

DR36767GG1M4-V

XW462-E1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-D / Part #

DR3676W4H7-V

XW462A-C1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-E / Part #

DR3676W4H7-V

XW462A-A1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-F / Part #

DR3676W4H7-V

XW462A-F1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-G / Part #

DR3676W4H7-V

XW462A-D1

Refrigeration Unit, Duracool, 8 X 12 X 7, Harford, CS-H / Part #

DR3676W4H7-V

XW462-B1

Refrigerator, Chest, Revco Ultima II, Thermo Scientific / Part #

ULT-2186-9-A

022189 Ultima II

Refrigerator, Chest, Revco Ultima II, Thermo Scientific / Part #

ULT-2186-9-A

022190 Ultima II

Refrigerator, Chest, Revco Ultima II, Thermo Scientific / Part #

ULT-2186-9-A

022191 Ultima II

Refrigerator, Upright, Thermo Scientific, 200 J / Part #

RFMS2320A

0115973901141119 UGL2320A

Refrigerator, Upright, Thermo Scientific, 200 K / Part #

RFMS2320A

0115974801141120 UGL2320A

Refrigerator, Upright, Thermo Scientific, 200 L / Part #

RFMS2320A

0115983901141126 UGL2320A

Refrigerator, Upright, Thermo Scientific, 200 M / Part #

RFMS2320A

0115986001141202 UGL2320A

Refrigerator, Upright, Thermo Scientific, 200 N / Part #

RFMS2320A

0153009901141203 UGL2320A

Welder, Control Box, Sonics GXL2200-20 59638C GXL2200-20 Welder, Control Box, Sonics GXL2200-20 59642C GXL2200-20 Welder, Press, Sonics 2050L 7887AY 2050L Welder, Press, Sonics 2050L 7888AY 2050L

SOW: AS&D for DBPAO CUI Page 14 of 18

4.2 Materials. The Government will provide materials (antibodies and antigens) to be used in the assembly/manufacture of end items that incorporate the Government-provided lateral flow immunoassay (LFI) strips. A complete list of Government Furnished Materials will be provided upon award of contract.

The contractor shall follow local, state and government regulations in the disposal of expired GFM.

4.3 Government Property (GP) Inventory Report (CDRL A013). The contractor shall provide monthly an updated GP inventory report. The GP inventory report shall be submitted at the delivery order level.

The Government will provide the GP inventory report template. Instructions on how to fill out the report will be included with the template.

4.4 Both the requiring activity and Contractor shall utilize GFP Property Transfer to document shipment and receipt of GFP per DoDI 4161.02 and DFARS 252.211-7007.

4.5 All GFP provided not consumed will be returned to the customer unless notification in writing is provided by the customer to submit specific items in Plant Clearance function of the GFP Module in Procurement Integrated Enterprise Environment (PIEE). Any remaining Government property not reutilized, transferred, or otherwise disposed of at contract closeout, shall be submitted in the Plant Clearance function of the GFP Module in PIEE. If applicable, Contractor is responsible for demilitarization. If applicable, Contractor is responsible for transportation or shipping to Defense Logistics Agency Disposition Services (DLA DS).

4.6 Government property will be inventoried at least every 3 years at a minimum and classified or sensitive property must be inventoried at least annually.

4.7 The Contractor shall prepare and submit a Property Management System procedures, in accordance with FAR 52.245-1(f), within 60 days of award of contract (CDRL A014).

The Contractor shall prepare and submit a Property Management Plan (CDRL A015) to describe its approach to managing Government property (GP), Government-furnished property (GFP) and/or contractor-acquired property (CAP), throughout the performance of this contract, per FAR 45.202(b). This plan shall address each of the following ten outcomes per FAR 52.245-1(f)(i)-(x) and provide a brief overview of how it is addressed within the Contractor’s written Property Management System Procedures:

Acquisition – Contractor shall describe how property acquisitions, Government-furnished property (GFP) and/or contractor-acquired property (CAP), are documented, per FAR 52.245- 1(f)(1)(i).

Receipt – Contractor shall describe how property receipt of all GP is documented, recorded, and identified, per FAR 52.245-1(f)(1)(ii) and DFARS 252.211-7007(f).

Records – Contractor shall describe how property records are created and maintained, per FAR 52.245- 1(f)(1)(iii).

Physical Inventory – Contractor shall describe a method to perform, record, and disclose physical inventory results, per FAR 52.245-1(f)(1)(iv). Contractor shall also disclose frequency of inventories.

SOW: AS&D for DBPAO CUI Page 15 of 18

Subcontractor Control – Contractor shall describe whether contractual terms and conditions are flowed down to subcontractors, per FAR 52.245-1(f)(1)(v)(A). Contractor shall outline how subcontracts are properly administered and when reviews of subcontractor Property Management Systems are performed, per FAR 52.245-1(f)(1)(v)(B).

Reports – Contractor shall describe a process to create and provide property-related reports, per FAR 52.245- 1(f)(1)(vi).

Relief of Stewardship Responsibility and Liability – Contractor shall describe a process to recognize, investigate, and report losses of Government property, per FAR 52.245-1(f)(1)(vii) and

DFARS 252.245-7002.

Utilization – Contractor shall describe how Government property is to be used, consumed, moved, and stored, per FAR 52.245-1(f)(1)(viii).

Maintenance – Contractor shall describe how Government property is to be maintained, and when property requiring replacement and/or capital rehabilitation is to be reported to the Property Administrator, per FAR 52.245-1(f)(1)(ix).

Property Closeout – Contractor shall outline how property closeout is performed and when it is reported to the Property Administrator, per FAR 52.245-1(f)(1)(x) and 252.245-7004 (Deviation).

The Contractor shall address the use of the GFP Module in Procurement Integrated Enterprise Environment (PIEE) for Property Loss in accordance with DFARS 252.245-7002, Plant Clearance in accordance with DFARS 252.245-7004 (Class Deviation) and Property Transfer in accordance with DFARS 252.211-7007(f).

The Contractor shall describe the use of the CAP Pre-Screening of the GFP Module in PIEE for any Contractor inventory (as defined in FAR 52.245-1) during the performance of the contract and for contract closeout.

Contractor submission shall also include a description of the Property Management System and any customary commercial practices, voluntary consensus standards, or industry-leading practices and standards to be used in managing Government property.

It is recommended that Contractor’s incorporate specific Statement of Work requirements into their GP Property Management Plan. For example, GP deliverables (e.g., CDRL) would be included in Reports.

The Property Management Plan is not part of the evaluation but will be reviewed for adequacy and to determine that it meets the requirements of FAR 52.245-1, and is appropriately tailored to complexity, sensitivity, and value of the property proposed to be provided and/or acquired.

5.0 Security

5.1 Certain aspects of the work under this contract are considered classified or proprietary. The contractor shall obtain and maintain a DoD SECRET level facility clearance by contract award.

Contractor personnel who will perform work under this contract and will have access to Government Furnished Information, shall obtain and maintain DoD SECRET level clearance and sign a non-disclosure agreement (Attachment 10) by contract award.

SOW: AS&D for DBPAO CUI Page 16 of 18

5.2 The contractor shall provide appropriately cleared personnel and supplies to uncode assays. The contractor shall develop procedures to assure the uncoding effort minimizes the possibility of errors during the relabeling process and in an environment that does not diminish the product’s shelf life. For uncoding the assays, the contractor shall follow the guidelines in the 2005 CRP Security Classification Guide.

5.3 IT Security Controls. The contractor shall have IT security controls for handling data associated with the work described in this SOW that shall meet at a minimum the following requirements:

• Device Encryption to include data at rest encryption

• Layered security approach

• Strong password encryption enabled

• Passwords must be change quarterly

• Domain authentication

• Virus protection

• Right based folders

• Segregated firewall protection

5.4 The contractor shall execute security requirements outlined in the Department of Defense Chemical, Biological, and Radiological (CBR) Defense Research, Development, and Acquisition (RD&A) Information Security Classification Guide (SCG), dated September 7, 2018 (SOW section 1.3.1), as well as any other applicable Security Classification Guides. The applicable Security Classification Guide(s) will be transmitted to the Contractor by the Contracting Officer Representative and will be available for download at the Defense Technical Information Center website (https://dtic.mil).

5.5 Per AR 530‐1, Operations Security, the contractor employees must complete Level I OPSEC Awareness training. New employees must be trained within 30 calendar days of their reporting for duty and annually thereafter.

5.6 The contractor will have access to and be required to store Controlled Unclassified Information (CUI). Contractor must comply with NIST 800-171 (Protecting Controlled Unclassified Information in Nonfederal Systems and Organizations) in accordance with DFARS clause 252.204-7012.

6.0 Organizational Conflict of Interest (OCI)

Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent OCI as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI (CDRL A014). The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

https://dtic.mil/

SOW: AS&D for DBPAO CUI Page 17 of 18

7.0 Performance Requirements Summary (PRS)

Deliverable Standards/AQLs Method of Surveillance

SOW 2.2.5

First Article Testing

The contractor shall perform First Article Testing on SPI and on manufactured end items. If First Article tests fail to meet any of the applicable requirements, the First Article sample shall be rejected.

COR review of test report.

SOW 3.2.4.1

First Article Test and Inspection Report

The contractor shall submit First Article Test (FAT) and Inspection Report to the Government via email within 10 business days after completion of testing, in accordance with CDRL A004.

The FAT report shall include test data and conclusions drawn from inspections and test results.

Government approval or comments will be provided 15 days after receipt of the report.

SOW 2.1.1.7

Process Controls

SOW 2.2.2.2

Standard Operating Procedures

SOW 2.2.12

Quality Records

The Contractor is required to institute manufacturing process controls at critical points.

The Contractor is required to document and follow Standard Operating Procedures in assembly & manufacturing, storage, and distribution of DBPAO products.

The Contractor is required to maintain quality records throughout the life of the contract.

The Government shall conduct site visits at mutually agreed-upon dates/times to monitor Contractor performance. The frequency of these visits will be at the Government’s discretion, with care taken not to disrupt the ability of the Contractor to maintain cost, schedule, and performance.

SOW 2.4.5

Monthly Technical Meetings

SOW 2.4.6

Monthly Status Reports

SOW 4.3

GP Inventory Report

SOW 2.4.7

Annual Program Review

The Contractor shall participate in monthly technical meetings with the Government to discuss contract status, work progress, and any existing or potential issues.

The contractor shall submit Monthly Status Reports seven business days after the end of each month, in accordance with CDRL A001.

The contractor shall provide monthly an updated GP inventory report in accordance with CDRL A013

The Contractor shall participate and provide input at a yearly program review.

The COR and the Contractor will participate in meetings that will occur monthly or as needed.

The COR will review each Monthly Status Report to ensure that the document contains cost data updates, status of GFM inventory (condition, expiration dates, lot numbers, quantities), notable events that will be occurring in the next month, and information on existing or potential problem areas and recommendations to resolve the problems.

SOW: AS&D for DBPAO CUI Page 18 of 18

The Government will review the GP Inventory Report to determine the condition, installation, and effectiveness of the GP.

The DBPAO office and the Contractor will participate in an annual program review at a mutually agreed-upon date, time, and location.

8.0 CDRLs

The contractor shall provide the data items requested in the DD Form 1423 Contract Data Requirements List (CDRLs):

• A001 – Monthly Status Reports

• A002 – Inspection and Test Plan

• A003 – First Article Test (FAT) Plan

• A004 – FAT Inspection Report

• A005 – General Incident

• A006 –…