B01. Request for Information - Storage Expansion WRAIR.pdf

Request for Information (RFI)

Walter Reed Army Institute of Research (WRAIR) Pilot Bioproduction Facility (PBF)

This is an RFI as defined in FAR 15.201(e) to ascertain whether a commercial item exists that provides the capabilities described herein.

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI will be treated as business confidential information. Nonetheless, submitters should properly mark their responses if the information is confidential. Responses to the RFI will not be returned. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract.

Responders are solely responsible for all expense associated with responding to this RFI.

RFI Response and due date: 28 October 2021

Instructions to Responders:

Responses from all capable and qualified sources are encouraged to respond to this request.

White papers should adhere to the following formatting and outline instructions:

1. All submissions shall be made electronically and be in one of the following formats:

Microsoft Word or Adobe PDF.

2. Cover Page (1page)

• Title

• Organization

• Responders technical and administrative points of contact (names, addresses, phone, fax number and email addresses)

• Topic area(s) addressed

3. Please note that the response shall provide sufficient technical data to determine how you fully meet the requirements as specified in the DRAFT Performance Work Statement.

Please note that responses are due no later than 28 October 2021 12:00PM EST. The preferred method of submission is via email. The point of contact for this action is Ashley Atkins, Contract Specialist ashley.n.atkins.civ@mail.mil. Only electronic responses are requested. No evaluation letters and/or results will be issued to the respondents. At this time no solicitation exists; therefore, please do not request a copy of the solicitation. NO PHONE

CALLS PLEASE.

QA/ QC Draft

DRAFT PERFORMANCE WORK STATEMENT

QA/ QC Draft

Contents

1. INTRODUCTION

2. PURPOSE AND BACKGROUND

3. SCOPE

4. PERIOD OF PERFORMANCE

5. WORK SCHEDULE AND LOCATION

6. PERFORMANCE REQUIREMENTS

7. DELIVERABLES

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

9. TRANSITION SUPPORT –

10. KEY PERSONNEL – May not be applicable

11. TRAVEL/TEMPORY DUTY (TDY) – May not be applicable

12. GOVERNMENT FURNISHED PROPERTY –

13. CONTRACT MANAGEMENT

14. COMPLIANCE DOCUMENTS

15. REFERENCE DOCUMENTS –

16. OTHER TERMS, CONDITIONS, AND PROVISIONS

17. ATTACHMENTS

PERFORMANCE WORK STATEMENT (PWS)

Title: Increase Storage Capacity

Requiring Activity Name: Walter Reed Army Institute of Research (WRAIR)

1. INTRODUCTION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter.

With headquarters dedicated to Senator Daniel E. Inouye and located in Silver Spring, Maryland, the Walter Reed Army Institute of Research is the largest biomedical research facility currently serving the Department of Defense.

Established in 1893, our research and development now reaches around the world from Maryland to Germany, Thailand, and Kenya.

WRAIR’s vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation.

The WRAIR Pilot Bioproduction Facility (PBF) manufacturing facility is located in Building 501 on the WRAIR campus. Its efforts are focused on manufacturing vaccine components, vaccines, and other biologicals that support the mission of WRAIR and support WRAIR’s commitment to also assisting other government and non-government entities in generating solutions to a full spectrum of health issues in a collaborative way. The manufacturing at the PBF is designed to be at the early (Phase 1/2) stage of vaccine and biologics development.

2. PURPOSE AND BACKGROUND

In order to support manufacturing, the PBF has been provided a warehousing storage space on the WRAIR campus.

This area (located in Building 509, Room 108) is a large warehouse-type space with a very high (> 21 feet) ceiling which allows for multi-bay vertical storage (see drawings/schematics and measurements provided- note perimeter measurements for the area are accurate. Existing shelving is not shown to scale.). The space is currently being utilized to store raw materials, supplies, and Work In Progress (WIP) and finished goods for the WRAIR PBF. This area is spatially divided into two halves. One half contains various low temperature controlled storage units (most are on wheels) which contain cGMP raw materials and manufactured vaccine materials. It also contains a non-fixed industrial storage rack along a portion of the back wall containing archived documents. All other items in this area are easily mobile (rolling carts and cages, etc.)These items are temporary and will be removed later. Three (3) AHU cooling units are suspended securely approximately 6 feet above the storage units. The other half of the area contains two long 3 bay high (2 - 4’ x 8’ bays) non-fixed industrial storage racks running the length of the room and one short non-fixed industrial storage rack along a portion of the back wall. This area currently contains raw materials, supplies, and equipment stored on the racks. There are no installations above these racks. There are some rolling shelves/carts and ladders in this area.

3. SCOPE

3.1. Vendor will meet with PBF personnel to review and maximize storage possibilities and configurations. This will include preliminary site visits and providing draft plans for review and discussion.

3.2. Vendor will deliver materials to Building 509, transport the materials from the Building 509 loading dock to

Room 108, and perform all installation of shelving.

3.3. Installation must be performed in stages (3 expected – storage over controlled storage units, half of warehouse area, second half of warehouse area) with time allowed in between for PBF to move stored materials to previously constructed sections. Existing storage swing space is very limited.

3.4. Salient Characteristics of Shelving (Mobile/Moveable)

1. Nominally 4 feet in depth with or without dividers in order to be two sided rack with a two foot depth.

2. Have the ability to be manually operated by one person for simplicity and durability. Electric motor assist for movement is acceptable if manual override is available in case of a failure.

3. Have no inventory management software associated with it.

4. Be modular to the point that half of the system can be installed, then the other half after inventory movement.

5. Be rectangular in shape to make maximum use of the existing space. No circular or other shape shelving is acceptable.

6. System must be floor mounted and not a raised floor configuration in order minimize dirt and dust accumulation and enhance cleanability.

7. Must have a minimum capacity of 7,000 pounds per storage section.

8. Wheels must have permanently lubricated and shielded radial ball bearings for durability and to minimize maintenance needs.

9. Drive/transportation system must be designed and installed to minimize binding, rack mis-alignment excessive wheel wear, and breakdowns.

10. All parts of system must be from same manufacturing company to enhance consistency and maintain warranty uniformity. All parts to be covered under the same warranty.

11. System/installer must have a positive track record of successful installation and performance in government facilities.

12. Metal finishes must be powder coated for cleanability and durability.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

Base period 01 September 2021 – 31 December 2021

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work location is 503 Robert Grant Avenue, Building 509, Room 108, Silver Spring, MD 20910.

5.1.1. Working During Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency situation is resolved and normal conditions are restored or the contract is terminated, whichever comes first. In case of a life threatening emergency, the COR will immediately make contact with the Contractor Managers to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, including base closures, the Contractor Manager shall promptly open an effective means of communication with the COR to verify:

a. Key points of contact (Government and Contractor)

b. Temporary work locations (alternate office spaces, telework, virtual offices, etc.)

c. Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier, etc.)

d. Essential duty personnel for emergency and contingency operations

e. Essential work products expected to continue production by priority

The Contractor Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR and Contracting Officer prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

Contractor shall not report to work on those days the Government or installation is closed due to safety conditions, inclement weather conditions, national emergencies, energy conservation or by direction of the Installation Commander for any other reason. During these periods of closure, the contractor employees that are not designated as essential IAW this contract shall not report for work nor will they be compensated for those days.

5.1.3. Federal Holidays

The contractor shall not perform services on days designated as a Federal Holiday by Federal Status, Executive Order, Presidential Proclamation or Installation Commander

Federal holidays are an exception to the regular duty hours. Any of the holidays listed below falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday.

The following is a list of legal federal holidays that services shall not be performed.

The following are Federal Holidays:

New Year’s Day Birthday of Martin Luther King, Jr.

Washington’s Birthday Memorial Day Independence Day

Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

5.1.4. Post Closure

All non-mission essential contract employees shall not report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, energy conservation. During these periods of closure, the mission essential contractor personnel shall report for work.

5.1.5. Work Schedule

The contractor shall provide support from 0700 to 1530 Eastern Time.

6. PERFORMANCE REQUIREMENTS

6.1. Objectives

Storage in Warehousing Area

• Increase storage capacity of presented storage area at least 100% utilizing an industrial scale collapsible shelving system where the sections move on tracks, or a significantly equivalent system.

• Shelving must be 3 storage bays high. These bays are currently 2 – 4’ deep by 4 feet high by 8 feet wide;

however, there is not a strict spatial requirement other than that the shelving system fit within the designated warehouse area demonstrated in the room drawing and that it be approximately 12 feet high utilizing 3 levels of storage.

• Shelving options must be provided to enclose/lock some sections for controlled storage needs (# of bays

TBD).

• Design must leave an open area at least 6 feet wide at the end of the room where door entry occurs to leave room for pallet movement/storage.

Overhead Storage Above Controlled Storage Units

• Install lighter weight industrial mesh or equivalent storage system above the existing controlled storage units.

• The system must be of a construction and installation scheme to allow significant airflow among the units for heat dissipation, as well as the ability to access the backs of the storage units for electrical access and servicing. This will generally require the shelving to be approximately 12” above the tallest storage unit.

• The shelving must be a single layer meant to support lighter supplies.

• To minimize down time, the contractor shall schedule and coordinate with the Technical Point of Contact

(TPOC) the installation and testing of the new system as installation occurs and as needed to demonstrate operational acceptability. The schedule may be modified on a periodic basis as required by project activities.

The TPOC will be responsible for approving all schedule modifications.

• Prior to the use of any welding or cutting torches (if needed), compliance with regulatory requirements and coordination with the TPOC is the responsibility of the contractor.

• Equipment shall comply with all industry and government design, testing, assembly, and fabrication requirements for specified equipment.

6.2. Specific Tasks / Requirements

6.2.1. Design/ Plan new storage system to meet customer needs (Deliverable 1).

Meet with requirements owners/ customers, assess existing space, and design new system to meet space needs, review with customer for approval.

6.2.2. Disassembly/Removal/ Disposal of Existing Shelving (Deliverable 2) As the project progresses, the contractor will disassemble and remove existing temporary metal shelving components (which are not affixed to the walls or floor - this is “knock apart” shelving that is not bolted together) at specific times once the shelves are emptied. The contractor shall dispose of the removed (existing) shelving units.

6.2.3. Installation of New Shelving (Deliverable 3)

The contractor will install shelving as described in Section 6.1 after agreement upon specific design details with the PBF as per Section 3.1. Mobile shelving will be of a design that allows the loaded sections to be moved readily by a single person for variable access, while compressing unused sections to minimize unused cubic storage space.

6.2.4. Transition of Shelving Assembly In Stages t (Deliverable 3) The contractor will work with the PBF TPOC to allow for movement of existing inventory in a 3 stage manner in order to facilitate clearance of space within limited storage capability. Time frame may be variable, but stoppage not to exceed 5 working days at both stoppages.

6.2.5. Equipment Testing

The contractor will demonstrate proper operation of installed shelving units.

6.2.6. Warranty (Deliverable 4)

The PBF will accept standard warranty on materials and installation, provided that the warranty is no shorter than 1 year from completed installation.

6.2.7. Training

The contractor will provide 2 hours of operational and maintenance training to selected WRAIR staff.

6.2.8. Equipment Specific Documentations (Deliverable 5)

The contractor will provide all as-built drawings and all specifications, schematics and operational and maintenance manuals associated with the shelving and its operation.

6.2.9. Quality Control Plan – (Deliverable 6)

The contractor/ vendor will provide a quality control plan to meet customer space needs, and maintain agreed schedule.

6.2.10. Reporting Requirements – per section 6.3 (below)

6.3. Management Reports and Plans

Contract Manpower Reporting Application (CMRA) (Deliverable 7). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the WRAIR via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address:

http://www.ecmra.mil.

Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013.

Contractors may direct questions to the help desk at:

www.ecmra.mil

The contractor shall register under the "All Other Defense Components" module. The WRAIR Unit Identification Code (UIC) is W03KAA. The Federal Supply Code (FSC) is 6515.

7. DELIVERABLES

The contractor shall complete and submit deliverables in accordance with the “Deliverables Table” below. Unless specified in the PWS within the description of the deliverable, all deliverables will be made to the COR electronically.

DELIVERABLES TABLE

PWS

Ref. Number Title/Description Due

6.2.1 Deliverable 1 Design/ Plan new storage system Upon start of contract PoP and at agreed upon points in the project

6.2.2 Deliverable 2 Disassembly, Removal/ Disposal of Existing Shelving - Upon start of contract PoP and at agreed upon points in the project

3.2 6.2.3 6.2.4

Deliverable 3

Delivery/ Installation/ Transition of New Equipment - The contractor shall deliver a fully operational shelving system, which conforms to all of the identified Minimum Essential Characteristics

Upon completion of installation

6.2.6 Deliverable 4 Warranty – The contractor shall provide a minimum one year warranty on materials and installation Upon start of contract PoP

6.2.8 Deliverable 5 The contractor shall provide three full sets of Operation and Maintenance manuals for each piece of equipment. Upon completion of installation

6.2.9 Deliverable 6 Quality Control Plan NLT 15 days after contract award

6.2.10 Deliverable 7 Reporting Requirements Upon final acceptance http://www.ecmra.mil/

7.1. Technical Reports and Documents – Not Applicable

7.2. Inspection and Acceptance

The COR delegated oversight of specific technical, functional and oversight responsiblities is responsible for inspection and acceptance of all services, incoming shipments, documents, and services.

Certification by the Government of satisfactory services provided is contingent upon the Contractor performing in accordance with the performance standards contained in the Performance Work Statement and all terms and conditions of this order, including all modifications.

7.3. COR Information

To be determined upon award.

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

The Government intends to utilize a Quality Assurance Surveillance Plan (QASP) to monitor the quality of the Contractor’s performance in relation to performance objectives. The Government will finalize the QASP immediately following award, and the COR will provide a copy of the final QASP to the contractor. The QASP is a living document and may be updated by the Government as necessary.

The Government will use the following performance requirements to measure the performance of the contractor. The contractor shall meet the Performance Objective(s) and Acceptable Quality Level(s) within the “Performance Requirements Summary Matrix” (PRS Matrix).

Performance Requirements Summary

# PWS

Ref. Performance Objective Performance Measurement Acceptable

Quality Level Method of

Surveillance Incentive

1 6.2.1 Design/ Plan new storage system The Contractor shall design and plan a replacement storage system Meets: 97% Direct observation by COR Positive Past Performance

2 6.2.2.

Disassembly, Removal, Disposal of

Existing Shelving

The contractor shall disassemble, and remove the existing shelving (once emptied) from the room to the Building 509 loading dock..

Meets: 97% Direct observation by COR Positive Past Performance

3 6.2.3 6.2.4

Turn Key Installation- Delivery/ Installation of New Equipment

The installation is intended to be turn-key, and the mobile shelving is intended to be easily moved by one person.

Meets: 97% Review by COR Positive Past

Performance

3.2

6.2.3 6.2.4

Transition of Materials

The contractor shall be responsible for ensuring shelving components (incoming/ existing) can be moved from loading dock to installation location, and for repairing any damage

Meets: 97% Review by COR Positive Past Performance

5 6.2.5 Equipment Testing

The contractor shall test all equipment following the completion of installation and ensure that the equipment is operating in accordance with OEM performance specifications.

Meets: 97% Review by COR Positive Past Performance

6 62.7 Training The contractor shall provide one 2-hour on site user training session to include basic operation, operator level maintenance and troubleshooting.

Meets: 99% Review by COR Positive Past Performance

9. TRANSITION SUPPORT – WRAIR personnel will move supplies off existing shelving prior to disassembly

10. KEY PERSONNEL – Not Applicable

11. TRAVEL/TEMPORY DUTY (TDY) – Not Applicable

12. GOVERNMENT FURNISHED PROPERTY – Not Applicable

13. CONTRACT MANAGEMENT

13.1. Government Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

Only the KO has the authority to enact changes to this award.

13.2. Contractor Management

The contractor shall designate a single Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract.

13.3. Contractor Organization

The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

13.4. Contractor Vacant Positions

The contractor shall fill vacant positions within thirty (30) business days. If contractor positions are vacant for more than thirty (30) days, the COR will provide a Contract Deficiency Report (CDR) to the KO.

13.5. Subcontract management

13.5.1. The contractor is responsible for any subcontract management necessary to integrate services performed on this contract.

13.5.2. The contractor is responsible and accountable for subcontractor performance on this contract

13.5.3. The contractor is responsible to manage task distribution to ensure there are no OCI considerations

13.5.4. Contractor may add subcontractors to their team after notification and written approval from the

KO.

13.5.5. Privy of contract is with the contractor and the subcontractor.

13.6. Foreign Nationals

A foreign national can only be hired if they have a special skill that a US Citizen cannot be found to perform.

A background investigation must be completed in its entirety before unescorted access to the facility is granted. Government computer access will not be approved until a background check is done in accordance with para 18.9. Typically, a background check cannot be performed on a foreign national unless the individual has lived in the United States for three (3) of the last five (5) years.

14. COMPLIANCE DOCUMENTS

14.1. General Compliance

14.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Research and Development Command

(USAMRDC) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

Federal regulations governing regulations for human subject’s protection are found in 45 CFR 46. The International Convention on Harmonization Guidelines for Good Clinical Practice is the standard governing the conduct of research trials. References for military regulations and policies governing regulated research may be found at https://MRDC.amedd.army.mil/rodorphrpo.asp.

14.1.2. Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and Health Administration Standard Number

1904.32. The contractor shall deliver the 300A by February 1 of each year (Deliverable 7).

14.1.3. DoD Compliance Documents – Not Applicable

14.2. Human Research Protections – Not Applicable

14.3. Research Involving Animals – Not Applicable

14.4. Information Technology Compliance – Not Applicable

14.5. Cybersecurity Management – Not Applicable

14.6. Medical and Laboratory Compliance – Not Applicable

15. REFERENCE DOCUMENTS – Not Applicable

16. OTHER TERMS, CONDITIONS, AND PROVISIONS

16.1. Non-Personal Services

This PWS identifies services that are strictly non-personal in nature, as defined by Federal Acquisition Regulation (FAR) Part 37, Service Contracting. To ensure there is no appearance of any personal services, the Government shall neither supervise contractor personnel nor control the method by which the contractor performs the required tasks. Under no circumstances shall the Government assign tasks or prepare work schedules for individual contractor personnel. It shall be the responsibility of the contractor to manage its personnel and to guard against any actions that give the perception of personal services. If the contractor believes that any actions constitute, or are perceived to constitute personal services, it shall be the contractor's responsibility to notify the Contractor Officer (KO) immediately.

16.2. Severable / Non-Severable Services

This award identifies services that are non-severable in nature.

16.3. Inherently Governmental Functions

This requirement has been reviewed and contains no services that are inherently governmental functions.

16.4. Acquisition Functions Closely Associated with Inherently Governmental Functions

This award identifies acquisition functions that are closely associated with inherently governmental functions as defined in Section 804 of the FY 2005 National Defense Authorizations Act. Appropriate military or civilian personnel of the Department of Defense cannot reasonably be made available to perform these functions.

However, appropriate military or civilian personnel of the Department of Defense will: (1) oversee Contractor performance of the contract; and (2) perform all inherently governmental functions associated with the functions to be performed under this contract.

16.5. Organizational Conflict of Interest

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart 9.5. These categories apply to all enterprise laboratories AFRIMS, USAMRD-A, and USAMRD-G.

These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating.

These services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI exists.

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information.

Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an OCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs; and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories. The applicable OCI category will be set forth in each award.

This requirement is categorized as ISOLATED SUPPORT.

Organizational and consulting conflicts of interest may arise by performing advisory or consulting support services. Organizational conflicts of interest include providing services or performing advisory or consulting work for private companies that participate or will participate in future services or contract activities (solicitations and award). See FAR subpart 9.5.

The Contractor shall ensure that the Participation Agreement, either A and / or B as identified on each award, is signed by all staff assigned to or performing on each award before performing any work, including all subcontractors and consultants. The Participation Agreement shall be cosigned by a corporate official (contractor Task Manager or higher). The Contractor shall also ensure that all staff understand and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the Contractor and the COR will immediately initiate a CDR.

16.6. Invoices

The contractor shall submit invoices monthly to Wide Area Work Flow (WAWF) with sufficient documentation to provide certification of invoice.

The contractor is responsible for properly preparing and forwarding to the appropriate Government official, the invoice and receiving report for payment. The contractor shall attach back up information to receiving reports for direct labor and Other Direct Costs (ODCs). Direct labor backup information shall reflect the person’s name, job title and quantity of hours worked for each pay period at a minimum. Backup information for ODCs shall list all elements of costs, such as travel breakout backup, including itinerary, dates of travel, name of employees traveling plus per diem costs shall accompany the receiving report. All ODCs exceeding $3,000 requires that the contractor conduct appropriate competition and obtain approval from the COR prior to purchase. Equipment purchases are not authorized under this contract. The Wide Area Workflow – Receipt and Acceptance application is the required method of submission.

Where applicable, contractor will include additional ODC invoice details as required per protocol for any volunteer payments in support of this PWS.

16.7. Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members who have a need to know, of information developed under this order or contained in the reports to be furnished pursuant to this order without prior written approval of the COR or the Contracting Officer.

DFARS 252.204-7012 Safeguarding Covered Defense Information and Cyber Incident Reporting. The contractor shall implement National Institute of Standards and Technology (NIST) Special Publication (SP) 800-171, “Protecting Controlled Unclassified Information in Nonfederal Information Systems and Organizations.”

16.8. Contractor Identification

When contractor personnel perform the services required in this contract on a Government installation they are required to possess and wear an identification badge that displays his or her name and the name of the Company. The contractor shall ensure that contractor personnel identify themselves as contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

While performing in a contractor capacity, contractor personnel shall refrain from using their retired or reserve component military rank or title in all written or verbal communications.

16.9. Attendance at Meetings

Contractor personnel may be required to attend meetings or otherwise communicate with Government and/or other contract or assistance agreement representatives to meet the requirements of this order. Contractor personnel shall make their contractor status known during introductions.

16.10. Data Rights – Not Applicable

16.11. Anti-Terrorism and Operational Security

16.11.1. AT Level I Training.

All contractor employees, including 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.

DFARS 204.7202 Contractor personnel who, as a condition of contract performance, require routine physical access to a Federally-controlled facility or military installation are required to complete Level I antiterrorism awareness training within 30 days of access and annually thereafter.

Include the clause at DFARS 252.204-7004 DoD Antiterrorism Awareness Training for Contractors, in solicitations and contracts, including solicitations and contracts using FAR part 12 procedures for the acquisition of commercial items, when contractor personnel require routine physical access to a Federally-controlled facility or military installation.

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.

16.11.2. Installation Access.

Contractor and all associated subcontractor employees shall provide all information required for background checks to meet installation access requirements to be accomplished by the installation Provost Marshal Office, Director of Emergency Services, or Security Office.

Contractor workforce must comply with all personal identity verification requirements (CFR clause 52.204- 9, Personal Identity Verification of Contract 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.

a) For contractors requiring CAC. – Not Applicable

b) For contractors that do not require CAC, but require access to a DoD facility or installation. Contractor and all associated subcontractor employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (Army Directive 2014-05/AR 190-13); applicable installation, facility and area commander installation and 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.

16.11.3. AT Awareness Training for Contractor Personnel Traveling Overseas. – Not Applicable

16.11.4. iWATCH Training. This standard language is for contractor employees with an area of performance within an Army-controlled installation, facility, or area. – Not Applicable http://jko.jten.mil/

16.11.5. Army Training Certification Tracking System (ATCTS) registration for contractor employees who require access to Government information systems. – Not Applicable

16.11.6. For Contracts That Require an OPSEC Standing Operating program. – Not Applicable

16.11.7. For Contracts That Require OPSEC Training. – Not Applicable

16.11.8. For IA/IT training. – Not Applicable

16.11.9. For Information Assurance (IA)/Information Technology (IT) Certification. – Not Applicable

16.11.10. For Contractors Authorized to Accompany the Force. – Not Applicable

16.11.11. For Contract Requiring Performance or Delivery in a Foreign Country. – Not Applicable

16.11.12. For Contracts That Require Handling or Access to Classified Information. – Not Applicable

16.11.13. Threat Awareness Reporting Program (TARP). – Not Applicable

16.12. Information Security Program Training – Not Applicable

16.13. System Security Plan and Associated Plans of Action – Not Applicable

16.14. Identification, Tracking, and Restricted Flow Down of all Covered Defense Information, and for

Requesting the Contractor’s Record of Tier 1 Level Subcontractors, Vendors, and/or Suppliers who Receive or Develop Covered Defense Information – Not Applicable

16.15. Compliance with Relevant DoD, Service, and Institutional Policy Regulations. – Not Applicable

16.16. Personally Identifiable Information (PII) and Protected Health Information (PHI) – Not

Applicable

16.17. Public Key Infrastructure Authentication and Encryption – Not Applicable

16.18. Network Security – Not Applicable

16.19. Workplace Safety

The contractor employee must be able to maintain a safe workplace and comply with occupational health and safety rules and regulations. Contractor employees are required to attend safety training(s) relative to his/her position and report any infractions of safety procedures to the COR immediately.

The Contractor will be required to ensure compliance with Occupational Health physicals or vaccinations in support of the PWS. These shall be documented and charged as an ODC.

The contractor shall maintain an OSHA 300a log for all reportables (greater than first aid, lost time, lost days, transfer). The contractor shall provide a quarterly report of all mishaps, regardless of class or reportability.

Annually, the contractor shall provide a 300A (summary) report to the COR and KO.

17. ATTACHMENTS

Attachment 1 – Acronyms List Attachment 2 – Organizational Conflict of Interest

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition

AFARS Army Federal Acquisition Regulation Supplement AFRIMS Armed Forces Research Institute of Medical Sciences

AKO Army Knowledge Online AOR Area Of Responsibility

AT OPSEC Antiterrorism and Operational Security ATCTS Army Training Certification Tracking System

CAC Common Access Card CFR Code of Federal Regulations

CONUS Continental United States COR Contracting Officer Representative

DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense EIT Electronic and Information Technology FAR Federal Acquisition Regulation FBI Federal Bureau of Investigation

FPCON Force Protection Condition FSC Federal Supply Code FSS Federal Supply Schedule GFE Government Furnished Equipment GFI Government Furnished Information GSA General Services Administration IA Information Assurance ID Identification

ID/IQ Indefinite Delivery / Indefinite Quantity IPT Integrated Product/Process Team IT Information Technology

NAC National Agency Check NACI National Agency Check with Inquiries

NCIC-III National Crime Information Center Interstate Identification Index NLT No Later Than OCI Organizational Conflict of Interest

OCONUS Outside Continental United States OPSEC Operational Security PMO Project Management Office PRS Performance Requirements Summary PWS Performance Work Statement

QASP Quality Assurance and Surveillance Plan QCP Quality Control Plan SOP Standing Operating Procedure

TARP Threat Awareness and Reporting Program

U.S.C. United States Code UIC Unit Identification Code US United States

USAMRAA United States Army Medical Research Acquisitions Activity USAMRD-G United States Medical Research Directorate – Georgia USAMRD-A United States Medical Research Directorate – Africa

WAWF Wide Area Work Flow WRAIR Walter Reed Army Institute of Research

ATTACHMENT 2: ORGANIZATIONAL CONFLICT OF INTEREST

Walter Reed Army Institute of Research (WRAIR) Acquisition Operational Support

Walter Reed Army Institute of Research (WRAIR) has categorized its requirements into two broad categories, as defined below, for purposes of identifying, avoiding or mitigating against OCIs in accordance with FAR Subpart

9.5. These categories apply to all enterprise laboratories (Armed Forces Research Institute of Medical Sciences (AFRIMS), United States Medical Research Directorate – Kenya (USAMRD-K), and United States Medical Research Directorate – Georgia (USAMRD-G). These categories are defined as follows:

Global Support: Where services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating.

This services are identified as those having a direct impact to the operations of the greater WRAIR enterprise.

Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts within subordinate directorates/Commands.

Mitigation strategies may include: avoidance (non-participation), firewalls between existing personnel and new requirement.

Isolated Support: Services which have focused impact on a specific Branch/ Department/ Program of WRAIR rather than the WRAIR enterprise.

Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

Mitigation Strategies: Contractor can provide a mitigation plan or acceptable self-certification that no OCI

Contractor participation in more than one of these areas may give rise to an unfair competitive advantage resulting from access to advance acquisition planning, source selection sensitive or proprietary information. Furthermore, Contractor participation in more than one area may give rise to a real or apparent loss of Contractor impartiality and objectivity where its advisory or planning assistance in one area potentially affects its present or future participation in another area. An unfair competitive advantage exists where a contractor competing for award of any Federal contract possesses –

(1) Proprietary information that was obtained from a Government official without proper authorization; or

(2) Source selection information (as defined in FAR 2.101) that is relevant to the contract but is not available to all competitors, and such information would assist that contractor in obtaining the contract.

The purpose of this categorization is to accomplish the following three objectives: (1) to inform prospective Offerors that WRAIR presumes that award of a contract or order in the subject category will give rise to real or apparent OCI’s with respect to requirements in the other category and or may give rise to an CCI in the same category; (2) to assist current Contractors and prospective Offerors in developing their own business strategies regarding participation in WRAIR requirements and in identifying and, where possible, avoiding or mitigating against OCIs;

and (3) to ensure that all current Contractors and prospective Offerors are afforded the maximum practicable opportunity to compete for all WRAIR requirements consistent with the restrictions required under FAR Subpart 9.5 and sound business practices.

For purposes of identifying and/or mitigating against OCIs, WRAIR will examine all its services requirements and acquisitions regardless of the cognizant contracting activity (e.g., USAMRAA, GSA, other agency Multiple Award

Schedules, etc.) or the type of contract vehicle used (e.g., FSS order, Fair Opportunity competitive order under Multiple Award ID/IQ Contracts, competitively negotiated awards under FAR Part 15, etc.).

Each WRAIR services solicitation will therefore be designated as falling within one of the above defined categories.

The applicable OCI category will be set forth in each task order. Contractors may submit a proposal for task orders in either of the OCI categories.

WRAIR will administer this clause for purposes of award eligibility for each solicitation as follows:

The offeror shall provide a listing of all contracts performed for the WRAIR and any enterprise laboratories (USAMRD-G, USAMRD-A, and AFRIMS) as well as with other MRDC laboratories (i.e. U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), U.S. Army Medical Materiel Development Activity (USAMMDA), the Telemedicine and Advanced Technology Research Center (TATRC) or MRDC) in the last three

(3) years. A single-category Offeror/Contractor wishing to submit an offer in the other category, or any Offeror/Contractor which now provides or previously has provided support in both categories, must include the following as part of its offer:

• Perform a comparative analysis of the potential new work against all current and previous work performed in support of WRAIR in any category. The comparative analysis must be included in the proposal for the new work, and must include a statement certifying whether the Contractor believes that its performance of the proposed new work would create a real or apparent OCI. If the Contractor believes that no real or perceived OCI will result from an award of the proposed work, no additional action by the Contractor is required, unless the Contracting Officer specifically requests an OCI mitigation Plan.

• If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award, the

Contractor shall also submit an OCI Mitigation Plan with its proposal.

Inclusion of the comparative analysis and OCI Mitigation Plan will not be counted against any offer page limitations otherwise stated in the solicitation.

The following subsections prescribe certain limitations on contracting as the means of avoiding, neutralizing or mitigating organizational conflicts of interest.

It is the contractor’s responsibility to notify the Contracting Officer of any potential OCI. In the event that an OCI exists the contractor shall propose a Mitigation Plan that shall be reviewed and accepted by the Contracting Officer prior to continuance of the work that presents an OCI. Should the proposed Mitigation Plan not be accepted by the Contracting Officer, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by the law or this contract.

Contractors shall sign a Non-Disclosure Agreement at the start of their performance on the contract.

If, under this contract, the contractor will provide systems engineering and technical direction for a system, but does not have overall contractual responsibility for its development, integration, assembly, checkout or production, the contractor shall not be awarded a subsequent contract to supply the system or any of its major components, or to act as consultant to a supplier of any system, subsystem, or major component utilized for or in connection with any item or other matter that is (directly or indirectly) the subject of the systems engineering and technical direction. The term of this prohibition shall endure for the entire period of this contract and for two (2) years thereafter.

If, under this contract, the contractor will prepare and furnish complete specifications covering non-developmental items, to be used in a competitive acquisition, the contractor shall not be permitted to furnish these items, either as a prime or subcontractor.