W81XWH-21-R-0074.pdf

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X H 94 - 99 jennifer.s.bassett.civ@mail.mil

RATING PAGE OF PAGES

7. ISSUED BY

(Date)

IMPORTANT - Award will be made on this Form, or on Standard Form 26, or by other authorized official written notice.

Previous Edition is Unusable 33-134 STANDARD FORM 33 (REV. 9-97)

Prescribed by GSA

FAR (48 CFR) 53.214(c)

1 99

(If other than Item 7)

15A. NAME 16. NAME AND TITLE OF PERSON AUTHORIZED TO

AND

ADDRESS

SIGN OFFER (Type or print)

OF

OFFEROR

AMENDMENT NO. DATE

15B. TELEPHONE NO (Include area code) 17. SIGNATURE15C. CHECK IF REMITTANCE ADDRESS

IS DIFFERENT FROM ABOVE - ENTER

SUCH ADDRESS IN SCHEDULE.

18. OFFER DATE

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

2. CONTRACT NO.

W81XWH 8. ADDRESS OFFER TO

See Item 7

9. Sealed offers in original and copies for furnishing the supplies or services in the Schedule will be received at the place specified in Item 8, or if handcarried, in the depository located in

CAUTION - LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME (NO COLLECT CALLS)

JENNIFER S. BASSETT 301-619-2268

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

1 - 2

3 - 41

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT X

PACKAGING AND MARKING

J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

43 - 44 X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 45 - 48 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 49 X M

L INSTRS., CONDS., AND NOTICES TO OFFERORS

EVALUATION FACTORS FOR AWARD

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52.232-8)

14. ACKNOWLEDGMENT OF AMENDMENTS

(The offeror acknowledges receipt of amendments

AMENDMENT NO. DATE

to the SOLICITATION for offerors and related documents numbered and dated):

FACILITY

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a different period

SOLICITATION, OFFER AND AWARD

X

(X) SEC. DESCRIPTION (X) SEC. DESCRIPTION PAGE(S)

PART I - THE SCHEDULE

26. NAME OF CONTRACTING OFFICER (Type or print) 27. UNITED STATES OF AMERICA 28. AWARD DATE

EMAIL:TEL: (Signature of Contracting Officer)

CODE CODE

B. TELEPHONE (Include area code) C. E-MAIL ADDRESS

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED 20. AMOUNT 21. ACCOUNTING AND APPROPRIATION

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

10 U.S.C. 2304(c)( ) 41 U.S.C. 253(c)( ) (4 copies unless otherwise specified)

23. SUBMIT INVOICES TO ADDRESS SHOWN IN ITEM

24. ADMINISTERED BY (If other than Item 7) CODE 25. PAYMENT WILL BE MADE BY CODE

PART IV - REPRESENTATIO NS AND INSTRUCTIO NS

PART III - LIST O F DO CUMENTS, EXHIBITS AND O THER ATTACHMENTS

50 - 61

PART II - CO NTRACT CLAUSES

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

FAX:

TEL:

FAX:

TEL:

NOTE: In sealed bid solicitations "offer" and "offeror" mean "bid" and "bidder".

SOLICITATION

6. REQUISITION/PURCHASE NO.5. DATE ISSUED

26 Jul 2021

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH21R0074

Section A - Solicitation/Contract Form

CLAUSES INCORPORATED BY REFERENCE

52.203-18 Prohibition on Contracting With Entities That Require Certain

Internal Confidentiality Agreements or Statements--

Representation

JAN 2017

52.203-19 Prohibition on Requiring Certain Internal Confidentiality

Agreements or Statements

JAN 2017

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 2 Job REPUBLIC OF GEORGIA (In-Country)

FFP

Crimean Congo Hemorrhagic Fever Virus (CCHFV), and Old World Hantaviruses

Both B and T cell responses will be tracked over time to develop a picture of the protective immune response in humans.

**Up to TWO (2) Blood Collections are planned for the Republic of Georgia;

however, only ONE (1) Trip may be necessary. Therefore, a price estimate PER

TRIP is being requested.

***This CLIN will be a Firm-Fixed-Price Not-To-Exceed (FFP NTE) CLIN as only ONE TRIP may be utilized during this period.

FOB: Destination

ADDITIONAL MARKINGS: POC: Dr. John Dye, #301-619-8782

PSC CD: Q301

NET AMT

0002 2 Job SIERRA LEONE (In-Country)

Lassa Mammarenavirus (LASV)

FOB: Destination

0003 2 Job MADAGASCAR (In-Country)

Yersinia Pestis (Y.Pestis)

FOB: Destination

0004 6 Job

OTHER DIRECT COSTS (ODC'S)

FFP

Other Direct Costs (ODCs) - The Contractor may be required to incur ODCs during contract performance in accordance with the Performance Work Statement

(PWS).

Other Directs Costs, if including travel, shall be in accordance with the Joint Travel

Regulations (JTR) as derived from the U.S.C. Title 5 statutes, General Service

Administration's (GSA) Federal Travel Regulation (FTR), and the Department of

State's Standardized Regulations.

FOB: Destination

1001 2 Job OPTION REPUBLIC OF GEORGIA (In-Country)

FOB: Destination

1002 2 Job OPTION SIERRA LEONE (In-Country)

FOB: Destination

1003 2 Job OPTION MADAGASCAR (In-Country)

FOB: Destination

1004 6 Job

OPTION OTHER DIRECT COSTS (ODC'S)

FFP

Other Direct Costs (ODCs) - The Contractor may be required to incur ODCs

Administration's (GSA) Federal Travel Regulation (FTR), and the Department of

State's Standardized Regulations.

FOB: Destination

2001 2 Job OPTION REPUBLIC OF GEORGIA (In-Country)

FOB: Destination

2002 2 Job OPTION SIERRA LEONE (In-Country)

FOB: Destination

2003 2 Job OPTION MADAGASCAR (In-Country)

FOB: Destination

2004 6 Job

OPTION OTHER DIRECT COSTS (ODC'S)

FFP

Other Direct Costs (ODCs) - The Contractor may be required to incur ODCs

Administration's (GSA) Federal Travel Regulation (FTR), and the Department of

State's Standardized Regulations.

FOB: Destination

3001 2 Job OPTION REPUBLIC OF GEORGIA (In-Country)

FOB: Destination

3002 2 Job OPTION SIERRA LEONE (In-Country)

FOB: Destination

3003 2 Job OPTION MADAGASCAR (In-Country)

FOB: Destination

3004 6 Job

OPTION OTHER DIRECT COSTS (ODC'S)

FFP

Other Direct Costs (ODCs) - The Contractor may be required to incur ODCs

Administration's (GSA) Federal Travel Regulation (FTR), and the Department of

State's Standardized Regulations.

FOB: Destination

4001 2 Job OPTION REPUBLIC OF GEORGIA (In-Country)

FOB: Destination

4002 2 Job OPTION SIERRA LEONE (In-Country)

FOB: Destination

4003 2 Job OPTION MADAGASCAR (In-Country)

FOB: Destination

4004 6 Job

OPTION OTHER DIRECT COSTS (ODC'S)

FFP

Other Direct Costs (ODCs) - The Contractor may be required to incur ODCs

Administration's (GSA) Federal Travel Regulation (FTR), and the Department of

State's Standardized Regulations.

FOB: Destination

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

FOR

DEVELOPMENT OF NOVEL MONOCLONAL ANTIBODIES AND LONGITUDINAL STUDY OF IMMUNE

RESPONSES USING SERUM AND PERIPHERAL BLOOD MONONUCLEAR CELLS (PBMC’s) OF

INFECTIOUS DISEASE SURVIVORS

FOR

UNITED STATES ARMY MEDICAL RESEARCH INSTITUTE OF INFECTIOUS DISEASES (USAMRIID)

SECTION 1 PURPOSE

1.1. Introduction

1.1.1. Since 1969, the U.S. Army Medical Research Institute of Infectious Disease (USAMRIID) has served as the

Department of Defense's (DoD) lead laboratory for medical biological defense research. While its core mission is to protect the warfighter from biological threats, USAMRIID also investigates disease outbreaks and threats to public health. Research conducted at USAMRIID leads to medical solutions - therapeutics, vaccines, diagnostics, and information that benefit both military personnel and civilians. USAMRIID is a subordinate laboratory of the U.S.

Army Medical Research and Materiel Command (USAMRMC) at Fort Detrick, located in Frederick, MD.

1.2. Mission

1.2.1. The mission of USAMRIID is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents. Specifically, the Viral Immunology Branch seeks to understand the relationship between human immunity and viral diseases, and use that knowledge to develop medical countermeasures to protect the Warfighter.

1.3. Background

1.3.1. The purpose of this contract is for the collection and shipping of whole blood and blood products to support the following tasks: development of monoclonal antibody therapeutics, evaluation of the humoral and cellular immune responses in humans to Crimean Congo Hemorrhagic Fever Virus (CCHFV), Old World Hantaviruses, Lassa Mammarenavirus (LASV), and Yersinia Pestis and examining specific memory immunity and its persistence over time.

1.3.2. Contractor shall provide all personnel, materials, equipment, tools, transportation, supervision and other items necessary to identify and engage survivors of CCHFV and Old World Hantavirus outbreaks in Georgia, LASV in

Sierra Leone, and Y. Pestis outbreaks in Madagascar. Subcontracting to local contractors with greater familiarity and expertise in the collection locales is encouraged.

1.4. Scope

1.4.1. The primary objective of this requirement is to identify and engage survivors of CCHFV and Old World

Hantaviruses, LASV and Y. Pestis in Georgia, Sierra Leone and Madagascar respectively. Both B and T cell responses will be tracked over time to develop a picture of the protective immune response in humans. This study will involve collaboration with the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID).

1.4.2 Identify a cohort of survivors of CCHFV and Old World Hantaviruses (Georgia), LASV (Sierra Leone) and Y.

Pestis (Madagascar) and perform whole blood collection. Blood samples will be delivered to the in-country host laboratory expeditiously following each collection. Peripheral Blood Mononuclear Cells (PBMC’s) must be isolated and stored at -80ºC within Twelve (12) Hours of collection.

1.4.3. Every six (±2) months, perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 1.4.1. Travel schedules will require coordination with USMARIID personnel.

1.4.4. Assist USAMRIID and/or host country personnel in blood processing and analysis as needed.

1.4.5. Ship blood products to laboratories at USAMRIID, or to collaborators, as needed. Shipments must occur within Fourteen (14) days of collections.

1.4.6 Contractor must provide evidence of pre-existing infrastructure within the countries identified to allow collections to occur immediately upon award of the contract.

1.4.7 Contractor must provide evidence of having an active human use protocol in countries to allow collections from survivors.

1.5. ORGANIZATIONAL CONFLICT OF INTEREST (OCI) & NON-DISCLOSURE STATEMENT (NDS)

1.5.1. Organization Conflict of Interest and Non-Disclosure Statement, (Deliverable #1). This Contract will be used to procure U.S. Army Medical Research and Development Command (USAMRDC) OCI Category Two (2) –

Program and/or Administrative Support, which falls within the scope of the PWS. The contractor shall provide an

OCI certification with their proposal. In additions, the contractor shall ensure that all contractor personnel are advised of nondisclosure policies as well as restrictions from communicating official business to media outlets. The contractor shall provide signed non-disclosure statements from each personnel assigned, prior to performing any services.

SECTION 2 GENERAL REQUIREMENT

2.1. PERFORMANCE

2.1.1. Place of Performance.

2.1.1.1. Place of Performance will be GEORGIA (In-Country), SIERRA LEONE (In-Country), MADAGASCAR

(In-Country) and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). Travel between these locations may be required.

2.1.2. Period of Performance. This contract is for one (1) Twelve (12) Month Base Period, and Four (4), Twelve

(12) Month Option Periods. The periods of performance for this contract are as follows:

DESCRIPTION PERIOD OF PERFORMANCE

Base Year 15 September 2021 – 14 September 2022

Option Year 1 15 September 2022 – 14 September 2023

Option Year 2 15 September 2023 – 14 September 2024

Option Year 3 15 September 2024 – 14 September 2025

Option Year 4 15 September 2025 – 14 September 2026

2.1.2.1. See Section 3 of the PWS for additional information regarding the deliverables and how they tie in with the

Period of Performance.

2.2. NON-PERSONAL SERVICES

2.2.1. 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.

2.2.2. Contract personnel performing services under this contract shall be controlled, directed and supervised by contract management personnel only. The contractor’s management shall ensure that personnel properly comply with the performance standards outlined in the Quality Assurance Surveillance Plan (QASP). Contractor personnel will perform independent of and without the supervision of any Government official. Actions of contractor personnel may not be interpreted or implemented in any manner that results in any contractor personnel creating or modifying Federal policy, obligating the appropriated funds of the U.S. Government, overseeing the work of Federal personnel, providing direct personal services to any Federal personnel or otherwise violating the prohibitions set forth in FAR 7.5 entitled, “Inherently Government Functions” as well as in FAR 37.1, entitled, “Service

Contracting.”

The Government will control access to the facility and will perform the inspection and acceptance of the completed work.

2.3. CONTRACT MANAGEMENT

2.3.1. 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. In the event that the COR is not available, a secondary Point of Contact (POC) identified by the COR will assume the COR’s responsibilities.

2.3.2. 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, Contract Specialist and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills. The name of the PM and an alternate (who shall act for the Contractor when the manager is absent) shall be designated in writing to the KO. The Manager or alternate shall have full authority to act for the Contractor on all contract matters relating to daily operation of this contract. The Manager or alternate shall be available (in-person or virtually) as required.

2.3.2.1. 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.

2.3.2.2. Contract Management Plan (CMP) (Deliverable #2). The Contractor shall develop and provide a Contract

Management Plan (CMP) with their proposal. The CMP shall include a detailed staffing plan which includes a listing of personnel utilizing a job description to describe the position that will be required to meet the objectives of the Performance Work Statement (PWS).

2.3.3. Quality Control Plan (QCP) (Deliverable #3). The Contractor shall provide a DRAFT QCP with their proposal and a FINAL QCP no later than Fifteen (15) days after contract award. The Contractor shall prepare and adhere to a

QCP describing how the Contractor intends to manage the contracts to achieve the established standards as set forth in the PWS Summary Matrix and the Contractor’s QCP.

2.3.4. Subcontract Management. The Contractor shall be responsible for the management and performance of

Subcontractors during this contract. Contractors may add Subcontractors to their team after notification and approval from the Procuring Contracting Officer (PCO) and COR. Cross Teaming shall be permitted.

2.3.5. Requirement to Fill Vacant Positions. The contractor shall fill vacant positions within Forty-Five (45) business days. If contractor positions are vacant for more Forty-Five (45) days, the Contracting Officer (KO) shall immediately be notified in writing.

2.3.6. Key Personnel. There are no Key Personnel for this project. The Contractor is expected to assign personnel for this requirement with a strong background in this work.

2.4. REPORTS

2.4.1. Reports and documents delivered by the contractor in the performance of this contract shall be considered

Technical Data as defined in the applicable FAR clause 52.227-14, Rights in Data. All documentation shall reflect the latest version of the work product or activity, unless specifically directed otherwise by the Government. All documentation shall be prepared in accordance with (IAW) standard industry practices, ensuring electronically produced documents which reflect logical flow of material, tables of contents indexes and page numbering. Where applicable, the contractor’s attention is called to the availability of commercial, industry, federal, and military guides, instructions, and standards for many of the topics addressed in this PWS and under this contract.

2.4.2. Post Award Conference – Including Quality Control Reporting (Deliverable #4). The Contractor shall attend a post award conference (kick-off meeting) in coordination with the Government within Five (5) business days after contract award. The Contractor shall meet with the Government to present an overview of their approach and establish schedules, procedures, and points of contact necessary to conduct the tasks outlined herein. The meeting may be held via teleconference or in-person at a Government facility, as determined by the Government. The meeting should be coordinated and led by the Contractor Program Manager with additional Contractor employees in attendance as needed. The Contractor shall ensure that meeting materials are provided to Government participants

Two (2) business days prior to the meeting.

2.4.3. Monthly Status Reports (Deliverable #5). The contractor shall provide monthly reports detailing all work completed within Seven (7) calendar days after each end of month. The report shall include, but not limited to a detailed list of all data deliveries completed during the previous month, all documentation scheduled for delivery during the next Two (2) months, those items which required Government approval during the previous month, and whether approval has been given or is still pending, a list of documentation which was due and not delivered, and the status of delinquent data deliveries to include impact statements for each delinquency. It shall be submitted with a transmittal letter that highlight major events in the reporting period. The report shall also include details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, inventories, and any problems/issues encountered as applicable. The format for the report shall be agreed upon by the Government and

Contractor.

2.4.4. Quarterly Reports (Deliverable #6). The Contractor shall submit a quarterly report summarizing the work performed and completed throughout the quarter. The Contractor shall provide a copy of the quarterly report to the

Contract Specialist, Contracting Officer, and COR no later than fifteen (15) calendar days from the end date of each quarter. Quarters run on a calendar basis (March, June, September, and December).

2.4.5. Final Report (Deliverable #7). The Contractor shall provide a Final Report to the KO and COR. The

Contractor shall prepare the Final Report that shall include, but not be limited to. The results of the work performed and completed throughout the life of the contract and list of deliverables provided by the Contractor as part of the requirement.

2.5. PERSONNEL TRAINING REQUIREMENTS

2.5.1. Completion of All Training Requirements (Deliverable #8). The contractor shall track and complete all initial and refresher trainings to maintain training compliance and readiness status. The contractor shall submit certificates of completion for each contractor and subcontractor personnel working under this contract to the COR within five

(5) calendar days after completion of training.

2.5.1.1. Anti-Terrorism (AT) Level 1. All contractor employees, including subcontractor employees, requiring access to Army installations, facilities, or 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 applies. 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) with 5 calendar days after completion of training by all employees and subcontractor personnel. AT Level I awareness training is available at https://atlevel1.dtic.mil.

2.5.1.2. Health Insurance Portability and Accountability Act (HIPAA) and Privacy Act Security Training.

Contractor shall complete this required non-residential course annually, available on-line at https://jkodirect.jten.mil.

It takes approximately two-hours to complete.

2.5.1.3. Sexual Harassment/Assault Reponses and Prevention (SHARP) Contractor Training. This paragraph is added to incorporate reporting and training requirements and to reference the Office of the Surgeon General

(OTSG)/Medical Command (MEDCOM) Policy Memo 16-033, dated 29 March 2016 as an attachment to the contract, Sexual Harassment Assault Response Prevention (SHARP) AKO ALMS instructions. This training is in accordance with USAMRAA Policy 17-01, SHARP FINAL DATED 19OCT2016 with attachments, and is applicable to all on-site contractors and contractor personnel supporting all Services type Contracts over the

Simplified Acquisition Threshold (SAT), that are awarded by USAMRAA, and who are performing those services on-site in a Government facility or work space, leased or owned. Training may be obtained online for contractor personnel with an Army Knowledge On-line (AKO) account or it can be taken in person. If the personnel has an

AKO account, they can access training online at Army AKO https://www.us.army.mil/.

2.5.1.3.1. In addition, All contractor personnel shall comply with OTSG/MEDCOM Policy Memo 16-033, Sexual

Harassment/Assault Response and Prevention (SHARP) Program which states that All allegations of sexual harassment and sexual assault shall be immediately addressed, no matter where they occur or who are involved. This includes all personnel working in Government facilities in support of contracts awarded by United States Army

Medical Research Acquisition Activity (USAMRAA). Department of Defense and Department of the Army

(DoDDA) civilian complaints of sexual harassment or sexual assault will be investigated and processed in accordance with the Equal Employment Opportunity (EEO) Program and AR 690-600. Contract personnel with knowledge of an incident of sexual harassment or assault will immediately report the incident to their employer and their employer will immediately report the incident to the Government’s Contracting Officer Representative (COR) or Contracting Officer.

2.6. DUTY HOURS

2.6.1. Contractor personnel shall perform services during regular duty hours; Monday through Friday. For purposes of when the Contractor has to schedule training and maintenance, the core hours of operation for USAMRIID are

7:30 – 4:30pm pm; however, times may be changed with little to no notice.

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

2.6.3. 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:

2.6.3.1. New Year’s Day, 1 January

2.6.3.2. Martin Luther King’s Birthday, 3rd Monday in January

2.6.3.3. President’s Day, 3rd Monday in February

2.6.3.4. Memorial Day, last Monday in May

2.6.3.5. Juneteenth, 19 June

2.6.3.6. Independence Day, 4 July

2.6.3.7. Labor Day, 1st Monday in September

2.6.3.8. Columbus Day, 2nd Monday in October

https://www.us.army.mil/

2.6.3.9. Veteran’s Day, 11 November

2.6.3.10. Thanksgiving Day, 4th Thursday in November

2.6.3.11. Christmas Day, 25 December

2.6.4. Contractor Personnel shall not perform services or report to work on days the Government or installation is closed due to local determinations relating to safety conditions, inclement weather conditions, national emergencies, or energy conservation. During these periods of closure, the contractor personnel who are not designated as essential personnel shall not report for work nor shall they be compensated for those days.

2.7. Travel / Temporary Duty (TDY).

2.7.1. The COR is the OCONUS travel order approval authority as designated in writing by the KO. Travel to other

Government facilities or other Contractor facilities may be required and will be specified in the PWS. All OCONUS travel requirements (including plans, agenda, itinerary, or dates) shall be pre-approved by the COR and is on a strictly cost reimbursable basis. The Contractor shall be authorized travel expenses consistent with the substantive provisions of the JTR and the limitation of funds specified in this contract. Costs for travel shall be billed in accordance with the regulatory implementation of Public Law 99-234 and FAR 31.205-46 Travel Costs, subject to local policy and procedures.

2.7.1.1. Travel Arrangements. Arrangements for and costs of all travel, transportation, meals, lodging, and incidentals are the responsibility of the Contractor. The Contractor shall remain current on applicable regulations, policies, and procedures that may impact processes for travel and modify their processes accordingly. No later than

30 calendar days prior to scheduled OCONUS travel date, the Contractor will prepare the estimate in an official memorandum format. The estimate shall include airline ticket costs, car rental, per diem, registration fees and any other allowable costs associated with the travel request. All travel and transportation shall utilize commercial sources and carriers provided the method used for the appropriate geographical area that results in reasonable charges to the government. The Government will not pay for economy plus, business class or first-class travel. The

COR will provide the Contractor a signed approval of Government Contractor Official Travel Letter of

Identification before the Contractor is authorized to travel OCONUS.

2.7.1.2. Travel Claim Procedures, Approval, and Reimbursement. Travel to be performed issued under this contract shall be reimbursed after the KO has determined fair and reasonable cost reimbursement IAW the JTR and FAR Part

31.205-46. The Contractor shall submit an estimate for travel to the COR no later than Thirty (30) calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost.

A. References:

i. Federal Travel Regulations, prescribed by the General Services Administration, for travel in the contiguous United

States

ii. Joint Travel Regulation, Volume2, DoD Civilian Personnel, Appendix A

iii. Standardized Regulations (Government Civilians, Foreign Areas), Section 925 “Maximum Travel Per Diem

Allowances for Foreign Areas.”

2.7.1.2.1. The COR will verify the travel receipts are valid and match the travel requirements identified in the PWS.

The Contractor shall provide a trip report to include costs associated with the travel to the COR within Ten (10) calendar days after the completion of travel trip. All travel costs shall be billed within 30 days after travel is complete unless an approval for later billing is approved by COR or KO. All travel cost reimbursement requests must detail all authorized expenses associated with the travel and all receipts including ticket stubs (booked airline, hotel receipts, etc.) shall be provided to substantiate claims for costs of all expense items in excess of $75.00.

2.8. OTHER DIRECT COSTS (ODC’S)

2.8.1. Other Direct Costs (ODC’s). ODCs shall be billed on a Firm-Fixed-Price Not-To-Exceed (FFP NTE) basis, and, shall be in accordance with the Federal Acquisition Regulation (FAR) 31.205-46, Travel Costs. The Contractor is expected to familiarize themselves with this regulation as this is the basis for the reimbursement of travel costs.

2.8.1.1. The Contractor shall plan for up to Six (6) International trips a year (A possibility of Two (2) trips per location, per year), with each trip lasting approximately Fourteen (14) days at a time. Contractor Employees shall arrange travel from their Contractor Location directly to any of the following Three (3) locations: The Republic of

Georgia, Sierra Leone or Madagascar.

2.8.1.2. Each trip will require Three (3) Contractor Personnel for blood sample collection, processing and shipping, as well as flow cytometry experiments in country.

2.8.1.3. Each trip will require supplies for collections, processing, storage and shipment of samples to USARMIID.

All costs associated with the shipment of product to USAMRIID should also be included in cost estimates.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. Technical requirements

3.1.1. The contractor shall provide all necessary services and supplies in the development The Contractor shall identify a cohort of survivors of CCHFV and Old World Hantaviruses (Georgia), LASV (Sierra Leone) and Y.

Pestis (Madagascar) and perform whole blood collection.

3.1.1.1. The Contractor shall identify a cohort of survivors of CCHFV and Old World Hantaviruses (Georgia), LASV (Sierra Leone) and Y. Pestis (Madagascar) and perform whole blood collection. Blood samples will be delivered to the in-country host laboratory expeditiously following each collection. PBMCs must be isolated and stored at -80ºC within 12 hours of collection.

<Add Tasks that will lead to the accomplishment of this Objective>

3.1.1.2. The Contractor shall perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 3.1.1. Travel schedules will require coordination with USMARIID personnel.

3.1.1.3. The Contractor shall assist USAMRIID and/or host country personnel in blood processing and analysis as needed.

3.1.1.4. The Contractor shall ship blood products to laboratories at USAMRIID, or to collaborators, as needed.

Shipments must occur within 14 days of collections.

3.1.2. The Contractor must provide evidence of pre-existing infrastructure within the countries identified to allow collections to occur immediately upon award of the contract.

3.1.3. The Contractor must provide evidence of having an active human use protocol in countries to allow collections from survivors.

3.2. Performance Requirement Summary Matrix

3.3. Quality Assurance Surveillance Plan (QASP).

3.3.1. Every DoD contract awarded for services in excess of $2,500.00 shall contain a Quality Assurance

Surveillance Plan (QASP) as discussed in the FAR 46, Government Contract Quality Assurance. A QASP is a plan that specify the particular services the COR will inspect and the method(s) used to complete that surveillance. Each

Offeror shall digest the PWS in this RFP and offer a QASP associated therewith. The QASP shall be submitted as part of the Offeror’s technical proposal. It will not be subjectively evaluated and rated. However, it may be discussed during the pre-award period for finalization prior to its inclusion in the awarded contract.

SECTION 4 SPECIAL REQUIREMENT

4.1 Government Furnished Property

4.1.1. Any applicable Government Furnished Equipment determined to be necessary in the performance of the required services shall be identified at the time of contract award. All government furnished equipment shall be used only for direct support of the services requested in this PWS. The Contractor shall not install any software on government-furnished equipment, unless approved by USAMRIID and the KO prior to installation. The Contractor shall maintain all Government-furnished information per Non-Disclosure Statement, regulations, and policies.

4.2. Unclassified Contract Security Requirements

4.2.1. The contractor shall ensure all personnel performing under this contract have a favorable National Agency

Check with written inquires (NACI), including a favorable completion of Federal Bureau of Investigation (FBI) fingerprint check, which the COR will coordinate with the United States Army Garrison (USAG) Fort Detrick

Security office prior to performance start date. The security requirements shall be maintained for the life of the contract, and citizenship shall be verified by presenting an original birth certificate, a U.S. passport, or the original

Naturalization Certificate to the USAG Fort Detrick Security office at the time of in processing for all contract personnel assigned to the contract. In order to maintain the security requirements any derogatory information, to include law enforcement issues, mental health issues, or alcohol/drug related issues shall be reported to the COR, and USAG Fort Detrick Security Office.

4.3. Proprietary Information Assurance and Security

PERFORMANCE

REQUIREMENT

PWS

PARAGRAPH

REFERENCE

PERFORMANCE STANDARD

ACCEPTABLE

QUALITY

LEVEL

(AQL)

SURVEILLANCE

METHOD

Identify a cohort of survivors

3.1.1.1.

The Contractor shall identify a cohort of survivors of

CCHFV and Old World Hantaviruses (Georgia), LASV

(Sierra Leone) and Y. Pestis (Madagascar) and perform whole blood collection. Blood samples will be delivered to the in-country host laboratory expeditiously following each collection. PBMCs must be isolated and stored at -

80ºC within 12 hours of collection.

100%

Complete

100%

Observation and Random

Sampling

Perform a

Follow-up 3.1.1.2.

The Contractor shall perform follow-up collection of survivor’s sera and lymphocyte samples (whole blood), as in 3.1.1. Travel schedules will require coordination with USMARIID personnel.

100%

Complete

100%

Observation and Random

Sampling

Blood

Processing

Analysis

3.1.1.3.

The Contractor shall assist USAMRIID and/or host country personnel in blood processing and analysis as needed.

100%

Complete

100%

Observation and Random

Sampling

Shipment of

Blood Products 3.1.1.4.

The Contractor shall ship blood products to laboratories at USAMRIID, or to collaborators, as needed.

Shipments must occur within 14 days of collections.

100%

Complete

100%

Observation and Random

Sampling

4.3.1. The contractor shall comply with Office of Management and Budget (OMB) Circular A-130, “Management of

Federal Information Resources,” which requires Certification and Accreditation (C&A) of all federal information systems every three (3) years at a minimum or as changes that require re-accreditation occur. This C&A requirement ensures the effective safeguarding of sensitive but unclassified (SBU) data against unauthorized modification, disclosure, destruction, and denial of service, as directed by the DoD.

SECTION 5 DELIVERABLES

5.1. Measureable Deliverables.

5.1.1. The contractor shall provide the following deliverables as listed below:

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Applicable Directives.

6.1.1. Services provided under this contract must be conducted in accordance with all applicable state, Federal, DoD, and local laws, regulations, policies, and procedures that govern the conduct of work described herein. Federal regulations governing current Good Manufacturing Practice (cGMP), Good Clinical Practice (GCP), Good

Laboratory Practice (GLP), Quality System Regulation (QSR), and Human Subjects Protection are found in Title 21

Code of Federal Regulations (CFR). Additional Human Subjects Protection regulations are found in Title 45 CFR 46 and Title 32 CFR 219. Other applicable documents include FDA Guidance Documents, ICH Guidance Documents, and ISO guidance documents (e.g.: ISO 17025 and ISO 9000).

6.1.2. The Contractor shall comply with all documents listed below as mandatory and referenced under Section 3, Performance Requirements

6.1.3. A list of mandatory and advisory policies, regulations, and other guidance can be found below. This list is not all inclusive. Other mandatory and advisory host nation guidance may be applicable to services provided

OOCONUS. Specific State and Host Nation requirements will be provided.

Regulation / Directive Description

29 CFR part 1910 OSHA General Industry Regulations

AR 5-5 Army Studies and Analyses

AR 50-1 Biological Surety

AR 280-5 DA Information Security Program

AR 380-40 Policy for Safeguarding and Controlling Communications Security

AR 385-10 The Army Safety Program

DoDD 1000.25 DoD Personnel Identity Protection (PIP) Program

DoDD 5200.1-R DoD Information Security Program

DoDD 5220.22-M Information Security Program

DoDD 5400.11 DoD Privacy Program

DoDD 5400.11-R DoD Privacy Program Regulation

DoDD 6220.22-R Industrial Security Regulation

ITEM

PWS

REF.

TITLE DIST.

ELECTRONIC

(E) OR HARD

COPIES (H)

1 1.5.1. Organization Conflict of Interest and Non-Disclosure Statement KO, COR 2 (E)

2 2.3.2.2. Contract Management Plan (CMP) KO, COR 2 (E)

3 2.3.3. Quality Control Plan (QCP) KO, COR 2 (E)

4 2.4.2. Post Award Conference – Including Quality Control Reporting KO, COR 2 (E)

5 2.4.3. Monthly Status Reports KO, COR 2 (E)

6 2.4.4. Quarterly Reports KO, COR 2 (E)

7 2.4.5. Final Report KO, COR 2 (E)

8 2.5.1. Completion of All Training Requirements KO, COR 2 (E)

SECTION 7 DEFINITIONS AND ACRONYMS

7.1. Definitions

7.1.1. Change Order. A written order, signed by the contracting officer, directing the contractor to make a change that the Changes clause authorizes the contracting officer to order without the contractor’s consent.

7.1.2. Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government.

The term used in this contract refers to the prime.

7.1.3. Contracting Officer (KO). A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the government. The Contracting Officer is the only individual who can legally bind the government.

7.1.4. Contracting Officer’s Representative (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

7.1.5. Day. Unless otherwise specified, a Day is a Calendar Day

7.1.6. Defective Service. A service output that does not meet the standard of performance associated with the

Performance Work Statement.

7.1.7. Deliverable. Anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

7.1.8. Key Personnel. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

7.1.9. Offer. A response to a solicitation that, if accepted, would bind the offeror to perform the resultant contract.

7.1.10. Offeror. An Offeror or Bidder.

7.1.11. Option. A unilateral right in a contract by which, for a specified time, the Government may elect to purchase additional supplies or services called for by the contract, or may elect to extend the term of the contract.

7.1.12. Organizational Conflict of Interest. Because of other activities or relationships with other persons, a person is unable or potentially unable to render impartial assistance or advice to the Government, or the person’s objectivity in performing the contract work is or might be otherwise impaired, or a person has an unfair competitive advantage

7.1.13. Physical Security. Actions that prevent the loss or damage of Government property.

7.1.14. Proper Invoice. An invoice that meets the minimum standards specified in FAR 32.905(b).

7.1.15. Quality Assurance Surveillance Plan (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.16. Quality Control. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.17. Registered in the System for Award Management (SAM). The Contractor has entered all mandatory information, including the unique entity identifier and the Electronic Funds Transfer indicator (if applicable), the

Commercial and Government Entity (CAGE) code, as well as data required by the Federal Funding Accountability and Transparency Act of 2006 (See FAR Subpart 4.14), into SAM.

7.1.18. Shall. Denotes the Imperative.

7.1.19. Subcontractor. One that enters into a contract with a prime contractor. The Government does not have privety of contract with the subcontractor.

7.1.20. Work Day. The number of hours per day the contractor provides services IAW the contract.

7.1.21. Work Week. Monday through Friday, unless specified otherwise.

7.2. Acronyms

The acronyms used are listed with in the document, and will assist in recognizing certain key words, phrases, or departments as defined in the contract, as well as any forthcoming dialogue with the contractor.

Acronym Description

AAALAC American Association for Accreditation of Laboratory Animal Care

ACOR Alternate Contracting Officer’s Representative

ADP/IT Automated Data Processing/Information Management

AFARS Army Federal Acquisition Regulation Supplement

AKO Army Knowledge Online

ALMS Army Learning Management System

AR Army Regulation

AT Anti-Terrorism

ATCTS Army Training Certification Tracking System

AWSNF Army Wide Network Security Focus

C&A Certification and Accreditation

CAC Common Access Card

COR Contracting Officer’s Representative

CTIP Combatting Trafficking in Persons

DFARS Defense Federal Acquisition Regulation Supplement

DHP Defense Health Department

DoD Department Of Defense

DoDDA Department of Defense and Department of the Army

DTIC Defense Technical Information Center

EEO Equal Employment Opportunity

FAR Federal Acquisition Regulation

FBI Federal Bureau of Investigation

FDA Food and Drug Administration

FPCON Force Protection Condition

FY Fiscal Year

HIPAA Health Insurance Portability and Accountability Act

HTML Hypertext Markup Language

HQDA Headquarters, Department of the Army

IACUC Institutional Animal Care and Use Committee

IA/IT Information Assurance / Information Technology

IASO Information Assurance Security Officer

IAW In Accordance With

IT Information Technology

JKO Joint Knowledge Online

JTR Joint Travel Regulation

K or k Kilogram

KO Contracting Officer

KS Contract Specialist

MEDCOM Medical Command

NAC National Agency Check

NACI National Agency Check with Inquiries

NCIC National Crime Information Center Interstate Identification Index

NDS Non-Disclosure Statement

OCI Organization Conflict of Interest

OMB Office of Management and Budget

OPSEC Operations Security

OSD Office of the Secretary of Defense

OSHA Occupational Safety and Health Administration

OTSG Office of the Surgeon General

PAM Post Approval Monitoring

PBMC Peripheral Blood Mononuclear Cell

PCO Procuring Contracting Officer

PDF Portable Document Format

PI Principal Investigator

PM Program Manager

POC Point Of Contact

PPM Pre-Protocol Meeting

PWS Performance Work Statement

QASP Quality Assurance Surveillance Plan

RDT&E Research, Development, Training & Evaluation

SBU Sensitive But Unclassified

SHARP Sexual Harassment/Assault Response and Prevention

TARP Threat Awareness and Response Program

TSDB Terrorist Screening Database

USAG United States Army Garrison

USAMRAA United States Army Medical Research Acquisition Activity

USAMRDC United States Army Medical Research and Development Command

USAMRIID United States Army Medical Research Institute of Infectious Diseases

USDA United States Department of Agriculture

VMD Veterinary Medicine Division

SECTION 8 MAINTAIN SAFETY, SECURITY AND BIOSECURITY STANDARDS

8.1. SAFETY

8.1.1. Established in 1969, USAMRIID has decades of experience operating containment laboratories and has provided extensive training and consultation to other agencies setting up their own facilities. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s

Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies. The program, which enables USAMRIID to safeguard both the biological materials we use in our laboratories and the personnel who work here, consists of the four key areas of biological safety, physical security, personnel reliability, and agent accountability.

8.1.2. There are four levels of biological containment, ranging from BSL-1, the lowest, to BSL-4, the highest. BSL-1 would be comparable to an open bench laboratory found in a school classroom—no special precautions would be needed. At BSL-2, USAMRIID employees wear laboratory coats and observe other basic precautions. For BSL-3 work, personnel are required to wear approved PPE and comply with established biosafety standards. BSL-4 is the highest level of containment, and employees wear positive-pressure encapsulating suits and breathe filtered air as they work. Other personal protective equipment may be required, depending on the tasks to be performed and biosafety level.

8.1.3. In addition, a combination of rigorous training, meticulous procedures, tight security, carefully designed structures, and elaborate and redundant operating systems is in place to protect laboratory workers. These measures also ensure the safety of those outside the suites. Investigators working in USAMRIID laboratories are and must be highly trained to follow and comply with established safety, biosafety and biosecurity procedures. Personnel may be required to demonstrate initial and continuous task proficiency with strict adherence to biosafety principles in order to conduct work in BSL 2-4. Adherence to the USAMRIID Biosafety Program; Biosafety Plan, standard operating procedures, biocontainment suite specific manuals, biosafety training program and biosafety mentorship program will be ensured through a compliance program. As a part of this compliance program, all personnel are required to self-report any deviation to standard procedures and designated personnel may be required to observe work of others in the suites and document observations and adherence to the biosafety plan. Lack of adherence to any component of the Biosafety Program or lack of skill proficiency will be grounds for revocation of biocontainment access.

Investigators in the laboratories study amounts of infectious agents and the diseases they cause in order to develop vaccines, treatments and diagnostic tools. USAMRIID's research involving infectious agents is reviewed and approved by the Institutional Biosafety Committee, the Animal Care and Use Committee, the Portfolio Review

Committee, and other internal and external reviewers as applicable. No studies can take place without careful examination of all protocols to assess risks.

8.1.4. Personnel with the appropriate, government-required training and certification to operate in biocontainment environments are not readily available in the commercial marketplace and are unique to the extremely small number of laboratories worldwide that perform research in BSL-3 and -4. As described above, approved work in biocontainment suites and using biological select agents and toxins requires stringent background checks, health screening, enrollment in specialized reliability programs, and mentored hands-on training. It takes an extensive amount of time and government effort for a new staff member to become fully trained and operational, and there is inherent risk that new personnel will not meet the stringent security and reliability program requirements.

8.2. SECURITY

8.2.1. USAMRIID considers the safety of its employees, neighbors, and the surrounding community its number one priority. USAMRIID’s Biosecurity Program is governed by a broad set of Federal, DoD and US Army regulations and policies, which enables USAMRIID to safeguard both the biological materials used in the laboratories as well as the personnel who work here.