21R0089 solicitation.docx

W81XWH21R0089

Section A - Solicitation/Contract Form

CLAUSES INCORPORATED BY REFERENCE

Section B - Supplies or Services and Prices

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

FOR

MaChupo VIRUS Cell Sorting for monoclonal antibody discovery

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. Successful antibody discovery pipelines depend on: (1) the source sample used for antibody discovery, (2) the availability of high-quality antigens to identify and down-select candidate mAbs, and (3) a detailed understanding of the underlying biology of the target.

1.3.2. One of the critical factors missing from existing arenavirus antibody discovery efforts is high-quality antigen that accurately recapitulate the wild-type antigens present on the viral surface to support antibody identification and characterization. The arenavirus glycoprotein ectodomain (GPe) consists of two non-covalently associated subunits, GP1 and GP2 that readily disassociate in solution. As a result, purification of soluble recombinant trimeric arenavirus GPs, including that for Machupo virus (MACV), to support antibody discovery has proven challenging. A stable viral GP trimeric spike is essential to facilitate isolation of conformational or mAbs targeting quaternary structural epitopes from survivor samples. Furthermore, a discovery program utilizing a collection of diverse arenavirus trimeric GPs will allow for rapid assessment of antibody breadth of reactivity, a useful tool to leverage during the antibody down-selection process. Responders are expected to have developed trimeric GP for multiple arenaviruses and should provide a detailed description of each trimeric GP that they have developed.

1.4. Scope

1.4.1. The primary objective of this requirement is to sort peripheral blood mononuclear cells (PBMCs) from Machupo virus survivors to discover and produce monoclonal antibodies for assessment in in vitro and in vivo assays at USAMRIID.

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

1.5.1. OCI & NDS, Deliverable #1, Exhibit #1. This Contract will be used to procure U.S. Army Medical Research and Development Command (USAMRDC) OCI Category Three (3) – Product 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 located CONUS depending on who recieves the requirement

2.1.1.2. Period of Performance. This contract is for one (1) twelve (12) month Base Period, and two (2) twelve (12) month Option Periods. The periods of performance for this contract are as follows:

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).

2.3.2.3. 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.

2.3.3. 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.

2.3.4. 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.

2.4.1.1. 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.

2.4.1.2. 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.

2.4.1.3. 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).

2.4.1.4. 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.

2.4.1.5 Service Contract Reporting (Deliverable #8). This is a mandatory requirement in accordance with Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services. Refer to Far 52.204-14.

2.5. PERSONNEL TRAINING REQUIREMENTS

Not Applicable to this requirement as all work will be completed at the Contractor’s site.

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 7:30am – 4:30 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. Juneteenth Independence Day, 19th of June

2.6.3.5. Memorial Day, last Monday in May

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

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).

The COR is the CONUS travel 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 CONUS 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 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 CONUS 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 CONUS.

2.7.2 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 COR no later than 30 calendar days prior to the first day of travel; in order for the Contractor to obtain economical travel arrangement and cost.

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) (Deliverable #9). ODCs shall be billed on a cost reimbursable basis. ODCs are defined as purchase price of materials, travel, accommodations or other services plus applicable indirect costs and tax (if applicable). Fees will not be paid on ODCs or travel. Only General and Administrative (G&A) may be applied to ODC expenses. Upon Government approval, the Contractor can bill against ODCs for supplies and travel costs or other direct costs beyond that provided by the Government to allow their Contract employees to accomplish research purposes as defined by the contract.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 The contractor shall provide all necessary services in support of the Department of Virology at USAMRIID. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1. MACHUPO VIRUS Cell Sorting services

3.1.1 The Contractor shall Generate a panel of fully human anti-MACV IgGs (Base Year)

3.1.1.1 The contractor shall select human B cells expressing antibodies that react with trimeric MACV glycoprotein (GP) from a population of peripheral blood mononuclear cells (PBMCs) collected from multiple survivors of MACV infection. PBMC samples from human survivors will be provided to the contractor. The contractor will be responsible for providing trimeric MACV GP used for selection. Following selection, the contractor shall clone the variable regions from cognate heavy and light chain pairs into a human IgG1 backbone. Binding of mAbs to MACV GP must be confirmed. Those mAbs that bind will be expressed in small-scale to produce material to support analyses in Task 2

3.1.2 The Contract shall conduct In Vitro Characterization of mAbs and down-selection of lead candidates for in vivo work. (Option Year 1, if exercised)

3.1.2.1. The contractor shall perform an in-depth characterization of the mAbs purified in Task 1, with the goal of down-selecting from the original panel to identify lead candidates for in vivo efficacy experiments. The panel will undergo testing to analyze antibody-antigen binding kinetics, binding assays to determine breadth of reactivity, as well as competition group binning and epitope mapping. Those mAbs with promising characteristics will be produced at sufficient scale to assess virus neutralization in vitro. The contractor will be responsible for identifying and removing sequence liabilities that would otherwise impact downstream developability (e.g. unpaired cysteines, glycosylation sites, etc.). Optimized candidates must be re-screened to ensure these mutations do not impact mAb activity.

3.1.3. The Contractor shall provide generation of material to support in vivo efficacy testing of single mAbs in rodents. (Option Year 1, if exercised)

3.1.3.1. The contractor shall produce 5-10 mg each of the 20 lead mAbs in a transient transfected ExpiCHO line (for MACV rodent challenge study).

3.1.4. The Contractor shall provide generation of material to support proof of concept efficacy experiment in NHPs with lead candidate pan-MACV cocktail (Option Year 2, if exercised)

3.1.4.1 The contractor will generate stable polyclonal CHO pools expressing the lead candidate mAbs. The contractor shall manufacture at least 4 g of each mAb from stable nonclonal pools. The contractor shall perform endotoxin testing, stability assessment, analytical specifications and assays (release criteria) required for NHP experiments.

3.1.5 DELIVERABLES

3.1.5.1. The following Deliverable is expected at the end of the Base Year

3.1.5.1.1. – A panel of human anti-MARV antibodies (100-300 total antibodies) isolated from survivors of MACV infection based on work done in Section 3.1.1 (Deliverable #10)

3.1.5.2. The following Deliverable is expected at the end of Option Year 1 (if exercised)

3.1.5.2.1 - Optimized lead candidate mAbs selected on the basis of neutralization, antigen binding and competition grouping (Deliverable #11, if option is exercised)

3.1.5.3. The following Deliverable is expected at the end of Option Year 2 (if exercised)

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 – NOT APPLICABLE

4.2 Contractor Furnished Property – NOT APPLICABLE

4.3. Security and Safety

4.3.1 Access and General Protection/Security Policy and Procedures. The contractor and all associated subcontractors’ personnel shall comply with applicable installation, facility, and area commander installation and facility access and local security policies and procedures. The contractor shall also provide all information required for background checks to meet installation access requirements to be accomplished by the installation, the Provost Marshal Office, the Director of Emergency Services, and/or the Security Office. The contractor workforce shall comply with all personal identity verification requirements (FAR clause 52.204-9, Personal Identity Verification of Contractor Personnel) as directed by DoD, Headquarters Department of the Army (HQDA), and/or local policy. Should the Force Protection Condition (FPCON) level at any individual facility or installation change, the Government may require changes in contractor security matters or processes.

4.3.2. Common Access Card (CAC). Not Applicable.

4.3.3. Non-CAC Eligible. Personnel of a Department of Defense contractor who is not eligible for a CAC credential, but still requires access to an Army installation or facility.

4.3.3.1. Contractors and all associated sub-contractor personnel shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB) (Army Directive 2014-05), applicable installation, facility and area commander installation/facility access and local security policies and procedures.

4.3.4. Force Protection Condition (FPCON). The Force Protection Conditions system has been approved by the Department of Defense to standardize the identification and recommended preventive actions and responses to terrorist threats against United States personnel and facilities. Strict adherence to FPCON measures is required. A terrorist attack can take place at any time. The greater the perceived threat based on the intelligence received, the higher the awareness needs to be to prevent the loss of life.

4.3.4.1. FPCON Normal. This condition applies when a general global threat of possible terrorist activity exists and warrants a routine security posture. At a minimum, access control will be conducted at all DOD installations and facilities.

4.3.4.2. FPCON Alpha. This applies when there is an increased general threat of possible terrorist activity against personnel or facilities, the nature and extent of which are unpredictable, and circumstances do not justify full implementation of FPCON Bravo measures. However, it may be necessary to implement certain measures from higher FPCONs as an additional deterrent or resulting from intelligence received. The measures in this FPCON must be capable of being maintained indefinitely.

4.3.4.3. FPCON Bravo. This applies when an increased or more predictable threat of terrorist activity exists. Sustaining Bravo measures for a prolonged period may affect operational capability and relationships with local authorities.

4.3.4.4. FPCON Charlie. This applies when an incident occurs or intelligence is received indicating that some form of terrorist action or targeting against personnel or facilities is likely. Prolonged implementation of Charlie measures may create hardship and affect the activities of the unit and its personnel.

4.3.4.5. FPCON Delta. This applies in the immediate area where a terrorist attack has occurred or when intelligence has been received that terrorist action against a specific location or person is imminent. FPCON Delta is usually declared as a localized condition. FPCON Delta measures are not intended to be sustained for an extended duration.

4.3.4.5.1. During FPCONs Charlie and Delta, non-essential services are discontinued. Designated essential service will resume when the FPCON level is reduced to level Bravo or lower.

4.4. Mission Essential Personnel Not applicable

4.5. Classified Contract Security Requirements - NOT applicible

4.6. Unclassified Contract Security Requirements

4.6.1. 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.

4.7. Proprietary Information Assurance and Security

4.7.1. 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.

4.8. Visitor Group Security Agreement

4.8.1. The contractor shall sign a Contractor Visitor Group Security Agreement to protect Government information involved in performance under this contract. The agreement shall outline responsibilities in the following areas: contractor security supervision; standard practice procedures; access, accountability, storage, and transmission of, and other responsibilities, as required.

SECTION 5 DELIVERABLES

5.1. Measureable Deliverables.

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

**Note – Deliverables 10 through 13 will only occur if the Options are exercised during the life of the Contract**

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Applicable Directives. 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).

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

6.2. Applicable Directives - A list of mandatory and advisory policies, regulations, and other guidance can be found below. This list is not all inclusive.

6.2.1. 29 CFR part 1910, OSHA General Industry Regulations.

6.2.2. Occupational Safety and Health Act.

6.2.3. AR 5-5, Army Studies and Analyses

6.2.4. AR 50-1, Biological Surety

6.2.5 AR 280-5, DA Information Security Program

6.2.6. AR 380-40, Policy for Safeguarding and Controlling Communications Security

6.2.7. AR 385-10, The Army Safety Program.

6.2.8. DoDD, 1000.25, DoD Personnel Identity Protection Program

6.2.9. DoDD 5200.1-R, DoD Information Security Program

6.2.10. DoDD 5220.22-M, Information Security Program

6.2.11. DoDD 5400.11, DoD Privacy Program

6.2.12. DoDD 5400.11-R, DoD Privacy Program Regulation

6.2.13. DoDD 6220.22-R, Industrial Security Regulation

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 privity 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.

QASP

Quality Assurance Surveillance Plan (QASP) MaChupo VIRUS Cell Sorting for monoclonal antibody discovery

FOR

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

1. Purpose. The Quality Assurance Surveillance Plan (QASP) is a government-developed document used to determine if the contractor's performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

1.1. Delivery of all items IAW the delivery schedule outlined in the PWS will be monitored, as well as Contractor technical performance on all assigned tasks.

1.2. Monitoring will take place on a monthly and/or quarterly basis.

1.3. All surveillance activities will be conducted by the COR or his/her designated appointee.

1.4. Surveillance results will be documented in memorandum format or by using the attached document templates. All deviations will be shared with the Contractor and the Contractor shall provide a written corrective action plan to the COR within seven (7) calendar days of notice.

1.5. The contractor is responsible for implementing and delivering performance that meets contract standards. The QASP provides the structure for the government's surveillance of the contractor's performance to assure that it meets contract standards. It is the government's responsibility to be objective, fair and consistent in evaluating contractor performance.

1.6. The QASP is a living document and not intended to duplicate the contractor’s quality control plan. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

1.7. The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

1.8. Bottom line, the QASP shall ensure early identification and resolution of performance issues to minimize impact on mission performance.

2. Authority

2.1. Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services Clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

3. Roles and Responsibilities

3.1. The following personnel shall oversee and coordinate contract surveillance activities.

3.1.1. Contracting Officer (KO). The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine and document the final assessment of the contractor's performance in the governments past performance tracking system.

Assigned KO: TBD Organization or Agency: U.S. Army Medical Research Acquisition Activity (USAMRAA) Email: TBD

3.1.2. CONTRACT SPECIALIST (CS). The CS assists the KO in administration of contracts and oversight of the COR.

Assigned CS: TBD Organization or Agency: U.S. Army Medical Research Acquisition Activity (USAMRAA) Email: TBD

3.1.3. Contracting Officer's Representative (COR). The COR is responsible for providing continuous technical oversight of the contractor's performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor's actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the KO. The COR is required to provide an annual performance assessment to the KO which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance. The COR is not empowered to many any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned COR: TO BE UPDATED AT TIME OF AWARD Organization or Agency: United States Army Medical Research Institute of Infectious Diseases (USAMRIID) Email: TO BE UPDATED AT TIME OF AWARD

3.1.4. CONTRACTOR (KTR). Once the contract is awarded, the contractor becomes a member of the Acquisition Team. FAR 46.105 (Reference (l)) requires that the contractor be responsible for carrying out its obligations under the contract by:

A. Controlling the quality of supplies or services.

B. Tendering to the Government for acceptance only those supplies or services that conform to contract requirements.

C. Maintaining evidence that the supplies or services conform to required quality requirements, are within the expected cost, and are delivered on time.

D. Furnishing required information to the Government.

Assigned KTR Point of Contact: TO BE UPDATED AT TIME OF AWARD Organization or Agency: TO BE UPDATED AT TIME OF AWARD Email: TO BE UPDATED AT TIME OF AWARD Phone: TO BE UPDATED AT TIME OF AWARD

4. Performance STANDARDS and MethodS of Surveillance

4.1 PERFORMANCE STANDARDS

4.1.1 The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR's contribution is their professional relationships with the KO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance.

4.1.2. Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

4.1.3. The Performance Requirements Summary Matrix includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Positive Past Performance