B08- Solicitation 20-R-0099 OVA TOXIN.pdf

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41 - 52 H 53 - 57 ryan.r.jorgensen.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 57

(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 2 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)

JORGENSEN, RYAN (301) 619-2359

11. TABLE OF CONTENTS

SOLICITATION/ CONTRACT FORM

SUPPLIES OR SERVICES AND PRICES/ COSTS

2 - 7

X I CONTRACT CLAUSES

DESCRIPTION/ SPECS./ WORK STATEMENT

PACKAGING AND MARKING

8 - 12 J LIST OF ATTACHMENTS

INSPECTION AND ACCEPTANCE

DELIVERIES OR PERFORMANCE

14 - 17

X K

REPRESENTATIONS, CERTIFICATIONS AND

OTHER STATEMENTS OF OFFERORS

CONTRACT ADMINISTRATION DATA 18 - 21 X

SPECIAL CONTRACT REQUIREMENTS

OFFER (Must be fully completed by offeror) 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 - REPRESENTATIONS AND INSTRUCTIONS

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

22 - 39

PART II - CONTRACT 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

03 Aug 2020

4. TYPE OF SOLICITATION

SEALED BID (IFB)

NEGOTIATED (RFP)

[ X ]

3. SOLICITATION NO.

W81XWH20R0099

Section B - Supplies or Services and Prices

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 4 Job Purification of Ovatoxin

FFP

Purification of Ovatoxin work as described in Performance Work Statement FOB: Destination

PSC CD: AJ11

NET AMT

0002 4 Job Other Direct Costs

FFP

Othere Direct Costs for Speciality Reagents, supplies, and equipment.

0003 1 Job Contractor Manpower Reporting

FFP

Contractor Manpower Reporting (CMR) - The Contractor, in accordance with USAMRAA Local Instruction, Contractor Manpower Reporting, shall report ALL Contractor manpower (including subcontractor manpower) required for performance of the contract. The reporting period shall be the period of performance not-to-exceed 12 months ending 30 September of each Government fiscal year and shall be reported by 31 October of each calendar year.

Reportingshall be at the task order level.Contractor shall provide the estimated total price (if any) incurred to comply with the annual CMR requirement.

USAMRIID

DoDAAC: W23MYC CMR Reporting Certification: The Contractor shall provide evidence of compliance with the CMR requirement no later than 15 November of each year tothe Contracting Officer's Representative (COR) and the Contract Speciali

1001 4 Job OPTION Purification of Ovatoxin

FFP

Purification of Ovatoxin work as described in Performance Work Statement

1002 4 Job OPTION Other Direct Costs

FFP

Othere Direct Costs for Speciality Reagents, supplies, and equipment.

1003 1 Job OPTION Contractor Manpower Reporting

FFP

Contractor Manpower Reporting (CMR) - The Contractor, in accordance with USAMRAA Local Instruction, Contractor Manpower Reporting, shall report ALL Contractor manpower (including subcontractor manpower) required for performance of the contract. The reporting period shall be the period of performance not-to-exceed 12 months ending 30 September of each Government fiscal year and shall be reported by 31 October of each calendar year.

Reportingshall be at the task order level.Contractor shall provide the estimated total price (if any) incurred to comply with the annual CMR requirement.

USAMRIID

DoDAAC: W23MYC CMR Reporting Certification: The Contractor shall provide evidence of compliance with the CMR requirement no later than 15 November of each year tothe Contracting Officer's Representative (COR) and the Contract Speciali

2001 4 Job OPTION Purification of Ovatoxin

FFP

Purification of Ovatoxin work as described in Performance Work Statement

2002 4 Job OPTION Other Direct Costs

FFP

Othere Direct Costs for Speciality Reagents, supplies, and equipment.

2003 1 Job OPTION Contractor Man Power Reporting

FFP

Contractor Manpower Reporting (CMR) - The Contractor, in accordance with USAMRAA Local Instruction, Contractor Manpower Reporting, shall report ALL Contractor manpower (including subcontractor manpower) required for performance of the contract. The reporting period shall be the period of performance not-to-exceed 12 months ending 30 September of each Government fiscal year and shall be reported by 31 October of each calendar year.

Reportingshall be at the task order level.Contractor shall provide the estimated total price (if any) incurred to comply with the annual CMR requirement.

USAMRIID

DoDAAC: W23MYC CMR Reporting Certification: The Contractor shall provide evidence of compliance with the CMR requirement no later than 15 November of each year tothe Contracting Officer's Representative (COR) and the Contract Speciali

3001 4 Job OPTION Purification of Ovatoxin

FFP

Purification of Ovatoxin work as described in Performance Work Statement

3002 4 Job OPTION Other Direct Costs

FFP

Othere Direct Costs for Speciality Reagents, supplies, and equipment.

3003 1 Job OPTION Contractor Man Power Reporting

FFP

Contractor Manpower Reporting (CMR) - The Contractor, in accordance with USAMRAA Local Instruction, Contractor Manpower Reporting, shall report ALL Contractor manpower (including subcontractor manpower) required for performance of the contract. The reporting period shall be the period of performance not-to-exceed 12 months ending 30 September of each Government fiscal year and shall be reported by 31 October of each calendar year.

Reportingshall be at the task order level.Contractor shall provide the estimated total price (if any) incurred to comply with the annual CMR requirement.

USAMRIID

DoDAAC: W23MYC CMR Reporting Certification: The Contractor shall provide evidence of compliance with the CMR requirement no later than 15 November of each year tothe Contracting Officer's Representative (COR) and the Contract Speciali

Section C - Descriptions and Specifications

PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT (PWS)

Isolation and Purification of Ovatoxin-a from O. Ovata Cell Pelle United States Army Medical Research Institute of Infectious Diseases (USAMRIID)

SECTION 1 PURPOSE

1.1. Introduction

The United States Army Medical Research Institute of Infectious Diseases (USARMIID) is located in Fort Detrick, MD. Since 1969, USAMRIID has served as the Department of Defense’s (DoD) lead laboratory for medical biological defense research. 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 Development Command (MRDC). The Diagnostic Systems Division within USAMRIID is responsible for developing an animal model of palytoxin (PLTX) aerosol toxicology for testing of potential medical countermeasures. This effort requires the development of good diagnostic methods to support aerosol toxin exposure. As with all good diagnostics, information on how the methods perform on toxins with similar structure is critical.

1.2. Mission

Provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

1.3. Background

USAMRIID is requesting a service contract to isolate and purify ovatoxin-a from O. ovata cell pellets provided by USAMRIID. This would allow USAMRIID to acquire sufficient purified toxins to support comparative aerosol toxicology studies and diagnostic method development.

1.4. Scope

1.4.1. The Contractor shall optimize and further develop their existing protocol for isolation of ovatoxins

1.4.2. The Contractor shall isolate and purify ovatoxin-a from O. ovata cell pellets provided by the USAMRIID.

1.4.3. Once complete, the contractor shall coordinate transfer of viable samples to the USAMRIID.

1.4.3.1 The Contractor shall ship/manage, store, and coordinate the shipment of investigational product(s) and study-related records in accordance with applicable regulation and laws, both foreign and domestic.

1.4.3.2 Ensure cold chain management and accountability of all investigational products used in relation to the study.

1.4.3.3 Purchase suitable shipping materials in adequate quantities to ensure successful product/record shipment.

1.4.3.3 Create and/or validate, or oversee the validation of, shipping procedures and methods.

1.4.3.4 Arrange for and/or provide a Broker(s) for international shipments (import and export), as necessary.

1.4.3.5 The Contractor shall provide the government a purification protocol/report supporting the service provided in this contract.

1.5. Organizational Conflict of Interest

1.5.1 Organizational Conflict of Interest (OCI) This contract will be used to procure U.S. Army Medical Research and Material Command products/services that falls within the scope of the PWS. The contractor shall provide an OCI certification with their proposal. If there is an OCI, the contractor shall provide a draft OCI Mitigation Plan with their proposal.

1.5.2. The United States Army Medical Research and Development Command (USAMRDC) has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating Organizational Conflicts of Interest (OCI) in accordance with (IAW) Federal Acquisition Regulation (FAR) Subpart 9.5. These categories are defined as follows:

Category 1: Command Wide Internal Support: Services which, by their very nature, give the Contractor access to non-public procurement sensitive data about the contract requirements, other contractors’ proprietary information, or put the contractor in a position to influence the award decision on a contract in which they are participating. Services would be characterized as having access to Command Wide procurement sensitive information, or work that could likely have an influence over follow-on awards or contracts with subordinate directorates/Commands.

Category 2: Program Management Support: Services which assist USAMRMC in planning and managing an organization’s activities and programs. These include, for example: requirements analysis, acquisition support, budget planning and management, business process reengineering, program planning and execution support, and independent technical management support. Services would be characterized as having access to only Directorate or Subordinate Command level procurement sensitive information or work that would have little influence on follow-on requirements or requirements of other directorates/Subordinate Commands.

Category 3: Product Support. Services or end items required to meet the mission requirements of the organization’s activities and programs. These include, for example: concept exploration and development, system design, system development and integration, COTS procurement and integration, internal development testing, deployment, installation, operations, and maintenance. Services can be characterized as having little or no access to procurement sensitive information other than the immediate requirement and little chances of follow-on work that can be influenced by the immediate requirement.

OCI Certification. USAMRDC OCI Category 3 is applicable for this acquisition. The Contractor shall perform a thorough comparative analysis of the potential new work against all current and previous works performed in support of the USAMRIID organization and ascertain whether they have a possible conflict of interest. If there is a conflict of interest or the appearance of a conflict of interest, the Contractor shall provide a comprehensive OCI Mitigation Plan. The Contractor shall complete the OCI Certification at time of proposal submission (Deliverable 6, Exhibit 1).

1.6 Non-Disclosure Statement (NDS) (Deliverable 7, Exhibit 2). 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 personnel may be required to sign specific non-disclosure statements as required by the contract. 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. Contractor’s Place of Performance

2.1.2. Period of Performance. This contract is for one (1) twelve (12) months Base Period and three (3) twelve (12) months Option Periods.

2.2. Non-Personal Services

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

2.3. Contract Management

2.3.1. Government Management. The Contracting Officer’s Representative (COR) and Alternate Contracting Officer’s Representative (ACOR) 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, the ACOR 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 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.

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. The contractor shall provide a draft Quality Control Plan (QCP) (Deliverable 4) with their proposal and a final QCP no later than 15 days after contract award. The contractor shall prepare and adhere to a QCP describing how the contractor intends to manage the contract to achieve the established standards set forth in the Performance Standards Summary Matrix and the contractor’s QCP.

2.3.3. Subcontract Management – N/A

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. Quarterly Report (Deliverable 1). The contractor shall provide a quarterly report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support. The report shall include a detailed list of all hours worked and workload accomplished, to include but not limited to, a list of equipment serviced and writing assignments in support of isolating and purifying samples according to the protocols developed and optimized. This report shall be submitted by the 15th of the month of each quarter.

2.4.3 Final Report (Deliverable 3) The contractor shall provide a final annual report detailing all work, including the subcontractor’s work, and where there is critical or significant data related to the provided support (protocol used).

The report shall include a detailed list of all hours worked and workload accomplished, to include but not limited to, a list of equipment serviced and writing assignments in support of isolating and purifying samples according to the protocols developed and optimized. This report shall be submitted by the 15 of the month of the final month within the Period of Performance.

2.4.4. Contract Manpower Reporting (Deliverable 4). This is a mandatory requirement IAW Army Federal Acquisition Regulation Supplement (AFARS) 5137.91, Accounting for Contract Services.

The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the (Name Component) via a secure data collection site.

The contractor is required to completely fill in all required data fields using the following web address:

http://www.ecmra.mil.

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

http://www.ecmra.mil/.

2.5. Training Requirements – N/A

2.6. Contractor Personnel, Disciplines, and Specialties – N/A

2.7. Travel/Temporary Duty (TDY) – N/A

SECTION 3 PERFORMANCE REQUIREMENTS

3.1 The contractor shall provide Support Services for Isolation and Purification of Ovatoxin-a from O. Ovata Cell Pellets. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1.1 The Contractor shall will develop and optimize a protocol for isolating and purifying Ovatoxin a from O.

Ovata Cell Pellets. Quarterly progress reports shall be submitted by Contractor while the protocol is being developed. (Deliverable 1)

3.1.2 The Contractor shall isolate and purify ovatoxin-a from O. ovata cell pellets provided by the USAMRIID according to protocols they have developed and optimized. Once complete, the contractor shall coordinate transfer of viable samples to the USAMRIID. (Deliverable 2)

3.1.3.1 The Contractor shall ship/manage, store, and coordinate the shipment of investigational product(s) and study-related records in accordance with applicable regulation and laws, both foreign and domestic.

3.1.3.2 Ensure cold chain management and accountability of all investigational products used in relation to the study.

3.1.3.3 Purchase suitable shipping materials in adequate quantities to ensure successful product/record shipment.

3.1.3.4 Create and/or validate, or oversee the validation of, shipping procedures and methods. Arrange for and/or provide a Broker(s) for international shipments (import and export), as necessary.

3.1.3 The Contractor shall provide the government an annual Purification Summary report that shall document progress made supporting the service provided in this contract. (Deliverable 3)

3.2. Performance Requirement Summary Matrix

Performance Objective PWS Performance Standard Acceptable Quality Level (AQL) Surveillance Method Develop and Optimize Purification Protocol 3.1.1; 2.4.2 Progress reports shall be submitted on a Quarterly Basis during the Base Year of the Contract. Protocol may not be finalized in Base Year and may extend to Option Year. AQL: Quarterly progress reports shall be submitted by the 15th of the month for each quarter based on Contract Award Date Observation and 100% Inspection by the COR and TPOC.

Isolation and Purification of Toxins 3.1.2 Samples shall be shipped to USAMRIID once protocol is finalized.

(Likely will not occur until the Option Periods). Frequency of shipments shall be determined by COR/TPOC.

Toxin profiles and quantity will be monitored by LC-MS. At the end of the purification procedure, toxin purity and the presence of contaminants will be assessed by FIA-HRMS and LC-HRMS. If less than 90% pure, an additional analytical HPLC step will be performed. Shipped samples will be labelled with amount and purity, and accompanied by analytical documentation. 100% Inspection of analytical documentation Annual Purification Summary Report 3.1.3 Provided by the 15th of the final month of the Period of Performance Protocol used and progress to date. 100% documentation

Types of Surveillance Methods of Surveillance Customer Complaints Management Information Systems Random Sampling Observation of Trask Attributes 100% Inspection Observation of Performance Periodic Surveillance

3.3. Quality Assurance Surveillance Plan. 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. (Deliverable 5)

SECTION 4 SPECIAL REQUIREMENT

4.1. Government Furnished Property

4.1.1 Data Rights. The Government has unlimited rights to all documents/material produced under this contract.

All documents and materials, to include the source codes of any software, produced under this contract shall be Government owned and are the property of the Government with all rights and privileges of ownership/copyright belonging exclusively to the Government. These documents and materials may not be used or sold by the contractor without written permission from the Contracting Officer. All materials supplied to the Government shall be the sole property of the Government and may not be used for any other purpose. This right does not abrogate any other Government rights.

4.2. Contractor Furnished Property – N/A

4.3. Security and Safety – N/A

4. 4. Security Requirements – N/A

4.6. Visitor Group Security Agreement – N/A

4.7. Other Direct Costs – N/A

SECTION 5 DELIVERABLES

5.1. Deliverables. The contractor shall provide the following deliverable as listed.

Item PWS Ref Title Distribute to COR 1 3.1.1 Protocol Quarterly Progress Reports due on the 15 of each month of each quarter – based on Contract Award date. Protocol may or may not be finalized in Base Year.

2 3.1.2 Viable Toxin Samples Once protocol has been finalized and purity has been defined, frequency of sample shipment will be determined by COR/TPOC.

3 3.1.3 Final Annual Report 15 of Final Month of Contract

4 2.4.4 Contractor Manpower Reporting October 31 of each calendar year 5 3.3 Quality Assurance Plan With Proposal Submission 6 1.5.2 OCI With Proposal Submission 7 1.6 NDA With Proposal Submission

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Environmental Requirements – N/A

6.2. Applicable Directives – N/A

6.3. Mandatory Compliance – N/A

SECTION 7 DEFINITIONS AND ACRONYMS

7.1. Definitions

7.1.1. 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.

7.1.2. CONTRACTING OFFICER. 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.

7.1.3. 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.

7.1.4. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

7.1.6. 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.

7.1.7. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

7.1.8. QUALITY ASSURANCE. The government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

7.1.9. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance.

7.1.10. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

7.1.11. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

7.1.12. WORK DAY. The number of hours per day the contractor provides services IAW the contract.

7.1.13. WORK WEEK. Monday through Friday, unless specified otherwise.

7.2. Acronyms – N/A

Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS

Supplies/services will be inspected/accepted at:

CLIN INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

0001 Destination Government Destination Government 0002 Destination Government Destination Government 0003 Destination Government Destination Government 1001 Destination Government Destination Government 1002 Destination Government Destination Government 1003 Destination Government Destination Government 2001 Destination Government Destination Government 2002 Destination Government Destination Government 2003 Destination Government Destination Government 3001 Destination Government Destination Government 3002 Destination Government Destination Government 3003 Destination Government Destination Government

CLAUSES INCORPORATED BY REFERENCE

52.246-4 Inspection Of Services--Fixed Price AUG 1996

Section F - Deliveries or Performance

QASP

QUALITY ASSURANCE SURVEILLANCE PLAN

Translation/Interpretation Services for Training for Medical Personnel Contract Number: TBD Contract Description: To conduct literature searches and provide a report on the potential long-term health effects of exposure of human volunteers to chemical & biological agents specified in the Performance Work Statement

(PWS).

1. PURPOSE.

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

What will be monitored?

How monitoring will take place.

Who will conduct the monitoring?

How monitoring efforts and results will be documented.

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

The following FAR clauses may apply depending on contract type:

52.246-4 Inspection of Services – Fixed-Price, 52.246-5 Inspection of Services – Cost-Reimbursement, or

2. GOVERNMENT ROLES AND RESPONSIBILITIES.

The following personnel shall oversee and coordinate surveillance activities.

a. 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 assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO:

Organization or Agency: USAMRAA Telephone: 301-619-XXXX Email:

b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Assigned COR:.

Organization or Agency: USAMRIID Telephone:

Email: l

3. CONTRACTOR REPRESENTATIVES:

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract.

a. Program Manager - Organization:

Telephone:

Email:

b. Task Manager – Organization:

Telephone:

Email:

4. PERFORMANCE STANDARDS.

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

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

PWS Reference Deliverable Indicator Standard Acceptable Quality Level Method of Surveillance PRS # 1 A list of samples (Isolated and Purified ovatoxin-a from O. ovata cell pellets) and a brief report on sample condition upon arrival will be sent to USAMRIID> 90% in purity invitro assay confirmed> 90% in purity invitro assay confirmed Validated invitro Assay with confirmation of results PRS # 2 Purification protocol and report Purification protocol and report PRS # 3 Extraction of cell pellets Sample aliquots will be extracted with MeOH/water (1:1) and individual extracts combined to obtain a single homogenous extract. LC-HRMS will be performed to identify toxin profile and content. The extract will then be divided into aliquots and concentrated under nitrogen flow prior to lyophilization.

Deviation with COR concurrence Quantification of toxin content in the initial and concentrated extracts will be performed using the commercially-available Waco PLTX as the standard.

PRS # 4 Toxin Purification Purification will progress through a 3-step process involving Combiflash chromatography, and semi-preparative and analytical HPLC chromatography steps. At each step, fractions will be analyzed and all ovatoxin a-containing fractions combined and separated from fractions containing other ovatoxins.

Toxin profiles and quantity will be monitored by LC-MS. At the end of the third step, toxin purity and the presence of degradation products will be assessed FIA-HRMS and LC-HRMS. If the purity at this point does not measure at least 90%, a final concentration and analytical HPLC step will be performed.Validated invitro Assay with confirmation of results

5. INCENTIVES.

This contract is Firm-Fixed Price (FFP). No incentives are provided under this contract.

6. METHODS OF QA SURVEILLANCE.

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause in the Contract becomes the basis for the KO’s actions.

7. RATINGS.

Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:

EXCEPTIONAL: Performance significantly exceeds contract requirements to the Government’s benefit.

SATISFACTORY: Performance meets contractual requirements.

UNSATISFACTORY: Performance does not meet contractual requirements.

8. DOCUMENTING PERFORMANCE.

a. ACCEPTABLE PERFORMANCE.

The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

b. UNACCEPTABLE PERFORMANCE.

When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

9. FREQUENCY OF MEASUREMENT.

a. Frequency of Measurement.

During contract/order performance, the COR shall take periodic measurements, as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

b. Frequency of Performance Assessment Meetings.

The COR shall meet with the contractor, as needed, to assess performance and shall provide a written assessment.

DELIVERY INFORMATION

CLIN DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

0001 POP 30-SEP-2020 TO

29-SEP-2021

N/A USA MED RESEARCH INST OF INFEC

DISEASES

COMMANDER, USAMRIID

1425 PORTER ST

FORT DETRICK, MD MD 21702-5011

W23MYC

0002 POP 30-SEP-2020 TO

29-SEP-2021

N/A (SAME AS PREVIOUS LOCATION)

0003 POP 30-SEP-2020 TO

29-SEP-2021

N/A (SAME AS PREVIOUS LOCATION)

1001 POP 30-SEP-2021 TO

29-SEP-2022

N/A (SAME AS PREVIOUS LOCATION)

1002 POP 30-SEP-2021 TO

N/A (SAME AS PREVIOUS LOCATION)

1003 POP 30-SEP-2021 TO

N/A (SAME AS PREVIOUS LOCATION)

2001 POP 30-SEP-2022 TO

29-SEP-2023

N/A (SAME AS PREVIOUS LOCATION)

2002 POP 30-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

2003 POP 30-SEP-2022 TO

N/A (SAME AS PREVIOUS LOCATION)

3001 POP 30-SEP-2023 TO

29-SEP-2024

N/A (SAME AS PREVIOUS LOCATION)

3002 POP 30-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

3003 POP 30-SEP-2023 TO

N/A (SAME AS PREVIOUS LOCATION)

Section G - Contract Administration Data

252.232-7007 Limitation Of Government's Obligation APR 2014

CLAUSES INCORPORATED BY FULL TEXT

252.232-7003 Electronic Submission of Payment Requests and Receiving Reports.

As prescribed in 232.7004(a), use the following clause:

ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

AND RECEIVING REPORTS (DEVIATION 2016-AOOOl) (NOV 2015)

(a) Definitions. As used in this clause-

(1) "Electronic form" means any automated system that transmits information electronically from the initiating system to all affected systems. Facsimile, e-mail, and scanned documents are not acceptable electronic forms for submission of payment requests. However, scanned documents are acceptable when they are part of a submission of a payment request made using Wide Area WorkFlow (WAWF) or another electronic form authorized by the Contracting Officer.

(2) "Invoice payment" has the meaning given in section 32.001 of the Federal Acquisition Regulation.

(3) "Payment request" means any request for invoice payment submitted by the Contractor under this contract.

(4) "Receiving report" means the data required by the clause at 252.246- 7000, Material Inspection and Receiving Report.

(b) Except as provided in paragraph (c) of this clause the Contractor shall submit payment requests and receiving reports using WAWF, in one of the following electronic formats that WAWF accepts: Electronic Data Interchange, Secure File Transfer Protocol, or World Wide Web input.

Information regarding WAWF is available on the Internet at https://wawf.eb.mil/.

(c) The Contractor may submit a payment request and receiving report using other than WAWF only when-

(1) The Contracting Officer administering the contract for payment has determined, in writing, that electronic submission would be unduly burdensome to the Contractor. In such cases, the Contractor shall include a copy of the Contracting Officer's determination with each request for payment;

(2) DoD makes payment for commercial transportation services provided under a Government rate tender or a contract for transportation services using a DoD-approved electronic third party payment system or other exempted vendor payment/invoicing system (e.g., PowerTrack, Transportation Financial Management System, and Cargo and Billing System);

(3) DoD makes payment for rendered health care services using the TRICARE

Encounter Data System (TEDS) as the electronic format;

(4) The Governmentwide commercial purchase card is used as the method of payment, only submission of the receiving report in electronic form is required; or

(5) Submitting payment requests and receiving reports to the Supplier Self Services (SUS) system accessible via the Wide Area WorkFlow (WAWF) website as an authorized participant in the vendor portal invoicing pilot program.

(d) The Contractor shall submit any non-electronic payment requests using the method or methods specified in Section G of the contract.

(e) In addition to the requirements of this clause, the Contractor shall meet the. requirements of the appropriate payment clauses in this contract when submitting payment requests.

(End of clause)

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)

(a) Definitions. As used in this clause—

“Department of Defense Activity Address Code (DoDAAC)” is a six position code that uniquely identifies a unit, activity, or organization.

“Document type” means the type of payment request or receiving report available for creation in Wide Area WorkFlow (WAWF).

“Local processing office (LPO)” is the office responsible for payment certification when payment certification is done external to the entitlement system.

“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission of Payment Requests and Receiving Reports.

(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.232- 7003, Electronic Submission of Payment Requests and Receiving Reports.

(c) WAWF access. To access WAWF, the Contractor shall—

(1) Have a designated electronic business point of contact in the System for Award Management at https://www.sam.gov; and

(2) Be registered to use WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self-registration available at this web site.

(d) WAWF training. The Contractor should follow the training instructions of the WAWF Web-Based Training Course and use the Practice Training Site before submitting payment requests through WAWF. Both can be accessed by selecting the “Web Based Training” link on the WAWF home page at https://wawf.eb.mil/.

(e) WAWF methods of document submission. Document submissions may be via web entry, Electronic Data Interchange, or File Transfer Protocol.

(f) WAWF payment instructions. The Contractor shall use the following information when submitting payment requests and receiving reports in WAWF for this contract or task or delivery order:

(1) Document type. The Contractor shall submit payment requests using the following document type(s):

(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.

(ii) For fixed price line items—

(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting Officer.

(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that require shipment of a deliverable.)

(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets the requirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by the Contracting Officer.

(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for fixed price line items for services.)

(iii) For customary progress payments based on costs incurred, submit a progress payment request.

(iv) For performance based payments, submit a performance based payment request.

(v) For commercial item financing, submit a commercial item financing request.

(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in the contract.

[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice and receiving report in one step.]

(3) Document routing. The Contractor shall use the information in the Routing Data Table below only to fill in applicable fields in WAWF when creating payment requests and receiving reports in the system.

Routing Data Table*

Field Name in WAWF Data to be entered in WAWF

Pay Official DoDAAC ____

Issue By DoDAAC ____

Admin DoDAAC** ____

Inspect By DoDAAC ____

Ship To Code ____

Ship From Code ____

Mark For Code ____

Service Approver (DoDAAC) ____

Service Acceptor (DoDAAC) ____

Accept at Other DoDAAC ____

LPO DoDAAC ____

DCAA Auditor DoDAAC ____

Other DoDAAC(s) ____

(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert “See Schedule” or “Not applicable.”)

(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)

(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the type of payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition Regulation 52.216-7, Allowable Cost and Payment, as applicable.

(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.

(g) WAWF point of contact.

(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s WAWF point of contact.

(Contracting Officer: Insert applicable information or “Not applicable.”)

(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.

Section I - Contract Clauses

52.202-1 Definitions JUN 2020 52.203-3 Gratuities APR 1984 52.203-6 Alt I Restrictions On Subcontractor Sales To The Government

(JUN 2020) -- Alternate I

OCT 1995

52.203-7 Anti-Kickback Procedures JUN 2020 52.203-8 Cancellation, Rescission, and Recovery of Funds for Illegal or

Improper Activity

MAY 2014

52.203-10 Price Or Fee Adjustment For Illegal Or Improper Activity MAY 2014 52.203-11 Certification And Disclosure Regarding Payments To

Influence Certain Federal Transactions

SEP 2007

52.203-12 Limitation On Payments To Influence Certain Federal Transactions

JUN 2020

52.203-16 Preventing Personal Conflicts of Interest JUN 2020 52.203-17 Contractor Employee Whistleblower Rights and Requirement

To Inform Employees of Whistleblower Rights

JUN 2020

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

52.204-3 Taxpayer Identification OCT 1998 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber

Content Paper

MAY 2011

52.204-7 System for Award Management OCT 2018 52.204-10 Reporting Executive Compensation and First-Tier

Subcontract Awards

JUN 2020

52.204-13 System for Award Management Maintenance OCT 2018 52.204-16 Commercial and Government Entity Code Reporting JUL 2016 52.204-17 Ownership or Control of Offeror JUL 2016 52.204-18 Commercial and Government Entity Code Maintenance JUL 2016 52.204-19 Incorporation by Reference of Representations and

Certifications.

DEC 2014

52.204-20 Predecessor of Offeror JUL 2016 52.204-21 Basic Safeguarding of Covered Contractor Information

Systems

JUN 2016

52.204-22 Alternative Line Item Proposal JAN 2017 52.204-24 Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment.

DEC 2019

52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

AUG 2019

52.209-2 Prohibition on Contracting with Inverted Domestic Corporations--Representation

NOV 2015

52.209-5 Certification Regarding Responsibility Matters OCT 2015 52.209-6 Protecting the Government's Interest When Subcontracting

With Contractors Debarred, Suspended, or Proposed for Debarment

JUN 2020

52.209-7 Information Regarding Responsibility Matters OCT 2018 52.209-10 Prohibition on Contracting With Inverted Domestic

Corporations

NOV 2015

52.209-11 Representation by Corporations Regarding Delinquent Tax Liability or a Felony Conviction under any Federal Law

FEB 2016

52.214-14 Place Of Performance--Sealed Bidding APR 1985 52.215-1 Instructions to Offerors--Competitive Acquisition JAN 2017 52.215-6 Place of Performance OCT 1997 52.215-8 Order of Precedence--Uniform Contract Format OCT 1997 52.215-9 Changes or Additions to Make-or-Buy Program OCT 1997 52.217-5 Evaluation Of Options JUL 1990 52.219-8 Utilization of Small Business Concerns…