A02-PERFORMANCE WORK STATEMENT.docx

PERFORMANCE WORK STATEMENT (PWS)

Isolation and Purification of Ovatoxin-a from O. Ovata Cell Pellets

United States Army Medical Research Institute of Infectious Diseases (USAMRIID)

Dr. Mark Poli/Candice Zodrow

16 MAR 2020

SECTION 1 PURPOSE

0. 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.

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

0. 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.

0. Scope

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

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

0. 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.

0. 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.

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

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

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

0. Organizational Conflict of Interest

1.

0.

0. 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).

0. 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

0. Performance

0. Place of Performance

0. Contractor’s Place of Performance

0. 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

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.

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

7.3. Related Docume