Attachment 1 - Draft PWS.docx

PERFORMANCE WORK STATEMENT (PWS)

Title: Multi-Matrix Sample Analysis Services

Requiring Activity Name: U.S. Army Public Health Center (APHC)

1. INTRODUCTION

The U.S. Army Public Health Center (APHC) is part of the U.S. Army Medical Command (MEDCOM) and focuses on epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance Army readiness and assure the quality and effectiveness of Army’s Public Health Enterprise. Ensuring high-quality services is an imperative of MEDCOM as it strives to become a high-reliability organization (HRO).

2. PURPOSE AND BACKGROUND

The mission of the APHC is to “Enhance Army readiness by identifying and assessing current and emerging health threats; developing and communicating public health solutions; and assuring the quality and effectiveness of the Army’s Public Health Enterprise.” The purpose of this contract is to provide analysis of the concentration of per- and polyfluoroalkyl substances (PFAS) in various matrices collected from toxicological studies. Data from this contract is used to identify potential health hazards in the operational environment and occupational exposures.

3. SCOPE

The scope of this Contract includes (1) shipment, receipt, handling, and processing, (2) homogenization of tissue and body samples, (3) determining the concentration of 40 PFAS analytes in various matrices via Environmental Protection Agency (EPA) Draft Method 1633, and (4) providing data, final reports, and any samples not completely consumed during analysis to APHC within 45 business days from the completion of sample analysis.

4. PERIOD OF PERFORMANCE

The periods of performance for this contract are as follows:

5. WORK SCHEDULE AND LOCATION

5.1. Work Location

The work locations for this requirement will be performed at the Contractor’s facility. There is no onsite support for this requirement.

PERFORMANCE REQUIREMENTS

5.2. Objectives

Objective 1 – Provide appropriate containers, shipment, receipt, handling, and storage of samples when the samples arrive at the contractor facility.

Objective 2 – Determine the concentration of 40 PFAS analytes in various matrices via EPA Draft Method 1633. Homogenize tissue and whole body samples prior to analysis. Contractor shall analyze 830 samples during the base year and 499 samples during Option Year 1.

Objective 3 – Provide data, final report, and any samples not completely consumed during analysis, to APHC within 45 business days from the completion of sample analysis.

5.3. Specific Tasks / Requirements

Objective 1:

Key Task 1 – The Contractor shall provide sample containers and shipment containers (i.e., coolers) that meet the contractor’s laboratory’s standards (size, shape, material, cleanliness, etc.). (Deliverable 1)

U.S. Army Public Health Center (APHC)

Key Task 2 – The Contractor shall provide paid priority shipping labels and instructions for the Government to ship coolers to the Contract laboratory. (Deliverable 2)

Key Task 3 – The Contractor shall immediately process samples or store them in accordance with parameters set forth in EPA Draft Method 1633 for processing later. Notify APHC upon receipt of samples via email no later than 48 hours after receiving shipment. (Deliverable 3)

Objective 2:

Key Task 1 – The Contractor shall homogenize whole body and tissue samples.

Key Task 2 – The Contractor shall determine the concentration of PFAS analytes in various matrices via EPA Draft Method 1633. Email notification of preliminary data quality to APHC study director no later than 14 days after sample analysis. (Deliverable 4)

Objective 3:

Key Task 1 – The Contractor shall send a final report to the COR within 45 business days after APHC study director concurrence with the report. (Deliverable 5).

Key Task 2 – The Contractor shall return any samples not completely consumed during analysis to APHC via paid express air shipping (Deliverable 6) within 45 business days from the completion of sample analysis.

U.S. Army Public Health Center (APHC)

6. DELIVERABLES

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

DELIVERABLES TABLE

6.1. Reports and Documents

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

6.2. Inspection and Acceptance

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

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

6.3. COR Information

TBD

8. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

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

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

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

8. CONTRACT MANAGEMENT

8.1. Government Management

The COR for this contract will be appointed by the Contracting Officer (KO). The COR will serve as the primary point of contact for all activities and issues that occur under this contract. Only the KO has the authority to enact changes to this award.

8.2. Subcontract management

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

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

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

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

9. COMPLIANCE DOCUMENTS

9.1. General Compliance

9.1.1. Federal Law

The services provided under this contract must be conducted in accordance with all Federal law, Department of Defense (DOD), Department of the Army (DA) and Medical Command (MEDCOM) laws and command laws, regulations, policies, and procedures that govern the conduct of regulated research.

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

9.1.2. Occupational Safety and Health Administration

The contractor shall comply with Occupational Safety and health Administration Standard Number 1904.32. The contractor shall deliver the 300A by February 1 of each year (Deliverable XX).

9.1.3. DoD Compliance Documents

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

A complete list of Department of Defense compliance documents providing specifications, standards, or guidelines can be found at http://www.dtic.mil/whs/directives/corres/dir.html

a) Army Regulation 340-21, Army Privacy Program. http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

b) Army Regulation 25-2, Information Assurance.

c) Title 21, CFR Part 11 Electronic Records: Electronic Signature. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11

9.2. Medical and Laboratory Compliance

9.2.1. Army Regulation 340-21, Army Privacy Program

Compliance information regarding Army Privacy program may be found at: http://www.army.mil/usapa/epubs/340_Series_Collection_1.html

10. OTHER TERMS, CONDITIONS, AND PROVISIONS

10.1. Non-Personal Services

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

10.2. Severable / Non-Severable Services

This award identifies services that are severable in nature.

10.3. Inherently Governmental Functions

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

10.4. Organizational Conflict of Interest

U.S. Army Public Health Center (APHC) 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 APHC 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.

10.4.1 OCI Certification. APHC 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 APHC 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.

10.5. Invoices

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

10.6. Dissemination of Information/Publishing

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

10.7. Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing any type of written correspondence, or working in situations where their actions could be construed as official Government acts. Contractors may not use or allude to former or current military rank during the performance of this work.

10.8. Attendance at Meetings

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

10.9. Data Rights

All data received, processed, evaluated, loaded, and created as a result of this contract shall remain the sole property of the Government and shall be returned to the Government at the conclusion of the contract, unless the KO grants a specific exception.

11. ATTACHMENTS

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

ATTACHMENT 1 – ACRONYMS LIST

ATTACHMENT 2: ORGANIZATIONAL CONFLICT OF INTEREST

The APHC has categorized all service procurements into one of the following three categories as defined below, for the purpose of identifying, avoiding or mitigating against Organizational Conflicts of Interests (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 APHC 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.

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

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

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

Each APHC non-purchased care solicitation will therefore be designated as falling within one of the three above defined categories. The work called for under this contract / order has been determined by APHC to fall within the following non-purchased care OCI category:

Category 2: Program Management Support

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

An Offeror that has never provided support to APHC in any of the categories is eligible for award in any category without any further action required under this clause.

An Offeror that provides or has provided support to APHC in only one category of work and has never supported APHC in any other category (a single-category Contractor) is eligible for award for any future requirement in that single category without further action under this clause.

A single-category Offeror/Contractor wishing to submit an offer in a different category, or any Offeror/Contractor which now provides or previously has provided support in more than one category, must include the following as part of its offer:

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

• If the Offeror/Contractor believes that a real or apparent OCI may exist as a result of an award, the Contractor shall also submit an OCI Avoidance or Mitigation Plan with its proposal.

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

The Contracting Officer (and when applicable the appropriate program office, acquisition manager, and legal counsel) will review the comparative analysis and, if provided, the Avoidance or Mitigation Plan, in accordance with the requirements of FAR Subpart 9.5 (Organizational Conflict of Interest) to determine whether award to that Offeror would be consistent with those requirements. If it is unilaterally determined by the Contracting Officer that no OCI would arise or that the OCI Avoidance or Mitigation Plan adequately protects the interests of the government in the event of award to that Offeror, the Offeror will be determined, for purposes of this clause, to be eligible for award. If the Contracting Officer reasonably determines that a Contractor has not provided either a comparative analysis or avoidance/mitigation plan, or both, or that the analyses or plan provided is inadequate, sanctions including elimination from the award process, or termination of the related contract effort already awarded, as well as other appropriate sanctions will be considered.

If the Offeror/Contractor knows of no OCI in accepting work under this contract, it shall certify its OCI status and submit the certification at the end of this clause with its proposal and any later award, if awarded the contract. The Contractor shall also obtain a similar certification of OCI status from all subcontractors, teaming partners or consultants prior to tasking any such party under this contract. The Contractor shall appropriately modify and include this clause, including this paragraph, in all consulting agreements and subcontracts of any tier to preserve the rights of the Government.

For breach of any of the above restrictions or for nondisclosure or misrepresentation of any relevant facts required to be disclosed concerning this contract, the Government may terminate this contract, disqualify the Contractor from subsequent related contractual efforts, and pursue any remedies as may be permitted by law or this contract.

Prior to a contract modification involving a change to the Statement of Work, or an increase in the level of effort or extension of the term of the contract, the Contractor shall submit any applicable organizational conflict of interest disclosure or an update of the previously submitted disclosure or representation.

The Offeror/Contractor should review the considerations below in determining whether or not a conflict of interest exists.

• Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have Unequal Access to Information? Would award to the Offeror result in the Offeror having the opportunity to access nonpublic information that may give the Offeror a competitive advantage in a later competition for a government contract? Specifically, will the Offeror/Contractor have access to any of the following information:

• Does the Offeror or any intended subcontractors, teaming partners, proposed employees, or affiliates have “impaired objectivity” because the Offeror’s ability to render impartial judgments may be compromised because of its conflicting role(s) on this effort and other government contracts?

• Do “biased ground rules” exist? Most commonly, this would include a situation where the Offeror has, as a government Contractor, written specifications or a statement of work for this effort, which could skew competition in favor of itself?

• Is the Offeror aware of any other information relating to this proposed contract/order, which could reasonably be construed as creating an OCI?

The Offeror/Contractor hereby certifies to the best of its knowledge its OCI status below:

(Offeror: Choose one of the following two statements. Indicate which one applies by placing an X in the box to the left of the statement.)

No real or perceived OCI, as defined in FAR 2.1 and discussed in FAR 9.5, will result from an award of the proposed work (there are no ‘Yes’ responses to the questions above).

A real or apparent OCI may exist as a result of an award and therefore an appropriate OCI Avoidance or Mitigation Plan is attached (Offeror shall include an appropriate OCI Avoidance or Mitigation Plan, as required by this clause, with its quote to the Contracting Officer).

Upon award the Contractor agrees that it will provide timely OCI training to all employees and subcontractor employees working on this effort, which will include emphasis on how work performed by Contractor employees (either prime Contractor, subcontractor, or other teaming partners) under one APHC OCI category can exclude the Contractor as well as its teaming partners from performing related tasks under a different OCI category of work.

____________________________ (Signature) ____________________ (Date)

____________________________ (Printed Name) ____________________ (Title)