B08-Attach 1 Final PWS W81XWH20R0028.pdf

PERFORMANCE WORK STATEMENT (PWS)

Metabolomics Analysis Services

US Army Research Institute of Environmental Medicine (USARIEM)

SECTION 1 PURPOSE

1.1. Introduction USARIEM's mission is to optimize Warfighter health and performance through medical research. USARIEM is internationally recognized as the premiere DoD laboratory for Warfighter health and performance research and focuses on environmental medicine, physiology, physical and cognitive performance, and nutrition research. USARIEM publishes guidance for DoD operations in hot weather, cold weather, and high-altitude environments, and nutrition for health and performance.

1.2. Mission The Military Nutrition Division is one of four research divisions within USARIEM. The mission of the Military Nutrition Division is to conduct research that provides a biomedical science basis for developing new rations, menus, policies and programs that enable Warfighter health-readiness and optimal performance. Its focus areas include: Recovery Nutrition, Healthy Eating, Dietary Supplements, and Physiological Resilience.

1.3. Background Research conducted by the Military Nutrition Division requires measuring multiple different biochemical markers of metabolic, nutritional, and physiologic status and function, known as metabolites, in a variety of biological matrices. The Military Nutrition Division requires metabolomics analysis (i.e., measurement of hundreds-to-thousands of metabolites in single biological samples) services to support these analysis in planned and future research studies.

1.4. Scope The contractor shall provide analytical services of blood (plasma/serum), urine, saliva, fecal, and tissue samples for metabolomics analyses as defined in section

3. Samples will be provided by USARIEM.

1.5. Organizational Conflict of Interest (OCI) NA

1.6. Non-Disclosure Statement (NDS) NA

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance: Contractor facility

2.1.2. Period of Performance: This contract is for one (1) twelve (12) months Base

Period and four (4) twelve (12) months Option Periods.

2.1. Type of Services

2.2.1 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.

2.2.2 Severable / Non-Severable Services: This award identifies services that are severable in nature.

2.2.3 Inherently Governmental Functions: This requirement has been reviewed and contains no services that are inherently governmental functions.

2.2.4 Acquisition Functions Closely Associated with Inherently Governmental Functions: Not applicable for this task.

2.3. Contract Management

The Contracting Officer’s Representative (COR) for this contract will be appointed by the KO. The COR will serve as the primary point of contact for all activities and issues that occur under this contract.

2.4. Reports

Reports and documents delivered by the contractor in the performance of this contract shall not 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.

2.4.2. Monthly Financial Tracking Report: NA

2.4.3. Monthly Report: NA

2.4.4. Contract Manpower Reporting (Deliverable 1). 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 Metabolomics Analysis Services 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 2019. Contractors may direct questions to the help desk at: DoD.ECMRA.Support.Desk@mail.mil. Register under the "All Other Defense Components" module. The US Army Research Institute of Environmental Medicine (USARIEM) Unit Identification Code (UIC) is W03WAA.

2.4.5 Contractor Performance Assessment Reporting System (CPARS). The Contractor CPARS is the DoD mandatory system to electronically capture assessment data and manage the evaluation process. CPARS is used to assesses a Contractor’s performance and provide a record, both positive and negative, on a given contract during a specific period of time. The CPARS process is designed with a series of checks and balances to facilitate the objective and consistent evaluation of Contractor performance. Both Government and Contractor program management perspectives are captured on the CPAR form and together make a complete CPAR. Once the Assessing Official completes the proposed assessment for the period of performance, the CPARS is released to the appropriate Government Contractor Representative for their review and comments. User ID and password will be provided to the designated Government Contractor Representative upon issuance of a task order. The Contractor has 30 days after the Government's evaluation is completed to comment on the evaluation. The Government Contractor Representative must either concur or nonconcur to each CPAR.

If the Contractor concurs with the proposed assessment and the Reviewing Official does not wish to see the CPAR, the Assessing Official may close out the CPAR.

Otherwise, they must forward the CPAR to the Reviewing Official for them to review, enter comments if appropriate, and close out. The Reviewing Official may at their option direct the Assessing Official to forward every CPAR to them for review.

2.5. Training Requirements: NA

2.6. Contractor Personnel, Disciplines, and Specialties

2.6.1. General/Specialized Experience: The contractor shall possess specialized experience necessary to provide untargeted metabolomics measurement in human biological (i.e. serum, urine, saliva, tissue and fecal) samples and associated analysis.

Specialized experience includes: 1) maintenance of an extensive library of >4000 http://www.ecmra.mil/ mailto:DoD.ECMRA.Support.Desk@mail.mil known and >8000 novel metabolites, 2) expertise in utilizing ultra-high performance liquid chromatography/tandem high resolution/accurate mass spectrometry in both positive and negative ion modes, and gas chromatography/mass spectrometry, for analyzing metabolites in human biological samples across >60 metabolite classes, 3) expertise in identifying known and unknown compounds detected in human biological samples, 4) expertise in bioinformatics analysis of metabolomics data, 5) ability to provide user-friendly portals/electronic reports for exploring and visualizing analytical results and access to PhD-level scientists to assist in interpretation of those results, and

6) documented history of peer-reviewed publications utilizing these technologies and expertise. Additionally, the vendor’s laboratory systems shall be governed by a set of Standard Operating Procedures (SOP) that are reviewed and updated. Quality control steps should be in place for the analyses conducted under this solicitation. All laboratory technicians assigned to perform procedures in the laboratory shall be trained on SOPs for specific methods and all instruments should be evaluated for performance prior to sample analysis.

2.7. Travel: No travel is required for this requirement.

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. The contractor shall provide all necessary personnel required to perform services at their designated location. The contractor shall provide metabolomics analysis support services. The following section specifies the objectives for the contract.

3.1.1. General Requirements.

The contractor shall conduct metabolomics analysis, and provide all equipment and consumables necessary for running those analyses on samples received from USARIEM in support of USARIEM research studies. The contractor shall also statistically analyze metabolomics data, and provide results of the analyses in various electronic formats. In addition, the contractor shall assist USARIEM scientists in study design as needed, in understanding the methods and analyses used, and in interpreting and reporting the results. The specific requirements are described below.

3.1.2. Specific Requirements:

3.1.2.1 The contractor shall provide untargeted metabolomics analyses of blood (plasma/serum), urine, saliva, fecal, and tissue samples. Samples will be provided by as individual projects led by individual USARIEM investigators.

3.1.2.2 The contractor shall analyze, summarize, and interpret the generated untargeted metabolomics data for all samples. Data analysis shall include, but not be limited to, a list of biochemicals detected, KEGG/HMBD links, relative quantitation, heat map and statistical results (i.e., detected biochemicals grouped by pathway and super-pathway, fold-change relative to comparator group, and associated statistical analyses, and summary of results). A report describing the results and their biological interpretation, and the methods used to generate results shall also be provided. These reports shall be delivered to the USARIEM investigator leading each individual project, or their designee, within 90 calendar days of sample receipt unless otherwise agreed upon within the individual task order for each project (Deliverable 2).

3.1.2.3 The contractor shall consult on data analysis, interpretation and reporting as needed by the USARIEM investigator leading each individual project, or their designee.

3.2. Performance Requirement 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

# PWS

Ref. Performance Objective Acceptable Quality

Level Performance Measurement Incentive

1 3.1.2.1 Conduct analysis of biological samples with 100% accuracy.

No more than one customer complaint per task order

In accordance with lab standard procedures

Positive

CPARS

2 3.1.2.2 Enter data, manage large databases, identify metabolites, and perform statistical and pathway analysis as required.

No more than one customer complaint per task order

The contractor-provided services shall be timely, accurate, and conform to established scientific professional standards.

Positive

CPARS

3 3.1.2.3 Consult on data analysis, interpretation and reporting

No more than one customer complaint per task order

Consultants are available as need, are expert in the field, and maintain high professional and scientific integrity

Positive

CPARS

SECTION 4 SPECIAL REQUIREMENT

4.1 Government Furnished Equipment/Information/Computer Utilization:

USARIEM will provide rat blood samples to the laboratory for analysis.

4.2 Security: There are no security requirements.

SECTION 5 DELIVERABLES

5.1. Deliverables:

DELIVERABLES TABLE

PWS

Ref. Number Title/Description Due

2.4.4 Deliverable 1 Contractor Manpower Reporting Due no later than 31 October each year of the contract or on the last day of the contract performance, whichever is first

3.1.2.2 Deliverable 2 Untargeted metabolomics analysis reports Due to the USARIEM Investigator no later than 90 calendar days of sample receipt

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1. Environmental Requirements

6.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1 Environmental Protection and Enhancement.

6.1.2. Non Mandatory Documents. Additional DoD and Army environmental program and regulations are available on-line at http://aec.army.mil.

6.2. Applicable Directives. The contractor shall comply with all documents listed above as mandatory and referenced under section 3 Performance Requirements.

6.3. Mandatory Compliance

6.3.1 Dissemination of Information/Publishing

There shall be no dissemination or publication, except within and between the Contractor and any Sub Contractors or specified Integrated Product/Process Team (IPT) members 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. Business Program Management Office (PMO) approval for publication will require provisions that protect the intellectual property and patent rights of both Business PMO and the Contractor.

6.3.2 Contractor Identification

The Contractor shall ensure that Contractor personnel identify themselves as Contractors when attending meetings, answering Government telephones, providing http://aec.army.mil/ any type of written correspondence, or working in situations where their actions could be construed as official Government acts.

6.3.3 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 order. Contractor personnel shall make their contractor status known during introductions.

6.3.4 Use of Military Rank by Contractor Personnel

Contractors may not use or allude to former or current military rank during the performance of this work.

6.3.5 Data Rights

The Government will retain rights to all data produced in the course of developing, deploying, training, using and supporting USARIEM or other federal agencies that utilize this order.

6.3.6 Data in Transit

The Parties are responsible for ensuring that any data shared is transmitted, protected, and stored in a secured information system network that is fully compliant with all applicable Federal legal authorities and DoD regulations. The data described above may be shared through electronic file transfer via a secure, mutually agreed upon method such as DOD SAFE (https://safe.apps.mil/). Hard copies of such files will be handled per applicable DoD or Service regulations and guidelines.

6.3.7 Section 508 Requirement

The Contractor shall comply with Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d). Specifically, the procurement, development, maintenance, or integration of electronic and information technology (EIT) under this contract must comply with the applicable accessibility standards issued by the Architectural and Transportation Barriers Compliance Board at CFR part 1194.

6.3.8 Protection of Human Subjects and Adherence to Ethical Standards in

Department of Defense (DoD)-Supported Research The Contractor shall adhere to all applicable DoD regulations pertaining to Human Subjects Protection and Ethical Standards. Specifically, 32 Code of Federal Regulations (CFR) 219, National Defense, Protection of Human Subjects; Department of Defense (DoD) Instruction 3216.02, Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research, dated November 2011; Army Regulation (AR) 70-25 (under revision): Use of Volunteers as Subjects of Research, Headquarters, Department of the Army, dated 25 January 1990. Applicable US CFR regulations are:

Title 21, CFR Part 50 Protection of Human Subjects, Title 21 CFR Part 56, Institutional Review Boards; Title 21 CFR Part 812, Investigational Device Exemptions, April 1, 2014; Title 32 CFR Part 219, Protection of Human Subjects; Title 45 CFR 46, Protection of Human Subjects, April 1, 2014.

http://www.access-board.gov/sec508/508standards.htm

6.3.9 Public Key Infrastructure Authentication and Encryption Contractors shall follow the DoD standards, policies, and procedures related to the use of Public Key Infrastructure (PKI) certificates and biometrics for positive authentication including authentication to DoD private web servers or applications. Where interoperable PKI is required for the exchange of unclassified information, including the encryption of e-mail containing sensitive information, between DoD and its Contractors, industry partners shall obtain all necessary certificates if they are not eligible for a DoD Common Access Card. (refer to: http://iase.disa.mil/pki/eca/ and http://www.cac.mil/)

SECTION 7 DEFINITIONS

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.

ATTACHMENT 1 – ACRONYMS LIST

Acronym Definition AFARS Army Federal Acquisition Regulation Supplement AFRIMS Armed Forces Research Institute of Medical Sciences

AKO Army Knowledge Online AOR Area Of Responsibility

AT OPSEC Antiterrorism and Operational Security ATCTS Army Training Certification Tracking System

CAC Common Access Card CFR Code of Federal Regulations

CONUS Continental United States COR Contracting Officer Representative

DFARS Defense Federal Acquisition Regulation Supplement DoD Department of Defense EIT Electronic and Information Technology FAR Federal Acquisition Regulation FBI Federal Bureau of Information

FPCON Force Protection Condition FSC Federal Supply Code FSS Federal Supply Schedule GFE Government Furnished Equipment GFI Government Furnished Information GSA General Services Administration

IA Information Assurance ID Identification

ID/IQ Indefinite Delivery / Indefinite Quantity IPT Integrated Product/Process Team IT Information Technology

NCIC-III National Crime Information Center Interstate Identification Index NLT No Later Thank OCI Organizational Conflict of Interest

OCONUS Outside Continental United States OPSEC Operational Security

PMO Project Management Office PRS Performance Requirements Summary PWS Performance Work Statement QASP Quality Assurance and Surveillance Plan QCP Quality Control Plan

SHARP Sexual Assault Prevention and Response Program SOP Standing Operating Procedure

TARP Threat Awareness and Reporting Program U.S.C. United States Code

UIC Unit Identification Code US United States

USAMRAA United States Army Medical Research Acquisitions Activity USARIEM United States Research Institute of Environmental Medicine

WAWF Wide Area Work Flow

ATTACHMENT 2

ORDERING INSTRUCTIONS

CONTRACT CEILING

(a) All services to be ordered under this contract shall be set forth in each individual task orders. All task orders will be issued in accordance with the provisions Ordering 52.216-19, Order Limitation, and 52.216- 22, Indefinite Quantity.

(b) IDIQ Minimum Guarantee: The minimum guarantee for the contract is one (1) Task Order.

(c) The anticipated maximum quantity for the award under this solicitation is 2,800 units per year or 14,000 units for the five (5) year Period of Performance. The maximum quantity shall not be construed as an obligation of the Government or guaranteed tasking value.

ORDERING PERIOD

The Government may issue orders under this contract from the date of contract award through 60 months thereafter, if option periods are exercised. The period of performance for work efforts ordered under this contract shall be specified in each task order issued and shall not require performance beyond the 78th month; i.e., a task order issued on the last day of the ordering period may have up to an 18 month period of performance.

AVAILABLE AND ALLOTTED FUNDS

The Base Contract is not funded. Funds will be allotted on Task Orders written against this contract.

Some orders under this contract may be incrementally funded pursuant to the Limitation of Government's Obligation clause 252.232-7007. If the order is incrementally funded, the FAR clause will be included on each order, as applicable.

SPECIAL CONTRACT REQUIREMENTS

1. TASK ORDER PERIOD OF PERFORMANCE

All task orders issued under this IDIQ during the effective period of this contract and not completed within that period shall be completed by the Contractor within the time specified in the individual task order. The contract shall govern the Contractor’s and Government’s rights and obligations with respect to that task order to the same extent as if the order were completed during the contract’s effective period.

2. TASK ORDER PROCEDURES:

2.1 All task orders issued under this contract shall abide by terms and conditions outlined within the base contract. Each task order shall contain the final negotiated terms and conditions regarding price, performance, delivery, and other relevant factors.

2.2. The Government will award Firm Fixed Price Task Orders under this contract. All prices associated with preparation, presentation, and/or discussion/negotiation of the Contractor’s order proposal shall not be directly charged to this contract or any order placed under this contract. The Contractor is responsible for determining the most appropriate method for recovering such costs based on its standard accounting practices.

2.3 Competition: Not Applicable this is a single award IDIQ contract.

The Task Order Proposal Request (TOPR): The TOPR will identify the specific task or group of tasks denoted in PWS of the Contract to be performed by the Contractor.

2.4. Contractor Proposals. Offeror submitting task order proposals shall submit the proposal in two parts – a technical proposal and a cost/price proposal. Both proposals must be submitted in Microsoft Office Word and Excel and/or Adobe Acrobat (.pdf) formats to the contract specialist assigned to the requirement as identified in the solicitation issued for individual requirement.

2.5 Technical Proposal. Specific requirements for submission of technical proposals will be described in the solicitation issued for individual requirements.

2.6 Cost/Price Proposal. Specific requirements for submission of cost/price proposals will be described in the solicitation issued for individual requirements.

2.7 Contract Points of Contact:

2.7.1 Contracting Officer:

USA Medical Research Acquisition Activity TBD at time of contract award

2.7.2. Contract Specialist:

USA Medical Research Acquisition Activity TBD at time of contract award

2.7.3. Ombudsman:

TBD at time of contract award

2.7.4. Contracting Officer’s Representative:

TBD at time of contract award

2.8. Authorized Users:

The USAMRAA Contracting Officer will be the only authorized user under this IDIQ. Orders by other individuals will not be honored without prior written approval from the USAMRAA Contracting Officer.

The following offices are hereby authorized to place orders under this IDIQ:

U.S. Army Medical Research Acquisition Activity (USAMRAA)

U.S. Army Research Institute of Environmental Medicine (USARIEM)

3. Task Orders: The Contracting Officer will order against the contract through issuance of Task Orders via a DD Form SF1449 signed by the Contracting Officer. Task Orders will be executed in writing by the Contracting Officer and transmitted either via facsimile or electronically via e-mail. The contractor shall acknowledge receipt via e-mail.