B08-2 Attach 1 Final PWS 20Q0077.doc

PERFORMANCE WORK STATEMENT (PWS)

Food Frequency Questionnaire and Analysis USARIEM, Military Nutrition Division

SECTION 1 PURPOSE

1.1 Introduction The US Army Research Institute of Environmental Medicine (USARIEM), located in Natick, Massachusetts, is an internationally recognized center of excellence for Warfighter health and performance science and its applications. The Institute functions as a world-class laboratory for environmental medicine, physiology, and nutrition research. The Military Nutrition Division (MND) conducts research on nutritional issues affecting the health and mission-readiness of military personnel, and supports the US Army Surgeon General’s responsibilities as the Department of Defense’s executive agent for nutrition research.

1.2 Mission USARIEM’s mission is to optimize Warfighter health and performance through medical research. The mission of Military Nutrition Division (MND) is to conduct research that provides the biomedical science basis for developing new rations, menus, policies, and programs that enable Warfighter health-readiness and optimal performance.

1.3 Background Research conducted by the MND requires measuring a history of intake of nutrients by the warfighter in various environments in order to evaluate and understand nutritional intake as part of the research objective, and ultimately how to improve policies, education, rations, and food options provided to the warfighter. In order to capture a history of nutritional intake, a validated questionnaire is needed for accurate data collection and analysis. An electronic food frequency questionnaire (eFFQ) is required to be able to perform important eating behavior research by the MND. Paper food frequency questionnaires require in person delivery and are not feasible for large scale survey work that the MND has been asked to accomplish by Installation Management Command (IMCOM). An eFFQ will allow the MND to survey a large number of Soldiers from multiple posts using web links to accomplish research for IMCOM. To support these efforts, MND has the requirement for the following contracted services.

1.4 Scope The contractor shall provide a customizable, eFFQ which shall be administered via web link. Data shall be stored and analyzed by the vendor and available for download by USARIEM MND researchers. The vendor shall be approved for use within the DoD and have passed or be able to pass information security verification (governance) by USARIEM’s Information Management Division. Governance approval is based on the requirements of Army Regulation AR 25-5: Information Management: Army Cybersecurity Regulation. Information security verification ensure the system being procured is compliant with applicable DoD/Army security requirements, ensures USARIEM’s information technology systems are compatible, and ensures the capability is unique and not a duplication of existing capabilities.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance: Contractor’s 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. The periods of performance for this contract are as follows:

2.2 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.

2.3. Contract Management

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

2.3.2. Contractor Management. The contractor shall designate a single Point of Contact (POC) to be the contractor’s authorized POC with the COR. The POC 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 Contractor shall be responsible for managing and overseeing the activities of all Contractor personnel used in performance of this contract. The Contractor's management responsibilities shall include all activities necessary to ensure the accomplishment of timely and effective services performed in accordance with the requirements contained in the PWS.

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. 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 Electronic Food Frequency Questionnaire via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: https://www.ecmra.mil/Default.aspx 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: 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.

2.6. Contractor Personnel, Disciplines, and Specialties

2.6.1. Personnel

Contractor personnel designated shall have in-depth knowledge of the development of the eFFQ, as well as expertise in methods of analysis of the eFFQ. The contractor shall provide e-mail and telephone support to respond to USARIEM’s questions regarding data analysis. The contractor shall accomplish the assigned tasks by employing and utilizing qualified personnel with appropriate combinations of education, training, and experience.

2.7. Travel/Temporary Duty (TDY)

Not applicable

2.7.3 Invoices

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

SECTION 3 PERFORMANCE REQUIREMENTS

3.1. The following specifies the Performance Objectives for the contract: The contractor shall provide a web-based platform for the eFFQ. The contractor shall provide a custom landing page specific to USARIEM where a participant will be able to self-generate a unique participant ID. The contractor shall use this participant ID to identify eFFQ data and also attach a date to each eFFQ report to ensure repeat reports can be differentiated. After completion of an eFFQ, the eFFQ data shall be available to be retrieved/downloaded by the COR within 24 hours of participant completion.

3.1.1. Analyze eFFQ's. Provide a minimum of the following nutrients, food groups, etc. in terms of daily intake (Deliverable 2):

3.1.1.1 Analyze the nutrients (kcal, protein, trans fat, total fat, carbohydrate, calcium, phosphorus, iron, sodium, potassium, thiamin, riboflavin, niacin, vitamin C, saturated fat, monounsaturated fatty acids, polyunsaturated fatty acids, cholesterol, dietary fiber, dietary soluble fiber, folate, alpha tocopherol, zinc, vitamin B6, magnesium, vitamin A, retinol, alpha-carotene, beta-carotene, cryptoxanthin, lutein-zeaxanthin, lycopene, folic acid, vitamin B12, vitamin D, vitamin K, selenium, sugars, isoflavones, cystine, arginine, PUFA 18:2, PUFA 18:3, PUFA 18:4, PUFA 20:4, EPA, DPA, DHA, omega 6 fatty acids, omega 3 fatty acids, fructose, lactose, maltose, galactose, sucrose, glucose, total and free choline, betaine, and sphingomyelin, dietary fiber from beans, dietary fiber from vegetables and fruits).

3.1.1.2 Analyze the percent of kcal from fat, protein, carbohydrates, and alcoholic beverages.

3.1.1.3 Analyze the food groups (vegetables, fruits, grains, meats, dairy).

3.1.1.4 Analyze the MyPyramid food groups (added sugars, alcohol, discretionary fat oil, discretionary fat solid, cheese/ milk equivalent, milk, total dairy, yogurt, citrus melon berries, other fruit, total fruit, solid fruit, juices, total grain, non-whole grains, whole grains, legumes, eggs, fish/ seafood, lunch meats, meat, nuts and seeds, organ meats, poultry, soy, deep yellow orange vegetables, dark green leafy vegetables, other vegetables, potatoes, starchy vegetables, tomatoes, total vegetables).

3.1.1.5 Analyze Healthy Eating Index variables.

3.1.1.6 Analyze volunteer/ Patient data reports.

3.1.2 Provide a minimum of the following nutrients in terms of daily intake: Calcium and Vitamin D which shall be available for download by the COR within 24 hours of participant completion (Deliverable 3).

3.1.3 Provide a graphical food intake presentation of portion sizes for every dietary recall option.

3.1.4 The eFFQ shall be completed in ≤ 30 minutes.

3.1.5 Collect details about selection and preparation of foods to support nutrient estimations.

3.1.6 Use skip patterns to reduce response burden by collecting information only about foods that are regularly consumed.

3.1.7 The eFFQ shall be a scientifically validated data collection tool.

3.1.8 Be available to assist USARIEM with any questions they may have regarding the data analysis.

Estimated Quantities:

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

3.1.2

3.1.2

3.1.4

3.1.5

3.1.6

3.1.7

SECTION 4

SPECIAL REQUIREMENT

4.1. Information Assurance

The Government shall ensure completion of the electronic FFQs in accordance with the research protocols data and/or samples such that they will be de-identified and will not contain Personally Identifiable Information (PII), nor will such information be added. Additionally, no information covered under the Health Insurance Portability and Accountability Act (HIPAA) will be shared without a Business Associate Agreement in place. In the event data received has not been properly de-identified, the contractor shall notify the Contracting Officer’s Representative (COR) immediately upon discovery.

4.2 Security Requirements.

Not applicable

SECTION 5 DELIVERABLES

5.1. Deliverables.

Provide results of all analyses to USARIEM through the COR via electronic download within 24 hours of each eFFQ participant completion. The contractor shall provide the support defined in section 3.1. Results will be delivered to USARIEM via electronic download after questionnaire analysis.

5.2 Delivery Schedule Abbreviations:

The following abbreviations are used in the delivery/deliverable schedule:

5.3 Deliverable/Delivery Schedule:

A summary of deliverables follows. Copies are to be provided to the Government officials indicated in electronic file (E).

KO

CS

No later than 31 October of each year of the contract

Due within 24 hours of participant completion

SECTION 6 APPLICABLE DIRECTIVES, REGULATIONS, AND POLICIES

6.1.1. Mandatory Compliance. Occupational Safety and Health Act and AR 200-1 Environmental Protection and Enhancement. The vendor must meet information management requirements outlined in AR-25-5 Information Management: Army Cybersecurity Regulation.

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 below as mandatory and referenced 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 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.

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.

6.3.5 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.

6.3.6 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.

6.3.7 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.

ACRONYMS LIST