A02-PWS_Nutrient Analysis Services.pdf

PERFORMANCE WORK STATEMENT (PWS)

Chemical Nutrient Analysis Services

U.S. Army Research Institute of Environmental Medicine

SECTION 1: PURPOSE

1.1 Introduction: The Military Nutrition Division is one of three research divisions within the

U.S. Army Research Institute of Environmental Medicine (USARIEM). 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 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 not only knowing the nutrient composition of foods that are provided to the warfighter, but also accurately capturing and assessing intake of nutrients by the individuals participating in various research protocols in order to evaluate and understand nutritional intake as part of the research objective. This will ultimately inform how to improve policies, education, rations, and food options provided to the warfighter. In order to capture exact nutritional intake from rations and other food products used in research protocols, chemical analysis for nutrient composition is required. The Military Nutrition Division additionally requires nutrient analysis services in order to maintain and grow its database of ration nutrient information (Ration Analysis Program), and in order to derive valid study data from feeding protocols and accurately analyze nutrient intake. Data contained within the Ration Analysis Program is used by other entities within the Dept of Defense to educate and advise warfighters for optimal health and performance. USARIEM for the last 13 years has used the nutrient derived nutritional analyses for over 400 ration components tested. USARIEM currently has built the most up-to-date and accurate nutrition database for rations that has ever existed.

1.4 Scope: The contractor shall accomplish chemical nutrient analytical services on

USARIEM-provided samples. To support this effort, USARIEM has a requirement for an Indefinite Delivery Indefinite Quantity (IDIQ) contract for the support of the analysis services. The contractor shall provide a panel of analyses on ration samples prior to storage (PRE). This panel of tests will consist of nitrogen and protein, fat by acid hydrolysis, fatty acid profile (saturated, unsaturated, and trans-fatty acids), omega fatty acids, moisture, ash, calories (calculated), carbohydrates (calculated), dietary fiber, α-Tocopherol HPLC, ICP Mineral Screen (calcium, iron, magnesium, potassium, sodium, zinc, phosphorous, iodine), selenium, folic acid, niacin, pyridoxine (B6), riboflavin (B2), thiamin (B1), vitamin A (retinol), β carotene, vitamin B12, vitamin C, sugar. The contractor shall provide a panel of analyses on ration samples after 6 months of storage (POST). This panel of tests will consist of α-Tocopherol HPLC, folic acid total, niacin, pyridoxine (B6), riboflavin (B2), thiamin (B1), vitamin A (retinol), β carotene, vitamin B12, vitamin C. Additionally, the contractor shall provide individual chemical analyses for samples that are sent in on an as needed basis.

The individual analyses requested may consist of: full amino acid profile, vitamin D, fructan/inulin, caffeine, resistant starch, soluble & insoluble fiber, total dietary fiber, calories, moisture, ash, carbohydrate, fat, protein, omega 3 fatty acids, vitamin C, zinc, calcium, vitamin A (from retinol), vitamin A (from carotenes). USARIEM will send all samples to the contractor for analysis at the time chemical analysis is requested/ordered.

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 12 month Base Period and four 12 month Option Periods.

Period of Performance Dates Base 22 Jan 2023 – 21 Jan 2024 Option Period 1 22 Jan 2024 – 21 Jan 2025 Option Period 2 22 Jan 2025 – 21 Jan 2026 Option Period 3 22 Jan 2026 – 21 Jan 2027 Option Period 4 22 Jan 2027 – 21 Jan 2028

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 contract 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.

2.3.2.1. 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 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 scientific services performed in accordance with the requirements contained in the statement of work.

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 nutrient 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: https://www.beta.sam.gov starting at the end of FY23.

ECMRA has been decommissioned effective June 19, 2020.

https://www.beta.sam.gov/

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 2022. Contractors may direct questions to the help desk at:

https://www.beta.sam.gov starting at the end of FY20, ECMRA has been decommissioned effective June 19, 2020

The contractor shall register under the "All Other Defense Components" module. The US Army Research Institute of Environmental Medicine (USARIEM) Unit Identification Code (UIC) is

W03WAA.

*The Office of the Secretary of Defense has issued a Memorandum dated 16 October 2019 which removes the requirement for contractors to report manpower data into the eCMRA system at https://www.ecmra.mil, beginning 1 Oct 2019. It is anticipated, however, that contractors shall be required to report similar manpower data to https://beta.sam.gov beginning sometime within the next year. Currently, there is no reporting requirement or transition plan but the contractor shall perform the documentation/tracking required demonstrating an understanding that manpower data reporting shall be required for the performance of this contract.*

2.6. Contractor Personnel, Disciplines, and Specialties

2.6.1. General/Specialized Experience:

The contractor shall have expertise as a chemical analytical laboratory. The laboratory must follow Association of Official Analytical Chemists (AOAC) guidelines and assure all laboratory technicians assigned to perform procedures in the laboratory are trained on SOPs for specific methods and all instruments are evaluated for peak shapes, sensitivity and proper run conditions prior to sample analysis. Each analytical run must include a series of standards and controls to monitor the performance of the analytical instrument and to minimize any drift that may occur during the course of the run.

2.7. Travel/Temporary Duty (TDY): Not Applicable

2.7.4 Invoices: The contractor shall submit invoices upon completion of requested work to Wide Area Workflow (WAWF) with sufficient documentation to provide certification of invoice.

SECTION 3: PERFORMANCE REQUIREMENTS

3.1. The contractor shall provide all necessary materiel and personnel required to perform chemical nutrient analytical services. The contractor shall provide non-personal services. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1.1. General Requirements.

The contractor shall provide nutrient chemical analyses to support the USARIEM Ration Analysis and Database Program and ongoing protocols requiring chemical analysis of foods.

https://www.beta.sam.gov/

The Ration Analysis and Program catalogs the nutritional composition of ration components and makes this information available to Warfighters via the ComRaD website (http://hprc-online.org/comrad/). This program analyzes ration components when they are freshly procured (pre-storage) and after a 3-yr shelf-life simulation (post-storage) to assess nutrient changes in ration components over the course of their shelf-life.

Chemical analysis of study foods is required so that researchers are able to design intervention diets for feeding protocols, control nutrient consumption of volunteers during the testing period and accurately assess dietary intake.

3.1.2. Specific Requirements: The contractor shall provide chemical nutrient analytical services of USARIEM-provided samples to include:

3.1.2.1 Pre-storage measures (Grouped analyses required by the Ration Analysis Program.

AOAC international methods are cited from the 18th edition and are subject to change if new additions are published during the lifetime of this contract). Deliverable 2

1. Sample gram weight

2. Sample prep-food

3. Ash (AOAC international, method 923.03)

4. Calories (calculated)

5. Carbohydrates (calculated)

6. β carotene (AOAC International, method 2005.07)

7. Calcium, iron, magnesium, potassium, sodium, zinc, phosphorous (Inductively coupled plasma (ICP) Emission Spectrometry, AOAC international, method 984.27)

8. Nitrogen and protein (Dumas method, AOAC international method 968.06 and 992.15)

9. Fat (Acid hydrolysis)

10. Saturated, unsaturated, trans and omega fatty acids (calculated as triglycerides, method

996.06, AOAC international)

11. Folic Acid (microbiological method, AOAC international method 992.05)

12. Moisture (AOAC international method 925.09)

13. Niacin (microbiological method, AOAC international 944.13 and 960.46)

14. Pyridoxine (AOAC international method 961.15)

15. Riboflavin (microbiological method, AOAC international method 940.33 and 960.46)

16. Selenium (AOAC international method 2011.19)

17. Sugar profile (Gas chromatographic method)

18. Thiamin (AOAC international methods 942.23, 953.17 and 957.17)

19. Total dietary fiber (Lee method, AOAC international method 991.43)

20. α-Tocopherol (High-performance liquid chromatography, HPLC)

21. Vitamin A as retinol (AOAC international methods 992.04, 992.06, and 2001.13)

22. Vitamin B12 (microbiological method, AOAC international methods 952.20 and 960.46)

23. Vitamin C (AOAC method 967.22)

24. Iodine (Inductively coupled plasma (ICP) Mass Spectronmetry

3.1.2.2 Post-storage measures (Grouped analyses required by the Ration Analysis Program.

AOAC international methods are cited from the 18th edition and are subject to change if new additions are published during the lifetime of this contract). Deliverable 3

1. Sample gram weight

2. Sample prep-food

3. β carotene (AOAC International, method 2005.07)

4. Folic Acid (microbiological method, AOAC international method 992.05)

5. Niacin (microbiological method, AOAC international 944.13 and 960.46)

6. Pyridoxine (AOAC international method 961.15)

7. Riboflavin (microbiological method, AOAC international method 940.33 and 960.46)

8. Thiamin (AOAC international methods 942.23, 953.17 and 957.17)

9. α-Tocopherol (HPLC)

10. Vitamin A as retinol (AOAC international methods 992.04, 992.06, and 2001.13)

11. Vitamin B12 (microbiological method, AOAC international methods 952.20 and 960.46)

12. Vitamin C (AOAC method 967.22)

3.1.2.3 Individual analyses (required by both the Ration Analysis Program and study protocols; all cited AOAC international methods are cited from the 18th edition and are subject to change if new additions are published during the lifetime of this contract). Deliverable

1. Vitamin D (Liquid chromatography-mass spectrometry (LCMS), AOAC international method 2011.11)

2. Amino acid profile (HPLC)

3. Caffeine (HPLC)

4. Saturated, unsaturated, trans and omega fatty acids (calculated as triglycerides, method

996.06, AOAC international)

5. Zinc (ICP Emission Spectrometry, AOAC international, method 984.27)

6. Carbohydrates (calculated)

7. Fat (acid hydrolysis)

8. Calories (calculated)

9. Calcium (ICP Emission Spectrometry, AOAC international, method 984.27)

10. Total Vitamin A (calculated from retinol and carotenes)

11. Vitamin C (AOAC method 967.22)

12. Total dietary fiber (Prosky method, AOAC international method 991.43)

13. Fructan (Inulin) (Spectrophotometric method)

14. Moisture (AOAC international method 925.09)

15. Ash (AOAC international, method 923.03)

16. Nitrogen and protein (Dumas method, AOAC international method 968.06 and 992.15)

17. Total Fiber: Soluble fiber and Insoluble fiber (AOAC international method 2011.25)

18. Resistant starch (AOAC international method 2002.02)

3.1.3 All analyses should be provided in an electronic report and quality control procedures must be available.

3.1.4 Contractor must be available to assist USARIEM with any questions they may have regarding the data analysis.

3.1.4.1 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.

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. The oversight provided for in the QASP will help to ensure that service levels reach and maintain the required levels throughout the contract term.

Further, the QASP provides the COR with a proactive way to avoid unacceptable or deficient performance, and provides verifiable input for the required Past Performance Information Assessments. The QASP will be finalized immediately following award and a copy provided to the Contractor after award. The QASP is a living document and may be updated by the Government as necessary.

SECTION 4: SPECIAL REQUIREMENT

4.2 Government Furnished Property

USARIEM will provide ration components and protocol foods to the laboratory for analysis.

SECTION 5: DELIVERABLES

# PWS

Reference

Performance Objective Acceptable Quality Level

Performance Measurement

Incentive

1 3.1.2.1 3.1.2.2 3.1.2.3

Contractor will analyze ration components for “Pre- and Post-storage analysis” as well as individual nutrients outlined in PWS according to AOAC methods

100% analysis completion

Surveillance by the

COR.

Past performance

2 3.1.3 Contractor will provide analysis results to USARIEM via electronic reports

Nutrient analysis should be completed within 30 days of receipt by contractor

USARIEM

POC/COR should receive all reports electronically within timely manner

Past performance

4 3.1.4 Contractor will be available to USARIEM for questions regarding data analysis

Response to

USARIEM

POC/COR within 2 business days

USARIEM

POC/COR should receive a call, email, or voicemail from the contractor

Past performance

5 2.4.2 The contractor shall report annual CMR requirements in a timely manner

Complete Surveillance by the

COR.

Contract requirement

5.1 Deliverables: The contractor shall provide the support defined in section 3.1. Results will be delivered to USARIEM via electronic reports upon completion of analysis of each sample.

5.2 Delivery Schedule Abbreviations:

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

Abbreviation Definition KO Contracting Officer COR Contracting Officer's Representative CS Contract Specialist E Electronic Copy PWS Ref Performance Work Statement Reference

(paragraph number)

5.3 Deliverable/Delivery Schedule:

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

Deliverable PWS Ref

Title Dist. E Initial Subsequent Due

Deliverable 1 2.4.2 CMR COR

KO

CS

N/A October 31st of each fiscal year.

Annual

Deliverable 2 3.1.2.1 Grouped Analyses

(PRE)

COR 1 As requested As requested Within 30 days after receipt of samples

Deliverable 3 3.1.2.2 Grouped analyses

(POST)

COR 1 As requested As requested Within 30 days after receipt of questionnaires

Deliverable PWS Ref

Title Dist. E Initial Subsequent Due

Deliverable 4

3.1.2.3 Individual analyses

• Vitamin D

• Amino Acid

Profile

• Caffeine

• Saturated, unsaturated, trans and omega fatty acids

• Zinc

• Carbohydrates

• Fat

• Calories

• Calcium

• Total vitamin A

• Vitamin C

• Total dietary fiber

• Fructan/Inulin

• Moisture

• Ash

• Nitrogen and protein

• Soluble &

Insoluble fiber

• Resistant starch

COR

As requested As requested Within 30 days after receipt of questionnaires

Deliverable 5 3.1.4 Questions on Analysis

COR 1 As requested As requested Response to questions within 2 business days

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 below as mandatory and referenced performance requirements.

http://aec.army.mil/

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.

6.3.6 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.

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

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.

6.3.8 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

Acronym Definition AFARS Army Federal Acquisition Regulation Supplement

AOR Area Of Responsibility CFR Code of Federal Regulations COR Contracting Officer Representative

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

FPCON Force Protection Condition FSC Federal Supply Code FSS Federal Supply Schedule GFE Government Furnished Equipment

IA Information Assurance ID Identification

IPT Integrated Product/Process Team IT Information Technology

OCI Organizational Conflict of Interest PMO Project Management Office PRS Performance Requirements Summary PWS Performance Work Statement QASP Quality Assurance and Surveillance Plan QCP Quality Control Plan SOP Standing Operating Procedure

U.S.C. United States Code UIC Unit Identification Code US United States

USARIEM United States Research Institute of Environmental Medicine WAWF Wide Area Work Flow