W81XWH22Q0067 Amendment 0002.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04 EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The reason for this Amendment is to provide responses to industrys questions and to correct numbering in section 2.3. Past Performance.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 14

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY

16B. UNITED STATES OF AMERICA 15C. DATE SIGNED 15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer) (Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X

W81XWH22Q0067

X 9B. DATED (SEE ITEM 11)

10-Jun-2022

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

U0002

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

15-Jul-2022

CODE

USA MED RESEARCH ACQ ACTIVITY

820 CHANDLER ST

FORT DETRICK MD 21702-5014

W81XWH 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODE CODE

EMAIL: TEL:

W81XWH22Q0067

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

INSTRUCTIONS TO OFFERORS

1. SUBMISSION OF COST OR PRICING DATA

1.1. It is expected that the resultant contracts will be awarded based upon a determination that there is adequate price competition; therefore, the offeror is not required to submit additional cost or price data (beyond that required by

Section 2 and subparagraphs) or to certify cost or pricing data with its proposal.

1.2. If, after receipt of the proposals, the Contracting Officer determines that adequate price competition does not exist in accordance with FAR 15.403-3 and FAR 15.403-4, the offeror shall provide other information requested to be submitted to determine reasonableness of price, or certified cost or pricing data as requested by the Contracting

Officer.

2. PROPOSAL CONTENT AND INSTRUCTIONS FOR PREPARATION OF PROPOSALS

2.1. This section specifies the format and content that offerors shall use in this Request for Proposal (RFP). The intent is not to restrict the offerors in the manner in which they will perform their work but rather to ensure a certain degree of uniformity in the format of the responses for evaluation purposes. This requirement is solicited under

North American Industry Classification System (NAICS) 621511, Medical Laboratories. Proposals will be accepted only from offerors who are registered under NAICS 621511. Offerors must submit a proposal that is legible and comprehensive enough to provide the basis for a sound evaluation by the Government. Information provided should be precise, factual, and complete. Legibility, clarity, completeness, and responsiveness are important. Proposals shall be in the form prescribed by, and shall contain a response to, each of the areas identified in Section 2 and subparagraphs. Any proposal that does not meet the requirements of the solicitation may be determined to be incomplete and may result in rejection of the offeror's entire proposal.

2.1.1. The proposal shall be submitted in five separate volumes:

Volume I – Technical

Volume II – Past Performance

Volume III – Business

Volume IV – Small Business Subcontracting and Participation Plan

Volume V – Pricing

2.1.2. A complete Technical, Past Performance, Business, Small Business Subcontracting and Participation Plan, and Pricing Volume shall be submitted at the same time via e-mail to: brian.d.miller1.civ@mail.mil by 10:00 am eastern on 20 July 2022. All five (5) Volumes shall be included as attachments within one e-mail from the offeror.

If more than one e-mail is received per offeror, the entire proposal will be not be considered. No further consideration will be given to any offeror who submits any of these Volumes late in accordance with FAR

15.208(b).

Any questions regarding this solicitation should also be submitted to this email address. Questions should be submitted no later than 17 June 2022. Questions should be listed to reference the corresponding solicitation section and paragraph. Responses to questions will be presented in the form of an amendment. The source of the questions will not be disclosed.

2.1.3. No hard copies of proposals will not be accepted. Please note only one e-mail per contractor will be accepted.

The e-mailed proposal (to include all attachments) shall be in either Adobe PDF or Microsoft Office Word or Excel format.

mailto:brian.d.miller1.civ@mail.mil

2.1.4. Each e-mailed proposal shall have the name of the offeror and the solicitation number in the subject line. It is the offeror’s responsibility to ensure that proposals are received by the due date and time required. The Government will acknowledge receipt of all proposals.

2.1.5. Upon receipt of proposals, and prior to actively engaging in proposal evaluation, a compliance review will be conducted to determine if each offeror met the submission requirements for each volume as outlined in Addendum to FAR 52.212-1 Instructions to Offerors -- Commercial Items of the solicitation. In order to be eligible for award, a proposal must comply in all material respects with the terms and conditions set forth in this solicitation. Failure to properly submit any items listed in Addendum to FAR 52.212-1 of the solicitation may result in rejection of the offeror's entire proposal.

2.2. Volume I: Technical. In accordance with electronic submission requirements given in this section, the offeror shall include the following:

2.2.1. Management Approach. The offeror shall present the degree to which the offeror’s methodologies, processes, and capabilities reflect an ability to effectively and efficiently manage the base contract, and implement and execute task orders under this contract at present and over the life of the contract. The approach shall address the following:

2.2.1.1. Approach to accomplishment of the specific tasks defined in the Performance Work Statement (PWS).

2.2.1.2. Subcontractor Teaming Arrangements

2.2.1.3. If the offeror is a small business concern under NAICS 621511 and a subcontractor has been proposed, the offeror shall specifically address FAR 52.219-14, Limitations on Subcontracting. The offeror’s Technical Volume shall clearly detail the nature of the relationship between the parties, (i.e. subcontractor, partner, etc) and shall address the responsibilities of all parties as they will relate to provision of services under the resultant contract.

2.2.1.4. If the offeror is proposing as a mentor/protégé or business relationship other than subcontracting, the offeror’s Technical Volume shall clearly detail the nature of the relationship between the parties, (i.e. mentor-protégé, joint venture, etc) and shall address the responsibilities of all parties as they would relate to provision of services under the resultant contract.

2.2.1.5. The Offeror shall address how its proposed management approach will be beneficial to the Government.

2.2.2. The Technical Volume shall be in Adobe PDF or Microsoft Office Word or Excel for Windows format. The total number of the pages submitted for Volume I (Technical) shall not exceed 20 pages, excluding a title page and table of contents. If Volume I contains more than 20 pages (excluding resumes and letters of commitment), only the first 20 pages will be evaluated. Cover letters and table of contents are not required; any information contained in a cover letter or table of contents will not be evaluated.

2.3. Volume II: Past Performance. In accordance with electronic submission requirements given in this section, the offeror shall include the following:

2.2.1. A maximum of three (3) Past Performance Information Narratives shall be submitted. An electronic file for

Volume II – Past Performance will be submitted along with the solicitation. The file will be named “Attachment II –

Past Performance Information Narrative.” Each of the Past Performance Information Narratives shall be completed in its entirety, and when completed, shall not exceed one page. If more than three Past Performance Information

Narratives are submitted, only the first three Past Performance Information Narratives received will be considered.

Each Past Performance Information Narrative shall identify no more than one customer POC. Each Past

Performance Information Narrative may include multiple contracts or one or more delivery/task orders under indefinite delivery indefinite quantity (IDIQ) contracts. Contracts cited must be current or have ended not more than three years prior to the closing date of the solicitation. If the contract performance ended more than three years prior to the closing date of the solicitation it will be determined not relevant. Cover letters are not required for Volume II;

any information contained in a cover letter will not be evaluated.

2.2.2. The offeror may submit Past Performance Information Narratives that demonstrate prior experience and how that experience relates to the solicitation PWS elements. If the submission does not clearly describe prior experience under the resultant contract, it will be determined not relevant.

2.2.3. The offeror may submit Past Performance Information Narratives that demonstrate experience by teaming partners (e.g., proposed subcontractor, partner, mentor, protégé, parent company, sister company, etc.) only if they will be performing in support of the contract resulting from this solicitation. Such past performance submissions shall clearly identify the relationship of the teaming partners to the offeror and how they will contribute to the performance under the resultant contract. If the submission does not clearly describe the relationship of teaming partners to the offeror and how the teaming partners will contribute to the performance under the resultant contract, it will be determined not relevant.

2.3.4. The Government may contact the customer POCs listed on the Past Performance Information Narratives.

Customer POCs shall be either Government personnel (civil service or military) or employees of private sector facilities for which the contractor has provided services. Past Performance Information Narratives that list POCs that work for, or have worked for, the offeror or teaming partner directly or indirectly will be determined not relevant.

2.3.5. If neither the offeror nor its teaming partner possesses relevant Past Performance, the offeror shall submit a statement affirming that it possesses no relevant Past Performance.

2.3.6. The Government is not restricted from evaluating and considering other recent and relevant Past Performance information in its possession. Past Performance information may be obtained from any other sources available to the

Government, such as PPIRS and interviews with Contracting Officer’s Representatives.

2.4. Volume III: Business. In accordance with file submission requirements given in this section, the offeror shall include the following:

2.4.1. The offeror must be registered in System for Award Management (SAM) in accordance with FAR 52.212-3.

The offeror shall verify its SAM record is current, accurate, complete and applicable to this combined synopsis/solicitation as of the date of this offer and is incorporated in this offer by reference. The offeror shall be registered in SAM under the applicable NAICS code for this combined synopsis/solicitation, 621511. The small business size standard is $27.5M. The offeror shall complete and submit FAR 52.212-3 OFFEROR

REPRESENTATIONS AND CERTIFICATIONS--COMMERCIAL ITEMS (OCT 2015) ALTERNATE I (OCT

2014).

2.4.2 The offeror shall complete and submit FAR Clause 52.209-11 [Representation By Corporations Regarding

Delinquent Tax Liability or a Felony Conviction under any Federal Law (Feb 2016)].

2.5. Volume IV. Small Business Subcontracting and Participation Plan. In accordance with file submission requirements given in this section, the offeror shall include the following:

2.5.1. All large business concerns under NAICS 621511 shall submit a Small Business Subcontracting and

Participation Plan. The offeror shall submit a subcontracting plan in accordance with FAR Clause 52.219-9 and

DFARS Clause 252.219-7003 (for reference see FAR 19.704 and DFARS 219-704). The negotiation of a subcontracting plan shall not be considered discussions or a reopening of the solicitation. The subcontracting plan requirement is not applicable to small business concerns qualified as such under the NAICS code, 621511, assigned to this solicitation. Master subcontracting plans can be included as an appendix to the subcontracting plan. Offerors shall include the name of any proposed subcontractors and any applicable references. The total number of the pages submitted for the Small Business Subcontracting and Participation Plan shall not exceed 5 pages, excluding a title page and table of contents. If the Small Business Subcontracting and Participation Plan contains more than 5 pages, only the first 5 pages will be evaluated. Cover letters and table of contents are not required; any information contained in a cover letter or table of contents will not be evaluated.

2.6. Volume V: Pricing. Pricing shall be submitted in the CLIN structure provided. The offeror shall complete all

CLINs included in the solicitation.

PERFORMANCE WORK STATEMENT

Microbiome Sequencing and Analysis Services

US Army Research Institute of Environmental Medicine (USARIEM)

SECTION 1

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 the composition of microorganisms living in the human gastrointestinal tract. The Military Nutrition Division requires DNA extraction, library preparation, high- throughput gene sequencing, and bioinformatics services to support these analysis within a research study.

1.4. Scope The contractor shall provide analytical services of fecal samples for 16S rRNA gene amplicon sequencing and shotgun metagenomics sequencing as defined in section 3. Samples will be provided by USARIEM.

SECTION 2 GENERAL REQUIREMENT

2.1. Performance

2.1.1. Place of Performance: Contractor facility

2.1.1.1. Primary On-Site Government Location: USARIEM

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.

2.2. 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.

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

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 Program Manager (PM) to be the contractor’s authorized point of contact (POC) with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communicating policies, purposes, and goals to subordinates. This will include coordination with the KO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. The PM shall demonstrate capability in the overall management of complex tasks, and strong team building skills.

2.3.2.1. The contractor shall establish clear organizational lines of authority and responsibility to ensure effective management of the resources assigned to the requirement. The contractor shall ensure that all contractor personnel are advised of their chain of command and who they should contact if they have questions.

2.4. 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. 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 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 FY20, ECMRA has been decommissioned effective June

19, 2020.

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

31 of each calendar year, beginning with 2013. 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 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.*

2.4.5 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 contract shall possess specialized experience necessary to conduct DNA extraction, library preparation, high-throughput DNA sequencing (16S rRNA gene amplicon sequencing and shotgun metagenomics sequencing), and bioinformatics Support Services.

2.6.2.2. The Government estimate is only put in place for offerors to ascertain the approximate or estimated level of effort for this procurement. However, this is not to be construed as either mandatory or necessarily the best technical approach. It is only in place as a reference to allow offerors to better understand the general scope of this effort from the Governments perspective. The Government is seeking the best level of effort and labor mix that the contractor has determined is right to accomplish the mission contained in this

PWS. The contractor is not bound to propose these labor categories or quantities, rather being expected to provide the best solution citing the labor mix and quantity required to accomplish the general scope of the contract requirements in each support areas. If the contractor has determined either the labor categories or overall level of effort provided are not the best technical solution, the contractor shall submit a level of effort consistent with all of the cost/price and non- cost/price aspects of contractors approach.

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 DNA extraction, library preparation, high-throughput DNA sequencing

(16S rRNA gene amplicon sequencing and shotgun metagenomics sequencing), and bioinformatics Support https://www.beta.sam.gov/ http://www.ecmra.mil/ http://www.ecmra.mil/

Services. The following section specifies the Performance Objectives and Performance Elements for the contract.

3.1.1. General Requirements.

The contractor shall conduct DNA extraction, library preparation, high-throughput gene sequencing and bioinformatics 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 sequencing 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. All procedures will be developed in consultation with USARIEM scientists prior to sample analysis, and follow best practice recommendations in place at the time of analysis.

The specific requirements are described below.

3.1.2. Specific Requirements:

3.1.2.1 The contractor shall conduct DNA extraction and library preparation from fecal samples provided as individual projects led by individual USARIEM investigators. Any primers used for library preparation will be determined in consultation with USARIEM investigators.

3.1.2.2 The contractor shall conduct amplicon sequencing and shotgun metagenomics sequencing in accordance with standard validated protocols.

3.1.2.3 The contractor shall conduct quality control, taxonomic assignment, and gene annotation of sequencing data using validated protocols and standards.

3.1.2.4 The contractor shall perform bioinformatics analyses in consultation with USARIEM investigators to include computing and analyzing measures of community and genetic diversity (alpha-and beta-diversity), differential abundance analyses, and generating graphical outputs in accord with best practices.

3.1.2.5 The contractor shall provide raw sequencing files, tables of read counts with taxonomy and gene annotations assigned, relative and absolute abundance of taxa and genes, diversity metrics, and results of all analyses as requested by USARIEM investigators. 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 60 calendar days of sample receipt unless otherwise agreed upon within the individual task order for each project

(Deliverable 2).

3.1.2.6 The contractor shall consult on all sample and data analysis protocols, interpretation and reporting with the USARIEM investigator leading each individual project, or their designee.

3.1.2.7 Fecal samples will be shipped by USARIEM to the performer's location overnight, frozen and on dry ice. Samples will be placed in storage at -80C within the performer’s facilities until analysis. The performer will inform USARIEM on the condition of the samples upon receipt. The performer and USARIEM will discuss whether to analyze any samples that do not arrive frozen. In those cases, USARIEM may send another set of samples for analysis.

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 Obtain sufficient DNA yields for sequencing analysis, and generate high quality amplicon libraries using appropriate primers and methods.

No more than one customer complaint per task order

In accordance with lab standard procedures;

proportion of samples yielding sufficient DNA.

Positive

CPARS

2 3.1.2.2 Generate high quality gene sequences at appropriate read depths and using appropriate methods.

No more than one customer complaint per task order

In accordance with lab standard procedures; read depth sufficient to cover community diversity.

Positive

CPARS

3 3.1.2.3 Quality control and annotation of sequencing data, identify taxa and genes, enter data, manage and provide databases with sequencing results (read counts and relative/ absolute abundances at different levels of taxonomy and gene pathway).

No more than one customer complaint per task order

In accordance with standard analysis pipelines using standard databases.

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

Positive

CPARS

4 3.1.2.4 Perform statistical analysis as required.

No more than one customer

The contractor-provided services shall be timely, Positive

CPARS

complaint per task order accurate, and conform to established scientific professional standards.

Analyses include, but are not limited to, diversity metrics, supervised and unsupervised multivariate analyses, and differential abundance analysis.

5 3.1.2.5 Databases suitable for statistical analyses, interpretable reports describing procedures and results.

No more than one customer complaint per task order

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

6 3.1.2.6 Consult on analytical approach and 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:

USARIEM will provide fecal samples to the laboratory for analysis.

SECTION 5 DELIVERABLES

5.1. Deliverables. The contractor shall provide the following deliverable as listed

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

3.1.2.5 Deliverable 2 Data files, analyses and reports as

described in 3.1.2.5. This will include 16S rRNA amplicon and shotgun metagenomics analyses

Due to the USARIEM investigator no later than 60 calendar days of sample receipt unless otherwise agreed upon within the individual task order for each project

3.1.2.6 Deliverable 3 Consultation on sample and data

analysis, and interpretation of methods and results.

Throughout the duration of each project

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 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 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.

http://aec.army.mil/

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.

6.3.6 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 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.

http://www.access-board.gov/sec508/508standards.htm http://iase.disa.mil/pki/eca/ http://www.cac.mil/)

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.

The following have been deleted:

252.211-7007 Reporting of Government-Furnished Property MAR 2022

(End of Summary of Changes)