W81XWH-17-R-0033-U0002.docx

W81XWH-17-R-0033

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0004

The CLIN description has changed from Surge HRDL / LDL to Surge HDRL / LDL.

CLIN 0011

The CLIN extended description has changed from:

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1.

To:

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1..

CLIN 0012

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2.

CLIN 0014

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3.

CLIN 0015

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4.

CLIN 1004

The CLIN description has changed from Surge HRDL /LDL to Surge HDRL /LDL.

CLIN 1005

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.1-4.3; 4.8-4.10

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.8-4.10.

CLIN 1011

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1..

CLIN 1012

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2..

CLIN 1013

Allow allowable and allocable costs associated with Travel and ODCs as outline in PWS paragraph 6.6.1.3, 7.3, 7.6 and 7.7.

Allow allowable and allocable costs associated with Travel and ODCs as outlined in PWS paragraph 6.6.1.3, 7.3, 7.6 and 7.7..

CLIN 1014

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3..

CLIN 1015

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4..

CLIN 2004

The CLIN description has changed from Surge HRDL/LDL to Surge HDRL/LDL.

CLIN 2005

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.1-4.3; 4.8-4.10

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.8-4.10.

CLIN 2011

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1..

CLIN 2012

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2..

CLIN 2014

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3..

CLIN 2015

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4..

CLIN 3004

CLIN 3005

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.1-4.3; 4.8-4.10

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.8-4.10.

CLIN 3011

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1..

CLIN 3012

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2..

CLIN 3014

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3..

CLIN 3015

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4..

CLIN 4004

CLIN 4005

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.1-4.3; 4.8-4.10

All labor required to perform services in support of Laboratory Operations as outlined in the PWS paragraph 4.8-4.10.

CLIN 4011

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.1..

CLIN 4012

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Laboratory Diagnosis and Monitoring (DLDM) as outlined in the PWS paragraph 4.17.2..

CLIN 4014

All Research Development Test & Evaluation (RDT&E) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3.

All Research Development Test & Evaluation (RDT&E) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.3..

CLIN 4015

All Operations and Maintenance (O&M) labor required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4.

All Operations and Maintenance (O&M) services required to perform optional short suspense specific protocols in support of the Department of Epidemiology and Threat Assessment (DETA) as outlined in the PWS paragraph 4.17.4..

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

The following have been modified:

INSTRUCTIONS TO OFFERORS

PROPOSAL SUBMISSION (Section L)

North American Industry Classification System (NAICS): The NAICS code and small business size standard for this acquisition is 541714 with a size standard of 1,000 employees.

POC: The Contract Specialist (CS) is the POC for this acquisition. Any questions or concerns regarding this acquisition shall be submitted electronically via e-mail to John Fitzsimmons at john.l.fitzsimmons8.civ@mail.mil.

Site Visit: A Request for Information (RFI) was posted 10 November 2016 which included information regarding a by invitation Industry Day which was held on 26 January 2017. No additional site visits are anticipated.

Question Submission Requirements: Offeror's who have questions pertaining to the solicitation requirements shall submit questions no later than 10:00AM Eastern Standard Time (EST) on 21 December 2017 to the Contract Specialist at john.l.fitzsimmons8.civ@mail.mil. All questions should be submitted electronically. Answers to all relevant and appropriate questions will be issued via amendment to the solicitation

Follow up questions are due by 8 January 2018 2PM EST.

Proposal Due Date: No Later Than: 19 January 2018, 10AM EST submitted to john.l.fitzsimmons8.civ@mail.mil

Submission of Offers: The Offeror’s proposal shall be electronically submitted as set forth below. Failure to submit all documents concurrently and in accordance with these instructions may render a proposal unacceptable. The use of hyperlinks in proposals is prohibited. Proprietary information shall be clearly marked.

Proposal Content and Format Instructions: The Offeror’s submission shall be submitted electronically to CS John Fitzsimmons via email john.l.fitzsimmons8.civ@mail.mil and include three separate volumes: Volume I – Business Proposal inclusive of Cost Proposal, Volume II – Non-Cost / Price Technical Proposal, and Volume III - Past Performance, small business participation plan, subcontracting plan . Proposal content shall be no smaller than Times New Roman font 12 pitch. Exhibits, graphics, charts, captions, etc., shall be no smaller than Times New Roman font10 pitch.

Format: The submission shall be clearly indexed and logically assembled. Each volume shall be clearly identified and shall begin at the top of a page. All pages of each volume shall be appropriately numbered and identified by the complete company name, date and Request for Proposal (RFP) number in the header and/or footer. A Table of Contents shall be provided. MS Word (doc) files shall use the following page setup parameters:

Margins - Top, Bottom Left, Right – 1 "Gutter - 0" From Edge - Header, footer - 0.5" Page Size, Width - 8.5" Page Size, Height - 11"

NOTE: 11x17 Folded pages are acceptable for tables/graphic representations; however, each 11x17 page counts as two (2) pages.

Electronic Packaging: The Non-Cost/Price proposal shall be submitted in MS Word or searchable PDF format. The Cost/Price proposal shall be submitted in MS Word or MS Excel 2000 or higher, but not greater than MS Word or MS Excel 2007 format. The firewall utilized by the Government contracting office does not authorize or accept zip files.

Incumbent Personnel: In accordance with Federal Acquisition Regulation (FAR) 52.222-17 (No displacement of Qualified Workers), incumbent personnel must be afforded the opportunity to obtain employment with a successor contractor. See 29 CFR section 541 for the definition of professional employees. Offeror's must submit an e-mail providing the Company Name, Company POC for Personnel with Contact Information to the CS at john.l.fitzsimmons8.civ@mail.mil Time. The CS will consolidate the contact information and shall provide a list of the vendors expressing interest in the requirement to the incumbent personnel. If the incumbents are interested in pursuing employment with your company, they will contact you.

Content Requirement: All information shall be confined to the appropriate volume. The Offeror shall confine submissions to essential matters, sufficient to define the proposal in a concise manner to permit a complete and accurate evaluation of each proposal. Content shall be indexed (cross-indexed, as appropriate) and logically assembled. Each volume of the proposal shall consist of a Table of Contents, Summary Section, and the Narrative discussion. The Summary Section shall contain a brief abstract of the volume. Proprietary information shall be clearly marked. The following shall be included in the Narrative discussion:

VOLUME I - Business Proposal Inclusive of Cost Proposal: The volume shall contain the following section documentations:

1. Company Cover Letter

1. SF 33 - Solicitation, Offer and Award with Blocks 12 - 17 completed by the Offeror signed by an authorized official of the firm.

1. Acknowledgment of Solicitation Amendments

1. Contract Administration Data

1. Representations and Certifications at FAR 52.204-8 (FAR 52.204-8(b) for those representations and certifications that the Offeror shall complete electronically) and Other Statements of Offeror's. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

1. Dun & Bradstreet Number (DUNS), CAGE Code, and Tax Identification Number (TIN).

1. Cost/Price proposal:

1. SF33, Pricing, Certifications/Representations, shall not be addressed separately from that submitted in Volume I - Business Proposal. Price information shall be included in Volume I only and shall not be discussed or exhibited in any other part of the Offeror's proposal.

1. Offeror's proposal must stipulate that it is predicated upon all the terms and conditions of this RFP.

1. OCI Mitigation Plan (if required).

VOLUME II – Non-Cost/Price Technical: (not to include FACTOR 5 past performance) Non-cost/price proposals are limited to 65 single-sided pages. Pages should be numbered consecutively throughout the document and not by sections.

Pages should be numbered consecutively throughout the document and not by sections. Pages exceeding the specified limit will be removed and not forwarded for evaluation. The following sections are not subject to the 65 single-sided page limits:

Table of Contents Title page Contractor POC Cover Page Quality Management Plan Resumes and letters of intent for Key Personnel (for those individuals proposed as key personnel who are not current emploiyees of your company, a signed letter of intent must be included).

Staffing plan (25 pages) Small Business Participation Plan and the Small Business Subcontracting Plan

VOLUME III – Past Performance (FACTOR 5): The offeror shall submit past performance information regarding similar contracts in size, complexity and scope. This volume shall not exceed 15 pages for the prime contractor and five (5) additional pages for each subcontractor (5 pages per sub). Offeror shall submit a listing of no more than three (3) references for Government and/or commercial contracts for the prime Offeror and one (1) reference for each subcontractor during the past three years which are relevant to the efforts required by this solicitation. Relevant efforts are defined as services/efforts that are the same as or similar to the effort required by the solicitation. Data concerning the Offeror shall be provided first, followed by each proposed subcontractor, in alphabetical order. Letters of commitment shall be included for all subcontractors for their past performance to be considered, these letters are not counted towards the page limts. This volume shall be organized in the following sections:

Section 1 – Contract Descriptions. This section shall include the following information in the following format.

Contractor/Subcontractor place of performance, CAGE Code and DUNS Number. If the work was performed as a subcontractor, also provide the name of the prime contractor and POC within the prime contractor organization (name, and current address, e-mail address, and telephone and fax numbers).

Government contracting activity, and current address, Procuring Contracting Officer’s name, e-mail address and telephone.

Government’s technical representative/COR and current email address and telephone.

Government contract administration activity and the Administrative Contracting Officer’s name, and current e-mail address and telephone.

Contract Number and, in the case of Indefinite Delivery type contracts, GSA contracts, and Blanket Purchase Agreements, include Delivery Order Numbers.

Contract Type (specific type such as Fixed-Price (FP), Cost Reimbursement (CR), Time & Material (T&M), etc.). In the case of Indefinite Delivery contracts, indicate specific type (Requirements, Definite Quantity, and Indefinite Quantity) and secondary contract type (FP, CR, T&M, etc.).

Awarded price.

Final or projected final price.

Period of Performance dates.

Section 2 – Performance. Offeror's shall provide a specific narrative explanation of each contract listed in Section 1, Contract Description, describing the objectives achieved and detailing how the effort is relevant to the requirement of this RFP. It is not sufficient to state that it is similar in magnitude and scope, a rationale must be provided to demonstrate that it is comparable. Projects completed or in progress described in the narrative will be evaluated.

The Offerors shall indicate if any of the contracts listed were terminated and the type and reasons for the termination.

Section 3 – Subcontracts. (If applicable) Offerors shall provide an outline of how the effort required by the RFP will be assigned for performance within the Offeror’s corporate entity and among the proposed subcontractors, efforts performed by subcontractors require Contracting Officer approval at all tiers. The information provided for the prime Offeror and each proposed subcontractor must include the entire company name, company address, CAGE Code, DUNS Number and type of work to be performed by citing the applicable Government PWS subparagraph number. This section will further include written consent of subcontractors to allow the disclosure of their subcontractor’s past performance information to the Offeror.

Past Performance Questionnaire. Offerors shall provide past performance information for the past 3 years of similar scope, size, complexity and subject matter expertise in accordance with the solicitation. For all contracts identified in Section 1, Contract Descriptions, a Past Performance Questionnaire (Solicitation Section J attachment S4) must be completed and submitted. The Offeror shall e-mail the questionnaire to both the Government contracting activity and technical representative responsible for the past/current contract. The POCs shall be instructed to electronically complete the questionnaire and e-mail the entire questionnaire to the Contract Specialist no later than the proposal due date: The Offeror shall e-mail to the Contract Specialist a list of all the POC’s who were sent a questionnaire. The Government must receive this list no later than the proposal due date. The POC List shall be submitted in MSWord for Windows Table Format to include the following fields: Solicitation Number; Company Name; Contract Number; Government Agency; POC Last Name, First Name; POC Title; POC Telephone Number; POC E-mail Address; and Date E-Mail to POC (month/day). The POCs must be either Government personnel (civil service or military) or employees of private sector clients (such as public or private sector medical facilities) with whom you have provided services. Information provided by or for POCs who work directly for your company, or indirectly (i.e. in a prime or subcontractor relationship), will NOT be considered relevant. Offerors shall ensure that contact information for designated references is accurate and up-to-date.

Information from Other Sources: The Government may consider information obtained through other sources.

SMALL BUSINESS PARTICIPATION PLAN & SMALL BUSINESS SUBCONTRACTING PLAN The negotiation of a subcontracting plan shall not be considered discussions or a reopening of Solicitation W81XWH-17-R-0033. The subcontracting plan requirement is not applicable to small business concerns qualified as such under the NAICS code assigned to this solicitation. Master subcontracting plans can be included as an appendix to the subcontracting plan and will not count towards the page count.

Small Business Particpation Plan and Small Business Subcontracting Plan (Factor 6) should be included in volume III.

NON-COST/PRICE PROPOSAL CONTENT INSTRUCTIONS. The Offeror’s non-cost/price proposal shall clearly reflect the Offeror’s approach to execute and comply with the performance requirements identified in the PWS, regardless of the Government’s estimated effort. Your non-cost/price proposal, including any supporting documentation, is to be clear and concise. The level of effort proposed must be consistent with the proposed solution outlined in your non-cost/price proposal. The proposal must fully document and substantiate a cross mapping of your cost/price approach as it equates to the non-cost/price proposal. If you intend to use any labor categories that you feel are consistent in duties with the level of effort labor categories but are titled differently, in accordance with your cost accounting procedures, you must cross map those labor categories to the Government’s PWS to ensure your proposal receives a proper evaluation.

The Offeror’s non-cost/price proposal shall contain the following:

FACTOR 1: Technical/Scientific Approach: The Offeror shall submit a Technical/Scientific Approach which effectively demonstrates the Offeror’s clear understanding of all the tasks and how the approach is likely to yield the required results within the required time frame. Additionally, the Offeror shall demonstrate the methodology and flexibility that will be used in accomplishing any resultant award.

The Offeror should describe, in detail, its technical approach and overall ability to perform Non Personnel Services Support for Walter Reed Army Institute Research (WRAIR), US Military Human Immunodeficiency Virus (HIV) Research Program (MHRP), Department of Laboratory Diagnostics and Monitoring (DLDM) and Department of Epidemiology and Threat Assessment (DETA). This description should specifically address the Offeror’s approach for:

1. Execution of all phases of clinical screening (serological/protein), supplemental confirmatory testing, clinical monitoring (viral load), and therapeutic monitoring (resistance genotype testing) for prevalent and emerging infectious pathogens; i.e., public/global health, diagnostic, clinical, applied research/study support for MHRP, WRAIR, vaccine, therapeutic, cure clinical trials/studies of infectious pathogens;

1. Execution of all phases of translational research for evaluation of new/novel products for Premarket Approval (PMA) to the U.S. Food and Drug Administration (FDA) and/or execution in clinical diagnostic and/or research settings;

1. Design, develop, evaluate, validate LDAs for detection, screening, supplemental confirmatory testing/diagnosis, and/or monitoring (viral load/resistance genotyping) of prevalent and emerging infectious pathogens;

1. Conduct comprehensive characterization of the epidemiology of infectious pathogens;

1. Conduct threat assessment studies of HIV/HIV-related and emerging BBIs and TTIs associated with the battlefield blood supply among U.S. and foreign Military personnel;

1. Conduct threat assessment studies of prevalent and emerging infectious pathogens among populations of interest to the CoCOMs and in geographic regions of U.S. military operational significance;

1. Understanding of and ability to utilize instrumentation listed on Equipment attachment.

1. Execution of all tasks in accordance with applicable laws, regulations, approvals and procedures required specifically for (1) regulated clinical testing of human and animal biological specimens; (2) clinical research, threat assessment studies, public health evaluations, non-clinical research, applied research; (3) human subjects and bio-behavioral research.

1. Transition In Plan. A detailed draft transition-in plan which addresses the specific requirements in the PWS and is achievable.

FACTOR 2: Quality Management Approach(QMA): The QMP shall document how the Contractor will meet and comply with the quality standards established in this PWS. The Offeror shall include as an attachment to the non-cost/price proposal a Quality Management Plan (QMP), which specifically addresses the following:

1. The QMP should address CAP/DOD CLIP compliance, Regulatory Compliance in accordance with US FDA Notice of Inspection, the US FDA Human Subjects Protection, and IRB approved non-human subjects and human subjects research compliance as well as the maintenance, advancement, and integration of the 12 Quality System Essentials (QSEs) into the QMP.

1. The QMP should also address and insure the seamless integration of all the DETA and DLDM requirements to include HDRL, LDL, TAL, and CEU to ensure best in class clinical screening, supplemental confirmatory testing, pathogen infection classification, and monitoring (viral load/genotype), parasite identification/speciation services for US Service members, their Beneficiaries, and all translational, vaccine, therapeutic, cure, and investigative and evaluation activities.

1. The QMP should also provide a methodology to obtain data, assess processes, identify parameters, correct and monitor compliance as integrated into the QMP as identified in paragraph 4.10 in the PWS.

FACTOR 3: Experience: The Offeror should submit written information which effectively demonstrates the Offeror’s relevant experience (for this purpose, experience refers to what an Offeror has done, not how well it was accomplished) identical to, similar to or related to performing services contained within the PWS. The Offeror’s proposal shall demonstrate the amount of relevant corporate experience the Offeror possesses. Offeror’s relevant experience shall support and substantiate that the organization (to include support contractors, consultants, key personnel, and business partners) has current capabilities for assuring performance of this requirement. Experience shall specifically show the following:

1. Corporate Experience conducting clinical trials/studies in support of manufacturer Pre-market Approval(PMA) submission for approval and/or licensure of assays and/or platforms through FDA submission process.

1. Corporate experience in the areas of program management, client services support, and administrative support services in a regulated laboratory and scientific environment.

1. The demonstrated experience of key personnel Resumes proposed to fill Key Personnel positions. Per attachment: PWS-P14: DLDM and DETA Key Personnel. For all individuals proposed to fill Key Personnel positions, you are to submit resumes. Resumes of Key Personnel do not count against the page totals. The resumes shall include a list of relevant training, education, and certifications. For those individuals proposed as Key Personnel who are not current employees of your company, include a signed letter of intent with your proposal.

FACTOR 4: Staffing Approach: The Offeror should submit written information that shall describe the Offeror’s Staffing Approach that will lead to the successful accomplishment of the requirement. The Offeror shall include a Staffing Plan, which shall not exceed 25 single-sided pages that should specifically address the following:

1. A clear delineation of the lines of authority associated with the proposed organization and how its methodologies, processes and capabilities will contribute in a positive manner to ensuring completion of all the tasks in the PWS (particularly emphasizing communications) and includes the following:

1. A Staffing Approach that will retain and attract a quality staff to lead to the successful accomplishment of the requirement and sufficient personnel resources and flexibility to execute activities based on Government priorities.

1. A Mission-Essential Contractor services approach that demonstrates the Offeror’s methodologies, processes and capabilities to perform identified mission essential tasks.

1. A Occupational Health and Safety approach will be evaluated to ascertain the degree to which the Offeror presents an understanding and methodology to meet and comply with the Occupational Health and Safety requirements in a CONUS medical laboratory environment as established in the PWS 6.6.3.3. The Government shall evaluate the Offeror’s procedures that it shall use to provide the required safety support while mitigating health and safety risks.

FACTOR 5: Past Performance: The Offeror (Prime Contractor) shall submit no more than three (3) references of relevant contracts within the past 3 years for its own performance. The Offeror shall also submit no more than one (1) reference for each Subcontractor proposed. The contracts may be past or current as long as the performance did not end more than 3 years prior to the due date for the submission of the task order proposal, and the contracts may have been with Federal, State and/or City agencies and commercial customers.

(a) Reference Content: It is the Offeror’s responsibility to provide valid, current and verifiable references. References must include:

Name of the Organization that will be providing the reference, Name of the POC, POC Telephone Number, POC Email address, Contract Number, Period of Performance, Scope of Work

(b) POCs: The above POCs must be either Government personnel (civil service or military) or employees of private sector clients (such as public or private sector medical facilities) with whom you have provided services. Information provided by or for POCs who work directly for your company, or indirectly (i.e. in a prime or subcontractor relationship), will NOT be considered relevant. Offerors shall ensure that contact information for designated references is accurate and up-to-date. Please verify the POC prior to submitting them.

(c) Information from other sources: The Government may consider information obtained through other sources, including but not limited to Contractor Performance Assessment Reports System (CPARS) and Past Performance Information Retrieval System (PPIRS).

FACTOR 6: Small Business Participation Plan & Subcontracting Plan

All Offeror’s (both large and small businesses) shall submit their level of small business commitment under the proposed acquisition and their level of commitment and ability to utilize small businesses in performance of prior contracts for similar products or services. Large businesses shall submit a small business sub-contracting plan. The following should show evidence in their small business participation:.

(a) The extent to which such firms, as defined in FAR Part 19, are specifically identified in proposals;

(b) The extent of commitment to use such firms (enforceable commitments will be weighted more heavily than non-enforceable ones);

(c) The complexity and variety of the work small firms are to perform;

(d) The realism of the proposal;

(e) Past performance of the offeror in complying with the requirements of the clauses at FAR 52.219-8, Utilization of Small Business Concerns, and, for all large business Offeror’s, FAR 52.219-9, Small Business Subcontracting Plan;

(f) The extent of participation of such firms in terms of the value of the total acquisition, consistency between the small business sub-contracting plan and the small business participation plan;

(g) The extent to which the offeror provides detailed explanations/documentation supporting the proposed participation percentages.

Small Business Participation Goal mandatory minimum shall be no less than 16%.

Category Small Business Goal (inclusive of all categories below) 16% requirement

Small Non-Disadvantaged Business 0%

FACTOR 7: Cost/Price Factor: The Offeror’s cost/price proposal shall include proposed cost/ price, be realistic for the work and skills required for contract performance; reflect a clear understanding of the requirements; and be consistent with the Offeror's proposed technical/scientific approach.

The Offeror shall submit and propose costs outlined in the Cost Schedule (Solicitation Section J Attachment S2), and propose transition cost/price separately in accordance with their transition-in plans. For Offerors with DCAA approved accounting systems, offerors shall provide evidence of such. Offerors that do not have DCAA approved accounting systems should submit the Defense Contract Audit Agency (DCAA) Pre-award Survey of Prospective Contractor Accounting System Checklist and the Standard Form 1408 (Pre-award Survey of Prospective Contractor Accounting System) (Solicitation Section J S3).

The Offeror’s proposal shall include a supplemental pricing sheet that provides a detailed breakdown of their proposed hours, labor rates, Overhead, G&A, and profit or fee including sub elements of each. The Supplemental Pricing Worksheet shall include all other direct and indirect costs including materials, equipment, travel, shipping, and any other costs associated with the performance of the resulting contract. Contractor shall ensure mathematical computations are correct. Offeror’s shall define which labor categories will be performed by a subcontractor(s) along with the subcontractor(s) company name. The offeror shall provide a detailed breakdown of the proposed labor rate for all proposed subcontractor labor. For Offerors with DCAA approved indirect rates, offerors shall provide evidence of such.

Defense Contractor Management Agency (DCMA) or Defense Contract Audit Agency (DCAA)

If the Offeror is currently under administration or audit cognizance of the Defense Contract Management Agency (DCMA) or the Defense Contract Audit Agency (DCAA), the name, address, and telephone number of the Government Agency’s Point of Contact shall be furnished. Request a copy of the most recent/current audits, pricing or rate agreements issued by the cognizant agency.

Estimating System: Provide a description of the estimating system or methods used. Indicate if there has been a Government review or audit of the accounting system. If the Government has reviewed the estimating systems of the Offeror and the proposed subcontractors, provide results of the review/audit (including date of review and contact numbers), or documentation of the results.

Purchasing System: Provide a summary description of the purchasing system or methods (how sources are selected, what provision is made to ensure quantity and other discounts) used. Identify any deviations from these standard procedures in preparing this cost proposal. Indicate if there has been a Government review or audit of the purchasing system. If the Government has reviewed the purchasing systems of the Offeror and the proposed subcontractors, provide results of the review/audit (including date of review and contact numbers), or documentation of the results.

Accounting System:Indicate if there has been a Government audit of the accounting system and if so, provide evidence of the accounting systems adequacy, as per DCAA policy 7641.90. Identify any deviations from these standard procedures in preparing this cost proposal.

Total contract value is the cumulative dollars obligated on the contract. Progress will be assessed by the contracting officer at the end of the base period, each option period, and at completion of the contract.

Other Direct Costs (ODCs) shall be billed on a cost reimbursable basis, not to exceed Government estimates and shall not include fee. Costs are defined as the purchase price of materials or service plus General and Administrative charges (G&A) or material handling charges (M&H).

The annually estimated plug-in dollar amounts for ODCs are to be used in the cost proposal. They are as follows:

Travel (PWS

7.3.1.3 and attachment PWS- P11)

Optional CLINs may be required to cope with periods of high intensity mission operational tempo during real world operations and/or to provide for additional skill sets or additional hours of service to support the increased mission requirements as stated in the PWS. Surge services and Optional Support required by WRAIR will be funded through exercise of optional CLIN(s) or surge CLIN(s) or both, via contract modification as required.

Annually estimated plug-in dollar amounts for short suspense CLINs and Optional CLINs are as follows:

(Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount)

(Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount)

(Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount)

(Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount) $ 350,000.00 (Ceiling amount)

Detailed description of the methodology used to estimate the plug-in numbers for the surge CLINs is attached to the PWS as attachment PWS-P12.

Discussions: The Government intends to evaluate proposals and award a contract without discussions. The Government reserves the right to conduct discussions if the Contracting Officer determines them to be necessary; the Contracting Officer will provide proposal revision instructions to the Offeror, as required. Therefore, the Offeror’s initial proposal should contain the Offeror’s best terms from a technical and price standpoint. All proposals shall be subject to evaluation by a team of Government personnel who will evaluate only one proposal from each prime Offeror.

Additional Information:

ALTERNATE PROPOSALS: Alternate proposals will not be evaluated by the Government.

INCUMBENT: The incumbent is Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc.W81XWH-16-C-0225

SECTION M - EVALUATION FACTORS FOR AWARD

The following have been modified:

BASIS FOR AWARD

BASIS FOR AWARD (Section M)

Proposal Evaluation

Award will be made on a competitive best value basis, using “best value tradeoff” among cost/price and non-cost/price factors. A best value tradeoff process will be used, thus, the Government may elect to award to other than the lowest priced offeror, or other than the offeror with the highest rated non-cost/price proposal. Past Performance and the Small Business Participation Plan will be evaluated independently from the other non-cost/price evaluation factors using different standards. The non-cost/price evaluation factors numbered in descending order of importance, are as follows:

1. Technical/Scientific approach

2. Quality Management Approach

3. Experience

4. Staffing Approach

5. Past Performance

6. Small Business Participation Plan

Cost is the least important factor; however, as the collective non-price/cost factors begin to reach equality in the evaluation, the cost factor becomes more important in the tradeoff analysis.

Government evaluators will not assume that the Offerors possess any capabilities or knowledge unless it is specified in the proposal.

After each of the first four non-cost/price factors (Technical/Scientific approach through Staffing Approach) is rated individually, an overall rating will be assigned collectively to these factors. If any of the above non-cost/price evaluation factors receives an individual rating of “Unacceptable”, the collective overall rating will also be “Unacceptable”. Only proposals receiving an overall rating of “Acceptable” for the first four non-cost/price factors or higher will be considered for award. In addition, only prices that are determined fair/or reasonable, and realistic will be considered for award and included in the competitive range, if established.

Capital Bridge, LLC will be providing administrative support to the Government evaluation panel during this source selection. All Capital Bridge employees have signed non-disclosure agreements.

Offerors are placed on notice that initial proposals should contain the Offeror’s best terms from a technical and cost standpoint. All proposals shall be subject to evaluation by a team of Government personnel who will evaluate only one proposal from each prime Offeror.

The Government reserves the right to: reject any or all proposals, award no contract at all depending on the quality of the proposal(s) submitted, and waive informalities and minor irregularities in offers received.

FACTORS TO BE EVALUATED

The following evaluation factors will be used to evaluate each proposal:

FACTOR 1: Technical/Scientific Approach FACTOR 2: Quality Management Approach FACTOR 3: Experience FACTOR 4: Staffing Approach FACTOR 5: Past Performance FACTOR 6: Small Business Participation Plan FACTOR 7: Cost/Price

EVALUATION APPROACH

Evaluation Factors

FACTOR 1: Technical/Scientific Approach: The Offeror’s Technical/Scientific Approach will be evaluated to the degree to which it effectively demonstrates the Offeror’s clear understanding of all the tasks and how the approach is likely to yield the required results within the required time frame. Additionally, the Offeror shall demonstrate the methodology and flexibility that will be used in accomplishing any resultant award.

The Offeror’s Technical Scientific approach will be evaluated to the degree it describes a clear and complete understanding of the PWS requirements, specifically:

1. Execution of all phases of clinical screening (serological/protein), supplemental confirmatory testing, clinical monitoring (viral load), and therapeutic monitoring (resistance genotype testing) for prevalent and emerging infectious pathogens; i.e., public/global health, diagnostic, clinical, applied research/study support for MHRP, WRAIR, vaccine, therapeutic, cure clinical trials/studies of infectious pathogens;

1. Execution of all phases of translational research for evaluation of new/novel products for Premarket Approval (PMA) to the U.S. Food and Drug Administration (FDA) and/or execution in clinical diagnostic and/or research settings;

1. Design, develop, evaluate, validate LDA (Laboratory Developed Assays) for detection, screening, supplemental confirmatory testing/diagnosis, and/or monitoring (viral load/resistance genotyping) of prevalent and emerging infectious pathogens;

1. Conduct comprehensive characterization of the epidemiology of infectious pathogens;

1. Conduct threat assessment studies of HIV/HIV-related and emerging BBIs (Blood Borne Infections) and TTIs (Transfusion Transmitted Infections) associated with the battlefield blood supply among U.S. and foreign Military personnel;

1. Conduct threat assessment studies of prevalent and emerging infectious pathogens among populations of interest to the CoCOMs (Combatant Commands) and in geographic regions of U.S. military operational significance;

1. Understanding of and ability to utilize instrumentation listed on Equipment attachment.

1. Execution of all tasks in accordance with applicable laws, regulations, approvals and procedures required specifically for (1) regulated clinical testing of human and animal biological specimens; (2) clinical research, threat assessment studies, public health evaluations, non-clinical research, applied research; (3) human subjects and bio-behavioral research;.

1. Transition In Plan. A detailed draft transition-in plan which addresses the specific requirements in the PWS and is achievable.

FACTOR 2: Quality Management Approach (QMA): The Offeror’s quality management approach shall be evaluated to the degree that the Offeror’s approach meets and complies with the standards established in the PWS. The Offeror’s Quality Management Plan shall be evaluated to the degree that the QMP meets the following.

1. The QMP should address CAP (College of American Pathologists) /DOD CLIP (Clinical Laboratory Improvement Program) compliance, compliance with US FDA (483 audits), the US FDA Human Subjects Protection, and IRB approved non-human subjects and human subjects research compliance as well as the maintenance, advancement, and integration of the 12 Quality System Essentials (QSEs) into the QMP.

1. The QMP should also address and insure the seamless integration of all the DETA and DLDM requirements to include HIV Diagnostics and Reference Laboratory, WRAIR (HDRL), Leishmania Diagnostic Laboratory (LDL), Technology Assessment Laboratory (TAL), and Clinical Evaluation Unit (CEU) to ensure best in class clinical screening, supplemental confirmatory testing, pathogen infection classification, and monitoring (viral load/genotype), parasite identification/speciation services for US Service members, their Beneficiaries, and all translational, vaccine, therapeutic, cure, and investigative and evaluation activities.

1. The QMP should also provide a methodology to obtain data, assess processes, identify parameters, correct and monitor compliance as integrated into the QMP as identified in paragraph 4.10 in the PWS.

FACTOR 3: Experience: The Offeror’s Corporate experience will be evaluated to the degree to which the Offeror demonstrates and provides evidence of their experience identical, similar or related to the requirements outlined within the PWS with emphasis on: (1) high complexity clinical testing of human and animal specimens, clinical research, knowledge product development, and public and global health missions; (2) human subjects research and biomedical research prevalent and emerging infectious pathogens; (3) epidemiological, public health practice evaluations, threat assessment, bio-behavioral, and natural history/observational studies of prevalent and emerging infectious pathogens military populations of geographical interest and/or significance; (4) application of US Government regulations in relation to biosafety, Health Insurance Portability and Accountability Act of 1996 ( HIPAA), Privately Identifiable Information (PII), Private Health Information (PHI), Clinical Laboratory Improvement Amendment (CLIA)/DoD Clinical Laboratory Improvement Plan (CLIP), College of American Pathologists (CAP) accreditation, Good Clinical Laboratory Practice (GCLP), DoD and US FDA human…