0.W81XWH18R0069-0001_CSS.docx

COMBINED SYNOPSIS/SOLICITATION W81XWH18R0069

AMENDMENT 0001

***AMENDMENT 0001***

The purpose of this amendment is to post revised technical approach and evaluation criteria, post a revised list of provisions/clauses and post responses to contractor questions:

Q1) What shall be the expected proportion of healing and non-healing dehisced wounds among the 90 enrolled patients?

A1) The Government expects approximately 4% from each wound category (trauma, abdominal wounds, etc.) become dehisced wounds

Q2) For 16S/ITS sequencing, does the number of reads required (100,000) refer to single or paired end reads? In other words, is the expected sequencing output 30 or 60 Mbp per sample?

A2) The Government requires paired-end sequencing workflow, each producing 100,000 reads per end per sample (200,000 total).

Q3) For WGS metagenomics sequencing, does the number of reads required (200 millions) refer to single or paired end reads? In other words, is the expected sequencing output 30 or 60 Gbp per sample?

A3) It refers to paired-end sequencing workflow, each producing 200 million reads per end per sample (200,000 total).

Q4) When does the project start if funded?

A4) The project will start once the contract is awarded.

Q5) Is there any guidance on what body parts and cause of wounds are eligible or preferred, that is skin vs muscle, leg vs abdomen, trauma such as gunshot wound or car accidents, general surgery, diabetic foot, etc.?

A5) If possible, the Government seeks a statistically sufficient amount of wounds per wound category (e.g., trauma, skin wounds, abdominal wounds, general surgical wounds). Currently, there are no restrictions to the type of wound injury; however, patients who are under 18, patients who are immunocompromised, and patients exhibiting chronic wounds and ulcers (e.g., diabetic foot) that are not from post-surgery would be restricted.

Q6) With regard to the Non-Disclosure Agreement document (2.W81XWH18R0069_NDA.DOC), which official shall be indicated as the “Task Manager or higher”?

A6) The contractor shall name a person who will be the main Point of Contact (POC) between the Government and their organization. This POC can be a program manager or a higher level in the contractor’s organizational structure.

Q7) Is there an incumbent, and if so, what is the contract number?

A7) This is a new requirement and there is no incumbent.

***END AMENDMENT***

This is an unrestricted combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR Subpart 12.6 – Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation for offerors to submit quotations. This solicitation is being issued under the authority of FAR Part 13 Simplified Acquisition Procedures.

This unrestricted solicitation is a Request for Quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-101 effective 07/20/2018.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541715 and the Product Service Code (PSC) is AN17 Research and Development: Biomedical-Commercialization.

Services to be provided The contractor shall provide wound specimen collection, storage, extraction, sample preparation, quantification, metagenomics sequencing and computational analysis of dehisced wounds in accordance with the Performance Work Statement.

Period and Location of Performance The services shall be performed at the awardee worksite.

The period of performance is two years after award.

RFQ SUBMISSION INSTRUCTIONS.

POINT OF CONTACT (POC): Proposals are to be sent via E-mail to the POC at susan.e.ruzicka2.civ@mail.mil. Questions will also be sent to this e-mail address. The Offeror is responsible for ensuring receipt by the POC.

RFQ QUESTIONS: Questions shall be submitted to the POC via email No Later Than 10 August 2018, 11:00 AM Eastern Daylight Time. Follow-up/additional questions will not be accepted after this date. Answers to Contractor submitted questions will be provided to all prime contract holders via TOPR modification.

RFQ DUE DATE: No Later Than: 29 August 2018, 1:00 PM Eastern Daylight Time ELECTRONIC SUBMISSION: Proposals shall be electronically submitted to the POC above. Your submission should include two separate parts: a Price proposal and a Non-Price proposal. The Non-Price proposal shall be submitted in MS Word or searchable PDF format. The Price proposal shall be submitted in MS Word or MS Excel 2000 or higher, but not greater than MS Word or MS Excel 2003 format. The firewall utilized by the Government contracting office does not authorize or accept zip files or attachments with a combined size exceeding 5 MB.

RFQ CONTENT AND FORMAT INSTRUCTIONS.

The Offeror’s submission shall include two separate parts: a Non-Price Quote and a Price Quote.

ADMINISTRATIVE FORMAT INSTRUCTIONS:

PAGE LIMITS: Non-Price quotes are limited to 25 single-sided pages, Times New Roman, 12 font and 1 inch margins. Pages should be numbered consecutively throughout the document and not by sections. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation.

The offeror shall provide a cover sheet to the non-price quote with the following information:

a. Offeror Name and mailing address

b. Point of Contact name, active phone number and email address

c. Offeror and Subcontractor(s) DUNS and CAGE Codes

The following sections are NOT subject to the overall non-price page limit:

· Table of Contents;

· Title page;

· Contractor Task Order POC Cover Page;

· Organizational Conflict of Interest (OCI) Certification;

· Non-Disclosure Agreement

· Small Business Subcontracting Plan

· Items within the Offeror’s proposal marked as an “Attachment” or “Annex” to the non-priced quote.

RFQ NON-PRICE CONTENT INSTRUCTIONS: The Offeror’s non-Price proposal shall clearly reflect how you propose to comply with the performance requirements identified in the Performance Work Statement regardless of the Government’s estimated effort. Your non-Price quote, 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-price quote.

Far Provision 52.212-1, Instructions to offerors applies to this solicitation. Additionally, the following information is provided as an addendum to the provision.

The Offeror’s non-Price proposal shall contain the following:

Factor 1 –Technical Approach Factor 2 – Past Performance

TECHNICAL APPROACH:

The “Technical Approach” section shall discuss the following:

a. The contractor’s access to qualified hospitals for study participants enrollment and dehisced wound specimen (swab, wound wash, and debridement when necessary) collection, storage at 4°C, and delivery within 3 hours of collection. Contractors may use established partnership or subcontracting relationships for the study participants and specimen collection. The contractor shall submit as part of this discussion, plans for IRB application and approval timeline for enrollment of study participants and specimen collection.

b. A discussion on the contractor’s plan to manage study participants and collect the required dehisced wound specimens. Contractors shall provide a draft schedule that outlines the anticipated timelines for scheduling study participants, collecting, storing and delivering specimens and providing complete metagenomics sequencing (whole-genome and 16S/ITS2 amplicon sequencing) analysis of specimens as specified in the Performance Work Statement (PWS).

c. A discussion on the laboratory capabilities and sequencing platforms used to perform the metagenomics sequencing and computational analysis that shows it meets the minimum criteria established in the PWS (e.g., read depth, read length, and paired-end reads).

d. A discussion on the DNA library preparation, quality control, sequencing, and detailed downstream computational analysis pipelines, types of data output (e.g., raw, processed sequence files, and figures), and data transfer the contractor intends to use to fulfill the PWS Objectives using the minimum criteria established in the PWS.

PAST PERFORMANCE:

The Offeror shall provide a narrative discussing no more than three (3) relevant past performance examples. If subcontractors are proposed, the offeror shall supply the same information for each subcontractor. Examples must be similar in size, scope, and complexity to the PWS and show capability in managing and completing human specimen (e.g., tissue and swab) studies.

The offeror shall state if it, or its’ subcontractors have no history of past performance.

ADDITIONAL SOLICIATION DOCUMENTS: The following documents will not be included in the evaluation on the non-priced factors. However, Offerors that do not submit completed copies of all the documents listed below will render the solicitation submission incomplete and not eligible for award:

· Completed OCI Certification Form

· Completed NDA Form

· Completed Small Business Subcontracting Plan

· Completed Provisions and Clauses

RFQ PRICE CONTENT. Offerors shall provide a firm fixed price for CLIN 0001 and an estimated Cost for CLIN 0002:

CLIN 0001, Dehisced wound collection and analysis. Quantity: 1, Unit: Job, Type: Firm Fixed Price, Unit Price CLIN 0002, Other Direct Costs, Quantity: 1, Unit: Job, Type: Cost For CLIN 0002, the contractor shall provide a discussion as to what materials, equipment and/or travel were used to form the basis of estimate on this CLIN.

The contract will incorporate a Contractor Manpower Reporting CLIN into the resultant award. The Contractor Manpower Reporting CLIN is not separately priced and will contain the following description:

The offeror shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the US Army Institute of Surgical Research via a secure data collection site. The offeror is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2017. Offerors may direct questions to the help desk at help desk at: http://www.ecmra.mil.

PRICING SHEET: The Offeror’s proposal shall include a completed pricing sheet in the attached format (Attachment 4). The Offeror shall ensure mathematical computations are correct. Errors in addition or multiplication may be considered nonresponsive to this RFQ.

Offerors shall propose on all contract line items, either by price or “NSP” (Not Separately Priced). A line item price left blank will be considered incomplete and may not be considered for award.

Offeror’s quote shall remain open for a minimum of 90 days from the date of submission.

CONTRACTOR MANPOWER REPORTING (CMR): CMR is a requirement of DOD contracts. Offerors are allowed to include a nominal fee in their cost/price proposal for providing this data. A “nominal fee” is defined as a computation of an administrative assistant equivalent labor category providing approximately 6-8 hours to complete data input. Offerors may opt to not separately price this required annual data input. CMR price will be evaluated as part of the total evaluated proposal price.

ADDITIONAL INFORMATION

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

4. FAR 52.212-2 EVALUATION – COMMERCIAL ITEMS (OCT 2014)

The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

1. Technical Approach and Capabilities

2. Past Performance

3. Price

BASIS FOR AWARD

The Government intends to award a contract without discussions. Offerors shall provide their best, complete proposal upon initial submission. The Government reserves the right to hold discussions if deemed necessary by the Contracting Officer. A Technical Evaluation Panel will evaluate all proposals based on the proposals/documentation provided. The evaluations will be based on the evaluation criteria set forth below.

Evaluations will be conducted utilizing the Best Value Tradeoff process.

Award of this contract will be made on a competitive best value basis, using “best value tradeoff” among price and non-price factors. Thus, the Government may elect to award to other than the lowest priced Offeror, or other than the Offeror with the highest rated non-Price proposal. The non-price evaluation factors numbered in descending order of importance are as follows:

1. Technical Approach

2. Past Performance

3. Price

Government evaluators will not assume that the Offeror possesses any capability or knowledge unless it is specified in the proposal.

After each of the above non-Price factors is rated individually, an overall rating will be assigned collectively to these factors. If any of the above non-price evaluation factors receives an individual rating of “Unacceptable”, the collective overall non-price rating will also be “Unacceptable.” Only proposals receiving an overall rating of “Acceptable” or higher will be considered for award.

The non-price factors are more important than price. As the non-price factors begin to reach equality in the evaluation, price becomes a more important factor in the tradeoff analysis.

7.1 Non-Price Evaluation Criteria: The following criteria will be used to evaluate the non-Price aspects of the proposal.

Factor 1, Technical Approach and Capabilities will be evaluated as follows:

a. The Government will evaluate the degree to which the discussion on the contractor’s access to qualified hospitals for study participants enrollment and dehisced wound specimen (swab, wound wash, and debridement when necessary) collection, storage, and delivery aligns with or exceed the minimum qualifications specified in the PWS. The Government will evaluate the degree to which contractors use of established partnership or subcontracting relationships for the study participants and specimen collection represent the best interest to the Government. The Government will evaluate the plans for IRB application and approval timeline for enrollment of study participants and specimen collection based on feasibility and reasonableness.

b. The Government will evaluate to the degree that the discussion on the contractor’s plan to manage study participants and collect the required dehisced wound specimens aligns with or exceed the minimum specifications as described in the PWS. The Government will evaluate the contractor’s draft schedule to the degree at which it aligns with or exceeds the Government’s estimated schedule as specified in the PWS. It will also be evaluated for reasonableness as to expectation of successful completion.

c. The Government will evaluate the discussion on the laboratory capabilities and sequencing platforms used to perform the metagenomics sequencing and computational analysis to the degree that it meets or exceeds the minimum specifications as described in the Performance Work Statement.

d. The Government will evaluate to the degree that the discussion on the DNA library preparation, quality control, sequencing, and detailed downstream computational analysis pipelines, types of data output (e.g., raw, processed sequence files, and figures), and data transfer the contractor intends to use meets or exceeds the minimum specifications as described in the PWS.

Past Performance will be evaluated as follows:

The offeror’s past performance will be evaluated to determine whether the past performance is recent (completed within the last two years), and relevant or not relevant to the required services. Offeror’s performance will be evaluated to determine if the offeror’s past performance shows satisfactory experience in managing human specimen (e.g., swab and tissue) studies similar to the requirements of the PWS.

Offeror’s having no record of past performance will be evaluated as “neutral” which will be considered as “acceptable”.

Price The price evaluation will determine whether the quoted prices are fair and reasonable in relation to the solicitation requirements. Quoted prices shall be entirely compatible with the technical quotations.

Please note that this procurement IS NOT being conducted under the GSA Federal Supply Schedule (FSS) program or another Government-Wide Area Contract (GWAC). If an offeror submits a quotation based upon an FSS or GWAC contract, the Government will accept the quoted price. However, the terms and conditions stated herein will be included in any resultant Purchase Order, not the terms and conditions of the offeror’s FSS or GWAC contract, and the statement required above shall be included in the quotation;

Rating Standards for the Non Price Proposal (Excluding Past Performance) Combined Technical/Risk Ratings Table

DEFINITIONS

PROVISIONS AND CLAUSES:

The clauses and provisions applicable to this solicitation can be found under the attachment Applicable Clauses & Provisions. The full text of a FAR and DFARS provision s or clauses may be accessed electronically at https://farsite.hill.af.mil or www.acquisition.gov/far.

ATTACHMENTS:

The following attachments apply to this solicitation:

1. Performance Work Statement

2. Non-Disclosure Agreement

3. Organizational Conflict of Interest Certification

4. Applicable Provisions and Clauses

5. Small Business Subcontracting Plan

6. Pricing Worksheet