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9/20/2024 - AMENDMENT 6: Uploaded revised RFQ Attachment 6 - Questions and Answers Part 2 with clarifications to answers in Amendment 5 and Amendment 4.. 9/20/2024 - AMENDMENT 5: Uploaded revised RFQ ... 9/20/2024 - AMENDMENT 6: Uploaded revised RFQ Attachment 6 - Questions and Answers Part 2 with clarifications to answers in Amendment 5 and Amendment 4.. 9/20/2024 - AMENDMENT 5: Uploaded revised RFQ Attachment 6 - Questions and Answers Part 2 with additional vendor questions. 9/20/2024 - AMENDMENT 4: Uploaded revised RFQ Attachment 6 - Questions and Answers Part 2 with an additional vendor question. 9/19/2024 - AMENDMENT 3: Added RFQ Attachment 6 - Questions and Answers Part 2 with vendor questions regarding the Quote Pricing Template and responses. 9/18/2024 - AMENDMENT 2: This amendment serves to: Add RFQ Attachment 4 – Amendment 2 Extend the due date for revised quotes to Monday, September 23, 2024 at 12:00pm EST Extend the due date for questions to Friday, September 20, 2024 at 12:00pm EST Amend Attachment 1 - Statement of Work to change quantity of “Clinical genome sequencing with interpretation and report” required deliverable quantity from n = 100 to n = 250 Add RFQ Attachment 5 – Quote Pricing Template Amend RFQ Submission Instructions (revisions in red on attachment 4 and duplicated below in bold/italics/underlined ): "INSTRUCTIONS All interested vendors must provide a quote for the requirement as outlined in Attachment 1 – Statement of Work (SOW) AND RFQ Attachment 5 – Quote Pricing Template. All quotes must include: Price(s) (unit price, total price) for all base and option quantities. One (1) fixed price must be quoted for each of the following items for every quantity listed and every period of performance on the Quote Pricing Template (Line #s 1, 2, and 5-24 for the Base Period and Option Period 1-3) : Genome Sequencing, 4-week turnaround time Genome Sequencing with interpretation and report One (1) fixed price may be quoted for the following Optional Tasks described in the SOW for every quantity listed and every period of performance on the Quote Pricing Template: Polygenic risk alleles (Line #3) Pharmacogenomic allele calls (Line #4) Capability for these tasks is not required, but will be considered beneficial in the Government’s evaluation of technical capability. If not capable of these optional tasks, leave these lines blank in the Quote Pricing Template 2. Clear indication of the capability of the vendor to meet all specifications and requirements 3. No more than three (3) references from within the last three (3) years indicating past performance of similar size and scope. Include organization name, point of contract information, and a brief description of the scope of the project. The Government may evaluate only those quotes that fully meet the requirements as outlined in the SOW and Quote Pricing Template and respond to the instructions and requirements below. Failure to furnish a full and complete quote as instructed may result in the Offeror’s response being considered non-responsive and will therefore be eliminated from further consideration and award. All or part of the successful vendor’s quote may be incorporated in any contract resulting from this solicitation. The successful vendor’s quote may be incorporated by reference. Any questions or concerns regarding this combined synopsis/solicitation are due by 12:00pm EST on September 20, 2024 and must be emailed to Seth.Schaffer@nih.gov. Quotes are due by 12:00pm EST on September 23, 2024. Quotes must be emailed to Seth Schaffer, Contract Specialist, at Seth.Schaffer@nih.gov. Late quotes will not be considered. All responsible sources may submit an offer that will be considered by this Agency. 9/11/2024 - AMENDMENT 1: Added RFQ Attachment 3 - Questions and Answers with vendor questions and responses. Uploaded revised Statement of Work to specify the type of required 96-well deep well sample plates which must be compatible with QIAgility robotic aliquoting. The updated SOW now notes that alternatives to the Fluidigm SNP trace are acceptable. Quotes with alternatives to the Fluidigm SNP trace must provide evidence of comparability. This notice is a combined synopsis/solicitation for commercial items using Simplified Acquisition Procedures. This acquisition will be made in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as applicable, and as supplemented with additional information included in this notice. This announcement constitutes the only solicitation (a written solicitation will not be issued) and quotes are being requested. The Solicitation number is RFQ-NIAID-24-2224314 and the solicitation is issued as a Request for Quotation (RFQ). This acquisition will be processed under FAR Part 13 Simplified Acquisition Procedures (SAP). The solicitation documents and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2024-05 Effective May 22, 2024. The North American Industry Classification System (NAICS) code for this procurement is 541380 – Testing Laboratories and Services with a size standard of $19M. The Product or Service Code (PSC) is Q301 – Medical-Laboratory Testing. The requirement is being competed as full and open competition without a small business set-aside. The government intends to award a firm-fixed-price purchase order to the responsible offeror as a result of this RFQ that will include the terms and conditions set forth herein. By submitting a quote, the offeror is accepting that all government terms and condition shall prevail over the award." STATEMENT OF NEED National Institutes of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Intramural Research (DIR) scientists study all aspects of infectious diseases, including the causative agent, vectors, and pathogenesis in human and animal hosts. Clinical research is an integral part of this mission, enabling key lab discoveries to be rapidly translated into methods to prevent, diagnose, or treat disease. DIR researchers annually conduct more than 200 clinical trials at the NIH Clinical Center on the Bethesda, Maryland, campus and at collaborating U.S. and international sites. In support of clinical research, the NIAID Centralized Sequencing Program (CSP) is comprehensive program that obtains genetic testing, harmonizes phenotypic and genomic data, performs variant interpretation, and provides clinically validated results for participants enrolled in a diverse set of protocols at the NIH Clinical Center. The goal of the NIAID CSP is both to contribute to the understanding of underlying genetic etiology of disease and to address the clinical need for genomic evaluations. The Government seeks commercially available clinical whole genome sequencing services, including interpretation and clinical reports, in support of DIR clinical research. These whole genome sequencing services will be conducted on multiple tissue types, including whole blood, saliva, fibroblast, peripheral blood mononuclear cell (PBMC), and other tissues, with results to be returned within 4 weeks. Contractor staff performing these services must include bioinformaticians and clinical molecular geneticists board certified by the American College of Genetics and Genomics with expertise in genetics and genomics with the capacity to complete high-throughput genome sequencing. Please reference the attached Statement of Work (SOW) and for detailed specifications and requirements. ESTIMATED PERIOD OF PERFORMANCE Base Period: September 23, 2024 – September 22, 2025 Option Period 1: September 23, 2025 – September 22, 2026 Option Period 2: September 23, 2025 – September 22, 2026 Option Period 3: September 23, 2025 – September 22, 2026 Option Period 4: September 23, 2025 – September 22, 2026 DELIVERY Return delivery of used sample well plates will be FOB: Destination to Bethesda, Maryland 20892 within 4 weeks of receipt of samples. INSTRUCTIONS All interested vendors must provide a quote for the requirement as outlined in Attachment 1 – Statement of Work (SOW). All quotes must include: Price(s) (unit price, total price) for all base and option quantities. Clear indication of the capability of the vendor to meet all specifications and requirements No more than three (3) references from within the last three (3) years indicating past performance of similar size and scope. Include organization name, point of contract information, and a brief description of the scope of the project. The Government may evaluate only those quotes that fully meet the requirements as outlined in the SOW and respond to the instructions and requirements below. Failure to furnish a full and complete quote as instructed may result in the Offeror’s response being considered non-responsive and will therefore be eliminated from further consideration and award. All or part of the successful vendor’s quote may be incorporated in any contract resulting from this solicitation. The successful vendor’s quote may be incorporated by reference. Any questions or concerns regarding this combined synopsis/solicitation are due by 3:00pm EST on September 9, 2024 and must be emailed to Seth.Schaffer@nih.gov. Quotes are due by 3:00pm EST on September 13, 2024. Quotes must be emailed to Seth Schaffer, Contract Specialist, at Seth.Schaffer@nih.gov. Late quotes will not be considered. All responsible sources may submit an offer that will be considered by this Agency. EVALUATION NIAID will evaluate quotes to determine the best value to the government. NIAID will make that determination based on technical capability, delivery, past performance, and price. NIAID will evaluate past performance and price only for those quotes which are rated as technically capable. The delivery/turnaround time requirement will be a part of the technical evaluation. In the event quotes are evaluated as technically equal, price will become a major consideration in selecting the successful Vendor. The Government will not award a purchase order to a Contractor at a significantly higher evaluated price to achieve only slightly superior performance capabilities. Likewise, the Government will not award to a Contractor simply because its quote is technically acceptable and also the lowest quoted price. The Government intends to award without discussions but reserves the right to conduct discussions should it be deemed in the Government’s best interest. The Government will evaluate quotes for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that a quote is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s). SPECIAL NOTICE TO VENDORS Vendors are advised that the Government may share your information with non-government personnel who are assisting with the evaluation of quotes. The exclusive responsibility for source selection will reside with the Government. By submitting your quote, you will be consenting to disclosure of your quote to non-government personnel for purposes of evaluation. ELECTRONIC INVOICING The successful vendor may submit an invoice once a shipment is delivered. NIAID will only accept invoices for units that have been delivered to NIAID and inspected and accepted. NIH is using a phased transition approach from the NIH Office of Financial Management (OFM) Electronic Invoice Submission instructions to the Department of Treasury’s Invoice Processing Platform (IPP). For contractors that have transitioned to IPP, the Contractor must submit invoices to the Department of Treasury’s IPP at https://www.ipp.gov. For contractors that have not transitioned to IPP, the Contractor shall submit invoices to the NIH OFM via email at invoicing@nih.gov with a copy to the approving official until the Contractor has been notified of its transition to IPP. REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (SECTION 889) All offerors shall have current documentation showing representation of compliance with Section 889 provisions. Prior to award of delivery order resulting from solicitation, quoters shall be prepared to provide copy of section 889 compliance if requested by the Contracting Officer. SECTION 508 Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities. Vendors must identify whether a quoted Information and Communication Technology (ICT) product or service is compliant with the Section 508 accessibility standards at 36 CFR 1194. The quote must also identify where full details of compliance can be found (e.g., vendor's website or other exact location.) For more information on Section 508 standards visit https://www.section508.gov/. PROVISIONS AND CLAUSES The following Federal Acquisition Regulation (FAR) provisions apply to this acquisition: FAR 52.252-1 – Solicitation Provisions Incorporated by Reference (Feb 1998) This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es): https://www.acquistion.gov/ (End of provision) FAR 52.203-18 – Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements – Representations (Jan 2017) FAR 52.204-7 - System for Award Management (Oct 2018) FAR 52.204-16 - Commercial for Government Entity Code Reporting (Aug 2020) FAR 52.204-24 - Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021) FAR 52.209-7 - Information Regarding Responsibility Matters (Oct 2018) FAR 52.212-1 - Instructions to Offerors – Commercial Products and Commercial Services (Sep 2023) FAR 52.212-3 - Offeror Representations and Certifications—Commercial Products and Commercial Services (May 2024) FAR 52.217-5 – Evaluation of Options (Jul 1990) Except when it is determined in accordance with FAR 17.206(b) not to be in the Government’s best interests, the Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. Evaluation of options will not obligate the Government to exercise the option(s). (End of provision) The following Federal Acquisition Regulation (FAR) clauses apply to this acquisition: FAR 52.252-2 – Clauses Incorporated By Reference (Feb 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquistion.gov/ (End of clause) FAR 52.203-19 – Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan 2017) FAR 52.204-13 - System for Award Management Maintenance (Oct 2018) FAR 52.204-18 – Commercial and Government Entity Code Maintenance (Aug 2020) FAR 52.204-21 - Basic Safeguarding of Covered Contractor Information Systems (Nov 2021) FAR 52.232-40 - Providing Accelerated Payments to Small Business and Subcontractors (Mar 2023) FAR 52.212-4 - Contract Terms and Conditions – Commercial Products and Commercial Services (May 2024) FAR 52.212-5 - Contract Terms and Conditions Required to Implement Status or Executive Orders Statements – Representation (May 2024) FAR 52.217-7 – Option for Increased Quantity-Separately Priced Line Item (Mar 1989) The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 14 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree. (End of clause) FAR 52.217-8 - Option to Extend Services (Nov 1999) The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 14 days. (End of clause) FAR 52.217-9 - Option to Extend the Term of the Contract (Mar 2000) (a) The Government may extend the term of this contract by written notice to the Contractor within 14 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 14 days before the contract expires. The preliminary notice does not commit the Government to an extension. (b) If the Government exercises this option, the extended contract shall be considered to include this option clause. (c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 30 months. (End of clause) By reference the Department of Health and Human Services Acquisition Regulation (HHSAR) provisions and clauses that are applicable to this requirement: HHSAR 352.203-70 – Anti-lobbying (Dec 2015) HHSAR 352.208-70 – Printing and Duplication (Dec 2015) HHSAR 352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) HHSAR 352.223-70 – Safety and Health (Dec 2015) HHSAR 352.224-71 – Confidential Information (Dec 2015) HHSAR 352.231-70 – Salary Rate Limitation (Dec 2015) By full text the Department of Health and Human Services Acquisition Regulation (HHSAR): HHSAR 352.232-71 - Electronic Submission of Payment Requests LIST OF ATTACHMENTS Attachment 1 – Statement of Work (SOW) Attachment 2 - FAR 52.212-5 Contract Terms and Conditions Required to Implement Status or Executive Orders Statements – Representation