Comb_Synop-Solicit-COMPETITIVE - PCR - (Final).pdf

TEMPLATE

STREAMLINED SOLICITATION FOR COMMERCIAL ITEMS

COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION

Title: Qiagen LLC’s Real Time semi-quantitative PCR (RT-qPCR) and digital PCR (dPCR) system or equal

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

(ii) The solicitation number is 75N95024Q00575 and the solicitation is issued as a quotation (RFQ). This acquisition is for a commercial item and is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, and FAR Part 12 – Acquisition of Commercial Items, and is not expected to exceed the simplified acquisition threshold.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2024-06, with effective date August 29, 2024.

(iv) The associated NAICS code 334516 and the small business size standard is 1000 employees. This requirement is a Service Disabled Veteran Owned Small Business set-aside procurement.

(v) The National Institute of Neurological Disorders and Stroke (NINDS) is a part of the National Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The NINDS National Center for Infections of the Nervous System (INSS) Section research focuses on understanding the pathophysiology of retroviral infections of the nervous system and the development of new diagnostic and therapeutic approaches for these diseases. The laboratory has developed sensitive novel assays to measure genomic viral RNAs and their transcriptional activity within biological fluids from individuals with neurodegenerative disease as well as people living with HIV. The INSS researchers also frequently perform nucleic acid extractions from experimental samples, followed by quantitation of the expression of a large panel of genes related to neuroinflammation and neurodegeneration. Therefore, there is a need for a system that is capable of multiplexed amplification and detection of gene expression to further conduct new and ongoing research in the INSS laboratory.

(vi) The purpose of this acquisition is to procure brand-name real-time system that meets the needs of this procurement for documenting nucleic acid levels in experimental and clinical samples that NINDS has identified is Qiagen LLC’s Real Time semi-quantitative PCR (RT-qPCR) and digital PCR (dPCR) system.

Specific Requirement: Real Time aPCR and digital PCR System

Contractor shall provide brand name or equal Real Time semi-quantitative PCR (RT-qPCR) and digital PCR (dPCR) system that meets the need of this requirement is as follows:

Part Number / Description Manufacturer Quantity 9003204 / QIAcuity One 5plex PLT-FUL-5 9003197 / QIAquant 96 5plex (115V) SYS-DFUL-5 9003078 / QIAcube Connect MDx SYS-FUL-5 250011 / QIAcuity Nanoplate 8.5k 24-well (10) 250021 / QIAcuity Nanoplate 8.5k 96-well (10) 250031 / QIAcuity Nanoplate 26k 8-well (10) 250001 / QIAcuity Nanoplate 26k 24-well (10) 250102 / QIAcuity Probe PCR it (5mL) 250098 / QIAcuity Nanoplate Tray (2) 250299 / QIAcuity Demo Assay 209003 / qPCR adhesive plate foil (100) 209002 / qPCR 96-well plate, white, skirted (10) 9003094 / QIAsphere Connectivity Package B 9026181 / O-Ring Change Tool for QIAcube Connect 900395 / Starter Pack, QIAcube 900394 / Rotor Adapters (10 x 24) 990382 / Sample Tubes CB (2ml) 990381 / Sample Tubes RB (2ml)

Qiagen LLC One (1)

Salient characteristics: The significant, essential physical, functional, performance, or material element(s) that are the Government’s minimum acceptable standards for an equivalent system to meet the government’s objective are as follows:

The digital PCR (dPCR) part of the system must:

• have a multiplex detection of 5 different gene targets

• have a partition-based amplification of RNA and DNA with single copy sensitivity

• have the ability for low inter- and intra-plate variability, with coefficient of variation (%CV) below 10%

• have a sensitive detection of genetic mutations, copy number variation (CNV), and gene expression

• have an all-in-one automated platform that does not require users to transfer samples from compartment to compartment or machine to machine after run is started; no accessory equipment required

• have a total run time <4 hours from cDNA generation to analysis

• have a Software Analysis Suite that is accessible via local area network (LAN) to multiple computers

• have a total bench footprint not to exceed 16” X 28” X 20” (LXWXH)

• be warranted, and the Contractor shall warrant its equipment against defects in material, fabrication, or workmanship for a minimum of five (5) years effective from the date of installation.

The Real Time semi-quantitative PCR (RT-qPCR) part of the system must:

• have a multiplex detection of 5 different gene targets

• have the ability for low inter- and intra-plate variability, with coefficient of variation (%CV) below 10%

• have an all-in-one automated platform that does not require user to transfer samples from compartment to compartment or machine to machine after run is started; no accessory equipment required

• have an analysis software capable of quality control (melting temperature analysis, inter-replicate variability, Ct threshold determination) and quantifying fold change in gene expression

• have the ability to switch between 96-well and 384-well blocks between runs

• be warranted, and the Contractor shall warrant its equipment against defects in material, fabrication, or workmanship for a minimum of five (5) years effective from the date of installation.

Quantity: One (1) Qiagen LLC’s Real Time semi-quantitative PCR (RT-qPCR) and digital PCR (dPCR) system or equal

Delivery: Within 42-56 days after receipt of order (ARO)

The delivery shall be addressed to:

NINDS National Center for Infections of the Nervous System (INSS) Section Bldg. 10 / Rm. 7C120 10 Center Drive Bethesda, MD 20892

The equipment shall be delivered and installed between the hours of 8:00 a.m. and 5:00 p.m., Eastern Standard Time, Monday through Friday, except Federal Holidays. Delivery must be Freight on Board (FOB) Destination and include inside delivery. The equipment shall be delivered and installed in coordination with the Contracting Officer’s Representative (COR) at the time the equipment is ready to be shipped. Original Equipment Manufacturer (OEM) certified technician to perform the setup and installation of the equipment

The Contractor shall provide an Original Equipment Manufacturer (OEM) certified technician to perform the setup and installation of the equipment and shall provide on-site training within 30 days after equipment installation

(vii) The Government anticipates a firm-fixed price purchase order.

(viii) The provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:

https://www.acquisition.gov/browse/index/far https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

(End of provision)

The following provisions apply to this acquisition and are incorporated by reference:

• FAR 52.204-7, System for Award Management (Oct 2018)

• FAR 52.204-16, Commercial and Government Entity Code Reporting (Aug 2020)

• FAR 52.204-29, Federal Acquisition Supply Chain Security Act Orders –

Representation and Disclosures (Dec 2023)

• FAR 52.211-6, Brand Name or Equal (Aug 1999)

• 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 (Feb 2024)

• HHSAR 352.239-73, Electronic and Information Technology Accessibility Notice (December 18, 2015)

The clause at FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998), applies to this acquisition. 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 these addresses:

(End of clause)

The following clauses apply to this acquisition and are incorporated by reference:

• FAR 52.204-13, System for Award Management Maintenance (Oct 2018)

• FAR 52.204-18, Commercial and Government Entity Code Maintenance (Aug

2020)

• FAR 52.212-4, Contract Terms and Conditions—Commercial Products and

Commercial Services (Nov 2023). Addendum to this FAR clause applies to this acquisition and is attached.

• HHSAR 352.239-74, Electronic and Information Technology Accessibility (December 18, 2015)

The following provisions and clauses apply to this acquisition and are attached in full text. Offerors MUST complete the provisions below and submit completed copies as separate documents with their proposal.

• FAR 52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Nov 2021)

• FAR 52.204-26 Covered Telecommunications Equipment or Services- Representation (Oct 2020)

• FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Products and Commercial Services (May 2024)

• FAR 52.225-6, Trade Agreements Certificate (Feb 2021)

• NIH Invoice and Payment Provisions

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Products and

Commercial Services (Nov 2021), applies to this acquisition and is included as an attachment. The Government will evaluate quotations or offers in accordance with FAR 13.106-2 and award a purchase order from this solicitation to the responsible offeror whose quote conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate quotes:

a. Technical capability of the brand name or equal item offered to meet the Government requirement;

b. Price; and

c. Past performance [see FAR 13.106-2(b)(3)].

(x) Offerors must include a completed copy of the provision at FAR clause 52.212-3, Offeror

Representations and Certifications—Commercial Products and Commercial Services (Feb 2024), with its offer. If the offeror has completed FAR clause 52.212-3 at www.sam.gov, then the offeror does not need to provide a completed copy with its offer.

(xi) The following additional contract requirement(s) or terms and conditions as determined by the contracting officer are necessary for this acquisition and consistent with customary commercial practices. There are no additional contract requirement(s) or terms and conditions applicable to this acquisition.

(xii) The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

(xiii) Responses to this solicitation must include sufficient information to establish the interested parties’ bona-fide capabilities of providing the product or service. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s), product description, and any other information or factors that may be considered in the award decision. Such factors may include: past performance, special features required for effective program performance, trade-in considerations, probable life of the item selected as compared with that of a comparable item, warranty considerations, maintenance availability, and environmental and energy efficiency considerations.

Respondents proposing on an equal product of the brand-name product specified in this announcement must provide, as part of their response: (a) product, catalog, model, and/or part number(s); (b) product description; (c) all relevant information and documentation that the item(s) offered meets the salient physical, functional, or performance characteristics as specified in the purchase description; quantity; estimated price or cost; shipping, handling, and/or installation charges; and delivery date after receipt of order.

Responses to this solicitation must include clear and convincing evidence of the offeror’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, an estimate of the number of hours required for each labor category, fully loaded fixed hourly rate or each labor category, breakdown and rationale for other direct costs or materials, and the total amount.

The Unique Entity ID from SAM.gov, the Taxpayer Identification Number (TIN), and the http://www.sam.gov/ certification of business size must be included in the response. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All quotations must be received by 9:00 a.m. Eastern Time on 17 September, 2024 and reference Solicitation Number 75N950Q00575. Responses must be submitted electronically to Frederick Weddington at Frederick.weddington@nih.gov.

Fax responses will not be accepted.

http://www.sam.gov/ mailto:Frederick.weddington@nih.gov