RFQ__FDA-RFQ-22-112237.docx

1. Solicitation Number: FDA-RFQ-22-112237

2. Title: QIACube

3. Product Service Code: 6640

4. NAICS Code: 334516

5. Posted Date: May 13, 20222

6. Response Date: May 20, 3:00 p.m. Eastern Time.

Section B: SOW Section C: Contract clauses, including agency-specific clauses Section E: Instructions to offerors, including offeror Representations and Certifications.

Section B: SOW B-1 Background The Denver Laboratory and the Pacific Northwest Laboratory require additional QIACube units so that the new instrument could be used for automated extractions for complex environmental samples for EHEC (Enterohemorrhagic E. coli) analysis, a routine regulatory analysis, in addition to the current use for Whole Genome Sequencing for regulatory isolates. These units could also potentially be used for any other pathogen analyses that require an extraction step. The ability to provide a more consistent DNA yield as compared to manual extraction methods and throughput by automating this step helps conserve time and resources, as well as protect against potential contamination routes inherent in manual extraction.

B-2 Statement of Work QIACube and accessories and service from Qiagen (multiple catalog numbers see below).

Minimum Technical Requirements

System Requirements Altitude- Unit must be able to function at high altitude, or up to 6500ft.

Centrifuge- Centrifuge component must be able to maintain 10,640 rpm maximum, 12,00g maximum, a swing-out rotor maximum of 45° and have at least 12 rotor positions.

Environmental Class- Unit should be 3K2 (IEC 60721-3-3).

Instrument Dimensions- Unit should be approximately as follows: width 65cm (25.6 in.), height 58cm (22.8 in.), depth 62cm (24.4 in.) with hood closed; width 65cm (25.6 in. ), height 86cm (34 in.), depth 62cm (24.4 in.) with hood open; QIACube Connect Mass of 71.5kg (157.6 lb.) and Mass of accessories of 3kg (6.6 lb.).

Operating Temperature- Unit must have operating temperature range of 18-28°C (64.4-82.4°F).

Pipetting System- Unit must have a syringe size of 1mL with a pipetting range of 5-900uL.

Place of Operation- Unit must be for indoor use only.

Pollution Level- Unit must have a pollution level of only 2.

Relative Humidity- Unit must work in relative humidity range of 15-75% (non-condensing).

Shaker- Shaker component must be able to operate at a speed of at least 100-2000rpm, amplitude 2 mm, heating range of ambient temperature to 70°C (158°F), ramp-up time of <5 minutes from ambient temperature to 55°C(±3°C) with the difference in the temperature detected by the internal sensor and the temperature of the sample liquid being approximately -2°C.

Special Feature- The handheld scanner to be used with this unit must be included and conform to the following: the scan pattern must have an area image of at least 838 x 640-pixel array, a motion tolerance of up to 610cm/ s (240 in/s) for 13 mil UPC at optimal focus, a symbol contrast of 20% minimum reflectance difference and a decode capability to read standard 1D, PDF, 2D, Postal and OCR symbology.

Storage Conditions- Unit must be able to be stored in a temperature range of 15 to 30°C (59 to 86°F) in manufacturer’s package, at a relative humidity maximum of 75% (non-condensing) and be an Environmental class of 1K2 (IEC 60721-3-1).

Table capacity- The unit must have a table capacity of up to 12 samples per run.

Technical Data- The unit must have power of 100-240 V AC, 50/60 Hz, 650 VA for up to 2 seconds during the centrifuge acceleration and can reach an approximate value of 1000 VA; Fuse: 2x T6.3A L 250V, and be overvoltage category II.

Touchscreen: Touchscreen component must be 10.4” TFT Touchscreen with an active area of 211.2 x 158.mm and resolution of 800*600 SVGA.

Transportation Conditions- Unit must be able to be transported in a temperature range of -25 to 60°C (-13 to 140°F) in manufacturer’s package, in maximum 75% relative humidity (non-condensing) and environmental class 2K2 (IEC 60721-3-2).

UV Lamp- The UV Lamp component must have a wavelength of 278nm and optical power of 200 to 300mW.

Trade and Service Specifications

1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

1. FOB Point destination to include inside delivery and clean-up of area after installation.

1. The entire system must be warranted for parts and labor for 12 months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include at least a one (1) year warranty and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts.

1. Instrument operators shall have access to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

1. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification.

1. Contractor shall provide, at no cost to the government, one (1) Periodic Maintenance in accordance with the manufacturer’s recommendations at the end of the warranty period.

EQUIPMENT PURCHASES

MATERIAL/SUPPLIES: (List Below)

Security/Privacy Requirements/Risk Assessment

1. Safety precautions will be taken prior to and during installation.

2. Contractor will be cleared by security as a visitor upon arrival to both laboratories. Coordinator must inform contractor of this process before their arrival.

3. Section 2 of FDA Security and Privacy Language does not apply to procurements for only hardware and software licenses.

Records and Reports The Contractor shall, commensurate with the completion of each service call relating to the first year warranty, provide the end-user of the equipment with a copy of the field corrective service report identifying the equipment name, manufacturer, model number, and serial number of the equipment being repaired and detailing the reason for the warranty call, a detailed description of the work performed. The parts and the test equipment used to repair the system shall be on the report. This will include the name (s) and contact information of the engineer who performed the repair, and for information purposes, the on-site hours expended, and parts/components replaced.

Deliverables

Corrective action to fix the system under any failures during warranty

Within 15 days of request for service due to any inoperability of the system.

Field Service Report

Upon completion of each repair or periodic maintenance

Period of Performance One full year from date of formal acceptance by the government.

Place of Performance/Shipping Destination Food and Drug Administration- 2 Systems Denver Federal Center 6th Avenue and Kipling Street Building 20 Entrance W10 Denver, CO 80225

Section C: Contract clauses, including agency-specific clauses FAR / HHSAR Clauses:

I. The provision at 52.212-1, Instructions to Offerors – Commercial DEVIATION 2018-O0018, applies to this acquisition. The following addenda have been attached to this provision:

In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong.

II. Evaluation Criteria - The specific evaluation criteria to be used are as follows: Lowest Price Technically Acceptable.

III. Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer.

IV. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause – Not Applicable V. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable:

52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) 52.219-28, Post Award Small Business Program Representation (Nov 2020) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-26, Equal Opportunity (Sept 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) 52.222-50, Combating Trafficking in Persons (Oct 2020) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.204-7 System for Award Management (Oct 2018) 52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 52.204-24 Representations Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment 52.204-26 Covered Telecommunications Equipment or Services-Representation 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 352.239-73 Electronic and Information Technology Accessibility Notice (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) 352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

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VII. This acquisition is rated under the Defense Priorities and Allocations System (DPAS) as N/A VIII. The following notes apply to this announcement: N/A

Section 508 Requirements The following standards are applicable for this requirement:

· Must meet WCAG 2.0 A and AA

· E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements)

· E203 Access to Functionality (Appendix A, Application and Scoping Requirements)

· E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements)

· E205 Electronic Content (Appendix A, Application and Scoping Requirements)

· E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements)

· Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements)

· 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

Section E: Instructions to offerors, including offeror Representations and Certifications.

FAR 52.212-1 Instructions to Offerors—Commercial Items (Jun 2020)

PROPOSAL SUBMISSION FORMAT:

*The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.* QUOTES DUE: All quotes are due, electronically via email to Michael.Gemmill@fda.hhs.gov for the RFQ no later than May 20, 3:00 p.m. Eastern Time.

The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros.

FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

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