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FDA RFQ: 75F40121Q00126 ABI 7500 Preventive Maintenance Offeror Name DUNS PART 1 – GENERAL INFORMATION This is a combined synopsis/solicitation for commercial items prepared in accordance with the for... FDA RFQ: 75F40121Q00126 ABI 7500 Preventive Maintenance Offeror Name DUNS PART 1 – GENERAL INFORMATION This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 and 13.302 as supplemented with additional information included in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021-06 dated July 12, 2021. ****************************BRAND NAME OR EQUAL************************* THIS ANNOUCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40121Q00126 and is being issued as a Request for Quotation (RFQ). The NAICS Code for this solicitation is 811219 – Other Electronic and Precision Equipment Repair and Maintenance and the Small Business Size Standard is $22.0 Million Dollars. This will be awarded as Firm-Fixed Price. Prospective Offerors are responsible for downloading the solicitation and any amendments. The Government reserves the right to award without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary. The provision at FAR 52.212-1, Instructions to Offerors-Commercial, applies to this acquisition and any addenda to the provision. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items, applies to this acquisition. PART 2 – LINE ITEMS AND PRICES The Government intends to issue a Purchase Order. Offerors are requested to provide a fixed price quote in accordance with the Statement of Work. The offeror shall indicate if the minimum salient characteristics have been met to be considered technically acceptable for this requirement. PART 3 - DESCRIPTION OF REQUIREMENT / STATEMENT OF WORK ABI 7500 Preventative Maintenance (X4) Background The Food and Drug Administration, Denver Laboratory (DENL) requires a one-time preventative maintenance service to be performed on four (4) Applied Biosystem (ABI) 7500 Fast Real-Time Polymerase Chain Reaction (PCR) systems (Serial Nos. 275013437, 2750107606, 2750107607, 275010788). These instruments are routinely used for regulatory analyses for the Microbiology branch at the Denver Laboratory. These regulatory analyses include EHEC (Enterohemorrhagic Escherichia coli), Cyclospora, Salmonella, Virology and FERN methods for Select Agents. Objectives To acquire one-time preventative maintenance for these systems which will allow the Denver Laboratory to properly continue performing regulatory analyses in accordance with federal regulations. The maintenance will be performed on all four units at the Denver Laboratory. The one-time preventative maintenance will include a Windows 10 software update, depending on needs and suitability of existing equipment, which will be determined at the time of servicing. Upgrade of ABI systems software will also be performed. Scope The preventive maintenance is to include inspection, cleaning, calibration, and complete instrument check to ensure optimum performance. At conclusion, the instrument performance and calibration are to meet Applied Biosystems standards of acceptable certification. Task Requirements Preventive Maintenance Specifications The instruments must be inspected according to manufacturer’s preventive maintenance protocol. The instruments must be cleaned according to manufacturer’s preventive maintenance protocol. The instruments must be calibrated according to manufacturer’s preventive maintenance protocol. A complete operation instrument check to ensure optimum performance that meets ABI standards of acceptable certification. Upgrade each system computer to Windows 10 operating system, if computer is compatible. Upgrade each system computer with latest ABI systems software within the capabilities of each computer. Use only new, factory-certified parts as directed under manufacturer’s protocol. Documentation of performance as found and after cleaning/optimization must be provided and include all supporting system generated data. This documentation should be a hardcopy report and must include signatures by the performing technician and provide for signature of acceptance by the TPOC. The calibration date must have an expiration date of one year. All labor, travel costs, and software updates must be included. Use only manufacturer reagents and solutions during inspection, cleaning, and calibration of the instruments. All service must be performed in accordance with the specifications contained in the manufacturer’s service manual. Security and Privacy Requirements The Contractor (and/or any subcontractor) shall ensure IT applications designed and developed for end users (including mobile applications and software licenses) run in the standard user context without requiring elevated administrative privileges. The Contractor (and/or any subcontractor) shall follow secure coding best practice requirements, as directed by United States Computer Emergency Readiness Team (US-CERT) specified standards and the Open Web Application Security Project (OWASP), that will limit system software vulnerability exploits. The Contractor (and/or any subcontractor) shall protect information that is deemed sensitive from unauthorized disclosure to persons, organizations, or subcontractors who do not have a need to know the information. Information which, either alone or when compared with other reasonably-available information, is deemed sensitive or proprietary by HHS/FDA shall be protected as instructed in accordance with the magnitude of the loss or harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the data. This language also applies to all subcontractors that are performing under this contract. Safety precautions will be taken prior to and during preventative maintenance contracted performance. Contractor will be cleared by security as a visitor(s) upon arrival to Denver Federal Center Building 20. Coordinator must inform inside contractor of this process before their arrival. Covid-19 precautions- Special precautions must be taken to ensure safety of building residents and contractor regarding Covid-19 as specified in local guidance. Contractor will contact local POC listed herein for specifics prior to arrival. Records and Reports The Contractor shall provide, commensurate with the completion of each preventive maintenance, the end-user of the equipment with a service report identifying the equipment name, manufacturer, model number, and serial number of each system and 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 Deliverable Quantity Delivery Date Preventative Maintenance of ABI7500 units at Denver Laboratory 4 Within 90 days of award Period of Performance Services should commence and complete within 90 days of award and warranted for at least 90 days from date of acceptance by the government. Place of Performance/Shipping Destination Food and Drug Administration Denver Federal Center 6th Avenue and Kipling Street Building 20 Entrance W10 Denver, CO 80225 PART 4 - GENERAL EVALUATION INFORMATION EVALUATION AND AWARD The Government intends to make award based on Lowest Priced, Technically Acceptable (LPTA). Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc.) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. The total number of pages for the technical quote shall not exceed ten (10) pages. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov. The solicitation does not commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition. PART 5 – CONTRACT CLAUSES 5.1 INSPECTION AND ACCEPTANCE Inspection and acceptance will be performed at the delivery location. The Technical Point of Contact will perform inspection and acceptance of the materials delivered. Acceptance is communicated in writing unless otherwise indicated by the Contracting Officer of Technical POC within 30 days of receipt of the deliverable(s). If a rejection is issued, the Contractor shall correct any deficiencies within fifteen (15) days from the time the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this time frame, the contractor shall immediately notify the Technical POC of the reason for the delay and provide a proposed corrective action plan within three (3) business days. 5.2 CONTRACT ADMINISTRATION DATA The following personnel shall represent the Government to this contract: Technical Representative: To be determined upon contract award The Technical Representative is responsible for: (1) monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance. Contracting Officer (CO): Contract Specialist (CS): Madeline Bryant Pamela T. Lee 4041 Powder Mill Rd 4041 Powder Mill Rd Beltsville, MD 20705 Beltsville, MD 20705 Madeline.Bryant@fda.hhs.gov Pamela.Lee@fda.hhs.gov The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the RFQ; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor any costs incurred during the performance of this contract; or, (5) otherwise change any terms and conditions of this contract. 5.3 FAR 52.252-2 Clauses Incorporated by Reference. 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): Federal Acquisition Regulation (FAR): www.acquisition.gov/far/ PART 6 – SOLICITATION PROVISIONS 6.1 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): www.acquisition.gov/far/ (End of provision) 6.2 General Evaluation and Award Information (a) The Government will award a purchase order 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: Lowest price, technically acceptable. (b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer’s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. (End of provision)