Elemental analysis attachment for Keyence Digital Microscope

Specifications/Requirements The contractor shall meet the following salient specifications for the Elemental analysis attachment for Keyence Digital Microscope: Salient Characteristics: The elemental analyzer attachment shall have a laser-induced breakdown spectroscopy. The elemental analyzer attachment shall have a Class 1 laser product with a wavelength of 355nm and spot size of 10 um. The elemental analyzer attachment shall have an image sensor equal to 1/1.8 inch, a magnification of 300x to 1000x, and a progressive scanning system with a frame rate of 50 fps (max). The elemental analyzer attachment shall have an optical system with a specifically designed reflective objective lens and a working objective distance lens of 25mm. The elemental analyzer attachment shall have an electronic shutter that can be both automatic and manual with the following 1/60, 1/120, 1/500, 1/1000, and 1/5000. The elemental analyzer attachment shall have a supercharger shutter that can be set in 0.01 s increments from 0.02 to 16 s. The elemental analyzer attachment shall have a built-in coaxial illumination light source that has a high-brightness LED with a service life of 10,000 hours and a color temperature of 5810K. The elemental analyze attachment shall have a build-in ring illumination light with a high-brightness LED with a service life of 10,000 hours and a color temperature of 5810K. The elemental analyzer attachment shall have a power supply with a dedicated cable form VHX Series controller camera port. The elemental analyzer attachment shall have dimensions of 280 (W) x 375 (H) x 210 (D) mm and 11.02”(W) x 14.76” (H) x 8.27”(D) with lens stored. The elemental analyzer attachment shall have a weight of approximately 7.2kg or 15.87 lbs. Trade and Service Specifications - The contractor shall ensure the following: The elemental analyzer attachment shall be a newly manufactured unit, not used and refurbished or previously used for demonstration. The elemental analyzer attachment shall include a twelve (12) month standard manufacturer warranty. The contractor shall be capable of servicing the instrument through the covered warranty period and shall include at a minimum: Coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, and 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 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 to perform maintenance and repairs. All parts used for Preventative Maintenance (PM) and repairs must be guaranteed, factory tested, OEM quality parts. Preventative Maintenance (PM) visit shall be included for the base contract year. Each PM visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers who perform this service shall be trained by the OEM. Contractor shall provide onsite familiarization training for 3-5 users at the time of installation or within 30 days such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training. Service Calls - The contractor shall provide the following: The Contractor shall respond within two (2) business days after receipt of a service call. The Contractor shall provide unlimited telephone and email access to instrument technical support at no additional charge Monday – Friday between the hours of 9am-5 p.m. EST. All repairs shall result in the instrument(s) serviced meeting the manufacturer specifications and must use factory new replacement parts. Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the site at the time of the service call or provide shipping instructions and return shipping information that the FDA may return the parts to the Contractor at the Contractor’s cost within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments. The Contractor shall perform a diagnostic test results or narrative summary demonstrating that the instrument is meeting the manufacturer’s specifications. The Contractor shall comply with the following: The Contractor shall contact the Lab POC upon contract award to pre-coordinate all site-specific preparation requirements to include electrical (e.g., circuit voltage/wattage and plug type), plumbing for water and/or gas, exhaust and any other site requirements that may be necessary for the equipment to be installed/setup. The Contractor shall pre-schedule delivery with the ordering lab/branch no less than two weeks prior to shipping date. Delivery shall be truck with lift gate (e.g., the FDA facility in Atlanta does not have a loading dock) Delivery shall include inside/to the bench delivery and setup at contractor’s expense. The Contractor shall have a tech on-site at time of delivery. The Contractor is responsible for removal of all packing and shipping materials to include crates and pallets at contractor’s expense at the completion of install/setup. The contractor shall demonstrate upon installation and testing that the item meets all performance specifications. Upon acceptance of the system, the contractor shall provide user on-site training for up to 6 (six) attendees, as well as classroom training (if available) for operating the system for up to 2 (two) attendees. Qualification Service Requirements The Contractor shall perform qualification for the software Installation Qualification and Operation Qualification (IQ/OQ) and hardware IQ/OQ at time of installation. All standard information on the equipment, including but not limited to User Manuals, Operation and Maintenance (O&M) Manuals, Material and Safety Data Sheets (MSDS), troubleshooting guides and any other applicable documentation, shall be provided upon installation of the system. Post-Warranty Service Requirements The contractor shall ensure the following: Preventive On-Site Preventive Maintenance inclusive of all labor, travel, and parts, components, subassemblies, etc. At a minimum, preventative maintenance shall include inspecting the materials testing machine for defects and correct operation. The system shall be cleaned, calibrated, and operationally tested to ensure correct function. A quality performance qualification test shall be completed, requiring the measurements to compare against the specifications. Unlimited on-site corrective maintenance/repairs shall be provided, inclusive of all labor, travel, parts, components, subassemblies, etc. to restore the system to qualified operational status. The Project Officer (PO) shall have access to the manufacturer’s call center for technical assistance. The call center must be staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. All maintenance/repairs shall be provided by service engineers who are trained and certified by the Original Equipment Manufacturer (OEM). Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. The contractor shall also include coverage for unlimited software and firmware updates. Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. Delivery: The contractor shall provide all labor, travel, and tools to install the equipment at the address provided below, to include inside delivery. Equipment shall be tested once installed to verify all aspects of the system are operating within parameters of the required specifications. The elemental analyzer attachment will be delivered and installed at: Southeast Feed and Food Laboratory, ORA Food and Drug Administration 60 Eighth Street NE Atlanta, GA 30309 POC: David Malakauskas 404-575-1564 [email protected] F.o.b. destination Period of Performance Delivery to include transportation to destination site at contractor’s cost, installation, testing and training, expected within 90 days of award with one year of corrective maintenance. Workplace is not available on the Government Holidays stated below, or as prescribed by an Executive Order (EO) due to inclement weather. Government Holidays January (New Year’s Day) September (Labor Day) January (Martin Luther King Day) October (Columbus Day) February (President’s Day) November (Veterans Day) May (Memorial Day) November (Thanksgiving Day) June (Juneteenth) December (Christmas Day) July (Independence Day) Type of Contract : Firm-Fixed-Price (FFP); The Government anticipates issuing a firm fixed-price purchase order. Set Aside: N/A Instructions to Offeror for Proposal Submission 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 [email protected] for the RFQ no later than July 18th, 2022, 4:00 p.m. Eastern Time. Late submissions may not be evaluated. The subject line shall read: FDA-RFQ-22- 1255390– Elemental analysis attachment for Keyence Digital Microscope. 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. Basis for Award/Evaluation Criteria The Government shall award a firm fixed price contract resulting from this solicitation to the responsible Quoter using the lowest price, technically acceptable (LPTA) evaluation method. The Government intends to evaluate quotes and award an order without discussions. Quoters' initial quote should contain the Quoters’ best terms from a price standpoint. The Government requests the Contractor to provide discounts off their established pricing for each line item. The Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The following factors shall be used to evaluate quotes: Lowest price, technically acceptable (LPTA). FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) (a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). http://www.ipp.gov/contractors/index.htm (b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov. (c) ----- (1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts. (2) Registration emails are sent via email from [email protected]. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to [email protected] or phone (866) 973-3131. (3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days. (4) If your company is already registered to use IPP, you will not be required to re-register. (5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures. (d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable). (e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. (1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred. - Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category. - Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirect)- show rate, base and total amount. - Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant. - Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed. - Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor. - Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and - Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable. (f) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (1) list of all invoices submitted to date under the subject award, including the following: - invoice number, amount, & date submitted - corresponding payment amount & date received - total amount of all payments received to date under the subject contract or order - and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance. (g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate. (h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO. (i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays. (j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort. (k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at [email protected]. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue. (END OF CLAUSE) 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 (LPTA). 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. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. (END OF CLAUSE) 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.