RFQ_1216698_-_XRF_Analyzer.docx

FDA-19-RFQ-1216698 Page 2 of 6 Energy Dispersive XRF Analyzer

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6 and 13.501(a), as supplemented with additional information in this notice. Quotes are being requested and this announcement constitutes the only solicitation. The Government contemplates issuing a firm fixed-price purchase order resulting from this solicitation. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2019-01 dated January 22, 2019.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334516 – Analytical Laboratory Instrument Manufacturing, with an associated size standard of 1,000 employees. This requirement is being solicited as a Full & Open/Unrestricted.

PART 2 – SUPPLIES OR SERVICES AND PRICES/COSTS

Contract Type: The Government intends to issue a firm fixed-price purchase order resulting from this solicitation.

Pricing Table:

PART 3 – DESCRIPTION OF REQUIREMENT

Background This purchase is intended to provide an energy dispersive X-ray fluorescence analyzer (EDXRF) to support the development and implementation of more advanced radioactive Sr method used by the Food and Drug Administration’s (FDA) Total Diet program. It will also be used to gain insight into food mineral composition in support of developing other radioanalytical methods needed by FDA radiological emergency response program. The liquid scintillation methods for the detection of radioactive Sr require a sensitive and direct measurement technique for determination of Sr and Y chemical yields. EDXRF analyzer has been proven to be suitable for direct quantification of Sr and Y in test sample without additional sample preparation after radioactivity measurement. The EDXRF’s ability to gain insight into sample mineral composition is indispensable in development of robust radiochemical separation schemes for ensuring a wide range of matrix tolerance.

Objectives The objectives of the requirement are for the Contractor to:

· Provide and install an energy dispersive X-ray fluorescence analyzer

· Demonstrate system functionalities and acceptable performance per manufacturer’s specifications after installation

· Provide onsite training on basic operation, routine maintenance, and sample analysis

Scope The requested XRF analyzer shall be provided as an off-the-shelf product without the needs for additional post-installation research, development, and validation. The installed XRF analyzer shall have all hardware, accessories, and software for performing qualitive and quantitative elemental analysis across the periodic table.

Minimum Technical Requirements The energy dispersive XRF analyzer shall meet or exceed the following salient characteristics:

· EDXRF analyzer must be able to quantify Sr or Y at concentration of ~100 ppm with ~1% accuracy while using measurement time of 5 min.

· Shall be a benchtop energy-dispersive XRF spectrometer capable of making versatile and rapid quantitative/qualitative analysis of Fluorine (F) through Uranium (U) from % to ppm levels in solid and liquid substances of any shape, size or composition.

The instrument shall be fully configurable for the applications that require air, vacuum or helium chamber options.

· Shall have main components to provide high sensitivity and wide elemental range to adapt to changing process, product and regulatory requirements. It shall feature a high-intensity primary-filtered X-ray beam with an excitation area of ~200 mm2 or higher for rapid and precise measurement of bulk materials. Optional collimators and sample camera shall be available to facilitate analysis of small samples or features. The spectrometer must use ultra-sensitive large-area Si drifted detector (SDD) to capture more X-rays and permit analysis of even weakly fluorescing materials or minute sample amounts down to nanogram levels. The spectrometer shall have single-sample stage large enough to accommodate analysis of large samples. A versatile auto-samplers with options for analyzing minimum samples up to 47 mm in diameter and providing custom solutions for different sample throughput must also be available. The analyzer shall be configured for vacuum pump operated at no less than 115 volts and meet the strictest American and European safety and design standards.

· All instrument components shall meet their respective specifications:

· Silicon (Si) drift detector (SDD) shall offer:

Energy resolution: FWHM ≤140 eV @ Mn Kα Enhanced light-element sensitivity Excellent resolution at high count rates Electrical cooling for care-free 24/7 unattended operation

· Digital pulse processor shall offer:

High resolution and throughput Adjustable peak-shaping time Real-time display of all instrument status and operating parameters Advanced built-in low-level diagnostic and tuning software Single-cable ethernet connection to computer for all control and data transfer

· X-ray tube and high-voltage power supply shall have:

Rhodium (Rh) as target for X-ray generation 50 W maximum output power (kV x mA) Adjustable voltage range between 4 - 50 kV Adjustable current range between 0.02 - 1.98 mA Design for maximum signal intensity Air cooling that requires no external accessories or connections Automated powered on/off feature for maximizing X-ray tube lifetime Radiation shielding and triple-redundant interlock safety system Ability to achieve minimum <0.3% RSD stability during sample analysis Radiation shielding and safety interlock that conform to the current electrical and radiation safety standards in the US

· Primary excitation shall be filtered for optimal control of peak-to-background and shall have:

Full coverage from F to U Attribute to be insensitive to sample geometry variations Requires no alignments or adjustments Customizable filters for specific applications

· X-ray beam size shall be adjustable:

To yield an excitation area on sample suitable for representative bulk analysis To allow use of changeable beam collimators for different applications

· CCD Camera for XRF sample imaging shall be:

A high-resolution digital camera should be included Provided with features for allowing identification, positioning, and analysis of small samples or articles with spatial resolution of <0.5 mm All-digital design and has dedicated light source Able to store sample image in form of retrievable file Able to operate in air, vacuum, or helium atmospheres Factory installed and tested

· Sample spinner shall be:

Controllable (on or off) through the software

· The instrument sample trays shall have the following sample loading capacities and features:

Shall have minimum a 20-position sample tray accommodating 31 mm diameter samples Shall have minimum a 10-position sample tray accommodating 47 mm diameter samples Shall be fabricated from anodized metal for longevity and durability Shall be enable a sample spinner to produce more representative sample analysis Shall be easily removable for loading and unloading samples Shall be able to maintain ±0.5% repeatability for each sample position

· Vacuum chamber for optimal analysis shall have the abilities:

To analyze elements from F to Ca in solids and pressed powders To work with computer-controlled vacuum pump To work with computer-controlled valve assembly for pumping and venting

· Helium Flush option shall have the abilities:

To analyze F to Ca in liquids and loose powders To work with computer-controlled valve assembly for He purge To use user supplies Helium gas cylinder and regulator

· Vacuum pump kit used for purging air from sample chamber environment shall include:

A computer-controlled vacuum pump no less than 100-240 VAC, 50/60 Hz A computer-controlled valve assembly for pumping and venting Necessary hose, fittings and power cables for plug-and-play operation

· Instrument applications software shall include:

A no-compromise XRF applications package for any analytical task ranging from routine process control to complicated materials and advanced research projects A system software for allowing complete computer control of all hardware, including X-ray power, filters, analysis time, resolution, auto-sampler, etc.

Multiple spectrum processing techniques for accuracy and flexibility in peak deconvolution Automatic escape peaks and sum peaks removal Multiple empirical (traditional) algorithms for quantitative calibrations with any type of standards Comprehensive theoretical calibration with any number and type of standards for any number of analytes Theoretical correction for inter-element absorption, stoichiometry and unmeasured compounds Display and manipulation of calibration curves to evaluate methodology Automatic simulation of standards as unknown samples to evaluate calibration accuracy Fundamental Parameters based thickness analysis module designed to analyze complex layered structures Automatic current (power) adjustment to guarantee optimal analysis of various samples with the same method Use of direct excitation and various filters on each sample for complete multi-element analysis with optimal sensitivity Feature for allowing analysis duration to be selected based on time or on peak counts Push-button routine operation directly from the Windows Start Menu Support for Microsoft Windows10 (64 bits) Feature for allowing operator environment to be easily customized using standard Microsoft Windows functions Password protection of key analytical tasks to assure safety of data and effort Pre-loaded software and ready to use out of the box

· Standardless analysis package shall be:

Capable of achieving superior accuracy with theoretical models that have been laboriously refined for the specific hardware parameters of the spectrometer Provided with EDXRF algorithm models enable to account for more variety in X-ray excitation, peak overlaps, background effects, and sample-specific properties, such as sample area, height, and mass Advanced enough for superior, versatile, and sensitive sample scan using 8 excitation conditions and able to obtain a complete elemental profile of the sample across multiple emission series and determine what’s there – and what isn’t – without any prior knowledge of the material Provided with other key features such as thorough analysis for all possible elements between F and U, fully pre-calibrated on the spectrometer and ready to analyze out of the box, iterative compositional analysis and spectrum deconvolution reduce false positives Able to exhibit clear and intuitive reporting of major, minor, and trace components Able to adjust method for specific applications and correct beam size and sample properties Capable of using application-specific standards to improve accuracy Capable of performing long-term hardware drift correction with pure elements

· Documentation and accessories shall include:

Complete user and technical documentation on CD-ROM Technical manual in electronic (pdf) format User guide and software manual in electronic (pdf) format QA/QC standard and procedures for monitoring system performance

· Desktop computer shall include:

Intel Core I5 processor, minimum 4 GB memory Minimum one hard disk drive (500 GB) Microsoft® Windows 10 Pro (64-bits) One 23" or larger widescreen flat panel display with a HDMI port USB keyboard and mouse Minimum 1 VGA port and 1 x HDMI port Minimum 2 Ethernet 10/100/1000 LAN interface (RJ-45 connector) Minimum 1 serial port Minimum 6 USB ports Minimum 1 USB color LaserJet printer Factory installation and configuration of operating system and instrument software

Trade and Service Specifications

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

2. Offered systems shall be a turn-key solution, i.e. the contractor shall be responsible for providing all hardware, components, and software. The products shall be fit for intended purpose.

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

4. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

5. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used are evaluation criteria for award. The instrument shall not be accepted until those performance specifications have been met.

6. 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.

7. 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.

8. Preventative maintenance (PM) visit shall be included for the base contract year. This 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 which perform this service shall trained by the OEM.

9. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 60 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.

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

Deliverables

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. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed).

Security Check in with security at front entrance.

Delivery Location Delivery must be coordinated with ORA/WEAC at least 48 hours in advance:

U. S. FDA Winchester Engineering and Analytical Center Attn: POC to be identified at time of award 109 Holton Street Winchester, MA 01890

Place of Performance:

U.S. FDA Winchester Engineering and Analytical Center 109 Holton Street, Winchester, MA 01890

Period of Performance:

The Period of Performance begins the date of contract award execution and continues for one year (or longer depending on how long the OEM offered warranty period is) from the date of formal government acceptance. Instrument to be delivered no later than 60 days from contract award.

PART 4 - PACKAGING, MARKING and SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and contractor name. The contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. All delivered equipment shall be newly manufactured, not used or refurbished or previously used for demonstration.

PART 5 – 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.

PART 6 – DELIVERIES OR PERFORMANCE

Deliveries and Place of Performance Satisfactory performance of this contract shall be deemed to occur upon delivery of equipment described above and/or upon acceptance by the Contracting Officer or the Technical Representative of these products/services. Deliveries required by the contractor shall be made F.O.B. destination no later than 60 Days from receipt of the award of order. One EDXRF shall be delivered and installed to the U.S. FDA Winchester Engineering and Analytical Center listed below:

Laboratory

109 Holton Street Winchester, MA 01890

The POC for this requirement will be identified at the time of award. The Contractor shall contact the Government POC at least 48 hours prior to delivery or service. Unless otherwise specified, deliveries shall be made to the Place of performance specified above, Monday through Friday (excluding Federal Holidays between the hours of 8:00 a.m. and 4:00 p.m. in accordance of the delivery location time zone (Eastern Time, Central Time, or Pacific Time)). Supplies or services scheduled for delivery on a Federal holiday shall be made the next business day.

PART 7 – 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.

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.

FDA Three-Way Match Invoicing Procedures A. The contractor shall submit all invoices to:

U.S. FOOD AND DRUG ADMINISTRATION

Attn: Vendor Payments Division of Payment Services 10903 New Hampshire Ave WO32 - Second Floor

MAIL HUB 2145

Silver Spring, MD 20993-0002 301-827-3742 FDAVendorPaymentsTeam@fda.hhs.gov

*** Acceptable methods of delivery include: E-mail (preferred) and Standard Mail.

B. Invoices submitted under this contract must comply with the requirements set forth in FAR Clauses 52.232-25 (Prompt Payment) and 52.232-33 (Payment by Electronic Funds Transfer - System for Award Management) and/or other applicable FAR clauses specified herein. To constitute a proper invoice, the invoice must be submitted on company letterhead and include each of the following:

(i) Name and address of the contractor;

(ii) Invoice date and invoice number;

(iii) Contract/Order number (including a reference to any base award for Indefinite-Delivery/Indefinite-Quantity Contracts or Blanket Purchase Agreements);

(iv) Description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed, including:

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on government bill of lading;

(vi) Terms of any discount for prompt payment offered (Prompt Payment terms other than NET 30);

(vii) Name and address of official to whom payment is to be sent (must be the same as that in the purchase order/award, or in a proper notice of assignment)

(viii) Name, title, and phone number of person to notify in event of defective invoice;

(ix) Taxpayer Identification Number (TIN);

(x) banking routing transit number of the financial institution receiving payment for Electronic funds transfer (EFT);

(xi) Name and telephone number of the FDA Contracting Officer Representative (COR) or other Program Center/Office point of contact, as referenced on the award;

(xii) For all Inspections, Time-and-Materials and Labor-Hour Awards, 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:

(xiii) Any other information or documentation required by the award.

C. An electronic invoice is acceptable if submitted in adobe acrobat (PDF) format. All items listed in (i) through (xiii) of this clause must be included in the electronic invoice. Electronic invoices must be on company letterhead and must contain no ink changes and be legible for printing.

D. Questions regarding invoice payments should be directed to the Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. 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.

Payment Schedule:

The Contractor shall submit invoices subsequent to the delivery of the required equipment.

PART 8 – CONTRACT PROVISIONS AND CLAUSES

This is an Order pursuant to the terms and conditions of the Contractor’s GSA FSS. In the event of a conflict between the clauses of this Order and the Contractor’s schedule contract, the clauses of the schedule contract shall take precedence.

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

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation.

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification.

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer.

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

(End of provision)

HHSAR Clauses:

HHSAR Clauses and Provisions can be viewed in full text at: https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html

352.222-70 -- Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015)

PART 9 – INSTRUCTIONS TO THE OFFEROR

Quotes shall be submitted no later than 4:00 p.m. (Eastern Time) on Wednesday, July 25, 2019 Quotes shall be submitted via email in native MS Word or Excel or PDF format to the Contract Specialist, Todd Johnston at Todd.Johnston@fda.hhs.gov.

The offeror’s quote must outline all characteristics of the requirement listed in Part 3 – Description of Requirements. The contractor quote shall provide sufficient information to allow the Government to evaluate that the Contractor is capable of meeting the requirement. The Government is not responsible for locating or securing any information which is not identified in the quote. In accordance with FAR 52.211-6 – Brand Name or Equal, offerors shall provide the brand name product referenced in this solicitation, unless the offeror clearly indicates that the product being offered is an “equal” product. Offerors may propose equivalent equipment; however, it shall demonstrate that the proposed equipment meets or exceeds the minimum salient characteristics. Offerors shall furnish as part of their quote all descriptive material necessary for the Government to determine whether the proposed products meet all technical requirements specified in Part 3.

The Offeror shall submit a completed pricing table in Part 2 for a firm fixed-price order. The Contractor shall provide the price and all detailed documentation to support the total cost of the quote. The firm fixed-price proposed shall be inclusive of all shipping and any other costs associated with meeting all the requirements listed in Part 3 – Description of Requirements. Equipment offered must be listed under the contractors GSA schedule contract. The Government is requesting additional discounts from the GSA schedule price list. Offers for equipment designated as open market must be clearly stated as “Open Market items” and may not be considered.

PART 10 – GENERAL EVALUATION INFORMATION

The Government intends to award a firm-fixed price order against the GSA Schedule 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. Contractor selection will be based on the lowest price technically acceptable (LPTA) offer that can “meet or exceed” the requirements stated in Part 3 and the delivery requirements in Part 6 of this solicitation. The Government reserves the right to award without discussions. The following factors shall be used to evaluate offers:

Technical Acceptability: The Government will evaluate the degree to which the quote meets or exceeds the requirements and specifications described in Part 3. The Offeror’s quote shall demonstrate the ability to “meet or exceed” the technical specifications of this requirement. Quotes will be rated either “Technically Acceptable” or “Technically Unacceptable.”

Price: Prices quoted shall be evaluated to ensure the best value to the Government and must be determined to be fair and reasonable in order to be considered for award. Prices quoted shall be in accordance with the offeror’s GSA Schedule, with any discounts applied, if any. The sum of the offeror’s proposed prices for all CLINs in the table in Part 2 will be evaluated. This RFQ does not commit the Government to pay any costs incurred in the preparation of the submission of the quotation or to contract for the supplies or services.