RFQ_-_FDA-18-RFQ_1200801(released).docx

Request for Quotation FDA-18-RFQ-1200801 Page 6 of 14 Gas Chromatographs

Offeror Name DUNS

PART 1 – GENERAL INFORMATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 and 13.1, as supplemented with additional information included 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 2005-100 dated August 22, 2018.

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 full and open.

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:

-Includes Shipping, Installation, Autoinjector,Sample Tray, Chemstation PC Bundle, Instrument Driver, IQ and OQ, and Maintenance.

(Base Period: Date of award through end of One-year Warranty Period)

(One-year after Base Period)

(One-year after Option Period I)

(One-year after Option Period II)

(One-year after Option Period III)

PART 3 – DESCRIPTION OF REQUIREMENTS

Background There is a need for the FDA to increase the efficiency with which nutritional analysis are performed. To meet this goal, we constantly strive to use the most innovative equipment and methods. Utilizing rapid analysis technologies such as gas chromatography is one way to improve efficiency. The GC is used in the analysis of Total Fat, Linoleic Acid, Omega 3, Omega 6, EPA, DHA, and Olive Oil adulteration.

The Gas Chromatograph (GC) will provide advanced separation capabilities, powerful new productivity features and real-time self-monitoring instrument intelligence. This new GC will provide retention time locking, faster oven heating and cool down, advanced automation features and at the lowest possible cost per sample. This GC will enable more sophisticated hydrocarbon analyses. A user-friendly software that will simplify method setup, system operation, routine maintenance and minimizes training time.

Objectives and Purpose The purpose of this requirement is to acquire two Gas Chromatographs (GC) with split/splitless injection capabilities, Flame Ionization Detectors, Electronic Pneumatic Control (EPC), fast heating ovens and cooling ovens, and low power consumptions or equivalent.

Scope The Contractor shall provide two (2) gas chromatographs. At a minimum, the system shall meet the specifications identified below:

SALIENT CHARACTERISTICS/SPECIFICATIONS

All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated the Government.

**Offerors shall address each of the salient characteristics in order to be considered.**

Both instruments shall have the following salient characteristics:

General

· Gas Chromatograph (GC) with FID detector.

· The system shall come equipped with a split/splitless injector, an autosampler capable of liquid injection (including all necessary connectors), sample tray, data system including computer, monitor, laser printer, instrument control software, data acquisition, data analysis, report formatting, and generation of data reports.

· The system shall come with fully validated software, computer, monitor, mouse, keyboard, and network compatible printer. The computer shall include all hardware necessary to communicate with the system. The computer system and software shall be LIMS compatible.

· The system shall be delivered with all necessary supplies and accessories required for installation, start-up, and qualification including standards for tuning the instrument, standards for setting up the detector, standards for verifying instrument performance, gas regulators, gas purification, gas tubing and fittings.

Warranty/Service Agreements/IQ-OQ

· A separate CLIN shall be included for a minimum of one (1) day onsite training at the installation location, for five people, on the operation and maintenance of the GC, including software. Onsite training shall occur on a date determined by the COR during installation. Contractor will arrange the date for training in advance.

· The instrument must be a newly manufactured unit, not used, refurbished, nor previously used for demonstration.

· A one-year manufacturer’s warranty shall be included with the purchase and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, autosampler, and unlimited on-site service visits with a maximum 72-hour on-site response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications.

· A minimum of three (3) GC shall have already been sold and successfully installed by the contractor in laboratories other than the contractor’s laboratories as a demonstration of performance history.

· As part of the evaluation process the Agency reserves the right to review the scientific literature and manufacturer’s application notes for information that demonstrates the instrument’s ability to:

· Perform retention time locking

· Low power consumption

· Provide an inlet that can be operated as a standard split/splitless injection port.

A separate CLIN shall be included for three option periods for post warranty and preventative maintenance. Post warranty and preventative maintenance shall include all services of the initial manufacturer’s warranty., which includes all parts, labor, travel, lodging and per diem expenses for service visits; 24-hour telephone technical support, 48-hour on-site response in addition to regularly scheduled PM service as prescribed by the manufacturer. The separate line items for each year’s service agreement will be used to determine the overall cost of ownership of the system.

All service shall be handled by vendor certified and trained engineers.

The system shall be quoted with separate line item for an Installation and Operation Qualification IQ/OQ for both hardware and software at the documentation level of the pharmaceutical sector or equivalent.

· The quotation for the IQ/OQ will be used to determine the overall costs of ownership in the event that qualification services are needed in subsequent years.

Automatic Sampler shall include the following:

· CTC type rail automatic sampler system (or equivalent) for liquid injection.

· Fully programmable to establish injector and tray position settings. Software to control the automatic sampler must be integrated in the instrument’s data and operating software.

· The automatic liquid sampler must have a tray that can hold 150 vials or greater (2-mL vials)

· Autosampler must have an active gripper sensor able to detect whether a vial has been grasped.

· Self-aligning injector and tray.

· User definable sandwich injection mode.

· Fully user definable dispense rate, draw rate and injection rate.

· Automatic sampler must be able to perform online dilutions and online Internal Standard additions.

· Shall be able to perform Large Volume Injections (LVI) up to 250 uL.

Gas Chromatograph shall include the following:

· Oven temperature set point resolution of at least 0.1oC.

· GC oven must support 20 oven ramps with 21 plateaus.

· GC oven shall be able to compensate for barometric pressure and ambient temperature changes. This reduces the influence of environmental factors on retention time repeatability. Methods remain stable when atmospheric pressure changes.

· Come equipped with both split/splitless injector and electronic pneumatic control (EPC).

· Injection port pressure set point should be adjustable with a pressure range from 0-150 psi with a pressure resolution of 0.01 psi and maximum operating temperature of 400oC.

The split/splitless injection port shall be designed to operate in the gas saver mode. Reduces gas consumption without compromising performance.

· The GC oven shall be able to operate in ambient temperatures from 5oC to at least 40oC and from 10% to 90% relative humidity.

· The GC shall provide a fast and precise oven temperature ramping from 4oC to 450oC with a resolution of 0.1oC.

· System shall be capable of back-flushing the column.

The system shall have Electronic Pneumatics Control (EPC).

The GC shall accommodate hydrogen as a carrier gas with minimal modification.

Data System

· The system shall have an integrated software package so that all simultaneous activities can be controlled through one interface. The GC data acquisitions shall be controlled through one software interface.

· The software package shall be able to run on the most up to date Windows platform and be compatible with Chemstation.

· The data system shall provide the tools needed to “lock” a retention time to a reference value even when the column is clipped for maintenance.

· Databases with the ability to lock spectra shall be available as an option for the customer.

· Integrated software shall be provided to customize the reports for the laboratory’s needs.

· The data system shall accept comma separated variable files to create an injection sequence.

· The data system shall allow the user to export a comma separated variable file with user specified fields.

· The data system shall be able to download methods from the supplier’s web site or from other instruments currently in the laboratory.

· Pricing shall be quoted in U.S. dollars.

Deliverables:

PART 4 – PACKAGING AND MARKING

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 new, not used or refurbished.

PART 5 – INSPECTION AND ACCEPTANCE

The Project Officer will perform inspection and acceptance of equipment, installation and services to be provided. The Project Officer – to be determined upon contract award - is the authorized representative of the Contracting Officer.

A final inspection and acceptance of all work performed, reports and other deliverables will be performed by the Government to ensure the services/products provided meet the requirements of the Statement of Work (SOW) at the time of delivery, and the contractor shall make changes as requested during the inspection and acceptance process.

Inspection and acceptance will occur at the place of performance and take place within 1 business day of task being completed. The Government will provide written notification of acceptance or rejection within 2 business days. Inspection will include review of the deliverables to ensure adequacy.

The Government will accept goods, reports and services only if they conform to all terms and conditions of the SOW, and satisfy the performance standards developed under this SOW.

The Government will reject non-conforming products and services. The Contractor shall correct any deficiencies within two 2-business days of when the Government issues the rejection notice. If the Contractor cannot correct the deficiencies within this period, the Contractor shall immediately notify the COR of the reason for the delay and provide a proposed corrective action plan within 1 day via email.

PART 6 – DELIVERIES OR PERFORMANCE

Satisfactory performance of this contract shall be deemed to occur upon delivery, installation, training, and performance of services described above or and upon acceptance by the Contracting Officer, or the COR, of these products/services. Most deliveries required by the contractor shall be made F.O.B. destination by September 30, 2018 to the address listed below:

Food and Drug Administration South East Regional Laboratory/ORA 60 8th Street, N.E.

Atlanta, GA 30309 POC: to be identified at time of award

Vendor must call the Government POC at least 48 hours prior to delivery. Unless otherwise specified, deliveries shall be made to the Delivery Point specified above, Monday through Friday (excluding Federal Holidays see below 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. Delivery must be inside the facility.

Period of Performance:

Base Period: Date of award through One Year Option Period I: One Year after Base Period Option Period II: One Year after Option Period I Option Period III: One Year after Option Period II Option Period IV: One Year after Option Period III

The systems shall be delivered and installed by September 30, 2018. The manufacturer’s warranty shall not begin until acceptance and installation of the equipment has occurred.

PART 7 – CONTRACT ADMINISTRATION DATA

The following personnel shall represent the Government for the purpose of this contract:

Program Office Technical Representative:

To be determined upon contract award

The Technical POC 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.

anthony.wimbush@fda.hhs.gov anthony.wimbush@fda.hhs.gov Tel: (240) 402-7628 Tel: (240) 402-7628

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. Provide a copy marked courtesy to the COR or Technical Point of Contact (TPOC). The COR/TPOC is (insert name and email address - TBD) 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:

(a) period of performance for which costs are claimed;

(b) itemized travel costs, including origin and destination;

(c) any other supporting information necessary to clarify questionable expenditures;

(d) the contractor shall include the award item number for each description, quantity, unit of measure, unit price, and extended price supplies delivered or services performed;

(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:

(a) list of all invoices submitted to date under the subject award, including the following:

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance;

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

Payment Schedule: The Contractor shall submit invoices after the delivery and installation of the required equipment.

PART 8 – CONTRACT CLAUSES AND PROVISIONS

FAR 52.252-2 Clauses Incorporated by Reference (Feb 1998) 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): https://acquisition.gov/far/

52.204-13 – System for Award Management Maintenance (Oct 2016) 52.204-18 – Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-4 – Contract Terms and Conditions – Commercial Items (Jan 2017) 52.232-39 – Unenforceability of Unauthorized Obligations (Jun 2013) 52.232-40 – Providing Accelerated Payments to Small Business Subcontractors (Dec 2013)

(End of clause)

FAR 52.212-5 - Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items (Jan 2018) The following FAR clauses cited in the clause are applicable to this acquisition:

_X_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note).

_X_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

_X_ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

_X_ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

_X_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_X_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

_X_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_X_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

_X_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

_X_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O. 13627).

_X_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) (E.O. 13513).

_X_ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

_X_ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

_X_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013) (31 U.S.C. 3332).

HHSAR Clauses HHSAR Clauses and Provisions can be viewed in full text at: http://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/part-352-solicitation-provisions-contract-clauses/index.html#352.1

352.222-70 – Contractor Cooperation in Equal Employment Opportunity Investigations (Dec 2015) 352.239-73 – Electronic Information and Technology Accessibility Notice (Dec 2015)

Full Text FAR Clauses 52.217-8 Option to Extend Services.

OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor anytime before contract expiration.

(End of clause) 52.217-9 Option to Extend the Term of the Contract.

OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor anytime prior to the contract expiration; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least one (1) day before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed 66months.

(End of clause)

Contract Provisions 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

52.212-1 - Instructions to Offerors – Commercial Items (Oct 2016)

· See Part 10 below 52.212-2 - Evaluation – Commercial Items (Oct 2014)

· See Part 11 below 52.204-7 - System for Award Management (Oct 2016)

· Prospective awardees shall be registered in the SAM database with completed representations and certifications.

52.204-16 - Commercial and Government Entity Code Reporting (Jul 2016) 52.204-18 - Commercial and Government Entity Code Maintenance (Jul 2016) 52.212-3 - Offeror Representations and Certifications -- Commercial Items (Nov 2017)

· If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.212-3 with this offer 52.219-1 - Small Business Program Representations (Oct 2014)

· If an offeror has not completed annual representations and certifications in the SAM database, offerors shall include a completed copy of the provision at 52.219-1 with this offer

(End of provision)

Section 508 Standard Compliance

Requirements for accessibility based on Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) are determined to be relevant for the following program need: "Data Services or Information Retrieval Systems."

Section 508 Deliverable Requirements The activity to be performed relates to or requires the use of EIT. Section 508 must be considered as a requirement for Systems Administration outputs/deliverables to ensure that it considers specific Section 508 accessibility requirements. Further, Systems Administration outputs/deliverables should not adversely affect accessibility features of existing EIT technologies. Technical standards from 36 CFR part 1194 Subpart B have been determined to apply to this acquisition. Solicitation respondents must describe how their background and experience will enable them to at least meet those technical provisions identified as applicable in the attached Government Product/Service Accessibility Template (GPAT).

Data Services or Information Retrieval Systems outputs/deliverables should meet applicable accessibility requirements and should not adversely affect accessibility features of existing EIT technologies.

Functional performance criteria from 36 CFR part 1194 Subpart C have been determined to apply to this acquisition. Solicitation respondents must describe how their Solicitation respondents must describe how their background and experience will enable them to at least meet those functional performance criteria identified as applicable in the attached Government Product/Service Accessibility Template (GPAT).

Information, documentation, and support requirements from 36 CFR part 1194 Subpart D have been determined to apply to this acquisition. Solicitation respondents must describe how the information, documentation, and support proposed for Data Services or Information Retrieval Systems outputs/deliverables will meet at least those information, documentation, and support requirements identified as applicable in the attached Government Product/Service Accessibility Template (GPAT).

Section 508 Evaluation Factors Responses to this solicitation will only be considered for award after it has been determined that the proposal adequately addresses the requirements for Section 508. Only proposals which contain adequate information to document their responsiveness to the Section 508 requirements (e.g. accessibility capabilities and past performance) will be eligible for any additional merit consideration.

Section 508 Acceptance Criteria Date and Information Services outputs/deliverables resulting from this solicitation will be accepted based in part on satisfaction of identified Section 508 requirements for accessibility. Data Services or Information Retrieval Systems outputs/deliverables must include a completed GPAT, a sample of which is included as a part of this solicitation.

Data and Information Services outputs/deliverables should meet applicable accessibility requirements and should not adversely affect accessibility features of existing EIT technologies The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS:

Subpart B, 1194.21 - Software Applications and Operating Systems Subpart C, 1194.31 - Functional Performance Criteria Subpart D, 1194.41 - Information, Documentation, and Support

PART 10 – INSTRUCTIONS TO THE OFFEROR

The provision FAR 52.212-1 incorporated above is tailored as follows. Quote is due September 4, 2018 at 3:00 p.m. (Eastern Time). Send via email in native (Word/Excel) or PDF format to the Contract Specialist, Anthony S. Wimbush at anthony.wimbush@fda.hhs.gov.

The offeror’s quote must outline all characteristics of the requirement listed in Part 3 – Description of Requirements. The quote shall include detailed technical qualifications to support the requirements. The Government is not responsible for locating or securing any information which is not identified in the quote. To ensure information is available, offerors must furnish as part of their quote all descriptive material necessary for the Government to determine whether the product and/or service meets all technical requirements specified in Part 3. The quote shall include any applicable technical specifications, descriptive material, literature, brochures and other information corresponding to each minimum performance specification, which demonstrates the capabilities of the offeror.

Price quoted shall be inclusive of all parts, labor, shipping and any other costs associated with the specifications listed in the Requirements (Part 3). If an offeror has not completed annual representations and certifications in the SAM database, offerors shall also include a completed copy of the provisions at 52.212-3 and 52.219-1.

PART 11 – GENERAL EVALUATION INFORMATION

The Government intends to award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be the most advantageous to the Government, price and other factors considered. Contractor selection will be based on the lowest priced technically acceptable (LPTA) quote. The quote shall be technically acceptable and price shall be determined fair and reasonable in order to be considered for contract award. 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.

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. Offerors shall confirm that delivery can be made within the delivery requirements. 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.