RFQ_-_FDA-18-RFQ_1199622(released).docx

Request for Quotation FDA-18-RFQ-1199622 Page 11 of 11 Ion Chromatography System

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:

PART 3 – DESCRIPTION OF REQUIREMENTS

Background The U.S. Food and Drug Administration (FDA), San Juan Laboratory in the Office of Regulatory Science (ORS), Office of Medical Products, Tobacco, and Specialty Laboratory Operations, needs to add an Ion Chromatography System to expand their analytical and research capabilities.

Purpose The San Juan Laboratory uses a wide variety of sensitive analytical instruments that provide the versatility needed by different analytical methods received under the diverse drug programs under FDA jurisdiction. The San Juan Laboratory is also an active participant in ongoing FDA and United State Pharmacopeia (USP) research (CARTS # IR01548 and IR01605). These methods include Ion Chromatographic techniques for both anion and cation species using a variety of detector types.

Ion Chromatography instruments are versatile and can perform analyses in cation or anion mode using a variety of detectors; however, the instruments are temperamental and take long periods of time to stabilize with drastic changes in the analytical methodology. In some cases, these changes are detrimental and expensive. The San Juan Laboratory has one Ion Chromatography System set up for both research and sample analysis. This instrument is set up to analyze anions using the conductivity detector and is in continuous use. To change from one set of conditions to another is not practical and may affect the quality and timeliness of our analyses and research. The goal at the San Juan Lab is to set up another instrument for cation analysis and have the option of alternate detector capabilities. This approach will eliminate down time and enable both cation and anion analyses with multiple detector types possible simultaneously.

Scope The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The Contractor shall provide a Modular Ion Chromatography System and additional services that meet the requirements below.

I. MINIMUM SALIENT REQUIREMENTS

All the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government prior to purchase **Offerors’ quotes shall address and meet or exceed each of the salient requirements to be considered for award**

· Modular Ion Chromatography System

· Capable of multiple applications:

· Anion

· Anion and Cation

· Cation

· Metal free flow path

· Integrated intelligent system components

· Operation pressure 0-35 MPa

· 1-year warranty

· Injection

· Full loop injection

· Optional partial loop injection

· Optional pick-up injection

· Internal Loops of 0.25 and 1 µL

· Sample Loops range from 1.5 to 1000 µL

· Column Thermostat with a temperature range of 0 to 80°C with <0.05°C stability

· Dual Piston Pump

· Capable of 0.001 – 20 mL/min flow rate

· <0.1% deviation reproducibility

· Capable of Low Pressure binary and ternary gradient

· Capable of High Pressure binary, ternary and quaternary gradient

· Suppressors

· Micro packed bed suppressor

· Organic modifier 0-100%

· 10-year warranty

· CO2 removal with green fluoropolymer technology

· Detector

· Conductivity Detector

· Measuring range 0 - 15'000 μS/cm (without partial range or range switching)

· Maximum backpressure of 5 MPa

· Temperature of 20 – 50 °C

· 0.8 μL Cell

· Optional UV/VIS Detection

· Optional Amperometric Detection

· Combinable Autosampler

· Instrument Control by Empower 3 Software

· Ion Chromatography Data Collection and Processing Software

II. Trade and Service Specs

· The Ion Chromatography system must be a newly manufactured unit, not used and refurbished or previously used for demonstration. The Government must be able to expect routine customer service and technical support to be available from the vendor during its lifecycle.

· The government requires a minimum one-year Original Equipment Manufacturer’s warranty on electronic components and shall include at a minimum: coverage on all non-consumable items and parts supplied and unlimited on-site service visits within 24 hours of call, factory-certified replacement parts, engineer labor and travel costs. The three-year warranty begins on the date of formal government acceptance and continues for the period of three years.

· The vendor shall provide to the user documentation of the qualification upon installation.

· The vendor shall demonstrate upon installation that the system meets or exceeds all salient characteristics which have been included in the vendor’s response and/or used are evaluation criteria for award, examples include, but are not limited to mass spectrometer sensitivity specification, mass spectrometer dynamic range, system reproducibility, etc. The instrument shall not be accepted until those characteristics have been met.

· All solutions and accessories for instrument maintenance, calibration and qualification must be provided by vendor at time of installation.

· Contractor shall provide on-site familiarization introductory on-site training for two users.

· Installation and familiarization shall be performed by a certified and trained engineer. Contractor to provide any necessary manuals and/or consumables to be used during training.

Repair Service (during warranty period)

· The Service Technician under the service agreement shall agree to unlimited repair service of any part or problem at no additional charge to the Government. This includes replace any part or parts that prove to be defective at no additional charge to the Government and includes upgrading any software etc. so that the system maintains its original functionality and intended purpose.

· The Contractor shall plan for the fastest delivery and will resume work upon receipt of parts within 72 business hours (3 days) or a mutually agreed upon time frame.

· Equipment repair and maintenance work is 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.

· Parts, labor, and travel/per-diem costs for PM and repairs to the PRLNW shall included in the price of the service agreement.

Documentation At the completion of each preventative maintenance inspection and emergency service call, the service technician is required to present a written service report to the SJNL Project Officer and Solicitation Point of Contact. This report should clearly indicate the date of the service, the type of service performed (emergency or preventative maintenance), the model and serial number(s) of the equipment serviced, the name of the field service technician and a brief description of the service performed. The Project Officer and/or Solicitation Point of Contact will sign the report and will receive a legible copy of the report from the Service Engineer.

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. Deliveries required by the contractor shall be made F.O.B. destination within 35 days from receipt of the award of order to the address listed below:

Food and Drug Administration San Juan Laboratory 466 Fernández Juncos Ave.

San Juan, PR. 00901-3223 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: The equipment shall be delivered within 30 days of contract award. 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)

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)

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.