HPLC with Diode Array

This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The solicitation number is FDA-SOL-1163202. This solicitation is issued as a Total Small Business Set, Request for Quote (RFQ). The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-85, Effective 04 Dec 2015. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 Employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. All quotes must be made valid until September 30, 2016. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 1 UHPLC Liquid Chromatography System 1 Each $ Total Amount $ STATEMENT OF WORK (SOW) I. General Description of Need Liquid chromatography is used extensively in the analysis of mycotoxins and antibiotics at PRLNW. The oldest of our liquid chromatographs dates from about 2008 and is no longer supported by the supplier. Because of the high usage of these instruments, it is critical that we replace the oldest of our chromatographs with a rugged, reliable, and accurate instrument. To augment the instrument's capacity, it is requested that the purchased instrument be capable of ultrahigh pressure (UHPLC) operation. II. SALIENT CHARACTERISTICS The desired instrument must perform ultra-high pressure chromatography. The provided instrument system must include: **Offerors shall address each of the salient characteristics in order to be considered** - Computer and monitor with installed software to run the UHPLC - Ultra High Pressure Liquid Chromatography instrument with a pressure 18,000 psi up to 1 mL/min, and 12,000 psi up to 2 mL/min - Automated, programmable sample dilution and standard addition capability - Binary pumps w/ high pressure solvent mixing - 6 port, 2 position multi-column selection valve - Integrated vacuum degassing, with minimum six line capacity - Column oven w/ minimum 2 column capacity and 2 independent temperature zones - Available gradient profiles: linear, step, concave and convex - Automated column information logging/tracking capability - Automated purge valve operation - A cooled sample compartment capable of maintaining samples down to at least 5'C - An autosampler - An ultraviolet/visible absorbance diode array detector - Fluorescence detector: 200-800 nm wavelength range - Single stage Mass selective detector with API electrospray interface.capable of acquiring full scan MS with Selected Ion Recording. Mass range 30-1250 m/z, mass accuracy better than +/- 0.2 Da over full mass range, 25 ms to switch between positive and negative ion modes. The system should be small enough to be placed on a laboratory bench. The supplier should be certified under ISO17025 or 9001. Upon installation, the supplier will perform preliminary performance checks on the instrument, including IQ, OQ, PQ, and provide documentation that it had been performed. A warranty for at least one year should be provided. Comprehensive Training for at least two analysts should be provided so that analysts are able to independently perform a FDA analysis upon completion of training. III. PERIOD OF PERFORMANCE The period of performance shall be for a base period of twelve (12) months. IV. GOVERNMENT FURNISHED PROPERTY The Government shall provide visitor's access to the FDA facilities during the performance of the contract. A. Special instructions The offeror shall include sufficient details on the technical specifications in order for a determination to be made as to whether the offeror meet all the technical requirements identified in the solicitation. Place(s) of Delivery: Food and Drug Administration - PRLNW Attn: LNW 16 365 22201 23rd Dr SE Bothell, WA. 98021 Hours of Operation: The Contractor will be responsible for delivering equipment between the hours of 8:00 am - 4:00 pm Monday thru Friday except Federal Holidays. When vendor arrives on site to deliver and install equipment, they will need to check in with the Front Security Guards and provide proper identification. They will receive an "Escort Required" temporary badge, which must be worn at all times in the building and will need to stay with lab personnel during their visit. If vendors need to enter into the laboratory, safety glasses must be worn. When their work is complete, they will check out with the same Security Guards, turning in their temporary badge. Tobacco, of any form, is not permitted on Federal Property, in Federal Buildings or parking lots. The following FAR and HHSAR clauses apply to this acquisition. FAR clauses and provisions can be obtained at https://www.acquisition.gov/far/index.html. The provision at 52.212-1, Instructions to Offerors-Commercial Items (Apr 2014), applies to this acquisition with the following addenda to the provision. Period for Acceptance of Offers: The offeror agrees to hold the prices firm through September 30, 2015. The provision at 52.212-2, Evaluation-Commercial Items (Jan 1999), is applicable to this requirement. The specific evaluation criteria to be included in paragraph (a) of that provision are as follows: The Government will award a contract resulting from this solicitation to the responsible offeror whose proposal meets the specifications listed under Part 3 of this solicitation and is the lowest priced proposal received in response to this solicitation. Therefore, award will be made to offeror whose proposal is determined to be Lowest Price Technically Acceptable. A written notice of award or acceptance of an offer mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award. The Provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Items (Mar 2015), applies to this acquisition. An offeror should complete only paragraph (b) of this provision if the offeror has completed the annual representations and certifications electronically at http://orca.bpn.gov. The clause at 52.212-4, Contract Terms and Conditions-Commercial Items (May 2015), applies to this acquisition with the following addenda: Invoice Submission: A. The contractor shall submit one original copy of each invoice to the address specified below: Office of Financial Services Food and Drug Administration W032- Second Floor MAIL HUB 2145 10903 New Hampshire Avenue Bldg 32, Rm# 2162, Mail Hub 2145 Silver Spring MD 20993-0002 Attn: Vendor Payments (301) 827-3742 or (866) 807-3742 fdavendorpaymentsteam@fda.gov B. The contractor shall submit one electronic copy of the invoice to each of the recipients listed below: Project Officer: TBD Email: Contract Specialist: Corina Genson Email: Corina.Couch@fda.hhs.gov 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 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) Purchase order/Award Number; (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; and (c) Any other supporting information necessary to clarify questionable expenditures; (V) Shipping number and date of shipping, 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; (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) Electronic Funds Transfer (EFT) banking information, including routing transit number of the financial institution receiving payment and the number of the account into which funds are to be deposited; (XI) Name and telephone number of the FDA Contracting Officer Representative (COR) or other program center/office point of contact, as referenced on the purchase order; and, (XII) Any other information or documentation required by the purchase order/award. C. QUESTIONS REGARDING INVOICES SHALL BE DIRECTED TO THE FDA AT THE TELEPHONE NUMBER PROVIDED ABOVE. The clause at 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Items (Dec 2015), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: (b) 52.203-13, Contractor Code of Business Ethics and Conduct (Apr 2010) (Pub. L. 110-252, Title VI, Chapter 1 (41 U.S.C. 251 note)). 52.219-6, Notice of Total Small Business Aside (Nov 2011) (15 U.S.C. 644 52.222-21 Prohibition of Segregated Facilities (Apr 2015) 52.222-26 Equal Opportunity (Apr 2015) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (Aug 2011) (E.O. 13513) 52.232-33 Payment by Electronic Funds Transfer - System for Award Management (Jul 2013) (31 U.S.C. 3332) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) FAR 52.222-41 Service Contract Labor Standards (May 2014) FAR 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) The following HHSAR clauses apply and can be obtained at the following website: http://farsite.hill.af.mil/VFHHSAR1.html 352.202-1 Definitions (Jan 2006) 352.203-70 Anti-lobbying (Jan 2006) 352.215-70 Late proposals and revisions (Jan 2006) 352.223-70 Safety and health (Jan 2006) 352.224-70 Privacy Act (Jan 2006) 352.228-7 Insurance--Liability to third persons (Dec 1991) 352.233-71 Litigation and claims (Jan 2006) 352.242-73 Withholding of contract payments (Jan 2006) 352.242-71 Tobacco-free Facilities (Jan 2006) 352.242-74 Final decisions on audit findings (Apr 1984) 352.270-1 Accessibility of meetings, conferences and seminars to persons with disabilities (Jan 2001) The supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officer's Representative (COR) specified at award. If the supplies or services are acceptable, the COR shall promptly forward a report of inspection and acceptance to the paying office. If the supplies or services are not acceptable, the COR shall document the nonconforming items/services and immediately notify the contracting officer. The COR name will be provided at time of award. The COR 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 contract; (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. It is the offeror's responsibility to monitor the internet site for the release of an amendment to the combined synopsis/solicitation (if any). Offerors that fail to complete the required representations and certifications, or reject the terms and conditions of the solicitation, may be excluded from consideration. All responsible sources may submit a quote, which if timely received, shall be considered. The quote shall reference solicitation number FDA-SOL-1163202. The quotes are due by email to the point of contact listed below on or before March 28, 2016 by 1:00pm ET. Please contact Corina Genson at 240-402-5352 or email at Corina.Couch@fda.hhs.gov