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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 10, 2015 FBO #4885
SOLICITATION NOTICE

66 -- Brand Name or Equal to an Agilent 1290 Infinity UHPLC System - Package #1

Notice Date

4/8/2015
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

334516 — Analytical Laboratory Instrument Manufacturing
 

Contracting Office

Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
 

ZIP Code

20857-0001
 

Solicitation Number

FDA-SOL-1145520
 

Archive Date

5/2/2015
 

Point of Contact

Corina L Couch, Phone: 2404025352
 

E-Mail Address

corina.couch@fda.hhs.gov
(corina.couch@fda.hhs.gov)
 

Small Business Set-Aside

Total Small Business
 

Description

Brand Name or Equal Combined Synopsis and Solicitation 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-1145520. This solicitation is issued as a, Total Small Business Set Aside in accordance with the SBA Non-Manufacture Rule waiver dated January 1, 2015, Request for Quote (RFQ), using the Simplified Acquisitions Procedures of FAR 13.5, Test Program for Certain Commercial Items. The solicitation documented and incorporated provisions and clauses in effect through the Federal Acquisition Circular (FAC) FAC 2005-80, Effective 02 Mar 2015. The associated North American Industry Classification System (NAICS) Code is - 334516 - Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 500 in number of employees. The US Food & Drug Administration (FDA) intends to issue a Commercial Item Firm Fixed-Price purchase order that meets the following specifications below. Please submit all quotes to be valid until September 30, 2015. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Agilent 1290 Infinity UHPLC System 3 EA $ Total Amount $ I. Background/Intro The Mycotoxin Group in the Southeast Regional Laboratory (SRL) analyzes various grains, nuts and milk commodities for toxic metabolites produced by certain fungi that can infect and proliferate on various agricultural commodities in the field and/or during storage. SRL serves as the national servicing lab for all districts for domestic aflatoxin testing. The increase in sample load for FY15 is justification for the need a Ultra High Performance Liquid Chromatography (UHPLC) system to analyze large volume of samples in less time would greatly increase sample throughput and decrease sample turn-around times. The demand for multi-residue analyses would require the use of this UHPLC system since it employs a dual detection system for both fluorescence and diode array detection. II. Minimum Salient Characteristics All of 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 FCC prior to purchase. A. General Characteristics: Pump: • Active seal wash or equivalent; Must be available for handling of solvents containing salt buffers so that it ensures longer lifetime of the seal when using higher buffer concentrations. • SW Features; To ensure that all the HW advantages can be automatically controlled and handled in SW o Variable stroke o Solvent bottle filling status o Pressure limit • SW features-diagnostics: to ensure high instrument uptime o Leak Test o Pressure test o Records, log files o Pump solvent delivered • The pump must have a settable flow range wider than 0.001 - 5 ml/min, in ≤0.001 ml/min increments that ensures flexibility over the whole flow rate range - standard analytical HPLC to semi-preparative HPLC • Must have a flow precision/retention of ≤0.07% RSD or 0.005 min SD, whatever is greater (0.2 - 5.0 mL/min) • Compressibility must be user selectable based on the solvent in use so that it ensures precise flow rates and therefore also RT precision • Variable stroke or equivalent. Usually is a system comprising of two dual piston in series pumps with proprietary servo-controlled variable stroke drive, floating piston design and active inlet valve which allows for Precise pumping results in precise flow rate and therefore in excellent RT precision. • Integrated Solvent degasser which is a system comprised of integrated two-channel degasser so that Reproducible solvent properties are maintained Mulitcolumn: • The temperature range must be 4°C to 110°C, (minimum 20°C below ambient) • The temperature accuracy must be ± 0.05 ° C or better • Must contain Pre-column heating and post column cooling • Must contain a local handheld control module must be available with plot-, diagnosis-, and error handling capabilities. • The temperature stability must be ±0.05°C or better • It must offer at least 2 different heat exchanger volumesLeak detection and safe leak handling design must be incorporated in the module housing • Must offer an electronic column-identification module as standard for GLP documentation of column type, and major column parameters • Must be able to contain a maximum of 24 columns of 100 mm length or 12 columns of 300 mm length (including pre-columns) • Must have to ability to change valve drive • Software must be available on the local controller and on the data system for single point control of the thermostatted column compartment as well as other modules of the same family FLD: • The instrument must have in single wavelength mode a Raman signal-to-noise of >500:1, with Ex350 nm, Em397 nm and using the reference dark value at 450 nm standard flow cell • The instrument must have in single wavelength mode a Raman signal-to-noise of >3000:1, with Ex350 nm, Em397 nm and using the reference dark value at 450 nm standard flow cell • The detector must be able to acquire spectra (excitation and emission) during the analysis (no stop flow needed) • The lamp can be switched on directly before the analysis because it needs no warm up time Autosampler: • Must have sample cooler configuration by adding a thermostatting module to control the temperature of the sample in the vial/well-plate • The metering device must have the capability to be always flushed after injection • Must have dual needle feature with two independent injection needles and loops optionally available • Offer different choices of rotor seals • Must have an accuracy of 0.7% (10 uL, n=10) or better • SW feature: The instrument must provide extensive information for diagnostic purposes and built-in tests • Thermostat: o Temperature range must be settable from 4°C to 40°C in 1°C increments (with a max. temperature of 5°C below ambient) o Temperature accuracy must be ±2°C at set-point of 4°C UV Detector: • Short term noise - Signal noise must be with 10 mm Max-Light cartridge cell: <±3·10-6 AU at 230/4 nm, slit width 4 nm, TC 2 s, ASTM with 60 mm Max-Light cartridge cell: <±0.6·10-6 AU/cm at 230/4 nm, slit width 4 nm, TC 2 s, ASTM • Wavelength accuracy must be at least ±1 nm, self-calibration with deuterium lines • Signal drift must be equal or less than 0.5 x10-3 AU/h at 230 nm after warm-up • Sampling rate must be settable 120 Hz (both spectra and signals) • Instrument manufacturer must be certified under ISO 9001 • Instrument manufacturer must be able to provide at shipment a declaration of conformity to specification describing tests performed as well as instrument serial number. • The manufacturer must provide software for hardware tests with printed reports (IQ/OQ) • The manufacturer must provide automated procedures for software performance verification. These tests must verify the structure and function integrity for data analysis compounds such as quantitation, integration, reporting, system suitability, library searching and peak purity for spectral analysis (IQ/OQ) • Must have electronic records of maintenance and errors. • Safe leak handling must be provided together with leak sensors B. Service Maintenance Agreement: The system shall include a one (1) year full manufacturer's warranty on all parts, travel and labor, including software and hardware and shall include at a minimum: coverage on all non-consumable items and parts supplied including base instrument, computer, monitor, printer, and unlimited on-site service visits with a maximum 72-hour response time, factory-certified replacement parts, engineer labor and travel costs, software updates and notifications. C. 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: One complete GC-IR-MS instrument to be shipped to and located at the following laboratory: US FDA Southeast Regional Laboratory 60 8th Street NE Atlanta GA 30309 The system must be delivered during normal business hours (M-F, 8:00AM - 4:30 PM EST). 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 (May 2014), 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 (Dec 2014), 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. 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 (Mar 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 (Feb 1999) 52.222-26 Equal Opportunity (Mar 2007) (E.O. 11246) 52.222-35 Equal Opportunity for Veterans (Jul 2014) (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 52.211-6 -- Brand Name or Equal (Aug 1999) FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 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 15-223-SOL-00053. The quotes are due by email to the point of contact listed below on or before April 17, 2015 by 1:00pm ET. Please contact Corina Couch at 240-402-5352 or email at Corina.Couch@fda.hhs.gov
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-SOL-1145520/listing.html)
 

Place of Performance

Address: US FDA Southeast Regional Laboratory, 60 8th Street NE, Atlanta GA 30309, Atlanta, Georgia, 30309, United States

Zip Code: 30309
 

Record

SN03693419-W 20150410/150408235147-0b2cc328d99f3ed2e0dc48a99988037e (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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