SOLICITATION NOTICE
66 -- Ion Chromatographs - Package #1
- Notice Date
- 4/2/2015
- 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-1145829
- 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
- Ion Chromatographs 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-1145829. 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, dated March 02, 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 Ion Chromatographs 2 EA $ 0002 IQ/OQ/PQ 2 EA $ 0003 Training 1 EA $ Total Amount $ I. Intro/Background The United States Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA) has a requirement to purchase two (2) Ion Chromatographs for the Denver Laboratory. II. Objectives The FDA needs to purchase two (2) Ion Chromatographs to enable to easily and reliably detect and quantify Ionic food additives, coloring agents, and drugs. Many of these compounds undergo analytical requests which are rejected due to the lack of instrumentation. The purchase of these ion chromatographs will allow FDA to analyze ionic foods that are currently not being analyzed. III. Requirements All of the following are minimum requirements. Equivalent requirements that differ from these minimum requirements must be justified by the proposing vendor and evaluated by the Government. A. General specifications: The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. The entire system shall be warranted for parts and labor for 12 months from date of installation acceptance. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. Installation, operator familiarization, and training for up to four analysts shall be included for all modules. The vendor shall demonstrate and document upon installation that the System meets all performance specifications, including the sensitivity specifications. The instrument shall not be accepted until those performance specifications have been met. B. Functional specifications for Ion Chromatograph (IC): The ion chromatography system to be quoted must meet the following specifications. In order to determine the true cost of ownership pricing for replacement consumables must also be provided along with a copy of the current published price list for those items. 1. OVERVIEW OF IC SYSTEM: a) Must be a modular ion chromatograph consisting of a pump, conductivity detector, pulsed amperometric detector, conductivity cell, degas assembly, column compartment, column heater, suppressor, injector, and columns. Other modular detectors must be available to increase the flexibility of the system. Optional detectors must include; absorbance detectors, electrochemical detectors, and mass spectrometric detectors as a minimum. b) Must have inert, non-metallic fluidic components throughout the system to ensure solvent compatibility, corrosion resistance, and metal contamination-free chromatography. c) Must have the ability to perform gradients with a low pressure mixing pump. d) Suppressor must be operated continuously. Suppressor regeneration must be carried out either chemically or electrolytically. e) Instrument must permit field installation of an optional automation manager consisting of up to two 6-port or one 10-port high pressure and two low pressure solenoid valves for post-column derivatization or automated sample preparation operations such as online matrix elimination, online filtration, pre-concentration, as well as large loop/small loop injections controlled by the data system. f) Must have leak detection for laboratory safety and management to allow fast response to system leaks. g) Must have a built in vacuum degas assembly which provides in-line degassing of eluents ensuring reproducibility and protection of eluents from contamination and decomposition. Control of the degas operation must be able to be automated to sense when degassing is required. 2. PUMPING SYSTEM: a) The pump(s) must be of a dual piston serial design, microprocessor controlled, constant stroke, variable speed, and have isokinetic eluent pre-compression capabilities. b) The pumping systems available must be suitable for either low pressure mixing or isocratic analysis, flow rates. c) The pump housing must be able to incorporate up to two independent pumping systems which would be a quaternary analytical pump and a capillary pump. Field upgradability to a second pump must be available. d) The pump must have a pressure range of at least 0-35MPa (0-5000 psi) in analytical and 0-41MPa (0-6000 psi) in capillary; flow rate range of 0.000-10.000 mL/min settable in 0.001ml/min increments in analytical without changing pump heads and 0.001-0.1 mL/min settable in 0.001ml/min increments and up to 3.000 mL/min for pump priming in capillary; flow rate precision of <0.1%; flow rate accuracy of <0.1%; pressure ripple of <1% at 1.0 mL/min, <0.2% (with Damper) at 10 L/min; gradient proportioning accuracy of 0.5 at 2 mL/min. e) The pumping system must be suitable for quaternary low pressure mixing, isocratic analysis, and capillary flow rates. f) Must have an automated integrated piston seal wash which prolongs seal lifetime by preventing eluent crystallization on the seal surfaces. g) The pump must have user-settable pressure limits to automatically stop pump flow in the event of leaks, flow restrictions, or depleted eluent reservoirs and an optical leak sensor in event of a leak. h) The quaternary pump must support an unlimited number of linear, convex, concave, or inverse gradient profiles. 3. DETECTOR CHROMATOGRAPHY COMPARTMENT (DC): a) The DC houses and organizes chromatography components such as valves and columns. The DC contains three sections: 1) separation, 2) detection, and 3) automation. The three distinct sections keep plumbing organized while minimizing connection lengths, and improving peak efficiencies by reducing delay volumes. The sections are thermally controlled and accessible by independent compartment doors, separation being one and detection/automation the other. The doors insure individual thermal isolation. A total of 6 separate temperatures can be maintained simultaneously: separation, detection, (2) detectors, (2) IC cubes (capillary only), and reaction coil. b) The quoted system shall be able to use both conductivity, and pulsed amperometric detection. Both of these detectors shall be included with the system. c) The separation section must be thermally controlled and configurable to hold two valves. The valves can be either injection or column switching valves in order to meet today's needs and future expansion. All valves must be field installable. Temperature range must from 10-70 C; accuracy of 0.5 C; stability of 0.2 C; precision of 0.2 C. d) The detection section must be thermally controlled and able to house any combination of up to two detectors, conductivity (with or without suppressors) or electrochemical and automatically detectable by the software. The detectors must be able to operate in series or separately. The detectors must be field upgradeable. Temperature range must be from 10-40 C. e) The automation manager must be able to house and manage up to two IC Cubes. f) The automation manager (analytical only) must house up to two high- pressure valves, two 6- and/or one10-port, and up to two inert low pressure valves, either 2 or 3 way, up to two reaction coils (temperature range 5 C above upper zone, 80 C maximum), dual loops for pre-concentration, and must be field upgradable. The different options shall be quoted as the may be used at diferent times. g) The fluidic flow path must be PEEK to prevent corrosion and contamination of samples. h) Leak sensors must be provided for safety purposes. 4. SUPPRESSION: a) Both electrolytic and chemical suppression of eluent for analyses must be available. b) Electrolytic suppressors reduce the operator's exposure to hazardous chemicals by not requiring sulfuric acid as a regenerant. c) The suppressor must be operated continuously. d) Suppressor device must be able to suppress carbonate, hydroxide, and methanesulfonic acid eluents as required for EPA or ASTM methods. e). f) No moving parts: cite external suppression system wear parts; i.e., peristaltic pumps, rotors, tubing, and in line filters if required. g) Provide product warranty statement and limitations, attach official documentation. If warranty does not cover full replacement under all circumstances during warranty period cite the exceptions to the limited warranty. 5. AS-AP (AUTOSAMPLER): a) Autosampler must be capable of performing full-loop and partial-loop injections. b) Instrument must have optional software and hardware capability to analyze and automatically re-inject samples which exceed specified, user-selectable parameters such as peak area, peak height and amount. Method may include data system selection of a smaller loop, reduced direct injection volume ("partial loop" injection) or true "vial to vial" sample dilution. c) Must have an all PEEK flow path and be compatible aqueous and reverse-phase solvents. d) Must be capable of simultaneous or sequential injection. e) Must be capable of performing dilutions without additional hardware. f) Must have a moving-needle design to guarantee reliable sampling from a variety of sample vials. g) Must be capable of handling vials sizes of 10 mL, 1.5 mL, or well plates. h) Must be capable of using polystyrene, polypropylene, and/or glass vials. i) Autosampler capacity must be flexible to accommodate (81) 10ml vials, (120) 1.5ml vials, or (3X96 or 3X384) well plates. j) Capable of modifying a run sequence anywhere within the sampler during the run without interrupting analysis. k) Must be capable of sampling a minimum volume of 10 L from a 300 L microvial and 20 L from a 500 L microvial. l) Must have a variable volume range of 1-100 L in 0.1 L increments or 100-7500 L in 1 L increments depending on which sampling option is used. Both options shall be provided. m) Must have an injection precision of <0.3% RSD at 20 L in full loop mode and <0.5% RSD at 20 L in partial fill mode. n) Must have a dilution precision of <1% RSD for a 1:10 dilution, a dispensing precision of <0.2% RSD (by weighing), and a carryover of <0.01% with a 500 L flush volume. o) Must have as an option the ability to perform fraction collection and sample reinjection. p) Must have as an option the ability to house either one or two 6-port or 10-port valves for sequential injection, sample preparation, fraction collection, or sample injection. 6. SOFTWARE: a) The software must be a 64 bit application for future upgradeability. b) The software must be able to provide full automatic control of the process of analyzing samples. This must include acquiring data, quantitation, producing a report, and the option to upgrade to an incorporated excel-like spreadsheet for report flexibility. c) Standard curves must be generated using a variety of curve fitting routines. a. Must be able to select curves with at least 5 point calibration curves b. Must be able to select linear, or quadratic fit curves d) The software must be able to automate integration updates without time consuming batch reprocessing of changes to integration in a data set. e) The Software must allow real time integration monitoring in order for an instrument operator to monitor real time progress. f) The software must have the ability to customize the report format and content g) The instrument software must include self-diagnostic functions. h) The software must be able to control and acquire data from third party instrumentation including but not limited to chromatography pumps, detectors, and autosamplers. i) The software must include an analyte Separation Simulator that assists in optimizing IC separations by modeling their behavior in software, using known retention data and IC-specific retention algorithms. This allows the users to specify the analytes you want to separate and choose appropriate column and eluent system you want to model, and the simulator can find and display the optimal separation, together with a resolution map indicating the eluent concentration(s) required. 7. WARRANTY: a) All labor must be covered during warranty period. b) All parts must be covered during warranty period. c) The warranty must not have any situational limitations. d) Travel charges must be included during warranty period. e) Remote trouble shooting and support must be provided during warranty period. f) An official company warranty statement must be included with the bid and must also be stated in the operator's manual. C. IQ/OQ/PQ Services: The Vendor shall provide initial qualification, operational qualification, and performance qualification for all provided components. D. Training: The vendor shall provide sufficient training on the instrument for at least four (4) analysts. This is to be in addition to the familiarization at the time of installation. E. Delivery Considerations: The system must be delivered on a truck with lift gate capability as there is no loading dock. F. Delivery Addresses: US Food & Drug Administration Denver Laboratory (DEN-LAB) Denver Federal Center 6th and Kipling Building 20 Denver CO 80225 G. Clauses 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 (Dec 2014), applies to this acquisition. The following additional FAR clauses cited in the clause are applicable to the acquisition: • 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)). • 52.222-21 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 52.232-40 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 FDA-SOL-1145829. The quotes are due by email to the point of contact listed below on or before April 17, 2015 by 10:00am 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-1145829/listing.html)
- Place of Performance
- Address: US Food & Drug Administration, Denver Laboratory (DEN-LAB), Denver Federal Center, 6th and Kipling, Building 20, Denver, Colorado, 80225, United States
- Zip Code: 80225
- Zip Code: 80225
- Record
- SN03687056-W 20150404/150402235743-9a12bc59ef9a65b05985fc51d39381f3 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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