SOLICITATION NOTICE
66 -- Dual Pressure Linear Ion Trap for FDA - Package #1
- Notice Date
- 4/1/2015
- 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-1145835
- Archive Date
- 4/25/2015
- 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
- N/A
- Description
- Combined Synopsis/Solicitation for Dual Pressure Linear Ion Trap 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-1145835. This solicitation is issued as a 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. SUPPLIES OR SERVICES AND PRICES/COSTS The contractor shall fill out the following pricing sheet: CLIN Description Qty Unit of Issue Price 0001 Dual Pressure Linear Ion Trap 1 EA $ 0002 IQ/OQ/PQ 1 EA $ 0003 Training 1 EA $ 0004 Option Year 1 - Post Warranty Preventative Maintenance 1 EA $ 0005 Option Year 2 - Post Warranty Preventative Maintenance 1 EA $ 0006 Option Year 3 - Post Warranty Preventative Maintenance 1 EA $ 0007 Option Year 4 - Post Warranty Preventative Maintenance 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 a Dual Pressure Linear Ion Trap for the Denver Laboratory. II. Objectives The FDA needs to purchase one (1) Dual Pressure Linear Ion Trap with Electro-Spray Ionization and Atmospheric Pressure Chemical Ionization (ESI and APCI). It is needed to perform work in a heavily used program area of the FDA chemistry laboratory in Denver. The purchase of this instrument will help with sample timeliness and increase the number of samples 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 and operator familiarization should be included for both UHPLC and mass spectrometer modules. The vendor shall also provide pricing for an optional extended warranty/maintenance agreement for four additional years.,However, this information shall not obligate FDA to purchase the extended warranty/maintenance agreement. The specific requirements for this optional service contract are: 1) Service contract coverage shall include trouble-shooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer. 2) Service shall be provided by service engineers who are trained and certified by the original manufacturer. Engineers shall have access to the manufacturer's latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. 3) The contract shall enable the Project Officer to have access to the manufacturer's call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. 4) The offeror shall be able to guarantee that a service engineer will be scheduled to work with priority over non service contracted work. 5) The vendor shall provide all travel, labor and parts at no additional charge. There shall be at least one (1) scheduled maintenance visit per year of the contract. The vendor shall also include coverage for software and firmware updates. The vendor shall demonstrate and document upon installation that the item meets all performance specifications, including the mass spectrometer sensitivity specification (IQ/OQ/PQ). The instrument shall not be accepted until those performance specifications have been met. B. Functional specifications for Mass Spectrometer (MS): 1. The mass spectrometer should be consistent with dual pressure linear quadrupole-Ion trap design. It should be designed to perform quantitative analysis. 2. The system must include a complete workstation for instrument control, data acquisition, and data analysis system including computer, monitor, and printer. There should be two licenses for the data analysis software to allow for remote data processing. The UHPLC must be controllable using the same system. 3. The mass spectrometer must be equipped with ESI and APCI. And be able to switch between positive and negative modes. 4. The system must be capable of Pulsed Q Collision Induced Dissociation (PQD). 5. The system must be capable High Resolution Isolation (HRI) down to 0.05Da FWHM (full width half maximum with Ultra Zoom Scan between m/z 50-2000. 6. The system must have multiple mass ranges m/z 15-200, m/z 50-2000, and m/z 200-4000. 7. The system must be capable of ultra-fast scans to improve signal to noise and sampling rate. 8. The system must demonstrate a sensitivity for 100 femtograms reserpine of S/N of >= 100:1in MS/MS mode for ion at 609, in both ESI and APCI modes. C. Functional specifications for Ultra High-Performance Liquid Chromatography (UHPLC) system: The UHPLC portion of the system must be capable of running two UHPLC columns continuously such that analysis is occurring on one column and forwarded for mass spectrometry while the second column is being washed or regenerated. This is often referred to as multiplexing or alternating column regeneration (ACR) technology. Detailed Requirements Solvent Pump: 1. The solvent pump must be of the binary design. 2. Each system should include two (2) binary pumps in order to perform multiplexing or alternating column regeneration (ACR). 3. The UHPLC pumps must have a flow rate range of at least 0.10 - 5 mL/minute and must be able to achieve a maximum pressure of 15000 psi. The pumps must have a delay volume of < 100 microliters. The binary pump must have a flow accuracy of ± 1%. 4. The pump must be able to compensate for the compressibility of various solvents. This will ensure precise flow rates and therefore precise retention times. 5. Each pump must have an option for a solvent selection valve, which would allow the binary mixture from four independent solvent sources. 6. The pump must be able to communicate directly with the software to perform diagnostic operations, such as leak and pressure testing. The pump and software should allow the tracking of log files, the amount of solvent delivered, and seal wear. 7. The binary pump must have typical pulsation of ≤ 1% amplitude when operated in isocratic mode at 1 mL/min with conventional HPLC back pressures. The typical pulsation must be ≤ 2% amplitude when operated isocratic mode at 1 mL/min with higher UHPLC back pressures and smaller delay volume. 8. Each UHPLC system shall be equipped with two (2) separate or integrated degasser modules which are capable of simultaneously degassing solvents from 4 different reservoirs with a flow rate of up to 2 milliliters per minute. 9. The pump must contain a leak sensor for safe liquid handling. Autosampler: 1. The UHPLC system must be equipped with an autosampler for unattended continuous operation. The autosampler must be capable of operating with standard 2 milliliter autosampler vials as well as with well-plate trays. 2. The autosampler must be capable of selectable injection volumes between 0.1 - 10 µL in 0.1 µL increments, without changing the injection loop. 3. The autosampler must be able to achieve a maximum pressure of 15000 psi. 4. The autosampler must include a thermostat option to control the temperature within the sample tray. The thermostat should operate from 4°C to 40°C in 1° increments. 5. The sampler draw and inject speed should be programmable. This will allow for compensation of viscous samples. 6. The autosampler must provide injection volume accuracy of ± 1% or better for injection volumes of 10 µL. 7. The well-plate sampler must offer an additional needle flush station with a peristaltic pump installed to wash the outside of the needle. 8. The autosampler must contain a leak sensor for safe liquid handling. 9. The autosampler must be capable of handling at least 96 1.5 ml vials. Column Compartment: 1. The UHPLC system shall be equipped with a temperature controlled column compartment which is capable of maintaining the columns at a steady temperature from at least 10 degrees centigrade below room temperature up to 80 degrees centigrade. This compartment shall be able to accommodate columns up to 4.6 mm in diameter and up to 200 mm in length. 2. The temperate control precision should be no less than ±0.15°C to ensure retention time reproducibility. The temperature accuracy should be no less than ±1.0°C. 3. The column compartment should allow for pre column heating and post column cooling to ensure the ability to optimize for best selectivity and lowest detector noise. 4. The UHPLC system shall be equipped with a 10-port column switching valve or two six port column switching valves which can be controlled by the system software. 5. The software should communicate directly with the column compartment for operation of the switching valve and temperature controls. 6. The column compartment should contain a leak sensor for safe liquid handling. Software: 1. The UHPLC portion of the system shall be compatible (controllable) using the mass spectrometer's software so that analysis is automatically coordinated. 2. The UHPLC system shall include an operator interface which may be used to control the UHPLC portion of the instrument independently of the mass spectrometer (for purposes of troubleshooting, maintenance, and flexibility of operation of the UHPLC). 3. The UHPLC modules shall be able to communicate with each other through a network. 4. The software should allow for seamless integration of sample multiplexing or alternating column regeneration (ACR). 5. The contractor should include a total of two licenses for the software. One will be used to operate the system, while the second will be used for off-line data processing and reporting. IQ/OQ/PQ Services: The Vendor will provide initial qualification operational qualification and performance qualification (IQ/OQ/PQ) for all provided components. They shall verify that the delivered instrument meets or exceeds all published specifications in this process. Training: The contractor shall provide on-site operator training/familiarization for both the UPLC and mass spectrometer. Such familiarization shall include system operations, calibration, optimization, and basic preventative maintenance procedures. Furthermore, the contractor shall include an additional four days on site training for mass spectrometer operation for at least four (4) operators. This training must have a minimum expiration of three years from the installation of the system. Delivery Considerations: The equipment shall be delivered on a truck with a lift gate. The instruments shall be delivered to the inside. Furthermore the vendor shall unpack and install the instrument as well. D. Delivery Addresses: US Food & Drug Administration Denver Laboratory (DEN-LAB) Denver Federal Center 6th and Kipling Building 20 Denver CO 80225 POC: Carl N. Syvertson E. 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 (Mar 2015), 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 52.217-5 Evaluation of Options (July 1990) FAR 52.217-9 Option to Extend the term of the Contract (Mar 2000) 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-1145835. The quotes are due by email to the point of contact listed below on or before April 10, 2015 by 5:00pm 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-1145835/listing.html)
- Place of Performance
- Address: US Food & Drug Administration, Denver Laboratory, Denver Federal Center, 6th and Kipling, Building 20, Denver, Colorado, 80225, United States
- Zip Code: 80225
- Zip Code: 80225
- Record
- SN03685829-W 20150403/150401235117-388f9dab60438e11d261a817d138e320 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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