SOLICITATION NOTICE
66 -- Lease to own Linear Ultra High Dual Pressure Ion Trap Mass Spectrometer - Attached Solicitation
- Notice Date
- 6/15/2010
- 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-1071446
- Point of Contact
- Jacqueline Richardson, Fax: 301-827-7151, Kimbalynn Dieng, Fax: 301-827-7151
- E-Mail Address
-
jacqueline.richardson@fda.hhs.gov, Kimbalynn.Dieng@fda.hhs.gov
(jacqueline.richardson@fda.hhs.gov, Kimbalynn.Dieng@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- Lease to own Dual Pressure Mass Spectrometer **A copy of this solicitation is also attached to be down loaded.** This is a solicitation for commercial services prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-40. This announcement constitutes the only solicitation and a written solicitation will not be issued. This combined synopsis/solicitation, NAICS code 334516, is to notify contractors that the government intends to award a Firm Fixed Price Purchase Order in accordance with FAR Part 13.106 for the following specifications, under the simplified acquisition procedures. This action shall be designated as Full and Open. The period of performance is a base and two (2) one (1) year options (if exercised). Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a Request for Quotes (RFQ). The Food and Drug Administration (FDA) intends to award a sole purchase order for equipment which meets specifications in reference to this solicitation as stated below: SPECIFICATIONS: Title: Ultra-High Sensitivity Dual-Pressure Linear Ion Trap Mass Spectrometer LC/MS Systems BACKGROUND: The FDA's field laboratories under the Office of Regulatory Affairs (ORA) is seeking a Lease to Own Agreement to acquire, four (4) Ultra-High Sensitivity, Dual Pressure Linear Ion Trap Mass Spectrometry LC/MS Systems. These laboratories have both work plan requirements, which include trace level analysis of adulterants in food and drug commodities, and FERN (Food Emergency Response Network) requirements (counter terrorism analytical needs), which include the ability to conduct poison screens and to be able to search for suspected or unknown deleterious compounds that this equipment will be utilized to meet. OBJECTIVE: Four (4) Ultra-High Sensitivity Dual-Pressure Linear Ion Trap Mass Spectrometer LC/MS Systems are needed to upgrade capability and replace instruments approaching obsolescence. Instruments will be used to support the regulatory analysis of trace level adulterants in food and drug commodities and FERN activities. REQUIREMENTS: Instruments are needed with the following capabilities: a) Autosampler: • Must be able to controlled by mass spectrometer software and interfaced to High Pressure Liquid Chromatograph • Power Requirements: 100-240V, 120W, 50/60Hz • Environment: 4°C - 40°C constant temperature, < 80% humidity (non condensing) • Syringe Sizes: 10μl, 25μl, 50μl, 100μl, 250μl, 500μl, 1000μl, 2500μl, 5000μl • Sample Trays: 1ml vials 200 positions, 2ml vials 54 positions (microplate footprint for sample stacks), 2ml vials 98 positions, 10ml vials 32 positions, 20ml vials 32 positions • Injection valves: up to 2 • Additional Switching valves: up to 6 • 4-fold Injection valve drive • 1000 bar UPLC Valve • Column Selector Valve • Active Washstation • Injection volume: 0.1 - 5000 uL • Sample Capacity: 600 1ml vials, 972 2ml vials, 96 10/20ml vials • Thermostatted Sample Capacity: 400 1ml vials, 648 2ml vials, 64 10/20ml vials • Sample compartment cooling • Third Party Instrument Drivers b) High Pressure Liquid Chromatograph: • Must be compatible with mass spectrometer software to be controlled and interfaced with the mass spectrometer. • Minimum Flow Rate 0.1 μL/min • Maximum Flow Rate 1000 μL/min • Flow Rate Resolution 0.1 μL/min • Pressure Range 0 to 15000 psi (0 to 1000 bar) • Pressure Resolution 0.15 psi (0.01 bar) • Solvent Capacity Quaternary valve system • Delay Volume 65 μL • Compositional Accuracy ± 1% at a flow rate of 25-500 μL/min • Primary Piston Volume 24 μL • Degasser Type Integral, self-adjusting, 4 channel vacuum membrane (Teflon® AF) • Degasser Hold Volume < 500 μL per channel • Pulse Dampener 3 μL, dynamic • Wetted Parts 316SS, titanium, PEEK TM, sapphire, TZP-ceramic, FEP, GFP, ruby • Remote Controls Start, USB interface for software control • Ambient Environment 10-40 °C, 40-80% relative humidity, non-condensing • Operating Temperature 10 °C to 40 °C • Power Requirements 100/120 Vac, 220/240 Vac nominal; 500 VA max, 50 to 60 Hz c) Linear Ion Trap Mass Spectrometer: • Have mass range capabilities of m/z 50-2000 • Be able to perform MSn experiments for n=1 through n=10 (n=1-10, standard) • Have Heated Electrospray Ionization and Atmospheric Pressure Chemical Ionization • Have MS/MS sensitivity meeting this specification: o An injection of 2 μL of a 50 fg/μL solution of reserpine (100 femtograms total sample) at a flow of 500μL/min of 30/70% Water/Acetonitrile with 0.1% Formic acid onto a 20mm x 2.1mm C18 column will produce a minimum signal-to-noise ratio of 100:1, for the transition of the unit isolated protonated molecular ion at m/z 609 to the two largest product ions, when the mass spectrometer is operated at unit resolution in the Full Scan MS/MS mode, scanning the product ion spectrum from m/z 165-615. • Have MSn sensitivity meeting this specification: o An injection of 2 μL of a 50 fg/μL solution of reserpine (100 femtograms total sample) at a flow of 500μL/min of 30/70% Water/Acetonitrile with 0.1% Formic acid onto a 20mm x 2.1mm C18 column will produce a minimum signal-to-noise ratio of 25:1, for the transition of the unit isolated protonated molecular ion at m/z 609 to the product ion at m/z 397 which is further fragmented to the product ion at m/z 365, when the mass spectrometer is operated at unit resolution in the Full Scan MS/MS mode, scanning the product ion spectrum from m/z 165-615. The API source must contain a Stacked Ring Ion Guide (SRIG) for increased ion source efficiency • Have High-Performance API Source: o Containing a Stacked Ring Ion Guide for increased ion source efficiency o Must support optional interchangeable ionization sources and probes (Heated Electrospray Ionization, Electrospray Ionization, Atmospheric Chemical Ionization, Atmospheric Pressure Photo Ionzation/Atmospheric Pressure Chemical Ionization Combination) • The transfer ion optics must: o include a bent RF only square quadrupole to remove the line of sight from the source to the mass analyzer, o include an RF only square quadrupole ion optic and an RF only octapole ion optic. o Must be designed for high stability and ion transmission efficiency • The Quadrupole Ion Trap Mass Spectrometer must: o Consist of a dual cell segmented linear ion trap o Be constructed using hyperbolic surfaces o Have parallel exit slits for radial ion ejection o Have slots in X and Y rods to balance the RF fields o Have no more than two roughing pumps o Have only one turbomolecular pump o Have a horizontally-mounted triple flow turbomolecular pump that controls vacuum in three regions o Have a dual rotary vacuum pump configuration • The Detection System: o Must have two detectors o Ions must be ejected radially from the ion trap o Instrument must be capable of switching polarities within 100ms. • The mass spectrometer must have an integrated syringe to allow for automated infusion under data system control. • The Tune User Interface: o Must allow access to activation Q, activation time, normalized collision energy • The Mass Spectrometer must be capable of isolation and fragmentation with the following: o Perform up to 10 stages of MSn automatically o Isolate ions down to 0.3 Da up to m/z 1000 and 1 Da isolation width for up to m/z 2000 o Isolate a 2 Da window across the entire 50-2000 mass range in 4 ms. o Perform Pulse-Q Dissociation (PQD) fragmentation. o Perform multiple activation steps in the same MS scan • The Mass spectrometer must be capable of MSn multi-stage MS experiments to provide greater structural information • The Mass spectrometer must have: o capability for high-resolution scan to resolve isotopic envelopes, of ions of at least 5+ charge state from 50-2000 Da at a scan speed of 2200 Da/sec o capability for ultra-fast scan to improve signal-to-noise and sampling rate of 125,0000 Da/s o capability for ultra-high resolution slow scanning for resolutions up to 20,000 o a predictive AGC algorithm to determine the ion injection time without carrying out a prescan event to increase the instrument scan speed/decrease the instrument cycle time. o capability to temporarily exclude an ion while allowing acquisition of MS/MS or MSn spectra; increases the selectivity of co-eluting compounds, and enhances the signal of a selected compound o scan capability to automatically perform MS/MS when a user-defined isotopic pattern is detected o capability to automatically generate a 3-Dimensional MS/MS map displaying Product Ion, Parent Ion and Neutral Loss data o capability to automatically fragment the [MH-H2O]+ ion within a single MS/MS experiment to produce additional structural information on compounds that normally show predominantly only [MH-H2O]+ ion o capability to automatically compensate for the mass dependent energy deposition and provide instrument-to-instrument reproducibility o allow multiple activation energies to be applied to the ion of interest before detection product ions o capable of experiments for automated 3-stage data-dependent experiments for charge state determination and structural elucidation of multiply charged ions o capable of performing a Precursor ion MS3 experiment in order to increase confidence and help eliminate false positive results for metabolite identification In addition to the above specifications: • The vendor should include IQ/OQ/PQ with delivery of the instruments. • The vendor must be willing to respond to service calls within 72 hours and must provide extended service (at least for the life of the lease) that is equal to that which would be provided with a comprehensive service contract. d) Acquisition Considerations: If in the unlikely event ORA, is unable to renew the lease for this equipment the instruments would be purged of any FDA data and/or information and returned to the vendor in accordance with the lease specifications. DELIVERABLES: The contractor shall deliver Ultra-High Sensitivity Dual-Pressure Linear Ion Trap Mass Spectrometer LC/MS Systems, one (1) each of the four (4) sites locations as follows: SITE DELIVERY LOCATIONS Pacific Region Lab Southwest 19701 Fairchild Irvine, CA 92612 Kansas District Office Laboratory 11630 West 80th Street Lenexa, KA 66214 Northeast Regional Laboratory 158-15 Liberty Avenue Jamaica, NY 11433 Southeast Regional Laboratory 60 Eighth Street NE Atlanta, GA 30309 PERIOD OF PERFORMANCE: The lease to own, period of performance is date of award up to one year under the base and two (2) one (1) year option periods (if exercised). The instrument offered shall have a typical operating period of 7-10 years. This operating period is determined by the date of obsolescence which is determined by the manufacturer and will determine when parts and repairs are no longer available. INSTRUCTIONS TO OFFERS In accordance with FAR 7.402 (b)(4), If a lease with option to purchase is used, the contractor shall state the purchase price and provide a formula which shows how the purchase price will be established at the time of purchase. Therefore all offers are required to submit two (2) offers: 1. An offer for the lease agreement for a base and two (2) one (1) year options including interest and the cost of purchasing the equipment at the end of the lease period. 2. An offer for the current cost to purchase the equipment. The Government reserves the right to purchase this equipment at anytime during the lease in accordance with FAR Clause 52.207-5 (Option to Purchase Equipment). EVALUATION AND AWARD: The Government intends to evaluate proposals and, if necessary conduct discussions with all responsible/capable offerors within the competitive range. The award will be made to the offeror whose proposal conforms to the terms and conditions of the solicitation and award may be made to other than the lowest price technically acceptable. However, the Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. Evaluation Factors for Selection of Ultra-High Sensitivity Dual-Pressure Linear Ion Trap Mass Spectrometer LC/MS Systems. The evaluation factors for this solicitation are as follows and are in descending order of importance: 1. Technical Requirements: Submitted offers for the systems requested under this solicitation shall meet the technical requirements outlined. 2. Service Personnel/Vendor support of instrumentation: The selected contractor shall provide trained service personnel to support this instrument throughout the term of the lease, as well as the capability to provide a comprehensive service 3. contract(s): 1) a demonstrated record of providing service to the instrument using local personnel or personnel within a days drive, 2) a record of offering service contracts should funds become available, have flexible service plan offerings, including balanced budget plans. 4. Cost: The major factor considered will be the best value for the cost. Vendor enhancements of instrument value through the addition of software licenses, extension of warranties and other features will be considered. Relative importance and trade-offs. The Government will base the determination of best value on performance and evaluation factors as identified above. CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to jacqueline.richardson@fda.hhs.gov no later than May 21, 2010 4:30 pm Eastern Time. QUOTATIONS DUE: All quotations are due, via email to: jacqueline.richardson@fda.hhs.gov, no later than 4:30 pm, Eastern Time on June 29, 2010. PROVISIONS and CLAUSES: FAR 52.213-3 Notice to Suppliers; FAR 52.207-5 Option to Purchase Equipment; FAR 52.213-2 Invoices; FAR 52.213-4 Terms and Conditions; 52.225-1 Buy America Act; 52.212-4 (1)Termination of commercial items; FAR 52.217-9 Option to Extend the Term of the Contract; FAR 52.232-33 Clauses and Provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to jacqueline.richardson@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/FDA-1071446/listing.html)
- Place of Performance
- Address: Various delivery sites, Rockville, Maryland, 20857, United States
- Zip Code: 20857
- Zip Code: 20857
- Record
- SN02178443-W 20100617/100615235837-e5c4d17a0dabf25049129ab5b6e3d9ef (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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