Inductively Coupled Plasma Mass Spectrometers (ICP-MS) with optional high-performance liquid chromatography (HPLC) system

SOURCES SOUGHT SYNOPSIS THIS IS A Sources Sought Notice ONLY. The U.S. Government desires to procure Inductively Coupled Plasma Mass Spectrometers (ICP-MS) with optional high-performance liquid chromatography (HPLC) system as a small business set-aside, provided 2 or more qualified small businesses respond to this sources sought synopsis with information sufficient to support a set-aside. Be advised that the U.S. Government will not be able to set aside this requirement if 2 or more small businesses do not respond with information to support the set-aside. We encourage all small businesses, in all socioeconomic categories (including, 8(a) Business Development Program, Small Disadvantage Business, Historically Underutilized Business Zone, Service-Disabled Veteran-Owned, Women-Owned Small Business concerns), to identify their capabilities in meeting the requirement at a fair market price. This notice is issued solely for information and planning purposes – it does not constitute a Request for Quote (RFQ)/Invitation for Bid (IFB)/Request for Proposal (RFP) or a promise to issue an RFQ, IFB or RFP in the future. This notice does not commit the U.S. Government to contract for any supply or service. Further, the U.S. Government is not seeking quotes, bids or proposals at this time and will not accept unsolicited proposals in response to this sources sought notice. The U.S. Government will not pay for any information or administrative costs incurred in response to this notice. Submittals will not be returned to the responder. Not responding to this notice does not preclude participation in any future RFQ or IFB or RFP, if any is issued. If a solicitation is released, it will be synopsized on the Governmentwide Point of Entry. It is the responsibility of potential offerors to monitor the Governmentwide Point of Entry for additional information pertaining to this requirement. The anticipated NAICS code is 334516 - Analytical Laboratory Instrument Manufacturing, with small business size standard of 1,000 employees. I. Minimum Performance Requirements/Salient Characteristics All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the FCC prior to purchase. Single Quadrupole Inductively Coupled Plasma Mass Spectrometer (ICP-MS) General Parameters: The system must be a compact, bench-top design with external rotary pump(s) configured to fit under or behind the laboratory bench. The offeror shall provide a full listing of facility requirements (electrical, exhaust, plumbing, etc.) with their response. The contractor shall provide the entire system including all necessary supplies and accessories and fittings required for immediate start-up and installation on-site at the designated laboratory delivery location. All solutions, standards, and/or consumable required to perform initial instrument qualification are the responsibility of the offeror. Single hyperbolic quadrupole for mass analysis Conical extraction and off-axis Omega lens located outside the high vacuum region. Octopole reaction system with a temperature-controlled collision/reaction cell capable of performing kinetic energy discrimination with Helium gas. Minimum RF Power Range from 1000 W to 1600 W The RF generator shall be able to change from volatile organic solvents to aqueous samples without affecting plasma stability, even if highly volatile organic solvents are introduced. Comprehensive auto-tuning capabilities for plasma parameters, torch position, collision cell, lenses, mass analyzer, detector, detector pulse/analog factors in one single step The main ion-lens assembly shall be located outside the main vacuum system and allow for removal, cleaning and replacement without opening the main vacuum system. The system must have the ability to connect to a HPLC system and perform fully automated LC-ICP-MS analyses for the purpose of speciation. Includes all components for using the ICP-MS System: Computer, monitor, mouse, keyboard, and operating software Laser printer Heat exchanger/chiller for cooling the interface Roughing pump with noise reduction (quiet) cover Software capable of coupling with HPLC for speciation analysis Gas regulator(s) Benchtop design with the following approximate maximum dimensions: Height x Width x Depth: ~24 in x ~30 in x ~24 in Weight: ~300 lb Sample Introduction: Temperature controlled spray chamber (-5 to 20 °C) Ultra-high matrix sample introduction capabilities capable of analyzing dissolved solids of up to 1%. A ≥3-channel, computer-controlled peristaltic pump is required for pumping sample, internal standard, and draining the spray chamber. The cooling water supply to the ICP-MS mainframe shall be supplied by a non-refrigerated heat exchanger to reduce maintenance cost. A high throughput autosampler is required with a minimum capacity of 240 10-mL sample vial. The autosampler should come with a cover to prevent dust from entering sample containers during analysis. Autosampler capable of automated monitoring of signal washout using computer software. Analysis/Detection Performance: The system shall be capable of a linear dynamic range of at least 9 orders of magnitude without the need to use increased resolution at the highest concentration point. The detector dead time shall meet industry standard timing and be identical in both pulse and analog modes. The sensitivity for low mass (>10), mid-range mass (59-115), and high mass range (205-238) shall be least 50 Mcps/ppm when operating under normal (no cell gas) instrumental conditions. The background at m/z 9 shall be less than 2 cps when operating under normal (no cell gas) instrumental conditions Oxide ratios measured using CeO+/Ce+ <2% when operating under normal (no cell gas) instrumental conditions. Double charged ratios measured using Ce2+/Ce+ <3% when operating under normal (no cell gas) instrumental conditions. Short-term signal precision measured under normal (no cell gas) instrumental conditions shall be <3% relative standard deviation over 20 minutes. Long-term signal precision measured under normal (no cell gas) instrumental conditions shall be <4% relative standard deviation over two hours. The system shall include a collision/reaction cell to eliminate or significantly reduce interferences from molecular species and allow for accurate multi-element analysis of elements such as chromium, arsenic, selenium, thallium, cadmium, lead, antimony, and mercury under the same experimental conditions. The systems must have the option of adding a 2nd and 3rd cell gas line to cover all possible applications, both current and future. The instruments shall be capable of eliminating interference at different masses, without the use of interference equations to correct for polyatomic interferences, in accurate determination of variable high matrix samples. The collision/reaction cell shall be able to reduce polyatomic interferences in collision mode using pure He. Triple Quadrupole Inductively Coupled Plasma Mass Spectrometer (QQQ-ICP-MS/MS For the QQQ-ICP-MS/MS instrument, all specifications from the single quadrupole ICP-MS (above) shall be met, with the additional following qualifications: General Parameters: An additional quadrupole placed before the reaction cell that allows for the selection of ions prior the entering the reaction cell. A quadrupole after the reaction cell for the selection of ions after the reaction cell and before the detector. Standard nickel cones with option for use of platinum cones Collision/reaction system: Four-channel cell gas control as standard The ICP-MS shall enable semi-quantitative analysis in collision cell mode using He cell gas. Use of reactive gases such as CH4 and NH3 or reactive gas blends is not acceptable. Benchtop design with the following approximate maximum dimensions: Height x Width x Depth: ~30 in x ~47 in x ~30 in Weight: ~420 lb High Performance Liquid Chromatography (HPLC) The HPLC system shall consist of at least the four following components 1)pump, 2) autosampler, 3) degasser, and 4) column compartment. The components should be a benchtop design and all modules can be configured into one vertical stack. Pump: Flow rates range 0.01 to 5 mL/min, per channel Flow rate precision 0.2% RSD Flow rate accuracy ±2% Maximum pressure of 5000 psi At least two chambers capable of mixing at percentages between 0 and 100% Recommended pH range of 1.0-12.5 Autosampler: Variable injection volumes from 1-100 µL Injection precision <1% RSD for all volumes Carry-over, <0.1% Capable of sending remote start signal to corresponding ICP-MS (or ICP-MS/MS) system. Software capable of coupling with LC for speciation analysis The ICP-MS shall be able to perform fully automated LC-ICP-MS runs (with the appropriate HPLC system). ICP-MS acquisition shall be enabled by a start signal from an LC system. The software shall enable real-time data calculation and operations, such as peak integration and concentration calculations, during the LC-ICP-MS run. Degasser: At least 2 channels pH range of 1-12.5 maximum flow rate of 10mL/min Column compartment: Capable of temperature control from 5-90 °C. Temperature accuracy of <0.1 °C and Temperature precision of <0.1 °C. Integration with ICP-MS or QQQ-ICP-MS/MS The system shall have the ability to integrate with either ICP-MS (Task 1) or QQQ-ICP-MS/MS (Task 2) systems in order to perform speciation. The HPLC system shall have the ability to integrate with existing Agency systems (Agilent 7500, Agilent 7700, Agilent 7900, and Agilent 8800) in order to perform speciation. Any additional software required shall be included and utilize existing operational computers to create a turnkey system. The system shall include all parts, software, consumables, tubing, etc. to seamlessly connect to the proposed ICP-MS systems (Task 1 and 2) and/or existing ICP-MS systems within the Agency’s laboratories (Agilent 7500, Agilent 7700, Agilent 7900, Agilent 8800, and Agilent 8900). Vendor shall provide all consumable requires to perform arsenic speciation per EAM 4.10 and EAM 4.11. The turnkey system shall meet all sensitivity, performance, and quality requirements of the aforementioned methods. II. Trade and Service Specifications The components and/or equipment shall be a newly manufactured, not used and refurbished, or previously used for demonstration. System installation shall occur no later than 90-days from the date of award. The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance . The warranty must include unlimited telephone/e-mail support for questions regarding operation. On-site response time for repairs during the warranty period should be no more than 72 hours, if needed. Coverage shall include all non-consumable items and parts supplied including base instrument, computer, monitor, printer, auto-sampler, and water chiller/heat exchanger ensuring proper functioning for the entire warranty period. As needed, factory-certified replacement parts, engineer labor and travel costs, software updates, notifications, and installation shall be included to ensure maximum system operational readiness. Offeror shall transfer all methods from existing ICP-MS systems to their system and confirm that quality control and sensitivity parameters are met. Methods are listed on the FDA EAM webpage. This shall occur prior to installation acceptance. Offeror shall develop equivalent reports to existing reports used to support the Agency’s mission prior to installation acceptance. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, laser printers, software, and that otherwise required to meet these specifications, the FDA’s stated need, and shall be fit for intended purpose. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up. The vendor shall demonstrate upon installation that the system meets or exceeds all performance specifications which have been included in the vendor’s response and/or used as evaluation criteria for award. The following shall be demonstrated at the time of installation: The results of the sensitivity test should meet or exceed the values supplied in the contractor’s response. For example, if the contract states that their system should achieve a response for m/z 7 of at least 50 Mcps/ppm when operating under normal (no cell gas) instrumental conditions, this should be demonstrated after installation. Additionally, the specifications regarding background, oxide ratios, double charged ratios, short-term signal precision, and long-term signal precision must be demonstrated after installation. Performance for each of the reaction/collision modes (helium for Task 1 and He, H2, and O2 for Task 2) must be demonstrated after installation. For Task 2, the contractor shall demonstrate and document that the system is capable of performing QQQ experiments. For Task 3, the flow rate accuracy, injection precision, and carryover listed in the contractor’s response must be demonstrated The contractor shall provide certificates of analysis (COA) for all chemical standards used to verify sensitivity, as well as a standard operating procedure (SOP) describing how the tests will be performed. Operator training for at least one operator at the vendor’s training facility shall be included. Contractor shall provide documentation to the laboratory to support this requirement at the time of installation. Documentation shall include a list of upcoming courses to meet this requirement and physical notification (e.g. paper certificate). Travel expenses will be the responsibility of the GOV. Onsite installation of the entire system shall be included and inclusive of labor, delivery, and travel costs. Onsite familiarization should include basic operations, routine maintenance, and familiarization for quantitative and qualitative analysis, and if appropriate use of the HPLC system to perform speciation. Offeror shall provide these services for up to three Agency staff per system install. Inside delivery, setup, installation, and clean-up of the area at the place of performance is required. In response to this sources sought, please provide : 1. Name of the firm, point of contact, phone number, email address, UEI number, CAGE code, a statement regarding small business status (including small business type(s)/certifications(s) such as SDB, 8(a), HUBZone, SDVOSB, WOSB, etc.) and the corresponding NAICS code. 2. Identify whether your firm is interested in competing for this requirement as a prime contractor or not. Identify subcontracting, joint ventures or teaming arrangement that will be pursued, if any. 3. Information in sufficient detail regarding previous experience (indicate whether as a prime contractor or subcontractor) on similar requirements (include size, scope, complexity, timeframe, government or commercial), pertinent certifications, etc., that will facilitate making a capability determination. 4. Information to help determine if the requirement of Inductively Coupled Plasma Mass Spectrometers (ICP-MS) with optional high-performance liquid chromatography (HPLC) system is commercially available, including pricing information, basis for the pricing information ( e.g. , market pricing, catalog pricing), delivery schedules, customary terms and conditions, warranties, etc. 5. Identify how the FDA can best structure these contract requirements to facilitate competition by and among small business concerns. 6. Identify any GSA Schedules your company has available to fulfill this requirement. This is a request for information and shall not be construed as a solicitation or obligation on the part of the FDA for any future solicitation. Telephone inquiries will not be accepted. All interested parties shall submit their capability statements to Cynthia Martin, FDA contracting office via email to [email protected] by May 26, 2022, at 1:00 p.m. Eastern Time.