UHPLC, (High Resolution Ion Trap Mass Spectrometer with UHPLC)

1. Solicitation Number: FDA-RFQ-22-1251793 2. Title: Ultra-High Performance Liquid Chromatography - Ion Trap Mass Spectrometer System 3. Product Service Code: 6640 4. NAICS Code: 334516 5. Posted Date: April 14th, 2022 6. Response Date: April 21, 2022, 1:00 p.m. Eastern Time. Section B: Continuation of SF-1449 – Schedule of line items and pricing Section C: Contract clauses, including agency-specific clauses Section E: Instructions to offerors, including offeror Representations and Certifications. Section B: Continuation of SF-1449, SOW B-1 Background Background The regulatory laboratories of the Food and Drug Administration (FDA), conduct a range of chemical analyses on pharmaceutical products to determine if they meet regulatory requirements. A high resolution ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system is necessary to complete regulatory work. Purpose/Objective The purchase of one (1) high resolution ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system for the Pacific Southwest Medical Products Laboratory (PSMPL), Irvine, CA is required to ensure the laboratory has sufficient instrumentation for the timely analysis of dietary supplements which are analyzed to detect the presence of undeclared active pharmaceutical ingredients as well as performing chemical analyses such as identification and quantitation of opioid compounds. B-2 Statement of Work Scope PSMPL requires one (1) high resolution ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system and accessories that meets or exceeds the requirements below: Requirements 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. General Requirements The contractor shall provide a Orbitrap Exploris 120 mass spectrometer or equivalent. The ion trap mass spectrophotometer shall meet or exceed the following requirements: The mass spectrometer must be a high-resolution, high-field bench top system that can occupy a bench space of 36 x 36 x 24 inches (h x d x w) and can connect to existing utilities to include nitrogen gas and an exhaust outlet. The mass spectrometer must be a quadruple (Orbitrap, or equivalent) ion trap configuration. The mass spectrometer must have an S-lens for ion transmission from atmosphere The mass spectrometer must have a minimum resolution of 15,000 (FWHM) at m/z 200 for all scan modes and both polarities and a maximum resolution of at least 120,000 (FWHM) at m/z 200 for all scan modes and both polarities. The mass spectrometer must operate in the m/z range of at least 40-3,000 The mass spectrometer shall utilize accelerated Higher Collisional Dissociation (HCD) cell for generating fragment spectra. The mass spectrometer must be equivalent to a LC-MS/MS system utilizing a Quadrupole Mass Filter consisting of segmented mass filter, providing variable and step-less precursor isolation width selection from 0.4 Da to full mass range. The mass spectrometer must only require nitrogen as an external gas. The mass spectrometer must have the following minimum sensitivity: MS/MS: 200 fg Reserpine on column yields S/N 100:1 RMS tSIM: 200 fg Reserpine on column yields S/N 250:1 RMS The mass spectrometer must have the following scan speed, at a minimum: Highest scan speed is 22 scans per second (R=15,000 at m/z 200) in Full MS Scan or SIM mode. Scan speed for MS/MS is up to 22 MS/MS scans per second at resolution (R=15,000 at m/z 200) in targeted or data dependent mode (max Top 4) The mass spectrometer must have the following mass accuracy, at a minimum: < 3 ppm RMS – with external calibration over 24 h and without any kind of mass recalibration < 1 ppm RMS – with internal calibration (used-defined lock mass) < 1 ppm RMS – with internal calibration for up to 5 consecutive days The mass spectrometer must be equipped with an atmospheric pressure chemical ionization (APCI) probe. The mass spectrometer must be equipped with a two position RoHS valve or equivalent, to allow for solvents coming from the UHPLC to be diverted to waste. A compatible computer running Windows 10 OS and monitor shall be included to run software and instrument components to include the UHPLC system described in Part II. Software for instrument control and for data acquisition to include analysis software such as TraceFinder, Xcalibur or equivalent. An uninterruptible power supply equipped with at least five (5) 5-15R output receptacles, at least four (4) 6-20R output receptacles, a compatible power distribution unit (PDU) module that has at least four (4) 5-15R receptacles, two (2) 6-20R receptacles and two (2) L6-20R receptacles and any necessary power cords for the specified equipment. The mass spectrometer must be compatible with the ultra high performance liquid chromatography system described in Part II. The contractor shall provide a Vanquish Horizon Binary Ultra High Performance Liquid Chromatography (UHPLC) System or equivalent. The UHPLC system shall meet or exceed the following requirements: The UHPLC System must be compatible with the mass spectrometer system described above in Part I. The UHPLC shall equipped with a binary pump with a minimum flow range of 0-5 mL/minute. The UHPLC shall be equipped with an autosampler to allow for split loop injection with an injection volume range of at least 0.1 µl to 25µl and an accuracy of at least ±0.5%. The UHPLC shall be equipped with a sample compartment temperature range from 4°C to 40°C, minimally and a sample capacity of at least four racks of at least 54 vials each. The UHPLC shall be equipped with a column compartment thermostat capable of regulating the temperature minimally in the range of 5°C up to 120°C and the column compartment capacity allows for 2 column slots. The UHPLC shall be equipped with a pre-heater and post-column cooler for the column compartment. The UHPLC shall include necessary accessories to connect to a mass spectrometer and complete installation to include a column, syringe and syringe filters. The UHPLC shall be equipped with a diode array detector with at least 10 UV channels and a UV-Vis lamp. The UHPLC shall have a titanium flow cell with a 7mm light path length and 2.5µl volume compatible with the diode array detector described above. Trade and Service Specifications The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration. FOB Point destination to include inside delivery and clean-up of area after installation. Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, 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 are evaluation criteria for award. The instrument shall not be accepted until those performance specifications have been met. The entire system must be warranted for parts and labor for a minimum of 12 calendar months from the date of formal government acceptance. The vendor must also be capable of servicing the instrument through the covered warranty period. The system must include, at a minimum: coverage on all non-consumable items and parts supplied including base instrument, factory-certified replacement parts, engineer labor and travel costs. Any equipment repair and maintenance work shall be performed by an OEM-trained engineer. This factory-trained engineer shall have (verified by the OEM) the following: 1) access to OEM factory telephone support; 2) access to the most current OEM factory training for both hardware and software components; and 3) access to all current OEM factory parts, not build-to-order parts. The OEM-trained service engineer shall not use salvaged parts from other instruments for performing maintenance and repairs. All parts used in PM and repairs must be guaranteed, factory-tested, OEM quality parts. Instrument operators shall have access, for the duration of the 12 month warranty period, to a technical representative call center at no additional charge, for technical assistance and trouble-shooting, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument. Operator level training for 2 users at the delivery onsite location shall be provided at time of installation or shortly thereafter (within 30 days), such that operators are able to independently operate the instrument and included software to conduct routine regulatory analyses on the instrument. The training shall include manuals and any consumables to be used during training. The Contractor shall provide installation by a trained and certified field service engineer who shall perform the necessary verification testing to demonstrate that the instrument meets the Original Equipment Manufacturer’s operational standards following installation. Calibration solutions and consumables used for the installation shall be included. Records and Reports The Contractor shall, commensurate with the completion of each service call (inclusive of warranty service), provide the end-user of the equipment with a copy of a field service report/ticket identifying the equipment name, manufacturer, model number, and serial number of the equipment being serviced/repaired and detailing the reason for the service call, a detailed description of the work performed, the test instruments or other equipment used to affect the repair or otherwise perform the service, the name(s) and contact information of the technician who performed the repair/service, and for information purposes, the on-site hours expended and parts/components replaced. In addition, the Contractor shall provide monthly reports to the FDA PROJECT OFFICER and Contract Specialist, not later that the 5th work day following the end of each month, summarizing all maintenance and repair activities (including warranty work) for the previous month (during months that work is performed). FOB Point destination to include inside delivery and clean-up of area after installation. Installation shall be completed at each site identified in the “Delivery Location and Place of Performance” section of the SOW and shall be inclusive of all fees associates with labor, travel, and lodging. Deliverables or Delivery Schedule One High Performance Liquid Chromatography System with an Ion Trap Mass Spectrometer and Accessories for PSMPL, Irvine, CA. meeting or exceeding the requirements stated above will be delivered, inside delivery required, in accordance to the following: Description of Deliverable Qty Due Date 1 High resolution ion trap mass spectrometer with an ultra high performance liquid chromatography (UHPLC) system and accessories 1 Delivery within 90 days after award. 2 Installation and training 1 Date to be agreed upon with the technical POC at delivery location. No later than 120 days after award. 3 Manufacturer’s warranty of equipment, parts and operational services. 1 Begins at the completion of installation and government acceptance through one year. Delivery Location and Place of Performance Shipping Destination: POC: To be identified at time of award FDA/PSMPL 19701 Fairchild Rd. Irvine, CA 92612 Period of Performance Equipment shall be delivered by 09/30/2022. The Period of Performance begins on the date of formal government acceptance and continues through the end of the manufacturer’s warranty period. Section C: Contract clauses, including agency-specific clauses FAR / HHSAR Clauses: I. The provision at 52.212-1, Instructions to Offerors – Commercial DEVIATION 2018-O0018, applies to this acquisition. The following addenda have been attached to this provision: In addition to the requirements set for the in FAR 52.212-1, all offers responding to this solicitation must provide their business size in relation to the NAICS code contained in this solicitation and shall identify any socioeconomic categories to which they belong. II. Evaluation Criteria - The specific evaluation criteria to be used are as follows: Lowest Price Technically Acceptable. III. Offerors shall include a completed copy of the provision at FAR 52.212-3 (with its Alternate I), Offeror Representations with its offer. IV. The clause at 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. The following addenda have been attached to this clause – Not Applicable V. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items applies to this acquisition. The following additional FAR clauses cited in this clause are applicable: 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) 52.219-28, Post Award Small Business Program Representation (Nov 2020) 52.222-3, Convict Labor (June 2003) 52.222-19, Child Labor-Cooperation with Authorities and Remedies (Jan 2020) 52.222-21, Prohibition of Segregated Facilities (Apr 2015) 52.222-26, Equal Opportunity (Sept 2016) 52.222-36, Equal Opportunity for Workers with Disabilities (Jun 2020) 52.222-50, Combating Trafficking in Persons (Oct 2020) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (Jun 2020) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) 52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Oct 2018) 52.204-7 System for Award Management (Oct 2018) 52.204-13 System for Award Management Maintenance (Oct 2018) 52.204-16 Commercial and Government Entity Code Reporting (Aug 2020) 52.204-18 Commercial and Government Entity Code Maintenance (Aug 2020) 52.204-24 Representations Regarding Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019) 52.204-25 Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment 52.204-26 Covered Telecommunications Equipment or Services-Representation 52.232-40 Providing Accelerated Payments to Small Business Subcontractors (Dec 2013) 352.239-73 Electronic and Information Technology Accessibility Notice (Dec 2015) 352.239-74 Electronic and Information Technology Accessibility (Dec 2015) 352.232-71 Electronic Submission of Payment Requests (FEB 2022) (a) Definitions. As used in this clause— Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract. (b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system. Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site. (c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures. (d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request. VII. This acquisition is rated under the Defense Priorities and Allocations System (DPAS) as N/A VIII. The following notes apply to this announcement: N/A Section 508 Requirements The following standards are applicable for this requirement: Must meet WCAG 2.0 A and AA E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria and Technical Requirements) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/accessibility-checklists/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional-resources/section-508-contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative. Section E: Instructions to offerors, including offeror Representations and Certifications. FAR 52.212-1 Instructions to Offerors—Commercial Items (Jun 2020) PROPOSAL SUBMISSION FORMAT: *The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.* QUOTES DUE: All quotes are due, electronically via email to [email protected] for the RFQ no later than April 21, 2022, 1:00 p.m. Eastern Time. The offeror or applicant shall submit all electronic documents for Microsoft Office suite products without the use of “macros”. When submitting proposals via email, DO NOT include .exe, .mso, or any other executable file types that could potentially trigger email security protections (i.e. email blocks, quarantine). If the offeror or applicant submits documents that contain macros, macro referenced files, and/or executable files, the Government will not be able to view or open such documents and the submission will be considered non-responsive to the solicitation. No additional time will be given to an offeror or applicant to correct the document submission and the Government will not inform the offeror or applicant that their submission is non-responsive prior to award. It is the offeror’s or applicant’s responsibility to ensure all electronic documents are submitted without the use of macros. FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022) (a) All Invoice submissions for goods and or services must be made electronically through the U.S. Department of Treasury’s Invoice Processing Platform System (IPP). http://www.ipp.gov/vendors/index.htm (b) Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov. (c) ----- (1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts. (2) Registration emails are sent via email from [email protected]. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to [email protected] or phone (866) 973-3131. (3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days. (4) If your company is already registered to use IPP, you will not be required to re-register. (5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures. (d) Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable). (e) Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts. (1) At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred. - Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category; - Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount; - Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant; - Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed; - Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor; - Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and - Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable. (f) Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes: (1) list of all invoices submitted to date under the subject award, including the following: - invoice number, amount, & date submitted - corresponding payment amount & date received - total amount of all payments received to date under the subject contract or order - and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance. (g) Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate. (h) If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO. (i) Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays. (j) The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort. (k) Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at [email protected]. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue. uthwest Medical Products Laboratory (PSMPL), Irvine, CA is required to ensure the laboratory has sufficient instrumentation for the timely analysis of dietary supplements which are analyzed to detect the presence of undeclared active pharmaceutical ingredients as well as performing chemical analyses such as identification and quantitation of opioid compounds.