Sources sought -121770.pdf

THIS IS A SOURCES SOUGHT ANNOUNCEMENT, A MARKET SURVEY

FOR WRITTEN INFORMATION ONLY. THIS IS NOT A SOLICITATION

ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE

AWARDED FROM THIS ANNOUNCEMENT. NO REIMBURSEMENT WILL

BE MADE FOR ANY COSTS ASSOCIATED WITH PROVIDING

INFORMATION IN RESPONSE TO THIS ANNOUNCEMENT OR ANY

FOLLOW-UP INFORMATION REQUESTS. NO TELEPHONE CALLS WILL

BE ACCEPTED REQUESTING AN RFQ PACKAGE OR SOLICITATION.

THERE IS NO RFQ PACKAGE OR SOLICITATION. IN ORDER TO

PROTECT THE PROCUREMENT INTEGRITY OF ANY FUTURE

PROCUREMENT, IF ANY, THAT MAY ARISE FROM THIS

ANNOUNCEMENT, INFORMATION REGARDING THE TECHNICAL

POINT OF CONTACT WILL NOT BE GIVEN AND NO APPOINTMENTS

FOR PRESENTATIONS WILL BE MADE.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) has issued this sources sought announcement on behalf of the Denver Laboratory (DENL) in order to determine if there are existing small business sources capable of providing a Gas Chromatograph Time of Flight Mass Spectrometer (GC-

TOFMS)

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees and believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Nina.Montgomery@fda.hhs.gov. The vendor should include information about the company and demonstrate that it can meet all of the minimum performance requirements.

Background

The General Chemistry group within Denver Laboratory (DENL) has over 15 years of working with GC coupled with single-quadrupole mass-selective detectors (MSD).

DENL seeks to increase the capabilities of the MS-suite by replacing an obsolete GC- FID/ECD with a GC-TOFMS system without losing FID capability.

Purpose

The Denver Laboratory group needs to acquire a new GC-TOFMS system. The instrument needs to accommodate the current validated methodology. The software needs to provide the functionality to support current data processing and QC requirements.

mailto:Yolanda.rankin@fda.hhs.gov

Scope

GC-TOFMS. Minimum Technical Specifications

System Requirements

• The vendor will provide a complete system capable of gas chromatography separations with FID and TOF mass spectrometry detection. The system will also include a robotic autosampler system capable of handling (at a minimum) liquid, static headspace, and SPME Arrow, and a complete instrument control and data processing system (computer and associated software).

• The control and operation of the autosampler, GC system, flame-ionization and mass spectrometer detectors, data collection and processing system shall be integrated within a single software platform.

• The system shall be provided with a power distributor/conditioner capable of providing power to the GC & TOFMS from a single 208V-30A NEMA L6-30R outlet. This system may, but is not required to be, an uninterruptable power supply (UPS). This system may, but is not required to, provide power to the autosampler, computer, or other peripherals unless those peripherals require other than 110V 15A service.

Autosampler Specifications

• The robotic automatic sampler shall provide:

• The capability to inject liquids from 0.1uL to at least 5uL in a single injection with a minimum of 0.1uL increments.

• The capability to inject static headspace samples from 0.1 to at least 2mL with a minimum of 0.1mL increments.

• The static headspace tool must be temperature controlled from ambient to at least 150oC and adjustable with a minimum of 1oC increments.

• The capability to inject SPME Arrow.

• The capability to store and robotically switch between the various tools/modes.

• 2 Vial trays, each configurable to hold standard 2mL or 10/20mL autosampler vials at ambient temperature. Each tray should be configurable to hold at least 162x 2mL vials or at least 45x 10/20mL vials each.

• A wash vial holder capable of at least two wash solvent vials and a waste vial.

• The capability to incubate, agitate & extract from standard 10/20mL vials to facilitate static headspace and SPME Arrow sample introduction.

• The capability to multiplex/ schedule the incubation, agitation, and extraction of headspace and SPME Arrow samples to facilitate continuous GC sample analysis.

GC Specifications

• The GC system should be capable of and user-configurable to use helium, hydrogen or nitrogen carrier gas.

• The GC should be equipped with a helium conservation device integrated into the instrument control software to schedule operation.

• The GC column oven shall be capable of programing 10 or more automated temperature ramp/hold steps with operating temperatures from at least ambient+5oC to at least 350 °C.

• The GC shall have at minimum, one split/splitless capillary inlet (SSL) which shall be equipped with electronic pressure and flow control:

The SSL shall have:

• Pressure ranges from 0 to at least 150 psi

• Total flow setting range of at least 0 to 1250 mL/minute

• Maximum operating temperature of at least 380 °C

• Accommodate split ratios from 1:1 to 1:100

• Shall accommodate capillary GC columns at least 0.05 mm to 0.530 mm ID.

• The GC shall have at minimum, one programmable-temperature-variable or multi-mode capillary inlet (PTV/MMI) which shall be equipped with electronic pressure and flow control:

The PTV/MMI shall have:

• Pressure ranges from 0 to at least 150 psi

• Total flow setting range of at least 0 to 1250 mL/minute

• Maximum operating temperature of at least 380 °C

• Accommodate split ratios from 1:1 to 1:100

• Shall accommodate capillary GC columns at least 0.05 mm to 0.530 mm ID.

• Cooling below ambient temperature provided by CO2 cryogen

• Capable of heating at >600oC/min.

• Compatibility with S/SL inlet consumables (such as septum and liner) is preferred but not required.

• The GC system shall be equipped with a flame-ionization detector (FID) capable of interfacing with capillary GC columns with electronic pressure and flow control for operation of the detector.

• The GC system shall be capable of calculating and providing a corrected constant flow mode based on the column set and temperature zones used for the GC method.

• The GC system must be capable of and user-configurable for individual FID analysis, individual TOFMS analysis, or simultaneous dual-detector analysis (i.e., split flow to both TOFMS & FID from one analytical column).

• The GC system must be equipped and user configurable for backflushing of the analytical column.

• The GC system must be fully integrated, providing automated control of the autosampler, GC, detectors, data collection and processing from a single software platform.

MS Specifications

• The MS shall consist of a low-maintenance EI source, focusing optics, Time-of-Flight (TOF) mass analyzer, and high-speed data collection system.

• The ionization source must be an Electron Ionization (EI) source and shall have:

• a dual filament design with automatic software selection of the other filament if one shall fail during analysis

• temperature control from 100 to 300 °C or better

• a duty cycle of greater than 85%.

• The system must have a mass range from 10 to ≥1000 m/z. Acquisition across this full range must not compromise system performance with respect to spectral resolution and mass accuracy.

• The mass analyzer must be capable of routine and sustained acquisition with a mass accuracy of 0.1 Da or better. This will apply in full mass range mode and be independent of acquisition speed or mass range. The mass accuracy specification shall typically apply to any m/z from a S/N of greater than 100 to a point below saturation with standard data processing methods.

• The system must produce an average similarity score on repeated injections 1 pg of octafluoronapthalene (OFN) of greater 800 as compared to the latest NIST library (2023)

• The stability (Root Mean Square RMS) of mass accuracy shall be <0.1 Da for 24 hours without a new mass calibration.

• The full mass range of acquisition speeds must be at least 1 to 500 spectra per second.

• The spectra acquisition speed of the mass analyzer will be equivalent or greater than 100,000 amu/sec.

• The mass analyzer must be capable of acquisition with a resolving power of 1,100 (FWHM) or greater while acquiring a full mass range spectrum. The resolving power of ≥1,100 must be available and consistent independent of acquisition speeds and mass ranges.

• The mass analyzer mass peak width shall be less than or equal to 0.2 Da (FWHH)

• The mass spectrometer must be compatible with helium, hydrogen, or nitrogen carrier gas.

• The EI source shall be designed to handle GC carrier gas flows greater than 2.5 mL/minute.

• MS Software control shall have an automated startup and shutdown of entire system, roughing pump, turbomolecular electronics and vacuum monitoring.

• Mass spectra must not be skewed by the MS.

• The GC-MS shall be capable of collecting, storing, and reporting at least 50 full-range mass spectra per second.

• While scanning in full mass range mode, the GC-MS system must be capable of detecting 50 fg or less of (OFN) and yield an Instrument Detection Limit (IDL) of less than or equal to 20 fg OFN

GC-TOFMS Performance Specifications

• While scanning in full mass range mode, the GC-TOFMS system must be capable of an Instrument Detection Limit (IDL) of less than or equal to 20 fg OFN.

• The GC-TOFMS system shall have a retention time reproducibility of no greater than ±100 milliseconds.

• The GC-MS system must have a spectral dynamic range of at least 10E5 (100,000) to allow for analysis and detection of isotopes and low-level analytes in the acquired spectra including trace analytes in the presence of high-level analytes.

• The GC-TOFMS system must have a linear dynamic range of no-less-than 10E4 for octafluoronapthalene (OFN) or equivalent test compound.

• The system must have a reproducibility of less or equal to 5% RSD (Relative Standard Deviation) on repeated injections of 1 pg of (OFN) or equivalent test compound.

Data System

• Provided hardware must include a complete PC workstation including monitor(s), keyboard, mouse, network connectivity, and any other required peripherals to operate the instrument system. The computer must provide at a minimum:

• Windows 11 operating system preinstalled

• Video hardware capable of driving at least two simultaneous displays

• At least one LAN connection (in addition to any required for use by the GC-

TOFMS system) to allow for connection to the laboratory network.

• The data system software shall include a complete data processing, acquisition and reporting software package which must provide:

• compliance with Windows 11 operating system

• automated peak finding (deconvolution) of GC-TOFMS data

• automated analyte quantification of GC-FID, GC-TOFMS, and GC-FID-TOFMS data

• analyte quantitation software that is capable of generating calibration curves with various mathematical models and across multiple orders of magnitude

• the ability to construct tables of known sample types for comparison to other samples (reference)

• the ability to automatically compare samples to the reference tables to quickly produce lists of differences and similarities between the samples

• automated data export in a variety of electronic formats including but not limited to Agilent (.d), Thermo (.raw), Andi (.cdf), Comma separated variable (.csv), etc.

• a view of the different sections of the GC method (columns, inlet, temperature zones, GC parameters) within the software

• capable of viewing of application windows on two computer monitors for easier data review.

• full contour chromatogram overview insert that highlights the zoomed region for easy operator orientation in the data.

• an operator interface which may be used to control the GC portion of the instrument independently of the mass spectrometer (for purposes of troubleshooting, maintenance, and flexibility of operation of the GC)

• automated overall system optimization algorithms that maximize signal intensity, maximize mass resolution, and calibrate the mass axis.

• for the addition of samples to an acquisition table and/or reordering of samples in the acquisition table without requiring the analyst to terminate the sequence

• integrated control of the autoinjector

• the ability to prepare analyst defined quality assurance protocols for system optimization, vacuum leak tests, and detector response correction

• the ability to schedule the quality assurance tests on a time basis, a per-sample basis, or both

• The system must be equipped with the Wiley Registry/ NIST Mass Spectral Library 2023 package.

• use of the NIST library search algorithm for comparing sample mass spectra to databases of mass spectra

• for the creation and use of analyst-defined libraries of mass spectra to be used for library searches

• for multiple libraries to be automatically searched simultaneously

• the ability to calculate retention time locking and calculate retention indices for analytes found in a sample based on previously recorded index data.

• fully automated qualitative analysis consisting of: location of all peaks that meet analyst-defined criteria; deconvolution of the mass spectra from background-, matrix-, or coeluting-analyte signals; and perform tentative analyte identification by library search.

• fully automated peak find algorithm capable of detecting coeluting analyte peaks, analyte peaks buried beneath the background of the total ion current chromatogram, or analyte peaks buried beneath significantly larger concentration analytes and/or matrix interferences.

• fully automated mass spectral deconvolution algorithm that removes background signal, removes interfering signal from matrix or other analytes, and accurately proportions shared signal found in both the analyte spectrum and the coeluting interference resulting in a clean, full-range mass spectrum for more accurate analyte identification.

• the presentation of deconvoluted mass spectra in coelution situations where the ion of interest is shared. The deconvoluted peak shapes shall represent the portion of shared signal contributed only by the specified analyte in the coelution.

• a reverse search of a peak table for a target spectrum to see if the analyte is present anywhere in the sample.

• for the automated comparison of two samples to generate a list of analytes found only in sample A, a list of analytes found only in sample B, a list of analytes found in both samples A and B, and a list of analytes found in both samples A and B but outside an analyst-defined concentration range.

• fully automated quantitative analysis based on single or multi-order calibration curves.

• simple user-customizable generation of written report templates

• the ability to choose the mass scale of mass defect plots on both raw and deconvoluted data.

• The contractor shall 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.

The contractor shall provide familiarity of all the new futures of the newer system. Such familiarization shall include system operations, calibration, optimization, and basic preventative maintenance procedures. This shall take place upon system Initial Qualification.

Trade and Service Specifications

1. The instrument must be a newly manufactured unit, not used and refurbished or previously used for demonstration.

2. Delivery shall be FOB Point destination per FAR Clause 52.247-35.

3. The entire system must be warranted for parts and labor for 12 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 least a one (1) year warranty and shall 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.

4. Instrument operators shall have access 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.

5. One Preventative maintenance (PM) visit shall be included for the base contract year. The visit shall occur prior to the expiration of the warranty but no more than 30 days prior to that expiration. This visit shall be inclusive of all parts, labors, travel, consumables, and supplies which are necessary to complete the OEM’s suggested PM protocol. Service engineers which perform this service shall trained by the OEM.

6. Sufficient familiarization training for 3-5 users per delivery onsite location will be provided at time of installation or shortly thereafter (within 30 days), such that operators may independently operate the instrument and with increased familiarity and proficiency. The training shall include manuals and any consumables to be used during training.

7. The Contractor shall provide installation qualification with an employee who can provide proof of installation qualification/Operation qualification (IQ/OQ) certification.

Deliverables

Deliverable Quantity Delivery Date

GC TOFMS 1 Within 90 days of award

Set-up and Qualification (IQ/OQ) 1 Within 30 days of delivery

Familiarization of the new main features, operation, and basic maintenance. 1 Within 30 days of delivery

Field Service Report As needed

Within 5 days of completion of service

Corrective action to fix the system under any failures during warranty 1

After occurrence and request due to a fault.

Annual Preventative Maintenance Service 1 Within 30 days prior to expiration of warranty

Shipping Destinations:

FDA Denver Laboratory 1 Denver Federal Center, Building 20, Door W10 Denver, CO 80225

Denver Laboratory is not equipped with a loading dock, forklift, or other cargo unloading equipment. Delivery of the system to Denver Laboratory must include a lift-gate truck or other suitable method of unloading the equipment without removal, damage, or modification of the manufacturers original shipping crate(s) or containers.

HHS Section 508 and Accessibility Standards

Section 508 of the Rehabilitation Act, as amended by the Workforce Investment Act of 1998 (P.L. 105-220) requires that when Federal agencies develop, procure, maintain, or use information and communication technology (ICT), it shall be accessible to people with disabilities. Federal employees and members of the public who have disabilities must have access to, and use of, information and data that is comparable to people without disabilities.

All products, platforms and services delivered as part of this work statement that are ICT, or contain ICT, must conform to the Revised 508 Standards, which are located at 36 C.F.R. § 1194.1 & Apps. A, B, C & D, and available at https://www.access-board.gov/ict/.

All requirements are applicable to support services and documentation deliverables. All functional performance criteria apply when using an alternative design or technology that achieves substantially equivalent or greater accessibility and usability by individuals with disabilities, than would be provided by conformance to one or more of the requirements in Chapters 4-6 of the Revised 508 Standards, or when Chapters 4-6 do not address one or more functions of ICT.

For each proposed product, platform, or service, a fully completed Accessibility Conformance Report (ACR) using the Voluntary Product Accessibility Template (VPAT) (https://www.itic.org/policy/accessibility/vpat) must be submitted. Evaluation will be on an Acceptable/Unacceptable basis.

Prior to acceptance of deliverables, the offeror must demonstrate conformance to the HHS Section 508 requirements via HHS Section 508 checklist(s) (https://www.hhs.gov/web/section-508/accessibility-checklists/index.html). The government reserves the right to perform testing on required ICT items to validate the offeror’s Section 508 conformance claims. If the government determines that Section 508 conformance does not meet the HHS Section 508 requirements, the government shall, at its option, require the offeror to remediate the item, at no additional cost to the government, to align with the HHS Section 508 conformance requirements prior to acceptance.

References:

•Section 508 Standards: https://www.access-board.gov/ict/ •HHS Policy on Section 508 Compliance and Accessibility of Information and Communications Technology (ICT): https://www.hhs.gov/web/governance/digital-strategy/it-policy-archive/department-of-health-and-human-services-hhs-policy-on-section-508-and-accessibility-of-technology.html •HHS Accessibility and Section 508 Compliance Checklists:

https://www.hhs.gov/web/section-508/accessibility-checklists/index.html

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before August 13, 2024 by 12:00pm (EST) at the Food and Drug Administration, Attn: Nina Montgomery, email nina.montgomery@fda.hhs.gov. Reference: 75F40124Q121770.

Disclaimer and Important Notes

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization’s qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in sam.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

mailto:nina.montgomery@fda.hhs.gov.

Confidentiality

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern. Though this is not a request for quote, informational pricing for the service would be helpful.