FDA-SOL-FY21-1238245.pdf

FDA-SOL-FY21-1238245

Ultra-High Sensitivity Liquid Chromatography-Hybrid Triple Mass Spectrometer with Training, Installation and Four (4) one (1) Year Optional Maintenance Agreement

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR Part 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2021- 05 dated 03/10/2021.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA-SOL-FY21-1238245 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 - Analytical Laboratory Instrument Manufacturing . This will be awarded as Firm-Fixed Price. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need to procure a Ultra-High Sensitivity Liquid Chromatography-Hybrid Triple Mass Spectrometer with Training, Installation and Four (4) one (1) Year Optional Maintenance Agreement

Background:

The laboratory at the FDA Center for Veterinary Medicine, Office of Research, Division of Residue Chemistry requires an ultra-high sensitivity, liquid chromatography-hybrid triple quadrupole-linear accelerator trap mass spectrometer for quantitative and qualitative analysis. The liquid chromatography-tandem mass spectrometer (LC-MS/MS) system will be used for identification of metabolites and food contaminants and for analyzing tissues from animals, animal feed, and other matrices for presence of residues of drugs, antibiotics, and xenobiotics. The instrument will support evaluation, development, validation, and application of regulatory methods to fulfill the surveillance and enforcement mission of the Center for Veterinary Medicine.

Minimum Required Salient Characteristics:

This requirement is for the purchase of an LC-MS/MS system including data acquisition computer and software.

The following are the requirements that the mass spectrometer shall meet:

• The instrument shall be a newly manufactured unit, not used and refurbished, or previously used for demonstration. The life cycle for this instrument is intended to be ≥10 years at full performance.

• The instrument shall accept flow rates from 200 to 3000 microliters per minute without splitting or loss of sensitivity.

• The instrument shall be equipped with both electrospray (ESI) and atmospheric chemical ionization (APCI) probes (or sources). The source shall be able to heat up to at least 750 °C.

• The instrument shall include a built-in syringe pump or a fluidic device for analyte infusion into the system.

• The instrument shall include a built-in switching valve.

• The instrument shall be capable of maintaining a mass stability of 0.1 Da over 24 hours.

• The instrument shall be capable of automatic mass axis calibration, automatic instrument resolution optimization, and automatic optimization of MS/MS parameters for specific target compounds.

• The instrument shall have features that contribute to the interface ruggedness, including orthogonal source geometry, curtain gas barrier, and desolvation gas that can efficiently desolvate analytes from chromatograph effluent and keep analyzer clean.

• The instrument shall be capable of acquiring highly selective mass spectra with full product ion scanning with a triple quad mass range of m/z 5 to 2000 and a linear ion trap mass range of m/z 50 to 2000.

• The instrument shall be capable of acquiring full MS scan, MS/MS product ion scan, MS/MS neutral loss scan, and MS/MS precursor ion scan, MRM, MS3 scan, and MRM3 scan.

• The instrument shall demonstrate a dynamic range for quantitation of at least 106.

• The instrument shall be capable of switching between positive and negative modes in 5 msec.

This is required for accurate quantitation.

• The instrument shall be capable of extended analyses of batches of complex samples such as honey or tissue extracts with little or no user maintenance.

• The instrument shall be capable of accurately quantitating low levels (<1 ng/mL, typically 20 pg on-column) of drugs in complex matrix extracts.

• The instrument shall be able to demonstrate that the instrument can detect 1 pg of reserpine on column and with a signal-to-noise ratio of >1600000.

• The instrument shall include a table capable of supporting the mass spectrometer and muting the noise from its vacuum pumps.

The following are the requirements that the LC shall meet:

• The LC system shall be compatible with the mass spectrometer and its accompanied operation software.

• The LC shall include a three-pumps (ternary) system capable of a high pressure mixing of solvents for gradient analysis at flow rates from 0.0001 to 3.000 mL/min and maximum pressure at 130 MPa.

• The LC shall be capable of blending solvents with mixers, minimizing the column equilibration time after a gradient elution.

• The LC shall be able to switch between UHPLC and HPLC mode.

• The LC shall have a multi-channel vacuum degasser suitable for solvent flows of up to 3 mL/min.

• The LC shall include a thermostatted autosampler capable of controlling a temperature range of

4 to 40°C and with reliable injections from 0.1 to 50 µL. Unit shall have needle wash functions to reduce sample carryover. Unit shall be supplied with racks to hold ≥80 standard 2 mL autosampler vials.

• The LC shall have low sample carryover rate (<1% of analyte) to the next injection.

• The LC shall include a thermostatted column oven capable of providing 10°C below ambient temperature to 80°C.

• The LC shall have a Photodiode Array Detector with a High Sensitivity Flow Cell (noise level as low as 4.5×10-6 AU).

• The LC shall include all hardware, cables, and interface cards for use with the mass spectrometer, so that the UHPLC system is ready for data acquisition after installation.

Requirements for the system:

• The system shall be a fully integrated system, including computer, software(s), licenses, and peripheral equipment necessary for instrument operation, data acquisition, and instrument networking capability. Associated computer equipment/software shall be compatible with and include Microsoft Windows 10 operating system 64-bit OS.

• The system shall have two licenses for each accompanied software. One license is for the acquisition computer and one license is for the data reprocessing computer CVM already owns, operating on Microsoft Windows 10 operating system 64-bit OS.

• The software shall be capable of qualitative processing, quantitative processing, and enable automatable presentation of tabular and graphical data.

• The data acquisition and processing software shall be 21 CFR Part 11 compliant.

• The data acquisition and processing software shall include standard features for external/internal standard calibration, linear and quadratic fit, statistical reporting, weighting, and extrapolation.

• The system shall allow for data export to common, non-proprietary file formats such as .PDF, .TXT, .CSV., Microsoft Word, or Microsoft Excel for downstream compatibility.

• The system shall conform to FDA IT Security requirements and be approved by FDA IT prior to award.

• Shall provide any system specific IT information including software names, version numbers, licensing requirements, and any requirements for exclusion from automatic/push updates, and internet/network connectivity requirements.

- Note: If the system computer must be supplied by the vendor, that information shall be included in the proposal.

• Shall have the following lab location requirements:

a. Shall have benchtop format due to space constraints of the laboratory.

b. Shall have a power system requirements/compatibility: 110 VAC, 60 Hz and 220-240 VAC, 50/60 Hz.

c. Shall have a maximum physical space footprint of 109 in. W x 36 in. D x 49 in. H based on intended lab placement.

d. System dimensions shall not exceed 39 in. W x 83 in. H to ensure proper entry and fit in intended location.

e. System weight shall not exceed 400 lbs.

Other Considerations:

• Pricing shall include shipping and installation cost, training, an option year maintenance agreement as specified below.

• Vendor Proposal shall include site-preparation information required for proper system operation and maintenance, including physical space footprint, ventilation, clearance requirements, noise outputs, and IT/network requirements.

***** IT PURCHASING REQUIREMENTS:

NOTE to Contractor: Before the task order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information

Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware

(rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the

Vendor will use in fulfilling this task order.

This list will need to include:

1. IT hardware: manufacture, nomenclature and model number

2. Software (all types): manufacture, nomenclature and version number

Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

End-User Training The proposal shall include an on-site multi-day training for 4-5 users, covering instrument operation, data acquisition software, and basic instrument maintenance, to be scheduled after the instrument has been accepted and CVM operators have become familiar with the system. This training session will be arranged by CVM technical point of contact. This multi-day training is to be at least 4 days in duration and will take place within the warranty period (within one year of date of acceptance).

Warranty and Maintenance The entire system shall be warranted for parts and labor for at least 12 months from the date of acceptance. Warranty service shall include the following at the minimum:

• Coverage shall include troubleshooting 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.

• Any necessary service shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

• The Technical Point of Contact (TPOC) or their designee shall have access to the manufacturer’s technical assistance call center during regular business hours (10am to 8pm EST). The technical assistance call center shall be staffed by engineers who provide a high level of expertise for troubleshooting the instrument.

• The vendor shall be able to guarantee that a service engineer will be able to work on site within two (2) business days of receiving a call from CVM. Upon the on-site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs. Turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed five (5) business days (120 hours).

o For repairs up to $2,500, not covered by the Maintenance/Support Agreement, the Government shall pay the vendor (with proper Government approvals) with a Government Purchase Card o For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a Purchase Order for the repairs o Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization

• All software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term.

• The vendor shall provide all travel, labor, and parts required at no additional charge.

Option Year Maintenance Agreement The contractor shall propose an option year maintenance agreement covering maintenance of the instrument for a period of up to four years; four one-year option years. The maintenance agreement shall cover the same requirements as the warranty requirements with the addition of a preventative maintenance service meeting the requirements below.

• There shall be one scheduled preventative maintenance visit per year over the term of the contract. Preventative Maintenance (PM) visit shall include all travel, labor, and parts included.

This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing and any other preventative maintenance measures deemed necessary by the vendor.

Certificate of Maintainability:

At such time as the services of the Contractor are terminated, expire contractually or are otherwise not extended, or upon request by the Contracting Officer at any time, the Contractor shall issue, within five

(5) working days, a "Certificate of Maintainability" for any or all equipment acquired and/or maintained under this contract. The certificate shall state that preventive maintenance in accordance with the specifications of the Original Equipment Manufacturer (OEM) has been performed and that the equipment is performing in accordance with the OEM's specifications such that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any one-time charges (including but not limited to repair or inspection charges) if such maintenance were assumed effective the day after the Contractor's performance ceases. The Contractor is responsible for bearing all costs associated with obtaining such certification at no separate charge to the Government. Should the Contractor fail to issue the required Certificate of Maintainability in accordance with this clause, or should any equipment fail to perform in accordance with the certification, the Contractor shall be liable to the Government for any reasonable costs incurred by the Government for the purpose of bringing the equipment up to the required OEM maintenance level. If equipment is acquired under this contract, without maintenance of such equipment being concurrently acquired under the contract, the Contractor shall issue a Certificate of Maintainability for such equipment at the time of delivery for each piece of equipment. The certificate shall state that the equipment is in such condition that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any charges to the Government. All charges required to, obtain the requisite performance of the equipment, up to the later of the time the equipment is accepted by the Government or the warranty expires shall be borne by the Contractor. The time the equipment is accepted by the Government is the date that the Government determines that the equipment has passed acceptance testing, not the effective date of acceptance. The fact that the equipment may have been acquired with a warranty does not relieve the Contractor of its obligations under this clause.

Acceptance:

Prior to final acceptance, the contractor will demonstrate upon installation that the item will meet all performance specifications by the manufacturer using supplied controls. Additionally, a verification run will be conducted to assess data generation capability and data quality using prepared research samples.

Period of Performance Base Period: 08/31/2021 – 08/30/2022 Option Year 1: 08/31/2022 – 08/30/2023 Option Year 2: 08/31/2023 – 08/30/2024 Option Year 3: 08/31/2024 – 08/30/2025 Option Year 4: 08/31/2025 – 08/30/2026

Installation and Delivery:

The vendor will be responsible for installation and setup of the instrument. Delivery hours are 10:00 am

– 4:00 pm, Monday – Friday, excluding Federal holidays and weekends. Installation shall be performed by a currently trained technician, certified by the manufacturer.

All installation costs shall be included in the proposal including, but not limited to: delivery, uncrating, placement, and setup of the instrument in the installation location, required installation kits and standards. The complete installation should be scheduled within thirty (30) days of delivery of all necessary components. The vendor shall provide any predefined specifications or requirements for the installation as part of the proposal information.

The items need to be delivered to:

Bldg MOD2 8401 Muirkirk Rd Laurel, MD 20708 Note: Loading dock delivery is acceptable

Government Holidays:

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

Evaluation and Award:

Best Value with Tradeoff

The Government intends to evaluate proposals and, if necessary, conduct discussions with all responsible 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 priced or the highest technically rated offer.

Relative importance and trade-offs. The Government will base the determination of best value on performance, and the other evaluation factors identified elsewhere in this solicitation. The determination of best value also considers the relative importance of the evaluation factors (see

Attachment 1). Technical factors and past performance when combined are significantly more important than price. It is pointed out; however, should technical competence between Offerors be considered approximately the same, then price could become primary.

FDA will base its award decision using a best value analysis that results in the most advantageous acquisition for the Government. FDA’s acquisition strategy used to obtain best value may result in an award to other than the lowest priced, technically rated Offeror. Best value analysis spans a continuum from the lowest priced, technically acceptable proposal to those proposals in which tradeoffs between price, past performance, and each Offeror’s technical solution is evaluated. This tradeoff process depends on the Government’s assessment of quality factors, including but not limited to past performance, compliance with solicitation requirements, technical excellence, management capability, personnel qualifications and prior experience, and price.

INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

FAR 52.212-1 Instructions to Offerors—Commercial Items (OCT 2018)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete.

The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

Quotes should explain why and how their instrument meets or exceeds each detailed technical requirement, and include supportive data and descriptions wherever possible.

The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***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.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Linda.Troutman@fda.hhs.gov no later than May 28, 2021 at 10:00 a.m. Eastern Standard Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

QUOTES DUE: All quotes are due, via email to Linda.Troutman@fda.hhs.gov no later than

June 11, 10:00 a.m. Eastern Standard Time. Please list the solicitation number FDA-SOL-FY21- 1238245 in the subject line of the email.

mailto:to%20Linda.Troutman@fda.hhs.gov mailto:to%20Linda.Troutman@fda.hhs.gov

PROVISIONS and CLAUSES:

The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items;

FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications- Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items;

52.211-6 Brand Name or Equal; FAR 52.217-5, Evaluation of Options; FAR 52.217-8, Option to Extend Services; 52.217-9, Option to Extend the Term of the Contract; FAR 52.219-6, Notice of Total Small Business Set-Aside; FAR 52.219-8, Utilization of Small Business Concerns; FAR 52.219-13 Notice of Set- Aside of Orders; FAR 52.222-3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR 52.222-21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity;

FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.232-18 Availability of Funds;

FAR 52.232-33 Payment by Electronic Funds Transfer—System for Award Management; FAR 52.232-40 Providing Accelerated Payments to Small Business Subcontractors. Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer.

Note: Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.beta.sam.gov.

https://www.acquisition.gov/far/ http://www.beta.sam.gov/