FDA-SSN-123100.pdf

Thermo Q-Exactive (QE) High Field (HF) Liquid Chromatograph High Resolution Mass Spectrometer (LC-HRMS) Preventative Maintenance & Repair Services

Sources Sought Notice

FDA‐SSN-123100

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of Office of Regulatory Affairs (ORA), in order to determine if there are existing small business sources capable of providing Thermo Q- Exactive (QE) High Field (HF) Liquid Chromatograph High Resolution Mass Spectrometer (LC- HRMS) Preventative Maintenance & Repair Services. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The appropriate NAICS code for the acquisition is 811210 – Electronic and Precision Equipment Repair and Maintenance; Small Business Size standards – $34 MIL.

Background:

The FDA, Office of Regulatory Affairs (ORA) has a high-resolution mass spectrometry liquid chromatography system. This system is used for untargeted analysis of shrimp and other aquaculture matrices. The system is located at Arkansas Laboratory and need a service contract.

The ORA Arkansas laboratory routinely performs complex untargeted multi-residue analysis on aquaculture products. The Thermo QE HF LCMS system is used to perform this analysis. This instrument is routinely used, and maintenance and service are routinely needed. The laboratory needs this system under a service contract with up to two option periods to expedite repairs and maintenance. This system is currently under a service contract through July 6, 2024.

Minimum Performance Requirements:

Shall include:

1. Coverage for-

a. Q-Exactive HF MS systems (includes HESI probe), S/N – SN05443L (Jefferson, AR)

b. Vanquish UPLC-

Vanquish Auto Sampler – Model # VF-A10-A with S/N 8304374 (Jefferson, AR) Vanquish Binary Pump – Model # VF-P10-A with S/N 8304613 (Jefferson, AR) Vanquish Column Compartment – Model # VH-C10-A with S/N 6500484 (Jefferson, AR)

c. PC Dell – Model # OptiPlex 7040 MT with Service Tag (S/N) 9KSDSG2 (Jefferson, AR) or its replacement from the OEM.

2. Certified Original Equipment Manufacturer (OEM) parts for all repairs and maintenance.

3. All maintenance and repair activities performed by service technicians/engineers who are formally trained and certified by the original manufacturer. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures. All repairs and PM services shall be performed following Original Equipment Manufacturer (OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.)

4. Enabling the instrument operators to have access to the manufacturer’s call center for technical assistance, which is staffed by senior engineers to provide a high level of expertise for troubleshooting the instrument.

5. Unlimited free OEM system software, firmware and hardware support and updates that are needed for reliability improvements and correction of any defects.

6. One (1) on-site PM (preventative maintenance) visit for the UPLC and mass spectrometer per year which shall include all labor, travel, and OEM factory-certified replacement parts, components, subassemblies, etc., as well as consumables.

7. Unlimited technical support (phone and email) and also includes application support.

Contractor shall begin working on a solution to identified problems within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.).

8. Unlimited corrective/remedial repair visits. Inclusive of all labor, parts, and travel costs. The government agency deals with time sensitive analyses that are critical to public health. The repair and maintenance of these instruments can be critical to public health. Therefore, the offeror shall guarantee onsite service for parts, repairs and maintenance within 3 business days from original notification.

9. The offeror’s service contract will guarantee that the instrument will be brought back to full working performance. If a component cannot be brought back to full working performance by a qualified service engineer the offeror will replace the component free of charge.

10. Computers purchased from Thermo-Fisher Scientific for the purpose of instrument operation that are not functioning shall be replaced at no cost to the government

Service 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 by email 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 a written report to the FDA Contracting Officer's Representative and Contract Specialist by email, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Anticipated Performance:

Base Year: 07/07/2024 - 07/06/2025 Option Year 1: 07/07/2025 - 07/06/2026 Option Year 2: 07/07/2026 - 07/06/2027

Pace of Performance:

U. S. FDA – Arkansas Laboratory TPOC: To be provided upon award 3900 NCTR Rd.

Bldg. 26 Jefferson, AR 72079

Responses to this source sought shall unequivocally demonstrate the respondent is regularly engaged in the sale of same or substantially similar service. Though the target audience is small business vendors or small businesses capable of supplying a U.S. product/service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, SAM UEI number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address.

Provide this same information again if responding to provide a service offered by another firm.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical/performance requirements identified above, to include descriptive material, literature, brochures, and other information.

3. Past Performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar instrument solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include the firm’s SAM Unique Entity Identifier (UEI) number and size status) if not the respondent.

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and

SINs that are applicable to this potential requirement are also requested.

5. If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on.

6. If a large business, provide if subcontracting opportunities exist for small business concerns.

7. Standard commercial warranty.

8. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

9. Though this is not a request for quote, informational pricing is being requested.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before May 29, 2024, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN‐123100.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole‐source acquisition procedures.

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.

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.