FDA-SSN-1242444.pdf

TapeStation 4150 System with Post Warranty Maintenance Sources Sought Notice

FDA-SSN- 1242444

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 the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing an TapeStation 4150 System three (3) option years of Post Warranty Maintenance Agreement. 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 associated North American Industry Classification System (NAICS) code is 334516 – Analytical Laboratory Instrument Manufacturing; Small Business Size standards – 1,000 employees.

Background:

The CBER, Division of Viral Products (DVP) lab is characterizing cell lines and virus stocks to be used as reference materials for next generation sequencing studies. This project requires the extraction of genetic material from the viruses and the preparation of many next generation sequencing libraries. For this reason, the lab requires the purchase of a TapeStation 4150 system to be used to check the integrity and concentration of the genetic material extracted and to check the quality and size of the next generation sequencing libraries

This requirements system is as Brand Name or Equal configuration:

1. Agilent Technologies, 4150 TapeStation, part # G2992AA, 1 - Each

Minimum Technical Requirements:

1. The system shall be able to provide quantitative results of RNA and DNA integrity, size and quantity.

2. The system shall determine size and quantification of DNA ranging in size from 35 base pairs up to 60 kilo base pairs (high molecular weight DNA) in as little as 5 pg/μl up to 100 ng/ul. The instrument must be compatible with the use of high molecular weight gDNA and cell free DNA.

3. The system shall provide a quantitative unambiguous measure of DNA integrity in the form of a DIN (DNA integrity number).

4. The system shall determine size and quantification of RNA ranging in size from 100 nucleotides up to 6000 nucleotides in as little as 100 pg/μl up to 500 ng/μl sample concentration.

5. System shall provide a quantitative unambiguous assessment of RNA integrity in the form of a RIN (RNA integrity number) or equivalent measure.

6. Shall be able to process any number between 1- 16 samples in one run to avoid reagent waste.

7. Shall use only minimal amount of sample input (1-2 μl of sample per assay)

8. Shall have an integrated pipette to handle sample transfers

9. Shall be compatible with downstream analysis of samples with Illumina and Oxford Nanopore technologies sequencers.

10. Vendor shall install the instrument and provide a scheduled training session. Date of installation and training to be agreed upon after system purchase.

11. Vendor shall provide a maintenance agreement that includes preventive maintenance visits and repairs using OEM parts and manufacturer trained technicians.

Minimum Performance Requirements:

Three (3) option years of Post Warranty Maintenance and Emergency On-Site Repair Service agreement:

1. Shall include the Tape Station 4150 System.

2. Minimum of one (1) preventative maintenance visits per contract period.

3. Unlimited phone and email support during the contractor's normal operating hours.

4. Preventative maintenance shall include all labor, travel, and parts (except consumables).

5. Unlimited on-site corrective/remedial maintenance/repairs maintenance, service and repairs shall include all labor, travel, and parts (except consumables); Provide service response time with quote.

On-site repair service shall be inclusive of all labor, travel, certified replacement parts, components, subassemblies, etc. needed to return the system to operational capacity.

6. Inclusive of all labor, travel, and parts, components, subassemblies, etc. necessary to provide the service.

7. Performance by formally trained and certified technicians/engineers for all maintenance and repair activities performed, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using new OEM replacement parts, components, subassemblies, etc.

8. Access by the FDA Contracting Officer’s Representative (COR), Technical Representative (TR) and system operator personnel 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.

9. System software and firmware updates required for reliability improvements and correction of any defects

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 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 COR and Contract Specialist, summarizing all maintenance and repair activities (including warranty work) each time service and/or repair is performed.

Period of Performance:

FOB Point Destination. Shipping, handling, in-side delivery, installation and on-site training shall be not later than 30 calendar days after receipt of contract award for the TapeStation 4150 System. The period of performance for the option periods in any resultant award will be estimated based on the date of award, required delivery, installation, and offered warranty period of the systems. If/when Option Year 1 is exercised, the periods of performance for all options will be firmed via bilateral modification.

Place of Delivery/Performance:

U. S. FDA - CBER

ATTN: To be provided at contract award 10903 New Hampshire Avenue Building 52/72, Room 1238 Silver Spring, MD 20993-0002

The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered product/services meet the technical requirements identified above. All interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, DUNS 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 requirements identified above.

3. Past Performance information shall include recent (within the last 3 years) and relevant (prior experience information for TapeStation 4150 System with Maintenance Agreement of the same or substantially similar of TapeStation 4150 System with Maintenance Agreement. For each past performance reference include the date of service, description of service provided, 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 DUNS number and size status) if not the respondent.

4. Documentation, if not the manufacturer of the equipment identified herein, of technical competency on the operation and repair of the brand name equipment. Such documentation should include certification from the original equipment manufacturer or other training certificates within the past calendar year.

5. 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.

6. Provide information if any of these specifications are too restrictive. No response will be considered that the listed specifications are adequate in a competitive environment.

7. If a large business, provide if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response.

8. Standard commercial warranty and payment terms.

9. Though this is not a request for quote, informational pricing for the service would be helpful.

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

The Government encourages any comments and/or suggestions from any interested party, regarding the specifications. While the Government will not respond directly to your comments and/or suggestions; we will consider them as we finalize the specifications in preparation for the forthcoming solicitation.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before June 3, 2021 by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and Reference: FDA-SSN- 1242444.

Notice of Intent:

Responses to this sources 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.

mailto:jennifer.johnson3@fda.hhs.gov

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 beta.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).