75F401SSN1251242 Hemostasis System Sources Sought Notice.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) issues this Sources Sought announcement on behalf of the Center for Biologics Evaluation and Research, Division of Biological Standards and Quality Control (DBSQC) in order to determine if there are existing small business sources capable providing a STA Compact Max Hemostasis system for blood products testing, plus also provide a post-warranty preventative maintenance service contract. The post warranty preventative maintenance service contract on the instrument shall consist of a base year plus four (4) possible one-year options. Each year shall be funded at the time the option year is exercised; options will be exercised based on funds availability and the needs of the Federal Government.

If your firm is considered a small business source under North American Industry Classification System (NAICS) 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1000 employees, and you believe that your firm would be able to provide the FDA with the service described below, please submit an email as instructed below. The vendor shall include information about the company and demonstrate that it can meet all of the minimum technical and performance requirements outlined herein.

Salient physical, functional, or performance characteristics that “equal” products must meet:

1. A fully automated, benchtop, Hemostasis workstation capable of performing clotting, chromogenic and immunological assays simultaneously in random access mode.

2. Coagulation Analyzer shall analyze potency of blood products like Factor VIII, Factor IX, thrombin and fibrinogen.

3. Instrument software should provide auto-verification, repeat/reflex testing, a comprehensive QC package, and automated maintenance logs.

Installation, Training and Additional System Requirements:

1. The components and/ or equipment shall be a newly manufactured, not used or refurbished, or previously used for demonstration

2. The system shall be delivered with all necessary supplies and accessories required for installation and start-up.

3. The instrument and its associated accessories shall include operations and maintenance manuals covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software. All manuals and documentation on the instrument shall be provided in hard copy and/or electronic format.

4. The contractor shall provide guidance on pre-installation site requirements.

5. The contractor shall provide installation and setup FDA test methods to assist lab scientists.

6. Test method(s) shall be run on both the new and the existing instrument (STA Compact, Serial No. 9027695, manufacturer: Diagnostica Stago, Inc.) and the performance of the new instrument shall be equivalent to the currently used equipment.

7. Contractor shall provide onsite training to CBER scientists on the equipment.

8. System shall be warranted for not less than one (1) year from FDA acceptance, to include on-site training. Warranty service shall include troubleshooting capabilities based on complete knowledge of the entire system, immediate access to replacement parts, and immediate access to system improvements and updates. Phone and email technical support shall be included for a minimum of one (1) year.

Minimum Performance Requirements for the post-warranty preventative maintenance service contract:

1. All maintenance and repair activities shall be performed by formally trained and certified technicians/engineers. All repairs and/or PM services shall be performed following Original Equipment Manufacturer (OEM specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.)

2. Post warranty maintenance service contract shall include two (2) on-site PM (preventative maintenance) visits per year, including unlimited free OEM system software updates, and parts, labor and travel.

3. Service contract shall include unlimited technical support; contractor shall begin working on a solution to the problem within 8 business hours of contact for assistance. (e.g., telephone-based, email-based, website-based, etc.)

Service Records and Reports: The Contractor shall, commensurate with the completion of each preventive maintenance service visit, 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, a detailed description of the work performed, the test instruments or other equipment used to perform the service, the name(s) and contact information of the technician who performed the 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 activities (including warranty work) each time service is performed.

Period(s) of Performance: Anticipated to be a Base plus four (4) Option Years (five total years) with projected period of performance dates estimated as:

Base Year: 02/16/2022 – 02/15/2023 Option Year 1: 02/16/2023 – 02/15/2024 Option Year 2: 02/16/2024 – 02/15/2025 Option Year 3: 02/16/2025 – 02/15/2026 Option Year 4: 02/16/2026 – 02/15/2027

Place of Performance

US FDA/NCTR

3900 NCTR Rd. Building 14-1015 Jefferson AR 72079

Responses to this Sources Sought shall unequivocally demonstrate that 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:

• 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.

• Past Performance (within the last 3 years) information for the sale of same or substantially similar product/service on the brand name instrument to include date of sale, description of service provided, 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 the manufacturer (to include DUNS number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. showing the products can meet the above requirements. The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services meet the technical requirements identified above.

• 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.

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

• Though this is not a request for quote, informational pricing is encouraged.

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

Interested Contractors must respond with capability statements which are to be submitted by email only to the point of contact listed below on or before 12:00 pm (Central Time in Jefferson AR) on January 24, 2022 to Suzanne Martella, email suzanne.martella@fda.hhs.gov. Reference:

75F401SSN1251242.

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 or combined synopsis/ solicitation may be published in SAM.gov – Contracting Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality and Proprietary Information

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).

mailto:suzanne.martella@fda.hhs.gov