Whole blood viscoelastic testing instrument

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 Center for Biological Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing an whole blood viscoelastic testing instrument meeting the requirements below.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516- Analytical Laboratory Instrument Manufacturing; Small Business Size Standard is 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 Warren.Dutter@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 FDA Center for Biological Evaluation and Research (CBER), Office of Blood Research and Review requires a whole blood viscoelastic testing instrument.  The viscoelastic testing instrument will be used to measure various aspects of coagulation biology in whole blood, including clotting initiation, kinetics, firmness/strength, and stability/fibrinolysis. Common technologies achieve this by measuring the effect of a continuously applied rotational force on whole blood that is transmitted to a detection system that displays results on a graph. This technique allows quantitative and qualitative measurement of many aspects of coagulation biology that integrates the role of platelets, cellular blood components, fibrinogen, microvesicles, and soluble coagulation factors. Strengths of this technique include rapid read-out, which has been leveraged for its use in point-of-care clinical testing and management of hemostasis. This ability to rapidly assess multiple coagulation parameters in real-time would uniquely benefit the whole blood PRT program, as the kinetics of the treatment process for several technologies are so rapid that capturing effects on component quality would otherwise not be available with conventional technologies (e.g., conventional coagulation testing or aggregometry).

Minimum Technical Requirements:

1. Acceptable sample types shall include whole blood collected in citrate based anticoagulant solutions (including citrate-phosphate-dextrose).
2. Shall be able to provide the following readout parameters: Clotting time (R/CT), Clot formation time/kinetics, Alpha angle, Clot firmness (MA/MCF), and Lysis.
3. Shall be able to perform the following tests: viscoelastic readouts of intrinsic and extrinsic coagulation pathways.
4. In order to fit existing lab space, the instrument shall be able to be placed on a bench top and fit within 30”x30” footprint.
5. Shall have a test time of less than 15 minutes.
6. Shall have a test volume less than 1 mL.
7. Contractor shall include onsite installation.
8. Contractor shall include training.

Offered systems shall be a turn-key solution i.e. the contractor shall be responsible for providing all hardware, components, instruments, computers, software, and that otherwise required to meet these specifications and the FDA’s stated need. The systems shall be delivered with all necessary supplies and accessories required for installation and start-up.

Systems shall be warranted for not less than one (1) year from FDA acceptance of the system(s). 

Period of Performance:

Delivery, Installation and Training shall occur within 120 calendar days from date of award.

Delivery Location:

FDA/CBER

10903 New Hampshire Ave.

Bldg. 52/72, Room 4234A

Silver Spring, MD 20993

Though the target audience is small business vendors or small businesses capable of supplying a U.S. 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, Unique Entity ID (SAM) 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 to include date of sale, description, 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 Unique Entity ID (SAM) number and size status) if not the respondent.
• Descriptive literature, brochures, marketing material, etc. detailing the nature of the service the responding firm is regularly engaged in manufacturing or selling.
• 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.
• The offeror’s capability to initiate service within 3 days of original notification. Estimated historical on-site response time for the brand name and model of instrument in this requirement.
• 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 applicable, identification of Best in Class (BIC) contract information or other Government-wide or HHS-wide contracts that the equipment/service is available on.
• If a large business, provide whether subcontracting opportunities exist for small business concerns.
• Standard commercial warranty and payment terms.
• 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.
• Though this is not a request for quote, informational pricing for the equipment/service would be helpful for market research purposes.

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 due by email to the point of contact listed below on or before January 17, 2023 by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: 75F40123SSN116214.

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