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Ektacytometer/aggregometer


Arkansas, United States
Government : Federal
RFP
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MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for an ektacytometer/aggregometer.


The FDA is seeking small business sources to determine the availability and capability of small business manufacturers or small businesses capable of supplying, and subsequently maintaining, a U.S. made product of a small business manufacturer or producer for the items described herein. 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 Standard is 1,000 employees.


The evaluation of the rheology of blood in parts of the body is a task central to the needs of the Office of Blood Research and Review (OBRR) within CBER therefore it is important to have a technique available that can accurately measure the following red blood cell (RBC) properties: Deformability (shear stress test), Osmotic Deformability (osmotic resistance test), Oxygen partial pressure change test and aggregation & dis-aggregation (extent of aggregation, aggregation kinetics). These specific tests are central to the evaluation of processed and the determination of their quality for FDA standards development. An ektacytometer/aggregometer instrument will provide critical measurements of RBCs to evaluate processes applied to human RBCs, which are regulated by FDA/CBER/OBRR. The contractor shall provide the instrument and necessary reagents to start up/run the equipment.


Performance requirements


General specifications:


The components and/or equipment shall be newly manufactured, not used, refurbished, or previously used for demonstration.
Minimum specifications- Brand name or equal



Installation, Training and Additional System Requirements.


The contractor shall provide in-side delivery, installation and operator familiarization training for the system. The contractor shall provide a minimum of one (1) day of on-site training (in addition to installation of the system) to include operations (including software), calibration, optimization, basic and routine preventative maintenance procedures and cleaning requirements.


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) to include on-site training. Warranty service shall include trouble-shooting 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 1-year.


Post-Warranty Preventative Maintenance Agreement shall, at a minimum, include the following


- Minimum of one (1) planned preventative maintenance visit per contract period.
- Unlimited phone and email support during the contractor's normal operating hours.
- Preventative maintenance shall include all labor, travel, and parts (except consumables);
- Performance by formally trained and certified technicians/engineers, following Original Equipment Manufacturer (OEM) specifications, manuals, and service bulletins, using OEM replacement parts, components, subassemblies, etc.
- 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.
- 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 or preventative maintenance visit, provide the end-user of the equipment and the Contracting Officer 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.


FOB Point Destination. All items shall include shipping, handling and in-side delivery to the destination identified herein. Delivery/installation date is within 30 calendar days after receipt of order. FOB Point of Delivery for Services and Supplies will be the FDA located at 10903 New Hampshire Ave, Bldg. 52, Room 4152, Silver Spring, MD 20903.


Alternative solutions will be considered insofar as any such alternate system and/or system components meet the minimum brand name or equal technical requirements.


The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered products/services and components meet the technical requirements identified above. Though the target audience is small business manufacturers or small businesses capable of supplying a U.S. made product of a small business manufacturer or producer all interested parties may respond. At a minimum, responses shall include the following:


• Business name, 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 if responding to provide a product manufactured by another firm);
• Sufficient descriptive literature that unequivocally demonstrates that offered products and services can meet the above requirements. All descriptive material necessary for the government to determine whether the service/product offered meets the technical requirements including: technical specifications, descriptive material, literature, brochures and other information, which demonstrates the capabilities of the contractor to meet the requirement.
• Information on available service/maintenance plans.
• Three (3) years of past performance information for the manufacture and/or sale and maintenance support in which the offeror has provided same or substantially similar system solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of sale, description, dollar value, client name, client address, client point of 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.
• If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement. Detailed list of items included and not included on the GSA contract to meet this requirement.
• 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.
• If a large business, identify the subcontracting opportunities that would exist for small business concerns;
• Standard commercial warranty and payment terms; and
• 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.


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 in person, by postal mail or email to the point of contact listed below on or before April 24, 2019 by 13:00 hours (Central Time in Jefferson, Arkansas) to nick.sartain@fda.hhs.gov, or mail to the Food and Drug Administration, OO/OFBA/OAGS/DAP, Attn: Nick Sartain, 3900 NCTR Road, Building 50, Room 422, Jefferson, AR 72079-9502. Reference FDA1211218.


Notice of Intent
Responses to this sources sought announcement will assist the Government in determining whether or not 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 FedBizOpps. 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).


 


Nicholas E Sartain, Contract Specialist, Phone 870-543-7370, Email nick.sartain@fda.hhs.gov

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