SPECIAL NOTICE
65 -- Belmont Instruments, LLC Blood Fluid Warmer, FMS 2000 Repair Parts and Service - Notice of Intent
- Notice Date
- 8/30/2018
- Notice Type
- Special Notice
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Army, U.S. Army Medical Research Acquisition Activity, U.S. Army Medical Research Acquisition Activity, Attn: MCMR-AAA, 820 Chandler Street, Frederick, MD 21702-5014, Maryland, 21702-5014, United States
- ZIP Code
- 21702-5014
- Solicitation Number
- W81XWH18Q0284
- Archive Date
- 9/25/2018
- Point of Contact
- Jessica L. Wright, Phone: 3016192110
- E-Mail Address
-
jessica.l.wright106.civ@mail.mil
(jessica.l.wright106.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Description
- Notice of Intent 1. Solicitation Number: W81XWH-18-Q-0284 2. Sole Source Title: Belmont Instruments, LLC Blood Fluid Warmer, FMS 2000 Repair Parts and Service 3. Agency: The requesting activity is the U.S. Army Medical Materiel Agency (USAMMA), Fort Detrick, MD 21702 4. Contracting Office: The Contracting Activity responsible for this action is the U.S. Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD 21702 5. Location: USAMMA, 693 Neiman Street, Fort Detrick, 21702 6. Description: The U.S. Army Medical Research Acquisition Activity (USAMRAA) intends to award a sole source Firm-Fixed Price supply contract to Belmont Instrument, LLC, located at 780 Boston Road, Suite 3, Billerica, MA 01821-5939 (DUNS 078330362; CAGE Code 5Z133). The statutory authority permitting the acquisition of this requirement by other than full and open competition is 41 U.S.C. 1901. The Federal Acquisition Regulation (FAR) citation is 13.106-1(b)(1)(i), and the FAR citation title is "Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)". 7. Background: The U.S. Army Medical Materiel Agency (USAMMA) requires medical equipment repair parts and service identified in Table 1 for the repair of Blood Fluid Warmer FMS 2000 equipment manufactured by Belmont Instruments, LLC. Medical equipment repair parts are available only from the manufacturer of the equipment or from a firm that has been licensed by the manufacturer to produce authorized parts. This conclusion is based on Army Regulations and market research. Army Regulation (AR) 40-61, Medical Logistics Policies, prohibits modifications or alterations of Army medical equipment without the manufacturer's consent. Section 6-17 provides that even "minor alterations without the manufacturer's consent may negate any further manufacturer product liability." AR 40-61 lists four circumstances under which Army medical maintenance personnel may modify medical equipment: modification work order, quality assurance alteration, minor alteration, and component modernization. All require manufacturer involvement or consent. Belmont Instruments Medical Equipment Repair Parts: Please see the notice attached for the required repair parts. 8. Scope and Purpose: USAMMA's requirement is for Belmont Instrument, LLC medical equipment repair parts and service for the Blood Fluid Warmer FMS 2000. Belmont Instrument, LLC is the manufacturer of the Blood Fluid Warmer FMS 2000 and there are no authorized resellers of the parts and repair of the equipment is performed by Belmont Instrument, LLC as the OEM. USAMMA is the Army's medical manager and therefore considers any medical equipment alteration, including the substitution of manufacturer-provided or approved repair parts with other repair parts to be contrary to Army and FDA regulations, endangering the device's FDA certification, and incurring product liability on behalf of the Army. 9. North American Industry Classification System (NAICS) Code: The North American Industry Classification System (NAICS) for this requirement is 339112, Surgical and Medical Instrument Manufacturing with a size standard of 1,000 employees. 10. Anticipated Period of Performance: The anticipated delivery date is 30 days after date of contract award. 11. Information to Industry: This is a Notice of Intent to Sole Source is for informational purposes only in accordance with (IAW) Federal Acquisition Regulation (FAR) 5.201 and not a request for competitive proposals. Therefore, no solicitation document exists for this requirement. Interested parties should submit a Capability Statement and pricing information for this requirement within ten (10) days of public notice to be considered by the Government. A determination to compete the proposed contract based upon responses to this notice is solely within the discretion of the Government. Responses received will be considered solely for the purpose of determining whether to conduct a competitive requirement.   12. Response Due Date: Interested vendors should submit the Capability Statement in response to this Notice of Intent to Sole Source electronically by 10:00 A.M. (EST) 10 September 2018 via e-mail to the Contract Specialist, Ms. Jessica Wright, at jessica.l.wright106.civ@mail.mil. No phone calls will be accepted. 13. Notice Closes: This Notice of Intent to Sole Source closes on 10 September 2018 at 10:00 A.M. (EST). 14. Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in response to this notice. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s).
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USA/USAMRAA/DAMD17/W81XWH18Q0284/listing.html)
- Record
- SN05065945-W 20180901/180830232153-5cf6aff112af4fbb507d76f898cde484 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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