A03_18-Q-0284_J&A_18-295_Belmont_Industries_SIGNED_09-12-2018_Redacted.pdf

Control No: JA-18-295

Sole Source Justification (SSJ) in accordance with FAR subpart 13.106 using Simplified Acquisitions Procedures (SAP)

Belmont Instrument Blood Fluid Warmer, FMS 2000 Repair Parts/Service

1. Contracting Activity: The Contracting Activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA), 820 Chandler Street, Fort Detrick, MD.

2. Requiring Activity: The U.S. Army Medical Materiel Agency (USAMMA), 693 Neiman Street, Fort Detrick, MD 21702. The equipment will be shipped to the Original Equipment Manufacturer (OEM) for repair, and returned to the USAMMA Medical Maintenance Operations Division depot located at 6149 Wardleigh Rd BLDG 1160 Bay 1, Hill Air Force Base, UT 84056-5848

3. Nature of Action:

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price* Time & Materials** Cost*

* See FAR 12.207(a) ** See FAR 12.207(b)

For Hybrid Contracts, list percentage of each type of pricing:

* Firm Fixed Price:

**Time & Materials:

* Cost:

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds:

Fiscal Year of Funds: FY 2018

Estimated Total Dollar Value including Options:

4. Contractor Name:

Name of Proposed Contractor(s): Belmont Instruments, LLC Street Address: 780 Boston Road City, State, Zip: Billerica, MA 01821 Phone: 866-663-0212

DUNS: 078330362

Cage Code: 5Z133

"For Official Use Only”

5. Description of Supplies/Services: The U.S. Army Medical Materiel Agency (USAMMA) has a requirement for 17 brand name Belmont Instruments, LLC repair parts for repair of the Belmont Industries FMS 2000 Blood Fluid Warmer used by deployed forces in theater. The FMS 2000 Blood Fluid Warmer will be shipped to Belmont Instruments, LLC for repair and returned to USAMMA’s medical equipment repair depot located in Hill Air Force Base, UT. Table 1 identifies the required brand name Belmont Instrument parts.

Table 1: Brand Name Belmont Instrument FMS 2000 Parts

Part Number Description Qty

106-00008 Touch Screen 7

202-00060 Batteries (Set) 7

101-00021B Bobbin Assembly 7

403-00114 Connector, Housing 7

103-00158 Push Pins (11) 7

599-00172 Housing 7

206-00017 Housing Heater 7

203-00107 Heater Disk 7

203-00112 Ferrite Slug 7

203-00113 Battery Foam 7

203-00278 Left Panel 7

206-00022 Box 7

205-00027 Cover Gasket 7

299-00034 Fluid Out Detector 7

310-00023 Air Detector 7

310-00024 Door Assembly 7

403-00109 Touch Screen 7

N/A Labor 7

Total Estimate:

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

I FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited: In addition to purchasing the brand name repair parts, this requirement includes repair of the brand name Belmont Industries, LLC FMS 2000 Blood Fluid Warmers. The FMS 2000 Blood Fluid Warmers require extensive repair beyond the scope of repair normally performed by the Government. Belmont Instruments, LLC as the manufacturer is the only source to obtain the required repairs.

While there are distributors of the brand name repair parts by Belmont Instruments, LLC, there are no authorized service centers. Prior purchases of the brand name Belmont Instruments, LLC repair parts did not require repair by the manufacturer.

Therefore, brand name only parts must be purchased by the Government to allow repair of the FMS 2000 Blood Fluid Warmers by the manufacturer.

USAMMA has three (3) medical equipment repair depots located in Tobyhanna, Pennsylvania; Tracy, California; and Hill Air Force Base, Utah. Medical equipment used by deployed forces around the world is returned to one of the three depots for repair, refurbishment, or replacement when the repair issue exceeds the deployed unit’s maintenance capability. There are limited spares in theater, so repair and return is a high priority activity at USAMMA’s depots.

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 as well as Food and Drug Administration (FDA) 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 instances under which Army medical maintenance personnel may modify medical equipment to include: (1) modification work order; (2) quality assurance alteration; (3) minor alteration; and (4) component modernization. All four instances require the manufacturer involvement or consent.

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.

8. Efforts to obtain Competition: The parts identified in Table 1 are required to repair the FMS 2000 Blood Fluid Warmer equipment and are available directly from the manufacturer. Direct correspondence with the Director of Business Operations for Belmont Industries, LLC stated “Within the US we are our own authorized service center. We do not work with distributors. We recommend that you send it back to us for return.” Due to the extensive nature of the equipment repair, the FMS 2000 Blood Fluid Warmer will be shipped to Belmont Industries, LLC for replacement of the repair parts identified in Table 1 and reconfigured back to Belmont Industries specifications, and shipped back to USAMMA’s medical equipment repair depot located in Hill Air Force Base, UT. The Government has also determined that installing parts purchased from unauthorized sources would also violate AR 40-61 referenced above. Therefore, there will be no efforts to consider quotes from any other sources as the market research efforts detailed under paragraph 10 below have determined that these parts can only be purchased from the manufacturer directly.

In accordance with FAR subpart 5.2, a Notice of Intent will be posted to FedBizOpps on or about 30 August 2018. This announcement will detail the Government’s intent to purchase the required items on a non-competitive basis, directly from Belmont Instrument, LLC. However, responses received will be reviewed for the purpose of determining whether a competitive procurement is in the best interest of the Government.

a. Effective competition. No competition is expected as this procurement action will be accomplished on a sole source basis.

b. Subcontracting competition. Not applicable; as this is a supply-type requirement, the Government does not anticipate subcontracting competition opportunities.

9. Actions to remove or overcome barriers Competition: The barrier to competition is the manufacturer is the only source to purchase the medical equipment repair parts.

There are no other distributors and as a result there is no competition. USAMMA will continue to conduct online research as part of its periodic market research efforts to locate other available sources capable of meeting any future requirements. Additionally, the Government may post a Request for Information (RFI) for any future procurement to determine if there are additional sources available in the market place that can meet the Government’s need.

10. Market Survey: Thorough market research has been completed by both USAMMA and USAMRAA for medical equipment repair and replacement parts. The recent market research efforts include searches conducted by USAMMA on 23 August 2018 for this requirement on General Services Administration (GSA) Advantage! for the required brand name Belmont Instrument parts included in Table 1. This search revealed no results for the required brand name parts including a review of Belmont Instrument’s GSA contract for medical equipment and supplies.

USAMMA conducted additional market research on 23 August 2018 using the Medical Product Data Bank (MedPDB) to search for potential purchasing options. The MedPDB is a system that resulted from the Defense Logistics Agency Troop Support and the Department of Veterans Affairs (VA) partnership to enable synchronizing of key data across their joint enterprise. The primary purpose of the MedPDB application is to make data from the MedPDB visible to the Department of Defense (DoD) and VA business processes. The MPDB is used to help identify contracts and pricing instruments available to the DoD and VA enterprises. The MedPDB helps identify the best cost for an item via a particular contract or pricing instrument (e.g. Federal Supply Schedule (FSS) / Blanket Purchase Agreement (BPA) / Distribution and Pricing Agreement (DAPA) / E-Catalog (ECAT)); assist in finding alternate sources of supply when an item goes on backorder from the main source of supply; and provides visibility of what peers are buying, where they are buying it from, and what their cost is for a medical supply item. The result of the search was unsuccessful in identifying the required brand name parts; therefore, these items are only available directly through the manufacturer.

11. Interested Sources: As previously stated, a Notice of Intent to Sole Source will be posted to FedBizOpps. This announcement will detail the Government’s intent to purchase the required items on a non-competitive, directly from Belmont Instruments, LLC. However, responses received will be reviewed for the purpose of determining whether a competitive procurement is in the best interest of the Government.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: Thorough market research was conducted to include a review of USAMRAA’s contracting writing system, Procurement Desktop-Defense (PD2), the USAMRAA Paperless Acquisition System (UPAS), and the Virtual Contracting Enterprise Paperless Contract File (VCE-PCF). The search resulted in two (2) previous Purchase Orders issued for medical equipment repair parts manufactured by Belmont Industries, LLC. Table 2 identifies the prior Purchase Orders and acquisition information.

Table 2: Prior Repair Parts Awards

Purchase Order Date Award

Amount Authority

W81XWH-18-P-0036 12 Feb 2018 $105,429.00 FAR 13.106-1(b)(1)(i)

W81XWH-18-P-0092 15 Jun 2018 $21,601.86 FAR 13.106-1(b)(1)(i)

Previously competed?

Yes. Belmont Instruments, LLC brand name repair parts was competed due to authorized resellers, reference Table 2. However, a review of the requirements previously awarded did not include service/labor. The extent of the repairs required under previous award fit within AR 40-61 of which the brand name equipment could be competed to authorized distributors. Due to the extent of the repair required for the FMS 2000 Blood Fluid Warmer, Belmont Industries, LLC is the only authorized source.

Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i)

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.