-20028.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>$150K)

Acquisition Plan Action ID: 36C261-19-AP-4811

1. Contracting Activity: Department of Veterans Affairs, Program Contracting Activity Central (PCAC), in support of VA Sierra Pacific Network (NCO 21), VA Palo Alto (VAPAHCS). Purchase request number 640-20-1-522-0001

2. Nature and/or Description of the Action Being Processed:

FAR13.5 Simplified Procedures for Certain Commercial Items: This is for a Sole Source Justification in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The VA Sierra Pacific Network (NCO 21), VA Palo Alto (VAPAHCS) has a requirement for a Fuijifilm VisualSonics Vevo 3100 Ultrasound Imager and required components in support of the new Palo Alto research Vivarium.

The Contractor shall deliver, install, and provide end user training for the Fuijifilm VisualSonics Vevo 3100 Ultrasound Imager to support timely opening of the new clinic.

Independent Government Cost Estimate (IGCE):

1 Fuijifilm VisualSonics Vevo 3100 Ultrasound Imager and required components

4. Statutory Authority Permitting Other than Full and Open Competition:

FAR13.5 Simplified Procedures for Certain Commercial Items: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

In ultrasound imaging, resolution is dictated by the frequency of the sound waves. The Vevo 3100 ultrasound employs high-frequency sound waves (30-70 MHz) that provide the resolution required (down to 30 microns) to visualize and measure the small anatomical and functional changes in mouse and rat anatomy. In addition, this ultrasound system was designed specifically for animal research with a data/software navigation that facilitates preclinical studies. Other commercially available ultrasound systems are developed for clinical (human) imaging and employ low frequency sound waves - less than 15 MHz. These low frequency ultrasounds do not provide sufficient spatial resolution to identify and measure anatomical structures in small animals. These other ultrasound systems are not capable of the rigorous quantification necessary for our small animal research projects.

The Vevo 3100 is the only commercially available ultrasound that operates at high frequencies and allows accurate visualization and measurement of mouse/rat heart, aorta, carotids, uterine artery and other anatomy critical to our research projects. In addition it images with high-frame rates (required for speckle-tracking echocardiography), multiple focal points, Color Doppler (blood flow maps), steerable Pulsed-Wave Doppler (blood flow velocity) large fields of view, and uniform focus at the required spatial resolution. The 4D imaging capability provides for more precise visualization of dynamic motion of blood flow and cardiac cycle. Further, the in vivo oximetry allows monitoring of blood oxygenation. Also, Nonlinear Contrast Imaging can be performed by intravenously injecting either target-ready or untargeted microbubble contrast agents.

The Vevo 3100 measures cardiovascular function in small animals such as mice and rats in vivo (while the animal is alive). It is a non-invasive imaging system which allows us to perform measurements at multiple time points throughout our studies on the same animals. This capability increases study efficiency by reducing the number of animals needed per study, decreases the time needed per study, and increases scientific rigor.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

See section 8 below for detailed efforts to ensure offers will be solicited from as many potential sources as deemed practicable.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost to the Government has been determined fair and reasonable by previously conducted market research by the researchers who have participated in the acquisition of the same equipment. Further, an informal quote was received by the facility from the OEM; the sole provider of the required system. A determination the price is fair and reasonable will be performed before award.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: Market research was conducted in accordance with FAR Part 10, details of which are in the market research document in the contract file. This effort did not yield any additional sources that can meet the Government’s requirements.

SDVOSB/VOSB Sources via VetBiz (VIP): In accordance with VAAR Subpart 819.7004, 819.7005,

819.7006 - https://www.vip.vetbiz.va.gov/, a search was conducted in an attempt to locate Service- Disabled-Veteran-Owned-Small-Business (SDVOSB) and Veteran-Owned-Small Business (VOSB) concerns utilizing NAICS code 334516. This search provided 96 SDVOSB and VOSB vendors. From these results, all vendors were contacted via email January 24, 2020 requesting responses by January 31, 2020. We received two (2) responses from SDVOSB vendors who claimed to be re-sellers of the Fujifilm Vevo 3100. The Contract Specialist contacted the Fujifilm Representative and was informed by the Fujifilm representative that the division of Fujifilm this vendor is authorized to distribute is not the same division that sells the Fujifilm Vevo 3100. The division that sells the Fujifilm Vevo 3100 is Fujifilm VisualSonics and they are the sole distributor of the Fujifilm Vevo 3100 https://www.vip.vetbiz.va.gov/ product. As there are no SDVOSB or VOSB vendors authorized to re-sell the Fujifilm Vevo 3100, an SDVOSB or VOSB set-aside is not appropriate.

Medical Surgical Prime Vendor (MSPV) Contracts: The Medical Surgical Prime Vendor (MSPV) Next Generation (NG) Formulary was downloaded from https://www.va.gov/opal/sac/mspvNG.asp. The prime vendor for Omaha, NE is Kreisers, LLC. A search of Kreisers, LLC’s formulary for the keywords “Fujifilm Vevo” was unsuccessful. The MSPV is not an appropriate source at this time.

Strategic Acquisition Center (SAC) Non-Expendable (NX) Equipment Contracts: A search of the SAC NX Equipment Contracts’ list at https://www.va.gov/opal/sac/nxEquipment.asp did not locate any SAC contracts for an ultrasound imager. The SAC NX Contracts are not an appropriate source at this time.

GSA eLibrary: https://www.gsaelibrary.gsa.gov/ElibMain/home.do. A search for “Fufjifilm Vevo” or an ultrasound imager did not result in any matches to GSA schedule contracts. GSA is not an appropriate source at this time.

Intent to Sole Source: A Notice of Intent to Sole Source was published to beta.sam.gov on January 24, 2020 requesting responses by January 31, 2020. We received one (1) response from Fujifilm VisualSonic who stated they are the sole authorized distributor of the Fujifilm Vevo 3100.

MARKET RESEARCH FINDINGS

OTHER PERTINENT INFORMATION

Per VHA specific requirements set forth in VHAPM Part 813.106-1/2, the VHA aims to prevent the sale of “gray market goods,” defined as goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e.

replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

The CO has reviewed the considerations of the above-referenced guidance in terms of the context of the subject procurement and has determined that it is in the best interest of the Government to purchase the item from either the Original Equipment Manufacturer (OEM) or an authorized distributor to preserve and guarantee the manufacturer’s warranty and servicing components.

The solicitation will be sent to the OEM Fujifilm VisualSonics as the sole provider of the required equipment as there are no authorized dealers for the Fujifilm Vevo 3100 product line. All product warranties and service and/or preventative maintenance agreements will transfer to the VA and will be honored by the OEM and the OEM guarantees fulfillment of all warranty, service, and/or preventative maintenance obligations for the equipment.

Vendor DUNS Socioeconomic Category

Authorized by OEM

Fujifilm VisualSonics 250968898 Other than Small Business Is the OEM https://www.va.gov/opal/sac/mspvNG.asp https://www.va.gov/opal/sac/nxEquipment.asp https://www.gsaelibrary.gsa.gov/ElibMain/home.do

NON-MANUFACTURING RULE (NMR)

The requirement that a Non-Manufacturer supply the product of a small business concern is referred to as the Non-Manufacturer Rule (NMR) [13 C.F.R. § 121.406]. In order to qualify as a small business concern for a small business set-aside, an offeror must either manufacture the item in accordance with the Limitations on Subcontracting (see FAR section 52.219-14, 52.219-27 and 13 C.F.R. § 125.6) or supply the product of a small business made in the United States.

FAR 19.102(f)(4) provides that, “in the case of acquisitions set aside for small business or awarded under section 8(a) of the Small Business Act, when the acquisition is for a specific product (or a product in a class of products) for which the SBA has determined that there are no small business manufacturers or processors in the Federal market, then the SBA may grant a class waiver so that a nonmanufacturer does not have to furnish the product of a small business.” The SBA Administrator has delegated the authority to make decisions on waivers of the NMR to the Associate Administrator for Government Contracting in the case of class waivers.

FAR 19.102(f)(5) provides that, “for a specific solicitation, a contracting officer may request a waiver of that part of the nonmanufacturer rule which requires that the actual manufacturer or processor be a small business concern if no known domestic small business manufacturers or processors can reasonably be expected to offer a product meeting the requirements of the solicitation.”

A class waiver is not applicable to a procurement unless the NAICS and PSC match those listed on the class waiver list. The current list of NMR Class Waivers is maintained by the SBA and can be found at https://www.sba.gov/contracting/contracting-officials/non-manufacturer-rule/class-waivers. For this requirement there is an existing class waiver for NAICS 334516 and PSC 6640.

Therefore, the CO has determined a NMR Waiver Request is not required to be submitted for this requirement.

RECOMMENDATION

Market research efforts have shown that there is not adequate competition among SDVOSBs/VOSBs for an SDVOSB or VOSB set-aside. Based upon the aforementioned information and FAR Part 13.501(a), the Contracting Officer finds that it would be in the best interest of the Government to sole source this acquisition to Fujifilm VisualSonics, an Other than Small Business with sole proprietorship of the Fujifilm Vevo 3100 ultrasound imager product. This sole source justification and authorization will be posted within 14 days after contract award in accordance with FAR 13.5010(a)(2)(i). In accordance with PCAC SOP Part 819 VA Form 2268 Submission 4.2 Exemptions dated November 1, 2018, the VA Form 2268 is required and will be completed and routed in accordance with the policy for approval prior to any quote is requested from the OEM.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Fujifilm VisualSonics is the sole manufacturer of the Vevo 3100 ultrasound imager product. There is no other existing product on the market that can meet the Government’s requirements in an ultrasound imager product and there is no authorized dealer of the Fujifilm Vevo 3100 outside of the manufacturer Fujifilm VisualSonics.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

https://www.sba.gov/contracting/contracting-officials/non-manufacturer-rule/class-waivers https://www.sba.gov/contracting/contracting-officials/non-manufacturer-rule/class-waivers

• Fujifilm VisualSonics

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: To remove or overcome any barriers to competition before future acquisitions for the same supplies and services are conducted, at the system’s end of life, the VA will ensure extensive market research is performed in a timely manner to evaluate vendor capabilities with the intent of opening competition to all brands of medication distribution systems that can potentially meet the Government’s requirements. Further, the Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Date http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx