-20030.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

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

Acquisition Plan Action ID: 36C776-19-AP-1111

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- 1-522-0009

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: VA Sierra Pacific Network (NCO 21), for the VA Palo Alto (VAPAHCS) has a requirement to purchase Sony Biotechnology MA900 Cell Sorter in support of the VA Palo Alto (VAPAHCS) new research facility currently under construction at the Palo Alto campus. The Contractor shall deliver, install, and provide end user training for the Sony Biotechnology MA900 Cell Sorter to support timely opening of the new research facility currently under construction at the Palo Alto campus.

Independent Government Cost Estimate (IGCE):

1 Sony Biotechnology MA900 Cell Sorter

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):

The Microfluidics sorting chip provides a precision molded, disposable, microfluidics chip with a fresh nozzle and flow cell with each day. In a multiuser environment, this allows chip exchange in-between applications to reduce sample carryover and maintenance and ensures optimal performance. Key benefits of the microfluidics sorting chips includes different chip orifice sizes (70um, 100um and 130um) with automatic sort settings for each type, software wizard for cleaning the chip in case of clogs, and automated daily alignment of the chip (flow cell) to the lasers and sort setup.

The Fully automated sort setup provides chip alignment to lasers and sort setup including optimization of droplet breakoff, side stream positioning, and drop delay calculation. Minimal user input is required during sort setup thereby reducing the workload of core lab personnel. In non-core lab environments, it allows end users with lesser expertise to setup and operate the instrument.

The Sony MA900 is a 12-parameter, 4-way cell sorter enabling both the multiparametric analysis of cell suspension samples commonly evaluated as part of research conducted at the VAPAHCS Palo Alto campus, and the selective sorting of individual cells from these samples. Currently, a consortium of almost 20 principal investigators (Scientific Researchers) take advantage of this technology on a regular basis and will make use of this instrument.

The facility and Contracting staff conducted extensive market research on products that may offer similar capabilities. There are no products on the market that offer the functions the Sony MA900 cell sorter offers. Further, the technology offered by the Sony MA900 provides the VA the capability of providing excellence in advanced medical research that ultimately provides technologically advanced medical care to our Nation’s Veterans.

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 authorized distributor; who is the sole authorized 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 97 SDVOSB and VOSB vendors. From these results, all vendors were contacted via email January 24, 2020 requesting responses by January 31, 2020. We received zero

(0) responses. As there are no SDVOSB or VOSB vendors authorized to re-sell the Sony Biotechnology MA900 Cell Sorter, 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 Palo Alto, CA is Kreisers, LLC. A search of Kreisers, LLC’s formulary for the keywords “Sony Cell Sorter” 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 a Sony Cell Sorter. 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 “Sony Cell Sorter” did not result in any matches to GSA schedule contracts. GSA is not an appropriate source at this time.

Intent to Sole Source Notice: 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 only one (1) response from an other than small business vendor (Sony Biotechnology) who also provided a quote. In the body of the response, the sender noted that Sony Biotechnology was the “authorized government distributor” for Sony Biotechnology MA900 Cell Sorter. The Contract Specialist contacted the Sony Biotechnology representative and was informed by the representative that this was correct.

MARKET RESEARCH FINDINGS

Vendor DUNS Socioeconomic Category Authorized by OEM

Sony Biotechnology (a Division of Sony) 129614512

Other than small business

OEM/only authorized distributor for Sony Biotechnology MA900 Cell Sorter

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 authorized distributor, Sony Biotechnology, as the sole provider of the required equipment as there are no authorized dealers for the Sony Biotechnology MA900 Cell Sorter 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.

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 an NMR Waiver Request is not required to be submitted for this requirement. Additionally, there are no SDVOSB/VOSB vendors capable of fulfilling the requirement as OEM authorized distributors.

VA RULE OF TWO

On June 16, 2016, the U.S. Supreme Court ruled that consistent with Public Law 109-461 (38 U.S.C. 8127 and 8128), the VA shall award contracts based upon competition restricted to SDVOSBs or VOSBs when a contracting officer has a reasonable expectation, based on market research, that two or more firms listed as verified in Vendor Information Pages (VIP) database are likely to submit offers and an award can be made at a fair and reasonable price that offers the best value to the United States. This is known as the “VA Rule of Two.”

Based on the market research conducted, the CO determined there are not two (2) or more SDVOSB or VOSB vendors who can fulfill the requirement. Due to Sony having no authorized dealers other than the Division of Sony identified above that can fulfill this requirement, this requirement must be completed by the OEM/only authorized distributor of the Sony Biotechnology MA900 Cell Sorter, Sony Biotechnology.

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 Sony Biotechnology, an Other Than Small Business who is the sole authorized distributor of the Sony Biotechnology MA900 Cell Sorter. A sole source justification and authorization will be filed in the official contract file in eCMS under P03 and 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 authorized distributor.

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

Sony Biotechnology is the OEM/sole authorized distributor of the Sony Biotechnology MA900 Cell Sorter.

There is no other existing product on the market that can meet the Government’s requirements and the only authorized dealer of the Sony Biotechnology MA900 Cell Sorter is Sony Biotechnology.

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

Sony Biotechnology (OEM/only authorized distributor)

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.

Activity Central (PCAC)

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.

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