Justification(r).pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 09 Page 2 of 5 Original Date: 03/22/11 Revision 09 Date: 04/17/2020

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

FAR 13.5 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).

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

(X) (8) FAR 13.5 in accordance with 41 USC 1901;

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 6.302-1 Only One Responsible Source.

6. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

Roche Diagnostics Inc. is the OEM, and sole affiliated distributor for all Ventana instrumentation (i.e.

Benchmark, HE600, etc.) and required reagents /ancillaries, to include the Benchmark ULTRA (serial #315948), Benchmark ULTRA (serial #5110528), and the HE 600 (serial #6000383) that are used at the W.G. (Bill) Hefner VA Medical Center. Additionally, the service of Ventana Medical Systems must be performed by Roche Diagnostics, Corporation service employees or the service agreement for the instrument is rendered null and void. The proprietary nature of the technology contained within the instrument requires that only Roche Diagnostics perform certain maintenance and service procedures. Per Roche Diagnostics, see attached proprietary letter, they do not authorize third-party firms to provide Preventative Maintenance services or software upgrades/updates on their equipment. Ventana Medical Systems does not provide Original Equipment Manufacturer (OEM) parts, tools or software upgrades/updates to any other third-party vendor, only its affiliate, Roche Diagnostics. The use of a non-Roche Diagnostics part or software upgrades/updates may invalidate any warranty that is in place and the reprocessing instruction. This in turn would prevent Roche Diagnostics from working on these pieces of equipment in the future.

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

Sources Sought Notice was posted on beta.Sam.gov with RFI 36C24620Q0574. The purpose of this posting was to determine if other companies could provide these services to the Department of Veterans Affairs utilizing a firm-fixed price purchase order for a full-service agreement and PM on Benchmark ULTRA (serial #315948), Benchmark ULTRA (serial #5110528), and the HE 600 (serial #6000383). This post allowed for other contractors to express the interest of this contract if able to provide the services and OEM parts for the specific models at the W.G.

OFOC SOP Revision 09 Page 3 of 5

Revision 09 Date: 04/17/2020

(Bill) Hefner VAMC. At the closing of the posting (3 days from issuance), there was one vendor which had reached out or provided their capabilities but were deemed not capable of providing and performing the full spectrum of services required for this procurement. Additionally, after speaking with one of the Senior Corporate Account Directors for Federal accounts at Roche Diagnostics, Inc., it was determined that Roche Diagnostics is the only vendor authorized to perform service on the North America Ventana Medical Systems manufactured equipment and instruments.

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

The Contracting Officer will ensure the prices being offered are fair and reasonable through use of reviewing past procurement history of these services, comparing the IGE, and the offerors quote.

9. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market Research for this acquisition was conducted. As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

The following Market Research was conducted:

1. Ability One – Not able to perform PM services.

2. VIP Database – A search combination of NAICS code 811219, product service code (PSC)

J066 and key words “Benchmark Ultra, Special Stains, HE 600”revealed that five (5) Service-Disabled Veteran Owned Small Businesses (SDVOSBs) and six (6) Veteran Owned Small Businesses (VOSBs) were registered. The following vendors were provided an opportunity to provide a capability statement with their potential service efforts of this procurement during the open market posting on beta.SAM.gov utilizing solicitation 36C24620Q0574. None of the SDVOSB/VOSB vendors found in the search on vetbiz.gov responded to the solicitation.

3. Beta.Sam.gov – A sources sought was posted on May 12, 2020 with a close date of May 15, 2020 with one response received from The Remi Group, who was found not capable to provide and perform the services. The determination was based on the interested Party’s lack of capability to provide software upgrades and/or updates to the equipment.

4. Contract Specialist reached out to the company Roche Diagnostics, Inc and was provided a proprietary letter. Additionally, contact with Senior Corporate Account Director of Federal accounts stated that “Roche is the only vendor authorized to perform service on our instruments”.

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

A Proprietary letter from Roche Diagnostics, Inc. was provided. In the letter it states, “that in North America Ventana Medical Systems is the sole manufacturer and its affiliate Roche Diagnostics Corporation is the distributor for all Ventana instrumentation (i.e. Benchmark, HE600, etc.) and required reagents/ancillaries.” “Additionally, the service of Ventana Medical Systems must be performed by Roche Diagnostics service employees or the service agreement for the instrument is rendered null and void. The proprietary nature of the technology contained within the instrument

OFOC SOP Revision 09 Page 4 of 5

Revision 09 Date: 04/17/2020 requires that only Roche Diagnostics perform certain maintenance and service procedures.” As a result of this letter, full and open competition has not been developed for this requirement.

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

The Remi Group

CAGE: 51LN4

Business Size: large 6325 Ardrey Kell Rd. Ste. 200 Charlotte, NC, 28277 Phone:(888)728-2151

12. 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:

Upon the expiration of this contract in July 2025, the contracting activity will continue to work with the requesting activity to determine if the proprietary software patches, and upgrades will still be required.