A5 6.3_Justification and Approval Other Than Full Open Competition (003).pdf

United States Department of Agriculture

Justification for Other than Full and Open Competition

Commercial Supplies/Services Exceeding $7.5 Million, and

Non-Commercial Supplies/Services Exceeding the Simplified Acquisition Threshold

FAR 6.3

Control No. (if applicable) _____________________

1. Identification of the agency and the contracting activity.

USDA APHIS AMES

2300 Dayton Ave

Ames, IA 50010-9684

USDA APHIS AAMD Contracting

250 Marquette Ave Suite 410

Minneapolis, MN 55401

2. The nature and/or description of the action being approved.

Service Contract

Roche Diagnostics Corporation, 9115 Hague Road, Indianapolis, IN 46256

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

Roche Diagnostics Corporation, Indianapolis, IN Full Service Maintenance Agreement with one yearly preventative maintenance for two Ventana Discovery Ultra immunohistochemistry stainers located at the NVSL, Ames, IA.

The Ventana Discovery Ultra Service Agreement is estimated to cost $181,706 for a base year

($32,884.22) plus four option years at 5% annual uplift charge included. Service to start as soon as possible for two Ventana Discovery Ultra units s/n 319618 and 319621.

4. The statutory authority permitting other than full and open competition.

The following circumstance provides the justification for other than full and open competition under

FAR 6.3:

41 U.S.C. 3304(a)(1), as implemented by FAR 6.302-1, titled "Only one responsible source and no other supplies or services will satisfy agency requirements."

5. A statement demonstrating the unique qualifications of the proposed contractor or the nature of the action requiring the use of the authority.

The Ventana Discovery Ultra immunohistochemical stainers are critical components of the testing methods used in the diagnosis or confirmation of scrapie and chronic wasting disease (CWD), for national programs at the NVSL and in NAHLN Laboratories. The Ventana Discovery Ultra staining modules for the PrP IHC is required to complete approved SOPs at the NVSL for case tissue evaluation. These instruments require a yearly preventative maintenance and onsite repair service. No other vendor has access to priority software, specifications, required maintenance parts, and certified service engineers. Ventana Medical Systems is a part of Roche Diagnostics Corporation.

6. Description of efforts made to ensure offers are solicited from as many potential sources as is practicable.

A sole source was posted on FBO 2019-SS74 and Roche was the only firm to reply to the announcement. Sole source posted again on 6/24/21 with no reponses.

7. Description of the market research conducted and the results or a statement of the reason

Market Research was not conducted.

RE: Sole Source

To whom it may concern, This letter is to verify that in North America Ventana Medical Systems is the sole manufacturer and its affiliate Roche Diagnostics Corporation is the distributor for all Ventana instrumentations and required reagents / ancillaries.

Sincerely, Grant M. McCoy, Contracting Manager Roche Diagnostics Corporation

8. Any other facts supporting the use of other than full and open competition.

The NVSL is evaluating other equipment platforms and sources for suitability to create options, however no other vendor has been identified that makes parts and reagents that work on the Ventana

Discovery Ultra platform or provides the necessary service requirements. The cost of the Roche service contract is in line with service cost offered by another vendor for a similar piece of equipment with priority requirements.

9. Listing of the sources, if any, that expressed a written interest in the acquisition.

N/A

10. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition if subsequent acquisitions are anticipated.

Program and contracting will continue to notify public of this requirement to find other firms who are able to provide preventive maintenance for this equipment in the future.

11. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

Pricing is considered fair and reasonable when compared to other preventative maintenance contracts.

Certifications & Approvals

☒ The information provided for this justification has been reviewed and certified accurate and complete by _____________________________ Sharon Lund, Program/Technical Personnel.

Contracting Officer (not exceeding $750,000). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

☒ Approved.

☐ Reviewed and forwarding to the Procuring Activity Advocate (MASCO or Delegate).

Kim Yen Nguyen Tu

Contracting Officer

Additional Reviews & Approvals

Signatures are required at each threshold up to the total estimated dollar value of the acquisition.

Advocate for competition for the procuring activity (MASCO or Delegate approved by HCA for

USDA) (if over $750,000, but not exceeding $15 million). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

☐ Approved.

☐ Reviewed and forwarding to the Head of the Procuring Activity/HCA.

Insert Name of the Procuring Activity Advocate (MASCO or Delegate)

Mission Area Advocate for Competition

Head of the procuring activity (HCA for USDA) (if over $15 million, but not exceeding $75 million). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

☐ Approved.

☐ Reviewed and forwarding to the Senior Procurement Executive (SPE).

Insert Name of the Head of the Procuring Activity/HCA

Head of the Contracting Activity

Senior Procurement Executive of the Agency (if over $75 million). I have reviewed this justification and certify it to be accurate and complete to the best of my knowledge and belief.

Therefore, as the Senior Procurement Executive, I approve this justification.

Insert Name of the Senior Procurement Executive (SPE)

Senior Procurement Executive

Page 5 Version 03152021

Notes and Guidance. Delete these notes prior to finalizing document for signature.

Program personnel are advised to work with contracting personnel early in order to promote and provide for full and open competition to the maximum extent practicable. Small businesses must be considered for competition. Coordination and questions can be submitted to the Office of Small &

Disadvantaged Business Utilization (OSDBU). USDA has required Small Business goals that must be considered in all acquisitions. In circumstances permitting other than full and open competition, program personnel shall provide necessary information to contracting personnel to support and document the circumstances limiting competition through the use of this form. Contracting without providing for full and open competition or full and open competition after exclusion of sources is a violation of statute, unless permitted by one of the exceptions permitted in FAR 6.302.

Advanced planning. Contracting without providing for full and open competition shall not be justified on the basis of (1) a lack of advance planning by the requiring activity or (2) concerns related to the amount of funds available to the agency or activity for the acquisition of supplies or services.

Brand Name. Items peculiar to one manufacturer can be a particular brand name, product, or feature of a product, peculiar to one manufacturer. A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. Brand name specifications shall not be used unless the particular brand name, product or feature is essential to the Government’s requirements and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet the Agency’s needs.

Posting. Contracting Officers shall make justifications (excluding brand name) publicly available within 14 days after contract award in accordance with the procedures at FAR 6.305(d), (e), and (f).

In the case of unusual and compelling urgency, justifications shall be made publicly available within

30 days after contract award in accordance with the procedures at FAR 6.305(b), (d), (e), and (f).

Brand name justifications shall be posted with the solicitation in accordance with FAR 6.305(c) and

5.102(a)(6).

Screening. Before posting this Justification, in accordance with FAR 6.305(e) and 24.202, the

Contracting Officer is responsible to redact any information that is exempt from disclosure under

Freedom of Information Act or information proprietary to the contractor.

Sole Source 8(a) over $25 million. As a minimum, each justification for a sole source 8(a) contract over $25 million shall include the information required by FAR 6.303-2(d)(1) through (5).

Signatures. After review and completion by the Program Office and Contracting Officer, the Word document shall be converted to an Adobe PDF file and routed for digital electronic. Signature blocks shall include dates.