Brand Name Justification redacted.pdf

Control Number: 20-RHCO-A-270 Solicitation Number: W91YTZ20Q0126

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Brand Name Justification for Actions under the Simplified Acquisition Threshold (Currently $250K)

1. Contracting Activity: Regional Health Contracting Office – Atlantic Dalecarlia Contracting Cell 6021 5th Street, Building 1467 Fort Belvoir, VA 22060-5505

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: _________ Total Dollar Value: $

Required delivery date or period of performance: _ 1 May 2020 to 31 July 2020__

Name of Intended Contractor: Roche Diagnostic Street Address:

City, State, Zip:

Phone:

3. Description of Supplies/Services:

Roche Diagnostic Cobas Laboratory Analyzer(s), data management system, all other equipment, chemistry immunoassay reagents, supplies and consumables necessary to operate the manufacturer's equipment. The Contractor shall be responsible for furnishing equipment maintenance, preventive services, unscheduled repairs, and parts as required in order to maintain the systems in optimal operating condition as well as training for government personnel necessary to fully perform testing in accordance with vendor specifications. The analyzers and supplies shall be capable of the tests listed in the Statement of Work.

4. Authority Cited:

(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

(c) FAR 8.405-6(a)(1)(i)(A): An urgent and compelling need exists, and following the procedures would result in unacceptable delays; OR

(d) FAR 8.405-6(a)(1)(i)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; OR

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(e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.

5. Reason for Authority Cited: In accordance with FAR 13.106-1(b)(1)(i), this will be solicited as a brand-name only requirement. There are two Government-leased Roche Diagnostic Cobas Analyzers at Blanchfield Army Community Hospital (BACH), Ft. Campbell, KY under contract W91YTZ20P0050 expiring 30 April 2020. This is a follow-on requirement until W91YTZ19P0359 is phased in and operational. The base period is for three months with no option periods.

Only Roche Diagnostic equipment and supplies can meet this requirement as they are currently in use at the Department of Pathology laboratory and do not require installation, validation, correlation, revisions to the current Standard Operating Procedures, or retraining of personnel. Continued use of the Roche equipment and supplies ensures uninterrupted testing capability while the awardee resulting from W91YTZ19P0359 conducts proper phase-in with Authority to Operate (ATO) in place.

The ATO process requires multiple levels of review and certification in order for the W91YTZ19P0359 awardee’s equipment to be connected to a government network. The various phases of this process have been expedited as much as possible and at this point, the estimated timeline is four months to complete. Hence, the need for the four month requirement for the existing equipment to remain.

Failure to procure the necessary analyzers and reagents will cause mission failure.

6. Actions to Increase Competition: Posting of this Brand Name Justification on the beta.sam.gov website. No additional action will be taken to increase competition for this requirement.

7. Market Survey: Market research was conducted in accordance with FAR Part 10 “Market Research.” The customer contacted three vendors, only one of which, Roche Diagnostics, can provide Cobas analyzers and supplies. All three vendors are large businesses. The customer contacted the following companies:

Name: Abbott Website: www.abbott.com Is the company small or large: Large

Name: Beckman Coulter Website: www.beckmancoulter.com Is the company small or large: Large

Name: Roche Diagnostics Website: www.roche.com Is the company small or large: Large

8. Procurement History:

Previous Contract or Purchase Order Number: W91YYZ20P0050 or N/A Previously competed? N/A No Yes Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i)

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

I certify this product/service is not available using mandatory sources or delivery cannot be made by the required delivery date.

Signature:

Submitted By:

Position Title :

Email address:

Date:

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: Barry L. Baxter Position Title: Contracting Officer

Email address:

Date: