Brand-Name Justification Roche Diagnostics redacted.pdf

Control Number: 19-RHCO-A-658

RFQ#: W91YTZ19Q0433

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

1. Contracting Activity:

Regional Health Contracting Office –Atlantic Dalecarlia Cell 6000 MacArthur Blvd.

Bethesda, MD 20816

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: 01 Oct 2019 to 31 Dec 2019

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 PWS.

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

(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 six Government-leased Roche Diagnostic Cobas Analyzers at Blanchfield Army Community Hospital (BACH), Ft. Campbell, KY under contract W91YTZ-14-F- 0273 expiring 30 September 2019. This is a follow-on requirement until RFQ W91YTZ-19-Q-0284 is awarded and the phase-in period for the new contract is complete. 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. The laboratory’s accrediting agency, the College of American Pathologists (CAP), requires a “full characterization of each test/method/instrument system before its use in patient testing. For each test performed, the laboratory must have data on accuracy, precision, analytic sensitivity, interferences and reportable range (i.e. analytic measurement range (AMR) as applicable)”. Continued use of the Roche equipment and supplies ensures uninterrupted testing capability while the awardee resulting from RFQ W91YTZ-19-Q-0284 conducts proper phase-in. Failure to procure the necessary analyzers and reagents will cause mission failure.

6. Actions to Increase Competition: This Brand Name Justification on the Federal Business Opportunities (FBO) website. No additional action will be taken to increase competition for this requirement.

7. Market Survey: 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

Name: Roche Diagnostic Website: www.roche.com

8. Procurement History:

Previous Contract or Purchase Order Number: W91YTZ-14-F-0273 Previously competed? N/A No Yes http://www.abbott.com/ http://www.beckmancoulter.com/ http://www.roche.com/

Previous authority for less than Full & Open Competition: N/A

9. Technical / Requirements Certification: I certify that the supporting 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 these supplies/services are not available using mandatory sources and delivery cannot be made by the required delivery 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 Baxter Position Title: Contracting Officer

Email address: Barry.l.baxter.civ@mail.mil Date:

mailto:Barry.l.baxter.civ@mail.mil