A.02.04_Justication_and_Approval_FINAL_Redacted_1.PDF

Control Number: 18-RHCO-C-408

Limited Sources Justification or Sole Source Justification for Acquisitions under the Simplified Acquisition Threshold (Simplified Acquisition Threshold is $150K)

1. Contracting Activity: Regional Health Contracting Office-Central, Fort Carson Health Contracting Cell, 5886 Barkeley Ave, Fort Carson, Colorado 80913.

2. Description of Action:

Requirement: New Repeat Pricing: Firm-Fixed Price Time & Materials Cost Funds: OMA Other Funds: DHP Total Dollar Value: $137,113.80

Name of Intended Contractor: Ortho Clinical Diagnostics Street Address: 1001 US Route 202 City, State, Zip: Raritan, NJ 08869-0606

Phone: 585-453-5409

3. Description of Supplies/Services: This requirement is for supply deliveries of MTS Gel Cards for the Provue Analyzer owned by William Beaumont Army Medical Center, Fort Bliss, TX. The Gel Cards are used to determine capability for blood transfusion patients and the blood donor. A delivery period for a base year and one option: 1 May 2018-30 April 2020..

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.

(11 September 2017)

5. Reason for Authority Cited: The authority cited above allows the Government to issue a sole source contract to Ortho Clinical Diagnositcs for MTS gel cards, which are the only cards compatiable with the Government owned Provue Analyzer that is housed at William Beaumont Army Medical Center (WBAMC). The Department of Pathology has a continuing need for MTS gel cards; these particular cards determine blood capability for blood transfusion patients.

6. Actions to Increase Competition: When other gel cards that are compatiable with the Provue Analyzer become available every effort shall be made to increase competition. WBAMC will continue to evaluate capabilities of other vendor’s products and if other products meet the needs of the government, the government will re-procure the specialized gel cards that provide the best value to the Government. The Government will continue to seek new resources that will satisfy these requirements through continued market research, requests for statements of capability, searches on the internet and telephonic inquiries.

7. Market Survey: A search of the GSA was accomplished on 13 April 2018. A search under schedule 65 VII, Invirto Diagnostics, Reagents, Test Kits and Test Sets identified 9 contractors, 7 of those are small businesses. Ortho Clinical Diagnostics, the incumbent, has a GSA contract under schedule 66 III, Clinical Analyzers, Laboratory, Cost-Per-Test, category 605-2A, Clinical Hematology Analyzers, High Maintenance/Complexity Analyzers, identified 5 contractors, all other than small businesses. . For this requirement, schedule 66III is not fitting to the requirement because the government owns the Provue Analyzer and only needs the Gel Blood cards compatible with the analyzer. To identify the GSA market further, a sources sought was posted to GSA, RFQ1279940, from 13 April to 16 April 2018.The sources sought resulted in zero companies responding to the sources sought posted to GSA.

A sources sought was posted to FBO from 10 April to 11 April 2018. The sources sought generated one response. This response was from Ortho Clinical Diagnostics (Ortho), stating that Ortho is the sole source manufacturer and supplier of the ORTHO Provue including the reagents and supplies for the proprietary ID- Micro typing system gel technology reagent products.

A review of mandatory sources to include GSA/VA Schedules, an on-line review of the open market, and sources sought submitted to both GSA and FBO indicate that the gel cards are only available using sole source set aside to Ortho Clinical Diagnostics This procurement has been identified as a commercial item IAW FAR 2.101. The NAICS is 339113, surgical appliance and supplies manufacturing and the Federal Supply Code (FSC) is 6515, Medical and Surgical Instruments, Equipment and Supplies. The SBA size standard is 750 Employees.

8. Procurement History:

Previous Contract or Purchase Order Number: W81K00-16-F-0129, GSA Contract V797D60637.

Previously competed? N/A No Yes

Previous authority for less than Full & Open Competition: Previous contract was a GSA price comparison for similar reagents from other companies. Price Fair and Resonable DF identifies, Ortho has the only vendor with gel cards compatible with the government owned analyzer.

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: Jorge Munoz

Position Title : COR Email address: jorge.munoz2.civ@mail.mil

Date: 16 April 2018

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: MAJ R Stephen Johnson Position Title: Contracting Officer

Email address: Robbie.s.johnson6.mil@mail.mil Date: 16 April 2018

(11 September 2017)

MUNOZ.JORGE.113

2157550

Digitally signed by

MUNOZ.JORGE.1132157550

Date: 2018.04.16 14:19:33 -06'00'

JOHNSON.ROBBIE.ST

EPHEN.JR.128878595

Digitally signed by

JOHNSON.ROBBIE.STEPHEN.JR.1

288785950 Date: 2018.04.17 12:16:40 -06'00'