Attachment_4_-_Brand_Name_Justification_Redacted.pdf

Justification and Approval (J&A) for Other Than Full and Open Competition

FOR OFFICIAL USE ONLY

FOR OFFICIAL USE ONLY14 Nov 2017

NOTE: If a Justification and Approval was approved for the preceding acquisition, a copy of the approved J&A for the predecessor action must be included in the staff package for approval of the instant J&A. This applies to J&A staff packages that are submitted for review and approval at a level above the contracting officer. The predecessor J&A will be used as a reference document by the approving official.

Is this a new or amended J&A Document? New Amended ( Prior to Award Only! )

Funding level for this acquisition: < $700K > $700K and < $13.5M > $13.5M and < $93M > $93M

Contracting Activity:

Department of the Air Force, 18th Contracting Squadron, LGCB, Unit 5199, APO AP 96368-5199, Kadena Air Base, Okinawa Japan.

Purchase Request / Local ID Number: F2H4A18040AW01

Program / Project (and PE, if applicable): Ortho Clinical Diagnostics VITROS 5600 Chemistry analyzer

Program Type (PEO or Other Contracting): N/A

Authority: 6.302-1 – 10 USC 2304(c)(1), Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

Estimated Contract Cost (including options):

J&A Type: Class Individual

COORDINATION (AFFARS 5306.304(a) )

Date

16 Feb 2018

Requiring Activity

Signature

Date

05 Mar 2018

Contracting Officer

APPROVAL (AFFARS 5306.304(a) )

Date

06 Mar 2018

18 CONS/PKB Flight Chief

FOR OFFICIAL USE ONLY

FOR OFFICIAL USE ONLY14 Nov 2017

I. Contracting Activity.

18th Contracting Squadron, Kadena AB Japan.

II. Nature and/or description of the action being processed.

The 18th Medical Support Squadron (MDSS) Clinical Laboratory Element proposes to procure, by means of brand name, the Ortho Clinical Diagnostics VITROS 5600 Chemistry Analyzer.

III. Description of supplies/services required to meet agency needs.

Acquisition of the Ortho Clinical Diagnostics VITROS 5600 chemistry analyzer is required to perform patient chemistry tests to aid in the diagnosis and prevention of disease. In addition to the VITROS 5600 analyzer, the supplies and services needed to perform chemistry tests are multiple chemical reagents, quality control matrix material, consumable supplies, instrument interface with the DoD Combined Health Care System (CHCS), and technical services. It is estimated that the chemistry analyzer contract value would be Japanese Yen.

IV. Statutory authority permitting other than full and open competition.

FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This acquisition will be for a brand-name product peculiar to one manufacturer.

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

The VITROS 5600 chemistry analyzer has an extended calibration time that requires less maintenance that improves both productivity and efficiency saving 50 man-hours and $2K per year. Additionally, the VITROS 5600 analyzer has adjustable thresholds for chemical inventories, calibration expirations and diluent volumes which reduce the amount of analyzer start up time by 30 man-hours per year thus saving the AF $1.2K. Effective logistics management has always been a challenge on Okinawa. We routinely encounter logistics and supply chain management issues with other vendors. Critical supplies are often delayed and had to be purchased locally under emergency order requests. This results to significant patient care delays and unnecessary burdens which requires additional work-hours and QA steps before the reagents can be used for patient testing. However, Ortho Diagnostics has been reliable and has no history of poor logistics management performance with Kadena Laboratory. The reagents for Vitros 5600 are also interchangeable with USNHO's Vitros analyzer and can be purchased via same vendor, Ortho Diagnostics Japan. It would also be beneficial for Kadena healthcare providers to compare chemistry lab results with USNHO because of similar analyzer testing methodology.

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

A review of peer-reviewed and clinical literature was performed to capitalize on industry knowledge and capabilities, and identify products in terms of performance, quality, safety, and accuracy. Online search and vendor interviews were also conducted for comparative evaluations of analyzers. The Ortho Clinical Diagnostics brand name was the only chemistry analyzer considered because it is the only analyzer that is capable of ensuring consistency of patient results between facilities and the only system that will provide ability to eliminate critical work stoppage issues for both Kadena AB and USNHO. Additionally, the Ortho Clinical Diagnostics system was the one that has an on-island technical and service representative that is capable of immediate technical and supply response. Furthermore, all Air Force clinical laboratory in Japan and Guam use Vitros Chemistry Analyzer (Misawa, Yokota, Andersen AFB).

FOR OFFICIAL USE ONLY

FOR OFFICIAL USE ONLY14 Nov 2017

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

A quote has already provided and is comparable to prices paid on previous contracts. Based on this, the Contracting Officer can determine that the anticipated costs will be fair and reasonable.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

The agency is unable to remove the barrier within this acquisition due to the nature and sensitivity of the requirement.

The medical field possesses unique, sensitive, and precise characteristics to ensure the health and accuracy of their provided services. Furthermore, market research will be conducted, sources sought notices posted, and examination of the results of the notices for future requirements of similar items.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

Approval of the brand name request is vital to provide critical patient testing and lifesaving medical care of the 42,000 island wide military service members and dependent family members. If not approved, Kadena AB may lose the ability to provide critical patient care if there is a break in the supply chain.

X. List of any sources that expressed, in writing, an interest in the acquisition.

Summit Shoji Inc., Okinawa Medix

XI. 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.

Other systems were evaluated based on the needs of the facility to include methodology, system dimensions, tests throughput, and maintenance requirements. Additionally, other platforms offered by the current vendor were evaluated and no other systems besides the instrument currently in-house meet the needs of the facility. The only known source that can distribute and manufacture the reagent cartridges needed by 18 MDG and is also compatible with USNH's chemistry analyzer is Ortho Clinical Diagnostics.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.