JA__-Sysmex_Jul-Sep15redacted.pdf

Brand Name (Limited/Sole Source) Justification and Approval

SOURCE SELECTION INFORMATION – SEE FAR 2.101 and 3.104

1. The Defense Logistics Agency (DLA) Troop Support Pacific, Procurement Office Westpac, is the contracting activity.

2. The action being approved is the ability to solicit for DLA requirements on an other than full and open competition basis – brand name limited/sole source justification.

3. Following is a description of the supplies required to meet DLA’s needs:

National Stock Number (NSN)/Item Description: Reagents, calibrators, media plates, quality controls and consumables, for use with SYSMEX XT-2000i, CA-1500, CA-550, CA-560 and VITEK II analyzers.

Quantity: various Unit Price: various Total Estimated Dollar Value: $148,000 Total Estimated Dollar Value including options: $148,000 Maximum Dollar Value: $150,000

4. The applicable statutory authority permitting other than full and open competition is 10 U.S.C. 2304(c) (1), FAR Part 6.302-1(a) (2).

5. The use of this authority is necessary because SYSMEX laboratory chemistry reagents, calibrators, quality controls and consumables are the only items that will satisfy the requirements of the US Naval Hospital Okinawa. The supplies are needed for the continuous operation of twenty six (26) Government owned chemical analyzers at US Naval Hospital Okinawa. The required supplies must be compatible with the existing SYSMEX, and analyzers. Reagents and other consumables used in analyzers from other manufacturers are not interchangeable. Use of supplies produced and distributed by other than SYSMEX or authorized SYSMEX dealers could potentially cause harm to the SYSMEX equipment and instruments, which would adversely affect test results and patient diagnoses.

DLA Troop Support Pacific will be using the Cost per Test (CPT) methodology for this procurement. The CPT methodology allows for the customer to utilize the equipment based on the consumption of the required supplies (all laboratory chemistry reagents, calibrators, quality controls and consumables. Although SYSMEX may not be the only vendor who can provide items on a CPT method, SYSMEX is the only vendor who can provide the reagents for the type tests the hospital requires with the existing hospital facility set up situation, i.e., lack of water hook up and drainage. Okinawa Medix K.K.

DBA has been designated by SYSMEX as its only dealer/distributor on Okinawa who can supply the reagents for the SYSMEX equipment; therefore, Okinawa Medix K.K.

DBA is the only supplier that can meet the needs of the US Naval Hospital Okinawa for this requirement. Review of the current market has shown that there are no other vendors in Okinawa distributing SYSMEX products.

Although other chemical analyzer systems exist and have the capability to perform the same tests on a CPT methodology, they are not suitable for this requirement as they would require additional analyzers, one for chemistry and one for immunoassay in order to meet customer requirements.

In addition, analyzer testing processes have been provided through on-the-job training throughout the United States Naval Hospitals and Branch Health Clinics in mainland Japan and Okinawa. If different analyzers and reagents are used in Japan and in Okinawa, the hospitals would have to go through extensive parallel testing, change all Standard Operating Procedure (SOP) manuals for using another company’s analyzers/ reagents and limit the hospitals’ ability to transfer personnel within the hospitals without a steep learning curve – all adversely affecting diagnosis of patients.

6. This office does not intend to synopsize based on the exception provided at FAR

5.202 (a) (12). In addition, this justification will be published with the solicitation in accordance with FAR 6.305(c).

7. As the Contracting Officer, I hereby determine that the anticipated prices will be fair and reasonable based on comparison with previous prices paid. Negotiations will be conducted, as necessary, to obtain fair and reasonable prices and favorable discounts.

8. Describe the market research conducted and the results or the rationale for not conducting market research.

A Sources Sought notice was posted on 09/16/2014. No responses were received from the Sources Sought notice.

9. Any other supporting facts:

There are no additional facts supporting the use of this authority.

10. A list of sources that expressed in writing an interest in the acquisition:

Okinawa Medix K.K. DBA is the only source that has expressed an interest in this acquisition.

11. Actions taken to remove or overcome any barriers to competition before any subsequent acquisition include:

For future requirements of this type, we will work with the customer to see if compatible items can be procured. Additionally, on-going research of the industry market place shall be conducted to determine if there are any new entrants into this product area.

12. As the contracting officer, I hereby certify that this justification is accurate and complete to the best of my knowledge and belief.

___7/7/15____ _______________________ Date ARLENE S. RENNER Contracting Officer