N6264919Q0330_N6264919Q0330.docx

J&A Number: YOK 19-046

(☐CLASS) JUSTIFICATION AND APPROVAL FOR USE OF SOLE SOURCE ACQUISITION

The procedures in FAR subpart 13.5 are used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

1. IDENTIFICATION OF AGENCY AND CONTRACTING ACTIVITY.

NAVSUP Fleet Logistics Center (FLC) Yokosuka

2. Description of the Action Being Approved.

This J&A authorizes the use of other than full and open competition for the procurement of leasing services and delivery of reagents/consumables from Instrumentation Laboratory (I.L.) through its Japanese subsidiary, I.L. Japan Co., Ltd., for the ACL TOP 500 Analyzers to U.S. Naval Hospital (USNH), Yokosuka.

3. Description of Supplies/Services.

The laboratory at USNH Yokosuka requires to procure leasing services and delivery of reagents/consumables from I.L. which will be exclusively used for existing automated coagulation and arterial blood gas analyser. Redundancy is required for USNH based on identical methods and technology to avoid a single point of failure, to maximize availability and minimize operator training/maintenance.

Following is the estimated amounts for the proposed contract periods:

Estimated Dollar Value

(¥111.1542=$1.00 based on FY20BER)

4. Statutory Authority Permitting SOLE SOURCE.

|X| 41 U.S.C. 1901(e)(2) - a sole source acquisition under the authority of the Simplified Procedures for Certain Commercial Items, as implemented by FAR 13.501(a).

|_| 41 U.S.C. 1903 Special Emergency Procurement Authority - a sole source acquisition in support of a contingency operation; or to facilitate the defense against or recovery from nuclear, biological, chemical, or radiological attack against the United States, as implemented by FAR 13.501(a).

5. Rationale Justifying Use of Cited Statutory Authority.

I.L. is the only manufacturer of reagents which meet the FDA clearance, and the reagents to be used in USNH Yokosuka can be obtained only from I.L. Japan.

Salient Feature of ACL TOP 500 CTS

(a) ACL TOP 500 CTS is one of the series of ACL TOP Analyzers. It is the only Coagulation Instrument which meets the Food and Drug Administration (FDA) clearance and is available in Japan. Stage STA-R was released in 2005 and there are no other sources in Japan which offer similar equipment that have passed the FDA clearance.

(b) ACL TOP 500 CTS is a no water required system and uses special rinse solution.

This ensures continued operation during disaster and under circumstance of no water supply. No other sources offer waterless systems which meet FDA clearance.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

USNH Yokosuka will continue market research and coordinate with equipment manager at the Naval Medical Logistics Command to identify opportunities for future competition. At this time, however, this is the only known source capable of meeting this equipment.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NAVSUP FLC Yokosuka has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, NAVSUP FLC Yokosuka will assess whether competition for future requirements is feasible.

9. CONTRACTING POINT OF CONTACT.

The point of contact at NAVSUP FLC Yokosuka, Contracting Department is Masami Kobayashi, Code 220 at DSN 243-6835, commercial 046-816-6835 or by email at masami.kobayashi.ja@fe.navy.mil.

CERTIFICATION AND APPROVAL

TECHNICAL/REQUIREMENTS CERTIFICATION

I certify that the facts and representations under my cognizance which are included in this Justification and its supporting acquisition planning documents, except as noted herein are complete and accurate to the best of my knowledge and belief.

Technical Cognizance:

“Same as Requirements Cognizance”

Signature Name (Printed) Phone No. Date

Requirements Cognizance:

LEGAL SUFFICIENCY REVIEW

I have determined this Justification is legally sufficient.

Signature Name (Printed) Phone No. Date

CONTRACTING OFFICER CERTIFICATION

I certify that this Justification is accurate and complete to the best of my knowledge and belief. To the extent that the J&A value is between SAT and $700K, the Contracting Officer’s signature below also represents approval of the J&A.

CONTRACTING ACTIVITY COMPETITION ADVOCATE APPROVAL

Upon the basis of the above justification, I hereby approve, as Competition Advocate, the solicitation of the proposed procurement(s) described herein using other than full and open competition, pursuant to the authority of 10 U.S.C. 2304(c)(Click and enter appropriate citation,). To the extent that the J&A value is between $700K and $7M ($13 million for acquisitions as described in 13.500(c)), the Competition Advocate’s signature below also represents approval of the J&A.

Attachment (II)

Source Selection Information – See FAR 2.101 and 3.104

NAVSUPFLCY 4280/3 (12-18) Attachment (II)