Justification and Approval Redacted.pdf

Controlled Unclassified Information (CUI)

Controlled Unclassified Information (CUI)

Source Selection Information – See FAR 2.101 and 3.104

Controlled by: DLA Troop Support Indo-Pacific Controlled by: Procurement Office Westpac CUI Category: PROCUREMENT Distribution/Dissemination Controls: FED ONLY POC: Bradley Ah Nee / bradley.ahnee@dla.mil

Justification and Approval (J&A) The following J&A format is structured in accordance with the requirements of Federal Acquisition Regulation (FAR) 6.303-2. Each J&A consists of 12 elements, and all submissions for approval must include these elements with sufficient detail to explain each one.

Some elements are standard and typically change little from one J&A to another, including elements 1, 2, 3, 4, and 12. Others may vary based on the authority being invoked. For instance, element 6 may detail the synopsis for a (c)(1) or indicate that the (c)(2) J&A does not permit a synopsis.

The core of the J&A lies in elements 5, 8, and 9. These sections must provide a narrative that justifies and explains the need for using the specific authority, outlines the market research efforts and results, and presents any additional facts that support the justification for the chosen authority.

1. The Defense Logistics Agency (DLA) Troop Support, C&E Supply Chain, serves as the contracting entity to fulfill the U.S. Navy's requirements for the Laboratory Department at Naval Hospital Okinawa, Japan.

2. The action being approved is the authorization to solicit DLA requirements on a basis other than full and open competition.

3. The following supplies are required to fulfill DLA's needs:

Reagents and related consumables compatible with VITROS Analyzers, used for conducting biological tests on a single sample using dry slide technology, with a capacity of over 200 tests per hour. This requirement will be met through an IDIQ delivery method, enabling USNHO LAB to maintain its inventory of essential reagents, quality controls, and consumables. This is a follow-on to the previous IDIQ contract SPE8EQ-22-D-0002.

Contractor Name and Contractor Part Number (if applicable): Summit Shoji Inc.

Quantity: 6,173 units (boxes, packages, or each) per year Unit Price: $1,800,061.07 (Base Year) Number of Options: 2 Estimated Dollar Value, inclusive of options: $ Maximum Dollar Value, inclusive of surge: $5,000,000.00

Note: See Attached Excel File for Further Details

4. The statutory authority permitting other than full and open competition is 10 U.S.C.

2304(c)(1) and FAR Part 6.302-1, which states that only one responsible source is available and that no other supplies or services will meet the agency's requirements.

Page of 5 Controlled Unclassified Information (CUI)

Source Selection Information – See FAR 2.101 and 3.104

5. The following demonstrates that the proposed contractor's unique qualifications or the nature of the acquisition necessitates the use of the cited authority:

For (c)(1) J&As:

1. Indicate the source(s) to be solicited and make sure you justify why only one or a limited number of specific sources can meet the minimum needs of the Government.

The use of this authority is essential because only OCD laboratory chemistry reagents, calibrators, quality controls, and consumables can meet the requirements of the U.S.

Naval Hospital (USNH) Okinawa. These supplies are critical for the continuous operation of two OCD VITROS 5600 Immuno Analyzers at USNH Okinawa. The necessary supplies must be fully compatible with the existing OCD analyzers. Using reagents and consumables from sources other than OCD or authorized OCD dealers could potentially damage the equipment, leading to inaccurate test results and compromised patient diagnoses.

2. State whether or not the Government possesses the requisite technical data required to evaluate alternate proposals or to solicit for competitive offers.

The government will publish the solicitation with the expectation that distributors of OCD laboratory chemistry reagents, calibrators, quality controls, and consumables across Japan will submit competitive bids.

3. State whether or not why only the item specified, and no other, meets the minimum needs of the Government.

These supplies are critical for the continuous operation of two OCD VITROS 5600 Immuno Analyzers at USNH Okinawa. The necessary supplies must be fully compatible with the existing OCD analyzers. Using reagents and consumables from sources other than OCD or authorized OCD dealers could potentially damage the equipment, leading to inaccurate test results and compromised patient diagnoses.

4. Explain, as best as you can with assistance from technical, the nature and use of the item being purchased. For replacement parts, identify the Original Equipment Manufacturer (OEM) and describe the system in which the item is used.

The Laboratory Department at USNH Okinawa utilizes the OCD VITROS 5600 Immuno Analyzers, which provide observable results for up to 24 hours for reaction confirmations. The OCD VITROS 5600 Immuno Analyzer is a state-of-the-art laboratory instrument designed for high-throughput immunoassay testing. It utilizes advanced dry slide technology, enabling the analysis of a wide range of biological samples with remarkable efficiency and accuracy. The analyzer has a capacity to perform over 200 tests per hour, making it an ideal solution for busy clinical environments.

The US Naval Hospital Okinawa Laboratory currently employs vendor-owned OCD VITROS 5600 Immuno Analyzers, manufactured by Ortho Clinical Diagnostics K.K. To ensure accurate test results, it is crucial that the OCD VITROS 5600 Immuno Analyzers are compatible with the Ortho Workstations. Therefore, it is essential that these analyzers be OEM-manufactured, as Ortho Clinical Diagnostics K.K. does not guarantee the accuracy of test results if non-OEM products are utilized.

Controlled Unclassified Information (CUI)

Source Selection Information – See FAR 2.101 and 3.104

6. A description of efforts made to ensure that offers are solicited from as many sources as is practicable, including whether a notice was or will be publicized as required by FAR

5.2 and, if not, which exception under FAR 5.202 applies, follows:

To enhance competition, a Sources Sought Notice was issued on August 31, 2024, with a response deadline of September 30, 2024, at 8:00 a.m. Japan Standard Time to inquire about sources available that could provide OCD laboratory chemistry reagents, calibrators, quality controls, and consumables. Responses were received from Kokua Analytical Consultants and Begini Howard Private Equity, both of which indicated their interest in the proposed acquisition. Summit Shoji Inc., the current vendor, has previously expressed interest in submitting an offer for a follow-on contract to the existing agreement they hold.

We will assess any restrictive language that may inadvertently exclude potential vendors from submitting responses while ensuring the integrity of the required products is upheld.

Additionally, this justification will be published alongside the solicitation in accordance with FAR 6.305(c) and made available for public inspection following the award, as stipulated by FAR 6.305(a).

Please Note: For (c)(1) J&As, the justification will be made publicly available on SAM.gov within 14 days after the contract award.

7. As the contracting officer, I hereby determine that the anticipated cost to the Government will be fair and reasonable based on (explain how you will determine the price fair and reasonable):

If adequate competition exists and quotes are received, the contracting officer will determine fair and reasonable prices by comparing the proposed prices submitted in response to the solicitation. Adequate price competition is a key indicator of fair and reasonable pricing.

In the event that no competitive prices are received, the contracting officer will compare the proposed prices to historical prices paid by the Government or other entities for the same or similar items. This method is applicable to commercial products or services, including those "of a type" or requiring minor modifications.

Additionally, the contracting officer will utilize at least one of the following approaches:

comparison with competitive published price lists, market prices of commodities, similar indexes, or discount/rebate arrangements; comparison of proposed prices with independent Government cost estimates; or comparison of proposed prices with prices obtained through market research for the same or similar items.

Controlled Unclassified Information (CUI)

Source Selection Information – See FAR 2.101 and 3.104

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

On October 7, 2024, market research was conducted via the internet to identify suppliers of OCD reagents, calibrators, quality controls, and consumables for use with the OCD Vitros 5600 Immuno analyzer. This search identified Fisher Scientific and confirmed GIS Medical & Surgical as potential sources for OCD products. Additionally, Summit Shoji Inc. is our current supplier/vendor; however, they did not respond to our Sources Sought Notice but expressed interest in submitting an offer upon solicitation. The market research also revealed that while several vendors, including Medex Supply, LabSource, DABOS, and CPR Life Wrap, can supply similar items, they do not provide the required OCD products.

9. Any other supporting facts (such as (a) an explanation of why the specifications, statements of work, etc. suitable for full and open competition have not been developed or are not available, (b) in the case of a FAR 6.302-1(a)(2)(ii) follow-on acquisition, an estimate of the cost that would be duplicated and how it was derived and (c) in the case of an unusual and compelling urgency, data, estimated cost or other rationale as to the extent and nature of the harm to the Government) follow:

N/A

10. Sources expressing an interest in the acquisition include:

Summit Shoji, an authorized distributor of OCD reagents, and Ortho Clinical Diagnostics Inc, Kokua Analytical Consultants and Begini Howard Private Equity.

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

The contracting officer conducted thorough market research and consulted with subject matter experts to confirm that no other suitable substitutes are available for use with the OCD VITROS 5600 Immuno Analyzers. This justification will be published alongside the solicitation in accordance with FAR 6.305(c) and made publicly available for inspection after the award, as per FAR 6.305(a).

Please Note: For (c)(1) J&As, the justification will be made publicly available on SAM.gov within 14 days after the contract award.

Controlled Unclassified Information (CUI)

Source Selection Information – See FAR 2.101 and 3.104

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

13. I hereby certify that the requirements which form the basis of this justification are accurate, that these supplies meet the Government’s needs in accordance with applicable specifications, and that this justification is accurate and complete to the best of my knowledge and belief.

14. I have reviewed this justification and recommend approval.

15. I have reviewed this justification for legal sufficiency.

Sheet1

FY25 Estimates

Total: ¥ 186,879,230

FY 25 US Dollar Equivalent (Yen 145.7323) $ 1,282,345.99

DLA Troop Support Pacific Cost Recovery Rate (CRR) of 4.9% = $ 62,834.95

Government Estimate + CRR = Total Estimated Cost $ 1,345,180.94

MIPR Funded for = $ 1,345,180.94

Name of the Preparer and Position Title: Mr. Luis Caburian Supply Tech

Preparer’s Organization: USNH OKINAWA MMD

Preparer’s Contact Information, including Telephone and Email: DSN: 646-7709 Email: luis.c.caburian.ctr@health.mil

Date IGE was Prepared: 9/26/24

Basis of Estimate Information: Price estimates are based on past vendor Quote. IGE valid for FY25

FY26 Estimates

Total: ¥ 188,674,553

US Dollar Equivalent (Yen 145.7323) (est) $ 1,294,665.31

DLA Troop Support Pacific Cost Recovery Rate (CRR) of 4.9% (est) $ 63,438.60

Government Estimate + CRR = Total Estimated Cost $ 1,358,103.91

MIPR Funded for = $ 1,358,103.91

Name of the Preparer and Position Title: Mr. Luis Caburian Supply Tech

Preparer’s Organization: USNH OKINAWA MMD

Preparer’s Contact Information, including Telephone and Email: DSN: 646-7709 Email: luis.c.caburian.ctr@health.mil

Date IGE was Prepared: 9/26/24

Basis of Estimate Information: Price estimates are based on past vendor Quote. IGE valid for FY26.

FY27 Estimates

Total: ¥ 190,460,136

US Dollar Equivalent (Yen 145.7323) (est) $ 1,306,917.79

DLA Troop Support Pacific Cost Recovery Rate (CRR) of 4.9% (est) $ 64,038.97

Government Estimate + CRR = Total Estimated Cost $ 1,370,956.76

MIPR Funded for = $ 1,370,956.76

Name of the Preparer and Position Title: Mr. Luis Caburian Supply Tech

Preparer’s Organization: USNH OKINAWA MMD

Preparer’s Contact Information, including Telephone and Email: DSN: 646-7709 Email: luis.c.caburian.ctr@health.mil

Date IGE was Prepared: 9/26/24

Basis of Estimate Information: Price estimates are based on past vendor Quote. IGE valid for FY27.