JA i-STAT Cartridegs Okinawa_redacted.pdf

CUI

Source Selection Information -- See FAR 2.101 and 3.104

Justification and Approval (J&A) Format

The following J&A format is based on the Federal Acquisition Regulation (FAR) 6.303-2 requirements. There are 12 elements to each J&A and each J&A submitted for approval must contain these elements, with sufficient detail to explain each element.

Some of the elements are standard and change very little from J&A to J&A, such as elements 1, 2, 3, 4 and 12. Others contain variations based on the authority being used.

For example, element 6 might describe the synopsis for a (c)(1), or it might state that the (c)(2) J&A does not allow time for a synopsis. The heart of the J&A are elements 5, 8 and 9. These paragraphs must contain a narrative that will justify and explain the need for using the specific authority, the market research efforts and results, and any additional facts supporting the J&A authority.

1. Defense Logistics Agency (DLA) Troop Support, _Indo-Pacific_ Supply Chain, 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.

3. Following are the supplies required to meet DLA’s needs:

National Stock Number (NSN)/Item Description/ Contractor Name and Contractor Part Number (if applicable):

Quantity: See Table below Unit Price: See Table below Number of Options: 1 Estimated Dollar Value, inclusive of options: $46,349.35 Maximum Dollar Value, inclusive of surge: $150,000.00

Base:

Item Category

Category

Line Item Item Description Unit of

Issue Qty UNIT PRICE

ESTIMATE

EXTENDED

PRICE

MEDICAL 3P85-25 1 I-STAT CARTRIDGE

CG4+ PG 36 ¥ 36,100 ¥ 1,299,600

MEDICAL 3P88-25 2 I-STAT CARTRIDGE

CG8+ PG 72 ¥ 47,600 ¥ 3,427,200

Japanese YEN (JPY) Subtotals ¥ 4,726,800 FY 25 US Dollar Equivalent (Yen 145.7323) $ 32,434.81

DLA Troop Support Pacific Cost Recovery Rate (CRR) of 41.2% = $ 13,914.54

Government Estimate + CRR = Total Estimated Cost $46,349.35

MIPR Funded for = $46,349.35

Option 1:

Item Category

Category

Line Item Item Description Unit of

Issue Qty UNIT PRICE

ESTIMATE

EXTENDED

PRICE

MEDICAL 3P85-25 1 I-STAT CARTRIDGE

CG4+ PG 36 ¥ 36,100 ¥ 1,299,600

MEDICAL 3P88-25 2 I-STAT CARTRIDGE

CG8+ PG 72 ¥ 47,600 ¥ 3,427,200

Japanese YEN (JPY) Subtotals ¥ 4,726,800 FY 25 US Dollar Equivalent (Yen 145.7323) $ 32,434.81

DLA Troop Support Pacific Cost Recovery Rate (CRR) of 41.2% = $ 13,914.54

Government Estimate + CRR = Total Estimated Cost $46,349.35

MIPR Funded for = $46,349.35

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, Only one responsible source and no other supplies or services will satisfy agency requirements.

5. A demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the cited authority follows:

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.

A solicitation will be posted on SAM.gov for i-STAT Cartridges with Brand Name restrictions due to the fact that the i-STAT portable handheld analyzers is manufactured by Abbott Point of Care Inc and requires CG4+ and CG8+ i-STAT cartridges, also manufactured by Abbott Point of Care Inc. Market research showed that generic substitutions/other Cartridges on i-STAT portable handheld analyzers are out of scope of the quality control and result which cannot be supported by Abbott Point of Care Inc. There are also temperature restrictions and shelf life restrictions that prevent procurement of reagents outside of Japan. There is optimism that there will be other distributors in the local area that can provide required items.

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 post the solicitation with the anticipation that there are distributors of CG4+ and CG8+ i-STAT cartridges products throughout Japan that will be able to provide competitive bids.

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

There are Brand Name restrictions due to the fact that the i-STAT portable handheld analyzers is manufactured by Abbott Point of Care Inc and requires CG4+ and CG8+ i-STAT cartridges, also manufactured by Abbott Point of Care Inc and is the only licensed manufacturer.

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.

USNH Okinawa Laboratory Department uses CG4+ and CG8+ i-STAT cartridges as catalysts in the screening and quantification of Blood Urea Nitrogen (BUN), Creatinine, Hematocrit (HCT), Hemoglobin (HGB) and Lactate analyses, among other blood tests. Used into the government owned i-STAT analyzers, tests results are achieved within a fraction of minutes, enabling healthcare providers a quick and accurate patient-side real time diagnoses. USNHO Lab is highly dependent on the continuous supply of these cartridges.

US Naval Hospital Okinawa Lab uses i-STAT portable handheld analyzers manufactured by Abbott Point of Care Inc. In order to have accurate test results, it is imperative that the cartridges must be compatible with the analyzers. Cartridges must therefore be OEM manufactured. Abbott does not guarantee the accuracy of test results if non-OEM cartridges are used.

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:

An RFI was posted for 30 days on SAM .gov (Notice ID DLATSP-24-SS-0006) for 30 days (August 09 – September 09, 2024) to inquire about sources available that could provide CG4+ and CG8+ i-STAT cartridges listed in the bill of materials required. We received three responses, from Abbott, BHPE LLC, and Okinawa Medix and will evaluate restrictive language that may exclude potential vendors from submitting responses while maintaining the integrity of the products required. In addition, this justification will be published with the solicitation in accordance with FAR 6.305(c) and this justification will be made available for public inspection, after award, in accordance with FAR 6.305(a).” PLEASE NOTE: For (c)(1) J&As, the justification shall be made publicly available in SAM.gov within 14 days after 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 there is adequate competition and quotes are provided, then the contracting officer shall determine prices fair and reasonable by comparison of proposed prices received in response to the solicitation. Adequate price competition establishes a fair and reasonable price.

If there are no competitive prices received in response to the solicitation, the contracting officer shall conduct comparison of the proposed prices to historical prices paid, whether by the Government or other than the Government, for the same or similar items. This method may be used for commercial products or commercial services including those “of a type” or when requiring minor modifications for commercial products.

Contracting Officer shall also utilize at least one of the following: comparison with competitive published price lists, published market prices of commodities, similar indexes, and discount or rebate arrangements, comparison of proposed prices with independent Government cost estimates and comparison of proposed prices with prices obtained through market research for the same or similar items.

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

The contracting officer posted a Request For Information (RFI) on SAM.gov as well as inquired with the subject matter experts available from the US Naval Hospital Okinawa. Contracting officer conducted an internet search to see if there were “generic” products that could be substituted in place of CG4+ and CG8+ i- STAT cartridges products. Generic substitutions on i-STAT portable handheld analyzers are out of scope of the quality control and result which cannot be supported by Abbott Point of Care Inc for customer Laboratories.

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:

Thus far sources expressing an interest in the acquisition are Abbott, BHPE LLC, and Okinawa Medix.

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

The contracting officer has conducted market research and consulted subject matter experts of the products within this requirement to insure that there were no other suitable substitutes available that will work with the i-STAT portable handheld analyzers. This justification will be published with the solicitation in accordance with FAR 6.305(c) and this justification will be made available for public inspection, after award, in accordance with FAR 6.305(a). PLEASE NOTE: For (c)(1) J&As, the justification shall be made publicly available in SAM.gov within 14 days after contract award.

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

Date Arlene M. Renner

Contracting Officer

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.

Date Tatsuya. Ku

U.S Naval Hospital Okinawa Materials Management Department

I have reviewed this justification and recommend approval.

Date

Kirk J. Moser IST Chief, Supplier Operation DLA Troop Support Indo-Pacific