JA Brand Name - Redacted.pdf

Justification and Approval for Other than Full and Open Competition Sole Source Acquisition

1. Identification of the agency and contracting activity:

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division, San Diego, CA, on behalf of the Navy to meet the requirements of the United States (U.S.) Naval Hospital Okinawa Japan.

2. Nature and/or Description of Action being approved:

Approval is being requested for the purchase of ten (10) Complete Tube Sealing Kits, part number (P/N): VT-2380-US-01, including delivery in support of the United States Pacific Command Armed Services Blood Bank Center (US PACOM ASBBC).

3. Description of Supplies/Services:

This requirement is for the procurement of ten (10) Complete Tube Sealing Kits, P/N: VT-2380- US-01, by Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD) to support U.S. Naval Hospital Okinawa Japan / US PACOM ASBBC. The requested delivery date is 30 September 2023. Direct delivery is to Camp Foster BLDG 968, 111 Futenma-bara, Ginowan City, Okinawa Japan 901-2221. Shipping cost paid through US PACOM ASBBC Fedex Account. The 2380 Complete Tube Sealing Kit is a portable device used to seal and/or detach the satellite container of a Terumo blood bag and to segment tubing of the main Terumo collection bag. It is mandatory to use on every unit of blood collected by the US PACOM ASBBC.

4. Statutory Authority Cited permitting other than full and open competition:

The statutory authority exception permitting other than full and open competition for this acquisition is 10 U.S.C. 3204(a)(1), as implemented by FAR Subpart 6.302-1, Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements (including brand name). The procedures in FAR Subpart 13.501 and 41 U.S.C. 1901, Simplified Acquisition Procedures were used.

5. Rationale Justifying Use of the Statutory Authority Cited:

Per FAR 6.302-1(b)(1)(ii), use of the cited authority may be appropriate in situations when there is a reasonable basis to conclude that the agency’s minimum needs can only be satisfied by unique supplies or services available from only one or a limited number of sources or from only one or a limited number of suppliers with unique capabilities.

This tube sealing kit is Food and Drug Administration (FDA) approved which is necessary to maintain US PACOM ASBBC license with FDA and Association for the Advancement of Blood and Biotherapies. Although there are other heat sealers approved by FDA, replacements of the

DHA PGI 213.5, Attachment 1 (06-21-2018) currently used SEBRA sealer kits, which are past life expectancy, is necessary to be of the same model. This piece of tube sealing kit is used with the Sebra 2380 power source generator which US PACOM ASBBC currently uses. It is the only tube sealer that the Armed Services Blood Bank Center (ASBBC) found that can seal in less than 2 seconds, streamlining their process, additionally is the only complete kit for small tubing sealing. For consistency and standardization purposes it is necessary to have the same instrument since this model is in the US PACOM ASBBC’s Standard of Operations Procedures (SOP) and competency assessments training.

There will not be a need to train technicians on new equipment, and procuring the same tube sealing kits will eliminate the need to create a new validation procedure which will take time and cause work-stoppage. It is crucial that US PACOM ASBBC does not experience work-stoppage or interruption to operations since US PACOM ASBBC is the only donor center that provides blood and plasma for the Indo-Pacific Command Area of Responsibility (INDOPACOM AOR).

6. Efforts to Obtain Competition:

Contract specialist conducted market research throughout July 2023 and determined via internet searches that this requirement is customarily available in the commercial marketplace. Research of mandatory sources AbilityOne, UNICOR, GSAXcess, and GSA Advantage did not yield any results. A small business dynamic search for small business firms meeting the requirement resulted in negative results under NAICS code 339112 and search terms “tube sealing kit”. A search on ECAT and MMC received one positive result; however, the P/N was not the same and price was higher than open market. A search on FPDSNG found Vante Inc was awarded a contract for complete tube sealing kits on 30 September 2022 for a total contract value of under contract 75N90022P00675. That procurement was solicited as only one source/brand. Another search was conducted on FPDSNG and found Agathos Laboratories, Inc.

was awarded a contract for Sebra 2380 Complete Tube Sealing Kit under N0025918P0571. CS reached out to the vendor to confirm if they were able to provide the Sebra complete tube sealing kits. A confirmation from the vendor was received on 02 August 2023. The recommendation is a 100% small business set aside with a brand name basis.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price found reasonable on previous purchases and a comparison of the price to the Independent Government Cost Estimate (IGCE) provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research:

As stated above, several market research methods were used to include the review of mandatory sources, reviews of similar previous procurements, using online search engines reviewed by United States Naval Hospital Okinawa and DHA Western Markets Contracting Division in July 2023. A combined synopsis/solicitation with a small business set aside under solicitation number HT941023Q2045 will be posted on PIEE/SAM.gov for 15 days as a brand name only acquisition. The use of such description in the acquisition is essential to the Government’s requirements, thereby precluding consideration of a product manufactured by another company.

9. Other Facts:

None.

10. Interested Sources:

Any source expressing interest in response to the combined synopsis/solicitation will receive consideration.

11. Actions to overcome barriers:

Naval Hospital Okinawa and the DHA Western Markets Contracting Division will continue to survey and engage the market of any potential vendors that can provide Complete Tube Sealing Kits and will consider competing future requirement if there are other vendors capable of meeting the requirements. In addition, review and due diligence will be conducted by the Government for any vendor submitting capability statements for the kits.

COORDINATION:

12. Technical/Functional Representative:

I certify that the information provided in this justification, is accurate and complete to the best of

Date Purchasing Agent, Naval Hospital Okinawa

13. Requirements Certification:

I certify that the information provided in this justification, is accurate and complete to the best of my knowledge and belief.

Date PACOM ASBBC Supply

8/15/2023

14. Fair and Reasonable Cost Determination:

This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5.

Complete Tube Sealing Kits are commercially available and have been previously procured, which establishes current and historical information that will be used as a basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.403-1(b)(3).

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

Date Contracting Officer, Western Markets Contracting Division

APPROVAL:

15. Contracting Officer:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

Date Contracting Officer, Western Markets Contracting Division