JustificationandApproval_23Q0095_posted.pdf

CUI//SP-

Control Number: 23-RHCO-P-326

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1 SEP 2021

Justification Review Document For Sole Source - FAR Part 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: Reagents for Stago Coagulation Analyzers, Brian D. Allgood Army Community Hospital, Korea

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5 :

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other: Brand Name Only

Amount: The total estimated value is This requirement will be for a 12-month base period and four (4) option periods as follows:

Base Period: 01 October 2023 to 30 September 2024 Value:

Option Period 1: 01 October 2024 to 30 September 2025 Value:

Option Period 2: 01 October 2025 to 30 September 2026 Value:

Option Period 3: 01 October 2026 to 30 September 2027 Value:

Option Period 4: 01 October 2027 to 30 September 2028 Value:

Controlled by: USAHCA Controlled by: RHCO-P CUI

Category:

LDC:

POC:

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Control Number: 26 RHCO P 326

Prepared by:

Typed Name: _________________DSN: ______________

Title: _______________________________________Date: _____________________

E-mail: _______

Typed Name: ____________________DSN: _______________

_________ Title: ________________________Date Reviewed: ______

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Legal Counsel

Typed Name: _ __________________DSN: ______________________

Signature: _________ __ Date: ______________________

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16MAY2023Chief, Pathology / Laboratory Manager

Contracting Officer:

Typed Name: Phone#:

Date Reviewed: _ ______ E-Mail:

Technical Representative:

Typed Name: ____________________DSN:

Chief, Pathology Title: ___________________________Date Reviewed: ________________________16MAY2023

Requirements Representative:

16MAY2023

Sole Source Justification and Approval Under FAR 13.501

Contracting Activity: Medical Readiness Contracting Office – Pacific, Clark Road, Bldg 339, Fort Shafter, Hawaii 96859

Description of Action: This requirement is for a new Indefinite Delivery Indefinite Quantity type contract with firm fixed prices. Defense Health Program funds will be used for this follow-on contract.

Description of Supplies/Services: The supplies are reagents for Stago coagulation analyzer. The total estimated value is . This requirement will be for a 12-month base period and four (4) option periods as follows:

Base Period: 01 October 2023 to 30 September 2024 Value:

Option Period 1: 01 October 2024 to 30 September 2025 Value:

Option Period 2: 01 October 2025 to 30 September 2026 Value:

Option Period 3: 01 October 2026 to 30 September 2027 Value:

Option Period 4: 01 October 2027 to 30 September 2028 Value:

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5 :

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization Other: Brand Name Only

5. Reason for Authority Cited:

laboratory currently owns two units of STAGO coagulation analyzers.

The only type of reagents that are compatible with the existing government owned STAGO coagulation analyzers are their branded reagents.

Market research has shown that the estimated additional cost to purchase a different brand’s analyzer is approximately A new correlation study and validation would require an additional two months for completion and another three

(3) months to be prepared (installment and training) for proper usage. Furthermore, the existing STAGO analyzer needs to be used for testing until the new analyzer is operable and staff properly re-trained. Lastly, software upgrade will need to be done to ensure hardware/software compatibility if a new analyzer and reagents are purchased. This will

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be additional costs to the US Government and will affect the hospital’s mission of providing timely service to its patients.

Retaining the same brand/methodology will help attain full efficient operational capability. The staff will require minimal equipment training/competency assessment if the brand/methodology remains the same; Standard Operating Procedures revision is minimized; there will be minimal revisions to the test file & table build in the laboratory information system; and will be able to retain the current Patient Reference Range associated with the STAGO brand/methodology without completing prolonged correlation and demographic population studies.

Based on the above, it has been determined that STAGO

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201 on the SAM.gov website and quotations received shall be considered. A Sources Sought Notice was posted on SAM.gov on 03 May 2023, with a closing date of 11 May 2023. Inviting all responsible sources to submit a capability statement. No inquiries were received from any potential sources.

7. Actions to Increase Competition: Ongoing market research will be performed to determine if alternative sources of this supply become available.

8. Market Research: Market research conducted in the past 12 months over the internet indicates that this product is commercial in nature. The only products that are compatible with the existing Stago coagulation analyzers are the Stago reagents. The Government found three vendors in Korea that could fulfill this requirement, see paragraph 9 below. This requirement will be solicited on SAM.gov as a brand name only combined synopsis/solicitation.

9. Interested Sources: Only three sources, have expressed interest in this acquisition by providing quotations at the market research stage. As mentioned in paragraph 6, no further sources were discovered as a result of the sources sought synopsis in SAM.gov.

10. Other Facts: None.

a. Procurement history.

(1)

(2) Unrestricted.

(3) Authority previously cited if less than full and open competition was used. N/A

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Control Number: 26 RHCO P 326

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

The previous contract was issued on a full and open competitive basis. The only quote was received from BMI that quoted Stago reagents.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes. N/A

b. Other facts. None.

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11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: ____________ __Date: ________________________

Typed Name: _______________Title:__________________________

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and complete to the best of my knowledge and belief.

Signature: _ __________ __Date: ________________________

Signature: ___________________Date: ________________________

Typed Name: Title: Contracting Officer

14. Contracting Officer Certification:

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

Signature: _ ________________Date: ________________________

Typed Name: Title:_Contracting Officer

Chief, Pathology / Laboratory Manager

16MAY2023

Typed Name: ________________Title:______Chief, Pathology / Laboratory Mana____________________

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. The basis for this determination will be price analysis in accordance with FAR 15.404-1(b).

ger

16MAY2023

-10'00'

7 SEP 2021

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Control Number: 26 RHCO P 326

Approval

Based on the foregoing justification, I hereby approve the procurement of reagents for the Stago coagulation analyzers for the estimated total dollar value of on an other than full and open competition basis pursuant to the authority of 41 U.S.C.

1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: ____ _____Date: ________________________

Typed Name: ____________________________Title:__________________________