REDACTED SSJ_PHADIA_initialed.pdf

J&A #:21 RHCO P 20

Version – March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: The Department of Pathology at Tripler Army Medical Center (TAMC), Hawaii requires a follow-on sole source contract with Phadia for RAST Allergy ImmunoCap Testing System reagents.

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

Amount: The total estimated price of the proposed action is for 12 month base + 2 option years.

Prepared by: DSN:

Date: 10 July 2020

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Contracting Officer: DSN:

Date: 17 July 2020

Email:

Technical: DSN:

Date:10 July 2020

Email:

Requirements:

Date: 10 July 2020

Email:

Reviews: I have reviewed this justification and find it adequate to support sole source.

Program Manager:

Typed Name:

DSN: 3

Signature:

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FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval

1. Contracting Activity: US Army Medical Command Army Health Contracting Activity Regional Health Contracting Office - Pacific Bldg 339, Clark Road Fort Shafter, HI 96858-5098

2. Description of Action: The Department of Pathology at Tripler Army Medical Center (TAMC), Hawaii requests a firm-fixed-price contract with Phadia. The total dollar value is for base plus 2 option periods. The Government projects award for 01 October 2020 and fiscal year 2021 DHP funds will be used.

An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

This action is a follow-on to contract W81K0217P0414. That contract was not competed under authority 13.501(a)(1)(ii). Paragraph, “Actions to Increase Competition” of the previous justification, stated: The Government will continue to conduct on-going research of the industry marketplace to determine if there are new entrants into this product arena.

Those actions were accomplished by conducting internet searches for other vendor sources that may provide these commercial reagents.

3. Description of Supplies/Services: The items being purchased are the RAST Allergy Immunocap reagents for the Phadia 250 analyzer currently being used by the Department of Pathology at Tripler Army Medical Center.

Base Period: 01-OCT-2020 to 30-SEP-2021 Value:

Option Period 1: 01-OCT-2021 to 30-SEP-2022 Value:

Option Period 2: 01-OCT-2022 to 30-SEP-2023 Value:

Total:

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C. 1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Unusual and compelling urgency Exclusive licensing agreements Industrial mobilization

Other:

5. Reason for Authority Cited: Phadia sells and distributes its products exclusively.

The products are not available through other medical supply sources. Substitution of reagents currently in use would incur substantial cost due to additional funding and labor time needed to validate alternate reagents per accrediting agency requirements. Mission requirements may not be met if additional resources are allocated to compiling correlation studies and re-training of staff on current procedures. TAMC does not have the capability nor the resources to conduct a correlation study. Without the correlative study, the Phadia reagents are the only reagent that can meet the Government's need.

Therefore, given the Government resources available, the Phadia reagents are the only reagents that meet the Government’s need.

Testing samples locally costs than shipping samples out to external laboratories. The department of Pathology will not meet mission requirements if additional resources are allocated to outsourcing the testing.

Phadia is the sole manufacturer and distributor of their allergy testing reagents. Phadia provided written confirmation that they are the sole manufacturer and distributor of the reagents.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted on 21 July 2020 to BetaSAM. There were no sources responding to the RFI to express interest. Effective competition is not expected to be high considering that Phadia is the only source which manufactures and distributes reagents for the Phadia allergy tests.

Only the Phadia reagents will meet the Government’s need. Notices required by FAR

5.201 shall be or have been published and any quotes received shall be considered.

7. Actions to Increase Competition: The Government will continue to conduct on-going research of the industry market place to determine if there are new entrants into this product arena. Subcontracting possibilities do not exist for this requirement because Phadia is the sole manufacturer and distributor of the reagents.

8. Market Research: Market research was conducted within the past 12 months by surveying the activity, marketplace, and reliable internet sources and has confirmed that this product is commercial in nature and no other company manufactures or distributes these reagents.

9. Interested Sources: To date, no sources have written to express an interest in this acquisition.

10. Other Facts:

a. Procurement history. Reasonable efforts to retrieve the following items from computer records, contract files, competition advocate office files or other sources are expected:

(1) Contract numbers and dates of the last several contracts for these same requirements:

(2) The competitive status of these actions: sole-source

(3) Authority previously cited if less than full and open competition was used: Federal Acquisition Regulation 13.501(a)(1)(ii) sole source under the authority of the simplified procedures for certain commercial items.

(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: A summary of the justification for is as follows.

(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: N/A

(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: There are no significant changes from the last procurement as Phadia remains the sole manufacturer and distributor.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated: N/A

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.

Typed Name: Date:

Title: Signature:

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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.

Typed Name: Date:

Title: Signature:

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13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable by comparison with previous acquisition and current pricelist for the same item in order to meet the needs of the Government. In accordance with FAR 15.403-1(c)(3), certified cost or pricing data is not required because the items and/or services being acquired are considered commercial items.

This determination will be made using the following: X price analysis cost analysis IGCE audit: other:

Typed Name: Date:

Title: Signature:

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14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Typed Name: Date:

Title: Signature:

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