SSJ_Beckman_redacted.pdf

Control No: JA20-07-00165

Contractor: Beckman Coulter

Program/Equipment: Pre and Post analytical specimen processing systems

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: This is a requirement for leasing, installation, and validation of pre- and post-analytical specimen processing instrumentation systems.

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

Subpart 13.5.

Amount: $ 4,300,000.00.

Prepared by: Kasey Carroll DSN:

Contract Specialist Date:

Email: Kasey.l.carroll.civ@mail.mil

Contracting Officer: Courtney Piar DSN:

Contracting Officer Date:

Email: Courtney.a.piar.civ@mail.mil

Technical: Dr. Sheela Peel DSN: (301) 319-3177

Department Chief, DCB Date:

Email: sheila.a.peel2.civ@mail.mil

Requirements: CPT Jennifer Burns DSN: (301) 319-2297

Lab Manager, COR Date:

Email: jennifer.l.burns8.mil@mail.mil

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

Program Manager:

Typed Name: CPT Jennifer Burns

DSN: (301) 319-3177

Signature:

Legal Counsel:

Typed Name: Dmitri G. Goubarkov

DSN:

Signature:

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

1. Contracting Activity: The Contracting Activity is the United States Army Medical Research

Acquisition Activity (USAMRAA). The Requiring Activity is the Walter Reed Army Institute of Research

(WRAIR).

2. Description of Action WRAIR requests a firm-fixed-price, new Indefinite-Delivery, Indefinite-

Quantity (IDIQ) contract with Beckman Coulter 250 S. Kraemer Blvd. Brea, CA 92821. The Government projects award for August 2020 and fiscal year 2020, Operations and Maintenance funds will be used for the first Delivery Order.

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).

3. Description of Supplies/Services: The Contractor shall provide leasing, installation, and validation of pre- and post-analytical specimen processing instrumentation systems. The Contractor shall provide preventative and emergency maintenance, as well as all consumables needed for the proper functioning of the systems. The contractor shall provide the following systems:

Pre-Analytical Specimen Processing Instrumentation System, which shall include two (2) AutoMate

2550, Part A99171.

Post-Analytical Specimen Processing Instrumentation System, which shall include two (2)

AutoMate 2550, Part A99171 and one (1) Sarstedt RC 1200 S 13 re-capper, Model 197201.

Period of Performance: August 2020 to August 2025

Total Value: $ 4,300,000.00.

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: Only one source reasonably available (including brand name);

5. Reason for Authority Cited:

The US Army HIV diagnostic algorithm is unique in that it uses a single clinical specimen to determine the

HIV infection status of each Service Member. This approach is unique to the US Army and is not employed in any known US or international clinical diagnostic laboratory. This test strategy was developed to eliminate the requirement for a second blood draw for molecular testing to detect genetic material of the virus during Acute or Early HIV infection when antibody responses to HIV are absent or not mature. Most importantly, the test strategy permits rapid identification and notification of acutely infected Soldiers when their potential to transmit HIV is highest and works to facilitate their rapid referral to clinical care. The single specimen virus testing procedures are a mandated process as defined in Army

Regulation (AR)600-110, April 22, 2014, Identification, Surveillance, and Administration of Personnel

Infected with Human Immunodeficiency Virus, Section H Human Immunodeficiency Virus Testing

Procedures.

Beckman Coulter is the only vendor that has the pre and post analytical testing platforms (AutoMate 2550) that is utilized DoD wide to perform the HIV force testing. The primary mission of the Diagnostics and

Countermeasures Branch (DCB), WRAIR is to provide HIV screening and supplemental confirmatory testing for US Army and US Military Entrance Processing Command (MEPCOM) accession candidates, US Army Soldiers and their Beneficiaries, and our sister services; the US Navy and US Air Force including Dover Air Force Base, Armed Medical Examiner System, and upon request. DCB serves as the

DoD Reference Laboratory for HIV-1 Diagnosis. The impact of switching to different testing platform/vendor would be catastrophic as it would require validation and linearity studies that will ultimately shut down the mission for a minimum of 6 months.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR

5.201.

7. Actions to Increase Competition: Until such a time that the FDA approves other serological analyzers, confirmatory testing analyzers, and confirmatory assays, full and open competition will remain impossible. Follow-on efforts will utilize effective market research strategies to identify other potential vendors who can meet the AR600-110 requirement.

8. Market Research: Beckman Coulter is the only vendor that has the pre and post analytical testing platforms (AutoMate 2550) that is utilized DoD wide to perform the HIV force testing. The primary mission of the Diagnostics and Countermeasures Branch (DCB), WRAIR is to provide HIV screening and supplemental confirmatory testing for US Army and US Military Entrance Processing Command

(MEPCOM) accession candidates, US Army Soldiers and their Beneficiaries, and our sister services; the

US Navy and US Air Force including Dover Air Force Base, Armed Medical Examiner System, and upon request. DCB serves as the DoD Reference Laboratory for HIV-1 Diagnosis. The impact of switching to different testing platform/vendor would be catastrophic as it would require validation and linearity studies that will ultimately shut down the mission for a minimum of 6 mo. Additional market research was conducted and illustrated that Beckman Coulter is the only vendor capable of meeting the

Government’s requirements.

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

10. Other Facts:

a. Procurement History

(1) Contract numbers and dates of the last several contracts for these same requirements: W81XWH-15-

D-0047 and W81XWH-15-P-0366

(2) The competitive status of these actions. COMPETED

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

(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.

(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.

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

(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.

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.

Dr. Shiela Peel Date:

Department Chief, DCB Signature:

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.

CPT Jennifer Burns Date:

Lab Manager, COR Signature:

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.

This determination will be made using the following: price analysis cost analysis

IGCE audit: other

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Typed Name: Courtney Piar Date:

Title: Contracting Officer Signature:

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

Typed Name: Courtney Piar Date:

Title: Contracting Officer Signature:

Approval Based on the foregoing justification, I hereby approve the procurement of leasing, installation, and validation of pre- and post-analytical specimen processing instrumentation systems on a sole source basis pursuant to the authority of the Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Erin K. Cross Date:

Command Advocate for Competition Signature: