BioRadSSJ_redacted.pdf

Control No:JA-20-05-0315

Contractor: Bio Rad Laboratories

Program/Equipment: Serology Analyzers and Consumables

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 follow-on requirement to acquire leased Serology Analyzers, Consumables, and Reagents for HIV Diagnostic Testing for the Diagnostics and Countermeasures

Branch (DCB) at the WRAIR

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

Amount: $6,950,000.00

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:

Version –March 2017 FOR OFFICIAL USE ONLY

Legal Counsel:

Typed Name: Dmitri G. Goubarkov

DSN:

Signature:

Version – March 2017 FOR OFFICIAL USE ONLY

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 Bio-Rad Laboratories, Inc at 1000 Alfred Nobel Drive, Hercules, California 94547, USA.. The Government projects award for September 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).

approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on

The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting approval.

This action is a follow-on to contract W81XWH-15-D-0050. That contract was not competed under authority FAR 6.302-1(a)(2). Paragraph, “Actions to Increase Competition” of the previous justification, stated: If market research shows that other competitors can meet the AR600-110 requirement, this acquisition will be competed. Those actions were accomplished by conducting market research in support of this follow-on effort.

3. Description of Supplies/Services: The Contractor shall provide the leasing/purchase, installation, and validation of serological automated analyzers with UPS backup systems. The Contractor shall also provide all reagents, consumables, and instrument maintenance/re-calibration related to the screening and confirmation of the HIV virus in patient specimens. The contractor shall provide the following leased analyzers:

Eleven (11) BioRad EVOLIS Analyzer, Catalog Number 1314.

Six (6) Geenius Confirmatory Analyzers, Catalog Number 92052.

Period of Performance: Sept 2020 to September 2025

Total Value: $ 6,950,000.00.

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: 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.

The Bio-Rad EVOLIS System is the only serological analyzer that meets the stringent requirements for HIV infection status determination from a single specimen with highest fidelity.

Test fidelity is a measure of precision and accuracy without cross-contamination of the specimen.

High fidelity testing of a single specimen without cross-contamination minimizes false positive test results, the need to re-draw a specimen from the patient, and duplicative cost to the

Government as required in AR600-110. The Bio-Rad Geenius Analyzer is the only FDA

Approved Analyzer for confirmatory testing. Bio-Rad Laboratories is the sole manufacturer of the FDA Approved supplemental confirmatory assays for HIV-1 and HIV-2 (HIV-1/2 Rapid Test, HIV-1 Western Blot, and the Geenius Analyzer) and the serological analyzer (model EVOLIS).

Failure to award this contract to Bio-Rad will result in the inability of Diagnostics and

Countermeasures Branch (DCB) to meet their established mission and an inability to conduct testing in accordance with AR600-110.

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:

Additional market research was conducted and illustrated that Bio-Rad Laboratories, Inc. is the only vendor capable of meeting the Government’s requirements. This market research was done via extensive internet searches, as well as feedback from subject matter experts in the field. A

Notice of Intent will be posted for 15 days, if any responses are received, they will be reviewed for acceptability.

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

10. Other Facts:

Program/Equipment: Serology Analyzers and Consumables

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements. . The analyzers were initially procured as leases under US HIV Research Program Cooperative

Agreement, W81XWH-11-2-0174. The leased equipment was then provided for under contract

W81XWH-15-D-0050, beginning in FY15.

(2) The competitive status of these actions. W81XWH-15-D-0050 was sole sourced to Bio-Rad

Laboratories.

(3) Authority previously cited if less than full and open competition was used. . The current contract was not competed under authority FAR 6.302-1(a)(2).

(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. Paragraph 7, “Actions to Increase Competition” stated: If market research shows that other competitors can meet the AR600-110 requirement, this acquisition will be competed.

(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. Not Applicable

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys. Not Applicable

(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 have been no significant changes in the circumstances justifying this procurement. The original justification statement made was as follows:

The US Army HIV diagnostic algorithm is unique in that is 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 HIC 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 USA regulation, AR600-110, April 22, 2014, Identification, Surveillance, and Administration of Personnel Infected with Human Immunodeficiency Virus, Section H Human Immunodeficiency Virus

Testing Procedures.

The Bio-Rad EVOLIS System is the only serological analyzer that meets the stringent requirements for

HIV infection status determination from a single specimen with highest fidelity. Test fidelity is a measure of precision and accuracy without cross-contamination of the specimen. High fidelity testing of a single specimen without cross-contamination minimizes false positive test results, the need to re-draw a specimen from the patient, and duplicative cost to the Government as required in USA

Regulation AR600-110. The Bio-Rad Geenius Analyzer is the only FDA Approved Analyzer for

Program/Equipment: Serology Analyzers and Consumables

Version – March 2017 FOR OFFICIAL USE ONLY confirmatory testing. Bio-Rad Laboratories is the sole manufacturer of the FDA Approved supplemental confirmatory assays for HIV-1 and HIV-2 (HIV-1/2 Rapid Test, HIV-1 Western Blot, and the Geenius Analyzer) and the serological analyzer (model EVOLIS).

b. Class J&A: Not Applicable

c. Discuss any other facts that should be addressed to support this action. Not Applicable

Program/Equipment: Serology Analyzers and Consumables

Version – March 2017 FOR OFFICIAL USE ONLY

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. Sheela 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:

Program/Equipment: Serology Analyzers and Consumables

Version – March 2017 FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated 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: (identify the audit type) other: (identify the methodology or combination of methodologies that will be used)

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:

Program/Equipment: Serology Analyzers and Consumables

Version – March 2017 FOR OFFICIAL USE ONLY

Approval Based on the foregoing justification, I hereby approve the procurement of serology analyzers and consumables 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: