J&A_(Redacted).pdf

Log #17-10030

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD to meet the requirements of United States Naval Hospital (USNH) Okinawa, Japan.

2. Nature and/or description of the action being approved.

The requirement is for the test kits of Grifols (formerly known as Chiron Novartis) Procleix TIGRIS analyzer system for blood screening. The test kits are required to test blood donations for infectious diseases. The

Government intends on awarding a Firm, Fixed-Price contract. The proposed source is Grifols Diagnostic Solutions

Inc., 4560 Horton St, Emeryville, CA 94608-2916.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

USNH Okinawa has a requirement for four (4) direct drop shipments to USNH Okinawa for the test kits of Grifols

(formerly known as Chiron Novartis) Procleix TIGRIS analyzer system for blood screening. In particular, the requirement is for (20) Ultrio 1k Kits, (2) West Nile Virus 5k Kits, (4) Procleix WNV Tigris IDV Cntl Kits, (8)

HIV-1 Discr Probe, Ultrio IVD, (8) HCV Discr Probe, Ultrio IVD, (8) HBV Discr Probe, Ultrio IVD, (16) Ultrio

Tigris Control Kits, (32) Procleix, Auto Detect, IVD-CE, (16) Kit, Procleix Oil (4btls/case), (32) Kit, Procleix Wash

Solutions, (20) Kit, Procleix Deactivation Buffer, (60) System Fluid Preservative IVD HX, (60) Kit, Multi Tube

Unit, MTU, (4) TIGRIS Waste Bin Lid-Cover, (4) Kit, TIGRIS Waste Bag, (4) Deflector, Waste, TIGRIS, (4) TCR

Reagent Spare Caps, (4) Amp Reagent Spare Caps; and (4) Enzyme Reagent Spare Caps. Procleix Ultrio Assay is intended for use in testing individual samples from living donors of whole blood, blood components, or source plasma, other living donors and heart-beating organ donors, and for testing individual blood specimens from cadaveric (non-heart-beating) donors. It is also intended for use in testing pools of human plasma comprised of equal aliquots of not more than 16 individual donations from donors of whole blood, blood components, or source plasma. This assay is intended to be used in conjunction with licensed tests for detecting antibodies to HIV-1, HCV, and hepatitis B core antigen (anti-HBc), and with licensed tests for hepatitis B surface antigen (HBsAG). The

Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of WNV RNA in plasma specimens from individual human donors, including volunteer donors of whole blood and blood components, and other living donors. It is also intended for use in testing plasma specimens to screen organ donors when specimens are obtained while the donor’s heart is still beating, and in testing blood specimens to screen cadaveric (no-heart-beating) donors. The test kits of Grifols Procleix TIGRIS analyzer system for blood screening allow USNH to maintain their capability to test blood donations for infectious diseases; a critical ability to manufacture and distribute blood products for transfusions.

Any claims made for the test kits shall be compliant with the Food and Drug Administration (FDA) regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.106-1(b)(2), soliciting from a single source for purchases exceeding the simplified acquisition threshold.

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Due to warranty provisions and to avoid potential damage to the analyzer (and test results), only PROCLEIX

ULTRIO and PROCLEIX WNV Assays are to be used. No other reagents are compatible with the current TIGRIS system. Only Grifols Diagnostic Solutions (formerly Novartis Diagnostics) is authorized to provide reagents on the

TIGRIS system as they are the Original Equipment Manufacturer. Grifols Diagnostic Solutions is the sole proprietor of the reagents, the use of an unauthorized source for donor testing reagents may cause malfunction or damage to the system or cause inaccurate testing results. Grifols Diagnostic Solutions is the only vendor that can meet the minimum requirements of the Government.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to Federal

Business Opportunities (FedBizOpps) in accordance with FAR 5.203. The Government will evaluate any responses received.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted in January 2017. It included a search of the Internet using Google and GSA

Advantage. Grifols Diagnostic Solutions is the only vendor that can provide reagent kits for Procleix TIGRIS analyzer system. Due to warranty provisions and to avoid potential damage to the analyzer (and test results), only

PROCLEIX ULTRIO and PROCLEIX WNV Assays are to be used. These reagents are part of a larger system.

Without these specific reagents the donor testing by PROCLEIX TIGRIS Nucleic Acid Test system will not function. No other reagents are compatible with the current TIGRIS system. Only Grifols Diagnostic Solutions

(formerly Novartis Diagnostics) is authorized to provide reagents on the TIGRIS system due to they are the Original

Equipment Manufacturer. Grifols Diagnostic Solutions is the sole proprietor of the reagents, the use of an unauthorized source for donor testing reagents may cause malfunction or damage to the system or cause inaccurate testing results.

9. Any other facts supporting the use of other than full and open competition.

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the notice of intent will receive consideration.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, NMLC will assess whether competition for future requirements is feasible.