N6847020RCBL001-Drop Shipment-Grifols-OK-Attachment V-JA 12_16_19_FINAL_Redacted.pdf

LOG #: 20-00002

PR N6847020RCBL001 Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet the requirements of the United States Naval Hospital Okinawa (USNHO) PACOM Armed Services Blood Bank Center.

2. Nature and/or description of the action.

The proposed action is for a drop shipment contract to support donor screening for HIV RNA, HCV RNA, HBV DNA, West Nile Virus RNA and Zika Virus RNA utilizing Nucleic Acid Testing (NAT). The drop shipment will be a shipment of reagents every quarter with a fixed quantity. USNHO PACOM Armed Services Blood Bank Center is one of two DOD donor testing laboratories. The Procleix Panther System is one of only two FDA-cleared donor testing platforms that utilizes NAT to detect Transfusion Transmitted Infections. The other testing platform that is FDA-cleared is the Roche model, however, due to its size (form factor) will not fit in the layout of the facility without significant construction costs. This testing equipment will be used to screen blood donors in order to produce FDA-licensed blood products for the Indo-Pacific AOR. The FDA’s approval is required and allows the site to manufacture the Procleix Ultrio Elite Assay through the use of the Panther System. The Panther was purchased in 1Q FY19 by Naval Medical Center San Diego (NMCSD) on behalf of USNHO PACOM Armed Services Blood Bank Center. The equipment was installed in July of 2019. It is currently operating and is almost ready for use as it has undergone a validation process required by regulatory guidelines to ensure the analyzer produces the desired results. This documentation has already been provided, and these tests are not optional for donor screening.

USNHO is in the process of purchasing Ultrio Elite, West Nile Virus and Zaka assay reagent kits for this equipment to sustain donor screening. A drop shipment contract is needed to procure the reagents to conduct blood donor testing. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Grifols Diagnostics Solutions, Inc. (Grifols), 4560 Horton St, Emeryville, CA, 94608-2916.

3. Description of the supplies/services required.

Drop shipments for Procleix Panther reagents below are required to sustain donor screening for HIV RNA, HCV RNA, HBV DNA, West Nile Virus RNA and Zika Virus RNA utilizing NAT. Requesting for a base and four (4) subsequent options years. The following is a breakdown of estimated quantities for the contract period:

Base Year

- Ultrio Elite Test Kit (1,000 tests)…4kits

- West Nile Virus Test Kit (5,000 tests) …1kit

- Procleix Zika Kit (1000)...4kit s

Option Years (1-4)

- Ultrio Elite Test Kit (1,000 tests)…6kits

- West Nile Virus Test Kit (5,000 tests) …2kits

- Procleix Zika Kit (1000)...6kits

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the Panther system which the reagents are being provided such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 41 U.S.C. 1901 (see also FAR 13.501(a)).

PR N6847020RCBL001 Page 2 of 4 1 Nov 12

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

Only one vendor, Grifols, can provide reagents for the currently installed Panther system. The Panther system is not capable of performing using the reagents from another manufacturer as no distributors exist. NMCSD procured this system on behalf of USNHO via an urgent and compelling justification. The only other FDA-approved NAT testing analyzer and reagents are made by Roche, and neither facility has the space to accommodate the larger sized analyzer made by Roche. Ultrio Elite Test Kit, West Nile Virus Test Kit and Procleix Zika Kit are reagents for donor screening of HIV, HBV, HCV, and West Nile Virus testing. These reagents are the only compatible reagents for use with the Procleix Panther and are the only reagents approved by the FDA for NAT testing of blood donors.

FDA approved tests for donor screening are found here: https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays. In addition, HIV RNA was approved by the FDA on 03 May 2018. This approval letter has been included in the contract file.

Approved by the FDA Center for Biologics Evaluation and Research (CBER) for NAT testing:

Procleix Ultrio Elite multiplex assay (HBV/HCV/HIV) Procleix WNV Assay Procleix Zika Assay

The site cannot use any other reagent with this analyzer, and only FDA-approved testing reagents and platforms can be used for donor screening. This is well documented in the 21 CFR and on the FDA Centers for Biologics Evaluation and Research (CBER) website. The requirement noted by the FDA is relevant as the reagents are used to perform blood donor screening. Therefore, Grifols is the only company that can provide the reagents required by the Government for the entirety of the designated test list.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to FedBizOpps in accordance with FAR 5.202.

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

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

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted by technical experts in May 2019. This research consisted of reviews of known open market contractors, EACT, and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage, ECRI, FBO, and SAM.

Based on market research it is determined that Procleix Ultrio Elite, WNV and Zika reagents are the only reagents that can be used on the Panther system. Roche manufactures similar reagents, but they can only be run on Roche's system. Roche does not offer a small(er) analyzer. The Panther system is not capable of performing using the reagents from another manufacturer. In addition, these reagents are the only NAT reagents approved for use by the FDA. Further market research was conducted on known sources where the items could possibly be procured (Cardinal Health, E-CAT and GSA Advantage) but no additional items could be found. As a result, only the reagent provided by Grifols are compatible with the currently installed base Panther system that meet the minimum requirement.

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

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FBO in accordance with FAR 5.201. Any sources expressing interest in response to the synopsis will receive consideration.

https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays https://www.fda.gov/vaccines-blood-biologics/complete-list-donor-screening-assays-infectious-agents-and-hiv-diagnostic-assays

PR N6847020RCBL001 Page 3 of 4 1 Nov 12

11. Statement of 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.

PR N6847020RCBL001 Page 4 of 4 1 Nov 12

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY FAR 13.501(a)(2)

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical and Requirements Cognizance

CONTRACTING OFFICER CERTIFICATION

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

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Authority (J&A) and find this J&A to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE

($700,000-$12.5M)