N6809620RC23017-Blood Bank-CERUS-GU-Attachment V-JA_FINAL_Redacted.pdf

LOG #: 20-00014

PR N6809620RC23017 Page 1 of 2 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. 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 (USNH) Guam.

2. Description of the Action Being Approved.

Award of a sole source contract to include Small Volume Processing sets, Platelet Processing sets with Dual Storage containers, and two occurrences of preventive maintenance in support of USNH Guam is anticipated as a result of this action. The proposed source is CERUS Corporation, 1220 Concord Ave Suite 600, Concord, CA, 94520.

3. Description of Supplies/Services.

Shipments of the sets below are required to manufacture and distribute blood products using the already procured CERUS INTERCEPT illuminator which is the FDA-approved pathogen reduction system for platelets and plasma at USNH Guam. The request is for a base and four (4) subsequent options years. The following is a breakdown of estimated quantities for the contract period:

Base and Option Years 1 – 4 Description Annual Quantity INTERCEPT Platelet Small Volume Processing Set 192 INTERCEPT Platelet Processing Set with Dual Storage Containers 168 Shipping 4 Technical Service Representative (2 visits annually) 2 Annual Maintenance Fee for Illuminator (Serial # V02081701) 1 Annual Maintenance Fee for Illuminator (Serial # V02081702) 1

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. Statutory Authority 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)).

5. Rationale Justifying Use of Cited Statutory Authority.

Only one vendor, CERUS, can provide platelet sets and preventative annual maintenance for the currently installed CERUS INTERCEPT illuminator system to assist in Pathogen-Reduction of apheresis platelets. CERUS is the only company that provides the intercept blood system along with the platelet processing sets and maintenance. CERUS sells directly to the customer and does not have any distributors. The CERUS INTERCEPT illuminator system is not capable of performing using any other platelet sets and no distributors exist. USNH Guam procured this system locally via a sole source procurement. CERUS is the only company that can provide the platelet sets and preventative annual maintenance for the CERUS INTERCEPT illuminator system. The CERUS INTERCEPT illuminator is currently the only FDA-approved device for pathogen-reduction of apheresis platelets.

6. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable.

Market research was conducted by technical experts in November 2019. This research consisted of reviews of known open market contractors, ECAT, and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage, ECRI, FBO, and SAM. The original contract that was awarded locally contained a base and option year for the CERUS INTERCEPT illuminator system, platelet sets, and preventative maintenance but expired on 24 October 2019. Based on market research it is determined that CERUS is the only source that is able to provide the platelet sets that can be used on the CERUS INTERCEPT illuminator system. CERUS is also the only source that can provide the annual preventative maintenance on the equipment. Further market research was conducted on known sources where the items could possibly be procured (ECAT and GSA Advantage) but no

LOG #: 20-00014

PR N6809620RC23017 Page 2 of 2 1 Nov 12 additional items could be found. As a result, only the platelet sets provided by CERUS are compatible with the currently installed base CERUS INTERCEPT illuminator system that meets the minimum requirement. To date, no other sources have written to express an interest. This requirement will be posted on beta SAM in accordance with FAR 5.201. A Notice of Intent was posted on 06 February 2020 to 21 February 2020. An RFQ was posted for one day from 23 March 2020 to 24 March 2020. No responses were received to either of these postings.

7. Determination of Fair and Reasonable Cost.

The Contracting Officer has determined the anticipated cost to the Government of the supplies/services covered by this J&A will be fair and reasonable.

8. Actions to Remove Barriers to Future Competition.

For the reasons set forth in Paragraph 5, NMLC has no plans at this time to compete future contacts 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. Future requirements will be synopsized in accordance with FAR 5.203.