N0025919RC0000X-Attachment_V-JA-Blood_Collection-Terumo-NMCSD_Redacted.pdf

LOG# 18-10061

Blood Collection-Terumo-NMCSD Page 1 of 3 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, Fort Detrick, MD on behalf of Naval Medical Center San Diego to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for Blood Pheresis Sets. The Government intends on awarding a Firm Fixed Price contract. The proposed source is TerumoBCT, Inc 10811 W Collins Ave, Lakewood, CO 80215-4440.

3. Description of the supplies/services required.

The Naval Medical Center San Diego has a requirement for an IDIQ contract for blood pheresis sets for NMC San Diego. The items shall be used to collect platelets and plasma to provide blood products in support of service members deployed or stationed overseas. The requested items shall be configured and validated for use with the Terumo BCT Trima Accel Collection System that NMC San Diego currently owns. The items shall be 510 FDA cleared and Armed Service Blood Program (ASBP) approved. The requested item must be one of two approved collection devices, to be used in conjunction with Cerus Intercept Pathogen Reduction technology. The requested items shall include disposable tubing sets and solutions to collect platelets, plasma and red blood cells for extended storage.

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 10 USC 2304(c)(1) and FAR 13.501(a), Only One Responsible Source.

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

The Terumo BCT is the manufacturer and sole supplier for the Terumo BCT/Trima™ Automated Blood Collection System. Therefore, no other product can be used without having to purchase new instrumentation. Should any supply needs to be replenished for the equipment, Terumo BCT is the only authorized distributor.

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

Blood Collection-Terumo-NMCSD Page 2 of 3 1 Nov 12

Terumo BCT is the sole manufacturer and distributer of the Terumo BCT/Trima™ Automated Blood Collection System kits. The Terumo BCT/Trima™ Automated Blood Collection System device is the only authorized collection kit for use on the Trima Accel apheresis instrumentation NMCSD currently owns. This collection device is one of two FDA approved collection kits that can be utilized in conjunction with Cerus Intercept Pathogen Reduction technology.

The Amicus PAS-3 collection kit is the second FDA approved apheresis collection kit that can be used in conjunction with Cerus Intercept Pathogen Reduction technology. However, the Amicus PAS-3 is not compatible with the Terumo BCT Trima Accel Collection system. In order to utilize the PAS-3 collection kit, NMCSD would be required to purchase new apheresis equipment (Amicus PAS-3) and would also need to validate this new methodology.

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 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

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.

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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/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 Approval 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)