J A_Redacted-13-D-5049.pdf

LOG # 10408-13

Form 02.4G.AB/TDP 13-173 / PR N0025914RCE0009/Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

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 or services.

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 Cardian BCT Trima

Accel Collection System that NMC San Diego currently owns. The items shall be FDA and

Armed Service Blood Program (ASBP) approved and shall be within FDA and ASBP standards. 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 blood pheresis sets by TerumoBCT is the only one that is configured and validated for use with CardianBCT Trima Accel Collection system that NMCSD currently owns.

TerumoBCT, Inc is the only manufacturer and distributor of the TerumoBCT blood pheresis sets. NMC San Diego’s Blood Donor Center has performed extensive validation testing and is licensed by the FDA to use the Terumo BCT blood pheresis sets with the

Cardian BCT Trima Accel collection system. The TerumoBCT blood pheresis sets are the only FDA and Armed Service Blood Program (ASBP) approved collection kits that can be

Form 02.4G.AB/TDP 13-173 / PR N0025914RCE0009/Page 2 of 4 1 Nov 12 used with the CardianBCT Trima collection system that NMC San Diego currently owns.

At this point another manufacturers system is unable to replace the one currently onsite because NMCSD would lose their FDA licensure. No other unit can meet the minimum requirements of the government.

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 TerumoBCT’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.

Market research was conducted by technical experts in June 2013. This research consisted of a market survey through search engines of open market contractors and Federal Supply

Schedule contractors. Search engines utilized include Google, Lab Compare, GSA

Advantage and ECRI sourcebook catalog. It was identified that no vendor other than

Terumo BCT can provide blood pheresis sets that is configured and approved by the FDA to be used with the CardianBCT Accel system. Haemonetics Corporation and Fenewal Inc.

also provide blood pheresis sets but neither of the products is configured and validated to be used with the Cardian BCT Trima Accel Collection system. Only TerumoBCT meets all of the government requirements. No other sources were identified that meet all of the government requirements.

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

None

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. 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.

Form 02.4G.AB/TDP 13-173 / PR N0025914RCE0009/Page 3 of 4 1 Nov 12

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.

12. Point of Contact

Form 02.4G.AB/TDP 13-173 / PR N0025914RCE0009/Page 4 of 4 1 Nov 12

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

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 Cognizance

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 found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

APPROVAL BLOCK COMPETITION ADVOCATE