A.02.04_Justification_and_approval_redacted.pdf

Control Number: 16-RHCO-P-312

Limited Sources Justification Under FAR 13.501

1. Contracting Activity:

US Army Medical Command

Army Health Contracting Activity

Regional Health Contracting Office – Pacific

Bldg 339, Clark Road

Fort Shafter, Hawaii 96858-5098

2. Description of Action: Request approval for a new firm fixed type contract. DHP funds will be used.

3. Description of Supplies/Services: The items being purchased are consumable reagent supplies for the Government to collect apheresis platelets from human donors.

The apheresis platelets are viable blood products that are labeled as biological/pharmaceutical product by FDA and will be used for patient care within

TAMC, DOD.

- TERUMOBCT Trima Accel Automated Blood Collection System

- TERUMOBCT Anticoagulant Citrate Dextrose Solution USP (ACD) Solution A

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: This is a brand name only requirement. All items to be purchased are verified to be the only acceptable reagents by the manufacturer, TERUMOBCT in the operation of their automated blood collection instrument TRIMA Accel Automated Blood Collection System. The TRIMA Accel Automated Blood Collection System, model number 917- 000-000, is the government-owned equipment currently in use at TAMC. The Trima Accel was purchased in FY16 and the life expectancy of the Trima Accel is ten years old. Therefore it is cost effective for the Government to keep the same equipment. Also the Army Blood Program Office and the U.S. Institute of Surgical Research is working with the French Ministry of Defense to

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Sole Source Justification

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8.6935 8613+ +,,.2 6.+0.487 /56 8+3, -5456 ,.48.6 63 &+&$* obtain FDA licensure to manufactured freeze dried plasma for improving patient care as well as increasing survival rate of wounded soldiers in the battlefield. The validation of the process includes the use of TRIMA Accel Automated Blood Collection System, model number 917-000-000.A delay of awarding the contract will seriously harm the Government’s mission of providing patient care to its soldiers and beneficiaries. The TRIMA Accel Automated Blood Collection System meets the FDA (CFRs 200-299 and parts 600-799), AABB and MEDCOM DoD Army FDA licensure that is held by the Army General Surgeon shared by other Army Blood Donor Centers for collection, manufacturing, and releasing of a biological/pharmaceutical product. In addition, other brands will not meet the Government’s needs due to calibration.

6. Efforts to Obtain Competition: Although the Government intends to make a brand name only award, a synopsis will be posted on FedBizOps for future requirements. A Request for Information (RFI) was posted to FedBizOps on 30 June 2016. There were no other sources responding to the RFI that have expressed an interest.

a. Effective competition: The Government will continue to conduct on-going research of the industry market place to determine if there are new entrants into this product arena.

Any responsible source may express interest which shall be considered by the agency.

b. Subcontracting competition: N/A

7. Actions to Increase Competition: We will continue to conduct on-going research of the industry market place to determine if there are new entrants into this product arena.

8. Market Research: Market research conducted over the past 12 months has shown that this product is commercial in nature. TERUMOBCT manufactures these products commercially and is available to the public. There are no other products, besides those of TERUMOBCT’s, which are compatible with the TRIMA Accel Automated Blood Collection System that is current apheresis collection system with ECN#: 075626, 075627. To be cost effective the same manufacturer and model should be purchased.

This would eliminate the additional cost from another consumable contract for reagents, preventive maintenance and repair cost, computer server, validation and training.

Reduce the possibility of jeopardizing donor safety from the presences of two different manufacturer automated blood collection system. An automated blood component collection system that can collect all blood components in all unit configuration: platelet (as a single, double or triple units), RBCs (as single with plasma or platelet, or double PRBCs), and plasma (using a closed system up to 1000ml volume). Capable of collecting all blood components in the configuration listed above in both fixed site and mobile environment. It also has a comprehensive electronic management system (Vista) for the management of all collection procedure within the automated blood collection system and meet maximum regulatory compliance. Also, a sources sought/RFI notice was posted to FedBizOps on 30 June 2016. There were no additional vendor sources who responded to the sources sought posting.

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9. Interested Sources: To date, no other sources have written to express an interest.

A synopsis will be posted on FedbizOps. The Government will consider all statements of interest and capability received for futher competitive procurement.

10. Other Facts:

a. Procurement history

(1) Contract numbers and dates of the last requirement.

W81K02-14-P-0002, effective 2 January 2014.

(2) The competitive status of these actions

Sole Source

(3) Authority previously cited if less than full and open competition was used.

FAR 13.501 (a), Sole Source acquisitions under the Test Program for Certain Commercial items.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

It is not possible to compete this acquisition since Terumo is the only source that manufactures and distributes this highly specialized item. Market research conducted within the past twelve (12) months indicates that this product is commercial in nature. The items must be compatible with existing government-owned equipment. It would not be practical or cost-effective to purchase other than the recommended manufactured equipment/item to meet mission requirements.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

N/A

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

There are no significant changes to report since the last procurement. It is not

Sandy.Mitsuda possible to compete this acquisition since Terumo remains the only source that manufactures and distributes this highly specialized item. On-going research will continue to be conducted in the industry market place.

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated.

N/A

11. Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

12. Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

14. Contracting Officer Certification:

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

Sandy.Mitsuda