J_&_A_Redacted.pdf

For Official Use Only (See FAR 2.101 and 3.104-4)

(25 February 2016)

Control Number: 18-RHCO-C-136

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Regional Health Contracting Office –Central, Joint Base San Antonio-Fort Sam Houston, Texas.

2. Description of Action: RHCO-C intends to issue a sole source award for Epicel- CEA Skin Grafts which must be received prior to schedule surgery date of 22 December 2017. OMA Funds will be used for this requirement.

3. Description of Supplies/Services: These Epicel-Cea Skin Grafts from Genzyme Biosurgery are lab grown epidermal tissues that are needed for a patient with greater than 50% total body surface area burns. The total estimated value is $156,225.00

4. Authority Cited: The statutory authority permitting other than full and open competition is 41 United States Code 3304(a)(2) as implemented in FAR 6.302- 2(a)(2)(b)(1)(2) Unusual and Compelling urgency.

5. Reason for Authority Cited: Vericel is the only known manufacturer that uses this procedure to produces the specialized service of growing epidermal tissues from the patient’s cells. The process of creating new skin for over 50% of the body will require a week and needs to begin as soon as possible since the patient is currently in the hospital in critical condition. The surgeon will have to remove a patch of skin from the patient and it must be transported to the Vericel facility to begin the autologous skin cell therapy process. Every day that passes is more critical to this patient life.

6. Efforts to Obtain Competition: The compelling urgency to have these skin grafts in time for scheduled surgery precludes competition to the maximum extent practicable.

Delay in award of a contract may cost the patient life. This company has proven success rate on this type of grafts. (See 5)

a. Effective competition. See 6 above. However, the Government will continue to assess the market for new entrants.

b. Subcontracting competition. Subcontracting is required for acquisition that exceeds $700K in accordance with FAR part 19.

7. Actions to Increase Competition: Epicels are lab grown epidermal tissues. Patient will not survive without Epicel. This is the only source for these types of skin grafts.

However the Government will continue to assess the market for new entrants.

8. Market Research: Market research was conducted online, on GSA, and VA websites; there is no manufacturer that produces the specialized service of growing epidermal tissues from the patients.

(25 February 2016)

Control Number: 18-RHCO-C-136

Epicel-Cea Skin Grafts for Brook Army Medical Center

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

Future notices required by FAR 5.201 shall be published and any bids or proposals received shall be considered.

10. Other Facts: Discuss any other facts supporting the use of other than full and open competition, such as the following:

a. Procurement history.

(1) Contract numbers and dates of the last several contracts are as follows:

Contract Number: W81K00-15-P-0987 Contractor: Vericel Corporation Delivery Period: 8 October 2015 - $127,809.00 Competitive Status of Actions: Sole Source.

Contract Number: W81K00-17-P-0514 Contractor: Vericel Corporation Delivery Period: 16 July 2017 - $147,681.00

Contract Number: W81K00-17-P-0571 Contractor: Vericel Corporation Delivery Period: 31August 2017 - $121,580.00

(2) The competitive status of these actions. N/A- Sole Source Awards.

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

Federal Acquisition Regulation 13.106-1(b)(1)(i)

(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. If the physician does not have these Epicel-CEA Skin Grafts during surgery, it could be detrimental to the patient’s life as well as the hospital’s overall medical mission.

(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. No prior contract was issued using full and open competition.

(25 February 2016)

(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. Yes, justifications were prepared and approved. There have been no significant changes since.

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

Epicel-CEA Skin Grafts

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.

BRUNDICK.DONNA.MARIE.1179361 Digitally signed by

Signature: 120

BRUNDICK.DONNA.MARIE.1179361120

Date: 2017.12.18 10:54:06 -06'00' Date:

Typed Name: Donna M. Brundick Title: ISR Operating Room

12. Requirements Certification: I certify that the supporting data under my cognizance, which are included in the justification, are

Typed Name: SSG Cedric J. Martin Title: NCOIC Burn operating Room

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.

VILLAFRANCO.ROBY Digitally signed by

VILLAFRANCO.ROBYN.A.1026959949

Signature: N_.A_.1_0_26_9_59_9_4_9 D_ate_: 2_017_.12_.20_09_:47_:49_-06_'00_' Date:

Typed Name: Robyn A. Villafranco Title: Contracting Officer

(25 February 2016)

VILLAFRANCO.ROBYN.A.1026959949

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

VILLAFRANCO.ROBY Digitally signed by

Signature: N_.A_.1_02_6_9_59_9_49 Da_te:_20_17.1_2.2_0 0_9:4_8:1_7 -0_6'0_0' Date:

Typed Name: Robyn A. Villafranco Title: Contracting Officer