JA Sole Source FAR Part 13.5_Cadaver Perfusion(KO approved)_Redacted.pdf

Control Number: 21-RHCO-C-401 CUI

CUI

(See FAR 2.101 and 3.104-4)

Mar 2021

Sole Source Justification and Approval Review Document Under FAR 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: Perfusion Services of Human Cadavers and Reanimated Tissue Training for a Joint Medical Exercise Training (JMEX) and ICTL (Individual Critical Task List) training and instruction on a perfused cadaver in the use of the REBOA- (Resuscitative Endovascular Balloon Occlusion of the Aorta) mortal wound damage control system for Carl R. Darnall Army Medical Center, Fort Hood, Texas, 76544.

Authority: 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.

Amount: quote # QTE0000002337 with potential six-month option of based on the full option year price for a possible total dollar value of

Prepared by:

Title: Contract Specialist Date: 4 May 2021

E-mail:

Contracting Officer: Date Reviewed: 13 May 2021

E-Mail:

Requirements Representative:

Title: Contract Administration Branch, COR Date Reviewed: 13 May 2021

E-Mail:

Reviews

I have reviewed this justification and find it adequate to support other than full and open competition.

Advocate for Competition: E-Mail:

Title: Local Advocate for Competition

Date: Reviewed and Approved 12 May 2021. Documentation in PCF.

Perfusion Services of Human Cadavers and Reanimated Tissue Training

Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: REGIONAL HEALTH CONTRACTING OFFICE-C

2. Description of Action: New contract action, firm fixed price, Operation and Maintenance, Army.

3. Description of Supplies/Services: Perfusion Services of Human Cadavers and Reanimated Tissue Training for a JMEX and ICTL training and instruction on a perfused cadaver in the use of the REBOA-(Resuscitative Endovascular Balloon Occlusion of the Aorta) mortal wound damage control system for Carl R. Darnall Army Medical Center, Fort Hood, Texas, 76544.

Estimated value: funded with currently available FY21 funding with potential six-month option of based on the full option year price for a possible total dollar value of

Estimated Period of Performance 7-11 June 2021 and 9-13 August 30 2021 with one option year Period of Performance 1 October 2021 through 30 September 2022 with individual training dates to be determined for FY22.

4. Authority Cited: 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: The government has a current need to provide training for the DoD medical professionals in a field setting. Using perfusion services of human cadavers greatly enhances the live setting for the medical professionals.

The perfusion of the cadavers adds a level of complexity that greatly benefits the medical professional. Utilizing the perfusion service on the human cadavers during both the ICTL labs and the JMEX exercise increases the probability that the warfighter on the battlefield shall be served by a more efficiently trained medical professional teammate. The perfusion services considerably enhances the medical training in its ability to create an environment which may be seen during combat operations. Without this specialized training the medical professional is not thoroughly and appropriately trained in order to support the warfighter in a battlefield environment.

6. Efforts to Obtain Competition: A notice of intent to award sole source with a redacted Justification and Authorization shall be posted on the GPE.

7. Actions to Increase Competition: Due to the specific supplies and services needs for the supplies and services this action was not solicited. The Government will continue to seek new resources that will satisfy these requirements through continued market research, request for Statements of Capability, and telephonic inquiries. When the current product becomes obsolete, or when equivalent products that meets the requested Government specifications becomes available, every effort shall be made to utilize the equivalent product. Regional Health Contracting Office – Central will continue to evaluate the capabilities of other vendor’s products and re-procure the products that provides the best value to the Government. CRDAMC in conjunction with MEDCOM will continue to evaluate the capabilities of other vendor's products and re-procure the system equipment that provides the best value to the Government. The Government will continue to seek new resources that will satisfy these requirements through continued market research, requests for Statements of Capability, and telephonic inquiries.

8. Market Research: Perfusion Services of Human Cadavers and Reanimated Tissue Training for a JMEX Training and ICTL training for Carl R. Darnall Army Medical Center, Fort Hood, Texas, 76544. An SBA Dynamic small business search and Quick Market search was conducted using key words “Cadaver Perfusion” and NAICS code “339113” that resulted in no small businesses found. Currently only one source is capable of providing the supplies and services required at the level of quality required because the services are unique and highly specialized. A sources sought was posted from 30 April 2021 to 4 May 2021 with one response from the preferred vendor. The contract specialist found a source that provides for REBOA training however the training does not include in the field training nor does it provide for cadavers that have been perfused.

9. Interested Sources: N/A

10. Other Facts: Due to the specific nature of the service there is currently no other business that may provide the requested specialized services and training.

a. Procurement history. To date there have been no services that provided for the perfusion of cadavers for training. However similar actions follow that provide strictly for cadavers for Carl R. Darnall Army Medical Center, Fort Hood, Texas, 76544 and the AMEDD C&S, Fort Sam Houston, Texas 78234.

W81K0020P0076 $33,906.00 Total Value. One time purchase of cadavers and associated items to include fees, testing, admin and cremation fees for a JMEX training.

Full and Open Solicitation. Carl R. Darnall Army Medical Center, Fort Hood, Texas, 76544 18 May 2020

W81K0021D0004 $33,510.50 Estimated dollar for a base and two options minimum/maximum quantity/amount 1 Quantity/156 Quantity and $16.00 Amount/$266,588.40 Amount. Delivery order for whole fresh cadavers and associated items to include fees, testing, admin and cremation fees. Full and Open Solicitation, AMEDD C&S, Fort Sam Houston, TX, 78234. Period of Performance 8 March 2021 through 7 March 2024.

b. Other facts. We shall continue to conduct on-going research of the industry marketplace determine if there are new technology into this particular service arena.

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.

Signature: Date: 13 May 2021

Typed Name: Title: Executive Officer, Troop BN

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.

Typed Name: Title: Executive Officer, Troop BN

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 based on price analysis.

Typed Name: Title: Contracting Officer

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief. I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition provided that the services or supplies herein described have otherwise been authorized for acquisition.

Approval

Based on the foregoing justification, I hereby approve the procurement of Perfusion Services of Human Cadavers and Reanimated Tissue Training for a JMEX and ICTL training and instruction on a perfused cadaver in the use of the REBOA-(Resuscitative Endovascular Balloon Occlusion of the Aorta) mortal wound damage control system for Carl R. Darnall Army Medical Center, Fort Hood, Texas, 76544 for quote # QTE0000002337 with potential six-month option of based on the full option year price for a possible total dollar value of on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, with available FY21 funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

Reviewed and Approved by 4 May 2021

Controlled by: U.S. Army Controlled by: HdHCB, RHCO-C CUI Category: SSEL Distribution Statement or LDC: Procurement and Acquisition

POC: