JA Sole Source FAR Part 13.5_ 7 July 21 Redacted.pdf

Control Number: 21-RHCO-C 504 Temporomandibular Joint (TMJ) Total Joint Prosthesis

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: Temporomandibular Joint (TMJ) Total Joint Prosthesis for the Department of Surgery, Oral Maxillofacial Department for Carl R. Darnall Army Medical Center (CRDAMC), Fort Hood Texas.

Authority: FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)

Amount: $20,000.00 # T21-0563

Prepared by:

Title: Contract Specialist

Date: 25 June 2021

E-mail:

Contracting Officer:

Date Reviewed: 30 June 2021

E-Mail:

Technical Representative:

Title:

Date Reviewed: 30 June 2021

Requirements Representative:

Title:

Date Reviewed: 30 June 2021

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: Temporomandibular Joint (TMJ) Total Joint Prosthesis individually fabricated for the unique anatomy of the specific patient.

Estimated value: $20,000.00 funded with currently available FY21 funding.

Estimated Period of Performance 15 July 2021 through 30 September 2021

4. Authority Cited: FAR 13.106-1(b)(1)(i): For purchases not exceeding the simplified acquisition threshold, Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)

5. Reason for Authority Cited: The Government has a current need in the Department of Surgery, Oral Maxillofacial Department in order to provide for Temporomandibular Joint (TMJ) Total Joint Prosthesis for the health and welfare of the patient. The surgeon has determined that the TMJ Prostheses are required for the positive outcome and the health and welfare of the patient. The essential functions for life of mastication, speech, swallowing and deglutination rely on proper functioning of the temporomandibular joint, and these functions put the TMJ under more cyclic loading than any other joint in the body. End stage temporomandibular joint disease that leads to architectural destruction and physiologic dysfunction dictates the need for total joint replacement. TMJ Total Joint Prostheses have been successfully used in degenerative TMJ disease for over two decades; success rates are higher than 90% which is documented in current literature. The prosthesis is individually fabricated for the unique anatomy of each individual patient and the patient specific precise implant components allow for excellent adaptation, fixation and optimum function for the patient. A TMJ Total Joint Prosthesis helps to preserve the patient’s maxillofacial functions, improve their quality of life, and enhance the patient’s ability to perform day to day functions.

6. Efforts to Obtain Competition: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.101 and FAR 5.203 do not apply due to the dollar threshold.

7. Actions to Increase Competition: Due to the patient specific needs for the supplies for the health and welfare of the patients this action was not solicited. However, in the future the requirement will be solicited to maximize competition. 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: This requirement is to procure Temporomandibular Joint (TMJ) Total Joint Prosthesis for patient needs. A sources sought was posted on beta.SAM https://www.sam.gov from 25 June 2021 through 29 June 2021 with only the preferred vendor responding. An SBA Dynamic small business search and Quick Market search was conducted using key words “Temporomandibular Joint Total Joint Prosthesis” and NAICS code “339113” that resulted in no small businesses found. Currently only one source is capable of providing the specialized supplies required at the level of quality required because the supplies are unique and highly specialized. TMJ Concepts provides for custom TMJ Total Joint Prosthesis that are individually fabricated for the unique anatomy of each individual patient. TMJ Concepts is currently the only vendor that provides the custom individually fabricated patient product for the TMJ Total Joint Prosthesis. Based on this information, the Contracting Officer has determined this is a sole source requirement. “Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization).

9. Interested Sources: The preferred vendor responded to the sources sought.

10. Other Facts: Due to the specialized and patient specific nature of the product currently no other business may provide the requested product.

a. Procurement history. Same or similar types of implants listed below:

W81K0018P0442 $30,501.43 Mandibular Implant Kit. Carl R. Darnall Army Medical Center Killeen, TX.

25 July 2018

W81K0018P0601 $165,000.00 EST Temporomandibular Joint Implants for multiple surgeries and patients. Brooke Army Medical Center, San Antonio, TX.

1 October 2018 to 30 September 2019 https://www.sam.gov/

W81K0019P0372 $228,000.00 EST Temporomandibular Joint Implants for multiple surgeries and patients. Brooke Army Medical Center, San Antonio, TX.

1 October 2019 to 30 September 2020 with two option periods through 30 September 2022.

b. Other facts. We shall continue to conduct on-going research of the industry marketplace to determine if there is any new technology into this particular product 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: 2021

Typed Name: Title:

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:

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.

Signature: Date:

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 Temporomandibular Joint (TMJ) Total Joint Prosthesis for $20,000 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, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

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

POC: