12182759-JA Sole Source FAR Part 13.5 (KO Reviewed).pdf

CUI//SP-SSEL

Control Number: 24-RHCO-C-372

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

1 SEP 2021

Justification Review Document For Sole Source - FAR Part 13.501*

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

Program/Equipment: Bone Marrow Donor Services

Authority: 41 U.S.C. 1901 as implemented by Federal Acquisition Regulation (FAR) Subpart 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items

Amount:

Prepared by:

Typed Name: DSN:

Title: Purchasing Agent Date: 11Sep 2024 E-mail:

Contracting Officer:

Typed Name: DSN:

Date Reviewed: 13 September 2024 E-Mail:

Technical Representative:

Typed Name: DSN:

Title: Bone Marrow Transplant Coordinator Administration Assistant Date Reviewed: 11 Sep 2024 Email:

Requirements Representative:

Typed Name: ________________________________DSN: ______________________

Title: _____________________________________Date Reviewed: _______________

Reviews

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

N/A

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

2 SEP 2021

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office-West

2. Description of Action: Bone Marrow Donor Services

3. Description of Supplies/Services: This Government’s requirement is for an urgent sole source acquisition with the National Marrow Donor Program requiring a bone marrow, stem cells or cord blood units transplants for patient who was diagnosed with B-All Leukemia and requiring bone marrow transplant. Patient is currently receiving treatment at the Zachary and Elizabeth M. Fisher Bone Marrow Transplant Program at Brooke Army Medical Center. A bone marrow transplant represents the only potential curative therapy for this patient. The purchase order shall not exceed. Delaying the search for donors may allow further progression of patient’s disease and have significant negative impact on the outcome in this case.

4. Authority Cited: 41 U.S.C. 1901 as implemented by Federal Acquisition Regulation (FAR) Subpart 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: Due to patient declining condition, it is imperative that the treatment commence as soon as possible. The National Marrow Donor Program (NMDP) is the only source reasonably available due to access to donor and cord blood registries and banks throughout the world. The NMDP registry includes mor than 50,000 cord blood units and 10 million potential donors. Through their connections with other national registries, the NMDP can access more than 20.5 million potential donors worldwide. They are the largest registry of cord blood in the United States and report a 95% success rate in matching patients to cord blood donors. They report the average likelihood of finding a potential donor of stem cells at least 86% of the time. In addition to maintaining the registry, they ensure safe transport of cell products by using trained, experienced certified couriers. Delaying the search will allow further progression of the patient’s diagnosis and will have a negative impact on patient’s health.

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 $ threshold, ☐ apply and will be followed, or ☒ do not apply due to an exception at 5.202 (2).

Requirement to post justification in accordance with FAR 13.105(c)

7. Actions to Increase Competition: The government will continue to monitor the market for additional sources, but at this time there is only one source that can provide these services due to having access to over 20 million donors with the possibility of success in finding a match. Past requirements of this nature have been solicited and posted on Government point of entry without obtaining responses form industry. The government

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

3 SEP 2021

will continue to seek new resources that will satisfy this requirement through continued market research to determine if there are new technologies and companies that can provide these services. This acquisition will be procured and evaluated using only one responsible source for a firm-fixed price contract to NMDP.

8. Market Research: Research was done by using public search engines such as Google and Bing. The search was done by using key words “Bone Marrow” and the majority of the results found were for the National Marrow Donor Program. A Dynamic Small Business Search was also conducted using key words “bone and Marrow” and transplant” with NAICS code 621991, Blood and Organ Banks; the results found do not indicate the capability to fulfill the Government’s requirements. Upon final approvals, this J&A will be posted to https//sam.gov, the Government Point of Entry.

9. 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: ________________________ Typed Name: Title:__________________________

10. 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.

Signature: Date: ________________________ Typed Name: ____________________________ Title: Program Director, BMT Program_________________________

11. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable. Price reasonableness will be based on independent Government estimate, previous awards, and price lists.

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.

Signature: ________________________________Date: ________________________

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

4 SEP 2021

Title: Contracting Officer

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

5 SEP 2021

Approval

Based on the foregoing justification, I hereby approve the procurement of Bone Marrow Donor Services on another than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501 and provided that the services and property herein described have otherwise been authorized for acquisition.

Signature: ________________________________Date: ________________________

Title: Contract Officer