0012235946-JA Sole Source FAR Part 13.5 redacted.pdf

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Bone Marrow Donor Services
Solicitation number
W81K0025PA021
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This is a Justification and Approval (J&A) document for a sole source acquisition of Bone Marrow Donor Services under FAR Part 13.501 from the Medical Readiness Contracting Office-West. The requirement is for an urgent sole source procurement from the National Marrow Donor Program (NMDP) for bone marrow, stem cells, or cord blood unit transplants for a patient diagnosed with Hodgkin Lymphoma Disease at Brooke Army Medical Center's Zachary and Elizabeth M. Fisher Bone Marrow Transplant Program.

The J&A justifies the sole source award based on NMDP being the only source reasonably available, with access to over 50,000 cord blood units and 10 million potential donors domestically, plus connections to over 20.5 million donors worldwide through other national registries. The contract value is $294,195.00. NMDP reports a 95% success rate in matching patients to cord blood donors and an 86% likelihood of finding potential stem cell donors. Market research found no other capable sources, and the urgency is driven by the patient's declining condition requiring immediate treatment commencement. The document includes required certifications from technical, requirements, and contracting personnel, with approval granted for other than full and open competition under 41 U.S.C. 1901.

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CUI//SP-SSEL

Control Number: 25-MRCO-WEST-68

CUI//SP-SSEL

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

1 SEP 2021

Control No:25-MRCO-WEST-68

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: Date: E-mail:

Contracting Officer:

Typed Name: DSN:

Date Reviewed: E-Mail:

Technical Representative:

Typed Name: DSN: Title:

Date Reviewed: 29 Jan 2025

Requirements Representative:

Typed Name: DSN: 210-916-0683

Title: Date Reviewed: 29 Jan 2025

Control Number:25-MRCO-WEST-68

CUI//SP-SSEL

2 SEP 2021

Reviews

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

N/A

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 Hodgkin Lymphoma Disease 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

CUI//SP-SSEL

3 SEP 2021

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 (a)(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 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.

CUI//SP-SSEL

4 SEP 2021

Signature: Date: _

Typed Name: Title:

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:

Typed Name: _ Title:

12. Contracting Officer Certification:

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

Typed Name: Title: Contract Officer

CUI//SP-SSEL

5 SEP 2021

Approval

Based on the foregoing justification, I hereby approve the procurement of Bone Marrow Donor Services for $294,195.00 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 and provided that the services and property herein described have otherwise been authorized for acquisition.

Typed Name: Title:_Contracting Officer

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